- Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 15, 2026 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, and 6–30 are unpatentable under §112(a) for lack of written description and lack of enablement; the §103 ground was not reached.
RulingsFinal written decision- Additional discoveryAdditional discovery, deniedDenied
“Patent Owner filed a Motion for Additional Discovery (Paper 42), Petitioner opposed the motion (Paper 44), and the Board denied the motion (Paper 47).” slip op. at 3
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“of the ’758 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’758 patent. Indeed, both the definitions of “PH20” and “modified PH20 polypeptide” require hyaluronidase activity. See Ex. 1001, 45:54–55, 50:39–41 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 48:43–46 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 63:39–46. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’758 patent. Id. at 72:63–65, 75:60–62. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–46.” slip op. at 21
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–251 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’758 patent.” slip op. at 56
Patent outcomesUS 12,054,758 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,054,758 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision
Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)).” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38
Patent outcomesUS 11,236,318 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - Alamar Biosciences, Inc. v. Olink Proteomics ABNo claims unpatentablePTAB · Mar 4, 2026 · IPR2024-01353 · APJ Tawen Chang · IPR · Final written decision
Claims 1–20 were not shown unpatentable: the asserted obviousness grounds failed, including because Kanan and Neri did not teach selecting the claimed cis-reactive cells.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Accordingly, for purposes of this decision we adopt Petitioner’s proposal of a person of ordinary skill in the art, with the following changes noted in italics below: A person with “an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to small molecules and proteins and would have been familiar with nucleic acid chemistry and conventional hybridization techniques; and (b) access to one or more team members having an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to high throughput screening techniques such as nucleic acid sequencing. A person could also have qualified as a POSA with less formal education and more technical or professional experience.11 We emphasize, however, that our decision would not change if we instead used Patent Owner’s proposed definition of a POSA.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Because the parties have placed the limitation “selecting all cis- reactive cells exhibiting the detectable trace” into controversy, we construe the term below, but only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)). For the reasons discussed below, we agree with Patent Owner that the plain and ordinary meaning of this phrase, in light of the language of the claims, the Specification, and the prosecution history of record, requires “selecting all of the [molecular complexes or structures] meeting the defined criteria for [cis-reactive cells (CRCs)] and exhibiting the detectable trace.” Sur-reply 8 (citing Ex. 2008 ¶¶ 94, 98–119). We further agree that cis-reactive cells should be construed to mean “an association of at least two interactor moieties, joined by an associated oligonucleotide.” (PO Resp. 9 (quoting Ex. 1001, 9:35-37)). Accordingly, we determine that, properly construed, the claims require that what is “selected” at step 1(d) — what is differentiated or set apart from other molecular complexes or structures in the reaction mixture at the conclusion of step 1(d) — to be “an association of at least two interactor moieties joined by an associated oligonucleotide” that exhibits the detectable trace.” slip op. at 16
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We agree that Petitioner has not shown that the combination of Kanan and Neri teaches “selecting all cis-reactive cells exhibiting the detectable trace,” as we have construed that phrase above. In particular, we determine that, properly construed, the limitation requires the selection of “all associations of at least two interactor moieties joined by an associated oligonucleotide and exhibiting the detectable trace.” Instead, as described in Kanan, what is “selected” is the molecules of interest joined by bond formation, with only one of the molecules of interest coupled to a nucleic acid moiety. Thus, the selected molecular complex or structure does not comprise two interactors (i.e., two molecules of interest coupled to NAMs). Moreover, to the extent there are two interactors, they are joined by the bond between the molecules of interest rather than an associated oligonucleotide.” slip op. at 35
- ExcludeMotion to exclude, deniedDenied
“III. PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE Patent Owner moved to exclude Exhibit 1008, on the ground that it contains settlement statements and that Rule 408 of the Federal Rule of Evidence prohibits Petitioner from using the statements to impeach or contradict Patent Owner. Mot. 5. Because we do not rely in our analysis on this exhibit, we dismiss the Motion to Exclude as moot.” slip op. at 43
