PTAB Archives - Page 8 of 13

In January of this year we reported on the Federal Circuit decision Donner Technology, LLC v. Pro Stage Gear, LLC, (link here) where the court clarified the “reasonably pertinent” test used to define the scope of analogous prior art (i.e., whether a reference outside the field of the inventor’s endeavor is “reasonably pertinent” to the particular problem with which the inventor is involved). In Donner the Federal Circuit explained that the problem to which the allegedly non-analogous reference relates must be identified and reviewed from the perspective of one of ordinary skill in the art who is considering turning to art outside their field of endeavor, and the question that must be answered is whether this person “would reasonably have consulted” the reference in solving the relevant problem.

On March 2, 2021, the Patent Trial and Appeal Board (“Board”) issued a decision in Ex parte Brophy (Appeal No. 2021-001800) reversing the Examiner’s rejection of claims to a salt substitute that relied on a reference requiring the use of an ingredient not safe for food. While two of the cited references used in the Examiner’s rejection were related to consumable salt compositions which included all the components recited in the claims, both references failed to describe the physical forms of the claimed salt substitute (solution and crystalline). In view of this omission, the Examiner cited a third reference describing an evaporative salt crystallization technique described as providing free-flowing salt crystals suitable for use in membrane electrolysis cells and in chlorine production using water, the salt to be crystallized, and a water-soluble acrylic polymer.

Appellants argued that the third reference was non-analogous with regard to its field of endeavor (salts for membrane electrolysis cells and for use in chlorine production), both in general and as evidenced by its use of acrylic acid, and provided the Examiner with a reference showing that a commercial polymer taught by the third reference was hazardous to humans. The Board agreed with Appellants and reversed the Examiner, and following the Federal Circuit’s guidance in Donner held that the Examiner failed to “address the underlying question why one of ordinary skill in the art would have looked to [the third reference’s] method for producing electrolysis salts to produce salt seasoning compositions intended for food.”

Takeaway: Non-analogous art arguments, while historically difficult, seem to be gaining more traction recently. Both the Federal Circuit’s and the Board’s recent guidance should be used during prosecution to establish all the elements of the argument, should appeal become necessary.

Judges: B. Franklin, J. Housel, and J. Snay

When evaluating whether a Petitioner’s inter partes review petition is based on matters previously presented to the Office, the Patent Trial and Appeal Board (“the Board”) uses the following two-part framework:

1. determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and
2. if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.

See Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 7 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). In making this determination the Board considers several non-exclusive factors, which are outlined in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“Becton, Dickinson”).

In Biocon Pharma Ltd. v. Novartis Pharmaceuticals Corp., IPR2020-01263, Paper 12 (PTAB Feb. 16, 2021) (“Biocon Pharma”), the Petitioner presented two grounds of unpatentability that each included a reference (EP ’072 and the ’996 patent) that was cited on an IDS but not applied in any rejection by the Examiner. According to the Petitioner, citation of a reference on an IDS was inconsequential because the Board “has consistently declined to exercise its discretion under § 325(d) based on the mere citation of references in an [Information Disclosure Statement (IDS)] that were not applied by the Examiner.” The Board disagreed.

Applying the first part of the framework, the Board found that the record showed the Examiner signed an IDS listing both of EP ’072 and the ’996 patent. The Board also pointed out the precedential Advanced Bionics decision states that “[p]reviously presented art includes art made of record . . . such as on an Information Disclosure Statement (IDS).” Biocon Pharma, 9 (quoting Advanced Bionics, 7–8). Consequently, the Board rejected the Petitioner’s argument that it should decline to exercise discretion under § 325(d) because these references “were not applied by the Examiner.”

Having found that the “same or substantially the same prior art” was presented previously to the Office, the Board did not assess whether the “same or substantially the same arguments” were presented previously to the Office before moving to the second part of the framework. See id., f.n. 4 (citing Advanced Bionics, 20).

Under the second part of the framework, the Board noted that “[i]f . . . the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.” Advanced Bionics, 8–9. This is similar to district court litigation where a challenger relying on previously considered references “has the added burden of overcoming the deference that is due to a qualified government agency presumed to have properly done its job, which includes one or more examiners who are assumed to have some expertise in interpreting the references and to be familiar from their work with the level of skill in the art and whose duty it is to issue only valid patents.” Ultra-Tex Surfaces Inc. v. Hill Brothers Chemical Co., 204 F.3d 1360, 1367 (Fed. Cir. 2000) (quoting American Hoist & Derrick Co. v. Sowa & Sons, Inc. 725 F.2d 1350, 1359 (Fed. Cir. 1984)).

