• CSPC Megalith Biopharmaceutical Co., Ltd. v. Shanghai Miracogen Inc.Instituted
  PTAB · Oct 14, 2025 · IPR2025-00685 · APJ John G New · IPR · Institution

  The Board instituted IPR on claims 1–23 and all petitioned grounds, finding a reasonable likelihood that the claims are obvious over Wei and Liu.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “Summary Based upon the record as presently developed, we conclude that Petitioner has met its burden of showing a reasonable likelihood of showing at trial that at least claim 1 of the ’370 patent is obvious over the cited prior art. Because we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in showing that at least one claim is unpatentable on at least one of the stated Grounds, we institute inter partes review of all challenged claims of the ’370 patent, based on all of the remaining grounds identified in the Petition. See 37 C.F.R. § 42.208(a); SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 44

  • Skill levelSkill level board ownOther

    “appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, at this point we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art. The actual inventor’s skill is not determinative”) (emphasis added, footnotes omitted). Consequently, and for the purposes of this Decision, we adopt Petitioner’s proposed definition as defining a person of ordinary skill in the art as a person who would have had “a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and would further have had at least five years of experience with antibodies and antibody engineering.”” slip op. at 6

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther

    “Petitioner states that no term of the challenged claims requires construction to resolve the challenges in this Petition. Pet. 32. Patent Owner does not contest Petitioner’s assertion. See generally Prelim. Resp. We find, for the purposes of this Decision, that no terms of the challenged claims require construction beyond the ordinary and customary meaning of the terms, as understood by a person of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at 1312–13.” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted

    “We find, based upon the present record and for the purposes of this Decision, that Petitioner has sufficiently established that a person of ordinary skill in the art would have been motivated to combine the teachings of Wei and Liu to determine the activity and suitability of Liu’s humanized anti- EGFR antibodies in an ADC. We acknowledge that Liu is silent regarding the pH selectivity or tissue preference of its binding affinity, but Patent Owner points to no prior art reference that would have informed a skilled artisan upon this point or that would have discouraged a person of ordinary skill in the art from combining the references. See fn.7, supra. And, even if a skilled artisan might have recognized that Liu’s humanized cetuximab might have been potentially problematic if it failed to show pH-selective activity like Wei’s Y104D, the mere fact that some disadvantage may come with an advantage when combining prior art does not foreclose their combination under § 103. Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). In the instance of Liu’s humanized anti-EGFR antibody, a person of ordinary skill in the art would have recognized that its advantages (enhanced activity against tumor cells compared to chimeric cetuximab, thus requiring smaller dosages) could balance or outweigh its possible disadvantages (e.g., possible activity against non-tumor cells). Furthermore, it is in the nature of scientific research to continue to try new substitutions in drug therapy, even if a promising candidate has been discovered. As the Supreme Court stated in KSR: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. 550 U.S. at 421.” slip op. at 39

  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,792,370
• Gettattle, Inc. v. Afterwords, Inc.Instituted
  PTAB · Oct 7, 2025 · IPR2025-00677 · APJ Ryan H Flax · IPR · Institution

