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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, drawn to nucleic acid molecules comprising a nucleotide sequence encoding at least one ASFV antigen and corresponding peptides and immunogenic compositions thereof, and the required species, in the reply filed on 9/16/2025 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/16/2025.
Applicant elected the following species:
Amino acid sequence of SEQ ID NO: 22 and the corresponding polynucleotide sequence of SEQ ID NO: 21.
The restriction and election of species requirement filed 5/16/2025 indicated that Applicant must elect one or more ASFV antigen amino acid sequences (claims 2, 6, 7, & 14) and their corresponding polynucleotide sequences (claims 4 & 8). Applicant elected a single amino acid sequence (SEQ ID NO: 22) and its corresponding polynucleotide sequence (SEQ ID NO: 21). Claims 6-8 require additional ASFV antigen sequences, and are thus not the elected species.
Claims 6-8 are withdrawn from further consideration as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/16/2025.
Claims 1-5 and 9-15 are under examination on the merits.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 9/16/2025 is in compliance with 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Drawings
The drawings are objected to because the drawings make reference to colors (Figs. 3-6: “blue”, “green”), without a petition for use of colored drawings having been granted. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 2, 4, 5, 10, 14, and 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.
Claims 2, 4, and 14 recite the limitation “at least about 90% identity over” an entire length of the amino acid sequence (claim 2, line 4; claim 14, line 3) or nucleotide sequence (claim 4, line 3), or at least 60% of the amino acid sequence (claim 2, lines 6-7; claim 14, line 6) or nucleotide sequence (claim 4, line 7;).
The “at least about” term renders the claims indefinite because it is unclear what minimum identity is claimed. Claim 15 is also indefinite because it depends from claim 14 but does not resolve the lack of clarity around the term “at least about.”
Claim 10 recites the limitation “wherein the nucleic acid molecule comprises a viral particle,” which is indefinite because, generally, nucleic acid molecules encode particular proteins, and viral particles may encapsulate nucleic acids—the viral genome. It is unclear to the examiner how a nucleic acid molecule could comprise a viral particle, which may comprise proteins, envelope lipids, and other molecules, in addition to the nucleic acid genome.
Claim 4 recites the limitation “a nucleotide sequence having at least about 90% identity over an entire length of a nucleotide sequence”, which is unclear, on lines 3-4. Claim 4 is indefinite because it is unclear, due to the wording of the limitation, whether i) the nucleotide sequence must be 90% identical over the entire length of all of SEQ ID NO: 22or ii) the nucleotide sequence must be 90% identical over a fragment of SEQ ID NO: 22.
Claim 5 recites the limitation "the encoded peptide" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 3, 5, & 9-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally-occurring element of nature that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013) (hereafter “Myriad”).
Based upon an analysis with respect to the claims as a whole, claim(s) 1, 3, 5, & 9-12 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility)).
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes the claims are directed to an ineligible product/process as further detailed below.
In this case, claim(s) 1, 3, 5, & 9-12 recite or are directed to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, nucleic acid molecule which encodes at least one synthetic African swine fever virus (ASFV) antigen) that are directed to a judicial exception (in this case, a natural phenomenon)(Step 2A). However, because “synthetic” is not defined in the specification, applying the broadest reasonable interpretation the term results in the term reading on natural sequences, such as ASFV p32 or p54 encoding nucleic acids. For example, ASFV is naturally a double-stranded DNA virus, which encodes RNAs, start codons, and stop codons. Further, ASFV genomes could be interpreted as an expression vector, and natural transmission would include a pharmaceutically acceptable excipient. Therefore, identifying the proteins as recombinant, synthetic or non-naturally occurring or combining the proteins with a pharmaceutically acceptable diluent do not remove it from being a judicial exception. Thus the claimed product is not markedly different from its naturally occurring counterpart. To summarize, the claims read upon a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception. The claimed invention does not require a limitation that does not amount to significantly more than the judicial exception.
As pursuant to the Office’s interpretation of the Myriad decision, a recitation of a naturally-occurring nucleic acid, or any natural product of nature that does not have a substantial or marked difference from the natural product is not patent eligible subject matter. Therefore, claims 1, 3, 5, & 9-12 as written, read upon a non-naturally occurring ASFV nucleic acids that encode the protein that are found to have occurred naturally in nature without being subject to the "hand-of-man" and resulting in a substantial or markedly different product from that found in nature. Therefore, claim(s) 1, 3, 5, & 9-12 do not recite eligible subject matter under 35 U.S.C. 101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter. This rejection is necessitated by expanded 35 USC §101 USPTO training in view of the USPTO’s interpretation of Myriad. Applicant is directed towards the USPTO memos, which support the analysis of the claims; please review the latest materials regarding 35 USC §101 rejections.
