- PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,115,233 - PTAB · Nov 21, 2023 · IPR2023-00865 · APJ Carl M Defranco · IPR · Institution
The Board instituted IPR of claims 1–19, finding a reasonable likelihood that claims 1 and 14 are obvious over Carr and Lauka.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION For the above reasons, we determine that the information presented in the Petition demonstrates a reasonable likelihood that at least claims 1 and 14 of the ’465 patent are unpatentable as obvious over Carr and Lauka. And because Instacart demonstrates that at least one claim of the ’465 patent meets the threshold for institution, we institute an inter partes review of all claims as challenged in the Petition. See 37 C.F.R. § 42.108(a),(c); SAS, 138 S. Ct. at 1359–60. IV. ORDER Accordingly, it is: ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes review of claims 1–19 of the ’465 patent is instituted; and” slip op. at 16
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Consumeron responds that one skilled in the art would have been “someone with a background in electrical engineering, computer science, or the like” and that “industry experience can make up for a lack of technical training, and more education can make up for a lack of industry experience.” Prelim. Resp. 29. Consumeron’s definition appears to overlap significantly with Instacart’s definition. Accordingly, for purposes of institution, we adopt the level of skill in the art as articulated by Instacart.” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“product ordered by the customer is available and does not contemplate a scenario where the product is unavailable or otherwise describe the action to be taken if the product is unavailable. See Pet. 17–22. We agree, at least based on the preliminary record. In particular, with reference to Figures 2 and 3, the ’848 parent application describes a method where (1) a customer chooses “a store where a desired product is being sold” (step 105), (2) the customer selects a delivery agent and sends an “acquisition request” to the delivery agent (steps 108, 109, 110), and (3) “the selected delivery agent travels to the store location . . . and finds the desired product to be acquired” (step 113). Ex. 1011 ¶¶ 17, 20, 23 (emphasis added). “The delivery agent then communicates to the customer that the product has been identified, and the customer has the option of inspecting the product in real-time” (step 117). Id. ¶ 23 (emphasis added). “Next, the customer either approves or rejects acquisition of the inspected product” (steps 119, 120, 122). Id. ¶ 24 (emphasis added). That description in the ’848 parent application clearly presumes that the product ordered by the customer has been located and is available for inspection, which is at odds with the additional requirements of claims 1 and 14 of “failing to locate an identified product” and “determining that the identified product is not available.” Ex. 1001, 11:20 (claim 1), 12:30 (claim 14) (emphases added). To the extent Consumeron argues otherwise, we are not persuaded at this preliminary stage. According to Consumeron, the customer’s rejection of the product means that “the agent fails to locate a product that is satisfactory.” See Prelim Resp. 11. But nowhere do we discern that the ’848 parent application hinges the identity and availability of a product on whether it is satisfactory to the customer. That a product might not meet a customer’s satisfaction does not negate the description in the ’848 parent application that the agent locates and identifies the product in the first instance before giving the customer the option to inspect and reject the product. Indeed, because the customer placed the online order with a store advertising the product, the presumption is that the advertised product is available and satisfactory to the customer.8 And, while conceivably the purchase of a product cannot be fulfilled in the event the product is unavailable, it would seem to be improper hindsight to derive written description support by “[w]orking backward from a knowledge of the claims.” Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349 (Fed. Cir. 2013). “Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. It extends only to that which is disclosed.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571–72 (Fed. Cir. 1997). Thus, based on the preliminary record, the ’848 parent application does not provide sufficient written description for the terms noted above. As such, we find that Instacart demonstrates a reasonable likelihood it will prevail in showing that the asserted references are prior art to the challenged claims.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“and Lauka. See Pet. 30–44, 47–49. We begin with Instacart’s challenge of method claim 1. Instacart provides a detailed mapping of how Carr satisfies all the recited limitations of claim 1, except limitation [1.0.3], for which Instacart points to Lauka. See id. at 35–44. In particular, Instacart cites the following evidence in support of its contentions that Carr and Lauka, when combined, teach or suggest each of the recited limitations of claim 1: Limitation 1.0.1—“A method for remote acquisition and delivery of goods through one or more agents of a service provider” (Pet. 35 (citing Ex. 1005 ¶¶ 36, 39, 43, 45, 92, Figs. 1, 3, 6;; Ex. 1001 ¶¶ 97–100)); Limitation 1.0.2—“each agent having a mobile agent system in communication with at least one remote server,” (Pet. 35–37 (citing Ex. 1005 ¶¶ 2, 6, 40–43, 53, Fig. 1 (annotated); Ex. 1003 ¶¶ 101–104)); Limitation 1.0.3—“with each mobile agent system including: a digital image capture device and a communication device, said method comprising:” (Pet. 37–38 (citing Ex. 1005 ¶¶ 74, 88, 94, 122; Ex. 1006, 3:19–28, 3:49–57, 4:10–21; Ex. 1003 ¶¶ 105– 109)); Limitation 1.1—“receiving, through the at least one remote server, a first acquisition request from a customer for a first set of one or more goods;” (Pet. 38 (citing Ex. 1005 ¶¶ 9, 60, 73, Fig. 1; Ex. 1003 ¶¶ 110–112)); Limitation 1.2—“contacting, through the communications device, the one or more agents;” (Pet. 38 (citing Ex. 1005 ¶¶ 57, 74; Ex. 1003 ¶¶ 113–115)); Limitation 1.3—“upon failing to locate an identified product of the set of one or more goods, electronically transmitting information on a replacement product for the identified product of the set of one or more goods to the customer using the digital image capture device of the agent, including:” (Pet. 38–40 (citing Ex. 1005 ¶¶ 90, 95, 96, 105, 107, ; Ex. 1003 ¶¶ 116– 119)); Limitation 1.4—“obtaining a bar or QR code of the replacement product;” (Pet. 40 (citing Ex. 1005 ¶¶ 95, 107; Ex. 1003 ¶¶ 120– 122)); Limitation 1.5—“determining the information from the bar or QR code, wherein the information includes at least one image of the replacement product; and” (Pet. 40–42 (citing Ex. 1005 ¶¶ 95–96, 116; Ex. 1003 ¶¶ 123–127)); Limitation 1.6—“sending the information for the customer to approve the purchase of the replacement product based on the information determined from the bar or QR code; and” (Pet. 42– 43 (citing Ex. 1005 ¶¶ 51, 96–99, Fig. 12; Ex. 1003 ¶¶ 128– 130)); and Limitation 1.7—“upon receiving approval of the purchase from the customer, acquiring the replacement product, via the agent.” (Pet. 43–44 (citing Ex. 1005 ¶¶ 99, 101; Ex. 1003 ¶¶ 131–132)); Instacart also provides a reason why one skilled in the art would have combined the teachings of Carr and Lauka with a reasonable expectation of success. See Pet. 31–34 (citing Ex. 1003 ¶¶ 86–96); see also id. at 37 (“In view of the teachings of Lauka, a POSITA would have recognized that it was obvious to implement the UPC scanner functionality of Carr’s handheld device using an ‘imaging device’ such as that taught by Lauka, which specifies that the ‘imaging device 206 can comprise a video or still camera’ and ‘can be used to capture images.’ Ex.1006, 3:49-57; Ex.1003, ¶¶105- 107.”).” slip op. at 11
Claim construction§ 103 obviousness§ 112 disclosurePatents in suitUS 11,238,465 - PTAB · Oct 13, 2023 · PGR2023-00022 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted PGR on claims 1–33 under all petition grounds, finding it more likely than not that at least one claim lacks written description and enablement.
