Loubert SuddabyDownload PDFPatent Trials and Appeals BoardJul 30, 20212021000225 (P.T.A.B. Jul. 30, 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. 15/403,544 01/11/2017 Loubert S. Suddaby SUDP116US 5208 24041 7590 07/30/2021 SIMPSON & SIMPSON, PLLC 5555 MAIN STREET BUFFALO, NY 14221-5406 EXAMINER KU, SI MING ART UNIT PAPER NUMBER 3775 NOTIFICATION DATE DELIVERY MODE 07/30/2021 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): patentEFS@idealawyers.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE _______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _______________ Ex parte LOUBERT S. SUDDABY ____________ Appeal 2021-000225 Application 15/403,544 Technology Center 3700 ____________ Before DANIEL S. SONG, STEFAN STAICOVICI, and WILLIAM A. CAPP, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant seeks our review under 35 U.S.C. § 134(a) of the final rejection of claims 1–3, 5–11, 13–15, 17–22, and 25. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. Appeal 2021-000225 Application 15/403,544 2 THE INVENTION Appellant’s invention relates to an intervertebral disc surgery device. Spec. ¶ 1. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. An endoscopically implantable inflatable interbody fusion device, comprising: an inflatable body having an inner wall, an outer wall; a top surface, and a bottom surface; a first cavity defined by the inner wall; at least one hollow space between the inner wall and the outer wall; a first delivery tube extending from outside the outer wall into the at least one hollow space; and, a second delivery tube extending from outside the outer wall, through the at least one hollow space, and terminating in the first cavity; wherein at least one of the inner wall, the outer wall, the top surface, and the bottom surface comprises an elastomeric material. THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: Name Reference Date Stubstad US 3,867,728 Feb. 25, 1975 Pisharodi US 5,123,926 June 23, 1992 Stalcup US 6,332,894 B1 Dec. 25, 2001 Conner US 2009/0138015 A1 May 28, 2009 Ahn US 2011/0004307 A1 Jan. 6, 2011 Hibri US 2010/0256766 A1 Oct. 7, 2010 Appeal 2021-000225 Application 15/403,544 3 The following rejections are before us for review: 1. Claims 13–15 and 17–22 are rejected under 35 U.S.C. § 112(a) for failure to comply with the written description requirement. 2. Claims 1–3, 5, and 10 are rejected under 35 U.S.C. § 103 as unpatentable over Stalcup and Stubstad. 3. Claims 6 and 7 are rejected under 35 U.S.C. § 103 as unpatentable over Stalcup, Stubstad, and Hibri. 4. Claims 8 and 9 are rejected under 35 U.S.C. § 103 as unpatentable over Stalcup, Stubstad, and Pisharodi. 5. Claim 11 is rejected under 35 U.S.C. § 103 as unpatentable over Stalcup, Stubstad, and Conner. 6. Claim 25 is rejected under 35 U.S.C. § 103 as unpatentable over Stalcup, Stubstad, and Ahn. OPINION Written Description The Examiner determines that the phrase “directly connected to the outer wall” in claim 13 constitutes new matter thereby violating the written description requirement. Final Act. 2–3. Appellant attempted to overcome this rejection by filing an amendment to remove the word “directly” from the claim, but the Examiner declined to enter such amendment.1 In the Appeal Brief, Appellant does not challenge this ground of rejection, but nevertheless, urges us to evaluate the patentability of a new, hypothetical, claim 13 “under the pretense” that the alleged new matter will be removed from the claim by amendment following this appeal. Appeal 1 See December 19, 2019 Response After Final Action and accompanying proposed amended claims; see also January 17, 2020 Advisory Action. Appeal 2021-000225 Application 15/403,544 4 Br. 9. However, we are not inclined to evaluate and analyze a hypothetical claim based on a “pretense” as to how the claim might be amended upon resumption of prosecution following this appeal. Moreover, there is no prior art rejection of claim 13 in the Examiner’s Final Action for us to review. See generally Final Act. With no actual art rejection to review, we are left to speculate as to what a hypothetical prior art ground of rejection would look like with respect to Appellant’s hypothetical, proposed amended claim. We are constrained to review the Examiner’s Final Action as entered and in view of the state of Appellant’s claims as presently pending at the time of the Examiner’s Final Action.2 Under the circumstances, we deem the Examiner’s rejection of claim 13 as containing new matter in violation of the written description to be unopposed by Appellant. Consequently, we sustain the written description rejection of claim 13 as well as the rejection of claims 14, 15, and 17–22 that depend therefrom. See 37 C.F.R. § 41.37(c)(iv) (requiring Appellant to present arguments that explain why the Examiner erred as to each ground of rejection and further explaining that the failure to separately argue claims constitutes a waiver of arguments for separate patentability). Furthermore, we offer no opinion on the Appellant’s and Examiner’s briefing with respect to a prior art rejection of claim 13 from an earlier office action and based on a prior version of claim 13 that is not properly before us in this appeal. Appeal Br. 35–52; Ans. 6–9. 