Category Archives: Obviousness

Reasonable Expectation of Success Made Claims Obvious

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In Salix Pharmaceuticals. Ltd v. Norwich Pharmaceuticals Inc., [2022-2153, 2023-1952] (April 11, 2024), the Federal Circuit affirmed the district court determination that Norwich infringed claim 8 of U.S. Patent 8,624,573, claim 6 of U.S. Patent 9,421,195, and claims 11
and 12 of U.S. Patent 10,335,397 and had failed to prove that those claims were invalid.

Rifaximin, the active ingredient in Salix’s commercial product Xifaxan®, has been widely used as an antibiotic for decades, having been first synthesized in the early 1980s
in Italy and approved there as an antibiotic in 1985. The FDA approved Xifaxan nearly 20
years later, in 2004, as 200 mg tablets for the treatment of travelers’ diarrhea. The FDA subsequently approved 550 mg tablets for hepatic encephalopathy in 2010 and for irritable bowel syndrome with diarrhea (“IBS-D”) in 2015.

Norwich sought to market a generic version of rifaximin and, in 2019, filed an ANDA for 550 mg tablets with the same indications as Xifaxan, certifying pursuant to 21 U.S.C. § 355(j)(2)(vii)(IV) that Salix’s rifaximin patents were invalid. Salix timely sued, asserting that Norwich’s
ANDA infringed dozens of valid, Orange Book-listed patents. By the time of trial, the case had been streamlined to three groups of patents:

  1. the ’573, ’195, and ’397 patents, directed to treating hepatic encephalopathy
  2. the ’569 and ’667 patents, directed to treating irritable bowel syndrome with diarrhea with 550 mg rifaximin three times a day (1,650 mg/day) for 14 days; and,
  3. the ’199 and ’206 patents, directed to rifaximin form β

Following a bench trial, the district court held that Norwich infringed the hepatic encephalopathy patents’ claims and had failed to establish their invalidity. Norwich did not appeal those holdings. The court also held that Norwich’s ANDA infringed the irritable bowel syndrome and polymorph patents, but that those patents’ claims would have been obvious
over the prior art. Salix appealed those invalidity holdings.

Norwich then amended its ANDA in an attempt to remove the infringing hepatic encephalopathy indication and moved to modify the judgment under Federal Rule of Civil Procedure 60(b), asserting that the amendment negated any possible infringement. The court denied Norwich’s motion, and Norwich cross-appealed.

Validity of the Irritable Bowel Syndrome Claims

The key limitation on appeal is the dosage amount that appears in the claims: 550 mg, three times per day (“TID”), for a total of 1,650 mg/day. Norwich challenged the IBS-D claims’ validity by asserting as prior art references a clinical trial protocol that had been published and a 2006 journal article by Pimentel. The Protocol described a Phase II study evaluating
twice-daily doses of 550 mg (1,100 mg/day) and 1,100 mg (2,200 mg/day) for 14 and 28 days for the treatment of irritable bowel syndrome. Pimentel taught administering 400 mg, TID (1,200 mg/day), for the treatment of irritable bowel syndrome but further opines that the “optimal dosage of rifaximin may, in fact, be higher than that used in our study.” The district court found that those two references disclose each and every limitation of the challenged irritable bowel syndrome claims, and further found that a skilled artisan would have been motivated to combine those two references to arrive at what is claimed with a reasonable expectation of success.

Salix appealed, asserting that the court erred in finding that a skilled artisan would have had a reasonable expectation of success in using the claimed 1,650 mg/day dosage to treat irritable bowel syndrome. According to Salix, the highest prior art dosage amount
that could have been supported with a reasonable expectation of success was the 1,200 mg/day dose evaluated by Pimentel. The Federal Circuit disagreed, noting that while the Protocol alone might not support the reasonable expectation of success, in combination with Pimentel, which taught that “[r]ecent data suggest that the optimal dosage of rifaximin may, in fact, be higher than that used in our study,” it was not error for the district court to conclude that there was a reasonable expectation of success as to the efficacy of 550 mg TID dosing.

Validity of the rifaximin form β Claims

Norwich challenged the polymorph claims’ validity by asserting, inter alia, Cannata, which discloses that rifaximin exists in crystalline form with “outstanding antibacterial properties.”

The district court held that expert testimony supported a conclusion that, in view of the prior art, (1) a skilled artisan would have had good reason to characterize the crystalline
rifaximin obtained by following the Cannata protocols, (2) that such characterization was routine and could have been performed “in one day,” and (3) that doing so would have led the skilled artisan to have “detected rifaximin β.”

The Federal Circuit noted that the scope and content of the prior art here includes preparations of crystalline rifaximin, which expert testimony supports would have yielded the β form of rifaximin. The difference between the prior art and the claims is thus effectively nothing more than the performance of routine characterization to identify the polymorphic forms that result from the known Cannata processes.

