DETAILED ACTION
Status of Claims
Claims 1-3 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final
Claim Rejections - 35 USC § 112 – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. § 112(a) or, (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites:
1. We have successfully synthesized one pot Cu-Ag bimetallic nanoparticles with particle size less than 15 nm by using coconut shell extract.
wherein claim 1 requires “Cu-Ag bimetallic nanoparticles with particle size less than 15 nm.” However, the instant specification provides inadequate written description of structure to support the functional requirements of the claimed invention so that one of ordinary skill in the art could conclude that the inventors had possession of the claimed invention. In this regard, it is noted that MPEP § 2163 II. A. 3. (a) ii) states:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004). A description of what a material does, rather than of what it is, usually does not suffice to provide an adequate written description of the invention. Univ. of Cal. V. Eli Lilly, 119 F.3d 1559, 1568 (Fed. Cir. 1997). Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing “sufficiently detailed, relevant identifying characteristics,” including “functional characteristics when coupled with a known or disclosed correlation between function and structure.” Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1427, 1432 (DC WNY 2003).
A review of the instant published application, US 2024/0269342 A1, describes “Synthesis of PVA/PAA Hydrogel” at par. [0015]-[0016], “Coconut Coir Extract Preparation” at par. [0017]-[0018], while subsequent par. [0019]-[0023] describes “Synthesis of Bimetallic Ag—Ni Nps in Polymer Matrix” using “filtered coconut coir extract”:
Synthesis of Bimetallic Ag—Ni Nps in Polymer Matrix
[0019] FIG. 3 shows PVA/PAA Hydrogel after nanoparticle incorporation.
[0020] FIG. 4 shows Schematic illustration of Synthesis of Ag—N PVA/PAA hydrogel.
[0021] The synthesis of Ag—Ni bimetallic nanoparticles was achieved by combining 12.5 ml of 12 mM AgNO3 with 12.5 ml of 9 mM Ni (NO3)3 in a PVA/AA matrix. After that, the tube was stirred while being heated to a temperature of 60° C. As soon as this temperature was attained, 6 mL of the filtered coconut coir extract was added to the mixture. The mixture was then maintained on a steady stir and heated to 80° C. for one hour. The transformation of the liquid mixture from translucent to light brown served as a monitoring and confirmation mechanism for the creation of the nanoparticles throughout the process.
Given Below are the Primary Goals of this Invention:
[0022] a) One-pot synthesis of Ag—Ni-PVA/PAA hydrogel using coconut coir extract
[0023] b) To study the antimicrobial activity of synthesized Ag—Ni-PVA/PAA hydrogel against microbes developed on a wound.
but no description of synthesis of “Cu-Ag bimetallic nanoparticles.” Only par. [0027] of the instant published application mentions “swelling results” for “different Ag-Cu/PVA/PAA hydrogel in pure water and CBS/PBS,” and par. [0030] discusses “size distribution and polydisperity index (PDI)” of “Cu-Ag NPs” with respect to Fig. 6 of the instant published application, but no further discussion of an “Ag-Cu/PVA/PAA hydrogel” Ag-Cu nanoparticles, and how either are obtained. Further discussion at par. [0031]-[0032] and Fig. 8 of the instant published application pertains to “Ag-Ni NP” and hydrogel thereof, while neither par. [0034]-[0036], nor corresponding Fig.’s 9, are clear as to a particular nanoparticle tested. Therefore, instant claim 1 is drawn to “Cu-Ag bimetallic nanoparticles” obtained by “one pot” synthesis, whereas the instant published application, at par. [0022]-[0023], describes the “Primary Goals of this Invention” as “a) One-pot synthesis of Ag—Ni-PVA/PAA hydrogel using coconut coir extract,” and the study of “antimicrobial activity” thereof. However, applicant has not provided any descriptive support to show “one pot” synthesis of “Cu-Ag bimetallic nanoparticles” using “coconut shell extract.” It is noted that the disclosure of species may provide an adequate written description of a genus when the species disclosed is representative of the genus. However, in the instant case, applicant has not described the instant “Cu-Ag bimetallic nanoparticles” by any relevant identifying structural or functional characteristics commensurate with the instant specification. For example, the instant “Cu-Ag bimetallic nanoparticles” encompass the silver / copper nanoparticles in a conductive paste, as disclosed by JP 2008248298 A by Yumi, et al., publ. Oct. 16, 2008, at title, abstract and claims thereof (as evidenced by English language translation of JP 2008248298 A). Mere statements that modifications can be made without departing from the scope of the invention, or statements of intent that the claims are intended to cover all generic and specific features of the invention, are not sufficient for a skilled artisan to know what type of nanoparticles, and composition thereof, applicant had in possession at the time the instant application was filed. Therefore, applicant has neither disclosed any relevant or identifying characteristics of the instant “Cu-Ag bimetallic nanoparticles,” nor shown possession of the entire genus by a representative number of species.
