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 .
Application Status
The claim set filed on 4/27/2023 is acknowledged. Claims 1-13 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
It is noted that the Examiner can identify the generic structures in the foreign priority applications, but cannot determine the variables. Since none of the certified copies of the foreign priority applications, including the PCT, contains a translation and a statement that the translation of the certified copy is accurate the earliest effective filing date for claims 1-9 and 11-13 is determined to be 4/27/2023 and 8/13/2021 for the specific compounds of claim 10.
As noted above, Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Information Disclosure Statement
The information disclosure statement filed on 6/01/2023 has been considered except where lined through.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 recites the limitation “C1-4alkoxy-C1-4alkylis”. It would appear that the correct way to write this is C1-4alkoxy-C1-4alkyl is.
Claim 11 contains the limitation a pharmaceutically acceptable salt refers to a salt prepared by the compound which seems grammatically awkward. Appropriate correction is required.
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.
Claim 13 is 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 claim 13 is drawn to an “application” of the compound of claims in the preparation of drugs for treating diseases…. Accordingly, claim 13 is being interpreted as a product claim, e.g. a drug.
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 2-3, 5-6 and 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 2-3 and 5 which depend from claim 1 recites the limitation "the alkyl or alkoxy or cycloalkyl or halogen or haloalkoxy or heterocycloalkyl or alkylcycloalkyl or cycloalkyl or alkylheterocycloalkyl". However, claim 1 recites multiple instances where each of the variables can be a alkyl or alkoxy or cycloalkyl or halogen or haloalkoxy or heterocycloalkyl or alkylcycloalkyl or cycloalkyl or alkylheterocycloalkyl. As such, it is unclear which alkyl or alkoxy or cycloalkyl or halogen or haloalkoxy or heterocycloalkyl or alkylcycloalkyl or cycloalkyl or alkylheterocycloalkyl is being referred to. Accordingly, there is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation alkoxyalkyl is selelected from c-14-alkoxy-C1-4alkyl, and the claim also recites the C1-4alkoxy-C1-4alkyl is further selected from … which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 6 which depend from claim 1 recites the limitation "the heteroatom". While the examiner recognizes that this is more than likely attempting to define the “hetero” containing variables, there are multiple cases of hetero containing variables in claim 1. As such, it is unclear which hetero containing variable being referred to. Accordingly, there is insufficient antecedent basis for this limitation in the claim.
Regarding claim 13, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Moreover, claim 13 is drawn to an application of the compound of formula 1 for the preparation of a drug for treating diseases. However, the claim does not specifically provide any active steps so it is unclear whether the claims are drawn to a pharmaceutical composition, e.g. a drug, a method of preparing a drug or a method of treating a disease. Accordingly, claim 13 is being interpreted as a product claim, e.g. a drug.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 102a(1)(2) as being anticipated by Xinthera (WO2023/283338A1, 2023-02-12, priority to US63/220,322 filed on 2021-07-09).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Xinthera teaches compounds of formula (I) or a pharmaceutically acceptable salt, solvate, stereoisomer or rotamer thereof useful in the treatment of a variety of disorder including, but not limited to, autoimmune disorders and chronic inflammatory disorders, wherein the compound of formula (I) has the generic structure:
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185
283
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(paragraphs 0041-0042). Specifically, the WO document teaches numerous species including, but not limited to,
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80
239
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which appears to be identical to the instantly claimed compound 1 in claim 10, as well as,
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216
271
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(page 27, cmpd 1A, paragraph 0089).
Conclusion
Therefore, No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent No. 11,685,719B2 to Hoffman et al. (2023-06-27).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626