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 .
Priority
The instant application is a 35 USC 371 National Stage filing of international application PCT/US22/029891, filed May 18, 2022, which claims the benefit of an effective US filing date under 35 USC 119(e) from US Provisional Applications 63/343,081 and 63/190,575, filed May 17, 2022 and May 19, 2021, respectively.
Information Disclosure Statement
No information disclosure statement has been filed in the instant application. Applicants are reminded of their duty to disclose all information known to them to be material to patentability as defined in 37 CFR 1.56.
Status of the Claims
Currently, claims 1-17 and 22-24 are pending in the instant application and under consideration herein.
As an initial matter, it is noted that the claim set dated 11/29/2023 is non-compliant because claim 17 differs from originally filed claim 17, with no claim set containing mark-ups to show the change. In particular, original claim 17 contains a recitation of the compound 2-(3,4-dimethoxyphenyl)-4-[[4-(6-methyl-2-propan-2-ylpyrimidin-4-yl)piperazin-l-yl]methyl]-1,3-thiazole. The corresponding claim in the preliminary amended uses the status identifier “Previously presented” but does not recite the above compound, while there is no amendment to delete the text from claim 17. Clarification is required on the scope of claim 17 due to the non-compliance. Further, if the compound is intended to be included in the scope of claim 17, it must be added back into the claim with proper mark-up.
Claim Objections
Claim 17 is objected to because each instance of “N.N.” should be replaced with “N,N-“. Appropriate correction is required.
Claim 22 is objected to for depending on a rejected base claim.
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 1-16, 22 and 24 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 pre-AIA the applicant regards as the invention.
The claims are rejected because they recite the variables R9, R10 and R11, which contain definitions having an incomplete or incorrect valence for the position of the structure they occupy. For example, where R9 is defined as the atom carbon, there is an incomplete valence as carbon is a tetravalent atom and R9 is a trivalent position. For example, if a trivalent position is occupied by “C” it must be made clear what is bonded to the fourth position on the tetravalent carbon atom. Similarly, divalent position R10 includes tetravalent “carbon” and trivalent “nitrogen” is definitions, which have two or one unfilled valence positions, respectively. Trivalent position R11 includes divalent “sulfur” and “oxygen” as definitions, which are chemically impossible. Accordingly, since the claimed structure contains groups which have an improper or incomplete valence, it is unclear which structure is intended at the positions described above. Any dependent claims which do not remedy the issue are also rejected.
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.
It is noted that with respect to the rejection below, for the purposes of determining if a reference is a “printed publication” for the purposes of 102(a)(1), MPEP 2128 states the following:
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Specifically regarding electronic publications, such as online databases, as prior art the following is noted:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since the database entries below list the dates that the compounds were entered into the on-line database, the compounds were made publicly available as of those dates in the citation, and the claims are anticipated.
Claim(s) 1-5, 9-10, 12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the STN Registry database entry for CAS RN 1278548-92-7, which has an entry date of 11 April 2011.
Since the entry date represents the date that the compound entered a publicly available database on STN, this represents the date that the compound was made accessible to the public.
The STN Registry database entry listed above discloses the compound
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which reads on the formula I where R1 is methoxy; R2-R6 are each H; R7 is Cl; R8 is NH2; R9 is CH; R10 is S and R11 is N. Since the compound disclosed in the prior art has the same structure as the instantly claimed compound, each and every required element of the claim is taught and the claim is anticipated. With respect to the instantly claimed pharmaceutical composition, it is noted that the prior art discloses molar solubility data which describes the anticipatory compound in unbuffered water, which is a pharmaceutically acceptable carrier. Accordingly, the claims are anticipated.
Claim(s) 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0314429 (“the ‘429 publication”).
The prior art teaches a method for treating a human subject with an inhibitor of a stimulator of interferon genes (STING) protein, wherein the human subject is suffering from a disease (paragraph [0040]; claim 1), the method comprising the steps of: determining whether a human subject has a defective functional activity of STING protein (paragraph [0014]; [0040]; claim 1; abstract), by: (i) isolating a sample from the human having the disease (paragraph [0244]); (ii) performing a PCR assay on the sample to determine a functional activity of STING protein in a cell population (paragraph [0040]; [0186]; [0210]); and (iii) if the human subject has an upregulated defective functional activity of STING, then identifying a selected inhibitor therapy; and internally treating the human subject with the selected inhibitor therapy (paragraph [0133]; [0244]; claim 1; abstract).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699