BASICS: Obviousness: 35 U.S.C. § 103(a): “A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.” Sec. 103 “was intended merely as a codification of judicial precedents embracing the Hotchkiss condition [“that a patentable invention evidence more ingenuity and skill than that possessed by an ordinary mechanic acquainted with the business”], with congressional directions that inquiries into the obviousness of the subject matter sought to be patented are a prerequisite to patentability.” Graham (U.S. 02/21/1966). Obviousness is a legal conclusion based on underlying factual inquiries: (1) scope and content of the prior art; (2) level of ordinary skill in the prior art; (3) differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness (aka “secondary considerations”) (e.g., failure of others, long felt need, commercial success). Old standard: A combination of old elements is obvious unless there is some non-trivial synergistic effect from the combination. Sakraida v. AG Pro, Inc., 425 U.S. 273, 281-282 (1976).
Determined From Perspective Of Hypothetical Person Of Ordinary Skill In The Art Having Knowledge Of All Pertinent Art: Court should “display the needed effort to place itself into the mindset of the hypothetical person of ordinary skill in the art considering prior-art knowledge without hindsight use of the patent claims as a guide.” Progressive Casualty (Fed. Cir. 08/24/15) (non-precedential) (aff’g PTAB obviousness decision while faulting it for being cursory.) Assume that skilled artisan “had knowledge of all prior art in the ‘field of endeavor’ relevant to the claim. Where prior art falls outside that field, it should still be considered if it is ‘reasonably pertinent to the particular problem with which the inventor was involved.’” In re Shaneour (Fed. Cir. 01/08/15) (non-precedential); In re Singhal (Fed. Cir. 03/10/15) (non-precedential) (“scope of the field of endeavor is a factual determination based on the scope of the application’s written description and claims”). Objective standard: “the knowledge of any prior art inventor is but one piece of evidence in determining what a person of ordinary skill would know and would be likely motivated to do.” In re Coutts (Fed. Cir. 04/06/18) (non-precedential) (aff’g obviousness despite inventor of primary reference possibly being aware of missing element but failed to note it in his prior art patent application).
Sec. 103 Is Applied To Give Effect To The Constitutional Restriction On Patent Grants: “Innovation, advancement, and things which add to the sum of useful knowledge are inherent requisites in a patent system which by constitutional command must ‘promote the Progress of . . . useful Arts.’ This is the standard expressed in the Constitution and it may not be ignored. And it is in this light that patent validity ‘requires reference to a standard written into the Constitution.’… It is the duty of the Commissioner of Patents and of the courts in the administration of the patent system to give effect to the constitutional standard by appropriate application, in each case, of the statutory scheme of the Congress.” Graham (U.S. 02/21/1966) (declaring two patents invalid for obviousness.)
Obviousness Under KSR: Sup. Ct. restated the law of obviousness in KSR (U.S. 04/30/2007), aff’g trial court Summ. J. of obviousness:
Flexible Approach to Motivation: Rejects “rigid approach” of Fed. Cir.’s original formulation of its “TSM” test requiring some Teaching, Suggestion or Motivation to combine the prior art references, but not rejecting principle of the TSM test (i.e., “identify a reason that would have prompted a person of ordinary skill in the relevant art in the way” recited in the claim). SeeMicrosoft (Parallel Networks) (Fed. Cir. 12/01/17) (non-precedential) (listing multiple KSR formulations of reasons to modify or combine prior art designs).
PHOSITA Has Ordinary Creativity; Is Expected To Take Inferences And Creative Steps: “A person of ordinary skill is also a person of ordinary creativity, not an automaton;” PHOSITA would not ignore a prior art reference simply because it was designed to solve a different problem; “the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claims, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” SeeIn re Ethicon (Fed. Cir. 01/03/17) (2-1) (aff’g PTAB obviousness ruling: “The normal desire of artisans to improve upon what is already generally known can provide the motivation to optimize variables such as the percentage of a known polymer for use in a known device.”); ClassCo (Fed. Cir. 09/22/16) (aff’g PTAB obviousness finding: “KSR does not require that a combination only unite old elements without changing their respective functions…. The rationale of KSR does not support ClassCo’s theory that a person of ordinary skill can only perform combinations of a puzzle element A with a perfectly fitting puzzle element B.”)
Test?: Court “Must Ask” Whether PHOSITA Would Have Seen A Benefit From The Claimed Combination: “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions;” “proper question to have asked was whether a pedal designer of ordinary skill, facing the wide range of needs created by developments in the field of endeavor, would have seen a benefit to upgrading Asano [closest reference] with a sensor.” Cf.Belden (Fed. Cir. 11/05/15) (aff’g PTAB IPR decision of obviousness; does not “suffice for obviousness that a variation of the prior art would predictably work, but requires consideration of whether, in light of factors such as ‘design incentives and other market forces,’ the hypothetical skilled artisan would recognize the potential benefits and pursue the variation.”)
Test?: Was There Any Reason To Make The Claimed Combination (And A Reasonable Expectation Of Success From Doing So): the court should “determine whether there was an apparent reason to combine the known elements in the fashion claimed.” Cf.E.I. du Pont (Fed. Cir. 08/19/16) (non-precedential) (aff’g Summ. J. obviousness; “the legally proper question is whether the thermal process would be a suitable option in some respects, not necessarily in every respect”; “the prior art teaches significant benefits of both digital imaging and thermal development over their counterparts, providing a reason for a person of ordinary skill to combine them in one sequential process.”); Intelligent Bio-Sys. (Fed. Cir. 03/09/15) (aff’g PTAB non-obviousness for petition’s failure to show that skilled artisan would believe secondary reference satisfied demand made in primary reference); Purdue Pharma (Fed. Cir. 03/24/16) (non-precedential) (aff’g PTAB non-obviousness decision; challenger failed to show that adding features from second reference “would have been reasonably expected to lead to a dosage form that satisfies the other limitations of the” claims); Spectrum Pharm. (Fed. Cir. 10/02/15) (aff’g substantially pure mixture obvious from 50/50 prior art mixture, knowledge that one isomer provided the benefit, and prior art pure mixture, and lack of unexpected results); Nantkwest (Fed. Cir. 05/03/17) (non-precedential) (2-1) (aff’g obviousness Summ. J.) (reviewing ex parte PTO app.); relying on statements in Spec. about prior art to support expectation of success; post-filing failure of prior art approach irrelevant to determining expectation of success from prior art); Innovention Toys II (Fed. Cir. 04/29/15) (aff’g jury verdict of no motivation to combine: “More fundamentally, the testimony gives little reason that a person of ordinary skill in the art—with [the two references] hanging somewhere on the figurative wall of pertinent art, …—would have defined a problem to be solved in such a way as to provide a motivation to pick out those references for combination.”); Bristol-Myers (Fed. Cir. 06/12/14) (“must demonstrate ‘by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success from doing so.’”); Institut Pasteur (Fed. Cir. 12/30/13) (“whether a person of ordinary skill in the art would, at the relevant time, have had a ‘reasonable expectation of success’ in pursuing the possibility that turns out to succeed and is claimed;” rev’g BPAI obviousness finding); In re Stepan (Fed. Cir. 08/25/17) (2-1) (vacating Sec. 103 rejection of app. claims; factfinder must explain why it would have been “routine optimization” to select and adjust elements of prior art to achieve claimed invention).
Must Show Skilled Artisan Would Have Selected These Particular References, And Then Combined Their Elements: “Too often the obviousness analysis is framed as an inquiry into whether a person of skill, with two (and only two) references sitting on the table in front of him, would have been motivated to combine (or, in Kohler’s view, could have combined) the references in a way that renders the claimed invention obvious. The real question is whether that skilled artisan would have plucked one reference out of the sea of prior art (Phipps) and combined it with conventional coolant elements to address some need present in the field (the need for low–carbon monoxide emission marine gen-sets). Whether a skilled artisan would be motivated to make a combination includes whether he would select particular references in order to combine their elements.” WBIP (Fed. Cir. 07/19/16) (aff’g denial of JMOL of nonobviousness; heavily relying on objective indicia); cf.Endo Pharm. (Fed. Cir. 10/14/16) (non-precedential) (aff’g judgment of non-obviousness in part due to existence of tremendous number of possible compositions to combine with lead reference).
Test?: PHOSITA Assumed To Start With Closest Reference (if reason existed to improve it): Designers had reason to make pre-existing pedals work with the new engines. “For a designer starting with Asano, the question was where to attach the sensor. The consequent legal question, then, is whether a pedal designer of ordinary skill starting with Asano would have found it obvious to put the sensor on a fixed pivot point.”
Combination Obvious If PHOSITA Would Recognize Technique Would Improve Similar Device In Same Way, But Not Obvious If Actual Application Beyond Ordinary Skill: “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” SeeUnwired Planet (Fed. Cir. 11/15/16) (aff’g PTAB obviousness; “For the technique’s use to be obvious, the skilled artisan need only be able to recognize, based on her background knowledge, its potential to improve the device and be able to apply the technique.”); MobileMedia (Fed. Cir. 03/17/15) (aff’g non-obviousness verdict, based on expert testimony that integrating prior art microprocessor to control the camera of a prior art mobile phone “in the manner required by the asserted claims would be beyond the technical ability of a skilled artisan.”)
Market Demand Or Design Need May Motivate The Claimed Combination: Often “market demand, rather than scientific literature, will drive design trends;” “when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp;” here “marketplace … created a strong incentive to convert mechanical pedals to electronic pedals, and the prior art taught a number of methods for achieving this advance.” SeeBayer (Fed. Cir. 11/01/17) (rev’g finding of non-obviousness; “skilled artisan motivated to formulate vardenafil ODT would have been faced with a design need for its release profile, and an immediate-release formulation would have been one of two options.”)
PHOSITA Not Limited To Problem Addressed By The Patent: Error to “look only to the problem that the patentee was trying to solve,” instead, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” SeeNike (Fed. Cir. 02/11/16) (aff’g PTAB finding of motivation to combine 1939 design for knitting helmets with reference for knitting shoe uppers because each serves same purpose of efficiently creating knitted articles and “a skilled artisan interested in Nishida’s preference to minimize waste in the production process would have logically consulted the well-known practice of flat-knitting, which eliminates the cutting process altogether.”)
“Obvious To Try” Sometimes = Obvious: Claim may be proven obvious merely by proving that it was “obvious to try” the claimed combination, where there is design need or market pressure to solve a problem and a finite number of identified, predictable solutions.
