- PTAB · Jun 11, 2025 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1–4, 7–19, and 22; it found written-description and enablement challenges likely to succeed, but the obviousness ground insufficient.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’298 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not be an expert in hyaluronidases. See Pet. 16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA. Patent Owner will have the chance to cross-examine Dr. Hecht and Dr. Park in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. Patent Owner will have further opportunity on a full record to assert that we should discount either experts’ testimony due to lack of appropriate qualifications. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 44:59–62. The ’298 patent provides an express definition of the term “modified PH20 polypeptide” which refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:15–30 (emphasis added).” slip op. at 14
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Under the second step of the Advanced Bionics framework, we must determine whether Petitioner has demonstrated Examiner error in a manner material to the patentability of the challenged claims. Advanced Bionics, at 10. Becton, Dickinson Factors (c), (e), and (f) inform our analysis at this step. Id. at 8.” slip op. at 21
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–4, 7–19, and 22 of the ’298 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 12,018,298 - Njoy, LLC / Njoy Holdings, Inc. v. Juul Labs, Inc.No claims unpatentablePTAB · Jun 10, 2025 · IPR2024-00231 · APJ Avelyn M Ross · IPR · Final written decision
Claims 14–16, 18, 27–29, 31, and 32 were not proven unpatentable because the asserted references failed to establish the claimed airflow path or a reason to make the proposed combinations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s and Patent Owner’s proposed levels of skill are similar and differ in that Petitioner’s relevant degrees and corresponding two years of experience additionally includes “industrial design” and “product design” and familiarity with “electrically powered vaporizing articles, their components or the underlying technologies” where Patent Owner requires two years of experience “designing electro-mechanical consumer products or an advanced degree.” Compare Pet. 7, with PO Resp. 2. Patent Owner alleges that “Petitioner has failed to establish unpatentability under either standard,” indicating that the level of skill in the art is not a dispositive issue. PO Resp. 3. In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’123 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand the ’123 patent and the prior art. We note that the outcome of this Decision would be the same under Patent Owner’s proposed definition.” slip op. at 11
- Expert testimonyPetitioner expert creditedOther
“In this case, Mr. McAlexander meets both Petitioner’s and Patent Owner’s proposed level of skill in the art. As a result, we are persuaded Mr. McAlexander has the requisite skill and relevant expertise to offer testimony in this matter. For example, Mr. McAlexander has a Bachelor’s Degree in Electrical Engineering and far more than 2 years of experience in the electrical engineering field. Ex. 1027, 3–6, 7. In addition, Mr. McAlexander has provided expert consulting services in a wide range of technology areas involving the process and design of electro-mechanical consumer products. Ex. 1003 ¶ 5. Through one of Mr. McAlexander’s business ventures, his laboratory has “performed detailed airflow analyses, designing and constructing specialized apparatuses to emulate human breath, allowing for precise activation testing of ENDS devices.” Ex. 1043 ¶ 16. That said, a declarant’s expertise, even clothed as a skilled artisan, does not entitle a naked opinion persuasive weight. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985). Here, Patent Owner had the opportunity to, and in fact did, thoroughly cross examine Mr. McAlexander about the purported deficiencies in his testimony. See, e.g., Exs. 2052, 2054; Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 595 (1993) (“Vigorous cross examination [and] presentation of contrary evidence . . . are the traditional and appropriate means of attacking shaky but admissible evidence.”). Therefore, to the extent Patent Owner credibly identifies deficiencies in Mr. McAlexander’s testimony or that testimony lacks factual support or is based on broad, conclusory assertions, we will assign appropriate weight. See Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (explaining that it is within the Board’s discretion, as the trier of fact, to accord appropriate weight to the evidence presented).