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Federal Circuit Emphasizes Flexible Approach to Obviousness Determination

April 4, 2024by Richard Treanor

Recently we reviewed the USPTO’s published Examiner guidance concerning “the flexible approach to determining obviousness that is required by KSR Int’l Co. v. Teleflex Inc. (KSR)” in which the Office instructed Examiners to avoid any type of formalistic or formulaic approach when providing a reason to modify the prior art in favor of relying on any possible source that “may, either implicitly or explicitly, provide reasons to combine or modify the prior art to determine that a claimed invention would have been obvious.” Unfortunately for applicants, this advice seems to have accurately captured the current sensibility of the Federal Circuit which, in Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258 (Fed. Cir. Apr. 1, 2024), recently openly admonished a District Court for using a “degree of rigidity” in its obviousness analysis that was foreclosed by KSR and, perhaps most devastatingly, for “ask[ing] the wrong questions about important aspects of the obviousness inquiry.”

In particular, and among the district court’s several identified errors, the Federal Circuit in Janssen found that the district court analyzed the prior art without giving the needed weight to the perspective of a person of ordinary skill in the art (POSA) who is “capable of deducing what references fairly suggest or employing ordinary creativity.” And instead of considering the prior art in context or in combination, the Federal Circuit criticized the district court’s consideration of each reference one-by-one, “identifying each difference or dissimilarity between an individual reference and the claims, but not fully assessing the teachings in toto” thereby yielding a “siloed and inflexible approach” that left insufficient room for consideration of how background knowledge in the art would have impacted a POSA’s understanding of, or motivation to modify, the primary references at issue.” This approach, in the view of the Federal Circuit, inflated the significance of “minor variations between the prior art and the claims,” leading to the district court’s erroneous conclusion of nonobviousness.

Given the general decorum typically surrounding court opinions, this level of direct and unfettered criticism can mean only one thing – that at least for the foreseeable future the USPTO guidelines got it right insofar as the Federal Circuit is concerned. As the Federal Circuit, citing KSR, emphasized in this case, “[a]ssessing obviousness is based on an ‘expansive and flexible approach’ that ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ’.” Applicant beware.

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Picking and Choosing – Single Salt Not Unpatentable Over 957 Member Genus

October 17, 2022by Jacob Doughty

Mylan Pharm. v. Merck Sharp & Dohme Corp., No. 2021-2121 (Fed. Cir. Sep. 29, 2022), is a recent decision of the Federal Circuit considering, inter alia, whether a prior art disclosure of a genus of salts was sufficient to anticipate or render obvious a single salt species.

In an Inter Partes Review proceeding before the PTAB, Mylan asserted that claims of a Merck patent were anticipated by or obvious over a prior Merck patent publication, Edmondson. The PTAB concluded that Mylan failed to prove unpatentability, and Mylan appealed. The claims of the Merck patent at issue were directed to sitagliptin dihydrogenphosphate (DHP). Exemplary claims include claims 1, 2, and 4:

1. A dihydrogenphosphate salt of a 4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro [1,2,4]tria-zolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-tri-fluorophenyl)butan-2-amine… or a hydrate thereof.

2. The salt of claim 1 of structural formula II having the (R)-configuration at the chiral center marked with an *

.

4. The salt of claim 2 characterized in being a crystalline monohydrate.

Edmondson disclosed sitagliptin in a list of 33 compounds. Edmondson further disclosed acids forming pharmaceutically acceptable salts including phosphoric acid in a list of eight preferred acids. Mylan argued that this was sufficient to anticipate claim 1, relying on the reasoning of In re Petering, 301 F.2d 676, 681 (C.C.P.A. 1962) (prior art may be deemed to disclose each member of prior art genus when skilled artisan can “at once envisage each member of this limited class”).

Merck countered that the combined list of 33 compounds and eight preferred salts, taking into account various stoichiometric possibilities, encompassed  957 salts, which was not sufficient for a skilled artisan to “at once envisage” the salt of claim 1.

The Federal Circuit agreed with Merck that Edmondson did not “expressly disclose a 1:1 sitagliptin DHP salt.” The Federal Circuit credited expert testimony (including testimony of Mylan’s own expert) that Edmondson did not direct a skilled artisan to sitagliptin among the list of 33 compounds and did not single out phosphoric acid or any phosphate salt among the enumerated salts. The Federal Circuit noted particularly that the 957 salts of Edmondson was “a far cry from the 20 compounds ‘envisaged’ by the narrow genus in Petering.”

