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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/16/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 11 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. New rejections were made in view of applicant’s amendments. It is noted that Nichols discloses other embodiments where the rods are placed in a side by side configuration (Fig 27a-27b).
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 1-20 is 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.
In claim 1 there exits an inconsistency between the language in the preamble and that of the body of the claim, thus making the scope of the claim unclear. In the preamble, line 1, applicant recites “A transverse connector” with the first and second spine rods being only functionally recited, i.e. “for interconnecting first and second spine rods ...”, thus indicating that the claim is directed to the subcombination, “A transverse connector”. However, in the last two clauses, applicant positively recites the first and second spine rods, i.e. “the first spine rod passes completely through the first connecting member…. the second spine rod passes completely through the second connecting member”, thus indicating that the combination, the transverse connector and the first and second spine rods, is being claimed. As such, it is unclear whether applicant intends to claim the subcombination or combination. Applicant is hereby required to indicate to which, combination or subcombination, the claim is intended to be directed, and amend the claim such that the language thereof is consistent with this intent. For examination purposes claim 1 will be considered as being drawn to the subcombination, a transverse connector. Claim 11 recites the same issue as claim 1.
Claim Rejections - 35 USC § 103
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) 1, 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Morris US 2022/0354546 in view of Ziemek US 8,998,961.
Regarding Claim 1, Morris discloses a transverse connector (Fig 27c) for interconnecting first and second spine rods (rods #320, Fig 27c), comprising:
a first connecting member connectable with the first spine rod (see Fig below, paragraph 123);
a second connecting member (see Fig below) connectable with the second spine rod and fixed a set distance from the first connecting member (see Fig below, paragraph 123);
a coupler (see Fig below) disposed between the first connecting member and the second connecting member (Fig below) and integrally attached to only one of the first connecting member (see Fig below) and second connecting members, and configured to angularly couple the first and second connecting members together such that an angle of deployment between the first connecting member and the second connecting member is adjustable (angle is pivotably adjustable via ball #430, paragraph 123); and
a fastener (#436, paragraph 123) having an extension (threaded portion of the fastener, see Fig below) extending through a body portion of the coupler and configured to fix the angle of deployment in one of a plurality of angular positions (Fig 27c, paragraph 123)
wherein
the first and second connecting members have first and second apertures (see Fig below, see also paragraph 121-122, the apertures receive set screws #434) opening respectively to the first connecting rod and the second connecting rod (Fig 27c), and
the body portion of the coupler has an upper surface extending laterally around both the fastener (see Fig below) and the first aperture of the first connecting member (see Fig below).
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Morris discloses the first and second spine rods are able to be placed in series with respect to each other (Fig 27c) and where Morris discloses other embodiments where the first and second spine rods are able to be placed side-by-side to each other (Fig 27a-27b) but does not disclose the first spine rod passes completely through the first connecting member underneath the upper surface of the body portion, and the second spine rod passes completely through the second connecting member underneath the second aperture.
Ziemek discloses a first connecting member connectable with a first spine rod (see Fig below); a second connecting member connectable with a second spine rod (see Fig below), the connecting members each have an opening to receive their respective spine rod such that the first and second spine rods are in series with each other (Fig 4, see Fig below); where the connecting members each have transverse openings such that the first spine rod passes completely through the first connecting member underneath the upper surface of the body portion (see Fig below, Fig 2), and the second spine rod passes completely through the second connecting member underneath the second aperture (see Fig below, Fig 2) such that the first and second rods are in a side-by-side configuration (see Fig below, Fig 2), where the transverse openings provides greater flexibility for the placements of the first and second spine rods depending on patient need (Fig 2, 4, 7, Col 3 lines 5-16).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first and second connecting members of Morris to include transverse openings such that the first spine rod passes completely through the first connecting member underneath the upper surface of the body portion, and the second spine rod passes completely through the second connecting member underneath the second aperture in view of Ziemek above because this provides greater flexibility for the placement of the first and second spine rods relative to each other.
Regarding Claim 6, Morris as modified discloses the first connecting member and the second connecting member have respective transverse openings for insertion of the first and second spine rods (as discussed in the rejection above in view of Ziemek).
Regarding Claim 7, Morris as modified discloses the first and second connecting members clamp respectively the first and second spine rods in the transverse opening (Fig 27c, paragraph 121-122 in Morris, clamped via set screws #434).
Regarding Claim 8, Morris as modified discloses the coupler permits angular variations around a longitudinal axis (Fig 27c in Morris, longitudinal axis extends along the left rod #320) of the transverse connector (Fig 27c, paragraph 123 in Morris).
