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 without traverse of Group II (claims 39-43) in the reply filed on 18July2025 is acknowledged again. Non-elected claims 1-20 were previously canceled.
Applicant’s election of “an active portion active against a plant gene” (see claim 57) and the virus being CTV (see claim 43) in the reply filed on 18July2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 60 and 62 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (please note that “a hairpin-like structure of the virus” at claim 60 is understood to mean that claim 60 is specific for the virus being CYVaV which was not elected for examination).
Election was made without traverse in the reply filed on 18July2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Response to Applicant’s Remarks dated 25February2026:
Applicant traverses the withdrawal of claim 60 on the grounds that “a hairpin-like structure of the virus” is not limited to CYVaV and may encompass vectors derived from (elected) CTV. In support of this assertion, Applicant cites ¶¶144 and 174.
This is not persuasive because neither Applicant’s remarks nor the cited sections of the specification remedy any difference between the Office’s interpretation of this phrase as compared to Applicant’s. Namely, ¶144 of the specification generically regards what is meant by the phrase “RNA vector” and ¶174 is discussing insertion into CYVaV. Note that claim 60 recites inserting an RNA segment into the location of “a hairpin-like structure of the virus”. If the Office is misunderstanding the meaning of claim 60 and the meaning of ¶¶144 or 174 of the specification, perhaps Applicant should amend claim 60 to clarify its intent.
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Status of the Claims
The amendments and arguments filed 25February2026 are acknowledged and have been fully considered. Claims 1-38, 44-49 were previously cancelled. 40-41, 50, 54, 58 are cancelled. Claims 39, 42-43, 51-53, 55-57, 59-62 are pending. Claims 39, 42, 51-53, 55-57, 59-62 are currently amended. Claim 43 was previously presented. Claims 60 and 62 remain withdrawn. Claims 39, 42-43, 51-53, 55-57, 59, 61 are examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 63338290 filed 04May2022] is acknowledged. Claim 39 (to which all claims refer) now recites New Matter (see Written Description rejection below), which means that the Office’s previous statement acknowledging that all examined claims had an effective filing date of 04May2022 (see ¶4 of the nonfinal dated 17September2025) is suspended.
Withdrawn Objections and/or Rejections
Objections and/or rejections made of record in the nonfinal office action dated 17September2025 that are not otherwise discussed herein are withdrawn. In particular:
RE ¶ 4: The objection to the specification is withdrawn in view of the amendments thereto;
RE ¶¶ 6-11: The claim objections are withdrawn in view of the claim amendments;
and
RE ¶ 13: The indefiniteness rejection for lack of antecedent basis is withdrawn in view of the claim amendments.
Claim Objections
Claim 39 is objected to because of the following informalities: at the first recitation of the abbreviation “RdRp” (currently claim 39), the claims must define the abbreviation as in “… encodes an RNA dependent RNA polymerase (RdRp) for replication ….”. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 39, 42-43, 51-53, 55-57, 59, 61 REMAIN 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.
Parts (B)(1) and (B)(2) of claim 39, to which all of the examined claims refer, recite words or phrases that are indefinite. To begin, it is not clear how parts (B)(1) and (B)(2) limit the RNA vector structure being claimed. In particular, parts (B)(1) and (B)(2) of claim 39 recite functional effects (Average Positional Entroly (APE), and minimum free energy (ΔG) and it is not clear whether those functional effects limit the structures being claimed. Trying to define the claimed RNA vectors by function makes it confusing to know what the structure of the claimed RNA vectors are (again, please note that these are product claims and not method claims). With respect to claim 51, details regarding functional effect of Positional Entropy (PE) are added. With respect to claims 52-53, additional APE details are added. With respect to claim 57, a functional effect of being “effective against a plant pathogen” is added. With respect to claim 59, additional functional effects are recited (that certain secondary structures are formed, namely base-paired regions). It would be understood in the art that base-pairing (as recited in claim 59) would occur after expression from the RNA vector has taken place (because such base-pairing is a secondary structure flowing from the primary structure). As a specific example, one cannot know whether “65-90% [of nucleotides] are base-paired” (claim 59) until after the RNA vector is expressed (e.g., within a cell) and secondary structures have been allowed to form. Therefore, it is unclear how these functional recitations further limit (if at all) the [primary] RNA vector structure being claimed in claim 39 (i.e., it is not clear what claim 59 adds to what is being claimed in claim 39—are the functions recited in claim 59 tied to, or flowing from, a particular structure recited in claim 39? Do the functions recited at claim 59 change what structures fall within claim 39? Does a third party need to express the RNA vector before it can infringe claim 59?). The same rhetorical questions may be asked of claims 51-53, 57.
