2022 Q2 Patent Defenses Update
Highlights and Strategies from Apr. – June Fed. Cir. Decisions on Substantive Patent Law.
This quarter’s most interesting decisions concerned Sec. 112. The Fed. Cir. continued its robust enforcement of Sec. 112(a)’s written description mandate, made questionable decisions uncharacteristically narrowing the scope of Sec. 112(f), and continued its generally weak enforcement of Sec. 112(b)’s mandate for particular and distinct claims.
The most interesting non-decision was the Supreme Court denying certiorari in the Sec. 101 patent eligibility case, American Axle, on June 30, despite the Solicitor General urging that the Court revisit and revise Alice.
Generic Claim Element Loses Entitlement to Ancestor Application’s Filing Date
To be entitled to an ancestor application’s filing date, a claim must, of course, encompass something described in that application. But, under Sec. 112(a), it also must not claim beyond the scope of that ancestor’s disclosure, such as claiming a genus where the ancestor criticized a species within the genus.
- Arthrex (Fed. Cir. 05/27/22) (aff’g PTAB finding that claims not entitled to priority date of ancestor’s filing date where generic claim element encompassed both flexible and rigid eyelets but ancestor application criticized flexible eyelet design described in incorporated parent application and instead touted rigid eyelet as solving problems associated with flexible eyelets).
A Negative Limitation Must Be Disclosed Expressly, Such as a Reason to Exclude That Element, or Inherently
Having a Fed. Cir. panel reverse itself on rehearing is exceedingly rare … unless one of the two Judges in the split decision against you, retires. After J. Hughes replaced retiring J. O’Malley, a Fed. Cir. panel reversed itself on rehearing and held claims invalid under Sec. 112(a) for lack of written description support, with a lengthy discussion of what’s required to support a negative claim limitation.
- Novartis (Fed. Cir. 06/21/22) (2-1) (rev’g D. Ct. finding that negative limitation was disclosed; where claim recited “administering fingolimod ‘at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen’”: “The question is not whether the patentee intended there to be a loading dose; the question is whether the patentee [in the specification] precluded the use of a loading dose.” Probabilities are insufficient.), vacating Novartis (Fed. Cir. 01/03/22) (2-1).
“Code” Configured to Perform Function Does Not Trigger Sec. 112(6/f) Where Conventional Code Available to Perform the Function
The Federal Circuit generally has strictly applied Williamson, with 13 post-Williamson opinions finding claim terms not using “means,” triggering Section 112(6/f). But in a precedential opinion on a claim reciting “code” “configured to” perform specific functions, it seems to ask the wrong question, namely did skilled artisans know of existing code for performing the function. The correct question is whether the claim recites particular structures, materials or acts for performing the function so that the claim does not encompass all possible ways of performing the function. 23 IP Professors have filed an Amici brief supporting a petition for rehearing en banc.
- Dyfan (Fed. Cir. 03/24/22) (rev’g indefiniteness; the claim limitations (“system comprising … code, when executed, further configured to …,” “application [configured to …],” and “system [configured to …]”) do not trigger 112(6/f) where challenger’s expert testified that skilled artisans would have understood that “conventional” “off-the-shelf” applications and code were available to perform the functions), petition for rehearing en banc (05/02/22) (treating “code” as structure is contrary to Williamson). See IP Professors’ Amici in support of rehearing (05/16/22) (“If software patentees can avoid Williamson and write purely functional claims merely by using the word ‘code’ in place of actual structure, this Court will have rendered Williamson a dead letter.”).
Fed. Cir. Continues Mixed Enforcement of Mandate That Claims Have Clear Boundaries
In two decisions finding claims not indefinite, the Court was satisfied that the specification disclosed examples inside the claims’ scope without analyzing, expressly at least, whether the skilled artisan could reasonably identify a clear boundary between what’s outside the claim vs. inside the claim.
- Clearone (Fed. Cir. 06/01/22) (aff’g PTAB that substitute claim’s “microphones arranged in a self-similar configuration” is not indefinite where Spec. provides examples showing “that self-similar configuration refers to repeating or fractal-like configurations, such as concentric rings, ovals, or other shapes”).