Salix argued that the rifaximin’s β form nonetheless constituted a non-obvious invention because, although skilled artisans actually succeeded in producing and characterizing it, they would not have expected to succeed because, as of the critical date, the polymorphic nature of rifaximin had not yet been reported and the identity of the β form remained undisclosed. Salix further argues that there could have been no expectation of success because the skilled artisan would not have been able to predict what polymorphic forms might result from following the preparation protocols disclosed in the prior art. The Federal Circuit disagreed, noting that Salix has done no more than combine known elements of the prior art to verify readily accessible information concerning a compound already in the hands of those of ordinary skill in the art, and such routine efforts do not justify removing this polymorph from the public domain.

The Federal Circuit noted that it was not holding that there is always a reasonable expectation of success in accessing or characterizing polymorphs. It was simply reviewing the district court’s decision before it as to its factual finding of a reasonable expectation of success, and in so doing, have not been left with a definite and firm conviction that a mistake was made in reaching that finding.

Norwich’s Cross Appeal

On cross-appeal, Norwich raises two related but distinct arguments that arose after the district court held that Norwich infringed the HE patents and failed to establish invalidity. Norwich first argues that the district court misinterpreted 35 U.S.C. § 271(e)(4)(A), which directs a court, following a finding of infringement, to order the FDA to defer final approval of an ANDA until the expiration of the infringed patent. According to Norwich, that statute precludes delaying final approval of an entire ANDA, and instead requires delaying only the approval of the infringing use.

The Federal Circuit said Section 271(e)(4)(A) instructs that, following a finding of infringement, “the court shall order the effective date of any approval of the drug or veterinary biological product involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed.” Norwich argued that the language of § 271(e)(4) requires courts to tie the restriction on FDA approval to the
indication for which the ANDA seeks approval when that indication was the source of infringement. The district court order concerned only the specific ANDA in question that included an infringing use, referred to the ANDA by its number, and enjoined the approval
of that ANDA.

Since the FDA does not approve drugs in the abstract, but rather approves drugs for particular uses (indications) of that drug, the statute is appropriately construed as directed to approval of particular infringing uses of the drug, not all uses of the drug including non-infringing uses. The statutory scheme makes clear that the relevant infringement is the submission of the ANDA that included an infringing use. That the ANDA further recited a non-patent-protected indication does not negate the infringement resulting from the ANDA’s submission. The order thus appropriately delayed the effective final approval date of “this
infringing ANDA” submission.

Norwich’s second argument arises from its decision to amend its ANDA to carve out the infringing HE use after final judgment. Following that amendment, Norwich filed a motion to modify the final judgment to allow for prompt approval of the amended ANDA that purportedly no longer sought approval for the infringing HE use. The district court denied that motion, holding that Norwich “fully litigated the merits of its non-infringement and invalidity case, lost, and now seeks a way around the final judgment through Rule 60(b).

The Federal Circuit said that a district court may reconsider its own finding of infringement
in light of an amended ANDA, but the court need not do so, and the Federal Circuit said that the court reasonably held that consideration of the amended ANDA would be inequitable
and inappropriate. The court noted that it is not a simple matter to determine whether an
ANDA applicant has successfully carved out language from a label to turn infringement into non-infringement” and that what Norwich sought in its Rule 60(b) motion would essentially be a second litigation” following final judgment.

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Reading Limitations into the Claims and Failure to Follow Proper Obviousness Inquiry Required Non-obviousness Determination to be Vacated

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In Jannsen Pharmaceuticals, Inc., v. Teva Pharmaceuticals USA, Inc., [2022-1258, 2022-1307] (April 1, 2024), the Federal Circuit affirmed the district court’s determination that the claims of U.S. Patent NO. 9,439,906 were not indefinite, and vacated and remanded the determination that the claims were not obvious.

The patent, which generally relates to dosing regimens of paliperidone palmitate, is the last remaining Orange Book patent for Invega Sustenna. Teva First argued that the district court’s analysis of obviousness required Teva to show that it would have been obvious to use the recited dosing regimens for the general population of patients—i.e., a generalized dosing regimen. The court found that the prior art did not demonstrate population-wide safety and efficacy and thus did not teach a generalized dosing regimen. Teva contended that the claims were not directed to a generalized dosing regimen and therefore the district court asked for a showing of obvious-ness that went beyond what was claimed, and the Federal Circuit agreed, saying nothing in the claims requires that the regimen be used for—let alone be ideal for—the patient population generally or a certain percentage of the patient population.

Teva argued that the court also read a “mild” limitation into the renal-impairment claims, whereas the claims do not specify a level of renal impairment. Janssen countered that Teva presented an obviousness theory that was pred-icated on dosing a patient with mild renal impairment. The Federal Circuit agreed that many of the district court’s statements suggest that it understood the claims themselves to require administration to a patient with mild renal impairment, yet there was no such requirement in the claims.

