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 .
Detailed Action
Status of Application
1. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, filed 28 January 2026, and the Amendment and Applicants’ Arguments/Remarks, filed 29 December 2025 are acknowledged.
Claims 1, 4-8, 10, and 18 are currently pending. Claims 2-3, 9, 11-17, and 19 have been cancelled. Claims 1, 4-8, 10, and 18 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 January 2026 has been entered.
Maintained/Modified Rejections
Claim Rejections – 35 U.S.C. 103
3. 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.
4. Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarnelli et al. (Phytotherapy Research, 2016).
Sarnelli et al. teach that palmitoylethanolamide (PEA) is a nutraceutical compound that has been demonstrated to improve intestinal inflammation. PEA is able to decrease cell proliferation and angiogenesis and could pave the way to PEA co-administration to the current chemotherapeutic regimens for colon carcinoma. See abstract. PEA is a safe compound and is easily prescribed as it has been already introduced in clinical practice as food for special medical purposes in chronic inflammatory conditions and chronic pain states. See Discussion.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to administer palmitoylethanolamide to a subject to prevent colorectal carcinoma. One would have been motivated, with a reasonable expectation of success, because Sarnelli et al. teach the effectiveness in decreasing cell proliferation and angiogenesis and that it is currently prescribed for chronic inflammatory conditions and chronic pain states (i.e., healthy subjects in the sense of subjects with chronic inflammatory conditions but not carcinoma). Since the same formulation is administered to the same patient population, it should have the same effect (i.e., act on both the activation and proliferation phase and prevent colorectal cancer).
5. Claim(s) 4-8, 10 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarnelli et al. (Phytotherapy Research, 2016) as applied to claim 1 above and further in view of Della Valle et al. (WO2011/027373).
Sarnelli et al. do not teach ultra-micronized form.
Della Valle et al. teach a pharmaceutical composition for human or veterinary use containing a therapeutically effective amount of palmitoylethanolamide in ultra-micronized form, wherein more than 90% by weight of palmitoylethanolamide has particle sizes lower than 6 microns. See abstract. It has been surprisingly noticed that such a composition, compared to known compositions containing PEA in micronized form, provide a high ability to peripherally and centrally act towards inflammatory diseases of the neurogenic or neuroinflammatory type. See page 8. The ultra-micronized PEA had 99.9% less than 6 microns, 59.6% less than 2 microns and only 2% less than 0.6 microns. See Table 1. PEA is administered in ranges from 50 mg to 1000 mg per dose unit and the dose unit is administered from 1 to 4 times a day. See page 31. Example 8 is directed to an oral dose. PEA was administered daily for 96 hours in the chronic model. See page 24.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute the ultra-micronized palmitoylethanolamides of Della Valle et al. with the palmitoylethanolamides of Sarnelli et al. to yield predictable results because Della Valle et al. teach that the ultra-micronized particles provide a high ability to peripherally and centrally act towards inflammatory diseases. It would have been obvious to modify the amount of palmitoylethanolamides within known effective ranges administered orally 1 to 4 times a day based on the teachings of Della Valle et al. regarding known effective dosing regimens.
Response to Arguments
Applicants’ arguments filed 29 December 2025 have been fully considered but they are not persuasive.
6. Applicants argued, "Results obtained from proliferation and migration assays in Caco-2 cells cannot be interpreted as evidence of chemo preventative activity. The models in the instant specification show the ability of PEA to prevent or delay neoplastic progression, a clear distinction from antitumor interventions. Della Valle does not provide any teaching regarding the use of PEA-um for disorders of an oncological nature but counterintuitively appears to confer a protective effect. Thus Della Valle is not relevant art."
In response to applicants’ arguments, Sarnelli et al. teach that PEA is able to decrease cell proliferation and angiogenesis and could pave the way to PEA co-administration to the current chemotherapeutic regimens for colon cancer. PEA-mediated synergic blockage of converging pathways leading to cancer cell growth, angiogenesis and tissue remodeling significantly increases the efficacy of potential anticancer compounds. See page 969. It is currently already prescribed for chronic inflammatory conditions and chronic pain states. Thus the formulation is currently already being administered to "healthy" subjects, in the sense of subjects with chronic inflammatory conditions but not carcinoma. Since the same formulation is administered to the same patient population, it should have the same effect. In addition, since the formulation is known to decrease cell proliferation and angiogenesis, and be used in current chemotherapeutic regimens for colon cancer, it would be reasonable to deduce that this effect would be preventative. With regards to Della Valle and Exhibit C, Exhibit C clearly states that limiting neuroinflammatory processes allows TRPV-1 to exert a protective role that restricts the initiation and progression of colon cancer. See abstract. Thus this supports substitution of one particle size for another and that treating inflammatory diseases correlates to restricting the initiation and proliferation of colon cancer.
Thus this rejection is maintained.
Correspondence
7. No claims are allowed at this time.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615