Recent Case Highlights

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 Cir. 11/15/21) (non-precedential) (rev’g R. 12(b)(6) dismissal on Alice Step One; claimed method improved operation of computer by using a “shifted USF operation” to “improve[] the normal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 %”
  • disclosure:
    • “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).

2021 Q3 Patent Defenses Update

Highlights from July – Sept. Fed. Cir. decisions on substantive patent law.

Williamson Strikes Again

Twelve post-Williamson Federal Circuit opinions have held that claim language lacking the word “means,” invokes interpretation under section 112(6/f). See https://patentdefenses.klarquist.com/1126f-claim-language/.

• Team Worldwide (Fed. Cir. 09/09/21) (non-precedential) (aff’g PTAB that “pressure controlling assembly … configured to” perform four functions, (1) invokes section 112(f) (based on functional claim format, “assembly” being generic, Spec. providing no structural definition, extrinsic evidence using term functionally, and giving no weight to Examiner’s silence on whether term invokes 112(f)), and (2) renders claims indefinite because Spec. lacks structural support for at least one of the functions).

Lack of Full-scope Written Description Erases $1.2 Billion Judgment

Many a patent owner has lost under this foundational principle of patent law: “What is claimed by the patent application must be the same as what is disclosed in the specification; otherwise the patent should not issue.” Festo (U.S. 05/28/2002). See https://patentdefenses.klarquist.com/written-description-sec-112/ (search “full scope”).

• Juno (Fed. Cir. 08/26/21) (rev’g denial of JMOL of no full-scope written description support, and damages award of $1.2 BB, where Spec. provides “no means of distinguishing which scFvs [single-chain antibody variable fragments] will bind to which targets.” The disclosure of two working embodiments “does not provide information sufficient to establish that a skilled artisan would understand how to identify the species of scFvs capable of binding to the limitless number of targets as the claims require.”).

A Reason to Add Efficacy or Utility Limitations to at Least Some Claims

“Because the claims are directed to humanized antibodies, the question before the Board was whether a skilled artisan at the time of the invention would have been motivated to make the claimed humanized antibodies, not whether a skilled artisan would have been motivated to use those antibodies to treat human disease.” Teva Pharm. (Fed. Cir. 08/16/21) (aff’g PTAB obviousness finding; question is “whether those concerns would have dissuaded a skilled artisan from making the claimed antibodies to study their therapeutic potential in the first place”).

Don’t Shortchange Reasonable Expectation of Success

In addition to showing motivation to combine references, patent challenger “was required to show that a skilled artisan would have had a ‘reasonable expectation’ of success in treating vasomotor symptoms, even if such success was not guaranteed in all cases.”  Eli Lilly (Fed. Cir. 08/16/21) (aff’g PTAB finding of no reasonable expectation of success, despite finding of motivation to combine, in part in view of lack of efficacy data in prior art references (although such data is not always required)).

Sec. 287: Absent Required Marking, No Substitute for Patent Owner Providing a Specific Charge of Infringement

Evidence showed that the defendant knew of the patent, collaborated with the patent owner, was warned by the patent owner not to infringe, and possibly knew he was infringing, but none of that satisfies the requirements of Sec. 287. Lubby Holdings (Fed. Cir. 09/01/21) (2-1) (rev’g jury award (and JMOL denial) of pre-suit damages).

Patent Infringement Liability … “I Was Just Doing My Job” is Not a Defense

Corporate officers are derivatively liable for their corporation’s patent infringements only if the corporate veil is pierced. But officers are personally liable for their own patent infringements (e.g., offers to sell) even if acting in corporate capacity. See https://patentdefenses.klarquist.com/271a-direct-infringement-of-any-type-of-claim/.

• Lubby Holdings (Fed. Cir. 09/01/21) (aff’g liability of corporate officer for direct patent infringement even though he was acting in his corporate capacity, without any need to pierce corporate veil or show that corporation was officer’s alter ego).

