SMed-TA/TD, LLC

Patent Trials and Appeals Board

Feb 22, 2022

2021001602 (P.T.A.B. Feb. 22, 2022)

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. 15/626,596 06/19/2017 Paul S. Nebosky SIT0004CIP.DIV 1077 41863 7590 02/22/2022 TAYLOR IP, P.C. P.O. Box 560 142. S Main Street Avilla, IN 46710 EXAMINER MERENE, JAN CHRISTOP L ART UNIT PAPER NUMBER 3773 NOTIFICATION DATE DELIVERY MODE 02/22/2022 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): mbrady@taylorip.com patent@taylorip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PAUL S. NEBOSKY and GREGORY C. STALCUP ____________ Appeal 2021-001602 Application 15/626,596 Technology Center 3700 ____________ Before JENNIFER D. BAHR, MICHAEL L. HOELTER, and MICHELLE R. OSINSKI, 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 1-17. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies SMed-TA/TD, LLC as the real party in interest. Appeal Br. 3. Appeal 2021-001602 Application 15/626,596 2 THE CLAIMED SUBJECT MATTER Claims 1 and 3 are independent. Claim 1 is reproduced below. 1. An orthopaedic implant, comprising: an implant body having a first surface with a first peak, a second surface opposite said first surface, and a cavity formed therein that extends through said first surface and said second surface, said first peak being a point on said first surface having a maximum height greater than all other points on said first surface, said implant body being substantially non-porous, said implant body further including a third surface with an opening enclosed by said third surface, said opening formed through said body to said cavity and a protrusion formed adjacent to said opening that extends away from said third surface, said protrusion shaped to interact with an insertion tool; and a load bearing member comprising a substantially porous material statically held within said cavity, said load bearing member is fully received in said cavity and, when fully received in said cavity, has a first contact surface extending out of said cavity past said first peak of said first surface, said load bearing member having a second contact surface opposite said first contact surface, said load bearing member having interconnecting pores extending from said first contact surface to said second contact surface, said load bearing member having a total volume and said interconnecting pores in aggregate occupying at least 20% of said total volume. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date McIntyre US 4,950,296 Aug. 21, 1990 Bresina US 2003/0105527 A1 June 5, 2003 Pafford US 2003/0195629 A1 Oct. 16, 2003 Khandkar US 2005/0177238 A1 Aug. 11, 2005 Curran US 7,918,891 B1 Apr. 5, 2011 Appeal 2021-001602 Application 15/626,596 3 THE REJECTIONS I. Claims 1, 2, and 16 stand rejected under 35 U.S.C. § 103 as unpatentable over McIntyre, Curran, Pafford, and Khandkar. Non- Final Act. 3-6. II. Claims 1, 2, 13, 14, and 16 stand rejected under 35 U.S.C. § 103 as unpatentable over Bresina, Khandkar, Curran, McIntyre, and Pafford. Id. at 6-10, 15-16. III. Claims 3-12, 15, and 17 stand rejected under 35 U.S.C. § 103 as unpatentable over Bresina, Khandkar, McIntyre, and Pafford. Id. at 10-15.2 OPINION Rejection I The Examiner’s obviousness rejection of claim 1 relies on a finding that Khandkar teaches a “load bearing member being porous with interconnecting pores extending from the [first and second] contact[] surfaces, in aggregate occupying at least 20% of said total volume.” Non- Final Act. 5 (citing Khandkar ¶¶ 12, 38). The Examiner concludes that it would have been obvious to modify McIntyre’s load bearing member so as to have “interconnecting pores in aggregate occupying at least 20% in total volume because this provides a known configuration for bone growth while providing high mechanical strength and load bearing capacity” as taught by Khandkar. Id. at 6. 