CLEARSTREAM TECHNOLOGIES LIMITED

Patent Trials and Appeals BoardJun 26, 2020

2019004449 (P.T.A.B. Jun. 26, 2020)

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. 14/383,754 09/08/2014 Sean Wall P-18266.US02 / 1626A-048 7367 138315 7590 06/26/2020 C. R. Bard, Inc./ClearStream/K&S KING & SCHICKLI, PLLC 800 CORPORATE DRIVE SUITE 200 LEXINGTON, KY 40503 EXAMINER NGUYEN, HIEN NGOC ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 06/26/2020 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): laura@iplaw1.net uspto@iplaw1.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte SEAN WALL __________ Appeal 2019-004449 Application 14/383,754 Technology Center 3700 __________ Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and LISA M. GUIJT, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING STATEMENT OF THE CASE Appellant1 filed a Request for Rehearing (“Req. Reh’g”) dated April 14, 2020 of the Decision on Appeal mailed February 14, 2020 (“Decision”). This Decision affirmed the Examiner’s rejections of claims 1, 2, 4–9, 11, 12, 14–16, 19, 20, 24–27, and 29–32. See Decision 12. Upon consideration of Appellant’s Request, we do not modify our opinion. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Clearstream Technologies Limited. Appeal Br. 2. Appeal 2019-004449 Application 14/383,754 2 A REQUEST FOR REHEARING A request for rehearing “must state with particularity the points believed to have been misapprehended or overlooked by the [Patent Trial and Appeal Board, hereinafter ‘Board’].” See 37 C.F.R. § 41.52(a)(1). This section also states that arguments not raised in the briefs before the Board and evidence not previously relied upon in the briefs “are not permitted in the request for rehearing except as permitted by paragraphs (a)(2) through (a)(4) of this section.” In addition, a request for rehearing is not an opportunity to express disagreement with a decision without setting forth points believed to have been misapprehended or overlooked by the Board in rendering its Decision. The proper course for an Appellant dissatisfied with a Board decision is to seek judicial review, not to file a request for rehearing to reargue issues that have already been decided. See 35 U.S.C. §§ 141, 145. ANALYSIS “Appellant believes a review of the respective burdens of proof in rejecting a patent claim is in order.” Req. Reh’g 1. “If the Examiner fails to establish a prima facie case, then applicant need not provide any rebuttal evidence and is entitled to a patent barring other grounds for unpatentability.” Req. Reh’g 1 (citations omitted). Appellant also contends, “[f]ocusing the § 103 inquiry on a particular aspect of the invention that differs from the prior art improperly disregards the ‘as a whole’ statutory mandate.” Req. Reh’g 2 (citations omitted). Claim 1 recites a balloon having “first and second ends and a cylindrical portion between the first and second ends that, when inflated, provides a working surface on the cylindrical portion” of the balloon. Appeal Br. 8 (Claims App.). Claim 1 also recites a wire having different Appeal 2019-004449 Application 14/383,754 3 radiopacity that extends between these first and second balloon ends “for identifying an end of the working surface of the balloon.” Id. Appellant contends that the “working surface ‘end’ is clearly not the same as the first and second ends of the balloon.” Req. Reh’g 2.2 As an initial matter, Appellant does not appear to raise this contention in the Appeal Brief or the Reply Brief other than in reference to Appellant’s arguments about Solar where Appellant states that Solar “fails to describe identifying the ends of the balloon working surface (which by the claim language itself are clearly different structures from the first and second ends of the balloon).” See Appeal Br. 4; see also generally, Reply Br. Indeed, the Examiner does not construe claim 1 such that the end of the balloon’s working surface is the same as the ends of the balloon itself. See Final Act. 5–6, 8–9; see also Ans. 9–10; id. at 11 (The Examiner’s annotated version of Tu’s Figure 3.). Appellant also contends that none of the references (Tu, Spencer, or Solar) disclose both a wire having portions of different radiopacity and using the differences in radiopacity to identify an end of a working surface of a balloon. See Req. Reh’g 2 (“[N]o substantial evidence cited by the Examiner or the Board indicates that there is any wire with a different radiopacity for identifying an end of the working surface of a balloon in Solar.”); see also id. at 3 (“[A]bsolutely nothing identified in Tu establishes that there is any wire with a different radiopacity for identifying an end of the working surface of a balloon.”); id. at 4 (Spencer “does not disclose any 2 Appellant acknowledges that “[c]laim 29 is similar in this respect.” Req. Reh’g 2. Appeal 2019-004449 Application 14/383,754 4 wire with a different radiopacity for identifying an end of