DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 03/01/2024, are acknowledged.
Claims 47-59 are pending in this action. Claims 1-46 have been cancelled. Claims 47-59 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a 371 of PCT/KR2022/012549, filed August 22, 2022, which claims benefit of foreign priority to KR10-2022-0105084, filed August 22, 2022, and to KR10-2021-0110275, filed August 20, 2021. No English translations of the certified copies of priority application(s) have been received. Failure to provide a certified translation may result in no benefit being accorded for the non-English application. 37 CFR 41.154(b) and 41.202(e).
Inventorship
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.
Specification
The lengthy specification (50 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The specification comprises multiple acronyms without proper definition, e.g., BNIP3, PINK1, NIX, TEM, GO-B, GO-P, NGO, PEG, FT-IR, ROS, CMC, EDC (Pages 4, 7-10, 26, 32). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The use of the trademarks/trade names has been noted in this application, e.g., “Primojel”, “Tween 80”, “Witepsol”, etc. (Pages 24, 26-27, 32-45). It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The data provided in the specification are unclear, given that the data are shown without units of measurements, e.g., “0.9% sodium chloride solution” (Page 26). Appropriate correction is required.
The specification comprises typographic errors, e.g., “dextrose+sodium” (Page 26) that needs to be corrected or clarified. Appropriate correction is required.
Drawings
The drawings, filed 03/01/2024, are objected to because in Figs, 1b, 3, 4b, 5b, 7a, 10b, 13, 19b x-axis and/or y-axis are not identified. Further, the images shown as Figs. 1a, 1b, 8a, 19a are not clear. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statements, filed 03/01/2024 and 03/05/2025, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
The information disclosure statements fail to comply with 37 CFR 1.98(b)(5), which requires that each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). In the present case, the examiner has considered all references filed by the applicant to expedite the prosecution. However, the applicant is informed that the references filed in an improper format (lined through) should be resubmitted in a proper format to be printed in the patent. MPEP 1302.12. Regarding electronic document(s) retrieved from an online source, it is noted that the format for the citation of an electronic document should be similar to the format used for paper documents of the same type, with the addition of the information in the locations (internet, database, etc.) indicated. MPEP 707.05(e).
The information disclosure statements do not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or do not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Claim Objections
Claims 48, 50, 53-55 are objected to because of the following informalities:
Claim 48 recites the limitation “PEG (polyethylene glycol) or NH2 (amino group)” that needs to be corrected to “polyethylene glycol (PEG) or amino group NH2” for clarity.
Claim 50 comprises the typographic error “a diameter of 24.4 to 38.8 nm” that needs to be corrected to “a diameter of from 24.4 nm to 38.8 nm”.
Claims 53 and 54 comprise acronyms “NIX”, “BNIP3”, “PINK1” without proper definitions. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed.
Claim 55 comprises the typographic error “a concentration of 0.01 to 200 µg/m” that needs to be corrected to “a concentration of from 0.01 µg/m to 200 µg/m”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 47-59 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.
Claim 47 attempts to define the subject-matter, i.e., “a nanographene oxide variant” in terms of the result to be achieved, i.e., “has a specific Raman shift”, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. In the present case, the claim language does not set forth well-defined boundaries of the invention, but only states a problem to be solved and/or a result to be obtained. To this point, it is noted that “Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation.” See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Clarification is required.
Claim 49 (dependent on claim 47, 48) recites the limitation “PEGylated nanographene oxide variant exhibits any one or more of the following characteristics: (1) the zeta potential of graphene ranges from -25.0 to -21.0 mV; and (2) it has a particle size of approximately 10 nm” that is unclear and indefinite. First, it is noted that where a claimed value (i.e., zeta potential, a particle size) varies with its method of measurement and several alternative methods of measurement are available (see Wikipedia), the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Second, it is unclear what particle size should be measured, given that independent claim 47 discloses a nanographene oxide variant having a circular plate shape. Third, it is noted that the term "approximately” is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claim 50 regarding the limitation “a diameter of 24.4 to 38.8 nm”. Clarification is required.
