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 . This action is in response to Applicant Arguments/Remarks Made in an Amendment. Claims 1, and 21-39 are currently pending.
Response to Arguments
Applicant's arguments filed May 26, 2026 have been fully considered but they are not persuasive. The written description requirement of 35 U.S.C. 112(a) is satisfied only when the originally filed disclosure reasonably conveys to one of ordinary skill in the art that the inventor had possession of the later-claimed subject matter as of the filing date. An amendment may not add subject matter that was not originally disclosed, either expressly or inherently. See MPEP §2163 and 608.04.
Applicant amended both the claims and the specification to include numerous structural relationships and dimensional limitations that were not present in the application as originally filed. The amendments do not merely clarify existing disclosure but instead introduce new positional and dimensional limitations, including, for example, specific thickness relationships, relative elevations between surfaces, curvature extending between identified portions of the implant, alignment relationships, and surface extension relationships.
The originally filed specification does not expressly disclose these limitations, nor does it provide sufficient descriptive support from which one of ordinary skill in the art would reasonably conclude that Applicant possessed these specific features on the filing date. Likewise, the originally filed claims do not provide written description support, they cannot support subject matter that was not originally claimed or otherwise described in the originally filed disclosure.
Applicant’s amendment to the specification cannot sure the deficiency because an amendment to the specification cannot supply written description support for subject matter that was absent from the application as originally filed. Such amendments constitute impermissible new matter under 35 U.S.C 132(a) and 37 CFR 1.121(f). Accordingly, the amendments to the specification do not overcome the written description rejection, and the rejection under 35 U.S.C. 112(a) is maintained (see the rejection below for further explanation).
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 1 and 21-39 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. Regarding claim 1, the specification fails to disclose the first and second sides extend between the top and bottom surfaces and define a thickness of the implant. Regarding claim 21, the specification fails to disclose wherein the thickness of the plate varies between the first end and the second end. Regarding claim 22, the specification fails to disclose wherein the body portion comprises a thickness greater than a thickness of the proximal portion of the distal portion. Regarding claim 24, the specification fails to disclose wherein the thickness of the body is greater than the thickness of the posterior portion of the implant. Regarding claim 25, the specification fails to disclose the implant extends farther from the top surface of the implant as the bottom surface extends between the proximal portion and the body portion. Regarding claim 26, the specification fails to disclose the implant extends farther from the top surface of the implant as the bottom surface extends between the distal portion and the body portion. Regarding claim 27, the specification fails to disclose wherein the top surface of the implant is substantially level between the proximal portion and the body portion. Regarding claim 28, the specification fails to disclose wherein the top surface of the body portion is positioned below the top surface of the distal portion. Regarding claim 29, the specification fails to disclose wherein the body portion is curved between the proximal portion and the distal portion. Regarding claim 30, the specification fails to disclose wherein the curvature extends between the first side and the second side of the implant. Regarding claim 31, the specification fails to disclose wherein the thickness of the body portion is the largest thickness of the implant. Regarding claim 32, the specification fails to disclose wherein the first and second alignment guides couple to the top surface of the implant for inserting a bone screw by each of the first and second alignment guides below the bottom surface of the implant. Regarding claim 34, a thickness of the body portion being greater than a thickness of the implant. Regarding claim 35, the specification fails to disclose the curvature comprises the bottom surface extending in a direction opposite that of the top surface along a curved path. Regarding claim 36, the specification fails to disclose a curvature the proximal portion of the implant and the body portion of the implant are aligned. Regarding claim 39, the specification fails the first and second sides extend between the top and bottom surfaces and define a thickness that is greater than the thickness of the proximal and distal portions of the implant.
The originally filed disclosure does not expressly or inherently disclose these specific structural and dimensional relationships. Accordingly, the originally filed application fails to demonstrate possession of the claimed subject matter as required by 35 U.S.C. 112(a).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Jeng et al. (US 2016/0354128), alone or in combination fails to teach or suggest a first alignment guide comprises: an alignment pin extending away from a bottom portion of the first alignment guide and removably couplable with a first alignment opening of the implant; and a first engagement member of a first fixation member extending through a portion of the first alignment guide and removably couplable with a first engagement opening of the implant and, wherein the second alignment guide comprises: an alignment pin extending away from a bottom portion of the second alignment guide and removably couplable with a second alignment opening of the implant; and a second engagement member of a second fixation member extending through a portion of the second alignment guide and removably couplable with a second engagement opening of the implant. The cited prior art neither discloses nor renders obvious this feature, and there is no teaching, suggestion, or motivation that would have led one of ordinary skill in the art to modify or combine the references to arrive at the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
Prosecution Insights