RulingsInstitution decision- Skill levelSkill level board ownOther
“Based on the information presented, we agree with Patent Owner that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). We do not find it necessary to define the level of skill in the art at the time of the invention at this time. However, for purposes of deciding whether to institute trial, we find that Dr. Silverstone is qualified to provide helpful opinion testimony on the issues regarding which we cite his testimony in this decision. See Ex. 1003 ¶¶ 6–15.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on the above, we agree with Patent Owner that many of the arguments raised by the Examiner are highly similar to the challenges in this proceeding, particularly the written description challenge. However, some arguments differ. For instance, Petitioner’s enablement argument identifies that, contrary to Applicant’s statement during prosecution reproduced above, amino acids and protein structure outside the disclosed AAD-12 motif can also affect the activity of the claimed dioxygenases to degrade phenoxy auxin and pyridyloxy auxin. See Ex. 1003 ¶¶ 42–50, 79 (Dr. Silverstone describing the mechanics of protein binding and explaining why the ’055 patent disclosure fails to provide sufficient information to the skilled artisan to know which amino acids could be changed while retaining the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides). See also Pet. 27–34 (asserting, e.g., 85% homology to AAD-12 motif alone is insufficient to predict enzymatic degradation activity). While the Examiner’s rejections regarded the disclosure corresponding to the ability to degrade herbicides, the Examiner plainly relied on Applicant’s statements that the AAD-12 motif’s structure alone was responsible when deciding to withdraw the rejection. Ex. 1002, 355. The Examiner did not have the additional testimony supplied by the Silverstone declaration explaining otherwise. See Ex. 1003 ¶¶ 42–50, 79. Petitioner, through Dr. Silverstone, also addresses the effort the skilled artisan would have needed to undertake to determine what proteins outside of the AAD-12 motif would affect the ability of homologues to enzymatically degrade the recited herbicides, and provides evidence for consideration regarding the lack of a clear link between the AAD-12 motif and the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides. Ex. 1003, 347. Therefore, the arguments are not entirely overlapping. And while these issues do in part overlap with Petitioner’s arguments pertaining to enablement, we agree with Petitioner that the Examiner did not complete a written Wands analysis. Although we conclude that the arguments are not entirely overlapping, we proceed to the second step in the analysis, for completeness.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because Petitioner has shown that it is more likely than not that Petitioner will prevail in showing that at least one claim lacks sufficient written description and is not enabled, we conclude the challenged claims are eligible for post-grant review. V. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has shown it is more likely than not that at least one challenged claim of the ’055 patent lacks written description and is unpatentable. Accordingly, we institute a post-grant review. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a), a post-grant review of claims 1–33 of the ’055 patent is instituted with respect to all grounds set forth in the Petition; and” slip op. at 57
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“85% identity as “highly identical” in this field and that the “conserved motif residues comprise ‘the active site that is essential for catalytic activity.’” Prelim. Resp. 31 (citing Ex. 1001, 11:1–6)). However, on the record before us, we are unpersuaded that this is sufficient because the Specification lacks disclosure supporting that a polypeptide of, for example, 86% identity to SEQ ID NO: 2 would retain the ability to degrade herbicides if the 5 amino acids in the general formula of HX109D(X)111-134 T(X)136-261H(X)263-272R, and the required chain lengths are present. In this regard we are persuaded by the testimony of Dr. Silverstone (Ex. 1003 ¶¶ 48–93) regarding the limitations of the disclosure of the ’055 patent and the lack of information supporting the skilled artisan in understanding that the inventor possessed the entire claimed genus (e.g., lack of example at lower end of sequence identity and lack of information to assist the skilled artisan in predicting whether an α-ketoglutarate-dependent dioxygenase would interact with or degrade either phenoxy auxin herbicides and/or pyridyloxy auxin herbicides). Dr. Silverstone testifies, and we are persuaded on this record, that the skilled artisan would not have read the guidance in the disclosure and understood that the inventors possessed the ability to design a modified SEQ ID NO: 2 at the 85% identity level that retained the function of degrading the recited herbicides, let alone the full scope of the claimed genus. Id. Patent Owner argues that Dr. Silverstone’s testimony that conserved amino acids of the AAD-12 motif are present in other α- ketoglutarate-dependent dioxygenases but do not have the claimed dual activity (Ex. 1003 ¶ 48) is misplaced because it “ignores that the location and spacing of those residues in other αKG-dependent dioxygenases differ from those in the AAD-12 motif.” Prelim. Resp. 38. However, Patent Owner offers no evidence that supports its argument. Id. It is thus unpersuasive.” slip op. at 36
