DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim(s) 1-7, 9-11, and 16 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Flickinger et al. (US 2007/0270873), herein referred to as Flickinger.
Regarding claim 1, Flickinger discloses a system comprising a resector (figures 1-20) configured to be inserted through a lateral access corridor to access and cut a targeted intervertebral disc of a spine (Abstract), wherein the resector comprises a cutter (92, 94) (¶38 and figure 10) configured to (i.e. capable of) access and cut an anterior longitudinal ligament (ALL) via a lateral approach (considered functional), and a tissue retractor (figures 17 and 18) slidably coupling the cutter (92, 94) such that the cutter is configured to (i.e. capable of) cut while sliding relative to the retractor (figures 17 and 18), the tissue retractor (figures 17 and 18) and configured to (i.e. capable of) provide a barrier that protects surrounding tissue of the targeted intervertebral disc (Abstract), the ALL, or both from the sliding movement of the cutter, and an implant (110) configured to (i.e. capable of) be inserted through the lateral access corridor and engage the spine (figure 20), wherein the implant (110) comprises a top surface (figures 13-16 and 20) configured to (i.e. capable of) engage a first vertebra of the spine (figure 20), a bottom surface (figures 13-16 and 20) configured to (i.e. capable of) engage a second vertebra of the spine (figure 20), a leading side (figures 13-16 and 20), a trailing side (figures 13-16 and 20), an anterior sidewall (figures 13-16 and 20), and a posterior sidewall (figures 13-16 and 20).
Regarding claim 2, Flickinger discloses wherein the cutter of the resector (figures 1-20) comprises an elongate extender (figure 10), a blade (figure 10) coupled to a distal end of the elongate extender (figure 10).
Regarding claim 3, Flickinger discloses wherein the cutter (figure 10) further comprises a distal finger (60) configured to (i.e. capable of) protect tissue from the blade at the distal end of the elongate extender (figure 10), a connector (figures 17 and 18) at a proximal end of the elongate extender (figures 17 and 18), and a handle (figures 17 and 18) coupled to the connector (figures 17 and 18) and configured to (i.e. capable of) control movement of the cutter (figures 10, 17, 18).
Regarding claim 4, Flickinger discloses wherein the elongate extender (figure 10) comprises a pair of distal wings (elements 60) dimensioned to (i.e. capable of) engage a proximal surface of the first vertebra and a proximal surface of the second vertebra to restrict movement of the cutter (¶34).
Regarding claim 5, Flickinger discloses wherein the tissue retractor of the resector (figure 18) comprises an elongate shaft (figure 18) including a track (figure 18) configured to (i.e. capable of) allow the cutter (92, 94) to translate along a length of the elongate shaft between a proximal end (figure 18) and a distal end (figure 18), a handle (considered as a portion of the shaft) coupled to the proximal end of the elongate shaft (figure 18) and a curved head (considered as another portion of the shaft) coupled to the distal end of the elongate shaft (figure 18) and dimensioned to (i.e. capable of) engage the spine (¶42).
Regarding claim 6, Flickinger discloses wherein the curved head comprises an inside surface (considered as an inner surface of the shaft) dimensioned to (i.e. capable of) engage the targeted intervertebral disc, and an outer surface (considered as an outer surface of the shaft) configured to (i.e. capable of) provide the barrier that protects surrounding tissue of the targeted intervertebral disc, the ALL, or both.
Regarding claim 7, Flickinger discloses wherein the lateral access corridor is created along a lateral, transpsoas path to the targeted intervertebral disc, and wherein the ALL is adjacent to the targeted intervertebral disc between the first vertebra and the second vertebra as this is considered functional.
Regarding claim 9, Flickinger discloses wherein the implant (110) further comprises one or more of a fusion aperture (114 or 116), a visualization aperture, an anti-migration feature, or a combination thereof.
Regarding claim 10, Flickinger discloses wherein the implant (110) comprises the anti-migration feature (117) on one or more of the top surface and the bottom surface (figures 14-16), wherein the anti-migration feature (117) is configured to (i.e. capable of) increase friction between the implant (110) and the respective first and/or second vertebra (¶40).
Regarding claim 11, Flickinger discloses wherein the anti-migration feature (117) comprises one or more of a ridge or a spike element (figures 14-16).
Regarding claim 16, Flickinger discloses further comprising an insertion instrument (100) (figures 11 and 12) configured to (i.e. capable of) position the implant (110) through the lateral access corridor, wherein the implant (110) further comprises a receiving aperture (112) configured to (i.e. capable of) receive the insertion instrument (100) therein.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flickinger (US 2007/0270873) in view of Thalgott et al. (US 2009/0210062), herein referred to as Thalgott.
Regarding claims 8, Flickinger’s system discloses all the features/elements as claimed but lacks wherein the top surface and the bottom surface of the implant converge towards each other at an angle of at least 20 degrees in a posterior direction.
However, Thalgott teaches a top surface and a bottom surface of an implant converge towards each other (¶51 and figure 6d).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Flickinger’s implant with wherein the top surface and the bottom surface of the implant converge towards each other as taught by Thalgott, since such a modification would ease insertion of the implant.
