Ex Parte Chuter et alDownload PDFPatent Trial and Appeal BoardOct 25, 201713286407 (P.T.A.B. Oct. 25, 2017) Copy Citation 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. 13/286,407 11/01/2011 Timothy A. Chuter 12730/761 (PA-6723-RFB) 4826 48003 7590 10/26/2017 ROT JCnnk - PTiiraan EXAMINER PO BOX 10395 CHICAGO, IL 60610 DUKERT, BRIAN AINSLEY ART UNIT PAPER NUMBER 3738 MAIL DATE DELIVERY MODE 10/26/2017 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TIMOTHER A. CHUTER, BLAYNE A. ROEDER, SHARATH GOPALAKRISHNAMURTHY, and ALAN R. LEEWOOD Appeal No. 2015-003567 Application No. 13/286,407 Technology Center 3700 Before: PATRICK R. SCANLON, BEVERLY M. BUNTING, and GORDON D. KINDER, Administrative Patent Judges. BUNTING, Administrative Patent Judge. DECISION ON APPEAL Appeal 2015-003567 Application 13/286,407 STATEMENT OF CASE Timothy A. Chuter et al. (“Appellants”)1 seek our review under 35 U.S.C. § 134 of the Examiner’s decision, as set forth in the Final Office Action, dated September 24, 2013 (“Final Act.”), rejecting pending claims 1, 2, and 5—20. We have jurisdiction under 35 U.S.C. § 6(b). An oral hearing was conducted on June 13, 2017. We AFFIRM. CFAIMED SUBJECT MATTER The claims are directed to an implantable medical device for the repair of a damaged aortic valve. Spec. 12. Claims 1, 9, and 15 are independent. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A medical device for implantation in a patient, the medical device comprising: a stent comprising: a proximal region comprising a cylindrical shape having a first outer diameter when the stent is in an expanded state; a distal region comprising a cylindrical shape having a second outer diameter when the stent is in the expanded state, where the second outer diameter is greater than the first outer diameter; a tapered region disposed between the proximal and distal regions, where the tapered region transitions the stent from the first diameter to the second diameter; a valve coupled to at least a portion of the stent, the valve having proximal and distal regions, where the proximal region of the valve is at least partially positioned within the proximal region of the stent and the distal region of 1 Appellants identity Cook Medical Technologies LLC as the real party in interest. Appeal Br. 1. 2 Appeal 2015-003567 Application 13/286,407 the valve is at least partially positioned within one of the tapered and distal regions of the stent; a plurality of closed cells disposed around the perimeter of the proximal region of the stent, and another plurality of closed cells disposed around the perimeter of the distal region of the stent, where the tapered region further comprises a plurality of closed cells, where an overall length of each of the closed cells of the tapered region is greater than an overall length of each of the closed cells of the proximal region of the stent and less than an overall length of each of the closed cells of the distal region of the stent when the stent is in the expanded state. Appeal Br. 29. REFERENCES The Examiner relies on the following prior art references in rejecting the claims on appeal: Nguyen US 2006/0265056 A1 McGuckin, JR. US 2008/0039891 A1 Tuval US 2010/0094411 A1 Ku US 2012/0053676 A1 REJECTIONS Appellants seek our review of the following rejections: Claims 1, 2, 6, 9, 10, 12, and 14 stand rejected under 35 U.S.C. § 102(b) as anticipated by Nguyen. Final Act. 5. Claims 5,11, and 15—18 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Nguyen. Id. at 7. Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Nguyen and Ku. Id. at 8. Nov. 23, 2006 Feb. 14, 2008 Apr. 15,2010 Mar. 1,2012 3 Appeal 2015-003567 Application 13/286,407 Claims 8 and 20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Nguyen and Tuval. Id. at 9. Claims 13 and 19 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Nguyen and McGuckin. Id. OPINION Anticipation Based on Nguyen Claims 1 and 9 As to independent claims 1 and 9, the Examiner finds that Nguyen discloses each of the limitations of the medical device for implantation in a patient set forth in claim 1, including, inter alia, a proximal region having a first outer diameter in an expanded state; a distal region having a second outer diameter in the expanded state, the second diameter being greater than the first outer diameter; a tapered region disposed between the proximal and distal regions; and a valve coupled to a portion of the stent. Final Act. 5—6. The Examiner annotated Figure 6 of Nguyen, reproduced below, to illustrate how Nguyen discloses a plurality of closed cells (fig 6) disposed around the perimeter of the proximal, tapered, and distal regions of the stent, wherein each closed cell has an overall length (shown), where an overall length of each of the closed cells of the tapered region (shown) is greater than an overall length of each of the closed cells of the proximal region (shown) of the stent and less than an overall length of each of the closed cells of the distal region (shown) of the stent when the stent is in the expanded state. Id. at 6. 