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 .
Priority
This application is a National-Stage entry of PCT/CA2021/050719, filed 5/27/2021, which benefit to U.S. Provisional Patent Application No. 63/102,002, filed on 5/27/2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/23/2022 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of claims 11-18 in the reply filed on 12/16/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Response to Amendments
Applicant’s amendment to the claims filed 12/16/2025 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claims 1-10 have been withdrawn from further consideration.
Claims 11-18 are pending and have been examined on the merits herein.
Drawings
The drawings filed 11/23/2022 are objected to because the figures are not properly label as they all use the label “Figure” instead of “FIG”. 37 CFR 1.84(u)(1) states that “The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.”
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.
Claim Interpretation
Claim 1 recites, in the preamble, the phrase “A test material for use in non-microbial prediction of antimicrobial efficacy of an antimicrobial item”. This has been interpreted as being drawn to an intended use of a composition, and afforded the appropriate patentable weight. See MPEP § 2111.02. In the instant case, there is no structural requirements imparted by the preamble, just that it is used for the prediction of the efficacy of an antimicrobial item. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) and Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997).
The claims have been interpreted under the broadest reasonable interpretation (B.R.I.), in light of the specification. Regarding the phrase “non-microbial prediction”, the following descriptions are of note in the specification: “The disclosure is directed at a method and system for non-microbial, or chemical, determination or indication of antimicrobial efficacy of an antimicrobial item” ([0046]) and “the test formulation of the disclosure does not require any bacterial or culture growth, such that the disclosure may be seen as a non-microbial system and method of determining antimicrobial activity for a surface, material or antimicrobial item of interest.” ([0048]). Therefore, the term “non-microbial prediction” is being interpreted to mean that culturing of living material is not necessary to determine the antimicrobial efficacy of an antimicrobial item, to that extent that this limitation may affect the structure of the test material.
The specification also states that “[the] use of the phrase "surface of interest" in the following description also includes a "material of interest"” (see [0049]). Thus, the “antimicrobial item” encompasses, under the B.R.I., any antimicrobial material, including suspensions, coatings, surfaces, et cetera. Further, it is evident from the specification that the test material can be of any suitable form, including a liquid, suspension, or spray ([0053]).
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 recites “PVP capped nanoparticles” and “PVP capped gold nanoparticles”, without first providing the meaning of the abbreviation “PVP”. It can be determined from the specification and the relevant art that the term means polyvinylpyrrolidone ([0098] of the specification). However, it is recommended for the sake of clarity to fully define the abbreviation when first recited in the claims, for example only, as: “polyvinylpyrrolidone (PVP)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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.
Claims 11 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites a component that changes color when in contact with metal ions leaching from the antimicrobial item or reactive oxygen species on the antimicrobial item.
Dependent claims 12-14 require that the component is bicinchoninic acid (BCA).
Claim 15 limits the genus of compounds to redox dyes, which are further limited to specific dyes in claim 16.
Claims 17 and 18 recite that the component is silver or gold nanoparticles, having specific structures (e.g. PVP- or citrate-capped, and/or having a prismatic shape).
Claim 11 encompasses any chemical that fulfills the desired result of changing color when in contact with metal ions leaching from the antimicrobial item or reactive oxygen species on the antimicrobial item. Claim 15 limits this to any redox dye, but does not provide limitations of specific compounds of chemical structures.
According to the B.R.I. of the claim, when viewed in light of the specification, there exists a large number of chemicals that encompassed within the claimed scope, because the claimed compounds of claims 11 and 15 are only described by functional properties and not by any structural features or chemical identity. Comparatively, the specification only recites a small number of species of this broad genus that meets the recited limitations.
MPEP § 2163.03, subsection V describes that “an original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement."Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002)”.
In the instant case, claim 11 only defines the component by reciting a functional property amounting to a desired result, thus there must be sufficient description that links this function to a specific structure to amount to evidence that the full scope of the claimed genus is adequately described. Similarly, claim 15 only further limits the component to a “redox dye”, without giving any specific structure that fulfills this functional property (i.e. that the dye is sensitive to the reducing or oxidizing compounds).
