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 .
Priority
This application is a 371 of PCT/EP2022/075374 filed on 09/13/2022, which claims foreign priority to EP21196406.9, EP21196390.5, and EP21196366.5, all filed 09/13/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. All claims are examined using the earlier priority date of 09/13/2021.
Claim Status
Claims 1-20 are pending and under examination. Claims 1 and 5 are independent claims.
Drawings
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claims 14, 19, and 20 are objected to because of the following informalities: typographical errors. Appropriate correction is required.
Claim 14 contains an unnecessary parenthesis “)” at the end of the claim.
Claim 19 and 20 recite “generating the pool according to according to claim 10 (or 11)” the duplicated “according to” is redundant and should be removed.
Claim Rejections - 35 USC § 112
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.
Claims 1-20 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 1 recites the limitation "the said translated RNA molecule" in lines 3-4 . There is insufficient antecedent basis for this limitation in the claim.
Claim 1 also recites “a segment for the translation of… [an RNA molecule]… into a peptide”. It is unclear is the same neoantigen/epitope-encoding segment or a separate element (e.g., a Kozak sequence, IRES, or start codon). As written, two segments are recited as if distinct, but no structure distinguishes them, this is functional language without a corresponding structural boundary. See MPEP 2173.05(g).
Claims 2-4, and 7-20 depend from claim 1 and do not rectify this deficiency and are likewise rejected.
Claim 2 recites multiple instance of “and/or” joining three or more alternative elements (e.g., stabilizing and/or targeting and/or trafficking… in a vesicular region and/or a sequence for addressing). This nested chain of alternatives renders the claim indefinite because it is unclear which combination of elements are actually required to fall within the scope of the claim, including combinations that would appear to omit any structural stabilizing/targeting/trafficking function altogether. Applicant should amend to clearly and separately identify the required alternative(s), for example using a proper Markush grouping (“selected from the group consisting of…”) or separate dependent claims.
Claim 2 is further indefinite in its recitation of “a vesicular region,” which is not defined in the claim or given a standard meaning in the art sufficient to determine the scope of the term (e.g., vesicular gland or vesicle structures such as endosomes, lysosomes, or other membrane-bound compartments).
Claim 3 recites the same nest “and/or” construction identified above with respect to claim 2 (e.g., “a translation enhancer and/or a 3'-UTR and/or a 3' Poly A tail segment(s) and/or a 5'-UTR), rendering the claim indefinite for the same reasons.
The term “about” in claim 4 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. About is repeatedly used to describe the nucleotide length while not providing a clear boundary for either end of the range.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation of “between 100 nucleotides per strand and about 2500 nucleotides per strand”, and the claim also recites “preferably between 300 nucleotides per strand and about 800 nucleotides per strand”, “between about 400 nucleotides per strand and about 700 nucleotides per strand”, and “between about 500 (or 550) nucleotides per strand and about 650 (or 600) nucleotides per strand” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 recites the limitation "a (second) portion of a peptide" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 5 is an independent claim and no “first” portion has been previously introduced anywhere in the claim from which a “second” portion could derive antecedent basis. It is unclear whether the parenthetical term “second” is intended as a required claim limitation (in which case there is no antecedent basis for it) or as non-limiting, exemplary language.
Claim 8 recites the parenthetical “(of at least 15 consecutive nucleotides)” describing the overlap between the first and second portions. It is unclear whether this parenthetical is intended as a required numerical limitation of the claim or as non-limiting exemplary language. Applicant should amend to remove the parenthetical format and clearly state whether this limitation is required.
Claim 15 recites “[a] vaccine obtainable by the process of claim 14 for use in a method of treatment of a cancer, or an infectious disease, affecting a patient.” This claim recites both a composition and a method of using it.
Claims 16-18 recites the limitation "the pool" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 7-9, from which claims 16-18 depend, are each directed to a process for producing the single DNA molecule of claim 1. No pool is recited or produced anywhere in claims 7-9.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 depends on claim 5 recites “A DNA molecule comprising (i) a segment encoding a (second) portion of a peptide… and (iii) a segment encoding a poly A tail”, limitations directed to the coding (sense) strand. Claim 6 further requires the DNA molecule to be in antisense. A DNA segment cannot simultaneously satisfy claim 5’s encoding limitation and be in antisense orientation, therefore claim 6 fails to incorporate all of the limitations of claim 5 and is improper under 112(d). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 depends on claim 14, which depends on claim 13, which expressly limits the process to “generation of a RNA vaccine towards a cancer”. Claim 15 however, recites the resulting vaccine as being “for use in a method of treatment of cancer, or an infectious disease, affecting a patient.” The infectious disease treatment use recited in claim 15 is not narrowing of, and is not encompassed within, the cancer only process incorporated from claims 13-14, rather it expands the scope of claim 15 beyond what the claim from which it depends on supports. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ciaramella et al. (US 2019/0008938 A1, published Jan. 10, 2019).
