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 .
Election/Restrictions
Applicant’s election without traverse of Invention III in the reply filed on July 1, 2025 and affirmed in the reply filed on December 1, 2025 is acknowledged.
Due to the amendments to claims 1-9 and 14 as filed on July 1, 2025, there are currently no withdrawn invention claims.
Applicant’s election without traverse of Implant species A (Figs. 1A to 1E) in the reply filed on December 1, 2025 is acknowledged.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (Implant species C, which includes Figs. 2B-1 to 2B-3), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 1, 2025.
Claims 1-3, 7-9, 14, 21-24, 26, 27, 29, 31, and 34 have been examined.
Drawings
The drawings are objected to because due to the figures being in grayscale and the reference characters being hand-drawn, some of the more detailed features and the reference characters are unclear (see all figures). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 14 recites the limitation "the release driver opening" in line 6. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite that the proximal portion of the implant includes a release driver opening. For examination purposes, the Examiner is interpreting "the release driver opening" as "a release driver opening."
Claims 26 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 26 recites that the at least one decorticator is a second decorticator, which, due to the use of the word “second,” implies the existence of a first decorticator. However, reciting “is” as opposed to “includes” seems to indicate that the claim includes only a second decorticator and not a first decorticator. Thus, it is unclear whether the claim includes two decorticators (a first decorticator and a second decorticator, wherein the second decorticator has the claimed structure) or one decorticator (only a second decorticator having the claimed structure). For examination purposes, the Examiner is interpreting claim 26 as only including a second decorticator having the claimed structure and not also including a first decorticator. Claim 27 is rejected because it depends from claim 26.
Claim 29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 29 recites that the at least one decorticator is a third decorticator, which, due to the use of the word “third,” implies the existence of a first decorticator and a second decorticator. However, reciting “is” as opposed to “includes” seems to indicate that the claim includes only a third decorticator and not first and second decorticators. Thus, it is unclear whether the claim includes three decorticators (first and second decorticators and a third decorticator, wherein the third decorticator has the claimed structure) or one decorticator (only a third decorticator having the claimed structure). For examination purposes, the Examiner is interpreting claim 29 as only including a third decorticator having the claimed structure and not also including first and second decorticators.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21, 22, 29, 31, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanaka et al. (WO 2020/061464 A1).
Claim 21. Tanaka discloses a system for lumbar fusion comprising:
an access chisel (chisel 3602 in Fig. 67);
at least one decorticator (decortication tool 500 in Figs. 25, 26, 28, and 29 as the first decorticator; decorticator 1410 in Figs. 70A-70C as the second decorticator for claims 26 and 27; decorticating burr 1126 in Fig. 44 as the second decorticator for claims 31 and 34; and/or chisel 2202 in Figs. 57A-57B as the third decorticator); and
a guide tube (guide tube 1118 in Fig. 43).
Claim 22. Tanaka discloses wherein the access chisel (chisel 3602) comprises a proximal end (see Fig. 67 inset) opposite a distal portion (see Fig. 67 inset), the distal portion having a thin, forked, tapered tip (see Fig. 67 inset), a positive stop (see Fig. 67 inset) and an arcuate shaped cut out (see Fig. 67 inset) opposite the positive stop.
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Claim 29. Tanaka discloses wherein the at least one decorticator is a third decorticator (chisel 2202) comprising a solid tubular body (see Fig. 57A inset) and a proximal portion (see Fig. 57A inset) opposite a distal portion (see Fig. 57A inset), the distal portion including one side having a keel (blade 2238) and a second side having a rasp (see Fig. 57A inset).
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Claim 31. Tanaka discloses wherein the at least one decorticator comprises a first decorticator (decortication tool 500), a second decorticator (decorticating burr 1126) and a third decorticator (chisel 2202).
Claim 34. Tanaka discloses wherein the first decorticator (decortication tool 500) is adapted to slide over the access chisel, the second decorticator (decorticating burr 1126) is received in the guide tube (guide tube 1118), and the third decorticator (chisel 2202) is received in the guide tube.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 23, 24, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (WO 2020/061464 A1).
Claim 23. Tanaka discloses wherein the at least one decorticator is a first decorticator (decortication tool 500) comprising a tubular body (see Fig. 29 inset) and a proximal portion (see Fig. 29 inset) opposite a distal portion (see Fig. 29 inset), the distal portion including teeth (see Fig. 29 inset) in a 180° degree array (see Fig. 29) or 360° degree array.
[AltContent: textbox (FIG. 29)]Claim 24. Tanaka discloses wherein the first decorticator has the teeth in a 180° array (see Fig. 29) and further includes an arcuate cut out feature (see Fig. 29 inset) opposite the bidirectional teeth.
Claim 26. Tanaka discloses wherein the at least one decorticator is a second decorticator (decorticator 1410) comprising a tubular body (see Fig. 70A inset) and a proximal portion (see Fig. 70A inset) opposite a distal portion (see Fig. 70A inset), the distal portion including teeth (teeth 1444) in a 180° degree array (see Fig. 70B), a 360° degree array or a 360° degree array with a center countersink.
Claim 27. Tanaka discloses wherein the second decorticator has the bidirectional teeth in a 180° array (see Fig. 70B) and further includes a linear or straight edge cut out feature (see Fig. 70A inset) opposite the bidirectional teeth.
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Tanaka fails to disclose that the teeth are bidirectional (claims 23, 24, and 26, and 27).
However, Tanaka teaches an alternate embodiment of decorticator (decorticator 1210 in Figs. 68A-68B), wherein the teeth (teeth 1244) are bidirectional (see para. 0195).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second decorticators of Tanaka such that the teeth are bidirectional (claims 23, 24, 26, and 27), as suggested by an alternate embodiment of decorticator as taught by Tanaka, as such a configuration would allow for cutting bone in both rotational directions of the first and second decorticators, thereby simplifying the surgical procedure.
