2021000629 (P.T.A.B. Sep. 15, 2021)

P Tech, LLC

Patent Trials and Appeals BoardSep 15, 2021

2021000629 (P.T.A.B. Sep. 15, 2021)

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. 15/726,555 11/09/2017 Peter M. Bonutti RAN-08-2; BNUP 2656.USC1 7445 94357 7590 09/15/2021 STINSON LEONARD STREET* 7700 Forsyth Boulevard, Suite 1100 St. Louis, MO 63105 EXAMINER WORSHAM, JESSICA N ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 09/15/2021 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): MCremens@bonuttitec.com stl.uspatents@stinson.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PETER M. BONUTTI ____________ Appeal 2021-000629 Application 15/726,555 Technology Center 1600 ____________ Before DONALD E. ADAMS, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 1, 3–6, 13–15, 18–21, and 23–26 (Appeal Br. 2). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 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 “P Tech, LLC” (Appellant’s June 23, 2020, Appeal Brief (Appeal Br.) 2). Appeal 2021-000629 Application 15/726,555 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to a method of reducing blood loss during surgery, while inhibiting the postoperative formation of fibrosis, and more particular for inhibiting scar formation and surgical adhesions, as well as decreasing exogenous bone formation” (Spec.2 ¶ 2). Appellant’s claim 1 is reproduced below: 1. A method of positioning an implant in a patient, the method comprising: providing an inflatable balloon implant; inserting the implant between at least one of bone and soft tissue in the shoulder of the patient; inflating the implant; and sealing the implant, wherein the inflated implant is at least one of sized and shaped to fit within the shoulder of the patient, and wherein the inflated implant is configured to change the spatial relationship between the at least one of the bones and soft tissue in the shoulder of the patient, wherein the implant is at least partially comprised of at least one of polylactic acid, polyglycolic acid, and a biodegradable co-polymer comprised at least partially of at least one of polylactic acid and a polyglycolic acid. (Appeal Br. 13.) Grounds of rejection before this Panel for review: I. Claims 1, 3–6, 13–15, 18–21, and 23–26 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Fell3 and Sahatjian.4 2 Appellant’s November 9, 2017, Specification. 3 Fell, US 2006/0190078 A1, published Aug. 24, 2006. 4 Sahatjian et al., US 6,409,716 B1, issued June 25, 2002. Appeal 2021-000629 Application 15/726,555 3 II. Claims 1, 3–6, 13–15, 18–21, and 23–26 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Richter,5 Fell, and Sahatjian. III. Claims 1, 3–6, 13–15, 18–21, and 23–26 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 2, 4–8, 20–22, and 27–46 of co-pending Application 15/726,599. Rejections I–II: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Appellant discloses that an “[i]mplant . . . can be a temporary spacer, left in position for a set time period, upon expiration of which the implant . . . is removed and/or replaced” (Spec. ¶ 115). FF 2. Appellant discloses that its implanted device, e.g. balloon or other implant, . . . may be formulated to be drug eluting, either through incorporation into the gelatin or gel matrix which coats the device . . . or by formulating the device to contain therapeutic substances which are released by known means, including biodegradation. (Spec. ¶ 30.) FF 3. Richter: [R]elates to a medical device and a method of delivering a drug to a target circulation or tissue. The medical device has an 5 Richter, US 2004/0087902 A1, published May 6, 2004. Appeal 2021-000629 Application 15/726,555 4 expandable portion which is fabricated from a porous elastomeric material with a plurality of voids therein. The voids are loaded with drugs in various formulations. Upon inflation of the expandable portion, the overall diameter increases, the wall thickness decreases and, consequently, the voids are stretched to cause the drug to be expelled from the voids and into the bodily lumen or tissue adjacent to the medical device. The voids include any open volume within the expandable portion capable of containing the drug. (Richter, Abstr.; see also id. ¶ 1 (Richter “relates to medical devices for delivering drugs to an internal tissue or lumen of a patient”); Final Act.6 5– 6.) FF 4. Richter discloses that its “medical device . . . includes any one of a number of medical devices that can be adapted for