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 .
Claim Objections
Claims 1 and 20 are objected to because of the following informalities:
Regarding claim 1, “the actuator” should be “the first actuator” all three times it appears in the last paragraph of the claim.
Regarding claim 20, “the first endplate and the second endplate” should be “a first endplate and a second endplate” the first time they are introduced. The examiner recommends stating that the expandable implant has a first endplate and a second endplate.
Appropriate correction is required.
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.
Claims 9-19 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.
Regarding claim 9, it is unclear if the lobes of claim 9 are the same or different from the divots of claim 1. For the purpose of examination, it is assumed they are the same.
Regarding claim 10, from which claims 11-19 depend, “the actuator” lacks antecedent basis. For the purpose of examination, it is assumed “the first drive screw” is referred to.
Regarding claim 19, it is unclear if the lobes of claim 19 are the same or different from the divots of claim 10. For the purpose of examination, it is assumed they are the same.
Claim Rejections - 35 USC § 102
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.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2018/0318101 (Engstrom).
Regarding claim 20, Engstrom discloses a method of treating a spinal deformity (see paragraphs [0001]-[0003]), comprising the steps: accessing an intervertebral disc space (5) via a lateral approach (see paragraph [0058] and Fig. 1); inserting an expandable implant (10) into the intervertebral disc space (see paragraph [0058] and Fig. 1), the expandable implant having a first endplate (20), a second endplate (22), a first translating member (124 or 126 of assembly 94) moveably coupled to a first actuator (98 of assembly 94), and a second translating member (124 or 126 of assembly 96) moveably coupled to a second actuator (98 of assembly 96), with the first translating member and the second translating member configured to change a spatial relationship between the first endplate (20) and the second endplate (22) as they move (see paragraphs [0075]-[0076], [0081], [0140], and Figs. 32-40); and actuating at least one of the first actuator and the second actuator to change the spatial relationship between the first endplate and the second endplate, thereby changing a dimension of the expandable implant (see paragraphs [0075]-[0076], [0081], [0140], and Figs. 32-40).
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-10, and 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Engstrom in view of U.S. Patent Application Publication No. 2013/0197642 (Ernst).
Regarding claim 1, Engstrom discloses an expandable implant (10) comprising: a first endplate (20) and a second endplate (22); a first translating member (124 or 126 of assembly 94) moveably coupled to a first actuator (98 of assembly 94); a second translating member (124 or 126 of assembly 96) moveably coupled to a second actuator (98 of assembly 96) (see paragraph [0081]); wherein the first translating member is configured to move independently from the second translating member (see paragraphs [0075]-[0076] and [0081]); and wherein the first translating member and the second translating member are configured to change a spatial relationship between the first endplate and the second endplate (see paragraphs [0075]-[0076], [0081], [0140], and Figs. 32-40), wherein the first translating member is configured to threadably receive a threaded portion (104 or 106) of the first actuator (see paragraph [0081]).
Further regarding claim 1 and regarding claims 7-9, Engstrom fails to disclose wherein the actuator further includes a plurality of divots circumferentially disposed around a non-threaded portion of the actuator. However, Ernst discloses an expandable intervertebral implant (10A) that comprises an actuator drive screw (40), the actuator further including a plurality of divots (spaces between teeth of gear 44B) circumferentially disposed around a non-threaded portion (44B) of the actuator, further comprising an anti-migration feature (44B/90) that comprises a plurality of plurality of flexible members (90B/90C; members 90B/90C can be flexed into engagement and disengagement with gear 44B teeth spacing) configured to restrict the rotation of the actuator (see paragraph [0033]), wherein the actuator further comprises lobes (gear 44B teeth spacing, see paragraph [0033] and Fig. 2E) configured to receive at least a portion of the flexible member configured to restrict a movement thereof (see paragraph [0033]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Engstrom to include divots and an anti-migration feature in the first actuator as suggested by Ernst in order to prevent against unintended rotation of the actuator from a desired expanded or collapsed configuration (see Ernst, paragraph [0033]).
Regarding claim 3, Engstrom discloses wherein at least one of the first translating member and the second translating member further comprise at least one wedge (51/52/53/54) configured to interface with at least one of the first endplate and the second endplate (see paragraph [0082]).
Regarding claims 4 and 5, Engstrom discloses wherein the first translating member is moveably coupled to the second translating member (translating members 124/126 of each assembly 94/96 are coupled via being linked/connected to endplates 20/22 such that the members 124/126 are still moveable, see Figs. 1-5 and paragraphs [0081], [0086], [0094], [0098], [0103], [0110]), and wherein the first translating member is moveably coupled to the second translating member by a dovetail coupling (dovetail-shaped slots 56/58 of each endplate 20/22 moveably couple the first and second translating members together, see Figs. 1-5 and paragraphs [0081], [0086], [0094], [0098], [0103], [0110]).
