DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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Claim(s) 1 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 of U.S. Patent No. 8,790,375 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
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 method of fusing a first vertebra to a second vertebra, said second vertebra being immediately adjacent and above the first vertebra, the method comprising:
creating a passage from a posterior end of a pedicle of the first vertebra through a superior endplate of the first vertebra, such that the passage extends into an intervertebral space located generally between the first and second vertebrae;
removing native tissue located within the intervertebral space by advancing a tissue removal tool through the passage and selectively moving said tissue removal tool within the intervertebral space; delivering at least one of an implant and a grafting material through the passage, wherein said implant or grafting material is configured to promote fusion between the superior endplate of the first vertebra and an inferior endplate of the second vertebra; and advancing a first bone screw through the passage, such that a distal end of the first bone screw extends at least partially into the intervertebral space.
1. A method of fusing a first vertebra to a second vertebra, said second vertebra being immediately adjacent and above the first vertebra, the method comprising: creating a passage from a posterior end of a pedicle of the first vertebra through a superior endplate of the first vertebra, such that the passage extends into an intervertebral space located generally between the first and second vertebrae; removing native tissue located within the intervertebral space by advancing a tissue removal tool through the passage and selectively moving said tissue removal tool within the intervertebral space; delivering at least one of an implant and a grafting material through the passage, wherein said at least one of the implant and the grafting material is configured to promote fusion between the superior endplate of the first vertebra and an inferior endplate of the second vertebra; and advancing a first bone screw through the passage, such that a distal end of the first bone screw extends at least partially into the intervertebral space, wherein the distal end of the first bone screw terminates within the intervertebral space; wherein the first bone screw comprises threads along its length, wherein at least some of the threads of the first bone screw, once the first bone screw has been fully advanced through the passage, engage a cortex of the posterior end of the pedicle, a cortex of a shaft of the pedicle and a cortex of the superior endplate of the first vertebra.
As is evident from the table above, Patent claim 1 discloses all of the features of application claim 1, with additional features not included in application claim 1.
Claim(s) 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 10 of U.S. Patent No. 10,987,228 B2 in view of Bar et al. (U.S. Pub. No. 2011/0319941 A1, hereinafter “Bar”).
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 method of fusing a first vertebra to a second vertebra, said second vertebra being immediately adjacent and above the first vertebra, the method comprising:
creating a passage from a posterior end of a pedicle of the first vertebra through a superior endplate of the first vertebra, such that the passage extends into an intervertebral space located generally between the first and second vertebrae;
removing native tissue located within the intervertebral space by advancing a tissue removal tool through the passage and selectively moving said tissue removal tool within the intervertebral space; delivering at least one of an implant and a grafting material through the passage, wherein said implant or grafting material is configured to promote fusion between the superior endplate of the first vertebra and an inferior endplate of the second vertebra; and advancing a first bone screw through the passage, such that a distal end of the first bone screw extends at least partially into the intervertebral space.
10. A method of fusing a first vertebra to a second vertebra, said second vertebra being immediately adjacent and above the first vertebra, the method comprising: creating a passage within bone extending from a posterior end of a pedicle of the first vertebra through a superior endplate of the first vertebra, such that the passage extends into an intervertebral space located generally between the first and second vertebrae, wherein the passage is linear or substantially linear; removing native tissue from the intervertebral space by advancing a tissue removal tool through the passage and selectively moving said tissue removal tool within the intervertebral space; and delivering at least one of an implant and a grafting material through the passage, wherein said implant or grafting material is configured to promote fusion between the superior endplate of the first vertebra and an inferior endplate of the second vertebra.
Patent claim 1 discloses all the features of the claimed invention, as set forth in the table above, except regarding application claim 1, and advancing a first bone screw through the passage, such that a distal end of the first bone screw extends at least partially into the intervertebral space.
Bar discloses, a method of fusing a first vertebra to a second vertebra, said second vertebra being immediately adjacent and above the first vertebra (see para. [0041]), the method comprising: creating a passage (57, see Fig. 6) from a posterior end of a pedicle of the first vertebra through a superior endplate of the first vertebra, such that the passage extends into an intervertebral space located generally between the first and second vertebrae (see Fig. 6, see also paras. [0042] and [0049]-[0053]), and advancing a first bone screw (22, see Fig. 2C) through the passage, such that a distal end of the first bone screw extends at least partially into the intervertebral space (see para. [0047], “inserting a … screw obliquely between the inferior and superior vertebrae along the first one of the oblique posterior entry passages”) in order to mutually and firmly fix the position of the vertebrae relative to each other (see paras. [0045] and [0047]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Patent claim 1 to include advancing a first bone screw through the passage, such that a distal end of the first bone screw extends at least partially into the intervertebral space in view of Bar in order to mutually and firmly fix the position of the vertebrae relative to each other.
