- PTAB · Aug 30, 2024 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Remand
On remand, the Board instituted inter partes review of claims 1–17, 20–21, 24–26, and 29–34 on all grounds stated in the Petition.
RulingsRemand decision- Director reviewOther
“Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17 (“Inst. Dec.”). Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel. Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Director Review Panel (“DRP”) vacated our decision and remanded the case to this panel with a revised construction for claim 1. Paper 23 (“DRP Dec.”).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect (2018). Upon reconsideration of the briefing and the evidence of record in light of the DRP’s claim construction, we conclude that Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable. Accordingly, we grant institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We find that Petitioner has demonstrated a material error by the Office in the prior consideration of Morales-Sanfrutos, Straus, Singh, and Lees. For instance, under the second prong of Advanced Bionics, we consider “(c) the extent to which the asserted art was evaluated during “(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art.” Becton, Dickinson, 17–18. We agree with Petitioner that the Office overlooked Morales- Sanfrutos’ and Singh’s teachings during examination and reexamination. Pet. 79. Although Morales-Sanfrutos, Straus, and Singh were listed on an IDS, they were not the subject of a rejection during examination or reexamination. Moreover, for the reasons discussed below at this stage with regard to Petitioner’s grounds over Morales-Sanfrutos, as evidenced by Straus, and over Singh, Petitioner sufficiently demonstrates that the Office materially erred in overlooking Morales-Sanfrutos’s and Singh’s teachings regarding their linker structures. Id. Further, to the extent the Lees’ teachings were considered during examination and reexamination, Lees’ disclosure of a homobifunctional sulfone linker was overlooked. Lees’ homobifunctional linker, which Patent Owner argues is substantially similar to Harris’ homobifunctional linker, which Petitioner chiefly relies upon in Grounds 2–5, was not the subject of a rejection during examination. Pet. Resp. Brief 1; Prelim. Resp. 25–26. We agree with Petitioner that only Lees’ heterobifunctional linker was applied in a rejection during examination. Pet. Resp. Brief 1; Ex. 1018, 42–43, 62. 4. Conclusion For the foregoing reasons, we decline to exercise discretion to deny institution under § 325(d).” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the (prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we apply Petitioner’s unopposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision
The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28
- ExcludeMotion to exclude, deniedDenied
“All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49
- Strike new argumentNew argument consideredDenied
“On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46
§ 112 disclosurePatents in suitUS 11,091,507 - PTAB · Oct 1, 2015 · IPR2014-00714 · APJ Kevin W Cherry · IPR · Final written decision
The Board canceled claims 11, 74, and 81 and denied substitute claims 154–156 because they broadened claim scope, lacked written-description support, and were not shown patentable over Mostov.
RulingsFinal written decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“A petition for inter partes review must identify “all real parties in interest.” 35 U.S.C. § 312(a)(2). The Office Patent Trial Practice Guide provides guidance regarding factors to consider in determining whether a party is a real party in interest. 77 Fed. Reg. 48,756, 48,759–60 (Aug. 14, 2012). Considerations may include whether a non-party “funds and directs and controls” an IPR petition or proceeding. Id. at 48,760. Additional relevant factors include: the non-party’s relationship with the petitioner; the non-party’s relationship to the petition itself, including the nature or degree of involvement in the filing; and the nature of the entity filing the petition. Id. Generally, a party does not become a “real party-in-interest” merely through association with another party in an unrelated endeavor. Id. A party also is not considered a real party in interest in an inter partes review solely because it is a joint defendant with a petitioner in a patent infringement suit or is part of a joint defense group with a petitioner in the suit. Id. Whether a party who is not a named participant in a given proceeding is a “real party-in-interest” to that proceeding “is a highly fact-dependent question.” Id. at 48,759. There is no “bright line test.” Id. Courts invoke the term “real party-in-interest” to describe relationships and considerations sufficient to justify applying conventional principles of estoppel and preclusion. Id. Here, even assuming this contention is timely, Patent Owner has failed to provide any evidence, besides the mere fact that the other parties are co-defendants in a lawsuit or alleged infringers, to support the contention that Petitioner has failed to name all of the real parties in interest. That one fact, without any further proof of control or involvement by these parties in this proceeding, is insufficient to establish that Petitioner has failed to name” slip op. at 11