- Niazi (Fed. Cir. 04/11/22) (where claim recited a double catheter comprising an outer “resilient catheter having shape memory” and inner “pliable catheter,” rev’g Markman order finding “resilient” and “pliable” indefinite; claims (including dependent claims identifying materials from which catheter can be made), Spec. (which, e.g., “provides an exemplary material that can be used to make a pliable inner catheter, explaining that the inner catheter is more flexible than the outer”) and dictionary definitions provided sufficient description and boundaries for the terms, e.g., skilled artisan would know “of exemplary materials that can be used to make a resilient outer catheter, i.e., one that has shape memory and stiffness such that it can return to its original shape”).
Indirect Infringement Damages Limited to Extent of Direct Infringement
A reasonable royalty must account for non-infringing uses of sold devices. Niazi (Fed. Cir. 04/11/22) (aff’g exclusion of expert opinion because he failed “to limit damages to a reasonable approximation of actual infringing uses of the claimed method.” “Damages should be apportioned to separate out noninfringing uses, and patentees cannot recover damages based on sales of products with the mere capability to practice the claimed method.”).
2022 Q1 Patent Defenses Update
Highlights and Strategies from Jan. – Mar. Fed. Cir. Decisions on Substantive Patent Law.
Another Application of Williamson
We now have 13 examples of claim language not using the word “means” but nevertheless invoking Sec. 112(6/f) in Federal Circuit opinions. See https://patentdefenses.klarquist.com/1126f-claim-language/#a-whether-sec-1126f-treatment-invoked
- Kyocera (Fed. Cir. 01/21/22) (rev’g ITC construction and remanding for determination of corresponding structure; “a lifter member which exhibits a contact surface that, at predetermined locations along said contact surface, makes contact with said plurality of spaced-apart protrusions of said driver member such that, when said lifter member is moved in a first direction, it causes a return stroke of an operating cycle and moves said driver member from a driven position toward a ready position, and when said lifter member is moved to a holding position, it temporarily holds said driver member at said ready position by use of a holding contact between said lifter member and said driver member” invokes 112(6/f) because (1) “lifter member” is “a non-structural generic placeholder (member) modified by functional language (lifter),” (2) “the only thing a skilled artisan could glean from the claim language is that the lifter member is moved by the prime mover and lifts the driver member. That is a purely functional description,” (3) the term has no plain meaning in the art, and (4) while Spec. gives examples of “lifter member” it does not give “a clear and unambiguous definition” thereof).
Information Now is “Structure”?
35 U.S.C. § 112(f) provides “An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof.” While “structure, material, or acts” is broad it presumably does not encompass mere information. Per USPTO Legal Training Module guidance (08/02/13): “Terms that represent only non-structural elements such as information, data, instructions, and software per se would not serve as substitutes for ‘means’, because the terms do not serve as placeholders for structure or material.”
But a week ago, the Federal Circuit issued a precedential decision on application of Section 112(f) to claim elements recited as program code configured to be executed by a processor. The decision is questionable in several respects including equating information with structure.
- “In determining whether software limitations … recite sufficient structure, we can look beyond the initial ‘code’ or ‘application’ term to the functional language to see if a person of ordinary skill would have understood the claim limitation as a whole to connote sufficiently definite structure.” Dyfan (Fed. Cir. 03/24/22) (rev’g indefiniteness; the limitations (“system comprising … code, when executed, further configured to … cause to be output, via the at least one mobile device, the second visual information based on the second location-relevant information.…,” and “application [configured to ….]”) recite sufficient structure where challenger’s own expert testified that skilled artisans would have understood that “code” is “a bunch of software instructions” and “conventional” “off-the-shelf” applications and code were available to display whatever information the developer chooses, which “demonstrates that the ‘code’/’application’ limitations here connote a class of structures to a person of ordinary skill”).
