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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 04/15/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
The application is examined in view of 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.
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.
Response to Argument:
Applicants argue that Kalbe et al. teaches encapsulation instead of solid solution. All related arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. Kalbe et al. teaches clearly teaches a solid solution comprising curcumin, Coenzyme Q and gum Arabic. “[A] prior art publication cited by an Examiner is presumptively enabling barring any showing to the contrary by a patent applicant.” In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). Applicants failed to provide sufficient to prove that prior art composition is not solid solution, and this is purely attorney’s opinion. MPEP 716.01(c), Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. Therefore, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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