- Expert testimonyPetitioner expert creditedDecided for petitioner
“ii. Petitioner’s Expert Patent Owner asks that we “dismiss [Petitioner’s] Expert Declaration and disqualify [Petitioner’s Declarant] for making and using a false writing.” PO Resp. 9. Patent Owner contends that Petitioner’s Declarant falsely claimed that certain patent applications were patents by listing them under the heading “Patents” in his Resume. Id. at 8–9. A Patent Owner Response is not the proper vehicle to seek to exclude testimony. See 37 C.F.R. § 42.64(c). Moreover, even if it were the proper vehicle, we are not persuaded that the alleged “falsehood” that Patent Owner identified—listing patent applications, which are clearly identified as such, under a heading titled “Patents”—is, in any way, misleading. Thus, we decline Patent Owner’s request that we dismiss Dr. Vishwanath’s testimony.3 C. Motion to Amend As discussed above, in the Motion to Amend, Patent Owner requests” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“i. Level of Ordinary Skill in the Art Neither party puts forward a succinct definition of the level of ordinary skill in the art. Petitioner’s declarant, however, has put forward a detailed discussion of various references dated before April 20064 (the date Patent Owner now alleges is the priority date) related to subject matter of the ’990 patent. See Ex. 1005 ¶¶ 20–74, 94–99. We have reviewed that discussion and the references cited in those paragraphs. We have found it accurately reflects the teachings of the references. Moreover, we agree with Petitioner’s declarant that the references are analogous to the claimed invention, and, as such, represent the level of skill in the relevant art at the time of the invention. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (finding that the Board did not err in concluding that the level of ordinary skill was best determined by the references of record); In re Oelrich, 579 F.2d 86, 91(CCPA 1978) (“[T]he PTO usually must evaluate . . . the level of ordinary skill solely on the cold words of the literature.”); see 4 We accept this date as the priority date only for the sake of argument. also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown.”’).” slip op. at 13
- ScopeMotion to amend, deniedDenied
“We agree with Petitioner and find, based on the Patent Owner’s own arguments, that these terms improperly broaden the scope of the claims. As Patent Owner explains, the added language is broad enough to include the removed items, and is intended to reflect the entire genus of “monitoring equipment” and “communications devices” that “are capable of communication and capable of receiving signals.” Mot. to Amend 4, 5. Thus, the claim has been broadened to not only include the listed species that have been removed, but anything falling within the claimed genus. Accordingly, we find that this amendment impermissibly broadens the claim. As for the second change in the claim language, we find that Patent Owner has failed to show why removal of the entire passage “wherein, the communication device receives a signal via any of one or more products listed in any of the plurality of product grouping categories,” would not impermissibly broaden the scope of claim 154. The deletion of this limitation necessarily broadens the claim in that limitation’s aspect. See In re Clement, 131 F.3d 1464, 1468 (Fed. Cir. 1997) (“For example, a reissue claim that deletes a limitation or element from the patent claims is broader in that limitation’s aspect.”). Given that Patent Owner has entirely deleted this limitation and Patent Owner bears the burden of showing entitlement to the amendment, it was incumbent on Patent Owner to explain why removing this entire passage from claim 154 would not broaden the scope of the claim. See In re Bennett, 766 F.2d 524, 526 (Fed. Cir. 1985) (en banc) (“[A] claim is broadened if it is broader in any respect than the original claim, even though it may be narrowed in other respects.”).” slip op. at 17
§ 102 anticipation - PTAB · Mar 16, 2015 · IPR2014-01110 · APJ Rama G Elluru · IPR · Order
The Board granted the parties’ joint motion and terminated the proceeding without a final written decision on the challenged claims.
