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 with traverse of claims 1-16 and 19 with species election of SEQ ID NOs:1, 30, and 31 in the reply filed on February 12, 2026 is acknowledged. The traversal is on the ground(s) that there would be no serious burden on the examiner to search and examine all pending claims. This is not found persuasive because a search/examination burden is not a criterion for restriction/election requirement for this national stage application.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-16, 19, 23-24, and 32 are currently pending in the instant application. Claims 23-24 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 1-16 and 19 are under examination on the merits in the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 7, 2023, October 15, 2025, and February 12, 2026 have been considered by the examiner.
Note that all foreign language documents submitted with English language title and abstract are considered only insofar as the English language portion as submitted by applicant.
Note that all NPL documents submitted without English language translation filed on October 15, 2025 are not considered.
Note that the BR foreign patent document filed on October 15, 2025 is in non-English language in its entirety. Hence. The reference is not considered.
Note that WO 2018/011225 A1 filed on April 7, 2023 pertains to a sensor-based breastfeeding volume measurement device. The examiner is unable to understand the relevance of this reference to the instant application. Hence, the reference is not considered. If applicant wishes the examiner to consider this particular reference, applicant is required to provide a reason as to how the reference is related to the field of the invention and why the examiner must consider this seemingly unrelated reference.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/014,394, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. It is noted that the ‘394 provisional application does not describe the instantly claimed limitation of “at least 100 nucleotides of a SARS-CoV-2 5’ untranslated region (5’ UTR), at least 100 nucleotides of a 3’ untranslated region (3’ UTR), or a combination thereof.” Further, the ‘394 provisional application does not disclose the deletion range of “at least 10 to at least 27,000 nucleotides”, nor does it disclose SEQ ID NOs:28-33. Accordingly, claims 1-16 and 19 are not entitled to the benefit of the ‘394 application filing date thus the effective filing date for claims 1-16 and 19 will be the filing date of the PCT application, which is April 23, 2021.
Specification
The disclosure is objected to because of the following:
1. The nucleotide position numbering “411” at line 29 of page 9; line 31 of page 11; line 35 of page 75; and line 39 of page 77 is incorrect.
2. The instant specification discloses conflicting information at least for the nucleotide sequence of “TIP1”. See page 7 disclosing “TIP1 encodes 450nt of 5’UTR and 330nt of 3’UTR.” (emphasis added). Compare the disclosure at page 7 to the disclosure at page 9 disclosing that the “3’ SARS-CoV-2 sequences in TIP1 are shown below as SEQ ID NO:29”, which is 361 nucleotides in length.
Clear explanation for the discrepancy in the disclosed information in the specification is required, and appropriate correction without introducing new matter is required, if deemed necessary.
Claim Objections
Claims 1-16 and 19 are objected to because of the following informalities: The claim text is not in black font, thereby reading the claims difficult. Applicant is required to use black font in the next reply. Note that application papers including claims must be clearly legible using black colored font text and black lines. See MPEP §608.01.
Claim 2 is objected to because of the following informalities: Claim 2 does not end with a period. Appropriate correction is required.
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 7-8 and 15-16 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 7-8 recite SEQ ID NO:18. It is noted that there is no sequence, either nucleic acid or amino acid, associated with SEQ ID NO:18. See the following reproduced from the sequence listing filed in this application:
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In fact, the instant specification is completely silent regarding the actual sequence of SEQ ID NO:18. Accordingly, it is impossible to ascertain the metes and bounds of SEQ ID NO:18 being claimed in the instant case, thereby rendering claims 7-8 indefinite.
Claims 7-8 recite “the SARS-CoV-2 genome encoding portions of any of SEQ ID NO:1-22.” It is noted that not all SEQ ID NOs:1-22 are amino acid sequences. For instance, SEQ ID NO:1 and SEQ ID NO:20 are nucleic acid sequences. Hence, the aforementioned limitation recites structurally conflicting limitations, thereby rendering the claims indefinite.
Claim 15 recites that the 3’ SARS-CoV-2 comprises SEQ ID NO:32. It is noted that the instant specification discloses SEQ ID NO:32 as a 5’ UTR sequence. As such, claim 15 recites structurally conflicting/impossible limitations, thereby rendering the claim indefinite.
Claim 15 recites the phrase "such as", which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 16 recites “extended poly A sequences.” The term “extended” is a relative term, which is open to different interpretations such that a 10-nt polyA may be considered “extended” by one person of ordinary skill in the art, whereas only up to 100-nt polyA should be considered “extended” by another. Neither the instant specification nor the claim itself provides a requisite number pertaining to the “extended” polyA bases. As such, the metes and bounds pertaining to the aforementioned limitation cannot be clearly ascertained, thereby rendering the claim indefinite.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are broadly drawn to a recombinant SARS-CoV-2 construct comprising “deletion of portions of the SARS-CoV-2 genome”, wherein the deleted portions are “at least 10 to at least 27,000 nucleotides”.
