DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-7, 14-16, 18-20, and 22-28 are pending. Claims 8-13, 17, and 21 are cancelled. Examiner previously required a restriction (dated December 2, 2025). In response, Applicant elected Group I which encompasses claims 1, 14-16, 18, and 19. Accordingly, claims 2-7, 20, and 22-28 are withdrawn.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/US2022/015096, filed on February 3, 2022. This application also claims priority to U.S. Provisional Application No. 63/145,807 filed on February 4, 2021.
Specification - Abstract
The abstract of the disclosure is objected to because it is not in compliance with 37 C.F.R. 1.72 (b). Specifically, the sheet presenting the abstract includes other parts of the application or other material. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Election/Restrictions
As a reminder, Applicant elected Group I which corresponds to claims 1, 14-16, 18, and 19. Applicant also elected the following compound having sigma receptor binding affinity:
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and indicated that claims 1-7, 16, 18-20, and 22-28 encompass the elected species. A method for treating SARS-CoV-2 infection in a subject, comprising administration to the subject AZ66, or salt thereof, was not found in the prior art and, thus, the search was expanded.
Applicant elected the invention group and elected species without indicating whether the election was made with or without traverse. As no reasons for traverse were provided, the election is considered to have been made without traverse.
Claim Rejections – Improper Markush Grouping
Claims 1, 16, and 18 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the Specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
Depicted below are some specific examples of compounds having sigma receptor binding affinity:
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(from instant specification, pg. 2). However, each compound possesses a distinct core chemical scaffold with no common structural features readily apparent among them.
Claim 16 further recites the method of claim 1, further comprising administration of an additional therapeutic agent. Examples of therapeutic agents include:
Lactoferrin (an 80 kDa iron-binding glycoprotein)
Exhibits antimicrobial, anti-inflammatory, and anticancer activities
See abstract of:
González-Chávez, S. A. et al. Lactoferrin: structure, function and applications. International Journal of Antimicrobial Agents 2009, 33, 301.e1–301.e8.
Hydroxychloroquine (structure shown below):
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typically used as an anti-malarial drug
See pg. 1480, right col., 1st paragraph of:
Singh, T. U. et al. Drug repurposing approach to fight COVID-19. Pharmacological Reports 2020, 72, 1479-1508.
Lopinavir (structure shown below):
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Typically used as an HIV drug
See pg. 1480, right col., 1st paragraph of:
Singh, T. U. et al. Drug repurposing approach to fight COVID-19. Pharmacological Reports 2020, 72, 1479-1508.
Each therapeutic agent possesses a distinct core chemical scaffold with no common structural features readily apparent among them.
As demonstrated above, even within the category of “compounds having sigma receptor binding affinity”, there exists substantial structural diversity. Claim 16 expands the scope further to include additional structurally distinct classes of therapeutic agents including those listed above. Hence, claims 1, 16, and 18 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives for reciting a general class of compounds which includes compounds lacking a shared structural feature.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR41.31 (a) (1) (emphasis provided).
Claim Rejections - 35 USC § 112(a) – Scope of 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, 14, and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A method for treating SARS-CoV-2 infection in a subject, comprising administration to the subject of a compound, or salt thereof, having sigma receptor binding affinity
wherein the compound is AZ66, CM398, SA4503, or diphenhydramine
The method of (1), further comprising administration of an additional therapeutic agent.
The method of (1), further comprising administration of an additional therapeutic agent, wherein the additional therapeutic agent is lactoferrin.
does not reasonably provide enablement for elements that are outside the scope of the enabling elements listed above. 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.
As stated in the MPEP 2164.01(a), “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.”
In evaluating the enablement question, several factors are to be considered. According to In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), these factors include:
1) The nature of the invention,
2) the state of the prior art,
3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present,
5) the presence or absence of working examples,
6) the breadth of the claims, and
7) the quantity of experimentation needed to make and use the invention based on the content of the disclosure, and
8) the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention
The nature of the invention claims compounds, compositions, and methods of treating viral infection, especially SARS-CoV-2 infection.
State of the prior art
See the “Claim Rejections - 35 USC § 102” and “Claim Rejections - 35 USC § 103” sections below.
The predictability or lack thereof in the art
Prior art teaches the repurposing of Sigma receptor ligands (i.e., compounds having sigma receptor binding affinity) for treating COVID-19 infection
Vela, J. M. Frontiers in Pharmacology 2020, 11, 582310. (see abstract).
Hashimoto, K. Repurposing of CNS drugs to treat COVID-19 infection: targeting the sigma-1 receptor. European Archives of Psychiatry and Clinical Neuroscience 2021, 271, 249-258. (Published January 5, 2021). (see abstract).