  Instituted review of claims 1–7, 10, 13, 16, 18, and 19 on all four anticipation grounds because the Petition showed a reasonable likelihood of prevailing.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “Under 37 C.F.R. § 42.4(a), we have authority to determine whether to institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’811 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “ORDINARY LEVEL OF SKILL IN THE ART Petitioner contends: As of the effective priority date of the ‘811 patent, a person of ordinary skill in the relevant field at the time would be familiar with the pre-existing point of sale and network-based technologies as above, for example in Section I.D. above as well as the “BACKGROUND OF THE INVENTION” portion of the ‘811 patent specification. Ex. 1001, col. 1, l. 21 – col. 5, l. 10. This person would include someone who has, through education or practical experience, at least 2-3 years of experience in software engineering, such as the development of data sets, database management, and networking integration for dynamic content generation and network-based distribution. Pet. 10. Patent Owner states, “[f]or the purposes of this Preliminary Response only, Patent Owner applies Petitioner’s definition of a person of ordinary skill in the art. See Petition, p. 10.” Prelim. Resp. 14. We accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears to comport with the level of skill in the art reflected in the prior art of record and the ’811 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “The claim language does little to identify any meaning of “point-of- sale interface.” Looking to the ’811 patent’s written description, it never uses the term “point-of-sale interface,” but it states “moder[n] Point-of-Sale (POS) systems . . . capture rich details around their customers’ purchasing activity.” Ex. 1001, 1:52–54. The Specification further states that “[t]he transaction data may be stored locally to a point-of-sale (“POS”) device or to a remote location, such as a cloud service provider.” Id. at 2:23–25. Regarding the associated term “interface,” the written description states, “[i]n general, as used herein, an interface is a component of computer executable instructions stored in a tangible, non-transitory medium and executed by processor 12 to present a display of information related to the interface allowing someone to view and/or interact with the presented information.” Id. at 4:32–37. We are pointed to and find nothing in the ’811 patent’s prosecution history that sheds any further light on the meaning of this language. See Pet. 12–14; Prelim. Resp. 12–13; Ex. 1003. Based on the intrinsic record, we find that the ’811 patent describes a point-of-sale as being local to a transaction, e.g., a sale/purchase of a product” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “At this point in the proceeding, we do not agree with Patent Owner that the recited survey module must be autonomous, self-contained, or a web-container package. As discussed above, we preliminarily interpret this term to mean software code for displaying a survey question. We find no support in the current record to add to this definition any additional requirements related to autonomy, self-containment, or a web-based context for the survey module. The Petition (at 19) points to Douglas as teaching the claimed survey module, i.e., in Douglas, software sent to the customer for taking a product survey on the display of the customer’s computer device. Douglas teaches, in response to a customer providing a survey trigger (e.g., purchase data signals), a survey generator creates a transaction-specific survey (e.g., “Was the item you found too expensive?”) and transmits it to the customer’s device (e.g., a mobile phone with a touchscreen); the survey is interactive; and the customer touches or clicks their device’s screen to respond to the survey questions. Ex. 1007 ¶¶ 34–35. Moreover, Douglas also discloses that its survey “interact[s] with the customer using one or more software applications on customer device 106,” which may be, e.g., a computer or mobile phone, further, “[t]he one or more software applications may be provided by survey system 101, or merchant 107, or a third party,” and finally, “[t]he one or more software applications may be web-based applications and/or native mobile applications installed on the customer device 106.” Id. ¶¶ 18–20; see also Prelim. Resp. 35 (conceding as much). Thus, Douglas appears to disclose a survey system where a survey server responds to a triggering survey token created by a merchant and sent by a customer, that connects the customer with a particular purchase, by creating a purchase-specific survey question and sending it to a customer’s electronic device, where the survey question is displayed on a web-browser by software, and the customer’s survey answers may then spur the system to generate and follow up with additional questions. See Ex. 1007 ¶¶ 18–20, 27–29, 33–39. This appears to include the claimed survey module at issue. As for Patent Owner’s argument that the recited survey module must” slip op. at 31

  Claim construction§ 102 anticipationcites Phillips
  Patents in suitUS 10,430,811
• Front Line Medical Technologies, Inc. v. Prytime Medical Devices, Inc.All claims unpatentable
  PTAB · Oct 1, 2025 · PGR2024-00028 · APJ Jeffrey N Fredman · PGR · Final written decision

  Claims 1–10 are unpatentable as obvious over Fogarty and Chengod; the Board found that combination sufficient for every challenged claim.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “7. Conclusion Based on the entirety of the record, we determine that a person of” slip op. at 13

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “3. Analysis In our claim construction analysis “[w]e begin, as we often do, with” slip op. at 18

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed board ownOther

    “the feature of the solid wire being “secured at a proximal-most end thereof within the proximal hub” was added during prosecution to overcome a rejection. Ex. 1002, 573-580. The prior art was distinguished because its guidewire “is configured to be steered and manipulated through the blood vessel, and subsequently removed, and, therefore, cannot be secured at a proximal end thereof to the luer hub 310.” Id., 578-79 (emphasis added). Accordingly, the prosecution history further demonstrates “secured” was not intended to cover removable attachment.” slip op. at 35

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

    “2. Patent Owner’s Arguments Concerning Claim 1 and Our Analysis a. Reasonable Expectation of Success in modifying catheters to less than 6 Fr Patent Owner asserts “Petitioner has failed to perform a proper obviousness analysis by not adequately demonstrating a reasonable expectation of success in modifying Fogarty.” PO Resp. 35. Patent Owner asserts “the category of ‘Fogarty catheters’ is broad and diverse” and “Dr. Resnick admits he has no idea whether Chengod’s or Deaton’s catheters have interior constructions similar to that of the cited Fogarty reference.” Id. at 35‒36 (citing Ex. 2002, 52:16‒57:1). Patent Owner asserts that Petitioner has therefore not demonstrated that a PHOSITA would have a reasonable expectation of success in modifying the particular catheter taught by the cited Fogarty patent (Ex. 1004) to the claimed size when considering the shaft has a spring coil and braid in addition to the outer tube and lumen. Id. Petitioner responds “(1) Fogarty did not indicate the catheter’s size; (2) Fogarty catheters smaller than 6 Fr were known and disclosed in Chengod (and Deaton); and (3) sizing Fogarty’s catheter less than 6 Fr would work (i.e., reasonable expectation of success) because it did work.” Pet. Reply 19. Petitioner asserts that Yassinzadeh “shows a catheter that is less than 6 Fr and that includes a similar spring coil construction as found in the Fogarty patent” where the “dilator 150 has a diameter of either 5 Fr or 6 Fr.” Id. at 19‒20 (citing Ex. 1033 ¶¶ 86‒97 (“Yassinzadeh”)). Petitioner asserts that Yassinzadeh’s “analogous construction being less than 6 Fr confirms a PHOSITA would have a reasonable expectation of success in sizing the catheter in Fogarty (Ex-1004) less than 6 Fr.” Id. at 20 (citing Ex. 1034 ¶ 97). Patent Owner responds “Petitioner fails to specify what” slip op. at 53

