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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the superior and inferior curved edges comprise a continuous curve between the anterior and posterior sides and the two opposing sides of claim 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7 and 9 of U.S. Patent No. 12,295,861 B2. 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 13, the recitation of “the superior and inferior curved edges comprise a continuous curve between the anterior and posterior sides and the two opposing sides.” Has no support in the original disclosure. Applicant is requested to provide support for such limitation from the original disclosure or cancel the claim to overcome this rejection.
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 – 9 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.
Claim 1 recites the limitation "the midline". There is insufficient antecedent basis for this limitation in the claim.
For the sake of examination, the preceding limitation is interpreted as referring to a midline.
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.
Claim(s) 1 – 8, 10 – 14 and 16 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waugh et al. (US Pub. 2008/0249569 A1) supported / evidenced by Michelson (US 2002/0099376 A1).
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Claims 1 – 2, Waugh discloses a cervical implant [abstract, para.26, Figs. 1 – 2 and 12-14 and Figure 12 to Waugh, above] comprising:
a single cage portion [100 or 400, Figs.3 – 4, 7 and 12-14, para.26, one of the devices to be applied to a region of the vertebral column] comprising an upper surface [at least a surface portion of one of: 108 or 110 for the cage 100, or 408 or 410 for the cage 400] having a contact area configured for engaging an inferior surface of a first cervical vertebral body [the upper surface defines a contact area for contacting a cervical body] and a lower surface [at least a surface portion of the other one of: 108 or 110 for the cage 100, or 408 or 410 for the cage 400] having a contact area configured for engaging a superior surface of a second cervical vertebral body [the lower surface defines a contact area for contacting a cervical body], wherein the second cervical vertebral body is at an immediate adjacent level inferior to the first cervical body [Fig. 2],
an opening [118 or that identified in Figure 12 above] formed through the upper and lower surfaces to define an interior portion for receiving bone growth material [para.62],
an outer perimeter surface extending in between said upper and lower surfaces [defined by the surfaces, i.e. 112a-b, 114, and 116 for the cage 100, or 412a-b, 402 and 414 for the cage 400, extending between the upper and lower surfaces surrounding the implant], said outer perimeter surface including an anterior side [by 116, 414, Figs.4 and 13] and an opposite posterior side [by 114, 402, Figs.4 and 13],
one upwardly projecting aperture [middle aperture 126 or 420] that extends through said anterior side and said upper surface and projects upwardly towards the first cervical vertebral body [Figs.4 and 13, wherein the middle aperture extends through the anterior side and one of the surfaces of the cage defining the upper surface], two downwardly projecting apertures [far apertures 126 or 420] that extend through said anterior side and said lower surface and project downwardly towards the second cervical vertebral body for receiving fastening devices [Figs.4 and 13, wherein the far apertures extend through the anterior side and the other one of the surfaces of the cage defining the lower surface], each of said downwardly projecting apertures having proximal and distal openings and a channel extending therebetween [Figs.4 and 13, wherein each of the far apertures defines entrance and exit openings and a channel extending therebetween], the proximal openings of said downwardly projecting apertures lying within angled planes relative to said outer perimeter surface [Figs.4 and 13, wherein each of the proximal openings defines a portion of the anterior side and a portion of one of the surfaces of the cage], each of said downwardly projecting apertures further comprising a longitudinal axis that extends at an angle from the midline to converge at a point outside of the posterior side of said outer perimeter surface [Fig.12 above].
Though, Waugh discloses that the longitudinal axes of the downwardly projecting apertures being at acute angles with respect to the midline. Waugh does not explicitly disclose wherein the longitudinal axes of the two downwardly projecting apertures at an angle between about 5 degrees and about 10 degrees or between about 6 degrees and about 8 degrees from the midline to converge at a point outside of the posterior side of said outer perimeter surface.
It would have been obvious to one having ordinary skill in the art at the time of the invention to construct the far apertures [420] of the implants of Waugh to have angles from the midline ranging from about 5 – 10 or 6 – 8 degrees, in order to provide the implants with apertures having a desired pattern that facilitates the passage of fastening devices therethrough and along their axes for securing the implant in place between adjacent superior and inferior vertebral bodies [Waugh, abstract, para.2], while providing the implants of Waugh with a configuration that allows fastening devices (screws) from different implants implanted at adjacent levels of the vertebral column to pass each other within a vertebral body where both adjacent disc spaces are to be fused with ensuring that fastening devices (screws) don’t interfere with one another [Michelson, para.10, wherein Michelson teaches that constructing the apertures of the implant(s) with a set pattern ensures that screws affixing implants at different vertebral levels do not interfere with one another], and since 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.
