DETAILED ACTION
Claims 1-20 are pending in the instant application.
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 .
Priority
The instant application is a CIP of PCT/CN2023/072356 filed on 1/16/2026 which claims priority to China PCT/CN2020/074500 filed 01/28/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
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.
The claimed invention is directed to non-statutory subject matter. The claim 20 does not fall within at least one of the four categories of patent eligible subject matter because “use” claim that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101.
The claimed invention is directed to a law of nature without significantly more. The claim recites a topical composition for preventing or improving skin aging, comprising an active compound which is ergothioneine or an analog, derivative, or dermatologically acceptable use thereof. This judicial exception is not integrated into a practical application because it is a topical composition containing ergothioneine which is applied to skin. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a topical composition is routinely applied to skin and ergothioneine is a naturally occurring compound.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL
EXCEPTION
Step 2A, Prong 1
Claim 1 recites “a topical composition for preventing or improving skin aging, comprising an active compound which is ergothioneine or an analog, derivative, or dermatologically acceptable use thereof.” Ergothioneine is a naturally occurring compound. It is a naturally occurring metabolite of histidine that is synthesized in nature by microorganisms such as bacteria and fungi and also found in plants, animals, and various food sources. The claimed ergothioneine does not possess markedly different characteristics from naturally occurring ergothioneine. The claimed ergothioneine has the same chemical structure and retains the same intrinsic chemical, physical, and biological characteristics, including its antioxidant and/or related biological activity. The claim does not require any structural modification of the ergothioneine molecule that is markedly different from that possessed by naturally occurring ergothioneine. The claim recites the ergothioneine as being an “analog”, “derivative”, do not establish a markedly different characteristic. An analog or derivative in itself does not impart a markedly different structure, function, or other property to the claimed ergothioneine. There is no indication in the claim or specification that the recited analog or derivative cause the ergothioneine itself to possess a structure, function, or other property.
Step 2A, Prong 2
The claim is further evaluated to determine whether any additional element, or combination of additional elements, integrates the product-of-nature exception into a practical application. Apart from the ergothioneine itself, a topical composition comprising it does not recite any additional element that applies or uses the naturally occurring compound in a manner that imposes a meaningful limit on the judicial exception. The claim merely describes the natural product and does not apply the product of nature in a manner that effects a meaningful transformation, improves another technology or technical field, or otherwise integrates the judicial exception into a practical application.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENT CONTRIBUTE AN "INVENTIVE CONCEPT"
The claim does not recite an additional element beyond the naturally occurring ergothioneine that provides an inventive concept. The inclusion of ergothioneine in the topical composition does not add significantly more because it does not alter the structure, function, or other characteristics of the ergothioneine relative to naturally occurring ergothioneine. Thus, the claimed elements do not amount to significantly more than the product-of-natural exception itself.
Claim Rejections - 35 USC § 112(a) (written description & enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14, 18 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The instant claims are drawn to prevent or prevention skin aging. The specification defines “prevent” or “prevention” as inhibiting deterioration of the visual system of an aging subject. Examiner therefore interprets the term to mean that no aging will ever occur.
The quantity of experimentation required to practice this method would be immense. A statistically significant number of subjects would be needed to receive the composition, then the symptoms of aging would have to be evaluated for the remainder of the subjects’ lives to see if any of them develop. If symptoms appear then there will have been no prevention.
The specification provides inadequate guidance to allow the one skilled in the art to determine how to evaluate whether prevention had occurred - what clinical signs, markers, or lab values would qualify as preventing an aging?
The specification provides no working examples of ergothioneine except in Example 5 ([0071]).
The nature of the invention is the use of ergothioneine as an anti-aging composition.
The state of the prior art is that ergothioneine is routinely used in skin compositions as detailed below in the rejection under 35 USC 103.
The relative skill of one of ordinary skill in this art would be quite high, for example, a medical doctor or a dermatologist accustomed to determining a plethora symptom of aging.
The predictability of whether ergothioneine can prevent aging is very low for the reasons detailed above.
Finally, the claims are narrow in the sense that the composition contains ergothioneine but broad in the sense that the ergothioneine is intended to prevent all aging.
Thus, based on the analysis above the conclusion that the instant claims are not enabled is inescapable.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 9, 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 1 recites a topical composition for preventing or improving skin aging, comprising an active compound which is ergothioneine or an analog, derivative, or dermatologically acceptable salt thereof. The claim prevents all skin aging. The scope of the instant claims is not commensurate with the enablement of the instant disclosure, because practice of the claimed invention would require undue experimentation by an artisan of ordinary skill in the art.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: “Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue,’ not ‘experimentation.’” (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single,
simple factual determination but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. Although the quantity of experimentation alone is not dispositive in a determination of whether the required experimentation is undue, this factor does play a central role. For example, a very limited quantity of experimentation may be undue in a fledgling art that is unpredictable where no guidance or working examples are provided in the specification and prior art, whereas the same amount of experimentation may not be undue when viewed in light of some guidance or a working example or the experimentation required is in a predictable established art. Conversely, a large quantity of experimentation would require a correspondingly greater quantum of guidance, predictability and skill in the art to overcome classification as undue experimentation. In Wands, the determination that undue experimentation was not required to make the claimed invention was based primarily on the nature of the art, and the probability that the required experimentation would result in successfully obtaining the claimed invention. (Wands, 8 USPQ2d 1406). Thus, a combination of factors which, when viewed together, would provide an artisan of ordinary skill in the art with an expectation of successfully obtaining the claimed invention with additional experimentation would preclude the classification of that experimentation as undue. A combination of Wands factors which provide a very low likelihood of successfully obtaining the claimed invention with additional experimentation, however, would render the additional experimentation undue.
