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 .
Status of the Claims
It is noted that several claim sets have been submitted in this application, with the newest on 03/17/2025. However, the claim set of 03/17/2025 are the original claims that were included with the submission an amended specification. While multiple claim sets were submitted on 03/12/2024, the claim set of 03/12/2024 with the claim status identifiers, the amendments removing the multiple dependencies, and the addition of new claim 16 is understood to be the claim set of the preliminary amendment of 03/12/2024 and is examined on the merits.
Claims 1 – 16 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
Claim Objections
Claim 2 is objected to because of the following informalities: “endosomial” seems to be a misspelling of “endosomal”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Independent claim 1 requires a process for producing a RNA vaccine comprising a plurality of epitopes specifically deduced from a target comprising the steps of: - obtaining a plurality of different synthetic DNA constructs encoding a plurality of different epitopes deduced from the said target and being in proximity of a sequence allowing the transcription of the said different epitopes encoded by the said different synthetic DNA constructs into a RNA sequence and of a sequence for the translation of the said transcribed RNA into a peptide by a eukaryotic cell, and of - transcribing in vitro the said plurality of synthetic DNAs into a corresponding plurality of RNAs, wherein the said target is a peptide from an infectious agent, or cancer neoepitopes specifically identified in one patient as having at least one amino acid difference as compared with peptides from normal cells of the said patient. The specification presents 97 mRNAs corresponding to neoepitopes identified in a lung tumor of a patient in Examples, p. 16 – 20. No other examples of neoantigens from other tumors or peptides from infectious agents are provided.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Applicant is directed to MPEP 2163 for guidelines on compliance with the written description requirement.
Here, Applicant has not described a reasonable number of infectious agents or cancer neoepitopes targets in the process for producing a RNA vaccine, i.e. the required starting materials for the claims, but rather, Applicant has presented the public with an idea of how to perform an assay that might identify some agents that fall within the scope of the claim. Of course, depending on what agents are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004). In Rochester, the Federal Circuit upheld the district court's ruling that patent claims which recited administration of compounds not disclosed, but rather to be identified in a screening assay, were invalid on their face. Because the agent administered in all the pending claims reads on fragments, derivatives and analogs thereof, the agent does not have any conserved structure. Moreover, the specification does not disclose a structure/function correlation. Agents claimed with no structure that are only defined by function are generally not considered described.
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of administered agents nor guidance as to which of the myriad of molecules encompassed by the instant method claims would meet the limitations of the claims.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
Furthermore, in Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the
Supreme Court, held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed by their ability to bind to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at issue were functional, in that they defined the genus by its function (the ability to bind to specific residues of PCSK9) as opposed to reciting a specific structure (the amino acid sequence of the antibodies in the genus). See MPEP 2164.01.
Presently, the claimed RNA vaccine is only defined by functional properties: its ability to be transcribed into peptides from infectious agents or cancer neoepitopes. In view of the fact patterns detailed in Amgen v. Sanofi, the Applicant is not in possession of such an RNA vaccine which can produce any infectious-agent or cancer-neoepitope peptides as presented by the claims.
The skilled artisan cannot envision the detailed chemical structure of the genus of claimed treatment agents, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). Therefore, the instant claims do not meet the written description requirement.
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 10 – 15 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.
Claim 10 recites that “said plurality of mRNAs encodes for at least 1% of all tumor neoantigens identified in the tumor”. However, the phrase “all tumor neoantigens identified in the tumor” includes indefinite, relative terminology because the number of all tumor neoantigens identified may change with each assay or with time (as more studies and experiments reveal more antigens). Thus, it is not clear what the metes and bounds of the phrase “all tumor neoantigens identified” are.
Claims 11 – 15 depend from claim 10, either directly or indirectly, and thus inherit the deficiencies of claim 10.
