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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 July 2026 has been entered.
Claim 21 has undergone amendments. Thus, Claims 19 and 21, submitted on 22 July 2026, represent all claims currently under consideration.
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.
Response to Arguments
The 35 U.S.C. § 112(a) rejection of Claim 21 is withdrawn. Applicant has amended Claim 21 to expressly require that the treated non-small cell lung cancers overexpress cannabinoid receptor type I (CB1), which is enabled by the specification.
The non-statutory double patenting rejection of Claim 21 over Claims 1-10 of co-pending Application No. 19/367,872 is withdrawn. Applicant has filed a terminal disclaimer, obviating the rejection.
Terminal Disclaimer
The terminal disclaimer filed on 22 July 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of co-pending Application No. 19/367,872 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 101- NEW GROUNDS OF REJECTION
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 19 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are a hybrid of a methods and process for preparing the product to practice the method, and thus are not drawn to a process, machine, manufacture or composition of matter (See MPEP § 2173.05 (q)). The Examiner suggests amending Claim 19 to remove the method for preparing the composition and placing this as its own claim to overcome this rejection. Claim 21 is similarly rejected since it depends on a rejected claim 19 without resolving the reasons underlying the rejection of claim 19.
Claim Rejections - 35 USC § 112(b)- NEW GROUNDS OF REJECTION
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 19 and 21 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. Claim 19 is indefinite because it is unclear if the claim is directed towards a method for preparing the composition, or for the composition itself. The Examiner suggests removing the method for producing the composition from Claim 19 and placing this method in independent form to overcome this rejection. Claim 21 is similarly rejected as indefinite for depending upon an indefinite claim without resolving the underlying issues of indefiniteness.
Conclusion
Claims 19 and 21 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./ Examiner, Art Unit 1625
/JOHN S KENYON/ Primary Patent Examiner, Art Unit 1625
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