- PTAB · Mar 29, 2024 · IPR2023-01439 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–7, 9–11, 24–26, 28, 29, 35, and 36 on all asserted §103 grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the Petition, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of the challenged claims of the ’803 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 17 (citing Ex. 1002 ¶¶ 15–16). We adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding 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 (Fed. Cir. 1985))).” slip op. at 6
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Claim Construction › Intrinsic evidence (Phillips canons) › Conventional terms ('about', 'substantially', 'a'/'an', 'configured to')Term construed petitioner constructionDecided for petitioner
“At this stage of the proceeding—and without a substantive response from Patent Owner—we determine Petitioner’s construction is consistent with the plain ordinary meaning of “about” and the intrinsic evidence. The claim recites that the carbon chain length of the bio-alkene is “about 5 to about 20 carbons atoms.” Ex. 1001, claim 1 (emphasis added). We agree with respect to the claimed range. See Cohesive Techs., Inc. v. Waters. Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (“When ‘about’ is used as part of a numeric range, the use of the word ‘about,’ avoids a strict numeric boundary to the specified parameter.”) (internal quotations omitted). In other words, the claim term “about 5 to about 20 carbon atoms” does not require precisely 5 to 20 carbon atoms. Moreover, we agree that a carbon atom in a compound is not divisible. Keeping these principles in mind, we find “about 5” at the lower end of the range encompasses a carbon chain length of 4 carbon atoms, and “about 20” at the upper end of the range encompasses a carbon chain length of 21. We also agree with Petitioner that the prosecution history of the related ’902 Application—which also claims the benefit of the ’985 Provisional and shares a virtually identical specification as the ’803 Patent— supports construing “about” to encompass one additional carbon atom, as evidenced by the amendment after allowance amending the term “carbon chain length of about 8 to about 20” to “carbon chain length of 7 to 20.” See Ex. 1006, 335 see also id. at 16, 23–63. Thus, the intrinsic evidence supports Petitioner’s construction and the plain ordinary meaning of “about.”” slip op. at 7
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,882,803 - 10x Genomics, Inc. v. President And Fellows Of Harvard CollegeInstitution deniedPTAB · Mar 7, 2024 · IPR2023-01299 · APJ Tina E Hulse · IPR · Institution
Denied institution on claims 1–12 because the Petition failed to address a disputed § 112(f) construction and the Fintiv factors favored discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“II. DENIAL UNDER 37 C.F.R. § 42.104(b)(3) Our rules require that a petition set forth “[h]ow the challenged claim is to be construed” and, “[w]here the claim to be construed contains a means-plus-function or step-plus-function limitation as permitted under 35 U.S.C. [§] 112(f), the construction of the claim must identify the specific portions of the specification that describe the structure, material, or acts corresponding to each function.” 2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat. 284, 287–88 (2011), amended 35 U.S.C. §§ 102 and 103, effective March 16, 2013. Because the ’303 Patent has an effective filing date after March 16, 2013, the AIA version of §§ 102 and 103 apply. Our decision, however, would be the same under either version. 3 Fan et al., US 10,829,814 B2, issued Nov. 10, 2020. Ex. 1005 (“Fan”). 4 Gunderson et al., Decoding Randomly Ordered DNA Arrays, 14 GENOME 870–77 (2004). Ex. 1007 (“Gunderson”). 5 Larsson et al., In situ detection and genotyping of individual mRNA molecules, 7 NAT. METHODS 395–97 (2010). Ex. 1008 (“Larsson”). 6 Bo U. Curry, US 8,765,642 B2, issued Jul. 1, 2014. Ex. 1009 (“Curry”). 37 C.F.R. § 42.104(b)(3). The Consolidated Trial Practice Guide7 (“CTPG”), which provides guidance to practitioners on our rules, further instructs that “[w]here claim language may be construed according to 35 U.S.C. § 112(f), a petitioner must provide a construction.” CTPG 45 (emphases added) (citing 37 C.F.R. § 42.104(b)(3)). The CTPG advises that a party “may choose to elaborate why § 112(f) should or should not apply to the limitation at issue.” Id. Notably, the CTPG warns that “[a] petitioner who chooses not to address construction under § 112(f) risks failing to satisfy the requirement of 37 C.F.R. § 42.104(b)(3).” Id.” slip op. at 7
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)Decided for patent owner