Patent outcomesUS 7,883,848 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,883,848 - Salvacion USA, Inc. v. Trutek CorpAll claims unpatentablePTAB · Dec 2, 2025 · IPR2024-00711 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–3 and 8 are unpatentable as anticipated by Chen, Baker, Wahi ’005, and, for claims 1, 2, and 8, Rolf; the Board also finds them obvious over the asserted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition of a person of ordinary skill in the art (“POSITA”) as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Based on our consideration of the full record, we maintain our determination that a POSITA at the time the application for the ’802 patent was filed “would have had at least an undergraduate degree in pharmacy, chemistry, biochemistry, biomedical engineering or a closely related field, such that the POSITA generally understand[s] pharmaceutical formulation.” Pet. 12. Additionally, we agree with Petitioner that “[a] POSITA would be familiar with the chemical ingredients in the [’802] Patent, biocidic agents, and cationic agents, have knowledge of airborne particles including viruses and bacteria, and understand electrostatic fields, electrostatic attraction and repulsion, adhesion and cohesion.” Id. (citing Ex. 1002 ¶¶ 38–39).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“of independent claims 1, 2, and 8 as limiting. Inst. Dec. 7–8. The parties do not dispute our construction of the preambles of claims 1, 2, and 8 as limiting. See generally PO Resp.; Pet. Reply 2–4. After consideration of the full trial record, we maintain our construction of the preamble of claims 1, 2, and 8 as limiting for the reasons set forth in our Institution Decision. Id. Briefly, the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body are used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.”” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“After consideration of the full trial record, we maintain our construction. From our perspective, the claims themselves support this construction as the claims expand upon the term “electrostatically inhibiting” with specific means for achieving such inhibition. Specifically, claims 1 and 2 recite electrostatically attracting the particulate matter, holding the matter in place, and inactivating the matter. Additionally, the Specification supports our construction as it describes the use of “an electrostatic field such that oppositely charged airborne particulates (including microorganisms) in the vicinity of the surface are electrostatically trapped, held thereto and one or more of the microorganisms so captured is neutralized, killed, inactivated, and rendered harmless.” Ex. 1001, 3:36–40; PO Resp. 10 n.6.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for petitioner
“We adopt the parties’ construction of “adequate impermeability” that has been accepted in the related district court litigation: “Adequate impermeability” refers to the “thin film holding harmful particles in place and inhibiting them from penetrating the thin film and contacting the skin or tissue of an individual’s nasal passages. This is done by varying the concentration of ingredients . . .[,] thereby adjusting the adhesion and cohesion of the thin film.” Pet. Reply 3 (quoting Ex. 1010, 17). Furthermore, as stated in our Institution Decision, along with that term, the claim language explains that the thin film is meant to stick to the skin or tissue and to hold the particulate matter in place. Inst. Dec. 9–10. The claim language also explains that the cohesion of the formulation is adjusted to provide adequate impermeability to the thin film. Thus, it is reasonable to consider the recited impermeability is a function of the cohesive properties of the thin film, and that such impermeability refers to a property of the thin film, i.e., inhibiting the penetration or passage of matter through it onto the skin or tissue at the application site.” slip op. at 10
Patent outcomesUS 8,163,802 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00669 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–8 and 11 are unpatentable as obvious over Makower, Fang, and Edwards, with claim 4 also obvious over those references and Stern; the Board did not reach Grounds 1–4.
RulingsFinal written decision- Skill levelSkill level board ownOther
“Based on the record before us, including the types of problems and solutions described in the ’077 patent and the cited prior art, we find a POSA would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in biomedical engineering or a related discipline, (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices that deliver energy to tissue, and 3) knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. Less work experience may be compensated by a higher level of education, and vice versa. 