- PTAB · Apr 19, 2023 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted review on all challenged claims and the sole anticipation ground: claims 1–4, 8–14, and 18–26, with a reasonable likelihood of unpatentability except claim 19.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialInstitutedDenied
“This case differs from other situations where the Board has exercised discretion under § 314(a) to deny institution. For example, we are not presented with a later-filed petition after having considered an earlier-filed petition challenging the same patent. See, e.g., General Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19, 6–11, 15–22 (PTAB Sept. 6, 2017) (precedential)). This is the first petition filed against this patent and contains only a single ground. Also, as Petitioner asserts, and Patent Owner does not contest, the Fintiv factors are neutral or favor institution. See Pet. 61–63. Instead, Patent Owner asks us to deny institution because Petitioner” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts A person of ordinary skill in the art (“POSA”) in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a PharmD with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29. Pet. 15–16. Patent Owner asserts “that a POSA for purposes of the ’087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers).” Prelim. Resp. 13. Patent Owner asserts “Petitioner’s definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners’ definition of a POSA, on the other hand, accounts for the claims’ focus on lymphoma and leukemia.” Id. at 14. At this stage in the proceeding, we find that Patent Owner’s analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot entitled to earlier dateMixed
“reasonable likelihood that claims 1 and 9 are not entitled benefit of priority to the ’087 or earlier priority Specifications prior to the publication of the November 2018 Venclexta label. Claim 1, for example, recites a GDC-0199 dosing regimen “compris[ing] a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC- 0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.” This disclosure is not found in a single example, but must be selected from disparate parts of the Specification. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 4 (Fed Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 22
§ 102 anticipation§ 112 disclosureDiscretionary denialPatents in suitUS 11,110,087 - PTAB · Apr 18, 2023 · IPR2022-00123 · APJ Zhenyu Yang · IPR · Final written decision
The Board cancelled original claim 1 and denied substitute claim 2 for lack of written-description support; it did not reach the obviousness or enablement grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“ordinary skill is inappropriate because it “requires qualifications that exclude even the sole inventor of the ’190 Patent, Dr. Edward Neuwelt.” MTA Opp. 1. According to Petitioner, Dr. Neuwelt is “a neurosurgeon,” not a pediatric oncologist, and lacks the requisite “at least 2 years” experience in platinum-based therapies. Id. (citing Ex. 1003, 18; Ex. 1038, 98:9–17, 100:15–101, 4). We agree with Petitioner. It is well settled that inventors are typically persons skilled in the field of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner presents persuasive evidence to show that under Patent Owner’s proposed definition of the level of ordinary skill, Dr. Neuwelt, the sole inventor, would not qualify as an ordinarily skilled artisan, because he is not a pediatric oncologist, even though he is considered “one of the world leading experts on this compound [STS] and otoprotection” and “an expert in the area of [STS] as a . . . drug to use in children with medulloblastoma.” Ex. 1038, 98:9–17, 99:17–18, 101:18–102:13.” slip op. at 10
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Paragraph 102 of Dr. Rassekh’s Declaration, however, does not support Patent Owner’s assertion. Instead, Dr. Rassekh testifies that [t]he stratum of previous craniospinal radiation therapy contained 8 participants: 2 of the 4 (50%) participants receiving STS had hearing loss compared to 4 of the 4 (100%) participants not receiving STS, and none of the hearing loss assessments were changed at the 1 year follow up period. (Ex. 1001 at 20: 28-32, 47-50.) Ex. 2024 ¶ 102. Dr. Rassekh offers no opinion on how many osteosarcoma patients with prior cranial irradiation and how many medulloblastoma patients with prior cranial irradiation had hearing loss.” slip op. at 20
- 112 supportMotion to amend, deniedDenied
