BAKER, Randal S. et al.Download PDFPatent Trials and Appeals BoardJan 10, 202014518414 - (D) (P.T.A.B. Jan. 10, 2020) 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. 14/518,414 10/20/2014 Randal S. BAKER BAK04 P-117A 7113 15671 7590 01/10/2020 Gardner, Linn, Burkhart & Ondersma LLP 2900 Charlevoix Dr., SE, Suite 300 Grand Rapids, MI 49546 EXAMINER DAVID, SHAUN L ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 01/10/2020 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): Vredeveld@gardner-linn.com clark@gardner-linn.com patents@gardner-linn.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte RANDAL S. BAKER, JAMES A. FOOTE, PAUL R. KEMMETER, and FREDERICK J. WALBURN ____________ Appeal 2018-002183 Application 14/518,414 Technology Center 3700 ____________ Before MICHAEL J. FITZPATRICK, MICHELLE R. OSINSKI, and JEREMY M. PLENZLER, Administrative Patent Judges. OSINSKI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1–28. An oral hearing was held on December 5, 2019.2 We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We REVERSE. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as BFKW, LLC. Appeal Br. 3. 2 The record includes a transcript of the oral hearing (“Tr.”). Appeal 2018-002183 Application 14/518,414 2 THE CLAIMED SUBJECT MATTER Claims 1, 8, 15, and 22 are independent. Claims 1 and 8 are reproduced below. 1. An implantable medical device adapted to be fixed in a hollow organ or cavity lined with mucosa, said medical device comprising: an expandable wall defining a lumen with proximal and distal ends thereof and configured to the size and shape of a portion of the organ or cavity; said wall configured to press against the mucosa of the hollow organ or cavity when expanded in the portion of the hollow organ or cavity; said wall having at least two adjacent openings separated by a bridge, said at least two adjacent openings being between said proximal and distal ends, each of said openings having a size that is large enough to cause the mucosa to bulge into that opening in a manner that maintains perfusion of the mucosa when said wall is expanded in the portion of the hollow organ or cavity; and said adjacent openings configured to be close enough together that the mucosa that bulges into said openings comes together over said bridge to fix said medical device in said hollow organ or cavity. 8. An implantable medical device adapted to be fixed in a hollow organ or cavity lined with mucosa, said medical device comprising: a wall having an outer surf ace with a size and shape that is configured to form an interference fit with a portion of a cavity or hollow organ lined with mucosa, said wall having an inner surface defining a lumen extending from proximal and distal ends of said wall; and a fixation mechanism that is adapted to fix said wall with the portion of the cavity or hollow organ, said fixation mechanism comprising at least two adjacent openings in said wall between said proximal and distal ends, said openings being large enough to receive a section of the mucosa extending in said Appeal 2018-002183 Application 14/518,414 3 openings when said wall is positioned in the hollow organ or cavity, said openings separated by a bridge, said openings configured to be close enough together that the mucosa that extends into said openings comes together in said lumen over said bridge to fix said medical device in the hollow organ or cavity. EVIDENCE The Examiner relied on the following evidence in rejecting the claims on appeal: Weller US 2003/0065359 A1 Apr. 3, 2003 Ortiz US 2007/0123994 A1 May 31, 2007 Baker US 8,894,670 B2 Nov. 25, 2014 REJECTIONS I. Claims 1–14 and 22–28 stand rejected under 35 U.S.C. § 102(b) as anticipated by Weller. Final Act. 3–9. II. Claims 15–21 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Weller and Ortiz. Id. at 10–13. III. Claims 1, 8, 15, and 22 stand rejected on the ground of nonstatutory double patenting as unpatentable over claims 1 and 9 of Baker. Id. at 14–15. OPINION Rejection I Claims 1–7 The Examiner finds that Weller discloses all of the limitations of independent claim 1. Final Act. 3–5. With respect to the language reciting “an expandable wall . . . configured to press against the mucosa of the hollow organ or cavity when expanded,” the Examiner takes the position that Weller’s overtube 120 is “capable of being expanded” because of the Appeal 2018-002183 Application 14/518,414 4 inclusion of “elongated channels 122, 122' which divide the distal portion of overtube 120 into two distinct halves” and “because the overtube is made of flexible materials.” Ans. 7 (citing Weller ¶¶ 33–34; Fig. 10A). The Examiner also takes the position that “Weller clearly shows the outside surface wall of