11 Patent Owner suggests a POSA’s ability to “learn about” the nasal anatomy invokes the wrong standard because a POSA “must have the necessary background at the time of the invention.” PO Sur-reply 27. We agree in part with Patent Owner; the hypothetical POSA is presumed to possess the requisite skill at the time of the invention. Nevertheless, as it concerns an engineer with extensive experience designing and developing RF ablation devices (like Dr. Martin), we see no basis to conclude that such person may not become familiar with the features of the nose through review of the literature and/or consultation with clinicians. Ex. 1098 ¶ 44 (testifying a person with device design experience could learn about the relevant nasal anatomy and apply their skill to problems or solutions for that area by reviewing the relevant literature). Moreover, that Dr. Martin may not have had personal experience designing devices for the nose prior to 2006 does not mean that he cannot testify from a POSA’s perspective. Osseo Imaging, LLC v. Planmeca USA, Inc., 116 F.4th 1335, 1341 (Fed. Cir. 2024) (“An expert need not have acquired the skill level prior to the time of the invention to be able to testify from the vantage point of a person of ordinary skill in the art” because “an expert can acquire the necessary skill level later and develop an understanding of what a [POSA] knew at the time of the invention”) (emphasis omitted). Petitioner that the ’077 patent discloses delivering neurotoxins to any target, and not just the nose, the claims of the ’077 patent are directed to methods of treating a nasal condition by delivering energy to the nasal cavity. Pet. Reply 32. Thus, to fill a gap between Petitioner’s POSA definition and the scope of the challenged claims, we add to Petitioner’s definition the requirement for knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. We additionally add that a POSA’s educational background may include a bachelor of science degree in biomedical engineering or related discipline to reflect the nature of the field of invention. Nonetheless, we also note that our analysis and conclusions herein would not change even under Petitioner’s proposed skill level for a POSA. We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’077 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. We also disagree that Dr. Martin’s testimony should be discounted for a lack of first-hand experience designing RF ablation devices specific for the nose (which experience Patent Owner’s engineer expert also lacks). Id. As Dr. Martin’s testimony concerns certain issues in dispute (i.e., use of bipolar electrodes), we find Dr. Martin is qualified and his testimony helpful in resolving those disputes. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (explaining And, even if there may be gaps in Dr. Martin’s experience or knowledge about the nasal anatomy, such gaps are filled by Dr. Bu-Saba’s extensive clinical expertise and testimony of record. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba or Dr. Martin; we give their testimony appropriate weight in reaching our conclusions here.” slip op. at 15
- Expert testimonyPetitioner expert creditedOther
“We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’077 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. We also disagree that Dr. Martin’s testimony should be discounted for a lack of first-hand experience designing RF ablation devices specific for the nose (which experience Patent Owner’s engineer expert also lacks). Id. As Dr. Martin’s testimony concerns certain issues in dispute (i.e., use of bipolar electrodes), we find Dr. Martin is qualified and his testimony helpful in resolving those disputes. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (explaining And, even if there may be gaps in Dr. Martin’s experience or knowledge about the nasal anatomy, such gaps are filled by Dr. Bu-Saba’s extensive clinical expertise and testimony of record. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba or Dr. Martin; we give their testimony appropriate weight in reaching our conclusions here.” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims’ language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only to the extent needed to resolve the dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019); U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (holding claim construction is for “resolution of disputed meanings”). Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner responds that “the Board need not construe any terms to determine Petitioners have failed to carry their burden in this proceeding.” PO Resp. 20. On the record before us, we conclude that the claims need not be expressly construed to resolve the dispute before us. Insofar as the parties dispute the mapping of the prior art to dependent claims 4 and 7, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by those claims.” slip op. at 17
- BurdenFwd all claims unpatentableUnpatentable
“For all the reasons above, we determine that the evidence supports Petitioner’s contention that a POSA would have reasonably expected success in combining the prior art to arrive at the subject matter of claim 1.” slip op. at 44
Patent outcomesUS 11,679,077 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,679,077 - Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00280 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1, 2, 5, 8–10, 12, and 14 are unpatentable as obvious over Makower, Fang, and Edwards; the Board did not reach Grounds 1–3.
RulingsFinal written decision- Skill levelSkill level board ownOther
“Based on the record before us, including the types of problems and solutions described in the ’011 patent and the cited prior art, we find a POSA would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in biomedical engineering or a related discipline, (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices that deliver energy to tissue, and 3) knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. Less work experience may be compensated by a higher level of education, and vice versa.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’011 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba and we give Dr. Bu-Saba’s testimony appropriate weight in reaching our conclusions here.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the record before us, we conclude that the claims need not be expressly construed to resolve the dispute before us. Insofar as the parties dispute the mapping of the prior art to dependent claim 9, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by claim 9.” slip op. at 14