Teva also argue that the court’s analysis was impermissibly rigid and did not comport with KSR or otherwise reflect the Federal Circuit’s obviousness jurisprudence. The Federal CIrcuit agree, noting that Instead of considering the prior art in context or in combination, the district court’s analysis seems to tackle the ex-press statements of each reference one-by-one—identifying each difference or dissimilarity between an individual ref-erence and the claims, but not fully assessing the teachings in toto. This seemingly siloed and inflexible approach left insufficient room for consideration of how background knowledge in the art would have impacted a POSA’s un-derstanding of, or motivation to modify, the primary refer-ences at issue, thereby inflating the significance of minor variations between the prior art and the claims.

Among other things, the Federal Circuit criticized the district court for concluding that in the pharma-ceutical context, if a prior art reference does not contain safety and efficacy data, there is no reason to combine it with other prior art references. The Federal Circuit also criticized the court for looking for Teva to demonstrate an explicit problem to provide motivation, notning among other things that the motivation analysis is not limited by the problem or need recognized by the inventors. The Federal Circuit said that:

A motivation “may be found explicitly or implicitly in market forces; de-sign incentives; the interrelated teachings of multiple patents; any need or problem known in the field of endeavor at the time of invention and addressed by the patent; and the background knowledge, creativity, and common sense of the person of ordinary skill.”

Overall, the district court’s analysis ran afoul of KSR’s basic mandate in a number of ways. It failed to consider the “interrelated teachings of multiple” references, “the back-ground knowledge possessed by a person having ordinary skill in the art,” or “the inferences and creative steps that a person of ordinary skill in the art would employ.” Instead, the court sought an explicit indication in the prior art that an improvement was re-quired—at times also suggesting that it was searching for an indication that the claims captured the singular way the protocol would be modified.

Finally, Teva argued and the Federal Circuit agreed, that the district court did not apply the correct test for teaching away. A teaching that a particular value is optimal is not a criticism of all other values, nor is the fact that a reference does not disclose the claimed value a teaching away. The Federal Circuit instructed that the district court should have analyzed whether the claimed value was “criticize[d], discredit[ed], or otherwise discourage[d].”

Indefiniteness

To satisfy the definiteness requirement, a patent’s claims, viewed in light of the specification and prosecution history, must inform those skilled in the art about the scope of the invention with reasonable certainty. The Federal Circuit has held that claim scope is not reasonably certain where a claimed characteristic can be measured in multiple ways, those different measurements “would typically yield a different result” when applied to the same sample, and the intrinsic record fails to provide reasonable certainty about which measurement was intended by the claims.

The claims contain a particle-size limitation, but do not specify what measurement technique should be used to determine whether the particle-size limitation is met. The specification states that the particle size can be measured by art-known conventional techniques, such as sedimentation field flow fractionation, photon correlation spectroscopy or disk centrifugation. Teva argued that the different particle-size measure-ment techniques, which were all allowed by the claims, would yield meaningfully different results. However, the district court found that the actual discrepancy in particle-size measurement that Teva relied on was “an outlier measurement taken with a defective device,” i.e., was not based on a discrepancy typical of the measurement technique used. Teva has not shown that the court’s outlier finding was clearly erroneous. As a result, the district court correctly determined that, on this record, Teva did not meet its burden to show that the challenged claims were invalid as indefinite.

Merely Because a Technology is Known, Does Not Mean There Was a Motivation to Use It

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In Virtek Vision International ULC v. Assembly Guidance Systems, Inc., [2022-1998, 2022-2022] (March 27, 2024), the Federal Circuit reversed the PTAB determination that certain claims of U.S. Patent No. 10,052,734 were unpatentable, and affirmed the determination that other claims of the ‘734 patent had not been shown to be unpatentable.

The ’734 patent discloses an improved method for aligning a laser projector with respect to
a work surface. On appeal, Virtek argued the Board’s findings that a skilled artisan would have been motivated to combine the references were not supported by substantial evidence, and the Federal Circuit agreed.

The Federal Circuit said that it does not suffice to meet the motivation to combine requirement to recognize that two alternative arrangements (such as an angular direction system using a single camera and a 3D coordinate system using two cameras) were both known in the art.

These disclosures, however, do not provide any reason why a skilled artisan would use 3D coordinates instead of angular directions in a system. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness 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.”).

The Federal Circuit said that the mere fact that possible arrangements existed
in the prior art does not provide a reason that a skilled artisan would have substituted the one-camera angular direction system in one prior art system with the two-camera 3D coordinate system disclosed in another. The Court noted that there was no argument in the petition regarding why a skilled artisan would make this substitution—other than that the two different coordinate systems were “known to be used.” The petition did not argue that the references articulates any reason to substitute one for another or any advantages that would flow from doing so, and neither did Petitioner’s expert articulate any reason why a skilled artisan would combine these references.

