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 .
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.
Claim(s) 21, 24-28, 30, 33-35, 40 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-7, 9-10, 12, 17 of U.S. Patent No. 11,832,851 B1 in view of Roberts et al. (U.S. Patent 11,439,437 B1, hereinafter “Roberts”).
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
21. A spinal construct comprising:
a first member including a closed receiver having a proximal portion defining a first cavity, and a distal portion defining a second cavity disposed at an angle relative to the first cavity,
the distal portion being configured for connecting with a second member, the second member being configured for fixation with vertebral tissue; and
a crown defining a first opening aligned with the first cavity and a second opening aligned with the second cavity; and a break away element connecting the crown and the distal portion.
1. A spinal construct comprising: a first member including a proximal portion defining a first cavity, and a distal portion defining a second cavity disposed at an angle relative to the first cavity, the distal portion being configured for connecting with a second member, the second member being configured for fixation with vertebral tissue; a crown defining a first opening aligned with the first cavity and a second opening aligned with the second cavity; and a break away element connecting the crown and the distal portion.
24. The spinal construct as recited in Claim 21, wherein the first cavity includes a proximal passageway defining a first longitudinal axis and the second cavity includes a distal passageway defining a second longitudinal axis, the second axis being disposed relative to the first axis at an angle in a range of about greater than 0 degrees to about 45 degrees.
2. The spinal construct as recited in claim 1, wherein the first cavity includes a proximal passageway defining a first longitudinal axis and the second cavity includes a distal passageway defining a second longitudinal axis, the second axis being disposed relative to the first axis at an angle in a range of about greater than 0 degrees to about 45 degrees.
25. The spinal construct as recited in Claim 21, wherein the second axis is disposed at an angle of 15 degrees relative to the first axis.
3. The spinal construct as recited in claim 2, wherein the second axis is disposed at an angle of 15 degrees relative to the first axis.
26. The spinal construct as recited in Claim 21, wherein the crown includes an outer surface being provisionally fixable with an inner surface of the distal portion.
4. The spinal construct as recited in claim 1, wherein the crown includes an outer surface being provisionally fixable with an inner surface of the distal portion.
27. The spinal construct as recited in Claim 21, wherein the crown includes an outer surface being releasably engageable with an inner surface of the distal portion.
5. The spinal construct as recited in claim 1, wherein the crown includes an outer surface being releasably engageable with an inner surface of the distal portion.
28. The spinal construct as recited in Claim 27, wherein the crown is releasably engageable with the inner surface such that the crown is movable between a provisional orientation with the first member and a fixed orientation with the second member.
6. The spinal construct as recited in claim 5, wherein the crown is releasably engageable with the inner surface such that the crown is movable between a provisional orientation with the first member and a fixed orientation with the second member.
30. The spinal construct as recited in Claim 29, wherein the break away element includes a frangible portion having a pre-determined force limit.
7. The spinal construct as recited in claim 1, wherein the break away element includes a frangible portion having a pre-determined force limit.
33. The spinal construct as recited in Claim 21, wherein the crown includes an outer surface defining a relief configured to allow expansion of the crown.
9. The spinal construct as recited in claim 1, wherein the crown includes an outer surface defining a relief configured to allow expansion of the crown.
34. The spinal construct as recited in Claim 21, wherein the first member is manually engageable with the second member to connect the members in a non- instrumented snap-fit assembly.
10. The spinal construct as recited in claim 1, wherein the first member is manually engageable with the second member to connect the members in a non-instrumented snap-fit assembly.
35. The spinal construct system as recited in Claim 21, wherein the closed receiver is selected from a plurality of alternate receivers and is configured for disposal with the second member such that the second member is interchangeable with the plurality of alternate receivers.
12. The spinal construct system as recited in claim 1, wherein the first member includes a receiver that is selected from a plurality of alternate receivers and is configured for disposal with the second member such that the second member is interchangeable with the plurality of alternate receivers.
40. A spinal implant system comprising: a first member including a closed receiver having a proximal portion defining a first cavity, and a distal portion defining a second cavity disposed at an angle relative to the first cavity;
a second member connectable with the distal portion and being configured for fixation with vertebral tissue;
a crown defining a first opening aligned with the first cavity and a second opening aligned with the second cavity; a break away element connecting the crown and the distal portion; and a longitudinal element disposable in the first cavity.
17. A spinal implant system comprising: a first member including a proximal portion defining a first cavity, and a distal portion defining a second cavity disposed at an angle relative to the first cavity; a second member connectable with the distal portion and being configured for fixation with vertebral tissue; a crown defining a first opening aligned with the first cavity and a second opening aligned with the second cavity; a break away element connecting the crown and the distal portion; and a longitudinal element disposable in the first cavity.
Patent claim 1 fails to disclose, regarding claim 21, wherein the first member is a closed receiver; Patent claim 14 fails to disclose, regarding claim 36, wherein the receiver is closed; and Patent claim 17 fails to disclose, regarding claim 40, wherein the receiver is closed, and wherein the crown defines a first opening aligned with the first cavity.
Roberts discloses a bone anchor assembly (400, see Fig. 11), with a first member including a receiver (406) with a proximal end (406p) that is closed (see Fig. 11, see lines 60-64 of column 14) in order to provide sufficient strength to the receiver member for use in high load applications while enabling a reduction in the size of the receiver (see lines 60-67 of column 14).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the receiver in the Patent claims to be closed in view of Roberts in order to provide sufficient strength to the receiver member for use in high load applications while enabling a reduction in the size of the receiver.
Allowable Subject Matter
Claim(s) 36-38 is/are allowed.
Claim(s) 30 and 40 would be allowable if a terminal disclaimer is timely filed in compliance with 37 CFR 1.321(c) or 1.321(d) based on nonstatutory double patenting set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim(s) 31-32, 41-42 is/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.
The following is a statement of reasons for the indication of allowable subject matter: The claims 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:
A spinal construct comprising: a receiver having a first cavity and a second cavity disposed at an angle relative to the first cavity; a crown having a first opening and a second opening; and as per claim 29, further comprising a break away element connecting the crown and the distal portion; and as per claim 39, and the bone fastener further comprises a break away element connecting the crown and the distal portion.
A spinal implant system comprising a receiver having a first cavity and a second cavity disposed at an angle relative to the first cavity; a crown having a first opening aligned with the first cavity and a second opening aligned with the second cavity; and as per claim 41, wherein the break away element includes a frangible portion having a pre-determined force limit; and as per claim 42, wherein the frangible is circumferentially disposed about the crown.
A bone fastener comprising a receiver having a first cavity and a second cavity disposed at an angle relative to the first cavity; a crown having a first opening aligned with the first cavity and a second opening aligned with the second cavity, wherein the receiver and the shaft are manually engageable for connection in a non-instrumented snap-fit assembly; and as per 36, the ben fastener further comprises a break away element connecting the crown and the distal portion.
Response to Arguments
Applicant's arguments filed 3/13/2026 have been fully considered, with respect to the nonstatutory double patenting rejection, but they are not persuasive.
The Applicant has not presented any arguments as to the nonstatutory double patenting; and instead asserts that it just be held in abeyance.
The Office respectfully disagrees, since the nonstatutory double patenting, discloses all of the features of the claims, as presented above.
A call was made to the attorney Leo Lenna on May 27th, 2026; but did not result in a terminal disclaimer being filed at the time. The Applicant is welcomed to reach out to the examiner, should they have any questions concerning this commination or feels that an interview would be helpful.
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 Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. 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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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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