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 .
Applicant’s amendment and response filed on 10/31/2025 has been received and entered into the case.
Claims 2, 13-19, 24, 26-36 and 38 have been canceled, claims 10-12 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1, 3-9, 20-23, 25, 37 and 39 have been considered on the merits. All arguments have been considered.
The claim rejections under 35 USC 35 U.S.C. 102 and 103 based on Burke et al. have been withdrawn due to the instant amendment.
Claim Rejections - 35 USC § 102 (New Rejection)
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.
Claim(s) 1, 6-7, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dajee et al. (US 2006/0069055 A1)
Dajee et al. teach an aqueous formulation comprising at least one penetration enhancer and alcohol in a concentration of about 1% to about 60% by weight (para. 160), and the formulation is for non-parenteral topical delivery of polynucleotide (para. 6-7), the formulation would inherently comprise polynucleotide. The penetration enhancer of Dajee et al. is sodium laureth sulfate and the alcohol is ethanol (para. 164). As the sodium laureth sulfate is not considered fatty acids or lipids, the components of the formulation would meet the limitation of claim 1. Dajee et al. teach that the polynucleotide is DNA or RNA (para. 104). One skilled in the art would have been at once envisaged that the RNA of Dajee et al. would be any RNA including mRNA encoding a protein.
Regarding the ethanol being about 0.3% v/v to 15% v/v, Dajee et al. teach that the concentration of ethanol is utilized at 10% (F2 formulation; para. 340), 5% (F3 formulation; para. 341) and 1% (F4 formulation; para. 342). While Dajee et al. teach the concentration of ethanol by weight, they do not teach by volume (v/v). However, the percentage by weight (w/v) of ethanol can be converted using the molecular weight of ethanol, 0.789 g/ml, and the 1% w/v of ethanol would be about 1.3%. This is overlapping with the claimed range of 0.3 % v/v to 15% v/v.
Regarding the wherein clause of claim 1 directed to the composition being free of fatty acids and lipids, while Dajee et al. disclose other components including fatty acids or lipids, however, these are considered optional and the exemplified formulations (F1-F4) as discussed above do not include fatty acids or lipids.
Regarding claim 6, the formulation of Dajee et al. is aqueous, i.e. liquid.
Regarding claim 7, the polynucleotide of Dajee et al. including RNA would meet the linear polyribonucleotide.
Regarding claim 9, the aqueous formulation of Dajee et al. is considered to meet the “(v) free of cationic liposomes”.
Thus, the reference anticipates the claimed invention.
Claim Rejections - 35 USC § 103 (New Rejection)
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.
Claim(s) 1, 6-7, 9 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dajee et al. (supra).
Dajee et al. teach an aqueous formulation comprising at least one penetration enhancer and alcohol in a concentration of about 1% to about 60% by weight (para. 160), and the formulation is for non-parenteral topical delivery of polynucleotide (para. 6-7), the formulation would inherently comprise polynucleotide. The penetration enhancer of Dajee et al. is sodium laureth sulfate and the alcohol is ethanol (para. 164). As the sodium laureth sulfate is not considered fatty acids or lipids, the components of the formulation would meet the limitation of claim 1. Dajee et al. teach that the polynucleotide is DNA or RNA (para. 104).
Even though RNA encoding a protein is not at once envisaged by a person skilled in the art as discussed above in the 102 rejection, however, it would have been obvious to use the formulation of Dajee et al. to deliver RNA encoding a protein, i.e. mRNA, to a cell with a reasonable expectation of success.
Regarding the ethanol being about 0.3% v/v to 15% v/v, Dajee et al. teach that the concentration of ethanol is utilized at 10% (F2 formulation; para. 340), 5% (F3 formulation; para. 341) and 1% (F4 formulation; para. 342). While Dajee et al. teach the concentration of ethanol by weight, they do not teach by volume (v/v). However, the percentage by weight (w/v) of ethanol can be converted using the molecular weight of ethanol, 0.789 g/ml, and the 1% w/v of ethanol would be about 1.3%. This is overlapping with the claimed range of 0.3 % v/v to 15% v/v.
Regarding the wherein clause of claim 1 directed to the composition being free of fatty acids and lipids, while Dajee et al. disclose other components including fatty acids or lipids, however, these are considered optional and the exemplified formulations (F1-F4) as discussed above do not include fatty acids or lipids.
Regarding claim 6, the formulation of Dajee et al. is aqueous, i.e. liquid.
Regarding claim 7, the polynucleotide of Dajee et al. including RNA would meet the linear polyribonucleotide.
Regarding claim 9, the aqueous formulation of Dajee et al. is considered to meet the “(v) free of cationic liposomes”.