Synonyms For “Obvious”: A “predictable variation,” “advances that would occur in the ordinary course without real innovation,” “the product … of ordinary skill and common sense,” “the results of ordinary innovation.”
“Likely To Be Obvious”: Combination of prior art elements “according to known methods” if yields predictable results.
Teaching Away: “When the prior art teaches away from combining certain known elements, discovery of a successful means of combining them is more likely to be nonobvious.” Here, patent owner’s expert declaration did not indicate that the Asano was “so flawed that there was no reason to upgrade it, or pedals like it, to be compatible with modern engines.”
Summ. J. Of Obviousness: Where content of the prior art, scope of the patent claim, and level of skill in the art are not in material dispute, and “the obviousness of the claim is apparent in light of these factors, summary judgment is appropriate.” [Elsewhere opinion refers to the secondary considerations].
Obvious Subject Matter Is Part Of The “Public Domain”: “A ‘patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.’ This is a principal reason for declining to allow patents for what is obvious. … Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may, in the case of patents combining previously known elements, deprive prior inventions of their value or utility.” KSR (U.S. 04/30/2007) (unanimous). “‘Obvious variants of prior art references are themselves part of the public domain.’” Intercontinental Great Brands (Fed. Cir. 09/07/17) (2-1) (aff’g Summ. J. obviousness); In re Wiseman (CCPA 04/06/79) (“A patent on such a structure would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.”).
“Obvious To Try” Sometimes ≠ Obvious: Two types of “obvious to try” situations do not render claim obvious: (1) obvious to try blindly varying all parameters without guidance from prior art or reasonable expectation of success, or (2) obvious to try exploring a new technology or general approach with only general guidance from the prior art. In re Kubin (Fed. Cir. 04/03/09) (aff’g BPAI ruling invalidating claims to cDNA encoding human NAIL protein); accordIn re Stepan (Fed. Cir. 08/25/17) (2-1) (vacating Sec. 103 rejection of app. claims; “‘[T]o have a reasonable expectation of success, one must be motivated to do more than merely to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result.’”); Grunenthal (Fed. Cir. 03/28/19) (aff’g no reasonable expectation of success where reference provided “insufficient guidance in discussing the wide array of conditions that could affect recrystallization”); Eurand (In re Cyclobenzaprine) (Fed. Cir. 04/16/12) (rev’g obviousness judgment from a bench trial); Teva Pharma. (Fed. Cir. 10/12/18) (aff’g obviousness where “a POSITA had only a limited number of permutations of dose and frequency to explore that were not already disclosed in the prior art”); Bayer Schering (Fed. Cir. 08/05/09) (prior art presented a finite number of identified, predictable solutions); Nantkwest (Fed. Cir. 05/03/17) (non-precedential) (2-1) (aff’g obviousness; only two types of immune cells known to have antitumor efficacy.)
Prior Art References Need To Be Enabling For Anticipation, But Not For Obviousness: One advantage of an obviousness defense is that a prior art reference may contribute to the finding of obviousness even if it is not itself enabling. Amgen (Fed. Cir. 01/06/03) (“Under [Sec.] 103, however, a reference need not be enabled; it qualifies as a prior art, regardless, for whatever is disclosed therein.”); accordABT Sys. (Fed. Cir. 08/19/15) (inoperative device is prior art for all that it teaches); I/P Engine (Fed. Cir. 08/15/14) (non-precedential) (2-1) (rev’g $30 Million verdict; finding obviousness as matter of law); George M. Martin (Fed. Cir. 08/20/10); Metso Minerals (Fed. Cir. 05/14/13) (non-published) (“A prior art reference does not need to be fully functional to qualify as prior art; indeed, a prior art reference ‘need not work’ and may even be ‘inoperative.’”) But, “the cited prior art as a whole must enable one skilled in the art to make and use the apparatus or method.” Therasense (Fed. Cir. 01/25/10) (reinstated en banc).
Common Sense and Common Background Knowledge: “Common sense has long been recognized to inform the analysis of obviousness if explained with sufficient reasoning.” Perfect Web (Fed. Cir. 12/02/09). Background prior art references (including ones not part of the proposed obviousness combination) may be the most reliable evidence of what is common sense and common knowledge in the field. Randall (Fed. Cir. 10/30/13). SeeI/P Engine (Fed. Cir. 08/15/14) (non-precedential) (2-1) (rev’g $30 Million verdict; finding obviousness as matter of law; “very basic logic dictates that a user’s search query can provide highly pertinent information in evaluating the overall relevance of search results.”) “The prior art must be viewed in the context of what was generally known in the art at the time of the invention.” In re Taylor Made (Fed. Cir. 09/30/14) (non-precedential) (vacating PTAB upholding of claims as non-obvious, in an inter partes reexamination, relying in part on evidence submitted by patent owner to support its BRI of claim term).
Caveats To Using Common Sense And Ordinary Creativity: “Caveats” to using common sense: (1) “typically invoked to provide a known motivation to combine, not to supply a missing claim limitation”; (2) should only be used to supply missing limitation that is “unusually simple and the technology particularly straightforward”; (3) “cannot be used as a wholesale substitute for reasoned analysis and evidentiary support, especially when dealing with a limitation missing from the prior art references specified.” In re Van OS (Fed. Cir. 01/03/17) (vacating PTAB obviousness ruling for failure to provide explicit and clear reasons why it would have been “intuitive” to combine the references’ teachings in claimed manner; Newman, J. would have reversed not vacated); accordWhatsApp (Fed. Cir. 11/14/18) (non-precedential) (vacating PTAB non-obviousness finding; “given the advantages of video as a powerful medium and consumer desire for video, it would have been common sense to include the video objects from Bellordre in the processing system of Coulombe”); Arendi (Fed. Cir. 08/10/16) (rev’g PTAB obviousness finding based on single reference that lacked one important, non-peripheral element, applying same caveats); DSS Tech. (Fed. Cir. 03/23/18) (2-1) (rev’g (not vacating) PTAB obviousness finding for insufficient reasoning, particularly in view of conclusory expert opinion from petitioner; applying same caveats to using “ordinary creativity” to fill gap in prior art.).
Physical Substitution Of Element From One Reference To Another Not Required: May combine references’ teachings even if could not physically substitute their respective elements. In re Mouttet (Fed. Cir. 06/26/12); Univ. of Maryland (Fed. Cir. 11/03/17) (non-precedential) (aff’g PTAB obviousness; skilled artisan not limited to physically combining references’ embodiments); B/E Aerospace (Fed. Cir. 10/03/17) (non-precedential) (aff’g PTAB obviousness finding; would have been obvious to extend teaching of prior art airplane coat closet to arrive at claimed airplane lavoratory, regardless of whether closet could be converted into a lavoratory); MCM Portfolio (Fed. Cir. 12/02/15) (aff’g PTAB obviousness decision). “To justify combining reference teachings in support of a rejection it is not necessary that a device shown in one reference can be physically inserted into the device shown in the other. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re Keller (CCPA 02/12/81); In re Etter (Fed. Cir. 02/27/85) (en banc) (“assertions that Azure cannot be incorporated in Ambrosio are basically irrelevant, the criterion being not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole.”); PGS Geophysical (Fed. Cir. 06/07/18) (aff’g PTAB obviousness decision; rejecting patent owner argument that “relies on the presumption that one of ordinary skill would blindly incorporate [one reference’s] exact methodology into [the other reference].”); But must explain adequately how one reference would be modified to incorporate teachings of second reference with reasonable expectation of success. Samsung (Fed. Cir. 06/12/19) (aff’g PTAB non-obviousness decision, where respective fabrication techniques of two references were quite different).
Combinations That Defeat Prior Art’s Principle Of Operation, Or Render It Inoperable For Its Intended Purpose, Are Unlikely: “Combinations that change the ‘basic principles under which the [prior art] was designed to operate,’ or that render the prior art ‘inoperable for its intended purpose,’ may fail to support a conclusion of obviousness.” Plas-Pak Indus. (Fed. Cir. 01/27/15) (non-precedential) (aff’g PTAB non-obviousness decision; relying in part on the prior art patent’s statements re its “invention.”); In re Schweickert (Fed. Cir. 01/26/17) (non-precedential) (vacating PTAB obviousness ruling for lack of substantial evidence; substitution would defeat purpose of primary reference’s system, solve no problem in primary reference, add unwanted cost and complexity, and be difficult to implement); Trivascular (Fed. Cir. 02/05/16) (aff’g IPR non-obviousness decision; no motivation to combine references where that “substitution would destroy the basic objective of” a key feature of one of the prior art designs).; In re Gordon (Fed. Cir. 05/10/84) (prior art reference taught away from turning its design upside down (as needed to arrive at claimed design) because that would render it “inoperable for its intended purpose.”); but seeRaytheon (Fed. Cir. 04/02/18) (non-precedential) (aff’g PTAB obviousness; even if modification would frustrate two of six stated goals in prior art reference, there is no showing that “resulting device, with just those two objectives frustrated, would be rendered inoperable rather than merely less efficient or less desirable.”); In re Zhang (Fed. Cir. 06/17/16) (non-precedential) (“While a prior art reference may indicate that a particular combination is undesirable for its own purposes, the reference can nevertheless teach that combination if it remains suitable for the claimed invention.”)
Obviousness May Be Based On A Single Reference: May be based on one reference or a combination of references. Realtime (Fed. Cir. 01/10/19) (aff’g PTAB obviousness over single reference that disclosed entire claimed subject matter as anticipation is the epitome of obviousness); Game and Tech. (Fed. Cir. 06/21/19) (aff’g PTAB obviousness over a single reference); In re Stepan (Fed. Cir. 08/25/17) (2-1) (vacating Sec. 103 rejection of app. claims over a single reference; “whether a rejection is based on combining disclosures from multiple references, combining multiple embodiments from a single reference, or selecting from large lists of elements in a single reference, there must be a motivation to make the combination and a reasonable expectation that such a combination would be successful, otherwise a skilled artisan would not arrive at the claimed combination.”); Arendi (Fed. Cir. 08/10/16) (rev’g PTAB obviousness finding based on single reference that lacked one important, non-peripheral element); Belden (Fed. Cir. 11/05/15) (aff’g PTAB IPR decision of obviousness over a single prior art reference); In re Merck & Cie (Fed. Cir. 04/11/18) (non-precedential) (aff’g PTO rejection of claims based on single reference; certain excerpts of reference “reasonably capable of being read as conveying sufficiently positive implications about” the claimed method, “that they would provide a relevant skilled artisan a motivation to do what [claim] requires with a reasonable expectation of success and not leave the artisan discouraged from doing so by the article as a whole within the meaning of the ‘teaching away’ principle.”)