Without clarity from Applicant, it is not clear what subject matter falls within, or outside of, these claims and it is not clear how references to Average Positional Entropy (APE), free energy (ΔG), and Potential Entropy (PE) functional effects further define the structures being claimed. It is highly recommended that Applicant clarify the claims (specifically, that the claims be amended so that structural elements are recited and that non-limiting or indefinite functional effects be removed from the claims). I.e., just recite what the RNA vector structure (sequence) is and delete all else.
Response to Applicant’s Remarks 25February2026:
Applicant traverses this rejection on the basis that the recited APE, ΔG, and PE features are not functional characteristics but rather properties of the claimed RNA vectors (pages 10-11) and that the MPEP permits claiming structures via a recitation of their [chemical] properties.
This is not persuasive. As an initial matter, Applicant has not provided a citation to support their argument, so it is not clear to the Office what section of the MPEP to which Applicant is relying upon. In an effort toward full consideration, the Office believes Applicant is referring to MPEP § 2173.05(t) entitled “chemical formula” and will respond accordingly. MPEP § 2173.05(t) tells us that (1) “[c]hemical compounds may be claimed by a name that adequately describes the material to one skilled in the art”, (2) “[a] compound of unknown structure may be claimed by a combination of physical and chemical characteristics”, and (3) “[a] compound may also be claimed in terms of the process by which it is made without raising an issue of indefiniteness”. None of these three points are relevant here: (1) these claims are not referring to a particular name, (2) these claims do not recite a combination of physical and chemical characteristics for the hairpin-like structure which is the subject of (B)(1) and (B)(2) of claim 39. Regarding (2), note that the only structure in these claims is part (A) of claim 39 stating that the exogenous RNA segment comprises about 40-about 300 nucleotides but the APE, ΔG, and PE features at issue in this rejection are with respect to a secondary hairpin-like structure formed thereby. Further regarding (2), it appears as though the structure for the claimed RNA vector is in fact known (but not recited) because Applicant suggests that APE and MFE can be determined by “entering an RNA sequence into software” (Remarks at page 10). This can only be done if one knows the RNA sequence = the sequence must not be an ”unknown structure” as is recited in MPEP § 2173.05(t). Furthermore, (3) these are product claims and not method claims or product-by-process claims.
Claim Rejections - 35 USC § 112 – Written Description (due to New Matter)
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 39, 42-43, 51-53, 55-57, 59, 61 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. This is a Written Description rejection on the basis of New Matter and, therefore, being presented as a rejection rather than an objection (MPEP §§ 2163.01, 2163.06(I)).
Claim 39, to which all claims refer, is amended 25February2026 to recite “… said hairpin-like structure exhibits a minimum free energy (ΔG) in kcal/mol that is within -11.17 to +13.83 of -.043 multiplied by the length.” Applicant has not provided any citations to the as-filed specification (including original claims and drawings) that, in Applicant’s opinion, evidence possession of this concept (see the Remarks filed 25February2026—usually such citations are provided in a Remarks statement like “support for these amendments is found throughout the as-filed specification including at: [citations to paragraphs/lines, figures, or pages of the disclosure]”). Further, the Office has reviewed the entirety of the as-filed specification and cannot identify evidence therein that Applicant possessed this concept at the time this application was filed.
For completeness, the phrase “… the nucleotides of said hairpin-like structure exhibit an Average Positional Entropy (APE) in the range of 0.01 to 0.75” finds support within the specification at, for example, ¶22 on page 10.
Absent evidence to the contrary, a skilled artisan would not reasonably recognize Applicant had possession of the following concept when this application was filed: “… said hairpin-like structure exhibits a minimum free energy (ΔG) in kcal/mol that is within -11.17 to +13.83 of -.043 multiplied by the length”.
Pursuant to MPEP § 2163.06(I), the subject phrase in claim 39 is considered (and rejected) within the obviousness rejection maintained below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 39, 42--43, 51-53, 55-57, 59, 61 REMAIN rejected under 35 U.S.C. 103 as being unpatentable over DAWSON et al. (US2015/0096078 published 02April2015) in view of CHENG et al. (“Expressing p20 hairpin RNA of Citrus tristeza virus confers Citrus aurantium with tolerance/resistance against stem pitting and seedling yellow CTV strains” 2015 J. of Integrative Agriculture 14(9):1767-1777) and GARCIA-MARTIN & CLOTE (“RNA Thermodynamic Structural Entropy” 2015 PLOS One 10(11): e0137859 available at https://doi.org/10.1371/journal.pone.0137859 (30 total pages)) and FAKHR et al. (“Precise and efficient siRNA design: a key point in competent gene silencing” 2016 Cancer Gene Therapy 23:73-82) and WESTERHOUT & BERKHOUT (“A systematic analysis of the effect of target RNA structure on RNA interference” 2007 Nucleic Acids Research 35(13):4322-4330) and SIMON et al. (WO2020/102210 published 22May2020).