In regards to claims 1 and 3, Ciaramella discloses “a synthetic DNA molecule comprising one segment encoding a tumor neoantigen, or an epitope from an infectious agent, under the control of a promoter for the transcription into a corresponding RNA molecule, and a segment for the translation of the said translated RNA molecule into a peptide.” Ciaramella discloses an “in vitro transcription [IVT] template” which is “deoxyribonucleic acid (DNA) suitable for use in an IVT reaction for the production of messenger RNA,” and states that such templates “encodes a 5' untranslated region, contains an open reading frame, and encodes a 3' untranslated region and a polyA tail” (see [0186]). Ciaramella further discloses that “IVT utilizes a DNA template featuring a promoter sequence upstream of a sequence of interest. The promoter sequence is most commonly of bacteriophage origin (ex. the T7, T3 or SP6 promoter sequence)” (see [0192]). Ciaramella discloses that encoded antigen may be a tumor-specific neoepitope (see [0041]), or in the alternative, an infectious-disease epitope (see [0020], [0134]). Thus, Ciaramella discloses every element of claim 1, including both alternatives. Additionally, the 5' UTR, 3' UTR and a polyA tail directly read on claim 3.
In regards to claim 2, Ciaramella discloses “the concatemeric antigen may have one or more targeting sequences. A targeting sequence, as used herein, refers to a peptide sequence that facilitates uptake of the peptide into intracellular compartments such as endosomes for processing and/or presentation within MHC class I or II determinants” (see [0146]).
In regards to claim 4, Ciaramella discloses “the polynucleotide includes from about 200 to about 3,000 nucleotides ( e.g., from 200 to 500, from 200 to 1,000, from 200 to 1,500, from 200 to 3,000, from 500 to 1,000, from 500 to 1,500, from 500 to 2,000, from 500 to 3,000, from 1,000 to 1,500, from 1,000 to 2,000, from 1,000 to 3,000, from 1,500 to 3,000, and from 2,000 to 3,000)”, including ranges that subsume the entirety of the claimed 100 to about 2500 nucleotides per strand (see [0191]). It would have been obvious to one of ordinary skill in the art to select a construct length within a narrower sub-range, which falls within Ciaramella’s broader discloses ranges, as a matter of routine optimization of a result effective variable as construct length affects manufacturability and IVT efficiency, and the claim is separately rejected under 35 U.S.C. 103 on that basis.
In regards to claim 5, Ciaramella discloses “a DNA molecule comprising (i) a segment encoding a portion of a peptide for addressing an antigen to MHC molecules, (ii) a segment for increasing the stability of a transcribed RNA or for increasing the translation of the transcribed RNA into a protein, and (iii) a segment encoding a poly A tail.” Ciaramella discloses sequences for targeting antigen to MHC molecules (see [0146]) as well as a segment for increasing translation of the transcribed protein (the 3’ UTR) and a polyA tail (see [0186]).
In regards to claim 6, Ciaramella discloses a two-strand synthesis method which by default would produce a second strand that is antisense to the strand encoding the DNA molecule such as the one disclosed by claim 1 or claim 5 (see [0195]).
In regards to claim 7, Ciaramella discloses a process for production of the claim 1 DNA molecule comprising chemical synthesis of the DNA molecule encoding the antigen under control of a promoter (see [0194], [0196]-[0197]).
