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. Priority Priority to US 63/416,241, filed 10/14/2022, US 63/434,219, filed 12/21/2022, US 63/442,566, filed 2/1/2023, 63/444,195, filed 2/8/2023, and 63/495,412, filed 4/11/2023 is acknowledged. Information Disclosure Statement The information disclosure statement filed 1/28/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The information disclosure statement (IDS) was submitted on 5/2/2024, before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification The use of the term “ CellTrace Violet, which is a trade name or a mark used in commerce, has been noted in this application on page 107, para. [0313]. 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. The disclosure is objected to because of the following informalities. The specification recites the following in para. [0015]: “ In some aspects, the first isolated mRNA has at least about 50%, alternatively at least about 60%, alternatively at least about 65%, alternatively at least about 70%, alternatively at least about 75%, alternatively at least about 80%, alternatively at least about 85%, alternatively at least about 90%, alternatively at least about 95% nucleic acid sequence identity to SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 12, SEQ ID NO: 14, SEQ ID NO: 16, or SEQ ID NO: 18 . ” (Specification, para. [0015]). The specification recites the following in para. [0045]: “ In some aspects, the pharmaceutical formulation includes the above delivery vehicle composition and an isolated mRNA comprising a sequence that has at least about 70%, alternatively at least about 75%, alternatively at least about 80%, alternatively at least about 85%, alternatively at least about 90%, alternatively at least about 95% nucleic acid sequence identity to SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 12, SEQ ID NO: 14, SEQ ID NO: 16, or SEQ ID NO: 18. ” (Specification, para. [0045]). The specification recites the following in para. [0146]: “ In other non-limiting examples, the isolated mRNA that encodes a membrane-stabilized LIGHT has at least about 50%, alternatively at least about 60%, alternatively at least about 65%, alternatively at least about 70%, alternatively at least about 75%, alternatively at least about 80%, alternatively at least about 85%, alternatively at least about 90%, alternatively at least about 95% nucleic acid sequence identity to SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 12, SEQ ID NO: 14, SEQ ID NO: 16, or SEQ ID NO: 18. ” SEQ ID NO: 9 is a protein sequence, not a nucleic acid sequence as listed in the sequence listing. This is likely intended to be SEQ ID NO: 8. Appropriate correction is required. Claim Status Claims 20-40, filed 1/26/2024, are pending. Claims 20-40 are under examination. Claim Interpretation In order to advance compact prosecution, claim 21 is interpreted to recite SEQ ID NO: 8, not SEQ ID NO: 9. Support for this is based on the fact that SEQ ID NO: 8 is absent from the specification and is missing from this sequence of even-numbered SEQ ID NOs: ““ In some aspects, the first isolated mRNA has at least about 50%, alternatively at least about 60%, alternatively at least about 65%, alternatively at least about 70%, alternatively at least about 75%, alternatively at least about 80%, alternatively at least about 85%, alternatively at least about 90%, alternatively at least about 95% nucleic acid sequence identity to SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 12, SEQ ID NO: 14, SEQ ID NO: 16, or SEQ ID NO: 18 . ” (Specification, para. [0015]). The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “… the composition is configured to be administered to a subject known to have cervical cancer, HPV-driven cancer, or a disease associated with HPV. ” in claim 35. “… the composition is configured to be administered as an injectable preparation .” in claim 36. Because these claim limitations /are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Regarding claim 35, MPEP 2181(I) states: “ Accordingly, examiners will apply 35 U.S.C. 112(f) to a claim limitation if it meets the following 3-prong analysis: (A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and (C) the term "means" or "step" or the generic placeholder is not modified by sufficient s tructure, material, or acts for performing the claimed function. ” Regarding prong one, MPEP 2181(I)(A) states: ““ "The standard is whether the words of the claim are understood by persons of ordinary skill in the art to have a sufficiently definite meaning as the name for structure." Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349, 115 USPQ2d 1105, 1111 (Fed. Cir. 2015) ”. In this case, the term “composition” serves this purpose. For claim 35, the term “composition” ultimately relates back to claim 22, which recites an isolated mRNA. Therefore, a person of ordinary skill in the art would recognize this composition to have some kind of structure present. Regarding prong two, MPEP 2181(I)(B) states: “ With respect to the second prong of this analysis, it must be clear that the element in the claims is set forth, at least in part, by the function it performs as opposed to the specific structure, material, or acts that perform the function .” This section additionally states: “ Typically, the claim limitation will use the linking word "for" to associate "means" or a generic placeholder with the function. However, other linking words may be used, such as "so that" or "configured to", provided it is clear that the claim element is reciting a function .” In this case, the term “configured to” is linking the composition to the function of “ to be