  Patent outcomesUS 11,857,737 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,857,737
• Kohler Co. v. Delta Faucet Co.Some claims unpatentable
  PTAB · Oct 1, 2025 · IPR2024-00700 · APJ Jane E Inglese · IPR · Final written decision

  Claims 1, 2, and 9 are unpatentable as obvious; claims 3–8 and 10–24 were not shown unpatentable because the asserted references failed to establish limitations including the claimed light pipe features.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “For purposes of this Decision, we adopt Petitioner’s definition of a POSITA. Petitioner’s witness (Mr. Cook) qualifies as a POSITA under this definition, and, therefore, is qualified to opine from the perspective of a POSITA on technical matters included within the areas of expertise prescribed by the definition. As indicated above, Petitioner’s definition of a POSITA does not require education in the field of optics and professional experience designing or analyzing optical apparatus, unlike Patent Owner’s definition. We are aware, however, that Patent Owner’s witness (Dr. Klopp) has more extensive experience with optical systems and methods than Petitioner’s witness (Mr. Cook). Compare Ex 1003 ¶¶ 8–14, Ex. 2005, 39:21–59:17, with Ex. 2003 ¶¶ 3–20, Ex. 2004, 1–2, Ex. 1015, 10:22–13:25. Although Mr. Cook possesses excellent credentials in the field of mechanical engineering, his experience in the design and analysis of optical systems and methods is sparse and insubstantial compared to that of Dr. Klopp. Id. Due to this difference in experience levels, in instances where the witnesses express differing views on factual issues related to optical systems and methods, we will accord more weight to Dr. Klopp’s testimony than to Mr. Cook’s.” slip op. at 8

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “through the light transmission portion and bottom output face 313 of light conductor 38, which teaches transmitting light in parallel with the longitudinal axis of the housing. Tseng does not disclose or teach that light is emitted through the side surface of annular protrusion 383 in a direction perpendicular to the longitudinal axis of the housing. Ex. 1004 ¶ 97. Petitioner’s assertions that this would be the case consist solely of conclusory statements, supported only by citations to Mr. Cook’s declaration. Mr. Cook, however, simply repeats Petitioner’s conclusory statements, without providing sound technical reasoning supported by objective evidence to explain and support his opinions. Ex. 2003 ¶¶ 101– 102, 105, 195–198, 202. We, therefore, accord little weight to Mr. Cook’s opinion on this particular matter because it “merely repeats, verbatim, the conclusory assertion for which it is offered to support,” and “does not cite to any additional supporting evidence or provide any technical reasoning [in] support.” Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). Furthermore, Mr. Cook’s opinion conflicts with that of Patent Owner’s witness, Dr. Klopp, who opines that a “POSITA would understand from Tseng’s third embodiment that light from the LED would bypass the annular protrusion 383 of outer cliff 381, while transmitting downwardly toward the output face 313.” Compare Ex. 1003 ¶¶ 174–175, 190–194, with Ex. 2003 ¶¶ 101–102, 105. As discussed above, Mr. Cook is qualified to opine from the perspective of a POSITA on technical matters included within the expertise of a person meeting Petitioner’s definition of a POSITA, which do not include optics and optical apparatus. We, therefore, credit Dr. Klopp’s opinion over that of Mr. Cook on this particular factual issue of how it is directly related to optical systems and methods about which Mr. Cook possesses limited relevant experience. See Ex. 1003 ¶¶ 6–15 (experience in communication systems and electronics); Ex. 2005, 55:16–58:19 (design experience with electronics that use indicator lights or fiber-optic communications; no professional experience with light pipes, diffusers, or plumbing fixtures). Dr. Klopp possesses substantial research and professional experience with optical methods, fiber optic light pipes, light guides, diffusers, prisms, and analysis of faucets, spray heads, and plumbing fixtures. See Ex. 2003 ¶¶ 6–10 Supra 8 (discussing weight accorded to conflicting witness testimony); see also Resp. 2–3 (arguing that “Petitioner’s expert, Mr. Cook, is a mechanical engineer with substantial professional experience in electronics for high-voltage power systems and communications, but he has limited experience with the claimed subject matter.”).” slip op. at 34

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed

    “would be used to construe the claim[s] in a civil action [held] under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under that standard, claim terms generally are given their plain and ordinary meaning as would have been understood by the ordinarily skilled artisan at the time of the invention when read in the context of the specification and prosecution history. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). We construe terms in controversy only to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner asserts that the claim terms do not require construction and should be afforded their plain and ordinary meaning. Pet. 13. Patent Owner contends that it applies the plain and ordinary meaning of the claim terms. Resp. 7. Taking into consideration the information presented, we determine that none of the claim terms requires express construction for purposes of resolving the dispute before us.” slip op. at 9

  • BurdenMixed

    “perpendicular to the longitudinal axis of Tseng’s housing (internal 33 and external 34 sleeves). “In an inter partes review, the burden of persuasion is on the petitioner to prove ‘unpatentability by a preponderance of the evidence,’ 35 U.S.C. § 316(e), and that burden never shifts to the patentee.” In re Magnum Oil Tools Int’l Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (quoting Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)); see also Aqua Products, Inc. v. Matal, 872 F.3d 1290, 1306 (Fed. Cir. 2017 (en banc (quoting Magnum Oil)).” slip op. at 40

  Patent outcomesUS 10,393,363 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,393,363
• Xencor, Inc. v. Merus N.V.Instituted
  PTAB · Sep 26, 2025 · IPR2025-00605 · APJ Tawen Chang · IPR · Institution

  The Board instituted IPR on claims 1–7 and all petitioned grounds, finding a reasonable likelihood that claim 1 is anticipated by Desjarlais or Moore or obvious over Lazar alone.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “SAS, 138 S. Ct. at 1356. Thus, because we determine, based on the arguments and evidence on the present record, that there is a reasonable likelihood Petitioner would prevail with respect to claim 1, we institute an inter partes review of all challenged claims under each Ground presented in the Petition. Id.; see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). III. CONCLUSION For the reasons provided above, we find that Petitioner has demonstrated a reasonable likelihood of showing at trial that at least one of the challenged claims of the ’859 patent is unpatentable under at least one ground. Accordingly, we institute inter partes review of all challenged claims based on all the Grounds presented in the Petition.” slip op. at 49

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351. In this case, Table A of the ’935 provisional discloses a list of CH3 domain interface residues and identifies, for each interface residue in heavy chain A, the contacting residue in the corresponding chain B. Ex. 1030, 17, Table A. Table A does not, however, describe any particular substitutions or pairs of substitutions that should be made to the CH3 domains. See, e.g., Pet. 28 (citing Ex. 1002 ¶¶ 109–119). Table 7 of the ’935 provisional does identify specific amino acid substitutions in CH3 domains, including substitutions resulting in a positively charged residue at position 364 (e.g., S364K) and a negatively charged residue (e.g., L368D) at position 368. Ex. 1030, 52, Table 7. Patent Owner argues that this table “discloses specific positions for ‘identification of novel charge pair mutants.’” Prelim. Resp. 13 (citing Ex. 2010 ¶ 48). As Petitioner points out, however, while Example 13 of the ’935 provisional relates to identification of novel charge pair mutants, Table 7 itself was only a “first step” in this identification process. Ex. 1030, 51:6–17. In this step, “many interface contact residues in the IgG CH3 domain were scanned one by one or in groups for substitutions that would result in repulsion of 35 identical heavy chains” so that identified substitutions can then be used to generate antibodies “by engineering matched pairs of CH3 residues in one or more IgG heavy chains – CH3 regions” in follow up experiments. Id. Accordingly, Table 7 does not appear to describe heterodimer combinations, such as those that would result from a pairing of chains with different substitutions. Pet. 29–30 (citing, e.g., Ex. 1002 ¶¶ 111–118). As Petitioner further points out, the follow up experiments testing the matched pairs of CH3 residues did not include paired substitutions at positions 364 and 368. Id. at 29–31. Patent Owner points to disclosure in the ’935 provisional describing, as a distinguishing feature of its invention, the substitution of non-charged or neutral amino acids in wildtype CH3 with charged residues, which according to the ’935 provisional has the “advantage that at least one additional charge-charge interaction in the CH3 interface is created.” Prelim. Resp. 12 (citing, e.g., Ex. 2010 ¶¶ 42–48). For the same reasons discussed above, Petitioner has sufficiently established, for purposes of institution, that such disclosure would not reasonably convey to an ordinarily skilled artisan that the inventors had possession of the entire genus of heterodimeric antibodies comprising CH3 domains wherein a non-charged amino acid is replaced with a charged residue so as to create an additional charge-charge interaction in the CH3 interface. In this regard, we also note that “a description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352.” slip op. at 34

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

    “adequately describes a heterodimeric antibody comprising the recited charged residues at the recited positions of the CH3 domains, i.e., “a positively charged amino residue at position 364” at a first CH3 domain and “a negatively charged amino acid residue at position 368” of the second CH3 domain. Having considered the evidence of record at this preliminary stage of the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’935 provisional does not provide adequate written description support for claim 1 of the ’859 patent and that, accordingly, Desjarlais and Moore qualify as prior art to that claim. As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351.” slip op. at 34

