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 .
DETAILED ACTION
Filing Receipt
The filing receipt mailed 10/01/2024 states that the instant application is a 371 of PCT/JP2022/043490, mailed 11/25/2022. The filing receipt also states that the instant application claims foreign benefit of application JAPAN 2021/191636, filed 11/26/2021.
The certified copy of the foreign application supports the instant claims. Therefore, the effective filing date is 11/26/2021.
Information Disclosure Statement
The information disclosure statement submitted 07/17/2026 has been considered.
Species Election
Applicant’s election of the following in the response submitted 07/07/2026 is acknowledged.
Applicant has elected without traverse i) compound I-005 and ii) Casirivimab.
At examiner’s discretion, examination has been broadened to include Indemivab.
Claim Objections
Claims 1 and 6 state “(provided that, excluding the compound represented by Formula (I) or a pharmaceutically acceptable salt thereof)”. It appears that applicant is attempting to include a proviso wherein the component (A) of claim 1 is excluded as a possible component (B). The limitation would be more grammatically correct if instead it stated “with the proviso that the compound of Formula (I) or a pharmaceutically acceptable salt thereof are excluded” or similar language.
Claim Rejections
Claim Rejections - 35 USC § 112(a)
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 1-5 and 9-16 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.
Claim 1 uses the term “COVID-19 exacerbation suppressant”. The term is undefined (see 112(b) rejection below), and critically, it is not a term that is well known within the art. Similarly, claims 13 and 14 use the term “enhancer” which is also not known within the art and is not defined within the instant specification.
Because the full scope of the terms “COVID-19 exacerbation suppressant” and “enhancer” is ambiguous and because the only examples of a “COVID-19 exacerbation suppressant” and “enhancers” are only listed in this disclosure, one of ordinary skill would not find that applicant has possession for the full scope of the claims.
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.
Indefiniteness
Claims 1-5 and 9-16 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 states “(B) a COVID-19 exacerbation suppressant”.
This term is not known within the art. The instant specification attempts to define the term on p. 8 where it states “Examples of the ‘COVID-19 exacerbation suppressant’ of (B) to be combined with (A) include an anti-SARS-CoV-2 agent, an immunomodulator, and an immunosuppressant. However, the ‘COVID-19 exacerbation suppressant’ used as (B) is a compound or antibody that is different from the compound represented by Formula (I) or a pharmaceutically acceptable salt thereof that is used as (A).”
Non-limiting examples are found on p. 9 of the specification where it states “Examples of the ‘COVID-19 exacerbation suppressant’ include mixtures of two neutralizing antibody drugs, known as antibody cocktail therapy, and examples thereof include Casirivimab and Imdevimab, and Tixagevimab and Cilgavimab.”
Additionally, the instant specification does not disclose how one of ordinary skill in the art would determine whether a known or new compound is a COVID-19 exacerbation suppressant.
Therefore, the claim is indefinite as one of ordinary skill in the art would know the metes and bounds of the claim.
As claims 1-5 and 9-16 are dependent on claim 1, they are also rejected.
Similar issues are found within claims 13-14 which state “enhancer”. The term “enhancer” is not explicitly defined within the specification and is also not known within the art. The specification does not detail how one of ordinary skill in the art could determine whether a compound or component is an “enhancer” for either (A) or (B).
Therefore, claims 13 and 14 are indefinite.
Antecedent Basis
Claims 13-14 state “An enhancer…according to claim 1”. Claim 1 does not state “enhancer” anywhere within the claim. There is insufficient antecedent basis for the term within the claims.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15-16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 is drawn to “A medicament for administration in combination with (B) according to claim 1, comprising (A) according to claim 1 as an active ingredient”.
Claim 16 uses identical claim language save that it swaps the component A for B and vice versa.
Claims 15 and 16 are essentially drawn to the combination of component (A) and component (B).
Claim 1 states “A medicament characterized by combining (A) a compound represented by Formula (I)….and (B) a COVID-19 exacerbation suppressant”. Claim 1 is essentially drawn to a medicament wherein (A) and (B) are combined.
Therefore, claims 15 and 16 are not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deeks (Drugs, 2021, 81:2047-2055, published online 10/30/2021).
Claim 14 states “An enhancer for (A) according to claim 1, comprising (B) according to claim 1.” The claim is drawn simply to the component (B).
Deeks discloses the combination medication Casirivimab/imdevimab (trademarked as Ronapreve™; REGEN-COV™). Deeks in its abstract states “Casirivimab/imdevimab (Ronapreve™; REGEN-COV™) is a co-packaged combination of two neutralizing immunoglobin gamma 1 (IgG1) human monoclonal antibodies…against the spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)…”.
Allowable Subject Matter
Claims 6-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims allowed.
Allowable subject matter indicated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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