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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-6 and 13) and the species of palmitoylethanolamide in the reply filed on 02/17/26 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 7-12 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-6 and 13 are included in the prosecution.
Priority
This Application claims foreign priority to BE 2022/6030 filed on 12/16/2022. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119 (a)-(d), which papers have been placed of record in the file.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) an English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/15/23 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement.
Please see the attached copy of PTO-1449.
Specification
The disclosure is objected to because of the following informalities:
Although the description of Figures 1-2 is provided in the Specification (Page 33, [0169] and [0170]), this description is not preceded by the section heading "BRIEF DESCRIPTION OF THE DRAWINGS." Based on MPEP § 608.01 (a) and (f), as well as 37 C.F.R. § 1.77(b), the Specification should be amended to recite the section heading "Brief Description of Drawings" on Page 33 before paragraph [0169].
Claim Objections
Claim 4 is objected to because of the following informalities: In claim 4, line 1, the term “further” should be added before the term “comprises.” Appropriate correction is required.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anastasiou et al. (US 2013/0216649 A1 – “Anastasiou”).
Instant claim 1 is drawn to a composition in the form of a thermoformed extrudate in any suitable form allowing administration to an animal or a human being, comprising at least one natural or synthetic N-alkylamide as active substance and at least one support of natural origin chosen from the group consisting of amino acids, peptides, polypeptides, proteins, saccharides, lipids, their derivatives and their mixtures.
Anastasiou teaches a chewing gum composition comprising spilanthol, which is a natural N-alkylamide (Abstract, [0009], claims 1-18). Maltodextrin having a dextrose equivalent (DE) between 10 and 18, and mixtures thereof with hydrogenated starch hydrolysates, can be used as the matrix carriers of the extruded spilanthol-containing component in powder form ([0040], Example 1 – [0159], TABLE 1). The mixture of components is formed into the desired final shape by employing conventional techniques, e.g., extruded ([0161]).
Regarding instant claims 1 and 2, the limitations of a composition in the form of a thermoformed extrudate in any suitable form allowing administration to an animal or a human being is anticipated by the extruded chewing gum composition ([0161]), as taught by Anastasiou.
Regarding instant claims 1 and 2-3, the limitations of at least one natural or synthetic N-alkylamide as active substance is anticipated by the spilanthol, which is a natural N-alkylamide (Abstract, [0009], [0040], Example 1 – [0159], TABLE 1, claims 1-18), as taught by Anastasiou.
Regarding instant claims 1 and 2, the limitation of at least one support of natural origin chosen from the group consisting of amino acids, peptides, polypeptides, proteins, saccharides, lipids, their derivatives and their mixtures is anticipated by the maltodextrin ([0040], [0059]), monosaccharides, disaccharides, polysaccharides, sugar alcohols, and polydextrose ([0059]), as taught by Anastasiou.
Regarding instant claim 4, the limitation of at least one plasticizing agent is anticipated by the plasticizers including lanolin, palmitic acid, etc., ([0055], [0062], [0064]), as taught by Anastasiou.
Regarding instant claim 5, the limitation of at least one additive is anticipated by the surfactant ([0064], [0143]), antioxidants ([0054], [0070], [0123], [0139]), and chelating agent ([0064], [0143]), as taught by Anastasiou.
Regarding instant claim 6, the limitation of at least one first additional compound of polyphenol type is anticipated by the polyphenols and flavonoids ([0140]), as taught by Anastasiou.
Regarding instant claim 13, the limitation of any suitable form allowing administration to an animal or a human being is anticipated by the extruded chewing gum composition ([0161]), as taught by Anastasiou. The limitation of “for use in preventive and/or curative treatment …” denotes a future-intended use and thus, does not accord patentable weight to the claims. The recited intended use does not alter the structure of the claimed composition.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Anastasiou et al. (US 2013/0216649 A1 – “Anastasiou”), as applied to claims 1-6 and 13 above, in view of Taglienti et al. (US 2020/0046759 A1 – “Taglienti”).
The elected species of natural or synthetic N-alkylamide is palmitoylethanolamide.
The teaching of Anastasiou is discussed above.
Although Anastasiou teaches spilanthol, which is a natural N-alkylamide (Abstract, [0009], claims 1-18), Anastasiou does not expressly teach the elected species of palmitoylethanolamide.
Taglienti teaches a sustained-release matrix prepared by melt-extrusion techniques ([0151], [0169]), wherein the active ingredient includes palmitoylethanolamide ([0158]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a thermoformed extrudate which is an extruded chewing gum composition that contains a natural N-alkylamide, i.e., spilanthol, as taught by Anastasiou, substitute the spilanthol with palmitoylethanolamide, as taught by Taglienti, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both references teach extruded products containing natural N-alkylamides. The simple substitution of one known element for another to obtain predictable results is obvious. Please see MPEP 2141(III)(B). One of ordinary skill in the art would have found it obvious to use various N-alkylamides based on the desired therapy of the composition, including those taught by Anastasiou and Taglienti. One of ordinary skill in the art would also have been motivated to use the palmitoylethanolamide of Taglienti because this reference teaches that this N-alkylamide is a cannabinoid receptor agonist ([0158]).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 3, the limitation of the elected species of palmitoylethanolamide would have been obvious over the palmitoylethanolamide ([0158]), as taught by Taglienti.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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