- PTAB · Jun 6, 2025 · IPR2025-00113 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on claims 1–5, 10, 11, 14, 16, and 17, finding a reasonable likelihood that claims 1–5, 10, 11, 14, 16, and 17 are obvious over Bourque and Wampler.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b) (2024); 37 C.F.R. § 42.4(a) (2024). 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). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review as to the Challenged Claims of the ’415 patent.” slip op. at 2
- BurdenNot shown unpatentable
“Decision we find “axially adjacent” to mean “adjacent to one another as measured along a central axis.” Petitioner does not contend or show in the Petition that Wampler teaches a magnetically driven rotor adjacent to a first magnetic device as measured along a central axis. See Pet. 24–25. In opposition, Patent Owner argues, and we agree on the current record, as follows: Wampler does not teach or suggest “a magnetically driven rotor . . . axially adjacent to a first magnetic device” based on its imbedding of permanent magnets 88 in the impeller 74 because these components are not adjacent to one another as measured along the central axis of the device. Instead, the magnet segments 88 and impeller 74 are aligned with, and overlap, one another as measured along the central axis in Wampler’s configuration. See Ex. 1008, [where the magnet segments are housed within the impeller blades.] Prelim. Resp. 23 (citing Ex. 1008, ¶ 18, Figs. 3, 4, 7, 9, 11, 13, 15, 17, 19). We find Patent Owner’s arguments refuting Petitioner’s contention that the Challenged Claims would have been obvious over Wampler, alone, have substantial merit. We, therefore, turn to Petitioner’s contentions based on Bourque, in combination with Wampler, which instead rely on Bourque as teaching the “axially adjacent” limitation.” slip op. at 26
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends a person of ordinary skill in the art at the time of the invention “would have at least a bachelor’s degree in engineering; knowledge and experience in human circulatory system anatomy and physiology; and at least five years’ experience designing and developing implantable medical devices.” Pet. 6 (citing Ex. 1003 ¶ 18). At this stage of the proceeding, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. See Prelim. Resp. 1. We find, for purposes of this appropriate level of skill at the time of the claimed invention and that the level of skill reflected in these references and in the ’415 patent is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 18
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“We find insufficient support for Petitioner’s assertion that “a magnetic element sealed within a rotor is ‘axially adjacent.’” Pet. 24. Moreover, we find Patent Owner’s definition of the claim language reflects its plain and ordinary meaning and is consistent with the disclosure of the ’415 patent (which illustrates only a “magnetically driven rotor” positioned adjacent to a “first magnetic device” as measured along a central axis). See Ex. 1001, Fig. 2. It is also consistent with the construction Petitioner appears to contend is the correct construction, as applied by Petitioner in, for example, it’s contentions based on the asserted combination of Bourque and Wampler. See Pet. 60 (relying on Bourque’s teaching of a rotor and magnetic device adjacent to one another as measured along a central axis with regard to the “axially adjacent” limitation and not on Wampler’s magnets embedded in the impeller at the same location along a central axis). Accordingly, we find, for purposes of this Decision and based on the current record, that the plain and ordinary meaning of “axially adjacent,” as shown by Patent Owner, is “adjacent to one another as measured along a central axis,” and apply this definition to our analysis of Petitioner’s contentions below.” slip op. at 25
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,376,415 - PTAB · Jan 11, 2022 · IPR2021-01201 · APJ David Cotta · IPR · Institution
Instituted review of claims 1–3, 5–8, 10–18, and 20 on all three proposed grounds because the petition showed a reasonable likelihood of prevailing on obviousness.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“(“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). In determining if non-institution under § 325(d) is proper, we follow the two-part framework set forth in Advanced Bionics, LLC v. MED- EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential, designated March 24, 2020). Specifically, the Board must determine: “(1) 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 first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Id. at 8.” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Id. at 6. “These factors relate to whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Id. In evaluating these factors, we take “a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. (citing Patent Trial and Appeal Board Consolidated Trial Practice Guide November 2019 (“CTPG”), 584). We address the Fintiv factors below.” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“IV. CONCLUSION For the foregoing reasons, we determine Petitioner has demonstrated there is a reasonable likelihood it would prevail in establishing the unpatentability of claims 1–3, 5–8, 10–18, and 20 as having been obvious over the teachings of ChloraPrep PAR alone or in combination with Degala. Accordingly, based on the Supreme Court’s holding that a decision under § 314 may not institute review on fewer than all claims challenged in the petition, we institute on all three proposed challenges. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Additionally, we decline to exercise our discretion under 35 U.S.C. § 325(d) or § 314 to deny the proposed challenges to patentability. Our factual findings, conclusions of law, and determinations at this stage of the proceeding are preliminary, and based on the evidentiary record developed thus far. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim. Our final decision will be based on the record as fully developed during trial.” slip op. at 45
- Skill levelSkill level board ownDecided for patent owner