Here, the petitioner argued that the Examiner erred because he found the patentee’s showing of synergistic results unexpected. However, the patent owner argued, and the Board agreed, that the prior art and evidence of record, which included a Declaration under 37 C.F.R. § 1.132, supported the Examiner’s finding of unexpected results. Accordingly, the Board exercised its discretion under § 325(d) and denied institution of trial.

Takeaway: No matter which side of an IPR petition you are on, it is important to note that the first part of the Advanced Bionics two-part framework may be satisfied when the references relied on in the IPR petition were merely cited on an IDS during prosecution. Thus, the Board’s discretion to institute an IPR based on references that were cited on an IDS during prosecution but never applied in a rejection will turn on the petitioner’s ability to demonstrate a material error by the Examiner.

Judges: E. Franklin, R. Pollock, K. Sawert

In Ex parte Gomez (Appeal 2020-001462), the Patent Trial and Appeal Board (“Board”) considered an Examiner’s obviousness rejection based on an allegedly overlapping range and, alternatively, optimization of a result-effective variable. The Board found neither of the Examiner’s two rationales were persuasive.

The sole independent claim 19 illustrated the claimed subject matter on appeal and was drawn to a method of improving the scratch resistance of a glass. The claimed method included, among other steps, a step of “forming a porous silica-rich layer on the surface of the glass, wherein the silica-rich layer extends from the surface to a depth of greater than or equal to 100 nm to less than or equal to 600 nm into the glass.”

The Examiner rejected claim 19 as obvious over Amin. The Examiner found Amin disclosed the formation of a porous silica-rich layer on a surface of a glass by treating the surface with an acid to improve the scratch resistance of the glass. The Examiner noted Amin disclosed the preferred depth of the silica-rich layer was less than 50 nm, which was outside the claimed depth range. However, the Examiner contended the claimed depth of the silica-rich layer would still have been obvious over Amin under two rationales.

First, the Examiner noted Amin disclosed that the surface of the glass had a root mean square (RMS) roughness of 50-5000 nm. While acknowledging “RMS roughness is not directly equivalent to the depth,” the Examiner believed “given that it is the root mean square of the peak-to-valley heights (i.e. root mean square of the depth across the surface) it is apparent that a RMS roughness of 50–5000 nm overlaps [the recited depth range].”

Second, the Examiner found the depth of the silica-rich layer was a result-effective variable because Amin disclosed that the silica-rich layer was selected “based on the desired balancing between the improved adhesion of the subsequent layer and a depth whereby the mechanical properties are not affected.” The Examiner then concluded it would have been obvious to optimize the depth and arrive at the claimed range “to obtain the desired chemical and mechanical properties.”

The Board found Amin’s disclosure of the RMS roughness of 50-5000 nm was related to an alternative embodiment of Amin’s invention that involved forming a glass article having a textured or patterned surface disposed between a chemically strengthened layer and an exterior amphiphobic layer. The Board pointed out the Examiner did not provide technical reasoning supported by objective evidence to prove that RMS roughness corresponded to, or was equivalent to, the depth of a silica-rich layer into a glass. Because the Examiner’s allegedly overlapping range disclosed in Amin appeared to relate to a variable irrelevant to the claimed depth of silica-rich layer, the Board concluded the Examiner’s assertion of overlap appeared to be based on speculation, which did not constitute a sufficient basis for establishing prima facie obviousness.

In addressing the Examiner’s allegation of optimization of a result-effective variable, the Board found that Amin described conducting an acid treatment to remove chemically exchanged (potassium) ions from the surface of a glass to a depth typically of ≤ 50 nm, “whereby the mechanical performance of the chemically strengthened glass (for example, strength, scratch resistance, impact damage resistance) is not affected.” Amin further disclosed the depth was preferably 5-15 nm and described a specific example in which the depth was only 10 nm. The Board noted these disclosed depth values were “all far below” the recited depth range and concluded “[one] of ordinary skill in the art would have understood this disclosure to implicitly indicate that removing chemically exchanged ions to a depth greater than 50 nm may adversely affect the mechanical performance of the glass.” The Board did not find the Examiner provided sound technical reasoning supported by objective evidence to establish that a skilled artisan would have disregarded Amin’s explicit disclosure of a typical depth of ≤ 50 nm and implicit disclosure that removing ions to a greater depth might adversely affect the mechanical performance of the glass.

