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 .
This Office action is in response to the amendment filed 06/30/2026. Claims 1-10, 12 and 18-26 are pending. Claims 1-9 and 18-20 remain withdrawn from consideration as directed to a non-elected invention. Claims 10 and 12 are currently amended. Claims 21–26 are new.
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 22, 23, 24 and 26 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 22 recites, "when the disc implant is inserted into a desired location." The term "desired" is a subjective term of degree. Neither the claim nor the specification provides a standard by which a location is determined to be "desired," so one of ordinary skill would not be apprised of the scope of the claim.
Claim 23 recites that the posts "facilitate coupling of the disc implant to the clip." The term "facilitate" does not define any structural relationship or degree of contribution, and it is unclear what structure is or is not encompassed. The scope of the claim cannot be determined.
Claim 24 includes a method step recitation that “when the disc implant is inserted into a disc space, the clip is in contact with a bone, at which point the handle is disconnected from the clip.” Applicant is reminded that the claims are directed to a system and therefore the method steps are not given patentable weight. It is furthered noted that “configured to” language should be inserted before “contact with bone.”
Claim 26 recites that the implant "is configured to be tamped with the handle either connected to the clip or disconnected from the clip." Because the claim expressly encompasses both mutually exclusive alternatives, it is unclear what structural or functional requirement, if any, is imposed.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 26 recites tamping with the handle "either connected to the clip or disconnected from the clip." Those two conditions are exhaustive of all possible states of the handle-clip interface recited in claim 10. A limitation reciting all possible alternatives excludes nothing and therefore imposes no further limitation on claim 10.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 10, 12 and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zubok (U.S. 10,398,572 B2).
Concerning claim 10, Zubok discloses a cervical disc replacement system, comprising: a disc implant (see Fig. 12B, element 100); and a cervical disc instrument configured to insert the disc implant into a disc space, wherein the cervical disc instrument comprises: a handle (see Figs. 9A-9D) comprising a receiving portion (see Fig. 9D, element 239); and a clip (see Figs. 7A-7C) comprising an engaging portion (see Fig. 7B, element 225) configured to receive the engaging portion of the handle, wherein the clip is configured to be removably coupled to the disc implant. Zubok further discloses that inserter head 210 and handle 230 are joined by a complementary male-female coupling: tapered stem 225 at the trailing end of inserter head 210 is received within tapered opening 239 at the leading end of handle 230, which Zubok expressly characterizes as creating a male-female connection (FIGS. 9D, 11A–11C).
However Zubok does not explicitly disclose that the handle comprises the engaging portion, or that the clip comprises a receiving portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reverse the male and female members of Zubok’s handle-to-head coupling such that the engaging portion is carried by the handle and the receiving portion is carried by the clip. A mere reversal of the essential working parts of a device is within the level of ordinary skill and does not impart patentability. The reversal is a binary design choice between two known, predictable alternatives for a complementary taper coupling, and would have yielded no more than the predictable result of removably joining the handle to the head.
Concerning claim 12, wherein the clip comprises one or more teeth (see Fig. 7A, elements 224A, 224B) configured to couple to the disc implant (see Figs. 8A-8F, element 100). It is noted that the term “teeth” is given the broadest reasonable interpretation and defined as “a projecting part on a tool or other instrument.”
Concerning claim 24, wherein, when the disc implant is inserted into a disc space, the clip is configured to contact bone (see Fig. 7B, elements 216 and 218), at which point the handle (see Fig. 9A) is configured to be disconnected from the clip.
Claim 25 recites that the receiving portion is a female portion and the engaging portion is a male portion. This is the direct consequence of the reversal set forth as to claim 10, and is rejected for the same reasons and on the same rationale.
Concerning claim 26, wherein the disc implant is configured to be tamped with the handle either connected to the clip or disconnected from the clip. It is noted that one could tamp striking surface 254 (see Fig. 10), 242 (see Fig. 9A), or 225 (see Fig. 7B).
Allowable Subject Matter
Claim 21 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.
Response to Arguments
Applicant’s arguments filed 06/30/2026 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.
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 ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
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