Claim Language With No Patentable Weight Cannot Distinguish Prior Art, Support An Objective Indicia Of Non-Obviousness, Or Be An Inventive Concept For Alice Step Two: Some claim language does not “define the inventions to be assessed for patentability.” Arctic Cat (Fed. Cir. 03/26/19) (aff’g preamble has no patentable weight); seePraxair (Fed. Cir. 05/16/18) (2-1) (“providing information” type claim language has no patentable weight and therefore cannot distinguish over prior art, or be the basis for secondary considerations, such as unexpected results, in support of non-obviousness: “Such printed matter cannot be brought within the ambit of patent eligibility by showing that it was surprising. No patentable weight means no patentable weight.”); In re Guldenaar Holding (Fed. Cir. 12/28/18) (aff’g Sec. 101 rejection of ex parte appln. claims; markings on dice are printed matter (information) having no functional relationship with the substrate and thus have no patentable weight in a claimed method for playing a dice game and do not constitute “inventive concept” for purposes of Step Two of Alice).
Whether Claim Language Has Patentable Weight (Can Be Used To Distinguish Prior Art) Is Related To But Distinct From Whether That Language Qualifies As Limitation For Infringement Purposes: Whether claim language has patentable weight is related to but different than whether claim language constitutes a limitation for infringement purposes. E.g., “‘process terms in product-by-process claims serve as limitations in determining infringement.’” Abbott Labs. (Fed. Cir. 05/18/09) (en banc in part), but cannot distinguish prior art, unless impart novel structure: “For product-by-process claims, that which anticipates if earlier does not necessarily infringe if later.” Amgen (Fed. Cir. 09/15/09). Courts, however, rarely acknowledge this distinction and sometimes conflate the two doctrines; partly as a result, the same answer normally applies to both issues. E.g., Textron (Fed. Cir. 09/07/12) (non-precedential) (citing at least some “no patentable weight” precedents in support of holding that functional language in an apparatus claim (at least when in the preamble) is a limitation only where “the language describes something about the structure of the apparatus rather than merely listing its intended or preferred uses.”); Bristol-Meyers (Fed. Cir. 04/20/01) (“Bristol cannot have an expression be limiting in this [anticipation] context and non-limiting in another [infringement context].”).
Many Types Of Claim Language Have No Patentable Weight When Comparing Claim To Prior Art: Sometimes claim language, even when it recites something new and non-obvious, has “no patentable weight,” or “no patentable consequence” (AstraZeneca (Fed. Cir. 11/01/10)) albeit it may or may not be a limitation for infringement purposes. E.g.: a preamble, a whereby or thereby clause, “printed matter,” intended result, intended use, new intended use of an old capability, “a newly discovered fact about the association between [an old product’s] components or functions”; process portion of a product-by-process claim, source or process limitations in claim to an old product, input signals in a circuit claim, and non-functional descriptive material in a method or non-method claim. But seeMayo (U.S. 03/20/2012) (“But §§102 and 103 say nothing about treating laws of nature as if they were part of the prior art when applying those sections. Cf. Diehr, 450 U.S., at 188 (patent claims ‘must be considered as a whole’).”); In re Jasinski (Fed. Cir. 02/15/13) (non-precedential) (rev’g BPAI refusal to give language patentable weight where the language “refer[s] to the ‘essence of the invention’”). Consider seeking such a ruling as part of Markman (e.g., “this claim language limits the claim but has no patentable weight”).
Patentable Weight Can Be Determined During Claim Construction: “The Board properly addressed the printed matter doctrine during claim construction. The Board’s printed matter analysis here only required analyzing and interpreting the meaning of the claim language. That is claim construction, which is ultimately a legal inquiry.” Praxair (Fed. Cir. 05/16/18) (2-1) (providing information claim language has no patentable weight); seeC R Bard (Fed. Cir. 11/10/20) (aff’g claim construction that printed matter not entitled to patentable weight but vacating JMOL of anticipation; Praxair decided that “the questions of whether certain claim elements are directed to printed matter and whether such printed matter is functionally related to other claim elements may properly be resolved during claim construction”).
AIA: the Act uses this “no patentable weight” concept: “for purposes of evaluating an invention under section 102 or 103,” “any strategy for reducing, avoiding or deferring tax liability”: “shall be deemed insufficient to differentiate a claimed invention from the prior art.” (Sec. 14(a).)