“Similarly, here, Petitioner asserts that the phrase “an error detection or correction system” is not governed by § 112(f) and that no construction is necessary. See Pet. 12 (“Solely for the purposes of this IPR, 10x applies Co- Plaintiff’s [(i.e., Vizgen’s)] interpretations of the 303 patent claims from the concurrent litigation.”); see also Ex. 2005, 7 (reciting Vizgen’s proposed construction: “This claim limitation is not governed by 35 U.S.C. § 112(f). No construction necessary”). Before the district court, however, Petitioner asserts that the claim phrase is subject to § 112(f), which the district court largely adopted.10 Ex. 1062, 34. Petitioner admitted the claim phrase was in dispute in the Joint Claim Construction Statement filed in district court. Ex. 2005, 4, 7 (identifying “an error detection or correction system” as a disputed claim term). Despite knowing the meaning of the claim phrase is in dispute, Petitioner did not offer a reasoned construction in the Petition. Thus, like the petitioner in Orthopediatrics, Petitioner should have provided reasons why the limitation is not governed by § 112(f) or provided an express construction of the claim phrase. See IPR2018- 01546, Paper 10 at 11. Because Petitioner has the burden to show a reasonable likelihood of prevailing in its assertion that at least one claim is unpatentable, our rules require that Petitioner substantively address any claim terms in dispute. Based on the circumstances presented here, by relying solely on Vizgen’s construction for “an error detection or correction system” that “no construction [is] necessary” without further explanation, Petitioner failed to satisfy its burden to set forth “[h]ow the challenged claim is to be construed.” 37 C.F.R. § 42.104(b)(3). Thus, we find the Petition is deficient on its face under 37 C.F.R. § 42.104(b)(3), as merely stating “no construction [is] necessary”—while knowing the construction is actually disputed under § 112(f)—is not sufficient for purposes of institution.” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“Given the coordinated schedule with the related cases, the prior denial of a motion to stay, and the lack of intent by either party to file a motion to stay, we agree with Patent Owner that it is unlikely the district court proceeding will be stayed. Thus, under the facts and circumstances of this case, we find this factor favors exercising our discretion to deny institution.” slip op. at 16
Claim constructionDiscretionary denialPatents in suitUS 11,098,303 - PTAB · Jan 31, 2024 · PGR2023-00043 · APJ Tina E Hulse · PGR · Institution
The Board instituted PGR of claims 1–22 on all petitioned grounds, finding at least one claim more likely than not unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has demonstrated that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Although Patent Owner’s definition of a POSA includes an additional four to six years of experience, we do not discern a substantive difference between the parties’ respective definitions for purposes of our analysis. Both definitions provide for a highly skilled POSA with experience in formulating drugs, and our Decision would be unchanged whether we applied Petitioner’s definition or Patent Owner’s. Nevertheless, on this record, we adopt Patent Owner’s definition as it is consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding 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 (Fed. Cir. 1985))). To the extent the parties dispute the level of ordinary skill and its impact on the analysis of the challenged claims, we encourage the parties to address this issue further during trial.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“We determine it is unnecessary to expressly construe any other claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Because Petitioner’s construction—with Patent Owner’s addition—is consistent with the Specification, we apply that construction of “enteric capsule” in this proceeding. See Ex. 1001, 39:22–26. We also note that Patent Owner appears to construe the claim phrase “the compound of Formula (III) is (Z)-endoxifen” to be limited to the free base form of (Z)-endoxifen. See, e.g., Prelim. Resp. 2 (“The ’334 patent claims enteric coated capsule formulations containing at least 90% (Z)- endoxifen free base, methods of delivering such formulations to a patient resulting in specific pharmacokinetic parameters, and methods of treating hormone-dependent breast and reproductive tract disorders.”) (emphasis added). The Specification, however, expressly states “‘a compound’, such as compounds of . . . Formula (III) . . . include the polymorphic salt, free base, co-crystal, and solvate forms of the formulas and/or compounds disclosed herein.” Ex. 1001, 12:48–52; see also id. at 12:52–59 (stating “‘compounds of Formula (III)’ . . . include . . . the free base of the compounds of Formula (III), and/or the gluconate salts as described herein”). To the extent there is any dispute as to the scope of “the compound of Formula (III) is (Z)-endoxifen” in the claims, the parties should address that construction at trial. For purposes of this Decision, we adopt the express definition set forth in the Specification. That is, we construe “the compound of Formula (III) is (Z)-endoxifen” to include the polymorphic salt, free base, co-crystal and solvate forms of (Z)-endoxifen. See Ex. 1001, 12:48–59.” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,572,334 - Twinstrand Biosciences, Inc. v. Guardant Health, Inc.No claims unpatentablePTAB · Jan 26, 2024 · IPR2022-01400 · APJ Michael A Valek · IPR · Final written decision
Claims 1–29 were not shown unpatentable over the asserted obviousness grounds because the prior-art combinations did not teach key limitations of claims 1, 17, and 29.
