- Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentablePTAB · Mar 5, 2026 · IPR2024-00634 · APJ Meredith C Petravick · IPR · Final written decision
Claims 1, 3, 8–13, 15, 16, and 19–24 are unpatentable over Brown and Ho, with claims 16 and 19 also relying on the Quick Connection Art; the remaining challenged claims were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner proposes that: A [person of ordinary skill in the art (“POSITA”)] in the field to which the ’105 Patent is directed would have had at least a Bachelor of Science degree in mechanical engineering or a related field or, as a substitute, at least two years of work or” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“of “integrally molded with” as “molded together as a single structure.” Paper 21, 15.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Patent Owner responds that: a POSITA would not have been motivated to make the proposed modification, nor does the Petition include any analysis regarding why a POSITA would be motivated to move from a vertical extended portion to a radial extended portion. Indeed, a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar as it introduces another sudden directional change into the fluid flow system. PO Resp. 58–59 (citing Ex. 2013 ¶ 242).” slip op. at 32
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Patent Owner argues that the ’105 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 63–65; PO Sur-reply 26–29. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 of the bowl fill valve 109, the flow of water through the bowl fill valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288. Further, the ’606 Application states: The bowl fill valve 109 may be, for example, a ball valve, a gate valve, a globe valve, a plug valve, a diaphragm valve, a butterfly valve, a needle valve, a sliding gate, a quick turn valve, a knife valve or any other appropriate type of valve as can be appreciated by those with ordinary skill in the art.” slip op. at 42
Patent outcomesUS 9,103,105 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,103,105 - Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentablePTAB · Dec 15, 2025 · IPR2024-00633 · APJ Meredith C Petravick · IPR · Final written decision
Claims 1, 7–15, 19, and 20 are unpatentable over Brown and Ho; claims 2–6 and 16–18 were not shown unpatentable on the asserted grounds.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“Brown’s adapter tube 23 (i.e., the extended portion) does not extend radially from a longitudinal axis of valve assembly 13 (i.e., the toilet fill valve). Ex. 1021, Fig. 1. Mr. Jobin testifies that a POSITA would not be motivated to move adapter tube 23 from a vertical position to a radial position because “a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar system.” Ex. 2013 ¶ 251; see Ex. 1021, 1:9–62. Patent Owner’s argument is persuasive. Petitioner’s analysis and Dr. Cameron’s testimony is conclusory and does not sufficiently explain why a POSITA would be motivated to make the proposed modification to Brown. For example, Petitioner does not sufficiently explain how such a modification would result in a more compact toilet fill valve system that could be adapted to fit in more toilet tank designs. Further, neither Petitioner nor Dr. Cameron sufficiently address Mr. Jobin’s testimony regarding Brown’s desire for a quieter toilet. See Pet. Reply 23; Ex. 1036 ¶ 84. Petitioner fails to meet its burden to show by a preponderance of the evidence that claim 2 is unpatentable over Brown and Ho.” slip op. at 35
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“description is an objective inquiry into the four corners of the specification from the perspective of a POSA. Using this test, the invention must be described in a manner sufficient to demonstrate that the inventor actually invented the claimed invention. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Written description is a question of fact judged as of the relevant filing date. Falko–Gunter Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006). An ipsis verbis disclosure, however, is not necessary to satisfy the written description requirement. Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The disclosure need only reasonably convey to a POSA that the inventor had possession of the subject matter in question, even if every nuance of the claims is not explicitly described in the specification. Id.; see Ariad, 598 F.3d at 1351. Patent Owner argues that the ’993 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 68; PO Sur-reply 28–30. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. Ex. 1012, 47, ¶ 8 (emphasis added); see also Ex. 1001, 2:28–39. As can be seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288.” slip op. at 48
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable
