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 .
Application Status
The Appeal Brief filed on 8/10/2026 is acknowledged and has been considered. Upon review of Applicants arguments, the Examiner determined that an explanation of how the amended claims would be rejected was not accurately provided in the Advisory Action. As such, the finality of the previous Examiner action is withdrawn to correct these deficiencies and to place the rejections set forth below in better condition for appeal.
Claims 6-8, 10-14, 16-17, 19-21, 23 and 26-30 are currently pending and under consideration.
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 6-8, 10-14, 16-17, 19-21, 23 and 26-30 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.
The phrase “active ingredient which serves a different purpose from that served by dihydromyricetin” in claims 6 and 17 is a relative phrase which renders the claim indefinite. The phrase “active ingredient which serves a different purpose from that served by dihydromyricetin” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the instant case, there no definition within the specification which defines what is encompassed by the phrase or specifically, what the “purpose” of dihydromyricetin . For example, the claims recites “[a]pplying to skin in need thereof dihydromyricetin in an amount which causes DNA-demethylation and/or reactivation of genes that have been hypermethylated with age….”. As such, one potential purpose of diydromyricetin could be reasonably interpreted as causing DNA-demethylation and/or reactivation of genes that have been hypermethylated with age. Therefore, an active agent which does not cause DNA-demethylation and/or reactivation of genes that have been hypermethylated with age such a UV-filter capable of absorbing UV light having an SPF of less than 2 would meet the claim limitation. An alternative purpose of dihydromyricetin could be for the care and protection of the skin, in particular sensitive skin and also, very especially, skin which is aging or has aged as a result of intrinsic and/or extrinsic factors (see specification, page 1, 1st full paragraph). Thus, as argued by Applicants in the Appeal Brief (starting on page 16-17, “Second”), premature skin aging caused by exposure to UV radiation is extrinsic skin aging and therefore, an ingredient which absorbs UV radiation would treat and prevent the symptoms of extrinsic skin aging which is the same purpose as dihydromyricetin. Accordingly, the meets and bounds of the claims cannot be determined.
For prior art purposes, the examiner is interpreting the purpose of dihydromyricetin to be causing DNA-demethylation and/or reactivation of genes that have been hypermethylated with age.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Examiner 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.
Claim(s) 6-8, 10-12, 17, 20-21, 23, 26-27 and 29-30 are rejected under 35 U.S.C. 102a(1) as being anticipated by Heuser et al. (EP2356980A2, 2011-08-17, Translation provided by applicants in IDS) as evidenced by Galdi et al. (US2012/0015016A1, 2012-01-19).
Heuser et al. teach a cosmetic or dermatological preparation comprising dihydromyricetin to increase dermal collagen synthesis and to treat and prevent the symptoms of intrinsic and/or extrinsic skin aging (paragraph 0009). With regards to the dihydromyricetin, Heuser et al. teach that dihydromyricetin is present in the preparation in an amount of 0.001 to 10% by weight, in particular, 0.01 to 1% by weight paragraph 0011). Moreover, Heuser et al. teaches that the preparations are in the form of an emulsion for topical use (paragraph 0013 and 0014). In particular, Heuser et al. teach a cream containing dihydromyricetin and diethylhexyl syringylidenemalonate (paragraph 0027, example 1). In addition to the emulsions and creams, Heuser et al. teach that the composition can be in the form of a gel or cosmetic stick (paragraph 0022 and 0024). As evidenced by Galdi et al. diethylhexyl syringylidenemalonate is a UV filter capable of absorbing UV light having an SPF of less than 2 (paragraph 0151). Moreover, while the prior art does not specifically teach that the amount of dihydromyricetin causes DNA-demethylation or reactivation of genes that have been hypermethylated with age, the prior art teaches administering a composition comprising dihydromyricetin in the claimed amount to what appears to be the same patient population. Applicants are reminded that the Office does not have the facilities and resources to determine that such an effect will occur. The burden is on applicant to show that the cosmetic or dermatological composition comprising 0.01 to 1% by weight of dihydromyricetin as taught by the prior will not have that effect. See MPEP 2112.01.
In response to the rejection, Applicant first seem to take issue with the Examiner’s statement that “[a]s evidenced by Galdi et al. diethylhexyl syringylidenemalonate is a UV filter.” In particular, Applicant argue that Galdi defines the very class into which it places dethylhedyl syringylidenemalonate as compounds “other than a UV screening agent”, wherein a UV screening agent is what the rejection means by a UV filter. For example, Applicant contend that Galdi, paragraph [0151], reads as follows:
“"The term 'UV light absorbing compound having an SPF of less than 2' means a
compound, other than a UV screening agent, which absorbs UV light in the range of from about
280 nm to about 400 nm (i.e., UVB/UVA). Examples of compounds capable of absorbing UV
light having an SPF of less than 2 include butyloctyl salicylate, diethylhexyl syringylidenemalonate (INCI name)…”.
