DETAILED ACTION
This office action is in response to applicant’s filling dated December 21, 2023.
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
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on March 5, 2024. It is noted, however, that applicant has not filed a certified copy of the PCT/ CN2021/101541 application as required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
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 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating choroidal neovascularization (CNV) comprising administering L-Ergothioneine, does not reasonably provide enablement for a method for treating or preventing any form of age-associated visual degeneration comprising administering any L-Ergothioneine analog, derivative, polymer, ester, or acid. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
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 of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative skill of those in the art
The invention relates to a method of treating or preventing age associated visual degeneration in a mammal subject with L-Ergothioneine or a pharmaceutically acceptable salt, acid, ester, polymer, analog, or derivative thereof.
The relative skill of those in the art is high, generally that of a M.D., Pharm.D. or Ph.D. The artisan using Applicant’s invention would generally be an optometrist, pharmacist, or biologist with a doctoral-level degree and several years of experience.
The factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant’s invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain). As illustrative of the state of the art, the examiner cites Freire et al (Periodontol 2000, 2013; 63(1):149-164) and Tabas et al (Science, 2013; 339(6116):166-172).
Furthermore, the instant claims encompass a method of treating or preventing any form of age-associated visual degeneration in a mammal. Currently there are no drugs which are 100% effective and reliable in “preventing” age associated visual degeneration. (U2, You, L. et al. “The Impact of Aging on Ocular Diseases: Unveiling Complex Interactions”. Aging and Disease, (October 2025) pp. 2803-2809.” cited for evidentiary purposes teaches currently, teaches that there are numerous types of different age associated visual conditions such as age-related cataracts, glaucoma, age-related macular degeneration, diabetic retinopathy, and dry eye disease (See e.g. pp. 2808, Fig 3). Each of these diseases and conditions is marked by their heterogeneity in their etiology and clinical manifestations, incomplete knowledge of their mechanisms of action, and different sorts of therapeutic targets. Furthermore, as stated in You et al. aging is an inevitable physiological process which affects all organisms and organ systems (See e.g. pp. 2803, paragraph 2). Virtually every organism with eyes is affected by some form of age-associated visual degeneration. Therefore, the state of the art (even after the filing date of the instant application) demonstrates that the treatment of all forms of age-associated visual degeneration is highly unpredictable.
Thus, the state of the art (even after the filing date of the instant application) demonstrated prevention and/or treatment of any form of age-associated visual degeneration with any pharmaceutically acceptable salt, acid, ester, polymer, analog, or derivative of L-Ergothioneine is highly unpredictable.
2. The breadth of the claims
Claims 1-20 are very broad in terms of the type of conditions being treated: all forms of age-associated visual degeneration are claimed treated with L-Ergothioneine or any pharmaceutically acceptable salt, acid, ester, polymer, analog, or derivative thereof. Claims 2-3 and 19-20 further narrow the scope of the diseases claimed, where claims 2 and 19 limit the type of disease to one “related to phenomenon comprising eyestrain, blurred vision, dry eyes, eye fatigue, or blindness” and claims 3 and 20 limit the characterization of the age-related visual degeneration to “retinal effusion, retinal hemorrhage, macular oedema, accumulation of lipofuscin and drusen-deposits, Bruch’s membrane (BM) thickening, subretinal choroidal neovascularization (CNV) and/or increase of inflammatory proteins in retinal pigment epithelium (RPE).” Claims 4-8 and claim 18 place limits on the inherent qualities of L-Ergothioneine and claims 9-14 and 16-17 are all related to the method or composition of L-Ergothioneine administration, although such claims may limit the administration of L-Ergothioneine, the claims are still extremely broad in terms of potential age-associated visual degeneration conditions in a mammal.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification and drawing provide examples of how L-Ergothioneine can be administered to a mouse or zebrafish disease model to limit choroidal neovascularization (Test 1 and 4-5), activate Nrf2-mediated antioxidant genes to decrease reactive oxygen species, VEGF levels, hif-1alpha, or vegfraa levels (Test 2, 6-8), and inhibiting oxidation-induced epithelial-to-mesenchymal transition (Test 3). However, the specification does not provide any data that shows that any pharmaceutically acceptable salt, acid, ester, polymer, analog, or derivative of L-Ergothioneine is useful for treating any form of age-associated visual degeneration, other than treating choroidal neovascularization, reactive oxygen species, VEGF, hif-1alpha levels, or vegfraa levels, and oxidation-induced epithelial-to-mesenchymal transition with L-Ergothioneine. Moreover, the specification does not provide any data that shows that any any pharmaceutically acceptable salt, acid, ester, polymer, analog, or derivative of L-Ergothioneine is useful for preventing any age associated visual degeneration condition.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that all any pharmaceutically acceptable salt, acid, ester, polymer, analog, or derivative of L-Ergothioneine could be predictably used as prevention or treatment for all forms of age-associated visual degeneration except treating choroidal neovascularization, reactive oxygen species, VEGF, hif-1alpha levels, or vegfraa levels, and oxidation-induced epithelial-to-mesenchymal transition with L-Ergothioneine.