BPAI Precedential And Informative Decisions Re No Patentable Weight: In re Schulhauser (PTAB 04/28/16) (precedential) (under broadest reasonable interpretation, steps triggered only if a condition precedent is met (“triggering an alarm state if the electrocardiac signal data is not within the threshold electrocardiac criteria; determining the current activity level of the subject from the activity level data if the electrocardiac signal data is within the threshold electrocardiac criteria”) need not be performed, such that an obviousness ground need not address those conditional steps; citing Cybersettle and Applera for parallel rule in infringement analyses); In re Nehls, No. 2007-1823, 2008 WL 258370, *10 (BPAI Jan. 28, 2008) (precedential) (expanded panel) (“There is no evidence that SEQ ID NOs 9-1008 functionally affect the process of comparing a target sequence to a database by changing the efficiency or accuracy or any other characteristic of the comparison. Rather, the SEQ ID NOs are merely information being manipulated by a computer; ….”); In re Curry, 84 USPQ2d 1272 (BPAI 2005) (“Informative Opinion”), aff’d (Fed. Cir. Appeal No. 2006-1003, June 12, 2006) (“Common situations involving nonfunctional descriptive material are: … – a computer that differs from the prior art solely with respect to nonfunctional descriptive material that cannot alter how the machine functions (i.e., the descriptive material does not reconfigure the computer), or – a process that differs from the prior art only with respect to nonfunctional descriptive material that cannot alter how the process steps are to be performed to achieve the utility of the invention.”).
Closely Related Doctrine: Admitted Inherency: A claimed property “is not an additional requirement imposed by the claims” where patent discloses that it is “a property necessarily present” where other claim limitations are present. Alcon Res. (Fed. Cir. 08/08/12) (quoting In re Kubin (Fed. Cir. 04/03/09)); Persion Pharma. (Fed. Cir. 12/27/19) (aff’g obviousness where combined prior art had same formulation as that disclosed in Spec.; “the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims”); cf.Par Pharm. (Fed. Cir. 12/03/14) (vacating obviousness judgment where no finding that claimed effects were “necessarily present” or the “natural result” of claimed steps); but seeEndo Pharma. (Fed. Cir. 05/16/18) (non-precedential) (distinguishing Par Pharm. because here claims require controlled release configuration which has been “specifically calibrated to produce the pharmacokinetic properties recited in the claims”).
Markman Position May Waive “No Patentable Weight” Or “Inherency” Argument: Mytee Prod. (Fed. Cir. 09/02/11) (non-precedential) (“Mytee waived any inherency arguments when it proposed a functional definition for a structural limitation.”).
TIPS: Unified Theory Of No Patentable Weight:
Whether Preamble Is Limiting Or Has Patentable Weight Is A Claim Construction Issue: “Whether preamble language is limiting is a claim-construction issue.” Simo Holdings (Fed. Cir. 01/05/21) (aff’g that preamble is limiting, rev’g broad claim construction thereof, rev’g Summ. J. of infringement, and granting Summ. J. of no infringement); Arctic Cat (Fed. Cir. 03/26/19) (preamble has no patentable weight; “We have treated the effect of preamble language as a claim-construction issue.”).
Preamble Statement Of Intended Use Has No Patentable Weight And Is Not Limiting, Generally: “A claim’s preamble may be limiting ‘if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.’ But, generally, ‘a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Sanofi Mature (Fed. Cir. 02/05/19) (non-precedential) (rev’g PTAB; preamble “method of increasing survival” is limiting because it “expresses the ‘intentional purpose [—increasing survival—] for which the method must be performed,” also in part because body of claim refers back to the preamble (“method of increasing survival comprising administering to a patient in need thereof”), and Spec. emphasizes increasing survival as important part of the invention). Preamble language, in article of manufacture claim, “for permitting a user to write thereon without the use of a marking implement,” not a limitation because mere statement of intended use and not clearly relied upon in prosecution history to distinguish over prior art. “[T]hat a structural term in the preamble is part of the claim does not mean that the preamble’s statement of purpose or other description is also part of the claim.” Marrin (Fed. Cir. 03/22/10) (claims anticipated); Outdry (Fed. Cir. 06/16/17) (aff’g PTAB obviousness decision; preamble (“A process for waterproofing leather”) “is simply a statement of intended use, not a separate claim limitation” and need not be disclosed in prior art reference); Acceleration Bay (Fed. Cir. 11/06/18) (aff’g that italicized language is intended use with no patentable weight: “A computer network for providing an information delivery service for a plurality of participants …”); Catalina (Fed. Cir. 05/08/02) (vacating Summ. J. non-infringement; italicized language in preamble not limiting: “system for controlling the selection and dispensing of product coupons at a plurality of remote terminals located at predesignated sites such as consumer stores wherein each terminal comprises…”); In re Rudy (Fed. Cir. 07/18/19) (non-precedential) (aff’g PTAB that preamble (“kit from which a web-mounting fishing plug can be assembled in a home environment”) is a mere intended use with no patentable weight).