Moreover, Applicant contend that GALDI claim 1 recites, as separate elements of the same composition, “(a) at least one organic UV sunscreen active” and “(d) at least one additional ingredient chosen from: 1)a UV light absorbing compound having an SPF of less than 2….”. Regarding the organic UV sunscreen actives, Applicant assert that the list includes “Ethylhexyl Salicylate," "Homosalate," "Butyl Methoxydibenzoylmethane," "Octocrylene" and "Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine" - which are the UV filters recited in appealed claims 13, 14 and 19 - and does not include diethylhexyl syringylidenemalonate.
Thus, Applicant assert that the Examiner has offered no other evidence, and no reasoning, for treating diethylhexyl syringylidenemalonate as an active ingredient of Heuser’s cream serving a purpose of its own.
In response to these arguments, the Examiner would like to reiterate the teachings of the reference. Heuser et al. teach a cosmetic or dermatological preparation comprising dihydromyricetin to increase dermal collagen synthesis and to treat and prevent the symptoms of intrinsic and/or extrinsic skin aging (paragraph 0009). In particular, Heuser et al. teach a cream containing dihydromyricetin and diethylhexyl syringylidenemalonate (paragraph 0027, example 1). As evidenced by Galdi et al. diethylhexyl syringylidenemalonate is a UV filter capable of absorbing UV light having an SPF of less than 2 (paragraph 0151). In the instant case, Applicant appears to insinuate that there needs to be a recognition within the reference in this case, Heuser, of why diethylhexyl syringylidenemalonate is included in the composition. The Examiner acknowledges that there is no express or specific teaching. However, the Examiner has provided evidence that diethylhexyl syringylidenemalonate is a UV filter capable of absorbing UV light having an SPF of less than 2. It should be noted that the specification does not define “active ingredient”.
Regarding Applicant arguments pertaining to Galdi characterizing diethylhexyl syringylidenemalonate to be different than an organic sunscreen active, the Examiner acknowledges and does not dispute Applicant characterization of Galdi. However, nowhere in the Final Examiner action does the examiner consider an organic sunscreen active to be synonymous with a UV filter. In the instant case, at the time the invention was filed, it appears that the use of the term UV filter and UV absorber are used interchangeably. For example, Huglin (Cited in the Final Examiner action), when discussing bis-ethylhexyloxyphenol methoxyphenyl triazine (BEMT), teaches “This oil-soluble filter, which today is widely used in both beach products and skin care products, exhibits inherent photostability and strong broad-spectrum absorbance (see Abstract, emphasis added). Moreover, while the Examiner acknowledges that Applicant claims recite UV filters selected from homosalate, ethylhexyl salicylate and bis-ethylhexyloxyphenol methoxyphenyl triazine, the specification does not define what is encompassed by UV filters or that diethylhexyl syringylidenemalonate is not a UV filter.
Second, and in the alternative, Applicant argue the Examiner’s own construction and findings the identified ingredient serves the same purpose as Heuser’s dihydromyricetin, not a different one. In this regard, Applicant contend that the Advisory Action makes the necessary finding that “the purpose of dihydromyricetin of Heuser et al. is to increase dermal collagen synthesis and to treat and prevent the symptoms of intrinsic and/or extrinsic skin aging.” (Emphasis added). Applicant further point to the 103 rejection which cites Huglin for the teaching “that the increasing awareness of the damaging effects of UV radiation to human skin triggered the market introduction of new cosmetic UV absorbers.” Thus, Applicant contend that premature skin aging is caused by exposure to UV radiation is extrinsic skin aging and therefore, an ingredient present in Heuser’s cream in order to absorb UV radiation is present in order to treat and prevent the symptoms of extrinsic skin aging- precisely one of the two purposes the Examiner attributes to Heuser’s dihydromyricetin.
In response to Applicant arguments, Applicant are reminded that the instant specification does not define “different purpose”. In view of the claims, it reasonable to assume that the purpose of dihydroxymyricetin is to cause DNA-demethylation and/or reactivation of genes that have been hypermethylated with age. Accordingly, any additional ingredient such as a UV filter, would fall within a “different purpose”. Moreover, Applicant appear to be arguing the ultimate outcome of the composition versus each of the individual components alone. Thus, while the ultimate “goal” of the composition may be to prevent the symptoms of intrinsic and/or extrinsic skin aging, each of the individual components purpose within the composition in order to achieve that goal are different.
Applicant 3rd argument seems to be similar to the second argument above and has been responded to above.
Applicant 4th comment has not been relied upon by the Examiner and does not appear to be an argument.
Applicant 5th argument involves the burden-shifting invoked by MPEP 2112.01, wherein Applicant believe no predicate. In particular, Applicant contend that because Heuser is not shown to disclose the preparation comprising a further active ingredient serving a different purpose from that served by dihydromyricetin, the method of Heuser’s example 1 is not the method of claim 6, and the predicate for the burden shift is absent.
