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. Applicant's preliminary amendment filed on 04/15/2026 is acknowledged.
Claims 1-2, 6-7 and 33-48 are pending.
3. Claim 7 is objected to because of an apparent typographical error in omitting the word “wherein” between “claim 6” and “the adjuvant.”
4. 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.
5. Claims 1-2, 6-7 and 33-48 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.
(i) Claim 1 is indefinite in the recitation of “a population of T cells that kill cancer cells, which present on the cell surface a peptide…” because it is unclear whether it is the T cells or the cancer cells that present the polypeptide.
(ii) Claim 6 is indefinite in the recitation of “derivatives,” because neither the nature nor the degree of acceptable derivation is defined.
(iii) Claims 2, 6-7 and 33-48 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. The following is a quotation 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.
7. Claims 1, 6-7 and 33-48 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not provide a sufficient enabling description of a population of “T cells that kill cancer cells” which present on the cell surface a peptide consisting of the amino acid sequence of TLDSYLKAV (SEQ ID NO: 155).
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in 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, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
A person skilled in the art would be aware that while a T cell expressing a TCR which binds a peptide presented by a cell may kill that cell, a generic population of T cells would not recognize a specific peptide or kill a cell presenting the peptide. The specification does not provide guidance, direction or working examples of undefined, unselected population of T cells which would kill the recited cancer cells. Based on this, a skilled artisan would reasonably conclude that experimentation aimed at making generic T cells with functional properties recited in claim 1 would be unsuccessful, and as such unnecessary, improper, and undue.
8. Claim 6 is rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not provide a sufficient enabling description of a method of treating cancer comprising administering generically recited “RNA” or generically recited “particulate formulations with poly(lactide co-glycolide) (PLG)” or “virosomes.”
A person skilled in the art would be aware that while certain specific RNA molecules may be effective in treating certain cancers, RNA as a chemical substance is not. Likewise, a skilled artisan would be aware that PLG formulations and virosomes may be used as carriers of anti-cancer medications, but do not, by themselves, have anti-cancer properties. The specification does not provide guidance, direction or working examples of treating cancer with unspecified RNA, or with empty PLG formulations or virosomes. Based on this, a skilled artisan would reasonably conclude that experimentation aimed at treating cancer with “RNA,” “particulate formulations with poly(lactide co-glycolide) (PLG)” or “virosomes” would be unsuccessful, and as such unnecessary, improper, and undue.
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 1, 6 and 33-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9994628.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘628.
Claim 1 of US ‘628 is directed to a method of eliciting an immune response in a patient who has cancer, comprising administering to said patient a composition comprising a population of activated T cells that selectively recognize cells in the patient that aberrantly express a peptide, wherein said peptide consists of the amino acid sequence of TLDSYLKAV (SEQ ID NO: 155), wherein the activated T cells are cytotoxic T cells produced by contacting T cells with an antigen presenting cell that expresses the peptide in a complex with an MHC class I molecule on the surface of the antigen presenting cell, for a period of time sufficient to activate said T cell specifically against the peptide, and wherein said cancer is selected from the same list as recited in instant claims 1 and 33-48.
A person of skill in the art would be aware that the purpose of eliciting a T cell response against a cancer cell in a cancer patient is to kill said cancer cells, thereby treating the cancer.
The limitations of instant claim 6 are recited in US ‘628 claim 8.
11. Conclusion: no claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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