Preamble Language Providing Antecedent Basis For Language In Body Of Claim, Generally Has Patentable Weight And Is Limiting: “We have repeatedly held a preamble limiting when it serves as antecedent basis for a term appearing in the body of a claim.” In re Fought (Fed. Cir. 11/04/19) (rev’g PTAB in ex parte appln.; term “travel trailer” in preamble and body of claim is a structural limitation (towability and a living area) and distinguishes prior art cargo truck trailer); Arctic Cat (Fed. Cir. 03/26/19) (preamble did not serve as antecedent basis).
Preamble Language Provding “Essential Structure” Is Limiting And Has Patentable Weight: “In general, a preamble limits the invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim. Conversely, a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Catalina (Fed. Cir. 05/08/02); Neapco (Fed. Cir. 03/10/21) (non-precedential) (aff’g PTAB that “venting a slip joint assembly” has no patentable weight, in part because Spec. does not describe that as essential, and thus does not limit claimed method to externally vented slip joints).
Jepson Claim (“Wherein The Improvement Comprises”) Preamble Has Patentable Weight And Is Limiting: “Jepson claiming generally indicates intent to use the preamble to define the claimed invention, thereby limiting claim scope.” Catalina (Fed. Cir. 05/08/02). SeeArctic Cat (Fed. Cir. 03/26/19) (holding claim preamble lacks patentable weight in part because of choice not to use Jepson claim format).
Preamble Recitation Of Conventional Structure, Not In Jepson Claim Format, And Not Relied Upon In Prosecution, Has No Patentable Weight And Is Not Limiting: “Where an applicant chose not to use the well-established Jepson transitional phrase, and the preamble is wholly conventional while only the body of the claim identifies an improvement, that choice is a powerful reason to deny the preamble the limiting effect it would have had if the ‘improvement’ transitional phrase had been used.” Arctic Cat (Fed. Cir. 03/26/19) (aff’g preamble (“A personal recreational vehicle comprising”) has no patentable weight, despite it reciting additional structure beyond that recited in body of claim (reciting an assertedly inventive electrical-connection box), and being identified in Spec. as part of the invention, because preamble (1) does not serve as antecedent basis for terms in claim body, (2) is not needed to make body itself structurally complete invention, but instead the body is a part of the preamble’s structure, (3) was not relied upon in prosecution to distinguish prior art, (4) is not described in Spec. as being unconventional or an improvement, and (5) does not follow Jepson claim format (reciting conventional or known elements in preamble following by transition phrase “wherein the improvement comprises”).
Whether Preamble Has Patentable Weight And Is Limiting May Depend On Whether Claim Before PTO Or In District Court: In re Taylor (Fed. Cir. 06/14/12) (non-precedential) (aff’g PTO ruling that preamble not limiting, and distinguishing prior cases as arising in infringement litigation context).
