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 .
This action is in response to the amendments filed 07/27/2026.
Claims 1, 3-12 and 35-51 are pending. Claims 1, 3-10 are being examined. Claims 2 and 13-34 are canceled. Claims 11-12 and 35-51 are withdrawn from further consideration. Claim 1-7 are amended.
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.
Claim 5 is 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 claim(s) 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. The claim recites “the fluorescent tag is uniformly distributed throughout the polymer matrix”; however, support is only found for the fluorescent tag being distributed through the polymer matrix, no support is found for it being “uniformly” distributed.
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 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.
Claims 1 and 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lv et al. (Lv et al., "A simple method for detecting and quantifying microplastics utilizing fluorescent dyes – Safranine T, Fluorescein isophosphate, Nile red based on thermal expansion and contraction property”, Environmental Pollution, 55 (2019), 11 pages) in view of Qu et al. (Qu et al., “Using acs-22 mutant Caenorhabditis elegans to detect the toxicity of nanopolystyrene particles”, Science of the Total Environment 643 (2018) 119-126).
Considering claims 1, 3 and 6-7, Lv teaches a nanoplastic or microplastic particle comprising a nanoplastic or microplastic polymer/polymer composite/polymeric matrix (i.e., polyethylene, polystyrene, polyvinyl chloride and polyethylene terephthalate (PET) plastic particles) and a fluorescent tag (i.e., fluorescent dyes to stain four common plastic particles) (Lv, abstract).
Lv teaches the fluorescent tag is Fluorescein isophosphate (FITC), Nile Red, or Safranine T (Lv, section 2.2 on page 2), he does not explicitly teach that it is rhodamine-B.
However, Qu teaches labeling particles of nanopolystyrene with rhodamine-B to assess the potential toxicity of nano plastics on environmental organisms (Qu, section 2.1 and 3.2). Thus, Qu teaches tagging nanopolystyrene particles with rhodamine-B to track the distribution and location of the nanopolystyrene particles.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use rhodamine-B as the fluorescent tag for the nanoplastic polymer. One of ordinary skill in the art, before the effective filing date of the claimed invention would have been motivated to do so because rhodamine-B is known to be suitable as a fluorescent tag for a nanoplastic polymer.
The claims are directed to a nanoplastic or microplastic particle comprising a fluorescent tag and the process by which the product is prepared does not impart any additional structural limitations to the product. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Considering claim 4, Lv teaches the fluorescent tag comprises a bioconjugate by teaching that the amino group at one end of the silane reagent can be bonded to the isothiocyano group on the FITC dye, and the siloxy group at the other end can be bonded to the hydroxyl group on the plastic, thereby allowing the plastic to be fluorescently labeled (Lv, section 2.3 on page 2).
Considering claim 5, Lv teaches the fluorescent tag is distributed throughout the polymer matrix by teaching the dye molecules can enter inside the microplastics (Lv, 1st column, 2nd paragraph on page 2). Lv teaches using a solution wherein the plastic particles are evenly distributed when staining them (Lv, last paragraph of section 2.2 on page 2). Thus, it would be expected that the fluorescent tag is distributed uniformly throughout the polymer matrix.
Considering claims 8-10, Lv teaches particle sizes of less than 100 microns (Lv, section 2.1 on page 2). A prima facie case of obviousness exists because the claimed ranges of about less than one micron, less than about 500 nm, and less than about 100 nm overlap the range taught by Lv (see MPEP §2144.05(I)).
Response to Arguments
Applicant’s arguments filed regarding Lv teaches a post-labeling approach that requires two steps in contrast to the nanoplastic or microplastic particle of the instant claims wherein the labeling of the nanoplastic or microplastic occurs during the generation of the particle have been fully considered but are not persuasive.
The claims are directed to a nanoplastic or microplastic particle comprising a fluorescent tag. The claims are not directed to the process by which the claimed product is produced. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
In support of the above argument, Applicant presents comparing the CI between unlabeled and labeled nanoparticles in asserting that the particles prepared as set forth in independent claim 1 do not exhibit significant change in structure/characteristics following labeling. Applicant shows ratio differences of 0.039 and 0.037 between labeled and unlabeled NPs and argues that Lv shows a significant change in CI with CI decreasing with increasing temperature. However, even though the CI decreases with increased temperature, Lv clearly teaches that this is not a significant change (about 0.05) and heating has little effect on the microplastics (Lv, 1st column of page 5).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ANITA NASSIRI-MOTLAGH/Primary Examiner, Art Unit 1734
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