- PTAB · Sep 9, 2024 · IPR2024-00101 · APJ Steven M Amundson · IPR · Institution
Instituted IPR of claims 1–20 on all petition challenges because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- Director reviewDirector review, grantedGranted
“On August 20, 2024, the Director granted Petitioner’s request and vacated the panel’s decision denying institution. Paper 12, 6. In doing so, the Director determined that Menard is not a real party in interest or a privy of Petitioner under § 315(b) and that § 315(b) does not bar institution. Id. at 5. The Director also determined that § 315(a) “does not apply to the ‘cross-claims’ asserted by Petitioner” and that § 315(a) does not bar institution. Id. Additionally, the Director declined to exercise discretion under § 314(a) to deny institution in view of the Wisconsin case because Petitioner submitted a Sotera stipulation. Id.; see Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022)1 at 3, 7–8 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Further, the Director remanded the case to the panel and instructed the panel “to determine whether the Petition presents a reasonable likelihood of prevailing with respect to at least one of the challenged claims under 35 U.S.C. § 314(a), and to determine whether to institute inter partes review accordingly.” Paper 12, 5–6. As noted above and explained in the patentability analysis below, we determine that there is a reasonable likelihood Petitioner would prevail with respect to at least one of the challenged claims. See supra § I; infra §§ III.E–III.H.” slip op. at 4
- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“On August 20, 2024, the Director granted Petitioner’s request and vacated the panel’s decision denying institution. Paper 12, 6. In doing so, the Director determined that Menard is not a real party in interest or a privy of Petitioner under § 315(b) and that § 315(b) does not bar institution. Id. at 5. The Director also determined that § 315(a) “does not apply to the ‘cross-claims’ asserted by Petitioner” and that § 315(a) does not bar institution. Id. Additionally, the Director declined to exercise discretion under § 314(a) to deny institution in view of the Wisconsin case because Petitioner submitted a Sotera stipulation. Id.; see Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022)1 at 3, 7–8 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)).” slip op. at 4
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“On August 20, 2024, the Director granted Petitioner’s request and vacated the panel’s decision denying institution. Paper 12, 6. In doing so, the Director determined that Menard is not a real party in interest or a privy of Petitioner under § 315(b) and that § 315(b) does not bar institution. Id. at 5. The Director also determined that § 315(a) “does not apply to the ‘cross-claims’ asserted by Petitioner” and that § 315(a) does not bar” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied discretionary otherDecided for petitioner
“On August 20, 2024, the Director granted Petitioner’s request and vacated the panel’s decision denying institution. Paper 12, 6. In doing so, the Director determined that Menard is not a real party in interest or a privy of Petitioner under § 315(b) and that § 315(b) does not bar institution. Id. at 5. The Director also determined that § 315(a) “does not apply to the ‘cross-claims’ asserted by Petitioner” and that § 315(a) does not bar institution. Id. Additionally, the Director declined to exercise discretion under § 314(a) to deny institution in view of the Wisconsin case because Petitioner submitted a Sotera stipulation. Id.; see Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022)1 at 3, 7–8 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)).” slip op. at 4
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,299,336 - Apple Inc. v. RJ Technology, LLCInstitutedPTAB · Aug 20, 2024 · IPR2024-00597 · APJ Jon B Tornquist · IPR · Institution
The Board instituted review of claims 1–18 on all asserted grounds and granted Apple’s motion to join IPR2023-01183.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may not be instituted “unless . . . the information presented in the petition . . . 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) (2018). Having considered the arguments and evidence presented by Petitioner, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’641 patent. Accordingly, we institute an inter partes review as to all the challenged claims of the ’641 patent on all the grounds of unpatentability set forth in the Petition. And, for the reasons set forth below, we grant Petitioner’s Motion for Joinder.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“In considering a motion for joinder, and whether such joinder is appropriate, the Board may consider “whether a new ground of unpatentability is raised in the second petition, how the cost and schedule of the first proceeding will be impacted if joinder is granted, and whether granting joinder will add to the complexity of briefing and/or discovery.” Patent Trial and Appeal Board Consolidated Trial Practice Guide November 20197 at 76 (citing Kyocera Corp. v. SoftView LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013)).” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art “would have had a Master’s degree in material science, chemical engineering, chemistry, or similar field with four years experience designing testing, and building secondary lithium batteries.” Pet. 11 (citing Ex. 1002 ¶ 51). Petitioner further contends that a person of ordinary skill in the art would have been aware of “(1) positive electrode materials, (2) negative electrode materials, (3) separators, (4) electrolytes, (5) charge-discharge parameters, and (6) protection circuits, as well as ‘battery failure modes’ such as plating and the formation of dendrites.” Id. at 11–12 (citing Ex. 1002 ¶¶ 50–51). Upon review of the prior art of record and the Petitioner’s arguments, we adopt Petitioner’s uncontested definition of the person of ordinary skill in the art for purposes of this Decision as it appears consistent with the ’641 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner provides constructions for the terms “A method for improving . . . characterized in that,” “ratio of positive electrode material to negative electrode material as calculated by a theoretic capacity with a charge cut-off voltage set at 4.2 V” (claim 5), “as calculated by a specific capacity with a charge voltage limited to 4.2 V” (claim 1), and “at least 7500 of capacity” (claim 11). Pet. 8–11. For purposes of this decision, we determine that no claim terms require express construction. See 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) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 8
Claim constructioncites Phillips · KSR · GrahamPatents in suitUS 7,749,641 - Spectrum Solutions, L.L.C. v. Dna Genotek Inc.All claims unpatentablePTAB · Feb 7, 2024 · IPR2022-01347 · APJ Donna M Praiss · IPR · Final written decision
Claims 1, 3–8, 11, and 12 are unpatentable as obvious over each of four grounds: Plante and Cho, with or without Maples, and Plante and Patterson, with or without Maples.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“(POSITA or POSA) “would have had at least a Bachelor’s degree in mechanical engineering, biomedical engineering, or similar technical degree and at least 3 years of experience in the medical device industry, including experience with containers and valves used in disposable medical devices.” Pet. 16 (citing Ex. 1002 ¶ 49). Petitioner further asserts that such a person would have collaborated with a team member with training and experience in the chemical/biological aspects of the invention, having a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline and “at least two years of post-graduate experience in the area of biological sample preservation and nucleic acid extraction, preservation, and analysis.” Id. at 16–17 (citing Ex. 1011 ¶¶ 24–26). Patent Owner does not dispute using Petitioner’s proposed definition. PO Resp. 6.8 We apply Petitioner’s proposed definition because it is consistent with the problems addressed in the ’646 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings on 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, 162 (Fed. Cir. 1985))).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). “In general, a preamble limits the invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Id. (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). “Conversely, a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). The court in Catalina noted that although no litmus test exists for determining whether to treat a preamble as a limitation, several “guideposts” have emerged from the case law in this area. Id. In particular, guideposts tending to show that the preamble is a claim limitation include: Jepson claiming, dependence on a particular disputed preamble phrase for antecedent basis, when the preamble is essential to understand limitations or terms in the claim body, and when the preamble recites additional structure or steps underscored as important by the specification. Id. On the other hand, the preamble might not constitute a claim limitation when the claim body describes such a structurally complete invention that deleting the preamble phrase does not affect the structure or steps of the claimed invention. Id. at 809. Also, “preambles describing the use of an invention generally do not limit claims because the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of the structure.” Id.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“the claim must be given their plain meaning unless the plain meaning is inconsistent with the Specification. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). Additionally, ordinary, simple English words whose meaning is clear and unquestionable are to be construed to mean exactly what they say–– absent, of course, any indication that their use in a particular context changes their meaning. Chef America, Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1372 (Fed. Cir. 2004). The abstract of the ’646 patent describes isolating and preserving cells from bodily fluids “for cellular analysis” and “genomic studies.” Ex. 1001, code (57). In the field of the disclosure portion of the ’646 patent, cells isolated from bodily fluids are preserved “for studies in any of: functional genomic and epigenetic studies, and biomarker discovery.” Id. at 1:25–29. In the background section, the ’646 patent describes the interest in “large-scale epigenetic research” for the purpose of “understanding the mechanisms of gene-environment interactions” suggesting that “epigenetic mechanisms may provide a molecular memory of environmental experiences.” Id. at 1:60–67. The background section further describes the challenges of collecting bodily fluids, such as saliva, is that it is a digestive fluid that can be rich in proteases and that existing solutions used to stabilize cells from blood, which is a transporter fluid, “will not protect cells from proteases found in some bodily fluids, such as saliva.” Id. at 3:24–36, 4:43–47. The detailed description section of the ’646 patent discloses “a solution for preserving cells in one or more bodily fluids, such as saliva and urine” that “may be beneficial for further separation into cell types and downstream molecular analysis” and “allows for storage of cells in the bodily fluid to retain their antigenicity and cellular architecture.” Id. at 16:9–15. The Specification describes some embodiments of solutions for preserving cells in one or more bodily fluids where the solutions contain a chemical fixing agent, a protease inhibitor, an antimicrobial agent, serum proteins, and are buffered to preferred pH ranges. Id. at 16:15–22. Thus, the plain meaning of “preserving a biological sample,” consistent with the ’646 patent disclosure focused on maintaining the architecture of cells contained in a bodily fluid that may include digestive proteases for further study downstream, is “preserving the integrity of a cell contained in a bodily fluid sample.”” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We agree that it is not necessary for us to construe these claim terms because neither party asserts that they are material to the asserted grounds in the Petition. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 18
Patent outcomesUS 11,002,646 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,002,646 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Rehearing grantedPTAB · Aug 10, 2023 · PGR2022-00023 · APJ Jeffrey N Fredman · PGR · Rehearing
On Patent Owner’s rehearing request, the Board held claim 25 unpatentable under § 112(a) because it depends from claim 14, which lacks written description support.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We therefore agree with Petitioner that we overlooked the correct dependency of claim 25. Claim 25, as a claim dependent from claim 14, lacks written descriptive support because claim 25 fails to cure the absence of descriptive support for claim 14.” slip op. at 4
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“In the Final Written Decision, we determined that claim 14 lacked descriptive support. We noted that Claim 14, in particular, recites a GDC-0199 dosing regimen “compris[ing] a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day.” Unlike for claim 1, such disclosure is not found in a single example, but results from picking and choosing three separate selections from column 24. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 *4 (Fed. Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 3
§ 112 disclosurePatents in suitUS 10,993,942 - Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision
Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24
Patent outcomesUS 10,900,034 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,900,034 - PTAB · Apr 7, 2022 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Rehearing
The Board granted rehearing, reversed its discretionary denial, and instituted PGR on claims 6–8 based on the threshold showing of likely lack of enablement and anticipation.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We agree with Petitioner that a rehearing of our prior decision to deny institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“35 U.S.C. § 324(a) provides that a post-grant review may not be instituted “unless the Director determines that the information presented in the petition filed under section 321, 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.” After considering the Petition and the Preliminary Response, and the evidence cited therein, we determine that Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we accept Petitioner’s proposed definition, which is supported by Dr. Lambert’s testimony (Ex. 1002 ¶ 20) and is consistent with the scope and content of the ’039 patent and the asserted prior art.” slip op. at 17
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted
“skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - Samsung Electronics Co., Ltd. v. Nucurrent, Inc.Rehearing grantedPTAB · Feb 7, 2020 · IPR2019-00861 · APJ Wesley B Derrick · IPR · Rehearing
The Board granted Samsung’s rehearing request and instituted review on all challenged claims and all grounds, finding a reasonable likelihood of prevailing on the asserted obviousness grounds.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“in an unusual place in time. As noted, the Petition was filed (March 22, 2019), and the Preliminary Response submitted (June 26, 2019), before promulgation of our 2019 Trial Practice Guide Update (July 16, 2019). At the time of filing, Petitioner could not have known of the guidance set forth in the 2019 Trial Practice Guide Update concerning multiple petitions. Although Petitioner “could, in theory, have filed a single petition including all of its grounds within the page limits,” Petitioner, acting on the guidance available to it at the time of filing, “determined that filing two separate IPR petitions allowed each asserted ground of unpatentability to be presented in a more clear and comprehensive manner.” Req. 4. Thereafter, the 2019 Trial Practice Guide Update issued on the same day as our conference call to discuss the parties’ requests for additional briefing (July 16, 2019), and these concurrent events would not have allowed the parties time to review and apply the guidance in a manner that would have permitted them to tailor their requests for additional briefing or their filing strategy to accommodate the newly-issued guidance. In the subsequent briefing by both parties, the impact of the 2019 Trial Practice Guide Update, although discussed briefly, was not the primary focus. See generally Reply; Sur-Reply. This is understandable, given the breadth of the complex estoppel issues raised in this case as well as the contemporaneous issuance of the guidance in the 2019 Trial Practice Guide Update. Thus, on account of the timing of the Petition filed in this case relative to other events, and based on the reasoning presented by Petitioner in the Request, which we discuss in more detail below, we are persuaded that we should reconsider whether to allow institution of inter partes review based on the arguments presented in the Petition.” slip op. at 11