Preamble Use Of Label For Invention As A Whole Not A Limitation (Infringement): Reciting “a label for the invention as a whole” (“photoselective vaporization of tissue”) rather than an essential structure or step, is not limiting in infringement analysis. Am. Med. (Fed. Cir. 09/13/10); seeStorage Tech. (Fed. Cir. 05/13/03) (rev’g Summ. J. non-infringement, in part faulting district court basing narrow claim construction on preamble reference to “policy caching” which is just convenient label for invention as a whole and not limiting of claim scope). Seesupra, “How Construed?,” “claim preamble.”
b) printed matter, instructions on use, mental steps
“Printed Matter” Without Functional Or Structural Relationship To Physical Realm Has No Patentable Weight: A claim limitation is directed to printed matter “‘if it claims the content of information,’” and such limitations “are not entitled to patentable weight unless the printed matter is functionally related to the substrate on which the printed matter is applied” “because such information is not patent eligible subject matter under 35 U.S.C. § 101.” Praxair (Fed. Cir. 05/16/18) (2-1) (claimed providing of information to doctor along with nitric oxide gas cylinders, has no patentable weight). “Printed matter encompasses any information claimed for its communicative content, and the doctrine prohibits patenting such printed matter unless it is ‘functionally related’ to its ‘substrate,’ which encompasses the structural elements of the claimed invention.” C R Bard (Fed. Cir. 11/10/20) (aff’g that “the content of the information conveyed by the claimed markers—i.e. that the claimed access ports are suitable for injection at the claimed pressure and flow rate—is printed matter not entitled to patentable weight,” but vacating Summ. J of anticipation); In re Guldenaar Holding (Fed. Cir. 12/28/18) (aff’g Sec. 101 rejection of ex parte appln. claims; markings on dice are printed matter (information) having no functional relationship with the substrate and thus have no patentable weight in a claimed method for playing a dice game and do not constitute “inventive concept” for purposes of Step Two of Alice). “A limitation is printed matter only if it claims the content of information… [It] must be matter claimed for what it communicates.” In re DiStefano (Fed. Cir. 12/17/15) (rev’g PTAB determination that claim element (“selecting a first element from a database including web assets authored by third party authors and web assets provided to the user interface or outside the user interface by the user”) lacks patentable weight: “Although the selected web assets can and likely do communicate some information, the content of the information is not claimed. And where the information came from, its ‘origin,’ is not part of the informational content at all.”); In re Taylor (Fed. Cir. 05/22/19) (non-precedential) (aff’g PTAB obviousness; claimed placing advertisements (including a barcode) of nearby businesses on advertising mat at base of a gas pump; “inclusion of a barcode is nothing more than another type of printed matter within an advertisement that does not change the function of the claimed advertising mat”); In re Theresa (Fed. Cir. 01/17/18) (non-precedential) (aff’g obviousness rejection; where claim recites symbols printed on labels affixed to memory devices, the symbols have “no patentable weight” because they “bear no functional or structural relationship to the labels on which they are printed and thus cannot form a patentable distinction with the prior art references … [The] labels relate to the contents of the memory devices labeled, not to the labels on which they are printed.”); In re Bryan (Fed. Cir. 03/31/09) (non-precedential) (aff’g obviousness rejection of claim to a “game board and game,” “the printed matter does not depend on the game’s structural elements, and the game’s structural elements do not depend on the printed matter.”); In re Xiao (Fed. Cir. 10/12/11) (non-precedential) (aff’g Board obviousness ruling based on ruling that wild-card position label on combination lock (which user could associate as part of a memorable word) has no patentable weight: “The claimed lock’s function turns solely on the physical alignment among tumbler rings, regardless of what may be printed at each position or how an individual user subjectively perceives any particular position label. In short, the presence or identity of a given position label has no bearing on the lock’s ultimate function, and the claimed device can be used in the same way and for the same purposes with or without wild-card position labels.” Information “useful and intelligible only to the human mind” has no patentable weight.) But seeIn re DiStefano (Fed. Cir. 12/17/15) (rev’g PTAB determination that claim element (“selecting a first element from a database including web assets authored by third party authors and web assets provided to the user interface or outside the user interface by the user”) constitutes “printed matter”); In re Gulack (Fed. Cir. 03/30/83) (2-1) (sufficient functional relationship where claims “require a particular sequence of digits to be displayed on the outside surface of a band. These digits are related to the band in two ways: (1) the band supports the digits; and (2) there is an endless sequence of digits — each digit residing in a unique position with respect to every other digit in an endless loop. Thus, the digits exploit the endless nature of the band.” “The critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate.”).