However, the instant specification discloses that:
“The sigma-1 receptor antagonist CM304 showed insignificant viral [i.e., SARS-CoV-2] inhibition” (pg. 52, para. 00120)
“CM304 was unable to reduce viral replication” (pg. 53, line 3)
According to molecular docking simulations:
“SA4503, an antiviral sigma-1 receptor agonist, was predicted to form contact with multiple residues in the central ligand-binding site of the sigma-1 receptor: V84, W89, Y103, I124, F133, V152, V162, W164, E172, T202 (FIG. 5A). In contrast, CM304, a highly specific sigma-1 receptor antagonist, but inactive against SARS-CoV-2, formed contact with a subset of residues in the ligand-binding site of the sigma-1 receptor: V84, W89, Y103, E172, T202 (FIG. 5B). These data suggest that sigma-1 receptor binding drugs may be optimized for agonist and antiviral binding activity by forming interactions with specific residues in the sigma-1 receptor ligand-binding site: I124, F133, V152, V162, and W164” (pg. 54, para. 00126).
Therefore, even though the prior art suggests repurposing sigma receptor ligands for COVID-19 therapy, the instant specification clearly discloses that not all sigma receptor ligands can inhibit SARS-CoV-2 activity (e.g., CM304).
As such, there is a lack of predictability in the art regarding which sigma receptor ligands are capable of inhibiting SARS-CoV-2 activity.
The level of the skill in the art
The level of ordinary skill in the art is relatively high. A person of ordinary skill would typically have formal training in medicinal chemistry and organic synthesis and would be familiar with standard methods for evaluating therapeutic efficacy of compounds.
The presence or absence of working examples
The instant application only provides working examples of AZ66, CM398, SA4503, diphenhydramine, and diphenhydramine + lactoferrin inhibiting SARS-CoV-2 activity in vitro. The instant application further discloses that CM304 does not inhibit SARS-CoV-2 activity, thereby demonstrating that not all compounds having sigma receptor binding affinity are capable of inhibiting SARS-CoV-2.
The amount of direction or guidance present; The quantity of experimentation needed to make and use the invention based on the content of the disclosure
As discussed above, the instant specification acknowledges that not all compounds having sigma receptor binding affinity exhibit inhibitory activity against SARS-CoV-2 (e.g., CM304). This disclosure establishes that sigma receptor binding affinity alone does not reliably predict SARS-CoV-2 inhibitor activity.
Furthermore, neither the prior art nor the instant specification provides a predictable structure-activity relationship or other guidance sufficient to enable a POSITA to determine, based solely on sigma receptor binding affinity, which sigma receptor ligands would possess SARS-CoV-2 antiviral activity and which would not.
In the absence of specific guidance or demonstrated structure-activity relationships, a POSITA would be required to engage in undue experimentation to identify which sigma receptor ligands are capable of inhibiting SARS-CoV-2 activity and, subsequently, be used in a method for treating SARS-CoV-2 infection in a subject.
The breadth of the claims
The claims are broad insofar as the instant claims recite a method for treating SARS-CoV-2 infection in a subject, comprising administration to the subject of any compound, or salt thereof, having sigma receptor binding affinity.
Claims 14 and 19, which are dependent on claim 1, are also rejected for further requiring and/or reciting elements that are outside the scope of the enabling elements listed above.
Note on 35 USC § 102 and § 103 Rejections
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.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Rejection Part 1:
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Lenze et al. (Lenze) (Lenze, E. J. et al. JAMA 2020, 324, 2292-2300.)
Lenze teaches that when 80 patients with symptomatic COVID-19 were treated with fluvoxamine (a sigma-1 receptor agonist; see pg. 2293, right col., the highlighted box titled “Key Points”), none of them experienced clinical deterioration over 15 days (pg. 2292, “Results” and “Conclusions and Relevance” section). On the other hand, when 72 patients with symptomatic COVID-19 were treated with a placebo, 6 of the 72 patients experienced clinical deterioration over 15 days (pg. 2292, “Results” and “Conclusions and Relevance” section). In other words, Lenze discloses fluvoxamine treating (i.e., “inhibiting the progress of”; see instant specification, pg. 9, para. 0020) the COVID-19 disease, clinically.
Rejection Part 2:
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Lauriola et al. (Lauriola) (Lauriola, M. et al. Clin Transl Sci 2020, 13, 1071-1076.)
Lauriola discloses their finding that “a reduced in-hospital mortality in patients treated with a combination of HCQ [i.e., hydroxychloroquine] and azithromycin after adjustment for comorbidities” (abstract, 2nd to last sentence).
Note:
HCQ is a compound having sigma receptor binding affinity
See Table 1 on pg. 5 of:
Vela (Vela, J. M. Frontiers in Pharmacology 2020, 11, 582310.)