2 Even though the Examiner failed to reference claim 15 in the heading for this rejection (see Final Act. 10), the Examiner makes reference to this claim within the body of the rejection (see id. at 15). We consider the Examiner’s oversight in the heading to be a typographical error, and therefore, we list claim 15 as being subject to this ground of rejection. Appeal 2021-001602 Application 15/626,596 4 More specifically, the Examiner explains that the rejection relies on Khandkar’s “embodiment of Figures 7-9[,] and paragraph 46 [of Khandkar] makes it clear that the high strength region . . . is #50 (analogous with an implant body) with an attached porous area #54.” Non-Final Act. 17. The Examiner further explains that Khandkar’s paragraph 12 “makes it clear that porosity can be 10% (resembling more cortical bone) to as high as 80% (for cancellous bone, see also paragraph 38).” Id. Because the primary reference of McIntyre has the load bearing member more centrally located within the implant body, the Examiner takes the position that “in use, the load bearing member would not really engage the cortical bone of the vertebra[,] but rather more of the cancellous bone of the vertebra” and “[a]s such, it is obvious . . . to have the load bearing member be more porous (at least above 20%, see paragraph 38 in Khandkar) to take into account cancellous bone that the load bearing members would be engaged to.” Id. Appellant argues that “Khandkar only fairly describes forming interconnecting pores in a substrate with a porosity of 5% or less, which is less than the 20% recited by independent claim[] 1.” Appeal Br. 14 (citing Khandkar ¶¶ 30, 47 which refer to the embodiment of Figs. 10-13). With respect to the embodiment of Figures 7-9 that was explicitly relied on by the Examiner, Appellant argues that Khandkar explicitly fails to state that the pores are “interconnected.” Id. at 15. As to Khandkar’s description of “open pores” (Khandkar ¶¶ 10, 12) or “an open lattice” or the structure being “open-celled” (id. ¶¶ 12, 35, 37, 50), Appellant argues that such terminology is “ambiguous” and “Khandkar does not use this term in the portion describing ‘continuous interconnection of pores’” such that “the Examiner has failed to show that the ‘open pores’ described by the cited portions of Appeal 2021-001602 Application 15/626,596 5 Khandkar are equivalent to ‘interconnected pores’ . . . as recited by independent claim[] 1.” Appeal Br. 16. The Examiner responds that [o]pen cell or open latticed structures are terms in the art used to describe sponge like structures having pores throughout the structure (including on first and second contact surfaces, the top and bottom surfaces thereof for contacting an[] upper vertebra and lower vertebra respectively) that are interconnected so as to provide a scaffold for bone[] growth throughout. Ans. 18 (citing US 2005/0112397 A1; pub. May 26, 2005 (hereinafter “Rolfe”) and US 5,282,861; iss. Feb. 1, 1994 (hereinafter “Kaplan”)). The Examiner adds that Khandkar’s load bearing member 54 “is porous and placed more interior of the vertebral space and against the softer[,] more porous cancellous bone,” for which the higher porosity of claim 1 would be applicable. Id. at 20 (citing Khandkar ¶ 38). 3 Appellant argues that the Examiner’s evidence of record does not support adequately that the prior art’s reference to “open cell” is equivalent to the claimed “interconnecting pores.” Reply Br. 4-5. More particularly, Appellant argues that Rolfe instead shows “that ‘open cell’ and ‘open lattice’ materials can widely vary in how the pores are interconnected (or not 3 Because we are affirming the Examiner on another position, we need not consider in detail the Examiner’s first alternative position that “[i]f the pores were not interconnected, bone ingrowth would be prevented/restricted and then Khandkar would not be able to fulfill its purpose of fusing two adjacent vertebra and interbody ingrowth” or Appellant’s arguments in response thereto. Ans. 18; Reply Br. 5. Similarly, we need not consider the Examiner’s second alternative position that “[b]y virtue of the pores being part of load bearing member #54, the pores would already [be] ‘interconnected’” or Appellant’s arguments in response thereto. Ans. 19; Reply Br. 3-4. Appeal 2021-001602 Application 15/626,596 6 interconnected) within the material” and “the terms ‘open lattice’ and ‘open cell’ are not universally known in the art to refer to materials with pores that interconnect from one surface to another . . . but rather refer to a huge variety of materials that have some degree of porosity.” Id. at 5. In our view, Rolfe does not state in the portions identified by the Examiner and Appellant (Rolfe ¶¶ 67, 108) whether its embodiment of a “highly porous three-dimensional lattice