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Petitioner contends that Makower and Fang7 are analogous art to the challenged claims. Pet. 77 (arguing Makower and Fang “are in the same field” and are “reasonably pertinent” to solving problems addressed by the claimed invention); Ex. 1002 ¶ 178. According to Petitioner, Makower and 7 Petitioner argues a POSA had reasons for combining Edwards with Makower and Fang with a reasonable expectation of success (see, e.g., Pet. 74–76, 81–85). We find persuasive Petitioner’s reasoning and evidence on the addition of Edwards, and Patent Owner provides no rebuttal about Edwards. energy to tissue and “each uses RF energy to treat tissue.” Pet. 77 (citing, e.g., Ex. 1005 ¶¶ 1, 43, 132, 164, 187; Ex. 1006, 876–877).” slip op. at 25
Patent outcomesUS 10,894,011 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,894,011 - PTAB · Jan 23, 2025 · IPR2024-01104 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–18 based on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, Paper 6, 8. “An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id., 8 n.9. We evaluate Becton, Dickinson factors (c), (e), and (f) to determine whether Petitioner has demonstrated material error. Id., 10. Those factors are: (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; . . . (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments. Becton, Dickinson, Paper 8 at 17–18.” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“summarized above, we are persuaded, based on the current record, that persons of ordinary skill in the art would have been motivated to combine Lesniak, Phinney, and Bianchi ’518 to arrive at the deodorant stick of at least claim 1 with a reasonable expectation of success for the reasons stated in the Petition. Pet. 24–37. In particular, we are persuaded by Petitioner that Lesniak teaches natural anhydrous personal care compositions, including a deodorant stick in the form of an antiperspirant stick. Pet. 24 (citing Ex. 1003, 1:16–35, 4:22, 5:5–32, 10: 27, 10:32–33). Lesniak explains that such compositions include at least one antimicrobial (i.e., zinc oxide) and a where the compositions are free of an aluminum salt. Id., 24–25. While Petitioner concedes that Lesniak does not expressly teach that its compositions include magnesium hydroxide, for that element, Petitioner combines Phinney disclosure for using magnesium hydroxide as an antimicrobial in a deodorant stick. Id., 25–26 (citing Ex. 1004, 2:33–37). And Petitioner provides a reason to combine Lesniak and Phinney, noting that “[b]oth Lesniak and Phinney are directed to deodorants with ‘natural ingredients’ and both describe the use of known antimicrobials”. Id., 26–27 (citing to Ex. 1003, 4:61–5:31, 9:45, 10:27, 10:31–33, 3:39–4:21, 8:31–9:59; Ex. 1004, 1:5–9, 1:15–19, 5:52–67, 6:31–34, 8:40–44). Petitioner concludes that “a POSA would have been motivated to incorporate magnesium hydroxide into Lesniak’s composition following Phinney’s guidance, as this combination would improve odor protection while maintaining the ‘natural’ composition intended by Lesniak.” Pet. 27; Ex. 1002 ¶ 62 (same). Petitioner also concedes that Lesniak also does not expressly teach hardness as measured by penetration within an ASTM-D 1321 needle test, but that Bianchi ’518 discloses a hardness range by needle penetration. Id at 26–28. By combining these references of record in the manner proposed by the Petitioner, we are persuaded on the record before us that those of ordinary skill in the art would combine the teachings of Lesniak, Phinney, and Bianci ’518 to meet each limitation of claim 1 for the reasons set forth in the Petition. See e.g. id., 27 (“a POSA would have known that hardness was an ‘important physical parameter affecting consumer acceptance,’ and would have looked to achieve hardness levels that were taught in the field to achieve consumer acceptance”); see also Ex. 1002 ¶¶ 63–64 (same). Patent” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“summarized above, we are persuaded, based on the current record, that persons of ordinary skill in the art would have been motivated to combine Lesniak, Phinney, and Bianchi ’518 to arrive at the deodorant stick of at least claim 1 with a reasonable expectation of success for the reasons stated in the Petition. Pet. 24–37. In particular, we are persuaded by Petitioner that Lesniak teaches natural anhydrous personal care compositions, including a deodorant stick in the form of an antiperspirant stick. Pet. 24 (citing Ex. 1003, 1:16–35, 4:22, 5:5–32, 10: 27, 10:32–33). Lesniak explains that such compositions include at least one antimicrobial (i.e., zinc oxide) and a where the compositions are free of an aluminum salt. Id., 24–25. While Petitioner concedes that Lesniak does not expressly teach that its compositions include magnesium hydroxide, for that element, Petitioner combines Phinney disclosure for using magnesium hydroxide as an antimicrobial in a deodorant stick. Id., 25–26 (citing Ex. 1004, 2:33–37). And Petitioner provides a reason to combine Lesniak and Phinney, noting that “[b]oth Lesniak and Phinney are directed to deodorants with ‘natural ingredients’ and both describe the use of known antimicrobials”. Id., 