“In sum, we find the disclosures of the ’243 application that Patent Owner relies on do not provide sufficient written-description support for the ototoxicity efficacy limitation.” slip op. at 21
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“F. Petitioner’s Asserted Unpatentability Grounds In light of our determination above that Patent Owner has not shown sufficient written-description support for proposed substitute claim 2 in the ’243 application, we do not reach the grounds of unpatentability set forth in Petitioner’s Opposition. See Revised MTA Opp. 17–25 (alleging non-enablement and obviousness).” slip op. at 26
§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,596,190 - Bausch & Lomb Incorporated v. Zeavision, LLCAll claims unpatentablePTAB · Apr 10, 2023 · IPR2022-00089 · APJ Tina E Hulse · IPR · Final written decision
Claims 12–14, 16–21, 23, and 24 are unpatentable: Lang anticipates some claims, and the asserted Lang-based combinations render all challenged claims obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition (Dec. Inst. 6–7), which Patent Owner states that it “does not contest.” PO Resp. 17. Because the parties do not dispute the level of ordinary skill in the art, we adopt Petitioner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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))). Moreover, we find that Dr. Johnson and Dr. Dorey are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art. See Ex. 1024 ¶¶ 2–11, App’x A; Ex. 2001 ¶¶ 4–14, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Similarly, here, the Specification consistently states that the invention relates to oral formulations for protecting eye health and that the benefits of carotenoids, such as zeaxanthin and lutein, include the ability to absorb UV and blue light. See, e.g., Ex. 1001, Abstract (“Oral formulations for promoting eye health”), 4:25–31 (stating carotenoids such as zeaxanthin are “very good at absorbing ultraviolet (UV) and blue light”), 15:45–47 (“one object of this invention is to disclose multi-component orally-ingestible formulations for protecting eye health in mammals”). Like the preamble in Proveris, the preamble in claim 12 is the only reference in any of the independent claims to the allegedly inventive concept of protecting eye health from the harmful effects of blue light. Proveris, 739 F.3d at 1373. Moreover, the preamble of claim 12 recites: “A nutrient formulation for oral ingestion for protecting a user’s eyes from the harmful effect of blue light, the formulation comprising:.” Ex. 1001, 37:13–15. The body of claim from the group consisting of capsules, tablets, liquids, and powders for oral ingestion.” Ex. 1001, 37:22–24 (emphasis added). Similarly, claim 22, which depends from claim 12, relies on the preamble of claim 12 for antecedent basis for the limitation “wherein the user has macular degeneration and a lens-related disorder.” Id. at 38:21 (emphasis added). Thus, “the nutrient formulation” and “the user” in the claim body derives antecedent basis from the “nutrient formulation” and “user” that is “defined in greater detail in the preamble.” See Proveris, 739 F.3d at 1373. Accordingly, reading the patent as a whole, because the inventor clearly relied on both the preamble and the body of claim 12 to define the claimed invention, the preamble of claim 12 should be construed as limiting. See id.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would understand this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 19 (citing Ex. 1024 ¶ 57, Ex. 1031, 3). Petitioner also contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and delta-tocopherols.” Pet. 22–24 (citing Ex. 1024 ¶¶ 65–66). Patent Owner does not address either of these claim terms in its Response. See generally PO Resp. Because there does not appear to be any dispute over the construction of these terms, we adopt Petitioner’s proposed constructions as they are consistent with the plain and ordinary meaning of the terms. See Wellman, terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 13
Patent outcomesUS 10,307,384 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,307,384 - Ricetec, Inc. v. BASF SEAll claims unpatentablePTAB · Mar 8, 2023 · PGR2021-00114 · APJ Tina E Hulse · PGR · Final written decision
Claims 1–17 are unpatentable: they lack written description support and are anticipated by Hinga; the Board also found the challenged dependent claims obvious over the listed combinations.