having tortuous pores 201 that propagate through structure 110” (id. ¶ 67) in which “[c]ombinations of interconnected and non-interconnected aperture are . . . within the scope of the present invention (id. ¶ 108) is even to be considered an “open cell” structure or to include “open pores.” Thus, the identified portions of Rolfe do not explicitly support how the term “open” would be understood by one of ordinary skill in the art. On the other hand, Kaplan is explicitly clear in equating “open” with “interconnectivity” in implant materials in that its “open cell metal structure . . . offers highly interconnected, three-dimensional porosity.” Kaplan 6:1-3; see also id. at 9:1-9 (“The advantages of the open cell metal structure for bone implants are . . . high interconnected, uniform, three-dimensional porosity with high void fraction; structure similar to natural cancellous bone, with resultant osteoconductivity”). In addition to the evidence of record provided by the Examiner, we consult a general dictionary definition for the word “open cell” for guidance in determining the ordinary and customary meaning of the term as viewed by a person of ordinary skill in the art. See 37 C.F.R. § 41.30; Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348 (Fed. Cir. 2010) (approving of “consult[ing] a general dictionary definition of [a] word for guidance” in determining ordinary meaning); Praxair, Inc. v. Appeal 2021-001602 Application 15/626,596 7 ATMI, Inc., 543 F.3d 1306, 1325 (Fed. Cir. 2008) (“[O]ur decisions, including Phillips [v. AWH Corp.], 415 F.3d [1303,] 1322 [Fed. Cir. 2005], do not preclude the use of general dictionary definitions as an aid to claim construction.”). Here, the ordinary and customary meaning of the term “open cell” is “involving or consisting of open cells; spec. designating a foam in which the cells interconnect, rendering the foam highly compressible and absorbent.” Oxford English Dictionary (defining “open cell”) (Exhibit A). Cf. Merriam Webster Dictionary (defining “closed-cell” as “consisting of numerous small sealed cavities usually filled with air”) (Exhibit B). The ordinary and customary meaning is consistent with the usage of the term in Kaplan in which pores are interconnected, rather than sealed from each other.4 Appellant does not address Kaplan’s teachings in 4 We note that additional references support that the terms “open cell” or “open pore” are widely recognized to mean pores that are interconnected. For example, US 2012/0100438 A1, pub. Apr. 26, 2012 (hereinafter “Fasching”) (Exhibit C), teaches that “[p]ores of a porous base can be interconnected (i.e., an open-cell structure) or separated (i.e., a close-cell structure.” Fasching ¶ 41. See also Liu, He & Zhao Xinpeng, Thermal Conductivity Analysis of High Porosity Structures with Open and Closed Pores, Vol. 183 INT’L J. OF HEAT AND MASS TRANSFER, Part A, Abstract (Feb. 2022) (Exhibit D) (referring to “interconnected ‘open’ pores/channels or sealed ‘closed’ pores, separated by matrix material.”). More particularly, as to the recognition of the term “open” in the biocompatible implant art meaning interconnectivity of pores, see L. J. Gibson, Cellular Solids, MRS BULLETIN, 270-274 (Apr. 2003), 270 (Exhibit E) (stating that “[p]orous scaffolds used in tissue engineering can be considered open-cell foams; their interconnected porosity is essential for cells to penetrate the scaffold and migrate through it”); and Gibson, Lorna J., Biomechanics of cellular solids, Vol. 38 J. OF BIOMECHANICS, 377-99 (2005), 392 (Exhibit F) (stating that “[o]pen-cell foams are of the most interest as biomaterials, as the interconnectivity of the pores allows for tissue ingrowth.”). Appeal 2021-001602 Application 15/626,596 8 which the term “open” equates with interconnected porosity. In addition, Appellant does not provide evidence to support that the term “open cell” is contrary to its ordinary and customary meaning in the dictionary and may instead be understood by those of ordinary skill in the art to refer to pores that are not interconnected. After determining that the evidence of record supports adequately that a person of ordinary skill in the art would understand the use of the term “open cell” or the use of the term “open” in connection with pores to equate to interconnectivity of the pores, we turn to