overtube 120 pressing against the mucosa of the hollow organ or cavity, as shown in Fig. 12, and thus similarly shows that the wall is fully capable of pressing against the mucosa of the hollow organ” when the wall is expanded. Id. (citing Weller Fig. 12). Appellant argues that Weller merely “teaches that the overtube can be flexible or bendable to conform at least partially to the curvatures within the body.” Appeal Br. 12. Appellant continues that “a flexible wall does not need to be expandable. One example is a flexible high-pressure hydraulic hose which is flexible but must be non-expandable to contain the pressure.” Reply Br. 3. We agree with Appellant that flexibility does not necessarily equate to expandability. As to the Examiner’s additional finding regarding the inclusion of elongated channels that divide overtube 120 into distinct halves, Appellant argues that “[t]he halves are joined together at the top portion of the views so they cannot be moved apart.” Appeal Br. 12. Appellant explains that the joining or connection of the two halves is necessary because one “need[s] to have channels that are fixed” (Tr. 8:17–18) so that fastened tissue can be manipulated through the channels in order to retract overtube 120 (id. at 9:24–10:7). We agree with Appellant that the inclusion of longitudinally extending channels on overtube 120 does not necessarily equate to overtube 120 being capable of being expanded, especially considering that the channels are rigid and/or fixed for guiding the retraction of overtube 120. Appeal 2018-002183 Application 14/518,414 5 As to Figure 12 of Weller showing the outside surface wall of overtube 120 pressing against the mucosa of the hollow organ or cavity, Appellant argues “overtube 12[0] is not expandable but rather the tissue is drawn to the wall.” Appeal Br. 12. That is, Weller uses a vacuum to draw tissue into the windows of overtube 120, such that “[t]he cited portions of Weller teach neither an expandable wall nor [one] configured to press against the hollow organ or cavity when expanded.” Id. We agree with Appellant that Weller’s Figure 12 is not indicative of expansion of the wall of overtube 112, but rather merely of the tissue being drawn into windows 124, 124' through use of a vacuum. For the foregoing reasons, Appellant apprises us of error in the Examiner’s determination that Weller anticipates claim 1. Accordingly, we do not sustain the rejection of claim 1, and claims 2–7 depending therefrom, under 35 U.S.C. § 102(b) as anticipated by Weller. Claims 8–14 and 22–28 The Examiner finds that Weller discloses all of the limitations of independent claims 8 and 22. Final Act. 5–8. With respect to the language reciting “a wall having an outer surface with a size and shape that is configured to form an interference fit with a portion of a cavity or hollow organ lined with mucosa,” the Examiner takes the position that “[a]s shown in Fig. 5 and Fig. 12, tissue of the stomach which is not being invaginated into the overtube but instead is adjacent to the windows of the overtube is shown forming an ‘interference fit’ against the outer surface of the overtube.” Ans. 7. The Examiner points in particular to “the tissue near the indicating line element #120 [that] is shown forming an interference fit with the overtube since the tissue is pressing against the overtube and there is no Appeal 2018-002183 Application 14/518,414 6 space therebetween” even though this tissue “is not near an invagination window.” Id. According to the Examiner “[t]hus, regardless of whether or not suction is used to draw the tissue within the window of the overtube, Weller clearly discloses a wall ‘configured to form an interference fit with a portion of a cavity or hollow organ’” because “Weller clearly shows an abutting relationship between tissue and the outer surface wall of the overtube.” Id. Appellant argues that Weller does not disclose a wall configured to form an interference fit with a portion of a cavity or hollow organ. Appeal Br. 11. More particularly, Appellant argues that Weller’s disclosure of drawing tissue into a lumen of the overtube via vacuum is not an explicit or inherent disclosure of a wall configured to form an interference fit with the cavity or hollow organ. Id. at 12. According to Appellant, “[a]n interference fit must be a result of the size and shape of the device wall.” Reply Br. 3 (underlining omitted); see also Tr. 11:8–19 (Appellant asserting that an interference fit “means that the outer diameter of the inner piece has to be at least as great as the inner diameter of the outer piece. . . . So the structure there would be that the outer diameter of the wall, which is going to be fundamentally cylindrical in most