Edward BoyleDownload PDFPatent Trials and Appeals BoardOct 4, 20212021001122 (P.T.A.B. Oct. 4, 2021) 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. 15/340,170 11/01/2016 Edward M. Boyle JR. PRET-52441US2 1070 86378 7590 10/04/2021 Pearne & Gordon LLP 1801 East 9th Street Suite 1200 Cleveland, OH 44114-3108 EXAMINER HENSON, DEVIN B ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 10/04/2021 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): patdocket@pearne.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte EDWARD M. BOYLE JR. __________ Appeal 2021-001122 Application 15/340,170 Technology Center 3700 __________ Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and ANNETTE R. REIMERS, Administrative Patent Judges. REIMERS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–5 and 7–17. Claim 6 has been canceled. Appeal Br. 13 (Claims App.). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 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 Precision Thoracic LLC. Appeal Brief (“Appeal Br.”) 1, filed July 7, 2020. Appeal 2021-001122 Application 15/340,170 2 CLAIMED SUBJECT MATTER The claimed subject matter “relate[s] to surgical tools and methods.” Spec. ¶ 2.2 Claim 1, the sole independent claim on appeal, is representative of the claimed subject matter and recites: 1. A biopsy device for use in extracting target tissue, comprising: a first needle defining a first-needle bore, a distal end of said first needle being effective to pierce a tissue upon advancement in a patient; a snare comprising a snare shaft and a deployable snare head at a distal end of the snare shaft, the snare shaft at least partially received within and extending through said first-needle bore, the snare head is compressed to a first, low-profile configuration while retained within the first-needle bore and deployed to a second, high-profile configuration upon advancing beyond the first-needle distal end; and a sheath insertable into said patient while accommodating said snare shaft through a bore of said sheath for guiding insertion thereof until a distal end of said sheath reaches a location adjacent said snare head, said sheath being configured to dilate a tissue tract along said snare shaft between said snare head and a space outside said patient to a sufficient diameter to accommodate withdrawal of a target tissue engaged by said snare head in said high-profile configuration, wherein the distal end of said sheath comprises a mechanism for sealing the tissue tract as the sheath is advanced into or withdrawn from the patient. Appeal Br. 12 (Claims App.) 2 Specification (“Spec.”), filed Nov. 1, 2016. Appeal 2021-001122 Application 15/340,170 3 THE REJECTIONS3 I. Claims 4, 5, and 11–17 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. II. Claims 1, 4, and 10–13 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Chu (US 5,961,526, issued Oct. 5, 1999), Dubrul (US 2004/0010206 A1, published Jan. 15, 2004), and Roberts (US 5,928,163, issued July 27, 1999). III. Claims 2 and 15–17 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Chu, Dubrul, Roberts, and McGurk (US 2006/0025815 A1, published Feb. 2, 2006). IV. Claim 3 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Chu, Dubrul, Roberts, and Fallin (US 7,811,303 B2, issued Oct. 12, 2010). V. Claims 5, 7, and 14 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Chu, Dubrul, Roberts, and Ginn (US 2006/0190037 A1, published Aug. 24, 2006). VI. Claims 8 and 9 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Chu, Dubrul, Roberts, Fallin, and Ginn. 3 The following rejections have been withdrawn by the Examiner: (a) claim 7 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement (Final Office Action (“Final Act.”) 2, dated Dec. 16, 2019); (b) claims 4, 5, 7, and 11–17 under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement (id. at 3); and (c) claim 7 under 35 U.S.C. § 112, second paragraph, as being indefinite (id. at 4). See Examiner’s Answer (“Ans.”) 3, dated Oct. 5, 2020. Appeal 2021-001122 Application 15/340,170 4 ANALYSIS Rejection I — Written Description In the Final Office Action, the Examiner determines that the Specification “fails to describe a single embodiment including multiple mechanisms for sealing the tissue tract/sealing elements, as required by the combination of features now recited in claims [4, 5,4] and 11–17.” Final