administered to a subject known to have cervical cancer, HPV-driven cancer, or a disease associated with HP .” A person of ordinary skill in the art would recognize that this a function of the claimed composition, not a specific structure. Regarding prong three, MPEP 2181(I)(C) states: “ With respect to the third prong of this analysis, the term "means" or "step" or the generic placeholder recited in the claim must not be modified by sufficiently definite structure, material, or acts for achieving the specified function. See Seal-Flex, 172 F.3d at 849, 50 USPQ2d at 1234 .” In this case, no specific structure is recited to go along with the function as discussed above. Consequently, claim 35 is interpreted under USC 112(f). Claim 35 is interpreted to included the following structure: The specification at para. [0041] recites: “ In an aspect, the composition is a therapeutic composition or a vaccine. In another aspect, the composition is a human papillomavirus (HPV) mRNA vaccine. In a yet a further aspect, the composition is used in a cancer immunotherapy. In an aspect, the composition is configured to be administered to a subject known to have cervical cancer, HPV-driven cancer, or a disease associated with HPV. Another aspect of the disclosure provides mRNA therapeutic formulations in delivery vehicle compositions including the compounds disclosed above or a pharmaceutically acceptable salts thereof. In some aspects, the delivery vehicle composition further includes one or more of a phospholipid, a sterol, and a PEGylated lipid. In some aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 30 mol% to about 60 mol%. In some aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 35 mol% to about 55 mol%. In various aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 30 mol% to about 45 mol%. In various aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 35 mol% to about 39 mol%. In some aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 39 mol% to about 52 mol%. In various aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 30 mol% to about 35 mol%. In various aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 40 mol% to about 45 mol%. In various aspects, the compound or salt of Formula (I) is present in an amount of about 42 mol% to about 49 mol%. In some aspects, the compound or salt of Formula (I) is present in an amount of about 50 mol% to about 52 mol%. ” (Specification, para. [0041] and [0042]. Emphasis added). Regarding claim 36, the above analysis also applies, except the function recited is “ to be administered as an injectable preparation. ” This does not change the above analysis with respect to claim 36 because it still fulfill all three prongs recited above for the exact same reasons. Consequently, claim 36 is interpreted under USC 112(f). Claim 36 is interpreted to include the following structure: The specification at para. [0053] recites: “ In another aspect, the composition is configured to be administered as an injectable preparation. In another aspect, the composition further includes one or more one or more therapeutically acceptable carriers, therapeutically acceptable diluents, therapeutically acceptable excipients or other therapeutic agents. In yet another aspect, the therapeutically acceptable excipients are selected from the group including of salts, buffering agents, preservatives, antiadherents , antioxidants, binders, coatings, compression aids, disintegrants, dyes, emollients, emulsifiers, fillers, film formers, coatings, flavors, fragrances, glidants, lubricants, sorbents, suspending or dispersing agents, sweeteners, and waters of hydration. ” Claim Objections Claim 27 is objected to because of the following informalities. The term “interleukin -12” has an extra space as compared to how it is written in the specification in para. [0017]. It is better written as “interleukin-12” for consistency. Appropriate correction is required. Examiner Note: A duplicate claim warning for claim 38 was considered because of the interpretation of claim 36 above. However, claim 38 also includes other elements of claim 37 from which it depends. Therefore, claim 36 and claim 38 are not substantial duplicates. 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 appl icant regards as his invention. Claims 21 and 32 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. Regarding claim 21, claim 21 recites “ The isolated mRNA of claim 20, wherein the isolated mRNA has at least about 80% nucleic acid sequence identity to SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 14, or SEQ ID NO: 16. ”. SEQ ID NO: 9 is a protein sequence, not an RNA sequence. It is likely that SEQ ID NO: 8 was intended. However, as currently claimed, it is not clear what sequence is being referred to by “SEQ ID NO: 9” in this claim. Claim 21 is rejected. Regarding claim 32, claim 32 recites the limitation "t he composition of claim 30, wherein the third isolated mRNA has at least about 80% nucleic acid sequence identity to SEQ ID NO:23 or SEQ ID NO:26 ". There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 32 is dependent upon claim 30, which is in turn dependent upon claim 22. Claim 22 recites a singular RNA molecul e by referencing claim 20 . Claim 30 recites an additional mRNA molecule. There is no “third” mRNA in claim 30. If a third mRNA is intended in claim 32, the usage of “further comprising” would communicate this. Alternatively, Applicant could use a numbered scheme throughout the claims starting with a “first” mRNA in claim 20 and by extension claim 22, a “second” mRNA in claim 30, and then adding a “third” mRNA in claim 32. If a third mRNA is not