Obviousness Determination Must Not Be Based On Hindsight Gained From Patent: Mintz (Fed. Cir. 05/30/12) (long discussion of dangers of hindsight and importance of considering objective evidence to combat it, vacating Summ. J. of obviousness); Amerigen Pharma. (Fed. Cir. 01/11/19) (aff’g PTAB non-obviousness finding; “Any compound may look obvious once someone has made it and found it to be useful, but working backwards from that compound, with the benefit of hindsight, once one is aware of it does not render it obvious.”); Knauf (Fed. Cir. 10/15/19) (non-precedential) (vacating PTAB obviousness FWD; “the apparent similarity between the prior art references, upon which the Board relied to motivate their combination, is an illusion built upon hindsight bias.”); Merck Sharp (Fed. Cir. 10/19/17) (non-precedential) (rev’g bench trial finding of obviousness: “the only way to arrive at the hypothetical ring is by using the [challenged] patent as a roadmap to piece together various elements of [the prior art reference]. That represents an improper reliance on hindsight.”); Yeda Research (Fed. Cir. 10/12/18) (aff’g PTAB obviousness, but have “cautioned against relying on hindsight bias in selecting a lead prior art reference after the fact”).
Obviousness Protects Public So Accused Infringer Not Estopped By Seeking Similar Patent: “Obviousness protects the public at large, not a particular infringer, and one is not estopped from asserting the invalidity of a patent by the fact that one has previously made an attempt to procure a patent for substantially the same invention. . . . The fact that Master Lock claimed that its external seal was novel bears no evidentiary significance.” Wyers (Fed. Cir. 07/22/10). SeeParamount Publix (U.S. 03/04/1935) (“However inconsistent this early attempt to procure a patent may be with petitioner’s present contention of its invalidity for want of invention, this Court has long recognized that such inconsistency affords no basis for an estoppel, nor precludes the court from relieving the alleged infringer and the public from the asserted monopoly when there is no invention.”); Haughey (U.S. 01/15/1894) (“no estoppel” against alleging lack of novelty arising from the challenger’s own unsuccessful effort to obtain a patent on supposed invention; also, the defense “operates not merely to exonerate the defendant, but to relieve the public from an asserted monopoly, and the court cannot be prevented from so declaring by the fact that the defendant had ineffectually sought to secure the monopoly for himself.”)
Need Show Obviousness Of Only One Embodiment Within Scope Of Claim: Need show obviousness of any (some) embodiment within claimed genus. Allergan (Fed. Cir. 06/10/14) (rev’g non-obviousness for failure to analyze reasonable expectation of success, or commercial success, ivo full scope of claim); MobileMedia (Fed. Cir. 03/17/15) (rev’g verdict of non-obviousness where patent owner expert testimony limited to specific application (cellphone) not required by the claim).
Unpredictable Arts: Higher Hurdle To Show Obviousness: “To the extent an art is unpredictable, as the chemical arts often are, KSR’s focus on these ‘identified, predictable solutions’ may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.” Eisai (Fed. Cir. 07/21/08).
Identifying “Lead Compound” In Prior Art Is Frequently Applied But Not Required In Chemical Cases: “When a patent claims a chemical compound, a prima facie case of obviousness . . . frequently turns on the structural similarities and differences between the compounds claimed and those in the prior art. Proof of obviousness based on structural similarity requires clear and convincing evidence that a medicinal chemist of ordinary skill would have been motivated to select and then to modify a prior art compound (e.g., a lead compound) to arrive at a claimed compound with a reasonable expectation that the new compound would have similar or improved properties compared with the old.” Daiichi Sankyo (Fed. Cir. 09/09/10). Although a prima facie case of obviousness for a chemical compound generally begins by identifying a lead compound in the prior art, the prior art need not point to only a single lead compound for further development efforts. Altana Pharma (Fed. Cir. 05/14/09) (aff’g denial of preliminary injunction). AccordOtsuka Pharm (Fed. Cir. 05/07/12) (aff’g non-obviousness judgment; challenger must show skilled artisan would have selected the asserted prior art compounds as lead compounds (starting points) and show motivation to modify those compounds to arrive at claimed compounds with reasonable expectation of success). But, “a lead compound analysis is not required in analyzing obviousness of a chemical compound when, in the inventing process, there was no lead compound. An inventor may not have tried to improve a compound known to have desirable properties.” UCB (Fed. Cir. 05/23/18) (aff’g not obvious). But seeNovartis Pharma. (Fed. Cir. 05/13/19) (aff’g non-obviousness; distinguishing “lead compound” cases; challenger need not show a particular combination is “the most desirable, combination described in the prior art”).
Adapting Existing Electronic Process To Web/Internet Commonplace In May, 1998: SeeMuniauction (Fed. Cir. 07/14/08) (finding claimed combination obvious relying in part on speech as evidence suggesting “the effects of demands known to the design community or present in the marketplace”; and finding that “adapting existing electronic processes to incorporate modern internet and web browser technology was similarly commonplace at the time the patent application was filed [May 29, 1998].”); Soverain (Fed. Cir. 01/22/13) (Internet-based claims invalid over CompuServe Mall art).
Deviating From Market Pressure Or Design Need Or Commonsense Path Likely Innovative: “when design need and market pressure may dictate a commonsensical path using a finite number of identified predictable solutions to one of ordinary skill, deviations from that path are likely products of innovation.” Unigene (Fed. Cir. 08/25/11) (aff’g Summ. J. of non-obviousness, citing ANDA requirements for bioequivalence as a design need and market pressure, but one that did not lead to the claimed invention).
Limited Number Of Combinations Of Known Elements: Acco Brands (Fed. Cir. 02/22/16) (rev’g PTAB: Examiner made prima facie showing of obviousness where motivation to combine and only two ways to combine prior art elements and one fell within the claims.)
In Vitro Success May Or May Not Make In Vivo Success Reasonably Expected: “whether the skilled artisan can extrapolate in vivo success from in vitro results is highly fact-specific.” Nantkwest (Fed. Cir. 05/03/17) (non-precedential) (2-1).
a) analogous art
Tests For Analogous Art: Same Field Or Reasonably Pertinent To Problem: Only analogous prior art is considered in obviousness analysis. Circuit Check (Fed. Cir. 07/28/15) (rev’g JMOL and reinstating jury verdict of non-obviousness, because references not analogous art.) “‘Two separate tests define the scope of analogous art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.’” Innovention Toys I (Fed. Cir. 03/21/11) (rev’g Summ. J. of non-obviousness), seeInnovention Toys II (Fed. Cir. 04/29/15) (aff’g jury verdict of non-obviousness); Unwired Planet (Fed. Cir. 11/15/16) (reference analogous where in same field of interface design and its focus (graphical user interfaces) overlapped with patent’s focus (interfaces for location-based services)); In re Natural Alternatives (Fed. Cir. 08/31/16) (non-precedential) (rev’g PTAB obviousness determination in reexamination for failure to show art (using DSBM as ballast for the purpose of balancing tires) was analogous to claimed invention (using DSBM as part of a mixture to deice road surfaces)); In re Clay (Fed. Cir. 06/10/92) (different fields of endeavor: the storage of refined liquid hydrocarbons (at ambient conditions in a human-made storage tank) vs. the extraction of crude petroleum); In re Dillon (Fed. Cir. 11/09/90) (en banc); cf.Sci. Plastic (Fed. Cir. 09/10/14) (2-1) (discussing precedents and aff’g PTAB decision that references were analogous; claims directed to sealing a flash chromatography cartridge to be used in low pressure liquid chromatography but secondary reference primarily directed to sealing a beverage container); In re Klein (Fed. Cir. 06/06/11) (inventor considering problem of making a nectar feeder with a movable divider to prepare different ratios of sugar and water would not have been motivated to consider references dealing with separation of solid objects or references that lack a movable divider); K-TEC (Fed. Cir. 09/06/12) (affirm Summ. J. art not analogous). Even if a reference constitutes “common knowledge” of humankind or of skilled artisans, a reference is reasonably pertinent only “when it ’logically would have commended itself to an inventor’s attention in considering his problem.’” Circuit Check (Fed. Cir. 07/28/15) (substantial evidence that a person of ordinary skill in the art “would not have thought about” rock carvings, engraved signage, or a particular machining technique “in considering how to mark interface plates” used in testing printed circuit boards); Polygroup (Fed. Cir. 01/28/19) (non-precedential) (aff’g PTAB that reference concerned with durability of electrical device not analogous art to patent concerned with easier assembly of artificial trees and their electrical connections), modified (Fed. Cir. 03/28/19) (non-precedential); Smith & Nephew (Hologic) (Fed. Cir. 01/30/18) (non-precedential) (rev’g PTAB obviousness decision; reference re. winding a glass fiber strand to form packages was not analogous art to patent’s problem of solving the difficulty in cutting large amounts of semi-rigid tissue. Board defined problem too narrowly—even though glass fiber packaging art involved a similar mechanical solution, it was not in a field a medical devices inventor would logically have considered).
Analogous Art: Field Of The Invention Is Relevant: stated “field of the invention” encompassed the reference argued to be non-analogous, as did the applicant’s expert’s testimony about the experience of one of skill in the art. In re Index Sys. (Fed. Cir. 08/11/14) (aff’g PTAB obviousness rejection) (non-precedential); E. Tech. (Fed. Cir. 11/17/16) (non-precedential) (aff’g PTAB obviousness; relying on patent’s title and abstract for determining broad scope of its field of the invention); but seeApple VI (Fed. Cir. 10/07/16) (en banc) (7-3) (overturning panel decision [Apple V (Fed. Cir. 02/26/16)] which had relied on reference being within patent’s stated field of the invention; substantial evidence supported implied jury finding of no motivation to combine elements “from a wall-mounted touchscreen for home appliances and a smartphone, particularly in view of the ‘pocket dialing’ problem specific to mobile devices that Apple’s invention sought to address.”); cf.Securus Techs. (Fed. Cir. 07/14/17) (non-precedential) (aff’g PTAB non-obviousness decision; no motivation to combine shown where no explanation provided why one would combine reference about telephone features in corporate setting with reference about telephone features in prison setting).
b) what a reference teaches
Reference Teaches What It “Fairly Suggests” As Well As Expressly Teaches: In Sec. 103 analysis, a “reference must be considered not only for what it expressly teaches, but also for what it fairly suggests.” In re Rhoads (Fed. Cir. 05/04/16) (non-precedential) (aff’g PTAB Sec. 103 rejection of application claim); Bradium (Fed. Cir. 05/13/19) (aff’g PTAB obviousness; disclosure that some tiles have higher priority than others “would fairly suggest to a person of ordinary skill in the art that a prioritization value is thus associated with requests for these tiles”).
