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 .
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.
Current Status of 18/133,497
This Office Action is responsive to the amended claims received 26 February 2026.
Claims 1-14 and 17-47 are currently pending.
Priority
Applicant’s claim for the benefit of the prior-filed patent applications 17/222,835 (filed 5 April 2021), 63/145,886 (filed 4 February 2021), 63/004,781 (filed 3 April 2020), 63/340,122 (10 May 2022), 63/329,601 (filed 11 April 2022, and 63/145,886 (filed 4 February 2021) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
The Examiner has determined, for the purposes of the instant action, that the effective filing date of the majority of the instant claims is 11 April 2023, because sufficient support was not found in earlier-filed documents. Claims 38, 41, 43-44, and 47 have an effective filing date of 5 April 2021.
Information Disclosure Statement
The information disclosure statements (IDS) received on 16 October 2023, 7 February 2024, and 7 November 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, these information disclosure statements are being considered by the examiner.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application for the following reasons: Figures 3 and 5 contain text that is too small to be legible.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 4. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. References to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01(VII).
Response to Amendments
New objections to the drawings are presented herein.
New objections to the specification are presented herein.
New objections to the claims are presented herein.
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. New rejections under 35 U.S.C. 112 are presented herein.
The 35 U.S.C. 101 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments.
New rejections under 35 U.S.C. 102 are presented herein.
New rejections under 35 U.S.C. 103 are presented herein.
New nonstatutory double patenting rejections are presented herein.
Response to Arguments
Applicant's arguments received 26 February 2026 have been fully considered. Applicant argues that the statutory double patenting rejections under 35 USC 101, in the previous office action, should be withdrawn. The previously presented statutory double patenting rejections under 35 USC 101 have been withdrawn.
Claim Objections
Claim 3 is objected to because of the following informalities: The phrase “B is an thiazole” should be corrected to “B is a thiazole”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5 and 13 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 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 inventors, at the time the application was filed, had possession of the claimed invention.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include: (a) Actual reduction to practice; (b) Disclosure of drawings or structural chemical formulas; (c) Sufficient relevant identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties, or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and knowledge in the art; and (f) Predictability in the art. While all of these factors are considered, a sufficient number for a prima facie case are discussed below.
Claim 5 requires a compound that falls within the scope of Formula (I) of claims 1 or 2, with additional limitations, such as ring B being specified to be a benzimidazole ring. The Examiner has not found any compounds within the instant claims or specification that provide an exemplary compound that falls within the scope of instant claim 5. Therefore, Applicant has provided no complete chemical structures that fall within the scope of instant claim 5. Because the predictability of the chemical arts is low, the partial structure provided is insufficient to show that the instant inventors had possession of the invention claimed within instant claim 5 at the time of filing.
Claim 13 requires a compound that falls within the scope of Formula VII of claim 11, with the additional limitation that X is NH. The Examiner has not found any compounds within the instant claims or specification that provide an exemplary compound that falls within the scope of instant claim 13. Therefore, Applicant has provided no complete chemical structures that fall within the scope of instant claim 13. Because the predictability of the chemical arts is low, the partial structure provided is insufficient to show that the instant inventors had possession of the invention claimed within instant claim 13 at the time of filing.
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 8, 19, 27-32, 37, 40, and 43-46 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.
Claims 8, 19, 29-30, 40, and 43-46 each recite the phrase “such as”. It is not clear if the limitations that follow the phrase “such as” are required limitations or are merely exemplary. This renders claims 8, 19, 29-30, 40, and 43-46 indefinite. Applicant may choose to remove the “such as” language. See MPEP 2173.05(d).
Claim 27 recites “The method according to any one of claims 18”. This renders claims 27-32 indefinite, because it is not clear how the method can be according to any one of a single claim. Applicant may choose to remove the “any one of” language.
Claim 27 recites “The method… further comprising a second therapy”. It is not clear how this second therapy is incorporated into the method. For example, the second therapy could be combined into the formulation containing a compound of Formula (I), or the second therapy could be administered only if the formulation containing a compound of Formula (I) fails to produce sufficient therapeutic results. This renders claims 27-32 indefinite. Applicant may amend claim 27 to make clear how the second therapy is incorporated into the method, with proper support.
Claim 37 recites “The method… further comprising a pharmaceutically acceptable excipient”. It is not clear how this pharmaceutically acceptable excipient is incorporated into the method. For example, the pharmaceutically acceptable excipient could be combined into the formulation containing a compound of Formula (I), or the second therapy could be administered separately from the formulation containing a compound of Formula (I). This renders claim 37 indefinite. Applicant may amend claim 37 to make clear how the pharmaceutically acceptable excipient is incorporated into the method, with proper support.
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.
Claims 39, 42, and 45-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
STEINER (WO 2021/203100 A1; International Publication Date 7 October 2021).
