DETAILED ACTION
The following is a non-final office action is response to communications received on 11/20/2023. Claims 26-46 are currently pending and addressed below.
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 .
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 26-32 & 34-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 & 9-18 of U.S. Patent No. 11,672,671. The elements of the instant application are to be found in the Patent and therefore are anticipated. Although the conflicting claims are not identical, they are not patentably distinct from each other because the Patent and the instant application all recite the same basic structure with a permutation of similar elements throughout.
Regarding Claims 26 & 31, patent claim 1 recites the same limitations.
Regarding Claims 27-30, patent claims 2-5 respectively recite the same limitations.
Regarding Claim 32, patent claim 9 recites the same limitations.
Regarding Claims 34-42, patent claims 10-18 respectively recite the same limitations.
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.
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.
Claim(s) 26-28, 30, 31, 37, 38 & 40-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernero (US 8,252,058) in view of Istephanous et al. (US 2006/0190079).
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Regarding Claims 26 & 37, Bernero discloses the invention substantially as claimed. Bernero teaches a joint prosthesis (10) comprising:
a first component (16) configured to be attached to a first vertebrae (12), the first component comprising:
a first body portion comprising a first surface (28) and a convex articulating surface (20) extending from the first surface, the first body portion further comprising a first bone facing surface (26) opposite the first surface, the first body portion sized to be positioned on a first articular facet of the first vertebrae without extending into a disc space (intended use limitations must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The Bernero device is fully capable of being positioned in the claimed manner.);
a second component (18) configured to be attached to a second vertebrae (14) adjacent the first vertebrae, the second component comprising:
a second body portion comprising a second surface (30) and a concave articulating surface (22) recessed from the second surface, the second body portion further comprising a second bone facing surface (26) opposite the second surface, the second body portion sized to be positioned on a second articular facet of the second vertebrae without extending into the disc space (intended use limitations must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The Bernero device is fully capable of being positioned in the claimed manner.);
wherein each of the concave articulating surface (22) and the convex articulating surface (20) is non-spherical with a major dimension (A or AA in Fig 2) and a minor dimension (B or BB in Fig 4), wherein the major dimension (AA) of the concave articulating surface is greater than the major dimension (A) of the convex articulating surface (Col 4: lines 53-57), and wherein the minor dimension (BB) of the concave articulating surface is greater than the minor dimension (B) of the convex articulating surface.
However, Bernero does not disclose a first flange extending from the first body portion and configured to be secured to a posterior facing side of the first vertebrae, the first flange comprising a first aperture; and a second flange extending from the second body portion and configured to be secured to a posterior facing side of the second vertebrae, the second flange comprising a second aperture.
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Istephanous teaches an artificial disc implant in the same field of endeavor. Said implant comprising a first flange (34) extending from the first body portion (22) and configured to be secured to a first vertebrae (26), the first flange comprising a first aperture (36); and a second flange (56) extending from the second body portion (24) and configured to be secured to a second vertebrae (27), the second flange comprising a second aperture (58). Said flanges are configured to anchor of the prosthesis within the disc space post-operatively [0045].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to add the first and second flanges, as taught by Istephanous, to the device of Bernero in order to further anchor the implant within the disc space post-operatively.
Regarding Claim 27, the combination teaches wherein the second flange is shaped differently from the first flange (Fig 3 illustrates both a different angle and different overall shape of flanges 34 & 56).
Regarding Claims 28 & 38, the combination teaches wherein the first component (16) comprises a first anchoring element (24) on the first bone facing surface, and wherein the second component (18) comprises a second anchoring element (24) on the second bone facing surface.
Regarding Claims 30, 40 & 44, the combination teaches wherein a depth of the concave articulating surface is less than a thickness of the convex articulating surface (Figs 3 & 5 illustrate the upper-most convex surface proud of the upper-most concave surface).
Regarding Claim 31, the combination teaches wherein each of the first flange and the second flange are configured to receive an anchor (37 in Fig 4).
Regarding Claims 41 & 45, the combination teaches wherein each of the concave articulating surface and the convex articulating surface is non-spherical with a major dimension and a minor dimension (Col 4: lines 53-57).
