DETAILED ACTION
Status of claim rejections
The objections to the claims are withdrawn in view of Applicant’s cancellation of the claims in the response filed 12/07/2025.
The objections to the specification is withdrawn in view of Applicant’s filing of a substitute specification in the response filed 12/07/2025.
The rejections of the claims under 35 USC 112(b) are withdrawn in view of Applicant’s cancellation of the claims in the response filed 12/07/2025.
The rejections of the claims under 35 USC 112(a) written description are withdrawn in view of Applicant’s cancellation of the claims in the response filed 12/07/2025.
The rejections of the claims under 35 USC 112(a) enablement are withdrawn in view of Applicant’s cancellation of the claims in the response filed 12/07/2025. However, please note that the rejection is now recast (and modified) to newly added claims 21-30.
This Action is Final, as necessitated by Applicant’s amendments.
New Claim Objections
Claim 22-30 is objected to because of the following informalities:
Claims 22-29 recite “the method of Claim 26” (emphasis added). The claims should be amended to recite “the method of claim 26”. Claim 30 recites, “the method of Claim26”. The claim should be amended to recite “the method of claim 26” for consistency. Appropriate correction is required.
New Claim Rejections - 35 USC § 112(b)
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.
Claims 22, 24, 27 and 29 are 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 22 recites the limitation "wherein the RNase 1 is recombinant Ribonuclease A”. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of any RNase 1 earlier in the claim or in claim 21, from which this claim depends. Thus, the claim is indefinite.
Claim 27 recites the limitation "wherein the RNase 1 is recombinant Ribonuclease A”. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of any RNase 1 earlier in the claim or in claim 26, from which this claim depends. Thus, the claim is indefinite.
Claim 24 recites the limitation “the RNase 1 is intravenously injected”. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of any RNase 1 earlier in the claim or in claim 21, from which this claim depends. Thus, the claim is indefinite.
Claim 29 recites the limitation "the RNase 1 is intravenously injected”. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of any RNase 1 earlier in the claim or in claim 26, from which this claim depends. Thus, the claim is indefinite.
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 21-30 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.
Newly added claim 21 recites “a method of inactivating an mRNA based SARS-CoV-2 vaccine comprising providing a mammal who was administered a SARS-CoV-2 mRNA vaccine, wherein said mRNA encodes an immunogen from a spike domain of SARS-CoV-2; and subsequently administering RNase A to said mammal.” Newly added claim 26 recites “a method of inactivating an mRNA based SARS-CoV-2 vaccine, comprising providing a mammal and concurrently administering a SARS-CoV-2 mRNA vaccine, wherein said mRNA encodes an immunogen from a spike domain of SARS-CoV-2; and RNase A to said mammal.” Neither the instant specification nor the originally filed claims appear to provide support for the recitation of either method.
Applicant points to various paragraphs for support for the newly added claims, such as the original claims, paragraph 0029 for “RNase A”, paragraph 0024 for “recombinant”, paragraph 0033 for “intravenously” and paragraph 0036 for “subsequently or concurrently”. However, this does not amount to adequate support for the instantly claimed methods. First, the original claims were drawn to “a method of inactivating an RNA-based therapeutic comprising administering a composition possessing RNase activity and/or having ability to stimulate RNase activity” (i.e., inactivation of any RNA therapeutic using any composition having RNase activity or any ability to stimulate RNase activity) and “a method of inhibiting an immunological hyperreaction to an mRNA vaccine comprising administration of a TLR3 antagonist”. Second, none of the cited paragraphs provide support for administration of RNase A subsequently or concurrently to any mammal. Paragraph 33 only broadly speculates administration to a human or animal (including non-mammalian animals). Paragraph 0036 speculates the suppression of spike protein induced toxicity via subsequent or concurrent administration of regenerative cells such as stem cells (i.e., mesenchymal stem cells) at the time of vaccination or subsequent to vaccination. Paragraphs 0029-36, in combination, do not provide adequate support for subsequent or concurrent administration of RNase A with a vaccine, as instantly claimed in both methods.
Thus, such a recitation constitutes NEW MATTER. In response to this rejection, Applicant is
required to point to support for the newly added claims or to cancel the new matter.