Also, claim 12 ends with “submitting a blood sample from a patient having been administered with the mRNA cancer vaccine according to claim 10.” Because claim 12 does not have additional limitations regarding the submission of the blood sample, the phrase with “submitting a blood sample from a patient having been administered with the mRNA cancer vaccine” is not clear.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. Abstract ideas include mathematical concepts (including mathematical relationships, formulas, equations, and calculations), mental processes (including concepts performed in the human mind), and certain methods of organizing human activity (including managing personal behavior, relationships, or interactions between people). The rationale for this determination is explained below:
Claim 16 is directed to an abstract idea (“Step 2A prong one”) and a judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “abstract idea” is: identifying which synthetic peptide neoepitopes triggers an immune response. Thus, claim 16 would be classified as “mere data gathering” and do not integrate the judicial exception(s) into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional limitations of identifying which synthetic peptide neoepitopes triggers an immune response (“Step 2B”). Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017).
The recited active steps of the claims impose no meaningful limit on the scope of the claims and are recited at a high level of generality such that substantially all methods of identifying which synthetic peptide neoepitopes triggers an immune response would conventionally and routinely perform such steps. The specification discloses that “[e]ach peptide of the 97 neoantigens is tested by an ELISpot assay wherein T cells isolated from the blood of the patient is put in contact with each neoantigen (the three peptides derived from one neoantigen are present, combined, in one well). Then, the antigen-presenting cells (APC) fraction is electroporated with each peptide in the presence of the CD8+ cells. Then the production of IFN-gamma has been measured. (specification, page 19, first paragraph). These techniques are well are well-known, routine, and conventional means of identifying which synthetic peptide neoepitopes triggers an immune response as evidenced by VALIANTE (WO 2018/144082 A1, published 08/09/2018; see PTO-892: Notice of References Cited and 102 rejection below).
VALIANTE teaches that “CD8+ T cell cytokine production can be determined by standard methods known in the art, including but not limited to measurement of secreted levels of cytokine production (e.g., by ELISA or other suitable method known in the art for determining the amount of a cytokine in supernatant) and/or determination of the percentage of CD8+ T cells that are positive for intracellular staining (ICS) for the cytokine. For example, intracellular staining (ICS) of CD8+ T cells for
expression of IFN-y, TNFa and/or IL-2 can be carried out by methods known in the art (see
e.g., the Examples).” See VALIANTE at p. 43, lines 1 – 8.
The present claims do not contain any significant additional elements or steps beyond the observation of judicial exception(s) present when performing routine and conventional methods. Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the judicial exception(s).
Further, just as methods comprising detecting paternal DNA sequences in particular samples by PCR was identified in Ariosa v. Sequenom as "well-known, routine, and conventional" (see first paragraph on page 13 of Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)) even though the prior art did not demonstrate detecting said paternal DNA sequences in said particular samples by PCR, the methods identifying which synthetic peptide neoepitopes triggers an immune response encompassed by the instant claims are well-known, routine, and conventional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression and treat subjects. Also, “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013).
Thus, the claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 102
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 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)(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.
Claims 1 – 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by VALIANTE (WO 2018/144082 A1, published 08/09/2018; see PTO-892).
Present independent claim 1 is directed to a process for producing a RNA vaccine comprising a plurality of epitopes specifically deduced from a target comprising the steps of: - obtaining a plurality of different synthetic DNA constructs encoding a plurality of different epitopes deduced from the said target and being in proximity of a sequence allowing the transcription of the said different epitopes encoded by the said different synthetic DNA constructs into a RNA sequence and of a sequence for the translation of the said transcribed RNA into a peptide by a eukaryotic cell, and of - transcribing in vitro the said plurality of synthetic DNAs into a corresponding plurality of RNAs, wherein the said target is a peptide from an infectious agent, or cancer neoepitopes specifically identified in one patient as having at least one amino acid difference as compared with peptides from normal cells of the said patient.
VALIANTE is directed to concatemeric mRNA cancer vaccines encoding several cancer epitopes on a single mRNA construct, i.e. poly-epitope mRNA constructs or poly-neo-epitope constructs. See VALIANTE at the abstract. VALIANTE teaches that one or more mRNA each having an open reading frame encoding a cancer antigen peptide epitope, wherein the mRNA vaccine encodes 5-100 peptide epitopes and at least two of the peptide epitopes are personalized cancer antigens. See VALIANTE at p. 3, lines 8 – 11.
