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 .
Applicant’s amendment and response filed on 9/30/2025 has been received and entered into the case.
Claims 9 and 12-14 have been canceled, and claims 1-8, 10-11 and 15-20 have been considered on the merits. All arguments have been considered.
The claim rejection under 35 USC 112 has been withdrawn due to the instant amendment.
Claim Rejections - 35 USC § 103 (maintained)
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.
Claim(s) 1-8, 10-11 and 15-20 stand rejected under 35 U.S.C. 103 as being unpatentable over Mastelli et al. (EP2407147; IDS ref.) in view of Yamada et al. (US 2009/0274627), Tribble et al. (2000, Periodontol.) and Casale et al. (2016, Int. J. Immunopathol. Pharmacol.) for the reason set forth in the OA mailed on 6/5/2025.
Response to Arguments
Applicant stated that applicants have demonstrated, within the constraints of the experimental model chosen, i.e., the in vitro culture of fibroblasts, that the combination of PN and HA shows statistically significant improvement in cell viability over the control at doses as low as 2.5 mg/ml, and it must be noticed that there are the limitations that affect all in vitro tests in general and not just the model selected and applied by Mastelli.
As discussed in the OA mailed on 6/5/2025, the Examiner has concluded that there is synergism at the concentration of HA and PN at 2.5 mg/ml each and total 5.0 mg/ml based on the data shown in the declaration filed on 5/16/2025.
However, the claimed concentrations of PN and HA (1-20 mg/ml or 5-12 mg/ml) are significantly higher (more than 1000 fold) than the concentration shown in the declaration. It is noted that the instant specification provides synergism between PN and HA for the in vitro gingival fibroblast culture study as shown in Table 3. Again the concentrations of the PN and HA utilized in the in vitro study are not commensurate with the claimed concentration. While there is a synergistic effect of HA and PN in vitro cell culture method, however, this does not necessarily provide if the same synergism exists for the method of regenerating interdental papilla in vivo at the concentrations of PN and HA as claimed. As applicant did not provide any evidence supporting the alleged synergistic effect of using the PN and HA at the claimed concentration for the in vivo method as claimed, it is considered that there is no unexpected results for the concentration of PN and HA utilized in the claimed method.
Therefore, it is the Examiner’s position that the teachings of Mastilli et al. in view of Yamada et al., Tribble et al. and Casale et al. would render the claimed invention obvious.
Conclusion
No claims are allowed.
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 TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES SCHULTZ can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631