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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/20/25 was filed after the mailing date of the previous Office Action on 3/24/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Cordaro et al (Effects of a co-micronized composite containing palmitoylethanolamide and polydatin in an experimental model of benign prostatic hyperplasia, Toxicology and Applied Pharmacology 329, 231-240, 2017 hereafter Cordaro) in view of Peritore et al (Therapeutic Efficacy of Palmitoylethanolamide and Its New Formulations in Synergy with Different Antioxidant Molecules Present in Diets, Nutrients, 11, 2175, 2019 hereafter Peritore) and Della Valle et al (EP 2 475 352 B1 hereafter Della Valle).
Cordaro discloses a co-micronized preparation comprising palmitoylethanolamide (PEA) and a resveratrol glucoside, polydatin [abstract]. The preparation is investigated at a concentration of about 10 mg/kg for activity and usefulness in treating benign prostatic hyperplasia [pg. 232]. The composition is applied orally [pg. 233]. Micronized PEA was shown to decrease prostate weight due to the inflammatory properties of PEA and polydatin [pg. 239]. The ratio of the PEA to the additional resveratrol is 10:1 [pg 232].
The reference discloses the use of micronized PEA in treating Benign Prostatic Hyperplasia, however does not disclose the use of the compound Baicalein with PEA. The combination of PEA and Baicalein is well known in the art as seen in the Peritore study.
Peritore discloses the therapeutic efficacy of PEA and synergy with difference antioxidants compounds (abstract). PEA can be combined with Baicalein , which is a flavone and antioxidant that has shown cancer treating, anti-thrombic and anti-viral properties (6.5). The combination has is shown to reduce myocardial tissue injury, reduced nitrotyrosine and PAR formation modulating apoptosis pathways (6.5). As benign prostatic hyperplasia is a disorder of in the balance of cellular proliferation and apoptosis, this combination would be an obvious synergistic addition to Cordaro as they could help solve the same problem.
While the combination would be useful in treating BPH, it is silene to the specific particles size of the combination. Specifically micronized PEA is known in the art as seen in the Della Valla patent.
Delle Valle discloses a micronized palmitoyl-ethanolamine where at least 90% of the particles are less than 10 microns [Table 1]. The composition have anti-inflammatory uses against chronic and acute inflammation [0038-0048]. An oral dosage such as a table comprises 300 mg of the micronized PEA along with an additional glucoside [Example 1]. The ratio of the PEA to the additional inflammatory agent is 6:1 [Example 8]. It would have been obvious to apply the micronized PEA into the formulation of Cordaro as it also has inflammatory properties and can be applied for the same purposes.
Regarding the means by which the particle size is determined and by what machine, it is the position of the Examiner that the claims are drawn to a product and not a diagnostic method, and as such, the micronized compound does not change depending on the tools used to measure said compound. The prior art describes micronized active agents all smaller than 10 microns, meeting the size limitations. The Office does not have the facilities for examining and comparing applicant’s product with the product of the prior art in order to establish that the product of the prior art does not possess the same material structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed products are functionally different than those taught by the prior art and to establish patentable differences. See Ex parte Phillips, 28 U.S.P.Q.2d 1302, 1303 (PTO Bd. Pat. App. & Int. 1993), Ex parte Gray, 10 USPQ2d 1922, 1923 (PTO Bd. Pat. App. & Int.) and /n re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
With these aspects in mind it would have been obvious to combine the prior art with an expected result of an anti-inflammatory formulation useful in treating benign prostatic hyperplasia. It would have been obvious to apply the synergistic PEA/Baicalein combination into the formulation of Cordaro as they solve the same problem of treating conditions with anti-inflammatory compounds. Della Valle discloses the specific sizes of micronized PEA available in the art and how they are used to treat inflammatory conditions, establishing the level of skill in the art. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable anti- inflammatory composition useful in treating anti-inflammatory disorders and reducing the size of the prostate.
Response to Arguments
Applicant’s arguments, see Remarks, filed 6/20/25, with respect to the rejection(s) of claim(s) 1-19 under 35 USC 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618