- PTAB · Aug 30, 2024 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Remand
On remand, the Board instituted inter partes review of claims 1–17, 20–21, 24–26, and 29–34 on all grounds stated in the Petition.
RulingsRemand decision- Director reviewOther
“Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17 (“Inst. Dec.”). Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel. Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Director Review Panel (“DRP”) vacated our decision and remanded the case to this panel with a revised construction for claim 1. Paper 23 (“DRP Dec.”).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect (2018). Upon reconsideration of the briefing and the evidence of record in light of the DRP’s claim construction, we conclude that Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable. Accordingly, we grant institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We find that Petitioner has demonstrated a material error by the Office in the prior consideration of Morales-Sanfrutos, Straus, Singh, and Lees. For instance, under the second prong of Advanced Bionics, we consider “(c) the extent to which the asserted art was evaluated during “(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art.” Becton, Dickinson, 17–18. We agree with Petitioner that the Office overlooked Morales- Sanfrutos’ and Singh’s teachings during examination and reexamination. Pet. 79. Although Morales-Sanfrutos, Straus, and Singh were listed on an IDS, they were not the subject of a rejection during examination or reexamination. Moreover, for the reasons discussed below at this stage with regard to Petitioner’s grounds over Morales-Sanfrutos, as evidenced by Straus, and over Singh, Petitioner sufficiently demonstrates that the Office materially erred in overlooking Morales-Sanfrutos’s and Singh’s teachings regarding their linker structures. Id. Further, to the extent the Lees’ teachings were considered during examination and reexamination, Lees’ disclosure of a homobifunctional sulfone linker was overlooked. Lees’ homobifunctional linker, which Patent Owner argues is substantially similar to Harris’ homobifunctional linker, which Petitioner chiefly relies upon in Grounds 2–5, was not the subject of a rejection during examination. Pet. Resp. Brief 1; Prelim. Resp. 25–26. We agree with Petitioner that only Lees’ heterobifunctional linker was applied in a rejection during examination. Pet. Resp. Brief 1; Ex. 1018, 42–43, 62. 4. Conclusion For the foregoing reasons, we decline to exercise discretion to deny institution under § 325(d).” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the (prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we apply Petitioner’s unopposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision
The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28
- ExcludeMotion to exclude, deniedDenied
“All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49
- Strike new argumentNew argument consideredDenied
“On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46
§ 112 disclosurePatents in suitUS 11,091,507 - 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 - PTAB · Mar 31, 2021 · IPR2020-00001 · APJ Jeffrey W Abraham · IPR · Final written decision
The Board canceled claims 1, 5, 8, and 10–12, but denied entry of substitute claims 20–25 because claims 20 and 24 were indefinite and claims 21–23 and 25 were obvious.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“LEVEL OF ORDINARY SKILL IN THE ART In the Institution Decision, we determined that “a person of ordinary skill in the art would have had sufficient experience and/or education in the food industry to possess an understanding of (1) sugar particle size as it pertains to brewed beverages and (2) sugar particle size screening.” Inst. Dec. 7. We observed that this level of ordinary skill is consistent with the level of ordinary skill that we adopted in a related case that involves similar subject matter. See Red Diamond, Inc. v. Southern Visions, LLP, PGR2019- 00045, Paper 9 at 6–8 (PTAB Oct. 15, 2019). We also asked the parties to expressly discuss the level of ordinary skill in the art in the remaining briefing if either party disagreed with our determination. Inst. Dec. 7–8. For purposes of this Final Written Decision, we maintain our determination from the Institution Decision because neither party disputes the level of ordinary skill identified in the Institution Decision (see Revised MTA 7–8), and because we continue to find that the stated level of ordinary skill is consistent with the record.” slip op. at 5
