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 .
Election/Restrictions
Applicant’s election without traverse of invention group, claims 19-28, in the reply filed on 09/03/2025 is acknowledged.
Claims 8-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/03/2025.
Applicants further elect co-enzyme Q10 as specific liposoluble active. Claims 19-28 read on the elected species and are under examination.
Claims 8-17 and 19-27 are pending, claims 19-27 are under examination.
Priority
Acknowledge is made that this application is national stage of international patent application PCT/EP2021/062476, filed on 05/11/2021; which claims priority from European Patent application EP20174201.2, filed on 05/12/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/08/2022 and 07/07/2025 is being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claims 19-27 are 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.
Regarding claim 19, claim 19 recites “A solid solution of gum Arabic and at least one liposoluble active ingredient” and it is unclear whether “of” allows additional ingredients or only “gum Arabic and at least one liposoluble active ingredient” are included. It is recommended to use “comprising” or “consisting of” for clarification. For compact prosecution purpose, “of” is examined as comprising that allows additional ingredients.
Claims 20-27 are rejected for depending on rejected claim 19.
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.
Claims 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Kalbe et al. (WO2012163937) in view of Vasisht et al. (US20210085622).
For compact prosecution purpose, additional active curcumin is also examined.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Kalbe et al. teaches solution of polyphenols and deliveries in a carriers materials (abstract). Solid solutions can in principle by melting or by solution process with subsequent coprecipitation of drug and carrier material as well as by combining the two methods. Freeze-drying, spray-drying and vacuum drying are suitable as methods for precipitation from a solution, an essential prerequisite being the choice of suitable solvents for pharmaceutical substances and adjuvants. A disadvantage of this, as mentioned, the need for removal and environmentally friendly disposal of large quantities of mostly organic solvents (page 22). From this, the carrier materials are particularly preferably selected from the group comprising gelatin, gum arabic, guar gum, alginates, tragacanth, xanthan, celluloses and cellulose derivatives, and starch and starch derivatives or in each case mixtures thereof. Very particularly preferred carrier materials are gelatin and gum arabic (page 26). Further preferred embodiments of the invention comprise solid solutions of polyphenols and derivatives thereof, in particular of resveratrol, curcumin or resveratrol- or curcumin-containing extracts, in a carrier material which additionally comprises at least one further cosmetically and / or pharmaceutically active ingredient such as Coenzyme Q (page 28). IN example 3, the solid solution comprising 640g of gum arabic (29.4%), Maltitol 956g (43.9%), sorbitol (6.4%) and Vineatril (comprising resveratrol) (1.5%) (page 34). According to the invention, between 0.05 and 50% by weight of polyphenol compounds, based on the composition of the recipe mass in the solid solutions are Incorporated (page 29). The particle size is less than 1 um and more than 50nm (page 27).
Vasisht et al. teaches A pharmaceutical active-containing transmucosal delivery device comprises a polymer film comprising a polymer matrix, wherein the film has a pH in the range of about 4 to about 9, and a pharmaceutical active composition disposed on a surface of the polymer film. The composition comprises at least one pharmaceutical active ingredient in the form of particles, and wherein the particles have an average particle size of about 100 nm to about 5 microns (abstract). Pharmaceutical active can further include one or more cosmetic agents, veterinary medicine agents, functional ingredients, and the like. Examples include alpha linoleic acid (ALA), cannabidiols (CBD), coenzyme Q10, curcumin, chondroitin, glucosamine, glutamine, hemp oils, lutein, L-Carnitine, melatonin, methionine, neem, omega-3 and -6 fish oil, St. John's Wort, saw palmetto, ubiquinone, vitamins, xylitol, or zeazanthin. Pharmaceutical active can be a solid solution, amorphous, and/or in a monomorphic crystalline microparticle state. For example, the pharmaceutical active can be present as solid solution or a substantially-uniform, dispersed, amorphous microparticle residing on the surface of the first discrete domain. The term “solid solution” as used herein refers to a solid that is molecularly dispersed in a domain to form a glassy state ([0063-0064]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Kalbe et al. is that Kalbe et al. do not expressly teach Coenzyme Q10. This deficiency in Kalbe et al. is cured by the teachings of Vasisht et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
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 invention of Kalbe et al., as suggested by Vasisht et al., and produce the instant invention.
Kalbe et al teaches a solid solution comprising curcumin, Coenzyme Q and gum arabic (29.4%) with a particle size less than 1 um. Since Active ingredient is at amount of 0.05 to 50%, when each of curcumin and Coenzyme Q is 0.5%, the ratio of gum arabic to curcumin or Coenzyme Q is 58.8:1 (about 30:1).
One of ordinary skill in the art would have been motivated to use Coenzyme Q10 as Coenzyme Q because Coenzyme Q10 is a known Coenzyme Q and suitable for solid solution as suggested by Vasisht et al. Therefore, it is obvious for one of ordinary skill in the art to use Coenzyme Q10 as Coenzyme Q and produce instant claimed invention with reasonable expectation of success.
Regarding the process of making solid solution in claims 19-21 and 26-27, Kalbe et al. teaches solution with organic solvent followed by spray drying but silent about exact same claimed procedure. This is considered as product by process.
With respect to the USC 102/103 rejection above, please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ hydrated (vitrified matrix) collagen gel differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding claim 22, this is considered inherency of prior art composition. Since Prior art teaches the same or substantially same solid solution, this same or substantially same solid solution is expected to have the same property “form micelles”.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
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 was 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.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613