Regarding Claims 42 & 46, the combination teaches wherein the major dimension (AA) of the concave articulating surface (22) is greater than the major dimension (A) of the convex articulating surface (20), and wherein the minor dimension (BB) of the concave articulating surface (22) is greater than the minor dimension (B) of the convex articulating surface (20) (Col 4: lines 53-57).
Regarding Claim 43, the combination as set forth in the rejection of claim 26 discloses the invention substantially as claimed. Further, Bernero teaches wherein the convex articulating surface (20) and the concave articulating surface (22) are sized and shaped to allow the first component to translate relative to the second component in an anterior-posterior direction (as shown by the oversized concave articular surface in Fig 3) and medial-lateral direction when implanted (as shown by the oversized concave articular area surface in Fig 5); wherein the convex articulating surface and the concave articulating surface are sized and shaped to allow the first component to tilt relative to the second component in the anterior-posterior direction (Fig 3) and the medial-lateral direction (Fig 5) when implanted; and wherein the convex articulating surface and the concave articulating surface are sized and shaped to allow the first component to be rotated relative to the second component (again due to the oversized concave articular surface in both the A-P and M-L planes).
Claim(s) 29, 32, 34-36 & 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernero (US 8,252,058) in view of Istephanous et al. (US 2006/0190079) and in further view of Reichen et al. (US 9,168,148).
Regarding Claims 29 & 39, as set forth supra, the combination discloses the invention substantially as claimed. However, the combination does not disclose wherein each of the first anchoring element and the second anchoring element comprises a keel extending in the anterior-posterior direction.
Reichen teaches an articulating disc implant (100) in the same field of endeavor. Said Implant comprises superior and inferior keels (17, 27) extending in an anterior-posterior direction (Fig 3) to aid in securing the implant to the vertebra (Col 8: lines 10-12).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to add the A-P oriented keels, as taught by Reichen, to the first and second components of the combination in order to further aid in securing the implant post-operatively.
Regarding Claim 32, the combination as set forth in the rejection of claim 26 discloses the invention substantially as claimed. Further, Bernero teaches wherein the first and second body portions comprise a generally flat surface around a perimeter their perimeters. And wherein the convex articulating surface (20) and the concave articulating surface (22) are sized and shaped to allow the first component to translate relative to the second component in an anterior-posterior direction (as shown by the oversized concave articular surface in Fig 3) and medial-lateral direction when implanted (as shown by the oversized concave articular area surface in Fig 5); wherein the convex articulating surface and the concave articulating surface are sized and shaped to allow the first component to tilt relative to the second component in the anterior-posterior direction (Fig 3) and the medial-lateral direction (Fig 5) when implanted; and wherein the convex articulating surface and the concave articulating surface are sized and shaped to allow the first component to be rotated relative to the second component (again due to the oversized concave articular surface in both the A-P and M-L planes).
Regarding Claim 34, the combination teaches wherein a depth of the concave articulating surface is less than a thickness of the convex articulating surface (Figs 3 & 5 illustrate the upper-most convex surface proud of the upper-most concave surface).
Regarding Claim 35, the combination teaches wherein each of the concave articulating surface and the convex articulating surface is non-spherical with a major dimension and a minor dimension (Col 4: lines 53-57).
Regarding Claim 36, the combination teaches wherein the major dimension (AA) of the concave articulating surface (22) is greater than the major dimension (A) of the convex articulating surface (20), and wherein the minor dimension (BB) of the concave articulating surface (22) is greater than the minor dimension (B) of the convex articulating surface (20) (Col 4: lines 53-57).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernero (US 8,252,058) in view of Istephanous et al. (US 2006/0190079) in view of Reichen et al. (US 9,168,148) and in further view of Muhlbauer (US 10,603,184).
Regarding Claim 33, as set forth supra, the combination discloses the invention substantially as claimed. However, the combination does not specifically disclose wherein the first body portion and the second body portion each comprises a length in the anterior posterior direction of less than 25 mm and a width in the medial-lateral direction of less than 15 mm.
Muhlbauer teaches an intervertebral disc implant in the same field of endeavor. Said implant comprising first and second body portions (i.e., endplates) with an A-P length (sagittal plane) of 12-18 millimeters and a M-L length (frontal plane) of 13-21 millimeters (Col 11: lines 15-25) in order to fit properly within the intervertebral disc space.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of the combination with the dimensions, as taught by Muhlbauer, in order to properly fit the device within the intervertebral space.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774