ANDERSON, JAMESDownload PDFPatent Trials and Appeals BoardDec 27, 201915058016 - (D) (P.T.A.B. Dec. 27, 2019) 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. 15/058,016 03/01/2016 JAMES ANDERSON 1001.2801102 1051 11050 7590 12/27/2019 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER KNAUSS, CHRISTIAN D ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 12/27/2019 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): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte JAMES ANDERSON __________ Appeal 2019-003324 Application 15/058,016 Technology Center 3700 __________ Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and LISA M. GUIJT, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s rejection of claims 1–3, 5, 6, and 8–22. Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM–IN–PART. 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 Boston Scientific SciMed, Inc. Appeal Br. 4. Appeal 2019-003324 Application 15/058,016 2 STATEMENT OF THE CASE Claims 1, 14, and 21 are the independent claims on appeal. Claims 1 and 14, reproduced below with disputed limitations italicized for emphasis, are exemplary of the subject matter on appeal. 1. A method of recanalizing a blood vessel by establishing a subintimal pathway around an occlusion, the method comprising: creating a subintimal pathway between a proximal opening into a vessel wall proximal of an occlusion and a distal opening into the vessel wall distal of the occlusion, the vessel wall including an intima layer, a media layer, and an adventitia layer, the subintimal pathway exposing a surface of the media layer of the vessel wall; positioning an expandable stent in the subintimal pathway; expanding the expandable stent in the subintimal pathway against the surface of the media layer; and promoting native tissue regrowth around the stent to create a superficial intimal layer within the vessel wall along the subintimal pathway, the superficial intimal layer being juxtaposed with and extending along the surface of the media layer. 14. A method of recanalizing a blood vessel by establishing a subintimal pathway around an occlusion, the method comprising: creating a subintimal pathway between a proximal opening into a vessel wall proximal of an occlusion and a distal opening into the vessel wall distal of the occlusion; positioning an expandable stent surrounding a body portion of an inflatable balloon structure in the subintimal pathway with a distal anchoring portion of the inflatable balloon structure positioned in a true lumen portion of the blood vessel distal of the occlusion, the distal anchoring portion being disposed distal of a distal end of the expandable stent; Appeal 2019-003324 Application 15/058,016 3 inflating the distal anchoring portion of the inflatable balloon structure in the true lumen portion distal of the occlusion to an inflated configuration; and inflating the body portion of the inflatable balloon structure to expand the expandable stent in the subintimal pathway to an expanded configuration; wherein the inflated distal anchoring portion anchors the inflatable balloon structure from unintentional proximal movement while the expandable stent is expanded in the subintimal pathway to maintain proper placement of the expandable stent in the subintimal pathway; wherein an outermost diameter of the distal anchoring portion in the inflated configuration is greater than an outermost diameter of the expandable stent in the expanded configuration. THE REJECTIONS I. Claims 1 and 13 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Makower (US 6,709,444 B1; issued Mar. 23, 2004) and Mandrusov (US 2006/0265043 A1; published Nov. 23, 2006). II. Claims 2, 3, 5, 6, and 9–11 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Makower, Mandrusov, and Heuser (US 7,300,459 B2; issued Nov. 27, 2007). III. Claims 8 and 12 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Makower, Mandrusov, Heuser, and Gerrans (US 2012/0259401 A1; published Oct. 11, 2012). IV. Claims 14–20 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Makower and Heuser. V. Claims 21 and 22 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Makower, Mandrusov, and Heuser. Appeal 2019-003324 Application 15/058,016 4 ANALYSIS Rejection I Claim 1: Regarding independent claim 1, the Examiner finds, inter alia, that Makower discloses a method of recanalizing a blood vessel by establishing a subintimal pathway around an occlusion, the method comprising the step of “creating a subintimal pathway between a proximal opening into a vessel wall proximal of an occlusion and a distal opening into the vessel wall distal of the occlusion (Figures 5A–5D, 7A, 7B),” in which “the vessel wall includ[es] an intima layer (I), a media layer (M), and an adventitia layer (A),” and “the subintimal pathway expos[es] a surface of the media layer of the vessel wall (Figure 5D).” Final Act. 