§ 112 disclosureDiscretionary denialPatents in suitUS 11,371,055 - Neuroderm Ltd. v. Abbvie Inc.InstitutedPTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution
The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19
- Skill levelSkill level board ownOther
“Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15
- Expert testimonyPetitioner expert creditedOther
“Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,091,507 - Human Power Of N Company v. Heartbeet LtdInstitution deniedPTAB · May 16, 2022 · PGR2022-00004 · APJ Devon Zastrow Newman · PGR · Institution
The Board denied institution on all challenged claims because Petitioner did not show the patent was eligible for post-grant review.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Determining whether a patent is subject to the first-inventor-to-file provisions of the AIA, and therefore eligible for post-grant review, is straightforward when the patentee filed the application from which the patent issued before March 16, 2013, or when the patentee filed the application on or after March 16, 2013, without any priority claim. The determination is more complex, however, for a patent that issues from a “transition application,” that is, an application filed on or after March 16, 2013, that claims the benefit of an earlier filing date. See MPEP § 2159.04 (9th ed. Rev. 10.2019, June 2020). Entitlement to the benefit of an earlier date under 35 U.S.C. §§ 119, 120, 121, or 365 is premised on disclosure of the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode)” in the earlier application. See 35 U.S.C. §§ 119(e), 120. Thus, a patent that issues from a transition application is not available for post-grant review if the claimed subject matter complies with the written description and enablement requirements of § 112(a) for an ancestor application filed prior to March 16, 2013.” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“B. Legal Standard The test for written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” based on an “objective inquiry into the four corners of the specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). If this test fails, the application is not entitled to the benefit of the earlier filing date.” slip op. at 11
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledDecided for patent owner
“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)). Undue experimentation is analyzed by applying the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988).5 Nothing more than objective enablement is required, and therefore it is irrelevant whether this teaching is provided through broad terminology or illustrative examples. In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971); see also In re Howarth, 654 F.2d 103, 105 (CCPA 1981) (“An inventor need not, however, explain every detail since he is speaking to those skilled in the art.”). slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“F. Person of Ordinary Skill in the Art Petitioner proposes that one of ordinary skill in the art would have had “an M.D. degree or a Ph.D. degree in biochemistry, pharmacology, nutrition chemistry, exercise physiology, or kinesiology, and at least two years of 2 This chart repeats the grounds as presented in Petitioner’s chart at Pet. 4. 3 Brunton, An Address on Blood Pressure in Man: Its estimation and indications for treatment, The British Medical Journal, pp. 64-67 (July 10, 1909) (Ex. 1032 “Brunton”). 4 Brunton et al., An Address on Longevity and the Means of Attaining It, The Lancet, Vol. 168, Issue 4342, pp. 1330–1355 (Nov. 17, 1906) (Ex. 1033 “Brunton 2”). post-doctoral research or clinical experience with physiology, biochemistry, or dietary supplements and formulation.” Pet. 13 (citing Ex. 1003 ¶ 21). Patent Owner does not challenge this definition at this time. Prelim. Resp. 7. For purposes of this decision, we apply Petitioner’s proposed definition as it is consistent with the level of skill presented in the ’747 patent and applied art. We also note that the level of ordinary skill in the art at the time of the invention may be reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 6
Claim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,083,747 - Human Power Of N Company v. Heartbeet LtdInstitution deniedPTAB · Feb 25, 2022 · PGR2021-00110 · APJ Devon Zastrow Newman · PGR · Institution
