Ex Parte Allex et alDownload PDFPatent Trial and Appeal BoardSep 17, 201812610102 (P.T.A.B. Sep. 17, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/610,102 10/30/2009 28213 7590 09/19/2018 DLA PIPER LLP (US) 4365 EXECUTIVE DRIVE SUITE 1100 SAN DIEGO, CA 92121-2133 FIRST NAMED INVENTOR Steven J. Allex 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 ATTORNEY DOCKET NO. CONFIRMATION NO. R41110-l 9735 EXAMINER ALEMAN, SARAH WEBB ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 09/19/2018 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): gtdocket@dlapiper.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVEN J. ALLEX, DONALD GEER, BRETT ALLYN WILLIAMS, BRADY JON HATCHER, and TRI ST AN LYNN TIE SO Appeal2016-007940 Application 12/610, 102 1 Technology Center 3700 Before LISA M. GUIJT, BRADLEY B. BAY AT, and FREDERICK C. LANEY, Administrative Patent Judges. LANEY, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Steven J. Allex et al. (Appellants) appeals under 35 U.S.C. § 134(a) from the Examiner's decision (filed Jan. 24, 2014 hereinafter "Non-Final Act.") rejecting claims 66-78. 2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b). We AFFIRM. 1 According to Appellants, the real party in interest is R4 Vascular, Incorporated. Br. 3. (filed Mar. 2, 2015). 2 Claims 1---65 are canceled. Br. 3. Appeal2016-007940 Application 12/ 610,102 INVENTION Appellants' invention "relates generally to medical devices and more specifically to radiopaque catheter balloons for use with balloon catheters." Spec. ,r 2. Claim 66, reproduced below, is independent and representative of the invention. 66. A radiopaque balloon for use with an intraluminal catheter, comprising: (a) an inflation layer, consisting of a compliant polymeric cylinder having a central region ending in opposing conical regions, said cylinder defining an outer surface and an inner lumen for retention of inflation fluid; (b) a fiber layer, consisting of at least two layers of inelastic, braided or non-braided fibers disposed around the length of the inflation layer; ( c) at least one coating layer, consisting of at least one adhesive disposed to affix the fiber layer to the inflation layer, wherein at least one adhesive penetrates the fiber layer to form the at least one coating layer; and, ( d) a radiopaque material disposed over substantially the entire length of the outer surface of the inflation layer, wherein the braided fibers have a pitch with respect to one another between 65° and 75° along the central region of the balloon and a pitch with respect to one another between 35° and 45° at both conical regions of the balloon to provide the balloon with a burst pressure of 16 atmospheres or greater. Br. 13 (Claims App.). REJECTIONS I. The Examiner rejected claims 66-78 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. 2 Appeal2016-007940 Application 12/ 610,102 II. The Examiner rejected claims 66-78 under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. III. The Examiner rejected claims 66-70 and 74--78 under 35 U.S.C. § I03(a) as unpatentable over Elton (WO 2010/027998 Al; pub. Mar. 11, 2010) and Davies, Jr. et al. (US 7,914,487 B2; iss. Mar. 29, 2011, hereinafter "Davies"). IV. The Examiner rejected claims 71-73 under 35 U.S.C. § I03(a) as unpatentable over Elton, Davies, and van Sloten et al. (US 2008/0228138 Al; pub. Sept. 18, 2008, hereinafter "van Sloten"). ANALYSIS Rejection I - Written Description The Examiner finds the Specification fails to convey to a skilled artisan that the applicants had possession of "braided fibers hav[ing] a pitch with respect to one another between 65° and 75° along the central region of the balloon and a pitch with respect to one another between 35° and 45° at both conical regions of the balloon," as claim 66 recites. Non-Final Act. 2- 4; Ans. 6-9. The Examiner asserts the written description is silent regarding the braid pitches in the central and conical regions of the claimed radiopaque balloon. Non-Final Act. 4. The Examiner also finds the Figures do not support a finding that the applicants were in possession of this recited limitation. Id. at 2--4. In particular, the Examiner finds that neither the originally filed Figure 5, which is a copy of a photograph of a braided fiber 3 Appeal2016-007940 Application 12/ 610,102 sheath (hereinafter "original Figure 5"), nor the subsequently submitted (filed Oct. 30, 2013) replacement Figure 5, which is a drawing of the photographed braided fiber sheath (hereinafter "replacement Figure 5"), are sufficient to evidence the braided fibers with the recited range of pitches at the central and conical regions. 3 Id. at 2--4; Ans. 6-9. 4 Appellants do not dispute the fact that the written description lacks any reference to using a specific range of pitches for the braided fibers at the central and conical regions of the disclosed radiopaque balloon. See Br. 7-8. Appellants instead rely solely on Figure 5, in either its photographic or drawing form, as evidence that the applicants possessed the claim ranges of pitch for the braided fibers. Offering the Declaration of Steven J. Allex (Appellants' Exhibit B), Appellants argue both forms of Figure 5 show the recited pitch ranges for the braided fibers in the central and conical regions. Id. at 8. We address each form of Figure 5 in tum. Regarding original Figure 5, the Examiner finds the photo is "unclear" and lacks the clarity necessary to support a finding the applicants had 3 We note that the clearest copy of the photographic version of Figure 5 is at Appendix A to the Declaration of Steven J. Allex, which is Appellants' Exhibit B in the Evidence Appendix. 