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
Claim status
Claims 50-52, 54-62, 66-67, 74-99 are pending
Claims 50-52, 54-60, and 83-94 are withdrawn
Claims 61-62, 66-67, 74-82, and 95-99 are under examination
Election/Restrictions
Applicant’s election of the following invention without traverse in the reply filed on 2/16/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 61-62, 66-67, 74-82, and 95-99, drawn to composition comprising a circular RNA.
Claims 50-52, 54-60, and 83-94 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Applicant’s election of the following species without traverse is acknowledged.
Made by a process without m6A residues
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/28/2023, 6/14/2023, 1/05/2024, 10/25/2024, 10/17/2025, 2/16/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
New Claim Rejections - 35 USC § 112(a)
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 61-62, 66-67, 74-82, and 95-99 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The new limitation directed to the circular RNA containing “less than 1% N6-methyladenosine (m6A) residues” in independent claim 74, and “not modified with N6-methyladenosine” in dependent claim 75, appear to represent new matter. MPEP 2163.06 notes that new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a), pre-AIA first paragraph - written description requirement. In re Rasmussen , 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). Although the basis for this limitation was identified in Applicant’s remarks filed 2/13/2024 as being “found in the claims as originally filed”, a review of the original claims and specification by the Examiner did NOT find any specific basis for the negative proviso or alternative embodiments (e.g., wherein the circular RNA comprises N6-methyladenosine (m6A) residues). Furthermore, although Applicant’s specification does describe modified bases such as 3-methyladenosine, these are structurally distinct modified bases and do not inherently or implicitly support N6-methyladenosine. As noted by MPEP 2173.05(i), any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). Specifically in regard to Applicant’s rationale of no description as a bases of a negative limitation, the courts have held that the mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.
Nevertheless, the MPEP does not require that the negative limitation be recited verbatim in the specification: “Note that a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993).” Otherwise, applicants may be unduly burdened in having to describe every known piece of prior art so as to expressly recite what is not included in their invention.
The following are examples of sufficient basis for negative limitations:
specification describes a reason to exclude the relevant limitation (Inphi Corp. v. Netlist, Inc.)
specification describes alternatives (Santarus, Inc. v. Par Pharm., Inc.)
description of prior art in the specification discusses shortcomings of certain features
drawings that show the presence of certain features which necessitates the absence of opposite features
specification explicitly describes the lack of a particular feature
The following are examples of insufficient basis for negative limitations:
attempting to avoid a prior art reference by simply excluding nickel from a named group of metals claimed for a metallic protective coating without providing a patentable basis for doing so (In re Langdon)
In instant case, the only basis Applicant has provided for the original disclosure for the exclusion is to distinguish the claimed invention from the prior art. Thus, instant claims do not satisfy 35 USC § 112 requirements to particularly pointing out and distinctly claiming the invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 74-75, 79, 81, and 95-97 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) naturally occurring immunogenic circular RNA. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Briefly summarized here, the guidance for subject matter eligibility cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
In regard to Step 1, the claimed invention is directed to a statutory class of invention, i.e., a product.
In regard to Step 2A, prong one, instant claims are directed to a composition comprising an immunogenic circular RNA with less than 1% N6-methyladenosine. As evidenced by Abbas et al., (WJH, 2013, 5(12):666-675), the lipid enveloped hepatitis D virus comprises an immunogenic circular RNA (Abstract, p. 667, Fig. 1). Note that although N6-methyadenosine modification has been reported to occur in Hepatitis D genomes and antigenome in a mammalian cell, Kim et al. (J Virol, 2022, 96(19):1-11) evidences that there is no m6A methylated bases in the virion-associated genome (Introduction, p.3). Thus, the claimed circular RNA has no different structural or functional characteristic than naturally occurring HDV circular RNA found in the virion particle. Under the holding of Myriad, this nucleic acid is not eligible because it is not different enough from what exists in nature to avoid improperly tying up the future use and study of naturally occurring HDV circular genome in a lipid-based virion envelope. In other words, the claimed nucleic acid is not markedly different, from its natural counterpart in its natural state, and thus is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A, prong one: YES).