The Board denied institution because Petitioner did not show the ’555 patent was eligible for post-grant review; the challenged claims were entitled to pre-AIA effective filing dates.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“The test for written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” based on an “objective inquiry into the four corners of the specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). If this test fails, the application is not entitled to the benefit of the earlier filing date. The written description requirement is satisfied when the specification “set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004). The specification does not have to provide exact or verbatim textual support for the claimed subject matter at issue. Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996). The Federal Circuit has clarified that [a]lthough [the applicant] does not have to describe exactly the subject matter claimed, . . . the description must clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed . . . . The test for sufficiency of support . . . is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (citations omitted). Moreover, “the written description requirement does not demand either examples or an actual reduction to practice.” Capon v. Eshhar, 418 F.3d 1349, 1352 (Fed. Cir. 2005). “An applicant is not required to describe in the” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that one of ordinary skill in the art would have had “an M.D. degree or a Ph.D. degree in biochemistry, pharmacology, nutrition chemistry, exercise physiology, or kinesiology, and at least two years of post-doctoral research or clinical experience with physiology, biochemistry, exercise science, or dietary supplements and formulation.” Pet. 16 (citing Ex. 1003 ¶ 21). Patent Owner does not challenge this definition at this time. Prelim. Resp. 7. For purposes of this decision, we apply Petitioner’s proposed definition as it is consistent with the level of skill presented in the ’555 patent and applied art. We also note that the level of ordinary skill in the art at the time of the invention may be reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We are unpersuaded that Dr. Volek’s reliance on Exhibit 1066 as the sole source of his conclusion that certain doses of inorganic nitrate would have been lethal in the context of the claimed methods is sufficient to establish undue experimentation under the Wands factors. As Patent Owner argues, the working example disclosed in PCT1 discloses administration of a dose Dr. Volek states would have been lethal, but was not. Rather, the result of that experiment was a demonstrated decrease in glucose consumption by the participants, a benefit of increased endurance. Ex. 1008 ¶ 106. We agree with Patent Owner that this case is distinguishable from those cited by Petitioner for the reasons explained by Patent Owner (Prelim. Resp. 31–33), and also from the recent case by our reviewing court, Amgen, Inc. v. Sanofi, 987 F.3d 1080 (Fed. Cir. 2021). In Amgen, the court found the claims lacked enablement because the claims recited dual functional limitations, and potentially millions of antibody candidates could be found to fall within those limitations. Id. at 1088. The court found the examples provided in the specification insufficient to enable the full scope of the claims given the high effort required to screen and identify all such antibodies. Id. Here, as Patent Owner has observed, the only effort required to practice claims within the range in light of the working example is to “simply administer a different dosage to the human for which increased exercise endurance is desired,” which would have been within the scope of the ordinarily skilled artisan. Prelim. Resp. 31. Moreover, Patent Owner correctly notes that methaemoglobinaemia15, the source of the lethality cited in Exhibit 1066, does not result via the claimed method. Prelim. Resp. 30, citing Ex. 1066 at 14–15. As Patent Owner explains, Petitioner’s sole cited Exhibit, 1066, discloses a risk of development of methaemoglobinaemia, a condition where more than 10% of the haemoglobin is transformed into methaemoglobin.” Id. When the conversion to haemoglobin exceeds 70% the condition can be fatal.” Ex. 1066 at 14–15. Patent Owner explains that the inventors discussed the risk of development of methaemoglobinaemia, and explained in PCT1 that their methods do not cause a significant rise in the methemoglobin level in the test subjects. Prelim. Resp. 30. Moreover, PCT1 discloses a working example where three test subjects were given a dose in the range Petitioner alleges would be lethal, with no ill result. Id., citing Ex. 1008 ¶ 106. Dr. Volek’s failure to address this discrepancy, or to provide alternate sources to explain why his conclusion is nonetheless correct, merits his brief testimony on this issue be assigned little probative” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“G. Claim Construction In a post-grant review, we apply the same claim construction standard as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.200(b) (2020). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012). Pet. 23–24. Patent Owner does not propose a construction for “inorganic nitrate.” Prelim Resp. 8–9. For purposes of determining whether to institute trial of the challenged claims, we determine it is not necessary to construe “inorganic nitrate.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA proceeding).” slip op. at 7