Claim 39 (to which all pending claims refer) is amended to recite that (1) the vector is derived from a plus-sense single stranded RNA virus, (2) that the vector encodes an RNA dependent RNA polymerase (RdRp), that (3) “… the nucleotides of said hairpin-like structure exhibit an Average Positional Entropy (APE) in the range of 0.01 to 0.75” and (4) “… said hairpin-like structure exhibits a minimum free energy (ΔG) in kcal/mol that is within -11.17 to +13.83 of -.043 multiplied by the length”. Regarding (1), that concept is addressed of record via CTV-based vectors (DAWSON et al.) and regarding (2), that concept is also addressed via DAWSON et al. (see, e.g., ¶8 on page 1 and FIG 1 thereof describing a CTV-based vector encoding an RdRp). Regarding (3) and (4), those features (what the Office calls “function(s)” and Applicant calls “properties”) would flow from the specific design (structure) of the vector as evidenced by GARCIA-MARTIN & CLOTE. Therefore, the claim amendments do not overcome this rejection.
↓ Rejection copied from the Nonfinal 17September2025 But-for the References to Claims, Please see the Response to Applicant’s Remarks section below for new content ↓
These claims (as elected) are generally directed toward an siRNA suppression vector derived from the plus-sense RNA plant virus Citrus Tristeza Virus (CTV) (see claims 39, 42-43, 55-57, 59, 61). To be clear, and further to the indefiniteness rejections herein above, these claims recite functional effects regarding the “exogenous segment” such as Average Positional Entropy (APE), free energy (ΔG), and Potential Entropy (PE) that must flow from the structures recited in these claims (see claims 39, 51-53) and/or base-paring particulars when the vector is in use and secondary structures have been formed (see claim 59). Also, these claims recite features of the “reference virus” (i.e., the virus to which the function of the “exogenous [RNA] segment” is being compared to) (see claims 39, 61).
DAWSON et al. teach siRNA gene silencing in Nicotiana and Citrus using a CTV-derived vector (Example 9 on pages 26-30, in particular ¶¶278-286 on pages 29-30) [relevant to claims 39, 42-43, 55-57, 59, 61]. To the extent that these claims are directed toward hairpin siRNA methodologies, DAWSON et al. teach the use of hairpins for gene suppression (e.g., short hairpin RNAs) at ¶¶57-58, 61, 65-66 on pages 7-8 [relevant to all examined claims].
DAWSON et al. does not anticipate these claims because, absent evidence to the contrary, DAWSON et al. do not appear to teach an exogenous RNA segment having a length of about 40 to about 300 nucleotides (the GFP fragment used by DAWSON et al. was 400 nucleotides long, for example, per ¶279 on page 29). Furthermore, DAWSON et al. does not discuss APE, ΔG, or PE (i.e., DAWSON et al. does not, therefore, discuss the “reference virus” particulars of these claims) and DAWSON et al. does not discuss secondary structure base-pairing particulars. The remaining features of these claims are accounted for as follows.
CHENG et al. teach suppression of CTV gene “p20” within an orange plant using hairpin RNA. Importantly, CHENG et al. demonstrate how to generate a vector for that purpose and teach that an artisan designs the length of the “hairpin” sequence with 50-1000 bp long working “fine” but that one of 300-600 bp long has higher efficiency in plants (left column on page 1773) [relevant to parts (A) and (B) of claim 39] To ensure a clear record, please note that CHENG et al. are not using CTV as the vector backbone (which is the subject of the elected, examined invention) but rather suppressing CTV genes (because CTV is a plant pathogen of, for example, Citrus plants). As evidenced by CHENG et al., the length of the “exogenous RNA segment” within the siRNA suppression vector would be the subject of design choice. MPEP § 2144.04(VI)(C). Furthermore, CHENG et al. evidence that the organization of the vector (position of regions that base-pair to form a hairpin) and the amount of nucleotides that base-pair to form a hairpin [claim 59] is also the subject of design choice. MPEP § 2144.04(VI)(C).
GARCIA-MARTIN & CLOTE evidence that Positional Entropy (PE) and Average Positional Entropy (APE) are sequence-specific. This means that, also in view of the indefiniteness issues raised hereinabove, those particulars being claimed [see part (B)(1) of claim 39 as well as claims 51-53] are also sequence-specific (and, therefore, subject of design choice). MPEP § 2144.04(VI)(C). With respect to claim 52, please note that it was well-known before the filing of this application that “GGGG” and/or “CCCC” sequences increase the risk for undesirable hairpin structures forming and, therefore, should be avoided (see FAKHR et al. at the right column on page 75).