RulingsOther- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“I. DISCUSSION On March 10, 2015, the parties filed a Joint Motion to terminate this proceeding (Paper 13), as well as a Joint Request (Paper 14) to have their settlement agreement treated as business confidential information under 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c). The parties also filed a true copy of their settlement agreement. Ex. 2011. The parties indicate in their Joint Motion that termination of this proceeding is appropriate because they have reached an agreement regarding their dispute with respect to this inter partes review. See Paper 13, 1. The parties indicate that they have agreed to move to dismiss the related district court litigation involving the ’183 patent. Id.” slip op. at 1
NonePatents in suitUS 8,474,183 - PTAB · Nov 24, 2014 · PGR2014-00010 · APJ Jon B Tornquist · PGR · Order
The Board granted the parties’ joint motion and terminated PGR2014-00010 without a final decision; it also granted confidential treatment of the settlement agreement.
RulingsOther- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“Patent Owner’s preliminary response is not yet due. On November 20, 2014, the parties filed a joint motion to terminate the proceeding (Paper 7) and a copy of their written settlement agreement (Ex. 2001). Along with the motion to terminate, the parties also filed a joint motion to treat the settlement agreement as business confidential information and keep it separate from the file of U.S. Patent No. 8,598,219 (“the ’219 patent”) pursuant to 35 U.S.C. § 327(b) and 37 C.F.R § 42.74(c). Paper 8, 1.” slip op. at 2
NonePatents in suitUS 8,598,219 - PTAB · Nov 18, 2014 · IPR2014-00116 · APJ Jacqueline Wright Bonilla · IPR · Order
The Board granted the parties’ joint motion to terminate the proceeding following settlement.
RulingsOther- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“On November 14, 2014, pursuant to 35 U.S.C. § 317(a), the parties filed a Joint Motion to terminate this proceeding. Paper 30. Accompanying the Motion, the parties filed a true copy of a settlement agreement along with a Joint Request to treat the settlement agreement as business confidential, to be kept separate from the patent file under 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74. Ex. 2017; Paper 31. We authorized the filing of these papers during a conference call conducted November 12, 2014. Paper 29.” slip op. at 2
NonePatents in suitUS 8,288,745 - PTAB · Oct 28, 2014 · IPR2013-00266 · APJ Christopher L Crumbley · IPR · Final written decision
The Board denied entry of substitute claims 20–26 as obvious, and granted cancellation of challenged claims 1, 2, 4, 11, 12, 17, 18, and 19.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner
“1. the cleavable linker and the protecting group are cleavable under identical conditions Proposed substitute claim 20 recites, inter alia, “a base that is linked to a detectable label via a cleavable linker,” a “protecting group attached via the 3' oxygen atom” of the nucleotide, and a step of “removing the label and the protecting group of the nucleotide . . . under a single set of chemical cleavage conditions.” Mot. 2 (emphasis added). These limitations are similar to those present in original claim 1, which we construed in our Decision on Institution. Specifically, we construed removal of the label and the protecting group under a single set of conditions “to mean what its plain language indicates: removal of the label and the protecting group under a single set of conditions.” Dec. 6. Neither of the parties contested this construction subsequent to institution, and we discern no reason to modify our initial construction for the purposes of this decision. Proposed claim 20 also requires that the cleavable linker comprise a disulfide linkage, but does not specify the protecting group. Thus, “a single set of chemical cleavage conditions,” under the broadest reasonable interpretation standard, limits the structure of the protecting group to one which can be cleaved under the same conditions as a disulfide linkage, but does not require a specific structure, such as a disulfide linkage.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for patent owner
“Illumina was essentially 100%. This is a significant and unexpected improvement over the disulfide cleavages of Ruby (~86%) and Herman (87%).” Ex. 2004 ¶ 84. There is no testimony, however, that the stated results were due to the claimed nucleotide rather than the reducing agent. While Dr. Romesberg refers to the “disulfide cleavage yield” as being unexpected, he does not testify that this yield was attributable to the claimed nucleotide configuration, rather than the reducing agent which performs the disulfide bond cleavage. Illumina has not distinguished the Vermaas results from the prior art by showing that the nucleotide is responsible for the disulfide yield, rather than it being a property of the disulfide bond and the yield being “the mere recognition” of the bond’s “latent properties,” which “does not render nonobvious an otherwise known invention.” Baxter, 952 F.2d at 392; In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997). Absent such evidence, Illumina has not shown that the claimed subject matter possesses “unexpected results relative to the prior art.” Galderma Labs., LP v. Tolmar, Inc., 737 F3d 731, 738 (Fed. Cir. 2013). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416.” slip op. at 28
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“After considering all the evidence as a whole, we conclude that Illumina has not met its burden in showing that the proposed substitute claims are patentable over the prior art considered in this Decision. The Motion to Amend is DENIED to the extent that it requests entry of substitute claims 20–26.” slip op. at 28
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,158,346 - PTAB · Sep 17, 2014 · IPR2014-00315 · APJ Lora M Green · IPR · Order
The Board granted the parties’ joint motion and terminated the proceeding after settlement; the petitioner withdrew its rehearing request.