Claim 11 of STEINER teaches the administration of the compound below (referred to as 17ya therein) for the treatment of a coronavirus infection in a subject. Claim 13 of STEINER teaches that the coronavirus infection is caused by SARS-CoV-2. Claim 14 of STEINER specifies that the subject is at high risk for ARDS.
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Regarding claims 39, 42, and 45-46: The outcomes within instant claims 39, 42, and 45-46 are solely the result of administering the compound therein to a patient having a coronavirus infection. There are no positive steps recited therein that would alter these outcomes unrelated to administering the compound of instant claim 1 to a patient having a coronavirus infection. Therefore, because the method of administering the compound of instant claim 1 to a patient having a coronavirus infection has been found to be anticipated, any direct outcomes are also rendered anticipated. These claims do not specify that the compound must be administered to a subpopulation not taught by STEINER.
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.
Claims 1-2, 4, 7, 9-10, 17-18, and 20-26 are rejected under 35 U.S.C. 103 as being unpatentable over:
HAYASHI (Hayashi, Y.; Tsuchiya, K.; Yamamoto, M.; et al. “N-(4-Hydroxyphenyl) Retinamide Suppresses SARS-CoV-2 Spike Protein-Mediated Cell-Cell Fusion by a Dihydroceramide D4-Desaturase 1-Independent Mechanism” September 2021, Volume 95, Issue 17, e00807-21)
as evidenced by:
AURELIO (Aurelio, L.; Scullino, C.V.; Pitman, M.R.; et al. “From Sphingosine Kinase to Dihydroceramide Desaturase: A Structure−Activity Relationship (SAR) Study of the Enzyme Inhibitory and Anticancer Activity of 4‑((4-(4-Chlorophenyl)thiazol-2-yl)amino)phenol (SKI-II)” J. Med. Chem. 2016, 59, 965−984).
HAYASHI teaches the testing of several compounds for their ability to inhibit cell-cell fusion and viral infection of SARS-CoV-2. HAYASHI teaches that one compound that performed well within their testing could be useful to treat COVID-19 (abstract). Table 1 and FIG 2(c) of HAYASHI teach that SKI-II was tested for cytotoxicity and SARS-CoV-2 cell-cell fusion inhibition. All of the compounds within Table 1 of HAYASHI were previously known to inhibit enzymes that carry out sphingolipid metabolism (FIG 1 and Pg. 4), and HAYASHI teaches sphingolipids to be critical to the viral life cycle of various viruses and involved in SARS-CoV-2 infection (Pg. 2).
AURELIO provides evidence that SKI-II was known to be equivalent to the structure below (Figure 1). This compound can be shown to fall within the scope of instant claim 1. Defining the variables of instant claim 1 as follows yields the compound of AURELIO: R1 is Cl, m is 1, Y is a bond, B is a thiazole, X is NH, A is hydroxy-substituted phenyl.
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HAYASHI does not explicitly teach the use of SKI-II to treat SARS-CoV-2 infection in a subject. HAYASHI does teach that SKI-II was tested in assays to assess its ability to prevent SARS-CoV-2 fusion at a non-cytotoxic concentration, and HAYASHI teaches the use of another one of the tested compounds as a therapeutic for COVID-19. The concept of SKI-II being a potential therapy for COVID-19 (a disease resulting from SARS-CoV-2 infection) in a patient is clearly present within HAYASHI.
It would have been obvious to one of ordinary skill in the art to immediately envisage the treatment of a coronavirus infection in a subject using each and every one of the compounds taught to have been tested by HAYASHI for the inhibition of SARS-CoV-2 fusion, for the purpose of treating COVID-19 (a disease resulting from SARS-CoV-2 infection). The artisan would have expected success in this treatment, because all of the compounds within Table 1 of HAYASHI were previously known to inhibit enzymes that carry out sphingolipid metabolism, and HAYASHI teaches sphingolipids to be critical to the viral life cycle of various viruses and involved in SARS-CoV-2 infection.
Regarding claim 2: The instant specification teaches that acute respiratory distress syndrome (ARDS) is a natural result of the later phase of COVID-19 (page 3). HAYASHI teaches treatment of COVID-19, and COVID-19 patients with ARDS is a subpopulation of COVID-19 patients. Therefore, with no teachings to the contrary, HAYASHI teaches the treatment of all subpopulations of COVID-19 patients, including patients having ARDS.
Regarding claims 7, 9-10, and 20-26: The outcomes within instant claims 7, 9-10, and 20-26 are solely the result of administering the compound therein to a patient having COVID-19. There are no positive steps recited therein that would alter these outcomes unrelated to administering the compound of instant claim 1 to a patient having COVID-19. Therefore, because the method of administering the compound of instant claim 1 to a patient having COVID-19 has been found to be obvious, any direct outcomes are also rendered obvious. These claims do not specify that the compound must be administered to a subpopulation not taught by HAYASHI. Claim 26 mentions the outcome of a combination of the claimed method with remdesivir and/or dexamethasone, but does not require the combination.