Novel Instructional Limitation Has No Patentable Weight Where It Lacks Functional Relationship With Rest Of Claimed “Invention”: “Printed matter” case law applies to method claims as well as product claims. Where “an instructional limitation” (“‘informing’ the patient that taking metaxalone with food will increase the drug’s bioavailability”) is added to an old method, it cannot avoid invalidity unless it has a “new and unobvious functional relationship” with the known method. “This relationship, however, is not functional. Informing a patient about the benefits of a drug in no way transforms the process of taking the drug with food. Irrespective of whether the patient is informed about the benefits, the actual method, taking metaxalone with food, is the same. In other words, the ‘informing’ limitation ‘in no way depends on the [method], and the [method] does not depend on the [‘informing’ limitation].’”); King Pharm. (Fed. Cir. 08/02/10) (citing In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004) (per curium)); accordIn re Kao (Fed. Cir. 05/13/11) (“no functional relationship” between the administering and informing steps). Cf.Warsaw I (Fed. Cir. 03/02/15) (rejecting convoyed sales lost profits because related products not “functionally related to the patented product, in part because they would work as well without the patented technology”).
Drug Label Has No Patentable Weight: “as in Ngai the claimed instructions here are not entitled to patentable weight. The instructions in no way function with the drug to create a new, unobvious product. Removing the instructions from the claimed kit does not change the ability of the drug to treat respiratory diseases.” AstraZeneca (Fed. Cir. 11/01/10).
Mental Steps Have No Patentable Weight If Informational Content Has No Functional Relationship To Physical Realm: “Because claim limitations directed to mental steps may attempt to capture informational content, they may be considered printed matter lacking patentable weight in an obviousness analysis. Accordingly, a limitation that merely claims information by incorporating that information into a mental step will receive patentable weight only if the limitation is functionally related to the substrate.” Praxair (Fed. Cir. 05/16/18) (2-1) (giving no patentable weight to a “limitation [which] merely requires a medical provider to think about the information claimed in the providing information [claim] limitation;” but limitation “providing information and a recommendation to the medical provider to discontinue nitric oxide treatment for a patient with preexisting LVD who experiences a pulmonary edema” has patentable weight where claim also recites “based on” the recommendation, discontinuing nitric oxide treatment due to the pulmonary edema).
c) non-functional descriptive material
Non-Functional Information Has No Patentable Weight: “Here, the descriptive material (SEQ ID NOs) recited in the claims is not functional material like the data structures in Lowry. There is no evidence that SEQ ID NOs 9-1008 functionally affect the process of comparing a target sequence to a database by changing the efficiency or accuracy or any other characteristic of the comparison. Rather, the SEQ ID NOs are merely information being manipulated by a computer; the SEQ ID NOs are inputs used by a computer program that calculates the degree of similarity between a target sequence and each of the sequences in a database. The specific SEQ ID NOs recited in the claims do not affect how the method of the prior art is performed – the method is carried out the same way regardless of which specific sequences are included in the database…. The recited sequences are not functionally related to the computer system carrying out the comparison because the computer compares a target sequence to a database the same way regardless of whether the database includes any of SEQ ID NOs 9-1008: the SEQ ID NOs and the computer do not depend on each other for their function. …. The claimed computer system requires the recited SEQ ID NOs, but not every claim limitation suffices to distinguish a claimed invention from the prior art. In this case, we conclude that the particular SEQ ID NOs recited in claim 13 do not patentably distinguish the claimed computer system from a prior art system that is otherwise identical.” In re Nehls, (BPAI Jan. 28, 2008) (precedential) (expanded panel) (footnotes omitted) (system claim).
Claim Language With No “Manipulative Difference” In A Process Claim Has No Patentable Weight: “Claim language without any bearing on the claimed methods should be deemed non-limiting when it does not result in ‘a manipulative difference in the steps of the claim.’” Teva Pharma. (Fed. Cir. 10/12/18) (aff’g emphasized claim language “non-limiting” (i.e., cannot distinguish over prior art): “‘[a] method . . . comprising administering to the human patient a therapeutically effective dosage regimen . . . , the regimen being sufficient to reduce the frequency of relapses in the patient.’”); L’Oreal (Fed. Cir. 01/28/21) (non-precedential) (aff’g PTAB non-obviouness finding; rejecting argument that dependent claim language “wherein following step (c) breakage of the hair is decreased by at least 5% compared to hair bleached with the bleaching formulation in the absence of the active agent” lacked patentable weight because it “‘state[s] specific requirements rather than a general purpose or aspirational result for the claimed method”’ and otherwise the dependent claims would be a nullity. Collecting cases in which claim language made no manipulative difference: “the language at issue identified a property in only very general terms and appeared in the very same claim that stated the other more concrete requirements”).
