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 .
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 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.
Claim(s) 8, 11, 12, 14-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abdelgany et al. (Pub. No. US 2011/0153020).
Regarding claims 8, 11, and 12, Abdelgany et al. discloses a method for implanting an intervertebral prosthesis between first and second adjacent vertebrae to provide a lordotic correction (figures 6A-6E, 8C; paragraph 0067), the method comprising: accessing a space between the first and second vertebrae (figure 8C); attaching a first endplate 216 to the first vertebrae (paragraph 0067; figures 6A-6E, figure 8C), the first endplate 216 comprising a first vertebra-facing side 216a and an opposite first insert-facing side 216b (figure 6E); attaching a second endplate 214 to the second vertebrae (figures 6A-6E, 8C; paragraph 0067), the second endplate 214 comprising a second vertebra-facing side 214A and an opposite second insert-facing side 214B (figure 6E), wherein the first endplate 216 is pivotably coupled to the second endplate (via hinge 218- figure 6E; paragraph 0057); selecting a non-adjustable insert 220 based on a desired correction angle (paragraph 0047; 0052), wherein the insert 220 comprises a non-adjustable wedge shape 222 (figure 6C) configured to be positioned between the distracted first 216 and second 214 endplates (figure 6C); positioning the insert 220 between the first endplate and the second endplate (figure 6C); and attaching the insert 220 to the first and second endplates to secure the first and second endplates at the desired correction angle (figure 6C, 8C; paragraph 0067), wherein the insert 220 forms at least a portion of an interior side of the intervertebral prosthesis when the insert 220 is secured to the first and second endplates 214, 216 (figure 6C), and wherein the insert 220 includes a superior surface 232 to engage at least one of the first vertebrae or the second vertebrae (figure 6C). The insert comprises a first wedge-shaped sidewall and a second wedge-shaped sidewall (figure 6C). The first endplate 216 comprises a first anterior surface 216E (figure 6E), wherein the insert 220 comprises a second anterior surface (illustrated in figure 6C), and wherein positioning the insert 220 between the distracted first endplate and the second endplate 214, 216 comprises positioning the insert 220 between the distracted first endplate 216 and second endplate 214 such that the first anterior surface 216E of the first endplate 216 and the second anterior surface of the insert 220 form an anterior side of the intervertebral prosthesis (figure 6C). The method further comprises determining the desired correction angle based on a lordosis of a spine, the spine comprising the first and second vertebrae (paragraphs 0047 and 0052).
Regarding claims 14-18, Abdelgany et al. discloses a method for implanting an intervertebral prosthesis (figures 6A-6E, 8C, paragraph 0067) between first and second adjacent vertebrae, the method comprising: attaching a first endplate 216 to the first vertebrae (figure 8C; paragraph 0067); attaching a second endplate 214 to the second vertebrae (figure 8C; paragraph 0067), the second endplate 214 pivotably coupled to the first endplate 216; rotating at least one of the first endplate or the second endplate such that the first endplate and second endplate form a distraction angle (paragraph 0067; figure 8C); positioning a non-adjustable insert 220 between the first endplate 216 and the second endplate 214 such that the insert 220 secures the first and second endplates at the distraction angle (figures 6A-6E, 8C; paragraph 0067), wherein the insert 220 comprises an angled shape corresponding to the distraction angle and includes a superior surface 232 to engage at least one of the first vertebrae or the second vertebrae (figure 6C). The method comprises selecting the second partial plate based on a lordosis of a spine, the spine comprising the first vertebrae and the second vertebrae (paragraphs 0047 and 0052). The spacer 220 comprises at least one wedge-shaped sidewall, the wedge-shaped sidewall corresponding to the angular orientation (figure 6C). The at least one wedge-shaped sidewall comprises a first wedge-shaped sidewall, wherein the first wedge-shaped sidewall is monolithic (figure 6C). The second partial plate 232 comprises an end wall defining a hole 246, and wherein securing the second partial plate to the second vertebrae comprises driving a screw through the hole and into the second vertebrae (paragraph 0067).
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.
Claim(s) 1-6, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdelgany et al. (Pub. No. US 2011/0153020) in view of Emerick (Pub. No. US 2015/0351925).