2 The Examiner’s refusal to enter an amendment is reviewable by petition to the Director under 37 C.F.R. § 1.181 and, consequently, is not within the jurisdiction of the Board. See Ex Parte Frye, 94 U.S.P.Q.2d 1072 (BPAI 2010). We are not inclined to allow Appellant to perform an “end run” around our rules to achieve, by appeal to PTAB, a matter that should have been taken up with the Director by petition. Appeal 2021-000225 Application 15/403,544 5 Unpatentability of Claims 1–3, 5, and 10 over Stalcup and Stubstad Appellant argues claims 1–3, 5, and 10 as a group. Appeal Br. 10–20. Claim 1 is representative. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Stalcup discloses the invention substantially as claimed except for using an elastomeric material, for which the Examiner relies on Stubstad. Final Act. 4–6. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to provide Stalcup with a least one wall or surface with an elastomeric material and so achieve the claimed invention. Id. at 5. According to the Examiner, a person of ordinary skill in the art would have done this as an elastomeric material would exhibit characteristics of being compliant, yielding, fixing, and stretching like the natural tissue that it replaces, and so would absorb shock without crushing adjacent tissue and distribute loads over wide areas. Id. Appellant argues that Stubstad does not disclose an inflatable implant. Appeal Br. 16. In Appellant’s own words: Stubstad discloses a molded prosthesis disc or implant that is formed of silicone elastomer such as SILASTIC® silicone elastomer or polyurethane. None of the prosthetic implants of Stubstad are designed to be inserted into a disc space in an uninflated state, and then subsequently inflated.3 Appeal Br. 16–17. In response, the Examiner points out that Stalcup, not Stubstad, was relied on for teaching an inflatable disc. Ans. 2–3 (citing Stalcup, col. 3, ll. 64–67 and Figure 9). 3 For purposes of clarity and consistency, we will use the spelling “disc” throughout this Decision instead of using the alternative spelling “disk.” Appeal 2021-000225 Application 15/403,544 6 Stalcup is directed to an artificial disc that fits between adjacent vertebrae. Stalcup, Abstract. Stalcup discloses a method of fusing adjacent vertebrae by forming an access hole in an annulus of a disc between the adjacent vertebrae; removing the nucleus within the disc to form a cavity surrounded by the annulus; placing a generally annular bag within the cavity; filling the bag with a polymer; injecting bone particles into the cavity surrounded by the annular bag; and hardening the polymer. Id. Figs. 4–7. In Stalcup, flexible bag 44, featuring a generally annular shape when in a relaxed state, is inserted into cavity 42 via pre-load tube 46. Id. col. 2, l. 63 – col. 3, l. 5, Fig. 4. Bag 44 is slid from pre-load tube 46 into cavity 42. Id. col. 3, ll. 4–5. Bag 44 is ejected from tube 46 using a plunger disposed in tube 46. Id. col. 3, ll. 6–10. Thereafter, fill hoses 52 and 54 are attached to bag 44. Id. col. 3, ll. 12–13, Fig. 5. Hose 52 extends through bag 44 and terminates in cavity 42 surrounded by bag 44. Id. col. 3, ll. 14–16. Hose 54 extends into and terminates in bag 44. Id. col. 3, ll. 16–17. A polymer is then injected into bag 44 through fill hose 54. Id. col. 3, ll. 17–19. Stubstad is directed to an artificial disc that conforms to the shape of a natural disc. Stubstad, col. 2, ll. 27–39. The disc may be a resilient block of elastomer. Id. col. 2, ll. 40–41. The elastomer may be unreinforced or may, for better resistance to compressive forces, be reinforced by an annular ring of fibrous material that is embedded in the elastomer. Id. col. 2, ll. 48–52. Appellant’s argument that Stubstad is not inflatable is not persuasive as it amounts to an individual attack on one reference in a two reference combination. Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a Appeal 2021-000225 Application 15/403,544 7 combination of references. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413, 425 (CCPA 1981). Appellant next argues that Stubstad is not endoscopically implantable. Appeal Br. 17. In response, the Examiner points out that, in the proposed combination, Stalcup, not Stubstad, is relied on for teaching an implant that is endoscopically implantable. Ans. 3. As before, Appellant’s argument is another individual attack on one reference in a two reference combination rejection and is, therefore, not persuasive. Merck, 800 F.2d at 1097; Keller, 642 F.2d at 425. Appellant next argues that Stubstad does not really disclose an elastomeric material as in the instant invention. Appeal Br. 17. According to Appellant, “the instant invention is elastomeric or compliant similar to that of a latex balloon.” Id. at 18. Appellant argues that “Stubstad simply does not disclose this.” Id. However, Appellant, nevertheless, concedes that Stubstad’s elastomer is “compliant, soft, yielding, flexing, and stretching.” Id. Nevertheless, Appellant asserts that such characteristics “are directed toward the compression of the [disc] rather than the inflation thereof.” Id. Appellant asserts that Stubstad does not disclose any wall that comprises an elastomeric material that is capable of being inflated, but rather that the device as a whole is capable of absorbing shock by being compressible, similar to a vertebral disc. Id. In response, the Examiner explains that Stubstad was specifically used to teach a core element/implant being made of elastic polymer. Ans. 3–4. Once again, Appellant’s arguments are not persuasive. Appellant concedes that the elastomeric material of Stubstad is compliant, soft, yielding, flexing, and stretching. Appeal Br. 18. If Stubstad’s elastomer exhibits such characteristics in response to external compressive forces, Appeal 2021-000225 Application 15/403,544 8 Appellant fails to explain how or why such material would not also exhibit similar characteristics if subjected to internal forces from being inflated in the manner taught by Stalcup. The Examiner’s finding that Stubstad discloses an elastomeric material within the meaning of claim 1 is supported by a preponderance of the evidence. Furthermore, Appellant’s argument that Stubstad’s elastomer material is intertwined with fabric particles, is off the mark. Appeal Br. 19. Stubstad expressly discloses use of “unreinforced” elastomeric material. Stubstad, col. 2, ll. 48–49. Appellant’s argument that Stubstad does not disclose an inflatable disc does not persuade us that a person of ordinary skill in the art would, therefore, categorically rule out any of the materials used in Stubstad in an inflatable disc as taught by Stalcup. “[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.” In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). Combining the teachings of references does not involve an ability to combine their specific structures. In re Nievelt, 482 F.2d 965, 968 (CCPA 1973). Familiar items often have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). Distilled to its essence, the Examiner’s rejection finds that Stalcup discloses the invention substantially as claimed except for use of a particular material, but that Stubstad discloses a material that a person of ordinary skill in the art would view as being suitable for use in Stalcup. Merely selecting a known material to meet known requirements is no more ingenious than selecting the last piece to put into the last opening Appeal 2021-000225 Application 15/403,544 9 in a jig-saw puzzle and, therefore, it is not invention. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945). Finally, Appellant argues that the Examiner’s prior art references fail to disclose any “teaching, suggestion, or motivation” (“TSM”) to modify the prior art. Appeal Br. 19. We note that the U.S. Supreme Court expressly abrogated the TSM test in 2007. We begin by rejecting the rigid approach of the Court of Appeals. Throughout this Court’s engagement with the question of obviousness, our cases have set forth an expansive and flexible approach inconsistent with the way the Court of Appeals applied its TSM test here. KSR, 550 U.S. at 415. Integral with its TSM argument, Appellant accuses the Examiner of engaging in an impermissible hindsight analysis. Appeal Br. 19. In advancing this hybrid TSM/hindsight argument, Appellant relies on In re Fine, 837 F.2d 1071, 1075 (Fed. Cir. 1988) for a proposition that was essentially abrogated by KSR. In the instant case, the Examiner provided