Determining if a particular compound will treat any particular condition would require formulation into a dosage form, and subjecting into clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. This is undue experimentation given the limited guidance and direction provided by Applicants.
Accordingly, the inventions of claims 1-20 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Claims 1-20 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 written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The Written Description Guidelines for examination of patent applications indicates, "the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical characteristics and/or other chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show applicant was in possession of the claimed genus." (Federal register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 column 3) and (see MPEP 2164).
Claims 1-20 are directed to a method of alleviating age associated visual degeneration in a mammal comprising administering an effective amount of a L-Ergothioneine and pharmaceutically acceptable analog, derivative, ester, or polymer of L-Ergothioneine or the use of a L-Ergothioneine and pharmaceutically acceptable analog, derivative, ester, or polymer of L-Ergothioneine for preparing a composition for effectively alleviating age associated visual degeneration in a mammal. Thus, the claims encompass a genus of compounds which are a pharmaceutically acceptable analog, derivative, salt, acid, ester, or polymer of L-Ergothioneine with no other defining structural components of the compound.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP states that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a method a method of alleviating and preventing age-associated visual degeneration or forming a composition for alleviating and preventing age-associated visual-degeneration, comprising the administration or incorporation of L-Ergothioneine or a pharmaceutically acceptable analog, derivative, ester, or polymer of L-Ergothioneine.
The claims are generic, broadly reciting a genus of “L-Ergothioneine and pharmaceutically acceptable analog, derivative, ester, or polymer of L-Ergothioneine.” As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claims 1-20 are broad and generic, with respect to all possible compounds encompassed by the claims.
Applicant has failed to show that they were in possession of all the diverse compounds encompassed by L-Ergothioneine and pharmaceutically acceptable analog, derivative, ester, or polymer of L-Ergothioneine. In the summary of the invention, the detailed description, and in all eight tests provided by the specifications, applicant only discloses L-Ergothioneine and does not describe any possible types of analogs, derivatives, esters, or polymers of L-Ergothioneine which may be used as a method of alleviating and preventing age-associated visual degeneration or forming a composition for alleviating and preventing age-associated visual-degeneration. As there are an innumerably large number of potential analogs, derivatives, esters, or polymers of L-Ergothioneine, it would require extensive manpower to make and test each compound to determine which compound would possess the recited properties (i.e., alleviate or prevent age-associated visual degeneration) and be useful in the instantly claimed compositions. Only reciting L-Ergothioneine cannot be viewed as being reasonably representative of the genus in its claimed scope because no readily apparent combination of identifying characteristics is provided.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize a method of treating a patient or creating a composition comprising all analogs, derivatives, esters, and polymers of L-Ergothioneine claimed in claims 1-20.
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 15-20 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 pre-AIA the applicant regards as the invention.
Claims 15-20 are directed to the use of L-Ergothioneine for preparing a composition for effectively alleviating and preventing age-associated visual degeneration in a mammal, it is unclear whether the claims are intending to encompass a product (i.e. a composition comprising L-Ergothioneine) or method/process of utilizing the claimed product (i.e. process of using the composition to alleviate and/or prevent age-associated vial degeneration).