- Parallel petitionsInstitutedInstituted
“review, addresses Lee-based grounds rooted in anticipation (and obviousness over Lee and secondary references). IPR2019-00859, Paper 1. The petition in IPR2019-00861 addresses Partovi-based grounds rooted in obviousness. IPR2019-00861, Paper 1. In the Request, Petitioner argues that there is “almost no overlap” between the Partovi-based Petition in this case and Petitioner’s Lee-based petition in IPR2019-00859 (Req. 3), noting that “all grounds of the instant Petition rely on Partovi as the primary reference while the ’859 proceeding grounds rely on Lee as the primary reference” (id. at 2). In support, Petitioner provides a table depicting the various grounds presented in the two cases, and the differences between the two. Id. at 3. Petitioner also argues that “Partovi’s teachings are not redundant of Lee’s” because the references “disclose the claimed features of the ’046 patent in different ways.” Id. More particularly, Petitioner explains that “Lee is generally focused on an inductor structure” while “Partovi contains a more complete and clear disclosure of methods and circuitry for operating inductors,” which is important because the “dependent claims involve additional circuitry used in an inductor’s operation.” Id. at 4. Although Petitioner acknowledges that it “could, in theory, have filed a single petition including all of its grounds within the page limits,” Petitioner contends that “doing so would have resulted in a reduction in the thoroughness and completeness of the analysis presented due to the large number of challenged claims.” Id. Specifically, Petitioner argues that “NuCurrent chose to assert 98 claims from four patents against Samsung in a parallel district court litigation” and that Petitioner had to file two petitions in order to address “the sheer number of claims at issue.” Id. at 5. On this record, we are persuaded that Petitioner’s arguments concerning the differences between the petitions, and Petitioner’s reasons for presenting its arguments in two petitions, as it did, merit reconsideration of our denial of institution. The differences between the petitions in this instance, as explained by Petitioner, support its position that there is a need for the Partovi reference to distinctly address certain limitations of the dependent claims. The number of claims asserted against Petitioner in corresponding litigation, as well, is a factor enumerated in the 2019 Trial Practice Guide Update as a circumstance in which more than one petition may be necessary. 2019 Trial Practice Guide Update, 26 (“circumstances in which more than one petition may be necessary” include “when the patent owner has asserted a large number of claims in litigation”). We note again that although Patent Owner was authorized to file a ten-page response to Petitioner’s Request (Dec. 5), in which it could have addressed, inter alia, Petitioner’s arguments about the differences between these Petitions or the number of claims at issue, Patent Owner did not file a response to the Request, leaving Petitioner’s contentions regarding rehearing undisputed on the present record.” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)InstitutedInstituted
“Rehearing, on this record, we do not agree that proceeding to trial would be an inefficient use of Board resources. The number of Patent Owner’s patents that are being challenged is not a reason to deny institution. “[R]ecogniz[ing] the potential for abuse of the review process by repeated attacks on patents,” the Board has enumerated factors that guide its discretion as to whether to deny institution under § 314(a), “especially as to ‘follow-on’ petitions challenging the same patent as challenged previously in an IPR . . . proceeding.” Trial Practice Guide Update 9 (August 2018) (quoting General Plastic, slip op. 16–17). Although a multiplicity of grounds relying on a number of principal references addressed in a number of separate petitions may raise concerns regarding fairness in some instances, we find no such concerns here, for largely the same reasons articulated above with respect to our disposition of the Request for Rehearing. In these circumstances, as discussed above, we are not persuaded that defending against both challenges is unfair, abusive, or unduly burdensome for Patent Owner. Accordingly, we decline to exercise our discretion to deny institution under 35 U.S.C. § 314(a). See Comcast Cable Communications, LLC v. Veveo, Inc., IPR2019-00237, Paper 15 at 14–15 (PTAB Jul. 5, 2019) (instituting inter partes review on two petitions addressing the same patent).” slip op. at 29
- BurdenInstitutedInstituted
“and 28, we discern no deficiency in Petitioner’s characterization of the cited references and the knowledge in the art, or in Petitioner’s assertions as to the reasonable inferences an ordinary artisan would have made from those references, to the extent the ground relies on AC current and voltage and the inherent characteristics of inductors for the limitation “wherein when an electrical current is propagated within at least the first conductor layer, a magnetic flux is generated within the inductor when a change occurs in at least one of a frequency, a magnitude, or a waveform shape of the propagated electrical current.” Because this showing is sufficient to demonstrate teaching of this claim element was in the prior art as alleged, we need not reach Petitioner’s alternative reasoning grounded on changes in the duty cycle as to frequency and waveform shape meeting this particular claim limitation. Thus, based on the information presented at this stage of the proceeding, Petitioner has shown sufficiently that there is a reasonable likelihood that it would prevail in establishing the unpatentability of independent claims 1 and 28 as obvious over Partovi in view of Chiang.” slip op. at 44