In the instant case, claims 1, 9, 11 are broader than the enablement provided by the disclosure 1) the quantity of experimentation to properly diagnose prevention of any aging would be immense 2) no amount of experimentation or direction is provided to determine 3) no working examples are provided to determine how the prevention would have occurred 4) the nature of the invention is a topical composition preventing any and all aging 5) the state of the prior art discloses that the antioxidant L-ergothioneine is routinely used in a topical composition (see 102, 103 rejection below). 6) relative skill of those in the art would have to be a dermatologist with a doctorate degree to properly diagnose any and all signs of aging 7) the unpredictability of aging is high 8) the breadth of the claims is immense. Thus, in view of the lacking working examples, lack of guidance in the specification, the unpredictable nature of the art and the great breadth of the claims, the expectation that one of ordinary skill in the art would successfully obtain the claimed invention without undue experimentation is extremely low and the entire scope of claims 1, 9, 11 is not enabled.
Claim Rejections - 35 USC § 112(b)
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 11 and 19 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. Claims recite “improving treating skin aging”, and the Examiner cannot determine what this means. For purposes of examination, it will be interpreted as treating.
Claim 20 is 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. A process without setting forth any steps involved in the process is indefinite.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Warrington et al. (US 2021/0361591 A1).
Warrington discloses compositions comprising combinations of cannabinoids, antioxidants, and cofactors (Abstract). The antioxidant is L-ergothioneine ([0030]). The composition is a topical composition ([0006]). L-ergothioneine is in an amount of about 0.0048 to 48.44 (% w/w) depending on the formulation (Table D, page 24). Another example of ergothioneine in an amount of 2 % w/w (Table F). The composition can comprise between about 0.00001% w/w to 5% w/w ([0301]). In some embodiments, the active ingredient portion of a composition comprises about 0.001% to about 99% of antioxidant (e.g., L-ergothioneine) ([0304]). In some embodiments, the compositions of the disclosure are applied for hydration of the skin. In some embodiments, the compositions of the disclosure are used as a sunblock. In some embodiments, the compositions of the disclosure are utilized to prevent photo-aging ([0381]). The compositions are used to regulate acne, burns, wrinkles, and sunburn ([0374]). The composition can increase luminosity ([0343]). In some embodiments, the compositions described herein restore hormesis including those humans carrying aberrant mtDNA ([0352]). The composition can further include hyaluronic acid ([0227]). The composition can be in the form of lotions ([0263]). The composition can be applied gently to the skin surface ([0133]) on humans ([0139]).
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, 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Warrington et al. (US 2021/0361591 A1) and Bazela et al. (L-Ergothioneine Protects Skin Cells against UV-Induced Damage – A preliminary study, cosmetics, 2014).
Warrington discloses compositions comprising combinations of cannabinoids, antioxidants, and cofactors (Abstract). The antioxidant is L-ergothioneine ([0030]). The composition is a topical composition ([0006]). L-ergothioneine is in an amount of about 0.0048 to 48.44 (% w/w) depending on the formulation (Table D, page 24). Another example of ergothioneine in an amount of 2 % w/w (Table F). The composition can comprise between about 0.00001% w/w to 5% w/w ([0301]). In some embodiments, the active ingredient portion of a composition comprises about 0.001% to about 99% of antioxidant (e.g., L-ergothioneine) ([0304]). In some embodiments, the compositions of the disclosure are applied for hydration of the skin. In some embodiments, the compositions of the disclosure are used as a sunblock. In some embodiments, the compositions of the disclosure are utilized to prevent photo-aging ([0381]). The compositions are used to regulate acne, burns, wrinkles, and sunburn ([0374]). The composition can increase luminosity ([0343]). In some embodiments, the compositions described herein restore hormesis including those humans carrying aberrant mtDNA ([0352]). The composition can further include hyaluronic acid ([0227]). The composition can be in the form of lotions ([0263]). The composition can be applied gently to the skin surface ([0133]) on humans ([0139]).
Bazela discloses that many changes related to aging at the cellular level may be due to the physiological condition of mitochondria. One of the most common types of damage of mtDNA is the so-called “common deletion” referring to a deletion of 4977 base pairs. In the skin cells this phenomenon probably is caused by oxidative damage of mtDNA induced by UV (Abstract). We have demonstrated that L-ergothioneine enhanced the level of reduced glutathione and protected cells from the induction of a photoaging-associated mtDNA “common deletion”. In view of our results, L-ergothioneine could be an effective skin care and anti-photoaging ingredient (Abstract).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to create a topical cosmetic composition comprising ergothioneine to treat skin aging. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claims 2-4, as discussed above, one of ordinary skill in the art would routinely adjust the % of ergothioneine in a topical composition.
Regarding claims 5-6, L-ergothioneine is taught above.
Regarding claims 7-8, skin aging and photoaging are taught above.
Regarding claim 9, mtDNA deletion is taught above.
Regarding claim 10, additional agent is taught above.
Regarding claim 11, skin aging is taught above.
Regarding claim 12, skin luminosity is taught above.
Regarding claim 13, formulations are taught above.
Regarding claim 14, application of ergothioneine is taught above.
Regarding claim 15, human subject is taught above.
Regarding claim 16, % w/w is taught above.
Regarding claim 17, photoaging is taught above.
Regarding claim 18, mtDNA deletion is taught above.
Regarding claim 19, skin aging is taught above.
Regarding claim 20, treating photoaging is taught above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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