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 .
Election/Restrictions
Claim 1 is allowable. The restriction requirement between Cap species, as set forth in the Office action mailed on July 28, 2025, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of July 28, 2025 is partially withdrawn. Claims 6-9, directed to non-elected Cap species, are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19-21 and 23-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 19 recites “the cap comprises a load-carrying portion protruding outward from the first lattice structure within which the first lattice structure is absent.” It is unclear how the first lattice structure is absent from within the first lattice structure. The Examiner believes that claim 19 should recite that the first lattice structure is absent from within the load-carrying portion. As such, the Examiner suggests amending claim 19 to recite “the cap comprises a load-carrying portion within which the first lattice structure is absent, wherein the load-carrying portion protrudes outward from the first lattice structure
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (US 2013/0123848 A1) in view of Akallal et al. (US 2022/0249083 A1) and Casey et al. (US 2019/0282367 A1).
Duggal discloses a facet fixation system, the system comprising:
a cap (cap 10) configured to span a vertebral facet joint (see abstract), the cap comprising a distal surface (bone engaging side 3 having teeth 14 and tooth 4) configured to seat against a bone proximate the vertebral facet joint (see para. 0068); and
a fastener (fastener 50) configured to secure the cap to the vertebral facet joint (see abstract) (Figs. 1A-1H, 5A-5B, 10-13, and 16A-16C; paras. 0067-0070, 0077-0078, and 0082).
Duggal fails to disclose wherein the cap comprises an indicator configured to move from a first position to a second position in response to engagement of the distal surface with the bone and wherein the indicator comprises a blunt bone contacting surface that is enlarged relative to a body of the indicator.
However, Duggal also discloses that the distal surface includes projections (teeth 14 and tooth 4) for fixing the cap to bone (see para. 0068), wherein some of the projections (teeth 14) are located at a perimeter of the cap and another projection (tooth 4) is located interior of the perimeter of the cap (see Fig. 1C) (Figs. 1A-1H, 5A-5B, 10-13, and 16A-16C; paras. 0067-0070, 0077-0078, and 0082).
Akallal teaches a cap (device 10) comprising a distal surface (apposition surface 24), wherein the distal surface includes projections (anchors 22 and indicators 26) for fixing the cap to bone (see para. 0094), wherein some of the projections (anchors 22) are located at a perimeter of the cap and other projections (indicators 26) are located interior of the perimeter of the cap (see Fig. 3), wherein the interior projections are each in the form of an indicator (indicator 26) configured to move from a first position (see Fig. 7A) to a second position (see Figs. 5, 6, and 7B) in response to engagement of the distal surface with the bone (see paras. 0103-0104), wherein the indicators provide a visual indicator that the cap is seated as desired against the bone (see para. 0104) (Figs. 3-7B; paras. 0097-0104).
Casey teaches a movable projection (tooth 202) comprising a blunt contacting surface (surface contacted by axial force 220) that is enlarged relative to a body (the remainder of tooth 202) of the projection (Fig. 25; para. 0024).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Duggal such that the projection (tooth 4) located interior of the perimeter of the cap is configured as an indicator as taught by Akallal, wherein the indicator is configured to move from a first position to a second position in response to engagement of the distal surface with the bone, as suggested by Akallal, as such can provide a visual indicator that the cap is seated as desired against the bone. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Duggal such that the indicator comprises a blunt bone contacting surface that is enlarged relative to a body of the indicator, as suggested by Casey, in order to better receive axial force acting on the indicator and better seat the indicator on the bone.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (US 2013/0123848 A1) in view of Akallal et al. (US 2022/0249083 A1) and Casey et al. (US 2019/0282367 A1) as applied to claim 27 above, and further in view of Yeh (US 2015/0080951 A1).
Duggal, Akallal, and Casey fail to teach wherein the cap comprises a lattice structure configured to promote bone growth into the cap.
Yeh teaches a cap (apparatus 10) configured to span a joint (see Fig. 3), wherein the cap comprises a distal surface (surface seated against vertebrae S and S’ as shown in Fig. 3) configured to seat against a bone, wherein the cap comprises a lattice structure (micro-lattice hollow structure 10’) configured to promote bone growth into the cap (see para. 0035) in order to enhance vertebral or spinal strength (see para. 0035) (Figs. 1-4; paras. 0022-0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Duggal such that the cap comprises a lattice structure configured to promote bone growth into the cap, as suggested by Yeh, in order to enhance vertebral or spinal strength.
Allowable Subject Matter
Claims 1-18 and 26 are allowed. Note that any amendment to claim 1 may result in claims 6-9 being withdrawn from consideration.
Claim 29 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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