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 claims 1-16 with species election of phosphate, trimethylglycine, pyridine-3,5-dicarboxylate, and cellulose in the reply filed on July 6, 2026 is acknowledged.
Status of Claims
Claims 1-3, 5-13, 15-16, and 38-50 are pending in the instant application. Claims 15-16 and 38-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Accordingly, claims 1-3 and 5-13 are under examination on the merits in the instant case.
Specification
The disclosure is objected to because of the following informalities:
1. Brief Description of the Drawings fails to identify and describe each of Figures 1A-1B, 2A-2D, 3A-3D, and so forth.
2. Brief Description of the Drawings for Figures 58-67 fails to identify what each numerical value (e.g., 600, 534) represents.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 recites that the composition of claim 1 “comprises a biostimulant.”
The instant specification appears to define the “biostimulant” as a substance “with the aim to alter or enhance characteristics” thus “a biostimulant composition may comprise one or more RNA stabilizing compositions as described herein.” See pages 136-137. Hence, claim 9 reciting the presence of “a biostimulant” fails to further limit the subject matter of claim 1, which already requires the presence of “at least one RNA stabilizing substance”, which is a biostimulant in light of the instant specification.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 8 is 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.
Claim 8 recites “the pharmaceutical composition is a medicament, a therapeutic”. It is unclear how the words “pharmaceutical”, “medicament”, and “therapeutic” are patentably and functionally distinct from each other. As such, the claim fails to particularly point out and distinctly claim the “pharmaceutical” composition.
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 1-3 and 5-13 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 drawn to a composition comprising an RNA and an RNA stabilizing substance comprising a modified polysaccharide (e.g., cellulose) comprising a phosphate group substituent.
Regarding the phosphate group-modified polysaccharides, it appears that the instant specification at best discloses “Na-PO4”-containing carboxymethylcellulose (CMC), alginate, gellan gum, xanthan gum, and hyaluronic acid (see Table 4), wherein use of “Na-PO4” for making a phosphate-modified polysaccharides as a drug delivery system was already art-recognized as evidenced by Lopez (A thesis, 2017, applicant’s citation). See Figures 4-5. The five “Na-PO4”-containing polysaccharides are not a representative number of species within the claimed genus of phosphate group-modified polysaccharides having the required “RNA stabilizing” function. Regarding the disclosed species, the instant specification does not appear to disclose a phosphate group-modified polysaccharide alone, especially applicant’s elected phosphate group-modified cellulose alone as broadly claimed, has the required function of stabilizing an RNA molecule. It appears that the specification appears to describe that an in vitro-transcribed RNA is stable at 60°C at 24 hrs when the RNA is in a mixture solution comprising the disclosed “Na-PO4”-containing polysaccharide species, for instance CMC, in combination with other additional elements such as Na-Acetate, trimethylglycine (TMG), cationic xanthan gum, and so forth, wherein the additional elements do not appear to include any of the substituted pyridine substances recited in claim 3. In addition, the RNA stability at 60°C at 24 hrs does not represent the entire genus of “RNA stabilizing” function at any and all temperatures other than the 60°C disclosed in the instant specification, wherein the temperature-dependent, thermal “RNA stabilizing” function provided by the mixture solution does not represent any and all types of the broadly claimed RNA stabilizing function including but not limited to an RNA stabilization against nucleases in a biological sample.
In view of the foregoing, the instant specification fails to describe the entire genus of the claims as currently written in the manner to reasonably convey that the instant co-inventors had possession of the entire genus as of the filing date sought in the instant case.
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.
Claims 1, 5, 7-9, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolotin (US 2003/0224974 A1).
Bolotin teaches making a pharmaceutical composition comprising a therapeutic RNA and a polymeric carrier, which includes “phosphorylated polysaccharides or oligosaccharides” having resultant “phosphate groups”, wherein the “phosphorylated polysaccharides or oligosaccharides” include “cellulose”, wherein the pharmaceutical composition further comprises “cationic” lipids. See paragraphs 0048, 0161, 0189, and 0242-0243.
Accordingly, claims 1, 5, 7-9, and 13 are described by Bolotin.
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 1-2 and 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bolotin (US 2003/0224974 A1) in view of Haas et al. (US 2020/0246267 A1).
Bolotin teaches making a pharmaceutical composition comprising a therapeutic RNA and a polymeric carrier, which includes “phosphorylated polysaccharides or oligosaccharides” having resultant “phosphate groups”, wherein the “phosphorylated polysaccharides or oligosaccharides” include “cellulose”, wherein the pharmaceutical composition further comprises “cationic” lipids. See paragraphs 0048, 0161, 0189, and 0242-0243.
Bolotin does not teach that the composition further comprises trimethylglycine and that the therapeutic RNA is an mRNA.
Hass teaches making “a syringe comprising a pharmaceutical composition” comprising a therapeutic mRNA, wherein the composition comprises “a stabilizer”, which includes “glycine betaine”, which is also known as trimethylglycine. See paragraphs 0001, 0393, and 0432-0433.
It would have been obvious to one of ordinary skill in the art before the effective filing date to readily envision that the therapeutic RNA included in Bolotin’s pharmaceutical composition reads on an mRNA molecule in view of the art-recognized scientific fact that an mRNA molecule qualifies as a therapeutic RNA as evidenced by Hass. It would have been obvious to one of ordinary skill in the art to further incorporate trimethylglycine (glycine betaine) into Bolotin’s pharmaceutical composition and to formulate the composition as a syringe. One of ordinary skill in the art would have been motivated to do so in order to enhance the RNA stability in a convenient pharmaceutical formulation because glycine betaine was an art-recognized “stabilizer” commonly used when making a pharmaceutical composition comprising an mRNA molecule as taught by Hass, who also taught making “a syringe comprising a pharmaceutical composition”, wherein the prefilled syringe comprising the therapeutic mRNA would have been deemed desirable as the prefilled syringe would provide convenience for the end user.
Since the prior art’s therapeutic RNA including mRNA is structurally indistinguishable from the “RNA substance” claimed in the instant case, it necessarily follows that the prior art’s RNA would inherently have the properties recited in claims 11-12, absent objective evidence to the contrary.
Accordingly, claims 1-2 and 5-13 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 1-2 and 5-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 and 52-53 of copending Application No. 19/059,030 in view of Bolotin (US 2003/0224974 A1) and Haas et al. (US 2020/0246267 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variation of the ‘030 claims drawn to and require a composition (e.g., syringe) comprising an RNA substance and an RNA stabilizing substance. As an initial matter, it is noted that the instant claims as written do not exclude the RNA stabilizing substance claimed in the ‘030 claims as evidenced by the open-ended “comprising” language. It would have been obvious to further include “phosphorylated polysaccharides” (e.g., cellulose) and trimethylglycine (glycine betaine) when making the composition of the ‘030 claims because both were known to be included in a pharmaceutical carrier for an RNA molecule as evidenced by Bolotin and Haas. Since “RNA substance” of the ‘030 is fully encompassed by the “RNA substance” claimed in the instant case, it necessarily follows that the “RNA substance” of the ‘030 claims would inherently have the properties recited in claims 11-12, absent objective evidence to the contrary.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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