Azithromycin is an antibiotic (i.e., a therapeutic agent)
See Lauriola, pg. 1072, left col., 2nd paragraph, 2nd sentence.
In other words, Lauriola discloses a method of treating (i.e., inhibiting the progress of) SARS-CoV-2 infection in a subject comprising administration to the subject HCQ in combination with a therapeutic agent, azithromycin.
The natural progression of a disease, if left unchecked, may ultimately result in death of the patient. Accordingly, reduction in in-hospital mortality among patients diagnosed with COVID-19 reflects that the administered combination of HCQ and azithromycin inhibits disease progression.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Rejection Part 1:
Claims 1, 14, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over:
Mirabelli et al. (Mirabelli) (Mirabelli, C. et al. Morphological Cell Profiling of SARS-CoV-2 Infection Identifies Drug Repurposing Candidates for COVID-19. bioRxiv 2020, https://doi.org/10.1101/2020.05.27.117184.)
Mirabelli teaches that “[n]ine out of the 17 hits -amiodarone, lomitapide, ipratropium bromide, gilteritinib, fedratinib, and clofazimine, remdesivir, S1RA and bovine lactoferrin- showed dose-responsive antiviral activity against SARS-CoV-2 in iAECs (Table 1). Remarkably, even at a high MOI of 10, bovine lactoferrin, human lactoferrin, S1RA, and remdesivir (IC50 = 18 nM) retained antiviral activity, reflecting the strong efficacy of these compounds in virus-saturated infection conditions” (lines 158-162).
Mirabelli further teaches: “[g]iven the pronounced single-agent efficacy of lactoferrin, we further tested whether combinations with the FDA-approved agent remdesivir could improve the overall antiviral activity. We found that lactoferrin potentiated the efficacy of remdesivir 8-fold (Fig. 6F), suggesting that lactoferrin could be beneficial in the management of COVID-19 both as a single agent or in combination” (lines 222-226).
In view of these disclosures, Mirabelli identifies:
S1RA and lactoferrin as independently effective antiviral agents against SARS-CoV-2, including under high MOI conditions and
Lactoferrin as a potentiating agent capable of enhancing the antiviral efficacy of another compound (i.e., remdesivir) that is also an effective antiviral agent against SARS-CoV-2 under high MOI.
Accordingly, one of ordinary skill in the art would have found it obvious to try, before the effective filing date of the claimed invention, to evaluate S1RA or combinations of lactoferrin with other antiviral active agents identified in Mirabelli (such as S1RA), in a subject with a SARS-CoV-2 infection, with a reasonable expectation that lactoferrin could similarly enhance the efficacy of S1RA and treat the SARS-CoV-2 infection in the subject or S1RA itself can treat SARS-CoV-2 infection in the subject.
Note: instant claim 14 lists S1RA as a compound having sigma receptor binding affinity.
Rejection Part 2:
Claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over:
Reznikov et al. (Reznikov) (Reznikov, L. R. et al. Identification of antiviral antihistamines for COVID-19 repurposing. Biochemical and Biophysical Research Communications 2021, 538, 173-179.) (Available online: December 3, 2020).
Reznikov found that “diphenhydramine… exhibit[ed] direct antiviral activity against SARS-CoV-2 in vitro” (abstract).
In view of this teaching, a person of ordinary skill in the art would have been motivated to administer diphenhydramine to a subject infected with SARS-CoV-2 in order to evaluate its therapeutic potential in treating the infection. Given the demonstrated antiviral activity in vitro, it would have been obvious to try administering diphenhydramine in a clinical setting with a reasonable expectation of some degree of therapeutic benefit.
Rejection Part 3:
Claims 1 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over:
Hashimoto (Hashimoto, K. Repurposing of CNS drugs to treat COVID-19 infection: targeting the sigma-1 receptor. European Archives of Psychiatry and Clinical Neuroscience 2021, 271, 249-258. (Published January 5, 2021).
Hashimoto teaches “that the sigma-1 receptor in the endoplasmic reticulum plays an important role in SARS-CoV-2 replication in cells. Knockout and knockdown of SIGMAR1 (sigma-1 receptor, encoded by SIGMAR1) caused robust reductions in SARS-CoV-2 replication, which indicates that the sigma-1 receptor is a key therapeutic target for SARS-CoV-2 replication” (abstract). SA4503 is a selective sigma-1 receptor agonist developed in 1996 (pg. 254, right col., section “Other candidate cutamesine and arketamine”, 1st sentence). “Importantly, SA4503 (1 mg/day and 3 mg/day for 28 days) was safe and well tolerated in humans... Therefore, it may be interesting to perform a clinical trial of SA4503 in SARS-CoV-2-infected patients (pg. 254, right col., section “Other candidate cutamesine and arketamine”, 3rd and 2nd to last sentence).