Claims 1-3, 7-9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (WO 2020/061464 A1) in view of Pavlov et al. (US 2013/0123923 A1).
Claim 1. Tanaka discloses a lumbar facet implant (see Fig. 75 inset), the lumbar facet implant comprising:
a proximal portion (see Fig. 75 inset) and a distal portion (see Fig. 75 inset);
a first surface (see Fig. 75 inset) opposite a second surface (lower surface, which is opposite the first, upper surface), the first and second surface each including one or more teeth (see Fig. 75 inset), each of the first and second surfaces extending between the proximal and distal portions.
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Tanaka fails to disclose a stop feature extending from the proximal portion and generally perpendicular to one of the first surface or the second surface, wherein the stop feature includes at least one opening configured to receive a fixation device (claim 1), wherein the distal portion comprises a blunt distal tip (claim 2), wherein the stop feature includes at least one rounded edge or corner (claim 3), a second stop feature extending from the proximal portion and generally perpendicular to the other of the first or second surface (claim 7), wherein the second stop feature comprises at least one rounded edge or corner (claim 8), wherein the first and second stop features increase a height but not a width of the implant (claim 9), and a delivery instrument comprising: an elongated body comprising a distal end and a proximal end, the distal end defining a lumbar facet implant receiving feature that is complimentary in shape to the proximal portion of the lumbar facet implant; a release driver configured to engage the release driver opening of the proximal portion of the implant; and a tubular body defined within the elongated body that is configured to receive the fixation device and change the trajectory of the fixation device being delivered to the fixation device opening of the implant (claim 14).
Pavlov teaches a facet implant (implant 402 in Figs. 20-25) comprising: a proximal portion (at first end 414) and a distal portion (at second end 416); a first surface (surface 418) opposite a second surface (surface 420), the first and second surface each including one or more teeth (teeth 492), each of the first and second surfaces extending between the proximal and distal portions; a stop feature (see Fig. 21 inset) extending from the proximal portion and generally perpendicular to one of the first surface or the second surface, wherein the stop feature includes at least one opening (opening 410) configured to receive a fixation device (fixation element 408); wherein the distal portion comprises a blunt distal tip (see Fig. 21 inset); wherein the stop feature includes at least one rounded edge or corner (see Fig. 21 inset); a second stop feature (see Fig. 21 inset) extending from the proximal portion and generally perpendicular to the other of the first or second surface; wherein the second stop feature comprises at least one rounded edge or corner (see Fig. 21 inset); and wherein the first and second stop features increase a height (see Fig. 24 inset) but not a width (see Fig. 24 inset) of the implant.
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Pavlov also teaches a delivery instrument (implant holder 406 in Figs. 20 and 26-30) comprising: an elongated body (body 454) comprising a distal end (distal end 500) and a proximal end (proximal end 512), the distal end defining a lumbar facet implant receiving feature (jaw members 460a and 460b) that is complimentary in shape to the proximal portion of the lumbar facet implant (see Fig. 20); a release driver (protrusions 518) configured to engage a release driver opening (recesses 496) of the proximal portion of the implant; and a tubular body (shaft 498) defined within the elongated body that is configured to receive the fixation device (in channel 522; see para. 0103) and change the trajectory of the fixation device being delivered to the fixation device opening of the implant (see para. 0103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tanaka by substituting the implant of Pavlov for that of Tanaka (claims 1-3 and 7-9), as such is a simple substitution of one implant for another, wherein the implant of Pavlov also enables additional fixation to the vertebrae via fixation devices, thereby reducing the potential for backout of the implant from the facet joint. In view of such a modification, the implant would include a stop feature extending from the proximal portion and generally perpendicular to one of the first surface or the second surface, wherein the stop feature includes at least one opening configured to receive a fixation device (claim 1), wherein the distal portion comprises a blunt distal tip (claim 2), wherein the stop feature includes at least one rounded edge or corner (claim 3), a second stop feature extending from the proximal portion and generally perpendicular to the other of the first or second surface (claim 7), wherein the second stop feature comprises at least one rounded edge or corner (claim 8), and wherein the first and second stop features increase a height but not a width of the implant (claim 9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tanaka by providing the delivery instrument of Pavlov (claim 14), as such delivery instrument is configured for holding the implant and delivering fixation devices to secure the implant to the vertebrae. In view of such a modification, the delivery instrument would comprise: an elongated body comprising a distal end and a proximal end, the distal end defining a lumbar facet implant receiving feature that is complimentary in shape to the proximal portion of the lumbar facet implant; a release driver configured to engage the release driver opening of the proximal portion of the implant; and a tubular body defined within the elongated body that is configured to receive the fixation device and change the trajectory of the fixation device being delivered to the fixation device opening of the implant (claim 14).
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,144,513. Although the claims at issue are not identical, they are not patentably distinct from each other. The difference between claim 1 of the application and claim 1 of the patent is that claim 1 of the patent includes more features (structure of the decortication tool and the inclusion of a multi-use instrument) and is therefore more specific. Thus, the invention of claim 1 of the patent is in effect a species of the generic invention of claim 1 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). Because claim 1 of the application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 26 of copending Application No. 18/950,286 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The difference between claim 1 of this application and claim 26 of the reference application is that claim 26 of the reference application includes more features (structure of the guide tube and structure of the access chisel) and is therefore more specific. Thus, the invention of claim 26 of the reference application is in effect a species of the generic invention of claim 1 of this application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Because claim 1 of this application is anticipated by claim 26 of the reference application, it is not patentably distinct from claim 26 of the reference application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773