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 .
2. Applicant’s amendment filed on 01/03/2025 is acknowledged.
3. Claims 28-40, 46 and 49-60 are pending and under consideration for their full scope.
4. Applicant’s IDS document filed on 01/17/2025 has been considered.
5. The disclosure is objected to because of the following informalities:
The specification is objected to for reference to SEQ ID NO:206. Applicant has assigned a SEQ ID NO to this tripeptide sequences. However, under ST.26, it is impermissible for a SEQ ID NO to be used to refer to such a short amino acid sequence. Based upon rule ST 26 these short sequences are “skipped sequences” that must be spelled out. It is noted that the XML sequence listing file contains no data for these tripeptides, as the sequence identified by SEQ ID number in the table is “blank” in the XML file (i.e. no data). While it is proper that such short three amino acid peptide sequences do not appear in the sequence listing, Applicant giving such sequences SEQ ID NOs in the specification sets up a situation wherein the application is logically inconsistent. The same term cannot have two different meanings, and since as per 37 CFR1.831 it is impermissible for amino acid sequences shorter than 4 specifically defined residues to be defined via SEQ ID NO it is the specification which is in error. As such, Applicant must remove all reference to all tripeptides by way of SEQ ID NOs. Note that such changes must be made at all occurrences everywhere in the specification, including figures, drawings, and text.
Appropriate correction is required.
6. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 46 and 51 are 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.
A. As discussed supra, the meaning of SEQ ID NO: 206 is unclear as the sequence listing indicates that this SEQ ID number is nothing (i.e. contains zero amino acids).
B. Claim 46 recites the limitation "the anti-PD-1 antibody" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Correction is required.
8. 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 § 2146 et seq. 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.
9. Claims 28-40, 46 and 49-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.10,844,137 (PTO-892; Reference A)). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of U.S. Patent 10,844,137 are directed to an antibody or antigen-binding fragment thereof that binds specifically to cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), wherein the antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (CDRs) (HCDR1, HCDR2 and HCDR3) contained within a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 194; and three light chain CDRs (LCDR1, LCDR2 and LCDR3) contained within a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 202; wherein the antibody or antigen-binding fragment comprises HCDR1-HCDR2-HCDR3-LCDR1-LCDR2-LCDR3 domains comprising, respectively, the amino acid sequences of SEQ ID NOs: 196-198-200-204-206-208; wherein the antibody or antigen-binding fragment thereof comprises a HCVR/LCVR amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs: 194/202; wherein the antibody or antigen-binding fragment thereof is a monoclonal antibody or a fully human antibody; wherein the antibody or antigen-binding fragment thereof comprises a human IgG1 heavy chain constant region; an antibody comprising a heavy chain and a light chain, wherein the heavy chain comprises the amino acid sequence of SEQ ID NO: 509; an antibody comprising a heavy chain and a light chain, wherein the light chain comprises the amino acid sequence of SEQ ID NO: 510; an antibody comprising a heavy chain and a light chain, wherein the heavy chain comprises the amino acid sequence of SEQ ID NO: 509 and the light chain comprises the amino acid sequence of SEQ ID NO: 510; a fully human monoclonal antibody that binds specifically to CTLA-4 comprising a heavy chain comprising the amino acid sequence of residues 1-445 of SEQ ID NO: 509 and a light chain comprising the amino acid sequence of SEQ ID NO: 510; comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 509 and a light chain comprising the amino acid sequence of SEQ ID NO: 510 and pharmaceutical compositions thereof and a pharmaceutically acceptable carrier or diluent.
Reference sequences/sequence identification numbers and instant sequences/sequence identification numbers are identical.
The claimed invention differs from the prior art in the recitation of the methods of treatment of claims 28-40, 46 and 49-60.
It would have been obvious to one of ordinary skill in the art at the time of invention to have used those antibodies to treat cancer of claims 28-40, 46 and 49-60.
It would also have been obvious to one of ordinary skill in the art at the time Applicant's invention was made to select cancer patients and to determine all operable features of optimal dosage of the components because dosage is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. The determination of the optimal dosage of antibody, including timing, frequency and route of treatment are well within the purview of one of ordinary skill in the art at the time the invention was made and lend no patentable import to the claimed invention. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II.
From the combined teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary.