Citing In re Sebek, the Board emphasized that “[when] the prior art disclosure suggests the outer limits of the range of suitable values, and that the optimum resides within that range, and where there are indications elsewhere that in fact the optimum should be sought within that range, the determination of optimum values outside that range may not be obvious.” In Gomez, the claimed depth range was outside an optimum range of ≤ 50 nm disclosed in Amin and Amin taught in multiple places that the depth should be within the optimum range. In other words, Amin appeared to teach away from the claimed depth range. Therefore, the Board also rejected the Examiner’s optimization rationale.

Because the Examiner did not provide a sufficient factual basis to support his conclusion that the claimed depth of the silica-rich layer would have been obvious over Amin, the Board reversed the rejection.

Takeaway: Claiming a range is particularly common in chemical arts. If a claimed range does not overlap a prior art range, examiners will sometimes argue the parameter of the range is a result-effective variable that could be optimized to reach the claimed range. As illustrated by Gomez (see also Nonobviousness: PTAB Rejects Examiner’s Optimization by Routine Experimentation Rationale), even if the parameter passes the muster to be a result-effective variable, the optimization rationale will not stand if the prior art implicitly teaches away from the claimed range by disclosing a non-overlapping optimum range and encouraging one to seek a value within the optimum range.

Judges: R. H. Delmendo, M. P. Colaianni, and J. E. Inglese

Section 101 broadly recognizes patent eligibility for “any new and useful process, machine, manufacture, or composition of matter.” However, the U.S. Supreme Court has identified exceptions to patent eligibility, including laws of nature, natural phenomena, and abstract ideas.

The Supreme Court has articulated a two-step framework for evaluating patent eligibility, based on the Alice (573 U.S. 208 (2014)) and Mayo (566 U.S. 66 (2012)) cases. Step 1 asks whether the claim relates to at least one of the statutory categories (process, machine, manufacture, or composition of matter). If the answer is yes, then step 2A asks whether the claim is directed to a judicial exception (law of nature, natural phenomenon, or abstract idea). If the claim is directed to a judicial exception, then step 2B asks whether the claim recites additional elements that amount to significantly more than the judicial exception.

When a claim recites a mathematical formula, examiners sometimes take the position that the claim is directed to an abstract idea, i.e., the mathematical formula itself. It has long been held that mathematical formulas, by themselves, cannot be patented (see, e.g., Gottschalk v. Benson, 409 U.S. 63 (1972)). Instead, to be patent eligible under § 101, such a claim must integrate the mathematical formula into a practical application.

This issue is illustrated in the recent Patent Trial and Appeal Board (“Board”) case of Ex parte Okura.

Independent claim 3 recited (in part):

A method for liquid chromatography,

…the method comprising the steps of:

…calculating elution time “t_r^c” based on Equation (1), the elution time “t_r^c” being from a start of flow-in of the sample into the column to elution of a component “c” which is one of the components from the column;

(1)

selecting the column based on the calculated elution time “t_r^c”; and

conducting the liquid chromatography using the selected column…

The examiner rejected claim 3 under section 101. Since this claim related to a method, it satisfied step 1 of the Alice/Mayo framework. At step 2A, however, the examiner took the position that claim 3 was “directed to an abstract idea,” specifically “equations for calculating mobility” which were “not integrated into a practical application because the additional steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity.”

In contrast, the applicant contended that claim 3 recited a method using “new equations to control the physical components of the liquid chromatography process.” In particular, the applicant contended that claim 3 was not directed to a mathematical formula, but an improved liquid chromatography method that used “more accurate estimates to control the physical parameters” of the process “to yield more accurate results.”

The Board agreed with the applicant. The Board acknowledged that claim 3 recited a mathematical formula, and thus recited an abstract idea. However, the Board found that the claim was “not ‘directed to’ an abstract idea because…the abstract idea is integrated into a practical application under Step 2A.” The Board found that “[t]he claimed process…requires generating an eluent by mixing two solvents, selecting the chromatography column based on the calculated elution time, and conducting the liquid chromatography.” The Board concluded that this “combination of steps…adds significantly more than the abstract idea the claims are alleged to be directed to so as to transform the abstract idea into an inventive concept.”

