C.R.Bard, Inc.

Patent Trials and Appeals Board

Feb 10, 2022

2021001046 (P.T.A.B. Feb. 10, 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. 15/061,719 03/04/2016 Garrett Gomes P-18502.US01 7285 79990 7590 02/10/2022 Andrew D. Dorisio 300 West Vine Street Suite 1700 Lexington, KY 40507 EXAMINER BACHMAN, LINDSEY MICHELE ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 02/10/2022 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): dwpatents@dickinson-wright.com ip.docket@bd.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte GARRETT GOMES, ANDREW MOLL, CAMERON MOORE, SAMUEL RADOCHONSKI, CHANDER VIRK, and ANTHONY YOUNG Appeal 2021-001046 Application 15/061,719 Technology Center 3700 ____________ Before BIBHU R. MOHANTY, BRADLEY W. BAUMEISTER, and ROBERT J. SILVERMAN, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge ROBERT J. SILVERMAN. Opinion Dissenting-in-part filed by Administrative Patent Judge BRADLEY W. BAUMEISTER. SILVERMAN, Administrative Patent Judge. DECISION ON APPEAL Appeal 2021-001046 Application 15/061,719 2 STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s decision rejecting claims 1-3, 6-10, 12-14, 16-18, and 20-24. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. ILLUSTRATIVE CLAIM Claims 1, 10, 16, and 21 are the independent claims in the Appeal. Claim 1 illustrates the subject matter at issue: 1. An apparatus for performing a medical procedure in a vessel for transmitting a flow of fluid, comprising: a shaft including a lumen for receiving a guidewire; an inflatable perfusion balloon supported by the shaft and including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition; and a valve attached to the shaft within the internal passage for controlling the fluid flow. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as C.R. Bard, Inc. Appeal Br. 2. Appeal 2021-001046 Application 15/061,719 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Mische US 5,360,403 Nov. 1, 1994 Spenser et al. (“Spenser”) US 6,893,460 B2 May 17, 2005 Molgaard-Nielsen US 2009/0118681 A1 May 7, 2009 Drasler et al. (“Drasler”) US 7,951,111 B2 May 31, 2011 Thielen et al. (“Thielen”) US 2011/0264039 A1 Oct. 27, 2011 Cartledge et al. (“Cartledge”) US 8,574,289 B2 Nov. 5, 2013 Tilson et al. (“Tilson”) US 2014/0066896 A1 Mar. 6, 2014 REJECTIONS I. Claims 1-3, 6, and 9 are rejected under 35 U.S.C. § 102(a)(1) as anticipated by Tilson. II. Claims 1 and 3 are rejected under 35 U.S.C. § 102(a)(1) as anticipated by Mische. III. Claims 1-3 are rejected under 35 U.S.C. § 102(a)(1) as anticipated by Cartledge. IV. Claims 7 and 8 are rejected under 35 U.S.C. § 103 as unpatentable over Tilson and Thielen. V. Claims 10, 12, and 13 are rejected under 35 U.S.C. § 103 as unpatentable over Cartledge and Spenser. VI. Claim 14 is rejected under 35 U.S.C. § 103 as unpatentable over Cartledge, Spenser, and Tilson. Appeal 2021-001046 Application 15/061,719 4 VII. Claims 16-18, and 24 are rejected under 35 U.S.C. § 103 as unpatentable over Thielen and Tilson. VIII. Claim 20 is rejected under 35 U.S.C. § 103 as unpatentable over Thielen, Tilson, and Drasler. IX. Claims 21-23 are rejected under 35 U.S.C. § 103 as unpatentable over Tilson and Molgaard-Nielsen. FINDINGS OF FACT The findings of fact relied upon, which are supported by a preponderance of the evidence, appear in the following Analysis. ANALYSIS The following sections address the Appellant’s arguments, in the order presented in the Appeal Brief (pages 3-14). For the reasons provided below, we sustain the anticipation rejection of claims 1 and 3 (based upon Mische), the obviousness rejection of claims 16-18 and 24 (based upon Thielen and Tilson), and the obviousness rejection of claims 21-23 (based upon Tilson and Molgaard-Nielsen). Further, we do not sustain the anticipation rejection of claims 1-3, 6, and 9 (based upon Tilson), the anticipation rejection of claims 1-3 (based upon Cartledge), the obviousness rejection of claims 7 and 8 (based upon Tilson and Thielen), the obviousness rejection of claims 10, 12, and 13 (based upon Cartledge and Spenser), the obviousness rejection of claim 14 (based upon Cartledge, Spenser, and Tilson), and the obviousness rejection of claim 20 (based upon Thielen, Tilson, and Drasler). Appeal 2021-001046 Application 15/061,719 5 Anticipation by Tilson Claims 1-3, 6, and 9 stand rejected, as anticipated by the Tilson reference. See Final Act. 4-5. The Appellant argues that independent claim 1 stands wrongly rejected, because Tilson does not teach the recited “valve attached to the shaft within the internal passage for controlling the fluid flow.” Appeal Br. 4-5. In particular, the Appellant contends that Tilson lacks the “attach[ment]” of the “valve” “to the shaft,” per claim 1. Id. The Examiner maps claim 1 to Tilson’s embodiment shown in Figures 31A-31C. See Final Act. 4-5; Answer 4-5. Figures 31A-31C of Tilson are reproduced below: Tilson’s Figure 31A is a cutaway drawing of a balloon catheter device, showing valve 730 that is “placed in central fluid passage 692”; Figures 31B and 31C show perspective views of valve 730 (having valve leaflets 734) in closed and open positions, respectively. Tilson ¶¶ 71, 72, 212-13, Figs. 31A-31C. As to the relationship between the valve 730 and shaft 2000b, Tilson states: “The valve leaflets [734] may contact the outside of second hollow shaft 2000b when in a relaxed state.” Id. ¶ 212. Appeal 2021-001046 Application 15/061,719 6 According to the Examiner, Tilson’s opening and closing valve 730 - wherein the valve leaflets 734 (when closed) contact the outside of shaft 2000b - teaches the claim 1’s “attach[ment]” of the “valve” “to the shaft,” because “the term ‘attached’ is not given a special definition in Appellant’s specification” and that “[t]he plain meaning of the term ‘attached’ does not require direct physical attachment, or bonding.” Answer 4 (citing The Merriam Webster Online Dictionary as “defining the word ‘attached’ to mean ‘connected or joined to something’.”) The word “attached” may, in some circumstances, have the breadth reflected in the Examiner’s position. However, in this instance, the intrinsic evidence - particularly, the claims and Specification - will not afford such a broad interpretation. Indeed, “[s]uch intrinsic evidence is the most significant source of the legally operative meaning of disputed claim language.