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 .
DETAILED ACTION
Status of the Application
Claims 1-20 and are currently under examination.
Information Disclosure Statement
The submission of the Information Disclosure Statement on 09/19/2023 and 08/22/2025 are in compliance with 37 CFR 1.97. The information disclosure statement has been considered by the examiner and signed copies have been placed in the file.
The submission of the Information Disclosure Statement on 09/19/2023 and is not in compliance with 37 CFR 1.97 because the contents of the Foreign Document EP4244351 are not provided in the file and therefore cannot be considered. The remaining documents have been considered.
Specification – Objection to Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps. Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single see para within the range of 50 to 150 words in length. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure filed 08/15/2023 is objected to because it contains statements of the alleged merits or functions of a deuterium-stabilized RNA “that display an increased resistance to thermal and enzymatic hydrolysis” and its speculative application “useful for in the manufacture of RNA-based therapeutics, such as mRNA vaccines, to render them less sensitive to temperature fluctuations”. Correction is required. See MPEP § 608.01(b).
The Abstract shall consist of the follow:
(a) The abstract shall consist of the following:
(i) a summary of the disclosure as contained in the description, the claims, and any drawings; the summary shall indicate the technical field to which the invention pertains and shall be drafted in a way which allows the clear understanding of the technical problem, the gist of the solution of that problem through the invention, and the principal use or uses of the invention;
(ii) where applicable, the chemical formula which, among all the formulae contained in the international application, best characterizes the invention.
(b) The abstract shall be as concise as the disclosure permits (preferably 50 to 150 words if it is in English or when translated into English).
(c) The abstract shall not contain statements on the alleged merits or value of the claimed invention or on its speculative application.
(d) Each main technical feature mentioned in the abstract and illustrated by a drawing in the international application shall be followed by a reference sign, placed between parentheses.
Claim Objections
Claim 2 is objected to because of the following informalities: The sentence would be clearer if rephrased “wherein said deuterium is present at a concentration of at least 85 atom% D”. Appropriate correction is required
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 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) 1-11 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Srivastava et al. (US Patent No. 9512162).
Claim interpretation:
The limitation “aqueous composition” is defined in the specification as “said aqueous composition comprising at least one of: (i) RNA molecules and deuterium for stabilizing the RNA molecules; and (ii) deuterium-stabilized RNA molecules that have been synthesized in the presence of deuterium [00012]. Therefore based on the definition, an aqueous composition can be deuterium-stabilized RNA molecules that have been synthesized in the presence of deuterium.
Regarding claims 1-11 and 13-20, Srivastava et al. teach reagents comprising deuterium stabilized RNA molecules wherein the RNA is synthesized in the presence of deuterium wherein the deuterium is present at 0.1 to 98% and is incorporated into the RNA (col. 15 ln. 40-65). Srivastava et al. further teach the RNA can be double stranded RNA for use in RNAi (siRNA) (col. 1-2) and a shRNA (col. 5, ln. 56-67).
Regarding claim 6, Srivastava et al. teach the RNA molecule comprise a deuterated Raney-Nickel catalyst, which is a substitution of protium (a hydrogen isotope) with a deuterium (see claim 2).
Regarding claim 7, Srivastava et al. teach a deuterium at the 2’ group on the ribose sugar moiety (col. 23 ln. 10, Figure 3).
Regarding claims 8, 9, 10 and 11, because Srivastava et al. teach the identical claimed structure, the properties of claims 8-11 are an inherent feature of the deuterium-stabilized RNA. Further, it is well established that the patentability of product claims depends on the structure, not function, of the product. See MPEP 2112.01: when the structure recited in the prior art is substantially identical to that of the claims, the claimed properties or functions are presumed inherent.
Regarding claims 14-20, Srivastava et al. teach the deuterium-stabilized RNA such as siRNA can be used as a therapeutic and therefore would be components of a therapeutic (see co. 10-11).
Thus Srivastava et al. anticipates the instant claims.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava et al. (US Patent No. 9512162) and Pathak et al. ("Water isotope effect on the thermostability of a polio viral RNA hairpin: A metadynamics study." The Journal of Chemical Physics 146.16 (2017).
Regarding claims 1-5, 13, 15 and 17, Srivastava et al. teach reagents comprising deuterium stabilized RNA molecules wherein the RNA is synthesized in the presence of deuterium wherein the deuterium is present at 0.1 to 98% and is incorporated into the RNA (col. 15 ln. 40-65). Srivastava et al. further teach the RNA can be double stranded RNA for use in RNAi (siRNA) (col. 1-2) and a shRNA (col. 5, ln. 56-67).
Regarding claim 6, Srivastava et al. teach the RNA molecule comprise a deuterated Raney-Nickel catalyst, which is a substitution of protium (a hydrogen isotope) with a deuterium (see claim 2).
Regarding claim 7, Srivastava et al. teach a deuterium at the 2’ group on the ribose sugar moiety (col. 23 ln. 10, Figure 3).
Regarding claims 8, 9, 10 and 11, because Srivastava et al. teach the identical claimed structure, the properties of claims 8-11 are an inherent feature of the deuterium-stabilized RNA. Further, it is well established that the patentability of product claims depends on the structure, not function, of the product. See MPEP 2112.01: when the structure recited in the prior art is substantially identical to that of the claims, the claimed properties or functions are presumed inherent.
Regarding claims 14, 16 and 18-20, Srivastava et al. teach the deuterium-stabilized RNA such as siRNA can be used as a therapeutic (see col. 10-11).
Regarding claim 12, Srivastava et al. teach the RNA such as siRNA can be used as a therapeutic but does not teach the deuterium stabilized siRNA in a deuterium composition.
Pathak et al. teach deuterium (also known heavy water or D2O) has been known for its ability to be used in a composition with RNA to increase stability for therapeutics and teach an increase in thermostability when used with a hairpin RNA structure (see abstract and Fig. 1 and 4).
It would have been obvious to one of ordinary skill in the art to try adding this deuterium heavy water in therapeutic reagents of Srivastava et al. to improve the thermostability of the RNA. It would have been obvious to try given the results demonstrated by Sen et al. Furthermore, KSR states an obvious to try rationale may be proper when the possible options for solving a problem are known, finite, and predictable, with a reasonable expectation of success. KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Also, see MPEP § 2143.
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
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. See 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);and, 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 4-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 2, 5-13 of U.S. Patent No. 11,780,869. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter
MPEP 804 “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 determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
The claims of Patent ‘869 are drawn to methods of synthesizing a RNA molecule in the presence of deuterium and it would have been obvious to use the method to synthesize the RNA molecule in the presence of deuterium as instantly claimed.
The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636