Two En Banc Rehearing Denials Divide Fed. Cir.: Skinny Label and Disclosure Support for End Point of a Range
- Last year, GlaxoSmithKline (Fed. Cir. 02/23/21) (2-1) reversed a JMOL of non-infringement where FDA’s “skinny label” approval of the generic drug required it to include infringing use, and generic marketed its drug as comparable to brand name drug that doctors already knew had that infringing use. In February, the Court, seven to three, denied en banc rehearing, with a 6-Judge Concurring opinion noting that the dissent’s fairness concerns tracked elements of equitable estoppel. Rehearing en banc denied (Fed. Cir. 02/11/22) (7-3) (6-Judge Concurring Op.).
- Last November, Biogen (Fed. Cir. 11/30/21) (2-1) affirmed written-description invalidity of a claim reciting a particular dosage even though the Spec. had disclosed that dosage as the end point of range of dosages. In March, the Court, six to three, denied en banc rehearing, with a dissent from Judge Lourie outlining asserted errors in the analysis. Rehearing en banc denied (Fed. Cir. 03/16/22) (6–3) (Lourie, J., dissenting) (error to (1) compare amount of disclosure of the claimed species versus the unclaimed subject matter, (2) put burden on patentee to prove efficacy, (3) import considerations of operability, best mode and inventorship, (4) improperly use extrinsic evidence beyond understanding what disclosure would have disclosed to skilled artisan).
Fed. Cir. Divided on Whether Alleged Priority Application, or Issued Application, is Subject of Written Description Invalidity Analysis
Sometimes the Federal Circuit perpetuates two lines of conflicting precedents without acknowledging the divide. That’s the case on this basic question: if claims are unsupported by the application the patent owner asserts for the claim’s effective filing date, does that invalidate the claims under section 112(a)? At least four times in the past 11 years, the Court has assumed Yes. And at least four times, it has assumed No, the latest in January. So, when asserting invalidity under Sec. 112(a), it’s best to challenge both the “priority” application and the issued application.
- “Both parties wrongly assume that, if the 2006 priority application lacks sufficient written description of the ’405 patent’s claims, those claims are invalid. If the 2006 priority application lacks sufficient written description for the ’405 patent’s claims, the ’405 patent’s claims are not automatically rendered invalid; they are merely deprived of the 2006 priority date.” Novartis (Fed. Cir. 01/03/22) (2-1).
Obviousness: Carefully Compare Skilled Artisan’s Field of Endeavor to Reference’s Field
As plaintiff or defendant, it’s tempting to focus only on comparing the claims at issue to the most relevant excerpts from the prior art reference. But remember to also compare the respective fields of endeavor. Even an exact-match disclosure may not help the patent’s challenger if the skilled artisan would not have considered the reference in the first place.
- Broadcom (Fed. Cir. 03/08/22) (aff’g PTAB non-obviousness; “a skilled artisan’s field of endeavor is ‘power management and processor clock control’ …. [E]ven if Van Hook did disclose this limitation, Van Hook relates to processor performance, not power management and processor clock control, so a skilled artisan would not have been motivated to combine Van Hook and Kiuchi.”).
Oops!: Our Expert is Less Than Ordinary
- The Federal Circuit excluded all infringement testimony of the patent owner’s expert witness, in an ITC proceeding, because he lacked the design experience the parties accepted as part of the definition of a person having ordinary skill in the art. Kyocera (Fed. Cir. 01/21/22).
2021 Q4 Patent Defenses Update
Highlights and Strategies from Oct. – Dec. Fed. Cir. Decisions on Substantive Patent Law.
Beware Bare Backgrounds
In any technological field where Alice looms, a specification Background (and/or Description) explaining in detail the physical-realm technological problem and technological solution—neither being purely information-based—can save the patent from early invalidation in litigation on the pleadings. Two decisions this quarter illustrate this, both involving patents from applications filed first in Europe and having detailed background sections.
- CosmoKey (Fed. Cir. 10/04/21) (rev’g R. 12(c) judgment on Alice Step Two; claim recites user simultaneously sending authentication info. to remote site and activating mobile device’s authentication function (by activating a phone or an app.); user is authenticated only if remote site over separate channel confirms mobile device’s authentication function is activated. Spec. touts advantages over prior art methods, and claims and specification “recite a specific improvement to authentication that increases security, prevents unauthorized access by a third party, is easily implemented, and can advantageously be carried out with mobile devices of low complexity”);
- Mentone (Fed. Cir. 11/15/21) (non-precedential) (rev’g R. 12(b)(6) dismissal on Alice Step One; claimed method improved operation of computer by using a “shifted USF operation” to “improve the normal operation of the communication system itself to ‘overcome a problem specifically arising in the realm of computer networks,’” where the specification “provides important details on the technological problem and how the claimed invention solves that problem”).