Second rejection
Claims 21-30 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.
While determining whether a specification is enabling, one considered whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would have required undue experimentation to make and use the claimed invention and whether working examples have been provided. There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors 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).
All Wands factors listed above have been considered with regard to the instant claims, with the relevant factors discussed below.
Furthermore, the USPTO does not have laboratory facilities to test if an invention with function as claimed when working examples are not disclosed in the specification, therefore, enablement issues are raised and discussed based on the state of knowledge pertinent to an art at the time of the invention, therefore, skepticism raised in the enablement rejection are those raised in the art by artisans of expertise.
Nature of the inventions:
Invention I (claims 21-25): Claim 21 recites “A method of inactivating an mRNA based SARS-CoV-2 vaccine, comprising providing a mammal who was administered a SARS-CoV-2 mRNA vaccine, wherein said mRNA encodes an immunogen from a spike domain of SARS-CoV-2; and subsequently administering RNase A to said mammal.” Claim 22 requires “the RNase 1 is recombinant Ribonuclease A.” Claim 23 requires the “the immunogen is the entire spike domain of SARS-CoV-2.” Claim 24 requires the “wherein the RNase 1 is intravenously injected into the mammal.” Claim 25 requires that “the immunogen is a peptide or protein of the spike domain of SARS-CoV-2.”
Invention II (claims 26-30): Claim 26 requires “a method of inactivating an mRNA based SARS-CoV-2 vaccine, comprising providing a mammal and concurrently administering a SARS-CoV-2 mRNA vaccine, wherein said mRNA encodes an immunogen from a spike domain of SARS-CoV-2; and RNase A to said mammal.” Claim 27 requires “the RNase 1 is recombinant Ribonuclease A.” Claim 28 requires “the immunogen is the entire spike domain of SARS-CoV-2.” Claim 29 requires “the RNase 1 is intravenously injected into the mammal.” Claim 30 requires “the immunogen is a peptide or protein of the spike domain of SARS-CoV-2.”
The breadth of the claims: The claims encompass a method for inactivating an mRNA based SARS-CoV-2 vaccine by having a mammal that was already given the vaccine and administering RNase A or concurrently administering the vaccine and RNase A. The term “inactivating an mRNA-based SARS-CoV-2” has been interpreted under broadest reasonable interpretation to include inactivation of vaccines such as the Moderna and Pfizer vaccines. The term “mammal” has been interpreted to encompass any mammal (human, dog, cat, zebras, horses, cattle, etc.). The claims also encompass a method for inactivating an mRNA based SARS-CoV-2 vaccine using various administration routes. Various administration routes include direct injection, subcutaneous, oral, intravenous, intramuscular, intrathecal, intraperitoneal, topical administration, intracorporeal injection, suppositories, etc.
The level of skill in the art: The level of skill is high, including, e.g., a researcher with a PhD degree.
The working examples and guidance provided: The specification fails to provide any working examples in which RNase A is administered to any mammal via any administration route.
The state and unpredictable nature of the prior art: The state of the prior art for inactivating an mRNA based vaccine by administering RNase A to a mammal after (or concurrently with) the mRNA vaccine was unpredictable before the effective filing date of the claimed invention.