“1. Analysis of Claims 1–18 Schuster is available as prior art if the ’993 patent is only entitled to its January 27, 2014, filing date and not entitled to claim priority to earlier filing dates of the parent applications. On its face, the ’993 patent claims priority to a number of earlier parent applications, including Application No. 12/786,904 (the ’904 Application) filed May 25, 2010, and the Application code 63. Petitioner contends that the ’993 patent is not entitled to claim priority to the filing date of the earlier parent applications, and, thus, Schuster, a parent application of the ’993 patent, is available as prior art.15 Pet. 91–92. Petitioner alleges that the earlier parent applications, specifically Application No. 12/786,904 (the ’904 Application), do not provide written description support for the ’993 patent’s claim term “water flow regulator.” According to Petitioner, “water flow regulator” encompasses both adjustable devices for restricting the flow of water (i.e., valves) and fixed devices for restricting the flow of water (i.e., restrictors). Pet. 15. Petitioner contends that the ’904 Application does not provide support for water flow restrictors and, thus, does not provide support for the broader claim term water flow regulators. Id. at 14–15, 91–92. Petitioner argues that only adjustable water flow devices (i.e., valves) are supported by the ’904 Application. Id. Petitioner, thus, asserts that earliest effective filing date of the ’993 patent’s claims is the filing date of its application, January 27, 2014. Id. at 92. To be entitled to claim the benefit of an earlier filing date under 35 U.S.C. § 120 each application in the priority chain must comply with the written description requirement of 35 U.S.C. § 112(a). See Hollmer v. 14 The parties do not dispute that the ’993 patent and the earlier parent applications, including the ’904 Application and the ’606 Application, have the same pertinent portions of their specifications. See PO Resp. 71, n.16; Ex. 1004 ¶ 324. 15 Schuster issued on January 31, 2012, from Application No. 12/786,904, filed on May 25, 2010. Ex. 1029, code (21), (22), (45). Schuster, thus, issued more than one year prior to January 27, 2014.” slip op. at 46
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“2. Analysis of Claims 19 and 20 Claim 19 depends from claim 14 and additionally recites, “wherein the waterflow regulator comprises an adjustable water flow regulator that is configured to adjust the flow rate of the second portion of the water based at least in part on a setting of the adjustable water flow regulator.” Ex. 1001, 12:16–20. Claim 20 depends from claim 14 and recites the same additional limitation. Id. at 12:21–24. Claims 19 and 20, thus, require the water flow regulator to be an adjustable water flow regulator. Petitioner indicates that the earlier parent applications provide written description support for an adjustable water flow regulator. Pet. 91 (“[T]he ’904 application specification makes it clear that the adjustability of the bowl fill valve is a desirable and essential feature of the invention”); PO Surreply 28. Accordingly, Petitioner fails to meet its burden to show, by a preponderance of the evidence, that claims 19 and 20 are unpatentable over Schuster.” slip op. at 50
Patent outcomesUS 9,139,993 mixed§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,139,993 - Fluidmaster, Inc. v. Danco, Inc.InstitutedPTAB · Sep 9, 2024 · IPR2024-00633 · APJ Meredith C Petravick · IPR · Institution
Instituted IPR of claims 1–20 on all asserted grounds; the Board found a reasonable likelihood that claim 1 is unpatentable over Brown and Ho.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), 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.” After considering the Petition, the Preliminary Response, the Reply, the Sur-reply, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’993 patent. Accordingly, we institute an inter partes review of claims 1–20 of the ’993 patent on the grounds asserted in the Petition.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“presented to the Office.” Prelim. Resp. 31– 36. In determining whether to deny institution under § 325(d) we use a two-part framework, as follows: (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 [the] 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. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 8
- BurdenDecided for petitioner
“At this stage of the proceeding, Patent Owner provides no sufficient evidence to rebut Dr. Cameron’s testimony as to what a POSITA would have known from Guoxin and Ho’s drawings and as to the alleged motivations to combine Guoxin and Ho. Based on Petitioner’s evidence and analysis, and taking into account the Preliminary Response, at this stage of the proceeding, we determine that the information in the Petition shows a reasonable likelihood that claim 1 is unpatentable over Guoxin and Ho.” slip op. at 24
- Skill levelSkill level patent owner adoptedDecided for patent owner
“A [person of ordinary skill in the art (“POSITA”)] in the field to which the ’993 Patent is directed would have had at least a Bachelor of Science degree in mechanical engineering or a related field or, as a substitute, at least two years of work or research experience in the design or development of toilet products, parts, and accessories. Prelim. Resp. 16. Petitioner’s declarant Dr. Cameron asserts that: A [POSITA] with respect to the subject matter of the ’993 patent at the time of the priority date, January 27, 2014, would have had an undergraduate degree in mechanical engineering, or other technical training in product design or equivalent work experience. This person would also possess at least one year of experience in developing and/or evaluating mechanical aspects of fluid systems. Ex. 1004 ¶ 29. For purposes of this Decision, we adopt Patent Owner’s proposed definition of a POSITA, as it is consistent with the ’993 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). However, we see no material difference between the level of skill proposed by Patent Owner and that proposed by Dr. Cameron.” slip op. at 12
