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 THE CLAIMS: Claims 28-47 are pending in this application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 28-34 re rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al., (CN113788833).
Applicants claim a pharmaceutical composition comprising the following:
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Zhou teaches a similar pharmaceutical composition comprising
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and a pharmaceutically acceptable carrier. (See claims 2 and 9).
Zhou does not teach the pharmaceutical composition wherein the particles have a particle size of D50 of at most about 70µm.
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the pharmaceutical composition of Zhou to include a particle size such as a particle size of D50 of at most about 70µm. One skilled in the art looking for an alternative pharmaceutical composition would modify the pharmaceutical composition of this reference to employ a particle size, especially since a person skilled in the art can control particle size by conventional means in the art such as milling and controlling crystallization conditions. Additionally, it is well known in the art that milling is a key unit operation in pharmaceutical manufacturing for reducing particle size and/or controlling particle size distribution after crystallization and is often used when the initial crystal size from crystallization does not meet the target specifications. Thus, the limitations of the particle sizes defined in the dependent claims are considered to define matters that are easily established for target specifications by routine experimentation. Therefore, one of ordinary skill in the art, confronted with providing an alternative pharmaceutical composition would modify the pharmaceutical composition of this reference and include a particle size for targeted specifications, especially since a person skilled in the art can control particle size by conventional means in the art such as milling and controlling crystallization conditions. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Zhou, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 28-34 re rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa et al., (CN104520300).
Applicants claim a pharmaceutical composition comprising the following:
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Yoshikawa teaches a similar pharmaceutical composition comprising
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and, a pharmaceutically acceptable carrier. (See Example 146 and claim 31).
Yoshikawa does not teach the pharmaceutical composition wherein the particles have a particle size of D50 of at most about 70µm.
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the pharmaceutical composition of Yoshikawa to include a particle size such as a particle size of D50 of at most about 70µm. One skilled in the art looking for an alternative pharmaceutical composition would modify the pharmaceutical composition of this reference to employ a particle size, especially since a person skilled in the art can control particle size by conventional means in the art such as milling and controlling crystallization conditions. Additionally, it is well known in the art that milling is a key unit operation in pharmaceutical manufacturing for reducing particle size and/or controlling particle size distribution after crystallization and is often used when the initial crystal size from crystallization does not meet the target specifications. Thus, the limitations of the particle sizes defined in the dependent claims are considered to define matters that are easily established for target specifications by routine experimentation. Therefore, one of ordinary skill in the art, confronted with providing an alternative pharmaceutical composition would modify the pharmaceutical composition of this reference and include a particle size for targeted specifications, especially since a person skilled in the art can control particle size by conventional means in the art such as milling and controlling crystallization conditions. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Yoshikawa, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 28-34 re rejected under 35 U.S.C. 103 as being unpatentable over Ishibashi et al., (WO2018/168815).
Applicants claim a pharmaceutical composition comprising the following:
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Ishibashi teaches a similar pharmaceutical composition comprising
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and a pharmaceutically acceptable carrier. (See Example 7 and paragraph [0002]).
Ishibashi does not teach the pharmaceutical composition wherein the particles have a particle size of D50 of at most about 70µm.
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the pharmaceutical composition of Ishibashi to include a particle size such as a particle size of D50 of at most about 70µm. One skilled in the art looking for an alternative pharmaceutical composition would modify the pharmaceutical composition of this reference to employ a particle size, especially since a person skilled in the art can control particle size by conventional means in the art such as milling and controlling crystallization conditions. Additionally, it is well known in the art that milling is a key unit operation in pharmaceutical manufacturing for reducing particle size and/or controlling particle size distribution after crystallization and is often used when the initial crystal size from crystallization does not meet the target specifications. Thus, the limitations of the particle sizes defined in the dependent claims are considered to define matters that are easily established for target specifications by routine experimentation. Therefore, one of ordinary skill in the art, confronted with providing an alternative pharmaceutical composition would modify the pharmaceutical composition of this reference and include a particle size for targeted specifications, especially since a person skilled in the art can control particle size by conventional means in the art such as milling and controlling crystallization conditions. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Ishibashi, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Allowable Subject Matter
Claims 35-47 are allowed. The methods of manufacturing in claims 35-47 were not found to be obvious or anticipated by the prior art of record. The prior art (WO2018/168815, CN1045520330 and CN113788833) does not teach or suggest the methods of manufacturing encompassing the compounds substituted in the manner claimed by the Applicant. Therefore, these claims are allowed.
Conclusion
Claims 28-47 are pending. Claims 28-34 are rejected. Claims 35-47 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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