a cogent reason as to why a person of ordinary skill in the art would have made the proposed combination, namely: [I]t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Stalcup’s device with wherein at least one of the inner wall, the outer wall, the top surface, and the bottom surface comprises an elastomeric material as taught by Stubstad, since such a material would be compliant, soft, yielding, flexing and stretching like the natural tissue it replaces, absorbing shock without crushing adjacent tissue and distributing loads over wide areas. Final Act. 5–6. The foregoing analysis constitutes explicit articulated reasoning with rational underpinning that is sufficient to support the rejection. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring an Appeal 2021-000225 Application 15/403,544 10 obviousness conclusion to be based on explicit articulated reasoning with rational underpinning) cited with approval in KSR, 550 U.S. at 418. Such rationale is sufficient to obviate Appellant’s hindsight argument. See In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (Explaining that a hindsight argument is of no moment where the Examiner provides a sufficient, non-hindsight reason to combine the references). The Examiner’s findings of fact are supported by a preponderance of the evidence and the Examiner’s legal conclusion of unpatentability is well- founded. In view thereof, we sustain the Examiner’s unpatentability rejection of claims 1–3, 5, and 10. Unpatentability of Claims 6, 7, 11, and 25 over Combinations based on Stalcup and Stubstad Claims 6, 7, 11, and 25 depend, directly or indirectly, from claim 1. Claims App. Appellant does not argue for the separate patentability of these claims apart from arguments presented with respect to claim 1 which we have previously considered. We sustain the Examiner’s rejection of claims 6, 7, 11, and 25. See 37 C.F.R. § 41.37(c)(1)(iv) (failure to separately argue claims constitutes a waiver of arguments for separate patentability). Unpatentability of Claims 8 and 9 over Stalcup, Stubstad, and Pisharodi Claim 8 Claim 8 depends from claim 1 and adds the limitation: “at least one filament having a first end and a second end, the at least one filament is arranged in the at least one hollow space and the first and second ends extend from the outer wall.” Claims App. The Examiner relies on Pisharodi as disclosing this limitation and concludes that it would have been obvious Appeal 2021-000225 Application 15/403,544 11 at the time of the invention to modify Stalcup by the teachings of Pisharodi to achieve the claimed invention. Final Act. 7–8. According to the Examiner, a person of ordinary skill in the art would have done this to urge the surfaces away from each other for engagement with the vertebra. Id. at 8. Appellant first argues that Pisharodi does not disclose a filament to “limit expansion in certain directions.” Appeal Br. 27. Appellant also argues that Pasharodi’s springs (12) do not extend from the outer wall as claimed. Id. In response, the Examiner points out that Appellant’s argument about limiting expansion in certain directions is not based on any limitation actually recited in the claim and, therefore, is not commensurate with the scope of the claim as recited. Ans. 5. With respect to the argument regarding extending from the outer wall, the Examiner finds that Pisharodi element 12 is properly characterized as a “filament” and that it has a first end and a second end. Id. (citing Pisharodi, Figs. 2 and 3). The Examiner interprets “extend from” as broad enough to encompass indirect extension from an outer wall in a manner that does not require touching the outer wall. Id. Pisharodi discloses an artificial disc. Pisharodi, Abstract. As shown in Figures 1 and 2, Pisharodi’s artificial disc is spring loaded and expandable. Id. col. 2, ll. 7–8. The disc is comprised of a strong thin elastic bag 4. Id. col. 2, ll. 8–9. The disc tapers from center region 7 to outer region 6 in all directions radially from center region 7. Id. col. 2, ll. 13–15. The upper and lower surfaces of the disc feature spikes 8 “for engagement of the vertebra.” Id. col. 2, ll. 15–19. The disc is expandable by injecting a Appeal 2021-000225 Application 15/403,544 12 liquid or gas substance through port 10. Id. col. 2, ll. 19-21. The disc expands like a balloon to its full dimensions and tightly fits into the disc space. Id. col. 2, ll. 19–25. A cross-sectional view of the disc shows that it contains a plurality of compression springs 12 extending vertically between the superior 5 and inferior 9 surfaces, at