RulingsFinal written decision- BurdenNot shown unpatentable
“Having considered these arguments on the full trial record, we find Patent Owner has the better position because Petitioner’s showing that element 1(b) is taught by Schmitt is unpersuasive. We begin with Patent Owner’s argument concerning the distinction between the cfDNA molecules and the duplex tag comprising the molecular barcode found in the text of claim 1. Element 1(a) recites “a population of cell-free deoxyribonucleic acid (cfDNA) molecules.” Ex. 1001, 61:7–9. Element 1(b) recites “tagging a plurality of the cfDNA molecules in the population” of element 1(a) “with duplex tags comprising molecular barcodes to produce tagged parent polynucleotides . . . wherein the duplex tags are attached to both ends of a added). We agree with Patent Owner and credit the testimony of its declarant that this claim language distinguishes the duplex tags from the ends of the cfDNA molecule to which they are attached. Resp. 8; Ex. 2015 ¶¶ 38–39, 60, 61. That is, the duplex tag is not part of the cfDNA molecule itself, but rather is “attached to both the ends” of that molecule by “tagging” it as recited in element 1(b). We also agree with Patent Owner that given this distinction, claim 1 does not encompass Schmitt’s hybrid embodiment. Resp. 18–20. As Petitioner notes, “[i]n Schmitt’s hybrid-tag embodiment, the strands are grouped based on the combination of the short n-mer barcode and the end of the target DNA.” Pet. 11; see Resp. 17 (“[T]he combination of the endogenous shear sequence and exogenous 3-mer sequence together provide the SMI used for grouping and matching in Schmitt’s DCS process.”). Petitioner and its declarant illustrate the grouping in Schmitt’s hybrid embodiment with the following diagram. Pet. 12; Ex. 1002 ¶¶ 96–98. Petitioner’s diagram shows the PCR products produced from sequencing a “Target DNA” molecule that has been tagged with 3-mers X and Y according to Schmitt’s hybrid embodiment. See Ex. 1002 ¶ 98 (describing diagram). A portion of the endogenous sequence of the DNA molecule labeled L and R is used in combination with the 3-mer sequence to group the resulting strands into two families labeled the “X+L→R+Y Family” and the “R+Y→X+L Family.” Ex. 1002 ¶ 98; Ex. 2015 ¶ 62 (explaining that Petitioner’s diagram shows that “the relied upon hybrid SMI sequences of Schmitt include sequence from the sample DNA molecule not contained in the adapter or the duplex tags”). SMIs, differently label the strands and therefore are the recited “duplex tags.” See Pet. 27–28 (“duplex tags comprise both the fragment DNA end sequences and a shorter n-mer tag”) (emphasis added) (internal quotations omitted). However, we credit Dr. Quackenbush’s testimony that end sequences L and R are not “attached to both ends” of the cfDNA molecule by “tagging” it as recited in element 1(b). See Ex. 2015 ¶ 59–62 (explaining that Schmitt’s hybrid SMI sequences include a portion of the sample DNA molecule, which is “not contained in adapter molecules or duplex tags that are attached to the DNA molecules”). Rather, end sequences L and R are the pre-existing, endogenous ends of that molecule. Id. Thus, Petitioner’s theory of unpatentability does not account for the distinction the claim language draws between the cfDNA molecule and the duplex tags. Petitioner’s argument that the ’306 patent defines “duplex tag” as a” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“That is, although Meyer teaches that its particular protocol results in 40–60% tagging efficiency, Petitioner has not sufficiently explained why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, the Petition does not address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer tag (such as 1 or 2 or 3 or 4 or more degenerate or semi degenerate bases) in the adaptor.” Ex. 1083 ¶ 30. sticky-end adapter-DNA litigation to be even more efficient than Meyer’s blunt-end adapter-DNA ligation” is also unpersuasive. See Pet. 60–61. The KAPA data sheet discloses sticky-end adapter DNA ligation, but KAPA teaches that only 0.5 to 15% tagging efficiency is expected when the starting sample is 100 pg–100 ng of “high quality DNA.” Ex. 1015, 4. Thus, the KAPA data suggests that the use of sticky-end adapters, such as what Schmitt discloses, does not in and of itself teach or suggest the tagging efficiency limitations. Moreover, the record shows that tagging efficiency depends on a variety of other factors, including the quality of the input DNA. The KAPA data sheet states that tagging efficiency “can be significantly lower for DNA of lower quality.” Ex. 1015, 4. Fisher also explains that “the efficiency of adaptor ligation varies between samples, probably because of variation in input DNA quality.” Ex. 1031, 5–6. Petitioner’s argument that the DNA the KAPA data sheet refers to as “lower quality” is “from formalin-fixed, paraffin-embedded (‘FFPE’) samples (well known