4 Appeal 2015-003567 Application 13/286,407 Figure 6 is a side view of the valve prosthesis of Nguyen, as annotated by the Examiner. Id. at 5. Appellants challenge the Examiner’s position that “[t]he lengths of the cells in the distal region are clearly larger than those of the tapered region, which are clearly larger than those in the proximal region, in the expanded state.” Appeal Br. 18 (citing Final Act. 3); See Reply 3—6. According to Appellants, the Examiner erroneously relies on his own measurements of Figure 6 because Nguyen does not disclose lengths of the closed cells in any of the proximal, tapered or distal regions and Nguyen doesn’t state that its figures are to scale. Id. at 19; Reply 4—6. Appellants support their arguments with citations to case law, the Manual of Patent Practice and Procedure (M.P.E.P.), and prior Board decisions.2 Id. at 18—20; Reply 3—6. 2 Appellants’ arguments directed to the MPEP and prior Board decisions are not controlling. “While the MPEP does not have the force of law, it is entitled to judicial notice as an official interpretation of statutes or regulations as long as it is not in conflict therewith.” Molins PLC v. Textron, 5 Appeal 2015-003567 Application 13/286,407 Additionally, Appellants view the statements in Nguyen regarding “relatively larger cells” as only referring to greater width and not length. Id. Noting that the length of each contracted closed cell in Nguyen is initially about the same, Appellants argue that when expanded, “the closed cells at outflow section 15 may increase in width while becoming smaller in axial length relative to the other cells. In any event, this text of Nguyen does not teach or suggest different lengths at three separate regions.'''’ Id. at 20. Turning to the language of claim 1, we observe that cell length is not defined absolutely, rather using relative language. We give the claims the broadest reasonable interpretation consistent with the specification, as we must. Thus, we interpret “overall length of each of the closed cells of the tapered region is greater than an overall length of each of the closed cells of the proximal region . . . and less than an overall length of each of the closed cells of the distal region” (Appeal Br. 29), as defining the overall length of the closed cells in the tapered region relative to the overall length of the closed cells in the proximal region (i.e., greater than) and the distal region (i.e., less than). Appellants’ arguments concerning the lack of disclosure in Nguyen regarding whether Figure 6 is drawn to scale are not convincing. As an initial matter, we note that “a reference must be considered not only for what it expressly teaches, but also for what it fairly suggests.” In re Bell, 991 F. 2d 781, 785 (Fed. Cir. 1993) {quoting In reBurckel, 592 F.2d 1175, 1179 (CCPA 1979)). At the same time, our reviewing court also informs us that when the reference does not disclose that the drawings are to scale and is silent as to dimensions, arguments based on measurement of the drawing Inc., 48 F.3d 1172, 1180 n.10 (Fed. Cir. 1995). Moreover, the cited Board decisions are not precedential. 6 Appeal 2015-003567 Application 13/286,407 features may be of little value. See Hockerson-Halberstadt, Inc. v. Avia Group Inti, 222 F.3d 951, 956 (Fed. Cir. 2000) (“[I]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.” (emphases added)). Contrary to Appellants’ contentions, however, the Examiner is not relying on Figure 6 for “precise proportions” or “particular sizes.” Instead, the Examiner has provided “more” (contra Reply Br. 4) by annotating Figure 6 and explaining how these annotations satisfy the corresponding claim limitations. Specifically, the Examiner relies on his annotated version of Figure 6 in identifying the distal, tapered and proximal regions, and the relative cell length of cells in each of these regions. Ans. 3^4. Appellants’ general argument regarding the use of drawings (Reply Br. 3—6) does not inform us of error in the Examiner’s assertion that “it would be clear to one of ordinary skill that the cell lengths (represented by LI, L2 and L3) are obviously varying in length such that cells of the distal regions (LI) are longer than the cells of the tapered regions (L2), which are in turn larger than the cells of the proximal region (L3).” Ans. 3^4. To support of its contention that Nguyen does not disclose cells having different lengths at three separate regions, Appellants argue that Nguyen describes how the closed cells at outflow section 15 increase in width while becoming smaller in axial length. Appeal Br. 20 (citing Nguyen 11 52, 81, Figure 2). Our review of these passages reveals a disclosure concerning “the use of relatively larger cells in the outflow section of frame 12” (Nguyen 1 52) and that “outflow section 15 of frame 12 employs relatively larger cells than the remainder of the frame” {id. at 1 81). As such, the Examiner reasonably responds that the cell size depends on strut length, 7 Appeal 2015-003567 Application 13/286,407 and “[a]s