Claims 1-3, 6-7, 9-12, 14, 17-18, 20-26, 33-37, 39, 42, and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over:
STEINER (WO 2021/203100 A1; International Publication Date 7 October 2021)
in view of:
LANGE (Lange, J.H.M.; Stuivenberg, H.H.; Coolen, H.K.A.C.; et al. “Bioisosteric Replacements of the Pyrazole Moiety of Rimonabant: Synthesis, Biological Properties, and Molecular Modeling Investigations of Thiazoles, Triazoles, and Imidazoles as Potent and Selective CB1 Cannabinoid Receptor Antagonists” J. Med. Chem. 2005, 48, 1823-1838).
Claim 11 of STEINER teaches the administration of the compound below (referred to as 17ya therein) for the treatment of a coronavirus infection in a subject. Claim 13 of STEINER teaches that the coronavirus infection is caused by SARS-CoV-2. Claim 14 of STEINER specifies that the subject is at high risk for ARDS.
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LANGE teaches that thiazole and imidazole compounds were designed as bioisosteres, and these compounds elicited CB1 antagonistic activity, along with receptor subtype selectivity (abstract). The specific structures of the thiazole and imidazole bioisosteres of LANGE can be seen in Scheme 1a and Scheme 3a therein. These compounds are similar to the instantly claimed compounds, as they each contain three aromatic ring systems, with the central ring being the imidazole.
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to replace the imidazole ring of the 17ya compound taught by STEINER with a bioisosteric thiazole ring as taught by LANGE, by exchanging either of the imidazole nitrogen atoms of compound 17ya for a sulfur atom, for the purpose of tuning the anti-SARS-CoV-2 efficacy of the compound taught by STEINER. The artisan would have expected success in this replacement, because LANGE teaches the exchange of an imidazole for a thiazole ring therein in similar compounds.
Regarding claims 7, 9-10, and 20-26: The outcomes within instant claims 7, 9-10, and 20-26 are solely the result of administering the compound therein to a patient having a coronavirus infection. There are no positive steps recited therein that would alter these outcomes unrelated to administering the compound of instant claim 1 to a patient having a coronavirus infection. Therefore, because the method of administering the compound of instant claim 1 to a patient having a coronavirus infection has been found to be anticipated, any direct outcomes are also rendered anticipated. These claims do not specify that the compound must be administered to a subpopulation not taught by STEINER.
Regarding claims 33-37: Paragraph [00142] of STEINER teaches the administration of 18 mg of compound 17ya in a capsule to a patient. The capsule therein reads on the pharmaceutically acceptable excipient of instant claim 37.
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 38-39 and 41-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 11 and 13-14 of U.S. Patent No. 11,648,236 (referred to below as the ‘236 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because: Claim 11 of the ‘236 patent teaches the administration of the compound below (referred to as 17ya therein) for the treatment of a coronavirus infection in a subject. Claim 13 of the ‘236 patent teaches that the coronavirus infection is caused by SARS-CoV-2. Claim 14 of the ‘236 patent specifies that the subject is at high risk for ARDS.
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Regarding claims 39 and 41-46: The outcomes within instant claims 39 and 41-46 are solely the result of administering the compound therein to a patient having a coronavirus infection. There are no positive steps recited therein that would alter these outcomes unrelated to administering the compound of instant claim 1 to a patient having a coronavirus infection. Therefore, because the method of administering the compound of instant claim 1 to a patient having a coronavirus infection has been found to be anticipated, any direct outcomes are also rendered anticipated. These claims do not specify that the compound must be administered to a subpopulation not taught by the ‘236 patent.
Claims 38-39 and 41-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 11, 12, and 15-16 of copending Application No. 18/552,799 (referred to below as the ‘799 application).
Although the claims at issue are not identical, they are not patentably distinct from each other because: Claim 11 of the ‘799 application teaches the administration of the compound below (referred to as 17ya therein) for the treatment of inflammation in a subject. Claims 12, 15, and 16 of the ‘799 application teach that the inflammation is caused by SARS-CoV-2, wherein the subject is at a high risk for ARDS.
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Regarding claims 39 and 41-46: The outcomes within instant claims 39 and 41-46 are solely the result of administering the compound therein to a patient having a coronavirus infection. There are no positive steps recited therein that would alter these outcomes unrelated to administering the compound of instant claim 1 to a patient having a coronavirus infection. Therefore, because the method of administering the compound of instant claim 1 to a patient having a coronavirus infection has been found to be anticipated, any direct outcomes are also rendered anticipated. These claims do not specify that the compound must be administered to a subpopulation not taught by the ‘799 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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