RulingsFinal written decision- Skill levelSkill level board ownOther
“As explained in our Institution Decision (Dec. Inst. 5–6), we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner states a POSITA must have one to two years of postdoctoral research experience and Patent Owner’s definition requires at least five years of “research experience,” Patent Owner’s definition does not indicate a specific time for that research (i.e., it could include research during or after a doctoral program). Neither party addresses or contests the other party’s definition in their post-institution papers. See generally PO Resp.; Pet. Reply; PO Sur-reply. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by 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))). Moreover, we find that Dr. Shaner and Dr. Somers are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. See Ex. 1002 ¶¶ 4–15; Ex. 2036 ¶¶ 5–11, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“amount.” Pet. Reply 14. Patent Owner, however, argues that we erred in our construction because the Specification explicitly defines “effective amount” to mean “the amount of herbicide required to achieve at least about 65% phytotoxicity of conventional [i.e., wild, non-mutant] rice (e.g., red rice) in field applications.” PO Resp. 10 (quoting Ex. 1001, 6:34–37). Because the inventors served as their own lexicographers, Patent Owner asserts the Specification’s express definition controls. Id. at 10–11 (citing Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir. 2009) (“When a patentee explicitly defines a claim term in the patent specification, the patentee’s definition controls.”)). Nevertheless, Patent Owner acknowledges that the “less than 10% injury” language “is indeed a limitation of the ’346 Patent claims.” Id. at 11. Having considered the arguments and evidence presented at trial, we agree with Patent Owner that the inventors acted as their own lexicographer to define “effective amount” and that that definition governs its meaning. Phillips, 415 F.3d 1316 (“[O]ur cases recognize that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”). We, therefore, construe the term “effective amount” to mean “the amount of an herbicide required to achieve at least about 65% phytotoxicity of conventional rice (e.g., red rice) in field applications.” As explained further below, however, whether incorporated into the construction of “effective amount” or not, the claim language itself further requires that the “effective amount” encompass a specific range of amounts of herbicide (i.e., 14 g AI/Ha to 40 g AI/Ha of quizalofop) and cause “less than 10% injury” to the mutant rice. See Ex. 1001, claim 1.” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“Mankin would derive the herbicide range suggested by Patent Owner and Dr. Somers from the “rules of thumb,” that range is much broader than the claimed range. Claim 1 recites that the effective amount is 14 g AI/Ha–40 g AI/Ha of quizalofop, but, according to Dr. Somers’s calculations from the Assure II herbicide label, a POSITA would understand the effective amount to be 19.25–154 (or 19.25–184.8) g AI/Ha. Ex. 2036 ¶ 54; PO Resp. 38. Patent Owner does not identify anything in the specification that would allow a POSITA to “immediately discern” the specific range limitations of the claims. See General Hospital, 888 F.3d at 1372. As the Federal Circuit has stated, “one cannot disclose a forest in the original application, and then pick a tree out of the forest and say here is my invention.” Purdue Pharma, 230 F.3d at 1326. Thus, we are not persuaded that the disclosure of a broad range of effective amounts via the Assure II herbicide label coupled with Dr. Somers’s undisclosed “rules of thumb” provide written description support for the narrower range limitations of the claims. Moreover, we agree with Petitioner that Patent Owner is impermissibly working backward from the claimed ranges to determine whether Dr. Somers’s “rules of thumb” can be used to re-create the claimed range from the herbicide label. Pet. Reply 15. That is not the test for written description. Written description “requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention.” Indivior UK Ltd. v. Dr. Reddy’s Labs. S.A., 18 F. 4th 1323, 1329 (Fed. Cir. 2021). Accordingly, we are not persuaded that Dr. Somers’s “rules of thumb” applied to the extrinsic herbicide label would be understood by a POSITA as a description in Mankin of the range limitation of the claims. Rather, as Dr. Somers concedes, his “rules of thumb” in conjunction with the herbicide label represent a starting point for a POSITA to test plants to determine what the effective amount range should be. See Ex. 2036 ¶ 53 (referring to a “dose response analysis” between 0.5x and 4x). But “a ‘mere wish or plan’ for obtaining the claimed invention is not sufficient.” See Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351 (Fed. Cir. 2011).” slip op. at 30
