Ex Parte Sengun et alDownload PDFPatent Trial and Appeal BoardApr 25, 201813242085 (P.T.A.B. Apr. 25, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/242,085 09/23/2011 27777 7590 04/27/2018 JOSEPH F. SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 FIRST NAMED INVENTOR Mehmet Ziya Sengun 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 ATTORNEY DOCKET NO. CONFIRMATION NO. MIT5150USNP 9590 EXAMINER LYNCH, ROBERT A ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 04/27/2018 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): jnjuspatent@corus.jnj.com lhowd@its.jnj.com pairjnj@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MEHMET ZIY A SENGUN, JUSTIN M. PICCIRILLO, GEROME MILLER, and ARTHUR G. STEPHEN Appeal2017-003973 Application 13/242,085 1 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and DAVID COTTA, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. § 134(a) involves claims 1-25 and 29- 31 (Br. 2). Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 Appellants identify the real party in interest as "DePuy Mitek, LLC which is a subsidiary of Johnson & Johnson" (Br. 2). Appeal2017-003973 Application 13/242,085 STATEMENT OF THE CASE Appellants' disclosure "relates to tools for inserting implants into bone and more particularly to drivers for suture anchors" (Spec. i-f 1 ). Appellants' independent claims 1, 12, and 19 are representative and reproduced below: 1. An inserter comprising: a rigid tip portion having a distal end and a proximal end, and at least the distal end being capable of being placed within an implant; an elongated, rigid shaft having a proximal surface which is capable of receiving a driving force and a distal end proximate the rigid tip portion; and a localized compliant region disposed between the tip portion and the shaft which requires less lateral force to bend than the tip portion, at least when the tip portion has been placed within the implant. (Br. 8.) 12. An inserter comprising: a rigid tip portion having a distal end and a proximal end, and at least the distal end capable of being placed within an implant to provide internal support for the implant during insertion into bone; an elongated, rigid shaft having a proximal surface which is capable of receiving a driving force and a distal end proximate the rigid tip portion; a distal-facing shoulder at the proximal end of the tip portion capable of engaging the proximal end of the implant; and a compliant region disposed between the shoulder and the shaft which requires less lateral force to bend than the tip portion, at least when the tip portion has been placed within the implant. (Id. at9.) 2 Appeal2017-003973 Application 13/242,085 19. A combination comprising: a suture anchor having a distal end and a proximal end, and defining a lumen open at the proximal end; a rigid tip portion having a distal end and a proximal end, and at least the distal end being capable of being placed within the lumen of the suture anchor to provide internal support for the suture anchor during insertion into bone; an inserter including an elongated, rigid shaft having a proximal surface which is capable of receiving a driving force and a distal end proximate the rigid tip portion; a distal-facing shoulder at the proximal end of the tip portion capable of engaging the proximal end of the suture anchor; and a compliant region disposed between the shoulder and the shaft which requires less lateral force to bend than the tip portion, at least when the tip portion has been placed within the suture anchor. (Id. at 10.) The claims stand rejected as follows: Claims 1-3, 5-10, 12, 13, 15-17, 19-22, and 24 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination ofHeckele2 and McGuire. 3 Claims 4, 14, 23, and 29-31 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Heckele, McGuire, and Kozak. 4 Claim 4 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Heckele, McGuire, and Appenzeller. 5 2 Heckele et al., US 6,830,574 B2, issued Dec. 14, 2004. 3 McGuire et al., US 5,797,918, issued Aug. 25, 1998. 4 Kozak, US 6,813,975 B2, issued Nov. 9, 2004. 5 Appenzeller et al., US 2009/0157123 Al, published June 18, 2009. 3 Appeal2017-003973 Application 13/242,085 Claims 11, 18, and 25 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Heckele, McGuire, and Nicholson. 6 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Heckele discloses an instrument [that] serves for the application in particular of bone grafts in the space between two vertebrae and includes a shank, a handle, and a holder for the implant, which forms the distal instrument part. The holder is pivotably mounted relative to the shank and can be fixed in any respective position which is reached by pivoting. (Heckele, Abstract.) FF 2. Heckele's Figure 1 is reproduced below: Fig.1 11 . .... ) i 9 Heckele's "FIG. 1 is a total view of [Heckele's] instrument according to [Heckele's disclosure] in a part longitudinal section" (Heckele 2: 37-38 (emphasis omitted); see generally Final Act. 7 4--6). 