Act. 3. In the Answer, the Examiner states that paragraphs 89 and 97 of the Specification “do not describe a single embodiment including a sheath comprising a mechanism for sealing the tissue” with a sealing mechanism from the first needle, as set forth in claims 4, 5, and 11. Ans. 3–4. The Examiner asserts that although a sealing mechanism is described, paragraph 97 “does not specify the sealing mechanism being positioned on any particular element, nor does it describe a single embodiment including multiple sealing mechanisms.” Id. at 4. The Examiner takes the position that although paragraph 89 discloses a needle that imparts energy to seal tissue and a sheath with a mechanism that imparts energy to seal tissue, “there is no suggestion that these embodiments are used in combination.” Id. The Examiner appears to cite to Fukijawa5 for the proposition that it is improper, with respect to the written description requirement, to simply provide a “laundry list” disclosure. Id. at 5. In rejecting a claim under 35 U.S.C. § 112, first paragraph, for lack of adequate descriptive support, it is incumbent upon the Examiner to establish 4 As indicated in footnote 3 above, the rejection of claim 7 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement, has been withdrawn. See Ans. 3. 5 Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Appeal 2021-001122 Application 15/340,170 5 that the originally-filed disclosure would not have reasonably conveyed to one having ordinary skill in the art that Appellant had possession of the now claimed subject matter. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Adequate description under 35 U.S.C. § 112, first paragraph, does not require literal support for the claimed invention. Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.”); In re Herschler, 591 F.2d 693, 701 (CCPA 1979); In re Edwards, 568 F.2d 1349, 1351–52 (CCPA 1978); In re Wertheim, 541 F.2d 257, 262 (CCPA 1976). Rather, it is sufficient if the originally-filed disclosure would have conveyed to one having ordinary skill in the art that Appellant had possession of the concept of what is claimed. In re Anderson, 471 F.2d 1237, 1242 (CCPA 1973). Thus, “written description is about whether the skilled reader of the patent disclosure can recognize that what was claimed corresponds to what was described.” Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1191 (Fed. Cir. 2014). We further note that “things patent drawings show clearly are [not] to be disregarded.” In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972) (emphasis in original). We first note that Appellant’s Figures 15A–15E clearly disclose an embodiment in which a needle for deployment of a snare is used with a needle for dilating tissue. See Spec. ¶ 88. More particularly, Figures 15D and 15E show elements 80A and 80B identified as “hollow needles” of “increasing outer diameter, respectively” that are “adapted to dilate a larger tract 49 by cutting through the lung tissue 46 to target tissue 43.” Id. Thus, we understand that elements 80A and 80B equate to the “sheath [] Appeal 2021-001122 Application 15/340,170 6 configured to dilate lung tissue” as recited in claim 1. Further, we note that the Specification discloses that “[i]t is anticipated that other elements may be housed within the outer sheath 71.” Id. ¶ 75 (emphasis added). Paragraph 89 discloses both “the needle 80 has a tip that imparts energy to the tissue to cauterize or seal the tissue as the needle 80 is advanced” and “each dilating sheath contains a distal tip with a mechanism to impart energy to seal the tissue as it dissects the channel.” Id. ¶ 89. Likewise, paragraph 97 discloses the use of both a needle with a sealing mechanism and a sheath with sealing mechanism by stating “a needle 80 is provided comprising a tip adapted to impart energy to the tissue to cauterize or seal the tissue as it is advanced” and “[m]ore than one sheath can be utilized to progressively dilate the tract. A sealing mechanism can be utilized as the tract is developed to the target tissue.” Id. ¶ 97. Thus, although the Specification does not explicitly state that a needle with a sealing mechanism is used with a sheath with a sealing mechanism in a single embodiment, the Specification implicitly discloses such combination in a single embodiment by virtue of describing both features in the