In stark contrast to the extremely broad generic claims, the instant specification appears to at best describe four constructs: TIP1 (T1), TIP1*(T1*), TIP2(T2), and TIP2*(T2*), wherein it appears that TIP1 comprises SEQ ID NOs:28-29; TIP2 comprises SEQ ID NOs:30-31; TIP1* comprises SEQ ID NO:32 and SEQ ID NO:29; and TIP2* comprises SEQ ID NO:33 and SEQ ID NO:31. The constructs disclosed in the instant specification, but not in the ‘394 provisional application, are far from comprising a 10-nt deletion from the SARS-CoV-2 genome, let alone the instantly claimed deletion range of “at least 10 to at least 27,000 nucleotides”. Furthermore, the four construct species significantly overlap in nucleotide sequence thus are not a representative number of species reflecting a myriad of innumerable structural variations encompassed by the extremely broad claims. Accordingly, the disclosure of the instant specification is insufficient to adequately describe the entire genus in such a manner to reasonably convey that the instant co-inventors had possession of the entire genus as of the filing date sought or granted in the instant application.
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 1-13 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yao et al. (bioRxiv, posted on November 23, 2020) as evidenced by GenBank accession number MW250351.
Note the priority benefit denial above.
Yao discloses a “short synthetic” “defective interfering (DI)” construct against SARS-CoV-2, wherein the construct comprises the DNA sequence of “GenBank accession number; MW250351” having nucleotides “1 to 789”, “19674 to 20340”, and “28477 to 29903” of “GenBank accession number: NC_045512.2” in the order from the 5’ end to the 3’ end. See the second and eighth pages.
Yao teaches that the DI construct comprises “the putative packaging signal”. See the third page.
It is noted that Yao’s DI construct identified as GenBank accession number MW250351 comprises the entire 713-mer sequence of SEQ ID NO:31 claimed in the instant case. See positions 2170-2882.
It is also noted that Yao’s MW250351 comprises 33-mer polyA sequence, which satisfies the “extended” polyA claimed in claim 16, absent objective evidence to the contrary.
Since Yao’s construct comprising GenBank accession number MW250351 fully satisfies all structural limitations set forth in the rejected claims, it necessarily follows that Yao’s construct inherently possesses all properties recited in the rejected claims, absent objective evidence to the contrary.
“[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mkt. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). That is, “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Accordingly, claims 1-13 and 15-16 are described by Yao et al.
Claims 1-14 and 16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US 2024/0192196 A1).
Note the priority benefit denial above.
Zhang discloses a “SARS-COV-2 replicon construct” of SEQ ID NO:30 comprising “nucleic acid sequences of 5’ UTR and 3’ UTR”. See paragraphs 0026, 0038, 0117; claim 1.
It is noted that Zhang’s construct of SEQ ID NO:30 comprises the entire 450-nt SEQ ID NO:28 claimed in the instant case at positions 7-456, thereby necessarily comprising a packaging signal, absent objective evidence to the contrary. In addition, Zhang’s construct of SEQ ID NO:30 comprises nucleotide positions 369-713 of SEQ ID NO:31 claimed in the instant case, thereby comprising an extended, 33-mer polyA sequence.
Since Zhang’s construct comprising SEQ ID NO:30 fully satisfies all structural limitations set forth in the rejected claims, it necessarily follows that Zhang’s construct inherently possesses all properties recited in the rejected claims, absent objective evidence to the contrary.
Accordingly, claims 1-14 and 16 are described by Zhang et al.
Claims 1-13, 16, and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jordan et al. (WO 2021/259883 A1) as evidenced by GenBank accession number NC_045512.2 (applicant’s citation).
Note the priority benefit denial above.
Jordan discloses a pharmaceutical composition comprising a synthetic nucleic acid molecule comprising a 5’ UTR and a 3’ UTR of “SARS-CoV-2” represented by “Genbank NC_045512.2), further comprising “a nucleotide sequence of a packaging signal localized in ORF1b” and a pharmaceutically acceptable excipient, wherein the packaging signal is “a conserved cis-regulatory element”. See claims 1, 17-18, 20-21, and 25-27; pages 3-4, 16, and 40.
It is noted that GenBank accession number NC_045512.2 discloses that the 3’ UTR is at positions 29675-29903, which comprises 33-mer polyA sequence which satisfies the “extended” polyA claimed in claim 16, absent objective evidence to the contrary.
Since Jordan’s molecule fully satisfies all structural limitations set forth in the rejected claims, it necessarily follows that Jordan’s molecule inherently possesses all properties recited in the rejected claims, absent objective evidence to the contrary.
