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 .
Election/Restriction
Claims 1-30 are generic to the following disclosed patentably distinct species:
Species A: a single and specific immunogenic composition including a single and specific polynucleotide encoding a single and specific amino acid sequence or combination thereof (i.e., one, two, or a single and specific combination) indicating the heteroclitic modifications including the KRAS mutation (please see claims 1, 4-8, 11-16, 19-23, and 26-30).
The species are independent or distinct because as disclosed the different species have mutually exclusive characteristics for each identified species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification;
(b) the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the species or groupings require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); and/or
(d) the species may raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
There is a serious search and/or examination burden because the species may raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Anastasia Greenberg (Applicant’s representative) on May 6, 2025, a provisional election was made to elect an immunogenic composition comprising a polynucleotide that encodes one amino acid sequence of SEQ ID NO: 158, claims 1-3 and 5-7. Affirmation of this election must be made by applicant in replying to this Office action. Claims 4 and 8-30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note that Species A has been expanded to include all the sequences recited in instant claim 1.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Status of Claims
Claims 1-30 were originally filed on March 12, 2024.
The amendment received on May 30, 2025, canceled claims 3 and 10; and amended claims 1-2, 5, and 12; and added new claims 31-32. The amendment received on September 16, 2025, canceled claims 20-21; amended claims 1 and 31; and added new claims 32-34. The amendment received on January 29, 2026, canceled claims 31 and 33; and amended claims 1 and 34. The amendment received on March 16, 2026, canceled claim 32; and amended claim 1.
Claims 1-2, 4-9, 11-19, 22-30, and 34 are currently pending and claims 1-2, 5-7, and 34 are under consideration as claims 4, 8-9, 11-19, and 22-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse telephonically on May 6, 2025.
Priority
The present application is a divisional of US Non-Provisional Application No. 18/170,994, filed on February 17, 2023, now issued as US Patent No. 12,064,475 B2, which is a continuation of US Non-Provisional Application No. 17/729,290, filed on April 26, 2022, now issued as US Patent No. 11,672,850 B2, which is a continuation of US Non-Provisional Application No. 17/243,096, filed on April 28, 2021, now issued as US Patent No. 11,464,842 B2.
Sequence Interpretation
Please note that the Examiner is interpreting the scope of claims 1 and 7 as open-ended requiring 100% identity to at least one of the claimed sequences but where each sequence encompasses any N-/C-terminal additions.
Response to Arguments
Applicant’s arguments, see Response, filed 3/16/26, with respect to the 112(a), new matter, rejection have been fully considered and are persuasive. The rejection of claims 1-2, 5-7, and 31-34 as failing to comply with the written description requirement has been withdrawn.
Applicant’s arguments, see Response, filed 3/16/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 1-2, 5-7, and 31-34 as being unpatentable over Seidel et al. WO 2021/055594 A1 published on March 25, 2021 (cited in the IDS received on 3/27/24), in view of Betts et al., “Chap. 14: Amino Acid Properties and Consequences of Substitutions,” Bioinformatics for Geneticists, Barnes et al., eds., John Wiley & Sons, Ltd., pgs. 297-316 (2003) (cited in the IDS received on 3/27/24) has been withdrawn.
New Rejections Necessitated by Amendment
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 1-2, 5-7, and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,672,850 B2 (cited in the IDS received on 3/27/24). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘850 claims:
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(‘850 claims 1-2 and 7). As such, the ‘850 claimed invention is directed to the instant administered immunogenic composition comprising at least one isolated polynucleotide encoding at least one amino acid sequence selected from SEQ ID NOs: 161, 163-164, 7882, 7884, 7887-7888, 7894, 7920-7921, 7933-7934, 7940, 7950-7951, 7970, 7972, 7976, 7982, 8139, 8267, 8269, 8272, 8277, 8296, and 8422 as recited in instant claims 1 and 7. ‘850 claims 2 and 5-6 read on instant claims 2 and 5-6, respectively.
However, ‘850 does not expressly claim the instant method of administering the ‘850 immunogenic composition as recited in instant claim 1 and where the at least one isolated polynucleotide encodes an MHC signal peptide or an MHC trafficking signal as recited in instant claim 34.
With respect to the instant method of administering the ‘850 immunogenic composition, pursuant to MPEP 804(II)(B)(1), [i]n AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. In the instant case, ‘850 teaches administering the immunogenic composition to a human subject in an effective in vivo dose dependent upon various parameters as determined by one skilled in the art to treat cancer (See ‘850, col. 589, last paragraph to col. 530, 1st paragraph), or providing the immunogenic composition in order to promote an immune response against cancer (See ‘850, col. 530, 2nd paragraph). Thus, the ‘850 claimed immunogenic composition can be used as instantly claimed.
With respect to where the at least one isolated polynucleotide encodes an MHC signal peptide or an MHC trafficking signal, as discussed supra, ‘850 claims where the at least one isolated polynucleotide is contained in a construct for in vivo expression. Pursuant to MPEP 804, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. See MPEP 804. Furthermore, the Federal Circuit found that “[t]he specification may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application. In the instant case, ‘850 teaches that the DNA molecules are administered for expression in vivo as is known in the art; for example, peptides are prepended with a secretion signal sequence at the N-terminus and followed by an MHC class I trafficking signal (MITD) (See ‘850, col. 453, last paragraph to col. 454, col. 1st paragraph). Thus, the ‘850 specification defines components included in a construct for in vivo expression. Therefore, the ‘850 claimed invention is not patentably distinct from the instantly claimed invention.