In regards to claim 8, Ciaramella discloses “mRNA vaccines… may be made using two DNA strand that are complementary across an overlapping portion of their sequence, leaving single-stranded overhands (i.e., sticky ends) when the complementary portions are annealed… In the primer extension method, a portion of the 3’-end of a first strand… is complementary toa portion of the 3’end of a second strand… the single first strand DNA may include a sequence of a promoter (e.g., T7, T3, or SP6), optionally a 5’-UTR, and some or all of an ORF (e.g., a portion of the 5’-end of the ORF). In some embodiments, the single second strand DNA may include complementary sequences for some or all of an ORF…and optionally a 3 ' - UTR , a stop sequence , and / or a poly ( A ) tail . Methods of making RNA using two synthetic DNA strands may include annealing the two strands with overlapping complementary portions , followed by primer extension using one or more PCR - like cycles to extend the strands to generate a double - stranded DNA template” (see [0195]). Reading on the specific two-single-stranded DNA hybridization and extension process of claim 8 comprising “the steps of performing the chemical synthesis of (i) a first single stranded DNA molecule comprising the promoter for the transcription in RNA, the segment for its translation and a targeting sequence for endosomal addressing fused in-frame with the tumor neoantigen, or the epitope from an infectious agent, and a first portion of a genetic element encoding the sequence for the loading of the encoded tumor neoantigen, or the epitope from an infectious agent, for presentation to T lymphocytes, and of (ii) a second single-stranded DNA molecule encoding a second portion of a genetic element encoding the sequence for the loading of the encoded tumor neoantigen, or the epitope from an infectious agent, for presentation to T lymphocytes, wherein the second DNA molecule is antisense and wherein the said first and second portions form the complete sequence for the loading of the tumor neoantigen or the epitope from an infectious agent for presentation to T lymphocytes and wherein the said first and second portions present an overlap (of at least 15 consecutive nucleotides) allowing a specific base pairing, the said process further comprising the step of hybridizing the DNA molecule under (i) with the DNA molecule under (ii) and of elongating the two molecules so as to generate a double stranded DNA molecule encoding a promoter, the translational enhancer, the targeting sequence for endosomal addressing fused in- frame with the tumor neoantigen, or the epitope from an infectious agent, and a genetic element encoding the sequence for the loading of the encoded tumor neoantigen, or the epitope from an infectious agent, for presentation to T lymphocytes.”
While Ciaramella’s disclosure doesn’t specify the numerical minimum overlap length, the selection of an overlap of at least 15 nucleotides to ensure specific and stable primer/strand annealing (as opposed to nonspecific or unstable hybridization) is a routine design choice well within the ordinary skill in the art of primer and oligonucleotide design, and one of ordinary skill would have been motivated to select such a length to achieve predictable, specific hybridization in the two-strand assembly method Ciaramella already teaches.
In regards to claim 9, Ciaramella discloses that the second DNA molecule further comprises a 3’-UTR, and/or poly A tail (see [0195]).
In regards to claim 10-12, Ciaramella does not disclose, in a single passage, a “pool” of multiple separate DNA molecules each encoding a different antigen in the precise architecture of claim 1. Ciaramella’s primary embodiment is a single concatemeric ORF encoding 2-100 epitopes (see [0006], [0018]). However, Ciaramella also discloses that “in certain embodiments, such a neoantigen-containing vaccine may be polycistronic vaccine including multiple neoepitopes or one or more single RNA vaccines or a combination thereof” (emphasis added; see [0213]), i.e., a vaccine composition comprising multiple separate, single-antigen RNA (and by extension, DNA template) molecules. It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine multiple single-antigen DNA molecule of the type disclosed by Ciaramella (see [0186]) into a pooled composition as recited in claim 10, with claims 11-12’s shared element limitation (common promoter, common targeting sequence, etc.) as an obvious consequence of manufacturing convenience, using a standardized backbone/regulatory element set across a patient specific pool of antigen encoding inserts, which Ciaramella’s own kit embodiment supports (see [0083], [0186], [0211]).
In regards to claims 13, Ciaramella discloses a process for generating an RNA vaccine comprising generating the claim 1 DNA molecule and performing in vitro transcription of the DNA into RNA. This is the central IVT process disclosed throughout [0192]-[0198], as applied to the cancer antigen encoding template of [0186].
In regards to claims 14 and 15, Ciaramella discloses formulating the RNA molecules into a vaccine (see [0290]-[0364]), for use in treating cancer (see [0234]) or infectious disease (see [0020], [0134]).
In regards to claim 16-18, for the sake of compact prosecution and adopting the broadest reasonable interpterion of claims 16-18 as directed to a pool comprising a plurality of different DNA molecules, each independently obtainable by the process of claim 7 (or 8, or 9), claims 16-18 are rejected for the same reasons as outlined above with regards to claims 10-12. Ciaramella’s discloses of “one or more single RNA vaccines” as an alternative to a single concatemeric construct (see [0213]), combined with Ciaramella’s disclosed chemical synthesis and two-strand hybridization production process (see [0194]-[0198], corresponding to claims 7-9), renders obvious a pool of multiple DNA molecule, each independently produce by one of Ciaramella’s discloses synthesis processes, comprising different tumor neoantigens or infectious agent epitopes.
