ILLINOIS TOOL WORKS INC.

Patent Trials and Appeals Board

Mar 7, 2022

2021003850 (P.T.A.B. Mar. 7, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/422,183 02/18/2015 Jan Willem Marinus Mijers 226-018 (61405) 9770 157817 7590 03/07/2022 Pilloff Passino & Cosenza LLP 2000 Duke Street Suite 300 Alexandria, VA 22314 EXAMINER FREDRICKSON, COURTNEY B ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 03/07/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): mail@pilloffpassino.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte JAN WILLEM MARINUS MIJERS __________________ Appeal 2021-003850 Application 14/422,183 Technology Center 3700 ____________________ Before STEFAN STAICOVICI, EDWARD A. BROWN, and JAMES P. CALVE, Administrative Patent Judges. CALVE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant requests a rehearing of the Decision mailed November 24, 2021 (“Decision”). Request for Rehearing (filed Jan. 24, 2022) (“Request”). Requests for Rehearing are limited to points that are believed to have been misapprehended or overlooked by the Board in rendering a decision. See 37 C.F.R. § 41.52(a)(1). We have jurisdiction over the Request under 35 U.S.C. § 6(b). As discussed more fully below, Appellant’s arguments do not apprise us that we overlooked or misapprehended any of the matters asserted in the Request in rendering the Decision. Accordingly, we deny the Request. Appeal 2021-003850 Application 14/422,183 2 At bottom, notwithstanding Appellant’s arguments, the fact remains that the original disclosure, including the original claims, does not describe a single embodiment/species of a valve device with a through-flow between the inlet and outlet lines, wherein the “through-flow is interrupted by a static underpressure prevailing on the inlet line and/or the outlet line or by an overpressure on the outlet line,” as claimed. Appeal Br. 165 (Claims App.). As discussed below in the identified sections, original claims are part of the disclosure but do not enjoy a “strong presumption” of support. § I. (p. 3). We correctly analyzed the written description based on the Examiner’s findings and Appellant’s arguments as an issue involving a claim to generic through-flow that is not supported by a single embodiment. § II. (p. 5). The claimed “one-way low-pressure check valve device” is designed and a valve is configured to interrupt through-flow in three situations. Thus, the device and valve must include structure that interrupts through-flow. § III. (p. 6). The original claims demonstrate that the claimed device lacks written description support. § IV. (p. 8). The level of skill in the art was considered in reaching this determination. § V. (p. 9). Appellant was not punished for providing too much description. Appellant failed to describe even a single through-flow structure that channels through-flow from an inlet to an outlet and interrupts that flow as claimed so that a skilled artisan would recognize Appellant’s possession of this subject matter. § VI. (p. 12). Applying the correct claim interpretation and legal analysis for genus-species, interrupted through-flow, and inoperability is not a new ground of rejection. §§ VII.-X. (pp. 14-18). Nor did we change the thrust of the rejection. § XI. (p. 19). The specification and drawing objections raise the same issues as the written description rejection and properly are resolved with it. § XII. (p. 22). Appeal 2021-003850 Application 14/422,183 3 I. No Strong Presumption of Written Description for Original Claims Appellant argues that we overlooked or disregarded arguments in the Appeal Brief that original claims have a “strong presumption [of] adequate written description.” Request 1; id. at 2-3 (“The only way this can happen is if the USPTO is disregarding the solid law on originally filed claims (strong presumption, not just a presumption, but strong presumption that there is written description support)”), 3 (“The case law that mandates that there is a ‘strong presumption’ that originally filed claims have their own written description support is not sufficiently followed. Just the opposite, it is discounted based on pages of technical evaluation.”), 20 (“Never does the PTAB address our arguments and case law on the strong presumption that there is written description support. There is only this lukewarm statement that original claims may provide written description support.”), 25 (“To be clear, a requirement that there is a strong presumption that our claims have written description support is completely ignored. This is reversible error. Where is there any evidence in any way shape or form that we were given a presumption that the claims have written description support, let alone the required strong presumption? There is none. . . . [T]he decision completely ignores any precedent on this issue, or any evaluation at all, and completely ignores our arguments.”), 25 (“Yet the strong presumption standard arises to something akin to the presumption of innocence, and thus it should be beyond a reasonable doubt or something along those lines. The decision does not rise to that level or any level anywhere near something which rebuts the strong presumption of adequate written description support.”), 26 (“[N]owhere does the decision explain why the findings of the examiner [and] the findings of the PTAB . . . overcome that strong presumption.”). Appeal 2021-003850 Application 14/422,183 4 We are not persuaded that we overlooked or disregarded guidance from our reviewing court that original claims enjoy a strong presumption of written description support. As our reviewing court explained in Ariad, [W]hile it is true that original claims are part of the original specification, In re Gardner, 480 F.2d 879, 879 (CCPA 1973), that truism fails to address the question whether original claim language necessarily discloses the subject matter that it claims. Ariad believes so, arguing that original claims identify whatever they state, e.g., a perpetual motion machine, leaving only the question whether the applicant has enabled anyone to make and use such an invention. . . . We disagree that this is always the case. Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010) (en banc) (emphasis added); see also Neology, Inc. v. Int’l Trade Comm’n, 767 F. App’x 937, 941 (Fed. Cir. 2019) (“On the other hand, genus claims, especially those that ‘use functional language to define the boundaries of a claimed genus,’ are unlikely to provide an adequate written description so as to be self-describing.”); Decision 8 (“Original claims may provide written description support.”)’ Request 20 (referencing Decision 8). Ariad indicates that original claims do not enjoy a strong presumption of written description support. In re Wertheim, 541 F.2d 257 (CCPA 1976) did not articulate such a standard. The decision simply stated, “[t]here is no question that the instant application supports claims 1, 2, and 4, which are original claims in the application.” Wertheim, 541 F.2d at 262 (cited in Request 21). No further explanation was provided in Wertheim. Appeal 2021-003850 Application 14/422,183 5 II. Genus-Species Governs Written Description in This Appeal Appellant contends that we disregarded law applicable to the written description requirement by analyzing the Examiner’s written description rejection in terms of whether Appellant’s Specification describes any species that support a generic claim that broadly claims “the one-way valve device being designed such that through-flow is interrupted by static underpressure prevailing on the inlet line and/or the outline line or by an overpressure on the outlet line.” See Request 5-6 (“The decision cites genus-species claiming for the first time ever”; “No, the Examiner never said anything about a generic claim or a species.”), 41 (arguing that our analysis of whether the Specification described any species to support the broad genus claim to through-flow “has no identified applicability to the written description requirement of 35 U.S.C. § 112, 1st paragraph.”). According to Ariad, a genus-species analysis is the appropriate legal standard to use to determine whether a broad generic claim is supported by any species described in the written description. Ariad, 598 F.3d at 1349. This approach is consistent with Wertheim. See Wertheim, 541 F.3d at 263 (explaining that applicants who originally claim a broad genus can narrow their claim scope to a patentable species in the written description). The upshot of our genus-species analysis was to require Appellant to identify a single embodiment of a one-way valve that is “designed such that through-flow is interrupted” in situations involving static underpressure and overpressure as claimed. Appellant has not yet done so. See Decision 5. We agreed with the Examiner’s analysis that the Specification does not describe a single embodiment of valve device structure that interrupts through-flow as claimed. Decision at 3-10; Final Act. 4-6, 10; Ans. 4-6. Appeal 2021-003850 Application 14/422,183 6 III. A Device “Designed” or Valve “Configured” Claims Structure Appellant argues that we overlooked or disregarded that a one-way check valve inherently has through-flow, and the Specification describes a medium flowing through the valve to displace air from pressure chamber 12b so that “Through-flow is permitted.” Request 1-2 (emphasis added). Whether a one-way check valve would be understood inherently to permit a generic through-flow and whether the Specification makes passing reference to a generic through-flow in the valve device is not relevant to whether the original disclosure provides a written description specifically of “the one-way valve device being designed such that through-flow is interrupted by a static underpressure prevailing on the inlet line and/or the outlet line or by an overpressure on the outlet line” as claimed.1 Appeal Br. 165 (emphasis added). Descriptions of a “through-flow” in a valve device are not commensurate with the scope of the claims under review, and thus, are insufficient to demonstrate possession of the claimed subject matter. The issue is not whether there is an adequate written description of a “through-flow” as Appellant asserts. The issue is whether the Specification provides an adequate written description of a one-way valve device that is designed/configured such that through-flow is interrupted in three pressure situations. See Decision 10. Appellant’s arguments overlook or disregard the actual claim language for which written description support is lacking. 1 Independent claim 4 recites a similar one-way low-pressure check valve device having “inlet and outlet lines being connected to a pressure space in the housing” and “the one-way check valve is configured such that through- flow is interrupted by a static underpressure prevailing on the inlet line and the through-flow is interrupted by a static underpressure prevailing on the outlet line.” Appeal Br. 165 (Claims App.) (emphasis added). Appeal 2021-003850 Application 14/422,183 7 The Examiner explained, “[i]n the instant application, the applicant claims the function and result of ‘through-flow’. However, the disclosure as originally filed fails to sufficiently disclose how this function or result is achieved.” Final Act. 4. The Examiner interpreted the lack of a description of a fluid flow channel to indicate that “fluid would need to flow through a separate, undisclosed channel which would allow the fluid to bypass pressure chamber 12b.” Id. at 4, 10 (emphasis added). The Examiner reiterated that “the disclosure as originally filed is devoid of any discussion or disclosure of how the fluid moves through the valve.” Id. at 4; id. at 10. The Examiner asked Appellant to identify particular structures of the disclosed one-way valve device that formed a through-flow channel so it could be determined how through-flow is interrupted as claimed. Id. at 10. The Examiner explained (Ans. 4 (emphasis added)): independent claims 1, 4, and 40 recite that through-flow is interrupted in the case of one of three conditions. As the claims are directed towards a valve, one of ordinary skill in the art would recognize the term ‘through-flow’ as a functional term which implies that fluid would be enabled to flow through the valve in the absence of these three conditions.” The Examiner sought a supporting description of through-flow that is interrupted. Id. The Examiner explained that Appellant’s arguments that a through-flow is described throughout the Specification just cite portions that “merely disclose prior art devices or further functionally describe” “through- flow,” but “[n]one of the portions cited by Appellant disclose the structure necessary to accomplish