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
Priority
This application, filed 05/24/2023 is a National Stage entry of PCT/EP2021/082532, International Filing Date: 11/22/2021. PCT/EP2021/082532 claims foreign priority to 20209647.5, filed 11/24/2020. A certified copy of the foreign priority application is of record.
Status of Claims
Claims 1-13 are currently pending.
Claims 1-13 were examined and are rejected.
Objection to Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See para [0007]. 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.
Claim Rejections-35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 4-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because these claims begin with “Compound 1 for use, use of compound 1 or method…”. It is uncertain if they are specifically drawn to a compound or process from the language given. As a claim must be directed to a single statutory class, e.g., a composition of matter or a process, the claims don’t meet the requirement under 35 USC 101 because the language of the claims is confusing and doesn’t differentiate between being drawn to a product or method.
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 1-13 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 1-12 all recite “compound 1”, but the actual IUPAC name or chemical structure of this compound are not provided in any of the claims. Since “compound 1” is a generic reference and provides no specific information as to the identity of this compound, the claims are indefinite. Claim 13 is similarly rejected for depending on claim 12 and not providing further clarity.
For search and examination, “compound 1” was interpreted by the examiner as having the following structural formula, as identified by Applicant’s specification:
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Claims 4-11 begin with “Compound 1 for use, use of compound 1 or method…”. The claims are indefinite as it is uncertain if they are specifically drawn to a compound or process from the language given.
For the sake of providing compact prosecution, and for purposes of examination and searching for prior art, these claims were examined as being drawn to a product, i.e., compound 1.
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) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brys et. al., WO 2019096944 A1, publ. 5/23/2019, cited in an IDS.
Brys discloses compounds and pharmaceutical compositions for the treatment of fibrotic diseases, wherein the compounds have antagonistic activity towards the G-protein coupled receptor, GPR84 (title & abstract; para [0001], [0012]). Brys discloses the compound 9-cyclopropylethynyl-2-((S)-1-[1,4]dioxan-2-ylmethoxy)-6,7-dihydro-pyrimido[6,1-a]isoquinolin-4-one (para [0122]), and administration of this compound alone for the treatment or prevention of a fibrotic disease (para [0162], [0176-0182]):
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. This compound is structurally identical to compound 1 defined in Applicant’s specification.
Claim 1 recites “Compound 1 for use in treating a patient in need of compound 1 therapy…”. This claim has been examined as being drawn to compound 1; “for use in treating a patient….” is drawn to intended use of the compound, and doesn’t impart further structural limitations to the compound. See MPEP 2111.02(II): If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. As Brys discloses compound 1, Brys anticipates the claim.
Claim 2 recites “The use of compound 1 in the manufacture of a medicament”. As such, this claim has been interpreted as being drawn to a process of manufacturing a medicament comprising compound 1. Brys discloses formulating compound 1 with 0.5% methylcellulose prior to administration for treatment, wherein the compound is administered without any other compound, including nintedanib (para [0176-0180]). Brys therefore anticipates claim 2.
Regarding claim 3, Brys discloses administration of compound 1 for the treatment or prevention of a fibrotic disease (para [0162], [0176-0182]), wherein compound 1 is not administered with nintedanib. As such, Brys anticipates the claim.
Regarding claims 4-11, these claims have been examined as being drawn to compound 1. Therefore, all language after “Compound 1”, reciting “for use….” has been interpreted as intended use of compound 1. As the language of intended use in these claims doesn’t impart further structural limitations to “compound 1”, the intended use is not considered part of the claim limitations, and don’t further distinguish from Brys. As such, Brys anticipates these claims.
Regarding claim 12, drawn to a package or kit comprising (i) compound 1 and (ii) a package insert, package label, instructions or other labelling comprising instructions to avoid or discontinue or contraindication of concomitant use or co-administration of nintedanib, Brys discloses the compound 9-cyclopropylethynyl-2-((S)-1-[1,4]dioxan-2-ylmethoxy)-6,7-dihydro-pyrimido[6,1-a]isoquinolin-4-one (para [0122]), and administration of this compound for the treatment or prevention of a fibrotic disease, wherein the compound is administered between 30 to 250 mg. (para [0162], [0176-0182]). Therefore, Brys meets the limitation of a kit of claim 12, as Brys discloses compound 1, and the disclosure of administering the compound in a dose between 30 to 250 mg. for treating a fibrotic disease constitutes instructions for using the compound. Regarding “instructions to avoid or discontinue or contraindication of concomitant use or co-administration of nintedanib”, if the instructions are not functionally related to the product, i.e., compound 1, the content of the instructions will not distinguish the product of the claims from the prior art. See MPEP 2112.01(III): “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art”. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product."). As compound 1 exists independently of the content of the instructions, the recitation of “instructions to avoid or discontinue or contraindication of concomitant use or co-administration of nintedanib” is not functionally related to the product, and doesn’t further distinguish the product from Brys. Brys therefore anticipates the claim. Brys further anticipates claim 13, as claim 13 depends directly from claim 12, and recites “further comprising one or more of the features according to claims 1 to 11”. As Brys anticipates the features of claims 1-11, Brys anticipates claim 13.
Information Disclosure Statement
The IDS filed on 9/12/23 has been considered.
Correspondence
Claims 1-13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627