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “The ’859 patent does not provide an explicit definition of “immunoglobulin class.” Nevertheless, we do not construe that term to require “two heavy chains with four domains, VH, CH1, CH2, and CH3, and two Fab arms.” As an initial matter, the Specification teaches that antibodies include, 16 e.g., IgE and IgM — which have an additional CH4 domain in their heavy chains — as well as functional derivatives and/or fragments of known antibody isotypes. Ex. 1001, 11:44–48. Patent Owner’s proposed construction, which limits antibodies to those having two Fab arms and “two heavy chains with four domains, VH, CH1, CH2, and CH3,” excludes these embodiments and cannot be correct. Moreover, the ’859 patent defines antibody as containing “one or more domains” that bind an epitope on an antigen. Ex. 1001, 11:39–44. Thus, an antibody does not require two Fab arms as in a native immunoglobulin molecule.12 The ’859 patent also describes a preferred embodiment as “Ig-like molecules.” Id. at 11:49–52. Thus, we look to the definition of “Ig-like molecule” in the ’859 patent, i.e., “a proteinaceous molecule that possesses at least one immunoglobulin (Ig) domain,” to inform our understanding of the phrase “immunoglobulin class of proteins.” Ex. 1001, 11:4–6. Accordingly, we further construe “immunoglobulin class of proteins” to mean proteinaceous molecules comprising at least one domain that is derived from or shares sequence homology with an immunoglobulin domain.” slip op. at 16

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 11,926,859
• Xencor, Inc. v. Merus N.V.Instituted
  PTAB · Sep 26, 2025 · IPR2025-00604 · APJ Ryan H Flax · IPR · Institution

  The Board instituted IPR on claims 1, 2, 7–24, 26–28, and 30–32 on all four grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’286 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A POSA at the time of the alleged invention would have at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and two or more years of experience in the production of bispecific antibodies. (EX1002, ¶¶16-17.) Pet. 15. Patent Owner states, “[f]or purposes of the Preliminary Response, Patent Owner applies Petitioner’s proposed definition of a POSA.” Prelim. Resp. 10. At this point, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ’286 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 12

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningNo construction neededDecided for petitioner

    “The ’286 patent uses the term “heavy chain” or “heavy chains” repeatedly; however, we find no express definition of the term. See generally Ex. 1001. Rather, the ’286 patent uses the term “heavy chain” in relation to antibody structure in a way that suggests the term is standard and well known in the art. See, e.g., id. at 3:19–59 (Background). The parties’ briefing on the technology reinforces this fact. See Pet. 5–14 (“The basic structure of natural IgG comprises four protein chains—two identical heavy chains (shown in red) and two identical light chains (shown in blue)—which are arranged in a Y-shaped configuration: . . . (EX1013, 112-13; EX1002, ¶¶23-30.)”); Prelim. Resp. 3–4 (“Natural or wild type Igs have a particular structure made of two identical light (L) chains and two identical heavy (H) chains. See EX2008 at ¶ 23. Each Ig heavy chain consists of three constant domains (CH1, CH2, and CH3) and one variable domain (VH), which is also isotypes, or a functional derivative and/or fragment of these. In a preferred embodiment, Ig-like molecules are produced that are antibodies of the IgG isotype because IgG antibodies e.g. have a longer half life as compared to antibodies of other isotypes. Ex. 1001, 11:9–21. As noted above (see supra Section I.C), IgG antibodies’ heavy chains have three constant domains, but IgE and IgM have four. Thus, Patent Owner’s argument that heavy chain means one variable and three constant domains, and two differently-binding Fab arms, ignores embodiments of the invention. consistent with the definition of heavy chain in the ’286 Patent. See EX2008 at ¶ 24; EX1001 at 11:58–66.”). This is also how the ’286 patent generally uses the term. See Ex. 1001, 11:58–12:1. But, the Specification does not limit its embodiments to only IgG antibodies because it also describes that the invention may be “IgG1, IgG2, IgG3, IgG4, IgA, IgE, and IgM” type antibodies, and fragments. Ex. 1001, 11:9–21; see also supra n.10 (quoting the ’286 patent’s definition of antibody). Other embodiments would not necessarily have the heavy chains as argued by Patent Owner. There is no evidence of record that the ’286 patent’s claims or the Specification generally use or limit the term “heavy chains” (or “heavy chain”) in any way deviating from its ordinary and customary meaning in the art. Therefore, at this stage of the proceeding, we decline to expressly interpret this claim language. 2. Summary on Claim Construction At this stage of the proceeding, we expressly construe no claim terms and give each claim term the ordinary and customary meaning it would have had to the person of ordinary skill in the art as of the invention date. See Nidec Motor Corp., 868 F.3d at 1017. If either party intends to further argue claim construction at trial, they should do so in a clearly designated section of their briefing so as to expressly identify such arguments. See, e.g., 37 C.F.R. § 42.104(b)(3) (content of petition); see also Board’s Consolidated Trial Practice Guide (CTPG) at 46, 48–45 (Nov. 2019).12 Claim construction arguments should not be relegated to patentability arguments on the facts.” slip op. at 16