6 Nicholson et al., US 5,968,044, issued Oct. 19, 1999. 7 Office Action mailed November 12, 2015. 4 Appeal2017-003973 Application 13/242,085 FF 3. Heckele' s Figure 6 is reproduced below: flg,6 Heckele's "FIG. 6 shows the instrument according to [Heckele's] invention in an application as a bone graft applicator" (Heckele 2: 47--48). FF 4. Examiner finds that Heckele's instrument comprises: [A] rigid tip portion (3) having a distal end (at 14) and a proximal end (at 12/13), and at least the distal end being capable of being placed within an implant (21) (as shown in [Heckele's] Fig. 6) an elongated, rigid shaft (4) having a proximal surface which is capable of receiving a driving force (via handle 2/head 9) and a distal end (7) proximate the rigid tip portion (3) (as shown in [Heckele's] Figs. 1-2); and a localized compliant region (pivotal interface of 8 and 12, [Heckele' s] Figs. 1-2) disposed between the tip portion (3) and the shaft ( 4) which requires less lateral force to articulate than the tip portion (force required to articulate spherical bearing body 12 within recess 8 is fully adjustable and allows for free articulation when fully released; [see Heckele,] col. 3, lines 40-43), at least when the tip portion (3) has been placed within the implant (21) (as shown in [Heckele's] Fig. 6). (Final Act. 4--5; see also Heckele 3: 31-39.) FF 5. Examiner finds that Hecke le teaches Appellants' claimed invention, but for a "compliant region being bendable and more malleable than the tip portion" (Final Act. 6; see id. at 5---6). FF 6. McGuire relates "to surgical screwdrivers for inserting bone screws and, more particularly, to surgical screwdrivers for inserting interference 5 Appeal2017-003973 Application 13/242,085 bone fixation screws in bone tunnels and to methods of performing arthroscopic cruciate ligament reconstruction of the knee" (McGuire 1: 19- 23). FF 7. McGuire's Figures 9 and 16 are reproduced below: F1G.9 FIG.16 McGuire's "FIG. 9 is an isometric view of a cannulated flexible screwdriver," within the scope of McGuire's disclosure (McGuire 4: 59---60 (emphasis omitted)). McGuire's FIG. 16 illustrates a cannulated flexible 6 Appeal2017-003973 Application 13/242,085 screwdriver, within the scope of McGuire's disclosure, in a flexed position (id. 5: 9-13 (emphasis omitted)). FF 8. Examiner finds that "McGuire teaches ... a surgical screwdriver comprising a compliant/articulating region that is either in the form of a malleable/bendable wire coil (212) ([see McGuire's] Fig. 9) or one or more articulating pivotal linkage members (311) ([see McGuire's] Fig. 16)" FF 9. Examiner finds that McGuire "teaches that a flexible shaft in the form of a bendable wire coil ... is an equivalent alternative, that is known in the art, to a flexible shaft in the form of one or more articulating pivotal linkage members" (Final Act. 6). FF 10. Examiner finds that the combination of Heckele and McGuire teaches Appellants' claimed invention but for "a compliant region [that] is [a] bellows-type structure consisting of a notch at a distal end of the shaft adjacent the tip portion with the notch being 2 millimeters in length" and relies on Kozak to make up for this deficiency in the combination of Heckele and McGuire (see Final Act. 7-9). FF 11. Examiner finds that the combination of Heckele and McGuire teaches Appellants' claimed invention but for a "compliant region [that has] bellows" and relies on Appenzeller to make up for this deficiency in the combination of Heckele and McGuire (see Final Act. 9). FF 12. Examiner finds that the combination of Heckele and McGuire teaches Appellants' claimed invention "except for the device being sterile and being provided within a sterility maintaining package" and relies on Nicholson to make up for this deficiency in the combination ofHeckele and McGuire (Final Act. 10). 7 Appeal2017-003973 Application 13/242,085 ANALYSIS The combination of Heckele and McGuire: Based on the combination of Heckele and McGuire, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie "obvious to substitute a malleable/bendable wire coil section of the device of McGuire for the articulating pivotal linkage of the device of Heckele, as they are taught to be art known equivalents by McGuire" (Final Act. 7). Claims 1 and 12: Appellants' independent claims 1 and 12 are reproduced above. Appellants contend that, notwithstanding Examiner's assertion to the contrary, the combination of Heckele and McGuire would, "[a]t best ... lead to an instrument in which the entire shaft was flexible, rather than a localized compliant region" (Br. 