Art-recognized uses of mammalian, bacterial, and yeast RNAses for inactivating mRNA-based COVID vaccines: Schwartz et al (“The Immunomodulatory and Antimicrobial Properties of the Vertebrate Ribonuclease A Superfamily. Vaccines (Basel). 2018 Nov 20;6(4):76; prior art of record) discloses that the Ribonuclease A Superfamily is composed of cationic peptides that are secreted by immune cells and epithelial tissues (abstract). Although their physiological roles are unclear, several members of the vertebrate Ribonuclease A Superfamily demonstrate antimicrobial and immune modulation activities (abstract). Schwartz indicates diverse physiological functions of the RNase A Superfamily members are still being defined (pg. 3, paragraph 3). In addition to their direct anti-pathogen functions, RNase A peptides modulate inflammatory responses via different mechanisms (pg. 3, paragraph 3). They can inhibit the expression of pro-inflammatory cytokines and chemokines, act as alarmins, chemoattractants, opsonins, and activate immune cells (pg. 3, paragraph 3). Additionally, they can also promote the clearance of extracellular RNA (eRNA) (pg. 3, paragraph 3). Schwartz teaches that ribonuclease 2 (also known as RNase 2 or EDN) has promise as a biomarker in eosinophil-associated disease states including asthma exacerbation, cow’s milk allergy, eosinophilic esophagitis, vaccine induced aberrant responses, and respiratory syncytial virus (RSV)-induced bronchiolitis (pg. 6, paragraph 2). Schwartz recognizes that RNases, such as ones within the RNase A, are not only capable of modulating immune responses to inhibit inflammation, but are also capable of activating immune cells. Schwartz teaches that RNase peptides are being researched as novel therapies—including anti-inflammatories, antimicrobials, neuroprotection, tissue remodeling, angiogenesis, and chemotherapies (pg. 11, paragraph 3), and specifically recognizes RNase 2 as a potential biomarker for eosinophilic vaccine-induced aberrant responses.
Menegazzi et al (Role of the Ribonuclease ONCONASE in miRNA Biogenesis and tRNA Processing: Focus on Cancer and Viral Infections. Int J Mol Sci. 2022 Jun 12;23(12):6556; prior art of record) teaches “secretory “pancreatic-type” (pt), or RNase A-like, RNases display structural and functional similarities with the well-known bovine pancreatic RNase A. Among the most known present in humans, and numbered as RNase 1–8, human pancreatic (HP)-RNase (RNase 1), angiogenin (RNase 5) are noteworthy. Beyond humans, mammalian bovine seminal (BS)-RNase intrinsically displays a relevant antitumor activity in mice and human cells. RNase 5 plays a crucial role in tRNA cleavage. Moreover, RNase 2 and 3, being, respectively, the eosinophil-derived neurotoxin (EDN) and the eosinophil cationic protein (ECP), are involved in host defense, as well as fungal RNases, such as α-sarcin. Importantly, the cellularly ubiquitous RNase L targets, upon its activation, viral ssRNAs and protects human cells from infections” (see pg. 5-6). Menegazzi also teaches bacterial RNases initiate immune responses and display relevant anticancer activity and amphibian RNases increasingly important for their antitumor and antiviral activities (see pg. 6). Here, Menegazzi, while teaching the ribonucleic, anticancer, and antiviral activities of RNAses, the reference is silent to the use of RNAses (and specifically RNAse A) to inactivate SARS-CoV-2 vaccines via administration to any mammal via any administration route, either subsequently or concurrently.
Dey et al (RIBOTACs: Small Molecules Target RNA for Degradation. Cell Chem Biol. 2019 Aug 15;26(8):1047-1049. doi: 10.1016/j.chembiol.2019.07.015) discusses RIBOTACs, which are “based on small molecules that selectively bind RNAs, especially RNAs that form intricate secondary and tertiary structures” (see abstract). Dey also teaches “RIBOTACs are bivalent molecules containing an RNA-binding module and a ribonuclease (RNase) recruitment module joined by a linker. Upon binding a target RNA, RIBOTACs recruit an RNase in close proximity of the target, thereby facilitating its degradation” (see FIG. 1 description). Specifically, Dey teaches the RIBOTAC recruit an active RNase L to an RNA of interest, causing its degradation (see pg. 1048, col 1). While Dey teaches the use of RNAse L bivalent molecules to deactivate RNAs of interest, Dey is silent to the inactivation of SARS-CoV-2 vaccines using RNAse A by subsequent or concurrent administration to any mammal via any administration route.
The extremely broad scope of the claims and lack of guidance in the specification exacerbates a highly unpredictable art. While the results presented in the art do not necessarily preclude Applicant’s hypotheses regarding inactivation of mRNA vaccines using RNase A, they certainly fail to support it in its totality the methods as instantly claimed. Applicants do not provide the details of how one of ordinary skill would reasonably administer the RNase as instantly claimed to a subject and assess the effect of the administered compound on the inactivation of the mRNA-based vaccine nor is there a reduction to practice the instant method.