2–3. The Examiner acknowledges that “Makower fails to explicitly disclose promoting native tissue regrowth around [a] stent to create a superficial intimal layer within the vessel wall along the subintimal pathway, the superficial intimal layer being juxtaposed with and extending along the surface of the media layer.” Id. at 3. The Examiner, however, finds that Mandrusov discloses a stent (1340) that promotes native tissue regrowth (i.e., plaque and fibrous cap 1320) around the stent upon delivery, creating a superficial layer around the stent. Id. (citing Mandrusov Figs. 13A–13B). The Examiner also finds that Mandrusov discloses that the stent has a coating of a drug or a bioactive agent that controls the thickness of the tissue that grows around the stent and that the superficial layer provides stabilization of a lumen. Id. (citing Mandrusov ¶¶ 69–72). The Examiner further finds that Mandrusov discloses that after the stent has been deployed at a desired location, it may cause platelet deposition, fibrosis, and Appeal 2019-003324 Application 15/058,016 5 neointimal formation in the stented region, and that this fibromuscular response may cause the original fibrous cap thickness to increase (i.e., “new tissue is present that did not exist prior to insertion of the stent”). Id.; see also Mandrusov ¶ 69 (“After stent 1340 has been deployed at a desired location, it may cause platelet deposition, fibrosis and neointimal formation in the stented region.” (emphasis added)). The Examiner reasons that it would have been obvious to modify the method of Makower to include a coating comprising a drug or a bioactive agent to promote native tissue growth around a stent, as taught by Mandrusov, to create a superficial intimal layer within the vessel wall along the subintimal pathway, the superficial intimal layer being juxtaposed with and extending along the surface of the media layer because the “modification would provide stabilization of the stent and subintimal pathway.” Final Act. 3–4. Appellant contends that “[t]here is no rational reason for one of ordinary skill in the art, upon reading Makower, directed to treating complete occlusions, to look to Mandrusov, directed to treating vulnerable plaques, for ways of modifying the technique of Makower.” Appeal Br. 10. In support, Appellant argues that “Makower provides no teaching or suggestion of a desire or need to have tissue growth within the vessel wall” and that “[t]he only reasons for modifying Makower to have these elements are found in Appellant’s specification, which is improper.” Id. Appellant submits that although the Examiner concludes that it would have been obvious to modify Makower’s method to “provide stabilization of the stent and subintimal pathway,” Makower already accomplishes this in disclosing inflation of the balloon “to radially expand the stent 208 such that the ends Appeal 2019-003324 Application 15/058,016 6 of the stent 208 firmly coapt with the intima I of the artery and the mid- portion of the stent 208 provides a scaffold which maintains the sub-intimal tract 205 in an open condition capable of carrying blood past the obstruction O.” Id. (quoting Makower 11:41–46); see also Reply Br. 2–4, 6. Appellant’s contentions are unpersuasive. [E]vidence of a motivation to combine need not be found in the prior art references themselves, but rather may be found in “the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved.” . . . When not from the prior art references, the “evidence” of motive will likely consist of an explanation of the well-known principle or problem-solving strategy to be applied. Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1366 (Fed. Cir. 2006) (emphases in original, quoting In re Dembiczak, 175 F.3d 994, 999 (Fed. Cir. 1999)). Here, the Examiner correctly responds that [o]ne having ordinary skill in the art would recognize that if a drug-eluting stent can provide the advantage of promoting native tissue growth around the stent to stabilize a vulnerable plaque positioned within a vessel wall and prevent rupture of the vessel wall (and further problems as a result of the vessel wall rupturing), promoting tissue growth around a stent in a pathway within a vessel wall to stabilize the stent and pathway would also be advantageous to prevent damage to the vessel and further issues that could arise as a result. Ans. 4–5 (emphasis added). The Examiner further explains that “[t]he motivation to modify Makower in view of Mandrusov was derived from the teachings of Mandrusov and the level of one having ordinary skill in the art” and that “[w]hile Makower does disclose that that the method results in a firm placement of the stent and an open subintimal tract, the modification presented by the Examiner is an improvement in that it would result in Appeal 2019-003324 Application 15/058,016 7 further stabilization of the stent and the subintimal pathway