- 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 · KSRPatents in suitUS 10,792,370 - Gettattle, Inc. v. Afterwords, Inc.InstitutedPTAB · 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 PhillipsPatents in suitUS 10,430,811 - Front Line Medical Technologies, Inc. v. Prytime Medical Devices, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,857,737 - Xencor, Inc. v. Merus N.V.InstitutedPTAB · 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 · GrahamPatents in suitUS 11,926,859 - Xencor, Inc. v. Merus N.V.InstitutedPTAB · 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 PhillipsPatents in suitUS 9,358,286 - PTAB · Sep 19, 2025 · PGR2025-00025 · APJ Kimberly Mcgraw · PGR · Institution
The Board instituted PGR on claims 1–19 and all asserted grounds, finding it more likely than not that claim 1 is anticipated by the Gatorade Label.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 determine that Petitioner has shown that the ’422 Patent is eligible for post-grant review and has shown it is more likely than not that at least one challenged claim of the ’422 Patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of the challenged claims of the ’422 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would possess at least (1) a Bachelor’s degree in chemistry or a related field, with (2) five years of experience in material identification and characterization using multiple analytical methods and field sampling, or equivalent research or professional experience.” Pet. 12 (citing Ex. 1014 ¶ 24). Patent Owner does not dispute Petitioner’s definition for one of ordinary skill in the art nor provide a proposed definition of its own. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed proposal regarding the level of one of ordinary skill in the art.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“336. The applicant explained that not all combinations of shrink films and light blocking materials are recyclable. Id. at 335. The applicant explained that films can be compatible with PET recycling in two ways, (1) the film can float in water and be separated from PET that sinks in water or (2) the PET films crystallize and “can be recovered with the PET stream.” Id. at 336 (citing “A Resource Document by the Association of Plastic Recyclers (APR)”) (found at Ex. 1002, 323–332) (emphasis omitted). The applicant explained that “removing the label before or during the recycling process is not evidence of the recyclability of the label” and that “[r]emoving the label during the recycling process is not equivalent to actually recycling the label.” Id. at 335. As such, a POSITA reading the prosecution history would understand that a label is not recyclable with a PET container, as recited by the independent claims, by removing the label from the PET recycle stream before or during the recycling process.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“To determine how a person skill in the art would determine if a shrink label is “recyclable” as recited in the independent claims, we look to how the Specification of the ’422 Patent describes or defines recyclable shrink labels. For example, the ’422 Patent states that PET shrink films are generally considered recyclable if no inks are retained on the film after a caustic wash cycle typically used in PET reclaiming processes. Ex. 1001, 6:61–65. The ’422 Patent further states that labels are fully recyclable if the polymers used are clear, preferably clear PET, and the labels include inks that can be washed off in a “typical PET recycling wash (caustic wash).” Id. at 11:44– 49; see also id. at 11:49–54 (describing embodiments in which the labels are free or substantially free of inks that cannot be washed off in a caustic wash or where the labels are free or substantially free of color plastics that cannot be recycled). The ’422 Patent further discusses “industry standards” for determining whether various embodiments of shrink labels are recyclable. See, e.g., id. at 11:29–53. For example, the Specification states that the “Association for Plastic Recyclers (APR) Critical Guidance Protocol for Clear PET Articles with Labels and Closures (PET-CG-02)” (Ex. 1005) can certify that a film is fully recyclable with a container or bottle. Id. at 11:34– 38. Additionally, the Specification states that labels “are recyclable according to the Evaluation of the Near Infrared (NIR) Sorting Potential of a Whole Plastic Article (SORT-B-01)” (Ex. 1010) and/or the “Evaluation of Sorting Potential for Plastic Articles Utilizing Metal, Metalized, or Metallic Printed Components (SORT-B-03)” (Ex. 1011). Ex. 1001, 11:39–44. The ’422 Patent further states that embodiments of the labels “are fully recyclable. For example, the labels may include inks that can be washed off in a typical PET recycling wash (caustic wash) and the polymers” are preferably clear PET. Id. at 11:44–48. The ’422 Patent thus provides various descriptions or standards to determine the recyclability of shrink labels. For the purposes of addressing the anticipation and obviousness grounds, we determine that any of these standards can be used to determine if a shrink label is “recyclable.” We note that our construction is preliminary and is based on the present record. We invite the parties to further the address the construction of “wherein the recyclable shrink label is recyclable with a PET container” during trial.” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 11,961,422 - Champion Laboratories, Inc. / First Brands Group, LLC v. Hengst SENo claims unpatentablePTAB · Sep 8, 2025 · IPR2024-00603 · APJ Sheldon M Mcgee · IPR · Final written decision