the claimed ‘through-flow’.” Id. at 4-5 (emphasis added). We agreed with the Examiner that the Specification fails to describe how through-flow is channeled by structure from inlet to outlet and how through-flow is interrupted in the three pressure situations. Decision 3-10. Appeal 2021-003850 Application 14/422,183 8 IV. The Original Claims Support Our Decision Appellant argues that we overlooked or disregarded the original claims’ description of a through-flow. See Request 11-12, 20-25. This argument erroneously applies a “strong presumption” as discussed earlier. Original claim 1 undermines Appellant’s argument that the original disclosure describes a through-flow, much less a through-flow interrupted in static underpressure and overpressure situations. Original claim 1 recites “the inlet and outlet lines (5, 14) being connected to a pressure space (12) in the housing (2, 3),” wherein “the pressure space (12) being constructed from two interconnected pressure chambers (12a, 12b)” and “wherein the two pressure chambers (12a, 12b) are arranged lying one above the other in the housing (2, 3) with respect to the flow direction between the first and second sides.” Claim 1, filed Feb. 18, 2015 (emphasis added). Original Figure 4 illustrates pressure chambers 12a, 12b lying above one another. However, chamber 12b has no outlet for a through-flow. The Examiner pointed out this through-flow dead-end problem to Appellant. [A]s seen in fig. 4, the fluid is trapped as chamber 12b is shown to be sealed to the outlet. For this reason, there is no through- flow disclosed. As such, the Examiner maintains that one of ordinary skill in the art would not readily understand how the function or result of ‘through-flow’ is achieved based on the originally filed disclosure. Ans. 5 (emphasis added); see Decision 6 (“The written description describes through openings 29 as connecting pressure chamber 12a to pressure chamber 12b, but pressure chamber 12b appears to be sealed off from outlet 14. It cannot conduct flow to outlet 14. See Final Act. 10.”). Original claim 1 thus describes pressure chamber 12 including pressure chamber 12b structure that stops any through-flow in the one-way valve device in all situations. Appeal 2021-003850 Application 14/422,183 9 V. The Level of Skill in the Art Was Considered Appellant also asserts, “there is no proper evaluation of the level of skill in the art, a requirement for evaluating written description. (Indeed, it is our firm position that any entity that declares that a one-way valve that is designed to have through-flow does not mean that there is through-flow has not sufficiently evaluated the level of skill in the art. . . .”). Request 3-4. Appellant further contends: This is no frivolous or empty statement. There is extensive technical evaluation in the Decision. If there is no evaluation of the level of skill in the art or the knowledge in the art, all of that evaluation is moot. As we detail below, this application comes down to a handful of issues, one of which is failure to properly ascertain the level of skill in the art - if one of skill would expect that one-way valve that is designed to have through-flow has through flow, which is a truism based on a word comparison and the 3,000 years of human history, the Decision will be reversed. Again, consider our hypothetical declaration: We need an expert to opine that a one-way check valve designed to have through flow has through flow? No. Request 4 n.1; see also id. at 24 (“Indeed, fatal to the Decision is that the PTAB does not address our arguments about the failure to assess the level of skill in the art. And this is material because we submit that the only way a decision could be found that a one-way check valve that has intermittent through flow does not have written description support for through flow is if the level of skill in the art is not understood. This is simple stuff.”), 27 (arguing the level of skill in the art “is 100% ignored” and the only way that someone can determine an originally filed claim to a one-way check valve does not have through flow “is if that person does not understand the level of skill in the art. Again, what valve in the 3000 years of humans utilizing valves did not have through flow?”). We disagree. Appeal 2021-003850 Application 14/422,183 10 We considered the level of skill in the art as described in Appellant’s Specification regarding the known need to prevent air from entering into the through-flow because adding air to the fluid that flows through the device into a patient’s veins can lead to an embolism and endanger the patient. See Decision 6-9 (citing Spec. ¶¶ 2-5, 52). We explained that the Specification describes through-flow from inlet 5 to outlet 14 via pressure chambers 12a, 12b that are connected by openings 29, but both chambers 12a, 12b connect to outside air pressure. Id. at 6-8 (citing ¶¶ 50, 60); Ans. 5. The Examiner reasoned that skilled artisans would not consider pressure chambers 12a, 12b to be through-flow structure because they connect to outside air. See Ans. 5. We explained that the Specification describes membrane 61 that seals inlet line 5 as being subjected to outside air pressure. Id. at 9 (citing Spec. ¶ 62). Subjecting membrane 61 to the outside air pressure via sectors 30 and channels 32 on the downstream side of membrane 61 would introduce air into fluid that flows by inlet line 5 and membrane 61 into chamber 12a. Id. Having outside air contact the through-flow pressure chambers would render a valve device unsafe and inoperable according to the Specification’s description of the understanding of skilled artisans in the field of valves that air should not be introduced into the chambers that channel through-flow. Thus, it is unclear how fluid flows from inlet line 5 to pressure chamber 12a when outside air flows into chamber 12a to subject membrane 61 to outside air pressure. Spec. ¶¶ 60-62. It is unclear that fluid flows from pressure chamber 12a to pressure chamber 12b if outside air flows into chamber 12b. A skilled artisan would not provide air to pressure chambers 12a, 12b that are used for through-flow. See Decision 6-10; Ans. 4-5. Other descriptions of this understanding in the art supported our analysis. Spec. ¶¶ 2-5, 25, 52. Appeal 2021-003850 Application 14/422,183 11 The Specification describes the device as designed so “the entry of air-enriched infusion liquid into the veins is prevented.” Spec. ¶ 25. The Specification indicates that the air-carrying connection between housing opening 18 and pressure chamber 12 (comprising chambers 12a, 12b) “is sealed off in relation to the fluid-carrying parts of the valve.” Id. ¶ 52. These teachings conflict with other descriptions that air enters air into pressure chambers 12a, 12b that supposedly channel the through-flow. See Decision 6-10. We thus agreed with the Examiner that a fluid through-flow channel was not described in the Specification because flow from inlet line 5 through chamber 12 (chamber 12a and chamber 12b) would cause the fluid to contact outside air contrary to the understanding in the art that through- flow channels do not entrain air in the through-flow. See Decision 9-10. Our understanding of the level of skill described in Appellant’s own Specification led us to determine that the written description did not provide a through-flow path that is interrupted in the claimed three situations. Id. Prior art of record illustrates that skilled artisans expect inventors to describe through-flow in one-way valves. For example, Mahoney provides a detailed description of the through-flow in the claimed one-way check valve. See Mahoney ¶¶ 1, 26, 34-37, Figs. 1-3 (arrows show through-flow paths). Kamen also illustrates and describes fluid through-flow in its one-way valve. See Kamen, 4:24-5:42, 6:12-7:3, Fig. 6 (arrows show through-flow paths). These references reflect the level of skill in the art and how through- flow is described for skilled artisans. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown.’”). Appeal 2021-003850 Application 14/422,183 12 VI. The Written Description is Inadequate Appellant argues repeatedly that, “We are being penalized because we disclosed more than we had to.” Request 3 (“And there is moral hazard here, because if this decision stands, this aggressively dampens the goal of promoting the useful arts, and if the USPTO starts making people be afraid for disclosing too much because it will be used against them.”). To the contrary, Appellant is being “penalized” for disclosing too little, i.e., for failing to comply with the written description requirement, as understood in light of the level of skill in the art, namely, that skilled artisans expect fluid through-flow to be described in one-way valves in sufficient detail that skilled artisans can understand what actually was invented and how the fluid flows through the valve. Even if valves have been around for 3000, as Appellant contends, nonetheless, skilled artisans routinely describe in detail the structure that channels fluid through-flow through their valves from an inlet to an outlet and how through-flow changes and is interrupted. The written description in the present application is lacking in this respect. Appellant has not adequately traced the through-flow of fluid in the claimed one-way valve device. Nor has Appellant described structure that channels and interrupts through-flow in the claimed situations. Appellant’s argument that the written description “simply identifies the wrong chamber, and the reference line is to the wrong chamber” (Request 43) is misleading. The only pressure chamber described in the original claims and Specification is pressure chamber 12, which comprises chambers 12a, 12b, both of which are open to outside air as discussed above, and chamber 12b is a dead end. Fluid that flows from inlet 5 to chamber 12a contacts air, and flow stops when it enters chamber 12b. Appeal 2021-003850 Application 14/422,183 13 Even if pressure chamber 12 is redesignated to include pressure chamber 12c, which Appellant identifies downstream of seal 62, (or vice pressure chamber 12c for pressure chamber 12b), the result is the same, namely, the air that is entrained in fluid flowing from inlet line 5 through pressure chamber 12a passes to chamber 12c with air entrained therein. Furthermore, paragraph 50 still indicates that these chambers are connected to each other and to outside air. See Decision 12 (citing Spec. ¶ 50). As it stands, a skilled artisan has no way of knowing from Appellant’s original disclosure how fluid flows through the one-way valve device from inlet 5 to outlet 14 or how the flow is interrupted “by a static underpressure prevailing on the inlet line and/or the outlet line or by an overpressure on the outlet line” as claimed. As a result, a skilled artisan would not recognize that Appellant possessed this claimed subject matter at the time of filing. The Specification describes the device as having a through-flow. See Decision 3 (cited in Request 39). Merely describing a “through-flow” is not commensurate with the more-specific claim scope. It does not identify any structure of the device “designed such that through-flow is interrupted” by a static underpressure or an overpressure as claimed. Through-flow is not tied to any valve structure. Contrary to the understanding in the art, a detailed description of through-flow is not provided and what description is provided contacts air. See Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 972 (Fed. Cir. 2002) (“Interpretation of written description as this court has done furthers the goal of the law to have claims commensurate in scope with what has been disclosed to the public.”); Ariad, 598 F.3d at 1360 (Newman J., concurring) (“[T]he patentee is obliged to describe and to enable subject matter commensurate with the scope of the exclusionary right.”). Appeal 2021-003850 Application 14/422,183 14 VII. Genus-Species Analysis is not a New Ground Appellant argues that “[t]he decision cites genus-species claiming for the first time ever” and “was never made by the Examiner.” Request 5-6. Appellant contends that “[t]he alleged fact and rationale that we did not disclose a single species was never used to substantiate the section 112, first paragraph rejections.” Id. at 7. (“This was completely unforeseen.”; “The Decision puts words in the Examiner’s rejection, and then presents cut and paste case law quotes in support of a rejection that was not made.”). As referenced in the discussion of the lack of a strong presumption of a written description attaching to original claims, our reviewing court has described this written description issue as one involving genus and species. See