while also preventing damage to the vessel.” Id. at 5 (emphasis added). Appellant contends that Mandrusov does not disclose that its “cited configuration (FIGS. 13A–13B) of a coated stent promotes the creation of a superficial intimal layer along a subintimal pathway, with the superficial intimal layer being juxtaposed with and extending along the surface of the media layer of a vessel wall.” Appeal Br. 11. Appellant also contends that Mandrusov does not disclose “the creation of a new layer of tissue (e.g., an intimal layer) juxtaposed with a distinctly different tissue layer (e.g., the dissected media layer).” Id. at 11–12; see also Reply Br. 4–5. Appellant further contends that “[t]he proposed modification would appear to merely stimulate growth of the layer(s) (e.g., the media and/or the adventitia) that the stent of Makower is in contact with along the subintimal pathway” and “[t]here is no teaching that adding the coating of [Mandrusov] would promote the creation of a (new) superficial intimal layer along the subintimal pathway that is juxtaposed with and extending along a surface of the media layer.” Id. at 12; see also Reply Br. 4–5. Appellant’s contentions are unpersuasive in that they do not address the Examiner’s rejection. “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references []. [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). As the Examiner points out, Mandrusov discloses that its stent has a coating of a drug or a bioactive agent and that after the stent “has been deployed at a desired location, it may cause platelet deposition, fibrosis, and neointimal Appeal 2019-003324 Application 15/058,016 8 formation in the stented region.” Final Act. 3 (quoting Mandrusov ¶ 69 with emphasis added); see also id. (explaining that “i.e.[,] new tissue is present that did not exist prior to insertion of the stent.”). Put another way, the Examiner finds that Mandrusov discloses promoting native tissue regrowth around the stent to create a superficial intimal layer. The Examiner finds that it is Makower that discloses using a stent to create a “subintimal pathway [that] expos[es] a surface of the media layer of the vessel wall (Figure 5D).” Final Act. 2–3. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Here, Makower provides a vessel wall having an intimal layer adjacent to and extending along a media layer and a stent that creates a subintimal pathway exposing a surface of the vessel wall’s media layer such that coating the stent to promote neointimal (new intimal) formation, as taught by Mandrusov, would yield predictable results of “a superficial intimal layer within the vessel wall along the subintimal pathway, the superficial intimal layer being juxtaposed with and extending along the surface of the media layer,” as claimed.2,3 2 We note that the Specification does not disclose that coating the stent with any particular agent would promote one type of cell growth, i.e., an intimal layer, rather than another type of cell growth, i.e., a media layer or an adventitia layer. 3 We agree with Appellant that a skilled artisan would recognize that the claimed superficial intimal layer has a similar tissue configuration as the claimed intima layer. See Reply Br. 5–6. However, as discussed above, the Examiner’s proposed combination of Makower and Mandrusov would result in the creation of a new layer of intima cells that has a similar tissue configuration as the native intima cells and that is juxtaposed with and Appeal 2019-003324 Application 15/058,016 9 Accordingly, we sustain the Examiner’s rejection of claim 1 as being obvious over Makower and Mandrusov. Claim 13: Claim 13 depends from claim 1. Appeal Br. 22 (Claims App.). Appellant does not provide substantive arguments for this claim and appears to rely on arguments made for claim 1. Id. at 15. As we do not find error in the rejection of claim 1, the rejection of claim 13 is sustained for the same reasons discussed above. Rejection IV Regarding independent claim 14, the Examiner finds, inter alia, that Makower discloses a method of recanalizing a blood vessel by establishing a subintimal pathway around an occlusion in which the method comprises the step of positioning an expandable stent 208 surrounding a body portion of an inflatable balloon structure in a subintimal pathway with a distal anchoring portion of the inflatable balloon structure positioned in a true lumen portion of a blood vessel distal of an occlusion. Final Act. 9–10 (citing Makower Figs. 7D, 7E). The Examiner acknowledges that Makower does not disclose that the distal anchoring portion of the inflatable balloon structure is disposed distal of a distal end of the expandable stent and wherein an extending along the surface of the media layer. Additionally, we note that claim 1 recites “the superficial intimal layer being juxtaposed with and extending along the surface of the media