Patent Pros Know: Claim Limitation v. Claim Element v. Claim Environment v. Patentable Weight

Some claim language has no patentable weight, i.e., cannot help defend the claim against an invalidity challenge. Some claim language is not a limitation, i.e., need not be considered when proving infringement. Some claim language is a limitation but has no patentable weight (e.g., some process limitations in a product-by-process claim). See https://patentdefenses.klarquist.com/no-patentable-weight/. Some claim language is a limitation but not a claim element, namely, it’s the claim “environment” which must be present for infringement but need not be provided or performed by the accused infringer. See https://patentdefenses.klarquist.com/271a-direct-infringement-of-non-method-claim/ (search “environment”).

• Where preamble language “three dimensional” spreadsheet was given patentable weight in prior section 101 eligibility decision, that indicates it is limiting for infringement analysis. Data Engine II (Fed. Cir. 08/26/21) (aff’g claim construction and non-infringement).

Patent Standing … in the Fog

Tax lawyers cost a client a $236 MM patent-infringement verdict, at least for now. For tax reasons, a corporate parent assigned patents to a subsidiary and got an exclusive license back, only it was not an exclusive license of exclusionary rights so the parent lacked “standing,” forcing a new trial with only the subsidiary as plaintiff. In denying mandamus, the Federal Circuit noted that its long-time law on what is needed for (non-waivable) Constitutional standing versus (waivable) statutory standing, is in doubt ivo Lexmark (Static Control) (U.S. 03/25/2014). See https://patentdefenses.klarquist.com/constitutional-standing/.

• In re Cirba (Fed. Cir. 09/22/21) (non-precedential) (“It is not clear … that Lexmark and Lone Star also require us to alter our precedent holding (as the district court summarized it) that ‘the touchstone of constitutional standing in a patent infringement case is whether a party can establish that it has an exclusionary right in a patent that, if violated by another, would cause the party holding the exclusionary right to suffer legal injury.’”).

Utility and Alice

Even useful abstract ideas are abstract. On the other hand, the asserted utility of a purported advance often is a factor helping a claim survive Alice scrutiny. The key is whether the utility arises from an advance in the physical realm or instead an advance in information, a mental process, etc. Patent challengers, therefore, should explain that the patent’s alleged utility is inherent in the idea itself.

• PersonalWeb (Fed. Cir. 08/12/21) (“the asserted efficiency improvements are not different in kind from those that would accrue in the library analogue—for example, using content-based identifiers to purge duplicate books”).

132 Post-Alice Fed. Cir. Opinions Articulating “Abstract Idea” to Which Claim is Directed

Patent Defenses quotes each “abstract idea,” including those below from decisions this quarter. See https://patentdefenses.klarquist.com/patent-eligible-subject-matter-sec-101/. Useful table to review when seeking to articulate the abstract idea of a patent to be challenged under Alice.

2021 Q2 Patent Defenses Update

We summarize below selected substantive patent law Fed. Cir. and S. Ct. decisions since Apr. 1—from Klarquist’s free, mobile-friendly legal research tool Patent Defenses (www.patentdefenses.com), updated frequently.

Prosecution Laches: New Life

Long-delayed broadening of claims in ancestor applications remains a problem for patent-infringement defendants.

While (1) Mr. Hyatt’s use of the patent system is unparalleled (he filed 381 placeholder applications at GATT bubble, later expanded number of claims to 115,000, delayed between 12 to 28 years (based on asserted priority dates) to present his claims for prosecution, and “adopted an approach to prosecution that all but guaranteed indefinite prosecution delay”), and (2) this panel decision is on appeal of a § 145 action against the Patent Office, the decision breathes new life into this defense by creating a presumption of intervening rights and prejudice if there were six or more years of unreasonable prosecution delay. Hyatt (Fed. Cir. 06/01/21).