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)(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.
Claims 1-5, 9, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guo, et al. (CN 110078801A, published 8/2/2019; machine translation provided due to original document being in the Chinese language; hereinafter referred to as “Guo”) as evidenced by Ras-Carmona, et al. (Ras-Carmona A, Lehmann AA, Lehmann PV, Reche PA. Prediction of B cell epitopes in proteins using a novel sequence similarity-based method. Sci Rep. 2022 Aug 12;12(1):13739. PMID: 35962028; hereinafter referred to as “Ras-Carmona”).
The claimed invention encompasses a nucleic acid molecule comprising a nucleotide sequence encoding at least one synthetic African swine fever virus (ASFV) antigen (claim 1). In another embodiment, the nucleic acid molecule comprises at least one nucleotide sequence encoding a peptide comprising an amino acid sequence selected from the group consisting of: a) an amino acid sequence having at least about 90% identity over an entire length of the amino acid sequence SEQ ID NO: 22, b) an immunogenic fragment comprising at least about 90% identity over at least 60% of the amino acid sequence SEQ ID NO: 22, c) the amino acid sequence SEQ ID NO: 22, and d) an immunogenic fragment comprising at least 60% of the amino acid sequence SEQ ID NO: 22 (claim 2). In a specific embodiment, the nucleic acid molecule is a DNA molecule or an RNA molecule (claim 3). In another embodiment, the encoded peptide is operably linked to at least one regulatory sequence selected from the group consisting of a start codon, an IgE leader sequence, and a stop codon (claim 5). In a different embodiment, the nucleic acid molecule comprises an expression vector (claim 9).
Alternatively, the nucleic acid molecule comprises at least one nucleotide sequence selected from the group consisting of: a) a nucleotide sequence having at least 90% identity over an entire length of a nucleotide sequence SEQ ID NO: 21, b) an immunogenic fragment of a nucleotide sequence having at least about 90% identity over at least 60% of the nucleotide sequence SEQ ID NO: 21, c) a nucleotide sequence SEQ ID NO: 21, and d) an immunogenic fragment of a nucleotide sequence SEQ ID NO: 21 (claim 4). Although claim 4 is indefinite for the reasons described above, in the interest of compact prosecution, the examiner is interpreting “immunogenic fragment” of parts b) and d) to mean that a fragment of SEQ ID NO: 21 that encodes an immunogenic polypeptide.
Another embodiment of the claimed invention is a peptide comprising at least one amino acid sequence selected from the group consisting of: a) an amino acid sequence having at least about 90% identity over an entire length of the amino acid sequence SEQ ID NO: 22, b) an immunogenic fragment comprising at least about 90% identity over at least 60% of the amino acid sequence SEQ ID NO: 22, c) the amino acid sequence SEQ ID NO: 22, and d) an immunogenic fragment comprising at least 60% of the amino acid sequence SEQ ID NO: 22 (claim 14).
The Prior Art
Guo teaches a recombinant plasmid encoding African Swine Fever Virus (ASFV) CD2v, which has a sequence identical to SEQ ID NO: 22 (Guo SEQ ID NO: 2; fragment SEQ ID NO: 4 of Guo lacks the C-terminal 150 amino acids; p. 3; Abstract; ). Below is an ABSS sequence alignment of instant SEQ ID NO: 21 and Guo SEQ ID NO: 2.
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Additionally, Guo’s CD2v construct possesses a start codon (Guo SEQ ID NOs: 2 & 4), and is configured for expression in CHO cells (Abstract). Furthermore, Guo discloses that by truncating the 150 amino acids of ASFV CD2v, it helps the protein to better fold, exposing antigenic sites therein (p. 3).
Guo further discloses the nucleotide sequence SEQ ID NO: 3, which encodes the ASFV CD2v sequence (pp. 2-3 and 10-11). Guo’s SEQ ID NO: 3 includes a fragment, nucleotides 595-623, which is identical to nucleotides 592-620 of the instant SEQ ID NO: 21. Because peptides as little as 8 amino acids in length can be antigenic (Ras-Carmona; Abstract; pp. 1-2, bridging para.), and the immune response will recognize virtually any non-self sequence as foreign and form specific immunity against it, the fragment encoded by nucleotides 595-623 of Guo’s SEQ ID NO: 23 would be an immunogenic fragment of ASFV CD2v.