layer” and does not recite the superficial intimal layer “covering the exposed” media layer. Appeal Br. 21 (Claims App.) (emphasis added); see also Reply Br. 6; In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (limitations not appearing in the claims cannot be relied upon for patentability). Appeal 2019-003324 Application 15/058,016 10 outermost diameter of the distal anchoring portion in the inflated configuration is greater than an outermost diameter of the expandable stent in the expanded configuration. Id. at 9. The Examiner, however, finds that Heuser discloses inflating a distal anchoring portion (i.e., flexible membrane 20) of an inflatable balloon structure to an inflated configuration and into contact with an intimal wall of a blood vessel. Id. at 10 (citing Heuser Fig. 3). The Examiner also finds that Heuser discloses that the distal anchoring portion of the inflatable balloon structure has an outermost diameter in the inflated configuration that is greater than an outermost diameter (at intermediate portion 30c) of the expandable stent in the expanded configuration. Id. (citing Heuser Fig. 4). The Examiner reasons that it would have been obvious to modify the method of Makower to have the inflatable balloon include a distal anchoring portion that is positioned distal of a distal end of the expandable stent, wherein the distal anchoring portion has an outermost diameter in the inflated configuration greater than an outermost diameter of the expandable stent in the expanded configuration, as taught by Heuser, to “provide[] a distal anchoring portion that can be initially inflated independently of the body portion of the balloon to ensure proper positioning of the stent within the vessel” and to “provide[] a balloon with a body portion that allows the proximal and distal ends of the stent to be expanded before fully expanding the stent, ensuring proper placement before fully expanding the stent.” Id. at 10–11. Appellant contends that an ordinary artisan “would not characterize the partially expanded configuration shown in FIG. 4 [of Heuser] to properly correspond to the claimed expanded configuration of the expandable stent in Appeal 2019-003324 Application 15/058,016 11 the expanded configuration” because an ordinary artisan “would clearly and easily recognize FIG. 4 [of Heuser] as showing a partially expanded stent.” Appeal Br. 17 (citing Heuser 2:31–34). The Examiner responds that “[i]n Figure 4 of Heuser, the second end 30a (characterized by the Examiner as the distal anchoring portion in the rejections) of the flexible membrane 30 is clearly in an expanded configuration” such that an ordinary artisan “would recognize that the flexible membrane 30 is in an uninflated configuration in Figure 3 [of Heuser] and in an inflated configuration in Figure 4 [of Heuser]” and that “[t]here is no language in claim 14 requiring the distal anchoring portion [to be] in a fully inflated configuration.” Ans. 9. Appellant’s contention is persuasive. 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 Smith International, Inc., 871 F.3d 1375, 1382–83 (Fed. Cir. 2017) (citing In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997) (citation and internal quotation marks omitted); In re Suitco Surface, 603 F.3d 1255, 1259–60 (Fed. Cir. 2010)). As an initial matter, we note that claim 14 recites “the expandable stent in the expanded configuration” rather than a portion of the expanded stent in the expanded configuration. Appeal Br. 23 (Claims App.) (emphasis added). With respect to Figure 5, the Specification discloses that “[t]he recanalization catheter 10 may be advanced through the subintimal space in Appeal 2019-003324 Application 15/058,016 12 a delivery configuration, such as with the balloon structure 20 in a deflated, folded configuration with the stent 40 surrounding the folded balloon structure 20.” Spec. 14:21–24 (emphasis added). Thus, Appellant discloses, with respect to Figure 5, the entire stent 40 is in an unexpanded configuration. The Specification further discloses that [o]nce positioned through the subintimal pathway, the balloon structure 20 may be inflated with an inflation medium directed through an inflation lumen of the catheter shaft 12 to radially expand the stent 40 in the subintimal pathway, and thus maintain a pathway for subsequent blood flow around the occlusion 90. As shown in FIG. 6, the distal anchoring portion 60 may be inflated in the true lumen 88 distal of the occlusion 90 to anchor the inflatable balloon structure 20, including the body portion 52 underlying the stent 40, from unintentional proximal movement while the stent 40 is expanded in the subintimal pathway to maintain proper placement of the stent 40 in the subintimal pathway. Id. at 15:3–11 (emphasis added). Thus, the Specification describes an “expanded stent,” as shown in Figure 6, to be a stent in which its entire body is in a