Regarding claim 37 directed to the polyribonucleotide comprises at least 100 nucleotides in length, while Dajee et al. do not teach the limitation, however, as the method and composition of Dajee et al. is intended to deliver a nucleic acid, and the nucleic acid can be polynucleotide including DNA and RNA, and the mRNA encoding growth factors is obvious selection of the mRNA as discussed above, it is expected that the combined teachings would render the limitation of claim 37 obvious.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dajee et al. (supra) as applied to claim 1 above, and further in view of Benenato et al. (US2017/0210698 A1; of record)
Regarding the polyribonucleotide being a therapeutic protein such as growth factors including EGF, PDGF, TGFb or VEGF (claims 3-5), Dajee et al. do not teach the limitation.
However, the scope of RNA delivered to the cells using the formulation taught by Dajee et al. would encompass any known RNA including any mRNA encoding any protein. As the topical delivery of mRNA encoding growth factor such as VEGF is known in the art according to Benenato et al. (Abstract; para. 119-121, 133 and 1071), one skilled in the art would use the topical delivery formulation of Dajee et al. for delivering mRNA encoding VEGF taught by Benenato et al. with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dajee et al. (supra) as applied to claims 1, 6-7, 9 and 37 above, and further in view of Hoge et al. (US 2016/0194368; IDS ref. filed 2/17/2022)
Regarding the circular polyribonucleotide (claim 8), Dajee et al. do not teach the limitation.
Hoge et al. teach a composition comprising circular RNA that encodes polypeptide including therapeutic proteins (para. 97-98). Hoge et al. teach that the composition of the circular RNA may include a pharmaceutically acceptable excipients such as lipid nanoparticle (para. 21).
It would have been obvious to a person skilled in the art to use the formulation taught by Dajee et al. utilizing ethanol for delivery of the circular mRNA taught by Hoge et al. to produce therapeutic proteins in a subject in need thereof with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated use the formulation of Dajee et al. for circular mRNA because the aqueous formulation of Dajee et al. is suitable for delivery of any polynucleotide including RNA and DNA, and thus, it would be considered as a suitable delivery tool for circular mRNA taught by Hoge et al. in the absence of any evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 20-23, 25 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dajee et al. (supra) as applied to claims 1, 6-7 and 9 above, and further in view of Glenn et al. (US 679276; of record).
Regarding claims 20-23 and 25 directed to the kit comprising the first application tool to apply a sterilizing agent (alcohol) such as a wipe comprising alcohol, and the second application tool to apply the composition to the surface area of the subject (e.g. skin), Dajee et al. do not teach the limitations.
Glenn et al. teach a transcutaneous system for the topical application of an adjuvant and an antigen or nucleic acid encoding for an antigen to skin, and the procedures require alcohol swabbing with an isopropyl pad, and then the composition is applied to the back of the mice using a pipette and tip (col. 24, lines 4-15; Example 1).
It would have been obvious to a person skilled in the art to prepare a kit comprising the formulation of Dajee et al. along with alcohol/isopropyl wipes and an applicator (e.g. pipette tip) for the application of the formulation of Dajee et al. A person of ordinary skilled in the art would have been motivated to do so because the composition of Dajee et al. is intended for topical delivery of a polynucleotide and one skilled in the art would recognize that such a topical formulation would accompany the alcohol wipes for the purpose of sterilization prior to applying the composition to the skin and applicators for applying the formulation of Dajee et al. with a reasonable expectation of success.
Regarding claim 39, Dajee et al. teach the use of phosphate buffer (para. Examples 1-4).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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, 3-9, 20-23, 25 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29, 35-55 of copending Application No. 17/433,655 (reference application) in view of Fabi et al. (2014, Facial Plastic Surgery; of record). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘655 application is directed to a composition comprising a circular polyribonucleotide and an alcohol which is ethanol at the concentration of about 0.3-15% v/v of the mixture. Claims of the ‘655 application do not particularly disclose the RNA encoding growth factors such as EGF, VEGF, PDGF or TGFb, however, it is known in the art that the expression of these growth factors are useful for rejuvenating skin as a cosmetic topical composition according to Fabi et al. Fabi et al. teach that growth factors including EGF, VEGF, TGFb and PDGF are active during the stages of wound healing (Fig. 2). Thus, it would have been obvious to a person skilled in the art to use circular mRNA expression any of these growth factors for the purpose of skin rejuvenation, i.e. cosmetic composition. By doing so, the composition of the ‘655 in view of Fabi et al. would arrive to the claimed product of the instant application. The mRNA encoding any of these growth factors is known to be at least 100 nucleotide long. The claims of the ‘655 application have identical limitations with regard to the kit comprising first and second application tools. Thus, the claims of the ‘655 in view of Fabi et al. render the claims of the instant application obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) under 102 and 103 based on Burke et al. have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the instant amendment. The instant amendment requires the claimed composition being free of fatty acid and lipid, and the previously cited reference, Burke et al. do not meet the limitation. A new reference, Dajee et al. is cited for the new rejections as discussed above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631