the localized delivery of drugs or therapeutic agents within the body” (Richter ¶ 19; see id. (Richter exemplifies a medical device that is a balloon catheter); see Final Act. 6). FF 5. Richter discloses: [I]t has become increasingly common to treat a variety of medical conditions by introducing an implantable medical device partly or completely into [a] . . . location within a human or veterinary patient. For example, many treatments of the vascular system entail the introduction of a device such as a . . . balloon . . . into the body. (Richter ¶ 2; see generally Final Act. 5–6.) FF 6. Richter discloses that its device has “an expandable portion made of a porous elastomeric . . . polymer and provided with a plurality of voids . . . infused with therapeutic drugs or reagents” (Richter ¶ 9; see generally Final Act. 5–6). 6 Examiner’s December 23, 2019, Final Office Action. Appeal 2021-000629 Application 15/726,555 5 FF 7. Richter discloses: In practice . . . [its] medical device (with its expandable portion) is configured for insertion into the body and contact with a tissue or lumen. Once the expandable portion reaches its target area, it is inflated under controlled pressure in order to expand the target portion of the body lumen, or to otherwise press against the target tissue. As the expandable portion is inflated, it stretches and increases in diameter, while the thickness of the wall of the expandable portion decreases. Upon inflation of the expandable portion, the voids which contain the drug are also stretched and, as a result, cause the drug to be expelled from the voids. (Richter ¶ 10; see Final Act. 6.) FF 8. Richter discloses that “[a]lthough the expandable portion can be formed by using a single type of polymer, any combination of polymers can be employed” (Richter ¶ 27; see Final Act. 5). FF 9. Richter discloses that “[a]ny type of drug or therapeutic reagent that may be delivered in a localized manner may be used in the present invention” (Richter ¶ 33; see Final Act. 5–6). FF 10. Richter discloses: [I]t may [be] desirable to position a protective layer over the expandable portion to prevent premature release of the drug from the voids of the expandable portion before the medical device has reached its target circulation or tissue. If utilized, the protective layer is preferably biodegradable and slowly consumed during the insertion or deployment of the medical device. (Richter ¶ 36; see generally Final Act. 6.) FF 11. Examiner finds that Richter does “not teach application to the shoulder of a patient or a polymer such as polyglycolic or polylactic acid” (Final Act. 6). Appeal 2021-000629 Application 15/726,555 6 FF 12. Fell “relates to a method and system for restoration and repair of a body joint” (Fell ¶ 3; see id. ¶ 27 (Fell discloses that its “system and method for joint repair . . . reduce[s] the amount of bone resection required for proper implant function”); Final Act. 6). FF 13. Fell’s method and system includes “a mold having a first surface and a second surface” that can be positioned within a “joint such that at least part of the mold first surface overlies [a] defect area,” so that “a repair material [can be deposited] under the mold first surface within the defect area to create a repaired site within the joint” (Fell, Abstr.; see generally Final Act. 6). FF 14. Fell discloses that its method and system may be used “within any joint such as . . . shoulder” (Fell ¶ 29; see Final Act. 6). FF 15. Fell discloses that its balloon type mold . . . can be provided with a generally rigid surface on one or both of its bottom . . . and top . . . surfaces. The balloon mold . . . may be capable of being collapsed . . ., such as in order to be inserted through an arthroscopic portal in the joint capsule, and then filled with gas or fluid and expanded . . . once inside the joint space. (Fell ¶ 52; see Final Act. 6.) FF 16. Sahatjian “relates to delivery of drugs to the walls of body lumens and other parts of the body” (Sahatjian 1:14–15; see also Richter ¶ 6 (Richter discloses that Sahatjian “describes a balloon catheter with a swellable hydrogel polymer layer adhered to the surface of the balloon”); see generally Final Act. 6–7). Appeal 2021-000629 Application 15/726,555 7 FF 17. Sahatjian discloses “a catheter and method for delivering drug to tissue at a desired location in the body such as, the wall of a body lumen,” wherein the catheter comprise a a catheter shaft and an expandable portion mounted on the