Ariad, 598 F.3d at 1349. Genus-species is the applicable standard for our review of the written description issue presented in this appeal. As discussed above, Appellant characterized the claim scope as a one- way low-pressure check valve device that has a through-flow. See Appeal Br. 52-63; Request 1-9, 32-49. Appellant thus interpreted the scope of the claims as reciting a generic valve device with a generic “through-flow” that is not tied to any particular structure, e.g., structure that interrupts flow. The Examiner explained that independent claims 1, 4, and 40 “recite that through-flow is interrupted in the case of one of three conditions” but the disclosure does not “disclose the structure necessary to accomplish the claimed ‘through-flow’.” Ans. 4-5 (emphasis added); see also Final Act. 10 (“Appellant has failed to provide sufficient disclosure showing how the fluid moves from one side of the valve to an opposite side [and] it is unclear if the fluid passes through a separate, undisclosed channel which would allow the fluid to bypass pressure chamber 12b.”). Appeal 2021-003850 Application 14/422,183 15 The Examiner further explained: Therefore, it is the Examiner’s position that the Applicant did not have possession of the claimed invention at the time of filing given that the Applicant has only recited the function of the fluid moving through the valve from the inlet to the outlet and has not set forth sufficient showing of how to accomplish such function and it is not enough to leave such structure of accomplishing the claimed function up to one of ordinary skill in the art. Final Act. 10 (emphasis added). The description was inadequate for skilled artisans to identify structure that conducts and interrupts the through-flow. Despite hundreds of pages of arguments in the Appeal Brief, Reply Brief, and Request for Rehearing, Appellant has not identified a single embodiment with a through-flow channel that connects inlet line 5 to outline 14 and also interrupts the through-flow in the three claimed situations. The bar is set as low as it can go. Appellant only needs to identify a structure that provides the claimed through-flow function and interrupts the flow in three situations.2 To date, we have only a schematic illustration in newly-submitted Figure 15. Under controlling precedent, the lack of even a single embodiment of a device designed/configured to provide the claimed through-flow means that a written description of through-flow sufficient to convey possession to a skilled artisan is lacking. Decision 3-10. 2 The Examiner essentially applied a genus-species analysis. “An original claim may lack written description support when the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved.” Final Act. 3; Ans. 5 (“None of the portions cited by Appellant disclose the structure necessary to accomplish the claimed ‘through-flow’.”). The Examiner sought a structure/species embodiment that provided the claimed interrupted through-flow. Ans. 4-5; Decision 3. Appeal 2021-003850 Application 14/422,183 16 VIII. Interrupted Through-Flow is not a New Ground Appellant also argues, “[t]he Decision changes the rejection from the simple fallacy that we did not disclose ‘through flow’ to an allegation that we did not disclose structure for ‘designed such that through-flow is interrupted’.” Request 7. We disagree. First of all, the through-flow and its claimed interruption by a static underpressure in the inlet and/or outlet line, or an overpressure on the outlet line, are opposite sides of the same coin as far as the written description issue is concerned. In other words, for the through-flow to be interrupted as claimed, there first has to be a through-flow that is described. The Examiner made clear that a written description is lacking for the claimed through-flow and its interruption by under- and overpressure conditions. See Ans. 4-5. Appellant’s selective quotation of the rejection ignores the Examiner’s findings that a description of through-flow being interrupted is lacking: In the instant application, independent claims 1, 4, and 40 recite that through-flow is interrupted in the case of one of three conditions. As the claims are directed towards a valve, one of ordinary skill in the art would recognize the term “through- flow” as a functional term which implies that fluid would be enabled to flow through the valve in the absence of these three conditions. Appellant further argues that the function of “through-flow” is described throughout the specification . . . . However, the cited portions provided by Appellant merely disclose prior art devices or further functionally describe the “through-flow” (e.g. “through-flow is permitted”, “through- flow is interrupted”). None of the portions cited by Appellant disclose the structure necessary to accomplish the claimed “through-flow”. Ans. 4-5 (emphasis added). The only “through-flow” that is claimed is the “through-flow” that “is interrupted.” See Appeal Br. 165 (Claims App.). Appeal 2021-003850 Application 14/422,183 17 IX. Structure for Through-Flow is not a New Ground Appellant argues that the Decision’s statement that “no description is provided of even a single species of the claimed through structure” “reads limitations into the claim [because] [w]e claimed a one-way check-valve with through flow [and] [t]he Examiner examined the claims in terms of function, not structure.” Request 9 (quoting Decision 5 and Final Act. 10). Appellant’s selective quotation of the Final Office Action omits part of a sentence where the Examiner made clear that the rejection was based on the lack of a written description of the structure used to perform the function of the fluid moving through the valve device from the inlet to the outlet: Therefore, it is the Examiner’s position that the Applicant did not have possession of the claimed invention at the time of filing given that the Applicant has only recited the function of the fluid moving through the valve from the inlet to the outlet and has not set forth sufficient showing of how to accomplish such function and it is not enough to leave such structure of accomplishing the claimed function up to one of ordinary skill in the art. Final Act. 10 (emphasis added); cf. Request 9. The Examiner made crystal clear that the written description rejection is based on the lack of a description of the structure