Hashimoto explicitly suggests evaluating SA4503 in treating COVID-19 in SARS-CoV-2 infected patients. Thus, a person of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to administer SA4503 to a subject as part of a method for treating SARS-CoV-2 infection in the subject.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 15, 16, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-3, 17-20, and 39 of U.S. Patent Application No. 17/995,050 (‘050),
claims 1-6, 8, 9, and 19-24 of U.S. Patent Application No. 18/257,237 (‘237),
claim 22 of U.S. Patent Application No. 19/141,441 (‘441), and
claim 70 of U.S. Patent Application No. 19/152,952 (‘952).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap between the instant claims and the claim sets from the co-pending applications.
Regarding Application No. ‘050:
Claims 1-3, 17-20, and 39 of ‘050 are directed to a method of treating a subject suffering from infection by or susceptible to infection by a SARS-CoV-related betacoronavirus comprising administering to a subject a therapeutically effective amount of diphenhydramine and azelastine. According to claim 20 of ‘050, SARS-CoV-related betacoronavirus includes SARS-CoV-2. Hence, claims 1-3, 17-20, and 39 of ‘050 encompasses instant claims 1, 15, 16, and 18 which are directed towards a method for treating SARS-CoV-2 infection in a subject, comprising administration to the subject of a compound, or salt thereof, having sigma receptor binding affinity.
Regarding Application No. ‘237:
Claims 1-6, 8, 9, and 19-24 of ‘237 are directed to a method of treating a subject suffering from infection by or susceptible to infection by a SARS-CoV-related betacoronavirus comprising administering to a subject a therapeutically effective amount of diphenhydramine and lactoferrin. According to claim 17 of ‘237, SARS-CoV-related betacoronavirus includes SARS-CoV-2. Hence, claims 1-6, 8, 9, and 19-24 of ‘237 encompasses instant claims 1, 15, 16, and 18 which are directed towards a method for treating SARS-CoV-2 infection in a subject, comprising administration to the subject of a compound, or salt thereof, having sigma receptor binding affinity.
Regarding Application No. ‘441:
Claim 22 of ‘441 is directed to a method of treating or preventing a disease or disorder associated with one or more sigma receptors comprising administering to a subject a therapeutically effective amount of the compound of any one of claims 1-20, or pharmaceutically acceptable salt thereof, or composition of claim 21.
According to Hashimoto (i.e., the prior art discussed above in subsection “Rejection Part 3” of section “Claim Rejections - 35 USC § 103” above), “sigma-1 receptor in the endoplasmic reticulum plays an important role in SARS-CoV-2 replication in cells” (abstract). Thus, the COVID-19 disease (caused by SARS-CoV-2 infection) is a disease or disorder associated with one or more sigma receptors.
Hence, claim 22 of ‘441 also encompasses instant claims 1, 16, and 18 which are directed towards a method for treating SARS-CoV-2 infection in a subject, comprising administration to the subject of a compound, or salt thereof, having sigma receptor binding affinity.
Even though claim 22 of ‘441 does not explicitly specify the administration of a compound in combination with additional therapeutic agents, the open-ended transitional phrase “comprising” in instant claims 1, 16, and 18 as well as in claim 22 of ‘441 indicates that the method claimed in both cases also includes the administration of additional therapeutic agents.
Regarding Application No. ‘952:
Claim 70 of ‘952 is directed to a method of treating or preventing a disease or disorder associated with one or more sigma receptors comprising administering to a subject a therapeutically effective amount of the compound of any one of claims 1-60, or pharmaceutically acceptable salt thereof, or composition of claim 61. According to Hashimoto (i.e., the prior art discussed above in subsection “Rejection Part 3” of section “Claim Rejections - 35 USC § 103” above), “sigma-1 receptor in the endoplasmic reticulum plays an important role in SARS-CoV-2 replication in cells” (abstract). Thus, the COVID-19 disease (caused by SARS-CoV-2 infection) is a disease or disorder associated with one or more sigma receptors.
Hence, claim 70 of ‘952 also encompasses instant claims 1, 16, and 18 which are directed towards a method for treating SARS-CoV-2 infection in a subject, comprising administration to the subject of a compound, or salt thereof, having sigma receptor binding affinity.
Even though claim 70 of ‘952 does not explicitly specify the administration of a compound in combination with additional therapeutic agents, the open-ended transitional phrase “comprising” in instant claims 1, 16, and 18 as well as in claim 70 of ‘952 indicates that the method claimed in both cases also includes the administration of additional therapeutic agents.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624