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The Federal Circuit has articulated particular guidance for interpreting claim language in view of the associated Specification: The correct inquiry in giving a claim term its broadest reasonable interpretation in light of the specification is not whether the specification proscribes or precludes some broad reading of the claim term adopted by the examiner. And it is not simply an interpretation that is not inconsistent with the specification. It is an interpretation that corresponds with what and how the inventor describes his invention in the specification, i.e., an interpretation that is “consistent with the specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997) (citation and internal quotation marks omitted); see also In re Suitco Surface, 603 F.3d 1255, 1259-60 (Fed. Cir. 2010). In re Smith Int’l, Inc., 871 F.3d 1375, 1382-83 (Fed. Cir. 2017). Appeal 2021-001046 Application 15/061,719 7 The Appellant’s claims and Specification describe multiple arrangements of valves, shafts, and balloons (defining passages therethrough). Notably, in regard to the interpretation of the claim language at issue, the Specification shows embodiments with a valve attached to a shaft or tube that passes through the valve (so as to permit or obstruct flow outside the valve, e.g., between the valve and the balloon), as well as embodiments with a valve attached (e.g., to a balloon) at its outer surface (so as to permit or obstruct flow through the valve). See Spec. ¶¶ 36-51. For example, in Figures 4 and 5 of the Specification, “the valve 18 is formed of a body comprised of a flexible material in a generally frusto- conical shape when actuated (Figures 4 and 4A) to restrict flow through [the passage through the balloon], and then collapsed to permit substantially unrestricted flow (Figures 5 and 5A).” ¶ 43. Figures 4 and 5, reproduced below, illustrate this embodiment: Appeal 2021-001046 Application 15/061,719 8 Figure 4 is a cross-sectional side view of an embodiment of the Specification, showing valve 18 in a configuration to inhibit flow through the device; Figure 5 is a cross-sectional side view of an embodiment of the Specification, showing valve 18′ in a configuration to permit flow through the device. Id. ¶¶ 22, 25, 43. In this embodiment, “the valve 18” “may be connected along the inner portion to the [central, axially extending] tube 14, such as by bonding (adhesive, welding (thermal or otherwise), tape, etc.)” and “[a]lternatively or additionally, the material forming valve 18 may be bonded to form part of the distal tip 10a of the device 10.” Id. ¶ 44. A valve similar to that of Figures 4 and 5 is shown in Figures 2 and 3. See id. ¶¶ 33- 42, Figs. 2, 2A, 3, 3A. In the embodiment of Figures 2 and 3, “the material forming the valve 18 is connected at the innermost portion to the shaft or tube 14 passing through the balloon 12,” wherein, “[t]he connection may be established by known bonding methods, such as adhesives, tapes, welding, or the like.” Id. ¶ 39. The Specification shows a different valve configuration, in Figures 10 and 11. The Specification (¶ 49) describes a valve having an exterior surface that is “adhered at least partially to the interior of the balloon 12,” as shown in Figures 10 and 11: Appeal 2021-001046 Application 15/061,719 9 Figures 10 and 11 are a cross-sectional drawings of a balloon catheter device, wherein Figure 10 shows valve 18 in a cylindrical shape, so as to permit fluid flow therethrough, and Figure 11 shows a portion of valve 18′ drawn against shaft 14, so as to prevent flow therethrough. Spec. ¶¶ 28, 30, 49, 50. In the embodiment of Figures 10 and 11, “[t]he attachment may be achieved using bonding, such as adhesives (glue, epoxy, etc.), tape, welding, or other forms of thermal adhesion, etc., such that a circumferential seal is formed along the periphery of the valve 18.” Id. ¶ 49. Independent claim 10 of the present Appeal corresponds to the valve embodiment shown in Figures 10 and 11. Notably, claim 10 recites “a valve comprising an elongated tube at least partially attached to the inflatable perfusion balloon, the elongated tube adapted for partially collapsing to control the fluid flow within the passage.” Further, dependent claim 12 recites: “The apparatus of claim 10, wherein the tube comprises a distal Appeal 2021-001046 Application 15/061,719 10 portion connected to the balloon and a proximal portion not connected to the balloon.” In the Specification, whether the valve is connected to a tube or shaft passing through the valve, as in Figures 2, 3, 4, and 5, or whether the valve is connected at its periphery (to the balloon), as in Figures 10 and 11, the connection involves a substantial degree of fixation. The embodiment of Figures 4 and 5 involves, for example, “bonding (adhesive, welding (thermal or otherwise), tape, etc.)” (Spec. ¶ 44); “[t]he attachment,” in the embodiment of Figures 10 and 11, “may be achieved using bonding, such as adhesives (glue, epoxy, etc.), tape, welding, or other forms of thermal adhesion, etc.” (id. ¶ 49). Mindful of the aim to interpret claim language in a manner “that corresponds with what and how the inventor describes his invention in the specification,” In re Smith Int’l, 871 F.3d at 1383, we understand claim 1 - reciting “a valve attached to the shaft within the internal passage for controlling the fluid flow” - to correspond to the valve configuration of Figures 2, 3, 4, and 5 of the Specification, having an attachment to a shaft or tube passing through the valve. The valve of claim 1 stands in contrast to that of independent claim 10 (reciting “a valve comprising an elongated tube at least partially attached to the inflatable perfusion balloon”), which, as discussed above, corresponds to the configuration shown in Figures 10 and 11 of the Specification. Further, the Specification’s description of the degree of the disclosed valves’ fixation to the central shaft or tube 14 (for the embodiments of Figures 2, 3, 4, and 5, per paragraphs 33-42 and 44 of the Specification), or to the balloon (for the embodiment of Figures 10 and 11, per paragraph 49 of Appeal 2021-001046 Application 15/061,719 11 the Specification), as discussed above, does not comport with the intermittent contact exhibited by Tilson’s valve 730 and shaft 2000b (see Tilson ¶ 212, Figs. 31A-3C). Therefore, in view of the foregoing, we are persuaded that the Examiner erred in rejecting independent claim 1 as anticipated by Tilson. This determination also applies to dependent claims 2, 3, 6, and 9, which rely upon the same mapping of claim 1 to Tilson. See Final Act. 5. Accordingly, we do not sustain the rejection of claims 1-3, 6, and 9 under 35 U.S.C. § 102(a)(1), based upon Tilson. Anticipation by Mische The Examiner rejects claims 1 and 3 as anticipated by the Mische reference. Final Act. 6. The rejection states that Figures 9 and 12 of Mische show the claimed “balloon” (Mische’s element 102) having an “internal passage” (Mische’s element 106), and a “shaft” (Mische’s element 114) including a “lumen” (Mische’s element 104). Id. These features are shown in Mische’s Figure 12: Appeal 2021-001046 Application 15/061,719 12 Figure 12 of Mische reference shows a longitudinal sectional view of a balloon catheter device. Mische col. 2, ll. 58-59. The Appellant argues that independent