for having chemically damaged DNA)” is unavailing. See Reply 25–26 (citing Ex. 1098 ¶¶ 96–98). First, neither Petitioner, nor its declarant, address the similar teaching in Fisher. Second, even if the specific type of lower quality DNA in the KAPA data sheet is different, the salient point, i.e., that tagging efficiency depends on DNA quality, remains unrebutted. This is significant because Petitioner does not sufficiently address how the quality of the cfDNA of Narayan compares to the quality of the genomic DNA samples of Meyer and Schmitt or how that would affect the expected tagging efficiency. Petitioner’s assertion that “significant quantities of cfDNA could be isolated from blood samples” (see Reply 26), fact that a significant quantity of cfDNA could be obtained does not show that the quality of that DNA is similar such that a POSA using such would have expected to achieve a tagging efficiency similar to that in Meyer.” slip op. at 40
- Strike new argumentNew argument disregardedDenied
“We are not persuaded. First, this is an inappropriate new argument. The Petition presents a different mapping, alleging that the “duplex tag” comprises both the endogenous end sequence of the cfDNA molecule and the 3-mer barcode of Schmitt’s hybrid tag embodiment. Pet. 27 (“the duplex tags comprise both the fragment DNA end sequences and ‘a shorter n-mer tag’ to serve as ‘unique molecular identifiers’”) (quoting Ex. 1083 ¶ 30, Ex. 1002 ¶¶ 162–163); see also Tr. 62:13–63:19 (Petitioner’s counsel noting he was unaware of any explicit statement in the Petition that Schmitt’s duplex tag comprised just the 3-mer without the end sequence). Nor did Petitioner regarding element 1(b). See Reply 8–10. Rather, consistent with the mapping in the Petition, the Reply identifies “Schmitt’s hybrid tags,” i.e., the combination of the endogenous end sequence and the n-mer, as the duplex tags in element 1(b). See Reply 8 (urging that “duplex tags” are “tags that differently label the complementary strands,” which “is precisely what Schmitt’s hybrid tags do”). Because this argument was not previously presented, Patent Owner has not been afforded a sufficient opportunity to address it. Thus, Petitioner’s new argument excluding the end sequences in Schmitt’s hybrid tag embodiment from the alleged “duplex tags comprising molecular barcodes” has been waived. Second, even if we were to consider it on the merits, Petitioner’s new mapping for element 1(b) is inconsistent with Petitioner’s allegations for element 1(e). Element 1(e) recites “reducing or tracking redundancy” in sequence reads “using at least sequencing information from the molecular barcodes of the duplex tags to determine distinct cfDNA molecules.” Ex. 1001, 61:26–30. For these limitations, the Petition points to Schmitt’s grouping of reads into families based on their SMI and asserts that Schmitt determines distinct cfDNA molecules based on “the complementary nature of the SMI on the two strands of the duplex.” See Pet. 30–32 (internal quotations omitted). Thus, like Petition’s mapping for element 1(b), Petitioner’s allegations for element 1(e) rely on a duplex tag that includes both the 3-mer and the end sequence of the cfDNA molecule. Petitioner has not sufficiently explained, much less shown by a preponderance of the evidence, that Schmitt teaches or suggests the limitations in element 1(e) based on its new mapping of the 3-mer alone as duplex tags.” slip op. at 25
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Motion to exclude, deniedDenied
“We do not rely on any of these exhibits in rendering our decision on Petitioner’s grounds. Therefore, we dismiss as moot Petitioner’s motion to exclude Exhibits 1069, 1074, 1078, 1079, and 1085–1088.” slip op. at 46
Patent outcomesUS 11,149,306 not shown unpatentable§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,149,306 - Padagis Israel Pharmaceuticals Limited / Padagis US LLC et al. v. Bausch Health Ireland LimitedInstitution deniedPTAB · Jan 12, 2024 · IPR2023-01114 · APJ Michael A Valek · IPR · Institution
The Board denied institution of IPR challenging claims 1–11 because substantially the same art and arguments were previously considered, and Petitioner did not show material error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“factors. In the first part, we consider factors (a), (b), and (d) to determine whether the art or arguments presented in the petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, 8–10. “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office,” then we advance to the second part of the analysis to determine “whether the petitioner has demonstrated a material error by the Office” in view of factors (c), (e), and (f). Id. Advanced Bionics instructs that “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id. at 9.” slip op. at 12