VALIANTE teaches that the mRNA, for example, is transcribed in vitro from template DNA, referred to as an "in vitro transcription template", and that the particular nucleic acid sequence composition and length of an in vitro transcription template will depend on the mRNA encoded by the template. See VALIANTE at p. 96, first paragraph.
Thus, VALIANTE anticipates present claim 1.
Regarding claim 2, according to the present specification, “the peptide sequence for endosomial targeting is the signal sequence of a lysosome-associated membrane protein (LAMP1 or LAMP2), for instance of dendritic cells (DC-LAMP) and/or a sequence targeting the epitope to the MHC-I receptor” (p. 8, last sentence – p. 9, top sentence of the present specification). VALIANTE teaches an mRNA cancer vaccine, wherein the concatemeric cancer antigen comprises one or more of: a) . . . ; e) at least 30% of the peptide epitopes have a highest affinity for class I MHC molecules from a subject (see VALIANTE at claim 32), suggesting that VALIANTE’s mRNA includes a sequence targeting the epitope to the MHC-I receptor.
Regarding claim 3, VALIANTE teaches that one or more mRNA each having one or more open reading frames encoding 1-500 peptide epitopes which are personalized cancer antigens and a universal type II T-cell epitope and that the mRNA encoding each peptide epitope have affinity for class I MHC and/or class II MHC. See VALIANTE at claims 1 - 9, 32, 38, 62, 78, and 128.
VALIANTE further teaches that an in vitro transcription template encodes a 5' untranslated (UTR) region, contains an open reading frame, and encodes a 3' UTR and a poly A tail and that the UTR can also include at least one translation enhancer polynucleotide, translation enhancer element, or translational enhancer elements (collectively, "TEE," which refers to nucleic acid sequences that increase the amount of polypeptide or protein produced from a polynucleotide. See VALIANTE at p. 96, lines 4 – 6 and p. 107, lines 26 – 29.
Regarding claim 4, VALIANTE teaches that single bottom strand DNA template generally includes a promoter sequence, e.g., a bacteriophage promoter sequence, to facilitate in vitro transcription (IVT) and that methods of making RNA using a single bottom strand DNA and a top strand promoter complementary oligonucleotide are known in the art. See VALIANTE, p. 97, lines 3 – 7.
Regarding claim 5, VALIANTE teaches that polynucleotides of the invention can include regulatory elements, for example, microRNA (miRNA) binding sites, transcription factor binding sites, structured mRNA sequences and/or motifs, artificial binding sites engineered to act as pseudo-receptors for endogenous nucleic acid binding molecules, and combinations thereof. See VALIANTE at p. 111, lines 15 – 18.
Regarding claims 6 and 11, VALIANTE teaches that the polynucleotides of disclosed mRNA vaccine can have a uniform chemical modification of all or any of the same nucleoside type or a population of modifications produced by mere downward titration of the same starting modification in all or any of the same nucleoside type, or a measured percent of a chemical modification of all any of the same nucleoside type but with random incorporation, such as where all uridines are replaced by a uridine analog, e.g., pseudouridine or 5-methoxyuridine. See VALIANTE at p. 74, lines 5 – 10.
Regarding claim 7, VALIANTE teaches that polynucleotides are codon optimized and that codon optimization methods are known in the art and may be used to match codon frequencies in target and host organisms to ensure proper folding; bias GC content to increase mRNA stability or reduce secondary structures. See VALIANTE at p. 64, lines 1 – 5.
Regarding claim 8, VALIANTE teaches 52 epitopes. See VALIANTE at FIG. 1, front page and Example 6, p. 320.
Regarding claim 9, VALIANTE teaches that the disclosed invention also includes a polynucleotide that comprises both a 5' Cap and a polynucleotide of the present invention (e.g., a polynucleotide comprising a nucleotide sequence encoding a cancer antigen epitope such as an activating oncogene mutation peptide) (see VALIANTE at p. 128, last sentence – p. 129, lines 1 – 2) and teaches the generic 5'-ppp-5' cap (see p. 129, lines 23 – 25), along with specific caps on pages 128 - 131. 5'-ppp-5' cap comprises two nucleotides separated by a triphosphate stretch.