applications, would be at least as large as the inner diameter of the lumen where it’s going to be positioned.”). According to Appellant, “[t]he only reason why the tissue is forced against the outer surface of overtube 120 in Fig. 12 of Weller is because of applied vacuum, not an interference fit.” Reply Br. 3. Appellant continues that “[i]t is clear that overtube 120 does not have a size and shape that is configured to form an interference fit with the stomach, which is much larger than the Appeal 2018-002183 Application 14/518,414 7 esophagus and therefore, overtube 120, which fits through the esophagus.” Id. We agree with Appellant that the Examiner’s reliance on the “abutting relationship between tissue and the outer surface wall of the overtube” as shown in Figure 12 of Weller (Ans. 7) is insufficient to support by a preponderance of the evidence that Weller discloses a wall configured to form an interference fit with a portion of a cavity or hollow organ lined with mucosa. An “interference fit” is defined as “[a] fit between two parts in which the external dimension of one part slightly exceeds the internal dimension of the part into which it has to be fit” (Lexico, a collaboration between Dictionary.com and Oxford University Press, available at https://www.lexico.com/definition/interference_fit) or “engineering a match between the size and shape of two parts, such that force is required for assembly as one part is slightly larger than the other” (Dictionary.com, available at https://www.dictionary.com/browse/interference-fit#). The Examiner provides no explanation regarding the dimensions of overtube 120 or the tissue surrounding overtube 120 so as to evidence a particular relationship between them that would support a finding of an interference fit according to the plain and ordinary meaning of the term “interference fit.” For the foregoing reasons, Appellant apprises us of error in the Examiner’s determination that Weller anticipates claims 8 and 22. Accordingly, we do not sustain the rejection of claims 8 and 22, and claims 9–14 and 23–28 depending therefrom, under 35 U.S.C. § 102(b) as anticipated by Weller. Appeal 2018-002183 Application 14/518,414 8 Rejection II Independent claim 15 recites “a wall . . . that is configured to form an interference fit with a portion of a cavity or hollow organ lined with mucosa.” Appeal Br. 24 (Claims App.). The Examiner’s rejection of claim 15 with Weller as the primary reference relies on the same erroneous finding that Weller discloses a medical device with a wall that is configured to form an interference fit with a portion of a cavity or hollow organ lined with mucosa. Final Act. 18–19; Ans. 6–7. The Examiner does not explain how Oritz could remedy the deficiency of Weller. Accordingly, we do not sustain the rejection of claim 15, or claims 16–21 depending therefrom, under 35 U.S.C. § 103(a) as unpatentable over Weller and Ortiz. Rejection III The Examiner rejects claims 1, 8, 15, and 22 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of Baker. Final Act. 14–15. According to the Examiner, “[a]lthough the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application describe the structure of the apparatus used in the method of [Baker].” Id. at 14. The Examiner acknowledges that where claimed subject matter is presented in a divisional application as a result of a restriction requirement made in a parent application under 35 U.S.C. § 121, a double patenting rejection of that subject matter generally is not permitted based on claims of the parent application. Id. at 15. The Examiner determines, however, that the safeguard of 35 U.S.C. § 121 “does not apply” because “the claims of the application under examination and claims of the patent are not consonant with the restriction requirement made by the [E]xaminer, since the claims Appeal 2018-002183 Application 14/518,414 9 have changed in material respects from the claims at the time the requirement was made.” Id. (citing MPEP § 804.01). More particularly, the Examiner states that “[t]he device claims in the current application are not the same scope as the device claims originally presented in the [Baker] application which resulted in a Restriction/Election Requirement.” Id. Appellant argues that in response to the Restriction/Election Requirement, Appellant elected Group II drawn to a method of implanting a medical device and Species B (Figs. 3–5) and presented new claims 24–42 complying with the definition of Group II and readable on the elected species. Appeal Br. 17–19. Appellant argues that “[t]he present application was filed with claims 1–28 all directed to an implantable medical device” which “read on . . . species B (FIGS. 3–5)” and, “[t]hus, [Appellant’s] actions