DETAILED ACTION
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 .
Formal Matters
Claims 1-30 were originally presented on 11/07/2022. The preliminary amendments to the claims also filed on 11/07/2022 have been received and entered. Claims 11 and 16-30 were cancelled.
Claims 1-10 and 12-15 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10) in the reply filed on 11/18/2025 is acknowledged.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/18/2025.
Priority
This application is a U.S. National Phase Application under 35 U.S.C. § 371 of International Patent Application No. PCT/US2021/031405, filed on May 7, 2021, which claims the benefit of U.S. Provisional Application Serial No. 63/021194, filed on May 7, 2020.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/021,194, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The claimed methods are not disclosed or described in the ‘194 application, i.e., nowhere does the ‘194 application disclose or describe administering an effective amount of “a benzimidazole” to treat a subject who an infection with a coronavirus (Claim 1) to for reducing the risk of infection, severity of infection, with a coronavirus (Claim 2) as now claimed.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed 08/04/2023 has been received and entered into the present application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
The listing of references in the specification at pages 14-18 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 or by Applicants in an Information Disclosure Statement, they have not been considered.
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 1-10 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 1 recites:
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Claim 2 recites:
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The metes and bounds of the claimed subject matter are unclear because the preambles of claims 1 and 2 are not so linked to the body of the claims to clearly and unequivocally convey to whom or what the effective amount of a benzimidazole is administered. Specifically, while claim 1 recites a method of treating “a subject who has an infection with a coronavirus”, the active method step of the claim does not require the administering is to the subject recited in the preamble. Claim 2 doesn’t recite any subject whatsoever. Accordingly, it is entirely unclear to whom or what an effective amount of a benzimidazole is administered in the claimed methods.
Claim 9 is 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.
The term "analog" in claim 9, appearing in the expression “JTR-009 or an analog thereof”, is a relative term which renders the claim indefinite. In particular, "analog" does not particularly point out the degree or type of derivation or analogization that a given compound may have in relation to the parent JTR-009 compound and still be considered a "an analog thereof" as intended by Applicants. Furthermore, it is unclear if “analog thereof” is referring to a structural or a functional/biological analog of JTR-009.
Applicants have failed to provide any specific definition for this term in the present specification. Lacking such a definition, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112(b), the claim is properly rejected.
Claim Rejections - 35 USC § 112(a) - Written Description
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-6 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.
The claims are drawn to methods comprising an active method step of “administering an effective amount of a benzimidazole” (Claims 1 and 2). Claim 5 requires that the benzimidazole binds to a sequence comprising SEQ ID NO:3 or SEQ ID NO:2. Claim 6 requires that the benzimidazole is an antihelmintic or antacid.
The specification discloses three species of antihelmintic benzimidazoles (albendazole, fenbendazole, and oxibendazole), four species of antacid benzimidazoles (lansoprazole, omeprazole, esomaprazole, or rabeprazole), and two additional, uncharacterized benzimidazoles (JTR-009 and BL-1) (Specification at p.2, l.26-30). These nine (9) species of benzimidazole are the only description of the claimed “benzimidazole”.
A person of ordinary skill in the art would not be able to predict, with any reasonable certainty, the operability of any given “benzimidazole” compound to a) treat a subject infected with a coronavirus (Claim 1); b) reduce the risk of infection or severity of infection with a coronavirus (Claim 2); c) bind to a sequence comprising SEQ ID NO:3 or SEQ ID NO:2 (Claim 5), and/or d) act as an antihelmintic or antacid (Claim 6), other than those benzimidazoles actually disclosed and described by Applicants.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). The court in Eli Lilly held that an adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries. Regents of the University of California v. Eli Lilly & Co., 119 F3d at 1568. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Here, “a benzimidazole” fails to provide adequate written description of the claimed genus because “benzimidazole” is nothing more than a heterocyclic scaffold.
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Benzimidazole
As such, “a benzimidazole” does not adequately describe the structural features required for any given compound containing a benzimidazole scaffold to have any particular biological and/or therapeutic activity. This is clearly evidenced by the fact that not all benzimidazoles have antihelmintic activity or antacid activity and those benzimidazoles having antihelmintic activity do not necessarily also have antiacid activity, and vice versa. As a non-limiting example, albendazole is a benzimidazole having antihelmintic activity and has the following structure.