In this regard, examiner suggests amending claim 1 to be drawn to the particular nanoparticle composition described at par. [0019]-[0023] of the instant published application, namely Ag-Ni nanoparticles in a polyvinyl alcohol/polyacrylic acid (PVA/PAA) hydrogel.
Appropriate correction is required.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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.
Claims 1-3 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 , that applicant regards as the invention.
A. Claim 1 is drawn to:
1. We have successfully synthesized one pot Cu-Ag bimetallic nanoparticles with particle size less than 15 nm by using coconut shell extract.
wherein the preamble phrasing, “We have successfully synthesized,” is indefinite. See MPEP § 2111.02 discussing effect of preamble. Under 35 USC. § 101, patentable subject mater is defined as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” However, it is unclear as to whether claim 1 is drawn to:
(i) a “composition of matter,” namely “Cu-Ag bimetallic nanoparticles” obtainable as a product-by-process via “one pot” synthesis “using coconut shell extract”; or
(ii) a “process,” namely a method of synthesizing “Cu-Ag bimetallic nanoparticles” by “one pot” synthesis “using coconut shell extract.”
To the extent applicant intends (i), claim 1 should be amended, for instance, to recite, “A plurality of Cu-Ag bimetallic nanoparticles, wherein the nanoparticles have a , and wherein the nanoparticles are obtained by one pot synthesis
Further, the use of the term, “successfully” in “successfully synthesized” claim 1 is a relative term which further renders the claim indefinite. The term “successfully” 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.
B. Claim 1 is further rejected under 35 U.S.C. 112, second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements, or in the alternative, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. In this regard, it is unclear as to whether the instant “Cu-Ag bimetallic nanoparticles” are obtained solely from “coconut shell extract,” or whether other materials and/or steps are involved. The instant published application, US 2024/0269342 A1, at par, [0017]-[0018], describes “Coconut Coir Extract Preparation, ” while subsequent par. [0019]-[0023] describe “Synthesis of Bimetallic Ag—Ni Nps in Polymer Matrix” using “filtered coconut coir extract,” which appears to be the only synthesis related to bimetallic nanoparticles in the instant application. Therefore, the instant product claims appear to be missing a polyvinyl alcohol/polyacrylic acid (PVA/AA) hydrogel as a necessary compositional component of the instant “Cu-Ag bimetallic nanoparticles.” Additionally, and to the extent applicant intends to recite product-by-process limitations (or alternatively, a claim drawn to a method of synthesizing), the recitations, “using coconut shell extract” in a “one pot” synthesis of “Cu-Ag bimetallic nanoparticles,” appear to be missing steps analogous to the synthesis described at par. [0019]-[0023] of the instant published application. For instance, and in light of the absence of support for synthesis of “Cu-Ag bimetallic nanoparticles” in a hydrogel matrix, a claim drawn to bimetallic Ag-Ni nanoparticles in a polyvinyl alcohol/polyacrylic acid (PVA/AA) matrix can include product-by-process claims (based on par. [0019]-[0023], and the instant abstract for a particle size of 12 nm) such as:
1. (Currently Amended) A hydrogel comprising a plurality of Ag-Ni nanoparticles with a particle size less than 12 nm in a polyvinyl alcohol/acrylic acid (PVA/AA) matrix by a one pot synthesis using coconut shell extract, wherein the one pot synthesis comprises the steps of:
(1) combining AgNO3 with Ni(NO3)3 in a polyvinyl alcohol/polyacrylic acid PVA/polyAA matrix to form mixture,
(2) heating the mixture in (1) 60° C,
(3) adding filtered coconut coir extract to the mixture in (2),
(4) heating the mixture in (3) at 80° C for 1 hour while monitoring a color change from translucent to light brown in order to obtain Ag-Ni bimetallic nanoparticles in a PVA/AA hydrogel.
