DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications, Application Nos. 16/666,822, 15/695,375, 15/694,579, 15/553,556, PCT/US2016/019896, 62/121,260, PCT/US2019/026740, and 62/655,329, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The aforementioned prior-filed applications fail to provide support for inserting a distraction tool between superior and inferior surfaces of an uncinate joint and inserting a monoblock implant between the superior and inferior surfaces of the uncinate joint (see claim 1). Accordingly, the claims have been examined in view of the filing date of 17/067,683, which is October 10, 2020.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 4, 7, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sahai et al. (US 2017/0100117 A1) in view of Chung et al. (KR 10-1822632 B1; see provided English-language translation for corresponding paragraphs; translation provided with the Non-Final Rejection mailed on August 20, 2024), Ganem et al. (US 2011/0172769 A1), Yang (US 2017/0189201 A1), and Goel et al. (US 2014/0350608 A1).
Claim 1. Sahai discloses a method of stabilizing a cervical spine segment, the method comprising:
inserting, from an anterior side of the cervical spine segment, a distraction tool (cervical distractor 10) into and between a superior surface of an uncinate joint and an inferior surface of the uncinate joint (defined by uncinate processes 310) (see Fig. 7); and
creating, using the distraction tool, an opening between the superior surface and the inferior surface of the uncinate joint (see Fig. 7) (Figs. 1-7; para. 0066).
Claim 7. Sahai discloses forming, from an anterior side of the cervical spine segment, an access path to the uncinate joint prior to creating the opening (Figs. 1-7). The Examiner is taking the position that such a step is inherent as an access path through the patient’s skin and adjacent tissue would necessarily need to be formed prior to creating the opening in the uncinate joint in order for the distraction tool to be able to reach the uncinate joint.
Sahai fails to disclose inserting, from an anterior side of the cervical spine segment, a monoblock implant into the opening formed between the superior surface and the inferior surface of the uncinate joint, the monoblock implant having two wings, each wing extending away from a central region of the monoblock implant along a lateral direction, each wing having a first surface and a second surface, such that the first surface of the wings contacts the superior surface of the uncinate joint and the second surface of the wings contacts the inferior surface of the uncinate joint, wherein the first surface and second surface of the wings includes a gripping mechanism having a barb for automatically securing the monoblock implant within the opening between the superior surface and the inferior surface of the uncinate joint, and each of the wings further comprises a rounded end (claim 1), loading a bone graft material in the monoblock implant prior to inserting the monoblock implant into the opening (claim 3), wherein loading bone graft material in the monoblock implant further comprises inserting the bone graft material into a cavity formed in the monoblock implant (claim 4), and wherein the gripping mechanism further comprises a rough surface (claim 21).
However, Sahai also discloses that the distraction tool is configured such that it has a similar geometric shape to a spinal implant (see “cage”) (see para. 0058).
Chung teaches inserting a monoblock implant (cage 100) into an opening formed between a superior surface and an inferior surface of the uncinate joint (see Fig. 7; see also abstract), the monoblock implant having two wings (wings 120 and 130), each wing extending away from a central region (body part 110) of the monoblock implant along a lateral direction, each wing having a first surface (upper surfaces 122 and 132) and a second surface (bottom surfaces 124 and 134), such that the first surface of the wings contacts the superior surface of the uncinate joint and the second surface of the wings contacts the inferior surface of the uncinate joint (see Fig. 7; see also abstract), each of the wings comprising a rounded end (see Fig. 4 inset, which shows that each of wings 120 and 130 is rounded at each end), loading a bone graft material (see “bone filling material”) in the monoblock implant prior to inserting the monoblock implant into the opening (see last paragraph of pg. 6), wherein loading bone graft material in the monoblock implant further comprises inserting the bone graft material into a cavity (cavity 140) formed in the monoblock implant (see last paragraph of pg. 6), and wherein the monoblock implant is complementary in shape to the space between the vertebral bodies such that the implant abuts the adjacent vertebral bodies along both the intervertebral disk space and between the uncinate joints (see Fig. 7; see also last paragraph of pg. 7) (Figs. 4-7).