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“consider” the Revised Motion to Amend and cancel original claims 1, 5, 8, and 10–12. Revised MTA 1. Because Patent Owner has not indicated that our consideration of the Revised Motion to Amend is contingent on a determination that original challenged claims 1, 5, 8, and 10–12 are unpatentable, we grant Patent Owner’s request to cancel original challenged claims 1, 5, 8, and 10–12. See Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018- 01129, Paper 15 at 3 (PTAB Feb. 25, 2019) (precedential) (“Lectrosonics”) (“A request to cancel claims will not be regarded as contingent.”). The remaining issue before us is whether to grant the Revised Motion to Amend as to proposed substitute claims 20–25.” slip op. at 6
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable
“sugar, which indicates that between 2–25% of the particles in EFG sugar can have a size in the range of U.S mesh sieve nos. 20–30. Ex. 2003, 42 (showing the “Typical Analysis” for “X-fine” granulated sugar). Even if we were to agree with Patent Owner that this shows a typical analysis for EFG sugar, it still presents a variance of up to 20% for particles having a size in the range of U.S. mesh sieve nos. 20 and 30. Ex. 2003, 42. Thus, the evidence of record suggests that the particle size distribution for EFG sugar, including the number of particles falling in the range of U.S. mesh sieve nos. 3–35, can vary among different EFG sugars. Thus, the term “typical grocery store sugar,” “might mean several different things” in terms of the number of its particles having a size in the range of U.S. mesh sieve nos. 3–35, and “no informed and confident choice is available among the contending definitions.” HZNP Meds. LLC v. Actavis Labs UT, 940 F.3d 680, 698 (Fed. Cir. 2019) (quoting Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1371 (Fed. Cir. 2015)); Opp. 9; Reply 4.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“sugar in its products (Ex. 1008, 11:2–5), and Mr. Ebersole’s testimony demonstrates that a person of ordinary skill in the art would have known that Standard Grade and Medium Grade sugars are commercial grade granulated sugars and that the particles in Standard Granulated and Medium Granulated sugars “are almost entirely within the range of U.S. mesh nos. 3–35” (Ex. 2076 ¶ 51). The evidence of record thus supports Petitioner’s assertion that following the typical industry practice of using 1 ounce of tea particles and 1 pound of sugar per gallon of tea, and using a commercial grade granulated sugar (as taught by Cooper) such as Standard Granulated or Medium Granulated sugar (which are known to be “almost entirely within the range of U.S. mesh nos. 3–35”), would yield a product having a blend ratio of tea particles to sugar granules having a size in the range of U.S. mesh sieve nos. 3–35 in the range of 1:16–1:25, as recited in proposed substitute claims 21 and 23. Opp. 20–21; Ex. 1008, 11:2–5; Ex. 1001, 17–20, 57–65. In view of the foregoing, we find Petitioner has established sufficiently that the teachings of Cooper, considered in view of admitted prior art sweetening practices, teaches or suggests all of the limitations of proposed substitute claims 21 and 23. Petitioner has presented evidence demonstrating sufficiently that Cooper teaches the use of sugar having particle sizes falling “almost entirely” within the range of mesh 3–35, that following typical industry practices using such sugar would result in the claimed blend ratio of tea to sugar having a size in the range of mesh 3–35, and that a person of ordinary skill in the art would have had reason to brew commercial-sized batches of tea, with a reasonable expectation of success in doing so, as Cooper allows.” slip op. at 26
§ 103 obviousness§ 112 disclosurecites KSR · NautilusPatents in suitUS 9,549,634 - PTAB · Mar 31, 2021 · IPR2019-01662 · APJ Jeffrey W Abraham · IPR · Final written decision
The Board canceled claims 1, 8, 13, and 17; it denied entry of substitute claims 23–26 because claims 23 and 25 lacked written-description support and claims 24 and 26 were indefinite.
