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 .
Allowable Subject Matter
Claims 19 and 20 are allowable over the prior art.
Claims 5-13 and 15-18 are 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, and upon overcoming the double patenting rejection.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or disclose wherein the system includes one or more cannulated pedicle screws that are configured to be insertable through one or more respective pedicles of the patient’s spine, and a distracting frame configured to operably connect the at least two cannulated screws to each other.
The prior art fails to teach or disclose wherein the posterior distractor rack assembly includes a first swivel tube subassembly having a first swivel tube, wherein the posterior distractor carriage assembly includes a second swivel tube subassembly having a second swivel tube, and wherein the first and second swivel tubes are each configured to receive a pedicle screw and screw tower therein.
The prior art fails to teach or disclose wherein the pinion assembly includes a knob, a post descending from the knob, a gear circumferentially engaging the post and having ridges that interdigitate with the ridges on the rack, and wherein the posterior distractor carriage assembly includes an aperture dimensioned to receive the post and gear of the pinion assembly therein.
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 19 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). Lines 13-14 of the claim recite “one or more cannulated pedicle screws that are insertable through one or more respective pedicles of the patient’s spine…” Examiner suggests language similar to “one or more cannulated pedicle screws that are configured to be insertable through one or more respective pedicles of the patient’s spine…” in order to avoid positively reciting the patient’s pedicle, and to overcome the rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,042,405. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose an internal fixation system for spinal surgery on a patient. The system comprises a lateral lumbar interbody fusion (LLIF) retractor having an LLIF retractor adaptor, a posterior compressor/distractor, an A-arm configured to mount on a surgical table, and a B-arm configured to engage an end of the table-mounted A-arm and to engage the posterior compressor/distractor. The posterior compressor/distractor includes a posterior distractor rack assembly, a posterior distractor carriage assembly configured to operably engage the posterior distractor rack assembly, and a pinion assembly configured to operably engage the posterior distractor rack assembly and the posterior distractor carriage assembly. The posterior distractor rack assembly and posterior distractor carriage assembly are movable relative to one another. The posterior distractor rack assembly includes a rack having a plurality of ridges on at least one surface thereof, and wherein the posterior distractor carriage assembly includes an opening configured to receive the rack therethrough. The posterior distractor rack assembly includes a first swivel tube subassembly having a first swivel tube, wherein the posterior distractor carriage assembly includes a second swivel tube subassembly having a second swivel tube, and wherein the first and second swivel tubes are each configured to receive a pedicle screw and screw tower therein. The first and second swivel tube subassemblies are configured to be moved and positioned with respect to each other. The second swivel tube subassembly has a first arm extending therefrom and a carriage hub including a first cavity configured to receive the first arm therein, wherein the first cavity includes a first opening surrounded by a first annular end having a first plurality of teeth extending therefrom, and wherein the second swivel tube subassembly includes a second plurality of teeth proximate to and surrounding the arm, the second plurality of teeth being configured to removably engage the first plurality of teeth.
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.
Claims 1, 2, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 2015/0018623 to Friedrich et al. in view of U.S. Patent Pub. No. 2012/0041272 to Dietze, Jr. et al.
As to Claim 1, Friedrich discloses an internal fixation system (10, Fig. 1) for spinal surgery on a patient [0009-0010]. The system comprises a lateral lumbar interbody fusion (LLIF) retractor (18, [0046]) having an LLIF retractor adaptor (40, [0042]) configured to connect to a surgical table [0033]. The LLIF retractor (18) is operative to approach the spine from a lateral side [0063], a posterior retraction instrument (12, [0033, 0035]), an A-arm (seen in Fig. 1, below, as a solid line) configured to mount (via 20) on a surgical table [0033], and a B-arm (seen in Fig. 1, below, as a dotted line) configured to engage an end of the table-mounted A-arm (at 46B, Fig. 1, below) and to engage the posterior retraction instrument (12, [0035]). The system (10, Fig. 1) is operative for performing prone lateral spine surgery on the patient without the use of a bolster, and the system enables a surgeon to access either the left or the right lateral side of the spine of the patient during the surgery [0063-0064].
As to Claim 2, Friedrich discloses an internal fixation system wherein the B-arm (seen in Fig. 1) includes a lateral connector (40), wherein the A-arm (seen in Fig. 1) includes a distal clamp (46B) on an end of the A-arm (Fig. 1) that is configured to engage the B-arm lateral connector (40, [0042]), and wherein the B-arm (seen in Fig. 1) further includes a B-arm posterior connector (30B) that is configured to engage the posterior retraction instrument (12, [0035]).
As to Claim 21, Friedrich discloses an internal fixation system wherein the B-arm (seen in Fig. 1) engages the LLIF retractor (18, [0046]) on one end and is configured to engages a posterior retraction instrument (12) on the other end (Fig. 1).
As to Claims 1, 2, and 21, Friedrich discloses the claimed invention except for wherein the system includes a posterior compressor/distractor operative to contact the spine at the patient's back and the back of the spine when the patient is prone for the surgery, the posterior compressor/distractor being configured to contacts and/or approaches the spine from the back.