Regarding claims 1-6 and 13, Abdelgany et al. discloses a method (figure 8C) for implanting an intervertebral prosthesis 210 between first and second adjacent vertebrae to provide a lordotic correction, the method comprising: accessing a space between the first and second vertebrae (figure 8C; paragraph 0067); attaching a first endplate 216 to the first vertebrae (figure 8C; paragraph 0067), the first endplate 216 comprising a first vertebra-facing side 216A, an opposite first insert-facing side 216B, a first anterior side, an opposite first posterior side, a first right side, an opposite first left side (figures 6A-6E); attaching a second endplate 214 to the second vertebrae (figure 8C; paragraph 0067), the second endplate 214 comprising a second vertebra-facing side 214A, an opposite second insert-facing side 214B (figure 6E), a second anterior side, an opposite second posterior side, a second right side, an opposite second left side (figures 6A-6E); distracting the first endplate 216 relative to the second endplate 214 to a desired correction angle; selecting an insert 220 based on the desired correction angle (paragraphs 0047, 0052); positioning the insert 220 between the first endplate 216 and the second endplate 214 (figure 6C), wherein the insert is non-adjustable and unitary (figure 6C), attaching the insert 220 to the first and second endplates 214, 216 to secure the first and second endplates at the desired correction angle (figure 6C), wherein the insert 220 forms at least a portion of an interior side of the intervertebral prosthesis and at least a portion of a superior side of the intervertebral prosthesis when the insert 220 is secured to the first and second endplates (figure 6C). Accessing the space between the first and second vertebrae comprises distracting the first and second vertebrae (paragraph 0067). The method further comprising determining the desired correction angle based on a lordosis of a spine, the spine comprising the first and second vertebrae (paragraph 0047, 0052). The insert 220 comprises a first end wall 232 on an anterior side of the insert, the first end wall defining a hole 246, and wherein the attaching the insert 220 to the first and second endplates comprises driving a screw through the hole 246 into the second vertebrae (paragraph 0067; figure 6B). The first endplate 216 comprises a second end wall 216E on an anterior side of the first endplate, the second end wall 216E defining one or more holes 250E (figure 6B), and wherein the attaching the first endplate to the first vertebrae comprises driving one or more screws through the one or more holes 250E of the first endplate 216E into the first vertebrae (paragraph 0067). Positioning the insert 220 between the first endplate and the second endplate comprises positioning the insert 220 between the first endplate and the second endplate such that the one or more holes 250E of the first endplate are unobscured by the first end wall 232 of the insert (figure 6B). The insert 220 comprises at least one wedge-shaped sidewall (figure 6C).
Abdelgany et al. discloses the claimed invention except wherein the first endplate comprises a hinge knuckle protruding from the first insert-facing side and the second endplate comprises a receiver formed in the second insert-facing side, wherein the hinge knuckle protrudes from the first insert-facing side toward the second endplate, wherein the hinge knuckle is received in the receiver to form a hinge between the first and second endplates, wherein the hinge knuckle is configured to pivot within the receiver about a hinge axis that extends along a right-left direction so that the first endplate pivots relative to the second endplate about the hinge axis. Abdelgany et al. discloses a hinge, but is silent regarding the specifics of the hinge.
Emerick et al. teaches a hinge 124/136 (figure 3) for connecting a first and second endplate, wherein the first endplate comprises a hinge knuckle 124 protruding from the first insert-facing side and the second endplate comprises a receiver 136 formed in the second insert-facing side, wherein the hinge knuckle 124 protrudes from the first insert-facing side toward the second endplate, wherein the hinge knuckle 124 is received in the receiver 136 to form a hinge between the first and second endplates (figure 3), wherein the hinge knuckle 124 is configured to pivot within the receiver 136 about a hinge axis that extends along a right-left direction so that the first endplate pivots relative to the second endplate about the hinge axis (figure 3).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the hinge disclosed by Abdelgany et al. with the teachings of Emerick, wherein the first endplate comprises a hinge knuckle protruding from the first insert-facing side and the second endplate comprises a receiver formed in the second insert-facing side, wherein the hinge knuckle protrudes from the first insert-facing side toward the second endplate, wherein the hinge knuckle is received in the receiver to form a hinge between the first and second endplates, wherein the hinge knuckle is configured to pivot within the receiver about a hinge axis that extends along a right-left direction so that the first endplate pivots relative to the second endplate about the hinge axis, in order to achieve the predictable result of providing a hinged interface between the two endplates, with the added advantage of providing a hinged interface that is resistant to wear and tear and allows the use of a modular implant assembly (i.e., the endplates can be modular and interchangeable).
Regarding claim 13, Abdelgany discloses the claimed invention except wherein the first endplate comprises a first hinge feature and the second endplate comprises a second hinge feature configured to engage the first hinge feature to form a hinge comprising a hinge axis, and wherein distracting the first endplate relative to the second endplate comprises pivoting at least one of the first endplate or the second endplate about the hinge axis. Abdelgany et al. discloses a hinge, but is silent regarding the specifics of the hinge.