of the valve device that is used for performing the through-flow and its interruption. Cf. Request 10. The Decision simply pointed out that the Examiner’s interpretation of the through-flow limitation as claiming the structure of the “one-way valve device” that interrupted through-flow in three situations was consistent with the controlling precedent of our reviewing court. Decision 5. A device that is “designed” (claims 1 and 40) or “configured” (claim 4) is understood to claim the device’s structure “such that through-flow is interrupted.” Id. Appeal 2021-003850 Application 14/422,183 18 X. Inoperability of the Device or Valve is not a New Ground Appellant argues that references in the Decision to the description of pressure chambers 12a, 12b being connected to outside air went beyond the rejection in the Final Office Action. Request 11-12. As discussed above, our discussion of the apparent inoperability of the claimed one-way valve device due to air entrainment considers how a skilled artisan would understand the written description of the device as claimed. The Specification’s description of the dangers resulting from one-way valves delivering fluid to patients’ veins with air entrained in the fluid casts doubt on the description of the valve’s chambers 12a, 12b and through openings 29 providing structure for through-flow when the Specification describes these elements being connected to outside air pressure. Spec. ¶¶ 2-5, 24, 25, 50, 51, 60. This description of a skilled artisan’s understanding of this problem indicates that skilled artisans may not view chambers 12a, 12b or openings 29 as structures that provide the claimed through-flow/interruption between the valve’s inlet and outlet when these structures connect to outside air and, consequently, can entrain air in any fluid that flows through them. Decision 6-10. We noted that any through-flow channels that connect to outside air appear to render the valve device inoperable/unusable for fluid delivery for patients. Skilled artisans would not understand these structures to provide a fluid through-flow channel. Id. We simply considered the Specification’s lengthy discussion of this known problem in the art of valves along with the written description of the structures of the claimed valve allegedly used to channel fluid through-flow. Skilled artisans would tend to discount such structures 12a, 12b, 29 as being channels for through-flow when they also connect to outside air according to Appellant’s Specification. Id. Appeal 2021-003850 Application 14/422,183 19 XI. The Thrust of the Rejection Did Not Change As illustrated by the foregoing discussion of the alleged new grounds of rejection asserted in the Request for Rehearing, our affirmance of the rejection did not change the thrust of the rejection. We affirmed the written description rejection because the Specification does not describe a single embodiment (species) of through-flow structure that interrupts through-flow as claimed. Decision 6-10. The basis of the Examiner’s rejection was the lack of description of any structure that performed the through-flow function to include interrupting the through-flow in three specified conditions. See Final Act. 3-4 (“[T]he fluid would appear to move to pressure chamber 12b through openings 29. However, pressure chamber 12b appears sealed to outlet 14. Therefore, it appears necessary that fluid would need to flow through a separate, undisclosed channel which would allow the fluid to bypass pressure chamber 12b.”; “the disclosure as originally filed is devoid of any discussion or disclosure of how the fluid moves through the valve”); 10 (same and “the Applicant has failed to provide sufficient disclosure showing how the fluid moves from one side of the valve to an opposite side”; “it is not enough to leave such structure of accomplishing the claimed function up to one of ordinary skill in the art”); Ans. 4-5 (interrupted flow). Regarding our alleged disregard for Wertheim and our use of a new legal theory, Wertheim did not accord a “strong presumption” of written description support for original claims, and Ariad indicates that situations involving broad generic claimed functions can be resolved by searching for species (embodiments) that support the broad genus claim. That is what the Examiner did. The Examiner sought a structural embodiment that channels and interrupts through-flow but found none. See Ans. 4-6. We agreed. Appeal 2021-003850 Application 14/422,183 20 We also agreed with the Examiner’s analysis that considered the level of ordinary skill in the art and determined, “one of ordinary skill in the art would not readily understand how the function or result of ‘through-flow’ is achieved based on the originally filed disclosure”, e.g., where that disclosure shows “the fluid is trapped as chamber 12b is shown to be sealed to the outlet” and “[t]he specification further discloses that the pressure chambers 12a and 12b are connected to outside air via slit 18 and connecting channel 19 (paragraphs 50 and 60).” Ans. 5. Our analysis made findings in line with the Examiner’s findings that the disclosed pressure chambers 12a, 12b, and through openings 29 appear inoperable because they do not permit through- flow and because they connect to outside air. We did not change the thrust of the rejection from the Examiner’s focus on the lack of any embodiment that includes structure to perform the claimed through-flow function and its interruption. Nor did we change the thrust of the Examiner’s underlying factual basis by considering whether the pressure chambers and flow paths were operable or not. See In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“The Board merely made explicit in its ‘findings of fact’ the bases for a rejection that would have been apparent to one with even a cursory command of prosecution practice from the examiner’s office actions.”). Appellant simultaneously argues that we failed to consider decisions such as In re Wertheim and the level of skill in the art and then alleges that our reliance on a genus-species analysis, which is the correct legal standard to apply, and our analysis of the description of air that is introduced into the pressure chambers and dead end flow paths, which takes into account the level of skill and understanding in the art as set forth in Appellant’s own Specification, constitute