Claims 1, 3, 5, 8–11, 15–17, 19, 23–25, and 28–30 were not shown unpatentable over Yokoyama, Yokoyama and Cline, or Honermann and Cline.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“On this record, we determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–64 (Fed. Cir. 1985))). Because the level of ordinary skill in the art is not in dispute, and because the parties’ definition is consistent with the disclosures in the ʼ203 patent, the prior art, and the declaration testimony of Mr. Nranian and Dr. Basirat, we view the prior art and arguments through this lens when determining whether the claims are unpatentable as obvious over the prior art.5 See Graham, 383 U.S. at 17 (identifying “the level of ordinary skill in the pertinent art” as an underlying factual inquiry to be resolved in deciding obviousness, which is a question of law).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Although the parties spend significant portions of their briefing discussing the term “eccentric” and how it applies to certain figures from the ʼ203 patent and the relied-upon prior art, we determine that it is not necessary to expressly construe the term “eccentric” beyond the parties’ agreed-upon definition. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Rather, we adopt Patent Owner’s proffered definition because it is consistent with the intrinsic record and because it is not in dispute. Specifically, Patent Owner asserts that the plain meaning of the term “eccentric” is defined as “located elsewhere than at the geometric center; also: having the axis or support so located.” PO Resp. 18–19 (citing the Merriam-Webster online dictionary definition of the term “eccentric” for support). Petitioner agrees with this definition. Pet. 35 (asserting that certain prior art elements are eccentric “because they are not located at the center of the filter insert or housing”); Pet. Reply 9 (arguing that certain elements are eccentric because they “do not have an axis located at the geometric center”); id. at 10 (arguing the eccentricity of an element that does “not have an axis in the center” which has “an off-center axis”); see also Ex. 2017 ¶ 33 (Dr. Basirat testifying that “[a] POSITA would understand that ‘eccentric’ in the context of [the] ʼ203 patent, means that central axis is located elsewhere than at the geometric center [and] not placed centrally or not having its axis or other part placed centrally”). The parties’ definition of “eccentric” is also consistent with the usage of the term in the ʼ203 patent. Ex. 1001, 10:23–31; Fig. 17.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Rather, we adopt Patent Owner’s proffered definition because it is consistent with the intrinsic record and because it is not in dispute. Specifically, Patent Owner asserts that the plain meaning of the term “eccentric” is defined as “located elsewhere than at the geometric center; also: having the axis or support so located.” PO Resp. 18–19 (citing the Merriam-Webster online dictionary definition of the term “eccentric” for support). Petitioner agrees with this definition. Pet. 35 (asserting that certain prior art elements are eccentric “because they are not located at the center of the filter insert or housing”); Pet. Reply 9 (arguing that certain elements are eccentric because they “do not have an axis located at the geometric center”); id. at 10 (arguing the eccentricity of an element that does “not have an axis in the center” which has “an off-center axis”); see also Ex. 2017 ¶ 33 (Dr. Basirat testifying that “[a] POSITA would understand that ‘eccentric’ in the context of [the] ʼ203 patent, means that central axis is located elsewhere than at the geometric center [and] not placed centrally or not having its axis or other part placed centrally”). The parties’ definition of “eccentric” is also consistent with the usage of the term in the ʼ203 patent. Ex. 1001, 10:23–31; Fig. 17.” slip op. at 14
- Expert testimonyPetitioner expert discountedDecided for patent owner
