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 .
Priority
This application was filed 09/14/2023 and is a 371 of PCT/CN2021/093185 (05/12/2021) which claims foreign priority to CN 202011277795.2 (11/16/2020). Claims 1-18 are before the Examiner.
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, 4, 5, and 9-18 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.
Specifically, the claims 4, 11 and 12 all have a process wherein the last step “S5) working to lyophilize the solution D”. What is “working”? Clarification is required.
Specifically, the claims 2 and 5 have weight ratios of “10:70 : 0.1-0.3” or “10:60-80 :0.1-0.3:1500”. Which is what compound and what is the weight ratio? Clarification is required.
Specifically, the claims 9-10 and 13-18 have the phrase “have adverse reactions such as”. This is ambiguous. It is suggested that this be delete or changed to “selected from” instead of “such as”.
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 9-10 and 13-18 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 “Usage of” does not fall within the four categories of patent eligibility. Correction is required.
Claim Objections
Claims 3 and 6-8 are objected to because of the following informalities: These claims depend from a rejected base claim but would be allowable if rewritten in independent form with all the intervening limitations. Appropriate correction is required.
Allowable Subject Matter
Claim 1 is allowed. Claims 3 and 6-8 are objected to as being dependent from a rejected base claim. The prior art (CN110799215) does not teach the combination of diltiazem HCl and pregabalin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
Prosecution Insights