Inherent Disclosures Often Inappropriate To Rely Upon In An Obviousness Analysis: “Use of inherency in the context of obviousness must be carefully circumscribed because ‘[t]hat which may be inherent is not necessarily known’ and that which is unknown cannot be obvious. What is important regarding properties that may be inherent, but unknown, is whether they are unexpected.” Honeywell (Fed. Cir. 08/01/17) (rev’g PTAB obviousness decision in IP Reexam). “‘A party must … meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis—the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.’” Knauf Insulation (Fed. Cir. 02/27/17) (non-precedential) (aff’g PTAB obviousness decision); Southwire (Fed. Cir. 09/08/17) (aff’g PTAB obviousness decision; error to rely on inherent disclosure of claimed result because that result was not necessarily present in reference, but harmless error); Millennium Pharm. (Fed. Cir. 07/17/17) (rev’g obviousness judgment; error to find inherency where claimed subject matter is “natural result” of the path the inventor took, because Sec. 103 provides that “‘(p)atentability shall not be negatived by the manner in which the invention was made.’”); Vivint (Fed. Cir. 07/26/18) (non-precedential) (rejecting PTAB finding of inherency of an element in a prior art reference, in an obviousness analysis, but aff’g obviousness on other grounds).
c) teaching away
“Teaching Away” Test: “A reference ‘teaches away’ when it ‘suggests that the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant.’”. Santarus (Fed. Cir. 09/04/12). “‘A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.’” In re Chaganti (Fed. Cir. 01/27/14) (non-precedential) (no teaching away here); seePolaris (Fed. Cir. 02/09/18) (vacating PTAB IPR obviousness; cannot dismiss teaching away as mere “subjective preference,” instead must determine whether “‘a person of ordinary skill, upon reading [reference], would be discouraged from following the path set out in [Denney], or would be led in a direction divergent from the path that was taken by the applicant’”); Idemitsu (Fed. Cir. 09/15/17) (aff’g PTAB obviousness decision; “evidence concerning whether the prior art teaches away from a given invention must relate to and be commensurate in scope with the ultimate claims at issue.”); Millennium Pharm. (Fed. Cir. 07/17/17) (rev’g obviousness judgment; “a person of ordinary skill would have avoided creating an ester with mannitol because several different esters, each with different chemical and possibly biological properties, could have formed.”); Endo Pharma. (Fed. Cir. 05/16/18) (non-precedential) (aff’g non-obviousness; skilled artisan “would have been strongly discouraged from using oxymorphone in a controlled release setting”); In re Hubbell (Fed. Cir. 04/07/16) (non-precedential) (aff’g PTAB that statement of preference does not teach away because it “does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed.”); Bayer (Fed. Cir. 11/01/17) (rev’g finding of non-obviousness; “the teaching away inquiry does not focus on whether a person of ordinary skill in the art would have merely favored one disclosed option over another disclosed option.”); Meieresonne (Fed. Cir. 03/07/17) (aff’g PTAB obviousness; criticizing text abstracts as cursory does not teach away from combination of text abstracts and graphical previews); In re Urbanski (Fed. Cir. 01/08/16) (aff’g PTAB obviousness: “In cases involving mechanical device or apparatus claims, we have held that ‘[i]f references taken in combination would produce a ‘seemingly inoperative device,’ . . . such references teach away from the combination and thus cannot serve as predicates for a prima facie case of obviousness.’”; but here secondary reference provided motivation to pursue the desirable properties it taught, even if meant foregoing the benefit taught by primary reference); Dome (Fed. Cir. 09/03/15) (reexamination; trial court finding of no teaching away not clearly erroneous where one reference described problems with particular approach but other references disclosed ways of overcoming that problem); Allergan (Fed. Cir. 08/04/15) (prior art taught away by teaching that claimed amount of ingredient would be ineffective and would have side effects); Gator Tail (Fed. Cir 06/22/15) (non-precedential) (prior art teaching that prior design configuration was inferior does not teach away from that design).
Must Consider Prior Art As A Whole To Determine If It Teaches Away: When evaluating whether prior art teaches away from claimed combination, must consider prior art as a whole, including later prior art references that resolve doubts raised by earlier references. Merck (Fed. Cir. 12/17/15) (aff’g PTAB determination of motivation to combine and obviousness.).
Pricing Relevant To Teaching Away: Andersen (Fed. Cir. 11/19/08) (non-precedential) (remanding Summ. J. of obviousness due to fact question whether significant differences in cost would have discouraged (i.e., taught away) PHOSITA from combining references).
Teaching Away May Be Indirect: “‘Teaching away’ does not require that the prior art foresaw the specific invention that was later made, and warned against taking that path.” Spectralytics (Fed. Cir. 06/13/11) (teaching away a question of fact; here all prior machines solved problem in a similar way, different than invention’s technique); but seeIn re Mouttet (Fed. Cir. 06/26/12) (aff’g BPAI conclusion that reference did not teach away from using electrical circuits where reference noted “fundamental difference” between electrical and optical circuits and advantages of the latter.)
Reference Need Not Rise To Level Of Teaching Away To Be Relevant To Whether Art As A Whole Supports Motivation To Combine And Reasonable Expectation Of Success: “Evidence suggesting reasons to combine cannot be viewed in a vacuum apart from evidence suggesting reasons not to combine.” Arctic Cat (Fed. Cir. 12/07/17) (aff’g non-obviousness where asserted combination of designs was reported to risk potential but difficult to predict danger of accidents; “‘known disadvantages in old devices which would naturally discourage the search for new inventions may be taken into account in determining obviousness.’”); Endo Pharma. (Fed. Cir. 07/13/18) (aff’g finding of no motivation to modify prior reference where one set of guidelines suggested reference’s dosage was overdosing (thus suggesting lowering to claimed lower dose) but FDA guidelines suggested not overdosing, noting that FDA guidelines did not “teach away.”)
Problems Identified In Art May Teach Away From Claimed Solution: the art taught that a single round of freezing caused severe damage to the cells and the patent owner’s expert testified that persons of skill in the art would expect that a second round of freezing (as claimed) would cause even more damage Celsis in Vitro (Fed. Cir. 01/09/12) (preliminary injunction affirmed).
d) motivation to combine or modify art
Post-KSR, Teachings, Suggestions, Motivations (TSM) Test Is “Flexible”: “The TSM test, flexibly applied, merely assures that the obviousness test proceeds on the basis of evidence – teachings, suggestions (a tellingly broad term), or motivations (an equally broad term) – that arise before the time of invention as the statute requires. As KSR requires, those teachings, suggestions, or motivations need not always be written references but may be found within the knowledge and creativity of ordinarily skilled artisans.” Ortho-McNeil (Fed. Cir. 03/31/08); Microsoft (Parallel Networks) (Fed. Cir. 12/01/17) (non-precedential) (listing multiple KSR formulations of reasons to combine or modify prior designs; “A reason ‘to modify a reference can come from the knowledge of those skilled in the art, from the prior art reference itself, or from the nature of the problem to be solved.’”)
Desire To Create Better Product Motivates Combination: SeeRandall (Fed. Cir. 10/30/13) (“By narrowly focusing on the four prior-art references cited by the Examiner and ignoring the additional record evidence Randall cited to demonstrate the knowledge and perspective of one of ordinary skill in the art, the Board failed to account for critical background information that could easily explain why an ordinarily skilled artisan would have been motivated to combine or modify the cited references to arrive at the claimed inventions.”); Stauffer (Fed. Cir. 07/24/08) (non-precedential) (Claim directed at a device for recording caller ID information immediately after receipt of first ring and printing caller ID information was obvious over a reference that discloses a telephone interface with caller ID capability combined with a reference that states that caller ID information is transmitted between the first two rings. PHOSITA would be motivated to combine these references in order to create a product that prints caller ID information more quickly.). SeeBosch (Fed. Cir. 12/22/17) (aff’g PTAB obviousness: “reasonably found that an ordinarily skilled artisan would have been motivated by the known compatibility issues in the art of RTMS systems and the known solution of a universal communication tool disclosed by both Dixit and Howell to combine the different activation means of McClelland and Kranz into a single universal tool.”); In re Nuvasive (Fed. Cir. 12/07/16) (vacating PTAB Sec. 103 determination for failure to state “a reason why a PHOSITA would have combined the prior art references,” such as minimizing waste or allowing for a greater degree of movement (citing precedents), “that had a foundation in the prior art.”); Celgene (Fed. Cir. 07/30/19) (aff’g PTAB obviousness decision; “where safety is a concern and where the potential adverse side effects are so severe, the Board did not err in finding that the desire to improve a system that is working well qualifies as a valid motivation”).
Reason Exists To Combine Reference Using An Element With Another Reference Disclosing Improvement To That Element: Senju Pharm. (Fed. Cir. 03/20/15) (aff’g obviousness judgment ivo multiple references). This is so even if second reference had some different goals. Slot Speaker (Fed. Cir. 02/17/17) (non-precedential) (artisan “would not have ignored Sadaie’s teachings on the use of sound damping materials on its sidewalls to absorb unwanted soundwaves just because Sadaie discloses that its material also absorbs pressure.”)
Motivation May Be Different Than What Motivated Patent Applicants: Alcon Res. (Fed. Cir. 08/08/12) (even though prior art taught away from what patent identifies as motivation for combination, art taught another motivation for that same combination; rev’g (on some claims) bench trial judgment of non-obviousness); Outdry (Fed. Cir. 06/16/17) (aff’g PTAB obviousness decision; “need not be the same motivation articulated in the patent for making the claimed combination”); In re Conrad (Fed. Cir. 03/22/19) (“The Supreme Court and this court … have repeatedly held that the motivation that a person of ordinary skill in the art would have had to combine prior art references need not be the same motivation that inspired the patent owner.”)
Only Need One Motivation To Combine: “We have never required a party to prove that all possible problems solved by an invention were known in the prior art. Proof of one motivation to combine, as shown here, is sufficient.” Everlight Elecs. (Fed. Cir. 01/04/18) (non-precedential) (aff’g jury verdict of obviousness).