The Federal Circuit said that KSR did not do away with the requirement that there must exist a motivation to combine various prior art references in order for a skilled artisan to make the claimed invention. The Federal Circuit said that there was no argument about common sense in the petition or in the expert’s declaration. There was no evidence that there are a finite number of identified, predictable solutions. There was no evidence of a design need or market pressure. In short, this case involved nothing other than an assertion that because two coordinate systems were disclosed in a prior art reference and were therefore “known,” that satisfies the motivation to combine analysis. That is an error as a matter of law. It does not suffice to simply be known. A reason for combining must exist.

Failure to Give Jury Instruction on Objective Indicia After Evidence Was Presented Was Error Requiring a New Trial

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In Inline Plastics Corp. v. Lacerta Group, LLC, [2022-1954, 2022-2295] (Fed. Cir. 2024), the Federal Circuit affirmed the judgment of non-infringement, but vacated the jury determination of invalidity because of an error in jury instructions on the objective indicia of nonobviousness.

The case involved U.S. Patent Nos. 7,118,003; 7,073,680; 9,630,756; 8,795,580; and 9,527,640, which describe and claim tamper resistant and tamper evident containers,

On the invalidity issue, the Federal Circuit rejected the argument that the references were “cumulative” of PTO-considered references, pointing out that Inline cites no authority that
precludes a successful obviousness challenge that rests on PTO-considered references.

The Federal Circuit also rejected the argument that there was no legally sufficient evidence of the motivation to combine references. The Federal Circuit said that it has consistently stated that a court or examiner may find a motivation to combine prior art references
in the nature of the problem to be solved” and that “[t]his form of motivation to combine evidence is particularly relevant with simpler mechanical technologies. Further, the Federal Circuit it has recognized that some cases involve technologies and prior art that are simple enough that no expert testimony is needed” regarding a motivation to combine.

Finally, the Federal Circuit rejected Inline’s argument that Lacerta’s challenge must fail because it did not rebut or even address Inline’s objective- indicia evidence. The Court said that is has never held that the challenger must present its own testimony on objective indicia or else the patentee’s evidence must be credited, much less must be credited as dispositive of the obviousness issue.

As to the jury instruction on objective-indicia, the Federal Circuit agreed that the instruction was legal error. The Federal Circuit noted that Inline presented evidence of industry praise for its products, as well as evidence for additional objective indicia, such as copying and licensing. The Court said that this evidence, taken together, called for an instruction, if properly requested, on the objective indicia to which the evidence pertains, so that the jury
could assess its weight as objective indicia and—where the jury was asked for the bottom-line answer on obviousness— in relation to the prima facie case. However, the district court
did not give such an instruction.

The error in the objective-indicia instruction here was not harmless (whether under Federal Circuit or First Circuit law). We cannot say that a proper instruction would have made no difference to a reasonable jury regarding invalidity.

Optimization Analysis Generally Requires Consideration of Whether a Person of Ordinary Skill in the Art Would have been Motivated, with a Reasonable Expectation of Success

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In Pfizer Inc. v. Sanofi Pasteur Inc., [2019-1871, 2019-1873, 2019-1875, 2019-1876, 2019-2224] (Fed. Cir. 2024), the Federal Circuit affirmed the Board’s conclusions
that claims 1–45 of U.S. Patent 9,492,559 are unpatentable, and the Board’s denial of Pfizer’s motions add certain claims, and vacated the denial as to certain other claims.

The ‘559 patent is directed to immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens (i.e., glycoconjugates)
for use in pneumococcal vaccines. Across five IPR’s the validity of all the claims was challenged.

Pfizer first contends that the Board erred in applying the “result-effective variable doctrine,” arguing that it is only appropriate in circumstances where there is actual overlap between a range in the prior art and a claimed range. Since the asserted prior art did not disclose a particular molecular weight range, there could be no presumption of obviousness, and it was
error for the Board to consider whether that variable was result-effective.

The Federal Circuit disagreed, saying that the determination whether or not a claimed parameter is a result-effective variable is merely one aspect of a broader routine optimization analysis. That analysis is rooted in the decades-old legal principle 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.”

The Federal Circuit said that a routine optimization analysis generally requires consideration whether a person of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to bridge any gaps in the prior art to arrive at a claimed invention. Where that gap includes a parameter not necessarily disclosed in the prior art, it is not improper to consider whether or not it would have been recognized as result-effective. If so, then the optimization of that parameter is “normally obvious.” The Federal Circuit found substantial evidence supported the Board’s conclusion that the varlaibe (molecular weight) would have been obvious over the references.

The Federal Circuit rejected the suggestion that unpredictability of the art affected its analysis, nothing that it has previously explained that “a rule of law equating unpredictability to patentability . . . . cannot be the proper standard since the expectation of success need
only be reasonable, not absolute.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007)(“[O] bviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success”).

Broad Ranges in the Written Descriptiion Supported Narrower Ranges in the Claims

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In Rai Strategic Holdings, Inc. v. Philip Morris Products, SA, [2022-1862] (February 9, 2024), the Federal Circuit affirmed-in-part, vacated-in-part, and remanded the PTAB’s final written decision holding claims of U.S. Patent No. 10,492,542 unpatentable as obvious or lacking written description. Te ’542 patent, which is directed to electrically powered smoking articles that provide an inhalable substance in vapor or aerosol form by heating tobacco or other substances without significant combustion.