new grounds of rejection. Appeal 2021-003850 Application 14/422,183 21 Ironically, there is no dispute as to the scope of the written description in this appeal. The Examiner, Appellant, and this panel all agree that the Specification and original claims disclose a one-way valve device that has some sort of a generic through-flow.3 Appellant apparently recognizes that the original written description does not describe through-flow structure that channels the through-flow from the device inlet to the device outlet and that interrupts the through-flow in three claimed situations because Appellant submitted changes to the original specification and drawings to try to add such a description. As it stands, the alleged through-flow structure, e.g., chambers 12a, 12b and openings 29, terminates in a dead end and introduces air into any through-flow that is conveyed, thus indicating (according to the understanding of skilled artisans described in Appellant’s own Specification) that this channel cannot be used for through-flow in the device. All that is required of Appellant is to identify originally-disclosed structure to channel through-flow between an inlet and outlet and interrupt that through-flow in three situations.4 As discussed above, the prior art of record indicates the level of skill and the understanding that applicants will describe structure that conducts and interrupts the through-flow in a valve. Indeed, Appellant describes the air flow into the valve but not the through- flow and its interruption. Spec. ¶¶ 50, 60, Fig. 4 (arrows show air flow into pressure chamber 12b). 3 Appellant’s arguments about a generic “through-flow” are irrelevant and moot as the parties agree there is a generic through-flow. The dispute is over a lack of structure for through-flow and its interruption. See Request 1-4; 20; see also Decision 1-4, 20-22, 29-44; Final Act. 10; Ans. 4-5. 4 Analogies to vehicle internal combustion engines are not relevant to the resolution of this issue. See Request 32-36. Appeal 2021-003850 Application 14/422,183 22 XII. We Properly Considered the Specification & Drawing Objections Appellant argues that the Board had no jurisdiction over objections to the specification and drawings because “[t]he MPEP cannot trump case law, and the text the PTO cites from the MPEP does not apply to this situation - there is no new matter issue in the claims.” Request 50, 50-51 (“Is the USPTO saying that an originally filed claim contains ‘new matter.’ If so, we submit res ipsa loquitur.”), 52 (“There is no new matter in the claim.”). The Decision reviewed the Examiner’s objection to amendments that Appellant submitted for the Specification and claims because they contained new matter. See Decision 16-19. We sustained the Examiner’s objections to the proposed amendments to the Specification and drawings because they were not supported by the written description, i.e., they were new matter. Id. Apart from the written description rejection of the claims, there is no new matter objection that was made to the claims as Appellant contends. Appellant also contends that “PTAB precedent requires an applicant to file petitions against objections (we prove this below). Yet when we filed the petitions, Technical Center 3700 and the Petitions branch told us that this was an appealable decision.” Request 53 (“That is 100% the record.”), 54 (“Yet PTAB precedent mandated that we petition. . . . But if we do not file the petition, the PTAB will say that we waive our right to appeal. We respectfully defy the PTAB to explain why the above scenario is not 100% the case based on the record.”). We did not overlook or misperceive the fact that the Specification and drawing objections for new matter involved the same factual issues as the written description rejection and were appealable matters. Decision 16-19. Nor was Appellant deprived of the right to argue those objections before us. Appeal 2021-003850 Application 14/422,183 23 Ex parte Frye states the general rule that challenges to specification and drawing objections are by petition. Ex parte Frye, 94 USPQ2d 1072 (BPAI 2010) (precedential) (citing MPEP § 1201, 8th ed., rev. July 2008). However, Frye’s petition to the Director was dismissed because “[a] review of the record indicates that the drawing objection and claim rejection are directed to the same issues.” See Ex parte Frye, Appeal 2013-001300, 10/790,923, 2013 WL 2727876, *2 (PTAB, June 11, 2013). As a result, the panel in Frye decided the drawing objections as part of the appeal. The panel held that, “[i]n light of the Petition Decisions, which determined that the review of the objection and the rejection depends on the same issue, the Board’s decision on the propriety of the enablement rejection is determinative of the propriety of the refusal to enter the proposed drawing corrections.” Frye, 2013 WL 2727876, at *2. The panel’s resolution of the facts underlying the enablement rejection allowed it to resolve the objection to Frye’s drawing corrections. Id. at *3. Frye addressed the same issue we have here and resolved it the same way by deciding the drawing objections. Here, Appellant’s petition of the Examiner’s objections to proposed amendments to the specification and drawings was dismissed because [T]the examiner’s objections are also correspondingly directed to the propriety of the examiner’s rejections of the claims under 35 USC 112, 1st paragraph . . . [which] is clearly an appealable issue under 37 C.F.R. 41.31(a)(1), [so that] all issues at hand should be resolved at the Patent Trial and Appeal Board. Therefore, the procedure to resolve these issues are through appeal, not petition. Decision on Petition, 14/422,183 (June 12, 2020), at 4. Here, the petition was dismissed because the specification and drawing objections relate to the written description rejection and thus are appealable to the PTAB as in Frye. Appeal 2021-003850 Application 14/422,183 24 The amendment to paragraph 50 identifies new pressure chamber 12c as part of pressure space 12. Thus, it conflicts with original claim 1, which recited “the pressure space (12) being constructed from two interconnected pressure chambers (12a, 12b)” and “the two pressure chambers (12a, 12b) are arranged lying one above the other in the housing (2, 3) with respect to the flow direction between the first and second sides.” Original