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“We are not persuaded. Given the state of the art in 2017, and the known availability of the G2096S seeds at that time, we find the ’346 patent specification enables the claims. The ’346 patent specification clearly describes the G2096S mutant ACCase rice and its use in the claimed method for treating rice. See, e.g., Ex. 1001, 2:37–45, 57:51–61. Contrary to Petitioner’s assertion, the ’346 patent specification has not omitted the G2096S herbicide tolerant rice. Rather, the ’346 patent specification expressly identifies the G2096S mutant rice that possesses the phenotype of tolerance to the effective amounts of herbicides, and describes the method for treating that mutant rice with those effective amounts. See, e.g., id. at 8:8–12; 57:51–61. Thus, we are not persuaded that we erred in relying on Hinga’s seed deposits to determine that Petitioner has failed to meet its burden to prove that the ’346 patent specification fails to enable the challenged claims. Cf. Wands, 858 F.2d at 736 (stating “[n]o deposit is necessary if the biological organisms can be obtained from readily available sources.”).” slip op. at 46
Patent outcomesUS 11,096,346 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,096,346 - Ricetec, Inc. v. BASF SEAll claims unpatentablePTAB · Mar 8, 2023 · PGR2021-00113 · APJ Tina E Hulse · PGR · Final written decision
Claims 1–15 are unpatentable: they lack written-description support, and claims 1–3, 7, and 11–15 are anticipated by Hinga or Hinga2013.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“As explained in our Institution Decision (Dec. Inst. 6–7), we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner states a POSITA must have one to two years of postdoctoral research experience and Patent Owner’s definition requires at least five years of “research experience,” Patent Owner’s definition does not indicate a specific time for that research (i.e., it could include research during or after a doctoral program). Neither party addresses or contests the other party’s definition in their post-institution papers. See generally PO Resp.; Pet. Reply; PO Sur-reply. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by 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))). Moreover, we find that Dr. Shaner and Dr. Somers are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. See Ex. 1002 ¶¶ 5–15; Ex. 2036 ¶¶ 5–11, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“Having considered the arguments and evidence presented at trial, we agree with Patent Owner that the inventors acted as their own lexicographer to define “effective amount” and that that definition governs its meaning. Phillips, 415 F.3d 1316 (“[O]ur cases recognize that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”). We, therefore, construe the term “effective amount” to mean “the amount of an herbicide required to achieve at least about 65% phytotoxicity of conventional rice (e.g., red rice) in field applications.” As explained further below, however, whether incorporated into the construction of “effective amount” or not, the claim language itself further requires that the “effective amount” encompass a specific range of amounts of herbicide and cause “less than 10%” injury to the mutant rice. See Ex. 1001, claim 1. We determine it is unnecessary to expressly construe any other claim terms for purposes of this Decision. See Wellman, 642 F.3d at 1361.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“labels is akin to relying on literature that clearly provides, on its face, the missing disclosure, as in Falkner. Id. On the contrary, Patent Owner’s argument makes clear that the herbicide labels, by themselves, are insufficient to describe the claimed range limitation. Specifically, because the label ranges do not align with the claimed ranges, Dr. Somers had to make additional assumptions and inferences to support Patent Owner’s written description argument. For example, to calculate the potential effective amount range of herbicides, Dr. Somers applied several different “rules of thumb,” none of which are disclosed in the Mankin specification. See Ex. 2036 ¶¶ 34, 54. According to Dr. Somers, to determine the effective amount for a plant with an unknown response to an herbicide, a POSITA “would naturally test the lowest label (1X) rate of the herbicide, along with a few rates below (starting at about half-X) and above the 1X rate (up to 4X) of the herbicide, to determine the effective dose for this ‘uncharacterized’ plant.” Id. ¶ 34. Dr. Somers refers to this as a “dose response analysis.” Id. ¶ 53. In other words, to determine what the actual effective amount of herbicides should be, Dr. Somers explains that a POSITA would have to test the plants at these “rule of thumb” amounts to determine the effective range. Id. ¶ 34. Given the additional assumptions and inferences that must be made to the herbicide labels to arrive at the range limitations, we are not persuaded that relying on the extrinsic herbicide labels for written description support is proper in this case. That said, even if we were to allow Patent Owner to rely on the herbicide labels and the “rules of thumb” for determining the effective herbicide dose, Patent Owner admits that the ranges calculated from the herbicide labels are broader than the range limitations of the claims. See PO Resp. 39. As Petitioner notes, however, the Mankin Application does not provide any guidance as to whether the effective amount range of herbicide would include a 0.5x dose, a 2x dose, or the 4x dose, such that a POSITA could immediately discern the claimed range from the herbicide label.17 Pet. Reply 16.” slip op. at 30
- Expert testimonyPatent owner expert discountedDecided for petitioner