Therefore, Guo anticipates claims 1-5, 9 and 14.
Claims 1, 3, 5, and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lopera-Madrid (Vet Immunol Immunopathol. 2017 Mar;185:20-33. doi: 10.1016/j.vetimm.2017.01.004. Epub 2017 Jan 24. PMID: 28241999; hereinafter referred to as “Lopera-Madrid”).
The claimed invention encompasses a nucleic acid molecule comprising a nucleotide sequence encoding at least one synthetic African swine fever virus (ASFV) antigen (claim 1), or an immunogenic composition comprising at least one nucleic acid molecule (claim 11). The immunogenic composition may further comprise a pharmaceutically acceptable excipient (claim 12). In a specific embodiment, the nucleic acid molecule is a DNA molecule or an RNA molecule (claim 3). In another embodiment, the encoded peptide is operably linked to at least one regulatory sequence selected from the group consisting of a start codon, an IgE leader sequence, and a stop codon (claim 5). In other embodiments, the nucleic acid molecule comprises an expression vector (claim 9), or a viral particle (claim 10). Although claim 10 is indefinite for the reasons described above, for the purpose of this rejection, and in the interest of compact prosecution, the examiner is interpreting it to mean that the nucleic acid is a component of a viral particle.
The Prior Art
Lopera-Madrid teaches mammalian cell derived and Modified Vaccinia Ankara (MVA) vector African swine fever virus subunit antigens in swine (Title). Lopera-Madrid further discloses that MVA-vectored CD2v (also called EP402R) resulted in interferon-gamma spot forming cell responses and T-cell proliferative responses against CD2v (Abstract; Fig.5). Lopera-Madrid teaches that MVA-ASFV constructs were administered IM at 107 TCID50 in 1 ml dose of Tris 1 mM (pH 9.0; p. 22, col. 2, para. 5). The CD2v MVA vector would inherently possess DNA and a start codon linked to the CD2v expression cassette because MVA is DNA virus and CD2v is expressed from the viral infection, respectively.
Therefore, Lopera-Madrid anticipates claims 1, 3, 5, and 9-12.
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.
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 1-5, and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lopera-Madrid (supra), as applied to claims 1, 3, 5, and 9-12 above, and in further view of Guo (supra).
The claimed invention encompasses a nucleic acid molecule comprising a nucleotide sequence encoding at least one synthetic African swine fever virus (ASFV) antigen (claim 1), or an immunogenic composition comprising at least one nucleic acid molecule (claim 11). The immunogenic composition may further comprise a pharmaceutically acceptable excipient (claim 12) or adjuvant (claim 13).
In a specific embodiment, the nucleic acid molecule is a DNA molecule or an RNA molecule (claim 3). In another embodiment, the encoded peptide is operably linked to at least one regulatory sequence selected from the group consisting of a start codon, an IgE leader sequence, and a stop codon (claim 5). In other embodiments, the nucleic acid molecule comprises an expression vector (claim 9), or a viral particle (claim 10). Although claim 10 is indefinite for the reasons described above, for the purpose of this rejection, and in the interest of compact prosecution, the examiner is interpreting it to mean that the nucleic acid is a component of a viral particle.
In another embodiment, the nucleic acid molecule comprises at least one nucleotide sequence encoding a peptide comprising an amino acid sequence selected from the group consisting of: a) an amino acid sequence having at least about 90% identity over an entire length of the amino acid sequence SEQ ID NO: 22, b) an immunogenic fragment comprising at least about 90% identity over at least 60% of the amino acid sequence SEQ ID NO: 22, c) the amino acid sequence SEQ ID NO: 22, and d) an immunogenic fragment comprising at least 60% of the amino acid sequence SEQ ID NO: 22 (claim 2).
Another embodiment of the claimed invention is a peptide comprising at least one amino acid sequence selected from the group consisting of: a) an amino acid sequence having at least about 90% identity over an entire length of the amino acid sequence SEQ ID NO: 22, b) an immunogenic fragment comprising at least about 90% identity over at least 60% of the amino acid sequence SEQ ID NO: 22, c) the amino acid sequence SEQ ID NO: 22, and d) an immunogenic fragment comprising at least 60% of the amino acid sequence SEQ ID NO: 22 (claim 14), or an immunogenic composition comprising the peptide (claim 15).