“Would Have Been Motivated To” Make The Combination Not Just “Could Have Combined”: “Obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden (Fed. Cir. 11/05/15) (aff’g PTAB IPR decision of obviousness over a single prior art reference); seeMetalcraft (Fed. Cir. 02/16/17) (aff’g preliminary injunction: “Without any explanation as to how or why the references would be combined to arrive at the claimed invention, we are left with only hindsight bias.”).
That Skilled Artisans Had Combined Elements (For Different Purpose) Can Be Evidence Of Motivation To Combine: Nalpropion Pharm. (Fed. Cir. 08/15/19) (rev’g district court finding of non-obviousness; “the inescapable, real-world fact here is that people of skill in the art did combine bupropion and naltrexone for reductions in weight gain and reduced cravings—goals closely relevant to weight loss … even without understanding bupropion’s mechanism of action but with an understanding that bupropion was well-tolerated and safe as an antidepressant.”)
If Rely On Problem For Motivation, Must Show, Without Hindsight, PHOSITA Would Have Recognized The Problem: “This statement of the problem represents a form of prohibited reliance on hindsight. The district court has used the invention to define the problem that the invention solves. Often the inventive contribution lies in defining the problem in a new revelatory way. …. Instead, PCM must prove by clear and convincing evidence that a person of ordinary skill in the meat encasement arts at the time of the invention would have recognized the adherence problem recognized by the inventors and found it obvious to produce the meat encasement structure disclosed in the ’148 patent to solve that problem.” Mintz (Fed. Cir. 05/30/12) (vacating Summ. J. of obviousness); Purdue Pharma (Fed. Cir. 03/24/16) (non-precedential) (aff’g PTAB non-obviousness decision; to extent challenger relies on problem to be solved to supply reason to combine prior art, challenger must show that “the problem was known in the art or that [its] formulation of the problem was derived directly from the prior art, rather than from the challenged claims.”); Novartis (Fed. Cir. 05/21/15) (non-precedential) (aff’g judgment of no obviousness because “the prior art does not unambiguously identify oxidative degradation to be a known problem with rivastigmine,” so no motivation to solve that problem by adding an antioxidant); Leo Pharm. (Fed. Cir. 08/12/13) (“an invention can often be the recognition of a problem itself,” rev’g BPAI obviousness finding); Purdue Pharma (Fed. Cir. 02/01/16) (discovering non-obvious problem can evidence that solution is non-obvious, but not here because solution did not require discovering the identified problem); Insite Vision (Fed. Cir. 04/09/15) (in considering motivation in the obviousness analysis, the problem examined is itself a finding of fact, and is not necessarily the specific problem solved by the invention.); In Re Omeprazole Patent Litig. (Fed. Cir. 08/20/08) (recognizing problem supported non-obviousness).
Also Consider Demotivation: “Evidence suggesting reasons to combine cannot be viewed in a vacuum apart from evidence suggesting reasons not to combine.” Arctic Cat (Fed. Cir. 12/07/17) (aff’g non-obviousness where asserted combination of designs was reported to risk potential but difficult to predict danger of accidents.); Hitachi Metals (Fed. Cir. 07/06/17) (non-precedential) (aff’g PTAB “factual determination that a skilled artisan would not have been demotivated by the potential reduction in yield”). When considering benefits of combining teachings, “the benefits, both lost and gained, should be weighed against one another.” Henny Penny (Fed. Cir. 09/12/19) (aff’g PTAB non-obviousness). But design tradeoffs do not necessarily obviate a motion to combine. Medichem (Fed. Cir. 02/03/06) (aff’g obviousness in context of an interference; “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”).
Combining Different Embodiments In Same Or Related References: Paice (Fed. Cir. 03/07/17) (non-precedential) (aff’g PTAB obviousness; combination of one strategy in one related paper with another strategy from which it was derived is “predictable variation” that does not “require a leap of inventiveness.”); Boston Sci. Scimed (Fed. Cir. 01/15/09) (rev’g trial court denial of JMOL against jury verdict of non-obviousness: “Combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness.”).
That References Are In Same Field Is Insufficient To Show Motivation To Combine: merely showing that two references are in same field is insufficient to show motivation to combine. Securus Techs. (Fed. Cir. 07/14/17) (non-precedential) (aff’g PTAB non-obviousness decision).
That References Address Same Problem And Disclose Similar Solutions In Functionally Equivalent Ways Supports Finding Of Motivation To Combine: Substantial evidence supports PTAB finding of motivation to combine where “(1) there were just two obvious design choices in the respect put at issue (Hochstein and Hildebrand), which solve the same problem in the same way but with the filter and current-conducting network swapped in their locations, (2) the two references ‘show the demand for designs that solve the known problem,’; (3) Hildebrand’s location choice was a common and approved design that could be used in Hochstein; and (4) Hochstein would not malfunction if modified to use such a design.” Philips Lighting (Fed. Cir. 04/18/18) (non-precedential); Zup (Fed. Cir. 07/25/18) (2-1) (aff’g Summ. J. of obviousness; “In the face of the significant evidence … regarding the consistent desire for riders to change positions while riding water recreational boards (and the need to maintain stability while doing so), and given that the elements of the ’681 patent were used in the prior art for this very purpose, there is no genuine dispute as to the existence of a motivation to combine.”); Samsung (Fed. Cir. 06/18/19) (non-precedential) (rev’g PTAB non-obviousness decision; that secondary reference addressed a different type of device than does the patent and primary reference did not defeat motivation to combine where both types of devices experience electrical interference and secondary reference proposes solution to that).
e) reasonable expectation of success
Need Not Show Absolute Certainty Or Predictability Of Success: Soft Gel (Fed. Cir. 07/26/17) (aff’g PTAB obviousness decision; need only be a reasonable expectation of success, not absolute predictability; a supplemental study to confirm what is expected “does not imply lack of awareness of the likely result”); Par Pharm. (Fed. Cir. 12/03/14) (a “reasonable expectation of success” does not require absolute certainty of success).
Insufficient To Show “Hope” Or “Cautious Optimism” That Claimed Result Could Be Achieved: OSI Pharma. (Fed. Cir. 10/04/19) (rev’g PTAB obviousness finding; “These references provide no more than hope—and hope that a potentially promising drug will treat a particular cancer is not enough to create a reasonable expectation of success in a highly unpredictable art such as this.”); Sanofi (Fed. Cir. 11/09/17) (aff’g finding of no reasonable expectation of success where skilled artisans “‘would have been at best cautiously optimistic that dronedarone could” achieve the claimed results).
Insufficient To Show The Absence Of An Expectation Of Failure: A lack of predictability (and thus absence of an expectation of failure) shows an absence of a reasonable expectation of success. Honeywell (Fed. Cir. 08/01/17) (rev’g PTAB obviousness decision in IP Reexam; error of law to base obviousness on reasoning that unpredictability would have led skilled artisan to conduct routine testing to arrive at optimal result.)
Disclosing That “Well-Established Procedures” Were Used To Make Combination May Help Show Reasonable Expectation Of Success: Trustees of Columbia (Fed. Cir. 07/17/15) (non-precedential) (reasonable expectation of success supported by each step of procedure to prepare combination being within skill of PHOSITA and Spec. said “well-established procedures” are used without providing “additional guidance with respect to chemical procedures.”)
Unpredictability Runs Counter To Expectation Of Success, And May Require More Direct Motivation to Combine: OSI Pharma. (Fed. Cir. 10/04/19) (rev’g PTAB obviousness finding; where effectiveness of drugs for treating this particular type of lung cancer was “highly unpredictable with an over 99.5% rate of failure for drugs entering Phase II clinical studies” and references lacked in vitro or in vivo data on effectiveness of claimed compound for this particular type of cancer, no substantial evidence supports reasonable expectation of success); Genzyme (Fed. Cir. 12/18/17) (non-precedential) (aff’g bench trial of non-obviousness; in part due to “great uncertainty about the role of” claimed receptor in the process of stem cell mobilization); BASF (Fed. Cir. 10/26/18) (non-precedential) (vacating PTAB non-obviousness decision; general unpredictability in the art might require “a more definitive motivation to combine”).
Failures And Extensive Experimentation By Inventors May Help Show Lack Of Reasonable Expectation Of Success: Endo Pharma. (Fed. Cir. 05/03/19) (2-1) (aff’g judgment of non-obviousness; lack of reasonable expectation of success supported by that fact that the inventors “engaged in extensive experimentation, involving much failure, to ultimately produce” the claimed composition).
In Chemical Arts, Structural Similarities May Suggest Functional Similarities And Support Reasonable Expectation Of Success: “The greater the structural similarity between the compounds, the greater the motivation to combine and reasonable expectation of success,” but evidence must show whether a nexus between “structural similarities (or dissimilarities) and functional similarities (or dissimilarities)” in chemical arts. Anacor Pharma. (Fed. Cir. 05/14/18) (aff’g Board obviousness).
Evidence Related To Unclaimed Features Not Relevant To Motivation To Combine With Reasonable Expectation Of Success: “The correct inquiry … asks whether a skilled artisan would have ‘ha[d] a motivation to combine accompanied by a reasonable expectation of achieving what is claimed in the patent-at-issue.’” Dr. Falk Pharma. (Fed. Cir. 06/12/19) (non-precedential) (aff’g PTAB decision of obviousness; dismissing alleged evidence of unpredictability as to an unclaimed feature).
f) the manner in which the invention was made
Shall Not Negate Patentability: “Patentability shall not be negated by the manner in which the invention was made.” 35 U.S.C. § 103 (AIA). “Patentability shall not be negatived by the manner in which the invention was made.” 35 U.S.C. § 103 (pre-AIA).
That Routine Testing Led Or Could Have Led To Claimed Invention Does Not Show Obviousness: Under last sentence of Sec. 103(a), “routine experimentation does not necessarily preclude patentability.” Honeywell (Fed. Cir. 08/01/17) (rev’g PTAB obviousness decision in IP Reexam; rejecting reasoning that lack of predictability of results would have led to routine testing and led to claimed invention.) But seeMerck (Fed. Cir. 10/26/17) (2-1) (aff’g obviousness finding: claim elements not disclosed in prior art references “are all experimental details that one of ordinary skill would have utilized via routine experimentation, armed with the principles disclosed in the prior art.”)
g) objective indicia of non-obviousness (secondary considerations)
BASICS: “Under 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As indicia of obviousness or nonobviousness, these inquiries may have relevancy.” Graham (U.S. 02/21/1966). Also: skepticism of others, licensing, unexpected results, praise of experts, copying. Millennium Pharm. (Fed. Cir. 07/17/17) (rev’g obviousness; unexpected results, long-felt but unsolved need, and commercial success rebut obviousness); Circuit Check (Fed. Cir. 07/28/15) (rev’g JMOL and reinstating jury verdict of obviousness based in part on substantial evidence of “copying, long-felt need, commercial success, skepticism, and unexpected results”); Transocean (Fed. Cir. 11/15/12) (seven objective indicia of non-obviousness overcame prima facie showing of obviousness (sufficiently to support jury verdict of non-obviousness) where Fed. Cir. had previously held that two references taught each claim limitation and provided motivation for their combination); Intercontinental Great Brands (Fed. Cir. 09/07/17) (2-1) (aff’g Summ. J. obviousness, despite strong objective indicia of non-obviousness).