Additionally, the Board found that claim 3 “reflects a specific asserted improvement in technology, rooted in computer technology, over that which was available in the prior art. Accordingly, we find the Appellant’s arguments persuasive that the claimed subject matter is not directed to merely performing mathematical processes but to a technical improvement.” Thus, the Board reversed the rejection under section 101.

Takeaway: If an examiner rejects a claim under section 101 for reciting a mathematical formula, it is important to emphasize that the claim is not directed to the mathematical formula, but that the claim integrates the mathematical formula into a practical application. It also can be helpful to emphasize how using the mathematical formula leads to an improvement in the underlying technology. In this way, Ex parte Okura is reminiscent of Diamond v. Diehr, 450 U.S. 175 (1981), where a claim for curing synthetic rubber recited the Arrhenius equation to improve an otherwise conventional method, and was found to be eligible under section 101.

Judges: Hastings, Wilson, McManus

Ex parte Whalen, is a 2008 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) precedential decisions. Ex parte Whalen, is indicated by the PTAB to be precedential as to “Anticipation – 35 U.S.C. § 102… Inherency… evidence and reasoning” and “Obviousness – 35 U.S.C. § 103… Rationales… optimizing a variable.”

According to the PTAB’s Standard Operating Procedure, “[a] precedential decision is binding Board authority in subsequent matter involving similar facts or issues.”

In Ex parte Whalen, the BPAI considered whether an examiner met his burden in asserting inherency, or alternatively routine optimization, of a claimed viscosity that was not explicitly disclosed in the prior art.

Independent claim 1 was identified as a representative claim:

A composition capable of embolizing an aneurysm at a vascular site comprising:

(a) a biocompatible polymer;

(b) a biocompatible contrast agent wherein a sufficient amount of said contrast agent is employed in said composition to effect visualization in vivo; and

(c) a biocompatible solvent which solubilizes said biocompatible polymer

wherein a sufficient amount of said polymer are [sic] employed in said composition such that, upon delivery to a vascular site, a polymer precipitate forms which embolizes said vascular site; and

further wherein the biocompatible polymer has a molecular weight sufficient to impart to the composition a viscosity of at least about 150 cSt at 40° C.

The claim was rejected as anticipated or obvious over several prior art references. All of the cited prior art references disclosed combinations of components (a), (b), and (c) in compositions for embolizing an aneurysm at a vascular site, but none explicitly disclosed a composition having “a molecular weight sufficient to impart to the composition a viscosity of at least about 150 cSt at 40° C.” The examiner argued that the prior art compositions inherently possessed the claimed viscosity or, alternatively, it would have been obvious to a skilled artisan to “optimize” the prior art compositions by increasing their viscosity to the level recited in the claims.

It was undisputed that the prior art disclosed compositions including components (a), (b), and (c) in amounts overlapping those in the specification and claims of the application on appeal. However, the only disclosure in the prior art of viscosity was of a preferred composition having a viscosity much lower than the viscosity specified in claim 1. The BPAI found that the examiner had not met his burden in establishing inherency. The BPAI stated that, even if some of the compositions encompassed by the prior art’s broad disclosure might have the claimed viscosity, “that possibility is not adequate to support a finding of inherent anticipation.” The BPAI noted that the examiner did not provide evidence or scientific reasoning to show that any specific composition disclosed in the prior art was within the scope of claim 1.

The examiner’s obviousness position rested on the assertion that a skilled artisan would have been motivated to optimize the viscosity of the prior art composition to achieve “the safest clinical outcome and avoiding transvenous passage.” The BPAI noted that the prior art disclosed “adjustment of the viscosity of the composition as necessary for catheter delivery can be readily achieved by mere adjustment of the molecular weight of the copolymer composition.” However, the prior art also disclosed that low viscosity was a desired property in embolic compositions and, as noted above, the only disclosed viscosity in the prior art was much lower than that of claim 1.

Taking the foregoing facts into consideration, and mindful of the Supreme Court’s (then) recent command of “flexibility” in the obviousness inquiry (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)), the BPAI nonetheless concluded that the examiner had not met his burden. Particularly:

… when the prior art teaches away from the claimed solution as presented here… obviousness cannot be proven merely by showing that a known composition could have been modified by routine experimentation or solely on the expectation of success; it must be shown that those of ordinary skill in the art would have had some apparent reason to modify the known composition in a way that would result in the claimed composition.