In regard to Step 2A, prong two, instant claims are directed to said circular RNA in a composition for delivery, and with the intended uses for administration. With respect to Step 2A, prong two, limitations that may be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2A, prong two, limitations that were found not to be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
In regard to Step 2A, prong two, instant claims do not recite additional elements or a combination of elements in the claims other than the natural product itself. Specifically, claim 96 recites a “delivery vehicle”, and claims 79 and 97 describe the circular RNA as a “vaccine” or to be “administered” as a prophylactic. However, placing the circular RNA in a “delivery vehicle” is claimed with such a high degree of generality it encompasses the HDV in any aqueous solution found it its natural environment, and the intended uses as a vaccine or prophylactic do not change the structure or function of the circular RNA as the embrace the natural course of an HDV infection where an immune response is mounted by the host.
Finally, in regard to Step 2B, does the claim recite additional elements that amount to significantly more than the judicial exception. In instant case, again generic vehicles were well-understood, routine and conventional in the art at the time of the invention. Viewed as a whole, these additional claim elements do not provide meaningful limitations to transform the natural product into a patent eligible composition.
Therefore, claims 74-75, 79, 81, and 95-97 add no additional elements that integrate the judicial exception into a practical application than the “product of nature” itself. Thus, instant claims do not amount to significantly more than the judicial exception itself and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 61-62, 66-67, 74-75, 79-80, and 96-98 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ares et al., (US 5,773,244, filed 5/1/1995, patented 6/30/1998, see IDS filed 2/28/2023), as evidenced by Chen et al. (Mol Cell, 67, 228-238, see IDS filed 2/28/2023).
In regard to claims 61-62, 66-67 and 74, Ares teaches a circular RNA generated in vitro by splicing of a Group I self-splicing intron from the bacteriophage T4 thymidylate synthase (Td) gene from a recombinant nucleic acid comprising in a 5’ to 3’ order the 3’ Td intron with 3’ splice site, a nucleic acid sequence of the circular RNA, and the 5’ Td intron with 5’ splice site (cols 11-14, Figs. 1-6) Furthermore, in regard claims 74 and 75, Kruse does not disclose the use of any N6-methyladenosine when making the circular RNA in vitro (col 18, Example 4).
However, in regard to claims 74 and 80, although Ares teaches the circular RNA is made by using Group I self-splicing intron from the T4 phage Td gene, they are silent to the circular RNA being immunogenic and having adjuvant effects. Nevertheless, MPEP 2112.01(II) recites that "products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable." Furthermore, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of filing of the invention, but only that the subject matter is in fact inherent in the prior art reference. Notably, Chen et al. (2017) evidence that circular RNA made by the Group I self-splicing intron from the T4 phage Td gene of Ares inherently has adjuvant effects (p. 234, Fig. 5A). Note Chen discloses the Group I self-splicing intron was provided by Ares (Method Details, 1st para.).
In regard to claim 79, and 96-98, Ares teaches that the circular RNA is in a Tris-based splicing buffer (col 18, Example 5). Thus, Ares teaches the circular RNA is in a suitable delivery vehicles and possess all of the structural elements to make the circular RNA a vaccine to prophylactically treat a disease. Furthermore, it must be noted that the claiming of the immunogenic circular RNA as a vaccine or to be administered as a prophylactic are the intended uses of the claimed composition.
Accordingly, Ares as evidenced by Chen anticipates instant claims.