Objective Indicia Of Non-Obviousness Is An Integral Part Of The Analysis Which Must Always Be Considered Before Reaching Conclusion On Obviousness. “Objective evidence of nonobviousness, i.e. ‘indicia’ of Graham v. John Deere, may in a given case be entitled to more weight or less, depending on its nature and its relationship to the invention’s merits; it may be the most pertinent, probative and revealing evidence available to aid in reaching a conclusion on the obvious/nonobvious issue. It should, when present always be considered as an integral part of the analysis.” L. Gore (Fed. Cir. 11/14/83); Apple VI (Fed. Cir. 10/07/16) (en banc) (7-3) (substantial evidence supported findings of industry praise, copying, commercial success, and long-felt need: “determination of whether a patent claim is invalid as obvious under § 103 requires consideration of all four Graham factors, and it is error to reach a conclusion of obviousness until all those factors are considered.”); WBIP (Fed. Cir. 07/19/16) (aff’g denial of JMOL of obviousness; heavily relying on objective indicia: “‘evidence of secondary considerations may often be the most probative and cogent evidence in the record’”); Nike (Fed. Cir. 02/11/16) (vacating PTAB decision that substitute claims not shown non-obvious, for PTAB failure to address evidence of secondary considerations); Transocean (Fed. Cir. 08/18/10) (rev’g Summ. J. of obviousness for failure to consider objective evidence of non-obviousness); PPC Broadband II (Fed. Cir. 07/03/18) (non-precedential) (vacating PTAB obviousness decision in part for failure to adequately consider evidence of commercial success; maintaining market share with a price premium is evidence of commercial success); Plantronics (Fed. Cir. 07/31/13) (same); Eurand (In re Cyclobenzaprine) (Fed. Cir. 04/16/12) (faulting district court for first finding obviousness and then considering whether objective indicia rebutted obviousness; explaining importance of objective indicia to combat hindsight); Mintz (Fed. Cir. 05/30/12) (long discussion of dangers of hindsight and importance of considering objective evidence to combat it, vacating Summ. J. of obviousness); Apple (Fed. Cir. 08/07/13) (vacating ITC obviousness finding for failure to consider secondary considerations); InTouch (Fed. Cir. 05/09/14) (where “an expert purports to testify, not just to certain factual components underlying the obviousness inquiry, but to the ultimate question of obviousness, the expert must consider all factors relevant to that ultimate question,” including objective indicia). But seeIntercontinental Great Brands (Fed. Cir. 09/07/17) (2-1) (objective indicia must be considered before drawing the ultimate obviousness conclusion but need not be evaluated before drawing a conclusion about whether a reasonable jury could find that a relevant skilled artisan had a motivation to combine the prior art.); Intercontinental Great Brands (Fed. Cir. 09/07/17) (Reyna, J., dissenting) (“For too long, this court has turned a blind eye to what I consider to be a grave concern: the application of a prima facie test that necessarily achieves a legal determination of obviousness prior to full and fair consideration of evidence of objective indicia of non-obviousness.”)
Patent Owner Has Burden Of Production On Objective Indicia: Patent owner “‘has the burden of going forward with’ evidence tending to rebut a challenger’s obviousness case,” and thus has burden of showing objective indicia. Enova (Fed. Cir. 09/06/17) (non-precedential) (aff’g PTAB IPR obviousness decision); Zup (Fed. Cir. 07/25/18) (2-1) (aff’g Summ. J. of obviousness; “While this burden of persuasion remains with the challenger, a patentee bears the burden of production with respect to evidence of secondary considerations of nonobviousness.”); but seeIntercontinental Great Brands (Fed. Cir. 09/07/17) (Reyna, J., dissenting) (“the burden of persuasion should not shift from the challenger to the patent holder after a legal determination of obviousness has already been made.”)
Long-Felt But Unmet Need: “whether there is a ‘long-felt need is analyzed as of the date of an articulated identified problem and evidence of efforts to solve that problem.’” WBIP (Fed. Cir. 07/19/16) (aff’g denial of JMOL of obviousness, relying heavily on substantial evidence of objective indicia). “A patent owner may establish a long-felt but unmet need without presenting evidence of failure of others.” In re Depomed (Fed. Cir. 02/21/17) (non-precedential) (aff’g PTAB obviousness decision). Long-felt need cannot be shown where differences from prior art are minimal. Zup (Fed. Cir. 07/25/18) (2-1) (aff’g Summ. J. of obviousness). Long-felt meet may have been for combination of features in a single product. Tris Pharma. (Fed. Cir. 11/20/18) (non-precedential) (modified Tris Pharma. (Fed. Cir. 01/16/19) (non-precedential)).
Copying: “Copying requires the replication of a specific product.” Iron Grip (Fed. Cir. 12/14/04); accordWyers (Fed. Cir. 07/22/10); seeEnova (Fed. Cir. 09/06/17) (non-precedential) (aff’g obviousness; knowledge of patent and admission of infringement not enough to show copying as part of obviousness analysis); Transocean (Fed. Cir. 11/15/12) (substantial evidence supports copying finding where infringer was aware of patents and patent owner’s products embodying the patents while it designed its accused product, and decided to incorporate the patent’s improvement over prior art because believe patents invalid); WBIP (Fed. Cir. 07/19/16) (“that a competitor copied technology suggests it would not have been obvious.”); Windsurfing (Fed. Cir. 01/28/86) (“copying the claimed invention, rather than one within the public domain, is indicative of non-obviousness.”)
Patent Spec. Can Provide Evidence Of Unexpected Results: Specific examples in patent Spec. can provide evidence of unexpected results (no discussion of whether hearsay). Süd-Chemie (Fed. Cir. 01/30/09).
A Range Of Opinions May Constitute Skepticism: Neptune Generics (Fed. Cir. 04/26/19) (aff’g PTAB non-obviousness finding; caselaw “recognizes a range of third-party opinion that can constitute skepticism”).
h) nexus to claimed invention
Objective Indicia Must Have Nexus To Described-Claimed “Invention”: To be relevant, alleged commercial success (and other secondary indicia) must have nexus to claimed invention, South Alabama (Fed. Cir. 12/17/15) (licenses may show “recognition and acceptance” of claimed subject matter even if licensee’s product not shown to have nexus to claimed invention), and must be shown to:
(1) have been caused by some advance both claimed and described in the patent, and absent from the closest art. Cf.Apple VI (Fed. Cir. 10/07/16) (en banc) (7-3) (substantial evidence of nexus; survey evidence that customers would be less likely to purchase device without the slide-to-unlock feature and would pay less for products without it; “There could be a long-felt need for what might be considered a relatively small improvement over the prior art”); Henny Penny (Fed. Cir. 09/12/19) (aff’g PTAB non-obviousness; feature praised in industry awards had not been combined in closest prior art reference); NuVasive (Fed. Cir. 10/09/18) (non-precedential) (rev’g PTAB “no nexus” finding; success is reasonably commensurate with claimed methods even if partly due to other uses of the patentee’s products); Novartis (Torrent) (Fed. Cir. 04/12/17) (aff’g PTAB obviousness decision: “In evaluating whether the requisite nexus exists, the identified objective indicia must be directed to what was not known in the prior art—including patents and publications—which may well be the novel combination or arrangement of known individual elements;” rejecting argument that “as a matter of law, a feature that is known in the art but not actually available to the market—i.e., in commerce—cannot be used to disprove [a patent owner’s] attempts to establish a nexus based on that claimed feature.”); Classco (Fed. Cir. 09/21/16) (aff’g obviousness, but PTAB should have given “some weight [to industry praise], taking into account the degree of the connection between the features presented in evidence and the elements recited in the claims,” where claims broader than praised features); LiquidPower (Fed. Cir. 10/18/18) (non-precedential) (vacating PTAB obviousness decision; patent owner established nexus); In re Natural Alternatives (Fed. Cir. 08/31/16) (non-precedential) (rev’g PTAB finding of lack of nexus; obviousness determination in reexamination); Graftech (Fed. Cir. 06/17/16) (non-precedential) (aff’g PTAB obviousness decision: no nexus of commercial success to claimed invention); Ethicon (Fed. Cir. 01/13/16) (aff’g PTAB obviousness; substantial evidence that alleged infringer’s commercial success primarily due to feature in prior art not to the claimed combination of elements); Merck (Fed. Cir. 12/17/15) (“Where objective indicia ‘result[ ] from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.’”); South Alabama (Fed. Cir. 12/17/15) (no nexus where accused product has active ingredients not recited in claims, and industry praise primarily due to ingredient in prior art and thus “not adequately tied to the novel features of the claimed invention”); Sightsound (Fed. Cir. 12/15/15) (aff’g PTAB obviousness decision; patent owner must show “the sales were a direct result of the unique characteristics of the claimed invention”); Trustees of Columbia (Fed. Cir. 07/17/15) (non-precedential) (“‘When a patentee can demonstrate commercial success, … and that the successful product is the invention disclosed and claimed in the patent, it is presumed that the commercial success is due to the patented invention.’”; “unexpected results ‘must be shown to be unexpected compared with the closest prior art.’”); Bristol-Myers (Fed. Cir. 06/12/14) (“To be particularly probative, evidence of unexpected results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention.”); rehearing denied (Fed. Cir. 10/20/14) (multiple opinions); Cadence Pharm. (Fed. Cir. 03/23/15) (commercial success of a product made by method outside literal claim scope is “not per se irrelevant” where difference in method is insubstantial); but seeWBIP (Fed. Cir. 07/19/16) (“proof of nexus is not limited to only when objective evidence is tied to the supposedly ‘new’ feature(s).”); Kao (Fed. Cir. 03/21/06) (“when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.”); Align Tech. (Fed. Cir. 08/22/18) (non-precedential) (remanding PTAB obviousness decision; “an obviousness determination should take account of commercial success (or industry praise) that is partly but not fully attributable to the merits of the invention.”)