“Dr. Somers, however, relies on the label for Fusilade II, which is a different fluazifop-P-butyl herbicide with a different range of 52.98–103.96 g AI/Ha, which—not surprisingly—aligns more closely with the claimed range of at least 56–150 g AI/Ha. Ex. 2036 ¶ 52. We note that Fusilade II does not appear to be one of the listed herbicides in Table 1, whereas Fusilade DX is. Ex. 2034 ¶ 219 (listing “Fusilade, Fusilade 2000, Fusilade DX, ICI-A 00009, ICI-A 00005, SL-236, IH-773B, TF-1169, and Fusion” as examples of synonyms and trade names for fluazifop-P-butyl). Regardless, that the dose range differs for the same herbicide calls into question the credibility of Dr. Somers’s assertion that a person of ordinary skill in the art would have been able to discern the claimed range limitation by simply looking at the EPA-approved herbicide labels (and applying his “rules of thumb”).18, 19” slip op. at 33
Patent outcomesUS 11,096,345 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,096,345 - Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentablePTAB · Nov 15, 2022 · IPR2021-00926 · APJ Julia Heaney · IPR · Final written decision
Claims 2, 4–6, 11–13, 17, and 18 are unpatentable as obvious over Stafford and Manno; claims 2, 5, 6, 11–13, 17, and 18 are also anticipated or obvious over Monahan.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. See Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include “(1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering;” and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of the coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner
“the earlier application must disclose the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode).” 35 U.S.C. §§ 119(e), 120. Section 112(a) requires that the specification contain a written description of the claimed invention. 35 U.S.C. § 112(a). “[T]he hallmark of written description is disclosure.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description requirement is met when the specification “conveys to those skilled in the art that the inventor had possession of” and “actually invented” the claimed subject matter. Id. The purpose of the written description requirement is to ensure that a patent’s claims “do[] not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000). The Federal Circuit has stated: The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought. Lockwood v. Am. Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997).” slip op. at 21
Patent outcomesUS 9,982,248 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 9,982,248 - Cradlepoint, Inc. / Honeywell International, Inc. et al. v. 3g Licensing SAAll claims unpatentablePTAB · Sep 15, 2022 · IPR2021-00639 · APJ Juliet Mitchell Dirba · IPR · Final written decision
Claims 1–25 are unpatentable as obvious; the Board denied the motion to amend because proposed substitute claims 26–50 would have been obvious over Oksala or Oksala and Yoshioka.
RulingsFinal written decision- Skill levelSkill level board ownOther
“B. The Level of Ordinary Skill in the Art Our reviewing court has explained that “the level of skill in the art is a prism or lens through which a judge, jury, or the Board views the prior art and the claimed invention.” Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (citing Al-Site Corp. v. VSI International, Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999)). “This reference point prevents these factfinders from using their own insight or, worse yet, hindsight, to gauge obviousness.” Id.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“e. Conclusion For the reasons provided above, we are persuaded that each limitation of independent claim 1 is either taught or suggested by Oksala. We are also persuaded that Oksala’s disclosure would have motivated a person of ordinary skill in the art to modify Oksala, as Petitioner contends, to yield the subject matter of claim 1. Accordingly, we conclude that Petitioner has shown, by a preponderance of the evidence, that the subject matter of claim 1 would have been obvious over Oksala.” slip op. at 52
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“Accordingly, we determine that Petitioner has shown, by a preponderance of the evidence, that the subject matter of proposed substitute claims 35 and 43 would have been obvious over Oksala.” slip op. at 78
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteNot shown unpatentable
“2. Indefiniteness In its Opposition, Petitioner contends the limitations “wherein each established data connection is a packet-switched connection; and wherein each requested data connection is a packet-switched connection,” as recited in substitute claim 26, and similarly recited in substitute claims 35 and 43, render the proposed substitute claims indefinite. MTA Opp. 12 (emphases added). First, according to Petitioner, the term “packet-switched connection” does not have a claim construction, which means that it can refer to two different types of packet-switched data (i.e., Layer 1 and packet network). Id. at 12. Second, Petitioner contends that there are two recitations of “a packet-switched connection,” making it “unclear if they are the same packet-switched connection or a different one.” Id. at 12–13. Third, Petitioner contends that the claims include “another antecedent issue” because “a wireless network” appears twice in the claim. Id. at 13.” slip op. at 81