RulingsOther- RehearingOther
“We note that we denied institution of inter partes review on July 8, 2014. Paper 14. Petitioner, however, filed a Request for Rehearing Pursuant to 37 C.F.R. § 42.71 of our decision not to institute trial, and that Request has not yet been decided. Thus, the possibility that trial may be instituted still remains. Petitioner also withdraws its Request for Rehearing in view of the joint motion to terminate. Based on the facts of this case, it is appropriate to enter judgment.2 Therefore, the joint motion to terminate the proceeding is GRANTED.” slip op. at 2
NonePatents in suitUS 8,318,738 - PTAB · Jul 25, 2014 · IPR2013-00128 · APJ Richard M Lebovitz · IPR · Final written decision
The Board granted cancellation of claims 1–8 but denied entry of substitute claims 9–12 because Illumina did not show they were patentable over the prior art.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“[l]abeling moieties are favorably in communication with or coupled to nucleotides via a linker of sufficient length to ensure that the presence of said labeling moieties on said nucleotides will not interfere with the action of a polymerase enzyme on said nucleotides.” Ex. 2015, p. 32, ll. 10-13. Rabani specifically mentions disulfide linkages as useful when a cleavable linker is desired: Linkages comprising disulfide bonds within their length have been developed to provide for cleavability24; reagents comprising such linkages are commercially available25 and have been used to modify nucleotides26 in a manner which may be conveniently reversed by treatment with mild reducing agents such as dithiothreitol. Id. at p. 32, ll. 29-33. Footnotes 24 and 26 of the above quoted passage cite to Ruby, S.W. et al. (1990), Methods in Enzymology, 181:97, which is Exhibit 2016. Id. at 49. Footnote 25 references “for example, from Pierce Chemical Co., [ ] of Rockford, IL., U.S.A.” Id. Rabani, therefore, would have given a skilled worker reason to have used a cleavable linker with a disulfide bond to ensure that the labeling moieties on the nucleotides will not interfere with the action of a polymerase enzyme during the synthesis reaction. Church IBS cited Church as evidence of the obviousness of using a disulfide linker in a sequencing reaction. Paper 53, 2. Church provides another example of the use of a disulfide linker to attach a label to base of a nucleotide, further establishing its conventionality at the time of the invention. Ex. 1031, 17:10-18, 68:12-21. Church describes a working example in which a label was attached to a nucleotide base using a disulfide linker and then cleaving it off with DTT. Id. at 86:6-30. slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner
“Secondly, the cleavage agents are different. The cleavage agent used in Ruby is DTT (Ex. 2016, 10, “Elution buffer” A and B) and in Herman, the cleavage agent is described as “a reducing agent such as DTT” (Ex. 2017, col. 7, ll. 47-48) with DTT being used in its example (id. at col. 10, ll. 47-54, col. 11, ll. 11-22; col. 12, ll. 3-8). Mr. Vermaas describes an experiment that utilized another cleavage agent, 2 mM tris- (hydroxymethyl)phosphine. Ex. 2028 ¶ 10. Illumina did not offer an explanation as to why the phosphine compound was used instead of DTT as used by both Ruby and Herman. Indeed, Church used DTT in a DNA sequencing reaction, similar to the sequencing carried out in the Vermaas experiments, providing an additional reason to have used DTT in Dr. Varmaas’s comparison to the prior art. Ex. 1031, Fig. 5; 68, ll. 12-13; 86, ll. 20-23. There is no testimony that the stated results were due to the claimed nucleotide rather than the reducing agent. Dr. Romesberg testified: “Therefore, the disulfide cleavage yield achieved by Illumina was essentially 100%. This is a significant and unexpected improvement over the disulfide cleavages of Ruby (~86%) and Herman (87%).” Ex. 2009 ¶ 74. Dr. Romesberg refers to the “disulfide cleavage yield” as being