DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/24/2025 has been entered.
Claim 1 and 7-16 are pending.
The instant application claims priority as a 371 filing of PCT/KR2023/006867 filed 5/19/2023 which claims priority to KR10-2022-0072485 filed 6/15/2022 and KR10-2023-0027127 filed 2/28/2023. A translation of the parent document has been filed on 5/28/2025 thus establishing support for the claims.
Information Disclosure Statement
An information disclosure statements has been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action. Two documents under Foreign Patent Literature were not in English and hence have been crossed off of the 1449.
Response to Amendments
Applicants amendments are sufficient to overcome the previous rejection under 35 USC 102. Applicants previous arguments of unexpected results would be successful in overcoming the art should the rejection be limited to immunotherapeutic vaccines comprising NK cells loaded with a-galactosylceramide and any of the listed antigens. There is not clear indication that the vaccine would be preventive of cancer.
Claim Objection
Claim 1 is objected to for the recitation “a breast cancer protein expressed by Her-2/neu”. This recitation is inconsistent with the remainder of the antigens and would be sufficient simply as Her-2/neu for consistency. This is a new observation.
Claim 12 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 11. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims are actually exact duplicates of one another. It is noted that if claim 1 is allowed, the abbreviations in claim 12 are duplicates of those in claim 1 and are not necessary. The point of abbreviations in patent claims is they are provided and then used throughout the remainder of the claims. This is a new objection necessitated by applicants’ amendment.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1 and 7-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is based upon a reconsideration of the language “variants of alpha-galactosylceramide.”
A closer look at this molecule did not demonstrate that variants are known or disclosed. The claims are drawn to use of an NKT ligand and while analogues of alpha anomericgalactosyceramide were known in the art. The same was not true of variants of alpha galactosylceramide. This term appears but does not provide any indication of what variants are or what they look like. Hence, the claims are drawn to a structural molecule wherein there is no disclosure of structures that are NKT ligands and variants of alpha-galactosylceramide. The specification only teaches alpha-galactosylceramide are desirable but does not disclose any structural properties of variants. As well, there is no disclosure of the structural properties that are required variants to mediate the required functional properties. The claims thus are drawn to a large genus of molecules which are not sufficiently described in the specification. The written description requirement for genus claims may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with known or disclosed correlations between function and structure, or by a combination of such characteristics sufficient to show that the applicant was in possession of the claimed genus.
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 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.
Claims 1 and 7-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al (EP 2029165) in view of Carlsten et al (frontiers in Immunology, 2016, pages 1-9). This is a new rejection necessitated by applicant’s amendment.
Kang et al teach cell based vaccines that comprise antigens and NKT ligands such as a-galactosylceramide, a-glucuronosylceramide or ganglioside GD3 (see e.g. claim 2). As well, the cell comprised antigens such as Her-2/neu and MAGE (see claim 6). Inclusion of NKT ligands benefits vaccine effects,
[0007] In contrast, ligand-mediated activation of iNKT cells lead to the activation of T, B, and NK cells as well as DC. Injection of αGalCer, an iNKT ligand, generates antitumor immunity via the mediation of NK and T cells (Moodycliffe, A. M., et al., Nat. Immunol., 1, 521-525, 2000).
Kang does not teach that the carrier cell is an NK cell. However, use of NK as a cancer therapeutic was gaining momentum. Carlsten provide means to engineer NK cells to comprise antigenic sequences and demonstrate that NK cells are cytotoxic cells that induce antitumor responses that is not altered by the engineering (see abstract and page 2. Col 1).
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the NK cells as cancer therapeutics as taught by Carlsten et al as the vaccines as taught by Kang. Such a modification would have resulted in vaccines as claimed in claims 1 and 7-14. As noted above: 1) Kang teaches vaccines comprising NKT ligands claimed as well as the antigens claimed; 2) Carlsten teach that prior to the invention, NK cells were explored for their antitumor effects and were shown to be easily engineered to comprise exogenous components. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the NK cells could be modified to form improved vaccines comprising the NKT ligands and cancer antigens.
As recited in claim 7, 10, 13 and 14, the sequences introduced are mRNA but expressed to be peptide sequences (see both Carlsten (figure 3) and Kang (see ¶ 0051).
Kang teaches use of adenovirus to introduce the antigen into the cell (see e.g. ¶0091) as claimed in claims 8, 9, 15 and 16
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634