various strengths and lengths to yieldably urge the superior 5 and inferior 9 surfaces away from each other. Id. col. 2, ll. 26–31, Fig. 2. Claim 1 of Appellant’s invention, from which claim 8 depends, differentiates between inner and outer walls on the one hand and top and bottom of surfaces on the other hand. Claims App.; see also Appellant’s Fig. 13C (depicting “wall” 74) and Fig. 15A (depicting “wall” 84b). Appellant’s Figures 19A–C and accompanying disclosure in paragraph 60 of the Specification depict and disclose what is meant by a “filament.” Filaments act as intervening struts that cross the disc and add stability to it. Spec. ¶ 60. The filaments limit lateral expansion and add tensile strength to the final construct. Id. Stated differently, the filaments inhibit the disc from bulging laterally. During examination of a patent application, pending claims are given their broadest reasonable construction consistent with the specification. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under the broadest reasonable interpretation standard, claim terms are given their ordinary and customary meaning as would be understood by one of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). However, even under the broadest reasonable interpretation, the Board’s construction “cannot be divorced from the specification and the record evidence.” In re NTP, Appeal 2021-000225 Application 15/403,544 13 Inc., 654 F.3d 1279, 1288 (Fed. Cir. 2011). A construction that is “unreasonably broad” and which does not “reasonably reflect the plain language and disclosure” will not pass muster. Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015). A person of ordinary skill in the art having been apprised of Appellant’s disclosure, would understand that Appellant intends to differentiate between the “walls” of the artificial disc and the upper and lower “surfaces” of the disc. Basically the “surfaces” of the disc contact the adjacent vertebra above and below the disc while the “wall” extends between the upper and lower surfaces such that the surfaces are spaced apart by a thickness of the disc. It is within this context that a person of ordinary skill in the art would understand what it means for a filament to “extend from” the wall as opposed to something that “extends from” the upper and lower surfaces. Here, the Examiner’s construction of “extend from” is overly broad. By allowing such extension to include indirect, as well as direct, attachments, the Examiner artificially expands the scope of the claim to include filaments extending between the upper and lower surfaces in addition to filaments extending between the lateral walls of the disc. Such a construction effectively renders the claim language reciting “outer wall” superfluous. See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007) (denouncing claim constructions which render phrases in claims superfluous). By using an overbroad and erroneous claim construction, the Examiner reads Appellant’s recited “filament” on Pisharodi’s spring element 12 even though the function and purpose of the two disparate elements are diametrically opposed to each other. Appellant’s Appeal 2021-000225 Application 15/403,544 14 filaments inhibit outward movement of the walls. Spec. ¶ 60. Pisharodi’s springs urge outward movement of the upper and lower surfaces. Pisharodi, col. 3, ll. 30–31 (“urge . . . away”). A person of ordinary skill in the art having reviewed Figures 1–3 of Pisharodi would understand that element 12 extends from the upper and lower surfaces of the disc rather than the wall. Properly construed, the claim language does not read on Pisharodi. The Examiner’s findings of fact are not supported by a preponderance of the evidence and, therefore, the Examiner’s legal conclusion of unpatentability is not well-founded. We do not sustain the Examiner’s unpatentability rejection of claim 8. Claim 9 Claim 9 depends from claim 8 and suffers from the same infirmity that was identified above with respect to claim 8. We do not sustain the rejection of claim 9. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992). CONCLUSION Claims Rejected 35 U.S.C. § References/Basis Affirmed Reversed 13-15, 17-22 112 Written Description 13-15, 17-22 1-3, 5, 10 103 Stalcup, Stubstad 1-3, 5, 10 6, 7 103 Stalcup, Stubstad, Hibri 6, 7 8, 9 103 Stalcup, Stubstad, Pisharodi 8, 9 11 103 Stalcup, Stubstad, Conner 11 25 103 Stalcup, Stubstad, Ahn 25 Overall Outcome 1-3, 5-7, 10, 11,13-15, 17-22, 25 8, 9 Appeal 2021-000225 Application 15/403,544 15 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