claim 1 stands wrongly rejected, as being anticipated by Mische, because “the rejection fails to account for the requirement for a perfusion balloon having an internal passage.” Appeal Br. 5. The Appellant argues: “Claim 1 expressly requires that the shaft include a lumen for receiving a guidewire, which is clearly not the internal passage associated with the ‘valve’ 110 in Mische.” Id. The Appellant emphasizes: “the claim requires a perfusion balloon having ‘an internal passage . . .” in addition to a shaft.” Id. According to the Appellant, the passage (identified by element 106, in Mische) “is not an internal passage of the balloon, as the claim expressly requires, but rather the shaft, a separately defined element in the claim.” Reply Br. 3. But the Examiner’s identified “internal passage” (element 106 of Mische) is within the balloon 102, even though it is also within the shaft 114. See Mische Fig. 12. The Appellant appears to maintain that the recited “internal passage” must have some amount of separateness from the “shaft” - a feature allegedly lacking in Mische. Yet, the Appellant does not articulate why the language of claim 1 would preclude the Examiner’s mapping of the “shaft” and the “internal passage” to Mische. Although Mische’s Figure 12 differs from embodiments disclosed in the Appellant’s Specification, the Appellant does not present a reason why the identified embodiment of Mische would not meet the limitations of claim 1. The Reply Brief includes various additional new arguments, not presented in the Appeal Brief. See Reply Br. 3. We do not address these new arguments. See 37 C.F.R. § 41.41(b)(2) (“Any argument raised in the Appeal 2021-001046 Application 15/061,719 13 reply brief which was not raised in the appeal brief, or is not responsive to an argument raised in the examiner’s answer . . . will not be considered by the Board for purposes of the present appeal, unless good cause is shown.”) The separate opinion (dissenting-in-part) raises issues that are not raised in the Appeal Brief, and that are otherwise not persuasive of error in the rejection of claim 1. The Appellant does not separately argue dependent claim 3. Therefore, we sustain the rejection of claims 1 and 3 under 35 U.S.C. § 102(a)(1) based upon Mische. Anticipation by Cartledge The Examiner rejects claims 1-3 as anticipated by the Cartledge reference, maintaining that Cartledge’s “check valve 216,” described in the reference as having “a monoleaflet, bileaflet, or ball/cage design” (Cartledge col. 13, ll. 58-60, Figs. 3D, 3E), and “hollow catheter 122” (id. col. 13, l. 46, Figs. 3D, 3E) teach the recited “valve attached to the shaft within the internal passage.” See Final Act. 6. The Appellant argues: “Nowhere is there any indication that the check valve 216 is attached to any shaft, as claim 1 expressly requires.” Appeal Br. 6. As discussed above, in regard to the rejection of claim 1 over the Tilson reference, the “attach[ment] to the shaft” in this claim requires substantial fixation between the “valve” and the “shaft” that cannot be satisfied by intermittent contact. The operation of Cartledge’s “check valve 216” is not sufficient clear, on the present record, to support a finding of such an “attach[ment]” between Cartledge’s “check valve 216” and “hollow catheter 122.” Indeed, the Examiner (in addressing claim 10) states Appeal 2021-001046 Application 15/061,719 14 that Cartledge “fails to teach how the valve (216) is attached to the device” and finds that “in order to be constructed as shown in Figures 3c, 3d, 3e, the valve (216) is attached to either (1) the balloon or (2) the shaft.” Final Act. 8. Accordingly, we do not sustain the rejection of independent claim 1 and dependent claims 2 and 3 under 35 U.S.C. § 102(a)(1) as anticipated by Cartledge. Obviousness Over Tilson and Thielen Claim 7 recites: The apparatus of claim 1, wherein the balloon comprises a plurality of cells in a single cross-section bounding the internal passage, wherein each cell comprises a neck having an inflation lumen for supplying fluid for inflating the inflatable perfusion balloon, and the valve when actuated occupies a space between the necks and the shaft. Claim 8 recites: “The apparatus of claim 7, wherein the valve is connected to at least one of the necks.” The Examiner rejects dependent claims 7 and 8 as obvious over Tilson, “as applied to [independent] claim 1,” in view of Thielen. Final Act. 7. As explained above, Tilson does not teach claim 1’s recited “valve attached to the shaft.” The rejection does not address any manner in which Tilson, Thielen, or their combination might overcome the identified deficiency. Therefore, we do not sustain the rejection of claims 7 and 8 as obvious over the combination of Tilson and Thielen. In addition, the Appellant disputes the sufficiency of the Examiner’s reason for combining Tilson and Thielen. See Appeal Br. 3-4. Appeal 2021-001046 Application 15/061,719 15 According to the Examiner, Thielen “was relied upon to show it would be obvious to move” Tilson’s valve “to a location towards the end of the balloons, such that the valve is located between the balloon neck and the shaft, as recited in claim 7.” Answer 6. The Examiner states that Tilson’s Figure 8 - “an alternate embodiment” of the reference - shows that “valve 718 can be placed [in] the tapered neck region of balloon 682” and Thielen is “cited to show further evidence that placement of a valve in a tapered neck region can be done without changing the performance of the device.” Id. at 7. As the Supreme Court explained, it is essential, in an obviousness analysis, to provide a reason for combining and/or modifying the teachings of prior art references, such as the Examiner proposes in this Appeal: [A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art. Although common sense directs one to look with care at a patent application that claims as innovation the combination of two known devices according to their established functions, it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does. This is so because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418-19 (2007). Relatedly, our reviewing court explained that “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Accordingly, the Federal Circuit has elsewhere stated, “[w]ithout any Appeal 2021-001046 Application 15/061,719 16 explanation as to how or why the references would be combined to arrive at the claimed invention, we are left with only hindsight bias that KSR warns against” and “we cannot allow hindsight bias to be the thread that stitches together prior art patches into something that is the claimed invention.” Metalcraft of Mayville, Inc., v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir. 2017). In regard to the proposed combination of Tilson and Thielen, the understanding that changing the location of the valve