Accordingly, claims 1-13, 16, and 19 are described by Jordan et al.
Claim Rejections - 35 USC § 103
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 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.
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 1-13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Brian et al. (Seminars in VIROLOGY, 1997, 8:101-111) in view of Wu et al. (Nature, published online on February 3, 2020, 579:265-269, applicant’s citation), GenBank accession number MN908947 (January 12, 2020), and Weinberger et al. (US 2016/0015759 A1, applicant’s citation).
Brian teaches making a “synthetic” coronavirus defective interfering (DI) RNA, which comprises a synthetic DI RNA genome comprising the 5’ UTR and 3’ UTR sequences with deletions of at least 20 kb coronavirus genome sequence, wherein the coronavirus DI RNA “would necessarily retain the cis-acting elements for RNA replication and an active polymerase but may lack the function of one or more structural proteins needed for virus assembly” and would have “the ability to competitively inhibit parental virus genome replication”. See the entire reference including Figure 1 and page 103.
Brian does not teach making a DI RNA against SARS-CoV-2 comprising cis-acting elements in the 5’ and 3’ untranslated regions. Brian also does not teach limitations recited in some dependent claims.
Wu discloses genome sequencing of 29,903 nt “WH-Human 1 coronavirus (WHCV)” that has been assigned GenBank accession number MN908947, which has at least “89.1% nucleotide similarity” to SARS-like coronaviruses, wherein WHCV has been renamed “SARS-CoV-2”, which causes “COVID-19” as released by the WHO. See pages 265-266 and 269; Figure 1.
It is noted that the 5’ UTR sequence at positions 28-281 of GenBank accession number MN908947 is 100% identical to nucleotide positions 12-265 of SEQ ID NOs:28, 30, and 32-33 of the instant application.
It is noted that the 3’ UTR sequence at positions 29,550-30,473 of GenBank accession number MN908947 is 100% identical to nucleotide positions 344-669 of SEQ ID NO:31 of the instant application.
Weinberger teaches that a defective interfering virus construct comprising cis-acting elements “has a basic reproductive ratio (R0) >1” and can be “formulated with a pharmaceutically acceptable excipient” to make a pharmaceutical composition for reducing viral load in an individual, wherein cis elements of RNA virus genomes include “viral genome packaging signals.” See claim 1; paragraphs 0004, 0006, and 0090-0092.
It would have been obvious to one of ordinary skill in the art before the effective filing date to make a synthetic DI RNA composition comprising the cis-acting elements for SARS-CoV-2, wherein the cis-acting elements include the 5’ UTR, a packaging signal, and the 3’ UTR of the art-recognized SARS-CoV-2 nucleotide sequence information that was available as of January 12, 2020. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to make a therapeutically useful composition for managing the WHO-declared pandemic caused by the spread of the SARS-CoV-2 that impacted the world because making a synthetic DI RNA composition comprising cis-acting elements of the coronavirus with deletions in the coronavirus genome sequence was an art-recognized goal as evidenced by Brian, wherein a synthetic DI composition was an art-recognized tool that is known to inhibit parental virus genome replication/viral load as evidenced by the teachings of Brian and Weinberger, and because there was an art-recognized, urgent need to manage the worldwide spread of the SARS-CoV-2 causing COVID-19. As such, one of ordinary skill in the art would have reasonably utilized the SARS-CoV-2 sequence information, GenBank accession number MN908947, which was publicly available as early as January 12, 2020 in making a synthetic SARS-CoV-2 DI RNA composition comprising art-recognized cis-acting elements, which are the 5’ UTR, a packaging signal, and the 3’ UTR, thereby arriving at the instantly claimed subject matter with a reasonable expectation of success.
Since the composition rendered obvious in the instant rejection fully satisfies all structural limitations set forth in the rejected claims, it necessarily follows that composition rendered obvious in the instant rejection inherently possesses all properties recited in the rejected claims, absent objective evidence to the contrary.
Accordingly, claims 1-13 and 19 taken as a whole would have been prima facie obvious before the effective filing date.
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 1-16 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 9, 11, 14, 19-20, 24, 36, and 40-43 of copending Application No. 18/553,900.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by and/or overlap in scope with the ‘900 claims drawn to a recombinant SARS-CoV-2 construct comprising a 5’ UTR region (e.g., “nucleotides 1-450 of SEQ ID NO: 1”, which appears to correspond to SEQ ID NO:28 claimed in the instant case) and a 3’ UTR region (e.g., “nucleotides 29191-29903 of SEQ ID NO: 1”, which appears to correspond to SEQ ID NO:31 claimed in the instant case), wherein the construct is capable of interfering with SARS-CoV-2 replication. That is, the subject matter claimed in the ‘900 claims fully satisfy all structural and functional limitations claimed in the instant claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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