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner contends that the parties proposed a construction for “pressure valve,” a limitation appearing in claims 18 and 31, during the ITC investigation. Pet. 7 (citing Ex. 1001, 41:58–65). Patent Owner contends that the terms of the ’123 patent should be given their plain and ordinary meaning. PO Resp. 4. Because resolution of the issues presented in this case do not require construction of the term “pressure valve,” we do not expressly construe this claim term. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner. To anticipate a claim, a reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, 545 F.3d at 1369. “The requirement that the prior art elements themselves be arranged as in the claim means that the claims cannot be treated . . . as mere catalogs of separate parts, in disregard of the part-to-part relationships set forth in the claims.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010). Indeed, the prior art reference “must clearly and unequivocally disclose the claimed [invention] or direct those skilled in the art to the [invention] without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.” Net MoneyIN, 545 F.3d at 1371 (citation omitted). “[D]ifferences between the prior art reference and the claimed invention, however slight, invoke the question of obviousness, not anticipation.” Id.” slip op. at 20
Patent outcomesUS 10,130,123 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,130,123 - PTAB · Jun 2, 2025 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Institution
Instituted PGR on claims 1–4 and 8–21 because the Board found a more-likely-than-not showing of written description and enablement failures; the obviousness ground did not meet that threshold.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the prior art relevant to the ’600 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not be an expert in hyaluronidases. See Pet. 16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 48:38–53 (emphasis added). Based on this express definition, the current record does not support the interpretation of Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’ therefore, has a purely structural meaning in the context of the specification.” Ex. 2001 ¶ 68.4 Indeed, when reproducing the definition from this column of the ’600 patent, Dr. Triggs-Raine does not include any text after the first period, but the ’600 patent text continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:44‒46. On this” slip op. at 13
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“on the ’429 patent, and there is no evidence of record that the Examiner meaningfully considered the relevant disclosures of the ’429 patent. We find unpersuasive Patent Owner’s reliance on the Examiner’s issuance of an office action with a written description rejection over a different issue that also included some double patenting rejections. As to Becton, Dickinson Factor (e), “whether Petitioner has pointed out sufficiently how the [E]xaminer erred in its evaluation of the asserted prior art,” Petitioner provides persuasive evidence of Examiner error. See Pet. 36–39 (citing Ex. 1009, 21–27). We agree with Petitioner that the Examiner overlooked the written description requirement with regard to claim 1. As discussed below, we find that, on the current record, the evidence sufficiently shows that it is more likely than not that the claims fail to comply with the written description requirement. See Section X. We, thus, find that the Examiner erred by either overlooking, or failing to appreciate, the factual underpinning necessary to support a written description for the breadth of an enormous genus claim such as claim 1 of the ’600 patent.” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XIII. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XIV. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 and 8–21 of the ’600 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 60
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,952,600 - Juul Labs, Inc. v. Njoy, LLCNo claims unpatentablePTAB · May 21, 2025 · IPR2024-00160 · APJ Kimberly Mcgraw · IPR · Final written decision
The Board held claims 1–48 not shown unpatentable on any of six § 103 grounds because the asserted references did not teach the required housing aperture and the proposed combinations lacked adequate support.