26–27 (citing to Ex. 1003, 4:61–5:31, 9:45, 10:27, 10:31–33, 3:39–4:21, 8:31–9:59; Ex. 1004, 1:5–9, 1:15–19, 5:52–67, 6:31–34, 8:40–44). Petitioner concludes that “a POSA would have been motivated to incorporate magnesium hydroxide into Lesniak’s composition following Phinney’s guidance, as this combination would improve odor protection while maintaining the ‘natural’ composition intended by Lesniak.” Pet. 27; Ex. 1002 ¶ 62 (same). Petitioner also concedes that Lesniak also does not expressly teach hardness as measured by penetration within an ASTM-D 1321 needle test, but that Bianchi ’518 discloses a hardness range by needle penetration. Id at 26–28. By combining these references of record in the manner proposed by the Petitioner, we are persuaded on the record before us that those of ordinary skill in the art would combine the teachings of Lesniak, Phinney, and Bianci ’518 to meet each limitation of claim 1 for the reasons set forth in the Petition. See e.g. id., 27 (“a POSA would have known that hardness was an ‘important physical parameter affecting consumer acceptance,’ and would have looked to achieve hardness levels that were taught in the field to achieve consumer acceptance”); see also Ex. 1002 ¶¶ 63–64 (same). Patent” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 24 (citing Ex. 1002, ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. Prelim. Resp. 8. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,540,999 - Nexus Pharmaceuticals, LLC v. Exela Pharma Sciences, LLCInstitution deniedPTAB · Aug 8, 2024 · PGR2024-00016 · APJ Ulrike W Jenks · PGR · Institution
The Board denied institution of PGR on claims 1–30 under § 325(d), finding substantially the same art or arguments had been presented to the Office and no material error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we exercise discretion to deny institution under § 325(d). Accordingly, we do not institute a post-grant review of the challenged claims of the ’370 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.”3 Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). We consider several non-exclusive factors as set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“Becton, Dickinson”), which “provide useful insight into how to apply the 3 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a). framework” under § 325(d). Advanced Bionics, 9. These non-exclusive factors include: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments. Becton, Dickinson, 17–18 (formatting added). “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office.” Advanced Bionics, 10.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art: would have had an advanced degree like a Ph.D. or equivalent in chemistry, biochemistry, pharmaceutics, pharmacy, or a related pharmaceutical field, with at least two years of experience in pharmaceutical formulation development, analysis, optimization and manufacturing, including experiences with processes and techniques for minimizing impurities in, and improving the stability of, pharmaceutical drug products during manufacture and storage. Pet. 27 (citing Ex. 1003 ¶ 24). Petitioner also states that one of ordinary skill in the art “may also have lesser levels of education but more years of experience” and “[a] multi-disciplinary team consisting of individuals with different skills and experience could also suffice.” Id. Patent Owner argues that: A person of ordinary skill in the art has attained a Pharm. D., or M.S. or Ph.D. in chemistry, chemical engineering, or a related field; has three or more years of experience in developing aqueous drug formulations; and has access to other scientists to collaborate and consult with on, for example, characterizing the drug formulation, manufacture of the drug formulation, and clinical use and effect of the drug formulation.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Because this Decision declining to institute trial does not necessitate the application of any express claim construction, we need not construe any terms. See 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))).” slip op. at 8
Claim constructionDiscretionary denialPatents in suitUS 11,642,370 - Osteomed LLC v. Stryker European Operations Holdings LLCAll claims unpatentablePTAB · Aug 8, 2023 · IPR2022-00488 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–3 and 6–18 are unpatentable as obvious over Arnould and Zahiri, with claim 6 also relying on Myerson; the Board did not reach Grounds 1–3.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“While both parties’ descriptions are similar, we find that Patent Owner’s description is better supported by the record. As Patent Owner points out, the main distinction between the parties’ proposals is that Patent Owner’s description is broader because it includes orthopedic surgeons. The record supports the inclusion of such individuals in the description of a POSITA. See Ex. 2005 ¶¶ 37, 41; Ex. 2009, 38:21–39:7 (Petitioner’s declarant testifying that he would “include an orthopedic surgeon that has some experience developing implants as a person of ordinary skill in the art”). Thus, we apply Patent Owner’s description of a POSITA for our analysis.