DETAILED CORRESPONDENCE
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The claim set and remarks filed on 10/14/2025 are acknowledged.
Claims 1-31 are cancelled.
Claims 32 and 34 are amended.
Claims 32-50 are pending.
Claim Interpretation
Regarding claims 32-41, the claimed formulation is drawn to product claims and therefore the intended use of the formulation, for use in treating or ameliorating at least one of a mouth, tongue and throat condition” does not carry patentable weight over the teachings of the prior art.
Claim Rejections - 35 USC § 101
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 32-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 32 is drawn to composition comprising: one or more curcuminoids, and a hydrophilic carrier or aqueous medium.
The broadest reasonable interpretation of the claimed compositions would be the material that is named, that is: one or more curcuminoids, and a hydrophilic carrier a dermatologically acceptable carrier or aqueous medium. Curcuminoids are a naturally occurring product, hydrophilic carrier or aqueous medium can comprise naturally occurring carriers that are naturally occurring unless otherwise specified.
Thus, the composition claimed in claim 32 is not markedly different from how the individual components are in nature. It is not integrated into a practical application because nothing in claim 32 relies on or uses the exception. There is nothing significantly more than the judicial exception because there are no additional elements in the claim. The instant specification discloses in Table 1 Composition A comprising 0.99 w/w% curcuma longa extract and 99.01 w/w% water without additional hydrophilic carrier. With regard to claims 33-41 the enumeration of the amounts or additional products of nature do not make the combination of the products of nature markedly different from how they occur in nature.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because the formulation at the broadest interpretation of the claim language is a mixture of products of nature comprising: one or more curcuminoids, and a hydrophilic carrier or aqueous medium, which does not appear to change the biological/pharmacological functions, chemical/physical properties, or the structure/form of said ingredients. Because the claimed formulation does not have markedly different characteristics, it is a product of nature.
Claim Rejections - 35 USC § 103
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.
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 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.
Claims 32-50 are rejected under 35 U.S.C. 103 as being unpatentable over Aggarwal et al. (US20050181036A1) hereinafter Aggarwal.
Regarding claims 32-50, Aggarwal is drawn to pharmaceutical compositions suitable for aerosol delivery to a subject that include curcumin dispersed in a lipid vehicle, wherein the lipid has a transition temperature of less than about 15° C., are disclosed. In addition, methods of treating a pathological condition in a subject that include providing one of the claimed pharmaceutical compositions and administering the composition to the subject (abstract).
Aggarwal discloses pharmaceutical lipid vehicle compositions suitable for aerosol delivery to a subject, the composition including curcumin, one or more lipids, and an aqueous solvent. Curcumin, lipids, and aqueous solvents for use in the present invention are discussed further in other sections of this specification. Any concentration of curcumin for inclusion in the present pharmaceutical compositions is contemplated by the present invention. In certain embodiments, for example, the average aerosol concentration of curcumin is 0.115 mg/L of aerosol [0013]. Aggarwal discloses the pharmaceutical compositions of the present invention include curcumin and one or more lipids dispersed as particles in an aqueous solvent. The particles include, but are not limited to, liposomes (micelles) [0014]. Aggarwal discloses the concentration of curcumin in the pharmaceutical lipid vehicle (in mg/ml) is about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.2, 5.4, 5.6, 5.8, 6.0, 6.2, 6.4, 6.6, 6.8, 7.0, 7.2, 7.4, 7.6, 7.8, 8.0, 8.2, 8.4, 8.6, 8.8, 9.0, 9.2, 9.4, 9.6, 9.8, 10.0, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 150, 200, 250, 300, 350, 400, 450, 500, and any concentration derivable therein or any range of concentrations derivable therein [0049].
Aggarwal does not explicitly disclose each of the components of the composition in a single embodiment.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Aggarwal, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Aggarwal discloses all the required components and discloses the composition as an aerosol comprising curcumin (claims 1-2). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615