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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 5, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seme et al. (US 2013/0231703 A1).
Claim 1. Seme discloses a system, comprising:
a tensioning element (adjustment assembly 32), comprising:
a connection element (tether 250 and connector head 252) that is configured to be coupled to a fixation element, and
an anchoring element (housing 210 and drive gear 216 of tensioner 208) that is configured to be coupled to an external fixation point (the external fixation point being a surgical instrument acting on actuation head 218 of drive gear 216),
wherein the tensioning element is operable to apply a tension between the connection element and the anchoring element (see para. 0077),
wherein the anchoring element comprises a hook, a clamp (see para. 0070, which indicates that housing 210 acts as a clamp), a ring, or a threaded anchor, and
wherein the anchoring element is configured to be coupled to the external fixation point that is a fixed location in a surgical environment, a point on an operating table, a point on an object in proximity to an operating table (a surgical instrument, during use, would be an object in proximity to an operating table, wherein the patient is presumably located on the operating table), or appoint on a surgical drape; and
a fixation element (transverse anchor 28 and fastener 36), comprising:
a first portion (transverse anchor 28) that is configured to be coupled to the tensioning element, and
a second portion (fastener 36) that is configured to be coupled to bony tissue in a bone of a patient (see para. 0062, which states that fastener 36 is a pedicle screw);
wherein the tensioning element and the fixation element are configured to cooperate with one another so as to apply a tension between (a) bony tissue to in a bone of a patient and (b) an external fixation point, when the anchoring element of the tensioning element is coupled to the external fixation point, the second portion of the fixation element is coupled to the bony tissue in the bone of the patient, and the tensioning element is operated to apply the tension, thereby to retain the bony tissue in the bone of the patient in a fixed position with respect to the external fixation point (see paras. 0077 and 0085) (Figs. 11-18; paras. 0062-0085).
Claim 4. Seme discloses wherein an angle is formed between the first portion of the fixation element and the second portion of the fixation element (fastener 36 extends through slot 184 in transverse anchor 28, thereby creating an angle between the shaft of fastener 36 and the plane of transverse anchor 28) (Figs. 11-18; paras. 0062-0085).
Claim 5. Seme discloses wherein the angle is in a range of between 0 degrees and 180 degrees (the angle as defined above would necessarily be in the range of between 0 degrees and 180 degrees as fastener 36 would extend roughly into the page when extending through slot 184 of transverse anchor 28 as shown in Fig. 18) (Figs. 11-18; paras. 0062-0085).
Claim 12. Seme discloses a kit, comprising:
at least one tensioning element (adjustment assemblies 32 and 34), wherein each of the at least one tensioning element comprises:
a connection element (tether 250 and connector head 252) that is configured to be coupled to a fixation element, and
an anchoring element (housing 210 and drive gear 216 of tensioner 208) that is configured to be coupled to an external fixation point (the external fixation point being a surgical instrument acting on actuation head 218 of drive gear 216),
wherein the anchoring element comprises a hook, a clamp (see para. 0070, which indicates that housing 210 acts as a clamp), a ring, or a threaded anchor, and
wherein the anchoring element is configured to be coupled to the external fixation point that is a fixed location in a surgical environment, a point on an operating table, a point on an object in proximity to an operating table (a surgical instrument, during use, would be an object in proximity to an operating table, wherein the patient is presumably located on the operating table), or appoint on a surgical drape;
wherein each of the at least one tensioning element is operable to apply a tension between the connection element and the anchoring element (see para. 0077); and
a plurality of fixation elements (transverse anchors 28 and 30), wherein each of the plurality of fixation elements comprises:
a first portion (arm portion 176) that is configured to be selectively coupled to the tensioning element, and
a second portion (connection portion 174) that is configured to be coupled to bony tissue in a bone of a patient (via fastener 36 extending through slot 184; see para. 0062, which states that fastener 36 is a pedicle screw);
wherein the tensioning element and a selected one of the plurality of fixation elements are configured to cooperate with one another so as to apply a tension between (a) bony tissue in a bone of a patient and (b) an external fixation point, when the anchoring element of the tensioning element is coupled to the external fixation point, the second portion of the selected one of the plurality of fixation elements is coupled to the bony tissue in the bone of the patient, and the tensioning element is operated to apply the tension, thereby to retain the bony tissue in a fixed position with respect to the external fixation point (see paras. 0077 and 0085) (Figs. 11-18; paras. 0062-0085).
