Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
2. Claims 1-17 are under consideration.
Specification
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see ¶ [0005] and ¶ [0089]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
4. The use of the terms ‘Wizard’, ‘RNeasy’, and ‘Monarch Kit’ in ¶ [0104], which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that ‘Wizard’, ‘RNeasy’, and ‘Monarch Kit’ are merely examples and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
5. 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.
6. Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosure located in ¶ [0035] does not have an associated SEQ ID NO.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Claim Objections
7. Claims 2, 6, 11, and 16 are objected to because of the following informalities:
Claim 2 should read “…claim 1, wherein the antigen…”.
In claim 6, “…which is further encodes an alphavirus non-structural proteins…” is unclear. For improved clarity, a suggested rewording would be: “…which further encodes alphavirus non-structural proteins…”.
Claims 6, 11, and 16 should have an additional comma before ‘and’ in the list.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 3, 4, and 11 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 3 and 4 recite the limitation "the influenza protein". There is insufficient antecedent basis for this limitation in the claim. It appears that the claim dependency may be incorrect.
The term ‘SG promoter’ in claim 11 is an undefined term which renders the claim indefinite. The term “SG promoter” is not defined by the claim or the specification. Examiner is interpreting this term to mean ‘subgenomic promoter’ for purposes of further examination. Additionally, the wording in claim 11 is unclear.
Claim Rejections - 35 USC § 102
10. 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.
11. 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.
12. Claims 1-3 and 5-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by GROßE (US 20240181037 A1; provisional application filed 26 March 2021) (See PTO-892: Notice of References Cited).
Regarding claims 1-2, 7-8, and 17, GROßE teaches that the invention is an “mRNA (see claims 8 and 17) comprising at least one coding sequence encoding an influenza HA stem polypeptide.” (¶ [0014]), which is a species of the claimed ‘antigen protein’ (see claims 1 and 17). The reference also teaches some embodiments: “the mRNA comprises at least one additional coding sequence which encodes one or more heterologous peptide or protein elements selected from a signal peptide (see claims 1 and 17), a linker (see claim 7), […], a transmembrane element (see claims 1 and 17), a protein nanoparticle…” (¶ [0046]) and “the protein nanoparticle is ferritin.” (¶ [0048]) (see claims 1 and 17). Additionally, “mRNA used herein are preferably provided in purified or substantially purified form…” (¶ [0349]), which is known to be synonymous with the claimed ‘isolated polynucleotide’ (see claim 1).
Regarding claim 3, GROßE further teaches that “the stem that anchors the HA protein […] is comprised of HA2 and a part of HA1.” (¶ [0005]).
Regarding claim 5, GROßE teaches that the ferritin is bacterial and from H. pylori (¶ [0050] and [0051]).
Regarding claim 6, GROßE teaches a self-replicating mRNA molecule and “The polymerase can be an alphavirus replicase e.g. comprising one or more of the alphavirus proteins nsPI, nsP2, nsP3 and nsP4 (wherein nsP stands for non-structural protein).” (¶ [0523] and [0526]).
Regarding claim 9, GROßE teaches that in embodiments, the mRNA is an in vitro transcribed RNA in which “RNA may be obtained by DNA-dependent in vitro transcription of an appropriate DNA template…” (¶ [0470] and [0471]), which indicates the usage of an isolated DNA polynucleotide.
Regarding claim 10, GROßE teaches a vector comprising the polynucleotide: “The self-replicating RNA can conveniently be prepared by in vitro transcription (IVT). IVT can use a (cDNA) template created and propagated in plasmid form in bacteria…” (¶ [0533]).
Regarding claim 11, GROßE teaches the signal peptide and transmembrane element (¶ [0046], see claim 1 analysis above) and the alphavirus nsPs (¶ [0523] and [0526], see claim 6 analysis above), as well as “In some embodiments, the mRNA has the configuration 5’cap-5’UTR-nonstructural proteins (NSP) 1-4-subgenomic promoter-influenza HA stem polypeptide-linker-protein nanoparticle-3’UTR-polyA.” (¶ [0129]), wherein the “influenza HA stem polypeptide” teaches the “gene of interest encoding the polypeptide comprising an antigen protein” as described in the claim. Finally, the promoter is taught in ¶ [0353]: “For example, the mRNA may comprise […] a control sequence such as a promoter…”.
Regarding claim 12, GROßE teaches “Also provided is an immunogenic composition comprising the carrier-formulated mRNA as defined herein, wherein the composition optionally comprises at least one pharmaceutically acceptable carrier.” (¶ [0130])
Regarding claims 13 and 14, GROßE teaches “In embodiments, the mRNA of the invention is complexed, encapsulated, partially encapsulated, or associated with one or more lipids (e.g. cationic lipids and/or neutral lipids), thereby forming lipid-based carriers such as liposomes, lipid nanoparticles (LNPs), lipoplexes, and/or nanoliposomes, suitably lipid nanoparticles.” (¶ [0545]).
Regarding claims 15 and 16, GROßE teaches “Also provided is a method of eliciting an immune response, wherein the method comprises applying or administering to a subject in need thereof the carrier-formulated mRNA as defined herein, the composition as defined herein, the vaccine as defined herein or the kit or kit of parts as defined herein.” (¶ [0151]) and “Also provided is a method of treating or preventing a disorder, wherein the method comprises applying or administering to a subject in need thereof the carrier-formulated mRNA as defined herein, the composition as defined herein, the vaccine as defined herein or the kit or kit of parts as defined herein.” (¶ [0148]).