Dietze, Jr. discloses an internal fixation system (1, Fig. 3, [0010]) for spinal surgery on a patient including a first arm (52) having attached a lateral lumbar interbody fusion retractor (56) and a second arm (58) having attached a posterior compressor/distractor (100, [0051-0052], Fig. 3)). The compressor/distractor (100) is operative to contact the spine at the patient's back and the back of the spine when the patient is prone for the surgery [0052], the posterior compressor/distractor (18) is configured to contact and/or approach the spine from the back [0052, 0089] in order to provide for a retractor that minimizes clutter in the working field to provide maximum site lines to the surgical site during minimally invasive procedures [0009].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the internal fixation system of Friedrich with the retractor and distractor modification of Dietze, Jr. in order to provide for a retractor that minimizes clutter in the working field to provide maximum site lines to the surgical site during minimally invasive procedures.
Claims 3, 4, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 2015/0018623 to Friedrich et al. in view of U.S. Patent Pub. No. 2012/0041272 to Dietze, Jr. et al. in view of U.S. Patent Pub. No. 2009/0227845 to Lo et al.
As to Claim 14, Friedrich discloses an internal fixation system (10, Fig. 1) for spinal surgery on a patient [0009-0010]. The system comprises a lateral lumbar interbody fusion (LLIF) retractor (18, [0046]) having an LLIF retractor adaptor (40, [0042]) configured to connect to a surgical table [0033]. The LLIF retractor (18) is operative to approach the spine from a lateral side [0063], a posterior retraction instrument (12, [0033, 0035]), an A-arm (seen in Fig. 1, below, as a solid line) configured to mount (via 20) on a surgical table [0033], and a B-arm (seen in Fig. 1, below, as a dotted line) configured to engage an end of the table-mounted A-arm (at 46B, Fig. 1, below) and to engage the posterior retraction instrument (12, [0035]). The system (10, Fig. 1) is operative for performing prone lateral spine surgery on the patient without the use of a bolster, and the system enables a surgeon to access either the left or the right lateral side of the spine of the patient during the surgery [0063-0064].
As to Claim 14, Friedrich discloses the claimed invention except for wherein the system includes a posterior compressor/distractor operative to contact the spine at the patient's back and the back of the spine when the patient is prone for the surgery, the posterior compressor/distractor being configured to contacts and/or approaches the spine from the back.
Dietze, Jr. discloses an internal fixation system (1, Fig. 3, [0010]) for spinal surgery on a patient including a first arm (52) having attached a lateral lumbar interbody fusion retractor (56) and a second arm (58) having attached a posterior compressor/distractor (100, [0051-0052], Fig. 3)). The compressor/distractor (100) is operative to contact the spine at the patient's back and the back of the spine when the patient is prone for the surgery [0052], the posterior compressor/distractor (18) is configured to contact and/or approach the spine from the back [0052, 0089] in order to provide for a retractor that minimizes clutter in the working field to provide maximum site lines to the surgical site during minimally invasive procedures [0009].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the internal fixation system of Friedrich with the retractor and distractor modification of Dietze, Jr. in order to provide for a retractor that minimizes clutter in the working field to provide maximum site lines to the surgical site during minimally invasive procedures.
As to Claims 3, 4, and 14, Friedrich and Dietze, Jr. et al. disclose the claimed invention except for wherein the posterior compressor/distractor includes a posterior distractor rack assembly, a posterior distractor carriage assembly configured to operably engage the posterior distractor rack assembly, and a pinion assembly configured to operably engage the posterior distractor rack assembly and the posterior distractor carriage assembly, whereby the posterior distractor rack assembly and posterior distractor carriage assembly are movable relative to one another, wherein the posterior distractor rack assembly includes a rack having a plurality of ridges on at least one surface thereof, and wherein the posterior distractor carriage assembly includes an opening configured to receive the rack therethrough.
Lo discloses an internal fixation system (Fig. 4, [0033]) wherein the posterior compressor/distractor (2) includes a posterior distractor rack assembly (38), a posterior distractor carriage assembly (84) configured to operably engage the posterior distractor rack assembly (38, [0033]), and a pinion assembly (90) configured to operably engage the posterior distractor rack assembly (38) and the posterior distractor carriage assembly (84, [0033]), whereby the posterior distractor rack assembly and posterior distractor carriage assembly are movable relative to one another [0033]. The posterior distractor rack assembly (38) includes a rack having a plurality of ridges on at least one surface thereof (Fig. 4, [0033]), and wherein the posterior distractor carriage assembly (84) includes an opening (50) configured to receive the rack therethrough [0033] in order to provide an adjusting mechanism capable of adjusting and locking positions of the posterior compressor/distractor and lateral lumbar interbody fusion retractor in a desired position [0033].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the internal fixation system of Friedrich and Dietze, Jr. with the rack and pinion modification of Lo in order to provide an adjusting mechanism capable of adjusting and locking positions of the posterior compressor/distractor and lateral lumbar interbody fusion retractor in a desired position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775