In regards to claims 19-20, Ciaramella discloses the IVT process for generating RNA vaccines from DNA templates (see [0192]-[0198]) and discloses or renders obvious a pool of DNA molecules of the type in claim 1. Combining these two teaching, performing the disclosed IVT process on the already-obvious pooled template composition would have been obvious to one of ordinary skill, as it is simply the application of Ciaramella’s own transcription process to Ciaramella’s own multi-molecule vaccine embodiment.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of copending Application No. 18/691,296 (reference application). The instant application and the copending application were filed on the same day, name overlapping inventors, and claim priority to the same foreign (EP) priority documents. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1, 10, 13, and 19-20 considered together are not patentably distinct from copending claim 1. Copending claim 1 recites a process for producing an RNA vaccine comprising: obtaining a plurality of different synthetic DNA constructs each encoding a different epitopes deduced from a target, each construct comprising a sequence permitting transcription of the epitope into RNA and a sequence for translation of the transcribed RNA into a peptide by a eukaryotic cell; and transcribing the plurality of synthetic DNA constructs in vitro into a corresponding plurality of RNAs; wherein the target is a peptide from an infectious agent, or a cancer neoepitope specifically identified ina patient as having at least one amino acid difference from peptides of normal cells of that patient. This is not patentably distinct from the combination of instant claim 1 (a synthetic DNA molecule comprising a segment encoding a tumor neoantigen or an infectious agent epitope under control of a promoter for transcription and a segment for translation), instant claim 10 ( a pool of the claim 1 DNA molecules comprising a plurality of different tumor neoantigens or infectious agent epitopes and instant claims 13, 19and 20 (a process for generating an RNA vaccine by generating the claim 1 DNA molecule or claim 10/11 pool and performing in vitro transcription into RNA). Both claim sets recite the identical dual-species target limitation (tumor/cancer neoepitope or infectious agent epitope), the identical pool of different DNA constructs architecture, and the identical in vitro transcription step producing a corresponding plurality of RNAs for use as a vaccine. The instant claims and the copending claims differ only in the manner in which the same subject matter is distributed across independent and dependent claims, and in claim 1’sadditional recitation that the plurality of constructs be “in proximity of” the transcription and translation sequences, which is not patentably distinct from the instant claims’ recitation of those sequences as segment s of the same DNA molecule.
Instant claim 2 and copending claim 2 both recite that the DNA construct further comprise a sequence encoding a peptide sequence for endosomal targeting of the encoded peptide.
Instant claim 3 and copending claim 3 both recite that the DNA construct further comprise segment encoding a translation enhancer and/or a 3'-UTR and/or a 3' Poly A tail segment(s) and/or a 5'-UTR.
Instant claim 11 and copending claim 4 each recite that the plurality of DNA construct shares the same promoter sequence.
Instant claim 10 is not patentably distinct from copending claim 8. Copending claim 8 recites that the plurality of DNA molecules is of at least 40, 50, 60, 80, 100, or 120 different DNA molecules encoding different epitope. This is merely a species falling within the genus of instant claim 10’s “plurality of different tumor neoantigens or…epitopes,” and the selection of a specific numerical quantity within an already disclosed genus of “a plurality” is an obvious variant not sufficient to render the claims patentably distinct.
Instant claims 10 and 12 are not patentably distinct from copending claim 10. Copending claim 10 recites an mRNA cancer vaccine comprising a plurality of mRNAs encoding a plurality of neoantigens deduced from the tumor, wherein the plurality of mRNAs encodes for at least a specified percentage of all tumor neoantigens identified in the tumor. This is not patentably distinct from the mRNA vaccine that results from performing the in vitro transcription process of instant claims 13/19/20 upon the pool of instant claims 10-12 and the percentage-based limitation of copending claim 10 is an obvious variant of the ”plurality of different tumor neoantigens” and shared element limitations of instant claims 10 and 12.
The subject matter claimed in the instant application is fully disclosed in and covered by the copending application. Although the copending application is not identical, they are not patentably distinct since the copending claims either anticipate or render obvious the instant claims and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew H Raymonda whose telephone number is (703)756-5807. The examiner can normally be reached Monday - Friday 10:00 am - 4:00 pm.
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/MATTHEW HAROLD RAYMONDA/Examiner, Art Unit 1684
/AARON A PRIEST/Primary Examiner, Art Unit 1681
