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 .
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 10 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 18 and 19 of U.S. Patent No. 12,357,473. Although the claims at issue are not identical, they are not patentably distinct from each other.
Independent claim 1 of the patent recites all of the elements of independent claim l0 of the application. The difference between claim 1 of the patent and claim 10 of the application lies in the fact that the patent further recites wherein the fastener implant comprises a head configured to “abut against a portion of the spacer implant” (see claim 1, col.16, ll.38-39). Thus the invention of claim 1 of the patent is in effect a "species" of the “generic” invention of claim 10 of the application. It has been held that the generic invention is “anticipated” by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 10 of the application is anticipated by respective claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Independent claim 16 of the patent recites all of the elements of independent claim l8 of the application. The difference between claim 16 of the patent and claim 18 of the application lies in the fact that the patent further recites inserting one of a spacer implant “or a spacer implant mimic disposed on a second leg of a handle of a drill guide” (claim 16, col.18, ll.26-28), “the spacer implant mimic having substantially the same geometric shape as the spacer implant” (claim 16, col.18, ll.29-31), “positioning one or more drill guide slider mates of the drill guide over a first leg of the handle such that one or more drill guide holes disposed in the one or more drill guide slider mates have substantially the same center line as the tunnel of the respective one of the spacer implant or spacer implant mimic” (claim 16, col.18, ll.34-39), “detaching the spacer implant from the drill guide, if the spacer implant is attached to the second leg of the drill guide” (claim 16, col.18, ll.44-46), and “inserting the spacer implant into the interlaminal space in place of the spacer implant mimic, if the spacer implant mimic is attached to the second leg of the drill guide” (claim 16, col.18, ll.47-49). Thus the invention of claim 16 of the patent is in effect a "species" of the “generic” invention of claim 18 of the application. It has been held that the generic invention is “anticipated” by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 18 of the application is anticipated by respective claim 16 of the patent, it is not patentably distinct from claim 16 of the patent.
Furthermore, dependent claims 18 and 19 of the patent recite all of the elements of dependent claims 19 and 20 of the application:
Claim 18 of the patent recites “wherein the implanting further comprises: screwing a threaded fastener portion of the fastener implant into the first pilot hole in the lateral mass until a head of the fastener implant abuts against a portion of the spacer implant”, thus reciting all of the elements of claim 19 of the application.
Claim 19 of the patent recites “wherein the head of the fastener implant abuts against a hard stop within the tunnel of the spacer implant”, thus reciting all of the elements of claim 20 of the application.
Allowable Subject Matter
Claims 11-17 and 21-22 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, once the nonstatutory double patenting rejections discussed above have been appropriately corrected/addressed.
Claim 11 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 10 and claim 11. In particular, none of the cited references teach or suggest wherein at least one of the spacer implant and fastener implant comprises a biocompatible material, as required by claim 11.
Claims 12-14 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 10 and claim 12. In particular, none of the cited references teach or suggest wherein the spacer implant is configured to be altered to conform to different patient anatomies, as required by claim 12.
Claims 15-17 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 10 and claim 15. In particular, none of the cited references teach or suggest wherein a length of the fastener portion of the fastener implant is based on a functional length of the spacer implant and a position of a hard stop within the spacer implant, as required by claim 15.
Claims 21-22 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 18 and claim 21. In particular, none of the cited references teach or suggest wherein a length of the fastener portion of the fastener implant is configured such that a threaded portion of the fastener implant enters the lateral mass to a controlled depth of the lateral mass upon abutting against the hard stop within the spacer implant, as required by claim 21.
Conclusion
The prior art made of record and not relied upon, but considered pertinent to applicant's disclosure, has been cited in the PTO-892 Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo 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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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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