As to obviousness, interestingly, Merck was able to eliminate Edmondson as a reference as to claims 1 and 2 by proving prior invention and relying on the obviousness exception for commonly owned prior art of pre-AIA 35 USC 103(c). However, this approach was not effective as to claim 4, which was limited to a crystalline monohydrate of the (R)-configuration of 1:1 sitagliptin DHP.

As to claim 4, Mylan relied on Edmondson’s indication that the described salts may exist in more than one crystal structure and in the form of hydrates. Mylan further relied on the disclosure in a secondary reference of the pharmaceutical importance and prevalence of crystalline hydrates of pharmaceutical compounds.

The CAFC agreed with the PTAB and Merck that the general teachings of the secondary reference would not have led a skilled artisan to prepare a crystalline monohydrate of the (R)-configuration of 1:1 sitagliptin DHP based on the teachings of Edmondson with a reasonable expectation of success, noting the unpredictability of hydrate formation and function for specific compounds.

The Federal Circuit briefly noted the PTAB’s consideration of Merck’s evidence of unexpected results, but also noted that “there is no need to reach objective indicia of nonobviousness where the petitioner has not made a showing necessary to prevail on threshold obviousness issues.”

Takeaway: During examination, claims directed to chemical compounds and compositions are often rejected over prior art disclosing generic chemical formulae or separate lists of components. The numbers of specific compounds or compositions encompassed by such prior art can be astronomical. The Mylan case provides some tips for arguing over such rejections (preferably without the need to rely on additional experimental results). Possible arguments include identifying the large number of species encompassed by a prior art genus, emphasizing the lack of direction in the prior art toward the specific selections necessary to obtain a claimed compound or composition, and pointing out the difficulty of applying general teachings regarding selection (e.g., of substituents, subcomponents, etc.) to specific compounds or compositions.

Judges: Lourie, Reyna, Stoll

 

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Negative Limitations Must be Supported by Positive or Inherent Disclosure

September 23, 2022by Richard Treanor

On June 21, 2022, the Federal Circuit decided Novartis Pharm. Corp. v. Accord Healthcare, Inc., No. 2021-1070 (Fed. Cir. June 21, 2022) finding that a negative limitation added during the course of prosecution was not supported by the original specification.

The claims in this case were originally directed to a method for treating multiple sclerosis by administering a certain “daily dosage” of the drug fingolimod to a patient. Importantly, a “daily dosage” was well known in the art to be different from a “loading dose,” which is a more concentrated dose typically given only once – at the initiation of treatment, and prior to the administration of daily dosages. During prosecution, a preliminary amendment was submitted in which the claims were amended to exclude the use of a loading dose. No support was cited for this amendment.

On rehearing, the Federal Circuit found that this negative limitation lacked written description support in the original specification, noting that the specification was completely silent regarding loading doses. The fact that the (prophetic) example did not use a loading dose was not helpful, according to the court, because it had not been shown that “a skilled artisan would understand the specification as inherently disclosing the negative limitation” for example by establishing “that in a particular field, the absence of mention of a limitation necessarily excluded that limitation.” Otherwise, the court noted, “[i]f silence were generally sufficient, all negative limitations would be supported by a silent specification.”

In Novartis, although the Federal Circuit reversed its prior decision and found the disputed limitation unsupported, the court mentioned all the usual forms of support for negative limitations (stated disadvantages; listed alternatives; etc.) and acknowledged the possibility that silence could also form the basis of support. This is an important reminder for the practitioner trying to distinguish a claim from the prior art – not everything at your disposal is before your eyes: “[w]hile a written description’s silence about a negative claim limitation is a useful and important clue and may often be dispositive, it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclosing the negative limitation.” Discussion of how the PTAB recently handled a similar can be found on our blog.

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Is Prior Art With Errors Prior Art At All? Apparent Error In Prior Art Undermines Obviousness Case

July 15, 2022by Jacob Doughty

LG Elecs. v. Immervision, Inc., No. 2021-2037 (Fed. Cir. July 11, 2022), is a recent decision of the Federal Circuit, considering whether errant information in a prior art reference can be relied upon to demonstrate unpatentability.

LGE challenged an Immervision patent directed to capturing digital panoramic images in an IPR. The Immervision patent claimed, inter alia, a method in which, “… the objective lens compresses the center of the image and the edges of the image and expands an intermediate zone of the image located between the center and the edges of the image.”