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,139,993 - Fluidmaster, Inc. v. Danco, Inc.InstitutedPTAB · Sep 9, 2024 · IPR2024-00634 · APJ Meredith C Petravick · IPR · Institution
The Board instituted IPR of claims 1–24 on all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Brown and Ho.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” After considering the Petition, the Preliminary Response, the Reply, the Sur-reply, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’105 patent. Accordingly, we institute an inter partes review of claims 1–24 of the ’105 patent on the grounds asserted in the Petition.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Previously presented art includes art made of record by the Examiner, and art provided to the Office by an applicant, such as on an Information Disclosure Statement (“IDS”), in the prosecution history of the challenged patent. Id. at 7–8. Here, it is not disputed that Brown and Bjerke were listed on an IDS and, thus, were previously presented to the Office. Pet. 12, n.4; Prelim. Resp. 33. It is also not disputed that Guoxin, Ho, Calmettes, Hall, Kimber, and Schuster were not previously presented to the Office. See Prelim. Resp. 33. Patent Owner argues that Guoxin, Brown, and Ho are cumulative of a reference, DeMarco9, that was previously presented to the Office and relied upon to reject the claims. Prelim. Resp. 33 Patent Owner argues that Guoxin, Brown, and Ho are cumulative to DeMarco because all of the “references are completely silent as to whether the purported ‘extended portion’ is integrally molded with the purported body of the toiled fill valve.” Id. at 33–36. Patent Owner’s arguments are unpersuasive. As can be seen from our discussion of Ho in our analysis below, on this record, we are persuaded that Petitioner has sufficiently shown for purposes of institution how Ho allegedly teaches the claimed integrally molded extended portion. We, thus, are not persuaded that at least Ho is cumulative of DeMarco. Grounds 1–4 rely upon combinations of prior art that include Ho. Ground 5 is based upon Schuster, which was not previously presented to the 9 U.S. Patent No. 5,708,991 (Ex. 1024). Office. Accordingly, we determine that discretionary denial is not warranted. Because we determine that part one of the framework is not satisfied, we need not turn to part two to determine whether Petitioner demonstrates that the Office erred in a manner material to the patentability of the challenged claims. For the reasons discussed above, we decline to exercise our discretion under § 325(d) to deny the Petition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“On this record, we are persuaded by Patent Owner that the claim phrase “integrally molded with” should be construed to mean “molded together as a single structure” and to exclude items created as separate pieces and attached together later. Patent Owner’s construction is consistent with the plain language of the claims, which requires the extended portion be “integrally molded with” the body and not just the extended portion be integral with the body. Further, we determine that Patent Owner’s construction is consistent with the ’105 patent, which discloses that “the bowl fill valve 109 may be molded as a portion of the toilet fill valve 100 or it may be snapped or clamped into place, or it may be attached to the toilet fill valve 100 in some other manner, etc.” Id. at 2:23–26 (emphasis added). At this stage of the proceeding, we construe “integrally molded with” to mean molded together as a single structure.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Patent Owner next disputes that a POSITA would have combined Guoxin and Ho and argues that Petitioner’s alleged rationale to combine Guoxin and Ho as conclusory and lacks sufficient support. Prelim. Resp. 40–42. We determine that Petitioner has sufficiently articulated a motivation to combine Guoxin and Ho to support institution. Petitioner asserted motivation to combine — improved strength and integrity of connection — is supported by the testimony of Dr. Cameron. Dr. Cameron testifies: “Integrally molding the extended portion of Guoxin with the inlet device as taught by Ho would be advantageous in improving the strength and integrity of the connection, and to make it easier to manufacture and assemble.” Ex. 1004 ¶ 125. Based on the record at this stage of the proceeding, we determine that Petitioner has sufficiently shown that the combination of Guoxin and Ho teaches element 1B.” slip op. at 20