It is noted that for the purpose of applying prior art, claims 15-20 have been construed as a product claim, requiring L-Ergothioneine or a pharmaceutically acceptable salt, acid, ester, polymer, analog, or derivative of L-Ergothioneine.
Claim Rejections - 35 USC § 101/112
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 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 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Instant claims 15-20 are directed to non-statutory subject matter because it is unclear whether the claims are intended to encompass a product or a process. Specifically, claims 15-20 recites limitations clearly directed to a product, i.e., the composition, but also states limitations that are clearly directed to a process, i.e., "for preparing a composition for effectively alleviating and preventing age-associated visual degeneration” (claim 15). Accordingly, it is unclear whether Applicant intends to claim a product or process. The overlap between these two statutory categories of invention (i.e., product and process) renders the subject matter of instant claims 15-20 non-statutory under 35 U.S.C. 101 because 35 U.S.C. 101 is drafted in a manner so as to set forth the statutory classes of invention in the alternative only. Please see Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) Id. at 1551.
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 1-11, 15-16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheah et al. (W1, CHEAH, I. K. et al. “Ergothioneine, recent developments.” Redox Biology, Vol 42, (26 January 2021) pp. 1-5.).
Cheah et al. teaches that L-Ergothioneine is an antioxidant which accumulates in the body from an individual’s diet (See e.g. pp. 1, Abstract, which reads on claims 1, 9-11, 13-16). L-Ergothioneine has anti-oxidant properties which have various beneficial effects throughout the body. L-Ergothioneine’s anti-oxidant properties are particularly beneficial to ocular health due to the eye being exposed to high levels of oxidative stress (See e.g. pp. 4, Paragraph 12, which reads on claims 1-2, 4-8, 15, 18-19). L-Ergothioneine is suspected to play a role alleviating various age-related ocular diseases such as age-related macular degeneration, cataracts, and corneal endothelial cell oxidative stress.
Regarding claims 1-2, 9-11, 15-16, and 18-19, Cheah et al. teaches a method where orally consumed food compositions of L-Ergothioneine alleviate various age-associated visual degeneration conditions related to eyestrain, blurred vision, eye fatigue, or blindness.
Regarding claims 4-8 and 18, Cheah et al. teaches the method of use where L-Ergothioneine can help alleviate age-related visual degeneration conditions. In 2112.01, the MPEP states, “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches of a method of use of L-Ergothioneine for alleviating age-associated visual degeneration, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Thus, the teachings of Cheah anticipate the instantly claimed method of claims 4-8 and 18.
Claims 1-2, 9-11, 13-16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borodina et al (V1, BORODINA, I. et al. “The Biology of Ergothioneine, An Antioxidant Nutraceutical.” Nutrition Research Reviews, Vol 33, (2020) pp. 190-199).
Borodina et al. teaches that L-Ergothioneine is an important nutrient and anti-oxidant present in almost all foodstuff an individual consumes (See page 190, paragraph 2, which reads on claims 1-2, 9-11, 13-16, and 19). Borodina then continues to emphasize that L-Ergothioneine is an important anti-oxidant which performs multiple roles throughout the body such as inhibiting cataract formation induced by glucocorticoid (See page 199, table 4, which reads on claims 1-2, 9-11, 13-16, and 19).
Regarding claims 1, 9-11, and 13-16, Borodina teaches a method where L-Ergothioneine alleviates an age-associated visual degeneration by being consumed in a nutritional food composition which is administered orally multiple times a day.
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.
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.
Claims 1-11, 15-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cheah et al., in view of Ambati et al. (U1, AMBATI, J. et al. “Mechanisms of Age-Related Macular Degeneration”, Neuron, Vol 75, No. 1, (July 12 2013) pp. 1-2.).