Philip Morris argued that dependent claims 10 and 27, which recite a heating member with
“a length of about 75% to about 85% of a length of the disposable aerosol forming substance,” are not supported by written description because “the claimed range is different
from and substantially narrower than the ranges disclosed in the specification.” Specifically, Philip Morris asserted that while the specification describes ranges such as 75% to 125%, 80% to 120%, 85% to 115%, and 90% to 110%, it does not disclose a heater length range
with an upper limit of 85%. RAI countered that the specification provides written description support because it teaches heating length embodiments at both ends of the claim range, pointing to the 75% to 125% and 85% to the 110% ranges. The Board found that the claims lack written description support because no range contains an upper limit of about 85% making it “‘less clear’ that the inventors contemplated a range of ‘about 75% to about 85%’ as part of the invention.”

The Federal Circuit began with a review of In re Wertheim, where its predecessor found that a disclosure of a range of 25% to 60% and provided support for claims to a range “between 35% and 60%. In Wertheim the Court said that whether the written description requirement is met, “[m]ere comparison of ranges is not enough,” and that instead, “we must decide whether the invention appellants seek to protect by their claims is part of the invention that
appellants have described as theirs in the specification.” “Where it is clear, for instance, that the broad described range pertains to a different invention than the narrower (and subsumed) claimed range, then the broader range does not describe the narrower range” and the written description requirement would not be satisfied.

The Federal Circuit also noted In re Blaser, 556 F.2d 534, 536–37 (C.C.P.A. 1977), where it held the specification, which disclosed heating a mixture to temperatures between 60º and 200º C, “adequately support[ ed] the limitation ‘80º to 200º C” and Kolmes v. World Fibers Corp.,107 F.3d 1534 (Fed. Cir. 1997), where it found that the specification stating a range of wrappings formed “at the rate of 4–12 turns per inch, with 8 turns per inch being preferred” supported a claim to a “rate of 8-12 turns per inch.”

However, in In re Baird, 348 F.2d 974 (C.C.P.A. 1965), cited by the Board, the CCPA held that a claimed range that was narrower than the disclosed range lacked sufficient disclosure. The issued patent explained the specific claimed range is preferred because the material would curl above 60º F and would be too brittle below 40º F. The application in interference, however, only disclosed that the quenching temperature may be between 32º F and 176º F, without providing any further guidance. The court found that the application’s claims lacked written description support because “the copied claims ‘are drawn to an invention different from that disclosed in the specification.”

Similarly, Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323 (Fed. Cir. 2021), also cited by the Board, held that a claimed range “about 40 wt % to about 60 wt %” lacked written description support because (1) neither the range nor the end values were disclosed in the specification; and (2) the inconsistent statements regarding the desired amount of polymer in the specification made it “even less clear that an invention of ‘about 40 wt % to about 60 wt %’ was contemplated as an aspect of the invention.”

Turning to the case before it, the Federal Circuit said the question thus is whether the disclosure of a length of about 75% to about 125%, about 80% to about 120%, about 85% to about 115%, or about 90% to about 110% “reasonably conveys to those skilled in the art that
the inventor had possession” of the claimed length of “about 75% to about 85%.” The Court said among other things, we consider whether “the broad described range pertains to a different invention than the narrower (and subsumed) claimed range,” in which case the specification does not provide written description support for the narrower claimed range.

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The specification need not expressly recite the claimed range to provide written description support. While the ’542 patent specification does not disclose the claimed range itself, it
does expressly disclose both endpoints by providing that the length of the heating member may be “about 75% to about 125%” or “about 85% to about 115%.” In addition to considering what the specification expressly discloses, we also consider the context of the technology at issue and the knowledge gained by a person of ordinary skill in the art
reading the specification. Given the predictability of electro-mechanical inventions such as the one at issue here, and the lack of complexity of the particular claim limitation at issue—i.e., reciting the length of a heating member—“a lower level of detail is required to satisfy the written description requirement than for unpredictable arts.” Further, nothing in the changes the invention, whether as to operability, effectiveness, or any other parameter.

Thus, the Federal Circuit we see no evidence suggesting that the broad described
ranges disclose a different invention than the claimed range of “about 75% to about 85%.” In other words, under the facts of this particular case, there is no evidence that the claimed
subrange results in a different invention than the invention disclosed in the specification. Accordingly, for all of the above reasons, we conclude that no reasonable fact finder could find that the claimed subrange is not within the appellant’s invention. In so holding, we note that our determination is highly factual and dependent on “the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.”

Though the Board relied on Indivior and Baird in its decision, the facts in this case align more closely with those in Wertheim, Blaser, and Kolmes, where the broader disclosed
ranges did not constitute a separate invention from the narrower claimed ranges. The Federal Circuit vacated the Board’s decision on this issue and remand for further consideration consistent with this opinion.