Regarding claims 10 – 11, VALIANTE teaches selecting a subset of 15-500 neoepitopes from the mutanome (see VALIANTE at p. 354, line 11). Considering that the specification discloses an example where 97 neoepitopes were discovered (specification at the Examples, p. 16 – 20), VALIANTE’s 15 – 500 neoepitopes likely covers at least 1% (present claim 10) or at least 25% (present claim 11) of all tumor neoantigens identified.
Regarding claim 12, VALIANTE teaches methods for identifying and/or detecting neoepitopes of an antigen (see VALIANTE at p. 36, lines 27 – 28) and that the disclosed cancer vaccines can be envisioned for use in the priming of immune effector cells, for example, to activate peripheral blood mononuclear cells (PBMCs) ex vivo, which are then infused (re-infused) into a subject (see VALIANTE at p. 157, lines 15 – 18).
Regarding claim 13, VALIANTE teaches that the disclosed mRNA vaccines may include an activating oncogene mutation peptide (e.g., a KRAS mutation peptide). VALIANTE teaches that oncogenic mutations are common in many cancers and that the ability to target these mutations and generate T cells that are sufficient to kill tumors has broad applicability to cancer therapy. See VALIANTE at p. 31, last paragraph.
Regarding claim 14, VALIANTE teaches methods of identifying a set of neoepitopes for use in
a personalized mRNA cancer vaccine having one or more polynucleotides that encode the set
of neoepitopes comprising: (a) generating a RNA-seq sample from a patient tumor. See VALIANTE at claim 130.
Regarding claim 15, VALIANTE teaches that T cells obtained from a treated subject can be stimulated in vitro with the cancer antigens. See VALIANTE at p. 42, line 32 (last line).
Regarding claim 16, VALIANTE teaches a method for treating a subject with a personalized mRNA cancer vaccine, comprising identifying a set of neoepitopes to produce a patient specific mutanome, selecting a set of neoepitopes for the vaccine from the mutanome based on MHC binding strength, MHC binding diversity, predicted degree of immunogenicity, low self reactivity, and/or T cell reactivity, preparing the mRNA vaccine to encode the set of neoepitopes, and administering the mRNA vaccine to the subject within two months of isolating the sample from the subject. See VALIANTE at claim 128.
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 – 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of copending Application No. 18/690,453 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims and the copending claims recite similar limitations.
For example, copending claim 1 recites 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;
Copending claim 2 recites the DNA molecule of claim 1 further comprising a segment encoding a sequence for stabilizing and/or targeting and/or trafficking the tumor neoantigen or the epitope from an infectious agent in a vesicular region and/or a sequence for addressing the encoded tumor neoantigen or the epitope from an infectious agent to MHC molecules;
Copending claim 7 recites a process for the production of the DNA molecule according to claim 1, comprising the steps of performing the chemical synthesis of the DNA molecule encoding the tumor neoantigen, or the epitope from an infectious agent, under the control of a promoter;
Copending claim 10 recites a pool of the DNA molecules according to claim 1, the said pool comprising a plurality of different tumor neoantigens or a plurality of different epitopes from an infectious agent;
Copending claim 11 recites that the plurality of the DNA molecules of the said pool have the same promoter for the transcription of the tumor neoantigen, or the epitope from an infectious agent, in RNA;
Copending claim 12 recites that that plurality of the DNA molecules of the said pool have the same genetic element encoding a sequence for endosomial targeting of the tumor neoantigen, or the epitope from an infectious agent, and/or the same translation enhancer and/or the same genetic element encoding a sequence for the loading of the encoded tumor neoantigen, or the epitope from an infectious agent, for presentation to T lymphocytes and/or the same 3'-UTR.
Thus, because the present claims recite similar limitations as the copending claims, the present claims are anticipated by the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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