catheter shaft, the expandable portion being expandable to a controlled pressure, e.g., to fill the cross-section of the body lumen and press against the wall of the body lumen. At least a portion of the exterior surface of the expandable portion is defined by a coating of a body-fluid soluble polymer, and incorporated within the soluble polymer, a preselected drug to be delivered to the tissue. The soluble polymer and drug are selected to allow release of the polymer from the surface of the balloon during compression of the polymer coating against the wall of the body lumen when the expandable portion is expanded to coat the wall of the body lumen. (Sahatjian 1:50–53; 3:15–29; see id. at 3:31–33 (Sahatjian discloses that its “polymer is selected from the group consisting of polycaprolactone, polyorthoesters, polylactic acids, polyglycolic acids, and albumin.”); see Final Act. 6–7.) ANALYSIS Rejection I: We vacate this rejection in favor of the cumulative rejection of the same claims over the combination of Richter, Fell, and Sahatjian. Rejection II: The evidence of record establishes that inflatable balloon implants, within the scope of Appellant’s claimed invention, were known in the art before the effective filing date of Appellant’s claimed invention (see FF 3– 17; cf. 1–2). The evidence of record further establishes that, prior to the Appeal 2021-000629 Application 15/726,555 8 effective filing date of Appellant’s claimed invention, those of ordinary skill in this art knew that inflatable balloon implants may be inserted between at least one of bone and soft tissue in, inter alia, the shoulder of a patient, inflated and maintained, i.e. sealed, in an expanded state during a surgical procedure (see FF 3–7, 12–17). As Examiner explains, because the prior art discloses insertion, and subsequent expansion, of a balloon implant in a shoulder joint, the balloon implant must necessarily be of a size and shape to fit within the shoulder of the patient and will necessarily change the spatial relationship between the at least one of the bones and soft tissue in the shoulder of the patient, at least to some degree (see Final Act. 6 (Examiner finds that the balloon implant made obvious by the combination of Richter, Fell, and Sahatjian “is at least one of size and shape to fit within the surgical site and changes the spatial relationship”); see also FF 14). The combination of Richter, Fell, and Sahatjian also makes obvious a balloon implant that is at least partially comprised of polylactic acid or polyglycolic acid (FF 10, 17). Thus, we find that it would have been prima facie obvious, before the effective filing date of Appellant’s claimed invention, to perform a method of positioning a balloon implant in the shoulder of a patient, as suggested by the combination of Richter, Fell, and Sahatjian, wherein the balloon implant is at least partially comprised of a biodegradable co-polymer, such as polylactic acid or polyglycolic acid (see FF 3–17; see also Final Act. 7). Claim 1: As discussed above, Appellant discloses that its “[i]mplant . . . can be a temporary spacer, left in position for a set time period, upon expiration of which the implant . . . is removed and/or replaced” (FF 1). Thus, an Appeal 2021-000629 Application 15/726,555 9 “implant,” within the scope of Appellant’s claimed invention, may be positioned in an area of interest, e.g. shoulder, retained in the area during a surgical procedure and then removed at the end of the procedure (see Ans.7 7 (Examiner explains, Appellant’s claims do not require “that the implant is permanent” and “[t]here is nothing precluding the implant from being removed at any point in time.”)). Therefore, we are not persuaded by Appellant’s contention that Richter’s “drug-eluting balloon . . . is not an implant as understood by those skilled in the art whereby the structure is implanted in the patient for use by the patient after the implanting procedure” (Appeal Br. 10; see Reply Br.8 3). For the same reasons, we are not persuaded by Appellant’s contention that “Fell also fails to disclose a balloon implant as recited in [Appellant’s] claim 1” (id.; see also Reply Br. 2). We are not persuaded by Appellant’s contention that Sahatjian fails to describe “a method of using the drug-eluting balloon in a joint space,” which fails to account for the contribution of Richter and Fell to the combination of prior art relied upon by Examiner (see Appeal Br. 10; cf. FF 3–17). Richter discloses: [I]t may [be] desirable to position a protective layer over the expandable portion to prevent premature release of the drug from the voids of the expandable portion before the medical device has reached its target circulation or tissue. If utilized, the protective layer is preferably biodegradable and slowly consumed during the insertion or deployment of the medical device. 