the working surf ace of a balloon.”). Appellant’s argument essentially vitiates obviousness as a valid basis for rejection because it would require a single reference to teach all the aspects of the claim to be valid. There is no requirement that motivation or discussion of a missing element be contained within a reference in order for an Examiner to combine a secondary reference to supply that missing element. As pointed out in the Decision, the Examiner relies on the teachings of Tu or Spencer for disclosing a balloon having a known, identifiable working surface and a wire for identifying an end of the working surface of the balloon and on the teachings of Solar for disclosing a wire using different radiopacities. See Decision 4; see also Final Act. 5–6, 8–9; Ans. 9–10 (“[T]he rejection states that Solar – not Tu – discloses wire with different radiopacity.”) (emphasis added). The Examiner then provides a reason with rational underpinnings for making the combination, namely, by determining that it would have been obvious to one skilled in the art to modify the wire of Tu or Spencer to include different radiopaque portions, as taught by Solar, “in order to allow for locating the wire, different regions of the wire as well as different regions of the balloon such as proximal and distal ends and to provide an area of focused force for cracking or breaking up hard or difficult lesions.” See Final Act. 5–6, 8–9; see also Decision 6. Appellant’s statements do not apprise us of error in the Examiner’s findings regarding the combined teachings of Tu and Solar or Spencer and Solar or of any points misapprehended or overlooked in our Decision. Appellant thereafter addresses Tu’s “marker band 33” stating that this marker “does not qualify as a wire.” Req. Reh’g 3. However, this argument Appeal 2019-004449 Application 14/383,754 5 is not persuasive because, in the Answer, the Examiner points out that Tu discloses “the wire for identifying an end of the working surface of the balloon.” Ans. 10; see also Decision 8. The Examiner correctly notes that “element 31 [of Tu] is the wire and element 33 is the radiopaque [marker band]”3 and explains that “when imaging[,] the radiopaque band/marker shows up in contrast to the surrounding image[,] which enables the viewer to identify the radiopaque band/marker location from the image.” Ans. 10. The Examiner further correctly notes that “the two locations of radiopaque ‘marker band 33’ in [Figure 3 of Tu are] located at the two ends of the working surface.” Ans. 10; see also id. at 11 (The Examiner’s annotated version of Figure 3 of Tu, which illustrates radiopaque marker band 33 located at (i.e., identifying) the two ends of the working surface of balloon 10 of Tu); Tu Fig. 3; Decision 7–8; In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972) (“[T]hings patent drawings show clearly are [not] to be disregarded.”) (emphasis in original). As discussed above, the Examiner relies on the teachings of Solar “merely” for disclosing a wire having a first portion with a different radiopacity than a second portion of the wire. See Final Act. 5; see also Ans. 9–10; Decision 4. As further discussed above, the Examiner provides a reason with rational underpinnings for modifying Tu’s wire to include different radiopaque portions, as taught by Solar, namely, “in order to allow for locating the wire, different regions of the wire as well as different regions of the balloon such as proximal and distal ends and to provide an 3 Tu disclose “stiffening wire 31” and “at least one radiopaque marker band 33.” Tu 8:29–44, Fig. 3; see also Ans. 10 (citing Tu 8:28–45, Fig. 3). Appeal 2019-004449 Application 14/383,754 6 area of focused force for cracking or breaking up hard or difficult lesions.” See Final Act. 5–6, 8–9; see also Decision 6. Appellant’s statements do not apprise us of error in the Examiner’s findings regarding the combined teachings of Tu and Solar or any points misapprehended or overlooked in our Decision. Regarding Appellant’s argument that the Board erroneously shifted the burden of proof to Appellant (see Req. Reh’g 3, 6, 7), we disagree. As discussed in the Decision and reiterated supra, the Examiner recognizes that Solar does not disclose a wire with a different radiopacity for identifying an end of the working surface, as claimed, but rather that Solar discloses that it is known to use a different radiopacity along a wire to identify optimal locations, for example, the ends of the balloon. See, e.g., Decision 4–5; see also Final Act. 5–6, 9; Ans. 10. As is also discussed in the Decision, the Examiner reasons that it would have been obvious to have selected an end of a balloon’s working surfaces as disclosed in Tu or Spencer as another example of an optimal location for a radiopaque marker along the wire of a balloon to allow for locating different regions of the balloon. Decision 4; see also Final Act. 5–6, 9; Ans. 10. Notably, the Examiner refers