DETAILED ACTION
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 .
Remark
The response and amendment filed on 03/03/2025 are noticed. Claim 2 is amended.
The status of claims
Claim 1 was canceled,
Claims 2-21 are pending.
Claims 2-19 with elected species of synthetic polynucleotides (poly IC/poly A) are considered.
Claims 21-22 were withdrawn from consideration .
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
The provisional rejection of Claims 2-19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 20-21 of copending Application No. 17,310, 461 (reference application) has been removed because the filling date of the copending Application No. 17,310, 461 was filed later than that of the rejection Application.
The rejection of Claims 2-8, 12-15, 18, and 19 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, 15-17 and 18 of US Patent No. 11,971,410B2 has been removed because the filling date of the alleged US Patent, No. 11,971,410 was filed later than of the rejection Application.
The provisional rejection of Claims 2-19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. US 16,617, 805 (reference application) has been removed because the Application No. US 16,617, 830 (reference Application was abandoned.
The rejection of Claims 2-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, 11-14, 20-21 and 73-75 of copending Application No. US 16,617, 830 (reference application) has been removed because the Application No. US 16,617, 830 (reference Application was abandoned.
Claims 2-4, 8, 10 and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US patent No. 11,976, 274 (reference claims) has been removed because the filling date of the alleged US Patent, No. 11,971,410 was filed later than of the rejection Application.
Claims 2-4, 8, 10 and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-12 and 14-22 of US patent No. 12,025,615 (reference claims) and further in view of Kloor et al. (US 99,205,140) has been removed because the filling date of the alleged US Patent, No. 11,971,410 was filed later than of the rejection Application.
Claims 2-5 10, 16-18 are still rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US Patent No. 12,018, 252B2, (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflict claims are obvious each from other rather than distinct each from other.
In the response, Applicants traverse the rejection and submit that the office action lacks of explaining how the two sets of claims are considered not patentable distinct, therefore, the rejection should be removed.
Applicants’ argument is considered respectively. However, it is not persuasive to withdrawn the rejection because the argument is not found factual based on the following paragraphs cited in the previous office actions that explain how the two sets of claims are not considered to be patentable distinct but obvious each from other although the two sets of claims are not drawn to an identical methods, particularly the issued reference claims are drawn to a same method with more detail and specific identified plurality of peptide cancer antigens caused by frameshift encoded by an mRNA having an RNA processing error, the RNA processing error, mis-splicing or an insertion or a deletion during transcription, and wherein each frameshift peptide of the plurality of frameshift peptides comprises 10 amino acids or more with more specific peptide antigen sequences. These explanations cited in the previous office action are remained set forth below:
In the instant case, the pending claims 2-5, 10, 16-18 are directed to a method of preparing a vaccine, the method comprising: a) for each of a plurality of samples obtained from a plurality of individuals having cancer: (i) contacting the sample with a frameshift peptide (FSP) array, the FSP array comprising a first population of peptides comprising a peptide encoded by a frameshifted mRNA having a frameshift caused by a transcription error or an RNA processing error; and (ii) identifying peptides that are immunoreactive with the sample; (b) selecting one or more immunoreactive peptides that are immunoreactive with 10% or more of the plurality of samples; and c) preparing a vaccine composition comprising a second population of peptides comprising the one or more immunoreactive peptides selected in step b), or a nucleic acid sequence encoding the one or more immunoreactive peptides selected in step b). Furthermore, the first population of peptides comprises peptides encoded by a frameshifted mRNA having an RNA processing error comprising a splicing error or the first population of peptides comprises one or more peptides having an error in intron excision. The sample is blood, plasma, serum, thymus, bone marrow, spleen, lymph node, bronchoalveolar lavage, breast, central nervous system, cerebrospinal fluid, eye, tears, gastrointestinal tract, saliva, feces, urine, heart, kidney, liver, lung, muscle, pancreas, peripheral nervous system, saliva, skin, thyroid, trachea, or tumor. The vaccine composition comprises a pharmaceutically acceptable adjuvant or excipient, wherein the adjuvant including (poly IC/poly AU),