“(opining that “Patent Owner’s construction of ‘having an axis no located in a geometric center’ is too narrow”). Mr. Nranian’s Declaration testimony in this respect is not persuasive for several reasons. First, it is internally inconsistent. Compare Ex. 1016 ¶ 3 (criticizing the “axis” language in Patent Owner’s definition), with id. ¶¶ 9, 11 (relying on that very language to support an argument). Also, Mr. Nranian’s proposed definition of “eccentric” to merely mean “not located at the center” begs the question of what, precisely, is “the center”? Mr. Nranian does not persuasively explain how far a person of ordinary skill in the art would understand she could travel from the exact center point of an object and still be in “the center” of that object. See Tr. 10:13–19 (Judge McGee asking whether the center is “a miniscule point in the middle of [the] disc”); see also id. at 10:25–12:26 (Judge Weatherly highlighting the significant ambiguity in referring to something as in “the center”). Also, Mr. Nranian’s opinion is inconsistent with how the ʼ203 patent compares something that is “central,” i.e., “at the center,” and something that is “eccentrically” located. Ex. 1001, 7:13–14 (describing pipe nozzle 15 as “central”); id. at 8:53–56 (describing a “through hole” as “located in the center of the front panel 22” depicted in Figures 7 and 8); id. at 10:23–31 (describing return 12 as “in the center” and outlet 13 as “eccentrically thereto” in Figure 17). Patent Owner’s colorized and annotated Figure 7 is reproduced below: Patent Owner’s colorized and annotated version of Figure 7 of the ʼ203 patent illustrates “central pipe nozzle 15” in yellow passing through the “through hole” located in “the center” of front panel 22. PO Resp. 20. Significantly, pipe nozzle 15 and the through hole in panel 22 are both described as “central” and in “the center” but must have different diameters; otherwise, “central pipe nozzle 15” would not be capable of traveling through “through hole 22.” Ex. 1001, Fig. 7. Thus, the ʼ203 patent intrinsically bases whether an element is “central” or “in the center” on whether its axis is located at the geometric center. This is also illustrated in Figure 17 of the ʼ203 patent, reproduced below: Figure 17 of the ʼ203 patent illustrates filter housing 10 with return 12 “in the center . . . and, eccentrically thereto, the outlet 13 with the seat 14 for the blocking element 24.” Ex. 1001, 10:23–30. Finally, Mr. Nranian’s narrow interpretation of “eccentric”––which excludes the “having the axis or support so located” in the geometric center language––is at odds with the arguments it was proffered to support. Cf. Pet. Reply 9 (arguing that certain elements are eccentric because they “do not have an axis located at the geometric center”); id. at 10 (arguing the eccentricity of an element that does “not have an axis in the center” which has “an off-center axis”).” slip op. at 29
Patent outcomesUS 9,023,203 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 9,023,203 - Mastercard Incorporated / Mastercard International Incorporated v. Ov Loop, Inc.All claims unpatentablePTAB · Aug 7, 2025 · IPR2023-01289 · APJ James A Tartal · IPR · Remand
On remand, the Board maintained that claims 1–33 are unpatentable as obvious over Collinge, including claims 10–13 and 27–30.
RulingsRemand decision- RemandDecided for petitioner
“Decision which components of Collinge “the Board relied on for claim 10’s limitation ‘receiving [at the remote computer system] an authorization request to authorize the transaction from the POS terminal.’” Remand Order 3. The Order instructs: “[o]n remand, the Board shall consider Patent Owner’s arguments as to claims 10 and 27, and their dependent claims. Regardless of the Board’s disposition on remand, the Board should address Patent Owner’s arguments and explain more fully its findings as to claims 10 and 27.” Id. The Remand Order further states that “this case is remanded to the Board for consideration of the arguments made in Patent Owner’s DR Request” and that we “should point more specifically to where in Collinge the argued limitation is taught, if anywhere, and which components of Collinge satisfy the limitation, if any.” Id. As instructed, in this Decision we consider Patent Owner’s arguments raised in the DR Request as to claims 10 and 27, and their dependent claims.3 As explained in detail below, and consistent with our determination in the Final Written Decision, we conclude Petitioner establishes by 3 We consider the arguments presented in Patent Owner’s DR Request in the context of arguments presented in Patent Owner’s Response, as arguments on the merits may be considered waived unless presented in that Response. See Paper 16, 9 (explaining that “Patent Owner is cautioned that any arguments not raised in the response may be deemed waived”). a preponderance of the evidence that the subject matter of claims 10–13 and 27–30 of the ’171 patent would have been obvious over Collinge.4” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“Ex. 1011 ¶ 77. In short, although paragraph 77 of Collinge is cited in the Petition and addresses both issuer processing server 308 and acquirer processing server 312, Petitioner relies on and shows that issuer processing server 308 (not acquirer processing server 312) receives “an authorization request to authorize the transaction from the POS terminal,” as required by claim 10. Pet. 58–59; Pet. Reply 16–18; DR Req. Opp. 2–4. Furthermore, there is no dispute that in Collinge the “authorization process” is performed at issuer processing server 308 in response to a request it receives. Ex. 1011 ¶ 77 (“The issuer processing server 308 may then validate the application cryptogram”). Claim 