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 .
RCE
The request filed on 02/18/2026 for a request for continued examination (RCE) under 37 CFR 1.114 (d) is acceptable and a RCE has been established. An action on the RCE follows.
Remark,
The amendment was filed on Feb. 28, 2026. Claims 1-2, 16, 51, 57 are amended. New claims 58- 60 are added.
Claims 3-8, 12-15, 21-30, 32-44, 48-50, 52-56 are canceled.
Claims 1-2, 9-11, 16-20, 31, 45, 47, 51, and 57-60 are pending.
Claims 1-2, 9-11, 16-20, 31, 45, 47, 51, 57-58 with the elected species of SEQ ID NO: 2 are preferably considered.
Claims 59-60 are withdrawn from consideration.
Claim Objections
The objection of Claims 6 and 15 for citing Tables has been removed. However, the examination of claims 6 and 15 are only focused on the elected species of SEQ ID NO: 2.
Claim Rejections - 35 USC § 102
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.
Claim Rejections - 35 USC § 103
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, 6, 8, 11, 19-20, 31, 45 and 47 are still rejected under 35 U.S.C. 102 (a) (1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US Application Publication No; 2016/0161486 A1 or US Patent NO. 10,317,402 B2 or US Patent No; 11,016,091 (B2) under 102 (a) (2) all to Patenteau et al.
In the response, Applicants traverse the rejection and submit that the cited US Patents all fail to disclose, teach, or suggest a vaccine or immunogenic composition comprising one or more isolated ALK peptides that shared by cancers having an ALK rearrangement and capable of binding to human leukocyte antigen (HLA) encoded by an HLA class I allele and generating an immune response against ore or more AKL-positive cancers, which express the ALK protein and/or have an ALK rearrangement; wherein the amino acid sequence of the peptide is selected from the group consisting of RPRPSQPSSL as set forth in SEQ ID NO: 2, IVRCIGVSL as set forth in SEQ ID NO: 3, and TAAEVSVRV as set forth in SEQ ID NO: 5, and wherein the one or more isolated peptides does not include the amino acid sequence AMLDLLHVA as set forth in SEQ ID NO: 1, as recited in claim 1 as amended.
Applicants’ argument has been respectfully considered; however, it is not found persuasive with following reasons:
Applicants’ argument has been respectfully considered; however, it is not found persuasive with following reasons:
(i) All cited US Patents disclose many ALK antigen epitopes, wherein many of them are HLA class 1 types (See Fig 1, step 2 and method of using HP-Ag).
(ii). The argued structural difference is not what the claimed subject matter, because the claimed peptide is the one that does not include the amino acid sequence AMLDLLHVA as set forth in SEQ ID NO: 1. Hence the disclose peptide as ALK epitope and HLA class I molecule cited reference still meets the limitations of the claims peptides in molecular structure and function.
Because there are no unexpected results have been provided, hence the claimed invention as a whole is prima facie obvious absence unexpected results.
Claims 1, 11-16, 17-20, 31, 45, 47, 51, 57-58 are rejected under 35 U.S.C. 103 as obvious over WO2016090177-A1 to Patenteau et al.
In the response, Applicants traverse the rejection and submit that the '177 Publication” fail to disclose, teach, or suggest a vaccine or immunogenic composition comprising one or more isolated ALK peptides that shared by cancers having an ALK rearrangement and capable of binding to human leukocyte antigen (HLA) encoded by an HLA class I allele and generating an immune response against ore or more AKL-positive cancers, which express the ALK protein and/or have an ALK rearrangement; wherein the amino acid sequence of the peptide is selected from the group consisting of RPRPSQPSSL as set forth in SEQ ID NO: 2, IVRCIGVSL as set forth in SEQ ID NO: 3, and TAAEVSVRV as set forth in SEQ ID NO: 5, and wherein the one or more isolated peptides does not include the amino acid sequence AMLDLLHVA as set forth in SEQ ID NO: 1, as recited in claim 1 as amended.
Applicants’ argument has been respectfully considered; however, it is not found persuasive with following reasons:
Applicants’ argument has been respectfully considered; however, it is not found persuasive with following reasons:
(i) The cited reference discloses many ALK peptides that are all HLA specific (Please see Table 1) , wherein most of them are HLA A2 ALK cancer epitopes and also HLA class I allele as evidenced by Chen et al. who teach that Human leukocyte antigen (HLA) class I molecules are involved in the presentation of antigenic peptides to CD8+ cytotoxic T lymphocytes (CTLs), which is important for the development of cellular immunity during viral infections and in cancers. HLA-A2 is one of the most frequent HLA class -1 epitope of a cancer antigen (Immunol Res. 2012, Vol. 53, pp. 182-190, Please see Abstract).
(ii). The argued structural difference is not what the claimed subject matter, because the claimed peptide is the one that does not include the amino acid sequence AMLDLLHVA as set forth in SEQ ID NO: 1. Hence the disclose peptide as ALK epitope and HLA class I molecule cited reference still meets the limitations of the claims peptides in molecular structure and function.
While the cited reference does not explicitly teach making the disclosed peptide(s) as a cancer therapeutic composition, it would have been obvious for any person with ordinarily skilled in the art to do so with an reasonable expectation of success. Because the cited reference teaches that they have disclosed a method for identifying T-cell epitopes which target cells capable of regenerating cancers ("C-RCs") is disclosed. The method identifies T-cell epitopes with a high curative potential i.e. durable elimination of the cancer. The high curative potential is afforded by: 1) a calculated probability of T cell recognition based on multiple biochemical parameters of antigen interaction that collectively are as good or better than known positive T cell antigens; and 2) a high potency afforded by: a) a requirement that the target cancer protein play an essential role in the perpetuation of the cancer type and stage; and b) stringent specificity of the peptide antigen that allows aggressive treatment with little or no on- or off-target T-cell activation and killing beyond the tumor (HP). The method includes: (i) identifying high curative potential target proteins (HP -TP) i.e., identifying HP-TP; (ii) identifying peptide sequences within the protein sequence of an HP-TP that have a high probability of eliciting T cell killing; and (iii) qualifying the sequence specificity based on the fold difference between the specific target and non-targets.
As there are no unexpected results have been provided, hence the claimed invention as a whole is prima facie obvious absence unexpected results.
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.
Claims 1, 11-16, 17-20, 31, 45, 47, 51, rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,650,614B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued reference claims read on a peptide wherein one or more isolated peptides that does not include the amino acid sequence AMLDLLHVA as set forth in SEQ ID NO: 1. Therefore, the reference claims and rejected claims are obvious for any person to any person ordinarily skilled in the art.
Claims 1, 11-16, 17-20, 31, 45, 47, 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No.8,890,287B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued reference claims read on a peptide wherein one or more isolated peptides that does not include the amino acid sequence AMLDLLHVA as set forth in SEQ ID NO: 1. Therefore, the reference claims and rejected claims are obvious for any person to any person ordinarily skilled in the art.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/ Primary Examiner, Art Unit 1671