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 .
DETAILED ACTION
Claims 1-13 and 15-20 are pending.
Election/Restrictions
Applicant’s election without traverse of the Invention of Group I, claims 1-11 in the reply filed on 11/26/25 is acknowledged.
Claims 12, 13 and 15-20 are withdrawn as being drawn to a nonelected invention.
Claims 1-11 are under consideration.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 6/22/23, 7/25/23, 12/17/24, and 8/7/25. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Specification
The use of the term “Triton X-100, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claim 9 is 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 9 contains the trademark/trade name “Triton X-100”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe octylphenoxypolyethoxyethanol and, accordingly, the identification/description is indefinite.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Myung et al. (Macromolecular Research, 2008; cited in IDS) in view of Dyakonov et al. (Journal of Drug Delivery, 2012).
Myung et al. teach the fabrication of silk fibroin nanoparticles (e.g. abstract). Myung et al. teach a method comprising:
adding an aqueous solution containing a silk fibroin (i.e. natural polymers) to cyclohexane (i.e. organic solvent) and Triton X-100 (i.e. nonionic surfactant), and homogenizing a resulting mixed solution to generate a natural polymer colloidal suspension; and
adding the natural polymer colloidal suspension to a mixture of methanol and ethanol (i.e. an alcohol) (e.g. page 605 “Formation of Silk Fibroin Nanoparticles”).
Myung et al. teach that the methanol has dual functions in this process, the removal of the microemulsions and the dehydration of the silk to induce its assembly into a crystalline form (e.g. page 606 “results and Discussion” and Figure 1). Myung et al. do not teach that the alcohol has 3 to 4 carbon atoms, or an alcohol recited in claims 2 and 3. This is made up for by the teachings of Dyakonov et al.
Dyakonov et al. teach a platform for controlled drug delivery based on silk fibroin (SF) and to explore the feasibility of using SF in oral drug delivery (e.g. abstract). Dyakonov et al. studied the effect of dehydrating solvents (methanol, ethanol, and isopropyl alcohol) on formation of β-sheets and concluded that isopropyl alcohol treatment gave good crystalizing effect (e.g. page 4 Section 3.2, Table 3).
Regarding Claims 1-4 and 7-10, it would have been obvious to one of ordinary skill in the art at the time of filing to replace the methanol and ethanol of Myung et al. with the isopropanol of Dyakonov et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both Myung and Dyakonov are directed to silk fibroin particles comprising methods utilizing alcohol dehydration agents and one of ordinary skill would have been motivated in order to provide the benefits of good crystalizing effect as taught by Dyakonov et al. Simple substitution of one known element for another to obtain predictable results is obvious.
Regarding Claims 5 and 6, Myung et al. teach that the aqueous silk fibroin solution was prepared by dissolving cocoons of Bombyx mori (e.g. abstract and “Experimental”).
Regarding Claim 11, Myung et al. teach that fluorescent molecule Rhodamine B was encapsulated in the silk fibroin nanoparticles (e.g. page 606 “results and Discussion” and Figure 1).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619