Claims 74-76, 79-81, and 95-99 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sarnow et al., (US 5,766,903, patented 6/16/1998, see IDS filed 2/28/2023), as evidenced by Chen et al. (Mol Cell, 67, 228-238, see IDS filed 2/28/2023)
In regard to claim 74, Sarnow claims a composition comprising a circular RNA that comprises an IRES and a RNA sequence that encodes repeating antigen polypeptides (see Claims 1, 13-17 of Sarnow). Note that Applicant’s specification defines “immunogenic” as capable of inducing an adaptive immunological response, which is elicited by at least one antigen. Furthermore, in regard claims 74 and 75, Sarnow does not claim nor disclose the use of a N6-methyladenosine when making the circular RNA in vitro (see col 16, Example 2).
In regard to claim 76, as stated supra, Sarnow claims the circular RNA comprises an IRES and encodes more than one type of antigen polypeptide.
In regard to claims 79, 97, and 99, Sarnow claims all of the structural elements to make the circular RNA encoding a therapeutic antigen polypeptide as a vaccine to prophylactically treat a disease (see also the pharmaceutical composition of claim 26 of Sarnow, as well as col 14, 3rd para., Sarnow acknowledging “the circular RNA is being administered as a vaccine”). Furthermore, it must be noted that the claiming of the immunogenic circular RNA as a vaccine or to be administered as a prophylactic are the intended uses of the claimed composition.
In regard to claim 80, Sarnow teaches and claims the circular RNA is made in vitro by using a DNA splint and T4 DNA ligase to make a splint ligated circular RNA from linear RNA (col 16, Example 2, Fig. 1, see Claim 43 of Sarnow). Although Sarnow is silent to the circular RNA itself having adjuvant effects, MPEP 2112.01(II) recites that "products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable." Furthermore, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of filing of the invention, but only that the subject matter is in fact inherent in the prior art reference. Notably, Chen et al. (2017) evidence that circular RNA made by a DNA splint with T4 DNA ligase inherently have adjuvant effects (p. 233, Fig. 4C).
In regard to claim 81, 95, 96, Sarnow claims the circular RNA is in an delivery vehicle such as liposome (see Claims 27, 29, and 30 of Sarnow).
In regard to claims 96 and 98, alternatively Sarnow claims the circular RNA is in a physiologically balanced aqueous solution (see Claim 27 of Sarnow), which is the absence of lipids is effectively naked. Furthermore, it must be noted that the description of the immunogenic circular RNA to be administered as naked RNA is the intended use of the claimed composition.
Accordingly, Sarnow, as evidenced by Chen anticipates instant claims.
Claims 74-75, 79 and 96-97 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mutzke et al., (WO 2016/165825, filed 4/13/2016, published 10/20/2016)
In regard to claim 74, Mutzke claims a composition comprising a circular RNA formulated with a cationic nanoparticle (Claims 1 and 2 of Mutzke), wherein the RNA is a vaccine for the treatment or prophylaxis of an infectious disease or cancer (Claims 52-53 of Mutzke), which by definition would be immunogenic.
In regard to claims 74 and 75, Mutzke does not claim the RNA comprises a N6-methyladenosine, and indicates that the RNA are made in vitro [0141].
In regard to claims 79, 96 and 97, as stated supra, Mutzke claims the RNA is vaccine for the prophylaxis of a disease, and therefore would necessarily be in some kind of delivery vehicle. Furthermore, it must be noted that the claiming of the immunogenic circular RNA as a vaccine or to be administered as a prophylactic are the intended uses of the claimed composition.
Accordingly, Mutzke anticipates instant claims.
Claim Rejections - 35 USC § 103
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 of this title, 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.
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 76-78, and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Mutzke et al., (WO 2016/165825, filed 4/13/2016, published 10/20/2016)
As state supra, Mutzke anticipates a composition comprising a circular RNA formulated with a cationic nanoparticle, wherein the RNA is an immunogenic vaccine.
In regard to claim 76, Mutzke teaches the RNA comprises the coding sequences of at least on protein or peptide, and comprises at least one IRES (p. 8, 3rd para.).
In regard to claim 77, Mutzke teaches the RNA encodes an antigen peptide derived from a bacterium, virus, or protzoan (p. 8, 2nd & 4th para., p. 10, 1st para.).