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “In brief summary, these limitations require one CH3 heavy chain to have a positive amino acid substituted in place of a neutral one, the other CH3 heavy chain to have a negative amino acid substituted in place of a neutral one, and that when the heavy chains are expressed by culturing the host cell these positive and negative amino acids interact and the antibody produced is a heterodimeric antibody. Petitioner asserts that Lazar expressly teaches engineering two CH3 domains so that, when expressed, they interact and form a heterodimeric CH3 interface by making neutral-to-positive and neutral-to-negative amino acid substitutions at known interacting residues on each CH3 domain, e.g., S364E (changing neutral serine to negative glutamic acid at residue 364) on one CH3 domain, and L368K (changing neutral leucine to positive lysine at residue 368) on the other CH3 domain; or T366D (swapping neutral threonine for negative aspartic acid at residue 366) on one CH3 domain and L351K (swapping neutral leucine for positive lysine at residue 351) on the other CH3 domain; that these residues were known in the art to be respective interfacing contact residues; that these modifications favor Fc heterodimerization; and that they result in a heterodimeric antibody (proof-of-concept shown by synthesizing and screening). Pet. 23–28 (citing Ex. 1001, 13:1–17, 17:67–18:3, 19:5–12; Ex. 1002 ¶¶ 111–119; Ex. 1004 ¶¶ 121, 183, 241 (Tables 1, 2); Ex. 1007, 8:9–10, 17:19–20 (Table 1); Ex. 1008, 244–36).” slip op. at 29

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,358,286
• Google LLC v. Metarail, Inc.Rehearing denied
  PTAB · Aug 25, 2025 · IPR2024-01270 · APJ Frances L Ippolito · IPR · Rehearing

  The Board denied Google’s rehearing request, leaving in place the denial of institution because the Petition did not show a reasonable likelihood that Belanger-Halevy teaches limitation [1C] of claims 1–26.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. ANALYSIS A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, a reply or sur-reply.” 37 C.F.R. § 42.71(d). The party challenging a decision bears the burden of showing the decision should be modified. Id. We address Petitioner’s rehearing arguments below.” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “[m]issing, however, from Halevy’s disclosure is any teaching or suggestion that a ‘plurality of computer-readable field identifiers’ are mapped ‘to one another’ as required by claim 1.” Dec. 22. We discussed and quoted extensively from Petitioner’s expert declaration of Dr. Fox and Patent Owner’s expert declaration of Dr. Malek. Id. at 22–26 (citing Ex. 1003 ¶ 104; Ex. 2001 ¶¶ 69, 71). In reviewing the parties’ submissions, we found that: Halevy’s disclosures are consistent with Patent Owner’s arguments and Dr. Malek’s testimony that Halevy does not teach mapping fields to one another or mapping of fields to one another through SO-properties. For example, as described, in Figure 6 and Halevy as a whole, Halevy does not teach or suggest mapping or linking different keywords to one another, rather the keywords are mapped to SO-properties. slip op. at 5

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Dr. Fox states that “Halevy’s disclosure of a form database in which corresponding fields from different forms on different websites map to the same SO-properties would have been recognized by a POSA as what the ’378 patent refers to as a universal variable map.” Ex. 1003 ¶ 108 (citing Ex. 1001, 17:42–46). Based on this conclusory opinion, Dr. Fox reasons that Halevy’s form database is a “universal variable map” that must also link computer-readable field identifiers (including parameter names) from multiple different websites to each other in the form database, because the field identifiers are mapped to the same SO-properties associated with an SO-class. Id. We observe first that Dr. Fox’s conclusion is not supported by the cited portions of the ’378 patent. In column 17, lines 42–46, the ’378 patent explains that fields or variables may be part of forms and variations of these data fields or variables “may include a source form, a destination form, a single source to many destination form, many sources to one destination form, cascading forms (e.g., a first form links to a second form which links to a third form, etc.) and so on.” Ex. 1001, 17:42–46. While this portion of the ’378 patent indicates that forms may include variations on fields or variables, it does not describe any linking or mapping of variables to one another. Ex. 2001 ¶ 76 (“[T]hat portion of the specification does not have anything to do with the definition of a “universal variable map.” Rather, it merely discusses different types of variables and fields that might appear in different types of forms.”). Dec. 28–29. We again referred to the disclosure of the ’378 patent to address evidence in the Petition relied upon by Dr. Fox to support Petitioner’s position. Id. We credited Dr. Malek’s testimony over Dr. Fox’s testimony because Dr. Malek underlined the distinctions between the asserted Belanger-Halevy prior art combination and limitation [1C]. Dec. 28–31. In short, any confusion applying the prior art Belanger-Halevy references to the claim limitation is rooted in the Petition. The Board denied the Petition because the Petition did not demonstrate a reasonable likelihood of showing that Belanger-Halevy discloses or teaches limitation [1C] of the ’378 patent.” slip op. at 5