Regarding Claim 9, Morris as modified discloses the first connecting member comprises a first threaded aperture (first aperture shown in the fig above in claim 1) through which a first set screw (#434 in Morris), upon advancing through the threaded aperture, fixes the first connecting member to the first spine rod (Fig 27c, paragraph 121-122 in Morris, it is noted that the set screw #434 fixes the first spine rod in place regardless of its orientation, ie side-by-side or in series, relative to the second spine rod).
Regarding Claim 10, Morris as modified discloses the second connecting member comprises a second threaded aperture (second aperture show in the fig above in claim 1) through which a second set screw (#434 in Morris), upon advancing through the second threaded aperture, fixes the second connecting member to the second rod (Fig 27c, paragraph 121-122 in Morris, it is noted that the set screw #434 fixes the first spine rod in place regardless of its orientation, ie side-by-side or in series, relative to the second spine rod).
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Morris US 2022/0354546 in view of in view of Ziemek US 8,998,961 as discussed above in claim 1 and in further view of other embodiments of Morris.
Regarding Claim 2, Morris as modified discloses the second connecting member comprises a ball (#430 in Morris) integrally attached to the second connecting member (Fig 27c in Morris), the ball is received in a socket (#432 in Morris) in the body portion of the coupler (Fig 27c in Morris) but does not disclose the ball having a fixed length arm integrally attached to the second connecting member, the arm extends towards the socket.
Morris discloses an alternative embodiment (Fig 26a) where a second coupler (#402) comprises a ball (“spherical head” as seen in Fig 26a, paragraph 119) having a fixed length arm (#410) integrally attached to the second connecting member (Fig 26a), the arm extends towards a socket (where the ball is located in Fig 26a) of a body portion of a coupler (#412), where this provides a known alternative configuration for a ball for a second connecting member (paragraph 119, Fig 26a).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the ball of Morris as modified to include a fixed length arm integral to the second connecting member in view of another embodiment of Morris because this provides a known alternative configuration for a ball joint that provides predictable results of allowing the second coupling member to be pivotally coupled to the socket of a coupler.
Regarding Claim 3, Morris as modified discloses the ball and socket collectively form a ball joint (paragraph 119, 123 in Morris).
Regarding Claim 4, Morris discloses the fastener of the coupler engages the ball of the ball joint to fix the angle of deployment (paragraph 123 in Morris).
Regarding Claim 5, Morris discloses the fastener comprises a screw (#436, paragraph 123 in Morris) engages the ball of the ball joint (Fig 27c, paragraph 123 in Morris).
Claims 11, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Morris US 2022/0354546 in view of Rinner US 2015/0073488 and Ziemek US 8,998,961.
Regarding Claim 11, Morris a system for stabilizing a spinal column (Fig 27c) comprising:
a first spine rod (left rod #320, Fig 27c);
a second spine rod (right rod #320, Fig 27c);
a first connecting member connectable with the first spine rod (see Fig below, paragraph 123);
a second connecting member (see Fig below) connectable with the second spine rod and fixed a set distance from the first connecting member (see Fig below, paragraph 123);
a coupler (see Fig below) disposed between the first connecting member and the second connecting member (Fig below) and integrally attached to only one of the first connecting member (see Fig below) and second connecting members, and
configured to angularly couple the first and second connecting members together such that an angle of deployment is adjustable between the first connecting member and the second connecting member (angle is pivotably adjustable via ball #430, paragraph 123); and
a fastener (#436, paragraph 123) having an extension (threaded portion of the fastener, see Fig below) extending through a body portion of the coupler and configured to fix the angle of deployment in one of a plurality of angularly diverse positions (Fig 27c, paragraph 123)
wherein
the first and second connecting members have first and second apertures (see Fig below, see also paragraph 121-122, the apertures receive set screws #434) opening respectively to the first connecting rod and the second connecting rod (Fig 27c), and
the body portion of the coupler has an upper surface extending laterally around both the fastener (see Fig below) and the first aperture of the first connecting member (see Fig below).
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Morris does not disclose one or more lateral connectors configured to extend across the spinal column to connect to rods on the other side of the spinal column.
Morris discloses the first and second spine rods are able to be placed in series with respect to each other (Fig 27c) and where Morris discloses other embodiments where the first and second spine rods are able to be placed side-by-side to each other (Fig 27a-27b) but does not disclose the first spine rod passes completely through the first connecting member underneath the upper surface of the body portion, and the second spine rod passes completely through the second connecting member underneath the second aperture.