same paragraph and showing both the needle and the sheath within the same series of steps, as depicted in Figures 15A–15D. Consequently, we agree with Appellant that the Specification would have reasonably conveyed to one of ordinary skill in the art that Appellant had possession of the claimed subject matter. Appeal Br. 3–5. We also agree with Appellant that the Specification does not merely disclose a “laundry list” of items that includes the needle with a sealing mechanism in combination with the sheath with a sealing mechanism as claimed because the Specification discloses how the former is Appeal 2021-001122 Application 15/340,170 7 linked to the later, as discussed above. Reply Br. 3.6 In regard to Fukijawa, which was cited by the Examiner, as Appellant points out, this case does not stand for the premise that all claimed features must be expressed in a single disclosed embodiment, but instead––for the proposition that claiming undisclosed species may violate the written description requirement. Id. For these reasons, we do not sustain the Examiner’s rejection of claims 4, 5, and 11–17 as failing to comply with the written description requirement. Rejection II — Obviousness over Chu, Dubrul, and Roberts As to independent claim 1, the Examiner finds that Chu discloses a biopsy device comprising: (a) a first needle (needle 60) having a first-needle bore and effective to pierce tissue; (b) a snare (distal loop 80) having a snare head and a snare shaft that is partially received within and extending through the first-needle bore; and (c) a sheath 1 accommodating the snare shaft. Final Act. 5–6 (citing Chu Figs. 2–4, 9–13); see also Chu Fig. 1. The Examiner acknowledges that Chu does not disclose that “the sheath [1 is] configured to dilate a tissue tract along [the] snare shaft . . . to a sufficient diameter to accommodate withdrawal of a target tissue engaged by [the] snare head.” Id. at 6. The Examiner, however, finds that Dubrul discloses a sheath (sleeve 36, tubular shaft 54, tube 117) configured to dilate a tissue tract along a snare shaft to a sufficient diameter to accommodate withdrawal of a target tissue engaged by a snare head. Id. (citing Dubrul Figs. 2, 3C–3F, 9A–9D). The Examiner concludes that it would have been obvious to a 6 Reply Brief (“Reply Br.”), filed Dec. 3, 2020. Appeal 2021-001122 Application 15/340,170 8 skilled artisan to modify the biopsy device of Chu “to include a sheath [that is] configured to dilate a tissue tract along [the] snare shaft between [the] snare head . . . to a sufficient diameter to accommodate withdrawal of a target tissue engaged by [the] snare head,” as disclosed by Dubrul, “to prevent seeding of tissue tract and provide convenient and accurate re-access to the target tissue site in order to reduce tissue trauma, chance of infection and cost while aiding healing.” Id. at 6–7 (citing Dubrul ¶¶ 18, 47, 48]).7 Appellant contends that “[i]n the present case, one skilled in the art would not have been motivated to combine the teachings of the cited references as Chu already disclose[s] a solution to the alleged problems asserted by the examiner.” Appeal Br. 6. Appellant has the better position. “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). As Appellant points out, “Chu discloses that the ‘sheath 1 is designed to pass through the working channel 30 of an endoscope 25.’” Appeal Br. 6 (citing Chu 4:42–44). We agree with Appellant’s assessment that “Chu already provides a means to re-access the target tissue site via the endoscope 25 and working channel 30, and one skilled in the art would have no reason or motivation to modify Chu’s device in order to provide a re- access point to the target tissue site as asserted by the [E]xaminer.” Id. Thus, “Chu already discloses a mechanism that prevents seeding of the 7 The Examiner relies on the teachings of Roberts for claimed subject matter other than that discussed above. Final Act. 6–7. Appeal 2021-001122 Application 15/340,170 9 tissue tract as the excised tissue is completely withdrawn into the sheath 1.” Id. at 7 (citing Chu 8:52–64). Appellant also persuasively explains that “Chu discloses that the entire lesion 205 is severed from the mucosa 210 and aspirated into the aspiration cylinder 40 of the endoscope 25” and thus, “Chu discloses a method of removing a lesion that prevents seeding of the tissue