intended, changing “third” to “additional” in claim 32 would communicate this intent, because this matches the language of claim 30. As currently claimed, claim 32 is rejected. Examiner note: Claims 35 and 36 were considered for rejection under USC 112(b) due to their interpretation under USC 112(f). MPEP 2181(II)(A) states: “ The proper test for meeting the definiteness requirement is that the corresponding structure (or material or acts) of a means- (or step-) plus-function limitation must be disclosed in the specification itself in a way that one skilled in the art will understand what structure (or material or acts) will perform the recited function. See Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1381, 53 USPQ2d 1225, 1230 (Fed. Cir. 1999) .” Regarding claim 35, claim 35 recites “ The composition of claim 33, wherein the composition is configured to be administered to a subject known to have cervical cancer, HPV-driven cancer, or a disease associated with HPV. ” This claim is inter preted under USC 112(f) as described above. The specification at para. [0041] recites: “ In an aspect, the composition is a therapeutic composition or a vaccine. In another aspect, the composition is a human papillomavirus (HPV) mRNA vaccine. In a yet a further aspect, the composition is used in a cancer immunotherapy. In an aspect, the composition is configured to be administered to a subject known to have cervical cancer, HPV-driven cancer, or a disease associated with HPV. Another aspect of the disclosure provides mRNA therapeutic formulations in delivery vehicle compositions including the compounds disclosed above or a pharmaceutically acceptable salts thereof. In some aspects, the delivery vehicle composition further includes one or more of a phospholipid, a sterol, and a PEGylated lipid. In some aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 30 mol% to about 60 mol%. In some aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 35 mol% to about 55 mol%. In various aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 30 mol% to about 45 mol%. In various aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 35 mol% to about 39 mol%. In some aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 39 mol% to about 52 mol%. In various aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 30 mol% to about 35 mol%. In various aspects, the compound or salt of Formula (I) is present in the delivery vehicle composition in an amount of about 40 mol% to about 45 mol%. In various aspects, the compound or salt of Formula (I) is present in an amount of about 42 mol% to about 49 mol%. In some aspects, the compound or salt of Formula (I) is present in an amount of about 50 mol% to about 52 mol%. ” ( Specification, para. [0041] and [0042]. Emphasis added) . A person of ordinary skill in the art would recognize that the because claim 35 refer s to claim 33, which claims a therapeutic composition or a vaccine, delivery into a subject is required. The specification discloses the structure of the delivery vehicle composition in the very next paragraph in sufficient detail to satisfy USC 112(b) and USC 112(a) because a person of ordinary skill in the art would recognize that “… configured to be administered to a subject known to have cervical cancer, HPV-driven cancer, or a disease associated with HPV. ” would be implemented by the pharmaceutically acceptable delivery formulation of para. [0042]. Consequently, adequate structure for claim 35 is disclosed by the specification and no rejection is made on the record. Regarding claim 36, claim 36 recites “ The composition of claim 33, wherein the composition is configured to be administered as an injectable preparation . ” This claim is interpreted under USC 112(f) as described above. The specification at para. [0053] recites: “ In another aspect, the composition is configured to be administered as an injectable preparation. In another aspect, the composition further includes one or more one or more therapeutically acceptable carriers, therapeutically acceptable diluents, therapeutically acceptable excipients or other therapeutic agents. In yet another aspect, the therapeutically acceptable excipients are selected from the group including of salts, buffering agents, preservatives, antiadherents , antioxidants, binders, coatings, compression aids, disintegrants, dyes, emollients, emulsifiers, fillers, film formers, coatings, flavors, fragrances, glidants, lubricants, sorbents, suspending or dispersing agents, sweeteners, and waters of hydration. ” Here, the specification immediately lists the structures in the same paragraph as the “configured to” sentence. A person of ordinary skill in the art would recognize that these structures carry out “… configured to be administered as an injectable preparation .” A person of ordinary skill in the art would recognize that the because claim 36 refers to claim 33, which claims a therapeutic composition or a vaccine, delivery into a subject is required. Consequently, adequate structure for claim 36 is disclosed by the specification and no rejection is made on the record. Double Patenting A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claim s 20-37 and 39-40 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim s 1-20 of copending Application No. 18/901,083 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. The ‘083 application is also a continuation of PCT/US2023/076531 and therefore shares a specification and sequence listing. Claims 1-20 of the ‘083 application are copies of claims 20-37 and 39-40 of the present Application, albeit with different claim numbers. The sequences referred to by the ‘083 application are identical to the sequences of the present Application. Consequently, claims 20-37 and 39-40 are rejected over claims 1-20 of the ‘083 application. 