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 .
Continued Prosecution Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June has been entered.
All previous claim rejections indicated in the Office action dated April 16, 2026, have been withdrawn in view of the amendment made to claim 1, which limits the subject group of the claimed invention to those who are “in need of aggregating the microplastic”, “in need of inhibiting inflammation caused by absorption of the microplastic” and “in need of inhibiting oxidative stress in a cell caused by the microplastic”.
A new rejection has been made to address the amended claims.
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 1-4 and 8-11 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 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.
Evaluating enablement requires determining whether any undue experimentation is necessary for a skilled artisan to determine how to make and/or use the claimed invention. Factors to be considered in determining whether any necessary experimentation is “undue” include, but are not limited to: a) the breath of the claims; b) the nature of the invention; c) the state of the prior art, the level of one of ordinary skill; d) the level of predictability in the art; e) the amount of direction provided by the inventor; f) the existence of working examples; and g) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 U.S.P.Q. 2d 1400, 1404 (Fed. Cir. 1988).
The breath of the claims: Claim 1 is directed to a method for reducing absorption of a microplastic in a body, comprising administering a composition comprising an effective amount of a green tea extract to a subject in need of aggregating the microplastic; a subject in need of inhibiting inflammation caused by absorption of the microplastic; or a subject in need of inhibiting oxidative stress in a cell caused by the microplastic The treatment method applies to only those subjects, either human or animals, that are identified to have the need to aggregate the microplastic or in need of inhibiting inflammation or oxidative stress in a cell specifically caused by absorption of the microplastic.
The nature of the invention
The claimed method is a targeted therapeutic treatment, as the treatment is done only when the symptoms are caused by microplastic absorption. As the subjects of the claimed method are limited to those who experience the symptoms caused by microplastic absorption, practicing the method inherently requires confirming that the subjects have been diagnosed or confirmed to have microplastic aggregation, inflammation or oxidative stress caused by absorption of microplastic.
The level of predictability in the art:
All human population is exposed to microparticles in drinking water, processed foods and environmental pollutants. See Zwierello et al. (“The influence of polyphenols on metabolic disorders caused by compounds released from plastics- Review”, Chemosphere, vol 240, p. 1-20, 2019, cited in IDS) It is not clear how a clinician would detect the level of microplastics in individual’s gastrointestinal tract or bloodstream to determine whether an individual is in need of aggregating the microplastic. The current medical arts currently lack any standardized, diagnostic methodologies to detect, quantify or monitor microplastic loads in living human or animal subjects. Because the prior art lacks a predictable method to quantify microplastic in a living body, a person or ordinary skill in the art cannot predictably identify which subjects harbor the level of microplastics requiring aggregation.
Furthermore, inflammation and oxidative stress are ubiquitous biological responses triggered by innumerable, everyday variables such as aging, food types, pathogens, other environmental pollutants, etc. For example, US 10434131 B2 states:
As used herein, “oxidative stress” refers to an imbalance between the manifestations of reactive oxygen species (ROS) and a biological system's ability to readily detoxify the reactive intermediates. ROS result in the formation of free radicals. Free radicals (e.g. hydroxyl, nitric acid, superoxide) or the non-radicals (e.g. hydrogen peroxide, lipid peroxide) lead to damage (called oxidative damage) specific molecules with consequential injury to cells or tissue. Disturbances in the normal redox state of cells can cause toxic effects through the production of peroxides and free radicals that damage all components of the cell, including proteins, lipids, and DNA. While short term oxidative stress can be beneficial; over time oxidative stress can be involved in the etiology of many conditions and diseases. Increased production of ROS occurs as a result of fungal or viral infection, inflammation, aging, U.V. radiation, pollution, excessive alcohol consumption, cigarette smoking, etc. Removal or neutralization of ROS is achieved with antioxidants, endogenous (e.g. catalase, glutathione, superoxide dismutase) or exogenous (e.g. vitamins A, C, E, bioflavonoids, carotenoids).
When attempting to identify a single cause for a systemic condition like inflammation or oxidative stress, one of ordinary skill in the art could not predictably diagnose a subject without a validated biomarker.
The state of the prior art:
Zwierello et al. teach that scientific community is aware that the chemicals released from microparticles, (Persistent Organic Pollutants, or POPs) can accumulate in living organisms and induce pro-inflammatory effects and oxidative stress. The reference teaches that polyphenols, including antioxidant chemicals such as epigallocatechin gallate in daily diet, may play a protective role against the harmful effects of POPs derived from plastics. See abstract; section 3.4.2. The reference mentions 1) epidemiological studies in which a certain population were studied for polychlorinated biphenyls (PCBs) exposure and 2) blood tests of mothers in the Faroe Islands in which 87 different environmental toxins including phthalates, PCBs, dioxins, etc, were found. See sections 3.3 and 5.1. However, the reference provides no correlation between an accumulated microplastic level and inflammation/oxidative stress in the living body of a subject. There is no clinical diagnostic guidance to detect microplastics or microplastic-induced inflammation or oxidative stress or damages in a living subject.
The amount of direction provided by the inventor and the existence of working examples:
Applicant discloses in vitro data which shows that artificially and highly dosed polystyrene microplastics cause cellular damage in isolated mouse macrophase/immune cells and human hepatocyte/liver cells. See published application, [0071-0076]. The specification teaches that qPCR, ELISA kits and fluorescent dyes were used to measure the damage the plastics caused to the cells. However, the specification does not disclose any guidance on methodology or working example on how to diagnose and identify a living subject in need of reducing microparticle absorption apart from the general human population who are inevitably exposed to microparticle pollutants ubiquitously found in the surrounding environment.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
To practice the presently claimed method, one of ordinary skill in the art would have to first identify the subject whose inflammation or oxidative stress level is causally linked to microplastic absorption. Because no standard medical diagnostic method is currently known to do this and Applicant provides no clinical baseline, the skilled artisan would have to develop a large-scale, independent clinical research just to identify such subject. The required effort in this case would be exceptionally high and constitute undue experimentation.
The claims require administering a therapeutic component only to a specific, living ‘subject in need’ based on specific physiological causation. However, the biological and medical arts are highly unpredictable, and the specification provides no guidance, diagnostic markers or clinical baseline for identifying such a subject. As a person of ordinary skill in the art would be forced to undertake extensive clinical research to come up with methodologies just to identify the subject group from the universally exposed general population, practicing the invention requires undue experimentation. A skilled artisan would not be able to practice the method without undue experimentation, and the specification fails to enable the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA CHI-EUN YU 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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