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Albendazole
In distinct contrast, lansoprazole is “a benzimidazole” is a proton pump inhibitor used as an antacid and has the following structure.
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Lansoprazole
Those skilled in the art would not administer albendazole as an antiacid and would not administer lansoprazole as an antihelmintic. Clearly, these “benzimidazole” compounds having nothing in common structurally or functionally, other than the fact that they happen to contain a “benzimidazole” heterocyclic ring.
Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010) states that “…a generic claim may define the boundaries of a vast genus of chemical compounds…the question may still remain whether the specification, including the original claim language, demonstrates that the applicant invented species sufficient to support a claim to a genus”. See page 1171. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or structural features common to the members of the genus, which features constitute a substantial portion of the genus, so that one of skill in the art can “visualize or recognize” the members of the genus (Emphasis added). Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Here, “a benzimidazole” as disclosed and claimed is not a structural feature that constitutes a substantial portion of the limitless genus of compounds that happen to contain a benzimidazole heterocyclic group. Neither is Applicant’s disclosure of three species of antihelmintic benzimidazoles (albendazole, fenbendazole, and oxibendazole), four species of antacid benzimidazoles (lansoprazole, omeprazole, esomaprazole, or rabeprazole), and two additional benzimidazoles (JTR-009 and BL-1) a “representative” number of species falling within the scope of the claimed genus of “a benzimidazole”.
As the courts have repeatedly stated, the purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.” Rochester, 358 F.3d at 920 (quoting Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 [54 USPQ2d 1915] (Fed. Cir. 2000)).
Here, Applicants desire patent protection for administering a virtually infinite genus of compounds, i.e., any chemical compound containing “a benzimidazole” heterocyclic group. To support such broad protection and right to exclude, Applicants describe the claimed genus only by a single structural feature (“a benzimidazole”) and by naming nine species of known benzimidazole compounds. However, the disclosure of these species merely provides a generic statement of an invention's boundaries but fails to demonstrate that the Applicants actually invented administering any and all compounds that happen to contain “a benzimidazole” heterocyclic group.
The Examiner acknowledges that a working example or exemplified embodiment is not necessarily a requirement for description. However, where a generic claim term is present in a claim, the specification must convey enough information, e.g., via sufficient representative examples, to indicate invention of species sufficient to constitute the genus. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 967 2 (Fed. Cir. 2002). The written description requirement “requires a description of an invention, not an indication of a result that one might achieve if one made that invention.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997); see also Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1350 (Fed. Cir. 2013) (“A patent…‘is not a reward for the search, but compensation for its successful conclusion.’ … For that reason, the written description requirement prohibits a patentee from ‘leaving it to the … industry to complete an unfinished invention.’” (citations omitted)).
At best, Applicant’s Specification directs one skilled in the art to screen compounds containing a benzimidazole heterocyclic ring and then figure out, through trial-and-error testing, which of these “benzimidazole” compounds are capable of a) treating a subject infected with a coronavirus (Claim 1); b) reducing the risk of infection or severity of infection with a coronavirus (Claim 2); c) binding to a sequence comprising SEQ ID NO:3 or SEQ ID NO:2 (Claim 5), and/or d) acting as an antihelmintic or antacid (Claim 6). This activity would require “excessive trial and error experimentation” (FF 14). See In re ʼ318 Patent Infringement Litigation, 583 F.3d 1317, 1327 (Fed. Cir. 2009) (“[A]t the end of the day, the specification, even read in light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient.”).
Accordingly, the specification does not provide adequate written description of the claimed “a benzimidazole”, which describes a limitless genus of compounds containing a benzimidazole heterocyclic group purported to have therapeutic activity in treating infections with a coronavirus. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 112(a) (Enablement)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-10 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 treating a subject infected with SARS-CoV-2 that comprises a sequence comprising CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2) comprising administering to the subject an effective amount of a benzimidazole that binds to CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2), does not reasonably provide enablement for a) treating a subject infected with other coronaviruses comprising administering to the subject an effective amount of a benzimidazole that binds to CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2) and/or b) treating a subject infected with SARS-CoV-2 that comprises a sequence comprising CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2) comprising administering to the subject an effective amount of other benzimidazoles. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention and breadth of the claims
The invention is drawn to methods for treatment of coronavirus infections comprising the administration of “a benzimidazole”.