claim 1, filed Feb. 18, 2015. The original drawings illustrated pressure chamber 12a lying above pressure chamber 12b. The original disclosure did not describe pressure chamber 12c. See Decision 17. The amendment also deletes any reference to pressure space 12 comprising pressure chambers 12a, 12b that are connected to outside air as described in the original Specification. Id. Appellant is correct that the drawings illustrated a space in the valve device that Appellant now wants to label with numeral 12c. However, the Specification and original claim 1 originally identified pressure chamber 12 as comprising pressure chambers 12a, 12b, and these pressure chambers 12a, 12b are “connected to each other and to the outside air as described.” Spec. ¶ 50. Appellant’s amendment introduces new matter because it changes the structure of pressure chamber 12 from comprising chambers 12a, 12b, which are connected to outside air, to comprising chambers 12a, 12c, which are not connected to outside air. See id. ¶¶ 50, 51, 60, Figs. 3, 4; see Decision 6-10. The amendment to the description of Figure 8 similarly changes the structure of pressure space 12 so pressure chamber 12a is not connected to chamber 12b and outside air. See Decision 6-10, 17-18. Deleting original disclosure describing pressure chamber 12a connected to pressure chamber 12b and to outside air pressure changes the structure of pressure chamber 12 as classic new matter. See Decision 18. Attorney argument is not evidence. Appeal 2021-003850 Application 14/422,183 25 The original disclosure including the original claims, specification, and drawings consistently describes pressure chamber 12 comprising pressure chambers 12a, 12b and both of these pressure chambers being connected to the outside air. Spec. ¶¶ 50, 51, 60, Figs. 3, 4. Appellant’s amendments to the Specification seek to add new matter in the context of redefining what is considered to be the components of the pressure space 12 and also how those new pressure chambers 12a, 12c connect to each other and/or to outside air. See Request 59-60. We have not misperceived or overlooked any matter in assessing Appellant’s arguments in this regard. The same holds true for Appellant’s amended and new drawings that seek to alter the composition of pressure chamber 12 in direct contradiction to what is described in the original disclosure and original claims without any evidence of what a skilled artisan would understand beyond Appellant’s attorney arguments as to what Appellant thinks a skilled artisan understands. The problem with Appellant’s attempt to down play the drawing and specification objections (and written description rejection) as typographical errors that mistakenly included pressure chamber 12b as part of pressure chamber 12 instead of new pressure chamber 12c, is one fact. The original disclosure describes pressure space 12 as comprising two pressure chambers 12a, 12b that are connected to each other and to outside air by channels 18, 19 that introduce outside air into pressure chamber 12b not a new pressure chamber 12c. Replacing pressure chamber 12b with pressure chamber 12c changes the structure of pressure chamber 12, which no longer includes pressure chamber 12b, which connects to outside air pressure. Therefore, pressure chamber 12a may not connect to outside air pressure as described in the rest of the original disclosure. See Spec. ¶¶ 50, 51, 60. Appeal 2021-003850 Application 14/422,183 26 Appellant’s arguments as to the meaning of the original disclosure to a skilled artisan is not evidence such as affidavits. It might be argued that a skilled artisan would understand pressure chamber 12, 12a, 12b as structure that is pressurized by outside air to control through-flow between inlet 5 and outlet 14 by closing sealing membranes 61, 62 in underpressure situations at the inlet 5 and the outlet 14 as claimed. Through-flow from inlet 5 to outlet 14 would flow through another channel that is not described as providing the claimed through-flow that is interrupted. See Final Act. 3-4, 10; Ans. 5-6. As pressure chamber 12a is supposed to connect to outside air, connecting it to through-flow from inlet 5 is problematic. See Spec. ¶¶ 50, 60-62, Figs. 3, 4; see also Transcript, Hearing, Nov. 8, 2021, 6:1-25. “Through-openings” 29 appear to provide structure for through-flow. See Fig. 8. Yet, through- openings 29 are described as connecting pressure chamber 12a to pressure chamber 12b, which is connected to outside air pressure. Spec. ¶ 60. This description undermines their use as through-flow structure because they also connect pressure chambers 12a, 12b, which are connected to outside air that would become entrained in any through-flow channeled through through- openings 29. Merely connecting a newly-designated pressure chamber 12c to pressure chamber 12a via through-openings 29 as Appellant seeks to do with new matter added to the Specification and drawings does not solve the problem because pressure chamber 12a also is described as being exposed to air pressure at inlet 5 and sealing membrane 61 by air conducted through channels 32 and sectors 30 as discussed above. See Spec. ¶ 62, Figs. 4, 8. Thus, air entering pressure chamber 12a would entrain with through-flow and pass to new pressure chamber 12c via through-openings 29. A separate through-flow channel used only for through-flow is not described. Appeal 2021-003850 Application 14/422,183 27 CONCLUSION Outcome of Request for Rehearing: Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Denied Granted 1, 3, 4, 7-9, 12, 13, 17, 22-24, 26-30, 36, 37, 39, 40, 42, 44, 46-51 112(a) 1, 3, 4, 7-9, 12, 13, 17, 22-24, 26-30, 36, 37, 39, 40, 42, 44, 46-51 7 112(b) Indefiniteness 4 103 McMahon, Kamen Overall Outcome 1, 3, 4, 7-9, 12, 13, 17, 22-24, 26- 30, 36, 37, 39, 40, 42, 44, 46-51 Final Outcome of Appeal after Rehearing: Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1, 3, 4, 7-9, 12, 13, 17, 22-24, 26- 30, 36, 37, 39, 40, 42, 44, 46-51 112(a) 1, 3, 4, 7-9, 12, 13, 17, 22-24, 26- 30, 36, 37, 39, 40, 42, 44, 46-51 7 112(b) Indefniteness 7 4 103 McMahon, Kamen 4 Overall Outcome 1, 3, 4, 7-9, 12, 13, 17, 22-24, 26- 30, 36, 37, Appeal 2021-003850 Application 14/422,183 28 Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 39, 40, 42, 44, 46-51 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). DENIED