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 .
Drawings
The Drawings filed 13 September 2022 are approved by the examiner.
Information Disclosure Statement
It is noted that no IDS were provided.
Priority
Receipt is acknowledged of the certified copies of papers required by 37 CFR 1.55.
Citation Notation
The following citations are made for the convenience of the reader:
Citations to PG publications are made to paragraph number under the ¶ format. Citations to other publications made under the format “ col 1/2” or pp 1 are directed to column and line number or to a page - whichever is appropriate. It is noted that any reference to a figure or a table is also directed to any accompanying text in the specification or the document. Notwithstanding those citations, the reference(s) is (are) relied upon for the teachings as a whole.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 2-8, in the reply filed on 20 August 2025 is acknowledged.
Claims 2 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 August 2025.
Claim Objections
Claims 2-8 are objected to because of the following informalities:
The second and subsequent recitation the components are missing “the” (see monolayer graphene oxide, EDC, NHS, CO and PGA); and
Claims 3-8: the listing is missing “and” before the last components
Appropriate correction is required.
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 2-8 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 2 recites the limitation "aptamer NH2-AS1411" in line 3; however, it is unclear as to the metes and bounds – see how the aptamer is not referenced subsequently; thus, there is either a lack of antecedent basis or lack of clarity regarding the claimed component. Claims 3-8 are dependent thus inherit the same deficiency.
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.
Claim(s) 2-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (CN109395086A, a machine translation is provided) in view of Tang ("Aptamer-Targeting Photoresponsive Drug Delivery System Using "Off-On" Graphene Oxide Wrapped Mesoporous Silica Nanoparticles." Nanoscale, 2013, 7) and Mashreghi ("Anti-Epcam Aptamer (Syl3c)-Functionalized Liposome for Targeted Delivery Of Doxorubicin: In Vitro And In Vivo Antitumor Studies in Mice Bearing C26 Colon Carcinoma. Nanoscale Research Letters (2020) 15:101).
Claim 2: Yang discloses a process of preparing a composite pharmaceutical carrier comprising the following raw materials: a monolayer graphene oxide, a chitosan oligosaccharide, γ-polyglutamic acid, EDC, NHS, an MES buffer and a PBS buffer (abs, pg. 2-4 and examples). Further, Yang discloses known experimental preparation methodologies such as mixing/suspending/dispersion in ultrapure water, sonication, centrifugation, supernatant removal, washing and pH monitoring/adjustment (pg. 4-9). The Yang reference discloses the claimed invention but does not explicitly disclose the feature of the aptamer NH2-AS1411. In an analogous art, the Tang reference discloses that a drug delivery system with AS1411 and Graphene oxide is well known (¶abs, pg. 2-4). Further, Mashreghi discloses that modifying aptamer with an amino group leads to stability and targeted interactions (abs, pg. 3). One of ordinary skill in the art would have recognized that applying the known technique of Tang and Mashreghi to the teachings of Yang would have yielded predictable results because the level of ordinary skill in the art demonstrated by the cited references shows the ability to apply such features into similar systems, methods and compositions for the benefit gain of enhanced stability and targeted interactions. See MPEP 2143. Further, it is noted that obviousness only requires a reasonable expectation of success and there is no evidence nor teaching that the substitution would be repugnant to a skilled artisan.
Claims 3-8: The Yang, Tang and Mashreghi references disclose the claimed invention but do not explicitly disclose the claimed experimental ranges and step sequence. It is noted that the claimed experimental ranges are construed as result-effective variables, i.e., a variable which achieves a recognized result such as the dispersion, separation and/or recovery of components and all the steps are disclosed by Yang and Tang. Given that the Yang, Tang and Mashreghi references disclose a similar method with similar components, it would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges and steps through process optimization such as varying the concentration, the loading amount or length of time of a reaction, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05. Thus, it would have been obvious to one of ordinary skill in the art at the time of the invention to optimize known variables, i.e. the experimental conditions, since the references also disclose a similar end-product and is motivated to optimize the experimental conditions (see at least Yang: pg. 4-9 and Tang: experimental section). Further, obviousness only requires a reasonable expectation of success and there is no evidence nor teaching that the selection or optimization of the claimed components/steps would be repugnant to a skilled artisan.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sharma discloses an overview of the functionalized graphene oxide for drug delivery into various systems and mentions the aptamer component; and
Craster discloses a nano-sized drug delivery system.
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/TRI V NGUYEN/Primary Examiner, Art Unit 1764