See https://patentdefenses.klarquist.com/prosecution-history-laches/

Assignor Estoppel Restricted: Prohibits One in Privity With Assignor Contradicting Assignor’s Implied (or Express) Representations of Patentability, Claim by Claim

Assignor estoppel (now) ”applies when, but only when, the assignor’s claim of invalidity contradicts explicit or implicit representations he made in assigning the patent.” Minerva Surgical (U.S. 06/29/2021) (5-4), vacating Hologic (Fed. Cir. 04/22/20).

There is no contradiction (or estoppel) when (1) the “assignment occurs before an inventor can possibly make a warranty of validity as to specific patent claims” (as in assignment of future inventions in an employment agreement), (2) intervening law renders the claims invalid, or (3) later claims in a patent are “materially broader” than the claims at the time of the assignment.

See https://patentdefenses.klarquist.com/assignor-estoppel/

Abstractness Angst When Invention Involves Physical Components of Physical Machines

Last year, it was claims directed to a “method for manufacturing a shaft assembly of a driveline system” that were declared patent ineligible, to much ridicule. See American Axle (Fed. Cir. 07/31/20) (2-1). This quarter it is claims on an improved digital camera:

Claim: “An improved digital camera comprising: a first and a second image sensor …; two lenses, each being mounted in front of one of said two image sensors; …; an analog-to-digital converting circuitry coupled to said first and said second image sensor …; an image memory, …; and a digital image processor, coupled to said image memory and receiving said first digital image and said second digital image, producing a resultant digital image from said first digital image enhanced with said second digital image.”

Ruling: Patent ineligible for being directed to abstract idea of “taking two pictures (which may be at different exposures) and using one picture to enhance the other in some way”. Yu (Fed. Cir. 06/11/21) (2-1) (aff’g R. 12(b)(6) dismissal; claims’ enhanced image is created by conventional digital camera components performing their basic functions and recited at high degree of generality, and what Spec. identifies as advance over prior art is not required by the claims).

See https://patentdefenses.klarquist.com/patent-eligible-subject-matter-sec-101/ (includes table quoting the “abstract idea” for each of 124 post-Alice Fed. Cir. opinions ruling that claims are directed to an abstract idea).

Contributory Infringement: Merely Hypothetical Non-Infringing Uses Unhelpful

Bio-Rad (Fed. Cir. 05/28/21) (aff’g contributory infringement and ITC finding that each proposed design-around is a “hypothetical system that is not yet available to 10X’s customers,” as consistent with precedent, “which focuses on the real way in which the accused product is made, used, and sold”).

See https://patentdefenses.klarquist.com/271c-contributory-infringement/

Unsettled: Who Has Burden On Whether Prior Art Non-Patent Publication is Enabled?

In late June, a Fed. Cir. panel, in a non-precedential decision, declared that in the context of district court litigation, patent prosecution, and AIA trial proceedings, “prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.” Apple (Fed. Cir. 06/23/21) (non-precedential) (PTAB (harmless) error to put burden of persuasion on challenger to prove prior art published Japanese application enabled.)

But this appears to extend prior precedents. In particular, In re Antor Media (Fed. Cir. 07/27/12) held that during patent prosecution, an Examiner may presume that a non-patent prior art publication is enabling unless shown otherwise, but its reasoning did not extend to district court litigation or even AIA trials.

See https://patentdefenses.klarquist.com/anticipation-sec-102/

Unsettled: Does AIA Trial Estoppel Arise Upon Board’s Final Written Decision or When Appeals Exhausted?

Court has not decided when AIA trial-based estoppel arises, although has held that for inter partes reexamination “whose language is similar but not identical to § 325(e)(2)—estoppel rights arose when all appellate rights were exhausted.” Olaplex (Fed. Cir. 05/06/21) (non-precedential) (aff’g application of PGR-based estoppel against written description and obviousness defenses).

See https://patentdefenses.klarquist.com/aia-trial-based-estoppel/