In the instance case, the reference claims 1 and 16 are directed a method of making an anti-cancer therapeutic composition, comprises: (a) contacting a biological sample obtained from a subject to a peptide array, which comprises a plurality of frameshift variant peptides, wherein the biological sample comprises antibodies, and wherein the plurality of frameshift peptides comprise one or more peptides having a sequence as set forth in any of SEQ ID NOs: 22-33, 35-54, 57-65, 67-68, 71-90, 92-94, 96-109, 111-117, 131, 133, 135, 137, 139, 141, 143, 145, 149, 151, 153, 165, 167, 169, 171, 173, 175, 177, 179, 181, 183, 185, 187, 189, 191, 197, 199, 203, 205, 207, 209, 213, or 221,22 117 or 128 223, G) wherein the plurality of frameshift variant peptides comprise peptides encoded by genes having a variant in a micro satellite (MS) in a coding region of the gene; or (ii) wherein the plurality of frameshift peptides comprise peptides encoded by an mRNA having an RNA processing error, the RNA processing error comprising a mis-splicing or an insertion or a deletion during transcription, and wherein each frameshift peptide of the plurality of frameshift peptides comprises 10 amino acids or more; (b) detecting binding of the antibodies in the biological sample to at least one peptide in the peptide array; and (c) producing a composition comprising one or more immune reactive neoantigens corresponding to the at least one peptide bound by the antibodies. Claims 4 and 16 also further limit the plurality of frameshift variant peptides are fixed on a substrate, wherein the substrate comprises glass, composite, resin, or combination thereof and wherein the peptide array is configured to detect binding by at least one of fluorescence, luminescence, calorimetry, chromatography, radioactivity, Bio-Layer Interferometry, and surface plasmon resonance. Claim 6 further limits the biological sample comprises blood, serum, plasma, cerebrospinal fluid, saliva, urine, or combinations thereof, claim 7 further limits the subject is a human, a dog, a cat, a mouse, a rat, a rabbit, a horse, a cow, or a pig. Claim 9 further limits the cancer is selected from the group consisting of acute lymphoblastic leukemia, acute monocytic leukemia, acute myeloid leukemia, acute promyelocytic leukemia, adenocarcinoma, adult T-cell leukemia, astrocytoma, bladder cancer, bone cancer, brain tumor, breast cancer, Burkitt's lymphoma, carcinoma, cervical cancer, chronic lymphocytic leukemia, chronic myelogenous leukemia, colon cancer, colorectal cancer, endometrial cancer, glioblastoma multiforme, glioma, hepatocellular carcinoma, Hodgkin's lymphoma, inflammatory breast cancer, kidney cancer, leukemia, lung cancer, lymphoma, malignant mesothelioma, medulloblastoma, melanoma, multiple myeloma, neuroblastoma, non- Hodgkin lymphoma, non-small cell lung cancer, ovarian cancer, pancreatic cancer, pituitary tumor, prostate cancer, retinoblastoma, skin cancer, small cell lung cancer, squamous cell carcinoma, stomach cancer, T-cell leukemia, T-cell lymphoma, thyroid cancer, and Wilms' tumor. Moreover, the frameshift peptide is further limit the peptide comprising a peptide encoded by an mRNA having an RNA processing error comprising intron retention.
Finally, the composition comprises an adjuvant (Clam 11), which including the elected species of synthetic polynucleotides (poly IC/poly AU) etc.
The two sets of conflict claims are obvious each from other although are not identical .
An obvious-type double patenting rejection is appropriate where the conflict claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g. Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887,225 USPQ 645 (fed. Cir. 1985).
Therefore, the reference claims and the rejection claims are not directed to a method for preparing or making products comprising the structurally same peptide antigens with an overlapping scopes, the issued claims have narrowed scopes cited by particular peptide sequences whereas the rejected claims are more generic peptides antigens, and the generic is anticipated by the specie as the ground of the obvious double patenting. The rejection is maintained., The Terminal disclaimer is required for overcoming the rejection.
Claims 2-4, 8, 10, 13-18 are still rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and of issued US patent No. 11,484,581B2. Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious each from other for anyone with an ordinarily skill person in the art.
In the response, Applicants traverse the rejection and submit that the office action lacks of explaining how the two sets of claims are considered not patentable distinct, therefore, the rejection should be removed.
