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 .
DETAILED ACTION
1. Applicant’s amendments/responses filed 4/14/23 and 1/20/26 are acknowledged and have been entered.
2. Applicant's election without traverse of the species of polypeptide SEQ ID NO: 12 and its corresponding RNA sequence SEQ ID NO: 245 in Applicant’s amendment and response filed 1/20/2025 is acknowledged.
Claims 19-33 read on the elected species. Upon consideration of the prior art, search and examination are presently being extended to SEQ ID NO: 234-244 and 246-267 that encode SEQ ID NO: 1-11 and 13-17, respectively.
Claims 19-22 are presently being examined. Claims 19 and 33 are independent claims.
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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 lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which Applicant may become aware in the specification.
5. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
6. The drawings are objected to because Figure 9 is upside down in relation to the “FIG. 9” label. 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.
7. The information disclosure statement filed 4/14/23 (3 pages that lists U.S. patent 10,973,909 and application serial no. 16/842,669) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because it is not in the proper format for an IDS (see below). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Applicant is reminded:
37 CFR 1.98 Content of information disclosure statement.
(a) Any information disclosure statement filed under § 1.97 shall include the items listed in paragraphs (a)(1), (a)(2) and (a)(3) of this section.
(1) A list of all patents, publications, applications, or other information submitted for consideration by the Office. U.S. patents and U.S. patent application publications must be listed in a section separately from citations of other documents. Each page of the list must include:
(i) The application number of the application in which the information disclosure statement is being submitted;
(ii) A column that provides a space, next to each document to be considered, for the examiner’s initials; and
(iii) A heading that clearly indicates that the list is an information disclosure statement.
(3)(b) (3) Each U.S. application listed in an information disclosure statement must be identified by the inventor, application number, and filing date.
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 19-33 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.
a) Claim 19 is indefinite in the recitation of “a. a polynucleotide that encodes a polypeptide: (i) having an amino acid sequence comprising any of SEQ ID NOs: 1-17; and (ii) consisting of at least 30 amino acids and no more than 60 amino acids;” because it is not clear what is meant, i.e., it is not clear if the polynucleotide only encodes one of the recited polypeptides (SEQ ID NO: 1-17 are 30 amino acid residues in length) plus or minus additional N- and/or-C-terminal sequences, or if the polynucleotide encodes two of the sequences represented in SEQ ID NO: 1-17 (that is, two 30-mer peptides).
Further, the Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications published Wednesday, February 9, 2011 in vol. 76, no. 27 of the Federal Register clearly indicates that “For example, if the language of a claim, given its broadest reasonable interpretation, is such that a person of ordinary skill in the art would read it with more than one reasonable interpretation, then a rejection under 35 U.S.C. 112, second paragraph is appropriate.”
Since as detailed above the said recited phrase can plausibly be interpreted in more than one way, the instant rejection has been set forth.
b) Claim 27 recites the limitation ”wherein the composition comprises a polynucleotide having a sequence consisting of SEQ ID NO: 235…238…240…242…245…246…247…248…249, and a polynucleotide having a sequence consisting of SEQ ID NO: 250”. There is insufficient antecedent basis for this limitation in the claim, since instant base claim 19 recites a polynucleotide that encodes a polypeptide consisting of at least 30 amino acids and no more than 60 amino acids, while instant dependent claim 27 recites multiple 30-mer peptides that together exceed 60 amino acid residues in length.
c) Claim 28 recites “wherein the composition comprises a polynucleotide having a sequence consisting of SEQ ID NO: 252, …255…257…259…262…263…264…265…266, and a polynucleotide having a sequence consisting of SEQ ID NO: 267”. There is insufficient antecedent basis for this limitation in the claim, since instant base claim 19 recites a polynucleotide that encodes a polypeptide consisting of at least 30 amino acids and no more than 60 amino acids, while instant dependent claim 28 recites multiple 30-mer peptides that together exceed 60 amino acid residues in length.
d) Claim 33 recites “wherein the adjuvant increases the immunogenicity of the polynucleotide and/or polypeptide”. There is insufficient antecedent basis for this limitation in the claim, since instant base claim 19 recites a composition that comprises a polynucleotide.