In regard to claim 78, Mutzke teaches the RNA encodes a tumor antigen peptide (p. 8, 2nd para., p. 10, 1st & 2nd para.).
In regard to claim 99, as stated supra, Mutzke teaches RNA encodes a therapeutic antigen peptide.
However, Mutzke does not claim nor provide a preferred embodiment of a circular RNA comprising an IRES and encoding antigenic peptides.
Nevertheless, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to have prepared said circular RNA because each of the individual elements of the instant claims are independently presented by Mutzke as embodiments and are taught that they can be combined in various embodiments; therefore a combination of all the elements into a single embodiment would be apparent to an artisan skilled in vaccine gene therapy in light of the Supreme Court’s KSR decision (see MPEP 2143 Exemplary Rationale (A)). Regarding the rationale for combining prior art elements according to known methods to yield predictable results, all of the claimed elements were known in the prior art and one skilled in the art could have combined the element as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of filing the invention. Each of the elements (circular RNAs, IRES, nucleic acid encoding antigenic peptides, as well as cloning methods) are taught by Mutzke and/or were well known in the prior art, and further they are taught in various combinations and are shown to be used in a method for producing circular RNA with an IRES operably linked to an antigenic peptide. It would have been therefore predictably obvious to use a combination of these elements in said composition.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Mutzke et al., (WO 2016/165825, filed 4/13/2016, published 10/20/2016), in view of Nelson et al., (WO 2016/01222, filed 7/16/2015, published 1/21/2016, see IDS filed 2/28/2023).
As state supra, Mutzke anticipates a composition comprising a circular RNA formulated with a cationic nanoparticle, wherein the RNA is an immunogenic vaccine for cancer.
However, Mutzke is silent with respect to further combining a chemotherapeutic agent.
Nelson teaches compositions of circular RNA that encode at least one peptide of interest that are more resistant to degradation by exonucleases and have a longer half-life than their corresponding linear counterparts (Detailed Description, [0163-0165]). With respect to claim 82, Nelson teaches the peptide of interest encoded by the circular RNA is to treat tumors [0862, 0948, 0965], and that the composition includes other anticancer or chemotherapeutic agents [0862-0865].
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have prepared the composition comprising a circular RNA vaccine for the treatment of cancer as taught by Mutzke, and further combine a therapeutic agent as taught by Nelson with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as a form of combination therapy for cancer. In addition, MPEP 2144.06 indicates that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
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 obviousness-type 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); 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 74-76, 77, 79, 81 and 95-99 are rejected on the grounds of nonstatutory double patenting over claims 1-12 of U.S. Patent No. 11,560,567 (Chang et al., Patented 1/24/2023), in view of Sarnow et al., (US 5,766,903, patented 6/16/1998, see IDS filed 2/28/2023).
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the composition comprising a circular RNA and IRES operably linked to a protein-coding sequence of cited patent makes obvious the composition comprising a circular RNA and IRES operably linked to an antigen protein-coding sequence of instant application. It is clear that all the elements of the cited patent claims are to be found in instant claims. The difference between the cited patent claims and the instant claims lies in the fact that the instant application claims are more specific with respect to the protein being an antigen.
Nevertheless, cited patent teaches that antigens and vaccination is within the genus of proteins claimed (col 43, 1st para.), and one of ordinary skill would have immediately envisioned the selection of an antigen as a protein from the limited genus of proteins to be expressed.