[AltContent: textbox (Rounded End)][AltContent: textbox (Rounded End)][AltContent: textbox (Rounded End)][AltContent: textbox (Rounded End)]
Ganem teaches inserting a monoblock implant (implant 1) into an opening formed between a superior surface and an inferior surface of the uncinate joint (unci 102) (see Fig. 4), such that a second surface (inclined flank 10) contacts the inferior surface of the uncinate joint (see Fig. 4), wherein the second surface includes a gripping mechanism in the form of a rough surface (ribs 15 create a rough surface in comparison to the smooth, non-textured surfaces of walls 2 and 3) for automatically securing the monoblock implant within the opening between the superior surface and the inferior surface of the uncinate joint and preventing expulsion of the monoblock implant (see para. 0038) (Figs. 1-4).
Yang teaches inserting a monoblock implant (cage 10) into an opening formed between a superior surface and an inferior surface of vertebrae (see Fig. 4), wherein the implant includes two wings (protrusions 200), each extending away from a central region (body 100) of the monoblock implant along a lateral direction, each wing having a first surface (see Fig. 1 inset) and a second surface (see Fig. 1 inset), wherein both the first surface and the second surface of the wings have a gripping mechanism in the form of a rough surface (see Fig. 1 inset, wherein the ribs create a rough surface in comparison to the smooth, non-textured surfaces of the side walls) (Figs. 1-4).
[AltContent: textbox (First Surface with
Rough Surface)][AltContent: textbox (First Surface with
Rough Surface)][AltContent: textbox (Second Surface with Rough Surface)][AltContent: textbox (Second Surface with Rough Surface)]
Goel teaches that a gripping mechanism resists expulsion from the vertebrae (see para. 0034), wherein the gripping mechanism is in the form of barbs (see “barbs” in para. 0034) and a rough surface (see “ribs” in para. 0034) (see para. 0034, which states that a gripping mechanism includes more than one type of structure) (para. 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to insert, from an anterior side of the cervical spine segment, a monoblock implant into the opening formed between the superior surface and the inferior surface of the uncinate joint, the monoblock implant having two wings, each wing extending away from a central region of the monoblock implant along a lateral direction, each wing having a first surface and a second surface, such that the first surface of the wings contacts the superior surface of the uncinate joint and the second surface of the wings contacts the inferior surface of the uncinate joint, wherein the first surface and second surface of the wings includes a gripping mechanism having a barb for automatically securing the monoblock implant within the opening between the superior surface and the inferior surface of the uncinate joint, and each of the wings further comprises a rounded end (claim 1), loading a bone graft material in the monoblock implant prior to inserting the monoblock implant into the opening (claim 3), wherein loading bone graft material in the monoblock implant further comprises inserting the bone graft material into a cavity formed in the monoblock implant (claim 4), and wherein the gripping mechanism further comprises a rough surface (claim 21), as taught by Chung, Ganem, and Yang, as Sahai clearly intends the distraction tool to be used prior to the insertion of an implant (see para. 0058 of Sahai) and such an implant is complementary in shape to the space between the vertebral bodies such that the implant abuts the adjacent vertebral bodies along both the intervertebral disk space and between the uncinate joints (see Fig. 7; see also last paragraph of pg. 7 of Chung) and prevents expulsion of the implant (see para. 0038 of Ganem) by ensuring all vertebral contacting surfaces include a gripping mechanism.
Response to Arguments
Applicant's arguments filed August 14, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments regarding priority (see pgs. 6-7) have been addressed in the Advisory Action mailed on April 4, 2025, which cited to MPEP 211.05(I)(B) and noted that a proper priority claim requires that each prior-filed application disclose the entirety of the claimed invention of the later-filed application. Only App. No. 17/067,683 discloses the claimed invention; the other prior-filed applications disclose parts of the claimed invention, but not the entirety of the invention as recited in claim 1. The Examiner further notes that Applicant appears to agree that none of the other prior-filed applications disclose the entirety of the invention as recited in claim 1 (see pgs. 6-7 of Applicant’s remarks, where Applicant identifies portions of the prior-filed applications that correspond to parts of the claimed invention but does not indicate that any of the identified prior-filed applications disclose the entirety of the claimed invention).
Applicant’s statement that neither Sahai, Chung, Ganem, or Yang teach wings having a rounded end (see pg. 11) is not persuasive as Chung teaches the claimed rounded ends (see the rejection above, including annotated Fig. 4 of Chung).
Applicant’s arguments with respect the barb as recited in amended claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See the rejection above, which relies upon Goel to teach a gripping mechanism in the form of a barb in combination with a rough surface.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773