DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1, 3, 5-10, 13-16, 31-34, 36 and 37 are pending upon entry of amendment filed on 6/15/26.
Applicant’s election of group I, claims 1, 3, 5-10 and 13-16 without traverse in the reply filed on 6/15/26 has been acknowledged.
Accordingly, claims 31-34 and 36-37 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claims 1, 3, 5-10 and 13-16 are under consideration in the instant application.
3. Applicant’s IDS filed on 7/12/23 and 6/15/26 have been acknowledged.
4. NO oath is of record.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
6. 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
7. Claims 1, 3, 5-10 and 13-16 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for method of eliciting immune response to a cancer antigen comprising directly administering a composition into lymph node wherein the composition comprising an OVA and polyIC microparticles, does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would use a composition comprising a cancer antigen and a biodegradable microparticle in treatment or prevention of cancer. Although use of OVA and polyIC microparticles in intranodal injection in treatment of melanoma model (Fig 12), no composition is used in prevention of cancer as in claim 16 of the instant application. A vaccine is a composition to induce a specific immunity that prevent or protect against a specific disease caused by a specific agent. One of the criteria for a vaccine is the level of antibody (humoral immune response) before and after immunization and the success of vaccination is judged by the extent of increase in the level of antigen - specific antibody. The second criterion for a vaccine is the ability to stimulate memory T lymphocytes (cell-mediated immune response). The specification provides no information on the vaccine formulation comprising any antigen such as any tumor antigen which is able to exhibit antigen-specific antibody response and the ability of such to protect or prevent cancer. Vaccines by definition trigger an immunoprotective response in the host vaccinated and mere antigenic response is insufficient. Spitler, (Cancer Biotherapy, 1995, v.10 pages 1-3) teaches that "Ask practicing oncologists what they think about cancer vaccines and you're likely to get the following response: "cancer vaccines don't work". Ask a venture capitalist or the director of product development at a large pharmaceutical company, and you're likely to get the same response" (see page 1, column 1, paragraph 1 in particular). The goal of tumor vaccination is the induction of tumor immunity to prevent tumor recurrence and to eliminate residual disease. Ezzell (NIH Research, 1995, Vol.7, pages 46-49) reviews the current thinking in cancer vaccines and states that tumor immunologists are reluctant to place bets on which cancer vaccine approach will prove effective in the long run (see entire document, particularly the last paragraph). It is well known in the art that tumor cells in vivo simply do not display their unique antigens in ways that are easily recognized by cytotoxic T lymphocytes (Ezzell; page 48, column 2, paragraph 2). Furthermore, no one is very optimistic that a single peptide or a virus carrying the gene encoding that peptide will trigger an immune response strong enough to eradicate tumors or even to prevent the later growth of micrometastases among patients whose tumors have been surgically removed or killed by radiation or chemotherapy (Ezzell; page 48, paragraph 6).
Thus, Applicant has not provided sufficient guidance to enable one skill in the art to use claimed vaccine formulation in manner reasonably correlated with the scope of the claims. The scope of the claims must bear a reasonable correlation with the scope of enablement. In re Fisher, 166 USPQ 18(CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
In view of the quantity of experimentation necessary, the unpredictability of the art, the lack of sufficient guidance in the specification, the limited working examples, and the limited amount of direction provided given the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
8. 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.
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claim(s) 1, 3, 5-7, 9-10 and 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andorko et al (Journal of Visualized Experiments, 2014, vol. 83, p.1-6, IDS reference).
Andorko et al teach intranodal administration of biodegradable polymers of PEG, PLGA and OVA and the size of biodegradable polymer is 2-8um (p. 2, 4-6). Given that the intranodal administration of biodegradable polymer of polyIC and OVA is identical to the method recited in claim 16, it would inherently treat cancer and claim 16 is included. Further, PEG and PLGA is toll-like receptor agonist as evidenced by [0075] of the instant application, claim 7 is included in this rejection. Therefore, the reference teachings anticipate the claimed invention.
11. Claims 1, 3, 5-10 and 13-16 are rejected under rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Pat, 10,517,946 (IDS reference)
The ‘946 patent teaches methods of inducing an immune response comprising administering composition comprising tumor antigen and TLR agonist (claims). The TLR agonist includes poly IC and various tumor antigens (note col. 10, 12) and the size of microparticle includes 1000nm (col. 9). The polyIC delivers the antigen to cortex of the lymph node (col. 31). The administration includes intranodal (col. 16). Therefore, the reference teachings anticipate the claimed invention.
12. 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 of this title, 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.
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.
13. Claims 1, 3, 5-10 and 13-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Andorko et al (Journal of Visualized Experiments, 2014, vol. 83, p.1-6, IDS reference) in view of U.S. Pat, 10,517,946 (IDS reference).
The teachings of the ‘946 patent and Andorko have been discussed, supra.
The disclosure of the Andorko et al. differs from the instant claimed invention in that it does not teach use of poly IC as in claim 8 of the instant application.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize polyIC taught by the ‘946 patent into method taught by the Andorko.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of polyIC improves delivery to lymph nodes.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
14. No claims are allowable.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
July 29, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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