Consequently, the state of the art, when combined with the lack of any disclosed direct experimental test of Applicant’s hypothesis, shows that one of ordinary skill would have no basis to reasonably predict or conclude that administration of RNase A would result in tangible effects (inactivation of the mRNA-based vaccines) as instantly claimed. Though not controlling, the lack of working examples is, nevertheless, a factor to be considered in a case involving both physiological activity and an underdeveloped art. When a patent applicant chooses to forego exemplification and bases utility on broad terminology and general allegations, they run the risk that unless one of ordinary skill in the art would accept the allegations as obviously valid and correct, the PTO may, properly, ask for evidence to substantiate them. Ex parte Sudilosky, 21 USPQ2d 1702, 1705 (BPAI 1991); In re Novak, 134 USPA 335 (CCPA 1962); In re Fouche, 169 USPQ 429 (CCPA 1971).
In essence, the specification (see, e.g., paragraph 0029-31, 0033, and 0035) merely presents an idea of, and leaves it entirely up to the practitioner to determine how to carry out the claimed methods. It has been established by legal decision that a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. Tossing out the germ of an idea does not constitute an enabling disclosure. While every aspect of a generic claim need not have been carried out by an inventor or exemplified in the specification, reasonable detail must be provided in order to enable one of ordinary skill to understand and carry out the invention. It is true that a specification need not disclose what is well known in the art. However, that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph.
Absent specific guidance, one skilled in the art before the effective filing date of the claimed invention would not know how to practice the claimed invention and would require undue experimentation to practice over the full scope of the invention claimed.
The amount of experimentation necessary: The specification merely contains a speculative embodiments of the potential of RNAse A and leaves it entirely up to one of ordinary skill to determine which population or subpopulations of patients would be able to be treated, which administration route would be appropriate given a variety of factors and unpredictable nature of effective delivery, effective dosages of the RNase A in mammalian populations, etc. One of ordinary skill in the art could not reasonably take these mere speculative embodiments and immediately apply it in the claimed methods. The specification offers no working examples or direction for inactivation of the mRNA-based SARS-CoV-2 vaccines in virtually any mammalian subject (humans, rats, mice, primates, etc.) through administration of RNase A. Nothing in the specification remotely demonstrates or suggests that the claimed would have any efficacy against mRNA-based SARS-CoV-2 vaccine, because the specification does not have any data suggesting that the RNase was administered to a subject.
The essential elements toward validation of a therapeutic is the ability to test the drug (in this case, an RNase A), on subjects monitored during mRNA vaccine administration and link those results with subsequent histological confirmation of the presence, decrease, or absence of symptomology. This irrefutable link between antecedent drug and subsequent knowledge of treatment of the reaction is the essence of a valid treatment agent. All of this underscores the criticality of providing workable examples which are not disclosed in the specification for inhibition/inactivation of mRNA-based vaccines.
For the reasons set forth above, one skilled in the art before the effective filing date of the claimed invention would not be able to make and/or use the invention as claimed. This is particularly true given the nature of the invention, the state of the prior art, the breadth of the claims, the amount of experimentation necessary, the level of skill which is high, the working examples provided and scarcity of guidance in the specification, and the unpredictable nature of the art.
Response to Arguments
Applicant's arguments filed 12/07/2025 have been fully considered but they are not persuasive. The Declaration/Affidavit under 37 CFR 1.132 filed 12/07/2025 is insufficient to overcome the rejection of the claims based upon lack of enablement as set forth in the last Office action for the reasons set forth below.
On pg. 8-9 of the remarks, Applicant argues that the invention is directed to a well-characterized RNase A and well-known treatment (SARS-CoV-2 vaccine) that encodes an immunogen from the spike domain. Applicant argues that narrowing the breadth of the claims to the new claims, and submission of the post-filing data (see Appendix A and also Declaration filed 12/07/2025) that is commensurate with the scope of the new claims is sufficient. Specifically, Applicant argues that the data shows that RNase A nearly completely suppressed immune response of mRNA SARS-CoV-2 vaccine (the Moderna vaccine) in a mammal such that the vaccine’s ability to prime spike protein-specific T-cell proliferative responses in vivo was barely measurable. Applicant argues while the state/nature of the art is unpredictable, a PHOSITA would understand the nature of RNase A, the structure and function of COVID vaccines encoding immunogen from the spike domain, and the data provided overwhelmingly overcomes any uncertainty in the prior art. Applicant argues much of the same for the amount of experimentation necessary to practice the claimed invention.