Regarding claim 6, Engstrom discloses further comprising the housing (46) configured to enclose at least a portion of the first actuator and at least a portion of the second actuator (see Figs. 1-5).
Regarding claims 10 and 17-19, Engstrom discloses an expandable implant (10) comprising: a first endplate (20) and a second endplate (22); a first translating member (124 or 126 of assembly 94) disposed between the first endplate and the second endplate (see Fig. 4) and moveably coupled to a first drive screw (98 of assembly 94); a second translating member (124 or 126 of assembly 96) disposed between the first endplate and the second endplate (see Fig. 4) and moveably coupled to a second drive screw (98 of assembly 96); wherein the first translating member is configured to move independently from the second translating member (see paragraphs [0075]-[0076] and [0081]); and wherein the first translating member and the second translating member are configured to change a spatial relationship between the first endplate and the second endplate (see paragraphs [0075]-[0076], [0081], [0140], and Figs. 32-40), wherein the first translating member is configured to threadably receive a threaded portion (104 or 106) of the first drive screw (see paragraph [0081]).
Further regarding claim 10 and regarding claims 17-19, Engstrom fails to disclose wherein the first drive screw further includes a plurality of divots circumferentially disposed around a non-threaded portion of the first drive screw. However, Ernst discloses an expandable intervertebral implant (10A) that comprises an actuator drive screw (40), the actuator drive screw further including a plurality of divots (spaces between teeth of gear 44B) circumferentially disposed around a non-threaded portion (44B) of the actuator drive screw, further comprising an anti-migration feature (44B/90) that comprises a plurality of plurality of flexible members (90B/90C; members 90B/90C can be flexed into engagement and disengagement with gear 44B teeth spacing) configured to restrict the rotation of the actuator drive screw (see paragraph [0033]), wherein the actuator further comprises lobes (gear 44B teeth spacing, see paragraph [0033] and Fig. 2E) configured to receive at least a portion of the flexible member configured to restrict a movement thereof (see paragraph [0033]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Engstrom to include divots and an anti-migration feature in the first drive screw as suggested by Ernst in order to prevent against unintended rotation of the first drive screw from a desired expanded or collapsed configuration (see Ernst, paragraph [0033]).
Regarding claims 12 and 13, Engstrom discloses wherein the first and second translating members each further comprises at least one wedge (51/52/53/54) (see paragraph [0082]).
Regarding claims 14 and 15, Engstrom discloses wherein the first translating member is moveably coupled to the second translating member (translating members 124/126 of each assembly 94/96 are coupled via being linked/connected to endplates 20/22 such that the members 124/126 are still moveable, see Figs. 1-5 and paragraphs [0081], [0086], [0094], [0098], [0103], [0110]), and the first translating member and second translating member are configured to move independently of one another (see paragraphs [0076], [0081], and [0131]), wherein the first translating member is moveably coupled to the second translating member by a dovetail (dovetail-shaped slots 56/58 of each endplate 20/22 moveably couple the first and second translating members together, see Figs. 1-5 and paragraphs [0081], [0086], [0094], [0098], [0103], [0110]).
Regarding claim 16, Engstrom discloses further comprising a housing (46), to enclose at least a portion of the first drive screw and at least a portion of the second drive screw (see Figs. 1-5).
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Engstrom in view of Ernst, and further in view of U.S. Patent Application Publication No. 2017/0105844 (Kuyler).
Regarding claims 2 and 11, Engstrom fails to disclose wherein at least one of the first endplate and the second endplate further comprise a porous bone engagement surface. However, Engstrom discloses the implant being configured to facilitate retention and fusion of the implant between adjacent vertebrae (see paragraphs [0002], [0064], and [0067]). Additionally, Kuyler discloses an intervertebral implant (10) with first and second endplates (140/150) that comprise porous bone engagement surfaces to facilitate anti-migration and/or osseointegration of the implant between adjacent vertebrae (see paragraph [0035]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify bone engagement surfaces of the first and second endplates to be porous as suggested by Kuyler in order to facilitate anti-migration and/or osseointegration of the implant between adjacent vertebrae (see Kuyler, paragraph [0035]).
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 1-6, 10-16, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-12, and 14 of U.S. Patent No. 12,427,036 (Besaw).
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 patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claims 1 and 6 are anticipated by claim 1 of Besaw.
Claims 2-5 are anticipated by claims 2-5 of Besaw.
Claims 10 and 16 are anticipated by claim 7 of Besaw.
Claims 11-15 are anticipated by claims 8-12 of Besaw.
Claim 20 is anticipated by claim 14 of Besaw.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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