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 .
Applicant’s response filed on December 31, 2025 has been fully considered.
All claim rejections as indicated in the Office action dated October 1, 2025 have been maintained for reasons of record.
Applicant asserts that claim 10 has not been addressed in the previous Office action. The rejection made under 35 U.S.C. 103 over Rabovsky et al. (US 9352008) as evidenced by Zwierello et al, (“The influence of polyphenols on metabolic disorders caused by compounds released from plastics”, Chemosphere, vol. 240, 1-20, 2019) as applied to claims 1, 2, 4, 9 and 11 and further in view of De Albertis (US 20080279986 A1) fully and specifically has addressed claim 10. The rejection specifically has addressed the limitation wherein the green tea extract composition is in the form of food, and explained why the references are relevant and how such limitation is rendered prima facie obvious in view the references. Since claim 10 is the only claim with the food composition in the limitation, it is viewed proper to make the present Office action final. The typographical error “claim 11” in the rejection statement is corrected to “claim 10”.
Claim Rejections - 35 USC § 102
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, 2, 4, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Rabovsky et al. (US 9352008, published on May 31, 2016) (“Rabovsky” hereunder) as evidenced by Zwierello et al. (“The influence of polyphenols on metabolic disorders caused by compounds released from plastics”, Chemosphere, vol. 240, 1-20, 2019, cited in IDS).
Claim 1 is directed to a method for reducing absorption of microplastic in a body, comprising administering a composition comprising an effective amount of a green tea extract to a subject in need thereof. The effective amount of a green tea extract in this case ranges from 1-200 mg/kg/day, according to the present specification. See published application, [0054]. see present specification. Since general public is exposed to microplastics through a various environments and ecosystems including food chain, the subject group in this case must include all population. See Zwierello.
Rabovsky discloses a process of administering a dietary supplement comprising green tea extract for treating pain, stiffness or inflammation in a mammal. See abstract. The reference teaches that the composition contains about 45-75 mg of the green tea extract; the daily effective dose of the green tea extract ranges from 50-1000 mg. See col. 9, line 45 – col. 10, line 22. Assuming that an average adult weighs 70 kg, the disclosed dose ranges from about 0.71 – 14.29 mg/kg/day, which overlaps with the effective amount of green tea extract in the present invention. Examples 1 and 2 show that 3.43 mg/kg/day of green tea was administered to subjects having joint and muscle discomfort. Four tablets comprising green tea extract in the amount of 60 mg per tablet were administered for two weeks.
Since the disclosed method requires administration of a composition comprising a green tea extract within the same amount to the same subject group who is in need of reducing absorption of a microplastic in a body, the presently claimed method is inherently practiced every time the prior art method was carried out.
Regarding claim 2, Rabovsky teaches that a green tea extract is obtained by alcoholic, hydroalcoholic or other hydrocarbon extraction. See col. 9, lines 46 – 51.
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.
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 3 and 5-8 are rejected under 35 U.S.C. 103 as obvious over Rabovsky as evidenced by Zwierello as applied to claims 1, 2, 4, 9 and 11 as above, and further in view of the same references.
Regarding claim 3, Rabovsky teaches that the green tea extract used in the invention has at least about 15 % of catechin compounds, which can include applicant’s range of 30-45 %. See col. 9, lines 56-58. Furthermore, even assuming that about 15 % of catechins are present in the prior art green tea extract in Examples 1 and 2, it can be said that about 0.5145 mg/kg of catechin compounds were present in the daily amount of 3.43 mg/kg/ of green tea extract administered to the subjects. Since applicant defines 1-200 mg/kg/day of green tea extract as the effective amount, 30-40 % of such dose would provide 0.3-80 mg/kg/day of the green tea catechin compounds. The amount of the green tea catechin compounds delivered to the subjects in the Rabovsky study is well within the range of the effective amounts of the catechins provided in the present invention. Thus, the examiner views that no patentable distinction is seen between the prior art method and the present invention unless shown otherwise.
Regarding claims 5-8, although Rabovsky does not specifically attribute the pain, inflammation, stiffness and/or discomfort of the subjects to accumulated microplastics in their bodies, it is established that all human populations in the last few decades have been inevitably and continuously exposed to microplastics entering the body. Thus, it is viewed that the volunteer subjects of the Rabovsky study obviously include those who are in need of the treatments of “aggregating the microplastic”, “inhibiting inflammation caused by absorption of the microplastic”, “inhibiting oxidative stress in a cell caused by the microplastic” and “preventing alleviating or treating lipid metabolism disorder in a cell caused by the microplastic”.
Claim 10 is rejected under 35 U.S.C. 103 as obvious over Rabovsky as evidenced by Zwierello as applied to claims 1, 2, 4, 9 and 11 as above, and further in view of De Albertis (US 20080279986 A1, published on November 13, 2008).