d) intended use
Intended Use Has No Patentable Weight: “[T]he grant of a patent on a composition or machine cannot be predicated on a new use of that machine or composition…. As a matter of claim drafting, therefore, the discoverer of a new use must protect his discovery by means of process or method claims and not product claims.” In re Hack (CCPA 1957). SeeIn re Dillon (Fed. Cir. 11/09/90) (en banc) (“composition claims on appeal are not structurally or physically distinguishable from the prior art compositions by virtue of the recitation of their newly-discovered use”). “The rule against giving invention-defining effect to intended-use preamble language reflects a longstanding substantive aspect of the patent statute—specifically, the ‘well settled’ fundamental principle ‘that the recitation of a new intended use for an old product does not make a claim to that old product patentable.’” Arctic Cat (Fed. Cir. 03/26/19) (aff’g preamble has no patentable weight; “the bodies of [the claims] ‘describe structurally complete inventions’ and the preambles refer to a personal recreational vehicle only as an intended use”); Cochlear (Fed. Cir. 05/15/20) (2-1) (aff’g PTAB obviousness determination; preamble phrase “for rehabilitation of unilateral hearing loss” a non-limiting statement of intended use); In re Chudik (Fed. Cir. 08/25/17) (non-precedential) (aff’g anticipation rejection of app. claims; “The patentability of an apparatus claim ‘depends on the claimed structure, not on the use or purpose of that structure.’” Claim to “a humeral implant comprising a humeral surface component having a non-articular surface configured for long-lasting fixation of the implant on a humeral head and no stem,” anticipated by glenoid implant); In re Anderson (Fed. Cir. 10/13/16) (non-precedential) (aff’g Examiner obviousness finding; claim language that data is transmitted “for use by motorists in determining a route of travel” is not limiting because it is “a statement of intended use” and “does not add a structural limitation to the claimed system or method.”); But seeMatthews (Fed. Cir. 03/27/18) (non-precedential) (rejecting argument that “casket body” has no patentable weight as mere intended use: “‘Casket body’ is a structural term in the body of the claim that further defines and limits the scope of the claimed invention. That structural terms are sometimes defined—through claim construction—by the functions they are designed to perform does not somehow convert those structural terms into ‘an intended use’ stripped of any patentable weight.”).
New Intended Use Of An Old Capability, Has No Patentable Weight: “Schreiber’s contention that his structure will be used to dispense popcorn does not have patentable weight if the structure is already known, regardless of whether it has ever been used in any way in connection with popcorn.” “The examiner and the Board both addressed the question whether the functional limitations of Schreiber’s claim gave it patentable weight and concluded that they did not, because those limitations were found to be inherent in the Harz prior art reference.” In re Schreiber (Fed. Cir. 10/23/97) (dispensing top for popcorn), distinguished in Mytee Prod. (Fed. Cir. 09/02/11) (non-precedential), in Bettcher (Fed. Cir. 10/03/11) (2-1) (claim required more capability than may have been inherent in prior art device.), and in In re Chudik (Fed. Cir. 01/09/17) (non-precedential) (rev’g anticipation rejection, no substantial evidence that reference taught the functional limitation).
e) wherein and whereby clauses
Wherein And Whereby Clauses Have No Patentable Weight Where Merely State Intended Result: Allergan (Fed. Cir. 08/29/19) (aff’g preliminary injunction, and that efficacy “wherein” clause and safety “wherein” clause each is “material to patentability and thus limiting,” because the Spec. “demonstrates that Allergan believed the increased efficacy and safety of the claimed methods to be material to patentability,” and applicants and examiner relied in prosecution on recited efficacy and safety); Minton (Fed. Cir. 07/29/03) (aff’g Summ. J. of invalidity for “on sale” bar: “A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”); MPHJ (Fed. Cir. 02/13/17) (O’Malley, J., dissenting) (in analyzing anticipation of system claim, “the “wherein” limitation at issue is conditional; it explains that a specific protocol is used when one of said external destinations is email application software. Under the broadest reasonable interpretation of claim 1, the limitations in the “wherein” clause would not apply because email application software is not required to be the external destination in all embodiments.”); Griffin (Fed. Cir. 04/02/02) (“wherein” clauses have “limiting effect … because they relate back to and clarify what is required by” the operative steps of the claim); cf.Hoffer (Fed. Cir. 04/22/05) (“when the ‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention”).
