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 § 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 1-11 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, “a corresponding second mating feature on the second endplate” is indefinite, as it is unclear how each of the first and second endplates can comprise a second mating feature configured to mate with a corresponding second mating feature on the second endplate. For the purpose of examination, it is assumed “a corresponding second mating feature on the second ramp” is intended.
Regarding claim 3, “an angle of the incline” is indefinite for having unclear antecedent basis, as both the second ramp wedge (in claim 1) and the expandable fusion device (claim 3) are recited as having an incline. For the purpose of examination, it is assumed the expandable fusion device incline is referred to.
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 of this title, 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, 2, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0277488 (Davenport) in view of U.S. Patent Application Publication No. 2013/0158664 (Palmatier).
Regarding claim 1, Davenport discloses an expandable fusion device (100) comprising: a first endplate (110); a second endplate (112); a first ramp comprising a wedge (168/168A) having an incline extending along a longitudinal axis of the expandable fusion device (see Figs. 4 and 8-10), the first ramp positioned between and configured to mate with the upper and lower endplates (see paragraph [0067] and Figs. 4 and 8-10); and a second ramp comprising a wedge (170/170A) having an incline extending along a lateral axis of the expandable fusion device (see paragraph [0109]; one lateral side of wedge 170/170A can be shorter than the other lateral side of wedge 170/170A, thus creating an incline extending along a lateral axis of the expandable fusion device), the second ramp positioned between and configured to mate with the upper and lower endplates (see paragraph [0067] and Figs. 4 and 8-10) and coupled to the first ramp by an actuating mechanism (154) (see Figs. 4 and 8-10), wherein each of the first endplate and second endplate comprise a first mating feature (ramps 166/166A) configured to mate with a corresponding first mating feature of the first ramp (ramps 166/166A mate with ramps 168/168A, see paragraph [0067] and Figs. 4 and 8-10), the first mating feature having a first angle relative to a vertical axis (see Figs. 8-10; angle of incline of ramps 166/166A relative to a vertical axis), and each of the first endplate and the second endplate comprise a second mating feature (164/164A) configured to mate with a corresponding second mating feature on the second ramp (ramps 164/164A mate with ramps 170/170A, see paragraph [0067] and Figs. 4 and 8-10), the second mating feature of the second ramp having a second angle relative to the vertical axis (see Figs. 8-10; angle of incline of ramps 164/164A relative to a vertical axis).
Further regarding claim 1, Davenport suggests wherein the ramps on the endplates and wedges can have different angles (see paragraph [0109]). Additionally, Palmatier suggests an expandable intervertebral implant in which wedges (116/122) have mating features (402/404) that form angles (beta1 and beta2), wherein one angle is greater than the other angle (see paragraphs [0037], [0070], [0074], and [0075]; the angles are shown in Figs. 12 and 13 relative to a horizontal axis, but one of ordinary skill in the art would understand they differ relative to a vertical axis as well). 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 mating features of the endplates and ramps of Davenport such that a first angle formed by the first mating features is greater than the second angle formed by the second mating features in order to regulate the amount and rate of expansion to restore the proper lordosis in the vertebrae as needed (see Palmatier, paragraphs [0037], [0070], [0074], and [0075]).
Regarding claim 2, Davenport discloses wherein the expandable fusion device is movable between a collapsed configuration and an expanded configuration (see paragraphs [0063] and [0064] and Figs. 2, 3, 9 and 10, e.g.).
Regarding claims 8 and 9, Davenport and Palmatier are silent regarding wherein the first angle is about 50-70°, wherein the first angle is about 60°, wherein the second angle is about 5-25°. However, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the invention to make the first angle between 50 and 70 degrees and the second angle between 5 and 25 degrees, as one of ordinary skill in the art would have recognized that the angles are result effective variables for determining the amount of vertebral height restoration and lordosis, and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Davenport in view of Palmatier, and further in view of U.S. Patent Application Publication No. 2013/0158663 (Miller).
Regarding claims 6 and 7, Davenport is silent regarding wherein, as the expandable device moves from the collapsed configuration to the expanded configuration, both the upper endplate and the lower endplate are configured to pivotally expand about a pivot point located outside the expandable fusion device, and wherein the pivot point is located a distance of 17 millimeters from a closest location of the expandable fusion device. However, , Miller discloses an expandable intervertebral device (10) wherein an endplate (16) is configured to pivotally expand about a pivot point located outside the expandable fusion device (see marked-up Fig. 11 below). 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 endplates of Davenport to pivotally expand about a pivot point outside the expandable fusion device in order to provide height restoration between adjacent vertebrae, decompression, restoration of sagittal balance and resistance of subsidence into the endplates of the vertebrae (see Miller, paragraph [0060], e.g.). Additionally, 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 make the pivot point located at a distance of 17 mm from a closest location of the expandable fusion device, as one of ordinary skill in the art would have recognized that the pivot point location is result effective variable that controls the pivot angle of the endplates, and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
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Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Davenport in view of Palmatier, and further in view of U.S. Patent Application Publication No. 2004/0193158 (Lim).
Regarding claim 10, Davenport is silent regarding wherein the first ramp and the second ramp are configured to provide symmetrical expansion of the first endplate and the second endplate. However, Lim discloses an expandable intervertebral device (10) in which endplates (50 and 52) are symmetrically expanded (see paragraph [0034]). 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 have the first and second ramps provide symmetrical expansion of the endplates in order to provide equal expansion of the endplates and separation of adjacent vertebrae as needed by the patient (see Lim, paragraph [0034]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Davenport in view of Palmatier, and further in view of U.S. Patent Application Publication No. 2010/0211176 (Greenhalgh).
Regarding claim 11, Davenport is silent regarding wherein the first mating feature of the first ramp comprises one or more tongues that are configured to slide within one or more inwardly facing grooves formed by the first mating feature of the first endplate. However, Greenhalgh discloses an expandable intervertebral device (2) wherein a ramp (96/180 in the Figs.; 22 in the specification) comprises one or more tongues (100) that are configured to slide within one or more inwardly facing grooves (284) formed by a mating feature of an endplate (6) (see paragraph [0045]). 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 have the ramp and endplate first mating features be tongue and grooves as suggested by Greenhalgh in order to allow for secure engagement between the ramp and endplate while still allowing for relative sliding movement (see Greenhalgh, paragraph [0045]).
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 2 of U.S. Patent No. 9,839,528 (Weiman).
Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claim and the patent claim lies in the fact that the patent claim includes the subject matter of the application claim, plus additional elements. Thus, the invention of the patent claim is in effect a “species” of the “generic” invention of the application claim. 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 claim is anticipated by the patent claim, it is not patentably distinct from the patent claim.
Allowable Subject Matter
Claims 3-5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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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