13. Claims 1-4, 7-10, and 12-17 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Ciaramella (US 20210187097 A1; provisional application filed 15 March 2017) (See PTO-892: Notice of References Cited).
Regarding claims 1- 4, 8, and 17, Ciaramella teaches “In some embodiments, the virus is a strain of Influenza A or Influenza B or combinations thereof. In some embodiments, the antigenic polypeptide encodes a hemagglutinin protein. In some embodiments, the hemagglutinin protein is H1, H2 […] In some embodiments, the hemagglutinin protein comprises a portion of the head domain. […] In some embodiments, the truncated hemagglutinin protein comprises a portion of the transmembrane domain.” (¶ [0232]). Ciaramella also teaches that “the mRNA polynucleotides of the present disclosure are isolated mRNA polynucleotides.” (¶ [0342]), “In some embodiments, antigenic polypeptides encoded by influenza RNA (e.g., mRNA) polynucleotides comprise a signal peptide.” (¶ [0369]), and “In some embodiments, a vaccine comprises at least one RNA (e.g., mRNA) polynucleotide having an open reading frame encoding influenza H7N9 HAI protein and ferritin.” (¶ [0322]). Therefore, this reference teaches an isolated polynucleotide that encodes at least part of the influenza H1 head protein, at least part of the transmembrane domain, includes a signal sequence, and ferritin, as claimed.
Regarding claim 7, Ciaramella teaches “Polynucleotides may comprise a region or regions of linked nucleosides. Such regions may have variable backbone linkages. The linkages may be standard phosphodioester linkages, in which case the polynucleotides would comprise regions of nucleotides.”
(¶ [0380]).
Regarding claim 9, Ciaramella teaches “Influenza virus vaccines of the present disclosure comprise at least one RNA polynucleotide, such as a mRNA (e.g., modified mRNA). mRNA, for example, is transcribed in vitro from template DNA, referred to as an “in vitro transcription template.” (¶ [0400]).
Regarding claim 10, Ciaramella teaches “Some embodiments of the present disclosure provide an isolated nucleic acid comprising a sequence encoding the novel influenza virus polypeptide sequences described above; an expression vector comprising the nucleic acid; and a host cell comprising the nucleic acid.” (¶ [0023]).
Regarding claims 12-14, Ciaramella teaches “Aspects of the invention also provide a unit of use vaccine, […] the open reading frame encoding a first antigenic polypeptide, and a pharmaceutically acceptable carrier or excipient, formulated for delivery to a human subject. In some embodiments, the vaccine further comprises a cationic lipid nanoparticle.” (¶ [0190]).
Regarding claims 15 and 16, Ciaramella teaches “Some embodiments of the present disclosure provide methods of inducing an antigen specific immune response in a subject, comprising administering to the subject any of the…” (¶ [0156]) and “Some embodiments provide methods of preventing or treating influenza viral infection comprising administering to a subject any of the vaccines described herein.” (¶ [0234]).
Double Patenting
17. 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.
18. Claims 1, 7-8, 10-14, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 14-19 of copending Application No. 19/098,884.
Claims 1, 11, and 14-19 of the copending Application No. 19/098,884 recite “An isolated polynucleotide which encodes a polypeptide comprising a receptor binding domain (RBD) of an S1 subunit in a spike protein of a SARS-CoV-2 fused to a transmembrane domain and optionally to a signal sequence, wherein the transmembrane domain is heterologous to the SARS-CoV-2.”, a linker fusing the transmembrane domain/signal sequence to the coronavirus protein, an RNA polynucleotide, a vector comprising “a promoter, 5’ UTR, polynucleotide encoding alphavirus non-structural proteins nsp1, nsp2, nsp3 and nsp4, SG promoter, a gene of interest encoding the polypeptide comprising a coronavirus protein fused to a signal sequence and/or transmembrane domain, 3’ UTR and poly A tail.”, a vaccine composition with the polynucleotide/vector and a pharmaceutically acceptable delivery vehicle, a delivery vehicle of alphavirus structural proteins or a lipid delivery system, and “A method of treating, preventing and/or immunizing against coronavirus viral infection in a subject, comprising administering an effective amount of the vaccine… to the subject in need thereof.”
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (i.e., coronavirus proteins) in the claims discussed above anticipate the genus (i.e., antigen protein) discussed in claims 1, 7-8, 10-14, and 16 of the instant Application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19. Claims 1, 6-8, and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 15-19 of U.S. Patent No. 12,280,102.
Claims 1, 11, and 15-19 of U.S. Patent No. 12/280,102 recite “An isolated polynucleotide, which encodes alphavirus non-structural proteins nsP1, nsP2, nsP3, and nsP4 and a polypeptide comprising a receptor binding domain (RBD) of an S1 subunit in a spike protein of a SARS-CoV2 fused to a transmembrane domain and optionally to a signal sequence…”, a linker fusing the transmembrane domain/signal sequence to the coronavirus protein, an RNA polynucleotide, a vector comprising the polynucleotide, the vector “which further comprises a promoter, 5’ UTR, SG promoter, 3’ UTR and poly A tail.”, a vaccine comprising the polynucleotide and a pharmaceutically acceptable delivery vehicle, and a delivery vehicle of alphavirus structural proteins or a lipid delivery system.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (i.e., coronavirus proteins) in the claims discussed above anticipate the genus (i.e., antigen protein) discussed in claims 1, 6-8, and 10-14 of the instant Application.
Conclusion
20. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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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/KRISTINA E. LY/Examiner, Art Unit 1671
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672