4). In this regard, Appellants contend that "when McGuire ... desire[ d] a local articulation they disclose only a mechanical joint, and do[ es] not teach that the flexing shaft is useful for localized articulation but rather only for a tool in which the entire shaft is flexible" (id.). We are not persuaded. As Examiner explains, "the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art" (Ans. 2). See In re Keller, 642 F.2d 413, 425 (CCP A 1981 ). On this record, Examiner relied upon Heckele to 8 Appeal2017-003973 Application 13/242,085 disclose a driving tool comprising a localized region of mechanical articulation in the form of a pivotal interface and McGuire to disclose "that it was well-known in the art of driving tools that a mechanical articulation point in the form of a bendable coil wire ... is equivalent to a mechanical articulation point in the form of a pivotal interface" (Ans. 2-3). We agree and discern no error in Examiner's conclusion that "[i]nterchanging a bendable wire coil for the articulating joint of Heckle ... provides a localized compliant region (i.e. a bendable coil in place of the articulating joint) between the rigid shaft (4) and the tip portion (3) of [Heckel's] device" (id. at 3). With respect to Appellants' claim 12, Appellants contend that "[t]he failing of the rejection of claim 1 apply to claim 12. The alleged combination of references would at best provide a fully flexible shaft" (Br. 5). For the reasons set forth above, with respect to Appellants' claim 1, we are not persuaded. Claim 2: Appellants' claim 2 depends from and further limits Appellants' claim 1 to require that "the tip portion is capable of providing internal support for the implant during insertion into bone" (Br. 8). Examiner finds that Heckele's "tip portion (3) is capable of providing internal support for the implant (21) during insertion into bone" (Final Act. 5; see FF 3--4). In this regard, Examiner finds "that Fig. 6 and col. 3, lines 36-39 of Heckele expressly disclose the tip portion of the device of Heckele inserted into and supporting an implant as the implant is inserted into a vertebral body" (Ans. 3--4; see FF 3--4). 9 Appeal2017-003973 Application 13/242,085 For the foregoing reasons, we are not persuaded by Appellants' unsupported assertion that Heckele's tip is the "kind of shape [that] would not really provide support" (Br. 5). See also, In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in a brief cannot take the place of evidence"). Claims 3 and 13: Appellants' claim 3 depends from and further limits Appellants' claim 1 to require that "the compliant region is formed of a material that is more malleable than that of the tip portion" (Br. 8 (emphasis added)). Similarly, Appellants' claim 13 depends from and further limits Appellants' claim 12 to require that "the compliant region is formed of a material that is more malleable than that of the tip portion" (Br. 9 (emphasis added)). Examiner's Final Rejection does not address claims 3 or 13. As Appellants' explain, Examiner failed to establish that either of Heckele or McGuire, alone or in combination, teach this requirement of Appellants' claimed invention (see Br. 5). We are not persuaded by Examiner's assertion that McGuire's "coiled wire ... is more easily bent into different shapes than the tip 3 and threaded spike 14 of Heckle" (Ans. 4). As Appellants' explain, McGuire's "coiled wire [] relies on the physical arrangement of the coils for flexure, and is silent as to the relative malleability of the materials" (Br. 5 (emphasis added)). Appellants' claims 3 and 13 require that the material used to form the compliant region is more malleable than that of the tip portion (see Br. 8 and 9). Because Examiner failed to address the requirements of Appellants' claims 3 and 13, the rejection of these claims is reversed. 10 Appeal2017-003973 Application 13/242,085 Claim 10: Appellants' claim 10 depends ultimately from and requires the inserter of Appellants' claim 1 to "further includ[ e] an implant retention element carried by the tip portion," "wherein the retention element includes a laterally-extending projection formed on the tip portion," and "wherein the projection has a smooth distal leading edge and a sharply-defined transition at a trailing edge" (Br. 8-9). Examiner finds that Hecke le' s implant retention element (threads; [see Heckele,] col. 3, lines 36-39) carried by the tip portion (14); ... include[] a laterally- extending projection (threads extend laterally from tip) formed on the tip portion (14); ... wherein the projection (threads) [have] a smooth distal leading edge (distal-facing thread surface) and a sharply-defined transition (sharp V-shaped transition between distal and proximal facing thread surfaces) at a trailing edge (proximal-facing