That is, the examiner was required but failed to provide an “explanation based on scientific reasoning” that would support the conclusion that a skilled artisan would have considered it obvious to optimize the prior art compositions by increasing their viscosity to the level recited in the claims.

Ex parte Whalen was decided by an expanded five-judge panel, instead of the usual three-judge panel. The Chief Administrative Patent Judge was one of the deciding judges. According to the PTAB’s Standard Operating Procedure, “[a]n expanded panel is not favored and ordinarily will not be used… [a]n expanded panel may be used, where appropriate, to secure and maintain uniformity of the Board’s decisions…”

Takeaway: One of the challenges of prosecuting composition claims (combinations of known components) is the seeming ease with which an examiner can assert that a property not explicitly disclosed in the prior art is inherent and/or would have been readily achieved by a skilled artisan as a matter of routine optimization. Of course, the burden-shifting framework for examination of claims reciting properties is reasonable; however, there remains some burden on the examiner. Rejections based on inherency or routine optimization require that the examiner provide “scientific reasoning” consistent with the overall teaching of the prior art. Conclusory or thinly reasoned assertions of inherency or routine optimization thus provide an avenue for challenge.

Judges: Fleming, Lane, Grimes, Lebovitz, Prats

AIAのpost-grant proceedingsにおける不明瞭性の基準について、2021年1月6日にUSPTOが通知を出しています。そこで、USPTOは、PGR、CBM、 substitute claims の審理におけるクレームの不明瞭性の基準はいわゆるNautilus基準を採用べきであることを明らかにしました。

Claimed ranges are prima facie obvious when they overlap a prior art range. When there is no overlap, Examiners will bridge the gap by arguing that the parameter of the range is a result effective variable (such that it would have been obvious to go beyond the literal range) or rely on Titanium Metals to assert that the claimed range is obvious simply because it is “close enough” to the prior art range. The Examiner in In re Yanez tried both of these approaches but failed. Appeal No. 2020-001246 (PTAB Dec. 10, 2020) (non-precedential).

The claim at issue in Yanez required a nickel-aluminide alloy comprising, among other things, 0.15 wt % or less zirconium (Zr). The prior art, Liu, disclosed a nickel aluminide composition that included “from about 0.1 to about 1.5[atomic]% zirconium.” The Examiner converted the lower endpoint of 0.1 at.% in Liu to 0.17 wt%.

The Examiner recognized that Liu’s lower endpoint of 0.17 wt% exceeded the Applicant’s upper limit of 0.15 wt%. However, the Examiner argued: (1) “0.17 wt% is considered close to presently claimed 0.15% or less according to MPEP 2144.05 I”; and (2) “Liu expressly disclose[s] varying amounts of Zr … leads to different YS [(yield strength)] and elongation as illustrated in Figure 2a and 2b … [I]t would have been obvious to one skilled in the art to have adjusted the result-effective variable of Zr amount, in the Nickel-aluminide alloy of Liu in order to achieve a desired VS [sic, YS] and elongation.”

The Board rejected the Examiner’s “close enough” position, stating “no evidence that Liu’s about 0.17 wt% Zr is sufficiently close to the Appellant’s 0.15 wt% Zr to have suggested 0.15 wt% Zr to one of ordinary skill in the art.”

Next, the Board found “[t]he result effective variable in Liu’s Figures 2a and 2b is [molybdenum] Mo concentration, not [zirconium] Zr concentration.” The Board further noted that an example in Liu having 0.3 at% of Zr had a yield strength between examples containing 0.5 at% and 1.0 at% of Zr; suggesting the Zr content did not correlate with yield strength.

Absent a factual basis to support the Examiner’s positions, the Board reversed the obviousness rejection.

Takeaways: When facing an obviousness rejection where there is a nonoverlapping range, it is important to assess how the prior art range is arranged relative to the claimed range and what the prior art teaches about the range.

The “close enough” rationale from Titanium Metals made sense in that case because the prior art disclosed two compositions (no ranges were described) and the claimed composition fell between those two compositions. Thus, while there was no overlap with the specific compositions in Titanium Metals, a skilled artisan would have expected that an intermediate composition would have the same properties.