In response to Applicant arguments, the Examiner recognizes the claims recite “applying to the skin in need thereof dihydromyricetin in an amount which causes DNA-methylation and/or a reactivation of genes that have been hypermethylated with age”. Accordingly, the Examiner is confused about what the further active ingredient serving a different purpose has to do with the effect an amount of dihydromyricetin has. As noted in the prior Examiner actions, the Examiner has provided a reason why the claimed limitation appears to have been met. For example, Hauser teaches a cosmetic or dermatological composition comprising 0.01 to 1% by weight of dihydromyricetin. It is noted that the instant specification provides one example of a composition comprising dihydromyricetin at 0.15%.
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 (i.e., changing from AIA to pre-AIA ) 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 Examiner 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.
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 as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention 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(s) 13-14, 16, 19 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Heuser et al. (EP2356980A2, 2011-08-17, Translation provided by applicants in IDS) as evidenced by Galdi et al. (US2012/0015016A1, 2012-01-19), as applied to claims 6-8, 10-12, 17, 20-21, 23, 26-27 and 29-30 above, in view of Huglin, Dietmar (CHIMA 2016; 70 (7/8): 496-501).
Heuser et al. teach a cosmetic or dermatological preparation comprising dihydromyricetin to increase dermal collagen synthesis and to treat and prevent the symptoms of intrinsic and/or extrinsic skin aging (paragraph 0009). With regards to the dihydromyricetin, Heuser et al. teach that dihydromyricetin is present in the preparation in an amount of 0.001 to 10% by weight, in particular, 0.01 to 1% by weight paragraph 0011). Moreover, Heuser et al. teaches that the preparations are in the form of an emulsion for topical use (paragraph 0013 and 0014). In particular, Heuser et al. teach a cream containing dihydromyricetin and diethylhexyl syringylidenemalonate (paragraph 0027, example 1). In addition to the emulsions and creams, Heuser et al. teach that the composition can be in the form of a gel or cosmetic stick (paragraph 0022 and 0024)As evidenced by Galdi et al. diethylhexyl syringylidenemalonate is a UV filter capable of absorbing UV light having an SPF of less than 2 (paragraph 0151). Moreover, while the prior art does not specifically teach that causes DNA-demethylation or reactivation of genes that have been hypermethylated with age, the burden is on applicant to show that the cosmetic or dermatological composition comprising 0.01 to 1% by weight of dihydromyricetin as taught by the prior will not have that effect. Applicants are reminded that the Examiner does not have the facilities or resources to determine that this effect will not occur. See MPEP 2112.01.
Heuser et al. does not specifically teach that the cosmetic or dermatological preparation further comprises bis-ethylhexyloxyphenol methoxyphenyl triazine.
Huglin, Dietmar teach that the increasing awareness of the damaging effects of UV radiation to human skin triggered the market introduction of new cosmetic UV absorbers (abstract). In particular, Huglin, Dietmar teach that BEMT (bis-ethylhexyloxyphenol methoxyphenyl triazine), MBBT and TBPT have been developed as cosmetic UV absorbers, wherein these filters give formulators new possibilities to cover the UV range from 290 to 400 nm, and to use less filter due to superior efficacy and today, sunscreens of many different brands apply these UV absorbers (page 501, 1st column, Conclusion).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the cosmetic or dermatological preparation taught by Heuser et al. to include an additional UV absorber such as bis-ethylhexyloxyphenol methoxyphenyl triazine in view of the teachings of Huglin, Dietmar. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Huglin, Dietmar teach that the increasing awareness of the damaging effects of UV radiation to human skin triggered the market introduction of new cosmetic UV absorbers;
- Huglin, Dietmar teach that BEMT provide formulators with a wide degree of possibilities because of the UV range; and
- BEMT is used today in many different brands of sunscreens which apply it as a UV absorbers. .
In response to the rejection, Applicant contend that every claim in this ground of rejection either is or depends from claim 6 or claim 17, and each of claims 6 and 17 requires a further active ingredient which serves a purpose different from that served by dihydromyricetin. For the reasons set out in response to the 102 rejection, Applicant contend that Heuser as evidenced by Galdi is not shown to disclose or suggest that limitation. Regarding Huglin, Applicant argue that the Examiner combines Heuser and Huglin because of the damaging effect of UV radiation to human skin and because BEMT is a “cosmetic UV absorber” used in sunscreens of many different brands. Thus, Applicant argue that a skilled artisan following the reasoning would add BEMT in order to treat and prevent the symptoms of extrinsic skin aging which is the same purpose the Examiner has identified for dihydromyricetin.
In response to Applicant arguments, the Examiner has already responded to arguments relating to the “different” purpose above and is incorporated herein.
Applicant further assert that independent claim 17 is separately patentable and point out that the 103 rejection was written for a different claim, and no explanation of how the claim now on appeal would be rejected was ever provided.
In response to this comment, the Examiner first thanks Appellant for pointing this out and the Examiner has amended the claim to be part of the 102 rejection since claim 17 essentially recites the same composition which is administered.
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
Prosecution Insights