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
Applicant’s election of Spinal Fixation Construct B (Fig. 7) and Flexible Member A (Figs. 3A-3B) in the reply filed on August 5, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (the elected species of Spinal Fixation Construct does not include three fixation members attached to three different vertebral bodies and a band connected to another vertebral body as recited in claim 1; the Spinal Fixation Construct of Fig. 7 includes two screws 40 attached to first and second vertebral bodies, fixation member 110 attached to a third vertebral body, and band 20 attached to the second and third vertebral bodies, not another vertebral body), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 5, 2026.
Claims 10-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (the elected species of Spinal Fixation Construct does not include a rod with an aperture formed therethrough as recited in claim 10; the Spinal Fixation Construct of Fig. 7 includes rod 30, which is also shown in Fig. 6 and does not include an aperture therethrough), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 5, 2026.
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (the elected species of Spinal Fixation Construct does not include a band attached to a fourth vertebral body; the Spinal Fixation Construct of Fig. 7 includes band 20 attached to a first vertebral body via screw 40 and a second vertebral body via fixation member 110), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 5, 2026.
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (the elected species of Spinal Fixation Construct does not include a rod with a passage through which the band extends; the Spinal Fixation Construct of Fig. 7 includes rod 30, which is also shown in Fig. 6 and does not include a passage), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 5, 2026.
Claims 15-17 and 20 have been examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 15-17 and 20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 15 recites “a first rod attached to a first vertebral body” (line 2) and “a first fixation member attached to a second vertebral body” (line 3). Claim 16 recites “the first spinal rod is attached to the first vertebral body” (lines 1-2). Claim 17 recites “the first spinal rod is attached to a third vertebral body” (lines 1-2). All of the aforementioned recitations include a human organism within the scope of the claims and thus claims 15-17 and 20 are unpatentable. In order to overcome this rejection, the Examiner suggests amending claim 15 to recite “a first rod configured to be attached to a first vertebral body” (line 2) and “a first fixation member configured to be attached to a second vertebral body” (line 3), amending claim 16 to recite “the first spinal rod is configured to be attached to the first vertebral body” (lines 1-2), and amending claim 17 to recite “the first spinal rod is configured to be attached to a third vertebral body” (lines 1-2).
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 15-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Calvosa et al. (US 2012/0136394 A1).
Claim 15. Calvosa discloses a spinal fixation construct comprising:
a first rod (rod-like element 8 extending from pedicle screw 2 to pedicle screw 15) configured to be attached to a first vertebral body (via pedicle screw 2);
a first fixation member (pedicle screw 3) configured to be attached a second vertebral body; and
a band (cord 16) connected to the first rod (via disk-like body 10 at pedicle screw 2) and the first fixation member (Fig. 2; paras. 0021-0039).
Claim 16. Calvosa discloses wherein the first spinal rod is configured to be attached to the first vertebral body with a first bone screw (pedicle screw 2) (Fig. 2; paras. 0021-0039).
Claim 17. Calvosa discloses wherein the first spinal rod is configured to be attached to a third vertebral body with a second bone screw (pedicle screw 15) (Fig. 2; paras. 0021-0039).
Claim 20. Calvosa discloses wherein the band is flexible (see para. 0031, which states that cord 16 forms a closed loop and is capable of being tensioned, which indicates that cord 16 has at least some amount of flexibility) (Fig. 2; paras. 0021-0039).
Conclusion
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
