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 the papers filed on May 21, 2026 and May 28, 2026.
The examiner acknowledges receiving an executed Declaration under 37 C.F.R. § 1.132 executed by Dr. Michiya Matsusaki on February 06, 2025 (“Matsusaki Declaration ”), and filed on 02/07/2025.
The examiner acknowledges receiving an executed Declaration under 37 C.F.R. § 1.132 executed by Dr. Michiya Matsusaki on September 24, 2025 (“ 2nd Matsusaki Declaration ”), and filed on 09/24/2025.
Claims 1 and 30 are amended, claims 8-12 and 31 are canceled, and claims 32-33 have been newly added as set forth in Applicant’s amendments filed on 05/21/2026.
No claims are amended, claim 33 is canceled, and claim 34 have been newly added as set forth in Applicant’s amendments filed on 05/28/2026.
Claims 1 and 34 are independent.
Therefore, claims 1, 4-6, 13-21, 28-30, 32 and 34 are pending in the application and examined on the merits.
Priority
The present application is a Continuation of a national stage filing of International Application No. PCT/JP2017/006691 filed 02/22/2017
Applicant’s claim for the foreign benefit of Japanese Application 2016-030916 filed 02/22/2016 is acknowledged.
Thus, the earliest possible priority for the instant application is February 22, 2016.
Response to arguments
Withdrawn objections/ Rejections in response to Applicants’ arguments or amendments
Claim Objections
Claim 30 has been amended to correct the unit measurement. Therefore, the claim objection is withdrawn.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 4-13, 16-18, 22, and 28-31 under 35 U.S.C. 103 as being unpatentable over Nishiguchi (Jan 2015. Macromol. Biosci., 15, 312–317; IDS Reference filed on 08/20/2018; Applicant’s own work) in view of Suri (Tissue Engineering Part A 16.5 (2010): 1703-1716) is withdrawn.
Applicant’s arguments and amendments filed 05/21/2026 and 05/23/2026 have been considered and are persuasive.
Applicant has argued unexpected results in their utilization of specific components such as Tris, collagens and heparin at specific concentrations which are now reflected in the claims. Therefore, the claims have been placed in commensurate with the scope of unexpected results found in Table 4. As pointed out by Applicant and discussed previously in the Interview held 05/12/2026, the thickness of the present invention surpasses that of the prior art of Nishiguchi as reflected in the data of Table 4 as the Fibronectin/heparin data set and in the previous Declaration’s calculations of Suri.
The rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over Nishiguchi (supra) in view of Suri (supra) as applied to claim 1 above and in further view of Nakamura et al. (2014. J Periodont Res 49: 363- 370) is withdrawn.
Applicant’s arguments and amendments filed 05/21/2026 and 05/23/2026 have been considered and are persuasive.
Applicant has argued unexpected results in their utilization of specific components such as Tris, collagens and heparin at specific concentrations which are now reflected in the claims. Therefore, the claims have been placed in commensurate with the scope of unexpected results found in Table 4. As pointed out by Applicant and discussed previously in the Interview held 05/12/2026, the thickness of the present invention surpasses that of the prior art of Nishiguchi as reflected in the data of Table 4 as the Fibronectin/heparin data set and in the previous Declaration’s calculations of Suri.
The rejection of claims 14, 15, 20 and 21 under 35 U.S.C. 103 as being unpatentable over Nishiguchi (supra) in view of Suri (supra) as applied to claim 1 above, and in further view of Nishiguchi2 (2011. Adv. Mater. 23, 3506–3510; Applicant’s own work) is withdrawn.
Applicant’s arguments and amendments filed 05/21/2026 and 05/23/2026 have been considered and are persuasive.
Applicant has argued unexpected results in their utilization of specific components such as Tris, collagens and heparin at specific concentrations which are now reflected in the claims. Therefore, the claims have been placed in commensurate with the scope of unexpected results found in Table 4. As pointed out by Applicant and discussed previously in the Interview held 05/12/2026, the thickness of the present invention surpasses that of the prior art of Nishiguchi as reflected in the data of Table 4 as the Fibronectin/heparin data set and in the previous Declaration’s calculations of Suri.
Maintained objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 112(b)
Claims 1, 4-6, 13-21 and 28-31 remain rejected and claims 32 and 34 are newly 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.
Regarding claims 1 and 34, the term “a liquid portion” in line 7 of claim 1 and in line 12 of claim 34 is indefinite. The metes and bounds of “portion” is not defined by the claims nor the specification. The amount could be 1% to 99% of the total amount of the liquid which is removed in order to obtain an aggregate. As advised in the Interview Summary filed 05/14/2026, the language of “portion” is advised to be removed from the claim.
Moreover, in claims 1 and 34, the phrases which recite an amount of component “mg/mL or more to […] mg/mL or less” renders the metes and bounds of the invention unclear. The phrase could be taken to mean the range of concentrations is between the two values or that the range is more narrow than the broader range which is recited. In order to correct the limitation, Applicant is advised, as stated in the Interview Summary filed 05/14/2026, to amend the limitations to read as a range of the compounds between two amounts utilizing language such as “between” and “to” and omit language of “or more” and “or less.”
All other claims depend on independent claim 1 and therefore, are also rendered indefinite.
In response to Applicant’s arguments and amendments regarding the 112b rejections,
Applicant’s amendments and arguments filed on 05/21/2026 and 05/28/2026 have been considered, however they are not persuasive.
Applicant states in the Remarks filed 05/21/2026 that “Applicant believes that the amendments of claim 1 to recite ‘a liquid portion’ […] overcome the issues raised.”
Examiner disagrees. As discussed in the Interview on 05/12/2026, and reflected in the Interview Summary of 05/14/2026, claims which still recite the term “portion” are still considered indefinite as portion does not define the metes and bounds of the invention. The removal of “a portion” could be a single drop or complete removal of all liquid components through centrifugation. Moreover, as discussed in the Interview and reflected in the Interview Summary, the proposed amendments that were presented had language which recites “or more” and “or less” as a range. In the Proposed Amendments section in the Interview Summary filed 05/14/2026, it was discussed that the removal of this language would better communicate to an artisan what the invention’s metes and bounds are and that language such as “between” or “to” were recommended to be amended into the claims instead.
Therefore, the 112b rejection is maintained.
Conclusion
No claims are allowed.
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.
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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634 /MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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