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) 1-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-14 of U.S. Patent No. 12,262,921 B2 in view of Ahn et al. (U.S. Pub. No. 2006/0247631 A1, hereinafter “Ahn”).
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:
1. A spinal fixation device, comprising: a bone screw including a head and a shank extending from the head; and a head assembly, comprising: a housing having a throughhole; an anvil slidable within a portion of the throughhole; a biasing member circumferentially surrounding the anvil to impart a distally directed force on the head; an assembly cap threaded to the housing, the assembly cap including an inner surface defining a first diameter and a second diameter smaller than the first diameter, the anvil located entirely above the assembly cap; a retaining ring positioned at least partially within the assembly cap, the retaining ring transitionable between the first diameter in which the retaining ring is in a first configuration sized to receive the head of the bone screw and the second diameter in which the retaining ring is in a second configuration compressed about the bone screw such that the bone screw is secured relative to the housing.
2. The spinal fixation device of claim 1, wherein the housing has a proximal surface and a distal surface, the throughhole formed through the housing from the proximal surface to the distal surface.
3. The spinal fixation device of claim 1, wherein movement of the retaining ring from the first portion to the second portion compresses the retaining ring from the first configuration to the second configuration.
1. A spinal fixation device, comprising: a bone screw including a head and a shank extending from the head; a modular head assembly, comprising: a housing having a proximal surface, a distal surface, and a throughhole formed through the housing from the proximal surface to the distal surface; an anvil slidable within a portion of the throughhole; a biasing member circumferentially surrounding the anvil to impart a distally directed force on the head of the bone screw; an assembly cap secured to the housing, the assembly cap including an inner surface defining a cavity having a first portion and a second portion, the first portion having a first diameter and the second portion having a second diameter smaller than the first diameter, the anvil located entirely above the assembly cap; a retaining ring positioned at least partially within the cavity of the assembly cap, the retaining ring transitionable between a first configuration in which the retaining ring is sized to receive the head of the bone screw and a second configuration in which the retaining ring is compressed about the bone screw, wherein movement of the retaining ring from the first portion to the second portion compresses the retaining ring from the first configuration to the second configuration and secures the bone screw relative to the housing.
4. The spinal fixation device of claim 1, wherein a distal portion of the housing defines a counterbore terminating at an annular face.
2. The spinal fixation device of claim 1, wherein a distal portion of the housing defines a counterbore terminating at an annular face.
5. The spinal fixation device of claim 4, wherein an inner surface of the housing defines at least one slot.
3. The spinal fixation device of claim 2, wherein an inner surface of the housing defines at least one slot.
6. The spinal fixation device of claim 5, wherein the anvil defines a proximal end, a distal end and a circumferential sidewall extending therebetween, the circumferential sidewall including at least one outwardly extending lug arranged to be slidably received within the at least one slot.
4. The spinal fixation device of claim 3, wherein the anvil defines a proximal end, a distal end and a circumferential sidewall extending therebetween, the circumferential sidewall including at least one outwardly extending lug arranged to be slidably received within the at least one slot.
7. The spinal fixation device of claim 6, wherein the at least one lug comprises two lugs diametrically opposed from one another about the circumferential sidewall of the anvil.
5. The spinal fixation device of claim 4, wherein the at least one lug comprises two lugs diametrically opposed from one another about the circumferential sidewall of the anvil.
8. The spinal fixation device of claim 6, wherein distal end of the anvil comprises an outwardly extending flange.
6. The spinal fixation device of claim 4, wherein distal end of the anvil comprises an outwardly extending flange.
9. The spinal fixation device of claim 8, wherein the biasing member is provided between the outwardly extending flange and the at least one outwardly extending lug.
7. The spinal fixation device of claim 6, wherein the biasing member is provided between the outwardly extending flange and the at least one outwardly extending lug.
10. The spinal fixation device of claim 9, wherein the biasing member is biased between the outwardly extending flange of the anvil and the annular face of the counterbore.
8. The spinal fixation device of claim 7, wherein the biasing member is biased between the outwardly extending flange of the anvil and the annular face of the counterbore.
11. The spinal fixation device of claim 9, wherein the biasing member is a wave spring.
9. The spinal fixation device according to claim 7, wherein the biasing member is a wave spring.
12. The spinal fixation device of claim 4, wherein the counterbore defines an internal threading and the assembly cap includes an external threading configured to threadably engage the internal threading of the counterbore.