In response, the examiner disagrees. First, the examiner appreciates the post-filing data provided by Applicant and the declaration was given its fullest consideration. Second, according to MPEP 2164.05 “to overcome a prima facie case of lack of enablement, applicant must present argument and/or evidence that the disclosure would have enabled one of ordinary skill in the art to make and use the claimed invention at the time of filing. This does not preclude applicant from providing a declaration after the filing date which demonstrates that the claimed invention works. However, the examiner should carefully compare the steps, materials, and conditions used in the experiments of the declaration with those disclosed in the application to make sure that they are commensurate in scope; i.e., that the experiments used the guidance in the specification as filed and what was well known to one of skill in the art at the time of filing. Such a showing also must be commensurate with the scope of the claimed invention, i.e., must reasonably enable the full scope of the claimed invention. See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021) (The court found that undue experimentation was required to enable the full scope of the claims where there was ample evidence that relevant artisans would not know how to perform the claimed invention for more than a narrow range of the claimed scope of invention. Moreover, there was no evidence of actual reduction to practice to support patentee’s rebuttal of the lack of enablement determination).”
In the instant case, the post-filing data seems to evidence that RNase A is capable of diminishing the ability of the Moderna COVID-19 vaccine to prime spike protein specific T-cell responses when the vaccine is pre-incubated (in vitro) with recombinant human pancreatic RNase A before the cocktail is administered to mice (see pg. 4-6 of the Appendix/Declaration). However, the steps, materials, and conditions utilized in the data provided is not commensurate in scope with the disclosure. First, the Appendix evidences the use of recombinant human pancreatic RNase for the inactivation of the vaccine, but the specification only broadly speculates the use of bacterial RNases, yeast RNases, compositions possessing RNase activity like lactoribonuclease from bovine milk, and Ranpirnase (which is amphibian pancreatic RNase A; see, e.g., paragraph 0035) and speculates use of other RNases like RNase H, I, T1, mixtures thereof, etc. There is nothing in the specification linking recombinant human pancreatic RNase A to the instantly claimed method.
Next, the Appendix evidences that the vaccine is combined in vitro with the human RNase A for inactivation before administering the cocktail to the mice, but the instant claims are drawn to either: 1) administering the vaccine to any mammal and then subsequently administering the RNase A via any administration route or 2) concurrent administration of both the vaccine and the RNase A via any administration route. While the Appendix provides support for an injectable human RNase A/COVID vaccine cocktail, the only mention of combining or subsequent administration of any material with the vaccine is where the specification discusses preferred embodiments related to suppression of spike protein induced toxicity by administration of regenerative cells (like stem cells), which the claims do not recite (see paragraph 0036) and not with the RNase. Nothing in the Appendix provides support for the broad scope of the claims, encompassing providing any mammal (i.e., human/primates, zebra, horses, elephants, cattle, etc.) a SARS-CoV-2 vaccine and then subsequently or concurrently administering an RNase A via any route (parenteral, intravenous, intramuscular, etc.).
Finally, and as discussed above, there is no protocol in the specification that one of ordinary skill could replicate. While the Appendix/Declaration seems to show that providing an injectable human RNase A/COVID vaccine cocktail works to suppress the Moderna COVID vaccine in mice, the instant specification is so threadbare that there is no guidance. None of the steps, materials, or methods used in the data provided are in the specification. At most, the specification merely contains a speculative embodiments of the potential of RNases (such as RNase A) and leaves it entirely up to one of ordinary skill to determine which population or subpopulations of mammals would be able to be treated, which administration route would be appropriate given a variety of factors and unpredictable nature of effective delivery, effective dosages of the RNase A in mammalian populations, etc. One of ordinary skill in the art could not reasonably take these mere speculative embodiments and immediately apply it in the claimed methods. In light of both the unpredictable nature of the art, the lack of data/guidance in the specification, and the post-filing data provided, the rejection is maintained as set forth above.
Conclusion
NO CLAIMS ALLOWED.
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.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672