The Federal Circuit concluded that substantial evidence supports the Board’s determination of obviousness.

The Proper Claim Construction of a Term is Not Necessarily the Sum of its Parts

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In Intel Corp. v. Qualcomm Inc., [2020-1664] (December 28, 2021), the Federal Circuit affirmed the final written decision of the originally challenged claims of U.S. Patent No. 8,229,043, but vacated and remanded as to the substitute claims.

The Federal Circuit addressed first considered the phrase “radio frequency input signal” in ’043 patent claims 17, 19, and 21. Intel argued that the term should be given its ordinary meaning, while Qualcomm argued for a more specific construction. The Federal Circuit noted that ‘[e]ven without considering the surrounding claim language or the rest of the patent document, . . .it is not always appropriate to break down a phrase and give it an interpretation that is merely the sum of its parts.” The Federal Circuit said that the surrounding language points in favor of Qualcomm’s construction, adopted by the Board. The Federal Circuit said the linguistic clues suggested that “radio frequency input signal,” to the relevant audience, refers to the signal entering the device as a whole, not (as Intel proposes) to any radio frequency signal entering any component. The Federal Circuit said that the specification provides further support for the Board’s reading.

The Federal Circuit concluded that in sum, while Intel’s interpretation may have superficial appeal, Qualcomm’s better reflects the usage of “radio frequency input signal” in the intrinsic record, and affirmed it.

On the question of obviousness, the Federal Circuit concluded that substantial evidence does not
support the Board’s determination that a skilled artisan would have lacked reason to combine the prior art to achieve substitute claims 27, 28, and 31. The Federal Circuit rejected the Board’s rationale for determining that it would not have been obvious to combine the references. The Federal Circuit noted that a rationale is not inherently suspect merely because it’s generic in the sense of having broad applicability or appeal.

Failure in the Art Undermines any Reasonable Expectation of Success

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In University of Strathclyde v. Clear-Vu Lighting LLC, [2020-2243], (November 4, 2021) the Federal Circuit reversed the PTAB’s determination holding unpatentable as obvious claims 1-4 of U.S. Patent No. 9,839,706, directed to photoinactivation of Methicillin-resistant Staphylococcus aureus (MRSA), and other Gram-positive bacteria, without using a photosensitizing agent.

The Board determined that claims 1 and 3 of the ’706 patent would have been obvious over Ashkenazi in view of Nitzan, and that claims 2 and 4 would have been obvious in further view of Jones. The Board found that Ashkenazi and Nitzan teach or suggest all the limitations of claims 1 and 3,” and that a person of ordinary skill in the art would have been motivated to combine these two references and “would have had a reasonable expectation of successfully doing so.

On appeal, Strathclyde challenges the Board’s obviousness determination, arguing that the Board erred in finding that the combination of Ashkenazi and Nitzan teaches inactivating one or more Gram-positive bacteria without using a photosensitizer. It also asserts that the Board’s
finding of a reasonable expectation of success is not supported by substantial evidence. Whether the prior art discloses a claim limitation, whether a skilled artisan would have been motivated to modify or combine teachings in the prior art, and whether she would have had a reasonable expectation of success in doing so are questions of fact.

The Federal Circuit said that both parties agreed that most of the limitations found in claims 1 and 3 are disclosed by Ashkenazi or Nitzan, and that the only dispute is whether these references teach inactivating one of the claimed Gram-positive bacteria without using a photosensitizer. The Federal Circuit found that the Board’s finding that this was taught by the combination of Ashkenazi and Nitzan is not supported by substantial evidence. The Federal Circuit said that all of Ashkenazi’s P. acnes cultures were grown in the presence of a photosensitizer—either riboflavin alone, or riboflavin together with ALA. The Federal Circuti found nothing in Ashkenazi that discloses or suggests inactivating P. acnes, or any other bacteria, without using a photosensitizer.

The Federal Circuit noted that while Nitzan provides an example in which MRSA and other bacteria were exposed to blue light without ALA or any other photosensitizer, there is no evidence that Nitzan successfully achieved inactivation under this condition. The Federaal Circuit noted that in finding that Nitzan did not anticipate claims 1 and 3, the Board found Clear-Vu failed to establish that Nitzan’s non-ALA MRSA demonstrated “inactivation” as required by the claims.

The Federal Circuit said that given neither Ashkenazi nor Nitzan teaches or suggests inactivation of any bacteria without using a photosensitizer, it failed to see why a skilled artisan would opt to entirely omit a photosensitizer when combining these references. The Federal Circuit said that the Board articulated no rational basis—and it could discern none—for combining Ashkenazi’s P. acnes experiments, which at all times used a photosensitizer, with Nitzan’s non-ALA MRSA experiment, which did not achieve inactivation, to arrive at an embodiment in which MRSA is inactivated by exposing it to 407–420 nm blue light without
using a photosensitizer.