10. The spinal fixation device of claim 2, wherein the counterbore defines an internal threading and the assembly cap includes an external threading configured to threadably engage the internal threading of the counterbore.
13. The spinal fixation device of claim 1, wherein the retaining ring defines a proximal end and a distal end, the proximal and distal ends defining a lumen therethrough.
11. The spinal fixation device of claim 1, wherein the retaining ring defines a proximal end and a distal end, the proximal and distal ends defining a lumen therethrough.
14. The spinal fixation device of claim 13, wherein the retaining ring is formed from a resilient material, and wherein an outer surface of the retaining ring defines a slit in communication with the lumen.
12. The spinal fixation device of claim 11, wherein the retaining ring is formed from a resilient material, and wherein an outer surface of the retaining ring defines a slit in communication with the lumen.
15. The spinal fixation device of claim 13, wherein the proximal end of the retaining ring defines an outwardly extending shelf arranged to contact the anvil.
13. The spinal fixation device of claim 11, wherein the proximal end of the retaining ring defines an outwardly extending shelf arranged to contact the anvil.
16. The spinal fixation device of claim 1, wherein the inner surface of the assembly cap includes an inwardly extending ledge at a distal end of the assembly cap to limit distal movement of the retaining ring.
14. The spinal fixation device of claim 1, wherein the inner surface of the assembly cap includes an inwardly extending ledge at a distal end of the assembly cap to limit distal movement of the retaining ring.
17. A spinal fixation device, comprising: a bone screw including a head and a shank; and a coupling element including a housing having a throughhole, an anvil slidable within a portion of the throughhole, a biasing member circumferentially surrounding the anvil to impart a distally directed force on the head, an assembly cap threaded to the housing, and a retaining ring positioned at least partially within the assembly cap, wherein the assembly cap includes an inner surface defining a first portion and a second portion smaller than the first portion, wherein the anvil is located entirely above the assembly cap, and wherein the retaining ring transitionable between the first portion in which the retaining ring is in a first configuration and the second portion in which the retaining ring is in a second configuration, the second configuration securing the bone screw relative to the housing.
1. A spinal fixation device, comprising: a bone screw including a head and a shank extending from the head; a modular head assembly, comprising: a housing having a proximal surface, a distal surface, and a throughhole formed through the housing from the proximal surface to the distal surface; an anvil slidable within a portion of the throughhole; a biasing member circumferentially surrounding the anvil to impart a distally directed force on the head of the bone screw; an assembly cap secured to the housing, the assembly cap including an inner surface defining a cavity having a first portion and a second portion, the first portion having a first diameter and the second portion having a second diameter smaller than the first diameter, the anvil located entirely above the assembly cap; a retaining ring positioned at least partially within the cavity of the assembly cap, the retaining ring transitionable between a first configuration in which the retaining ring is sized to receive the head of the bone screw and a second configuration in which the retaining ring is compressed about the bone screw, wherein movement of the retaining ring from the first portion to the second portion compresses the retaining ring from the first configuration to the second configuration and secures the bone screw relative to the housing.
18. The spinal fixation device according to claim 17, wherein the biasing member is a wave spring.
2. The spinal fixation device of claim 1, wherein a distal portion of the housing defines a counterbore terminating at an annular face.
3. The spinal fixation device of claim 2, wherein an inner surface of the housing defines at least one slot.
4. The spinal fixation device of claim 3, wherein the anvil defines a proximal end, a distal end and a circumferential sidewall extending therebetween, the circumferential sidewall including at least one outwardly extending lug arranged to be slidably received within the at least one slot.
6. The spinal fixation device of claim 4, wherein distal end of the anvil comprises an outwardly extending flange.
7. The spinal fixation device of claim 6, wherein the biasing member is provided between the outwardly extending flange and the at least one outwardly extending lug.
9. The spinal fixation device according to claim 7, wherein the biasing member is a wave spring.
19. The spinal fixation device of claim 17, wherein the inner surface of the assembly cap includes an inwardly extending ledge at a distal end of the assembly cap to limit distal movement of the retaining ring.
14. The spinal fixation device of claim 1, wherein the inner surface of the assembly cap includes an inwardly extending ledge at a distal end of the assembly cap to limit distal movement of the retaining ring.
20. The spinal fixation device of claim 17, wherein the housing defines an internal threading and the assembly cap includes an external threading configured to threadably engage the internal threading.