C. Claim 2 is drawn to:
2. The as synthesized nanoparticles by using green approach are successfully incorporated in medical grade hydrogels.
which is indefinite in the recitation, “[t]he as synthesized nanoparticles by using green approach.” There is insufficient antecedent basis for this limitation in the claim as no “synthesized nanoparticles by using green approach” are previously recited in claim 2. See MPEP § 2173.05(e). Further, the use of the term, “successfully” in “successfully incorporated” claim 2 is a relative term which further renders the claim indefinite. The term “successfully” 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. Based on the proposed amendment to claim 1, in C., above, a possible amendment for “medical grade hydrogel” can recite: “2. (Currently Amended) The hydrogel of claim 1, wherein the hydrogel is a
D. Claim 3 is drawn to:
3. The synthesized hydrogels are showing excellent antimicrobial activities, average inhibitory zone diameter to the nearest millimetre (mm) was found to be 22.75 (mm) and because of this, it can be used to reduce infection, pain relief, and rapid healing.
which is indefinite in the recitation, “[t]he synthesized hydrogels.” There is insufficient antecedent basis for this limitation in the claim as no “synthesized hydrogels” are previously recited in claim 3. See MPEP § 2173.05(e). Further, the use of the term, “excellent,” in claim 3 is a relative term which further renders the claim indefinite. The term “excellent” is not defined by the claim (since it is unclear whether or not “excellent antimicrobial activities” is a further limitation in addition to the recited “average inhibitory zone diameter” of 22.75 mm), 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. In this regard, applicant suggests amending claim 3 and adding new claim 4 (with the latter for reciting an intended use, wherein the instant hydrogel “can be used to reduce infection, pain relief, and rapid healing,” as a separate claim) to read:
3. (Currently Amended) The of claim 1, wherein the hydrogel exhibita activity byofmm
4. (New) The hydrogel of claim 1, wherein the hydrogel can be used to reduce infection, reduce pain relief, and rapid healing.
Further clarification is required.
Claim Rejections – 35 U.S.C. § 102
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.
Claims 1-3 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by SIP (Sip, Y.Y.L., et al., Cu–Ag Alloy Nanoparticles in Hydrogel Nanofibers for the Catalytic Reduction of Organic Compounds, ACS Appl. Nano Mater., 4 (May 25, 2021) pp. 6045-6056; hereinafter, “Sip”).
Sip is directed to:
Cu–Ag Alloy Nanoparticles in Hydrogel Nanofibers for the Catalytic Reduction of Organic Compounds
Abstract
Nanoalloys or alloy nanoparticles containing multiple metals are of great interest because the combination of multiple metals in close proximity can grant enhanced properties including stability, activity, and selectivity arising from synergism that cannot be accessed by the combination of individual metals. In this study, we have produced nanoalloys in stable flexible electrospun hydrogel nanofibers composed of poly(acrylic acid) and poly(allylamine hydrochloride). The hydrogel fibers were loaded with metal ions such as copper and silver through an immersion in metal salt solutions followed by a chemical reduction to form the metal nanoparticles. The hydrogel matrix allowed for the absorption of metal ions into the fibers and provided a viscous environment to promote the formation of alloy particles in the small diameter range (<25 nm). The proposed fabrication process is advantageous in terms of simplicity, controllability, and versatility. The reductions of 4-nitrophenol and methylene blue were performed to test and compare the catalytic activity of monometallic nanoparticles and copper–silver bimetallic nanoparticles. The copper–silver bimetallic nanoparticles demonstrated preferred selectivity for the reduction of 4-nitrophenol and higher catalytic activity for the reduction of methylene blue. Overall, we have developed promising stable flexible nanocomposites for catalytic reduction of organic redox compounds, and other catalytic nanoalloy systems could be further studied by modification of the procedure.
Sip, title & abstract.
Regarding independent claim 1 and the requirements
1. We have successfully synthesized one pot Cu-Ag bimetallic nanoparticles with particle size less than 15 nm by using coconut shell extract.
