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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 23, 2026 has been entered.
By way of this submission, Applicant has amended claims 203, 208, 209, and 236, and cancelled claims 206 and 210.
Claims 203, 205, 207-209, 211-216, 218, 220, and 222-241 are pending in the application. Claims 205, 211 and 230-240 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (205 and 211) or invention (230-232), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 30, 2024.
Claims 203, 207-209, 212-216, 218, 220, 222-229 and 241 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated September 22, 2025.
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 203, 207-209, 212-216, 218, 220, 222-229 and 241 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (reversing the PTO’s determination that claims directed to methods for detection of hepatitis B surface antigens did not satisfy the enablement requirement). In Wands, the court noted that there was no disagreement as to the facts, but merely a disagreement as to the interpretation of the data and the conclusion to be made from the facts. In re Wands, 858 F.2d at 736-40, 8 USPQ2d at 1403-07. The court held that the specification was enabling with respect to the claims at issue and found that "there was considerable direction and guidance" in the specification; there was "a high level of skill in the art at the time the application was filed;" and "all of the methods needed to practice the invention were well known." 858 F.2d at 740, 8 USPQ2d at 1406. After considering all the factors related to the enablement issue, the court concluded that "it would not require undue experimentation to obtain antibodies needed to practice the claimed invention." Id., 8 USPQ2d at 1407.
Breadth of claims and nature of invention
The claims are drawn to a vaccine comprising at least one ribonucleic acid (RNA) encoding at least one cell surface protein or a fragment thereof of at least one methanogen, wherein the at least one ribonucleic acid comprises at least one non-canonical nucleotide, wherein the at least one methanogen comprises Methanobrevibacter gottschalkii, wherein the cell surface protein is a metal-binding protein, and wherein the vaccine reduces the methane production by a ruminant by at least about 10%. Under the broadest reasonable interpretation of the claims, any RNA encoding any fraction of any metal-binding cell surface protein of Methanobrevibacter gottschalkii is within the scope of the claims. The claims do not put limitations as to the size of the RNA.
The level of ordinary skill, the state of the art and level of the predictability of the art
According to the Declaration under 37 C.F.R. 1.132 from Dr. Andre-Denis Wright submitted by Applicant on July 30, 2025 (“the Wright Declaration”), the development of a vaccine that reduces methane production by a methanogen is a highly challenging endeavor. As of the priority date of the instant application (July 11, 2022), no vaccine had been successfully proven effective for use in ruminants (para. 9).
The Wright Declaration further states that it is extremely challenging to study methanogens or the importance of their cell surface protein as a specific antigen for a vaccine because of the unique features of methanogens, and the unique features of methanogens prevented characterization and in-depth study of individual methanogens and their proteins as specific antigens for a vaccine (para. 10).
The Wright Declaration further states that conventional practice in this field was to use a broad variety of antigens, such as by using whole cells or cell fractions as vaccines (para. 12). The Wright Declaration also states a failure by others in the field to create a vaccine that relies on only one specific antigen (para. 15-16). This indicates that the field was highly unpredictable as of the effective filing date of the invention.
The amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure
Applicant's experiments described in Figures 16 and 17 show selective reduction of methane production when treated with ARK007, a nucleic acid vaccine encoding a protein present in M. ruminantium. This is only one species in the vast genus claimed by the invention. Applicant’s specification also does not disclose the sequence of ARK007. There is nothing to indicate the properties of ARK007 that give this vaccine its alleged superior result.
Applicant does not offer any indication as to which cell surface proteins would possess the claimed property of reducing methane production by a ruminant by at least about 10%. Applicant does not give any indication as to what RNA fragments of said protein would possess said claimed property. Applicant has also not provided any evidence that the many sequences recited in the dependent claims would have this property, especially since the claims as amended are limited to RNA from M. gottschalkii.
Given that Applicant has only disclosed one such product with the claimed function, conspicuously without disclosing the properties of said product that give it this claimed function, the ordinary artisan would be relied upon trial and error to make a product with the claimed property of reducing methane production by a ruminant by at least about 10%, which the Wright Declaration has stated is an extremely challenging endeavor.
There is insufficient guidance and direction as well as objective evidence provided for making the full scope of RNA vaccines with the claimed property encompassed by the invention. In view of the lack of predictability of the art to which the invention pertains, undue experimentation would be required to make the claimed product.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. MPEP 2164.02. In view on the quantity of experimentation necessary, the lack of working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trial and error to make the claimed invention across its full scope.
Applicant argues that the claims as amended are fully enabled, allowing a person of ordinary skill in the art to make and use the claimed invention without undue experimentation, as the specification describes RNA sequences and how to make them, as well as working examples efficacy data.
Applicant's arguments have been considered fully but are not found to be persuasive.
The results of the experiments described in Figure 42 are performed with lipid nanoparticles (LNPs) comprising one of ARK001-ARK010, ARK012, ARK013, and ARK015. (see the instant specification at page 9). Applicant’s specification also does not disclose the compositions of these compounds, or the RNA sequences contained within. There is nothing to indicate the properties of these compounds that give their properties. At best, ARK007 comprises an unknown RNA from M. ruminantium, while the claims require an RNA from M. gottschalkii.
The claims are not drawn to ARK001, or any of these compounds. The claims are drawn to ribonucleic acid encoding a metal-binding protein of fragment thereof of M. gottschalkii. Even for the narrowest dependent claim, claim 241, which recites the specific sequence of SEQ ID NO: 11301, there is no disclosure that shows the sequence will possess the claimed property of reducing the methane production by a ruminant by at least about 10% when used in the context of a vaccine.
As stated in the Wright Declaration, there have been numerous failings by others to create a vaccine that relies on only one specific antigen (para. 15-16). The Wright Declaration also emphasizes the challenges of this field of invention, as well as the unpredictability of the field, as described above.
Due to the breadth of the claims and the unpredictability of the art, it is likely that there are numerous inoperative embodiments within the scope of the claims. The disclosure offers no guidance as to which RNAs would possess the claimed function of reducing the methane production by a ruminant by at least about 10% when used in the context of a vaccine. Claims reading on significant numbers of inoperative embodiments render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative. Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971). MPEP 2164.08(b).
The specification does not clearly identify the operative embodiments of ARK001-ARK010, ARK012, ARK013, and ARK015 because their relative characteristics are not disclosed; they are referred to only by a product number. One of ordinary skill would therefore not be able to make said products. If Applicant wishes to claim these products, Applicant must disclose their composition.
This rejection is therefore maintained.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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