Claim construction§ 112 disclosurecites PhillipsPatents in suitUS 10,835,555 - LKQ Corporation / Keystone Automotive Industries, Inc. v. GM Global Technology Operations LLCNo claims unpatentablePTAB · Oct 8, 2021 · PGR2020-00054 · APJ Robert L Kinder · PGR · Final written decision
The sole claim was not shown unpatentable: it is definite, and neither asserted obviousness combination renders the design unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. The Designer of Ordinary Skill in the Art (“DOSA”) LKQ contends that: a designer of ordinary skill would be an individual who has at least an undergraduate degree in transportation or automotive design experience in the field of transportation design, or someone who has several years’ work experience in transportation or automotive design. Pet. 51 (citing Ex. 1003 ¶ 42; Ex. 1004 ¶ 41). Based on the final record, which includes testimony by LKQ’s witnesses, we adopt LKQ’s proposed definition of the ordinary designer.” slip op. at 19
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Based on the final record, the purported issues related to a double line on the convex crease and the length of the single line do not create internally inconsistent drawings that would preclude the overall understanding of the drawing as a whole. We have considered the testimony of each witness and we find Mr. Peters’ explanation most convincing that “the claimed design describes the convex band consistently because each of the figures presents at least one of the ways that a convex band can be represented. . . . Figure 1 illustrates the two intersecting lines of the convex band, while Figures 2-4 illustrate the single max height line of the convex band.” Ex. 2004 ¶ 58. Thus, we agree with GM that these figures are not inconsistent, but rather complementary because both connecting lines (as shown in Figure 1) and the max height line (as shown in Figure 2) are accurate depictions of the convex band of the claimed design. Further, GM has presented persuasive evidence that the varied length of the line between figures is also understandable depending on the point of reference of a particular figure. Ex. 2004 ¶¶ 55, 56; Ex. 2006, 143:11–16, 144:4–7.” slip op. at 27
- Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteNot shown unpatentable
“7. Overall Indefiniteness Analysis The figures of the ’065 patent are not perfect and the issues discussed above demonstrate that attention to detail matters when conveying the scope of a three-dimensional object in two dimensions. The proper standard for indefiniteness does not, however, require perfection, but instead requires that an invention is shown with “reasonable certainty.” Nautilus, Inc., 572 U.S. at 910. The purpose of the definiteness standard is “to ensure that the disclosure is clear enough to give potential competitors (who are skilled in the art) notice of what design is claimed – and therefore what would be infringed.” Maatita, 900 F.3d at 1376. Based on the totality of the evidence before us, we determine that the claimed design of the ’065 patent is reasonably understandable and gives potential competitors, and the public, notice of the scope of the claim. As analyzed above, LKQ has not shown that most of the alleged inconsistencies are, in fact, inconsistent features within the claim. Further, we determine that the inconsistencies argued by LKQ do not in the aggregate “preclude the overall understanding of the drawing as a whole.” Id. at 1375–76.” slip op. at 45
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“The Petition fails to adequately address the differences between the claimed ornamental fender design and the Fiat Toro in several important areas, including: the distinct upper portions of each design, the claimed design’s inwardly folded (L-shaped) top edge, and the rear lateral edge. Based on the final record, these differences combined with the other differences noted by LKQ (Pet. 81) are substantial and prevent the Fiat Toro from having design characteristics that are basically the same as that claimed in the ’065 patent – as required for a Rosen reference.” slip op. at 67
Patent outcomesUS D864,065 not shown unpatentable§ 103 obviousness§ 112 disclosurecites Nautilus
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.