More Often Consider Filing a CIP, & Casting a Wide Net May Show an Absence of Invention Possession
Whether to avoid a new piece of prior art, cover a competitor’s product, or focus on the inventor’s post-application refinements or developments, patent prosecutors routinely draft new definitions of the claimed invention using ingredients pulled from the specification filed perhaps years earlier. (And, anticipating this future possibility, patent drafters often cast a wide net in a specification, beyond the actual discoveries of the inventors.) The written description requirement polices the outer reaches of such after-the-fact “synthetic definitions” of inventions.
This quarter two divided Federal Circuit panels affirmed rulings invalidating two drug patents under this requirement. They serve as a reminder to more often consider (1) adding new matter to the first non-provisional application and (2) filing a CIP, as a hedge against this written description requirement defeating a later-drafted claim. And, the Biogen decision also flags that a patent drafter’s broad description of an invention, e.g., with multiple and/or broad ranges of parameters, may suggest a lack of “possession” of any particular invention.
- Biogen (Fed. Cir. 11/30/21) (2-1). Claims recite a method of treating multiple sclerosis with a “therapeutically effective amount of dimethyl fumarate [DMF], … [of] about 480” mg/day. The 480 mg/day dose was not tested in clinical trials until after the provisional application was filed. In a bench trial, the claims were held invalid for lack of adequate written description despite that dosage being mentioned in the specification. The split panel affirmed, finding no clear error, noting:
- The specification focuses on drug discovery, not clinical drug doses. Only one paragraph of disclosure addresses dosage levels of DMF for treatment, and it is not limited to treatment of MS and does not state that 480 mg/day is therapeutically effective for treating MS:“Effective doses will also vary, as recognized by those skilled in the art, dependent on route of administration, excipient usage, and the possibility of co-usage with other therapeutic treatments including use of other therapeutic agents. For example, an effective dose of DMF or MM[F] to be administered to a subject orally can be from about 0.1 g to 1 g per pay, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day; or from about 480 mg to about 720 mg per day; or about 720 mg per day). For example, the 720 mg per day may be administered in separate administrations of 2, 3, 4, or 6 equal doses.”
- That the specification makes only one reference to the later-claimed dosage (480 mg/day) “constitutes a significant fact that cuts against Biogen’s case, particularly because it appears at the end of one range among a series of ranges, including DMF concentrations of 100–1,000, 200–800, 240–720, and 480–720 mg/day. That is in stark contrast to DMF720, which is referenced independently as one dose ….”
- “That [the single paragraph] recites several DMF doses in the 100–1,000 mg/day range as ‘effective’ without even identifying a target disease is further indicative that the inventors were not in possession of a complete and final invention as of” the provisional’s filing date.
- “The specification’s focus on basic research and broad DMF-dosage ranges show that the inventors did not possess a therapeutically effective DMF480 dose at the time of filing in 2007.”
- No clear error in district court’s finding that a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS.
- “A written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention.” Indivior UK (Fed. Cir. 11/24/21) (2-1) (aff’g PTAB that claimed ranges not supported by priority application, in part because “one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the [ancestor app.] to create an otherwise unstated range. That is not a written description of the claimed range”).
- claimed ranges: “about 40 wt % to about 60 wt % of a water-soluble polymeric matrix”; “about 48.2 wt % to about 58.6 wt %”
- “at least 25%,”
- “at least 50%,”
- example amounting to 48.2%,
- example amounting to 58.6%,
- other examples amounting to values between 40% and 60%
Some Help on this Common Conundrum: How to Argue to Court That a Claim is Indefinite Because a Claim Element Triggers Sec. 112(f) But Lacks Corresponding Structure, Material or Acts But Also Argue to PTAB That Claim is Unpatentable Under Sec. 102 or 103?