Thus the breadth of these claims includes any and all structures that results in the desired color changing properties, upon fulfilling the conditions of claim 11 (i.e. when in contact with a metal ion or a reactive oxygen species).
MPEP § 2163.(II)(A)(3)(a) states that 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 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 inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The specification fails to reasonably describe the full genus of the claimed invention by providing identifying characteristics or functional properties of the dyes such that a specific structural feature may be linked to the claimed desired result (i.e. the color change).
The instant specification does not disclose relevant identifying characteristics, such as key structural or other physical properties, or functional characteristics coupled with a known or disclosed correlation between function and structure, such that the entirety of the claimed genus is encompassed by the description in the disclosure.
The specification states, generally, that the test material comprises “a component that changes color when in contact with metal ions leaching from the antimicrobial item or reactive oxygen species on the antimicrobial item” ([0016]), which is the same as the claim language, but does not provide any specific definitions or structural relevance.
The specification does give specific examples of structures that fulfill the claimed function. These are listed in [0017]-[0019] and encompass the specific compounds of claims 12-14, 16, and 17-18. However, there is no evidence of any known or newly disclosed relationship between these particular chemical structures and the color changing function that is sufficient to fulfill the written description requirement.
The specific examples in the specification include (i) BCA for testing copper ions ([0059]-[0067]; Figures 3a and 3b), (i) resazurin for testing zinc and similar specifically named redox dyes ([0080]-[0088]; Figures 8a, 8b, 10a, and 10b), and (iii) the citrate capped silver nanoparticles (nanoprisms) and the detection thereof ([0093]-[0105]; Figures 16a, 16b).
Thus, the specification only provides only three working examples of the claimed genus of claim 11, which cannot be considered a sufficient description of a representative number of species by actual reduction to practice of the full breadth of the vast genus, said genus defined only by the functional language amount to a desired result.
Claim 15 limits the genus to “redox dyes” but there is no practical definition of redox dyes based off a structure or identified chemical components. Thus, there is no manner for determining if applicant was in possession of the full genus of all redox dyes, and these is no correlation a between specific structures and the desired functional properties.
There is no evidence that, at the time of filing, the Applicant possessed additional representative species of the full genus recited in claims 11 and 15 beyond those provided in the working examples.
For these reasons, the disclosure fails to provide adequate written description to support the entirety of the broad genus claim to any and all components which have the function of the claimed color change, nor any and all redox-sensitive dyes, beyond those specified herein.
Claims 11 and 15 are rejected under 35 U.S.C. § 112(a) because the claimed subject matter is not described in the specification in such a way as to reasonably convey to a skilled artisan that the inventor, or joint inventor, had possession of the genus of the claimed invention.
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.
Claim 18 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 18 recites the limitation "the silver nanoparticles" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 17, on which claim 18 depends recites “citrate capped silver nanoparticles”. It is unclear whether the silver nanoparticles of claim 18 is the same as the citrate capped silver nanoparticles or this is in reference to any silver nanoparticles. The resulting claim is indefinite as the boundaries of the claimed subject matter is not property set forth.
Claim Rejections - 35 USC § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cao et al. ("Portable colorimetric detection of copper ion in drinking water via red beet pigment and smartphone." Microchemical Journal 150 (2019): 104176.).
Claim 11 recites a material, intended for detecting antimicrobial activity, comprising a component that changes color when in contact with metal ions leaching from the antimicrobial item. Therefore, the claimed test material encompasses any colorimetric composition or solution, that can be used to detect antimicrobial components on a material (e.g. the metal ions or reactive oxygen species).
Cao et al. discloses an efficient and selective method for the detection of Cu2+ in water, using a natural food pigment, red beet pigment that was selected as a colorimetric indicator for the detection of Cu2+ (Fig. 1, Abstract: “red beet pigment reacted selectively with Cu2+ by redox reaction and chelation, resulting in a color change from purple to orange-red.”).
Therefore, Cao discloses a composition, i.e. a solution, used for a test material, that comprises a component that changes color when in contact with metal ions (“as the concentration of Cu2+ increased, the red beet pigment solution gradually changed from bright purple to orange-red”, pg. 2, right col., under section 3.1. Construction of red beet pigment based colorimetric sensor for the detection of Cu2+; Fig. 1a). Cao discloses a composition including a dye having all of the claimed structural limitations of the instantly claimed invention.