were fully consistent with the requirements set forth in the office action in the parent [Baker] entitled ‘Election/Restrictions.’” Id. at 19. Appellant argues that merely because “the device claims in the current application are not the same scope as the device claims originally presented in the parent application” is not the test with respect to whether the safeguard of 35 U.S.C. § 121 applies. Id. at 20. Instead, Appellant maintains that the claims of the present application “are indeed consonant with the line of demarcation set forth in the restriction requirement and species election requirement so the non-statutory double patenting rejection is improper and should be reversed.” Id. at 21. Consonance requires that the line of demarcation between the “independent and distinct inventions” that prompted the restriction requirement be maintained. Though the claims may be amended, they must not be so amended as to bring them back over the line imposed in the restriction requirement. Where that Appeal 2018-002183 Application 14/518,414 10 line is crossed the prohibition of the third sentence of Section 121 does not apply. Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 688 (Fed.Cir.1990). “The corollary to this Court’s statement in Gerber Garment is that new or amended claims in a divisional application are entitled to the benefit of § 121 if the claims do not cross the line of demarcation drawn around the invention elected in the restriction requirement.” Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991). The Election/Restriction Requirement grouped certain claims as being drawn to an implantable medical device and other claims as being drawn to a method of implanting medical device in a hollow organ or body cavity. Office Action (Apr. 2, 2012), 2. The basis for the restriction was that the device can be used differently than as described in the method—“the device can be used outside the body and as a fastener for a variety of objects.” Id. The Election/Restriction requirement also identified claim 1 as generic to species A–E. Id. at 2–3. That “[t]he device claims in the current application are not the same scope as the device claims originally presented in the [Baker] application which resulted in a Restriction/Election Requirement” (Final Act. 15) is not enough to show that the amended claims of the current application cross the line of demarcation drawn around the invention elected in the restriction requirement. The Examiner indicates in the Answer that “there was never any identification by Appellant as to which of the originally filed claims in the parent application read on the elected species” and that “the claims which were subject to the restriction/election requirement were . . . all cancelled in response to the restriction/election requirement with new claims presented.” Ans. 18. According to the Examiner, “the line of demarcation is no longer Appeal 2018-002183 Application 14/518,414 11 present because the current claims are directed to at least Species A and Species B.” Id. at 18–19. The case law contemplates that claims may be amended, but they must not be so amended as to bring them back over the line imposed in the restriction requirement. Gerber Garment, 916 F.2d at 688. Merely because the claims of the instant application cover both Species A and Species B, we are not persuaded that the claims have been brought back over the line imposed in the restriction requirement in that “[c]laim 1 of the parent application was a device claim deemed by the [E]xaminer to be generic” to all species A–E and “[t]he device claims of the present application contain generally the same subject matter of claim 1 of the parent application but include additional limitations that are directed to species B (FIGS. 3–5).” Appeal Br. 20. The Examiner has not adequately explained how the fact that the claims of the current application also cover Species A results in the claims of the current application crossing the line of demarcation drawn around the invention elected in the restriction requirement. For the foregoing reasons, we are not persuaded that the safeguard of 35 U.S.C. § 121 fails to apply and that Baker is available as a reference against the application at issue. Accordingly, we do not sustain the rejection of claims 1, 8, 15, and 22 on the ground of nonstatutory double patenting as unpatentable over claims 1 and 9 of Baker. Appeal 2018-002183 Application 14/518,414 12 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–14, 22– 28 102(b) Weller 1–14, 22– 28 15–21 103(a) Weller, Ortiz 15–21 1, 8, 15, 22 Obviousness-type Double Patenting (Baker) 1, 8, 15, 22 Overall Outcome 1–28 REVERSED Copy with citationCopy as parenthetical citation