DETAILED ACTION
This Action is in response to the communication filed on 04/09/2026.
Claims 1-9, 12-13, 20-23, 25-29 are pending.
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 .
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.
It is noted that claim 25 has been amended from “the artificial circular RNA…” (a product) to “a method of preventing and/or treating a viral infection…” (a method, not previously addressed). Claims 26 is dependent on claim 25 and thus is also drawn to a method that encompasses preventing a viral infection.
Claims 25-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a viral infection in a subject in need thereof, does not reasonably provide enablement for a method of preventing a viral infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
It should be made clear that, the enabling specification must teach those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. “Although not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." Vaeck, 947 F.2d at 495, 20 USPQ2d at 1444; Wands, 858 F.2d at 736-37, 8 USPQ2d at 1404; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (the first paragraph of section 112 requires that the scope of protection sought in a claim bear a reasonable correlation to the scope of enablement provided by the specification).” In re Wright (CAFC) 27 USPQ2d 1510 at 1513. Although a working example is not required to enable an invention, the skilled artisan must be able to practice the claimed invention without undue experimentation. See also, MPEP §2164.02, which states in part: The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
In this case, the claims explicitly encompass preventing a viral infection in a subject. Looking to the prior art for guidance, a search of the prior art did not identify any methods which utilized the artificial circular RNA of claim 1 to effectively prevent a viral infection in a subject. In fact, no prior art was identified which taught effective prevention of a viral infection using any agent similar to the artificial circular RNA utilized in the instant claim. The specification also does not provide any working example demonstrating prevention of a viral infection in a subject using the artificial circular RNA. Therefore, given the lack of knowledge present in the prior art and the lack of guidance provided in the specification with respect to preventing viral infection, further experimentation would be required. Considering that the additional experimentation would require de novo experimentation without a guarantee of success, and further considering that any positive results (i.e., successful prevention of viral infection in a subject) would amount to a significant advancement in the state of the art, the additional experimentation required is considered undue.
Furthermore, in In re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here where there is a relatively incomplete understanding in the biotechnological field involved, as described above, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims.
Therefore, it is appropriate to reject the claims under 35 USC 112(a) for not being enabled to their full scope. It is noted that amending the claims to be limited to, for example, a method of treating a viral infection in a subject in need thereof in a subject in need thereof (i.e., removing “preventing” from the claims), would obviate this rejection.
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 27 and 29 are rejected under 35 U.S.C. 101 because the invention of the instant claims is directed to an abstract idea (a judicial exception) without significantly more. Claim 27 recites a method of screening wherein the method comprises the steps of (a) identifying two or more hybridization regions wherein the two of more hybridization regions comprised in the artificial circular RNA are identified by RNA inverse folding tools, (b) designing an artificial circular RNA, and (c) optionally selecting the artificial circular RNA designed in step (b) and optionally packaging it into a product. Claims 29 is dependent on claim 27. It is noted that step (a) identifying hybridization regions includes the requirement of using RNAi inverse folding tools, while step (b) designing an artificial circular RNA does not require any active method steps as “designing” can be accomplished in the mind, and step (c) is an optional step which is not required and thus does not impart any required active steps to the method. Accordingly, the claimed method of screening comprises steps of identifying target hybridization regions using a computer program, and designing an artificial circular RNA without any active method steps, amounts to an abstract idea, which is a judicial exception to patent eligibility. The judicial exception is not integrated into a practical application because the claimed method only comprises steps for identifying or determining information, specifically hybridization regions capable of disrupting by hybridization one or more target disruption structures without a specific transformative physical step, and the claims do not add a meaningful limitation to the abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the use of RNA inverse folding tools (i.e., the step indicating wherein the hybridization regions are identified by RNA inverse folding tools, which is the only active step required by the claims), amounts to using a computer/mathematical algorithm to identify the secondary structure of an RNA sequence without transforming the abstract idea into patent-eligible form. Furthermore, using well-known and available tools, including RNA inverse folding tools (e.g., NUPACK, RNAifold, MoiRNAiFold, etc.), is well-understood, routine and conventional in the field of bioinformatics and RNA research and does not add “significantly more” to elevate the claims into a patent-eligible invention.
Therefore, the instant claims are rejected under 356 U.S.C. 101 as being drawn to a judicial exception (an abstract idea).
Allowable Subject Matter
Claims 1-9, 12-13, 20-23, 26, 28 are allowed as the prior art does not teach or suggest the claimed artificial circular RNA.
Conclusion
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 J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637
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