Discretionary denialPatents in suitUS 11,311,482 - Guardant Health, Inc. v. University Of WashingtonAll claims unpatentablePTAB · Jan 11, 2024 · IPR2022-01158 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–28 are unpatentable because Eltoukhy anticipates them; the Board found they were not entitled to a priority date before Eltoukhy’s publication.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that an ordinarily skilled artisan “would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields.” Pet. 8–9 (citing Ex. 1002 ¶ 38). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 2 (citing Ex. 2023 ¶¶ 21, 22). After reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“1. “Sequence Reads” Petitioner argues that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 10–11. Petitioner, however, seeks to provide context for understanding the scope of the term “sequence reads.” Specifically, Petitioner contends that “sequence reads” are produced by sequencing at least some of the tagged strands, whereas “consensus sequences” are generated by collapsing sequence reads. Id. at 11 (citing Ex. 1001, 4:45–47, 20:50–22:25, 23:29–57, 24:46–48, claim 1, claim 6). In the Decision to Institute, we agreed with Petitioner that “[t]he claims of the ’951 patent as well as the specification make clear that a ‘sequence read’ is different and distinct from a ‘consensus sequence.’” DI 7 (quoting Pet. 11). Patent Owner does not dispute Petitioner’s assertion. PO Resp. 12. Based on the complete record, we see no reason to change our determination of the scope of the term “sequence reads.”” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“We disagree with Patent Owner’s proposed construction of the terms “paired sequence reads” and “unpaired sequence reads.” Even though the ’951 patent Specification discloses grouping sequence reads “sharing a unique set of SMI tags” into paired families,4 “[t]he written description part of the specification itself does not delimit the right to exclude. That is the function and purpose of claims.” Phillips, 415 F.3d at 1312 (“[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude.”). Here, claim 1 explicitly defines the terms “paired sequence reads” and “unpaired sequence reads.” Indeed, in the context of paired versus unpaired sequence reads, claim 1 specifies that the complementarity is related to the “original parent polynucleotide molecule,” and not the duplex tags. For example, claim 1 recites that “each unpaired read represents a first tagged strand having no second differently tagged complementary strand derived from an original parent polynucleotide molecule represented among said sequence reads in said set of sequence reads.” Ex. 1001, 37:50–55 (emphasis added). Thus, the plain claim language contradicts Patent Owner’s argument” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Claim 1 defines the terms “paired sequence reads” and “unpaired sequence reads” based on the complementarity of the target sequence strands derived from the “original parent polynucleotide molecule.” Ex. 1001, 37:46–55. As explained above, we reject Patent Owner’s contention that a sequence read is considered unpaired solely based on the complementarity of the SMI tags. See supra Section II.C.2. Due to the “errors introduced during sample preparation and sequencing” (Ex. 1029 ¶ 5), there are four outcomes when determining the complementarity of the sequence reads of two strands of SMI-linked target sequence: (1) the first SMI tag and the first strand target sequence are complementary to the second SMI tag and the second strand target sequence, respectively; (2) the first SMI tag is complementary to the second SMI tag but the first strand target sequence is not complementary to the second strand target sequence; (3) the first SMI tag is not complementary to the second SMI tag but the first strand target sequence is complementary to the second strand target sequence; and (4) the first SMI tag is not complementary to the second SMI tag, and the first strand target sequence is not complementary to the second strand target sequence. It is undisputed that Schmitt groups sequence reads into paired families based on the SMI tags, and Schmitt only considers sequences in which “information from both DNA strands was in perfect agreement.” Ex. 1029 ¶¶ 14, 96; PO Resp. 18. Thus, among the four outcomes, only scenario (1), in which both the SMI tags and the target sequences are complementary, represents a “paired sequence read,” which claim 1 defines as corresponding to “sequence reads generated from a first tagged strand and a second differently tagged complementary strand derived from an original parent polynucleotide molecule.” Ex. 1001, 37:46–50. Contrary to Patent Owner’s argument (see PO Resp. 26), in Schmitt,” slip op. at 18
Patent outcomesUS 10,752,951 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,752,951 - Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing grantedPTAB · Dec 20, 2023 · IPR2023-00050 · APJ Ulrike W Jenks · IPR · Rehearing