lengths of the outflow section (annotated as ‘distal region’) stmts are the only variable accounting for a change in cell size, a ‘relatively larger’ cell size in the outflow section must comprise an increase in the stmt length.” Ans. 4. Appellants do not challenge this response. {See generally, Reply Br. 3—6). Thus, Appellants arguments and evidence do not persuade us that the Examiner’s findings regarding claim 1 are in error, and we sustain the Examiner’s rejection of claim 1 under 35 U.S.C. § 102(b). Claim 9 As to independent claim 9, the Examiner relies on the findings for claim 1. Final Act. 3. Appellants counter that the Examiner erred by not addressing claim 9. Appeal Br. 20-21; Reply Br. 6—7. Specifically, because “claim 1 recites lengths of closed cells in a given region relative to each other, claim 9 differently recites ‘each closed cell has an overall length, when the stent is in the expanded state, that is greater than a length of every other closed cell that is disposed yroximally thereof. ’” Appeal Br. 21. Notwithstanding this assertion, Appellants rely on the arguments provided with respect to claim 1. Id.', Reply Br. 6—7. The Examiner disagrees, arguing that annotated Figure 6 shows that each individual cell in either the distal and/or tapered region has a length that is greater than a length of every other cell(s) disposed proximally thereof.” Ans. 4—5. In turn, Appellants argue that “proportions of features in a drawing are not evidence of actual proportions when drawings are not to scale.” Reply Br. 7 (citations omitted). For the same reasons discussed above with respect to claim 1, Appellants’ unpersuasive argument regarding the use of drawings does not inform us of error in the Examiner’s assertion that annotated Figure 6 shows 8 Appeal 2015-003567 Application 13/286,407 how “each individual cell in either the distal and/or tapered region has a length that is greater than a length of every other cell(s) disposed proximally thereof.” Ans. 4—5. Nor do Appellants apprise us of error in the Examiner’s assertion that in annotated Figure 6, “said proximal region is finite with distinct borders (as drawn). Any additional structure beyond said region is not considered in the rejection. The examiner notes that the use of the transitional phrase ‘comprising’ in the preamble is open-ended and allows for additional structure beyond the annotated proximal region.” Ans. 5. Because we found no such shortcomings in Nguyen as described hereinabove, we are not persuaded of Examiner error and we sustain the Examiner’s rejection of claim 9 under 35 U.S.C. § 102(b). Dependent Claims 2, 6, 10, 12, and 14 Claims 2 and 6 depend from independent claim 1, and claims 10, 12, and 14 depend from independent claim 9. App. Br. 29-32. Appellants present no separate arguments or reasoning for these claims. See Id. at 18— 21. For the foregoing reasons, we also sustain the Examiner’s rejections of claims 2, 6, 10, 12, and 14 under 35 U.S.C. § 102(b). Obviousness Based on Nguyen Claim 15 Independent claim 15 is similar to claim 1, and further recites in relevant part that “the plurality of closed cells of the proximal region of the stent comprise a higher radial force relative to the plurality of closed cells of the distal region of the stent when the stent is in the expanded state.” Appeal Br. 32—33. Observing that Nguyen does not specifically disclose this limitation, the Examiner maintains that Nguyen teaches the structural limitations as shown for claims 1 and 9 and further finds that because “[t]he 9 Appeal 2015-003567 Application 13/286,407 higher radial force is a structurally-dependent property and absent any additional structural characteristics/limitations, it is reasonably deemed as inherent to the device.” Final Act. 7—8. The Examiner further reasons that, alternatively, “it would have been obvious to one having ordinary skill in the art to provide a higher radial force in the proximal region to enhance the anchoring and expansion capabilities of the implanted device.” Id. at 8. Appellants argue that the Examiner has not established inherency. Appeal Br. 22 (citing In re Robertson, 169 F.3d 743, 745, 49 USPQ2d 1949, 1950-51 (Fed. Cir. 1999)). In the Reply, Appellants convincingly argue that the Examiner’s reliance on U.S. Patent No. 5,938,697 to Killion in the Answer is “untimely.” Reply 7—8 (See Ans. 6 “Therefore, the examiner believes there is sufficient evidence and structure in the Nguyen reference to support a rejection wherein the radial force in the proximal region is inherently higher than in the distal region. This argument is predicated on the well-known fact that in stent construction, a stent portion/segment that is expanded to fill the cavity of a larger diameter vessel will have less radial force due to its expanded state. This concept is further evidenced by Killion et al. (US 5,938,697); force provided would be greater in a smaller diameter than in the larger diameter'' (Column 2: lines 13—14)).” Nonetheless, as discussed above, we determine that Nguyen discloses that the