to the motivation as stated in Solar: “to provide an area of focused force for cracking or breaking up hard or difficult lesions.” Final Act. 5–6 (citing Solar ¶ 47). Thus, the Examiner has stated a prima facie case of obviousness. The PTO bears the initial burden of showing a prima facie case of obviousness. In re Giannelli, 739 F.3d 1375, 1379 (Fed. Cir. 2014). When a prima facie case of obviousness is made, the burden then shifts to the applicant to come forward with evidence and/or argument supporting patentability. Id. Appeal 2019-004449 Application 14/383,754 7 Accordingly, it is Appellant’s burden to apprise us of error in the Examiner’s findings or reasoning. In other words, we are not persuaded by Appellant’s argument that the Board erroneously shifted the burden of persuasion to Appellant. Here, Appellant has not identified any error in the Examiner’s prima facie finding of obviousness. See Req. Reh’g 1, 3, 6, 7. In sum, Appellant has not explained how this matter has been misapprehended or overlooked by the Board. Appellant contends that “Solar does not provide the necessary missing teaching to describe the inventions of claims 1 and 29 ‘as a whole’” and directs the Board’s attention to “the Examiner’s own admission of the same in the final Office Action, page 10, paragraph 11: ‘Spencer and Solar . . . do not disclose identifying an end of the working surface of the balloon.’ (emphasis added).” Req. Reh’g 2; see also id. at 4. However, page 10 of the Final Office Action addresses the rejection of claims 19 and 30–32, not the rejection of claims 1 and 29. See Final Act. 10. To the extent Appellant focuses on “the problem addressed by Appellant,” (Req. Reh’g 3), the Supreme Court stated, “[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007); see also In re Kahn, 441 F.3d 977, 987–88 (Fed. Cir. 2006). Hence, we must look to the claim language, not Appellant’s avowed purpose or problem addressed. In the Request for Rehearing, Appellant contends that the subject invention “resolves a need completely unaddressed by the cited references” and directs the Board’s attention to the Specification, in particular page 3, Appeal 2019-004449 Application 14/383,754 8 lines 3–13, of the Specification, which discusses “avoiding [a] geographic miss [(i.e., a misalignment)] between a working surface . . . and a lesion by identifying a specific location on the balloon - an end of the working surface - using a wire with a differential radiopacity.” See Req. Reh’g 3–4; see also Spec. 3:3–13.4 However, claim 1 broadly recites a wire extending longitudinally from a first end to a second end of a balloon, the wire including a first portion with a different radiopacity from a second portion of the wire for identifying an end of the working surface of the balloon. See Appeal Br. 8 (Claims App.). There is no recitation in claim 1 of misalignment, let alone, avoidance of a geographic miss (i.e., a misalignment) between a working surface and a lesion by identifying a specific location on the balloon. See id. “[L]imitations are not to be read into the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). See also In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[A]ppellant’s arguments fail from the outset because . . . they are not based on limitations appearing in the claims.”). As such, on this point, and as addressed in the Decision, Appellant is not persuasive that the cited art fails to disclose the recited limitations. See generally, Decision. Consequently, even should the Board have failed to focus on “[t]he problems addressed by Appellant,” as asserted above, such failure is not indicative the Board misapprehended or overlooked this matter. Appellant additionally asserts that “the Board never discusses [the Spencer] reference, which also does not disclose any wire with a different 4 Appellant cites to paragraph 6 of the Specification. Req. Reh’g 3–4. The Specification before the Board does not contain paragraphs. Appeal 2019-004449 Application 14/383,754 9 radiopacity for identifying an end of the working surface of a balloon.” Req. Reh’g 4. Such an assertion by Appellant is not understood in view of the many references to the teachings of Spencer in the Decision. See, e.g., Decision 4, 6–9. Further, as discussed above, Appellant’s argument essentially vitiates obviousness as a valid basis for rejection because it would require a single reference to teach all of the aspects of the claim to be valid. As pointed out in the Decision, the Examiner relies on the teachings of Spencer for disclosing a balloon having a known, identifiable working surface and a wire for identifying an end of the working surface of the balloon and on the teachings of Solar for disclosing a wire using different radiopacities. See Decision 4; see also Final Act. 8–9. Appellant again directs the Board’s attention to page 10 of the Final Office Action. Req. Reh’g 4. However, as discussed above, page 10 of the