Claim 53 recites the limitation “the nanographene oxide variant specifically inhibits NIX” that is not reasonably clear. First, it is unclear that the term “specifically inhibits” does imply. To this point, it is noted that neither the claims nor the instant specification provides a definition for the term “specifically inhibits”. Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Second, neither the claims nor the instant specification provides a definition for the acronym “NIX”. Similar is applied to claim 54 regarding the acronyms “BNIP3”, “PINL1”. Clarification is required.
Claims 48, 51-52, 55-59 are rejected as being dependent on rejected independent claim 47 and failing to cure the defect.
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.
Claims 47-59 are rejected under 35 U.S.C. 103 as being unpatentable over Gonçalves et al. Nano-Graphene Oxide: A Potential Multifunctional Platform for Cancer Therapy. Adv. Healthcare Mater. 2013, 2, 1072–1090 (hereinafter referred as Gonçalves), in view of Cao et al. Visualization of size-dependent tumour retention of PEGylated nanographene oxide via SPECT imaging. J. Mater. Chem. B, 2016, 4, 6446—6453 (hereinafter referred as Cao).
PNG
media_image1.png
274
364
media_image1.png
Greyscale
Gonçalves teaches nano-graphene oxide and its derivatives and their potential to be uses as nanoparticles for cancer therapy (Title. Abstract, Pages, 1073-1074), wherein said nano-graphene oxide variants can be used as anticancer therapeutic agents (Page 1079), and/or as delivery systems for hydrophobic anticancer drugs, e.g., for treatment a cancer, i.e., breast cancer, colon cancer, etc. (Pages, 1079, 1081, 1084 as applied to claim 47, 51, 56-59).
Gonçalves specifically teaches that the surface chemistry, size and shape of said nanoparticles (as shown on the right) have an important influence on the biodistribution and cellular internalization dynamics of said nanoparticles into cells, and the planar and flexible structure of nano-graphene oxide is an additional factor that makes graphene a high-potential material for the interaction with biological structures, identifying thereby said parameters as result effective variables (Fig. 4; Pages 1075-1077 as applied to claim 47).
Gonçalves teaches the use of nano-graphene oxide functionalized with polyethylene glycol (PEG), and specifically teaches that surface-modification of nanoparticles with PEG (i.e., PEGylation) allows improving/controlling the stability and in vivo performance, preventing the opsonization of particles by the macrophages of the reticulo-endothelial system and increasing their cytoplasmic transport (Pages 1079-1081 as applied to claims 47, 48).
Gonçalves does not specifically teaches controlling nanoparticle size as disclosed in claims 49, 50.
Cao teaches size-dependent tumor retention of PEGylated nanographene oxide and related derivatives thereof, and specifically teaches that ultra-small PEGylated nanosized graphene oxides, i.e., having a size of below 50 nm, e.g., 28±20 nm, can be used for providing faster and higher dynamic cellular uptake and more efficient tumor accumulation of PEGylated graphene oxide via the enhanced permeability and retention effect (Abstract; Pages 6447-6450).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control the size of nano-graphene oxide variants as taught by Cao preparing nano-graphene oxide variants to be used for cancer therapy as taught by Gonçalves. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach can be used for providing/controlling efficient tumor accumulation of nano-graphene oxide variants via the enhanced permeability and retention effect.
Regarding the properties of the disclosed nano-graphene oxide variants (claims 47, 49, 52-54), it is noted that the cited prior art teaches variants that are substantially the same as the variants recited by the instant claims, e.g., PEGylated nano-graphic oxide. Therefore, it is expected that the same beneficial properties and effects would also be provided. The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
With regard to concentrations as instantly claimed (claim 55), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Applicant is advised to clarify the claimed language, the structure of the claimed variants/product and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615