10. The spinal fixation device of claim 2, wherein the counterbore defines an internal threading and the assembly cap includes an external threading configured to threadably engage the internal threading of the counterbore.
As is evident from the table above, Patent claim 1, discloses all of the features of application claim 1, except wherein the assembly cap is threaded to the housing. While Patent claim 1 uses slightly different wording for the limitations, than application claim 1, for example Patent claim 1 recites “the retaining ring transitionable between a first configuration in which the retaining ring is sized to receive the head of the bone screw and a second configuration in which the retaining ring is compressed about the bone screw” instead of “the retaining ring transitionable between the first diameter in which the retaining ring is in a first configuration sized to receive the head of the bone screw and the second diameter in which the retaining ring is in a second configuration compressed about the bone screw”. However it is clear that Patent claim 1 recites the limitation of application claim 1, since Patent claim 1 also recites the limitation that the inner surface “defining a cavity having a first portion and a second portion, the first portion having a first diameter and the second portion having a second diameter smaller than the first diameter” and that the retaining ring is “positioned at least partially within the cavity”.
As is evident from the table above, Patent claim 1, discloses all of the features of application claim 17, except wherein the assembly cap is threaded to the housing. While Patent claim 1 uses slightly different wording for the limitations, than application claim 17, for example Patent claim 1 recites “the retaining ring transitionable between a first configuration in which the retaining ring is sized to receive the head of the bone screw and a second configuration in which the retaining ring is compressed about the bone screw” instead of “the retaining ring transitionable between the first portion in which the retaining ring is in a first configuration and the second portion in which the retaining ring is in a second configuration”; Patent claim 1 recites “a modular head assembly” instead of “a coupling element”; and “Patent claim 1 recites “an inner surface defining a cavity having a first portion and a second portion, the first portion having a first diameter and the second portion having a second diameter smaller than the first diameter” instead of “an inner surface defining a first portion and a second portion smaller than the first portion”. However it is clear that Patent claim 1 recites the limitation of application claim 17, since Patent claim 1 also recites the limitation that the inner surface “defining a cavity having a first portion and a second portion, the first portion having a first diameter and the second portion having a second diameter smaller than the first diameter” and that the retaining ring is “positioned at least partially within the cavity” and that “movement of the retaining ring from the first portion to the second portion compresses the retaining ring from the first configuration to the second configuration”; since the modular element comprises all of the elements of the coupling element; and since the first and second diameters are represent the size of the first and second portions.
As is evident from the table above, Patent claim 10, discloses all of the features of application claim 20. While Patent claim 10 uses slightly different wording for the limitations, for example Patent claim 10 recites “wherein the counterbore defines an internal threading” instead of “wherein the housing defines an internal threading”, since Patent claim 2 from which Patent claim 10 depends from recites that “the housing defines a counterbore”.
Ahn discloses a pedicle screw assembly (100, see Figs. 2-3) with housing (110) and a cap (150) secured to the housing (see Figs. 2-3), wherein the cap is threadably coupled to the housing (see Fig. 2, see para. [0032]) in order to enable the housing to be removably secured to the housing (see paras. [0008], [0032] and [0039]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the cap secured to the housing in Patent claim 1 to be threadably coupled in view of Ahn in order to in order to enable the housing to be removably secured to the housing.
Allowable Subject Matter
Claim(s) 1-20 would be allowable if a terminal disclaimer is filed to overcome the Nonstatutory Double Patenting Rejection, set forth in this Office action.
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 fixation device, comprising: a head assembly, comprising: an anvil slidable within a portion of the throughhole; a biasing member to impart a distally directed force on the head; an assembly cap threaded to the housing; a retaining ring transitionable between the first diameter in which the retaining ring is in a first configuration sized to receive the head of the bone screw and the second diameter in which the retaining ring is in a second configuration compressed about the bone screw; and as per claim 1, wherein the biasing member circumferentially surrounding the anvil and the anvil located entirely above the assembly cap.
A spinal fixation device, comprising: a coupling element including an anvil slidable within a portion of the throughhole, a biasing member to impart a distally directed force on the head, an assembly cap threaded to the housing, and a retaining ring, and wherein the retaining ring transitionable between the first portion in which the retaining ring is in a first configuration and the second portion in which the retaining ring is in a second configuration, and as per claim 17, wherein the biasing member circumferentially surrounding the anvil and wherein the anvil is located entirely above the assembly cap.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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