Rinner discloses a similar system (see Fig below) where on the other side of the spinal column, there are other rods and other connectors (similar to the first and second spine rod and first and second connecting members) to provide stability to both left and right sides of the spinal column (paragraph 120), and one or more lateral connectors (#200, see Fig below) extending across the spinal column to connect to the rods on the other side of the spinal column (see Fig below) in order to provide additional rigidity to the overall construct (paragraph 124).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Lee and include other rods and connecting members (similar to the first and second spine rods and first and second connecting members) for placement on the other side of the spinal column and a lateral connector in view of Rinner because the other rods and connectors would provide stabilization on the other side of the spinal column (so that there is stabilization on both the left and right sides of the spinal column) and where the lateral connector provides additional rigidity to the overall construct.
Ziemek discloses a first connecting member connectable with a first spine rod (see Fig below); a second connecting member connectable with a second spine rod (see Fig below), the connecting members each have an opening to receive their respective spine rod such that the first and second spine rods are in series with each other (Fig 4, see Fig below); where the connecting members each have transverse openings such that the first spine rod passes completely through the first connecting member underneath the upper surface of the body portion (see Fig below, Fig 2), and the second spine rod passes completely through the second connecting member underneath the second aperture (see Fig below, Fig 2) such that the first and second rods are in a side-by-side configuration (see Fig below, Fig 2), where the transverse openings provides greater flexibility for the placements of the first and second spine rods depending on patient need (Fig 2, 4, 7, Col 3 lines 5-16).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first and second connecting members of Morris to include transverse openings such that the first spine rod passes completely through the first connecting member underneath the upper surface of the body portion, and the second spine rod passes completely through the second connecting member underneath the second aperture in view of Ziemek above because this provides greater flexibility for the placement of the first and second spine rods relative to each other. It is noted that the lateral connector is able to be used when the first and second spine rods are in series or side-by-side with each other.
Regarding Claim 16, Morris as modified discloses the first connecting member and the second connecting member have respective transverse openings for insertion of the first and second spine rods (as discussed in the rejection above in view of Ziemek).
Regarding Claim 17, Morris as modified discloses the first and second connecting members clamp respectively the first and second spine rods in the transverse opening (Fig 27c, paragraph 121-122 in Morris, clamped via set screws #434).
Regarding Claim 18, Morris discloses the coupler permits angular variations around a longitudinal axis (Fig 27c in Morris, longitudinal axis extends along the left rod #320) of the transverse connector (Fig 27c, paragraph 123 in Morris).
Regarding Claim 19, Morris as modified discloses the first connecting member comprises a first threaded aperture (first aperture shown in the fig above in claim 11) through which a first set screw (#434 in Morris), upon advancing through the threaded aperture, fixes the first connecting member to the first spine rod (Fig 27c, paragraph 121-122 in Morris).
Regarding Claim 20, Morris as modified discloses the second connecting member comprises a second threaded aperture (second aperture show in the fig above in claim 11) through which a second set screw (#434 in Morris), upon advancing through the second threaded aperture, fixes the second connecting member to the second rod (Fig 27c, paragraph 121-122 in Morris).
Regarding Claim 12, Morris as modified discloses the second connecting member comprises a ball (#430 in Morris) integrally attached to the second connecting member (Fig 27c in Morris), the arm is received in a socket (#432 in Morris) in the body portion of the coupler (Fig 27c in Morris) but does not disclose the ball having a fixed length arm integrally attached to the second connecting member, the arm extends towards the socket.
Morris discloses an alternative embodiment (Fig 26a) where a second coupler (#402) comprises a ball (“spherical head” as seen in Fig 26a, paragraph 119) having a fixed length arm (#410) integrally attached to the second connecting member (Fig 26a), the arm extends towards a socket (where the ball is located in Fig 26a) of a body portion of a coupler (#412), where this provides a known alternative configuration for a ball for a second connecting member (paragraph 119, Fig 26a).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the ball of Morris as modified to include a fixed length arm integral to the second connecting member in view of another embodiment of Morris because this provides a known alternative configuration for a ball joint that provides predictable results of allowing the second coupling member to be pivotally coupled to the socket of a coupler.
Regarding Claim 13, Morris as modified discloses the ball and socket collectively form a ball joint (paragraph 119, 123 in Morris).
Regarding Claim 14, Morris as modified discloses the fastener of the coupler engages the ball of the ball joint to fix the angle of deployment (paragraph 123 in Morris).
Regarding Claim 15, Morris as modified discloses the fastener comprises a screw (#436, paragraph 123 in Morris) engages the ball of the ball joint (Fig 27c, paragraph 123 in Morris).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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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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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773