NON-FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Mar. 27, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 4-6, 8, 9, 11-18, 21, and 22 have been canceled.
Claims 1-3, 7, 10, 19, 20, 23, and 24 have been amended and incorporate no new matter.
No new claims have been added.
Thus, claims 1-3, 7, 10, 19, 20, 23, and 24 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
No new Information Disclosure Statements (IDS) have been submitted.
RESPONSE TO ARGUMENTS
Applicant’s amendments filed Mar. 27, 2026, overcome the rejections under 35 U.S.C. §§ 112(a), 112(b), 102/103, and on the ground of obviousness-type double patenting set forth in the non-final office action dated Dec. 31, 2025.
Therefore, these rejections have been withdrawn. However, upon further consideration, new grounds of rejection are set forth below. (All paragraph numbers cited herein refer to the published application, US 2023/0127965).
NEW REJECTIONS
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1-3, 7, 10, 19, 20, 23, and 24 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 pre-AIA the applicant regards as the invention.
As recognized by MPEP § 2173.05(c)(III), the common phrase "an effective amount" may or may not be indefinite. The proper test is whether or not one skilled in the art could determine specific values for the amount based on the disclosure. See In re Mattison, 509 F.2d 563, 184 USPQ 484 (CCPA 1975).
Here, independent claims 1-3 are drawn to methods of:
disrupting virus lifecycle, infection, or dissemination in a virus-infected subject, or preventing and/or minimizing virus infection or dissemination in a subject, wherein the virus is a coronavirus;
inhibiting, minimizing, or preventing formation of virus particles in a virus-infected subject, wherein the virus is a coronavirus; and
(i) altering production, post-translational modification, assembly, maturation, or functional cell surface expression of at least one virus protein involved in viral entry or viral infection in a subject's cell;
(ii) initiating or stimulating selective autophagosomal, lysosomal, or proteasomal degradation of at least one virus protein involved in viral entry or viral infection in a subject's cell;
(iii) decreasing or inhibiting increase of amount, concentration, or production of at least one virus protein involved in viral entry or viral infection in a subject's cell;
(iv) altering or disturbing subcellular localization or virus promoting activity of at least one virus protein involved in viral entry or viral infection in a subject's cell; or
(v) minimizing or preventing incorporation of a surface viral protein into a virion in a virus-infected eukaryotic cell,
wherein the virus is a coronavirus,
comprising administering to the subject a therapeutically effective amount of a compound of formula (III):
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As recognized by MPEP § 2173.05(g), when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.
The instant specification defines the phrase "therapeutically effective amount" as follows:
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Despite these disclosures, the instant specification fails to define, quantify, or particularly point out the "therapeutically effective amount" of a compound of formula (III) that achieves the claimed results; namely:
the amount which disrupts virus lifecycle, infection, or dissemination in a virus-infected subject, or minimizes virus infection or dissemination in a subject, as recited by claim 1;
the amount which inhibits, minimizes, or prevents formation of virus particles in a virus-infected subject, as recited by claim 2; or
the amount which achieves the various molecular and cellular effects recited by claim 3.
While the specification asserts that those of ordinary skill in the art are able to determine "a therapeutically effective amount" without undue experimentation, the specification fails to provide any objective criteria, dose ranges, blood-level targets, minimum efficacy thresholds, or other boundaries that would allow a skilled artisan to determine the amount of a compound of formula (III) achieves the claimed effects.
Example 5 discloses that Syrian golden hamsters were treated with compounds that restrict CoV-2 infection in primary cells, by administering 10 and 30 mg/kg of each compound or drug vehicle by i.p. injection the day before viral infection (para. [0246]).
However, the compounds administered are not identified as compounds of formula (III), or indeed, identified at all. Nor is accompanying dose-response data or other guidance provided, which is insufficient to clearly define the metes and bounds of the dosage range that constitutes a "therapeutically effective amount."
As noted above, the claims recite numerous biochemical effects that administering "a therapeutically effective amount" of a compound of formula (III) allegedly achieves. However, it is unclear (1) which of these effects must be achieved; (2) to what degree each must occur; or (3) whether all of them or some combination define the term "therapeutically effective amount."
Because the specification fails to unambiguously define a "therapeutically effective amount" of a compound of formula (III), one of ordinary skill in the art would be unable to determine the specific amount of a compound of formula (III) to administer to achieve the claimed effects. Accordingly, the terms "effective amount" and "therapeutically effective amount" do not permit one of ordinary skill in the art to distinguish between infringing methods and non-infringing methods, rendering the metes and bounds of the claims indefinite.
Claim Rejections - 35 U.S.C. § 112(a) – Enablement
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 1-3, 7, 10, 19, 20, 23, and 24 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 without undue experimentation.