f) intended result
Intended Result And Purpose Has No Patentable Weight: Roche (Fed. Cir. 07/09/08) (“in a stabilizing amount” is an intended result and not a claim limitation for infringement purposes; in a composition claim); Bristol-Myers (Fed. Cir. 04/20/01) (italicized language is mere statement of purpose and intended result that is “non-limiting” (i.e., cannot distinguish prior art): “method for reducing hematologic toxicity in a cancer patient undergoing [t]axol treatment comprising parenterally administering to said patient an antineoplastically effective amount of about 135-175 mg/m2 taxol over a period of about three hours,” and “[a] method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity.” “The expression does not result in a manipulative difference in the steps of the claim.”); but seeLos Angeles Biomedical (Fed. Cir. 02/28/17) (emphasized language (“‘arresting or regressing the [penile] fibrosis, wherein the PDE-5 inhibitor is administered at a dosage up to 1.5 mg/kg/day for not less than 45 days’”) is not mere intended result without patentable weight because part of separate step of the method not a preamble (although that is “not dispositive”), and it demands efficacy not otherwise found in the claim language); L’Oreal (Fed. Cir. 01/28/21) (non-precedential) (aff’g PTAB non-obviouness finding; rejecting argument that dependent claim language “wherein following step (c) breakage of the hair is decreased by at least 5% compared to hair bleached with the bleaching formulation in the absence of the active agent” lacked patentable weight because it “‘state[s] specific requirements rather than a general purpose or aspirational result for the claimed method”’ and otherwise the dependent claims would be a nullity. Collecting cases in which claim language made no manipulative difference: “the language at issue identified a property in only very general terms and appeared in the very same claim that stated the other more concrete requirements”).
g) process portion of product-by-process claim
Process Limitation Has No Patentable Weight Unless Imparts Structural Difference: “For product-by-process claims, that which anticipates if earlier does not necessarily infringe if later.” Amgen (Fed. Cir. 09/15/09); In re Pond (Fed. Cir. 01/18/12) (non-precedential) (“a product-by-process claim does not add a patentable distinction when the claimed product is the same as the cited art’s product”). But, “there is an exception to this general rule that the process by which the product is made is irrelevant. As we recognized in Amgen, if the process by which a product is made imparts ‘structural and functional differences’ distinguishing the claimed product from the prior art, then those differences ‘are relevant as evidence of no anticipation’ although they ‘are not explicitly part of the claim.’” Greenliant (Fed. Cir. 08/22/12); Purdue Pharma (Fed. Cir. 02/01/16) (limitation that element be “derived from” a particular source was a process limitation, not a structural or functional limitation, because “source of the 14-hydroxy has no effect on its structure or its removal through hydrogenation,” and therefore could not distinguish prior art in obviousness determination); In re Thorpe (Fed. Cir. 11/21/85) (“The patentability of a product does not depend on its method of production.”). “For validity purposes, the ‘invention’ in a product-by-process claim is the product.” The Medicines Co. II (Fed. Cir. 07/11/16) (en banc).
Where Can Be Interpreted As Structural Limitation Or Process Or Functional Limitation, Default Is Structural Interpretation: In re Nordt (Fed. Cir. 02/08/18) (vacating PTAB construction of “injection molded” as process limitation with no patentable weight: “words of limitation that can connote with equal force a structural characteristic of the product or a process of manufacture are commonly and by default interpreted in their structural sense, unless the patentee has demonstrated otherwise;” citing multiple examples in precedents); Palo Alto Networks (Fed. Cir. 07/02/19) (non-precedential) (aff’g PTAB non-obviousness; “code scanner” is a structural limitation; that reference teaches something with function of claim’s “scanner” does not mean it discloses structure of claim’s “scanner”); In re Garnero (CCPA 06/26/69) (interpreting as structural that particles are “‘interbonded one to another by interfusion between the surfaces of the perlite particles’” because as capable of being construed as a structural limitation as “intermixed,” “ground in place,” “press fitted,” “etched,” and “welded,” all of which at one time or another have been separately held capable of construction as structural, rather than process, limitations”). SeeAlere (Fed. Cir. 10/29/19) (2-1) (non-precedential) (aff’g that “wherein” clause in device claim recites “functional language that informs us of the structural requirements of the claim,” and does not impart process limitation).