In regard to instant claims, Sarnow claims a composition comprising a circular RNA that comprises an IRES and a RNA sequence that encodes repeating antigen polypeptides (see Claims 1, 13-17 of Sarnow). Furthermore, Sarnow teaches the circular RNA is being administered as a vaccine, and can be used for the treatment of viral, bacterial, or parasitic disease, and therefore makes obvious the use of these antigens. In addition, Sarnow claims the circular RNA is in an delivery vehicle such as liposome (see Claims 27, 29, and 30 of Sarnow). Alternatively Sarnow claims the circular RNA is in a physiologically balanced aqueous solution (see Claim 27 of Sarnow), which is the absence of lipids is effectively naked. Furthermore, it must be noted that the description of the immunogenic circular RNA to be administered as naked RNA is the intended use of the claimed composition.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have claimed the composition comprising a circular RNA comprising an IRES operably linked to a protein, and choose an antigen to treat a pathogen as taught by Sarnow with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to so as taught by Sarnow to use the composition as a vaccine for pathogens. Furthermore, it would have been prima facie obvious to have claimed the circular RNA in a naked delivery composition or liposome as taught by Sarnow with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to so in order to deliver the circular RNA to a subject.
Since the instant application claims are obvious over cited patent claims in view of Sarrow, said claims are not patentably distinct.
Provisional Double Patenting
Claims 74-79 and 96-99 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 4, 6 of copending Application No. 17/635,760. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the vaccine composition comprising a circular RNA that does not contain any N6-mtheyladenosine, and comprises and IRES operably linked to an antigen of cited application anticipates the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Claims 61, 66, 74-77, 79-81, and 95-99 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 42-74 of copending Application No. 18/340,582, in view of Sarnow et al., (US 5,766,903, patented 6/16/1998, see IDS filed 2/28/2023). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the comprising a circular RNA that comprises an IRES operably linked to a protein makes obvious the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims.
The difference between the cited application claims and the instant claims
lies in the fact that the instant application claims are more specific with respect to the protein being an antigen.
Nevertheless, cited patent teaches that antigens and vaccination is within the genus of proteins claimed ([0103] and one of ordinary skill would have immediately envisioned the selection of an antigen as a protein from the limited genus of proteins to be expressed.
In regard to instant claims, Sarnow claims a composition comprising a circular RNA that comprises an IRES and a RNA sequence that encodes repeating antigen polypeptides (see Claims 1, 13-17 of Sarnow). Furthermore, Sarnow teaches the circular RNA is being administered as a vaccine, and can be used for the treatment of viral, bacterial, or parasitic disease, and therefore makes obvious the use of these antigens.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have claimed the composition comprising a circular RNA comprising an IRES operably linked to a protein, and choose an antigen to treat a pathogen as taught by Sarnow with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to so as taught by Sarnow to use the composition as a vaccine for pathogens.
Since the instant application claims are obvious over cited application claims in view of Sarnow, said claims are not patentably distinct.
Claims 74-76, 78-79, and 96-99 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 6, and 29 copending Application No. 18/847,095, in view of Sarnow et al., (US 5,766,903, patented 6/16/1998, see IDS filed 2/28/2023). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the comprising a circular RNA that comprises an IRES operably linked to a protein makes obvious the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims.
The difference between the cited application claims and the instant claims
lies in the fact that the instant application claims are more specific with respect to the protein being an antigen.
Nevertheless, cited patent teaches that antigens and vaccination is within the genus of proteins claimed [0137] and one of ordinary skill would have immediately envisioned the selection of an antigen as a protein from the limited genus of proteins to be expressed.
In regard to instant claims, Sarnow claims a composition comprising a circular RNA that comprises an IRES and a RNA sequence that encodes repeating antigen polypeptides (see Claims 1, 13-17 of Sarnow). Furthermore, Sarnow teaches the circular RNA is being administered as a vaccine, and can be used for the treatment of bacterial, or parasitic disease, and therefore makes obvious the use of these antigens.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have claimed the composition comprising a circular RNA comprising an IRES operably linked to a protein, and choose an antigen to treat a pathogen as taught by Sarnow with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to so as taught by Sarnow to use the composition as a vaccine for pathogens.
Since the instant application claims are obvious over cited application claims in view of Sarnow, said claims are not patentably distinct.
Conclusion
No claims are allowed.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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