Cheah et al. teaches that L-Ergothioneine is an antioxidant which accumulates in the body from an individual’s diet (see e.g. pp. 1, Abstract). L-Ergothioneine has anti-oxidant properties which have various beneficial effects throughout the body. L-Ergothioneine’s anti-oxidant properties are particularly beneficial to ocular health due to the eye being exposed to high levels of oxidative stress. L-Ergothioneine is suspected to play a role alleviating various age-related ocular diseases such as age-related macular degeneration, cataracts, and corneal endothelial cell oxidative stress (See e.g. pp. 4, paragraph 12).
While Cheah et al. teaches that L-Ergothioneine can be used to alleviate various age-associated visual degeneration conditions related to eyestrain, blurred vision, eye fatigue, or blindness and that L-Ergothioneine is often administered orally through food compositions, Cheah et al. does not teach that the age-related visual degeneration is characterized by retinal effusion, retinal hemorrhage, macular oedema, accumulation of lipofuscin and drusen-deposits, Bruch's membrane (BM) thickening, subretinal choroidal neovascularization (CNV) and/or increase of inflammatory proteins in retinal pigment epithelium (RPE) or that the L-Ergothioneine is capable of controlling choroidal neovascularization level in a mammal’s retina.
However, Ambati et al. teaches that age-related macular degeneration is characterized by the accumulation of drusen-deposits and choroidal neovascularization (see e.g. pp. 2, paragraph 2).
Regarding claims 1-3, 15, and 19-20, a person of ordinary skill in the art before the effective filing date would have a reasonable expectation of success to treat an age associated visual degeneration condition characterized by drusen-deposits and subretinal choroidal neovascularization through administration of L-Ergothioneine. It would have been obvious to try to treat such a disease characterized by drusen-deposits and choroidal neovascularization because of L-Ergothioneine’s anti-oxidant properties are beneficial for alleviating age-associated macular degeneration, which Ambati teaches is characterized by choroidal neovascularization and drusen-deposits.
Regarding claim 4, because L-Ergothioneine has been used to treat cases characterized by choroidal neovascularization, Ergothioneine’s capability to control choroidal neovascularization is also obvious. In 2112.01, the MPEP states, “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches of a method of use of L-Ergothioneine for alleviating age-associated visual degeneration, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 1-2, 9-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Borodina. in view of EFSA Panel on Dietetic Products et al.
Borodina et al. teaches that L-Ergothioneine is present in almost all foodstuff an individual consumes and that it has important anti-oxidant effects which can help alleviate certain age-related visual degeneration diseases such as cataract formation induced by glucocorticoid (See e.g. pp. 190, paragraph 2 and pp. 190, paragraph 2).
While Borodina et al. teaches a method where L-Ergothioneine alleviates an age-associated visual degeneration by being consumed in a nutritional food composition which is administered orally multiple times a day, it does not teach that the composition comprises L-Ergothioneine with a dose ranging from 2 to 2000 mg.
However, EFSA Panel on Dietetic Products teaches that synthetic Ergothioneine, branded as Ergoneine®, can be ingested as food supplements with a recommended dose of 30 mg per day for adults and 20 mg per day for children (See e.g. pp. 1, Abstract).
As such, a person of ordinary skill in the art before the effective filling date would have a reasonable expectation of success in consuming synthetic Ergothioneine dietary supplements as reviewed by the EFSA Panel on Dietetic Products to have a dose of 2-2000 mg of the nutrient to alleviate age-associated visual degeneration related to eyestrain, blurred vision, dry eyes, eye fatigue, or blindness. The skilled artisan would have been motivated to consume such dietary supplements to obtain a dosage of L-Ergothioneine between 2 mg and 2000 mg following the suggestion that eating foods with high L-Ergothioneine may help alleviate age-related diseases made by Borodina et al. This suggestion would have led one of ordinary skill in the art to make the obvious modification to the method from Borodina et al. to eat food compositions with high dose values in the range stated in claims 12 and 17 of the instant application.
Conclusion
Claims 1-20 are rejected, none are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON RAFANAN ULLMAN whose telephone number is (571)272-6623. The examiner can normally be reached 7:30 am to 5:00 pm M-F.
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/AARON RAFANAN ULLMAN/ Examiner, Art Unit 1628
/AMY L CLARK/ Supervisory Patent Examiner, Art Unit 1628
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