The rationale from Titanium Metals starts to break down when the nonoverlapping claimed range is next to the prior art range and the prior art does not teach that the range is flexible (i.e., does not use the modifiers “about” or “approximate”) or suggest that the properties outside the disclosed range would be expected to be the same (i.e., does not state that any concentration is acceptable before setting forth preferred ranges). See In re Patel, 566 F. App’x 1005 (Fed. Cir. 2014) (nonprecedential) (rejecting the PTO’s position that proximity of nonoverlapping ranges alone is sufficient to establish a prima facie case of obviousness). In Yanez, while the prior art used the modifier “about,” it appears that the Board concluded a skilled artisan would not have expected the claimed composition to have the same properties since the concentration of Zr did not correlate with the yield strength (i.e., the lowest concentration of Zr had an intermediate yield strength).

Yanez also shows the importance of assessing the prior art teachings surrounding the alleged result-effective variable. Here, the data relied on by the Examiner showed that the result effective variable was a completely different element than asserted by the Examiner. As such, there was no basis for the Examiner’s rejection. For another good illustration on this topic, readers are referred to Matthew Barnet’s recent blog, “Nonobviousness: When a Result-Effective Variable Is Different from the Claimed Variable.”

Judges: T. Owens, B. Baumeister (concurring), B. Range

Obviousness requires both a reason to modify or combine prior art to achieve a claimed invention and a reasonable expectation of success. Evidence showing there was no reasonable expectation of success would support a conclusion of nonobviousness. In Ex parte Hewes (Appeal 2019-006474), the Patent Trial and Appeal Board (“Board”) reversed the Examiner’s obviousness rejection because the Board found Appellant’s evidence showing no reasonable expectation of success was persuasive.

The claimed invention in Hewes, as recited in the illustrative claim 17, was directed to “a method for treating a BcrAbl positive leukemia in a subject that is resistant to imatinib.” Imatinib is a drug typically used to treat patients with chronic myelogenous leukemia (CML) because it blocks an abnormal protein called “the tyrosine kinase protein ‘BcrAbl’” that drives overproduction of abnormal white blood cells characteristic of leukemia. Some patients, however, develop resistance to imatinib “due to point mutations in the bcr/abl gene.” F317L is such a mutation. The claimed method at issue comprises “administering to the subject a therapeutically effective amount of [bosutinib], wherein the subject has a mutation in BcrAbl protein selected from F317L.”

The Examiner rejected claim 17 as obvious over Manley and over Boschelli ‘780 in view of Shah.

In the obviousness rejection over Manley, the Examiner admitted Manley did not disclose a single embodiment regarding administration of bosutinib to a patient suffering from imatinib resistant BcrAbl positive leukemia. However, the Examiner asserted a skilled artisan would have been motivated to practice the claimed method with reasonable expectation of success based on Manley’s teaching that bosutinib was one of a class of promising new inhibitor compounds for treating imatinib-resistant CML, that imatinib resistance was due to emergence of clones expressing mutant proteins, and that F317L was alleged to be among the “most frequently occurring mutants.”

Appellant contended that Manley did not suggest any promising new CML drug, including bosutinib, could treat imatinib-resistant CML associated with F317L and that F317L was actually a rare mutation. More importantly, Appellant argued for unpredictability in treatment of imatinib-resistant leukemia in patients with the F317L mutation, citing, in particular, the affidavit by Dr. Murray. The Murray affidavit testified that the F317L mutant was especially resistant to treatment even with second generation drugs like dasatinib and nilotinib, citing several references. The Murray affidavit explained that different patients, even with the same mutation, were known to display different clinical response upon treatment. Therefore, along with other documentary references, the Murray affidavit proved that imatinib resistance arising from mutations of the Bcr-Abl gene was poorly understood at the time of the invention. The Murray affidavit also testified that “clinical findings show F317L to be a[n] imatinib/dasatinib-resistant mutation” although preclinical models might have predicted drug potency against F317L mutants; and thus proved the preclinical models in this area were poor predictors of clinical efficacy and success.

Although the Board agreed with many of the Examiner’s readings of Manley, the Board agreed with Appellant that none of the second-generation drugs in Manley were disclosed as effectively treating imatinib-resistant CML associated with the F317L mutation. The Board found Appellant’s argument and supporting evidence that showed a lack of predictability in treating imatinib-resistant patients particularly with the F317L mutation were convincing. The Board noted that Appellant’s evidence, especially Dr. Murray’s testimony, “calls into significant doubt whether the ordinarily skilled person would have reasonably expected success with bosutinib when other second-generation, Bcr-Abl/Src inhibitors were known and shown to be ineffective in treating subjects with the F317L mutation.” The Board found that the Examiner provided no persuasive rebuttal in the face of Appellant’s argument and evidence.

