3DETAILED 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 .
The preliminary amendment filed 5-10-2024 has been entered. The response filed 2-2-2026 has been entered into the record.
Status of Claims
Claims 1-4, 6, 9, 12, 15-23, 26-28 and 30 are pending. Claims 5, 7, 8, 10, 11, 13, 14, 24, 25 and 29 have been canceled.
Election/Restrictions
Claims 6, 9, 18, 20-23, 26-28 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2-2-2026. Claims 1-4, 12, 15, 16, 17 and 19 are under examination.
Information Disclosure Statement
The information disclosure statements filed 5-10-2024 and 6-26-2024 have been considered. Initialed copies are enclosed.
Claim Rejections - 35 USC § 112
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.
Claims 16 and 17 are rejected under 35 U.S.C. 112(d), 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. The instant claims depend on claim 1 which is drawn to a compound claim per se. The additional limitation of lipid nanoparticle or vaccine does not limit the particular structure of the RNA itself (e.g. add more sequence structure). As such, the claims fail to properly further limit the independent claim. Applicant may redraft the claims as composition of matter claims to obviate this rejection. 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 § 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 1-4, 12, 15, 16 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they are drawn to a natural product.
The claims are drawn to mRNA encoding one or more coding regions of at least one antigenic peptide or protein wherein the protein is present at one or more life cycle stages of a malarial parasite ( is a Plasmodium falciparum circumsporozoite protein (PfCSP) having at least 90% identity to the sequence set forth in SEQ ID NO:2 or 8 or the nucleic acid sequence of SEQ ID NO:10.
The claimed invention is directed to non-statutory subject matter the claims are drawn to a genus of mRNA molecules encoding one or more coding regions of an antigenic peptide or protein of naturally mRNA molecules from Plasmodium falciparum, or a surface circumsporozoite (PfCSP) protein in particular vaccines comprising such. The mRNA molecules are naturally occurring products produced in a natural process of transcription and translation of DNA into proteins. They have no structure that distinguished that are found or isolated from nature. Sequencing nucleic acid or description of the mRNA structure produced thereform does not provide for or confer a marked structural difference from the naturally occurring product. Eligibility requires more than the hand of man (e.g. sequencing), to be eligible the claimed product must be both non-naturally occurring and markedly different from naturally occurring products (see page 1, third full paragraph). In the instant case the claimed mRNA encoding polypeptide or polypeptide fragments does not markedly structurally differ from that found in nature whose mRNA sequence encodes the claimed fragments. The removal of the mRNA from nature does not provide a marked structural difference of the mRNA from that which is naturally occurring. As such, the claimed product is not patent eligible see analgous rationale in Association for Molecular Pathology v Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013)) set forth for isolated nucleic acids. The claimed composition comprising the isolated polypeptide fragment does not meet the criteria as it merely combines the isolated mRNA with naturally occurring products or adjuvants such as CpG, cytokines and lipopolysaccharides. The term “recombinant” would also not confer a structural difference with respect to the naturally occurring mRNA as the means of producing the polypeptide does not appear to confer a marked structural difference from the naturally occurring structure/sequence. With respect to the elements recited in addition to the judicial exception of a naturally occurring polypeptide or fragment thereof, the following is found: (1) it recited at a high level of generality such that substantially all practical applications of the judicial exception is covered and/or (2) it recites an element that is well understood, purely conventional or routine in the field of biotechnology. The claimed composition is also merely a combination of natural products (1) isolated recombinant polypeptide fragment and (2) an adjuvant. Funk Brothers Seed Co. v. Kalo Inoculant Co., 33 U.S. 127 (1948).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 12, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GenBank Accession number XM_001351086.1; available May 6, 2020 as set forth below.
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From the Blast sequence alignment, the sequences are 100% identical and as set forth in the GenBank description, the molecule is an mRNA from P. falciparum 3D7. The term vaccine is merely an intended use and does not differ from the mRNA molecule itself. The claims are therefore anticipated.
Claims 1-4, 12, 15-17 and 19 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Schwendt et al (WO 2020/128031 published June 25, 2020 with priority to at least 12-20-2019).
Schwendt et al teach coding mRNA for a malaria vaccine comprising a coding region from at least one antigenic protein derived from circumsporozoite protein from a malarial parasite (e.g. Plasmodium falciparum). The vaccines comprising a coding RNA are place in association with polymeric carrier, a polycationic protein or a lipid nanoparticle (see Abstract). Schwendt et al teach that RNA vaccines are superior advantages over DNA-based vaccines (see page 2, lines 34-45). Schwendt et al teach coding RNA preferably derived from an CSP protein results in expression of the CSP antigen in a subject (see page 12). The coding species Pf3D7 List 1 pages 13-14) encoded by SEQ ID NO:4 is 100% identical to SEQ ID NO:2 herein as set forth below.
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Schwendt et al teaches the sequence of P. falciparum 3D7 and the particular regions (see page 17, lines 35- page 18, line 16) CSP and regions for 3D7 epitopes are presented in page 18, lines 28-32. The coding RNA can be a mRNA (see page 45, lines 25-27 and page 46, lines 10-14; pages 177-178 claims 26-32). Preferably the mRNA is suitable for a vaccine and contains a polymeric carrier or LNP. IN a preferred embodiment the composition of the RNA comprises lipid nanoparticles (see page 129, lines 36-page 132, line 29). Schwendt et al exemplified the preparation of LNP/mRNA compositions and vaccination using these (see pages 156-174). As such, Schwendt et al anticipate the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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