Claim 14. Seme discloses wherein an angle is formed between the first portion of each of the plurality of fixation elements and the second portion of each of the plurality of fixation elements (angle defined between direction R1 and direction R2), wherein the plurality of fixation elements comprises at least a first fixation element (transverse anchor 28) and a second fixation element (transverse anchor 30), wherein the angle of the first fixation element is different than the angle of the second fixation element (see para. 0064, which states that the angle between direction R1 and direction R2 can be about 45 degrees, or from about 30 degrees to about 60 degrees, or at no angle) (Figs. 11-18; paras. 0062-0085).
Claim 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seme et al. (US 2013/0231703 A1).
Claim 12. Seme discloses a kit, comprising:
at least one tensioning element (adjustment assemblies 32 and 34), wherein each of the at least one tensioning element comprises:
a connection element (tether 250 and connector head 252) that is configured to be coupled to a fixation element, and
an anchoring element (housing 210 and drive gear 216 of tensioner 208) that is configured to be coupled to an external fixation point (the external fixation point being a surgical instrument acting on actuation head 218 of drive gear 216),
wherein the anchoring element comprises a hook, a clamp (see para. 0070, which indicates that housing 210 acts as a clamp), a ring, or a threaded anchor, and
wherein the anchoring element is configured to be coupled to the external fixation point that is a fixed location in a surgical environment, a point on an operating table, a point on an object in proximity to an operating table (a surgical instrument, during use, would be an object in proximity to an operating table, wherein the patient is presumably located on the operating table), or appoint on a surgical drape;
wherein each of the at least one tensioning element is operable to apply a tension between the connection element and the anchoring element (see para. 0077); and
a plurality of fixation elements (transverse anchor 28 and fastener 36 is one fixation element; transverse anchor 30 and fastener 36 is another fixation element), wherein each of the plurality of fixation elements comprises:
a first portion (transverse anchor 28 or 30) that is configured to be selectively coupled to the tensioning element, and
a second portion (fastener 36) that is configured to be coupled to bony tissue in a bone of a patient (see para. 0062, which states that fastener 36 is a pedicle screw);
wherein the tensioning element and a selected one of the plurality of fixation elements are configured to cooperate with one another so as to apply a tension between (a) bony tissue in a bone of a patient and (b) an external fixation point, when the anchoring element of the tensioning element is coupled to the external fixation point, the second portion of the selected one of the plurality of fixation elements is coupled to the bony tissue in the bone of the patient, and the tensioning element is operated to apply the tension, thereby to retain the bony tissue in a fixed position with respect to the external fixation point (see paras. 0077 and 0085) (Figs. 11-18; paras. 0062-0085).
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Seme et al. (US 2013/0231703 A1) in view of Jacob et al. (US 2012/0041490 A1). For this rejection, see the rejection of claim 12 on pgs. 6-8 above).
Claim 13. Seme discloses wherein the plurality of fixation elements comprises at least a first fixation element (transverse anchor 28 and fastener 36) and a second fixation element (transverse anchor 28 and fastener 36) (Figs. 11-18; paras. 0062-0085).
Seme fails to disclose wherein the first fixation element has a different length than the second fixation element (claim 13).
However, as noted in the rejection of claim 12, Seme discloses that fasteners 36 are pedicle screws.
Jacob teaches that pedicle screws (anchors 110A, 110B, 110C) can have different lengths (see para. 0023) (Fig. 2; para. 0023).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify fasteners 36 of Seme such that they have different lengths, as suggested by Jacob, as doing so would allow the surgeon to choose an appropriate fastener for each vertebra of a patient. In view of such a modification, because fasteners 36 have different lengths, the first fixation element would have a different length than the second fixation element (claim 13).
Response to Arguments
Applicant’s arguments with respect to Seme 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. Note that the Examiner has interpreted Seme wherein housing 210 and drive gear 216 of tensioner 208 are the anchoring element (see the rejections above) as opposed to lumen 220 of tensioner 208 being the anchoring element (see the Non-Final Rejection mailed on October 10, 2025). Furthermore, per this new interpretation of Seme, the Examiner has identified the external fixation point as a surgical instrument acting on actuation head 218 of drive gear 216 and noted that a surgical instrument, during use, would be an object in proximity to an operating table, wherein the patient is presumably located on the operating table.
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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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