“encountered in the art, the art’s solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Petitioner contends that a person of ordinary skill in the art at the time of the alleged invention would have possessed “at least an undergraduate degree in the pharmaceutical sciences, pharmacy, biochemistry, microbiology, or a related field, and a Masters in a similar field and at least 6 years industry experience or a Ph.D in a similar field and at least 4 years industry experience in the field developing sterilization processes, sterile medical devices and/or formulations or tests for evaluating sterility.” Pet. 15. Patent Owner states that it “does not believe the particular definition of a POSA is determinative at this stage because the Petition can be denied under Petitioner’s own proposed skill level.” Prelim. Resp. 16. Patent Owner nonetheless challenges Petitioner’s proposal, stating:” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,398,642 - PTAB · Jan 11, 2022 · IPR2021-01202 · APJ Georgianna W Braden · IPR · Institution
The Board instituted IPR on claims 1–3, 5–8, and 10–19 for all three grounds, finding a reasonable likelihood of obviousness over ChloraPrep PAR alone or with Degala.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“We turn next to the second part of the Advanced Bionics framework and consider Becton factors (c), (e), and (f) in determining “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, Paper 6 at 10. As explained below in our patentability analysis, Petitioner has demonstrated a reasonable likelihood that it will prevail in showing that at least one of the challenged claims would have been obvious over the cited art. In this regard, Petitioner has shown the materiality of Degala (as applied in combination with ChloraPrep PAR) to the patentability of the challenged claims. See infra §§ III. We find that the Examiner erred in overlooking the teachings of Degala, including specifically Degala’s express description of a “method for sterilizing an antiseptic solution.” Ex. 1007 ¶ 7. Furthermore, Petitioner has presented additional evidence and facts that were not before the Examiner, including support for why an ordinarily skilled artisan would have combined the teachings of Degala and ChloraPrep PAR. See Pet. 61– 63; Ex. 1003 ¶¶ 163–166. Thus, Becton factors (c), (e), and (f) weigh heavily in favor of finding error under the second part of the Advanced Bionics framework. Accordingly, we decline to exercise our discretion to deny institution under 35 U.S.C. § 325(d).” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Based on the facts of the case as discussed below, we find that the merits of the case support institution. Our determination is preliminary, however, and we are not prepared on this preliminary record to characterize the merits of Petitioner’s challenge as especially “strong.” Accordingly, we find this factor to be neutral. 7. Summary We consider the above factors and take “a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv, Paper 11 at 6. Weighing the factors together, we determine that they weigh against exercising our discretion not to institute inter partes review. For the above reasons, we do not exercise our discretion under 35 U.S.C. § 314(a) to deny institution of a trial proceeding.” slip op. at 20
- Skill levelSkill level board ownOther
“Response, it “does not believe the particular definition of a POSA is determinative at this stage because the Petition can be denied under Petitioner’s own proposed skill level.” Prelim. Resp. 16. Patent Owner nonetheless challenges Petitioner’s proposal, stating: Petitioner’s proposal regarding the level of ordinary skill for a POSA is disconnected from the disclosure of the 067 Patent. (Pet. 15.) As a preliminary matter, even though the 067 Patent relates to sterilized chlorhexidine products, Petitioner’s proposed definition requires no experience with antiseptics or chlorhexidine. Thus, under Petitioner’s definition, the POSA who is generally aware of “sterilization processes, sterile medical devices and/or formulations or tests for evaluating sterility” may be unfamiliar with the unique challenges of sterilizing antiseptics such as CHG or creating antiseptic products and articles that are able to contain and deliver sterilized CHG compositions. Additionally, while not requiring knowledge in the relevant field (experience with sterilization processes for medical products and their components, as well as familiarity with antiseptics such as chlorhexidine), Petitioner artificially inflates the educational requirements without explanation to require a Master’s or PhD. Id. at 16–17 (emphasis and footnote omitted). At this stage of the proceeding, we determine that a person of ordinary skill in the art at the time of the invention would have possessed at least an undergraduate degree in the pharmaceutical sciences, pharmacy, biochemistry, microbiology, or a related field, with experience with sterilization processes for medical products and their components, as well as familiarity with antiseptics such as chlorhexidine. Such level of skill in the art is consistent with the ’067 patent and the asserted prior art of record.” slip op. at 26
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionOther
“Moreover, Patent Owner’s proposed construction is consistent with the Specification, which discloses that “the terms the chlorhexidine article, or components and compositions thereof, may be referred to as the ‘sterilized’ component or composition upon being exposed to suitable processing where such sterility can be validated.” Ex. 1001, 3:58–65. Accordingly, on this preliminary record, we construe “sterilized” to mean that the “component or composition has been subjected to a suitable sterilization process such that sterility can be validated.” Additionally, based on our review of the Petition and Preliminary Response, we do not believe that any other claim terms require express construction at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017); 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 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,688,067
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.