10. 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.
11. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 16/842,669 case that issued as US Patent No. 10,973,909 as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
The open transitional phrase “comprising” recite in instant base claim 1 opens the pharmaceutical composition to comprise other non-recited ingredients.
Claims 19-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US 10,973,909 in view of Clinical Trials.gov NCT04283461, record dated 3/26/2020, pages 1-20) and Hassett et al. (Mol. Ther. Nucleic Acids, 2019, 15: 1-11).
The claims of US 10,973,909 are drawn to an immunogenic composition comprising at least two distinct polypeptides, each consisting of at least 30 amino acid residues and no more than 60 amino acid residues and comprising a sequence selected from the group consisting of SEQ ID NO: 1-17 (that are identical to instantly recited SEQ IDNO: 1-17), and a method of stimulating an immune response against a SARS-CoV-2 infection comprising administering the said composition. At least one polypeptide in the composition comprises a fragment of a Coronavirdae protein that is a CD8+ T cell epitope that is restricted to at least two HLA class I alleles of an individual, or wherein at least one polypeptide comprises a fragment of a Coronavirdae protein that is a CD4+ T cell epitope restricted to at least two HLA class II alleles of an individual, or wherein at least one polypeptide comprises a linear B cell epitope.
The claims of US 10,973,909 do not recite wherein the immunogenic composition comprises instead of at least two distinct polypeptides, a polynucleotide encoding the polypeptide.
Clinical Trials.gov NCT04283461 teaches a mRNA vaccine (Moderna) that encodes a protein of SARS-CoV-2 encapsulated in a lipid nanoparticle (i.e., an adjuvant according to evidentiary reference Nature (2026, npj vaccines, nature.com/collections, 4 pages) besides constituting a delivery system [instant specification at page 26 at lines 15-21, page 27 at lines 15-21]). The lipid nanoparticle comprises an ionizable lipid, SM-102, and lipids, cholesterol, DSPTC and PEG2000 DMG (arms and interventions section). See entire reference.
Hassett et al. teach that mRNA vaccine delivered with lipid nanoparticles generates robust immune responses.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made a pharmaceutical composition comprising the encoding mRNA for the polypeptides in combination with an adjuvant such as a lipid nanoparticle taught by the secondary references, and to have administered it to a SARS-CoV-2 infected individual.
One of ordinary skill in the art would have been motivated to do this, with a reasonable expectation of success in doing so, in order to make a composition that can be more easily produced than a polypeptide or protein vaccine, and to have administered it, including in an investigational capacity, particularly in light of the claims of ‘909 that are drawn to an immunogenic composition that is administered to stimulate an immune response against an individual infected with SARS-CoV-2, and the teachings of the secondary references that lipid nanoparticles may be combined with an mRNA vaccine, including one against SARS-CoV-2, to yield a robust immune response in an individual.
Claims 24 and 25 are included in this rejection because evidentiary reference Nance and Meier (ACS Ent. Sci. 2021, 7: 748-756) teaches that the Moderna mRNA vaccine as well as another mRNA vaccine against SARS-CoV-2 comprises a modified, non-naturally occurring uridine, i.e., N1-methylpseudouridine. Nance and Meier further evidence that these vaccines are non-replicating mRNAs (see entire reference, especially introduction and primary structure sections).
Note that the polynucleotide sequences recited in instant dependent claim 27 and 28 are RNA and DNA sequences, respectively, that encode the polypeptides corresponding to SEQ ID NO: 2, 5, 7, 9 and 12-17.
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE DIBRINO whose telephone number is (571)272-0842. The examiner can normally be reached on M, T, Th, F.
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, MISOOK YU can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne DiBrino/
Marianne DiBrino, Ph.D.
Patent Examiner
Group 1640
Technology Center 1600
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641