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,103,105 - Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentablePTAB · Sep 6, 2023 · IPR2022-00608 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–21 are unpatentable: claims 1–14, 17–19, and 21 as obvious over Teigen and Grey; claims 15–16 over Teigen, Grey, and Yang; and claim 20 over Teigen, Grey, and Matteo.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. PERSON OF ORDINARY SKILL IN THE ART In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art 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). The level of ordinary skill in the art is “a prism or lens through which . . . the Board views the prior art and claimed invention” to prevent hindsight bias. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“as adopted by the Board in the Institution Decision. The ’253 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 38:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’253 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 3:8–11. In the ’253 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’253 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1034 ¶¶ 13–14. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” We disagree with Patent Owner’s contention that our construction imports limitations from a single embodiment into the claims. As explained above, the ’253 patent clearly defines the term “forward flow” and this definition is not limited to a single embodiment. In fact, the ’253 patent indicates that, while “[f]orward flow is defined as greater than 6 microliters of fluid . . . [l]ess forward flow is also included in this definition.” Ex. 1001, 38:21–24. The ’253 patent specifies that “the amount of forward flow can be restricted to no greater than 2 microliters or, in a particularly beneficial embodiment, forward flow is approximately zero microliters.” Id. at 38:24– 29. This language indicates that our construction encompasses multiple embodiments from the ’253 patent. We also disagree with Patent’s Owner’s proposed construction of “forward flow” because it is not supported by the ’253 patent specification. Patent Owner contends that “there is ‘no forward flow’ until the full extent of the distal portion” exits the distal end and thus forward flow is prevented when only less than “the full extent of the distal portion” exits the distal end. PO Resp. 9 (emphasis omitted). To adopt Patent Owner’s proposed construction, we would have to essentially ignore the ’253 patent’s express definition of this term. Further, there is no support in the ’253 patent specification for “full extent” or “fully exiting.” We also agree with Petitioner that Patent Owner’s construction effectively eliminates the concept of preventing forward flow because, as Patent Owner acknowledges, it could allow, for example, 20 milliliters of fluid to exit the catheter, which could displace the thrombus into the patient’s vasculature, a problem that the ’253 patent seeks to avoid. See PO Resp. 10–12 (citing Ex. 2014 ¶¶ 48–51); Pet. Reply 8–9 (citing Ex. 1034 ¶¶ 14–15).” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As discussed above, we construe “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosures from the ’011 provisional application that describe the desire to have “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” these disclosures would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 35 (citing Ex. 1003 ¶¶ 15, 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 36–37 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges that fall within the ’253 patent’s definition of “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1034 ¶ 25; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Further, we note that the ’253 patent differentiates between embodiments that allow forward flow and embodiments in which no forward flow occurs. See Ex. 1001, 32:58–60, 37:19–22; Pet. Reply 10–11. For example, the ’253 patent describes an embodiment in which the “momentum causes a small amount of fluid to move through the distal portion of the catheter [] and create a small distal movement of the clot.” Ex. 1001, 32:47– 51. This same embodiment is disclosed in the ’011 provisional application. Compare Ex. 1003 ¶ 126 with Ex. 1001, 32:16–60. The ’253 patent describes this disclosure as an “exemplary embodiment” in which the “flow of fluid forward . . . is intentional, which is in contrast to other exemplary embodiments herein where substantially no forward flow occurs.” Ex. 1001, 32:57–60; see also, id. at 37:19–22 (“Turning now to embodiments . . . without the forward flow”).8 The ’011 provisional application does not include the subsequent embodiments from the ’253 patent that are described as being “without the forward flow.” See Ex. 1005 ¶ 68; Ex. 1034 ¶¶ 22–23. This further demonstrates that the ’011 provisional application does not support the limitation of “prevent[ing] forward flow.” We also note that the ’011 provisional application does not contain adequate support for the limitation of “substantially prevent[ing] forward flow” even under Patent Owner’s proposed construction. While the ’011 provisional discloses “controlling the distal movement of the fluid column” (Ex. 1003 ¶¶ 15, 16), this does not support Patent Owner’s assertion that the ’011 provisional teaches that “the distal portion of the fluid column is substantially prevented from fully exiting the distal end.” PO Resp. 35–36. For example, as discussed above, the ’011 provisional application discloses permitting distal flow of up to 1,000 microliters, which would likely exceed the amount that could be characterized as the full distal portion. Ex. 1003 ¶ 91; Ex. 1034 ¶ 25. Thus, we find that the ’011 provisional application does not “clearly allow persons of ordinary skill in the art to recognize that [the inventors] invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989); Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 8 Patent Owner contends that the statement in the ’253 patent regarding the “exemplary embodiment” of “forward flow” is referring to an embodiment in which the volume of the liquid drawn out from the lumen of the catheter is “approximately 0.2 ml.” PO Resp. 40–41 (citing Ex. 1001, 32:35–36; Ex. 1003 ¶ 126; Ex. 2014 ¶ 99). Even if this is correct, the ’011 provisional application does not include the embodiments that the ’253 patent specifically characterizes as being “without the forward flow.” Pet. Reply 10–11; Ex. 1005 ¶ 68; Ex. 1034 ¶ 22–25.” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“Based on the above, we determine that, for prior-art determinations under AIA § 102, “there is no need to evaluate whether any claim of [a reference] patent document is actually entitled to priority or benefit under 35 U.S.C. 119, 120.” MPEP § 2154.01(b) (emphasis added). Rather, under the AIA, a reference patent document need only meet the “ministerial requirements” of §§ 119 and 120, and the provisional or other earlier application(s) to which the reference patent document claims a right of priority must “describe[] the subject matter” relied upon in the reference patent document as prior art. 35 U.S.C. § 102(d)(2). Patent Owner has not contested that Teigen meets the procedural requirements for claiming priority to the ’712 patent or the ’095 PCT application. Teigen also appears to meet the ministerial requirements for claiming priority to the provisional applications because it properly claims the benefit of these applications, the ’095 PCT application was filed co-pending with the provisional applications, and the applications share common inventors. Ex. 1007, codes (22), (60), (63), (72); Ex.1008, 2; Ex. 1009, 2; Ex. 2005, codes (22), (30), (72). Patent Owner does not dispute that Teigen meets the “ministerial requirements” of § 119. Because we find that the Dynamic Drinkware analysis does not apply here, we agree with Petitioner and Patent Owner, that we need not reach the issue of whether a claim from Teigen is supported by either Teigen provisional application. PO Sur-Reply 8; Pet. Reply 12–13.” slip op. at 30
Patent outcomesUS 10,722,253 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,722,253 - PTAB · Apr 18, 2023 · IPR2022-00123 · APJ Zhenyu Yang · IPR · Final written decision
The Board cancelled original claim 1 and denied substitute claim 2 for lack of written-description support; it did not reach the obviousness or enablement grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“ordinary skill is inappropriate because it “requires qualifications that exclude even the sole inventor of the ’190 Patent, Dr. Edward Neuwelt.” MTA Opp. 1. According to Petitioner, Dr. Neuwelt is “a neurosurgeon,” not a pediatric oncologist, and lacks the requisite “at least 2 years” experience in platinum-based therapies. Id. (citing Ex. 1003, 18; Ex. 1038, 98:9–17, 100:15–101, 4). We agree with Petitioner. It is well settled that inventors are typically persons skilled in the field of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner presents persuasive evidence to show that under Patent Owner’s proposed definition of the level of ordinary skill, Dr. Neuwelt, the sole inventor, would not qualify as an ordinarily skilled artisan, because he is not a pediatric oncologist, even though he is considered “one of the world leading experts on this compound [STS] and otoprotection” and “an expert in the area of [STS] as a . . . drug to use in children with medulloblastoma.” Ex. 1038, 98:9–17, 99:17–18, 101:18–102:13.” slip op. at 10
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Paragraph 102 of Dr. Rassekh’s Declaration, however, does not support Patent Owner’s assertion. Instead, Dr. Rassekh testifies that [t]he stratum of previous craniospinal radiation therapy contained 8 participants: 2 of the 4 (50%) participants receiving STS had hearing loss compared to 4 of the 4 (100%) participants not receiving STS, and none of the hearing loss assessments were changed at the 1 year follow up period. (Ex. 1001 at 20: 28-32, 47-50.) Ex. 2024 ¶ 102. Dr. Rassekh offers no opinion on how many osteosarcoma patients with prior cranial irradiation and how many medulloblastoma patients with prior cranial irradiation had hearing loss.” slip op. at 20
- 112 supportMotion to amend, deniedDenied
“In sum, we find the disclosures of the ’243 application that Patent Owner relies on do not provide sufficient written-description support for the ototoxicity efficacy limitation.” slip op. at 21
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“F. Petitioner’s Asserted Unpatentability Grounds In light of our determination above that Patent Owner has not shown sufficient written-description support for proposed substitute claim 2 in the ’243 application, we do not reach the grounds of unpatentability set forth in Petitioner’s Opposition. See Revised MTA Opp. 17–25 (alleging non-enablement and obviousness).” slip op. at 26