RulingsFinal written decision- Skill levelDecided for patent owner
“time it was made, we consider the level of ordinary skill in the pertinent art at the time of invention. Graham, 383 U.S. at 17. Petitioner does not provide its own definition of the level of ordinary skill in the art. Instead, Petitioner asserts: In previous litigation involving the ’881 patent – the parent patent to the ’864 patent (Fuma International LLC v. R.J. Reynolds Vapor Company, Case No. 1:19-cv-260 (M.D.N.C. 2019)) with an identical specification – Patent Owner’s predecessor-in-interest asserted that a person of ordinary skill in the art (“POSITA”) at the time of the purported invention would have had a mechanical or electrical engineering degree, industrial design degree, or a similar technical degree, or equivalent work experience, and 5 to 10 years of experience in electromechanical devices. Ex. 1007, ¶¶14-17. Pet. 11–12; see also Ex. 1007 ¶ 16 (Mr. Sturges testifying that he meets “that qualification” without affirmatively providing a definition for a POSITA). Before institution, Patent Owner stated it did not challenge this definition (Prelim. Resp. 9), and we adopted Petitioner’s proposed definition in our Decision granting institution. During trial, Patent Owner also adopted this definition. PO Resp. 10–11. Upon a complete record, we see no reason to change and we maintain the agreed upon definition of a POSITA.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Patent Owner argues, and Petitioner does not dispute, that an aperture is a “hole” or an “opening.” See, e.g., id. at 21; see generally Reply. Patent Owner asserts that, in the proper context, the plain and ordinary meaning of a housing having an aperture is that the aperture is a hole, or an opening, on the housing structure itself. Id. at 21–22. We agree. In order for an object to have an “aperture” or an “opening,” the aperture or opening must be on the structure itself and not on a separate object that is located in the structure. This construction is in accord with the Specification of the ’864 patent, which refers to apertures in context of the structure on which they are located. See, e.g., Ex. 1001, 6:12–18 (referring to a first end comprising a first aperture), 7:11–12, 7:65–67 (stating that the wall of an airflow passageway may have apertures).” slip op. at 18
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner
“large obstructions that force the air flow to near the peripheral surface of the housing, render the passageway non-central. During prosecution of the ’864 patent, the Examiner rejected certain claims (i.e., dependent claims 49, 63, and 75) over Han. To overcome this rejection, the applicant argued that Han cannot meet the limitation “wherein the airflow passageway extends centrally and axially from the first aperture to the second aperture.” Ex. 1002, 273. The applicant explained that Han does not meet this limitation because Han’s shell (b) does not include a central airflow passageway and instead places the perforated component for liquid storage (9) in the middle of shell (b), thereby forcing the airflow around the peripheral surface of the perforated component for liquid storage (9). Id. at 273–274. The examiner relied on this argument in determining that the applicant had overcome an earlier rejection. Id. at 195. Thus, some obstructions of a passageway render the passageway non-central; in particular those obstructions that force air to flow near the peripheral surface of the housing are large enough to render the passageway non-central.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“lacks motivation and is plagued by improper hindsight.” Sur-reply 15–17. On the record developed during trial, we agree with Patent Owner that Petitioner has not shown by a preponderance of the evidence that a person of ordinary skill in the art would have had a reason to combine the teachings of Xia with those of Wang to arrive at the claimed limitations. Relying on the testimony of Patent Owner’s declarant Dr. Singhose, Petitioner argues that a person of ordinary skill in the art “would have known a central straight path has less airflow resistance than a circuitous one.” Reply 22 (citing Ex. 1035, 127:15–128:9). But the same witness also testified that higher airflow resistance might be desirable and explained that providing more resistance to airflow might result in improved mixing. Ex. 1035, 21:21–22:12, 127:20–24, 170:10–14. In addition, Dr. Singhose testifies that the complicated design of the airflow passageway in Xia “serves important functions,” including “allow[ing] large droplets to be reabsorbed by the liquid-guiding mechanism,” allowing “excessive liquid in the airflow [to] condense,” and “prevent[ing] the chemical liquid from being sucked into the mouth.” Ex. 2022 ¶ 190 (citing Ex. 1004, 11, 13–14, 16). Although Petitioner’s declarant Dr. Sturges testifies that a straight airflow passageway “would provide improved, smoother air flow,” he does not provide any evidence supporting the view that the air flow would be improved. Ex. 1007 ¶ 144. We credit the testimony of Dr. Singhose that using a straight passageway in Xia would have been detrimental rather than beneficial. Ex. 2022 ¶ 190. slip op. at 40
Patent outcomesUS 11,497,864 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,497,864 - Juul Labs, Inc. v. Njoy, LLCNo claims unpatentablePTAB · May 21, 2025 · IPR2024-00161 · APJ Christopher M Kaiser · IPR · Final written decision
Claims 1–27 were not shown unpatentable because the asserted obviousness grounds failed to establish the claimed central airflow passageway or a reason to combine the references.