whether Khandkar describes an open-cell material or material having open pores as extending from a first contact surface to a second opposing contact surface, as claimed.5 Khandkar teaches an “improved bone graft compris[ing] a substrate block . . . [that] may be porous, open-celled, or dense solid.” Khandkar ¶ 12. Khandkar further teaches that “[t]he substrate block may be porous, having a porosity of about 10% to about 80% by volume with open pores distributed throughout.” Id. (emphasis added). In our view, the reference to the “open pores” being “distributed throughout” supports by a preponderance of the evidence that Khandkar’s open pores extend from a first surface to a second opposing surface. Khandkar’s Figure 8 also illustrates pores located at opposing surfaces and throughout element 54. Khandkar Fig. 8. 5 Appellant’s Specification states that “[i]t can be useful if the pores 117 of the load bearing member 114 interconnect from the first contact surface 116 to the second contact surface 120 so that a travel path through the entirety of the load bearing member 114 can be formed through interconnected pores 117 formed therein.” Spec. ¶ 19. Therefore, we understand the “interconnecting pores” to interconnect in a manner so as to allow a pathway from a first contact surface to a second opposing contact surface as asserted by Appellant. Reply Br. 4. Appeal 2021-001602 Application 15/626,596 9 As to the pores occupying at least 20% of a total volume, Khandkar explicitly teaches “a porosity of about 10% to about 80% by volume.” Id. In addition, Khandkar teaches that “increased porosity (ranging from about 30% to about 80%) mimicking cancellous bone structure” is suitable for making up “the interior surfaces of the substrate block.” Id. ¶ 38. The Examiner explains adequately that it is the more centrally located or interior portion of McIntyre’s implant that is being modified with Khandkar’s teachings, and thus, would have a porosity of at least 20% to correspond to the “cancellous bone that the load bearing members would be engaged to” based on its more central location. Non-Final Act. 17. The Examiner has supported by a preponderance of the evidence that Khandkar teaches a load bearing member having interconnecting pores extending from a first surface to a second surface, the interconnecting pores in aggregate occupying at least 20% of the total volume. Thus, the Examiner’s conclusion of obviousness has not been shown to be based on an erroneous finding as to the scope and content of Khandkar. For the foregoing reasons, Appellant does not apprise us of error in the Examiner’s determination that the combination of McIntyre, Curran, Pafford, and Khandkar renders obvious the subject matter of claim 1. Accordingly, we sustain the rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over McIntyre, Curran, Pafford, and Khandkar. We also sustain the rejection of claims 12 and 16 for which Appellant relies on the same arguments and reasoning as in connection with claim 1 (Appeal Br. 16), under 35 U.S.C. § 103(a) as unpatentable over McIntyre, Curran, Pafford, and Khandkar. Appeal 2021-001602 Application 15/626,596 10 Rejections II and III Appellant relies on the same arguments and reasoning we found unpersuasive in connection with the rejection of independent claim 1 in Rejection I as the basis for seeking reversal of the rejection of independent claim 1 in Rejection II, the rejection of independent claim 3 in Rejection III, and the rejection of dependent claims 2 and 4-17 in Rejections II and III. Appeal Br. 16. Accordingly, for the same reasons discussed above in connection with the rejection of claim 1 in Rejection I, we also sustain the rejections, under 35 U.S.C. § 103, of: claims 1, 2, 13, 14, and 16 as unpatentable over Bresina, Khandkar, Curran, McIntyre, and Pafford; and claims 3-12 and 17 as unpatentable over Bresina, Khandkar, McIntyre, and Pafford. CONCLUSION The Examiner’s rejections are affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 16 103 McIntyre, Curran, Pafford, Khandkar 1, 2, 16 1, 2, 13, 14, 16 103 Bresina, Khandkar, Curran, McIntyre, Pafford 1, 2, 13, 14, 16 3-12, 15, 17 103 Bresina, Khandkar, McIntyre, Pafford 3-12, 15, 17 Overall Outcome 1-17 Appeal 2021-001602 Application 15/626,596 11 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). AFFIRMED