Claim constructionDiscretionary denialcites Phillips · KSRPatents in suitUS 9,300,046 - Samsung Electronics Co., Ltd. v. Nucurrent, Inc.Rehearing grantedPTAB · Feb 7, 2020 · IPR2019-00860 · APJ Kristina M Kalan · IPR · Rehearing
The Board granted Samsung’s rehearing request and instituted review of claims 1–8, 10, 12, 13, 15–22, and 24–30 on every asserted obviousness ground.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“On this record, we are persuaded that Petitioner’s arguments concerning the differences between the Petitions, and Petitioner’s reasons for presenting its arguments in two Petitions, as it did, merit reconsideration of our denial of institution. The differences between the Petitions in this instance, as explained by Petitioner, evince a need for the Partovi reference to distinctly address certain limitations of the dependent claims. The number of claims asserted against Petitioner in corresponding litigation, as well, is a factor enumerated in the 2019 Trial Practice Guide Update as a circumstance in which more than one petition may be necessary. 2019 Trial Practice Guide Update, 26 (“circumstances in which more than one petition may be necessary” include “when the patent owner has asserted a large number of claims in litigation”). We note again that although Patent Owner was authorized to file a ten-page response to Petitioner’s Request (Dec. 5), in which it could have addressed, inter alia, Petitioner’s arguments about the differences between these Petitions or the number of claims at issue, Patent Owner did not file a response to the Request, leaving Petitioner’s contentions regarding rehearing undisputed on the present record.” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Decided for petitioner
“Rehearing, on this record, we do not agree that proceeding to trial would be an inefficient use of Board resources. We also do not agree that the number of Patent Owner’s patents that are being challenged is a reason to deny institution. “[R]ecogniz[ing] the potential for abuse of the review process by repeated attacks on patents,” the Board has enumerated factors that guide its discretion as to whether to deny institution under § 314(a), “especially as to ‘follow-on’ petitions challenging the same patent as challenged previously in an IPR . . . proceeding.” Trial Practice Guide Update 9 (August 2018) (quoting General Plastic, slip op. 16–17). Although a multiplicity of grounds relying on a number of principal references addressed in a number of separate petitions may raise concerns regarding fairness in some instances, we find no such concerns here, for largely the same reasons articulated above with respect to our disposition of the Request for Rehearing. In these circumstances, as we have already discussed above, we are not persuaded that defending against both challenges is unfair, abusive, or unduly burdensome for Patent Owner. Accordingly, we decline to exercise our discretion to deny institution under 35 U.S.C. § 314(a). See Comcast Cable Communications, LLC v. Veveo, Inc., IPR2019-00237, Paper 15 at 14–15 (PTAB Jul. 5, 2019) (instituting inter partes review on two petitions addressing the same patent).” slip op. at 27
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005). See Changes to the Claim Construction Standard for Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b) effective November 13, 2018) (now codified at 37 C.F.R. § 42.100 (2019)). Under Phillips, claim terms are generally afforded “their ordinary and customary meaning,” read “in the context of the entire patent, including the specification.” Phillips, 415 F.3d at 1312–13. “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1313. Only terms that are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner does not propose a construction for any of the limitations of the claims. Pet. 13 (citing Ex. 1002 ¶ 37). Patent Owner also declines to address the construction of the claims. See generally Prelim. Resp. We decline to construe any claim term of the ’960 patent because it is not necessary to do so in reaching our decision that Petitioner has established a reasonable likelihood that it would prevail in establishing the unpatentability of at least one challenged claim.” slip op. at 14
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons set forth above, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one claim of the ’960 patent. Thus, we institute an inter partes review. IV. ORDER Accordingly, it is: ORDERED that Petitioner’s Request for Rehearing is granted; FURTHER ORDERED that an inter partes review is instituted on each of the grounds asserted in the Petition; and” slip op. at 49
Claim constructionDiscretionary denialcites Phillips · KSRPatents in suitUS 8,680,960 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision
Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3
- Skill levelSkill level patent owner adoptedDecided for patent owner
“B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14
Patent outcomesUS 6,407,213 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 6,407,213
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.