RulingsFinal written decision- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Relying on the testimony of Patent Owner’s declarant Dr. Singhose, Petitioner argues that a person of ordinary skill in the art “would have known a central straight path has less airflow resistance than a circuitous one.” Reply 22–23 (citing Ex. 1035, 127:15–128:9). But the same witness also testified that higher airflow resistance might be desirable and explained that providing more resistance to airflow might result in improved mixing. Ex. 1035, 21:21–22:12, 127:20–24, 170:10–14. In addition, Dr. Singhose testifies that the complicated design of the airflow passageway in Xia “serves important functions,” including “allow[ing] large droplets to be reabsorbed by the liquid-guiding mechanism,” allowing “excessive liquid in the airflow [to] condense,” and “prevent[ing] the chemical liquid from being sucked into the mouth.” Ex. 2022 ¶ 183 (citing Ex. 1004, 11, 13–14, 16). Although Petitioner’s declarant Dr. Sturges testifies that a straight airflow passageway “would provide improved, smoother air flow,” he does not provide any evidence supporting the view that the air flow would be improved. Ex. 1007 ¶ 118. We credit the testimony of Dr. Singhose that using a straight passageway in Xia would have been detrimental rather than beneficial. Ex. 2022 ¶ 183. Petitioner also argues that the inventors’ use of a straight path is evidence that the use of a straight passageway was “merely common-sense obviousness.” Reply 22–23. This is hindsight. Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012) (“The inventor’s own path itself never leads to a conclusion of obviousness; that is hindsight.”). Moreover, it does not address the testimony of Dr. Singhose that the use of a complicated passageway like that in Xia had benefits not present in a straight central passageway.” slip op. at 29
- Skill levelSkill level petitioner adoptedOther
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art (“POSITA”) “would have had a mechanical or electrical engineering degree, industrial design degree, or a similar technical degree, or equivalent work experience, and 5 to 10 years of experience in electromechanical devices.” Pet. 10 (citing Ex. 1007 ¶ 16). Prior to institution, Patent Owner stated that, for “the limited purpose of this Preliminary Response,” it “does not challenge the definition of a POSITA set forth in the Petition.” Prelim. Resp. 9. We adopted Petitioner’s proposed definition in our Decision granting institution. During trial, neither party disputed this definition. Upon a complete record, we see no reason to change the adopted definition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Patent Owner argues, however, that this presumption is overcome in the present case, and we agree. PO Resp. 28–32. We note that, although the claims require the first aperture to be “on the first end,” the claims still require that the “housing hav[e] a first aperture.” Thus, the issue is whether the aperture must be on the housing itself or part of the housing, as well as whether the aperture is on the first end of the housing. Although “having” and “includes” are used with respect to the solution holding medium to refer to elements located inside the housing, the specification of the ’881 patent suggests that the ends of the housing are part of the housing itself, rather than located inside the housing. First, “the first end . . . can be integrated into a single assembly as part of the housing.” Ex. 1001, 6:16–17. Second, “the housing . . . may comprise the cylindrical wall and two end-caps,” or “the housing . . . may comprise the cartridge wall and a single end-cap.” Id. at 3:55–59. The only figures of the ’881 patent that depict first end 206 show it at the end of the housing rather than located within the interior of housing 202. Id. at Figs. 2, 3. Moreover, there is no requirement to construe a claim term uniformly across multiple uses in the claims when doing so would be nonsensical. Microprocessor Enhancement Corp. v. Texas Instruments, Inc., 520 F.3d 1367, 1375 (Fed. Cir. 2008). Here, construing a first element that is recited as “having” or “includ[ing]” a second element always as encompassing not only second elements that are part of the first element, but also second elements that are located within the interior of the first element, would lead to nonsensical results. Claim 2 recites an airflow passageway “having a length having a circular cross section.” Ex. 1001, 17:59–60. It would be nonsensical to interpret this claim as encompassing an airflow passageway of non-circular cross section that contains another object that has a circular cross section, and neither party argues in favor of such a reading. Similarly, claim 16 recites an “airflow passageway having an interior having a uniform cross-sectional area,” and there is no reason to interpret this claim as encompassing an airflow passageway of non-uniform cross-sectional area that contains another object that itself has uniform cross-sectional area. Id. at 19:47–48. Thus, the claims do not use “having” or “includes” consistently to refer to elements located within the interior of an object; instead, they sometimes use these terms to refer to elements that are a part of an object. See Epcon Gas Sys., Inc. v. Bauer Compressors, Inc., 279 F.3d 1022, 1030–31 (Fed. Cir. 2002) (terms should be construed based on the context of how the terms are used in the claims).” slip op. at 13