Final Office Action addresses the rejection of claims 19 and 30–32, not the rejection of claims 1 and 29. See Final Act. 10. Appellant further contends that making the combination capable as per the above discussion, would require “substantial reconstruction and redesign.” Req. Reh’g 4–5. However, Appellant does not explain how modifying the radiopaque markers of Tu or Spencer to have different radiopacities, as taught by Solar, requires “substantial reconstruction.” See id.; see also Decision 4–6; Final Act. 5–6, 8–9; Ans. 9–10. As such, Appellant is not persuasive the Board misapprehended or overlooked this point. Specific to claim 30, Appellant argues that “the Examiner in rejecting claim 30 never identifies the corresponding structure in Appellant’s specification.” Req. Reh’g 6; see also id. at 7. This argument is Appeal 2019-004449 Application 14/383,754 10 unpersuasive because the Board’s Decision clearly identifies where the Examiner addressed Appellant’s “means for identifying an end of the working surface of the balloon” and correlated such end identification to similar ends of Burgmeier’s radiopaque portion 40. See Decision 9–10; see also Final Act. 10, Ans. 13–16, Burgmeier Fig. 2.5 Based on the above, it is not clear how the Board has misapprehended or overlooked this argument. “Appellant further challenged the alleged reason for the combination of references as lacking any rational underpinning.” Req. Reh’g 7 (referring to Appeal Br. 6). This matter was discussed at page 11 of the Decision. In short, Appellant’s contentions are not persuasive that the Examiner’s motivation to combine the cited references is in error. Again, Appellant has not explained how this matter has been misapprehended or overlooked by the Board. Appellant additionally contends that the Examiner’s proposed modification “cannot be done without using improper hindsight reasoning.” Req. Reh’g 8. We disagree. The Examiner’s sound reasoning dispenses with Appellant’s hindsight argument. See In re Cree, Inc., 818 F.3d 694, 5 We note Burgmeier discloses that “[t]he balloon assembly 14 can include an expandable balloon portion 28, a proximal balloon waist 30 and a distal balloon waist 32” and that as shown in Figure 2, “the radiopaque portion 40 is positioned such that the location of substantially the entire length of the expandable member 28 can be determined using a suitable imaging technique.” Burgmeier ¶¶ 31, 45 (emphasis added), Fig. 2. As Burgmeier’s radiopaque marker 40 covers the entire length of expandable balloon portion/working surface 28 of balloon assembly 14, it stands to reason that radiopaque marker 40 identifies the two ends of expandable balloon portion/working surface 28 of balloon assembly 14. See id.; see also Ans. 14–15; id. at 15 (The Examiner’s annotated version of Burgmeier’s Figure 2.). Appeal 2019-004449 Application 14/383,754 11 702 n.3 (Fed. Cir. 2016) (explaining that a hindsight argument is of no moment where the Examiner provides a sufficient, non-hindsight reason to combine the references). See also Decision 4–7, 9–11. Thus, in view of Appellant’s request “for rehearing of the Board’s decision to affirm the rejections, which lack prima facie support” (Req. Reh’g 8), we are not in agreement with Appellant’s conclusion for the reasons expressed. In other words, we are not in agreement that the Examiner and/or the Board improperly shifted the burden to Appellant. See also Decision 4; Req. Reh’g. 1, 3, 6, 7. As a consequence, Appellant fails to provide persuasive argument or evidence to rebut the Examiner’s prima facie case of obviousness. See generally, Decision. In summation, and for the reasons expressed, Appellant’s contention that the Board misapprehended or overlooked certain points made by Appellant is not persuasive. DECISION Appellant’s Request for Rehearing has been granted to the extent that the Board reconsidered its Decision in light of the statements made in this Request, but is denied with respect to the Board making any modification to the Decision. DENIED Outcome of Decision on Rehearing: Claims 35 U.S.C. § Reference(s)/Basis Denied Granted 1, 2, 4, 6–8, 11, 12, 14, 15, 24–27, 29 103(a) Tu, Solar 1, 2, 4, 6-8, 11, 12, 14, 15, 24–27, 29 16 103(a) Tu, Solar, Dror 16 Appeal 2019-004449 Application 14/383,754 12 1, 2, 5, 6, 9, 14 103(a) Spencer, Solar 1, 2, 5, 6, 9, 14 19, 30–32 103(a) Spencer, Solar, Burgmeier 19, 30–32 20 103(a) Spencer, Solar, Burgmeier, Aita 20 Overall Outcome 1, 2, 4–9, 11, 12, 14– 16, 19, 20, 24–27, 29– 32 Final Outcome of Appeal after Rehearing: Claims 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 4, 6–8, 11, 12, 14, 15, 24–27, 29 103(a) Tu, Solar 1, 2, 4, 6–8, 11, 12, 14, 15, 24–27, 29 16 103(a) Tu, Solar, Dror 16 1, 2, 5, 6, 9, 14 103(a) Spencer, Solar 1, 2, 5, 6, 9, 14 19, 30–32 103(a) Spencer, Solar, Burgmeier 19, 30–32 20 103(a) Spencer, Solar, Burgmeier, Aita 20 Overall Outcome 1, 2, 4–9, 11, 12, 14–16, 19, 20, 24– 27, 29–32