h) source or process restrictions in product claim or product limitation
Process Or Source Restriction Has No Patentable Weight In Product Claim Or Product Limitation Unless Imparts Structural Difference: “when considering obviousness and anticipation issues relating to the ’080 and ’422 patents the district court should be cognizant of the rule that a claimed product shown to be present in the prior art cannot be rendered patentable solely by the addition of source or process limitations. Gen. Elec. (1938); Cochrane (1884).” Amgen (Fed. Cir. 01/06/03); Biogen (Fed. Cir. 09/28/20) (reinstating jury verdict of anticipation (by naturally occurring human interferon-β) of a method of treatment claim using “a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule”; “the recombinant origin of the recited composition cannot alone confer novelty on that composition if the product itself is identical to the prior art non-recombinant product.” Because “an old product is not patentable even if it is made by a new process,” it follows that “an old method of administration of an old product made by a new process is not novel and cannot be patented.”); Purdue Pharma (Fed. Cir. 02/01/16) (“Because the source of the 14-hydroxy has no effect on its structure or its removal through hydrogenation, the limitation that it be ‘derived from 8α’ cannot be a structural limitation.”); In re Dilnot (CCPA 04/13/92) (“The addition of a method step in a product claim, which product is not patentably distinguishable from the prior art, cannot impart patentability to the old product.”); Cf.Amgen (Fed. Cir. 09/15/09) (source limitation imparted novel structure).
i) optional, conditional steps
Optional And Conditional Steps May Have No Patentable Weight: In re Johnston (Fed. Cir. 01/30/06) (aff’g anticipation: “optional elements [“may be”] do not narrow the claim because they can always be omitted”); In re Schulhauser (PTAB 04/28/16) (precedential) (under broadest reasonable interpretation, steps triggered only if a condition precedent is met need not be performed, such that an obviousness ground need not address those conditional steps; citing Cybersettle and Applera for parallel rule in infringement analyses); cf.MPHJ (Fed. Cir. 02/13/17) (O’Malley, J., dissenting) (in analyzing anticipation of system claim, “the ‘wherein’ limitation at issue is conditional; it explains that a specific protocol is used when one of said external destinations is email application software. Under the broadest reasonable interpretation of claim 1, the limitations in the ‘wherein’ clause would not apply because email application software is not required to be the external destination in all embodiments.”). But seeHytera (Fed. Cir. 01/19/21) (non-precedential) (aff’g PTAB non-obviousness finding; prior art needs to teach both prongs of conditional if then else clause in a method claim because the “claim specifies what action must occur in each scenario of the conditional limitation,” citing Lincoln Nat’l (Fed. Cir. 06/23/10) (aff’g infringement, no need to prove account ever exhausted only that system configured so would perform step even if account exhausted: “periodically paying the scheduled payment to the owner for the period of benefit payments, even if the account value is exhausted before all payments have been made”): “the ‘selecting’ step in claim 7 is not met unless the TDMA system is configured to perform each claimed responsive action in response to each corresponding claimed prerequisite condition,” and distinguishing Brown and In re Schulhauser (as reciting two methods not one)).
j) input signals in a circuit
Input Signals In A Circuit Claim Have No Patentable Weight: “In fact, Translogic admits, as is proper for a structural circuit, that the input variables (i.e., signals) are not part of the claimed invention.” In re Translogic Tech. (Fed. Cir. 10/12/07).
k) theory of operation
Newly Discovered Association Between An Old Product And Its Function, Has No Patentable Weight: “nothing material to anticipation is added,” in a product claim, by claim language “weight concentration ratio correlating to the quality of fabric safety of the product solution selected with the range of damaging to abated damage to cotton-safe” because “a newly discovered fact about the association between [an old product’s] components or functions” “does not alter what the product is or even does.” In re Taylor (Fed. Cir. 11/06/15).
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