The Board granted rehearing and instituted IPR on claims 17, 19, 20, and 22–29 on all petitioned grounds, finding a reasonable likelihood of success and declining § 325(d) denial.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“II. STANDARD OF REVIEW A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was 1 US 7,888,328 B2, issued Feb. 15, 2011 (Ex. 1029, “Bodor”). 2 Rice et al., Cladribine and progressive MS: Clinical and MRI outcomes of a multicenter controlled trial, NEUROLOGY, 54(5):1145–1155 (2000) (Ex. 1008, “Rice”). addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Having reconsidered the record before us, we are persuaded that Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis by administering cladribine to a patient in the same claimed total amounts for both induction and the maintenance period to support Petitioner’s challenge to claim 17.” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Having considered the record, we agree with Petitioner that the Office erred in its evaluation of the cited art (now asserted) as required by Advanced Bionics. Advanced Bionics cautions that “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Paper 6, 9. Here, both Examiner and Patent Owner interpret Bodor to disclose administering the same dose of cladribine in both the induction and maintenance phase. Claim 17 encompasses administering the same dose of cladribine – 1.7 mg/kg – in both the induction and maintenance phase. By interpreting claim 17 as requiring a maintenance dose that is lower than the induction dose, we agree with Petitioner that Examiner misapprehended the scope of claim 17. We, therefore, decline to exercise our discretion to deny institution under § 325(d).” slip op. at 12
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“the claims. “All that is required is that the total dose reach a stated level in each period, and Bodor discloses a total dose within that range for what a person of ordinary skill in the art would understand to be an average patient.” Req. Reh’g 14 (emphasis omitted) (citing Pet. 42–50). Dr. Greenberg testifies that Bodor’s total dosage of cladribine ranges from 100–140 mg in the two-month treatment period. Ex. 1005 ¶ 104. The issue, as presented by Petitioner, is that the ’903 patent claims simply use a different way of reciting a total dose of cladribine administered during the treatment phase when compared to the methods and dosage taught by Bodor. We agree with Petitioner that the method and cladribine dosage in the ’903 patent claims overlap with the method and dosage taught by Bodor. To determine the total amount of cladribine administered as claimed in the ’903 patent requires knowledge of the weight of the patient. In the Petition, Petitioner relied on a patient weighing 70 kilograms (≈ 154 pounds) to be an acceptable average human weight as understood in the medical community. Pet. 32 (citing Ex. 1005 ¶ 105). Patients, however, come in all shapes and sizes as recognized in the ’903 patent disclosure and further supported by Dr. Greenberg’s testimony and referenced exhibit. See Ex. 1001, 3:8 (“patients of about 52 and about 75 kilos); see also Ex. 1005 ¶ 106 (“the average weight of individuals in the United States is higher than the global average, with an overall average weight (men and women combined) of roughly 177 lbs in 2002.”); Ex. 1030 (“the average weight for men aged 20-74 years rose dramatically from 166.3 pounds in 1960 to 191 pounds in 2002, while the average weight for women the same age increased from 140.2 pounds in 1960 to 164.3 pounds in 2002.”). To arrive at the average weight of 177 pounds means that there are patients in the population that are above and below that average. See generally Ex. 1030.” slip op. at 6
§ 103 obviousnessDiscretionary denialPatents in suitUS 8,377,903 - Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing grantedPTAB · Dec 20, 2023 · IPR2023-00049 · APJ Ulrike W Jenks · IPR · Rehearing
The Board granted rehearing and instituted IPR on claims 36, 38, 39, and 41–48 on all petition grounds, finding a reasonable likelihood of unpatentability and declining § 325(d) denial.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315– 16 (Fed. Cir. 2000).” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating multiple sclerosis by administering cladribine to a patient in the same claimed total amount for both the induction period and maintenance period to support Petitioner’s challenge to claim 36.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“To summarize, Bodor teaches two treatment regimens for treating multiple sclerosis with a cladribine-cyclodextrin complex. 