unexpected, but he did not testify that this yield was attributable to the claimed nucleotide configuration, rather than the reducing agent which performs the disulfide bond cleavage. Illumina has not distinguished the Vermaas results from the prior art by showing that the nucleotide is responsible for the disulfide yield, rather than it being a property of the disulfide bond and the yield being “the mere recognition” of the bond’s “latent properties,” which “does not render nonobvious an otherwise known invention.” Baxter, 952 F.2d at 392; In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997). Absent such evidence, Illumina has not shown that the claimed subject matter possesses “unexpected results relative to the prior art.” Galderma Labs., LP v. Tolmar, Inc., 737 F3d 731, 738 (Fed. Cir, 2013).” slip op. at 28
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“Patent Owner bears the burden of proof to establish that it is entitled to the relief requested in the Motion to Amend. 37 C.F.R. § 42.20(c). Patent Owner, therefore, bears the burden of showing the patentability of the amended claims. Patent Owner must show that the conditions for novelty and non- obviousness are met for the prior art available to one of ordinary skill in the art at the time the invention was filed, not just the prior art cited in the Petition. See Idle Free Sys., Inc. v. Bergstrom, Inc., Case IPR 2012-00027, slip op. at 7 (PTAB June 11, 2013) (Paper 26). Also, a motion to amend “must include a claim listing, show the changes clearly, and set forth: (1) The support in the original disclosure of the patent for each claim that is added or amended.” 37 C.F.R. § 42.121(b)(1).” slip op. at 6
- ExcludeMotion to exclude, deniedMixed
“characterizations of Figure 6 from Ex. 1031, and all arguments based on it be excluded as evidence from this inter partes review. Illumina argues that the Figure should be excluded “because it includes poor quality black and white reproductions of images that do not accurately reflect the original underlying data.” Paper 70, 1. We agreed with Illumina that the figure of Church is of poor quality and gave it no weight. We, therefore, did not rely on Figure 6 of Church in reaching our decision. Accordingly, Illumina’s motion is dismissed as moot.” slip op. at 29
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,057,026 - PTAB · Jul 21, 2014 · IPR2013-00429 · APJ Lora M Green · IPR · Order
The Board granted the parties’ joint motions, terminated the proceedings under 37 C.F.R. § 42.72 without a final written decision, and granted the request to seal the settlement agreement.
RulingsOther- Adverse judgmentAdverse judgmentGranted
“2014. Papers 9, 8, and 9. The briefing and discovery processes have not been completed in these proceedings, and the panel has not yet decided the merits of the proceedings. The parties have identified other related matters involving the patents at issue between Alcon Research, Ltd. (“Alcon”), and other parties, but indicate that there are no other related proceedings between the Patent Owner, Alcon, and Petitioner, Apotex Corp., and the patents at issue in these proceedings. Papers 57, 2; 55, 2; and 55, 2. Under these circumstances, we determine that it is appropriate to enter judgment3 and terminate the trials without rendering a final written decision. 37 C.F.R. § 42.72. It is, therefore, ORDERED that the joint motions to terminate the proceedings are GRANTED and the proceedings are hereby terminated; 2 The listed paper numbers refer to the paper numbers of the proceedings in numerical order, that is, the first paper number is the paper number in IPR2013-00428, the second paper number is the paper number in IPR2013- 00429, and the third paper number is the paper number in IPR2013-00430. 3 A judgment means a final written decision by the Board, or a termination of a proceeding. 37 C.F.R. § 42.2” slip op. at 2
NonePatents in suitUS 8,323,630
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.