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 because of heavy shading (Figs. 4A-4D and 5) making it difficult to see the details. 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 37-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 14 and 15 of U.S. Patent No. 12156821.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the pending claims of the present application and the patented claims is that the patented claims are more specific. Thus, the invention of the patented claims is in effect a “species” of the “generic” invention of the claims of the present application. 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 claims of the present application are anticipated by the patented claims, they are not patentably distinct from the patented 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.
Claims 22, 34 and 40 are 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 22, the recitation “non-adjustable” and in claim 40, the recitation “non-adjustable implant” seeks to introduce new matter. Applicant’s disclosure, as originally filed, does not describe this type of implant.
In claim 34, the recitation “evenness condition” seeks to introduce new matter. Applicant’s disclosure, as originally filed, does not describe this condition.
Appropriate correction is required.
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 22, 31-34 and 40 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.
In claims 22 and 40, the recitation “non-adjustable” is not described in Applicant’s disclosure to understand the scope of Applicant’s invention. Applicant does not define the structure or features of a “non-adjustable” cage. For examination, “non-adjustable” is interpreted to mean a cage having a fixed shape with a height that is not adjustable during or after implantation.
In claim 31, the recitation “prior to inserting the adjustable cage template” followed by “…inserting a second adjustable cage template” renders the claim vague and indefinite because it is unclear what the first adjustable cage template is. It appears that the adjustable cage template in claim 21 is the first adjustable cage template.
In claim 34, the recitation “evenness condition” renders the claim vague and indefinite because it is not described in Applicant’s disclosure to understand the scope of Applicant’s invention. For examination, “evenness” is interpreted to mean a desired force applied by the adjacent vertebrae on the implant.
Appropriate correction is required.
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(s) 21-28, 30, 31, 34, 37 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aryan (US 9820869).
Regarding claims 21, 30 and 37, Aryan discloses a method of inserting an instrumented cage or adjustable cage template (the functional recitation “adjustable” is not supported by recitation of structure and the instrumented cage 102 (Figs. 1 and 5-7) of Aryan is capable of being replaced with a differently-sized and shaped cage, interpreted to mean adjustable) disposed at a distal end of a sizing tool (insertion handle and instrumented distractor) into a spinal cavity between two vertebra segments; adjusting, by the sizing tool, a configuration of the trial or adjustable cage template, wherein adjusting the configuration of the adjustable cage template is configured to modify a lordotic angle of the adjustable cage template, a height of the adjustable cage template, or both; and replacing the sizing tool and the adjustable cage template with an interbody implant (appropriately-sized instrumented cage) based on an adjusted configuration of the adjustable cage template in the same location as the adjustable cage template, wherein the adjusted configuration of the adjustable cage template is based at least in part on the adjusting of the adjustable cage template (Figs. 5, col. 3, lines 25-62, col. 4, lines 5-23).
Regarding claims 22 and 40, once a particular size of the instrumented cage works for an intervertebral space, the cage is fixed and interpreted to mean “non-adjustable.”
Regarding claim 23, Aryan discloses measuring, by a plurality of sensors of the adjustable cage template, forces applied to the adjustable cage template by at least one of the two vertebra segments, wherein adjusting the configuration of the adjustable cage template is performed based on the forces applied to the adjustable cage template measured by the plurality of sensors of the adjustable cage template to identify a satisfactory configuration of the adjustable cage template (col. 4, lines 34-51).
Regarding claim 24, Aryan discloses: generating, by the plurality of sensors of the adjustable cage template, sensor data based on the forces applied to the adjustable cage template by the at least one of the two vertebra
segments; sending, by the plurality of sensors of the adjustable cage template, the sensor data to one or more processors; and outputting, by the one or more processors, information associated with the forces applied to the adjustable cage template, wherein the information associated with the forces applied to the
adjustable cage template includes pressure data (Fig. 2).
Regarding claim 25, Aryan discloses outputting the information associated with the forces to include transmitting the information associated with the forces applied to the adjustable cage template to a remote device for display (Fig. 2).
Regarding claim 26, Ayran discloses at least one sensor of the plurality of sensors of the adjustable cage template disposed about a peripheral edge (sidewall) of the adjustable cage template (col. 4, lines 34-51 and Figs. 5-7).
Regarding claim 27, Aryan discloses a sensor disposed about a central aperture of the adjustable cage template (Fig. 5).
Regarding claim 28, Aryan discloses a plurality of sensors (force and/or pressure, Fig. 1) disposed about or near a sidewall or peripheral edge of the adjustable cage implant and a central aperture of the cage implant (Fig. 6 and col. 4, lines 34-51).
Regarding claim 31, Aryan discloses inserting a first or second adjustable cage template in the spinal surgery involving the two vertebra segments; determining whether a satisfactory configuration of the second or first adjustable cage template is achievable using the second or first adjustable cage template; and selecting a different (either first or second) cage template in response to determining that a satisfactory configuration of the second adjustable cage template is not achievable using the second adjustable cage template, wherein the different cage template is the adjustable cage template (col. 6, lines 25-67).
Regarding claim 34, Aryan discloses the determining whether the satisfactory configuration of the second or first adjustable cage template is achievable using the second or first adjustable cage template includes determining whether a distribution of compressive forces between the second adjustable cage template and the two vertebra segments satisfies an evenness condition (col. 4, lines 24-33).
Claim(s) 37 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernhardt et al. (US 9937055).
Regarding claim 37, Bernhardt et al. disclose a method of switching between trials including: inserting a first trial or adjustable cage template 104 (“portions 116a and 116b are rotatable or linearly movable (col. 6, lines 18-59)” and thus the cage template 104 is interpreted to be adjustable because no specific structure of adjustable cage template is being claimed) disposed at a distal end of an inserter or sizing tool 202 into a spinal cavity; determining whether a satisfactory configuration of the first adjustable cage template is achievable using the first adjustable cage template for implanting a cage implant between the two vertebra segments; selecting, in response to determining that a satisfactory configuration of the first adjustable cage template is not achievable using the first adjustable cage template (interpreted to mean not an appropriate size), a second trial or adjustable cage template; removing the first adjustable cage template from the spinal cavity; inserting the second adjustable cage template into the spinal cavity; and determining whether a satisfactory configuration of the second adjustable cage template is achievable using the second adjustable cage template for implanting the cage implant between the two vertebra segments (Figs. 7-11, col. 3, lines 56-67, col. 4, lines 1-5, col. 5, lines 50-67 and col. 6, lines 1-67 and col. 7, lines 1-44).
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.
In the alternate, claim(s) 21-26, 29, 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Zucker et al. (US 20220008221A1) in view of Landry et al. (US 7637952).
Regarding claims 21 and 30, Zucker et al. disclose a method of inserting a trial or adjustable cage template disposed at a distal end of a sizing tool (robotic arm or manually, paras [0028] and [0052]) and into a spinal cavity (disc space, para [0029]) between two vertebra segments; adjusting, by the sizing tool, a configuration of the trial or adjustable cage template, wherein adjusting the configuration of the adjustable cage template is configured to modify a lordotic angle of the adjustable cage template, a height of the adjustable cage template, or both (paras [0029]-[0031], [0065]-[0073]); and replacing the sizing tool and the adjustable cage template with an interbody implant based on an adjusted configuration of the adjustable cage template in the same location as the adjustable cage template, wherein the adjusted configuration of the adjustable cage template is based at least in part on the adjusting of the adjustable cage template (Fig. 5 and paras [0078]-[0087]).
Regarding claim 23, Zucker et al. disclose measuring, by a plurality of sensors of the adjustable cage template, forces applied to the adjustable cage template by at least one of the two vertebra segments, wherein adjusting the configuration of the adjustable cage template is performed based on the forces applied to the adjustable cage template measured by the plurality of sensors of the adjustable cage template to
identify a satisfactory configuration of the adjustable cage template (“one or more sensors 134 are used to measure a force or pressure exerted on the adjustable cage template to ensure that the force or pressure does not exceed a predetermined threshold (interpreted to mean a satisfactory configuration),” para [0047]).
Regarding claim 24, Zucker et al. discloses: generating, by the plurality of sensors of the adjustable cage template, sensor data based on the forces applied to the adjustable cage template by the at least one of the two vertebra
segments; sending, by the plurality of sensors of the adjustable cage template, the sensor data to one or more processors; and outputting, by the one or more processors, information associated with the forces applied to the adjustable cage template, wherein the information associated with the forces applied to the
adjustable cage template includes pressure data (“For example, the communication interface 138 may be utilized for receiving operating instructions and/or control signals from an external source (such as the computing device 102, the robot 140), and/or for transmitting data (e.g., corresponding to one or more measurements made by the gauge(s) 136) or other information to an external system or device (e.g., the computing device 102, the robot 140, the database 144, the cloud 148, and/or a portable storage medium (e.g., a USB drive, a DVD, a CD)). In some embodiments, the communication interface 138 may be useful for enabling the device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason,” para [0050]).
Regarding claim 25, Zucker et al. disclose outputting the information associated with the forces to include transmitting the information associated with the forces applied to the adjustable cage template to a remote device for display (para [0058]).
Regarding claim 26, Zucker et al. disclose at least one sensor of the plurality of sensors of the adjustable cage template disposed about a peripheral edge of the adjustable cage template (Figs. 4A-4C).
Regarding claim 29, Zucker et al. disclose the adjustable cage template to include a top portion and a bottom portion, and wherein the plurality of sensors of the adjustable cage template includes at least one sensor included in the top portion and at least one sensor included in the bottom portion (Figs. 4A-4C).
Regarding claims 21-26, 29, 30 and 40, Zucker et al. disclose all elements of the claimed invention except for: (1) an interbody implant in the form of a cage implant (claims 21 and 30); (2) and interbody implant that is non-adjustable (claims 22 and 40).
It is well known to use an interbody implant in the form of a cage in a spinal fusion procedure, as evidenced by Landry et al. (Figs. 2 and 10, col. 2, lines 37-53, col. 9, lines 11-17 and col. 11, lines 14-28). Landry et al. also disclose providing a set or kit of implant members of various sizes and lordotic alignment (col. 3, lines 12-46).
It would have been recognized by one of ordinary skill in the art that applying the known technique of selecting an appropriately-sized interbody implant in the form of a cage from a set of cages provided in various sizes, after implementing the method of Zucker et al., would have yielded predictable results, i.e., success of the fusion procedure by selecting an appropriately-sized implant to restore lordosis of the patient’s spine.
Allowable Subject Matter
Claims 32 and 33 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.
Claims 35 and 36 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Non application of prior art to claims 38 and 39 indicates allowable subject matter provided the double-patenting rejections made in this office action are overcome.
The primary reason for indicating allowable subject matter: closest prior art cited in the attached PTO-892 and in the related parent application cite some features of Applicant’s claimed invention, either singly or in combination, for e.g. art used in the rejections in this office action. However, no references or a reasonable combination thereof, could be found which disclose all the elements of Applicant’s invention in the claims listed in this section.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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February 21, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775