Applicants’ argument is considered respectively. However, it is not persuasive to withdraw the rejection because the argument is not found persuasive because the argument for lacing an explanation of the ground of rejection is not factual . Please see the detail explanations cited in the previous office action set forth below:
The reference claims are directed to a method comprising treating an individual in need of treatment for a cancer, the method comprising: a) contacting a biological sample from the individual with a frameshift peptide (FSP) array, wherein the FSP array comprises a first population of peptides encoded by a frameshifted mRNA created in a splicing error or a transcription insertion or deletion error, wherein the first population of peptides comprising the peptide sequence of SEQ ID NO: 1; b) identifying peptides in the FSP array that are immunoreactive with the biological sample; c) preparing a vaccine composition comprising the immunoreactive peptides identified in step b) or a nucleic acid sequence encoding the immunoreactive peptides; and d) administering an effective amount of the vaccine composition to the individual, thereby treating the cancer, wherein the individual is a canine. The method of further comprises obtaining the biological sample from the individual. The biological sample is selected from the group consisting of blood, plasma, serum, thymus, bone marrow, spleen, lymph node, bronchoalveolar lavage, breast, central nervous system, cerebrospinal fluid, eye, tears, gastrointestinal tract, saliva, feces, urine, heart, kidney, liver, lung, muscle, pancreas, peripheral nervous system, saliva, skin, thyroid, trachea, and tumor. The biological sample comprises an antibody and involves in ELISA, surface plasm on resonance, mass spectrometry, phage display, ELISPOT, flow cytometry, cytometric bead array, immunohistochemistry, high density array, microarray, delayed-type hypersensitivity (DTH), and combinations thereof, wherein the high density array, microarray in considered to be a bioinformatics. the vaccine composition comprises a pharmaceutically acceptable adjuvant or excipient. The cancer is variety of cancers.
The pending method is also directed to a method of preparing a vaccine, the method comprising: a) for each of a plurality of samples obtained from a plurality of individuals having cancer: (i) contacting the sample with a frameshift peptide (FSP) array, the FSP array comprising a first population of peptides comprising a peptide encoded by a frameshifted mRNA having a frameshift caused by a transcription error or an RNA processing error; and (ii) identifying peptides that are immunoreactive with the sample; (b) selecting one or more immunoreactive peptides that are immunoreactive with 10% or more of the plurality of samples; and c) preparing a vaccine composition comprising a second population of peptides comprising the one or more immunoreactive peptides selected in step b), or a nucleic acid sequence encoding the one or more immunoreactive peptides selected in step b), wherein the first population of peptides comprises peptides encoded by a frameshifted mRNA having an RNA processing error comprising a splicing error or the first population of peptides comprises one or more peptides having an error in intron excision. The sample is blood, plasma, serum, thymus, bone marrow, spleen, lymph node, bronchoalveolar lavage, breast, central nervous system, cerebrospinal fluid, eye, tears, gastrointestinal tract, saliva, feces, urine, heart, kidney, liver, lung, muscle, pancreas, peripheral nervous system, saliva, skin, thyroid, trachea, or tumor. The vaccine composition comprises a pharmaceutically acceptable adjuvant or excipient, wherein the adjuvant including (poly IC/poly AU).
While the reference claims are method for the treatment using a composition rather than the rejection claims are directed to a method for making a composition , they are directed to patentable distinct as the composition used in the method cited in the reference claims are one of the compositions made by the method cited in rejected claims. Therefore, the rejection is maintained.
A Terminal disclaimer is required to overcome the rejection.
Claim Rejections - 35 USC § 102
The rejection of Claims 2-8, 13-16, 18-19 under 35 U.S.C. 102 (a) (1) as being anticipated by Kloor et al. (US 9,205,140) has been removed necessitated by the claims amendment and persuasive argument that the claimed method for searching the peptide(s) as a vaccine depended on a frameshift peptide (FSP) mutation resulted from splicing error or transcription insertion or deletion, whereas the FSPs disclosed by Kloor et al. is the microsatellite instability rather than splicing error or transcription insertion or deletion.
The rejection of Claims 2, 4, 6, 7, 12, 14 and 19 under 35 U.S.C. 102 (a) (1) as being anticipated by Johnston et al. (US Application No. 2015/0241420A1) has been removed necessitated by Applicants’ amendment and persuasive argument that the claimed method for searching the peptide(s) as a vaccine depended on a frameshift peptide (FSP) mutation resulted from splicing error or transcription insertion or deletion, whereas the FSPs disclosed by Johnson et al. is caused by ribosomal translation rather than splicing error or transcription insertion or deletion during a gene replication.
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.
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/ Primary Examiner, Art Unit 1671