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “Finally, with regard to the Reply and Sur-Reply submitted by the parties (Req. 9), we note that our Decision on Institution reviewed the parties’ discussion of claim construction, but ultimately determined that “[b]ased on our review of the preliminary record, we do not need to construe any terms expressly to reach our decision.” Dec. 11. Thus, we disagree with Petitioner that we misconstrued the mapping limitation where we did not find it necessary to construe any claim term for the purposes of our institution decision because we determined the Petition deficient for failing to meet our threshold requirements as discussed above and in detail in the Decision on Institution. See Req. 1–11.” slip op. at 7

  Claim construction
  Patents in suitUS 9,633,378
• Ceva Santé Animale S.A. / Egg-Chick Automated Technologies S.A.S et al. v. Targan, Inc.Some claims unpatentable
  PTAB · Jul 24, 2025 · IPR2024-00595 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–15 are unpatentable as obvious over the asserted §103 grounds; Petitioner did not show claims 16–18 unpatentable because the angled-conveyor combination lacked a supported rationale.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us, including the ’124 patent, the Gershman, Pierre, Yavnai, Tao, and Goodwin references, and the background and qualifications of both sides expert witnesses that reflect the knowledge and experience of a POSITA, including knowledge of systems for assessing and transporting poultry in an industrial setting. Patent Owner’s proposed skill level overlaps with Petitioner’s proposed skill level, and any differences would not alter the outcome of this proceeding. Therefore, we adopt Patent Owner’s proposed skill level with two modifications. A POSITA also could have a Bachelor of Science degree in Animal Science or similar discipline, and a POSITA would be familiar with techniques for assessing and transporting poultry in an industrial setting, such as visual and/or anatomical characteristics of a chick.” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “Therefore, we find that Applicant distinguished Tao from “an unrestrained chick” because in Tao’s automated system a chick is restrained—the chick is held in place—by a retainer unit on a moving platform, whereas in Applicant’s claimed system a chick is not held in place on a moving platform. We further conclude that Applicant’s reason for distinguishing the claimed invention over Tao informs the claim construction even if the “prosecution history statements do not rise to the level of unmistakable disavowal . . . .” Personalized Media, 952 F.3d at 1345 (Fed. Cir. 2020). In view of the ’124 patent claims, specification, and prosecution history, we determine “an unrestrained chick” is a chick not held in place on the moving platform and free to open its wings.” slip op. at 19

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

    “For the reasons given below, we find the Petition has established that Gershman discloses and teaches “a moving platform to support an unrestrained chick of a particular breed” by a preponderance of the evidence.” slip op. at 29

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “to determine a characteristic [of the chick] . . . [that] manifests in one of two or more possible states, e.g., sex (male vs. female), health (healthy vs. unhealthy), genetic mutation (present vs. not present).” Reply 13 (citing Ex. 1004, 3). The recitation of a generic “database of images” does not distinguish limitation [1.4] from the asserted combination of Gershman-Pierre, particularly in view of Pierre’s disclosure of “a computerized processing process is implemented in order to compare the captured images to reference images,” as asserted in the Petition. Ex. 1004, 3 (emphasis added); see Pet. 23–24 (citing Ex. 1003, 2–5; Ex. 1004, 3, 5). Thus, we find that storage of Pierre’s reference images of male and female wing feathers in a database used for comparison in Gershman’s computerized digital chick image processing system would have been obvious to a POSITA and satisfies limitation [1.4].19 We agree with Petitioner that it would have been obvious and well within the skill level of a POSITA—someone with a Bachelor of Science degree in agricultural, industrial, or electrical engineering and two years of experience in industrial poultry sexing and/or image processing (Resp. 20)—to store reference images as taught by Pierre in a “computerized processing” database. The rationale argued by Petitioner, to organize the collection of reference images for comparison to determine whether the characteristic of interest was present, finds direct support in Gershman and Pierre. Both references disclose comparing digital images of a chick’s wing feathers to reference data (Gershman) or reference images (Pierre) of male and female chick wing patterns. Pet. 23–24; Reply 12–13. Storing digital reference images in a database for comparison to captured digital images is, moreover, a basic and straightforward task in any computerized image processing” slip op. at 44

  Patent outcomesUS 10,806,124 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,806,124
• Google LLC v. Brodti Inc.Instituted
  PTAB · Jul 24, 2025 · IPR2025-00472 · APJ Stephen E Belisle · IPR · Institution