tract.” Id. (citing Chu Fig. 13). In other words, using its biopsy device for sampling tissue as depicted in Figures 8–13 of Chu, it does not appear that there is a reason to use a sheath (either by adding a sheath or modifying Chu’s existing sheath 1) configured to dilate tissue because the type of tissue being sampled (mucosa layer 210 within a gastrointestinal tract) can be grasped and severed by distal loop 85 without the need of dilating the mucosa layer disclosed in Chu (or any other tissues). Moreover, we note Chu discloses that its sheath “is preferably formed as an insulator to guard against short circuiting with an interior surface of the working channel 30 and to protect tissue surrounding the lesion from damage prior to locating a final position and deploying a desired one of the needle 60 and the snare 80.” Chu 6:5–10. Thus, Chu’s sheath 1, which the Examiner appears to suggest modifying, operates with the endoscope (as further discussed below) and does not appear to be intended for tissue contact (i.e., the sheath appears to contact the endoscope instead for insulating the needle). As such, in addition to Appellant’s contentions above, which we find persuasive, and as Chu’s sheath 1 serves a different purpose than accessing tissue by operating with an endoscope, the Examiner’s proffered reason for modifying Chu’s sheath to be configured to dilate tissue, lacks rational underpinning. In the Answer and in response to Appellant’s contentions, the Examiner takes the position that with the proposed modification, “such a Appeal 2021-001122 Application 15/340,170 10 sheath would eliminate the need for the endoscope 25 [of Chu] by incorporating some of its advantageous features into sheath 1.” Ans. 6. In other words, the Examiner proposes eliminating Chu’s endoscope in order to further the Examiner’s modification of Chu’s sheath. However, throughout its disclosure, Chu indicates that the endoscope is used and is operable with the sheath, as discussed above. See Chu 4:42–5:12, 5:44–6:12, 7:42–9:1, Fig. 1A. The Examiner also takes the position that an ordinary artisan could have combined the elements in the manner proposed which would produce predictable results (Ans. 5) and that the proposed modification would not “render Chu’s sheath unsatisfactory for its intended purpose or change its principle of operation (id. at 6–7). However, whether an ordinary artisan could have made the proposed modification and whether the proposed modification would not render something unsatisfactory for its intended purpose or would not change its principle of operation, are not enough to make the proposed modification obvious. An obviousness determination requires finding both “that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–68 (Fed. Cir. 2016) (emphasis added, quoting Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012)). As discussed above, on this record, the Examiner does not persuade us that an ordinary artisan would have been motivated to modify Chu’s biopsy device in the manner proposed. Appeal 2021-001122 Application 15/340,170 11 Accordingly, for the above reasons, we do not sustain the Examiner’s rejection of claim 1, and claims 4 and 10–13 depending therefrom, as unpatentable over Chu, Dubrul, and Roberts. Rejections III — VI — Obviousness over Chu, Dubrul, Roberts, and any of McGurk, Fallin, and/or Ginn The Examiner’s rejections of claims 2, 3, 5, 7–9, and 14–17 are predicated on the same deficient rationales addressed above. Final Act. 8– 13. Accordingly, for reasons similar to those discussed above for claim 1, we do not sustain the Examiner’s rejections of claims 2, 3, 5, 7–9, and 14–17 depending therefrom, as unpatentable over the various combinations of cited prior art. CONCLUSION The Examiner’s rejections are reversed. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § References/Basis Affirmed Reversed 4, 5, 11–17 112 Written Description 4, 5, 11–17 1, 4, 10–13 103(a) Chu, Dubrul, Roberts 1, 4, 10–13 2, 15–17 103(a) Chu, Dubrul, Roberts, McGurk 2, 15–17 3 103(a) Chu, Dubrul, Roberts, Fallin 3 5, 7, 14 103(a) Chu, Dubrul, Roberts, Ginn 5, 7, 14 8, 9 103(a) Chu, Dubrul, Roberts, Fallin, Ginn 8, 9 Appeal 2021-001122 Application 15/340,170 12 Claim(s) Rejected 35 U.S.C. § References/Basis Affirmed Reversed Overall Outcome 1–5, 7–17 REVERSED Copy with citationCopy as parenthetical citation