Waugh supported by Michelson discloses the limitations of claim 1, as above, and further, Waugh discloses:
Claim 3, wherein the anterior and posterior sides have superior and inferior curved edges that adjoin said outer perimeter surface to the upper and lower surfaces, respectively, and are configured to reduce frictional interference with adjacent body portions [Figs. 13 – 14, the connecting edges between the outer perimeter and the upper/lower surfaces 408 and 410 being curved].
Claim 4, wherein the upper and lower surfaces of the cervical implant further include ridges for engaging the first and second cervical vertebral bodies [similar to engaging features 120, projecting from the upper and lower surfaces of the implant, Figs.3 and 14, para.49].
Claim 5, wherein the fastening devices comprise screws, pins, staples, or bollards [106, Fig.3].
Claim 6, wherein at least one of the upper and lower surfaces is a domed surface [paras.28 and 56, interface with the load bearing endplates of the upper and lower vertebrae, and wherein the preparation of endplate of vertebra 14 may result in a surface contour, i.e. pocket that match bone engaging features 120 on surfaces of the implant].
Claim 7, wherein the upwardly projecting aperture is centrally located on the anterior side [middle aperture 126 or 420 being centrally located between far apertures, Figs. 4 and 13].
Claim 8, wherein one or more of the apertures comprises guide portions configured for engagement with corresponding guide portions of a fastening device [wall portions of at least one of apertures 420 define guide portions capable of guiding a fastening device, i.e. Fig.4].
Claims 10 – 11, Waugh discloses a cervical implant [abstract, para.26, Figs. 1 – 2 and 12-14 and Figure 12 to Waugh, above]comprising:
an upper surface [at least a surface portion of one of: 108 or 110 for the cage 100, or 408 or 410 for the cage 400] having a contact area configured for engaging an inferior surface of a first cervical vertebral body [the upper surface defines a contact area for contacting a cervical body], and a lower surface [at least a surface portion of the other one of: 108 or 110 for the cage 100, or 408 or 410 for the cage 400] having a contact area configured for engaging a superior surface of a second cervical vertebral body [the lower surface defines a contact area for contacting a cervical body],
an opening [118 or that identified in Figure 12 above] formed through the upper and lower surfaces to define an interior portion for receiving bone growth material [para.62];
an outer perimeter surface extending in between said upper and lower surfaces [defined by the surfaces, i.e. 112a-b, 114, and 116 for the cage 100, or 412a-b, 402 and 414 for the cage 400, extending between the upper and lower surfaces surrounding the implant], said outer perimeter surface including an anterior side [by 116, 414, Figs.4 and 13] and an opposite posterior side [by 114, 402, Figs.4 and 13];
one upwardly projecting aperture [middle aperture 126 or 420] that extends through said anterior side and said upper surface and projects upwardly towards the first cervical vertebral body [Figs.4 and 13, wherein the middle aperture extends through the anterior side and one of the surfaces of the cage defining the upper surface]; and two downwardly projecting apertures [far apertures 126 or 420] that extend through said anterior side and said lower surface and project downwardly towards the second cervical vertebral body for receiving fastening devices [Figs.4 and 13, wherein the far apertures extend through the anterior side and the other one of the surfaces of the cage defining the lower surface], each of said downwardly projecting apertures having proximal and distal openings and a channel extending therebetween [Figs.4 and 13, wherein each of the far apertures defines entrance and exit openings and a channel extending therebetween], the proximal openings of said downwardly projecting apertures lying within angled planes relative to said outer perimeter surface [Figs.4 and 13, wherein each of the proximal openings defines a portion of the anterior side and a portion of one of the surfaces of the cage], each of said downwardly projecting apertures further comprising a longitudinal axis that extends at an angle from an axis extending perpendicularly through the cervical implant [Fig.12 above, angled with respect to an axis perpendicular to upper /lower surfaces of the implant].
Waugh does not explicitly disclose wherein, in each of the cervical implants, the longitudinal axes of the two downwardly projecting apertures extend at an angle between about 40 degrees and about 50 degrees or between about 44 degrees and about 46 degrees from an axis extending perpendicularly through the cervical implant.
It would have been obvious to one having ordinary skill in the art at the time of the invention to construct the far apertures [420] of the implants of Waugh to have angles between about 40 degrees and about 50 degrees or between about 44 degrees and about 46 degrees from an axis extending perpendicularly through the cervical implant, in order to facilitates guiding fastening devices therethrough, along their axes and into at least one of adjacent superior and inferior vertebral bodies for securing the implant in place between the adjacent superior and inferior vertebral bodies [Waugh, abstract, para.2], while providing the implants of Waugh with a configuration that allows fastening devices (screws) from different implants implanted at adjacent levels of the vertebral column to pass each other within a vertebral body where both adjacent disc spaces are to be fused with ensuring that fastening devices (screws) don’t interfere with one another [Michelson, para.10, wherein Michelson teaches that constructing the apertures of the implant(s) with a set pattern ensures that screws affixing implants at different vertebral levels do not interfere with one another], and since 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.
Waugh supported by Michelson discloses the limitations of claim 10, as above, and further, Waugh discloses:
Claim 12, wherein the outer perimeter surface includes two opposing sides connecting the anterior side to the posterior side [112a-b, 114 for the cage 100, or 412a-b for the cage 400], and wherein the outer perimeter surface comprises superior and inferior curved edges that adjoin said two opposing sides to the anterior and posterior sides, respectively, and are configured to reduce frictional interference with adjacent body portions [Figs. 13 – 14, the connecting edges between the outer perimeter and the upper/lower surfaces 408 and 410 being curved].
Claim 13, wherein the superior and inferior curved edges comprise a continuous curve between the anterior and posterior sides and the two opposing sides [Figs. 13 – 14, the connecting edges between the outer perimeter and the upper/lower surfaces 408 and 410 being curved].
Claim 14, wherein one or more of the apertures comprises guide portions configured for engagement with corresponding guide portions of a fastening device [wall portions of at least one of apertures 420 define guide portions capable of guiding a fastening device, i.e. Fig.4].
Claim 16, wherein the second cervical vertebral body is at an immediate adjacent level inferior to the first cervical body [Fig.2].
Claim 17, wherein the anterior and posterior sides have superior and inferior curved edges that adjoin said outer perimeter surface to the upper and lower surfaces, respectively, and are configured to reduce frictional interference with adjacent body portions [Figs. 13 – 14, the connecting edges between the outer perimeter and the upper/lower surfaces 408 and 410 being curved].
Claim 18, wherein the upper and lower surfaces of the cervical implant further include ridges for engaging the first and second cervical vertebral bodies [similar to engaging features 120, projecting from the upper and lower surfaces of the implant, Figs.3 and 14, para.49].
Claim 19, wherein the fastening devices comprise screws, pins, staples, or bollards [106, Fig.3].
Claim 20, wherein at least one of the upper and lower surfaces is a domed surface [paras.28 and 56, interface with the load bearing endplates of the upper and lower vertebrae, and wherein the preparation of endplate of vertebra 14 may result in a surface contour, i.e. pocket that match bone engaging features 120 on surfaces of the implant].
Claims 9 and 15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Waugh et al. (US Pub. 2008/0249569 A1) supported / evidenced by Michelson (US 2002/0099376 A1), as above, and further in view of Waugh et al. (US Pub. 2008/0249575 A1).
Waugh ‘569 discloses the limitations of claims 8 and 14, as above, except for explicitly disclosing wherein the guide portions each comprise a substantially annular projection between the proximal and distal openings, the substantially annular projection extending outward into the channel and being configured to maintain the fastening device substantially within a three degree cone angle.
Waugh ‘575 teaches an analogous implant [abstract, Figs. 7 – 8] having an aperture [206] having a substantially annular projection extending outward into the channel between openings of the aperture [defined by at least an annular portion by the tapering surface 234, defining annular projection into the channel, Fig.8], the substantially annular projection is capable of maintaining the fastening device substantially within a three degree cone angle [Fig.8].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Waugh ‘569 and Waugh ‘575, and construct the aperture of Waugh ‘569 having the annular projection of Waugh ‘575. One would have been motivated to do so in order to facilitate directing the fastening device through the aperture at a desired angle for securing the implant in place against vertebrae [Waugh ‘575, ¶41].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL S. HANNA whose telephone number is (571)270-3248. The examiner can normally be reached 8-5 M-F.
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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775
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