In addressing the Examiner’s characterization of the Murray affidavit as “merely opinions” on the state of the art, the Board noted that the affidavit could not be summarily swept aside in this way because “Dr. Murray cites repeatedly to the scientific literature[, including Manley and Shah, which are the references asserted by the Examiner,] in support of his opinions, grounding those opinions in an adequate factual basis.” The Board found it was the Examiner who failed to “grapple persuasively with Dr. Murray’s opinions or the facts on which they are based.”

The Board thus concluded that even if the Examiner’s reasoning provided some motivation to treat patients with the F317L mutation with bosutinib, considering the totality of the evidence, the Examiner’s rejection failed “on the issue of reasonable expectation of success.” Accordingly, the Board reversed the Examiner’s obviousness rejection over Manley.

Regarding the obviousness rejection over Boschelli ‘780 in view of Shah, the Board found it was unsustainable for substantially the same reason.

Takeaway: As noted by the Board in Hewes, there are two different inquiries in an obviousness rejection – the motivation and the reasonable expectation, with the latter referring to the likelihood of success in modifying prior art to reach a claimed invention. A determination of obviousness is not proper if, upon consideration of all the evidence, the outcome would not have been reasonably predictable and there would not have been a reasonable expectation of success at the time of the invention. As illustrated by Hewes, such evidence could be in the form of an expert’s affidavit. To provide a probative expert’s affidavit, the expert should set up facts suggesting the unpredictability and corroborate her opinions with scientific literature preferably authored by other people skilled in the field.

Judges: D. E. Adams, E. B. Grimes, and T. G. Majors

U.S. patent examiners often use an optimization rationale when rejecting claims as obvious. Such situations typically arise when a claim recites a range of possible values for a certain variable, and the prior art discloses a value of the variable that is outside the claimed range. In these situations, examiners usually take the position that the claimed range would have been obvious to obtain by routine optimization of a “result-effective variable,” i.e., a variable that achieves a recognized result in the prior art.

However, in such a rejection, it is important that the claimed variable matches the result-effective variable from the prior art. This issue is illustrated in the recent Patent Trial and Appeal Board (“Board”) case of Ex parte Amini (Appeal No. 2020-000285).

Claim 1 recited (in part):

An article comprising:

a MAX phase solid in the form of particles, the MAX phase solid having a formula M_n+1AX_n, where n=1-3, M is an early transition metal, A is an A-group element, and X includes at least one of carbon and nitrogen; and

a high temperature melting point metallic material through which the particles of the MAX phase solid are dispersed such that the particles are spaced apart and the metallic material surrounds the particles…wherein the high temperature melting point metallic material and the MAX phase solid together define a porosity of 50 vol% to 80 vol%.

The MAX phase solid particles could be, for example, Ti₂AlC or Ti₃SiC₂, and the high temperature melting point metallic material could be Ti, Zr, Y, Sc, Be, Co, Fe, Ni, or an alloy thereof. The inventors found that the composite material, formed from the MAX phase solid particles dispersed in the metallic material, was well suited for damping applications in high temperature environments, for example as a component of a gas turbine engine.

The examiner rejected claim 1 as obvious over a combination of two references. The examiner relied on the primary reference (“Barsoum”) for a composite material comprising MAX phase particles dispersed in a metallic material. The examiner acknowledged that Barsoum did not disclose a porosity of 50 vol% to 80 vol% as recited in claim 1, and relied on the secondary reference (“Sun”) for this limitation.

In particular, the examiner relied on a description in Sun of a MAX phase having a porosity of approximately 43 vol%. The examiner took the position that this value was close enough to the numerical range of 50 to 80 vol% recited in claim 1 to render this limitation obvious. Alternatively, the examiner took the position that Sun established the porosity to be a result-effective variable that would have been obvious to optimize to obtain the claimed range.

The Board disagreed with the examiner. The Board noted that Sun described the porosity only for the MAX phase solid. In contrast, claim 1 recited the porosity for the MAX phase solid together with the metallic material, i.e., the porosity of the composite material formed by dispersing the MAX phase solid particles in the metallic material. Based on this, the Board found that the numerical value of approximately 43 vol% for the porosity in Sun could not be directly compared to the range of 50 to 80 vol% in claim 1, because these porosities were different variables.

