DETAILED ACTION
This office action is in response to applicant’s filing dated August 24, 2023.
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 .
Status of claims
Claims 1 - 12 are pending in the instant application.
Priority
The present application is a CON of PCT/CN2023/078695, filed February 28, 2023 and claims the benefits of priority of Chinese patent application CN2022101926632, filed March 1, 2022.
Drawings
Acknowledgement is made of the drawings received on August 24, 2023. These drawings are accepted.
Claim Objections
Claim 10 is objected to because of the following informalities: as being incorrectly dependent on itself. Clam 10 in line 1, recites: “The application method as claimed in claim 10[…]”. With respect to proper dependency, claims should be either independent or dependent on preceding claims. Appropriate correction is required. In the instant office action claim 10 will be examined as reading on instant claim 1.
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.
Claims 1 – 12 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.
The claims recite: “An application method of one of riluzole and a prodrug thereof, comprising: preparing a drug to treat a subject with oligospermia by using one of the riluzole and the prodrug thereof”. It is unclear whether the claims are intended to encompass the method of preparing a drug comprising riluzole or the claims are intended to encompass the method of treating oligospermia with the drug comprising riluzole. The claims as written can be interpreted as either method of preparing a drug and a method of treatment.
In the instant office action, in the interest of compact prosecution, for the purposes of applying art, the claims have been construed as a method of preparing a drug (composition ) comprising riluzole or a prodrug thereof, wherein the method of application of said drug is an intended use of the claimed composition.
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.
Claims 1 – 10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wrobel et al (WO 2016/140878 A2, hereinafter Wrobel).
As set forth above in the 112(b) rejection section, the instant claims are directed to a method of preparing a drug comprising riluzole and a prodrug thereof, wherein the prodrug has a structure:
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, such as
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. Said drug is prepared for oral, nasal, intraperitoneal injection etc. administration to the subject, where the subject is a male vertebrate, such as mammal, such as rodent or human. The drug, comprising riluzole or a prodrug thereof is formulated into a tablet, pills, solutions, suspensions or injections.
Wrobel teaches a method of preparation of riluzole derivatives such as riluzole prodrugs, according to formula (I):
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(page 3, lines 16 – 17), such as having a formula (XVIII)
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, where R23 is hydrogen, such as compound of formula
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(page 154, ex. 204). Wrobel teaches that said compounds are useful for the treatment or inhibition of a pathological condition or disorder in a mammal, for example, a human subject (page 194, lines 1 – 2). Wrobel further teaches formulations, comprising effective amount of riluzole or riluzole prodrugs, where the formulations can be administered orally, parenterally or intraperitoneally (page 192, lines 25 – 26), where the forms for oral administration are tablets (page190, lines 3 – 4).
Regarding limitations of claim 8, which clams the method of preparation of known drug “for use” in treating, this limitation is not given a patentable weight as it is considered an intended use of known product (i.e. an intent to use riluzole prodrug for treating oligospermia) which does not impart any physical or material characteristics to the known composition (see also MPEP 2144.07).
Thus, teachings of Wrobel anticipate the method of preparing a composition of instant claims 1 – 10.
Claims 1, 11 and 12 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dib (US 2002/0019426 A1, hereinafter Dib).
As set forth above in the 112(b) rejection section, the instant claims are directed to a method of preparing a drug comprising riluzole, where riluzole is administered in combination with one of another drug, such as riluzole is administered in combination with vitamins. Said drug is suitable in treatment of oligospermia.
Dib teaches a method of preparing a pharmaceutical composition comprising combination of riluzole and a-tocopherol (vitamin E) (page 2, [0032] and claim 20).
Regarding limitation of claim 11, which recites “for treating oligospermia”, this limitation is not given a patentable weight as it is considered an intended use of known product (i.e. an intent to use drug comprising combination of riluzole and a vitamin for treating oligospermia) which does not impart any physical or material characteristics to the known composition (see also MPEP 2144.07).
Thus, teachings of Dib anticipate the method of preparing a composition of instant claims 1, 11 and 12.
Conclusion
Claims 1 – 12 are rejected, clam 10 is objected to. No claim is allowed.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691