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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Status
Claims 1-6, 8, 10-12, 17, 20, 27, 33, 53, 55, and 57-58 were previously pending.
Claims 1-6, 8, 10-12, 17, 20, 27, 33, 53, and 55 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Receipt is acknowledged of the claim amendments and arguments submitted on 05 February, 2026. Claims 1-6, 8, 10-12, 17, 20, 27, 33, 53, and 55 are cancelled. Claim 57 is amended. Claims 59-68 are newly added.
Therefore, claims 57-68 are pending and are the subject of the present Official Action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2020/063490, filed 04 December, 2020, which claims priority to United State Provisional Application No. 62944824, filed 06 December, 2019. Acknowledgment is made of applicant’s claim for priority.
The earliest possible priority for the instant application is 06 December, 2019.
Drawings
The drawings are objected to because FIG. 2, 3, 4, 8A-B, 9, 13A-B, and 17B are out of focus and illegible. 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.
Withdrawn Objections/Rejections in view of Applicant’s Amendments/Arguments
Claim Objections
The objection to claim 57 is withdrawn in view of Applicant’s amendments to the claims. Claim 57 has been amended to be in independent form and to require the limitations of previously withdrawn claim 1.
Claim Rejections - 35 USC § 103
The rejection of claims 57-58 under 35 U.S.C. 103 as being unpatentable over US 2014/0147432 (Published: 29 May, 2014) (hereinafter “Moderna”) is withdrawn in view of Applicant’s amendments to the claims.
Applicant has amended claim 57 to require “an engineered nucleic acid comprising an initial transcription sequence (ITS) comprising the nucleotide sequence of SEQ ID NO: 1, wherein the ITS is located downstream of a promoter and operably linked to the promoter, and wherein the ITS is located upstream of a sequence of interest”
The sequence of Moderna which contains the sequence of instant SEQ ID NO: 1, does not have these additional features. Specifically, the sequence of Moderna does not teach instant SEQ ID NO: 1 downstream of a promoter and operably linked to the promoter.
New Rejections Necessitated by Applicant’s Amendments to the Claims
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 57-68 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.
The terms “upstream” and “downstream” in claim 57 are relative terms which render the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Nowhere in the claim nor the specification is there a limiting definition of “upstream” nor of “downstream”. Thus, a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought insofar as they would not know how far downstream of the promoter nor how far upstream of a sequence of interest the ITS can be to fall within the scope of the instant claims.
Claims 58-68 are further rejected for their dependency on a rejected base claim.
Claim 68 is rejected for being indefinite because it is unclear how a “sequence of interest” in itself “targets a genomic sequence of interest”. The specification which Applicant cites to for support of this claim language teaches RNA interference. However, the claim itself does not require such a mode of action and instead ambiguously refers to an ability to “target” without providing how that ability is to be met to fall within the scop of claim 68. Accordingly, a person having ordinary skill in the art would not be apprised of the scope of the invention claimed in instant claim 68.
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.
Claim 58 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0147432 (Published: 29 May, 2014) (hereinafter “Moderna”). This rejection has been necessitated by Applicant’s amendments to claim 57 because these amendments limited the scope of the claim such that new grounds of rejection are required to address the entire scope of the instantly pending claims.
Moderna discloses modified mRNA molecules and methods of making the same (Moderna, [0006]). It is noted that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP 2113. In disclosing an mRNA molecule, Moderna has disclosed the same product as that produced by the method of claim 57.
Double Patenting
Claims 57-58 remain provisionally rejected and claims 59-68 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11-13, 15-19, and 21-22 of copending Application No. 17/734,703 (reference application) in view of US 2014/0147432 (Published: 29 May, 2014) (hereinafter “Moderna”). This rejection has been modified as necessitated by Applicant’s amendments to the claims.
Claim 1 of 17/734,703 is directed to : An mRNA encoding a SARS-CoV-2 spike protein, the mRNA comprising a 5’ UTR comprising an Initial Transcribed Sequence (ITS) of SEQ ID NO: 8 or SEQ ID NO: 9, optionally comprising one or more modified nucleobases.
Claim 2 of 17/734,703 is directed to: ITS sequences comprising SEQ ID NO: 10.
Claim 1 of the invention is directed to: An in vitro method of producing an RNA transcript, comprising:combining in a transcription reaction in the presence of nucleotide triphosphates (NTPs): an engineered nucleic acid comprising an initial transcription sequence (ITS) comprising the nucleotide sequence of SEQ ID NO: 1, wherein the ITS is located downstream of a promoter and operably linked to the promoter, and wherein the ITS is located upstream of a sequence of interest; and a RNA polymerase; and producing an RNA transcript.
Reference SEQ ID NO: 10 is identical to instant SEQ ID NO: 1. Therefore, the reference claims are related to the instant invention as a species of the instant invention where the sequence of interest is a SARS-CoV-2 spike protein.
It is well established that a species of a claimed invention renders the genus obvious. In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978). Thus, the reference claims render obvious the instantly pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the double patenting rejection should be withdrawn because they believe that it is the last remaining rejection (Remarks, page 8). It is acknowledged that the reference application has a later effective filing date. However, the double patenting rejection is not in fact the last remaining rejection. Thus, Applicant’s arguments have been fully considered but have not been found persuasive and the double patenting rejection is maintained and newly applied to newly added claims.
Additional Comments
Claims 57, and 59-68 are indicated as free of the prior art of record. Claims 59-68 all depend from claim 57. Claim 57 has been amended to require “an engineered nucleic acid comprising an initial transcription sequence (ITS) comprising the nucleotide sequence of SEQ ID NO: 1, wherein the ITS is located downstream of a promoter and operably linked to the promoter, and wherein the ITS is located upstream of a sequence of interest”
The sequence of Moderna which contains the sequence of instant SEQ ID NO: 1, does not have these additional features. Specifically, the sequence of Moderna does not teach instant SEQ ID NO: 1 downstream of a promoter and operably linked to the promoter. As Applicants concede at page 8 of the remarks Moderna describes modified mRNA molecules, where SEQ ID NO: 1 within its coding region with an overall length of 1,428 nucleotides.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA G LEAVITT can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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