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 .
DETAILED ACTION
Claim Status
Applicant's amendment filed December 15, 2025 has been received and entered.
Claims 1, 3-5, 7, 9, and 13-14 have been amended.
Claims 2 and 11-12 have been canceled.
Claim 15 has been added.
Claims 1, 3-10, and 13-15 are pending and under consideration.
Priority
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 of PCT/JP2021/029387 filed August 6, 2021, which claims the benefit of Japan Applications 2020-135294 filed August 7, 2020 and 2021-081152 filed May 12, 2021.
Receipt is acknowledged of certified English translations of foreign priority documents JN2020-135294 - August 7, 2020 and JN2021-081152 - May 12, 2021 as required by 37 CFR 41.154(b) and 41.202(e).
However, Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
Claims 1, 3-4, 6-10, and 13-15 have the benefit of priority for application JN2020-135294 filed August 7, 2020. However, the disclosure of the prior-filed applications JN2020-135294 and JN2021-081152 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 5 is drawn to adjuvants, including saponin adjuvants.
The specifications of prior applications JN2020-135294 and JN2021-08115 do not disclose the subject matter of the presently claimed invention. Specifically, the prior applications do not contemplate saponin adjuvants derived from Quillaja saponaria or Quillaja saponin. The first disclosure of the instant invention as recited is in PCT/JP2021/029387 filed August 6, 2021. Accordingly, instant claim 5 is not entitled to the benefit of the prior application dates of August 7, 2020 May 12, 2021.
Should Applicant disagree with the examiner’s factual determination as to the disclosure of the claim limitation, Applicant may point out the particular places within JN2020-135294 and JN2021-081152 which discloses the specific subject matter. Accordingly, PCT/JP2021/029387 filed August 6, 2021 will be used for the purpose of applying art to claim 5.
Specification
In view of the Applicant’s amendment, the previous objections to the specification are withdrawn.
Claim Objections
In view of the Applicant’s amendment, the previous claim objections are withdrawn.
Claim Rejections - 35 USC § 112(b) and 35 USC § 101
In view of the Applicant’s claim amendments, the previous grounds of rejection are withdrawn. The following are new grounds of rejection necessitated by Applicant’s claim amendments. However, Applicant’s arguments relevant to the new grounds of rejection will be addressed below.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 3-10, and 13-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites “a combined preparation” which indicates the claim is directed to a product. However, the claim also recites “the second preparation is applied to the skin, followed by the first preparation being applied to the same site”, which suggests the claim requires method steps. As such, it is unclear whether the claim is directed to a product or a method, and therefore what constitutes infringement of instant claim 1.
Claims 3-10 and 13-14 are included in the rejection because they depend from or otherwise require all the limitations of the rejected claim and fail to clarify the issue.
Response to Arguments
Applicant has argued on pg. 6 in the Reply received December 15, 2025 that the claims are no longer indefinite as the rejected claims have been canceled.
Applicant’s arguments filed December 15, 2025 have been fully considered but they are not persuasive.
The limitations of previously rejected claim 2 (now canceled) were added to instant claim 1, however, the same issue remains as to whether the claim is drawn to a product or a method as set forth above.
Claim Rejections - 35 USC § 103 - Maintained/Updated
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 and 3-10 are rejected under 35 U.S.C. 103 as being obvious over Okubo et al. (US 2014/0220057) (“Okubo”), in view of Yamaguchi et al. (US 2010/0256174) (“Yamaguchi”).
The instant claims are drawn to a combined preparation comprising a first preparation for transdermal administration comprising an antigenic peptide and an aliphatic carboxylic acid-based ionic liquid, and a second preparation for transdermal administration comprising an adjuvant and an aliphatic carboxylic acid-based ionic liquid, wherein the second preparation for transdermal administration is applied to the skin and then the first preparation for transdermal administration is applied to the same site, wherein the antigenic peptide is a WT1 cancer antigenic peptide, wherein the adjuvant is resiquimod, wherein the aliphatic carboxylic acid-based mixed ionic liquid selected from salts of ethanolamine, diethanolamine or triethanolamine with a short-chain fatty acid and an aliphatic carboxylic acid-based ionic liquid having 2 to 20 carbon atoms, wherein each of the first and second preparations for transdermal administration further comprises an excipient. Further, the combined preparation is a preparation for a vaccine and is an agent for inducing cytotoxic T lymphocytes.
The specific places where Okubo and Yamaguchi teach the limitations recited in the instant claims are set forth in the office action mailed September 15, 2025.
Response to Arguments
Applicant has argued on pg. 7 in the Reply received December 15, 2025 that Okubo and Yamaguchi fails to teach a first and second preparation that are physically separate.
Applicant’s arguments filed December 15, 2025 have been fully considered but they are not persuasive.
The Examiner agrees that Okubo and Yamaguchi do not teach a first and second preparation that are physically separate. However, the language of amended instant claim 1 does not require independent, separate preparations as Applicant asserts.
As currently written, instant claim 1 is drawn to a combined preparation…wherein the second preparation is applied to the skin, followed by the first preparation being applied to the same site.
As such, one of ordinary skill in the art could envisage a method of administering a first and second preparation to the same site wherein the combined preparation is contained in a single vessel of administration (i.e. syringe or dermal patch).
Accordingly, the rejection is maintained as being prima facie obvious in light of the prior art of Okubo and Yamaguchi.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being obvious over Okubo et al. (US 2014/0220057) (“Okubo”), in view of Yamaguchi et al. (US 2010/0256174) (“Yamaguchi”), as applied to claims 1 and 3-10 above, and in further view of Takasu et al. (US 2018/0140691) (“Takasu”)
The instant claims are drawn to a kit for preparation for transdermal administration comprising a first preparation for transdermal administration comprising a cancer antigenic peptide and an aliphatic carboxylic acid-based ionic liquid, a second preparation for transdermal administration comprising an adjuvant and an aliphatic carboxylic acid-based ionic liquid, and instructions for administering in combination.
The teachings of Okubo, Yamaguchi, and Takasu are set forth in the office action mailed September 15, 2025.
Response to Arguments
Applicant has argued on pg. 7-8 in the Reply received December 15, 2025 that Okubo and Yamaguchi fail to teach a first and second preparation that are physically separate, and Takasu does not remedy the deficiency.
Applicant’s arguments filed December 15, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments in respect to Okubo in view of Yamaguchi have been addressed above.
In respect to Takasu, the prior art teaches kits comprising separate compositions, including WT1 antigen, thus providing a case of obviousness for the rejected instant claims. Furthermore, the term “kit" doesn't imply any particular structure and a teaching on the chemical compound itself anticipates the claim.
Accordingly, the rejection is maintained as being prima facie obvious in light of the prior art of Okubo, Yamaguchi, and Takasu.
REASONS FOR ALLOWANCE
Claim 15 is allowed.
The following is an examiner’s statement of reasons for allowance:
Claim 15 is directed to a combined preparation comprising a first preparation for transdermal administration comprising an antigenic peptide and an aliphatic carboxylic acid-based ionic liquid, and a second preparation for transdermal administration comprising an adjuvant and an aliphatic carboxylic acid- based ionic liquid, wherein the first preparation and the second preparation are physically separate.
The closest prior art, Okubo et al. (US 2014/0220057) cited above, teaches a cancer vaccine composition for transdermal administration comprising a WT1 peptide, however, does not teach or suggest the presently claimed product, wherein the first preparation and second preparation are physically separate.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 MAUREEN DRISCOLL whose telephone number is (571) 270-0730. The examiner can normally be reached Monday through Friday.
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, Samira Jean-Louis can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1642
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645