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 . Claims 1-10 are pending; claim 1 is examined, claims 2-10 are currently withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I, claim 1, in the reply filed on 09 December 2025 is acknowledged. Accordingly, claims 2-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Interpretation
Claim 1 recites a composite nano-agent, wherein the composite nano-agent material comprises specific ingredients. Based on paragraphs [0003], [0018], and [0028] of the instant Specification, it reasonably appears that tetrabutylammonium hydroxide (TBAH), polyvinyl alcohol (PVA), and silver ions are ingredients used during the process of producing the composite nano-agent. For example, para. [0003] discloses wherein TBAH is added to a solution comprising silver salt and water to hydrolyze the silver salt to obtain silver ions, and the silver ions are added to an aqueous solution containing PVA to reduce the silver ions into silver nanoparticles. Therefore, it is not clear how TBAH, PVA, and silver ions are present in the final product. For sake of compact prosecution, the examiner has interpreted claim 1 as a composite nano-agent comprising silver nanoparticles, PEG, and liposomes, wherein the process of producing said composite involves silver ions, PVA, and TBAH.
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 1 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the composite nano-agent material" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, line 1 recites a composite nano-agent. Clarification is requested.
Claim 1 recites a composite nano-agent, wherein the composite nano-agent material comprises specific ingredients. The claim is indefinite because the scope of the claim is unclear. Based on paragraphs [0003], [0018], and [0028] of the instant Specification, it reasonably appears that tetrabutylammonium hydroxide (TBAH), polyvinyl alcohol (PVA), and silver ions are ingredients used during the process of producing the composite nano-agent. For example, para. [0003] discloses wherein TBAH is added to a solution comprising silver salt and water to hydrolyze the silver salt to obtain silver ions, and the silver ions are added to an aqueous solution containing PVA to reduce the silver ions into silver nanoparticles. Therefore, it is not clear how TBAH, PVA, and silver ions are present in the claimed product (i.e. the composite nano-agent). Clarification is requested.
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.
The factual inquiries 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Blosi et al. (US 2011/0313059 A1, 12/22/2011) (hereinafter Blosi) in view of Yusuf et al. (“Surface modification of silver nanoparticle (AgNP) by liposomal encapsulation mitigates AgNP-induced inflammation”, 12/2019) (hereinafter Yusuf).
Blosi discloses a stable suspension of Ag metal nanoparticles (abs) applicable to the biomedical field ([0003]) produced with a precursor salt of the metal (i.e. providing silver ions), a reducing agent, a chelating agent, and a catalyst ([0033]). The chelating agents include polyethylene glycol (PEG) ([0039]).
Blosi differs from the instant claim insofar as not explicitly disclosing inclusion of liposomes.
Yusuf discloses wherein silver nanoparticles (AgNP) are widely used in a variety of products as antibacterial to prevent or treat infection, but can induce inflammation. It is found that AgNP can be encapsulated in a liposome to form Lipo-AgNP (abs) with immunosuppressive properties and will likely mitigate AgNP-mediated inflammation (§ 5).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included liposomes in the silver nanoparticle of Blosi since it is a known and effective ingredient that will likely mitigate silver nanoparticle-mediated inflammation as taught by Yusuf.
Regarding the claim reciting silver ions, PVA, and TBAH, as discussed above, it reasonably appears such components are reagents used during the process of producing the composite nano-agent. As such, the claim is interpreted as not requiring the manipulations of the steps (e.g., reagents) set forth in the claim, but only the structure implied by the steps. See MPEP § 2113. As such, the silver nanoparticle of Blosi meets the instantly claimed limitations of silver ions, PVA, and TBAH.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Blosi et al. (US 2011/0313059 A1, 12/22/2011) (hereinafter Blosi) in view of Stroiuk et al. (US 2017/0157676 A1, 06/08/2017) (hereinafter Stroiuk), further in view of Yusuf et al. (“Surface modification of silver nanoparticle (AgNP) by liposomal encapsulation mitigates AgNP-induced inflammation”, 12/2019) (hereinafter Yusuf).
The disclosures of Blosi and Yusuf have been discussed in detail above. While Blosi and Yusuf is believed to support a finding of obviousness, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, instant claim 1 has been interpreted as requiring silver ions, PVA, and TBAH.
Blosi discloses a stable suspension of Ag metal nanoparticles (abs) applicable to the biomedical field ([0003]) produced with a precursor salt of the metal (i.e. providing silver ions), a reducing agent (e.g., glucose ([0037])), a chelating agent, and a catalyst ([0033]). The chelating agents include polyvinyl alcohol (PVA) and polyethylene glycol (PEG) ([0039]). The catalyst includes alkali metal hydroxide such as NaOH ([0038]).
Blosi differs from the instant claim insofar as not explicitly disclosing inclusion of tetrabutylammonium hydroxide or liposomes.
Stroiuk discloses synthesizing silver nanoparticles (NP) ([0001]) comprising reducing silver ions with a biocompatible reducing agent (e.g., glucose ([0031])) in an alkaline medium ([0010]). Stroiuk further discloses conventionally used inorganic alkalis (NaOH, KOH) are insoluble in most dispersion media, therefore an organic basis tetraalkylammonium hydroxide, including tetrabutylammonium hydroxide, which is readily soluble in polar solvents, can be added ([0028]-[0029]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included tetrabutylammonium hydroxide in the preparation of silver nanoparticles since it is a known and effective substance readily soluble in polar solvents as taught by Stroiuk.
Blosi and Stroiuk do not explicitly disclose inclusion of liposomes.
Yusuf discloses wherein silver nanoparticles (AgNP) are widely used in a variety of products as antibacterial to prevent or treat infection, but can induce inflammation. It is found that AgNP can be encapsulated in a liposome to form Lipo-AgNP (abs) with immunosuppressive properties and will likely mitigate AgNP-mediated inflammation (§ 5).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included liposomes in the silver nanoparticle of Blosi since it is a known and effective ingredient that will likely mitigate silver nanoparticle-mediated inflammation as taught by Yusuf.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Iizaka et al. (JP 2023/060627, 04/28/2023) (hereinafter Iizaka), directed to silver nanoparticles suitable for various applications produced with materials including silver ions, a reducing agent, and a particle protective agent and further treated.
Magdassi et al. (US 2012/0241693 A1, 09/27/2012) (hereinafter Magdassi), directed to dispersions of metal nanoparticles comprising polyethylene glycol.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/ Examiner, Art Unit 1612
/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612