Claims 1-2, 5-7, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-40 of copending Application No. 19/236,476 (US 2026/0000743 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘476 claims:
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(See ‘850, claims 31-32 and 39-40). As such, the ‘476 claimed invention is directed to the instant administered immunogenic composition comprising at least one isolated polynucleotide encoding at least one amino acid sequence selected from SEQ ID NOs: 176 and 187 (note: ‘476 SEQ ID NOs: 176 and 187 are 100% identical to instant SEQ ID NOs: 161 and 7976, respectively) where the immunogenic composition is configured to prevent or treat cancer in a subject as recited in instant claims 1, 5 and 7. ‘476 claims 32-33 read on instant claims 2 and 5-6, respectively.
However, ‘476 does not expressly claim administering and effective amount of the ‘476 immunogenic composition as recited in instant claim 1 and where the at least one isolated polynucleotide encodes an MHC signal peptide or an MHC trafficking signal as recited in instant claim 34.
With respect to the instant method of administering the ‘476 immunogenic composition, pursuant to MPEP 804(II)(B)(1), [i]n AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. In the instant case, ‘476 teaches administering the immunogenic composition to a human subject in an effective in vivo dose dependent upon various parameters as determined by one skilled in the art to treat cancer (See ‘476, [0153]-[0155]). Thus, the ‘476 claimed immunogenic composition can be used as instantly claimed.
With respect to where the at least one isolated polynucleotide encodes an MHC signal peptide or an MHC trafficking signal, as discussed supra, ‘476 claims where the at least one isolated polynucleotide is contained in a construct for in vivo expression. Pursuant to MPEP 804, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. See MPEP 804. Furthermore, the Federal Circuit found that “[t]he specification may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application. In the instant case, ‘476 teaches that the DNA molecules are administered for expression in vivo as is known in the art; for example, peptides are prepended with a secretion signal sequence at the N-terminus and followed by an MHC class I trafficking signal (MITD) (See ‘476, [0112]). Thus, the ‘476 specification defines components included in a construct for in vivo expression. Therefore, the ‘476 claimed invention is not patentably distinct from the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner Comment
Notwithstanding the obviousness-type double patenting rejections above, claims 1-2, 5-7, and 34 are free of the prior art. It is noted that the instantly claimed immunogenic composition of claims 1-2, 5-7, and 34 is novel and nonobvious because there is no teaching in the art to achieve nucleic acids encoding at least one amino acid sequence selected from the specific claimed sequences. The closest prior art is Seidel et al. WO 2021/055594 A1 published on March 25, 2021 (cited in the IDS received on 3/27/24). Seidel et al. teaches compositions comprising a nucleic acid or a recombinant expression vector (i.e., same as a construct) (See Seidel specification, paragraph [00277], [00282]) where the recombinant expression vector comprises nucleic acids encoding a heterodimeric and single-chain T-cell modulatory polypeptides (TMPs) and dimers thereof (See Seidel specification, paragraph [0003], [00264]-[00265], [00270]). The TMPs comprise an immunomodulatory polypeptide, class I HLA polypeptides (a class I HLA heavy chain polypeptide and a β2 microglobulin polypeptide), and a KRAS peptide (e.g., a KRAS peptide comprising a cancer-associated mutation) that presents an epitope to a T-cell receptor (See Seidel specification, paragraph [0003], [00282]). Mutated forms of KRAS associated with certain cancers include a substitution of G12 such as G12C (See Seidel specification, paragraph [0056], [0058]). The KRAS peptide can have one or more amino acid substitutions relative to the wild-type, non-cancer associated KRAS peptide (See Seidel specification, paragraph [0056]) where the mutated KRAS peptide with one or more amino acid substitutions includes SEQ ID NOs: 179, 181, 185, 187, 190, and 216 (See Seidel specification, paragraph [0092]-[0093], [0096], [0099], [00101], [00250]). When comparing Seidel’s SEQ ID NO: 181 with instant SEQ ID NO: 158, there is 100% identity except for where the lysine residue at position 10 is arginine in instant SEQ ID NO: 158; and when comparing Seidel’s SEQ ID NO: 187 with instant SEQ ID NO: 164, there is 100% identity except for where the lysine residue at position 10 is arginine in instant SEQ ID NO: 164. Although the amino acid differences can be considered a conservative amino acid substitution, there is no teaching or suggestion in Seidel to substitute these particular amino acids, which are located at specific positions within the sequences. In other words, there is no motivation to conservatively substitute the amino acid residue that is distinct between instant SEQ ID NOs: 158 and 164 and Seidel’s SEQ ID NOs: 181 and 187, respectively. Moreover, Seidel does not teach or suggest how many amino acid substitutions to make within these sequences. Therefore, an ordinary skilled artisan would not be motivated to make the necessary substitution to result in the claimed amino acid sequences. Thus, the scope of claims 1-2, 5-7, and 34 is novel and nonobvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
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