10. Claims 28-40, 46 and 49-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No.12,024,570 (IDS filed on 03/18/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-21 of U.S. Patent No.12,024,570 are directed to polynucleotide molecules encoding an antibody or antigen-binding fragment thereof that binds specifically to cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), wherein the antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (CDRs) (HCDR1, HCDR2 and HCDR3) contained within a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 194; and three light chain CDRs (LCDR1, LCDR2 and LCDR3) contained within a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 202; wherein the antibody or antigen-binding fragment comprises HCDR1-HCDR2-HCDR3-LCDR1-LCDR2-LCDR3 domains comprising, respectively, the amino acid sequences of SEQ ID NOs: 196-198-200-204-206-208; wherein the antibody or antigen-binding fragment thereof comprises a HCVR/LCVR amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs: 194/202; wherein the antibody or antigen-binding fragment thereof is a monoclonal antibody or a fully human antibody; wherein the antibody or antigen-binding fragment thereof comprises a human IgG1 heavy chain constant region; an antibody comprising a heavy chain and a light chain, wherein the heavy chain comprises the amino acid sequence of SEQ ID NO: 509; an antibody comprising a heavy chain and a light chain, wherein the light chain comprises the amino acid sequence of SEQ ID NO: 510; an antibody comprising a heavy chain and a light chain, wherein the heavy chain comprises the amino acid sequence of SEQ ID NO: 509 and the light chain comprises the amino acid sequence of SEQ ID NO: 510.
Reference sequences/sequence identification numbers and instant sequences/sequence identification numbers are identical.
The claimed invention differs from the prior art in the recitation of the methods of treatment administering the antibodies of claims 28-40, 46 and 49-60.
It would have been obvious to one of ordinary skill in the art at the time of invention to have used those antibodies encoded by the reference polynucleotides to treat cancer of claims 28-40, 46 and 49-60.
It would also have been obvious to one of ordinary skill in the art at the time Applicant's invention was made to select cancer patients and to determine all operable features of optimal dosage of the components because dosage is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. The determination of the optimal dosage of antibody, including timing, frequency and route of treatment are well within the purview of one of ordinary skill in the art at the time the invention was made and lend no patentable import to the claimed invention. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II.
From the combined teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary.
11. Claims 28-40, 46 and 49-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 14-24, 27-31, 36-46 and 50-52 of copending Application No. 18/813,100 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 37 are directed to a method of treating or inhibiting the growth of a tumor, comprising:(a) selecting a patient with a cancer; and(b) administering to the patient in need thereof a combination comprising: (i) aor antigen- binding fragment thereof;wherein the oncolytic virus, the anti-PD-1 antibody or antigen-binding fragment thereof, and the anti-CTLA4 antibody or antigen-binding fragment thereof are administered to the patient concurrently of claim 1; 19. (currently amended) The method of claim 1, wherein the anti-CTLA4antibody or antigen- binding fragment thereof is an anti-CTLA4 antibody, and wherein the anti-CTLA4 antibody is administered to the patient in one or more doses of about 0.1 mg/kg to about 15 mg/kg of body weight of the patient of claim 19; wherein the anti-CTLA4antibody or antigen- binding fragment thereof is an anti-CTLA4 antibody, and wherein the anti-CTLA4 antibody is administered to the patient in a single dose of about 0.1 mg/kg to about 15 mg/kg of body weight of the patient of claim 20; wherein the anti-CTLA4 antibody or antigen- binding fragment thereof is an anti-CTLA4 antibody, and wherein the anti-CTLA4 antibody is administered to the patient in one or more doses of about 1 mg to about 600 mg of claim 21; wherein the PD-1antibody or antigen-binding fragment thereof is an anti-PD-1 antibody, and the anti-CTLA4antibody or antigen-binding fragment thereof is an anti-CTLA4 antibody, and wherein the anti-PD-1 antibody and the anti-CTLA4 antibodycancer, sarcoma, skin cancer, stomach cancer, testicular cancer, thyroid