WESTERHOUT & BERKHOUT evidence that free energy (ΔG) values depend upon the target (i.e., are sequence-specific) (see the left column on page 4325). This means that, also in view of the indefiniteness issues raised hereinabove, those particulars being claimed [see part (B)(2) of claim 39] are also sequence-specific (and, therefore, subject of design choice). MPEP § 2144.04(VI)(C).
Further to the teachings by GARCIA-MARTIN & CLOTE and WESTERHOUT & BERKHOUT (i.e., that PE, APE, and ΔG depend upon the sequence structures), as well as the indefiniteness rejections hereinabove, what “reference virus” is used as a comparator (to determine whether (B)(1) and/or (B)(2) of claim 39 are met) would be subject to design choice [relevant to claims 39, 61]. For the sake of a clear record, please note that the sequences referenced at claims 54 and 61 appear to be Citrus Yellow Vein-associated Virus (CYVaV) sequences. MPEP § 2144.04(VI)(C). To that end, SIMON et al. teach CYVaV as well as sequence structures thereof and CYVaV-based vectors. SEQ ID NO: 1 of this application appears to be the same as SEQ ID NO: 1 of SIMON et al. but-for the fact that SEQ ID NO: 1 in SIMON et al. is RNA (“U”) whereas SEQ ID NO: 1 here is DNA (“T”) (see Result 1 of the ABSS sequence search result file of record entitled “20250905_115322_us-18-311-495a-1.rnpm”).
Absent evidence to the contrary, it would have been obvious to a person with ordinary skill in the art at the time the present application was filed to make an siRNA suppression vector derived from CTV because the same was done by DAWSON et al. To the extent these claims require it, it would have been obvious for such CTV-derived vector to operate via hairpins (in view of at least DAWSON et al. and CHENG et al.) and the remaining structural features recited in these claims would have been obvious design choices in view of at least CHENG et al., GARCIA-MARTIN & CLOTE, WESTERHOUT & BERKHOUT, and SIMON et al. MPEP § 2144.04(VI)(C).
In view of the prior art and rejections within this action (including indefiniteness), Applicant is encouraged to amend the claims so that the structures of the claimed RNA vector are clearly recited whereas indefinite functional language is removed. In so doing, and with respect to amendments which may overcome this obviousness rejection, Applicant is cautioned that not even one CTV-derived siRNA suppression vector is specifically described within the as filed specification. The specification is generally directed toward CYVaV-derived vectors, not CTV-derived ones (please recall that CTV-derived vectors were elected and are under examination).
Response to Applicant’s Remarks 25February2026:
(1) Applicant traverses this rejection because, to Applicant, the claim amendments overcome it (Remarks at the top of page 12).
This is not persuasive for the reasons stated in the first (new) paragraph above.
(2) Applicant provides helpful background regarding the inventors’ work (Remarks bridging pages 12-13), but this is not addressed further because there is no link (or argument) with respect to the claimed subject matter. In particular, how the stated background information is relevant to this rejection.
(3) At pages 13-14 of the Remarks, Applicant takes issue with cited references individually.
This is not persuasive because, as Applicant no doubt knows, references are not read in a vacuum and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
(4) Applicant asserts that none of the cited references relate to plus sense single stranded RNA vectors (Remarks at page 14).
This is not persuasive in view of DAWSON et al. (discussed within the first paragraph of the rejection above).
(5) Applicant traverses the Office’s reliance on “design choice” (Remarks at the bridge of pages 14-15) principally because “[m]erely stating that something is a design choice does not support a prima facie rejection for obviousness without establishing that the choice is obvious”.
This is also not persuasive because the Office has provided a rationale, and supporting evidence, underpinning the rejection and the MPEP shows that “design choice” is an appropriate argument in support of concluding that subject matter would have been obvious (see MPEP §§ 2144.04(I), 2144.04(IV)(C), 2144.05(II). Finally, Applicant is in the best position to provide evidence showing how the claimed subject matter (the structures in particular) is nonobvious over the cited references. Applicant may wish to consider amending these claims so that they recite structures (a suggestion made repeatedly throughout this record) and thereafter providing arguments (supported by evidence) explaining why those claimed structures are nonobvious over the prior art.
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 39-43, 50-59, 61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21-28, 30-32 of copending Application No. 18311552 (published as US20240002881, Attny. Dkt. No. 30059-P72448US01). Although the claims at issue are not identical, they are not patentably distinct from each other. Both sets of claims are directed toward an RNA vector including one derived from CTV and with certain Average Positional Entropy (APE), free energy (ΔG), and/or Potential Entropy (PE) functional features.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Remarks 25February2026:
Applicant’s representative suggests that the reference to Appl. No. 18311552 (published as US20240002881) “is a reference to the present application, not a copending application.” (Remarks at the last paragraph on page 15).
This is not persuasive because it is incorrect.
Conclusion
THIS ACTION IS MADE FINAL. 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 Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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