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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1 – 4 and 12 in the reply filed on October 14, 2025 is acknowledged.
Claims 1 – 17 are pending; claims 5 – 11 and 13 – 17 are withdrawn; claims 1 – 4 and 12 have been considered on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 19, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 1 – 4 and 12 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.
Claim 1 and its dependents are drawn to a method for preparing catechol nanoparticles, however are rendered indefinite for reciting “natural herb medicine” as the phrase is not adequately defined by the claim language or specification. The term “natural” is subjective in nature without any defined limits to what applicant regards as natural, thereby failing to clearly set forth the scope of the claims.
In claim 2, line 2, the recitation of “drug” renders the claim indefinite as the members of the Markush group are plant species and not drugs.
In claim 2, the terms “Oliv.,” “Mill.,” and “L.” should first be spelled out then followed by any desired abbreviations.
In claim 2 lines 4 – 5 are grammatically confusing and should be clarified for what the ratio is regarding. For purposes of examination, the ratio is interpreted to be drawn to the components of the mixture in claim 1.
In claim 4, it appears that the second centrifugal separation yields additional catechol nanoparticles rather than the only nanoparticles. Thus, in line 2, “the catechol nanoparticles” appears to be “additional catechol nanoparticles.” Clarification is required.
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.
Claim 1 is rejected under 35 U.S.C. 102a1 as being anticipated by KR 20110019789A.
Regarding claim 1, KR ‘789 teaches methods for preparing catechin (catechols) extracts (abstract), the methods comprising adding water to a natural product containing catechin (catechols, or a tannin containing natural herb product) for heated reflux extraction followed by separation of the layers (or fractionation) (example 1). Although the reference does not expressly state the extracts are nanoparticles, the method steps are the same. As such, when practicing the method of the prior art one is inherently preparing nanoparticles as claimed.
The reference anticipates the claimed subject matter.
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.
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 – 2 are rejected under 35 U.S.C. 103 as being unpatentable over KR 20110019789A in view of Burlacu et al. (2020).
Regarding claim 1, KR teaches methods for preparing catechin (catechols) extracts (abstract), the methods comprising adding water to a natural product containing catechin (catechols, or a tannin containing natural herb product) for heated reflux extraction followed by separation of the layers (or fractionation) (example 1). Although the reference does not expressly state the extracts are nanoparticles, the method steps are the same. As such, when practicing the method of the prior art one is inherently preparing nanoparticles as claimed.
Regarding claim 2, KR does not teach the method wherein the tannin containing natural product is selected from the claimed plants; has the claimed plant to water ratio; or wherein the claimed parameters are applied for extraction. However, Burlacu teaches Quercus infectoria Olivier is a significant source of catechines, catechol and tannins that can be successfully extracted with water (Table 1). In this regard, at the time the claims were filed, one of ordinary skill in the art would have been motivated to practice the methods of KR with Q. infectoria Olivier as the natural product containing catechin (catechols or tannins) with a reasonable expectation for successfully obtaining catechin extracts.
Regarding the ratio of components and extract variables, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. In the instant case, these parameters are not indicated as critical. Specifically, the specification states “There is no special limitation on the processes of the preparation of the herb medicine extract” (0059). Thus, at the time the claims were filed it would have been obvious to one of ordinary skill in the art to optimize the process of extraction as a matter of routine practice and experimentation and with a reasonable expectation for successfully obtaining a catechol nanoparticle.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims1 and 3 – 4 are rejected under 35 U.S.C. 103 as being unpatentable over KR 20110019789A in view of Khoddami et al. (2013).
Regarding claim 1, KR teaches methods for preparing catechin (catechols) extracts (abstract), the methods comprising adding water to a natural product containing catechin (catechols, or a tannin containing natural herb product) for heated reflux extraction followed by separation of the layers (or fractionation) (example 1). Although the reference does not expressly state the extracts are nanoparticles, the method steps are the same. As such, when practicing the method of the prior art one is inherently preparing nanoparticles as claimed.
Regarding claims 3 and 4, KR does not teach the method wherein separation (fractionation) occurs via a first and second centrifugation as claimed. However, at the time the claims were filed, centrifugation was commonly used after extraction of plant phenol compounds (e.g., catechin, catechols, tannins). In support, Khoddami teaches phenolic extraction from plants commonly includes techniques such as centrifugation following a solvent extraction (p.2331 – 2332, sections 3.1 – 3.2). Regarding the force and time, the specification indicates “There is no special limitation on the processes of…the first centrifugal separation, and the second centrifugal separation…” (0059). Thus, at the time the claims were filed, one of ordinary skill in the art would have been motivated by routine practice, experimentation and the instant specification to optimize the separation parameters and with a reasonable expectation for successfully obtaining a catechin or catechol nanoparticle.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1, 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over KR 20110019789A in view of Burlacu et al. (2020) and further in view of Khoddami et al. (2013).
Regarding claim 1, KR teaches methods for preparing catechin (catechols) extracts (abstract), the methods comprising adding water to a natural product containing catechin (catechols, or a tannin containing natural herb product) for heated reflux extraction followed by separation of the layers (or fractionation) (example 1). Although the reference does not expressly state the extracts are nanoparticles, the method steps are the same. As such, when practicing the method of the prior art one is inherently preparing nanoparticles as claimed.
Regarding claim 2, KR does not teach the method wherein the tannin containing natural product is selected from the claimed plants; has the claimed plant to water ratio; or wherein the claimed parameters are applied for extraction. However, Burlacu teaches Quercus infectoria Olivier is a significant source of catechines, catechol and tannins that can be successfully extracted with water (Table 1). In this regard, at the time the claims were filed, one of ordinary skill in the art would have been motivated to practice the methods of KR with Q. infectoria Olivier as the natural product containing catechin (catechols or tannins) with a reasonable expectation for successfully obtaining catechin extracts.
Regarding the ratio of components and extract variables, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. In the instant case, these parameters are not indicated as critical. Specifically, the specification states “There is no special limitation on the processes of the preparation of the herb medicine extract” (0059). Thus, at the time the claims were filed it would have been obvious to one of ordinary skill in the art to optimize the process of extraction as a matter of routine practice and experimentation and with a reasonable expectation for successfully obtaining a catechol nanoparticle.
Regarding claim 12, the combined teachings of KR and Burlacu do not teach the method wherein separation (fractionation) occurs via centrifugation as claimed. However, at the time the claims were filed, centrifugation was commonly used after extraction of plant phenol compounds (e.g., catechin, catechols, tannins). In support, Khoddami teaches phenolic extraction from plants commonly includes techniques such as centrifugation following a solvent extraction (p.2331 – 2332, sections 3.1 – 3.2). Regarding the force and time, the specification indicates “There is no special limitation on the processes of…the first centrifugal separation, and the second centrifugal separation…” (0059). Thus, at the time the claims were filed, one of ordinary skill in the art would have been motivated by routine practice, experimentation and the instant specification to optimize the separation parameters and with a reasonable expectation for successfully obtaining a catechin or catechol nanoparticle.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699