- Prior constructionPrior construction not adoptedDecided for patent owner
“When we instituted trial, we preliminarily construed this phrase to encompass apertures that are located within the first end of the housing, determining on the record available at that time that “[t]he term does not require that the first aperture be located in the housing itself.” Inst. Dec. 16. We invited the parties to “address [the] construction of this term during trial,” id., and, on the full record developed during trial, we reach a different conclusion.” slip op. at 10
Patent outcomesUS 10,334,881 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,334,881 - Beone Medicines USA, Inc. / Beigene, Ltd. v. Pharmacyclics LLCAll claims unpatentablePTAB · May 1, 2025 · PGR2024-00009 · APJ Sheridan K Snedden · PGR · Final written decision
Claims 1–8, 12, and 20 are unpatentable for lack of written description under § 112(a); the Board did not reach the enablement, anticipation, or obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting and that the terms “optionally substituted fused heterocyclic ring system” and “irreversible” BTKIs should be construed consistent with the definitions provided in the Specification. Pet. 42–45; see also id. at 42 (citing Ex. 1001, 19:57–20:7 (defining “optionally substituted” or “substituted”), 14:51–52 (defining “fused”), 15:66–16:21 (defining “heterocycle”), 14:36–44 (defining “ring” and “ring system”), 26:23–25 (defining “irreversible Btk inhibitor”); PO Resp. 26.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“To satisfy written description for the claimed genus of iBTKIs, the Specification must describe either a representative number of members of the genus or structural features common to the members of the genus with enough precision that a POSA can visualize or recognize the members of the genus. See Ariad, 598 F.3d at 1350. Patent Owner concedes that the Specification does not describe a representative number of members of the genus, stating “this is a common structural features case.” Tr. 65:25–66:3. We, therefore, focus our analysis on whether the Specification adequately describes common structural features of the genus. We find that it does not.” slip op. at 30
Patent outcomesUS 11,672,803 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 11,672,803 - Aardevo North America, LLC v. Agventure B.V.Institution deniedPTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution
Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable
“Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,140,841 - PTAB · Apr 25, 2025 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR of claims 1–9 on all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Chee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial.” slip op. at 13
- BurdenDecided for petitioner
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededDecided for petitioner
“tags,” and “locus of origin” need be addressed at this stage of the proceeding. We determine that no express construction of “consensus base call” is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))). 1. “Set of [Unique] Differentiator Tags” Petitioner asserts that both “set of differentiator tags” as used in claim 1 and “set of unique differentiator tags” as used in claim 9 should be given the same construction—“set of prepared tags where each tag includes a unique sequence as compared to the other tags.” See Pet. 16 (citing Ex. 1005 ¶ 89; Ex. 1001, 28:25–29, 28:53–57). Petitioner further asserts that “[t]hese unique differentiator tags are associated with target nucleic acids so that each nucleic acid is uniquely identifiable.” Pet. 16. Petitioner also points to the prosecution history of the ’730 patent in which Petitioner asserts the Patent Owner argued and the Board acknowledged that each differentiator tag is unique. Id. at 16–17. Petitioner concludes that “[a]n interpretation of ‘differentiator tags’ to include non-unique tags is not possible, and if it were, Applicant disclaimed any interpretation that would allow non-unique tags.” Id. at 17.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,840,730 - Lam Research Corp. v. Inpria Corp.All claims unpatentablePTAB · Apr 18, 2025 · IPR2024-00033 · APJ Grace Karaffa Obermann · IPR · Final written decision
Claims 1–12 are unpatentable as anticipated by the ’888 Publication; Patent Owner’s motion to add substitute claims 13–23 is granted.