MPEP § 2164.01(a), citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), sets out the factors to consider whether experimentation is undue, which include:
(A) The breadth of the claims. Independent claims 1-3 are drawn to methods of:
disrupting virus lifecycle, infection, or dissemination in a virus-infected subject, or preventing and/or minimizing virus infection or dissemination in a subject, wherein the virus is a coronavirus;
inhibiting, minimizing, or preventing formation of virus particles in a virus-infected subject, wherein the virus is a coronavirus; and
(i) altering production, post-translational modification, assembly, maturation, or functional cell surface expression of at least one virus protein involved in viral entry or viral infection in a subject's cell;
(ii) initiating or stimulating selective autophagosomal, lysosomal, or proteasomal degradation of at least one virus protein involved in viral entry or viral infection in a subject's cell;
(iii) decreasing or inhibiting increase of amount, concentration, or production of at least one virus protein involved in viral entry or viral infection in a subject's cell;
(iv) altering or disturbing subcellular localization or virus promoting activity of at least one virus protein involved in viral entry or viral infection in a subject's cell; or
(v) minimizing or preventing incorporation of a surface viral protein into a virion in a virus-infected eukaryotic cell,
wherein the virus is a coronavirus,
comprising administering to the subject a therapeutically effective amount of a compound of formula (III):
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Thus, in general, the claims are narrowly drawn to methods of treating or preventing coronavirus infection in a subject by administering a therapeutically effective amount of a compound of formula (III).
However, the claimed patient population is very broad: the instant specification defines the terms “patient,” “subject,” and “individual” as interchangeable, and refer to any animal, or cells thereof whether in vitro or in situ, amenable to the methods described herein. In a non-limiting embodiments, the patient, subject or individual is a human (para. [0067]), or any mammal (paras. [0029], [0030], [0164]). Thus, the claimed patient population encompasses virtually any living organism capable of being infected with a coronavirus.
In addition, the specification defines "treatment" or "treating" to encompass methods of treating, preventing, and/or curing coronavirus infection (para. [0069]):
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This definition of "treating" includes curing, i.e., preventing, i.e., interventions prior to the development of a coronavirus infection which precludes its coming into existence, which cannot be predicted or measured with any certainty.
(B) The nature of the invention. The disclosure focuses on the mechanism of action of the claimed compounds as sigma-1 receptor modulators, and the finding that only certain Sigma1 inhibitors block SARS-CoV-2 infection (see, e.g., paras. [0034], [0043]-[0045]). Only Sigma1 inhibitors that induce ER stress (IPAG, CT189, and haloperidol) were found to suppress SARS-CoV-2 infection, in rank order of ER stress inducing potency (Example 3; Fig. 3). Of these, only CT-189, the elected compound species, falls within the scope of claimed formula (III):
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Compound G
(1-(3-(4-fluorophenoxy)propyl)-3-(4-chlorophenyl)guanidine).
Further, the claims encompass methods of inhibiting, treating, and/or preventing any coronavirus infection by administering any compound of formula (III). However, the development of a viral infection cannot be reliably predicted in advance of its occurrence. While risk factors can be identified prior to the onset of infection, it remains impossible to determine with any certainty that a particular intervention was responsible for delaying the onset the disease, after it occurs, or that the disease would have occurred in its absence.
(C) The level of predictability in the art. "Prevention" and "curing" connote the absolute absence of a condition which cannot reasonably be achieved with regard to the claimed conditions, or in medicine generally. Further, there is no method by which to reliably determine whether a patient will develop the claimed conditions in the future, and thus, be in need of preventive therapy. Even if a patient can be identified as having known risk factors, there is no way to predict that a patient will, in fact, develop that disease. Further, the failure of a condition to develop cannot reliably be attributed to the active agent; for example, the condition may reverse or resolve due to other factors. Thus, the terms "preventing" and "treating," which encompasses curing, are unsupported by the disclosure.
(D) The amount of direction provided by the inventor. While the specification generically provides for methods of administering a compound of formula (III) to treat a coronavirus infection, and describes a proposed mechanism (e.g., Examples 3-4) no specific embodiments are disclosed or tested.
Example 5 discloses that Syrian golden hamsters were treated with compounds that restrict CoV-2 infection in primary cells, by administering 10 and 30 mg/kg of each compound or drug vehicle by i.p. injection the day before viral infection (para. [0246]). However, the compounds are not identified as compounds of formula (III), or indeed, identified at all.
Example 6 discloses the in vitro treatment of U2OS cells with the elected compound species, CT-189, at a concentration of 10 μM, to inhibit Dengue virus infection, Zika virus infection, and Powassan virus infection (paras. [0247]-[0249]; Figs. 6-8).
Thus, no examples wherein a compound of formula (III) is administered to treat or prevent a coronavirus infection are disclosed or tested. In addition, as noted supra, the specification provides no guidance as to the dosage range that constitutes a "therapeutically effective amount" to achieve the claimed biochemical effects, in any subject or species.
Therefore, the claims are not enabled because there is no expectation that the claimed methods would in fact treat or prevent a coronavirus infection in a living patient.
(E) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Despite the narrowly drawn genus of compounds of formula (III), a proposed mechanism of action and demonstration of activity against unrelated viruses in vitro, without more, is insufficient to enable methods of treating or preventing coronaviral infections. Therefore, in view of the unpredictability in the art, coupled with a lack of guidance and direction provided by the instant disclosure, one of ordinary skill in the art would be required to engage in undue experimentation to practice the claimed invention.
CONCLUSION
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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