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 . Claim 38 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 FILLIN "Indicate the claim(s) of the copending application." \d "[ 2 ]" of copending Application No. 18/901,083 (reference application) in view of Chaudhari et al. ( Chaudhari, et al. Int J Adv Pharm Biol Chem 1.1: 21-34 (2012) ). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Regarding claim 38, claim 37 is identical in scope to claim 18 of the ‘083 application as discussed above. Chaudhari discloses the usage of excipients for a variety of reasons: “ Many dosage forms formulated today are complex system containing many other components along with the active pharmaceutical ingredient (API); these compounds are generally added along with the active pharmaceutical ingredients in order to : Protect, support or enhance stability of the formulation :- Most of the times it is observed that the active pharmaceutical ingredient in its pure form does not retain its stability for long which results in its denaturation, or sticking to the container wall thus rendering it unfit, hence in order to stabilize the API excipients are added which aid in maintaining the stability of the product and ensures that API retains its stability for a considerable period of time thus improving the shelf life of dosage formulation. Bulk up the formulation in case of potent drug for assisting in formulation of an accurate dosage form. Improve patient acceptance. Help improve bioavailability of active drug : Excipients usually help in improving the bioavailability of the active pharmaceutical ingredient for e.g. In many cases an active substance (such as aspirin) is not absorbed easily by human body in such cases the active ingredient is dissolved in or mixed with an excipient which may either act as solvent or assist in absorption of the drug in human body. Enhance overall safety and effectiveness of the formulation during its storage and use. ” (Chaudhari et al., page 21, col. 1, para. 1) Chaudhari also discloses the usage of antioxidants and buffering agents in Table 2 of their disclosure (Chaudhari et al, page 29, Table 2). It would have been obvious to a person of ordinary skill in the art to use the excipients of Chaudhari with the composition of claim 18 of the ‘083 patent to arrive at the composition of claim 38 of the present Application. A person of ordinary skill in the art would be motivated to add such excipients to achieve the benefits disclosed by Chaudhari and would have a reasonable expectation of success because Chaudhari discloses that these are well-known and successful practices. Consequently, claim 38 is obvious over the ‘083 application in view of Chaudhari et al. and rejected. Free of the Prior Art Regarding claim 20, t he LIGHT protein and the TNF family in general is known in the prior art. For example, Nishi et al. US 6 , 235 , 878 , published 5/22/2001 discloses SEQ ID NO: 1, aligned against Applicant SEQ ID NO: 3 below: LENGTH: 240 TYPE: PRT Query Match 97.2%; Score 1203; Length 240; Best Local Similarity 97.5%; Matches 234; Conservative 0; Mismatches 4; Indels 2; Gaps 1; Qy 1 MEESVVRPSVFVVDGQTDIPFTRLGRSHRRQSCSVARVGLGLLLLLMGAGLAVQGWFLLQ 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 MEESVVRPSVFVVDGQTDIPFTRLGRSHRRQSCSVARVGLGLLLLLMGAGLAVQGWFLLQ 60 Qy 61 LHWRLGEMVTRLPDGGGGG--SLIQERRSHEVNPAAHLTGANSSLTGSGGPLLWETQLGL 118 ||||||||||||||| | |||||||||||||||||||||||||||||||||||||| Db 61 LHWRLGEMVTRLPDGPAGSWEQLIQERRSHEVNPAAHLTGANSSLTGSGGPLLWETQLGL 120 Qy 119 AFLRGLSYHDGALVVTKAGYYYIYSKVQLGGVGCPLGLASTITHGLYKRTPRYPEELELL 178 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 121 AFLRGLSYHDGALVVTKAGYYYIYSKVQLGGVGCPLGLASTITHGLYKRTPRYPEELELL 180 Qy 179 VSQQSPCGRATSSSRVWWDSSFLGGVVHLEAGEKVVVRVLDERLVRLRDGTRSYFGAFMV 238 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 181 VSQQSPCGRATSSSRVWWDSSFLGGVVHLEAGEKVVVRVLDERLVRLRDGTRSYFGAFMV 240 However, neither this nor any other available prior art teaches or suggests the substitutions at the engineered section of the protein shown above. References such as Zhao et al. ( Zhao, Linlin , et al. Frontiers in cell and developmental biology 8: 569684 (2020) ) discuss aspects of the transmembrane domain of TNF receptors, but do not suggest such a replacement strategy or scheme much less a scheme using these particular residues. Consequently, claim 20 is free of the prior art. Regarding claim 21, none of the searched RNA sequences meet the sequence identity limitations of claim 21. Consequently, claim 21 is free of the prior art. Regarding claims 22-38, these claims are dependent upon claim 20. Because claim 20 is novel and nonobvious, these claims are as well. Consequently, claims 22-38 are free of the prior art. Regarding claim 39, this claim recites the same SEQ ID NOs as claim 20, and therefore claim 39 is free of the prior art. Regarding claim 40, this claim recites the same SEQ ID NOs as claim 21, and therefore claim 40 is free of the prior art. Conclusion No claim is allowed. Claims 20-40 are rejected. Claim 27 is objected to. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT David Paul Bowles whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0919 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8:30-5:00 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Lianko Garyu can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-7367 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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