RulingsFinal written decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“priority issue are based on the cited disclosures of the ’867 application discussed above. Ex. 2009 ¶ 29. For the reasons discussed above, we do not view the cited disclosures as sufficiently supporting Dr. Banerjee’s conclusion that the ’867 application provides support for claim 1’s average thickness range (id.) and, therefore, give this testimony little weight. Stated somewhat differently, Dr. Banerjee’s advances an opinion (really a legal one) that is not supported by the facts and not in line with the caselaw discussed in this section (such as RAI).” slip op. at 26
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artPrinted publication establishedDecided for petitioner
“priority issue are based on the cited disclosures of the ’867 application discussed above. Ex. 2009 ¶ 29. For the reasons discussed above, we do not view the cited disclosures as sufficiently supporting Dr. Banerjee’s conclusion that the ’867 application provides support for claim 1’s average thickness range (id.) and, therefore, give this testimony little weight. Stated somewhat differently, Dr. Banerjee’s advances an opinion (really a legal one) that is not supported by the facts and not in line with the caselaw discussed in this section (such as RAI).” slip op. at 26
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“d) Conclusion For the reasons discussed above, Petitioner has demonstrated by a” slip op. at 30
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“For these reasons, Patent Owner has met its burden to show by a” slip op. at 34
Patent outcomesUS 9,823,564 unpatentable§ 102 anticipationcites Phillips · KSR · Graham · NautilusPatents in suitUS 9,823,564 - PTAB · Apr 11, 2025 · IPR2024-01498 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–19, finding a reasonable likelihood of unpatentability on multiple obviousness grounds, while declining institution under Ground 9 at the preliminary merits stage.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–19 of the ’752 patent is unpatentable.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“summarized above, we determine that Petitioner has established a reasonable likelihood of prevailing in showing that claims 1 and 4–14 are obvious over the combination of Native and Bianchi ’254. In particular, we are persuaded by Petitioner that the combination of Native and Bianchi ’254 discloses a deodorant stick comprising each element of claims 1 and 4–14. Pet. 41–50. We also find that Petitioner has shown sufficiently on the record before us that a person of ordinary skill in the art would have had a reasonable expectation of success to implement Bianchi ’254’s hardness range in Native’s formula. Here, we credit Dr. Michniak-Kohn’s testimony that a person of ordinary skill in the art would have understood how to adjust hardness using the structurants in a deodorant composition. Ex. 1002 ¶ 41, 191–192.” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“biased testimony from an employee” and the Petition therefore lacks sufficient evidence to establish the images provided in the Squatch declaration as containing prior art printed publication material. Id. at 27–28 (citing Finnigan Corp. v. ITC, 180 F.3d 1354, 1366 (Fed. Cir. 1999) (“[T]he law has long looked with disfavor upon invalidating patents on the basis of mere testimonial evidence absent other evidence that corroborates that testimony.”); Nobel Biocare Services AG v. Instradent USA, Inc., 903 F.3d 1365, 1377-78 (Fed. Cir. 2018) (“corroboration is required of any witness whose testimony alone is asserted to invalidate a patent, regardless of his or her level of interest.”). 3. Discussion Having considered the parties’ positions and evidence of record, summarized above, we find Patent Owner to have, at this stage of the proceeding, the better position.. Accordingly, we determine that there is insufficient evidence to indicate a reasonable likelihood that Petitioner will prevail in establishing that that claims 15–19 would have been obvious over the combination of Squatch and Sturgis for the reasons set forth in the Preliminary Response and summarized above. However, we will make our final determination on these issues on the full record developed during this proceeding. See Hulu LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29, 11 (PTAB Dec. 20, 2019) (precedential) (“To prevail in a final written decision in an inter partes review, the petitioner bears the burden of establishing by a preponderance of the evidence that a particular document is a printed publication.”).” slip op. at 30
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“35 U.S.C. § 325(d). Prelim. Resp. 29–38. In determining whether to deny institution under § 325(d), we use the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17– 18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 32
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,844,752
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.