Alternatively, the nucleic acid molecule comprises at least one nucleotide sequence selected from the group consisting of: a) a nucleotide sequence having at least 90% identity over an entire length of a nucleotide sequence SEQ ID NO: 21, b) an immunogenic fragment of a nucleotide sequence having at least about 90% identity over at least 60% of the nucleotide sequence SEQ ID NO: 21, c) a nucleotide sequence SEQ ID NO: 21, and d) an immunogenic fragment of a nucleotide sequence SEQ ID NO: 21 (claim 4). Although claim 4 is indefinite for the reasons described above, in the interest of compact prosecution, the examiner is interpreting “immunogenic fragment” of parts b) and d) to mean that a fragment of SEQ ID NO: 21 that encodes an immunogenic polypeptide.
The Prior Art
The teachings of Lopera-Madrid are described above. Additionally, Lopera-Madrid discloses administration of sub-unit vaccines with TS6 adjuvant (p. 22, col. 2, last para.). Lopera-Madrid also discloses that adjuvant systems were used in conjunction with an adenovirus-vectored study (p. 31, col. 1, para. 2). However, Lopera-Madrid does not teach a) an amino acid sequence having at least about 90% identity over an entire length of the amino acid sequence SEQ ID NO: 22, b) an immunogenic fragment comprising at least about 90% identity over at least 60% of the amino acid sequence SEQ ID NO: 22, c) the amino acid sequence SEQ ID NO: 22, and d) an immunogenic fragment comprising at least 60% of the amino acid sequence SEQ ID NO: 22.
The teachings of Guo (supra) are described above.
It would have been obvious to one of ordinary skill in the art to modify the ASFV CD2v-encoding MVA vectors taught by Lopera-Madrid to incorporate the ASFV CD2v constructs taught by Guo. Lopera-Madrid discloses that MVA-vectored CD2v is antigenic, and Guo teaches an ASFV CD2v construct with sequence identical to SEQ ID NO: 22. Guo further provides motivation to use a truncated fragment of ASFV CD2v (Guo’s SEQ ID NO: 4), which helps the protein to better fold and expose antigenic sites. One of ordinary skill in the art would have been motivated to vaccinate against ASFV. It would have also been obvious to one of ordinary skill in the art to administer the MVA vectors with an adjuvant, as Lopera-Madrid discloses administration of other vaccines with TS6 adjuvant. There would be a reasonable expectation of success because Lopera-Madrid discloses use of such compositions in swine. Therefore, claims 1-5, and 9-15 were prima facie obvious before the priority date of the instant invention.
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 1-5 & 9-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 19/483,085 (reference application) in view of Guo (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because each set of claims is drawn to a nucleic acid molecule comprising a nucleotide sequence encoding at least one synthetic African swine fever virus (ASFV) antigen (instant claim 1 and copending claim 1). Each application also includes embodiments wherein the nucleic acid molecule is selected from the group consisting of a DNA molecule and an RNA molecule (instant claim 3 and copending claim 2), the encoded peptide is operably linked to an IgE leader sequence (instant claim 5, copending claim 3), the nucleic acid molecule comprises an expression vector (instant claim 9, copending claim 4). Further, each set of claims encompass an immunogenic composition comprising at least one of the nucleic acid molecules (instant claim 11 and copending claim 6), and more specific embodiments wherein the immunogenic composition further comprises a pharmaceutically acceptable excipient or adjuvant (instant claims 12-13, copending claims 7-8). The claim sets differ in that the instant claims are more generic, whereas the copending claims are limited to particular sequences (instant claim 1 and copending claim 1). However, one of the claimed sequences in the copending application, SEQ ID NO: 1, has a fragment that is 87.2% identical to the instant SEQ ID NO: 21, see ABSS sequence alignment summary:
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However, the copending application does not specifically disclose amino acid sequences that read on the sequence requirements of the instant claims (i.e., 90% sequence identity to SEQ ID NO: 22).
The teachings of Guo are described in detail above. Guo teaches a sequence that is 100% identical to SEQ ID NO: 22.
It would have been obvious to one of ordinary skill in the art that the sequence taught by Guo could be utilized in the compositions of the copending application, so the instant claims would have been obvious to one of ordinary skill in the art from claims 1-8 of the copending application in view of Guo.
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 JEFFREY MARK SIFFORD whose telephone number is (571)272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet Andres can be reached at 571-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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