Claim(s) 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 of U.S. Patent No. 9,265,620 B2 in view of Bar et al. (U.S. Pub. No. 2011/0319941 A1, hereinafter “Bar”).
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 method of fusing a first vertebra to a second vertebra, said second vertebra being immediately adjacent and above the first vertebra, the method comprising:
creating a passage from a posterior end of a pedicle of the first vertebra through a superior endplate of the first vertebra, such that the passage extends into an intervertebral space located generally between the first and second vertebrae;
removing native tissue located within the intervertebral space by advancing a tissue removal tool through the passage and selectively moving said tissue removal tool within the intervertebral space; delivering at least one of an implant and a grafting material through the passage, wherein said implant or grafting material is configured to promote fusion between the superior endplate of the first vertebra and an inferior endplate of the second vertebra; and advancing a first bone screw through the passage, such that a distal end of the first bone screw extends at least partially into the intervertebral space.
1. A method of fusing a first vertebra to a second vertebra, said second vertebra being immediately adjacent and above the first vertebra, the method comprising: creating a passage from a posterior end of a pedicle of the first vertebra through a superior endplate of the first vertebra, such that the passage extends into an intervertebral space located generally between the first and second vertebrae; and advancing a first bone screw through the passage, such that a distal end of the first bone screw extends at least partially into the intervertebral space, wherein a tip of the first bone screw is positioned to buttress an inferior endplate of the second vertebra.
Patent claim 1, fails to disclose regarding claim 1, removing native tissue located within the intervertebral space by advancing a tissue removal tool through the passage and selectively moving said tissue removal tool within the intervertebral space; delivering at least one of an implant and a grafting material through the passage, wherein said implant or grafting material is configured to promote fusion between the superior endplate of the first vertebra and an inferior endplate of the second vertebra through the passage.
Bar discloses, a method of fusing a first vertebra to a second vertebra, said second vertebra being immediately adjacent and above the first vertebra (see para. [0041]), the method comprising: creating a passage (57, see Fig. 6) from a posterior end of a pedicle of the first vertebra through a superior endplate of the first vertebra, such that the passage extends into an intervertebral space located generally between the first and second vertebrae (see Fig. 6, see also paras. [0042] and [0049]-[0053]); wherein the method further includes removing native tissue located within the intervertebral space by advancing a tissue removal tool through the passage (58, see Fig. 6) and selectively moving said tissue removal tool within the intervertebral space (see para. [0043]); delivering at least one of an implant and a grafting material through the passage (102, see Fig. 10, see also paras. [0044], [0048], and [0095]), wherein said implant or grafting material is configured to promote fusion between the superior endplate of the first vertebra and an inferior endplate of the second vertebra (see paras. [0044] and [0048]) in order to clean out the vertebral space (see para. [0041]) and provide material capable of aiding in bone growth between the vertebrae until fusion is completed (see para. [0048], see also para. [0002]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Patent claim 1 to include removing native tissue located within the intervertebral space by advancing a tissue removal tool through the passage and selectively moving said tissue removal tool within the intervertebral space; delivering at least one of an implant and a grafting material through the passage, wherein said implant or grafting material is configured to promote fusion between the superior endplate of the first vertebra and an inferior endplate of the second vertebra through the passage in view of Bar in order to clean out the vertebral space and provide material capable of aiding in bone growth between the vertebrae until fusion is completed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Bar et al. (U.S. Pub. No. 2011/0319941 A1, hereinafter “Bar”).
Bar discloses, regarding claim 1, a method of fusing a first vertebra to a second vertebra, said second vertebra being immediately adjacent and above the first vertebra (see para. [0041]), the method comprising: creating a passage (57, see Fig. 6) from a posterior end of a pedicle of the first vertebra through a superior endplate of the first vertebra, such that the passage extends into an intervertebral space located generally between the first and second vertebrae (see Fig. 6, see also paras. [0042] and [0049]-[0053]); removing native tissue located within the intervertebral space by advancing a tissue removal tool through the passage (58, see Fig. 6) and selectively moving said tissue removal tool within the intervertebral space (see para. [0043]); delivering at least one of an implant and a grafting material through the passage (102, see Fig. 10, see also paras. [0044], [0048], and [0095]), wherein said implant or grafting material is configured to promote fusion between the superior endplate of the first vertebra and an inferior endplate of the second vertebra (see paras. [0044] and [0048]); and advancing a first bone screw (22, see Fig. 2C) through the passage, such that a distal end of the first bone screw extends at least partially into the intervertebral space (see para. [0047] “inserting a … screw obliquely between the inferior and superior vertebrae along the first one of the oblique posterior entry passages”, see also annotated Fig. 2C below).
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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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