would not impair performance, as the Examiner finds (Answer 7), might not deter a person of ordinary skill in the art from combining these references. Nevertheless, the Examiner has not articulated a reason for doing so. Accordingly, the Appellant persuades us of error in the rejection of claim 7. The rejection of claim 8, which depends from claim 7, is subject to the same error. Therefore, we do not sustain the rejection of claims 7 and 8 under 35 U.S.C. § 103 based upon Tilson and Thielen. Obviousness Over Cartledge and Spenser The Examiner rejects independent claim 10 and dependent claims 12 and 13 as obvious over Cartledge and Spenser. See Final Act. 8-9. Claim 10 recites: 10. An apparatus for performing a medical procedure in a vessel for transmitting a flow of fluid, comprising: a shaft; an inflatable perfusion balloon supported by the shaft and including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition; and a valve comprising an elongated tube at least partially attached to the inflatable perfusion balloon, the elongated tube Appeal 2021-001046 Application 15/061,719 17 adapted for partially collapsing to control the fluid flow within the passage. In rejecting claim 10, the Examiner relies upon Cartledge for the recited “shaft” and “balloon” associated with a “valve,” and the Examiner relies upon Spenser for the specific form of the recited “valve” - i.e., an “elongated tube” that is “adapted for partially collapsing to control the fluid flow within the passage.” Final Act. 8-9. Yet, the Examiner does not rely upon Spenser for teaching the recited “elongated tube at least partially attached to the inflatable perfusion balloon.” Further, the Examiner acknowledges that Cartledge “fails to teach how the valve (216) is attached to the device.” Id. at 8. “However,” the Examiner maintains, “in order to be constructed as shown in [Cartledge’s] Figures 3c, 3d, 3e, the valve (216) is attached to either (1) the balloon or (2) the shaft.” Id. The Examiner further reasons: [I]t would have been obvious to one of ordinary skill in the art to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In particular, the device of Cartledge ’289 would have performed equally well if the valve is attached to either the balloon or the shaft because both attachment locations would provide the same predictable result of controlling fluid flow through the internal passage of balloon (114). Id. The Examiner’s reasoning, here, is drawn from the Supreme Court’s KSR opinion. See KSR, 550 U.S. at 421 (“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads Appeal 2021-001046 Application 15/061,719 18 to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”) The Federal Circuit regards this form of reasoning as a so-called “design choice.” Uber Techs., Inc. v. X One, Inc., 957 F.3d 1334, 1338-1340 (Fed. Cir. 2020). A design-choice analysis requires a factual determination that there are only a finite number of known techniques for accomplishing a particular purpose. See Uber, 957 F.3d at 1340 (“Okubo’s terminal-side plotting and Konishi’s server-side plotting were both well known in the art, and were the only two identified, predictable solutions for transmitting a map and plotting locations, it would have been obvious to substitute server-side plotting for terminal-side plotting in a combination of Okubo and Konishi.”) See also CRFD Research, Inc. v. Matal, 876 F.3d 1330, 1347 (Fed. Cir. 2017) (“[A] person of ordinary skill would have two predictable choices for when the [prior art] would transmit browser information, providing a person of ordinary skill with a simple design choice.”); ACCO Brands Corp. v. Fellowes, Inc., 813 F.3d 1361, 1367 (Fed. Cir. 2016) (“The prior art consistently locates the two sensors at issue in the shredder’s feed, and no party disputes that an ordinary artisan would have found this the obvious location for the combination of sensors. The ordinary artisan would then be left with two design choices.”) In the present Appeal, as the Appellant argues (see Appeal Br. 9-10), the Examiner has not identified predicate factual findings needed to support the assertion that “the device of Cartledge ’289 would have performed equally well if the valve is attached to either the balloon or the shaft” (Final Act. 8). Indeed, to the contrary, the Examiner points out (as noted above) that Cartledge “fails to teach how the valve (216) is attached to the device.” Appeal 2021-001046 Application 15/061,719 19 Id. at 8. Contrary to the Examiner’s position in the Answer (page 8), the absence of such a teaching is not remedied by Cartledge’s non-specific disclosure (col. 13, ll. 53-54) that “check valve 216 is incorporated into the balloon expansion mechanism 112.” Therefore, we are persuaded of error in the rejection of independent claim 10. The rejection of dependent claims 12 and 13 (see Final Act. 9; Answer 8-9) does not apply Cartledge or Spenser in a manner that might overcome the error identified above. Accordingly, we do not sustain the rejection of claims 10, 12, and 13 under 35 U.S.C. § 103 based upon Cartledge and Spenser. Obviousness Over Cartledge, Spenser, and Tilson Claim 14 recites: “The apparatus of claim 10, wherein the balloon comprises a plurality of cells in a single cross-section, and the tube is positioned in a part of the passage formed by the plurality of cells.” The rejection of claim 14 relies upon the same application of Cartledge and Spenser, to independent claim 10, discussed above. See Final Act. 10. Accordingly, for the reasons addressed in regard to claim 10, we do not sustain the rejection of claim 14 under 35 U.S.C. § 103 based upon Cartledge, Spenser, and Tilson. Obviousness Over Thielen and Tilson Independent claim 16 and dependent claims 17, 18, and 24 stand rejected as obvious over Thielen and Tilson. See Final Act. 11-12. Claim 16 recites: 16. An apparatus for performing a medical procedure in a vessel for transmitting a flow of fluid, comprising: Appeal 2021-001046 Application 15/061,719 20 a shaft; an inflatable perfusion balloon supported by the shaft and including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition, the balloon comprising a generally tapered portion extending toward the shaft; and a valve positioned in a space between the shaft and the balloon in the generally tapered portion for controlling the fluid flow within the passage. The Appellant argues that the rejection “fails to account for” claim 16’s limitation of “a valve positioned in a space between the shaft and the balloon in the generally tapered portion for controlling the fluid flow within the passage,” which, according to the Appellant, neither Thielen nor Tilson teaches. See Appeal Br. 12. In view of the Appellant’s use of underlining and boldface in the Reply Brief, it appears that the Appellant’s position is that neither Thielen nor Tilson, considered