On this record, the Federal Circuit concluded that no reasonable fact finder could have found that the combination of Ashkenazi and Nitzan discloses inactivating one or more Gram-positive bacteria without using a photosensitizer.

Regarding whether there was a reasonable expection of success, the Federal Circuit disagreed with the Board’s finding that a skilled artisan would have expected that MRSA could be inactivated by blue light without using a photosensitizer due to the presence of at least some amount of naturally produced porphyrin in the bacteria. The Federal Circuit said that the only suport for the finding was “pure conjecture coupled with hindsight reliance on the teachings in the [challenged patent].”

The Federal Circuit said that the Board, relying on Ashkenazi’s teaching that “blue light may” inactivate “other bacterial cells that produce porphyrins,” reasoned that because light-activated
porphyrin molecules were shown in Ashkenazi to cause inactivation for P. acnes (even though Ashkenazi’s experiments applied a photosensitizer), the fact that MRSA has some level of endogenous porphyrin suggests to a skilled artisan that MRSA, too, would exhibit some amount of inactivation after exposure to 407–420 nm blue light. But, the Federal Circuit said that there is simply no evidence of record at the time of the ’706 patent to support this assumption. The Federal Circuit said that the evidence of record—Nitzan and an earlier publication by Nitzan, showed the opposite. The data Dr. Nitzan reported would have indicated to a person of ordinary skill in the art that those natural levels are insufficient to inactivate MRSA using 407–420 nm blue light without also using a photosensitizer.

Thus, the Federal Citcuit found, not only is there a complete lack of evidence in the record that any bacteria were inactivated after exposure to 407–420 nm blue light without using a photosensitizer, there is also evidence showing that others had failed to inactivate MRSA—one of the claimed Gram-positive bacteria— without using a photosensitizer, despite experimenting with different light doses and different wavelength ranges of blue light.

The Federal Circuit raffirmed that absolute predictability of success is not required, only a reasonable expectation. Howver in the present case, where the prior art evidences only failures to achieve that at which the inventors succeeded, no reasonable fact finder could find an expectation of success based on the teachings of that same prior art.

Mmm, Mmm, Obvious

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In Campbell Soup Company v. Gamon Plus, Inc., [2020-2344, 2021-1019](August 19, 2021), the Federal Circuit reversed the PTAB determination that U.S. Design Patent Nos. D612,646 and D621,645 would not have been obvious.

The ’646 and ’645 patents, which each claim “[t]he ornamental design for a gravity
feed dispenser display, as shown and described. The ‘646 patent has one figure:

U.S. Patent No. D612646, Fig. 1

Most of the features in the drawings are shown in dashed lines meaning that they are not part of the claimed design. In the ‘646 patent, the only parts claimed, were athe label area, the can stops, and one of the cans:

The ‘645 patent similarly excludes most of the drawing, except the label area and the cylindrical object in the display.

Linz, discloses a similar dislay rack. that has a similar display area and stops:

Linz, U.S. Patent No. D405,622

After buying $31 million of display racks from Gamon, Campbell’s began buying similar displays from Trinity, which caused Gamon to sue Campbells. Campbells petitioned for inter partes review of Gamon’s patents. The Board held that Appellants had failed to prove unpatentability, finding that Linz is not similar
enough to the claimed designs to constitute a proper primary reference.
The Federal Circuit vacated and remanded, reasoning that the “ever-so-slight differences” the Board identified between Linz and the claimed designs did not
support its finding that Linz is not a proper primary reference. On remand, the Board again help that the patents had not been shown to be obvious. The Board reasoned Abbate was not a proper primary reference, and while Linz was a proper primary references, the claimed designs would not have been obvious over Linz alone or in combination with other references. The Board acknowledged that Linz had the same overall visual appearance as the claimed designs, but objective indicia nonobviousness, namely: commercial success, Campbell praise for the design, and the copying of the design.

On this second trip to the Federal Circuit the Federal Circuit agreed that Linz creatd the same overall visual appearance as the claimed designs. However, as to objective indicia, the Federal Circuit found that the Board erred in presuming a nexus between any commercial success and the claimed designs. The Board found that the unclaimed portions of the desings were insignificant to the ornamental design, but the Federal Circuit held that: “[i]n determining coextensiveness, the question is not whether unclaimed features are insignificant to a product’s ornamental design. The question is instead whether unclaimed features are
“insignificant,” period. The Federal Circuit explained that the purpose of the coextensiveness requirement is to ensure that nexus is presumed only when the
product “is the invention disclosed and claimed. The Federal Circuit said by limiting its analysis to ornamental significance, the Board simply did not answer the relevant
question: whether the commercial produtc “is the invention.”

Under the correct legal standard, substantial evidence does not support the Board’s finding of coextensiveness, the Federal Circuit finding that at most, the claims cover only a small portion of the commercial product: its label area, cylindrical object, and stops. Thus it was improper to presume a nexus between the claimed invention and the commercial success, and it was up to Gamon to establish a nexus, which it failed to do.