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex . . . would be administered [orally] once per day for a period of five to seven days in the first month, repeated for another period of five to seven days in the second month, followed by ten months of no treatment. Alternatively the patient would be treated with 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex in the instant dosage form once per day for a period of five to seven days per month for a total of six months, followed by eighteen months of no treatment. Ex. 1029, 13:20–30. Petitioner acknowledges that Bodor does not explicitly suggest applying the same regimen again after a cladribine-free period but finds that repeating the treatment protocol is reasonably inferred. Pet. 33 (citing Ex. 1005 ¶¶ 109, 111–113), see id. at 48 (citing Ex. 1005 ¶¶ 168–170); Ex. 1029, 18:45–19:3, 20:1–20 (Examples 4 and 5 each describing that treatment days are separated by cladribine-free days); Ex. 1003 at 389; Ex. 1004 at 141. Bodor also teaches that the dosing regimen can be tailored to suit the needs of the patient. Specifically, Bodor teaches that “one of skill will appreciate that the therapeutically effective amount of cladribine administered . . . may be lowered or increased by fine tuning and/or by administering cladribine . . . with another active ingredient.” Ex. 1029, 13:31–35, see also id. 13:37–40 (“Therapeutically effective amounts may be easily determined . . . empirically by starting at relatively low amounts and by step-wise increasing with concurrent evaluation of beneficial effect.”). Based on these disclosures, we agree with Petitioner that it would be reasonable to infer from Bodor’s teachings in conjunction with the knowledge of the ordinary artisan that the cladribine dosing protocol in Bodor is repeated. Pet. 33; see also Ex. 1005 ¶¶ 109–123, 119 (“common practice in the industry when prescribing a second round of an” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“(1) [determining] whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, [determining] whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 9
§ 103 obviousnessDiscretionary denialPatents in suitUS 7,713,947 - PTAB · Dec 20, 2023 · IPR2023-01069 · APJ Robert A Pollock · IPR · Institution
The Board instituted review of claims 1–8 on all three §103 grounds, finding a reasonable likelihood that Petitioner would show the claims unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“and accompanying evidence under 35 U.S.C. § 314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We integrate the above considerations into the Advanced Bionics two- part framework in deciding discretionary denial under § 325(d), first considering Becton, Dickinson factors (a), (b), and (d) to determine whether the same or substantially the same art or arguments were previously presented to the Office, and if so, evaluating Becton, Dickinson factors (c), (e), and (f) to determine whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, 7–11.” slip op. at 58
- Other 314aDenied
“Patent Owner points to § 314(a)27 as a basis for denying institution but provides no substantive argument or evidence on this point. See Prelim. Resp. 2 (citation), 4 (citation), 15 (section heading), 31 (citation in parenthetical). At best, Patent Owner asserts that if we find “that fewer than all three Grounds meet the standard for Section 325(d), institution of Samsung’s petition should still be denied in full, because institution on all three Grounds ‘would not be an efficient use of the Board’s time and 27 Under certain circumstances, the Board may apply its discretion under § 314(a) to deny institution in light of a parallel district court proceeding involving the same patent. See, e.g., Apple Inc. v. Fintiv, Inc., IPR2020- 00019, Paper 11 (PTAB Mar. 20, 2020) (precedential). But as noted by Petitioner, the patent at issue here “has never been asserted in any litigation.” Pet. 63. 66 resources.’” Prelim. Resp. 31 (citing Deeper, UAB v. Vexilar, Inc., IPR2018- 01310, Paper 7 at 41–43 (PTAB Jan. 24, 2019) (informative)). Because we decline to exercise our discretion with respect to any of the Grounds under § 325(d), the Board’s Deeper decision is inapposite.” slip op. at 66
- Skill levelSkill level petitioner adoptedOther
“Patent Owner does not presently dispute this definition “except to clarify that the POSA would have at least two years of experience in engineering monoclonal antibodies for human therapeutic use, either in the laboratory or industry.” Prelim. Resp. 44–48 (emphasis omitted); see also id. at 48–49 (arguing that Petitioner cannot prove unpatentability of the challenged claims under either party’s definition). At this stage in the proceeding, we accept and apply Petitioner’s proposed definition of the skilled artisan, as being both unopposed by Patent Owner and inclusive of Patent Owner’s additional qualification. In this respect, it appears that Petitioner’s language “at least two years of experience in the discovery, development, and design of therapeutic antibodies for use as potential treatments in human disease” encompasses Patent Owner’s proposed modification, and is consistent with the level of skill in the art reflected in the prior art of record. 