(2) tie invention to what drives sales, not simply regulatory approval. AstraZeneca (Fed. Cir. 05/07/15) (non-precedential) (“‘Whether or not there is a nexus between the novel features of the patented product and the commercial success must be evaluated in terms of what is driving sales, not what is allowing the product to reach the shelf in the first place.’”); and
(3) not be attributable to improvements or modifications made by others. Cf.In re Magna (Fed. Cir. 05/07/15) (non-precedential) (skepticism must relate to technical infeasibility or manufacturing uncertainty, not economic reasons). But, “where the marketed product is coextensive with the claimed features, then the court should presume that commercial success of the product is due to the patented invention.” Gator Tail (Fed. Cir. 06/22/15) (non-precedential) (discounting of commercial success was harmless error because patent owner showed only number of units sold, not market share).
(4) not be attributable to other economic reasons. Cubist Pharma (Fed. Cir. 11/12/15) (aff’g obviousness; Lilly had no incentive to investigate later-claimed formulation because it was selling $400-500MM/yr. of leading drug on the market).
Require Nexus To Claimed Combination: In re DBC (Fed. Cir. 11/03/08) (no showing success due to patented combination rather than one of its ingredients).
Require Nexus To Full Scope Of Claim: MPEP 716.03(a): “Objective evidence of nonobviousness including commercial success must be commensurate in scope with the claims. In re Tiffin, 448 F.2d 791, 171 USPQ 294 (CCPA 1971) (evidence showing commercial success of thermoplastic foam ‘cups’ used in vending machines was not commensurate in scope with claims directed to thermoplastic foam ‘containers’ broadly).”; Allergan (Fed. Cir. 06/10/14) (rev’g non-obviousness for failure to analyze reasonable expectation of success, or commercial success, ivo full scope of claim). But, evidence need only be reasonably commensurate with claims; don’t need evidence for each embodiment within claim, if can show that unexpected results or commercial success would apply to other embodiments as well. In re Kao (Fed. Cir. 05/13/11). SeeIn re Ikeda Food (Fed. Cir. 01/29/19) (non-precedential) (aff’g PTAB finding that objective indicia not commensurate with scope of claim; claim transition of “comprising” “does not exclude [glucose] biosensors that employ a cofactor,” therefore claims do not satisfy alleged need for biosensors that do not use cofactor).
Require Nexus To Disclosed (And Claimed) Technology: MPEP 716.03(a): “To be pertinent to the issue of nonobviousness, the commercial success of devices falling within the claims of the patent must flow from the functions and advantages disclosed or inherent in the description in the specification. Furthermore, the success of an embodiment within the claims may not be attributable to improvements or modifications made by others. In re Vamco Machine & Tool, Inc., 752 F.2d 1564, 224 USPQ 617 (Fed. Cir. 1985).” In re Vamco (Fed. Cir. 01/17/85) (“the commercial success of a machine ‘claimed’ may be due entirely to improvements or modifications made by others to the invention disclosed in a patent. Such success, we are holding, is not pertinent to the non-obviousness of the invention disclosed.”); In re Affinity Labs (Fed. Cir. 05/05/17) (aff’g PTAB obviousness decision; allegation that $25 billion industry developed around technology claimed by patent unsupported by showing of nexus).
Copying Requires Nexus To Claimed Invention: although defendant did copy patent owner’s product, evidence was that each party routinely copied the other’s products, rather than show that defendant copied on account of the novel combination of elements. WM Wrigley (Fed. Cir. 06/22/12) (aff’g Summ. J. of obviousness); Pregis (Fed. Cir. 12/06/12) (no nexus of copying to claimed features).
Nexus Is Presumed If Tied To Specific Product Described And Claimed In Patent: Polaris (Fed. Cir. 02/09/18) (vacating PTAB IPR rejection of commercial success evidence; where claims cover “entire vehicle” and expert showed claims covered patent owner’s successful vehicle); WBIP (Fed. Cir. 07/19/16) (rebuttable presumption applies for all objective indicia; substantial evidence of nexus); PPC Broadband I (2015-1361) (Fed. Cir. 02/22/16) (vacating PTAB IPR obviousness decision; when product includes “‘the invention disclosed and claimed in the patent,’ we presume that any commercial success of these… is due to the patented invention” even if product includes unclaimed features too); PPC Broadband II (Fed. Cir. 07/03/18) (non-precedential) (vacating second time for same errors on remand, including failure to require evidence from petitioner rebutting presumption of nexus).
No Presumption Of Nexus Where Product Covered By Two Patents: product covered by patent owner’s prior art patent and patent in suit. Therasense (Fed. Cir. 01/25/10) (reinstated en banc). But seeMerck (Fed. Cir. 10/26/17) (2-1) (“multiple patents do not necessarily detract from evidence of commercial success of a product or process, which speaks to the merits of the invention, not to how many patents are owned by a patentee.”)
(Maybe Not) If Nexus Is To Patent-Ineligible Subject Matter, Then Irrelevant?: Panel so held in In re Comiskey (Fed. Cir. 09/20/07), but then withdrawn by panel Jan. 13, 2009, after en banc order.
Licenses Lack Nexus If Not Entered Due To Merits Of Claimed Invention: patent applicant failed to provide evidence that licensing program was successful “because of the merits of the claimed invention,” rather than due to business decisions to avoid litigation, or prior business relationships, or other economic reasons. In re Antor Media (Fed. Cir. 07/27/12); In re Cree (Fed. Cir. 03/21/16) (aff’g PTAB Sec. 103 unpatentability; no showing of nexus of licenses to merits of claimed invention; “it is often ‘cheaper to take licenses than to defend infringement suits.’”); (Soverain (Fed. Cir. 01/22/13) (commercial success did not support non-obviousness where licensing program unsuccessful except for post-suit settlements and licensees of patent owner’s software abandoned that software.); In re Affinity Labs (Fed. Cir. 05/05/17) (evidence of licensing accorded little weight when licensing agreements and their circumstances not in record) ; SeeBosch (Fed. Cir. 12/22/17) (aff’g PTAB obviousness: license entered to settle litigation entitled to less weight where no showing it was based on merits of invention.)
A Blocking Patent May Explain Why Others Did Not Develop The Claimed Subject Matter: “A blocking patent may or may not deter innovation in the blocked space by commercially motivated potential innovators other than the owners or licensees of the blocking patent.” Acorda Therapeutics (Fed. Cir. 09/10/18) (aff’g obviousness; based in part on blocking patent lowering incentives to innovate).
i) objective indicia of obviousness
Contemporaneous Development Is Objective Indicia Of Obviousness And Can Rebut Secondary Considerations Of Non-Obviousness: When potential prior art turns out to be too late to qualify as prior art, it still may be useful as evidence of contemporaneous independent development. This is relevant both as evidence of the level of skill in the art, and also to show that any long-felt need solved by the “invention” had already been solved by another. Cf.Univ. of Cal. (Broad Institute) (Fed. Cir. 09/10/18) (aff’g no reasonable expectation of success; “simultaneous invention may bear upon the obviousness analysis in two ways. First, it is evidence of the level of skill in the art. Second, it constitutes objective evidence that persons of ordinary skill in the art understood the problem and a solution to that problem.”); Everlight Elecs. (Fed. Cir. 01/04/18) (non-precedential) (aff’g jury verdict of obviousness based in part on evidence of independent development of a white LED “within weeks” of the patent applicant); Trustees of Columbia (Fed. Cir. 07/17/15) (non-precedential) (independent “simultaneous invention demonstrates what others in the field actually accomplished.”); George M. Martin (Fed. Cir. 08/20/10) (invention year later than patent’s reduction to practice date, coupled with other close prior art, was evidence of simultaneous invention showing level of ordinary skill in the art and that “the claimed apparatus was the product only of ordinary mechanical or engineering skill.”).
Success, etc. Of Prior Art Helps Rebut Objective Indicia Of Non-Obviousness: Ohio Willow Wood (Fed. Cir. 11/15/13) (success, copying, etc. of patented device discounted where “these factors equally apply to the prior art SSGL device.”)
j) admissions and omissions supporting obviousness
Lack Of Detail In Patent Implies Known To PHOSITA: In re Fox, 471 F.2d 1405, 1407 (CCPA 1973) (claim elements which are not described in detail in the patent Spec. are presumed to be known to those of ordinary skill in the art): “We agree with the solicitor’s principal contentions that appellant’s claims are directed to what is essentially a tape lending library operation wherein the library makes the copies as demand warrants and that all of the equipment and technical knowledge required to perform the claimed method is admittedly old. The latter admission is to be found in part in express statements in appellant’s specification and in part is deducible from the fact that it assumes anyone desiring to carry out the process would know of the equipment and techniques to be used, none being specifically described.” In re Epstein, 32 F.3d 1559, 1568 (Fed. Cir. 1994) (citing In re Fox with approval: “we find that the disclosure of appellant’s system fails to provide the same detailed information concerning the claimed invention. In the absence of such a specific description, we assume that anyone desiring to carry out such computerized warehousing and inventory control systems would know of the equipment and techniques to be used.”) SeeTrustees of Columbia (Fed. Cir. 07/17/15) (non-precedential) (reasonable expectation of success supported by patent saying “well-established procedures” are used without providing “additional guidance with respect to chemical procedures”; and rejecting argument that prior art non-enabling because patent did not disclose what the prior art supposedly lacked); In re Morsa II (Fed. Cir. 10/19/15) (2-1) (PTAB properly relied on application’s statements regarding what skilled artisans knew, in determining that prior art reference was enabling: “considering that the PMA reference discloses each claim limitation, and that the application’s specification indicates that a person of ordinary skill in the art is capable of programming the invention, the Board’s conclusion that the PMA reference is enabling is correct.”). “There is a crucial difference between using the patent’s specification for filling in gaps in the prior art, and using it to determine the knowledge of a person of ordinary skill in the art.” In re Morsa II (Fed. Cir. 10/19/15) (2-1).