7 Examiner’s September 1, 2020, Answer. 8 Appellant’s November 2, 2020, Reply Brief. Appeal 2021-000629 Application 15/726,555 10 (FF 10.) Sahatjian discloses suitable biodegradable polymers, i.e. polylactic acid and polyglycolic acid, for use on balloon implants (see FF 17). Thus, we are not persuaded by Appellant’s contention that “there would have been no reason to modify the device in Richter to include at least one of polylactic acid [or] polyglycolic acid” (Appeal Br. 10). We recognize Appellant’s contention that “there is no reason to equip the device in Richter with adhesion prevention drugs” and “a person skilled in the art would not look to Sahatjian to include polylactic or polyglycolic acids in the Richter device because they would not provide the intended purpose of such acids,” i.e. preventing adhesion (Appeal Br. 10; see Reply Br. 2). We find, however, no requirement in Appellant’s claim 1 that requires the biodegradable polymers to prevent adhesion. Fell discloses a method of inserting a balloon implant into the shoulder of a patient (see FF 12–15). Therefore, we are not persuaded by Appellant’s intimation that such a method was not known or recognized in the art at the time of Appellant’s claimed invention (Appeal Br. 10). Claim 13: Appellant contends that “claim 13 recites language similar to the language recited in claim 1. Therefore, claim 13 is submitted as patentable over the cited references for at least the same reasons as claim 1” and “[c]laims 14, 15, and 18-20 depend from claim 13 and are submitted as patentable over the cited references for at least the same reasons as claim 13” (Appeal Br. 11). We are not persuaded for the reasons set forth above with respect to Appellant’s claim 1. Appeal 2021-000629 Application 15/726,555 11 Claim 21: Appellant contends that “claim 21 recites language similar to the language recited in claim 1. Therefore, claim 21 is submitted as patentable over the cited references for at least the same reasons as claim 1” and “[c]laims 23-26 depend from claim 21 and are submitted as patentable over the cited references for at least the same reasons as claim 21” (Appeal Br. 11). We are not persuaded for the reasons set forth above with respect to Appellant’s claim 1. CONCLUSION Rejection I: We vacate, as cumulative, the rejection of claims 1, 3–6, 13–15, 18–21, and 23–26 under 35 U.S.C. § 103(a) as unpatentable over the combination of Fell and Sahatjian. Rejection II: The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over the combination of Richter, Fell, and Sahatjian is affirmed. Claims 3–6, 13–15, 18–21, and 23–26 are not separately argued and fall with claim 1. Rejection III: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness-type double patenting? Appeal 2021-000629 Application 15/726,555 12 ANALYSIS Examiner finds that Appellant’s claimed invention is not patentably distinct from claims 1, 2, 4–8, 20–22, and 27–46 of co-pending Application 15/726,599 (Final Act. 9). Appellant contends that it “will address the double patenting rejection upon favorable resolution of the other issues on appeal” (Appeal Br. 3). Because Appellant does not present arguments against this rejection, it is summarily affirmed. CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness-type double patenting. The provisional rejection of claim 1 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 2, 4–8, 20–22, and 27–46 of co-pending Application 15/726,599 is affirmed. Claims 3–6, 13–15, 18–21, and 23–26 are not separately argued and fall with claim 1. Appeal 2021-000629 Application 15/726,555 13 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3–6, 13–15, 18–21, 23–26 103 Fell, Sahatjian9 1, 3–6, 13–15, 18–21, 23–26 103 Richter, Fell, Sahatjian 1, 3–6, 13–15, 18–21, 23–26 1, 3–6, 13–15, 18–21, 23–26 Obviousness-type Double Patenting, Co-pending Application 15/726,599 1, 3–6, 13–15, 18–21, 23–26 Overall Outcome 1, 3–6, 13–15, 18–21, 23–26 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv) (2019). AFFIRMED 9 We vacate this rejection as cumulative to the rejection over the combination of Richter, Fell, and Sahatjian.