Claim 15 recites that the component comprises a redox dye. Cao discloses that the red beet pigment solution is a redox dye and that the color change of red beet pigment after addition of Cu2+ is attributed to a redox reaction and chelation between the red beet pigment and Cu2+ (pg. 3, right col, under 3.3. Possible mechanism of the colorimetric sensor). Thus, the dye as used in Cao is a “redox dye”, encompassed by the B.R.I. of the instant claim terms.
Regarding the preamble of the intended use for testing an antimicrobial item, it is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See also MPEP §§ 2112.01 and 2111.02.II. In the instant case, the copper detecting dye of Cao could inherently be used to perform the recited use of detecting copper ions that have anti-microbial efficacy, without modification.
Therefore, the redox-sensitive, copper-detecting dye composition of Cao anticipates claims 1 and 15.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977), In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Claims 11, 15, and 16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being are anticipated by McSherry et al. (US PGPub No. 20170071200).
McSherry discloses self-indicating chemistries for visual detection by a user of efficacious levels of peroxycarboxylic acid concentrations in a solution, including a combination of dyes providing a visual color indication (Abstract), useful for detecting a minimum concentration of peroxycarboxylic acid for efficacy as an antimicrobial (claim 1, Title). McSherry discloses that the composition can be used along with peroxycarboxylic acid for hard surface treatment until the self-indicating chemistry compositions provides a user with a visual indicator ([0140]).
McSherry discloses that peracid-selective dyes suitable include chromophores which have been shown to be sensitive to oxidation (e.g. a redox dye) by hydrogen peroxide in the presence of HRP and which presumably will show peracid sensitivity ([0051]), including resazurin (Amplex Red: 7-hydroxy-10-oxidophenoxazin-10-ium-3-one, [0052]), as recited in the instant claims 15 and 16.
McSherry thus discloses a test material (e.g. “a self-indicating peroxycarboxylic acid chemistry composition”, claim 1) comprising (but not limited to just) a component that changes color when in contact with reactive oxygen species on the antimicrobial item (i.e. “...upon oxidation by the peroxycarboxylic acid provides a visual indication the presence of a minimum concentration of peroxycarboxylic acid for efficacy as an antimicrobial”, claim 1 of McSherry).
Regarding claims 15 and 16, the composition of McSherry contains additionally a latent dye of a visual indicator composition with a peroxycarboxylic acid to oxidize the latent dye, which, according to the specification includes the redox sensitive dye resazurin (e.g. Amplex Red, [0051-[0052]).
Claims 11, 15, and 16 are thus anticipated by the disclosed embodiments of McSherry.
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.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Brenner et al. (1995. “A quantitative test for copper using bicinchoninic acid.” Analytical Biochemistry, 226(1), 80-84, referred to herein as “Brenner”), in view of Jiang et al. (US PGPub No. 20150225572).
Brenner teaches a direct colorimetric assay for copper in serum and biological samples using 2,2'-bicinchoninic acid (BCA) (Title, Abstract). Brenner teaches that the basis for the analysis lies with the complexation with BCA at alkaline pH with cuprous ions and that the color development is rapid and takes advantage of the highly specialized interaction of BCA with Cu(I) (see pg. 80, right col; FIG. 2; and pg. 84, Conclusions).
Brenner teaches that the assay uses multiple reagents including (i) Reagent A, comprising trichloroacetic acid (TCA); (ii) Reagent B, comprising L-dihydroascorbic acid (i.e. ascorbic acid or ascorbate); and (iii) Reagent C, comprising bicinchoninic acid disodium salt (pg. 81, left col). Brenner further teaches that the composition can comprise sodium phosphate dibasic (pg. 81, right col: “the pH of the solution was fixed by adjusting the ratio of Na2HPO4/NaH2PO4”).
Brenner does not explicitly teach that the copper detection assay is used for detection of an antimicrobial activity on an antimicrobial item leeching copper ions.