individually, teaches the particular location of the valve - i.e., “a valve positioned in a space between the shaft and the balloon in the generally tapered portion for controlling the fluid flow within the passage.” Reply Br. 12. According to the Appellant: “The valve 130 in Thielen plainly does not meet this requirement, nor does Tilson. Thus, the invention ‘as a whole’ has not been shown present in the prior art, as Section 103 commands.” Id. Contrary to the Appellant’s position that neither “Thielen . . . nor . . . Tilson” alone teaches the limitation at issue, however, the Examiner relies upon Thielen’s and Tilson’s combined teachings. See Final Act. 11; Answer 11. Specifically, the Examiner relies upon Thielen for teaching a valve “in the generally tapered portion,” but relies upon Tilson for teaching a valve “positioned in a space between the shaft and the balloon.” See Final Appeal 2021-001046 Application 15/061,719 21 Act. 11; Answer 11. Consequently, the Appellant’s arguments, as to the teachings of the cited references, does not persuade us of error in the rejection, because “one cannot show non-obviousness by attacking references individually where, as here, the rejections are based on combinations of references.” In re Keller, 642 F.2d 413, 426 (CCPA 1981). The Appellant also argues that the rejection of claim 16 lacks an adequate reason to combine the identified teachings of Thielen and Tilson. Appeal Br. 12. According to the Examiner, a reason for combining Tilson’s teachings, wherein “the shaft is centered within the internal passage,” with those of Thielen, would have been the “advantage” of Tilson’s “lumen (154, formed by shaft 2000b) being used to insert a guidewire into the lumen of the shaft 2000b to locate the balloon during a medical procedure.” Final Act. 12 (citing Tilson ¶ 206). The Appellant contends that the Examiner does not articulate “a reason with a rational underpinning that would motivate a skilled artisan to combine the reference teachings, but rather simply an observation of the teaching of Tilson in isolation.” Appeal Br. 12. The Appellant does not indicate why “an observation” (Appeal Br. 12) of a reference’s teaching could not be a sufficient reason for combining that reference with another. After all, reference teachings constitute a proper source of reasons to combine or modify references. See WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1355 (Fed. Cir. 1999) (“The suggestion to combine may be found in explicit or implicit teachings within the references themselves.”) Furthermore, the Supreme Court has explained: “Under the correct analysis, any need or problem Appeal 2021-001046 Application 15/061,719 22 known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at 420. Therefore, the Appellant’s assessment of the Examiner’s reason for combining Thielen and Tilson does not persuade us of error in the rejection of claim 16. Claim 17 recites: “The apparatus of claim 16, wherein the valve comprises a body having a generally frusto-conical shape in an expanded condition.” The Examiner relies upon Thielen for teaching the limitations of claim 17, stating that Thielen’s valve 130, shown in Figure 1B, has the claimed “generally frusto-conical shape in an expanded condition.” Final Act. 12. The Appellant argues that Thielen fails to teach these limitations, maintaining that Thielen’s valve 130 “is in a collapsed, rather than an expanded condition.” Appeal Br. 13. However, the Appellant does not dispute that Thielen teaches a valve having the claimed “generally frusto- conical shape.” As discussed above, the Specification describes multiple valve configurations. In regard to valves being in an “expanded condition,” the Specification, in one aspect, refers to a valve being “collapsed,” in the course of, e.g., “removal of the device” from a patient’s body, whereby the valve may be “forcibly collapsed,” in order “to ensure that removal of the device 10 may be reliably achieved without interference from valve in the actuated or expanded condition.” Spec. ¶ 42. The Specification further explains: Appeal 2021-001046 Application 15/061,719 23 [T]he material forming the valve 18 may . . . be provided with properties to facilitate preferential folding when the balloon 12 is collapsed, and then expansion. This may be achieved, for example, by the use of different thickness of material to create living hinges or like structures that cause the material to fold or otherwise behave in a certain manner. The material of the valve body may also be provided with fold lines, pleats, beads, or supports to cause folding and unfolding to occur in a preferential manner to ensure that the valve 18 expands or collapses in the intended way to achieve the desired valving function. Id. ¶ 48 (emphasis added). This reference to the “valving function” (id.) refers to the expanding/collapsing behavior of disclosed valves in alternately permitting and hindering fluid flow. For example, a disclosed valve embodiment, “[w]hen unactuated (folded down or collapsed; see valve 18' in Figures 3, 3A), such as during systole, the valve 18 allows substantial flow through the passage P”; “[t]he valve 18 may thus repeatedly and regularly restrict and allow fluid flow through the passage P.” Id. ¶ 36. The Specification continues: “In the illustrated embodiment, the valve 18 comprises a single piece of a flexible material having a generally frusto- conical shape,” but “may take other forms.” Id. ¶ 37. See also id. ¶ 43 (“In this embodiment, the valve 18 is formed of a body comprised of a flexible material in a generally frusto-conical shape when actuated (Figures 4 and 4A) to restrict flow through passage P, and then collapsed to permit substantially unrestricted flow (Figures 5 and 5A).”) In view of the Specification, the term “expanded” - as applied to a valve - may refer either to the valve’s operative state (as opposed to, e.g., a folded state for insertion/removal of the device) or to the periodic Appeal 2021-001046 Application 15/061,719 24 configuration for hindering fluid flow (by contrast with a collapsed state that permits such flow). Claim 17’s “expanded condition” language (“the valve comprises a body having a generally frusto-conical shape in an expanded condition”) is drafted broadly enough to encompass either sense of an “expanded” valve in the Specification. The Appellant argues that the expression “expanded condition,” in claim 17, refers exclusively to the valve’s periodic configuration in hindering or permitting fluid flow, arguing: “‘Expanded’ is logically the opposite of ‘collapsed.’ Hence, the expanded condition corresponds to actuation to restrict flow through the passage.” Answer 6. However, Thielen manifests the Specification’s other sense of the expression “expanded condition” (and satisfies the “expanded” limitation of claim 17), because it contrasts the form shown in Thielen’s Figure 1B with a “compressed” form used for insertion of the device into a patient’s body: A temporary valve (130) can be located within the perfusion lumen (25). This valve would be formed from a thin and flexible polymer or biological material such that it could be compressed down to a small diameter as the perfusion balloon (10) is being inserted into the body and will unfold to become a functioning valve while the perfusion balloon (10) is expanded. Thielen ¶ 44. Therefore, the Appellant does not persuade us of error in the Examiner’s mapping claim 17’s limitations to Thielen. The Appellant does not separately argue claims 18 and 24, which both depend from claim 16. Accordingly, in view of the foregoing, we sustain the rejection of claims 16-18 and 24 under 35 U.S.C. § 103 based upon Thielen and Tilson. Appeal 2021-001046 Application 15/061,719 25 Obviousness Over Thielen, Tilson, and Drasler Claim 20 stands rejected as obvious over Thielen, Tilson, and Drasler. See Final Act. 12-13. Claim 20 recites: “The apparatus of claim 16, wherein the generally tapered portion is at a distal end portion of the balloon.” As stated above, claim 16 recites “a valve positioned in a space between the shaft and the balloon in the generally tapered portion.” The Examiner finds that Drasler shows “a tapered neck portion of the balloon at both the proximal and distal portions” of the disclosed device. Final Act. 12 (citing Drasler Fig. 26). In addition, the Examiner finds that Drasler further teaches that “the balloon can be provided with a valve at the proximal or distal portions of the central flow area (292) to prevent regurgitation of fluid passing through the balloon.” Id. (citing Drasler col. 25, ll. 18-27). The Examiner maintains that it would have been obvious for a person of ordinary skill in the art, at the relevant time, to modify Thielen’s device, in order to have the “the generally tapered portion . . . at a distal end portion of the balloon” (per claim 20), because Drasler teaches that either end of the balloon may be tapered and “one of ordinary skill in the art would expect the perfusion balloon to perform equally well whether the valve is placed at the proximal or distal portion of the balloon.” Id. at 13. The Appellant argues that the rejection lacks a sufficient reason to combine the teachings of the cited references. Appeal Br. 13. We agree with the Appellant. A determination that a particular combination of teachings might be operable does not amount to a reason to combine those teachings. See Belden, 805 F.3d at 1073. Appeal 2021-001046 Application 15/061,719 26 Accordingly, we do not sustain the rejection of claim 20 under 35 U.S.C. § 103 based upon Thielen, Tilson, and Drasler. Obviousness Over Tilson and Molgaard-Nielsen Claims 21-23 stand rejected as obvious over Tilson and Molgaard- Nielsen. See Final Act. 13. Independent claim 21 recites: 21. An apparatus for performing a medical procedure in a vessel for transmitting a flow of fluid, comprising: a shaft; an inflatable perfusion balloon supported by the shaft and including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition; a valve for controlling the fluid flow within the passage; and a connector for connecting to the valve to control the position thereof. Dependent claims 22 and 23 add additional features to the recited “connector.” Claim 22 recites: “The apparatus of claim 21, wherein the connector comprises a tether extending between the valve and the balloon for preventing the valve from inverting.” Claim 23 recites: “The apparatus of claim 21, wherein the connector comprises a tether extending between the valve and the shaft or an associated sheath.” The Examiner maintains that it would have been obvious for a person of ordinary skill in the art, at the relevant time, to combine Molgaard- Nielsen’s tethers, to the Tilson device, because Molgaard-Nielsen’s tethers “prevent the valve from inverting.” Final Act. 13 (citing Molgaard-Nielsen ¶¶ 73, 76). As Molgaard-Nielsen (¶ 73) states: “These tethers assist in preventing eversion of the valve element 126 as a catheter, pusher or other Appeal 2021-001046 Application 15/061,719 27 insert 24 is passed through the valve assembly 100.” Molgaard-Nielsen ¶ 73. The Appellant argues that the Examiner does not provide an adequate reason for combining Tilson with Molgaard-Nielsen. Appeal Br. 13. According to the Appellant, the Examiner’s position “is simply an observation of the teaching of the Molgaard-Nielsen reference, rather than a proper reason with a rational underpinning for combining the reference teachings, as the law commands.” Id. Contrary to the Appellant’s argument, the Examiner’s identified benefit of employing Molgaard-Nielsen’s tethers - i.e., preventing inversion of the valve - is a reason to combine drawn from one of the references, such as our reviewing court countenances. See WMS Gaming, 184 F.3d at 1355. Therefore, we are not persuaded of error in the rejection of independent claim 21, as well as dependent claim 23 (which is not argued separately). The Appellant raises an additional argument, concerning the adequacy of the references’ teachings, in regard to dependent claim 22. Specifically, the Appellant contends that the references do not teach claim 22’s feature of “a tether extending between the valve and the balloon.” See Appeal Br. 13- 14. The Appellant argues: Nowhere does any cited reference propose, teach, or even remotely suggest a tether between a valve and a balloon, nor does the Examiner explain why it would have been obvious to attach the tethers to a balloon, as opposed to the shaft or some other location. Simply citing to the tethers 132, 134 of Molgaard-Nielsen in no way establishes a skilled artisan would connect the tether to a balloon, when there is no teaching of such whatsoever. Appeal 2021-001046 Application 15/061,719 28 Id. at 14. Yet, the Examiner’s position does not require that either reference, individually, teaches the recited “tether extending between the valve and the balloon,” as the Appellant contends (Appeal Br. 14). The Examiner, instead, finds that this limitation is satisfied by the combined teachings of Tilson and Molgaard-Nielsen. Final Act. 13. The Appellant does not identify an error in the Examiner’s position. Tilson depicts valve 730 disposed in a fluid passage that is surrounded by balloon segments 656. Tilson ¶ 212, Fig. 31A. Tilson also teaches, “[t]he valve leaflets 734 may be anchored to the balloon segments 656 or the inside of the shell wall 684.” Id. ¶ 212. Molgaard-Nielsen teaches using a tether to “tie the end of the valve element 126 to the opposite end of the casing” (Molgaard-Nielsen ¶ 73, Fig. 4) - i.e., a tether can extend from the outlet leaflets of valve 126 to the valve casing 114 (the casing being a structure that surrounds the valve leaflets). Molgaard-Nielsen ¶ 73, Fig. 4. Furthermore, the Appellant disputes neither Molgaard-Nielsen’s teaching of a “connector for connecting to the valve” (in regard to claim 21), nor Tilson’s teaching of the relative locations of the “valve” and the “balloon” (in regard to claim 22) - such that, in their combined teachings, a “connector” or “tether” would “extend[ ] between the valve and the balloon.” See Appeal Br. 13-14. In view of the foregoing, as to the rejection under 35 U.S.C. § 103 based upon Tilson and Molgaard-Nielsen, we sustain the rejection of claims 21-23. Appeal 2021-001046 Application 15/061,719 29 CONCLUSION The Examiner’s rejection of claims 1 and 3 under 35 U.S.C. § 102(a)(1), and the Examiner’s rejections of claims 16-18, 21-23, 24 under 35 U.S.C. § 103 are affirmed. The Examiner’s rejections of claims 2, 6, and 9 under 35 U.S.C. § 102(a)(1) and the Examiner’s rejections of claims 6-10, 12-14, and 20 under 35 U.S.C. § 103 are reversed. Specifically: We reverse the rejection of claims 1-3, 6, and 9 under 35 U.S.C. § 102(a)(1) as anticipated by Tilson, We affirm the rejection of claims 1 and 3 under 35 U.S.C. § 102(a)(1) as anticipated by Mische. We reverse the rejection of claims 1-3 under 35 U.S.C. § 102(a)(1) as anticipated by Cartledge. We reverse the rejection of claims 7 and 8 under 35 U.S.C. § 103 as obvious over Tilson and Thielen. We reverse the rejection of claims 10, 12, and 13 under 35 U.S.C. § 103 as obvious over Cartledge and Spenser. We reverse the rejection of claim 14 under 35 U.S.C. § 103 as obvious over Cartledge, Spenser, and Tilson. We affirm the rejection of claims 16-18, and 24 under 35 U.S.C. § 103 as obvious over Thielen and Tilson. We reverse the rejection of claim 20 under 35 U.S.C. § 103 as obvious over Thielen, Tilson, and Drasler. We affirm the rejection of claims 21-23 under 35 U.S.C. § 103 as obvious over Tilson and Molgaard-Nielsen. Appeal 2021-001046 Application 15/061,719 30 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-3, 6, 9 102(a)(1) Tilson 1-3, 6, 9 1, 3 102(a)(1) Mische 1, 3 1-3 102(a)(1) Cartledge 1-3 7, 8 103 Tilson, Thielen 7, 8 10, 12, 13 103 Cartledge, Spenser 10, 12, 13 14 103 Cartledge, Spenser, Tilson 14 16-18, 24 103 Thielen, Tilson 16-18, 24 20 103 Thielen, Tilson, Drasler 20 21-23 103 Tilson, Molgaard- Nielsen 21-23 Overall Outcome 1, 3, 16- 18, 21-23, 24 2, 6-10, 12-14, 20 TIME PERIOD FOR RESPONSE 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). AFFIRMED IN PART Appeal 2021-001046 Application 15/061,719 31 BAUMEISTER, Administrative Patent Judge, dissenting in part. I agree with all of the Majority’s determinations and reasoning with two exceptions. I would reverse the anticipation rejection of claim 1 and 3 over Mische. I also would reverse the obviousness rejection of claims 16-18 and 24 over Thielen and Tilson. My reasoning is set forth below: The Anticipation Rejection Based on Mische Appellant argues that claim 1 in not anticipated by Mische. Appeal Br. 5. I agree. Mische describes that invention as follows: An apparatus for and method of selectively occluding a lumen of a multilumen catheter during a medical procedure. The catheter may have any variety of functions of either diagnostic and/or therapeutic nature. A first open lumen to be occluded may have one or more orifices at the distal tip and/or in the side wall of the catheter for infusion of a liquid, injection of a dye, or operation of a guide wire or other control device. A small balloon adjacent the lumen to be occluded is inflated with fluid from a second, closed lumen. Whenever the small balloon is completely inflated, the first, open lumen is occluded. Whenever the small balloon is deflated, the lumen is open to the orifices distal to the small balloon. Mische, Abstr. (emphasis added). The Examiner relies on the embodiment of Mische’s Figures 9 and 12. Final Act. 6. Mische describes this embodiment of multi-lumen catheters, as follows: [C]atheter 100 has an outer sheath 114. First lumen 106 is open at the distal tip and is separated from closed second lumen 104 by septum 108. In the alternative embodiment, catheter 100 has inflatable balloon 102 attached near the distal end. Inflatable balloon 102 is in fluid communication with second lumen 104 via aperture 109. Inflatable balloon 102 is inflated in the manner know[n] in the art by injection of a pressurized fluid into the Appeal 2021-001046 Application 15/061,719 32 proximal end of second lumen 104 (not shown). Balloon may be inelastic as with a dilatation balloon or elastic as with a positioning device. Inner balloon 110 is sealingly fixed over aperture 112. Because inner balloon 110 is located within inflatable balloon 102, it will tend to expand in the direction of aperture 112 as the fluid within inflatable balloon 102 is pressurized. Mische, col. 4, ll. 12-28 (emphasis added). The Examiner interprets Mische’s catheter embodiment as corresponding to the claim elements in the following manner: Claim 1: Mische ’403 discloses a device (Figures 9, 12) having a shaft (114) which includes a lumen (104) that is able to receive a guidewire because it is a hollow lumen; an inflatable balloon (102) supported by the shaft and including an internal passage (106) for permitting fluid flow while the balloon is inflated and a valve (110) attached to the shaft within the passage for controlling the fluid flow. Final Act. 6. In the Response to Arguments section of the Final Action, the Examiner re-emphasizes that Mische’s second, closed lumen 104 is being interpreted as corresponding to the claimed lumen of “a shaft including a lumen for receiving a guidewire.” Id. at 2 (“In Mische ’403, the shaft 114 includes an internal passage (106) that passes through the balloon. Although this is disclosed as an inflation lumen, it is capable of receiving a guidewire.”). Final Act. 2. Appellant argues that it is improper to interpret lumen 104 as a lumen for receiving a guidewire. Appeal Br. 5 (“Claim 1 expressly requires that the shaft include a lumen for receiving a guidewire, which is clearly not the internal passage associated with the ‘valve’ 110 in Mische.”). Appellant’s Appeal 2021-001046 Application 15/061,719 33 argument is persuasive because the Examiner has not established that Mische’s second, closed lumen 104 is capable of receiving a guidewire. First, the Examiner provides no technical reasoning or evidence that the lumen 104 is dimensioned so as to be capable of receiving a guidewire. For example, the Examiner points to no evidence that the catheter of Figures 9 and 12 is drawn to scale, as opposed to being drawn with features and dimensions exaggerated for clarity. See generally Final Act. Nor has the Examiner provided any evidence regarding the inherent sizes of catheter lumens or guidewires. Id. And Mische only discloses that a guidewire may pass through the first lumen 106, which is