Emerick et al. teaches wherein the first endplate comprises a first hinge feature 124 and the second endplate comprises a second hinge feature 136 configured to engage the first hinge feature 124 to form a hinge comprising a hinge axis, and wherein distracting the first endplate relative to the second endplate comprises pivoting at least one of the first endplate or the second endplate about the hinge axis (figure 3).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the hinge disclosed by Abdelgany et al. with the teachings of Emerick, wherein the first endplate comprises a first hinge feature and the second endplate comprises a second hinge feature configured to engage the first hinge feature to form a hinge comprising a hinge axis, and wherein distracting the first endplate relative to the second endplate comprises pivoting at least one of the first endplate or the second endplate about the hinge axis, in order to achieve the predictable result of providing a hinged interface between the two endplates, with the added advantage of providing a hinged interface that is resistant to wear and tear and allows the use of a modular implant assembly (i.e., the endplates can be modular and interchangeable).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdelgany et al. (Pub. No. US 2011/0153020) in view of Emerick (Pub. No. US 2015/0351925) and further in view of Krueger (Pat. No. US 8308804 B2).
Regarding claim 7, Abdelgany et al. as modified by Emerick et al. discloses the claimed invention except wherein the first endplate comprises at least one groove, and wherein positioning the insert between the first endplate and the second endplate comprises positioning the at least one wedge-shaped sidewall of the insert to engage the at least one groove of the first endplate.
Krueger et al. teaches wherein the first endplate comprises at least one groove 70 (figure 8A and 8B), and wherein positioning the insert 24 between the first endplate 12 and the second endplate 12 comprises positioning the at least one wedge-shaped sidewall of the insert to engage the at least one groove 70 of the first endplate (figure 1), for the purpose of holding the insert and the endplates together (col. 7, lines 37-52).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the first endplate such that it comprises at least one groove, and to modify the insert such that positioning the insert between the first endplate and the second endplate comprises positioning the at least one wedge-shaped sidewall of the insert to engage the at least one groove of the first endplate, as taught by Krueger et al., in order to hold the insert and plates together and prevent the insert from slipping laterally relative to the endplates.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdelgany et al. (Pub. No. US 2011/0153020) in view of Krueger (Pat. No. US 8308804 B2).
Regarding claims 9 and 10, Abdelgany et al. discloses the claimed invention except wherein the first endplate comprises at least one groove, and wherein positioning the insert between the first endplate and the second endplate comprises positioning the wedge-shape of the insert to engage the at least one groove of the first endplate; wherein the first endplate comprises a first groove and a second groove, and wherein positioning the wedge-shape of the insert to engage the at least one groove of the first endplate comprises positioning the insert between the first endplate and the second endplate such that the first wedge-shaped sidewall engages the first groove and the second wedge-shaped sidewall engages the second groove.
Krueger teaches wherein the first endplate 12 comprises at least one groove 70, and wherein positioning the insert 24 between the first endplate 12 and the second endplate 14 comprises positioning the wedge-shape of the insert 24 to engage the at least one groove 70 of the first endplate 12 (figure 1); wherein the first endplate 12 comprises a first groove 70 and a second groove 70 (figures 1 and 8A), and wherein positioning the wedge-shape of the insert 24 to engage the at least one groove of the first endplate comprises positioning the insert 24 between the first endplate 12 and the second endplate 14 such that the first wedge-shaped sidewall engages the first groove 70 and the second wedge-shaped sidewall engages the second groove 70 (figure 1), for the purpose of holding the insert and the endplates together (col. 7, lines 37-52).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the first endplate such that it comprises at least one groove, and wherein positioning the insert between the first endplate and the second endplate comprises positioning the wedge-shape of the insert to engage the at least one groove of the first endplate; wherein the first endplate comprises a first groove and a second groove, and wherein positioning the wedge-shape of the insert to engage the at least one groove of the first endplate comprises positioning the insert between the first endplate and the second endplate such that the first wedge-shaped sidewall engages the first groove and the second wedge-shaped sidewall engages the second groove, as taught by Krueger, in order to hold the insert and plates together and prevent the insert from slipping laterally relative to the endplates.
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, 8, 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 10925747. 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 more 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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12178709. Although the claims at issue are not identical, they are not patentably distinct from each other because 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 more 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynnsy Summitt whose telephone number is (571)270-78567856. The examiner can normally be reached on Monday through Thursday from 8am until 5pm.
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/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773
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