§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,596,190 - Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentablePTAB · Mar 10, 2023 · IPR2021-01466 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–18 are unpatentable under §103: claims 1–12, 15, 16, and 18 over Teigen and Grey; claims 13–14 over Teigen, Grey, and Yang; claim 17 over Teigen, Grey, and Matteo.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Based on our consideration of the full record, we find that, overall, Patent Owner’s definition is more specifically tailored to the claimed subject matter of the ’883 patent. We also find that, a person with a biomedical engineering degree could have the required background in fluid mechanics. See Ex. 1031, 45:21–46:7. Therefore, we find that a person of ordinary skill in the art would have a B.S. in mechanical or biomedical engineering with at least three years of experience in designing systems for minimally invasive intravascular procedures for treating occluded vessels or the equivalent and in consultation with medical professionals such as interventional neurosurgeons. Although we agree with, and have primarily adopted Patent Owner’s definition for an ordinarily skilled artisan in this proceeding, our analysis and conclusions herein would not change even under Petitioner’s definition. The parties also do not indicate that the outcome would differ based on the definition of the person of ordinary skill in the art. See Pet. 15; PO Resp. 6; Pet. Reply 1.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“as adopted by the Board in the Institution Decision. The ’883 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 36:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’883 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 2:62–65. In the ’883 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’883 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1030 ¶¶ 13–14; Ex. 2001 ¶¶ 53, 62. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.”” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As discussed above, we construed “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosure from the ’011 provisional application which describes “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” it would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 33 (citing Ex. 1003 ¶¶ 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 34 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the disclosure of the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges which fall within the ’883 patent’s definition of no “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1030 ¶ 29; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996).” slip op. at 21
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“AIA § 102 draws a distinction between actually being entitled to a right of priority to, or the benefit of, a prior-filed application according to the definition of “effective filing date” of a claimed invention in AIA 35 U.S.C. § 100(i)(1)(B), and merely being entitled to claim a right of priority to, or the benefit of, a prior-filed application for prior-art purposes according to the use of “effectively filed” in AIA 35 U.S.C. § 102(d). See 35 U.S.C. §§ 100(i)(1)(B), 102(a)(2), 102(d)(2); MPEP § 2154.01(b). USPTO guidance also indicates that AIA § 102 prior-art reference effective-filing-date determinations differ from pre-AIA law. For example, a 2018 Memorandum to the Patent Examining Corps states, in the context of prior-art determinations, that “[t]he requirement that one of the claims in the patent [document] . . . be supported by the written description of the provisional application in compliance with pre-AIA 35 U.S.C. § 112, first paragraph (or AIA 35 U.S.C. § 112(a)), is not applicable when examining an application subject to the first inventor to file provisions of the AIA.” Robert W. Bahr, Memorandum re: Critical Reference Date Under pre-AIA 35 U.S.C. §102(e) (Apr. 5, 2018), available at http://www.uspto.gov/sites/ default/files/documents/dynamic_memo_05apr2018_0.pdf (emphasis added) (citing Dynamic Drinkware, 800 F.3d at 1381 n.2; 157 Cong. Rec. 3423 (2011) (explaining the distinction between being entitled to claim priority or benefit in AIA 35 U.S.C. § 102(d) and actually being entitled to priority or benefit under 35 U.S.C. § 119, 120, or 365)). This Memorandum further indicates: The date subject matter was “effectively filed” under AIA 35 U.S.C. § 102(d) for purposes of considering a U.S. patent, a U.S. patent application publication, or an international application publication as prior art under AIA 35 U.S.C. § 102(a)(2) is discussed in MPEP § 2154.01(b), and is not affected by Dynamic Drinkware or [Amgen v. Sanofi, 872 F.3d 1367, 1380 (Fed. Cir. 2017)] and is not being modified by this memorandum. Id. at 2. MPEP § 2154.01(b) explicitly states, as a result of the distinction discussed above, in application of the AIA version of § 102, “the question of whether a patent or published application is actually entitled to priority or benefit with respect to any of its claims is not at issue in determining the date the patent or published application was ‘effectively filed’ for prior art purposes.” MPEP § 2154.01(b) (emphases added).” slip op. at 31
Patent outcomesUS 10,531,883 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,531,883
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.