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“That said, we do not agree with Patent Owner that the Specification defines “bone plate” as it contends. In the background of the invention, the Specification states that “[t]he invention relates to the technical field of orthopedic implants. More particularly, the invention relates to a plate for arthrodesis or osteosynthesis adapted to be fixed between two bone parts.” Ex. 1001, 1:27–31. Contrary to Patent Owner’s argument, this passage does not “define” the term “bone plate” nor otherwise suggest that the patentee acted as its own lexicographer. See Resp. 9. Moreover, nothing in the record suggests that the ordinary meaning of “bone plate” requires the plate to be fixed between two bone parts. The medical dictionaries Patent Owner cites do not include such a requirement in their definitions. See Ex. 2012, 1478 (defining “bone plate” as “a metal bar with perforations for the insertion of screws, used to immobilize fractured segments”); Ex. 2013, 241 (defining “bone plate” as “a metal plate used to reconstruct a bone that has been fractured” and “designed to hold the bone fragments in apposition”). Both of these definitions are consistent with Mr. Sherman’s testimony that a bone plate is “not always” placed across the fracture. See Ex. 2009, 52:9–53:1 (identifying particular instances in which a plate is not placed across the fracture). We credit that testimony over the competing testimony of Patent Owner’s declarant, Mr. Leinsing. Ex. 2005 ¶ 34 (referring to the statements from the Specification and dictionary definitions discussed above). For these reasons, we agree with Petitioner that the term “bone plate” as recited in the challenged claims has its ordinary meaning and that meaning does not exclude plates located on only one side of a joint or fracture.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We do not agree that the ordinary meaning of “between” is as restrictive as Patent Owner contends. First, Patent Owner’s definition of “between” does not require an object that is “between” two others to lie along the same axis defined by the two other objects. A “space separating two objects” is not so restrictive. Instead, a more expansive ordinary meaning of “between” is evidenced by the intrinsic evidence of the ’751 patent as Petitioner explained with reference to Figure 2 of the ’751 patent, which shows a third hole 1a1 between the other holes even though it is “offset” and in a different plane from the longitudinal axis of the bone plate. Patent Owner attempts to draw a distinction between Arnould’s Figure 2 and Figure 2 of the ’751 patent, by asserting “like Arnould, a hand is in a different plane and offset and its axis is not in relation to the body. In contrast, the angled tab shown in Figure 2 of the ’751 patent is not in a different plane and offset from the plate, and the hole axis forms an angle with the plate.” Sur-reply 8. Patent Owner’s distinction here appears to be whether the third hole lies at an angle below or above the bone plate as shown in Figure 2 of the ’751 patent (which would be “between” according to Patent Owner) versus also being positioned to either side of the bone plate as shown in Figure 2 of Arnould (which in Patent Owner’s view would mean that hole is no longer “between” the others). We see no basis for drawing such a fine distinction regarding the meaning of “between,” especially when the narrower definition Patent Owner seeks is not made explicit in the Specification of the ’751 patent. To the extent any further claim construction is necessary to resolve” slip op. at 16
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“contends. A reference is considered to be analogous art if it is in the “same field of endeavor” as the patent at issue. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Here, the Specification states that “[t]he invention relates to the technical field of orthopedic implants.” Ex. 1001, 1:27–28. Zahiri falls squarely within this field, describing “fixation devices for compressing bone fractures of a human being.” Ex. 1007, 1:9–11; see also, e.g., id. at Fig. 1 (depicting the use of Zahiri’s plate as an orthopedic implant to fix two bone parts). The differences Patent Owner identifies in Zahiri’s device do not show otherwise. In this regard, we find the testimony of Mr. Sherman (Ex. 1002 ¶ 245) on this point to be more credible than the competing testimony offered by Mr. Leinsing (see Ex. 2005 ¶¶ 121–29, 238). Mr. Sherman persuasively testifies that “Arnould and Zahiri disclose bone plates with diagonal fixation members configured to compress the intersection of a first and second bone,” demonstrating Arnould and Zahiri “are therefore in analogous fields of invention” to the ’751 patent. Ex. 1002 ¶ 245. Mr. Leinsing, on the other hand, continues to assert that Zahiri discloses only “a guide that directs a lag screw at a precise angle into a humeral head, not a bone plate” because it is located on only one side of the joint or fracture. Ex. 2005 ¶ 238. Therefore, Mr. Leinsing concludes that the “Zahiri device is directed to a completely different function than Arnould,” and is non-analogous art. Id. Because we find Zahiri discloses a “bone plate” according to the ordinary meaning of that term, Mr. Leinsing’s testimony is unconvincing. See supra § III.C.i (explaining that the ordinary meaning of “bone plate” does not exclude plates located on only one side of a joint or fracture). But even if we agreed with Patent Owner’s and Mr. Leinsing’s interpretation of bone plate, Zahiri’s plate is still an orthopedic implant and therefore analogous art because it is within the same field of endeavor as the ’751 patent.” slip op. at 34
Patent outcomesUS 10,993,751 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,993,751
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.