4 The Examiner did not enter the subsequently submitted replacement drawing of Figure 5 because it introduced new matter. Non-Final Act. 3. The Examiner finds that the replacement drawing shows variations in the pitch of the braided fibers along the length of the balloon, which the original application does not disclose. Id. Because we determine that the Examiner's findings that neither the original Figure 5 photograph or the replacement Figure 5 drawing do not evidence applicants' had possession of the specifically claimed ranges of pitch angles that claim 66 recites, see infra, we deem the issue of whether replacement Figure 5 should, or should not, have been entered to be moot. 4 Appeal2016-007940 Application 12/ 610,102 possession of specific pitch ranges recited for the braided fibers in the central and conical regions because "the structure of the braid is distorted by glare, fading, etc." Non-Final Act. 2. Appellants do not dispute the Examiner's characterization of the quality of original Figure 5 and, having considered it ourselves, we agree with the Examiner's characterization. Appellants' expert, Mr. Allex, declares, "a skilled artisan ... would have been able to determine the braided orientation including pitch angles from [the] originally filed Figure 5 ... by conventional methods which were known and customary in the art at the time of filing." Br. (Evidence App., Ex. B, ,r 4) (emphasis added). Although Mr. Allex declares the pitch of the braids at central and conical regions of the balloon "could have been routinely determined from originally filed Figure 5," he does not represent that he actually took any steps to determine the pitch of the braids from the original Figure 5. Id. (Evidence App., Ex. B, ,r 5) (emphasis added). Nor does Mr. Allex explain why the Examiner is mistaken about the quality of original Figure 5 being too unclear and inadequate to show the specific pitch angle ranges recited. Mr. Allex's conclusory remarks about what a skilled artisan "could have" done or "would have been able" to do has little, if any, evidentiary value. Therefore, Appellants have not persuasively rebutted the Examiner's determination that original Figure 5 lacks the clarity necessary to the satisfy the written description requirement for the specific range of pitch angles claim 66 recites, which a preponderance of the evidence supports. Turning to replacement Figure 5, the Examiner determines this illustration cannot be relied upon because there is no indication within the Specification that it was drawn to scale. Non-Final Act. 4; Ans. 7-8 (citing 5 Appeal2016-007940 Application 12/ 610,102 Hockerson-Halberstadt, Inc. v. Avia Group lnt'l, 222 F.3d 951, 956 (Fed. Cir. 2000)). Appellants argue the Examiner erred because "[a]n applicant may show possession of an invention by disclosure of drawings ... that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole." Br. 7 (citing Vas-Cath, Inc. v. Mahurkar, 935 F2d 1555, 1565 (Fed. Cir. 1991)). Although, under proper circumstances, we agree with Appellants that drawings alone may provide a "written description" of an invention as required by the first paragraph of 35 U.S.C. § 112, we do not agree this case presents the proper circumstances. These are not the proper circumstances because it would require evaluating replacement Figure 5 for precise dimensional attributes, rather than approximations, and there is no dispute the written specification is devoid of any indication replacement Figure 5 is drawn to scale. 5 Thus, relying on replacement Figure 5 on this record would be contrary to Federal Circuit precedent that "arguments based on drawings not explicitly made to scale ... are unavailing." Nystrom v. Trex Co., 424 F.3d 1136, 1149 (Fed. Cir. 2005) (citing Hockerson-Halberstadt, Inc., 222 F.3d at 956; In re Wright, 569 F.2d 1124, 1127 (CCPA 1977)). However, even if the proper circumstances were present in this case and replacement Figure 5 could be relied upon, Appellants still have not shown persuasively that replacement Figure 5 shows the claimed ranges of angles for the braided fibers in the central and conical regions. Having 5 Appellants contend that replacement Figure 5 is a "computer drawn replica" of the actual device photographed in original Figure 5. Br. 6. Even accepting this as true, it does not change the fact that Appellants do not provide any indication that the replacement Figure 5 was drawn to scale in the written description. 