Claims 1 and 2 are representative:
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Claim 3 is narrower, limiting the coronavirus to SARS-CoV-2. Claim 4 is also narrower, limiting the coronavirus to one that comprises a sequence comprising CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2).
The claims encompass the administration of any “benzimidazole”, i.e., any chemical compound that contains a benzimidazole heterocyclic group. This genus is virtually limitless and renders the breadth of the claims indeterminable. Claims 5-10 are narrower, limiting the benzimidazole to ones having a particular activity (binding to a specific sequence, acting as an antihelmintic or acting as an antacid) or to specific species of benzimidazole.
Applicant’s invention is predicated on their discovery that two CRRM RNA stem loops in the replicase open reading frame of SARS-CoV-2 have high homology with the 5’UTR of amyloid precursor protein (APP). Based on this discovery, they tested some known drugs that were previously shown to inhibit APP translation via its 5’untranslated region for antiviral activity against SARS-CoV-2 (Specification at p.1, l.21-26; Figures; Examples 1-3).
These factors weigh against enablement for the full scope of the claimed invention. The invention, as disclosed, is the application of known benzimidazole drugs that bind to CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2) to treat SARS-CoV-2 infections in which the SARS-CoV-2 comprises a sequence comprising CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2). In distinct contrast, the claims encompass the treatment of any coronavirus infection with any “benzimidazole”.
The state and predictability of the art, and relative skill of those in the art
At the time the application was filed benzimidazoles were not known to have antiviral activity against coronaviruses. As such, the treatment of coronaviruses generally with any chemical compound that happens to contain a benzimidazole heterocyclic ring is not considered enabled. FAN ET AL. (Gastroenterology, January 2021, vol.160, p.455-458) teaches that the use of acid suppressants, e.g., the claimed benzimidazoles, did not reduce the risk of SARS-CoV-2 infection. Indeed, they found that omeprazole use alone was significantly related to an increased risk of SARS-CoV-2 infection from the subgroup analysis in patients with upper gastrointestinal diseases (Abstract; p.455, right column, “Primary Outcome”; p.456).
It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.), Nationwide Chemical Corporation, et al. v. Wright, et al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances), Ex parte Sudilovsky 21 USPQ 2d 1702 (Appellant's invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable) In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian recombinant virus vaccine was uncertain). As long as the Specification discloses at least one method of making and using the claimed invention that bears a reasonable correlation to the entire scope of the claim, then the enablement requirement of 35 U.S.C. 112, 1st Paragraph is satisfied. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). To that extent, if little is known in the prior art about the nature of the invention and the art is unpredictable, the Specification would need more detail as to how to make and use the invention in order to be enabling. See Chiron Corp v. Genetech, lnc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) ("Nascent technology, however, must be enabled with a specific and useful teaching. The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee's instruction. Thus, the public's end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.")
Here, the claimed therapeutic use of “a benzimidazole” to treat a coronavirus infection is clearly nascent technology. A person of ordinary skill in the art therefore has little to no knowledge independent from what Applicants have disclosed. In this case, Applicant’s specification discloses their discovery that two CRRM RNA stem loops in the replicase open reading frame of SARS-CoV-2 have high homology with the 5’UTR of amyloid precursor protein (APP). Based on this discovery, they tested some known drugs that were previously shown to inhibit APP translation via its 5’untranslated region for antiviral activity against SARS-CoV-2 (Specification at p.1, l.21-26; Figures; Examples 1-3). This disclosure, however, does not bear any reasonable correlation to the entire scope of the instant claims.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for determining the particular administration regimens (e.g., dosages, timing, administration routes, etc.) necessary to treat all coronavirus infections, particularly in humans. Indeed, Applicants do not disclose any doses whatsoever for any benzimidazole compound intended to be administered to a subject.
Working examples are limited to contacting Vero-E6 cells infected with USE-WA1/2020 [SARS-CoV-2] at a MOI of 0.0001 or 0.0002 with albendazole, lansoprazole, or JTR-009 (Example 1; Figures 10 and 11A-C).
