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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3 March 2026 has been entered.
Claims 5, 11, 12, 17, 18 , and 20 have been cancelled. Claim 19 has undergone amendments. Thus, Claim 19, submitted 3 March 2026, represent the claim 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 Amendment
The 35 U.S.C. § 103 rejection of Claims 5, 11-12, and 14-20 over Purdum in view of Brandi, Rivas, Badri, and Mora-Huertas is withdrawn. Applicant has cancelled Claims 5, 11, 12, 17, 18, and 20, rendering those rejections moot. Applicant has further amended Claim 19 to require an encapsulation efficiency of 39.9 ± 14.7% and/or a release of 44.7 ± 9.9% of the ACPA within 72 hours at 37°C. The cited prior art does not teach, suggest, or provide a motivation to arrive at a ACPA polycaprolactone nanoparticle which has an encapsulation efficiency of 39.9 ± 14.7% and/or a release of 44.7 ± 9.9% of the ACPA within 72 hours at 37°C.
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.
Claim 19 is 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 contains the trademark/trade name PLURONIC F68. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a nonionic block copolymer surfactant and, accordingly, the identification/description is indefinite.
Allowable Subject Matter
Claim 19 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: There is no prior art which teaches, suggests, or provides motivation for a polycaprolactone ACPA nanoparticle which has the claimed encapsulation efficiency and/or release profile (See STN Search, Search Notes). The closest prior art comes from Brandi (Electrophoresis, 2013 May; 34 (9-10):1359-68) and Purdum (US 2012/0052119; Publication Date: 1 March 2012). Brandi (See IDS, 8 December 2021) teaches that ACPA is a CB1 receptor agonist, and is capable of inhibiting the growth of the pancreatic adenocarcinoma cell line Pacn1. Brandi fails to teach PCL nanoparticles of ACPA. Purdum teaches PCL nanoparticles of cannabinoids such as CBD and THC, but does not teach the formulation of ACPA, nor does Purdum provide any teaching, suggestion or motivation to arrive at the claimed encapsulation efficiency or release profile of ACPA.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claim 19 is 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 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625