thread surface). (Final Act. 5-6.) In this regard, Examiner provides the following annotated illustration of "conventional screw threads" smooth distal leading edge lateral projection . ?. sl>arply-d<>flned transition to traillng edg• Examiner's illustration of "conventional screw threads" annotates what Examiner finds are "a smooth distal surface and a sharply defined transition at a trailing edge" of a lateral projection (see Ans. 4--5). In response, Appellants simply assert that a "screw thread [] fails to meet" the requirements of Appellants' claimed invention (Br. 5). Appellants, however, fail to explain why Examiner's rationale is incorrect. Therefore, we are not persuaded by Appellants' unsupported contention. 11 Appeal2017-003973 Application 13/242,085 See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (37 C.F.R. § 41.37 requires "more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art"). The combination of Heckele, McGuire, and Kozak: Based on the combination of Heckele, McGuire, and Kozak, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious to modify the device ... [suggested by the combination of Heckele and McGuire] to have the compliant region comprise a bellows-type structure consisting of a notch at a distal end of the shaft adjacent the tip portion in order to prevent a user's fingers from being pinched while allowing the shaft to be manipulated from a straight to a bent position and further preventing dirt and other foreign substances from entering the flexible joint portion, as taught by Kozak. (Final Act. 8 (emphasis added); see Kozak 7: 42--45 and 53-54 ("bulges[, such as those forming a bellows configuration,] prevent a user's fingers from being pinched while allowing the shaft [] to be manipulated from a straight to a bent position" and "prevent[ s] dirt and other foreign substances from entering via the first end portion").) Examiner further finds that "[a] change in size is generally recognized as being within the level of ordinary skill in the art," and, therefore, "[i]t would have been an obvious matter of design choice to form the notch" in the device suggested by the combination of Heckele, McGuire, and Kozak, to have "a length of 2 millimeters," because "such a modification would have involved a mere change in the size of a component" (Final Act. 8-9). 12 Appeal2017-003973 Application 13/242,085 Claims 4, 14, and 23: Appellants' claims 4, 14, and 23 depend from and further limit Appellants' claims 1, 12, and 19, respectively, to require that the "compliant region is a bellows" (Br. 8 (emphasis added)). Appellants contend that Examiner "misinterpreted the claims as employing [the transitional term] 'comprising' instead of 'is' in defining the compliant region" (Br. 5). We agree. Examiner's rationale is based on a construction of Appellants' compliant region as comprising a bellows-type structure (see Final Act. 8 ("Claim 4 is interpreted as lacking any express negative limitations and further utilizes the open-ended transitional phrase 'comprising' thereby allowing for additional structure in the compliant region as opposed to an interpretation requiring a 'bellows-only' compliant region"); see also Ans. 5). As Appellants' correctly explain, Examiner's claim interpretation is incorrect. According to Appellants' claimed invention the compliant region is a bellows, thus, it is improperly to interpret Appellants' claims as comprising bellows. Because, Examiner misinterpreted Appellants' claimed invention, we reverse the rejection of Appellants' claims 4, 14, and 23. Claims 29-31: Appellants' claim 29 depends from and further limits Appellants' claim 1 to require that the "compliant region consists of a notch at a distal end of the shaft adjacent the tip portion" (Br. 11 ). Appellants' claim 30 depends from and further limits Appellants' claim 29 to require that the "notch has a length of about 2 millimeters" (Br. 11 ). Appellants' claim 31 depends from and further limits the "compliant region" of Appellants' claim 13 Appeal2017-003973 Application 13/242,085 19 to "consist[] of a notch at a distal end of the shaft adjacent the tip portion" (Br. 11 ). Appellants contend that "it makes no logical sense how a notch is going to protect a user's fingers" and "Examiner is just clearly throwing elements together to make a rejection with little or no regard to how they might motivate one of skill in the art" (Br. 6). Appellants' contention lacks an evidentiary basis on this record and is, thus, not persuasive. For clarity, we reproduce Examiner's annotation of Kozak's Figure 11 below: Fig 11 Kozak describes its Fig. 11 as "yet another alternative device for protecting a user's fingers when operating [a] prior art [flexible extension shaft] device" (Kozak 3: 39--40 and 51-52 (emphasis added)). Examiner