fully expanded configuration, rather than one portion being expanded and another portion being unexpanded or partially expanded. See Spec., passim. In other words, the Specification never discloses a partially expanded configuration; rather, the Specification discloses a fully expanded configuration when describing an “expanded stent.” We, thus, construe the term “the expandable stent in the expanded configuration” as the entire stent being in a fully expanded configuration. In finding that Heuser discloses the limitation at issue, the Examiner looks to Figure 4 which shows that the end portions of the stent, excluding the middle portion of the stent, are in an expanded configuration. Thus, in effect, the Examiner interprets the term “the expandable stent in the Appeal 2019-003324 Application 15/058,016 13 expanded configuration” to include a stent that has a portion that is unexpanded or partially expanded––an interpretation that does not correspond with what and how the inventor describes his invention in the Specification, i.e., it is not an interpretation that is “consistent with the specification.” It is Figure 5, not Figure 4, of Hueser that discloses an entire stent that is in a fully expanded configuration, i.e., “an expandable stent in the expanded configuration.” Here, comparing the outermost diameter of flexible membrane 20 and the outermost diameter of stent 40, it cannot be said that Heuser’s Figure 5 discloses “an outermost diameter of [a] distal anchoring portion [of an inflatable balloon structure] in the inflated configuration is greater than an outermost diameter of [an] expandable stent in the expanded configuration,” as claimed because both diameters appear to be the same size. As such, we agree with Appellant that the Examiner’s interpretation of the term “expanded” and “inflated” to encompass “partially expanded” and “partially inflated,” respectively, is unreasonable, and the Examiner’s finding that Heuser discloses that a distal anchoring portion of an inflatable balloon structure has an outermost diameter in the inflated configuration that is greater than an outermost diameter of the expandable stent in the expanded configuration, is in error. Accordingly, we do not sustain the Examiner’s rejection of independent claim 14, and claims 15–20 depending therefrom as being obvious over Makower and Heuser. Rejection V Independent claim 21 recites a similar limitation as that of claim 14, namely, “wherein the distal anchoring portion of the inflatable balloon Appeal 2019-003324 Application 15/058,016 14 structure has an outermost diameter in the inflated configuration greater than an outermost diameter of the expandable stent in the expanded configuration.” Appeal Br. 24 (Claims App.). The Examiner relies on Makower and Heuser for disclosing the limitations of claim 21, and uses the same rationale for combining the teachings of these references in the same manner as discussed above for claim 14. Final Act. 12–15. Thus, the rejection is based on an incorrect finding with respect to the Heuser reference as discussed above. Accordingly, for reasons similar to those discussed above for claim 14, we do not sustain the rejection of independent claim 21, and claim 22 depending therefrom as being obvious over Makower, Mandrusov, and Heuser. Rejections II and III Claim 2: Claim 2 depends from claim 1. Appeal Br. 21 (Claims App.). Appellant does not provide substantive arguments for this claim and appears to rely on arguments made for claim 1. Id. at 15. Accordingly, for reasons similar to those discussed above, we sustain the rejection of claim 2 over Makower, Mandrusov, and Heuser. Claims 3, 5, 6, and 8–12: Claim 3 depends indirectly from claim 1 and recites a similar limitation as that of claim 14, namely, “wherein the distal anchoring portion of the inflatable balloon structure has an outermost diameter in the inflated configuration greater than an outermost diameter of the expandable stent in the expanded configuration.” Appeal Br. 21 (Claims App.). Claims 5, 6, Appeal 2019-003324 Application 15/058,016 15 and 8–12 depend either directly or indirectly from claim 3. Id. at 21–22 (Claims App.). Similar to the rejection of claim 14, the Examiner incorrectly finds that Heuser discloses the limitation of claim 3. Final Act. 5. Accordingly, for reasons similar to those discussed above for claim 14, we do not sustain the rejection of claims 3, 5, 6, and 8–12 over the various combinations of cited prior art. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 13 103(a) Makower, Mandrusov 1, 13 2, 3, 5, 6, 9– 11, 21, 22 103(a) Makower, Mandrusov, Heuser 2 3, 5, 6, 9– 11, 21, 22 8, 12 103(a) Makower, Mandrusov, Heuser, Gerrans 8, 12 14–20 103(a) Makower, Heuser 14–20 Overall Outcome 1, 2, 13 3, 5, 6, 8– 12, 14–22 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED IN PART Copy with citationCopy as parenthetical citation