Particularly since the PTAB adopted the Phillips claim construction standard used in district courts, the above arguments seem irreconcilable because, it is assumed, a Section 112(f) element lacking the required corresponding structure, material or acts in the specification cannot be construed, but construction is the first step for comparing a claim to prior art under a Section 102 or 103 patentability analysis. And PTAB panels have dismissed IPR patentability challenges under this logic. So IPR petitioners defending infringement charges in court have been forced to tiptoe around the issue in the PTAB to avoid arguing, in effect, indefiniteness, while preserving, they hope, the ability to argue indefiniteness in court.
The premise, however, is faulty because Section 112(b) “indefiniteness” is not limited to a lack of clarity of claim scope but also encompasses a lack of particularity. The scope of a purely functional claim element, unlimited by structure, material or acts, can be clear, but not “particular” because it is not limited to a particular way of performing the function. This was the logic of the Supreme Court decisions that led to enactment of the claim-drafting shortcut that is Section 112(f). See https://patentdefenses.klarquist.com/particular-and-distinct-claims-aka-indefiniteness-sec-1122b-other-than-sec-1126f/#f-functional-and-result-claims. Therefore, a Section 112(f) claim element unlimited by structure, material or acts can be compared to prior art because it covers any prior art disclosure of the claim-recited function.
In the final week of 2021, the Federal Circuit did not go so far as suggested above but did come partly to the rescue of patent challengers facing this conundrum. Now, at least post-Institution, the PTAB can no longer simply cite the petitioner’s failure to show “structure, material or acts” support for a Section 112(f) element. Now, the Board can dismiss the 102/103 patentability challenge only if it actually decides that the claim element lacks support (and the claim is indefinite) and in a way making the 102/103 analysis impossible. So, less tiptoeing is required post-Institution.
- “If the Board determines both that there is indefiniteness and that such indefiniteness renders it impossible to adjudicate the prior-art challenge on its merits, then the Board should conclude that it is impossible to reach a decision on the merits of the challenge and so state in its decision,” and in that case there is no estoppel effect. Intel (20-1828) (Fed. Cir. 12/28/21) (vacating PTAB refusal to determine patentability based on IPR petitioner argument that is no structural support for a Section 112(f) claim element).
Investigating Lead Prior Art and Surrounding Development Efforts Can Pay Off for Patent Owner (Applicant) on “Reasonable Expectation of Success” Prong of 103 Analysis
It can be tempting to distinguish prior art based on the surface words of the reference alone. But in prosecution and litigation, sometimes digging into the prior art reference and its authors and contemporaneous work of their peers pays dividends, on the “reasonable expectation of success” prong of the Section 103 analysis.
For example, an expert (or named inventor) might discover that the reference implicitly disparages the combination or modification asserted by the Examiner or patent challenger. Or, one might discover that the prior art authors tried and failed to achieve the claimed results of the claimed invention. Or, one might be able to catalog many technical challenges facing the authors and others working in the field.
- Astrazeneca (Fed. Cir. 12/08/21) (aff’g non-obviousness; “the district court properly relied on expert testimony regarding how a skilled artisan would interpret the data in [the art] to find implicit disparagement”);
- Univ. of Strathclyde (Fed. Cir. 11/04/21) (rev’g PTAB finding of obviousness; failure by one of the co-authors of the lead prior art reference to achieve the claimed results undercuts finding of reasonable expectation of success);
- Qiagen North (Fed. Cir. 10/29/21) (non-precedential) (aff’g PTAB finding of no reasonable expectation of success where challenger’s expert was conclusory on point and patent owner’s expert explained “host of specific technical difficulties” presented by the development of microfluidic PCR devices).
Similarly, a Patent Owner may be able to refute a reasonable expectation of success where multiple result-effective variables exist.
- “It has long been established law that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ It is also well-established that ‘the parameter to be optimized must have been recognized by those skilled in the art to be a ‘result-effective variable.’’ But, more recently, we clarified that in cases with multiple result-effective variables, ‘[e]vidence that the variables interacted in an unpredictable or unexpected way could render the combination nonobvious.’” Moderna (Fed. Cir. 12/01/21) (aff’g PTAB non-obviousness).