10 requires “performing an authorization process” including “receiving an authorization request to authorize the transaction from the POS terminal” at the remote computer system. We recognize that acquirer processing server 312 facilitates receiving transaction information from the POS terminal and communicating an authorization request to the issuer processing server 308. See Ex. 1011 ¶ 77. It is merchant point-of-sale terminal 120, however, that transmits “the received payment information and any additional transaction information (e.g., transaction amount, merchant identifier, etc.) to the acquirer processing server 312,” so that “acquirer processing server 312 may then generate and submit an authorization request for the financial transaction” through payment network 124 to issuer processing server 308 for validation. Id. Thus, Petitioner shows that in Collinge the request received by the issuer processing server 308 is “from” the POS terminal, as required by claim 10. See Pet. 58–6-; Ex. 1011, ¶ 77, Fig. 7.” slip op. at 20
- Expert testimonyPetitioner expert creditedDecided for petitioner
“’095 Provisional, reproduced above). Reply 17–18 (citing Ex. 1009 ¶ 46, Fig. 7). We credit Dr. Fiske in this regard, who explains that “the functionality performed” in the components in the “Blue-Box Structures,” that is Collinge’s Cloud Systema and Issuer System, “share a ‘connection 178’ therebetween,” as shown in Figure 7 of the ’095 Provisional. Ex. 1050 ¶ 43. We also considered Dr. Easttom’s opinion that Collinge’s Cloud System 110 and Issuer System 108 (see Ex. 1011, Fig. 7) are not one computer system because, in his view, each item “is (one or more) separate systems that operated independently from the others.” Ex. 2009 ¶ 150; see also PO Resp. 36–37 (arguing that Petitioner presents “no evidence” to show that allegedly “distinct” components are part of one remote computer system). We find Dr. Easttom’s opinion untenable because it is contrary to the express disclosure of Collinge, which demonstrates that, rather than operating “independently,” Cloud System 110 and Issuer System 108, and specifically remote-SE system 110 and issuer processing server 308, are connected and operate together through that connection, remotely from the mobile device. The Final Written Decision expressly agrees with and adopts Petitioner’s contentions with regard to claim 10, and we maintain that position here. See FWD 56–59.” slip op. at 26
Patent outcomesUS 10,032,171 unpatentable§ 103 obviousnessPatents in suitUS 10,032,171 - Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,634,781 - PTAB · Jun 3, 2025 · IPR2025-00054 · APJ John G New · IPR · Institution
The Board instituted inter partes review of claims 1–16 on all petitioned grounds, finding a reasonable likelihood that claim 1 is obvious over Dohil.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Analysis After considering the as-yet uncontested evidence and arguments presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in proving that at least one challenged claim of the ’828 patent is unpatentable. In particular, because Petitioner has demonstrated a reasonable likelihood that at least claim 1 is rendered obvious over Dohil in view of the understanding of a person of ordinary skill in the art, as argued in Ground 1, we institute inter partes review with respect to claim 1. Furthermore, 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 ’828 patent, based on all of the 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 yesor-no institution choice respecting a petition, embracing all challenges included in the petition”)” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We determine that no express construction of any claim term beyond the definitions provided by the Specification and, in the absence of such definitions, the ordinary and customary meaning, as understood by a person of ordinary skill in the art at the time of the invention, is necessary for the purpose of rendering this Decision. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017); see also 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 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“appears to be consistent with the level of skill presented in the cited prior art. See, e.g., Exs. 1004–1007; 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 a medical doctor with a specialty in gastroenterology, and other individuals with expertise related to the above subjects,” as not reflecting the individual level of skill of a given skilled artisan. See 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). 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., another advanced degree, or its equivalent, in areas related to pharmaceutics, chemistry, biology, medicine, or a related discipline, and 2–3 years of experience in formulation development. Alternatively, a POSA would have a lesser degree in those fields, with at least five or more years of experience in formulation development.” slip op. at 7
Claim constructioncites Phillips · KSRPatents in suitUS 11,246,828
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.