Patent outcomesUS 8,189,611 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 8,189,611 - Cradlepoint, Inc. / Honeywell International, Inc. et al. v. 3g Licensing S.A.All claims unpatentablePTAB · Sep 12, 2022 · IPR2021-00584 · APJ Monica S Ullagaddi · IPR · Final written decision
Claims 16–19, 21, 22, 39, 40, and 42 are unpatentable under § 103: Meeting45 anticipates claims 16–19, 21, 22, and 39, and Meeting45 with Meeting45bis renders claims 40 and 42 obvious.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“In order to obtain the benefit of the filing date of an earlier application, 35 U.S.C. § 120 requires that the earlier application include a disclosure that complies with the written description requirement of 35 U.S.C. § 112. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571–2 (Fed. Cir. 1997). To comply with the written description requirement, a specification “must describe the invention sufficiently to convey to a person of skill in the art that the patentee had possession of the claimed invention at the time of the application, i.e., that the patentee invented what is claimed.” Lizardtech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005) (emphasis added). The written description requirement “guards against the inventor’s overreaching by insisting that he recount his invention in such detail that his future claims can be determined to be encompassed within his original creation.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991). “[O]ne skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (emphasis added). “Entitlement to a filing date extends only to the subject matter that is disclosed; not to that which is obvious . . . Therefore the parent application must actually or inherently disclose the elements of the later-” slip op. at 23
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Disclaimer not foundDecided for petitioner
“We are not persuaded that the disclosures of the ’625 patent cited by Patent Owner “‘clearly set forth a definition of the disputed claim term’ other than its plain and ordinary meaning.” See Thorner v. Sony Comput. Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)). “We depart from the plain and ordinary meaning of claim terms based on the specification in only two instances: lexicography and disavowal.” Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014) (citing Thorner, 669 F.3d at 1365). “‘To act as its own lexicographer, a patentee must clearly set forth a definition of the disputed claim term other than its plain and ordinary meaning’ and must ‘clearly express an intent to redefine the term.’” Id. (quoting Thorner, 669 F.3d at 1365). “Disavowal requires that ‘the specification [or prosecution history] make[] clear that the invention does not include a particular feature,’ or is clearly limited to a particular form of the invention.” Id. at 1372 (alterations in original) (internal citations omitted).” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We determine that the usage and description of the term E-AGCH in documents accompanying the 3GPP TS 25.211 v6.2.0 (2004-09) standard along with at least one later version––3GPP TS 25.211 v6.7.0 cited by Patent Owner in its infringement complaint (see, e.g., Ex. 1017, 3)––are consistent and that E-AGCH would have been known and understood by a POSITA to carry the meaning set forth therein as of the filing date of the application underlying the ’625 patent, March 31, 2005.10 We further conclude that one of skill in the art would have understood that the patentee used that term in the ’625 patent in accordance with the 3GPP’s definition.” slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“accessibility with respect to any of the cited references. See generally PO Resp. 17–18. For the reasons that follow, we find that Petitioner’s showing sufficiently demonstrates public availability and accessibility for Meeting45, Meeting39, and Meeting45bis prior to March 31, 2005. 1. Meeting45 Petitioner asserts that Meeting45 (Ex. 1004) “is a 3GPP change request document that was publicly available on the 3GPP FTP server no later than December 3, 2004.” Pet. 18 (citing Ex. 1021 ¶¶ 64, 77). In support of this assertion, Petitioner cites the Bishop Declaration, in which Mr. Bishop describes in detail how he searched for and found the Meeting45 document by navigating the 3GPP FTP website. Ex. 1021 ¶¶ 54–63. Based on this process, Mr. Bishop testifies that “by December 3, 2004, an interested POSITA using reasonable diligence could have located Meeting45 on the 3GPP website, downloaded the reference without providing any credentials, and disseminated the reference to others without restriction.” Id. ¶ 64. We have reviewed the relevant portions of Mr. Bishop’s Declaration and are persuaded that his testimony sufficiently demonstrates that Meeting45 was publicly available and accessible prior to March 31, 2005 (the earliest priority date to which the ’625 patent is entitled). See id. ¶¶ 54– 63; see also id. ¶¶ 55–57 (testimony as to availability and accessibility of attachment distributed via email and stored on an email list archive).” slip op. at 27
Patent outcomesUS 7,551,625 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 7,551,625 - Thorne Research, Inc. v. Trustees Of Dartmouth CollegeAll claims unpatentablePTAB · May 31, 2022 · IPR2021-00268 · APJ John E Schneider · IPR · Final written decision
Claim 2 is unpatentable as anticipated by Stamler and, alternatively, obvious over Stamler.