annotated Kozak's Fig. 11 to identify a bellows region and a notch. Notwithstanding Appellants' unsupported assertion to the contrary, Kozak expressly states that such a configuration will, inter alia, "prevent a user's fingers from being pinched while allowing the shaft [] to be manipulated from a straight 14 Appeal2017-003973 Application 13/242,085 to a bent position" (Kozak 7: 42--45). Appellants' contentions regarding their claims 30 and 31 are equally unsupported and, therefore, not persuasive. Accordingly, we are not persuaded by Appellants' unsupported assertion regarding the rejection of Appellants' claims 29-31 (see Br. 6). The combination of Heckele, McGuire, and Appenzeller: Based on the combination of Heckele, McGuire, and Appenzeller, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious "to substitute the flexible tubular neck or wall of the device of Heckele in view of McGuire for the localized compliant region in the form of a hollow bellows of the device of Appenzeller, as they are taught to be art known equivalents by Appenzeller" (Final Act. 9). Having found no deficiency with respect to the rejection of Appellants' claim 1, we are not persuaded by Appellants' contention that "[t]his rejection suffers from the same failings as the rejection of claim 1 discussed above" (Br. 6). Appellants' further contend that "there is no suggestion for putting this compliancy into the [claimed] inserter" (id.). We are not persuaded. As Examiner explains, the combination of Heckele and McGuire "teaches an articulating surgical instrument having a compliant and flexible articulating region or neck" and "Appenzeller is cited for its express teachings that a hollow bellows ... is a well-known equivalent alternative to a flexible tubular neck," thus, "it would have been obvious to substitute a bellows structure for a flexible articulating structure as set forth in the pending rejection" (Ans. 7). Appellants failed to address Examiner's reason for 15 Appeal2017-003973 Application 13/242,085 making the proposed modification. Therefore, we are not persuaded by Appellants' unsupported assertions. In re Pearson, 494 F.2d at 1405. The combination of Heckele, McGuire, and Nicholson: Based on the combination of Heckele, McGuire, and Nicholson, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious to modify the device of Heckele in view of McGuire to be sterile and to be provided within a sterility maintaining package in order to provide a sterile, ready-to-use kit to a surgeon that facilitates the procedure, reduces operation time, and minimizes a patient's risk of infection/ contamination, as taught by Nicholson. (Final Act. 10.) Having found no deficiency in Examiner's rejection of Appellants' claims 1, 12, and 19, we are not persuaded by Appellants' contention that "[t]his rejection suffers the same failings as put forward with respect to [Appellants'] claims 1, 12 and 19 respectively" (Br. 7). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness as it relates to the rejection of Appellants': claims 1, 2, 5-10, 12, 15-17, 19-22, and 24 over the combination of Heckele and McGuire; claim 4 over the combination of Heckele, McGuire, and Appenzeller; claims 11, 18, and 25 over the combination of Heckele, McGuire, and Nicholson; and claims 29-31 over the combination of Heckele, McGuire, and Kozak. The rejection of claims 1, 2, 10, and 12 under 35 U.S.C. § 103(a) as unpatentable over the combination of Heckele and McGuire is affirmed. 16 Appeal2017-003973 Application 13/242,085 Claims 5-9, 19-22, and 24 are not separately argued and fall with claim 1. Claims 15-17 are not separately argued and fall with claim 12. The rejection of claim 4 under 35 U.S.C. § 103(a) as unpatentable over the combination of Heckele, McGuire, and Appenzeller is affirmed. The rejection of claim 11 under 35 U.S.C. § 103(a) as unpatentable over the combination of Heckele, McGuire, and Nicholson is affirmed. Claims 18 and 25 are not separately argued and fall with claim 11. The rejection of claims 29-31under35 U.S.C. § 103(a) as unpatentable over the combination of Heckele, McGuire, and Kozak is affirmed. The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness as it relates to the rejection of Appellants' claims 3 and 13 over the combination of Heckele and McGuire and Appellants' claims 4, 13, 14, and 23 over the combination of Heckele, McGuire, and Kozak. The rejection of claims 3 and 13 under 35 U.S.C. § 103(a) as unpatentable over the combination of Heckele and McGuire is reversed. The rejection of claims 4, 14, and 23 under 35 U.S.C. § 103(a) as unpatentable over the combination of Heckele, McGuire, and Kozak is reversed. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. § 1.13 6( a). AFFIRMED-IN-PART 17 Copy with citationCopy as parenthetical citation