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 .
Election/Restrictions
Applicant's election with traverse of Claims 1-10 in the reply filed on August 13, 2025 is acknowledged. The traversal is on the grounds that there would not be a search burden. This is not found persuasive because the method claims for preparing the implant require at least the process steps of drying, dipping, drying, and sterilizing that are not found in the limitations claimed for the device of claims 1-10. Proper unity of invention was established in the restriction requirement set forth on June 17, 2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 13, 2025.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 5 is objected to for claiming an element that is not disclosed in the specification. Claim 5 as amended recites that the protective layer is “free from any salt.” The specification does not support this claim, as the specification in [0027] discloses that the protective layer is “essentially free from any salts” which indicates that some salt may be present.
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.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gilgenbach Blume et al. (US 2022/0087784 A1, hereinafter “Gilgenbach Blume”) in view of Van Dyke (US 2015/0367043) in further view of Cardamone (US 8,530,626 B1).
Regarding Claims 1 and 10, Gilgenbach Blume discloses a dental implant (Figure 1) comprising an implant surface (surfaces as seen in Figure 3) having at least partially a contact angle of less than 20° ([0175]) , the implant surface being at least partially covered with a protective layer (abstract). Gilgenbach Blume discloses the invention substantially as claimed, but does not disclose the use of a keratin hydrolyzate for the protective layer, where the protective layer has a water content of less than 10% by weight.
In the art of coatings for biomedical implants, Van Dyke teaches the use of keratin coatings for coating an implant (abstract). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize a keratin coating as taught by Van Dyke for treatment of an implant surface as is desired by Gilgenbach Blume in order to provide an effective delivery matrix for growth factors (Van Dyke [0012]) thus improving adherence of the implant to the bone structure upon implantation.
Gilgenbach Blume as modified by Van Dyke discloses the invention substantially as claimed, but does not specifically teach that the keratin is in the form of keratin hydrolyzate with a water content of less than 10% by weight.
In the art of keratin elastomer production, Cardamone teaches the use of keratin hydrolysate for biomedical applications (Column 3, lines 20-22, and Column 2 lines 10-15) which is in a powder form and therefore have a water content of less than 10% by weight. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize keratin hydrolysate as taught by Cardamone for the coating of Gilgenbach Blume in view of Van Dyke, in order to provide a coating that could be easily stored, transported, and utilized.
Regarding Claim 2, Gilgenbach Blume as modified by Van Dyke in further view of Cardamone discloses the implant of claim 1 as described above, and Cardamone teaches that keratin has a mean molecular weight of less than 20,000 Daltons (Column 12, lines 10-13, where the molecular weight of keratin protein is 8,000 Daltons). As the molecular weight of keratin is less than 20,000 as taught by Cardamone, the molecular weight of the keratin hydrolysate (i.e. powder) would also be less than 8,000 Daltons as this is a physical property of keratin.
Regarding Claims 3 and 4, Gilgenbach Blume as modified by Van Dyke in further view of Cardamone discloses the implant of claim 1 as described above, and Gilgenbach Blume further teaches that the thickness of the protective layer is in a range from 60 to 170 nm (abstract) which would include a range of 60-90 nm thus falling in the claimed ranges.
Regarding Claims 5 and 6, Gilgenbach Blume as modified by Van Dyke in further view of Cardamone discloses the implant of claim 1 as described above, and Gilgenbach Blume further teaches embodiments where the protective layer is free from any salt ranging to embodiments where the protective layer additionally comprises a salt (see [0172-3] which discloses that one of ordinary skill in the art could adjust the salt concentration from high concentrations to low concentrations, and thus could adjust the amount to zero which would be free from salt).
Regarding Claim 7, Gilgenbach Blume as modified by Van Dyke in further view of Cardamone discloses the implant of claim 1 as described above, and Gilgenbach Blume further teaches that the dental implant is made of ceramic ([0189]).
Regarding Claim 8, Gilgenbach Blume as modified by Van Dyke in further view of Cardamone discloses the implant of claim 1 as described above, and Gilgenbach Blume further teaches that the dental implant surface is provided with surface roughness Sa in a range between 2 and 10 um (as seen in Figure 3 and described in [0133]).
Regarding Claim 9, Gilgenbach Blume as modified by Van Dyke in further view of Cardamone discloses the implant of claim 1 as described above, and Gilgenbach Blume further teaches that the dental implant has a machined surface ([0042]).
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
For example, the applicant argues that Van Dyke teaches away from keratin with a water content of the protective layer of less than 10% by weight, however, the Van Dyke reference is not relied on for this teaching, merely for the teaching of the use of keratin coatings for coating an implant.
Similarly, the Cardamone reference is cited for teaching the use of a keratin hydrolysate for biomedical applications, and in combination with the teachings of Gilenbach Blume in view of Van Dyke as described above would meet the limitations as claimed.
The applicant further argues the functionality and performance characteristics of the present invention, but is reminded that the intended use of the claimed invention 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTINE L NELSON whose telephone number is (571)270-5368. The examiner can normally be reached M - F 7:30-4:30 PT.
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, Eric Rosen can be reached at 571-270-7855. 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.
/CHRISTINE L NELSON/ Examiner, Art Unit 3772
/EDWARD MORAN/ Primary Examiner, Art Unit 3772
Prosecution Insights