RulingsFinal written decision- BurdenDecided for petitioner
“2. Anticipation2 “Under 35 U.S.C. § 102, every limitation of a claim must identically appear in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997). “[U]nless a reference discloses within the four corners of the document not only all of the 2 As noted above, the pre-AIA provisions of 35 U.S.C. apply to the ’086 patent. the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateDecided for patent owner
“Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 . As discussed above and in our Decision to Institute, the ’086 patent meets this criterion. While we agree with Petitioner that the face of the ’086 patent does not include a citation of the ‘701 application, the specification does contain a clear claim of priority back to the ’701 application. Ex. 1001, col. 1. ll. 7–13; Ex. 1004 1.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“the art offered by Patent Owner in the ’1795 IPR, which, as noted above, also involved the ’086 patent, should apply to this proceeding, namely “someone with a Ph.D. in biochemistry or similar field in the pharmaceutical sciences, with familiarity and experience with pharmacokinetics.” Pet. 33. Patent Owner does not dispute Petitioner’s definition and, indeed, Patent Owner’s expert, Dr. Amiji, used the same definition in his analysis. Ex. 2014 ¶ 21. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention and supports Petitioner’s definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We have considered the arguments presented by the parties, and find that our initial construction is proper for the reasons set forth in the ’1795 proceeding. Ex. 1018 12–14. We decline to adopt Patent Owner’s construction that calls for an isolation step separate from the process used to manufacture synthetic NR.” slip op. at 16
Patent outcomesUS 8,383,086 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,383,086 - Ricetec, Inc. v. BASF SEInstitutedPTAB · Mar 11, 2022 · PGR2021-00114 · APJ Tina E Hulse · PGR · Institution
The Board instituted PGR on claims 1–17 on all petition grounds, finding the claims more likely than not unpatentable over Hinga and related art.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has demonstrated that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2
- Skill levelSkill level board ownOther
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner states a person of ordinary skill in the art must have one to two years of postdoctoral research experience and Patent Owner’s definition requires at least five years of research experience, Patent Owner’s definition does not indicate a specific time for that research (i.e., it could include research during a doctoral program). On this record, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by 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))). Moreover, we find on this record that Dr. Shaner and Dr. Burgos are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. See Ex. 1002 ¶¶ 5–15; Ex. 2003 ¶¶ 5–17.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Patent Owner states that it “agrees that the claim terms of the ’346 Patent should be given their ordinary and customary meaning.” Prelim Resp. 20. We interpret Patent Owner’s statement to mean that it agrees with Petitioner’s proposed constructions of “endogenous non-transfected mutant” and “effective amount.” Because Petitioner’s construction of “endogenous non-transfected mutant” is consistent with the ’346 patent’s express construction of the term, that construction in this proceeding.” slip op. at 7
- Disclosure Requirements (§112) › Written description (Ariad)Instituted
“limitation of each of the challenged claims is not adequately supported by the Mankin Application. Although the Mankin Application does generally describe herbicidal compositions that “comprise an herbicidal effective amount” of at least one ACCase herbicide (Ex. 2034 ¶ 233), that generic disclosure is not sufficient written description support for the specific effective amount recited in the claims. Indeed, we agree with Petitioner that the Mankin Application does not disclose any effective amounts of quizalofop within the claimed range, let alone one that causes less than 10% injury. See Ex. 1002 ¶¶ 90, 91. 94; Ex. 1013 ¶¶ 128, 237 (Table 1), 248, Fig. 17.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 11,096,346
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.