In challenging the patent, LGE relied on a prior art U.S. patent, Tada, which did not expressly disclose compressing the center and edges of an image and expanding an intermediate zone, but which included tables setting forth various measurements of specific embodiments of the disclosed lens system. LGE retained an expert who performed calculations based on the measurements and concluded that one of the lens systems of Tada (Embodiment 3) compressed the center and edges of an image and expanded an intermediate zone.

Immervision also retained an expert, who, in the course of performing his own calculations, discovered discrepancies in the measurements for Embodiment 3 of Tada. After some detailed examination of other embodiments of Tada and the Japanese patent application from which priority was claimed, Immervision’s expert determined that the measurements for Embodiment 3 shown in Tada erroneously included measurements for a different embodiment.

That is, due to an apparent cutting-and-pasting error in translating the Japanese application on which Tada was based, LGE’s expert’s calculations indicated that the lens system of Embodiment 3 of Tada compressed the center and edges of an image and expanded an intermediate zone. However, if LGE’s expert had used the correct measurements, this would not have been the case.

Based on the testimony of Immervision’s expert, the PTAB concluded that LGE failed to carry its burden in demonstrating unpatentability. LGE appealed.

The Federal Circuit noted that “… the standard for evaluating these types of apparent or ‘obvious typographical error[s],’” is set forth in a decision of its predecessor court, more than 50 years ago, in In re Yale, 434 F.2d 666 (C.C.P.A. 1970). Particularly:

The court in Yale held that where a prior art reference includes an obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art who would mentally disregard the errant information as a misprint or mentally substitute it for the correct information, the errant information cannot be said to disclose subject matter.

In Yale, the CCPA concluded that a reference could not be relied on for disclosing a compound that appeared in a single instance due to an error (CF3CHClBr was shown as CF3CF2CHClBr in a graph).

LGE argued that the error in Tada could not possibly be an obvious error because it took Immervision’s expert hours of detailed investigation to find. LGE further argued that the error in Tada was not “of a typographical or similar nature.” The Federal Circuit was not persuaded. In affirming the PTAB, the Federal Circuit noted that the length of time and manner in which an error was discovered did not diminish its obviousness. Further, the Federal Circuit further stated that “[t]he distinction between the typographical error in Yale and the copy-and-paste error here is a distinction without a difference.”

In dissent, Judge Newman was more sympathetic to LGE’s position:

I agree with the panel majority that Yale establishes the correct standard to determine if an error would be obvious to a person of ordinary skill in the field. However, I do not agree with the majority’s application of this standard to the facts herein. An “obvious error” should be apparent on its face and should not require the conduct of experiments or a search for possibly conflicting information to determine whether error exists. When a reference contains an erroneous teaching, its value as prior art must be determined.

Takeaway: It is not uncommon for technical documents relied on as prior art (e.g., patent publications, journal articles) to include errors – particularly in descriptions of experimental results. Such errors may undermine an assertion that a property or parameter is inherent – and thus possibly provide an avenue for attacking a prior art rejection or assertion of invalidity.

Judges: Newman (dissenting in part), Stoll, Cunningham

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Beware of Fool’s Gold – Seemingly Significant Clerical Errors by Patentee During Prosecution May Not Be Sufficient to Avoid Infringement or Willfulness

June 10, 2022by Jacob Doughty

Pavo Sols. v. Kingston Tech. Co., No. 2021-1834 (Fed. Cir. June 3, 2022), is a recent decision of the Federal Circuit considering, inter alia, whether a district court acted appropriately in “judicially correcting” an error in claim language. Kingston was found by the district court to have willfully infringed the judicially corrected claim.

The claim at issue recited:

A flash memory apparatus comprising:

a flash memory main body including a rectangular shaped case within which a memory element is mounted, a[] USB (Universal Serial Bus) terminal piece electrically connected with the memory element and installed at a front end of the case in a projecting manner, and a hinge protuberance formed on at least one side of the case; and

a cover including [a] pair of parallel plate members facing each other and spaced by an interval corresponding to the thickness of the case, the cover having an open front end and a closed rear end with a pair of lateral side openings; the parallel plate members having at least one hinge hole receiving the hinge protuberance on the case for pivoting the case with respect to the flash memory main body, whereby the USB terminal piece is received in an inner space of the cover or exposed outside the cover.

As emphasized above, the claim requires cover features that permit the case to pivot with respect to the flash memory main body.  However, the case is part of the flash memory main body and not part of the cover, so it is unclear how the features of the cover could cause a part of the flash memory main body to pivot with respect to itself (or another part thereof). The district court found that it was apparent from the claim language that “pivoting the case” should be “pivoting the cover” and judicially corrected the language in its claim construction order.