Patent Applicant Arguments Re Enablement May Help Prove Obviousness: Prosecution argument “‘that one skilled in the art would be able to manipulate the processes and formulations of the [prior art] by other methods to obtain the claimed pharmacokinetic parameters of the present invention by routine experimentation.’” is a characterization of the “predictability and skill in the art” that “provides further evidence that it would have been a routine and obvious design choice” to make the alleged combination of prior art. Sciele Pharma (Fed. Cir. 07/02/12) (vacating grant of preliminary injunction); Intellectual Ventures I (Fed. Cir. 09/25/19) (non-precedential) (aff’g PTAB obviousness; patent applicants’ argument to overcome section 112 rejection (“it would have been obvious to one of ordinary skill in the art that the client agent programs must assess unused or under utilized capabilities for it to be able to …”) similar to challenger’s expert’s obviousness opinion).
Use Of Standard Techniques To Isolate Claimed Gene Sequence Is Relevant To Obviousness: “Kubin and Goodwin cannot represent to the public [in the patent] that their claimed gene sequence can be derived and isolated by ‘standard biochemical methods’ discussed in a well-known manual on cloning techniques, while at the same time discounting the relevance of that very manual to the obviousness of their claims.” In re Kubin (Fed. Cir. 04/03/09).
k) genus – species
Genus May Render Species Or Sub-Genus Obvious; And Burden Of Production Shifts To Patent Owner: “Species are unpatentable when prior art disclosures describe the genus containing those species such that a person of ordinary skill in the art would be able to envision every member of the class.” AbbVie (Fed. Cir. 08/21/14) (double patenting case). “Where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations.” Galderma (Fed. Cir. 12/11/13) (rev’g bench-trial non-obviousness judgment); Prometheus (Fed. Cir. 11/10/15) (aff’g Summ. J. of obviousness of claim directed to treating sub-species of genus of patients claimed in prior art patent); seeUniv. of Cal. (Broad Institute) (Fed. Cir. 09/10/18) (aff’g PTAB no interference in fact; claims to use of CRISPR based on Spec. disclosing use with prokaryotic cells did not render obvious claims to use of CRISPR with eukaryotic cells due to lack of reasonable expectation of success); Allergan (Fed. Cir. 08/04/15) (aff’g judgment of non-obviousness; even if ranges disclosed in prior art reference were narrow enough to shift burden of production to patent owner, claimed ranges of two ingredients “could and did materially and unpredictably alter the property of the claimed formulation.”)
Broader Range Disclosed In Prior Art Reference May Render Claimed Range Obvious: There is a “presumption of obviousness” where claimed invention falls within a range disclosed in prior art, rebuttable “either by a showing that the prior art taught away from the invention or by a showing of new and unexpected results relative to the prior art.” Tyco Healthcare (Fed. Cir. 06/22/11) (aff’g Summ. J. of obviousness); cf.Genetics Inst. (Fed. Cir. 08/23/11) (aff’g judgment of non-obviousness, in interfering patents action, in view of (1) structural differences between the claimed proteins, (2) failure to identify “some reason that would have prompted a researcher to modify the prior art compounds in a particular manner to arrive at the claimed compounds,” (3) prior art taught away from the claimed compound, (4) prior art range encompassed 68,000 protein variants, (5) unexpected results, even though not appreciated pre filing and not 100% commensurate with scope of claim.) To overcome prima facie obviousness of claim with range overlapping prior art range, with unexpected results, applicants “need to show unexpected results for the entire claimed range.” In re Patel (Fed. Cir. 07/16/14) (non-precedential) (aff’g PTAB rejection). SeeE.I. duPont (Fed. Cir. 09/17/18) (rev’g PTAB IPR non-obviousness decision; “‘[a] prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art’” but can be overcome by patent owner showing that objective indicia of non-obviousness or modification of process parameter produces unexpected result, or prior art taught away from the claimed range, or parameter not recognized in prior art as result effective (which is a narrow exception), or disclosed ranges so broad as to not invite routine optimization); Allergan (Fed. Cir. 08/04/15) (aff’g judgment of non-obviousness based on unexpected results and teaching away.)
Claimed Range Close To Prior Art Range Not Sufficient (In PTO) For Prima Facie Obviousness: no prima facie obviousness where prior art range approaches claimed range without overlapping, absent teaching in prior art that the end points of the prior art range are approximate, or can be flexibly applied. In re Patel (Fed. Cir. 07/16/14) (non-precedential) (rev’g PTAB rejection).
l) method claims
Where Reference Expressly Discloses Claimed Method, Burden May Shift (In PTO) To Patent Owner To Show Claim-Recited Function Not Achieved By Reference: Where “‘all process limitations . . . are expressly disclosed by [the prior art reference], except for the functionally expressed [limitation at issue],’ the PTO can require an applicant ‘to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on.’” Southwire (Fed. Cir. 09/08/17) (aff’g PTAB obviousness decision; “mere quantification of the results of a known process” is not patentable).
m) obvious as a matter of law
Obvious As Matter Of Law: Selected post KSR cases finding obviousness as matter of law: Intercontinental Great Brands (Fed. Cir. 09/07/17) (2-1) (aff’g Summ. J. obviousness and citing post-KSR Cir. decisions granting and denying Summ. J. under Sec. 103); ABT Sys. (Fed. Cir. 08/19/15) (rev’g denial of JMOL; one reference rendered claims “nearly obvious” and combination of references was obvious); Warner Chilcott (Fed. Cir. 11/18/14) (non-precedential) (combining six references; lack of certainty not defeat obviousness where reasonable expectation of success); Hoffmann-La Roche (Fed. Cir. 04/11/14) (aff’d Summ. J.; reasonable expectation of success; no teaching away); Metso Minerals (Fed. Cir. 05/14/13) (non-precedential) (rev’g jury verdict (infected by erroneous jury instruction) of non-obviousness); Bayer Healthcare (Fed. Cir. 04/16/13) (rev’g trial court Summ. J. of no obviousness, in ANDA context); Soverain (Fed. Cir. 01/22/13) (all claims invalid; rev’g trial court pre-verdict JMOL of non-obviousness); Inventio (Fed. Cir. 11/27/12) (non-precedential) (rev’g trial court denial of JMOL after jury verdict of non-obviousness); WM Wrigley (Fed. Cir. 06/22/12) (aff’g Summ. J. of obviousness despite evidence of copying and commercial success, in part for failure to show nexus); Stone Strong (Fed. Cir. 10/17/11) (non-precedential) (rev’g judgment post bench trial); Cimline (Fed. Cir. 03/02/11) (non-precedential) (rev’g denial of Summ. J. of obviousness and holding as matter of law that claims are invalid for obviousness, despite lack of cross motion seeking such judgment); Tokai (Fed. Cir. 01/31/11) (aff’g Summ. J. of obviousness of claims to safety utility lighters); Western Union (Fed. Cir. 12/07/10) (rev’g $16.5 Million jury verdict (and denial of JMOL), finding commonsense and commonplace to replace facsimile with electronic terminal, and to move from network to Internet (TCP/IP)); George M. Martin (Fed. Cir. 08/20/10) (aff’g JMOL of obviousness); Wyers (Fed. Cir. 07/22/10) (rev’g trial court denial of JMOL to defendant, re patent concerning design of car-trailer hitch pin locks); Dow Jones (Fed. Cir. 05/28/10) (aff’g Summ. J. of obviousness, combining dynamic HTML art with non-Web based functionality); Ecolab (Fed. Cir. 06/09/09) (rev’g denial of JMOL of jury verdict of non-obviousness); Ball Aerosol (Fed. Cir. 02/09/09) (rev’g Summ. J. of non-obviousness and denial of SJ of obviousness); Friskit (Fed. Cir. 01/12/09) (non-precedential) (aff’g Summ. J. of obviousness despite evidence of copying, where trial court had denied Summ. J. initially but then granted Summ. J. after KSR); Boston Sci. Scimed (Fed. Cir. 01/15/09) (rev’g trial court denial of JMOL against jury verdict of non-obviousness: “Combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness.”); Tokyo Keiso (Fed. Cir. 01/09/09) (non-precedential); Sundance (Fed. Cir. 12/24/08) (rev’g trial court JMOL of non-obviousness); Asyst Tech. (Fed. Cir. 10/10/08) (aff’g JMOL of obviousness overturning jury verdict of non-obviousness); Agrizap (Fed. Cir. 03/28/08) (rev’g jury verdict of non-obviousness despite strong secondary indicia of non-obviousness, as combination of old elements with predictable results); Daiichi Sankyo (Fed. Cir. 09/12/07); Aventis Pharm. (Fed. Cir. 09/11/07); Ormco (Fed. Cir. 08/24/07); In re Trans Texas Holdings Corp. (Fed. Cir. 08/22/07). But seeCommonwealth Sci. (Fed. Cir. 09/19/08) (rev’g Summ. J. of non-obviousness due to material fact disputes, including regarding motivation to combine references). Cf.Duramed (Fed. Cir. 03/25/11) (rev’g Summ. J. of non-obviousness and noting that record supported a Summ. J. of obviousness had it been requested).
Post-KSR, Summ. J. Or JMOL Often Appropriate Despite Conflicting Expert Testimony: “KSR and our later cases establish that the legal determination of obviousness may include recourse to logic, judgment, and common sense, in lieu of expert testimony. . . . Thus, in appropriate cases, the ultimate inference as to the existence of a motivation to combine references may boil down to a question of ‘common sense,’ appropriate for resolution on summary judgment or JMOL.” Wyers (Fed. Cir. 07/22/10). See Bob Dylan, Subterranean Homesick Blues (1965) (“You don’t need a weather man to know which way the wind blows.”); cf.Alexsam (Fed. Cir. 05/20/13) (aff’g jury verdict of no obviousness where challenger presented no expert opinion on motivation to combine complex references); ActiveVideo (Fed. Cir. 08/24/12) (aff’g pre-verdict JMOL of no obviousness where challenger’s expert’s testimony was generic and conclusory); but seeIvera Med. (Fed. Cir. 09/08/15) (rev’g Summ. J. of obviousness ivo declarations of expert and a prior art reference’s inventor citing conventional wisdom point away from claimed invention); Outside the Box (Fed. Cir. 09/21/12) (remanding judgment of obviousness, due to wrongful exclusion of expert testimony); Mintz (Fed. Cir. 05/30/12) (“mere recitation of the words ‘common sense’ without any support adds nothing to the obviousness equation.”); InTouch (Fed. Cir. 05/09/14) (rev’g jury verdict of obviousness ivo expert failure to identify sufficient motivations to combine prior references, focus on the relevant time frame, and consider objective evidence of nonobviousness). Cf.Belden (Fed. Cir. 11/05/15) (aff’g PTAB IPR decision of obviousness despite lack of expert declaration with petition, in “simple” mechanical case, in part because PTAB Board members may have technical expertise).