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)).” slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,590,189 - PTAB · Dec 19, 2023 · IPR2023-01070 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR of claims 1–29 on all twelve asserted obviousness grounds, finding a reasonable likelihood that at least one challenged claim would be shown unpatentable.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage in the proceedings, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, as being both generally unopposed by Patent Owner and inclusive of Patent Owner’s supplemental definition. It appears that Petitioner’s language “at least two years of experience in the discovery, development, and design of therapeutic antibodies for use as potential treatments in human disease” includes Patent Owner’s proposed level of experience. Pet. 17–18. We also take into account the level of skill in the art reflected in the prior art of record. 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)).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“For the purposes of this institution decision, we find it unnecessary to construe any claim language because it is readily understandable on its face and there is no dispute. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). As the case continues, we may determine that certain claim language should be interpreted.” slip op. at 17
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Petitioner, supported by the testimony of Dr. Ravetch, contends that Bowdish is analogous art. Pet. 36–37 (citing Ex. 1003 ¶ 128). In this respect, Dr. Ravetch testifies: A POSA looking for the amino acid sequences encoding eculizumab would have easily found Bowdish, and considered it to be analogous art to Bell and Evans for at least three reasons: (1) it provides express disclosures about the structure of the antibody “5G1.1,” (2) it identifies “Alexion Pharmaceuticals” as the inventors’ addressee that is the same as the assignee for Evans, and (3) it cites to the same Evans patent as does Bell for the structure of 5G1.1. Thus, a POSA would have been motivated to combine the teachings of Bowdish and Evans in view of Bell to arrive at the claimed sequence. Ex. 1003 ¶ 128. On the present record before us, it appears that Bowdish is both reasonably pertinent and within the same field of endeavor as the ’809 patent for the reasons identified by Dr. Ravetch, because it is directed to the construction of a humanized monoclonal antibody comprising a TPO mimetic peptide graft into the heavy chain CDR3 of antibody framework 5G1, and because it uses “the parental 5G1.1” sequence as a control for FACs analysis of the TPO mimetic antibody. See Ex. 1004 ¶¶ 191–193. Moreover, it is reasonable that an ordinarily skilled artisan seeking to understand the Alexion anti-C5 antibody disclosed in, for example, Bell or Hillmen or Hill as a treatment for PNH, would look to other Alexion prior art for guidance.” slip op. at 42
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation foundDecided for petitioner
“overarching argument that Petitioner’s positions are fatally flawed by hindsight or that “[a] POSA as of March 15, 2007[,] would have understood that Alexion had developed a humanized antibody named ‘eculizumab,’ . . . [b]ut a POSA at that time would not have known that “eculizumab” had the sequence claimed in the ʼ809 patent.” See Prelim. Resp. 4, 7, 9. It appears that Petitioner’s positions here consider only the disclosures of the prior art and how the person of ordinary skill in the art would have read prior art references in view of one another. Regarding Patent Owner’s foundational preliminary argument that all prior art pointed exclusively to Thomas for the structure of eculizumab, rather than to Evans or Tacken or Mueller PCT, for example, we are unconvinced. We find Patent Owner’s position mischaracterizes Bell’s incorporation of Thomas by wholly ignoring that, in the very same sentence, and preceding the cite to Thomas, Bell also incorporates Evans by reference. Ex. 1007 ¶ 52. Bell incorporates Evans as disclosing “[p]articularly useful anti-C5 antibodies . . . h5G1.1-mAb, h5G1.1-scFv and other functional fragments of h5G1.1,” and “[m]ethods for the preparation” of these. Id. It appears that the ordinarily skilled artisan, like Bell’s inventors, would not have looked solely to Thomas for eculizumab’s structure. Moreover, the ’809 patent itself states that Evans, which is a part of Bell, discloses “a preferred whole antibody (now named eculizumab),” and how to produce it. See, e.g., Ex. 1001 12:34–37. Thus, even the ’809 patent, like Bell, acknowledges that Evans is an important reference regarding eculizumab, its structure, and how to make it.” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 10,703,809
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.