  The Board instituted IPR of claims 1–20 on all petitioned grounds, finding a reasonable likelihood that claims 1, 10, and 19 are obvious over Nicholas, Laidlaw, Mayadas, and Error.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “review. 35 U.S.C. § 314(b) (2024); 37 C.F.R. § 42.4(a) (2024). We may not institute an inter partes review “unless . . . there is 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). The “reasonable likelihood” standard is “a higher standard than mere notice pleading” but “lower than the ‘preponderance’ standard to prevail in a final written decision.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential). When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim. 37 C.F.R. § 42.108(a).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). Considering the subject matter of the ’898 patent, the background technical field, the prior art, and Petitioner’s proposed and unopposed definition of the skilled artisan (Ex. 1002 ¶¶ 9–12), we apply the level of skill set forth above.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed

    “Petitioner submits that all terms in the Challenged Claims should be given their plain and ordinary meaning in this proceeding, and that no specific construction of any claim term is required to resolve this case. Pet. 6 (“Petitioner does not believe express claim construction is necessary to resolve this Petition.”). Patent Owner has not submitted a preliminary response, and thus does not propose any terms for construction at this stage. In determining that Petitioner has demonstrated a reasonable likelihood of establishing unpatentability of at least one Challenged Claim, we need not and do not construe expressly any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (stating that “we 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 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

    “Petitioner argues the skilled artisan would have had various rational reasons for combining the teachings of these four references, and would have had a reasonable expectation of success in doing so. See, e.g., Pet. 18–21 (discussing reasons to combine Nicholas and Laidlaw and expectation of success in doing so), 33–37 (discussing reasons to combine Nicholas and Mayadas and expectation of success in doing so), 44–45 (discussing reasons to combine Nicholas, Laidlaw, Mayadas, and Error and expectation of success in doing so). Based on the record before us, we find Petitioner sufficiently shows that the combination of Nicholas, Laidlaw, Mayadas, and Error would have taught or at least fairly suggested to the skilled artisan the limitations of claim 1.4 Thus, for the reasons stated in the Petition (Pet. 8–51), we determine that Petitioner has established a reasonable likelihood that it would prevail in showing that independent claim 1 would have been unpatentable as obvious over the combination of Nicholas, Laidlaw, Mayadas, and Error.” slip op. at 21

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,416,898
• Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentable
  PTAB · Jul 9, 2025 · IPR2024-00459 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious under § 103 over each of the six asserted grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Here, as in our Institution Decision, we do not discern a significant difference between the parties’ respective proposed definitions beyond the number of years of experience after obtaining a doctoral degree. Compare Pet. 12, with Prelim. Resp. 47, and Resp. 19–20; see also DI 7–8. Under either proposed definition, the ordinarily skilled artisan would have been very highly skilled and educated. For purposes of this Final Decision, we maintain that Patent Owner’s definition appears to be reasonable (and it falls between Petitioner’s two definitions asserted in the reexamination request and in the Petition). Further, Patent Owner’s proposed definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent itself, for example, Vilkin’s authors are a group of medical doctors and an editor of the journal is a PhD, Joost Louwagie, the named inventor of the ’781 patent, holds a PhD in Biochemistry, and the authors of Itzkowitz are medical doctors and PhDs. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)); see Ex. 1005, 3 (list of authors); Ex. 1016 (Dr. Louwagie profile); Ex. 1055; see also generally Reply (Petitioner did not contest our similar determination at Institution). Therefore, we adopt and use Patent Owner’s definition of the ordinarily skilled artisan, set forth above. C.” slip op. at 13

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner asserts that no claim construction is necessary in this proceeding. See generally Pet. Similarly, Patent Owner states that it “does not believe that claim construction is necessary to resolve patentability” in this proceeding. Resp. 21. “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We agree with the parties that no construction of any claim term is necessary for purposes of our Final Decision. D.” slip op. at 14

  • Expert testimonyOther

    “Pet. 12. In support of these grounds for unpatentability, Petitioner relies on, inter alia, the 1st and 2nd Declarations of Duncan Whitney, PhD. Ex. 1002; Ex. 1080. In support of its positions, Patent Owner relies on, inter alia, the 1st and 2nd Declarations of Vadim Backman, PhD, and the Declaration of Peter Wood. Ex. 2001; Ex. 2022; Ex. 2023.” slip op. at 10

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “We have no reasonable doubt that aspects of the Cologuard product practice the invention of the ’781 patent’s claims 1 and 3, which are most generally directed to steps of collecting two portions of a fecal sample at home, and combining a respective buffer stabilizer/preservative with each of the two portions for claim 1, and then processing those fecal samples by testing for blood and nucleic acids (e.g., DNA) for claim 3. These appear to be nearly the most basic steps for using the Cologuard kit. See generally Ex. 2032. And, these steps do illustrate a certain ease of use and consumerfriendliness that may be a contributing factor in Cologuard’s success. See, e.g., Ex. 2022 ¶¶ 140–142, 155, 158–159, 170–171.” slip op. at 25

  Patent outcomesUS 11,634,781 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,634,781

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.