Rabovsky fails to teach administering the green tea extract in the form of food. However, providing nutritional supplements such as vitamins and a green tea extract in form of a ready-to-eat bar for regular consumption is well known in the art. See De Albertis, [0011-0012]; Examples.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Rabovsky and provide the green tea extract in a ready-to-eat food composition as motivated by De Albertis. The skilled artisan would have been motivated to do so, as the latter suggests that the subjects can conveniently consume and administer the nutrients in a ready-to-eat formulation. Since both references are directed to orally administering a daily dose of the catechin compounds in green tea extracts, the skilled artisan would have had a reasonable expectation of successfully directing the subjects to comply with the treatment method by combining the teachings of the references.
Oath/Declaration
The declaration filed under 37 CFR 1.132 on December 31, 2025 has been fully considered, but does not place the application in allowable condition.
The co-inventor/declarant argues that the present invention results in superior effects over the EGCG studies in Zwierello and has submitted data which shows that a green tea extract performed better in reducing cellular toxicity or pro-inflammatory cellular stress, increasing cell viability and reducing microplastic aggregation compared to EGCG. However, the declaration fails to rebut the anticipation rejection over Rabovsky, which discloses a method of reducing inflammation in a subject by administering a dietary supplement comprising 50-1000 mg/day of green tea extract. Zwierello was cited to show that the Rabovsky user group falls within the subject group of the present invention. See below, Response to Arguments.
Response to Arguments
Applicant's arguments filed on December 31, 2025 have been fully considered but they are not persuasive.
Applicant argues that the pending anticipation rejection is “based on speculation and mere conjecture”. However, applicant does not point out specifically which part of the examiner’s reliance on Zwierello is a mere conjecture. Zwierello defines the microplastics as “persistent organic pollutants (POPs)” as these are constantly released into water, soil and air. See abstract, 1st line. The abstract goes on to state that humans are under “[c]ontinuous exposure” of these persistent organic pollutants due to the slow biodegradation, “ubiquitous use as industrial materials and everyday products. (emphasis mine). In fact, even applicant’s own disclosure indicates that humans are continuously in contact with microplastics through “resin pellets, scrubs in facial wash or toothpaste, industrial abrasives” and from simply “using plastic products” and “due to corrosions by ultraviolet rays or various collisions of discarded plastic waste”. See the present specification as filed, p.1.
The examiner is also available to take a judicial notice that general human population in developed and developing countries long have been exposed to microparticles by simply going about daily life, which includes consuming beverages in plastic bottles, food wrapped or prepared in plastics, etc. See MPEP 2144.03. The examiner maintains the position that the subjects of the present invention and Rabovsky are all in need of reducing absorption of a microplastic in the body; such is not a mere conjecture but clearly supported by Zwierello as well as applicant’s own disclosure and common knowledge.
It is also noted that the scope of the subject group “in need thereof” includes those who are “in need of preventing”, as defined in the present claim 8. Such user group would clearly include all human population.
Applicant also goes on to argue “’even if microplastic exist generally, it does not necessarily follow that disclosure of Rabovsky necessarily ‘reduces absorption of a microplastic in a body” or suppress microplastic absorption-induced inflammation.”
The examiner has indicated that the presently claimed process is inherently practiced since the same method step is carried out on the same subject group. In patent law, it is a well-established principle that a known subject matter does not become patentable simply because a new property has been discovered. See MPEP 2112 I.
Furthermore, for a feature to be considered “inherent” in a prior invention, it does not necessarily need to have been recognized or understood at the relevant time. See MPEP 2112 II. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. See Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency).
Regarding process claims, under the principles of inherency, when the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993) (The Board rejected a claim directed to a method for protecting a plant from plant pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526 bacteria for protecting the plant from fungal disease. Dart was silent as to nematode inhibition but the Board concluded that nematode inhibition was an inherent property of the bacteria. The Board noted that applicant had stated in the specification that Wisconsin 526 possesses an 18% nematode inhibition rating.) (emphasis mine).
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. See In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use.
In this case, the user groups of the Rabovsky and the present invention are all have been and continuously are exposed to microparticle absorption and are in need of reducing thereof, and the present method step of administering a composition comprising an overlapping amount of green tea extract to the same user group is explicitly disclosed in the reference. The presently claimed use is based on the same composition that has been used by the same subject group who are in need of reducing absorption of a microplastic in a body, and it follows that the present invention is practiced each and every time the users of the Rabovsky invention intake the comprising the green tea extract.
Applicant also argues that the present invention has an unexpected results of
“a lower inflammatory response compared to EGCG used in Zwierello”. However, the premise of the present 102 and 103 rejections is that the administration of a green tea extract according to the Rabovsky teaching treats the same subject groups of the present invention and reduces absorption of a microplastic in the body. The 132 declaration fails to rebut the rejections.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20040097429 discloses administration of 40 mg/kg/day of green tea extracts to subjects for improvement of health.
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 GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 AM - 5 PM.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
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