The Board found nexus from the success and praise for the label area, but the Federal Circuit pointed out, this was not new. To establish nexus, Gamon needed to present evidence that the commercial success and praise of the commercial product derived from those “unique characteristics.” The evidence of commerical success presented was tied only to the label area, which was old. The Federal Circuit rejected testimony of the inventor tying the commercial success to the label area, noting that it was both self-serving and unssupported by any other evidence. Furthermore the Federal Circuit rejected the Boards view that in design patent cases, objective indicia need not be linked to the claimed design’s unique characteristics.

The Federal Circuit also relied upon evidence of copying as establishing non-obviousness, saying that even if there were copying, that alone did not overcome the strong evidence if obviousness.

Weighing all of the Graham factors, including (1) the Board’s finding that, from the perspective of a designer of ordinary skill, Linz creates the same overall visual impression as the claimed designs and (2) copying by Trinity of the claimed designs’ unique characteristics, the Federal Circuit concluded that the claimed designs would have been obvious over Linz.

Broad, Functional Claims Made it Hard to Presume Nexus for Commerical Succes

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In Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, [2020-1747, 2020-1748, 2020-1750] (August 16, 2021), the Federal Circuit affirmed that Board’s determination that the claims of U.S. Patent Nos. 9,340,614, 9,266,951, and 9,890,210 are unpatentable because they would have been obvious over the cited prior art. The patents are directed to humanized antagonist antibodies that target calcitonin gene-related peptide (“CGRP”), that has been shown to be a potent vasodilator in the periphery.

Teva raised three challenges to the Board’s decision. First, Teva contended that the Board erred as a matter of law in its motivation to combine analysis by deviating from the motivation asserted by Lilly in its petitions for inter partes review. Second, Teva contended that even under the motivation to combine that the Board did analyze, substantial evidence does not support the Board’s factual findings. And third, Teva contended that the Board erred in its analysis of secondary considerations of nonobviousness.

Lilly asserted that a skilled artisan would have been motivated to combine the teachings of the references to make a humanized anti-CGRP monoclonal antibody for therapeutic use in humans, but the Board instead considered whether a skilled artisan would have been motivated to make the antibody merely to study or use it. Teva insists that by not requiring Lilly to support its therapeutic motivation, the Board incorrectly discounted important safety and efficacy concerns that would have been demotivating factors—i.e., reasons why a skilled artisan would have been motivated not to make a humanized anti-CGRP monoclonal antibody. The Federal Circuit held that the Board did apply the motiviation that Lilly asserted. The Federal Circuit said that “common sense and scientific reality dictate that scientists do not “study or use” humanized anti-bodies with an end goal of treating diseases in test tubes or in rats. At bottom, the prior art supports a motivation to humanize antibodies with the goal of treating human disease.”

Teva also argued that the substantial evidence did not support the Board’s factual findings. The Federal Circuit agreed with Lilly that substantial evidence supports a motivation to make a humanized anti-CGRP antibody to study its therapeutic potential for use in treatment of human disease, noting that Lilly identified evidence that supports the Board’s reasonable readings of each reference. Under the deferential standard of review, the Federal Circuit could not replace the Board’s reasonable interpretation of references with Teva’s interpretation.

Finally, with respect to secondary considerations, the Board found that the commercial products and the license lacked sufficient nexus to the challenged claims. Teva argued that the Board made two legal errors: first, in finding no presumption of nexus between the claims and the secondary considerations based on the commercial products; and second, with regard to the asserted licenses, Teva argued that the Board erred by focusing on the licensee’s products rather than the scope of the license.

The Federal Circuit found that the Board erred in its articulation of the standard for presuming nexus, but nonetheless conducting the necessary factual analysis of the unclaimed features of the commercial products, and reached the correct conclusion that no presumption of nexus applied. The Federal Circuit noted that the claims at issue used functional language, and that a claim to “anything that works” hardly has a nexus to any particular product. Because the claims in this case have a broad scope due to their lack of structural limitations, the unclaimed features in the commercial products cited here are of particular importance to the coextensiveness analysis. The Federal Circuit thus found that the Board’s factual findings regarding unclaimed features are thus supported by substantial evidence, and Teva has not shown otherwise.

Teva also argued that the Board erred by requiring a direct nexus between the challenged claims and the licensee’s products. The Federal Circuit found that the Board’s conclusion that the license lacked nexus to the challenged claims was supported by substantial evidence. The significance of licensing a patent as a secondary consideration in enhancing the nonobviousness of an invention is that an independent party with an interest in being free of the patent has chosen to respect it and pay a royalty under it rather than litigate and invalidate it. Such action tends to support its validity. The Federal Circuit said that given that 188 patents were licensed, the nexus between the license and the validity of any particular claim is rather tenuous to say the least. The Federal Circuit noted that Teva failed to show anything more than the existence of the license. Teva did not present direct evidence that the licensee’s motivation for entering into the license was related to the validity or enforceability of the patents at issue.