cancer, tracheal cancer, urogenital cancer, and uterine cancer of claim 24; wherein the anti-PD-1 antibody or antigen-binding fragment thereof is an anti-PD-1 antibody is-selected from cemiplimab, nivolumab, pembrolizumab, pidilizumab, MEDI0608, BI 754091, PF-06801591, spartalizumab, camrelizumab, JNJ-63723283, and MCLA-134 of claim 25; wherein the anti-CTLA4 antibody or antigen- binding fragment thereof is an anti-CTLA4 antibody i&-selected from ipilimumab, tremelimumab, and REGN4659 of claim 36; wherein the anti-CTLA4 antibody or antigen-binding fragment thereof comprises three HCDRs of the amino acid sequence of SEQ ID NO: 13 and three LCDRs of a LCVRcomprising the amino acid sequence of SEQ ID NO: 14 of claim 37; wherein the anti-CTLA4 antibody or antigen-binding fragment thereof comprises three HCDRs (HCDR1, HCDR2, and HCDR3) comprising the respective amino acid sequences of SEQ ID NOs: 15, 16, and 17; and three LCDRs (LCDR1, LCDR2, and LCDR3) comprising the respective amino acid sequences of SEQ ID NO: 18, AAS, and SEQ ID NO: 20 of claim 38; wherein the anti-CTLA4 antibody or antigen-binding fragment thereof comprises a HCVR comprising the amino acid sequence of SEQ ID NO: 13; and a LCVR comprising the amino acid sequence of SEQ ID NO: 14 of claim 39; wherein the anti-CTLA4 antibody or antigen-binding fragment thereof is an anti-CTLA4 antibody comprising a heavy chain and light chain amino acid sequence pair of SEQ ID NOs: 21 and 22, respectively of claim 40; wherein the treatment produces a therapeutic effect selected from one or more of: delay in tumor growth, reduction in tumor cell number, tumor regression, increase in survival, partial response, and complete response of claim 41; wherein the tumor growth is inhibited by at least 50% as compared to an untreated patient of claim 42; wherein the tumor growth is inhibited by at least 50% as compared to a patient administered the oncolytic virus, the PD-1antibody or antigen- binding fragment thereof, or the anti-CTLA4 antibody or antigen-binding fragment thereof as monotherapy of claim 43; and wherein the tumor growth is inhibited by at least 50% as compared to a patient administered any two of the oncolytic virus, the PD-1antibody or antigen-binding fragment thereof, and the anti-CTLA4antibody or antigen- binding fragment thereof of claim 44; further comprising administering an additional therapeutic agent or therapy to the patient of claim 45; and wherein the additional therapeutic agent or therapy is selected from: radiation, surgery, a chemotherapeutic agent, a cancer vaccine, a B7-H3 inhibitor, a B7-H4 inhibitor, a lymphocyte activation gene 3 (LAG3) inhibitor, a T cell immunoglobulin and mucin-domain containing-3 (TIM3) inhibitor, a galectin 9 (GAL9) inhibitor, a V-domain immunoglobulin (Ig)-containing suppressor of T-cell activation (VISTA) inhibitor, a Killer-Cell Immunoglobulin-Like Receptor (KIR) inhibitor, a B and T lymphocyte attenuator (BTLA) inhibitor, a T cell immunoreceptor with Ig and ITIM domains (TIGIT) inhibitor, a CD47 inhibitor, an indoleamine-2,3-dioxygenase (IDO) inhibitor, a vascular endothelial growth factor (VEGF) antagonist, an angiopoietin-2 (Ang2) inhibitor, a transforming growth factor beta (TGF3) inhibitor, an epidermal growth factor receptor (EGFR) inhibitor, an antibody to a tumor- specific antigen, Bacillus Calmette-Guerin vaccine, granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytotoxin, an interleukin 6 receptor (IL-6R) inhibitor, an interleukin 4 receptor (IL-4R) inhibitor, an IL-10 inhibitor, IL-2, IL-7, IL-12, IL-21, IL-15, an antibody-drug conjugate, an anti-inflammatory drug, and combinations thereof of claim 46;
Instant SEQ ID NOs 196, 198, 200, 204, 206 and 208 are found in reference SEQ ID NOs 13 and 14.
It would also have been obvious to one of ordinary skill in the art at the time Applicant's invention was made to select patients and to determine all operable features of optimal dosage of the components because dosage is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. The determination of the optimal dosage of antibody, including timing, frequency and route of treatment are well within the purview of one of ordinary skill in the art at the time the invention was made and lend no patentable import to the claimed invention. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II.
From the combined teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (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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June 24, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
Prosecution Insights