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 .
Non-Final Rejection
The Status of Claims:
Claims 1-18 are pending.
Claims 1-18 are rejected.
Claims 1-2, 10-12 are objected.
DETAILED ACTION
1. Claims 1-18 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/JP2023/001243 01/18/2023 , which has foreign priority documents, JAPAN JP2022-006725 01/19/2022, JAPAN JP2022-012386 01/28/2022, JAPAN JP2022-017132 02/07/2022,JAPAN JP2022-027629 02/25/2022, JAPAN JP2022-120325 07/28/2022,JAPAN JP2022-149666 09/21/2022.
Drawings
3. The drawings filed on 7/17/24 are accepted by the examiner.
IDS
4. The IDS filed on 12/30/25 & 10/10/24 are reviewed by the examiner.
Specification
The abstract of the disclosure is objected to because the use of the term “novel” is improper . The examiner recommends to remove the term “novel” from the abstract. 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).
Regarding the title of the invention,
The following title is suggested: because the use of the term “novel” is improper . The examiner recommends to remove the term “novel” from the title of the invention.
Claim Objections
Claims 1-2, 10-12 are objected to because of the following informalities: In claims 1-2 and 10-12, the term ”novel” is recited.
This expression can be improper. The examiner recommends to remove the term “novel” from the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-9 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.
In claim 1, the phrases , “A pharmaceutical composition for treating novel coronavirus infections (COVID-19” is recited. This expression can be confusing because this is a hybrid claim of combining a composition claim and a method for the treatment claim. The examiner recommends to separate each into two different claims.
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.
Claim(s) 1 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated clearly by Tachibana et al (EP 4122926 A1), which claims the priority date of Aril 14, 2021.
Tachibana et al discloses a pharmaceutical composition containing Formula (I-B) and fumaric acid and and a method of treating coronavirus by using its pharmaceutical composition in the following:
31. The complex according to claim 30, wherein the compound represented by Formula (I-B):
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36. A pharmaceutical composition comprising the cocrystal according to any one of claims.(see page 363, claims 31, 36)
23. A method for treating and/or preventing a disease associated with coronavirus 3CL proteases, such as SARS-CoV-2 (see page 13, lines 54-57), COVID-19 (see page 27, lines 16-17) characterized by administering the compound according to any one of claims 1 to 17, or a pharmaceutically acceptable salt thereof. (see page 362, claim 23).
These are inherently identical with the claims.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
6. Claim(s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over .
Determination of the scope and content of the prior art
Tachibana et al discloses a pharmaceutical composition containing Formula (I-B) and fumaric acid and a method of treating coronavirus by using its pharmaceutical composition in the following:
31. The complex according to claim 30, wherein the compound represented by Formula (I-B):
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36. A pharmaceutical composition comprising the cocrystal according to any one of claims.(see page 363, claims 31, 36) as in claims 1-2
23. A method for treating and/or preventing a disease associated with coronavirus 3CL proteases, such as SARS-CoV-2 (see page 13, lines 54-57), COVID-19 (see page 27, lines 16-17) as in claims 3-4,11-13, characterized by administering the compound according to any one of claims 1 to 17, or a pharmaceutically acceptable salt thereof. (see page 362, claim 23) as in claim 10.
in the case of oral administration, as in claims 9 and 18, the amount of administration is usually 0.05 to 200 mg/kg/day as in claims 5 and 14 and is preferably in the range of 0.1 to 100 mg/kg/day. In the case of parenteral administration, the amount of administration may vary greatly depending on the route of administration; however, the amount of administration is usually 0.005 to 200 mg/kg/day and is preferably in the range of 0.01 to 100 mg/kg/day. This may be administered once a day as in claims 8 and 17 or several times a day. (see page 71 ,a paragraph# 372).
Tachibana et al teaches thatt the oral composition can be a tablet, a granular preparation, or a capsule, each containing an excipient, a disintegrating agent, a binder, a lubricating agent, and the like, as well as an active ingredient and the like. (see page 355 ,lines 2-3).
The current invention, however, differs from the prior art in that the claimed daily dose of the active ingredient on Treatment Day 1 of 375 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 125 mg each or a daily dose of the active ingredient on Treatment Day 1 of 750 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 250 mg each is unspecified in the prior art.
Ascertainment of the difference between the prior art and the claims
The difference between the current application and the applied Tachibana et al art is that the Tachibana et al does not expressly teach the claimed the claimed daily dose of the active ingredient on Treatment Day 1 of 375 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 125 mg each or a daily dose of the active ingredient on Treatment Day 1 of 750 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 250 mg each.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claims 6-7 and 15-16, with respect to the lack of disclosing the claimed daily dose of the active ingredient on Treatment Day 1 of 375 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 125 mg each or administering a daily dose of the active ingredient on Treatment Day 1 of 750 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 250 mg each, the prior art is silent about them. However, the prior art does teach generally that in the case of oral administration, the amount of administration is usually 0.05 to 200 mg/kg/day; after considering the age and body weight of the patient, the type and degree of the disease (see page 71 ,a paragraph# 372), the dosage and its frequency, the duration of treatment can be determined and adjusted.
So, if the skilled artisan in the art had desired to treat a patient successfully with a daily dose of the active ingredient on Treatment Day 1 of 375 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 125 mg each or a daily dose of the active ingredient on Treatment Day 1 of 750 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 250 mg each, it would have been obvious to the skilled artisan in the art to be motivated to do that depending on the type and degree of the disease. This is because the skilled artisan in the art would expect such a manipulation to be within the purview of the skilled artisan in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Tachibana et al expressly discloses the pharmaceutical composition containing Formula (I-B) and fumaric acid and the method of treating coronavirus by using its pharmaceutical composition.
Although Tachibana et al does not teach the claimed daily dose of the active ingredient on Treatment Day 1 of 375 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 125 mg each or administering a daily dose of the active ingredient on Treatment Day 1 of 750 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 250 mg each, the prior art does give a guidance that in the case of oral administration, the amount of administration is usually 0.05 to 200 mg/kg/day and after considering the age and body weight of the patient, the type and degree of the disease (see page 71 ,a paragraph# 372), the skilled artisan in the art can adjust the dosage and its frequency, the duration of treatment.
So, if the skilled artisan in the art had desired to treat a patient successfully with a daily dose of the active ingredient on Treatment Day 1 of 375 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 125 mg each or a daily dose of the active ingredient on Treatment Day 1 of 750 mg and the daily dose of the active ingredient from Treatment Day 2 to Treatment Day 5 of 250 mg each, it would have been obvious to the skilled artisan in the art to be motivated to do that depending on the type and degree of the disease. This is because the skilled artisan in the art would expect such a manipulation to be within the purview of the skilled artisan in the art.
Conclusion
Claims 1-18 are rejected.
Claims 1-2, 10-12 are objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 6/12/2026
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