There is no working example of treatment of any coronavirus infection in any animal model or in humans. The in vitro Vero-E6 infection model (Example 1) provides evidence that some three benzimidazole compounds inhibit SARS-CoV-2 viral plaque formation in a petri dish. However, there is no evidence of record that this in vitro Vero-E6 infection model predictably correlates to clinical efficacy in a subject.
The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept the assertion that the instantly claimed genus of “a benzimidazole” could be predictably used as a treatment for all coronavirus infections in a subject as inferred in the claims and contemplated by the specification.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and ‘patent protection’ is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” (42 USPQ 2d 1001, Fed. Circuit 1997).
In the instant case, Applicants have presented a general idea that because two CRRM RNA stem loops in the replicase open reading frame of SARS-CoV-2 have high homology with the 5’UTR of amyloid precursor protein (APP) then any benzimidazole must therefore, a priori, be useful in the treatment of any coronavirus in a subject. However, the claims encompass administration of a virtually limitless genus of compounds, i.e., any chemical compound containing a benzimidazole heterocycle, to treat any viral infection caused by any coronavirus. It is clearly evident that Applicant’s claims are not at all commensurate in scope with their disclosure. A very small, insignificant percentage of the claimed “benzimidazole” compounds were actually tested by Applicants and even here they were only tested for antiviral activity in vitro against a SARS-CoV-2 virus strain.
Given the extremely diverse compounds encompassed by the claims and the limited examples provided in the specification, the skilled artisan cannot predict what structural features (other than those of the compounds actually tested) are important for binding to CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2) to treat SARS-CoV-2 infections in which the SARS-CoV-2 comprises a sequence comprising CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2). In other words, the structure activity relationship demonstrated in the examples is limited to specific compounds. A person of ordinary skill in the art would not believe that any and all compounds that happen to contain a benzimidazole heterocyclic group, regardless of their overall chemical structure, will also predictably bind to CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2).
Determining if any particular claimed “benzimidazole” would treat an infection with any particular coronavirus would require synthesis of the compound, testing it for binding to CAGUGCAAGG (SEQ ID NO: 3) or CAGUGU (SEQ ID NO: 2), formulation into a suitable dosage form, and subjecting it to clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. This is undue, completely unpredictable experimentation given the scope of the claims, the lack of predictability in the art, and the limited guidance and direction provided by Applicants.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. § 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 (i.e., changing from AIA to pre-AIA ) 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)(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.
Claim(s) 1-3 and 5-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2022/079496 A1 (Published April 21, 2022; Filed Feb. 1, 2021)2.
Regarding claims 1-3 and 5-7, WO ‘496 teaches a method for the treatment of SARS-CoV2 in a 3-10 day course comprising administering a therapeutically effective amount of the combination of nitazoxanide, albendazole, and pyrantel, wherein the dosage of nitazoxanide, albendazole, and pyrantel for each day remains the same (p.16, l.4-8).
Claim(s) 1-3, 5-6, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by FAN ET AL. (Gastroenterology, January 2021, vol.160, p.455-458)3.
Regarding claims 1-3, 5-6, and 8, FAN ET AL. teach patients taking benzimidazole antacids, i.e., lansoprazole, omeprazole, esomeprazole, or rabeprazole, developed SARS-CoV-2 infections (Abstract; p.455, right column, “Primary Outcome”; p.456). Accordingly, they were subjects having a coronavirus infection administered an effective amount of a benzimidazole as required by the instant claims. They teach lansoprazole use was potentially associated with a reduced risk of death (paragraph bridging p.456-457).
Conclusion
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 7:30 am - 4:00 pm PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
500 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.
2 As discussed above (“Priority”), Applicants are not entitled to the benefit of priority to U.S. Provisional Application Serial No. 63/021194, filed on May 7, 2020. The earliest effective filing date of the claimed invention is May 7, 2021 and WO ‘496 therefore qualifies as prior art under 35 U.S.C. 102(a)(2).
3 As discussed above (“Priority”), Applicants are not entitled to the benefit of priority to U.S. Provisional Application Serial No. 63/021194, filed on May 7, 2020. The earliest effective filing date of the claimed invention is May 7, 2021 and FAN ET AL. therefore qualifies as prior art under 35 U.S.C. 102(a)(2).