lengths of cells in the distal region are larger than those of the tapered region, which are larger than those in the proximal region, in the expanded state. Appellants’ argument — “the mere fact that a different radial force at the proximal region versus the distal region may result from the given set of circumstances” (Appeal Br. 22) is not sufficient reasoning or evidence explaining why this additional finding of the Examiner is in error. Specifically, Appellants have not explained the error in the Examiner’s 10 Appeal 2015-003567 Application 13/286,407 finding that Nguyen’s stent inherently possesses a higher radial force in the proximal region relative to the distal region because radial force is a structurally-dependent property. Final Act. 7—8; Ans. 6—7. Indeed, once a prima facie case of unpatentability has been established, the burden shifts to the Appellant to prove that the prior art product does not necessarily or inherently possess the characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.”). See also In re Spada, 911 F.2d 705, 708-09 (Fed. Cir. 1990). Next, Appellants challenge the articulated reasoning provided by the Examiner, i.e., that one of skill in the art would provide a higher radial force in the proximal region to enhance the anchoring and expansion capabilities of the implanted device. Appeal Br. 22—24; Reply 7—9. Appellants argue that the Examiner’s articulated reasoning is speculative because “the Examiner does not cite to any portion of Nguyen, or any other reference whatsoever, to support this broad assertion.” Id. at 22—23. We are not persuaded by Appellants’ arguments.3 Our reviewing courts inform us that it is not sufficient to demonstrate that each of the components is known. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“a patent composed of several elements is not proved obvious 3 Appellants’ arguments directed to the MPEP are likewise unavailing. “While the MPEP does not have the force of law, it is entitled to judicial notice as an official interpretation of statutes or regulations as long as it is not in conflict therewith.” Molins PLC v. Textron, Inc., 48 F.3d 1172, 1180 n. 10 (Fed. Cir. 1995). 11 Appeal 2015-003567 Application 13/286,407 merely by demonstrating that each of its elements was, independently, known in the prior art”). The Examiner must also explain how a person of ordinary skill in the art would combine those embodiments, and why such a person would be motivated to do so. See, e.g., In re Chaganti, 554 F. App’x 917, 922 (Fed. Cir. 2014) (“It is not enough to say that... to do so would ‘have been obvious to one of ordinary skill. ’ Such circular reasoning is not sufficient—more is needed to sustain an obviousness rejection.”). Indeed, this articulated reasoning must include some rational underpinning to support the legal conclusion of obviousness. See KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Appellants’ assertion that the Examiner’s proffered reasoning lacks rational underpinnings, i.e., because the Examiner does not cite Nguyen or another reference for support, is unavailing. It is well settled that “[a] suggestion, teaching, or motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art, as the teaching, motivation, or suggestion may be implicit from the prior art as a whole, rather than expressly stated in the references.” Kahn, 441 F.3d at 987. Here, the Examiner’s stated rationale for providing a higher radial force in the proximal region (i.e., to enhance the anchoring and expansion capabilities of the implanted device) is supported by technical reasoning as to why one of ordinary skill in the art would be led to make the proposed modification. Final Act. 4. Appellants’ arguments do not convince us that this rationale is not implicit from the prior art as a whole. For the foregoing reasons, we are not persuaded that the Examiner erred in concluding that the Nguyen renders obvious the subject matter of independent claim 15, and we sustain the rejection of independent claim 15. 12 Appeal 2015-003567 Application 13/286,407 Dependent Claims Claims 5,11, and 16—18 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Nguyen. Final Act. 7. Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Nguyen and Ku. Id. at 8. Claims 8 and 20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Nguyen and Tuval. Id. at 9. Claims 13 and 19 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Nguyen and McGuckin. Id. Appellants rely on the same arguments relating to the alleged shortcomings of Nguyen alone, as well as in combination with one of Ku, Tuval or McGuckin, respectively. See Appeal Br. 24—27; Reply Br. 8—9. Because we found no such shortcomings in Nguyen as described hereinabove, we are not persuaded of Examiner error and we sustain the Examiner’s rejections of claims 5, 7, 8, 11, 13, 16—20 under 35 U.S.C. § 103(a). DECISION For the above reasons, the Examiner’s rejection of claims 1,2, and 5— 20 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv) (2009). AFFIRMED 13 Copy with citationCopy as parenthetical citation