open at the distal tip. E.g., Mische, Abstr. Mische is silent as to whether the second lumen 104 is dimensioned in a manner that would make it theoretically capable of receiving a guidewire. Second, even if one were to assume arguendo that second lumen 104 has dimensions that would otherwise make it capable of receiving a guidewire, Mische expressly states that the second lumen 104, which is only for inflating balloon 102, is a closed chamber. E.g., Mische, Abstr. As such, Mische expressly teaches that the second lumen 104 is not capable of receiving a guidewire. And the Examiner has not sufficiently explained how the chamber would be capable of receiving a guidewire (not merely possessing a guidewire) in spite of the fact that the chamber is closed. Appellant also argues, the rejection fails to account for the requirement for a perfusion balloon having an internal passage. The valve 110 cited by the Examiner is within the shaft 114, but the claim requires a perfusion balloon having “an internal passage for permitting the Appeal 2021-001046 Application 15/061,719 34 fluid flow in the vessel while the perfusion balloon is in an inflated condition” in addition to a shaft. Appeal Br. 5. This argument also is persuasive because, as Appellant contends, claim 1 requires that the internal passage permits fluid flow in the vessel while the perfusion balloon is in an inflated condition. Appeal Br. 15 (Claim Appx). The Examiner interprets this limitation as reading on Mische’s open, first lumen 106. Final Act. 6. However, Mische is quite clear that when the inflatable balloon 102 is inflated, inner balloon 102 also inflates, thereby shutting off the internal passage 106, thereby preventing fluid flow in the vessel. Mische col. 4, ll. 12-28. The Obviousness Rejection Based on Thielen and Tilson Appellant argues that claim 16 is not rendered obvious by the combination of Thielen and Tilson: The Examiner’s proposed combination of Tilson and Thielen for rejecting claim 16 . . . lacks a reason with a reasonable underpinning for combining the reference features. The Examiner contends that it would be obvious to combine the reference teachings “because Tilson ’896 teaches the advantage of this lumen . . . being used to insert a guidewire into the lumen of the shaft 2000b to locate the balloon during a medical procedure . . . .” Office Action, p. 11. This is not a reason with a rational underpinning that would motivate a skilled artisan to combine the reference teachings, but rather simply an observation of the teaching of Tilson in isolation. Hence, reversal of the rejection of claim 16 as lacking prima facie support is in order. The rejection also fails to account for the requirements of the claim, which expressly requires “a valve positioned in a space between the shaft and the balloon in the generally tapered portion for controlling the fluid flow within the passage.” Appeal 2021-001046 Application 15/061,719 35 The valve 130 in Thielen plainly does not meet this requirement, nor does Tilson. Appeal Br. 12. I understand Appellant’s position to be that the obviousness rejection merely sets forth what Thielen teaches and fails to teach, what Tilson teaches, and what advantages arise from Tilson’s configuration, but that the rejection does not set forth sufficiently how Thielen is being modified by Tilson or how the two references are being combined. I agree. The Examiner simply has not put Appellant on reasonable notice of what the basis of rejection is. [T]he PTO carries its procedural burden of establishing a prima facie case when its rejection satisfies 35 U.S.C. § 132, in “notify[ing] the applicant . . . [by] stating the reasons for [its] rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of [the] application.” That section “is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection.” In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (citations omitted) (alterations in original). Moreover, it is not reasonably apparent how the two references could be combined. Thielen’s referenced temporary valve 130 is a one-way-flow flap valve that is disposed within the flow path of perfusion lumen 25 in order “to prevent back flow from occurring from the aorta back into the left ventricle after the heart has ejected blood and is available for filling.” Thielen ¶ 44; Fig. 1B. It does not seem reasonable that the Examiner would be proposing that Thielen be modified by adding an additional one-way flap valve outside of the perfusion lumen, such as within Thielen’s inflation Appeal 2021-001046 Application 15/061,719 36 lumen 90. That lumen allows air to be communicated to and from the outer inflation balloon. E.g., Thielen ¶ 43. Placing a one-way valve in the flow path of the inflation lumen would defeat the intended purpose of the lumen, as the valve would prevent the lumen from communicating air in two directions in the intended manner. It might alternatively be the case that the Examiner is proposing that, with one exception, Thielen’s entire catheter system be completely replaced by Tilson’s embodiment depicted in Figures 31A-C. That is, the Examiner might be proposing that Tilson’s flap valve 730 be moved and positioned in the tapered region of Tilson’s central fluid passage 692, as taught by Thielen. But if this is the theory, the modification would be problematic because the Examiner does not set forth sufficient reasoning for displacing Tilson’s valve. See generally Final Act. Furthermore, this proposed modification also is based completely on impermissible surmise or speculation. The Examiner simply has not explained sufficiently what the basis of the rejection is. For these reasons, I would reverse the obviousness rejection of independent claim 16 over the combination of Thielen and Tilson. I would also reverse the obviousness rejection of claims 17, 18, and 24, which depend from claim 16.2 2 I agree with the Majority’s basis for affirming the obviousness rejection of claims 21-23 over the combination of Tilson and Molgaard-Nielsen. Upon any further prosecution, though, the Examiner and Appellant should consider whether Tilson, alone, anticipates independent claim 21. More specifically, although Tilson’s valve is depicted schematically, Tilson’s Specification expressly states, “valve leaflets 734 may be anchored to the balloon segments 656 or the inside of the shell wall 684.” Tilson ¶ 212. I see no reason for why this disclosed means of anchoring would not Appeal 2021-001046 Application 15/061,719 37 reasonably constitute “a connector for connecting to the valve to control the position thereof,” as claimed. That is, claim 21 does not appear to limit the position of the “connector for connecting” as being located at the leaflet end of the valve. And I see no reasons precluding the claim language from reading on Tilson’s anchors that are positioned at the end of the valve body.