Since these porosities were different variables, the Board also disagreed with the examiner’s rationale relating to a result-effective variable. The Board noted that “[i]t is well established that optimization of a prior art range flows from the normal desire of scientists or artisans to improve upon what is already generally known. But it is equally well established that when the parameter optimized was not recognized to be a result-effective variable, optimization would not have been obvious.” The Board found that the examiner had “not identified evidence in the present record that the prior art recognized the need for the porosity of the composite (‘the high temperature melting point metallic material and the MAX phase solid together’) to be between 50 vol% to 80 vol% as required by independent claim 1.” The Board concluded that “[b]ecause the disclosed porosity of Sun is different than the claimed porosity, there is no basis to conclude that the claimed porosity is a result-effective variable.” Accordingly, the Board reversed the obviousness rejection.

Takeaway: Whenever an examiner takes the position that a claimed variable is a result-effective variable that would have been obvious to optimize, it is important to carefully evaluate the teachings of the prior art relating to the claimed variable. If, as in Ex parte Amini, the claimed variable is distinguishable from the variable in the prior art, then this distinction can help overcome an examiner’s obviousness rejection.

Judges: Smith, Dennett, Cashion Jr.

Ex parte Grillo-Lopez, is a 2020 decision of the Patent Trial and Appeal Board (PTAB) that is listed among the Board’s precedential decisions. Ex parte Grillo-Lopez, is indicated by the PTAB to be precedential as to “[i]ssues specific to ex parte appeals… printed publication.”

According to the PTAB’s Standard Operating Procedure, “[a] precedential decision is binding Board authority in subsequent matter involving similar facts or issues.”

In Ex parte Grillo-Lopez, the PTAB considered a request for rehearing based on applicant’s assertion that the PTAB, in its original decision, improperly affirmed an obviousness rejection relying on the transcript of the July 25, 1997 meeting of the FDA’s Biological Response Modifiers Advisory Committee (FDA Transcript) as a prior art reference (a “printed publication” under pre-AIA 35 USC 102(b)).

Relevant to the discussion: the fact and subject matter of the advisory committee meeting were announced in the Federal Register; a member of the public attended the advisory committee meeting; and the FDA is required by law to prepare a transcript of advisory committee meetings and to make such transcripts available. The FDA Transcript was available in the FDA’s reading room more than one year before the critical date of the application on appeal.

In the PTAB’s original decision, it concluded that the FDA Transcript was made sufficiently accessible to the public interested in subject matter of the claimed invention to render the transcript a printed publication. Applicant countered that the PTAB’s decision was contrary to a prior PTAB decision in which the exact same transcript was found not to be available as prior art.

The PTAB noted that the prior decision finding that the transcript was not prior art related to Inter Partes Review (IPR) proceedings, not ex parte examination. The PTAB noted that, in the IPR proceedings, the burden was on the petitioner to establish that the transcript was prior art, while, in examination, the examiner may shift the burden of demonstrating that a reference is not prior art to the applicant after making a prima facie case. Thus, the PTAB concluded that the prior IPR decisions relating to the transcript did not conflict with the conclusion in its original decision. The PTAB further noted that the Federal Register Notice and the attendance of a member of the public were not in evidence in the prior IPR proceedings.

The PTAB noted applicant’s arguments that the Federal Register notice, the attendance of the member of public, and the legal requirement of preparing the transcript did not prove that the transcript itself was publicly available – applicant argued that someone would have to have been a lawyer – not skilled artisan in the subject matter of the claimed invention – to be aware of, much less find, the FDA Transcript. However, the PTAB found that the established facts, together, were sufficient to establish a prima facie case that a skilled artisan would have been aware of the meeting and aware that a transcript would be available. Thus, it was applicant’s burden to prove with contrary evidence that the transcript was not readily available to a skilled artisan.

Takeaway: This case highlights differences in the burdens of persuasion between post-grant proceedings, like IPRs, and ex parte examination. The burden on a petitioner in an IPR to prove, e.g., that a document is a printed publication, is much higher than the burden on an examiner in ex parte prosecution. Take note of the differing burdens when making arguments based on PTAB precedent during ex parte examination. Further, if an examiner persists in a position for which he/she is only obligated to make a prima facie case, be prepared to supplement your arguments with evidence (e.g., declaration evidence).

Judges: Fredman, Chang, and Cotta

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