Sip clearly teaches “copper–silver bimetallic nanoparticles” loaded into “flexible electrospun hydrogel nanofibers composed of poly(acrylic acid) and poly(allylamine hydrochloride)” (Sip, abstract), WHERBY it is noted “copper–silver bimetallic nanoparticles” (Sip, abstract) read on “Cu-Ag bimetallic nanoparticles” of claim 1. With respect to particle size, Sip teaches Cu−Ag nanoparticles with a particle size “around 10 nm”:
[…]. The 2-step Cu−Ag nanoalloy-functionalized fibers (Figure 2a) displayed an interesting assembly of NPs. As previously mentioned, Cu NP formation results in 4−5 nm particles inside the fiber. After successive reduction, the particle amount appeared to increase, and larger particles were visible on the fiber surface with the particle size around 10 nm. Figure 2b displayed the EDX line scan of a particle near the surface, suggesting more of an alloy morphology with a 1:2 Cu−Ag ratio. […].
(Sip. p. 6049, par. 3, cont. on p. 6049), which reads on a “particle size less than 15 nm” of claim 1. In this regard, it is noted that MPEP § 2131.03 states “[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is 'anticipated' if one of them is in the prior art.” Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)). It is further noted that the requirements, “synthesized [by] one pot” and “using coconut shell extract,” are product-by-process limitations. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113. Since Sip teaches “copper–silver bimetallic nanoparticles” (Sip, abstract), the substance and structure of the claimed “nanoparticles” do not appear to be structurally affected by the functional limitations, “synthesized [by] one pot” and “using coconut shell extract,” which merely reflect one version of a process that could be used to make the product.
Thus, Sip anticipates claim 1.
Regarding independent claim 2 and the requirements
2. The as synthesized nanoparticles by using green approach are successfully incorporated in medical grade hydrogels.
Sip clearly teaches “copper–silver bimetallic nanoparticles” loaded into “flexible electrospun hydrogel nanofibers composed of poly(acrylic acid) and poly(allylamine hydrochloride)” (Sip, abstract), WHERBY it is noted:
“copper–silver bimetallic nanoparticles” (Sip, abstract) read on the broadest reasonable interpretation of “nanoparticles” of claim 2, and
“flexible electrospun hydrogel nanofibers composed of poly(acrylic acid) and poly(allylamine hydrochloride)” (Sip, abstract) read on the broadest reasonable interpretation of “medical grade hydrogels” of claim 2.
It is also noted that the requirement, “using green approach” is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113. Since Sip teaches “copper–silver bimetallic nanoparticles” (Sip, abstract), the substance and structure of the claimed “nanoparticles” do not appear to be structurally affected by the limitation, “using green approach,” which merely reflects one version of a process that could be used to make the product. It is further noted that the requirement, “medical grade hydrogels,” is given its broadest reasonable interpretation encompassing poly(acrylic acid) and poly(allylamine hydrochloride)” (Sip, abstract) absent further limiting structural limitations.
Thus, Sip anticipates claim 2.
Regarding independent claim 3 and the requirements:
3. The synthesized hydrogels are showing excellent antimicrobial activities, average inhibitory zone diameter to the nearest millimetre (mm) was found to be 22.75 (mm) and because of this, it can be used to reduce infection, pain relief, and rapid healing.
Sip clearly teaches “copper–silver bimetallic nanoparticles” loaded into “flexible electrospun hydrogel nanofibers composed of poly(acrylic acid) and poly(allylamine hydrochloride)” (Sip, abstract), which reads on the broadest reasonably interpretation of “synthesized hydrogels” containing no further structural requirements. It is further noted that the requirements of claim 3 for “showing excellent antimicrobial activities, average inhibitory zone diameter to the nearest millimetre (mm) was found to be 22.75 (mm) and because of this, it can be used to reduce infection, pain relief, and rapid healing” are functional limitations. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claim 3, which achieve the resulting antimicrobial, infection, pain relief, and rapid healing effects. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: intended antimicrobial, infection, pain relief, and rapid healing effects of a composition that meets the structural requirements of claim 3 for “synthesized hydrogels.” Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claim 1 will achieve the intended result of the functional limitations and fall within the boundaries of the claims.
Thus, Sip anticipates claim 2.
Conclusion
Claims 1-3 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611