6 Appeal2016-007940 Application 12/ 610,102 considered the Allex Declaration ourselves (see Br. 16 (Evidence App., Ex. B)), we agree with the Examiner's following rationale for why it is unpersuasive: Claim 66 recites a range for the braid pitch in a central region and a second range for the braid pitch of the conical regions. A measurement of a braid angle at a specific point, as shown in Appendix C of the Allex Declaration, would result in a single angle, such as 67°. [A] measurement[] at [a] specific point[] of ... the replacement drawing cannot be relied upon for the claimed ranges of angles. Ans. 8. Therefore, we are not persuaded the Examiner's finding that replacement Figure 5 does not satisfy the written description requirements for claim 66 was in error. As a result, for all of the foregoing reasons, we sustain the Examiner's rejection of claim 66, as well as claims 67-78 depending therefrom, under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Rejection II-Indefiniteness Appellants do not present any arguments contesting this rejection in the Appeal Brief. Thus, Appellants have waived any argument of error. See 37 C.F.R. § 4I.37((c)(iv) ("Except as provided for in§§ 41.41, 41.47 and 41.52, any arguments ... not included in the appeal brief will be refused consideration by the Board for purposes of the present appeal."). Accordingly, we summarily sustain the rejection of claims 66-78 under 35 U.S.C. § 112, second paragraph. See In re Berger, 279 F.3d 975, 984, 985 (Fed. Cir. 2002) (holding that the Board did not err in sustaining a rejection under 35 U.S.C. § 112 when the applicant failed to contest the rejection on appeal); MPEP § 1205.02, 8th ed., Rev. 8, August 2012 ("[I]f a 7 Appeal2016-007940 Application 12/ 610,102 ground of rejection stated by the examiner is not addressed in the appellant's brief, that ground of rejection will be summarily sustained by the Board."). Rejections III and IV- Obviousness In contesting obviousness Rejections III and IV, Appellants group all of the claims together. Br. 5, 9--11. Like the Appellants, we select claim 66 to decide the appeal of these rejections, with claims 67-78 standing or falling with claim 66. See 37 C.F.R. § 4I.37(c)(l)(iv) (permitting the Board to select a single claim to decide the appeal as to a single ground of rejection of a group of claims argued together). The Examiner determines that the combined teachings of Elton and Davies discloses the combination of elements claim 66 recites, except "the specific pitch of the braided fibers in the central region to be in the range of 65-75° and the pitch in the conical regions to be in the range of 34--45°." Non-Final Act. 7; see also Ans. 4--5. The Examiner, however, finds that "Davies teaches that th[ e] variation in pitch [ of the braided fibers] enhances the fit of the braided layer over the length of the balloon." Non-Final Act. 6 ( citing Davies col. 8, 11. 1-1 7). The Examiner determines the claimed ranges are not an inventive distinction over the prior art because, at most, they are the discovery of optimum or workable ranges that are within the capabilities of a skilled artisan and involve only routine skill. Id. at 7 (citing In re Aller, 220 F.2d 454,456 (CCPA 1955)). Appellants assert that the Examiner is mistaken because Davies gives no direction "as to where along the balloon variations should be made" or "as to what kind of variations should be made." Br. 10. According to Appellants, "no one reading Davies would recognize that specific pitch parameter on the conical regions as compared to the central region of the 8 Appeal2016-007940 Application 12/ 610,102 balloon should be varied." Id. at 10-11. Appellants contend, "even if one were to experiment with variations to pitch, nothing but serendipity would produce the pitches producing the claimed burst pressures as unexpectedly discovered and claimed by Appellants." Id. at 11. Appellants' argument is unpersuasive because it fails to undermine the Examiner's determination that selecting "the specific pitch of the braided fibers in the central region to be in the range of 65-75° and the pitch in the conical regions to be in the range of 34--45°" is nothing more than an application of the ordinary skill possessed by an artisan. Ans. 4. Appellants do not dispute the Examiner's finding that the combination of Elton and Davies disclose the general conditions of the device claim 66 recites. Nor do Appellants dispute that Davies evidences (see Davies col. 8, 11. 11-14) a skilled artisan knew varying the pitch angles of the braided fibers "from location to location over the surface of the balloon" could enhance the fit of the braided layer over the length of the balloon. Thus, the Examiner has established the pitch angles of the braided fibers at different locations of the balloon were known to be "result-effective variables." "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Applied Materials Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (quoting In re Aller, 220 F.2d at 456). Although Appellants offer attorney argument that claimed configuration of pitch angles for the braided fibers at the central and conical regions provides "unexpected results," such conclusory remarks without any evidentiary support have little, if any, probative value. Furthermore, the Specification does not support Appellants' contention the claimed range of 9 Appeal2016-007940 Application 12/ 610,102 pitch angles enable the claimed burst. The Specification states, "the braided sleeve may be formed from inelastic fibers of any configuration, e.g., fibers of single or multiple threads, so long as the formed braided sheath prevents radial distortion of the [inflated] balloon." Spec. ,r 33. Therefore, we sustain the Examiner's obviousness rejection of claim 66, as well as claims 67-78, which fall with therewith. DECISION The Examiner's rejections of claims 66-78 are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation