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 .
Election/Restrictions
Claims 1, 4, 9, 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/10/25.
Applicant's election with traverse of Group I in the reply filed on 11/10/26 is acknowledged. The traversal is on the ground(s) that there is no serious burden on the Examiner to search the subject matter of Invention I and Invention II. This is not found persuasive because Group II is using a computer system capable of finding and using the patient’s specific bone void to develop and create the implant. Group II uses a 3D scan system, sending the information to a computer, the computer developing a #D model with the exact dimensions and then sending the information to a system that can create and match the exact bone void in an implant. Therefore, the Examiner maintains the restriction.
The requirement is still deemed proper and is therefore made FINAL.
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 6 and 12 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.
Neither the claims or the specification clearly identifies the denominator or test for “percentage of BMP exposed”. It is unclear whether 8% refers to total native BMP, weight percentage, surface exposure, extractable BMP, etc…
Claim Rejections - 35 USC § 102
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 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.
Claims 2, 7, 21-24 and 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tjon US patent Pub. 2020/0337774A1.
Regarding claims 2, 21-24, 28 and 29, Tjon discloses a method of forming an allograft or xenograft bone plug comprising acquiring scan data including a virtual three-dimensional (3D) image of a patient including a bone void at a surgical site; selecting at least one dimension of the bone void of the patient from the virtual 3D image; developing a 3D virtual representation of a bone plug; and selecting at least one feature of the 3Dvirtual representation of the bone plug based on the selected at least one dimension of the bone void. See paragraphs 10-14 and 17.
Regarding claim 7, see col. 3, lines 16-35.
Regarding claim 27, it is inherent to store in a database the scanned data of a patient. It can be in a backup database, in the cloud, etc..
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6, 8, 12-14, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Tjon US patent Pub. 2020/0337774A1 in view of Scarborough US Patent Pub. 2008/0058953.
Tjon discloses the invention substantially as claimed. However, Tjon is silent regarding demineralization, the type of solution used to demineralize the bone plug and does not disclose the different percentage of BMP in different regions of the implant and does not disclose that the desired percentage of BMP exposed after the demineralization is less than or equal to about 8%.
Regarding claims 8, 13, 14, 25 and 26, Scarborough discloses a cortical implantable matrix capable of being demineralized by a hydrochloric acid for the purpose of reducing the amount of mineral in the allograft or xenograft bone for the purpose of exposing the matrix to certain percentage of BMP. The implantable matrix composed of the different structures, the first region (22) of lesser demineralization (lesser exposure of BMP) and a second region (24) of greater demineralization (greater exposure of BMP) for the purpose of imparting a degree of flexibility in certain areas and imparting some strength to other areas to provide structural support.
It would have been obvious to one ordinary skill in the art to modify the bone plug of the Tjon reference with the demineralized bone matrix of the Scarborough reference to provide some degree of flexibility to certain areas and provide strength to other areas of the implant, in addition to expose a larger amount of BMP for the purpose of promoting the growth of bone tissue through the porous matrix of the implant.
Regarding claims 6 and 12, Scarborough disclose the claimed invention except for the percentage of BMP exposed after the demineralization (less or equal to 8%). It would have been obvious to one having ordinary skill in the art at the time the invention was made to expose less than 8% of BMP after demineralization, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM 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, Thomas Barrett can be reached at 571-272-4746. 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.
/ALVIN J STEWART/Primary Examiner, Art Unit 3799 9/11/26
Prosecution Insights