Furthermore, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the modified Flickinger’s implant with wherein the top surface and the bottom surface of the implant converge towards each other at an angle of at least 20 degrees in a posterior direction, since such a modification is considered optimization of the size of the prior art and one of ordinary skill in the art would have come up with the measurement as claimed. Furthermore, it would be patient dependent.
Claims 12-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flickinger (US 2007/0270873) in view of Cowan, JR. et al. (US 2012/0245690), herein referred to as Cowan, JR.
Regarding claims 12, 13, 14, 15, Flickinger’s system discloses all the features/elements as claimed but lacks further comprising a fixation anchor configured to couple the implant to the spine, wherein the implant comprises a fixation aperture configured to receive the fixation anchor therein, further comprising a locking element configured to engage the fixation anchor to inhibit decoupling of the implant, wherein the implant further comprises a tab having the fixation aperture therein, wherein the tab is configured to extend vertically above the top surface and engage the first vertebra, further comprising a second fixation anchor configured to couple the implant to the spine, wherein the implant further comprises a second tab having a second fixation aperture configured to receive the second fixation therein, wherein the second tab is configured to extend vertically below the bottom surface and engage the second vertebra.
However, Cowan, JR. teaches a fixation anchor (16) configured to (i.e. capable of) couple an implant (10) to the spine (figures 5 and 6), wherein the implant (10) comprises a fixation aperture (34) configured to (i.e. capable of) receive the fixation anchor (16) therein (figures 5 and 6), a locking element (18) configured to (i.e. capable of) engage the fixation anchor (16) to inhibit decoupling of the implant (10), wherein the implant (10) further comprises a tab (portion of element 12) having the fixation aperture (34) therein, wherein the tab (portion of element 12) is configured to (i.e. capable of) extend vertically above the top surface and engage the first vertebra (11a) (figure 6), a second fixation anchor (another element 16) configured to (i.e. capable of) couple the implant (10) to the spine (figure 6), wherein the implant (10) further comprises a second tab (another portion of element 12) having a second fixation aperture (another element 34) configured to (i.e. capable of) receive the second fixation therein (another element 16), wherein the second tab (another portion of element 12) is configured to (i.e. capable of) extend vertically below the bottom surface and engage the second vertebra (11b) (figure 6).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Flickinger’s implant with a fixation anchor configured to couple the implant to the spine, wherein the implant comprises a fixation aperture configured to receive the fixation anchor therein, a locking element configured to engage the fixation anchor to inhibit decoupling of the implant, wherein the implant further comprises a tab having the fixation aperture therein, wherein the tab is configured to extend vertically above the top surface and engage the first vertebra, further comprising a second fixation anchor configured to couple the implant to the spine, wherein the implant further comprises a second tab having a second fixation aperture configured to receive the second fixation therein, wherein the second tab is configured to extend vertically below the bottom surface and engage the second vertebra as taught by Cowan, JR., since such a modification would lock the spinal fusion device in position (Abstract).
Claim 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flickinger (US 2007/0270873) in view of Flickinger et al. (US 2010/0121388).
Regarding claim 17, Flickinger’s system discloses all the features/elements as claimed but lacks wherein the insertion instrument comprises a handle at a proximal end of the insertion instrument, a thumbwheel housing coupled to the handle, a thumbwheel disposed within the thumbwheel housing, an elongate tubular element coupled to the thumbwheel housing, wherein the elongate tubular element comprises an inner bore, a shaft disposed within the inner bore of the elongate tubular element and rotatably coupled to the thumbwheel at a proximal end of the shaft, and a distal insertion head coupled to the shaft at a distal end of the insertion instrument and configured to engage the implant.
However, Flickinger et al. teaches an insertion instrument (figures 21 and 22) comprises a handle (220) at a proximal end of the insertion instrument (figures 21 and 22), a thumbwheel housing (portion of element 220) coupled to the handle (220), a thumbwheel (222) disposed within the thumbwheel housing (portion of element 220) (figures 21 and 22), an elongate tubular element (200) (¶62) coupled to the thumbwheel housing (figures 21 and 22), wherein the elongate tubular element (200) comprises an inner bore (¶62), a shaft (240) disposed within the inner bore (¶62) of the elongate tubular element (200) and rotatably coupled to the thumbwheel (222) at a proximal end of the shaft (figures 21 and 22), and a distal insertion head (portion of element 240) coupled to the shaft (240) at a distal end of the insertion instrument (figures 21 and 22) and configured to (i.e. capable of) engage the implant (figure 22).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Flickinger’s insertion instrument with wherein the insertion instrument comprises a handle at a proximal end of the insertion instrument, a thumbwheel housing coupled to the handle, a thumbwheel disposed within the thumbwheel housing, an elongate tubular element coupled to the thumbwheel housing, wherein the elongate tubular element comprises an inner bore, a shaft disposed within the inner bore of the elongate tubular element and rotatably coupled to the thumbwheel at a proximal end of the shaft, and a distal insertion head coupled to the shaft at a distal end of the insertion instrument and configured to engage the implant as taught by Flickinger et al., since such a modification would provide an alternative insertion instrument and it appears the insertion instrument would perform equally well in inserting an implant.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,150,638. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the USP claims lies in the fact that the USP claims includes more elements and are thus, more specific. Thus, the USP is in effect a “species” of the “generic” invention of the instant application’s claims. It has been held that the generic invention is “anticipated” by the “species”.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775