RulingsFinal written decision- Skill levelSkill level board ownOther
“C. LEVEL OF ORDINARY SKILL IN THE ART In the Institution Decision, we determined that “a person of ordinary skill in the art would have had sufficient experience and/or education in the food industry to possess an understanding of (1) sugar particle size as it 1 “One degree Brix is one gram of sucrose in 100 grams of solution . . . . Brewed sweetened tea has a typical Brix level of 10½ to 11.” Ex. 1001, 1:35–43. pertains to brewed beverages, (2) sugar particle size screening, and (3) the storage and use of sugar in commercial settings.” Inst. Dec. 7. We observed that this level of ordinary skill is consistent with the level of ordinary skill that we adopted in a related case that involves similar subject matter. See Red Diamond, Inc. v. Southern Visions, LLP, PGR2019-00045, Paper 9 at 6– 8 (PTAB Oct. 15, 2019). We also asked the parties to expressly discuss the level of ordinary skill in the art in the remaining briefing if either party disagreed with our determination. Inst. Dec. 8. For purposes of this Final Written Decision, we maintain our determination from the Institution Decision because neither party disputes the level of ordinary skill identified in the Institution Decision (see Revised MTA 12–13), and because we continue to find that the stated level of ordinary skill is consistent with the record.” slip op. at 4
- 112 supportMotion to amend, deniedDenied
“Structurally, Patent Owner has claimed a broad genus of brewing products – any product that includes sugar having particles in the range of U.S. mesh size nos. 3–35. Patent Owner attempts to further distinguish the genus by including the functional limitation of requiring the product to be capable of producing a tea with a Brix level of at least 10.5 degrees. Patent Owner does not dispute that there are products falling within the structural limitations that do not satisfy the functional limitations. Indeed, there is undisputed testing evidence on the record demonstrating that the entire range of recited structures does not perform the recited function. See Ex. 2076 at Exhibit C, 20–29 (Table 3); Revised MTA 8 (Patent Owner arguing the claims only cover products that include particles within the claimed range that perform the recited function). Here, we discern no evidence on this record of “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. Nor do we discern “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials” in the disclosures, or evidence that “the art has established a correlation between structure and function.” Id. Instead, we view Patent Owner’s proposed substitute claims to involve “merely drawing a fence around the outer limits of a purported genus,” which “is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. We recognize that the subject matter here is different from, and less complex than, the chemical and biochemical subject matter in Ariad. Nevertheless, the written description requirement still requires sufficient description to convey to one of skill in the relevant art that the inventors “had possession of the claimed invention” and “showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Id. at 1351, 1356. Thus we consider the difference in technology in determining “the level of detail required to satisfy the written description requirement,” but do not consider the difference in technology to eliminate entirely the need for some disclosure in the specification indicating possession of the claimed invention. Id. at 1351. Patent Owner has not directed us to any portion of the ’526 or ’881” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Structurally, Patent Owner has claimed a broad genus of brewing products – any product that includes sugar having particles in the range of U.S. mesh size nos. 3–35. Patent Owner attempts to further distinguish the genus by including the functional limitation of requiring the product to be capable of producing a tea with a Brix level of at least 10.5 degrees. Patent Owner does not dispute that there are products falling within the structural limitations that do not satisfy the functional limitations. Indeed, there is undisputed testing evidence on the record demonstrating that the entire range of recited structures does not perform the recited function. See Ex. 2076 at Exhibit C, 20–29 (Table 3); Revised MTA 8 (Patent Owner arguing the claims only cover products that include particles within the claimed range that perform the recited function). Here, we discern no evidence on this record of “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. Nor do we discern “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials” in the disclosures, or evidence that “the art has established a correlation between structure and function.” Id. Instead, we view Patent Owner’s proposed substitute claims to involve “merely drawing a fence around the outer limits of a purported genus,” which “is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. We recognize that the subject matter here is different from, and less complex than, the chemical and biochemical subject matter in Ariad. Nevertheless, the written description requirement still requires sufficient description to convey to one of skill in the relevant art that the inventors “had possession of the claimed invention” and “showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Id. at 1351, 1356. Thus we consider the difference in technology in determining “the level of detail required to satisfy the written description requirement,” but do not consider the difference in technology to eliminate entirely the need for some disclosure in the specification indicating possession of the claimed invention. Id. at 1351. Patent Owner has not directed us to any portion of the ’526 or ’881” slip op. at 20
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable
“which indicates that between 2–25% of the particles in EFG sugar can have a size in the range of U.S mesh sieve nos. 20–30. Ex. 2003, 42 (showing the “Typical Analysis” for “X-fine” granulated sugar). Even if we were to agree with Patent Owner that this shows a typical analysis for EFG sugar, it still presents a variance of up to 20% for particles having a size in the range of U.S. mesh sieve nos. 20 and 30. Ex. 2003, 42. Thus, the evidence of record suggests that the particle size distribution for EFG sugar, including the number of particles falling in the range of U.S. mesh sieve nos. 3–35, can vary among different EFG sugars. Thus, the term “typical grocery store sugar,” “might mean several different things” in terms of the number of its particles having a size in the range of U.S. mesh sieve nos. 3–35, and “no informed and confident choice is available among the contending definitions.” HZNP Meds. LLC v. Actavis Labs UT, 940 F.3d 680, 698 (Fed. Cir. 2019) (quoting Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1371 (Fed. Cir. 2015)); Opp. 7–10; Reply 4. Proposed substitute claims 24 and 26 compare the dissolution of the claimed beverage brewing product against the dissolution of a product using typical grocery store sugar (i.e., EFG). Patent Owner explains that the size of the particles affects dissolution – namely that larger sugar is more advantageous – in the claimed invention. See, e.g., Revised MTA 5; Ex. 1001, 9:23–27, 10:19–22. This suggests that an EFG sugar product having a greater percentage of large particles will be capable of dissolving “more of granulated sugar” as compared to an EFG sugar product having a lower percentage of large particles. As a result, using the dissolution properties of “typical grocery store sugar” as a comparator in the claims is problematic as there is a potential for inconsistent results based on which particular EFG sugar product is used. The potential for inconsistent results undermines Patent Owner’s argument that these claims satisfy the definiteness requirement because a person of ordinary skill in the art “can buy EFG . . . and perform brew tests with it in order to determine the scope of the claims.” Reply 4. Particle size is a critical factor for proposed substitute claims 24 and 26, which require a comparison of dissolution properties of the sugar used in the recited brewing product and typical grocery store sugar. Patent Owner contends “[t]here is an ‘informed and confident’ choice for ‘typical grocery store sugar’ - EFG sugar.” Reply 4. The evidence of record, however, shows the number of large particles (3–35 mesh) varies among EFG sugars. Ex. 2003, 42; Ex. 1004, at pages 51–53. In view of this, we find a person of ordinary skill in the art would not have understood “typical grocery store sugar” identifies sugar having particles of a particular size with sufficient specificity to allow the comparisons that proposed substitute claims 24 and 26 require. Accordingly, proposed substitute claims 24 and 26 are indefinite because they “fail[ ] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014); see USPTO Memorandum on the Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021); MPEP 2173.05(e) (9th ed., Rev. 08.2017, June 2020).” slip op. at 25
§ 112 disclosurecites NautilusPatents in suitUS 9,725,232 - PTAB · Oct 13, 2020 · PGR2019-00045 · APJ Christopher C Kennedy · PGR · Final written decision
The Board cancelled claims 13, 18, and 19, but denied substitute claims 23–25 because their percentage-and-range limitations introduced new matter.
RulingsFinal written decision- ScopeMotion to amend, grantedGranted
“3. Scope of Proposed Substitute Claims A motion to amend “may not enlarge the scope of the claims of the patent.” 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(a)(2)(ii). Although Patent Owner does not appear to separately address this requirement in the Revised Motion to Amend, see generally Revised MTA, we have reviewed the proposed substitute claims and determine that they do not enlarge the scope of the claims of the patent because they add limitations that render each proposed substitute claim narrower than original challenged claim 13.2 Petitioner does not contend otherwise. See generally Opp. On this record, we determine that the Revised Motion to Amend satisfies this requirement.” slip op. at 9
- 112 supportMotion to amend, deniedDenied
“description support for numerical ranges identified by the parties is General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372 (Fed. Cir. 2018).4 In that case, the Federal Circuit explained: The disclosure of a broad range of values does not by itself provide written description support for a particular value within that range. Instead, where a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to immediately discern the limitation at issue in the claims. Id. (emphasis added); cf. Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 1000 (Fed. Cir. 2006) (“[T]he disclosure of a range is no more a disclosure of the end points of the range than it is of each of the intermediate points.”). The Federal Circuit has also stated that, “[i]n the absence of blazemarks” that point to a particular species or sub-genus, “simply describing a large genus of compounds is not sufficient to satisfy the written description requirement.” Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). We find those cases to be instructive because we discern no guidance in the original disclosure that points to the percentage+range limitation of proposed substitute claim 23. Nor do we find anything in the original disclosure that would “allow one skilled in the art to immediately discern” 4 Despite the fact that Sienna was cited in (1) Petitioner’s opposition to Patent Owner’s original Motion to Amend, Paper 24 at 11; (2) the Preliminary Guidance issued by the Board, PG at 8; and (3) Petitioner’s opposition to Patent Owner’s Revised Motion to Amend, Opp. at 12, Patent Owner fails to cite or discuss Sienna, see generally Revised MTA; Reply. the percentage+range limitation. See Sienna, 888 F.3d at 1372. Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to any mesh sieve number range other than 3–35, and Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to having a particular proportion of particles (e.g., 61 wt%) falling within some narrower mesh sieve number range. See Ex. 1021 (Coffield Decl.) ¶¶ 23–24.” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner
“description support for numerical ranges identified by the parties is General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372 (Fed. Cir. 2018).4 In that case, the Federal Circuit explained: The disclosure of a broad range of values does not by itself provide written description support for a particular value within that range. Instead, where a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to immediately discern the limitation at issue in the claims. Id. (emphasis added); cf. Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 1000 (Fed. Cir. 2006) (“[T]he disclosure of a range is no more a disclosure of the end points of the range than it is of each of the intermediate points.”). The Federal Circuit has also stated that, “[i]n the absence of blazemarks” that point to a particular species or sub-genus, “simply describing a large genus of compounds is not sufficient to satisfy the written description requirement.” Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). We find those cases to be instructive because we discern no guidance in the original disclosure that points to the percentage+range limitation of proposed substitute claim 23. Nor do we find anything in the original disclosure that would “allow one skilled in the art to immediately discern” 4 Despite the fact that Sienna was cited in (1) Petitioner’s opposition to Patent Owner’s original Motion to Amend, Paper 24 at 11; (2) the Preliminary Guidance issued by the Board, PG at 8; and (3) Petitioner’s opposition to Patent Owner’s Revised Motion to Amend, Opp. at 12, Patent Owner fails to cite or discuss Sienna, see generally Revised MTA; Reply. the percentage+range limitation. See Sienna, 888 F.3d at 1372. Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to any mesh sieve number range other than 3–35, and Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to having a particular proportion of particles (e.g., 61 wt%) falling within some narrower mesh sieve number range. See Ex. 1021 (Coffield Decl.) ¶¶ 23–24.” slip op. at 14
§ 112 disclosurePatents in suitUS 10,071,852 - PTAB · Aug 12, 2020 · PGR2019-00032 · APJ David Cotta · PGR · Final written decision
The Board granted cancellation of claim 8 and denied entry of substitute claim 11 because Petitioner showed it would have been obvious over Omura, Tsuji, and the knowledge of a person of ordinary skill.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“In our Institution Decision, we agreed with the position Patent Owners took in their Preliminary Response – i.e, that the focus of the challenged claims was enzyme-based biosensors and thus the POSA would have more than just a familiarity with enzyme-based biosensors and protein chemistry. Inst. Dec. 8–9. Accordingly, based on the record before us at the time, we accepted the definition provided in Patent Owners’ Preliminary Response, which was consistent with the level of skill reflected in the asserted prior art references and in the specification of the ‘987 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). Neither party challenges the identification of the POSA set forth in our Institution Decision. See generally, R. Mot.; Opp.; Reply; Sur-reply. Additionally, we find that the fully developed trial record supports the POSA identification we made in our Institution Decision. Accordingly, in this decision, we apply the identification of the POSA set forth in our Institution Decision. Inst. Dec. 9.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). For purposes of this decision, we need not expressly construe any claim terms.” slip op. at 10
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“first, substitute claim 11 would have been obvious over Omura in view of the knowledge of the POSA, and second, substitute claim 11 would have been obvious over the combination of Omura and Tsuji in view of the knowledge of the POSA. Opp. 7–24. We have considered the question of patentability in view of all the evidence and arguments presented in this proceeding. Based on the record developed during this proceeding, we determine that Petitioner has shown by a preponderance of the evidence that substitute claim 11 would have been obvious over the combination of Omura, Tsuji, and the knowledge of the POSA. Because Petitioner has proven that substitute claim 11 would have been obvious, as discussed in detail below, we do not consider whether Patent Owners’ motion otherwise complies with the statutory and regulatory requirements for a motion to amend. See, 35 U.S.C. § 326(d)(1)(B) (requiring that the amendment propose a “reasonable number of substitute claims” and requiring that the substitute claims do “not enlarge the scope of the claims of the patent or introduce new matter”); 37 C.F.R. § 42.221 (additionally providing, inter alia, that a motion to amend “may be denied where . . . [t]he amendment does not respond to a ground of unpatentability involved in the trial”). Similarly, because we have determined that substitute claim 11 would have been obvious over the combination of Omura, Tsuji, and the knowledge of the POSA, as discussed in detail below, we do not reach the question of whether substitute claim 11 would also have been obvious over only Omura in view of knowledge of the POSA.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“includes “research experience and/or knowledge in enzymology . . . and biosensors,” we agree with Petitioner that it would have been obvious to a POSA to substitute FAD-conjugated glucose dehydrogenase derived from the claimed strain of Aspergillus oryzae for FAD-conjugated glucose dehydrogenase derived from Aspergillus terreus as disclosed in Omura.” slip op. at 18
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,976,125
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.