The Federal Circuit noted that it is permissible for a court to correct “an obvious minor typographical or clerical error” in a patent claim “only if (1) the correction is not subject to reasonable debate based on consideration of the claim language and the specification and (2) the prosecution history does not suggest a different interpretation of the claims.”

Kingston argued that the error could not possibly be minor because the correction replaced one structural element with another and broadened the claims. Kingston further argued that alternative corrections were plausible in view of the claim language, specification, and prosecution history.

The Federal Circuit found that its precedent did not prohibit corrections that resulted in changes to recited structure. Further, the Federal Circuit found Kingston’s arguments with respect to broadening and plausible alternative corrections (and the supporting expert testimony) to be insufficient to raise a reasonable debate about claim scope.

Having affirmed the district court’s correction of the claim, the Federal Circuit concluded that the district court’s finding of willful infringement was also appropriate. Specifically, “[w]e hold, however, that reliance on an obvious minor clerical error in the claim language is not a defense to willful infringement.”

Takeaway: When performing a clearance or freedom-to-operate analysis, patent counsel often search for “errors” made in drafting or prosecution of a patent application that could result in a narrow construction or estoppel that will give a client comfort that a finding of infringement is unlikely. However, it is important not to be too strict or literal in this analysis. If the intended meaning of claim term is clear using common sense, it may be risky to base a conclusion of non-infringement on errors in a claim even if they seem significant.

Judges: Lourie, Prost, Chen

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How Resilient Is Resilient, How Pliable is Pliable? Indefiniteness and Terms of Degree

May 6, 2022by Jacob Doughty

Niazi Licensing Corp. v. St. Jude Med. S.C., No. 2021-1864 (Fed. Cir. Apr. 11, 2022), is a recent decision of the Federal Circuit considering, inter alia, the definiteness of descriptive words (or terms of degree) in a claim.

The claim at issue recited:

A double catheter, comprising:

an outer, resilient catheter having shape memory and a hook shaped distal end configured for cannulation of the coronary sinus with at least one curved bend;

an inner, pliable catheter slidably disposed in the outer catheter and of greater length than the outer catheter…

The district court found that the terms “resilient” and “pliable” rendered the claim invalid as indefinite. The Federal Circuit disagreed and reversed.

The Federal Circuit began by noting that, while terms of degree in a claim may inherently result in broader claim scope, a claim is not indefinite just because it is broad. However, terms of degree will render a claim indefinite when the intrinsic evidence (or extrinsic evidence, when relevant and available) provides insufficient guidance as to any objective boundaries for the claim – i.e., when claim scope is “purely subjective.”

With respect to the term “resilient,” the Federal Circuit found that the claim itself provided guidance with respect to the meaning of the term by requiring that the outer catheter have “shape memory.” Dependent claims further indicated exemplary materials that could be used to make the outer catheter. Likewise, the specification indicated that the outer catheter should have “sufficient shape memory to return to its original shape when un-distorted.” Although the Federal Circuit indicated that reliance on extrinsic evidence was not necessary, dictionary definitions were consistent with the claims and specification. Thus, the Federal Circuit concluded that a skilled artisan reading the claims and specification 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.

As to “pliable,” the claim language was not as illuminating, but the specification indicated that, relative to the outer catheter, the inner catheter “is constructed of a more pliable, soft material such as silicone.” Dictionary definitions, again, were consistent with the specification. The Federal Circuit found that a skilled artisan would have understood that the inner catheter is made of a more flexible material than the outer catheter.

Thus, the Federal Circuit concluded that the intrinsic and extrinsic record provided objective boundaries by which a skilled artisan could determine the scope of the claims. The terms “resilient” and “pliable” were determined not to be “purely subjective terms,” resulting in a variable claim scope depending on the particular eye of any one observer.

Takeaway: Terms of degree in a claim can be troublesome during prosecution – an examiner can easily make a rejection, and a response proving “objective boundaries” can be difficult. However, if a term of degree cannot be deleted, the Niazi decision provides some suggestions for responding to an assertion of indefiniteness. Any indications of the scope of the term from the claims and specification can be supplemented with evidence (literature, opinion declaration, etc.) of how a skilled artisan would view the term. Although not explicitly stated in the Niazi decision, the court’s reasoning suggests that an explanation of why terms do not overlap in scope can be particularly persuasive.

Judges: Taranto, Bryson, Stoll

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