Jiang teaches antimicrobial coatings that exhibit high antimicrobial performance which comprise a plurality of copper particles, comprising copper ions of Cu1+, and Cu2+ (Abstract, Title, claims 1 and 2). Jiang teaches that copper is a known effective antimicrobial material and has been approved by the US Environmental Protection Agency (EPA) ([0003]). Jiang teaches that the core/shell structure of the copper particles taught therein results in a significantly better anti-oxidation performance and controlled release of active copper species ([0050]). Jiang teaches there is a linear relationship between Cu1+ concentration and antimicrobial activity ([0066]; FIG. 13). Jiang also teaches measuring the concentration of the copper particles in leachates from the coatings tested therein ([0104]-[0105]; FIG. 12). Thus, Jiang teaches an anti-microbial item (i.e. the coating) comprising copper particles.
To one of ordinary skill in the art, prior to the effective filing date of the claimed invention, it would have been prima facie obvious to test the concentration of copper from an antimicrobial item using a colorimetric reagent containing bicinchoninic acid and a weak reducing agent, ascorbic acid, as taught in Brenner, for the predictable benefit of detecting the presence of antimicrobial copper ions, according to the cited teachings of Jiang.
The instantly claimed test solution would have been clearly obvious over the testing composition taught in Brenner (both comprising BCA as the critical color changing dye) and the application of testing a composition having copper ions for antimicrobial activity would have been an obvious application of this test reagent. One of ordinary skill would have been motivated to apply the colorimetric assay for copper ion detection to test for the presence of antimicrobial activity, because Jiang teaches that copper ions are well-known in the art for antimicrobial activity, and teaches coating surfaces with particles for leaching copper ions. One would have been motivated from the combined teachings of Jiang and Brenner to use the visible, colorimetric assay to rapidly detect whether copper ions were present or not, as this would replace the more complex analysis techniques with a simple to use color changing assays.
MPEP § 2143.I.A describes that a claim is rendered obvious when all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395. This is the instant case, as both copper containing antimicrobial items are known in the art, as evidenced by Jiang, and copper ion detection assays using the colorimetric dye BCA are taught in Brenner. Further, MPEP § 2143.I.G. describes that “the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. "[A]n implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient.”. For the instantly claimed invention, it is clear from the teachings of Brenner, that the copper detection assay using BCA would amount to a visible colorimetric assay for the presence of copper ions, indicating the presence of anti-microbial activity, and would be recognized by one of ordinary skill in the art.
From the teachings of the cited references, it is apparent that there would have been a reasonable expectation of success in combining the teachings therein to arrive at the claimed invention because each reference is relevant to the issue of copper ion detection and/or application of copper ions for antimicrobial activity and the copper ion detection method of Brenner is substantially identical to that claimed herein. It would have been predictable that the assay could successfully be used to indicate copper ions for an item including that of Jiang.
Therefore, claims 11-14 would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, especially in the absence of evidence to the contrary.
Claims 11, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Noble et al. (WO2014165968) in view of Karandikar et al. (EP2859961).
Claim 11 recites a component that changes color when in contact with metal ions leaching from the antimicrobial item or reactive oxygen species on the antimicrobial item, while claims 17 and 18 limit the component to citrate capped silver nanoparticles, PVP capped nanoparticles, citrate capped gold nanoparticles or PVP capped gold nanoparticles, and/or to silver nanoparticles comprising prismatic silver nanoparticles (claim 18).
Noble pertains to the use of silver nano-particles for the treatment of cancer, viral infections and/or bacterial infections (Abstract, claims 11 and 20). Noble teaches that “Silver nano-particles are widely used as antibacterial agents in numerous consumer products, such as clothing, pharmaceuticals, cleaning solutions, and even plastics” ([0003]). Noble teaches that the anti-microbial silver nanoparticles may comprise citrate-capped silver nanoparticles or polyvinylpyrrolidone (PVP) - capped silver nanoparticles ([0017]; [0044] and claims 16-17 and 25-26). Noble teaches that “The selection of a particular capping agent for a particular method, use or kit of the present disclosure can be made by a person skilled in the art in light of common general knowledge and with reference to the present disclosure.” ([0044]).
Regarding claim 18, Noble also teaches that the silver nano-particles may be silver nano-prisms ([0017], claims 15 and 24), and teaches that “It will be appreciated by a person skilled in the art that a variety of silver nano-particle shapes are known in the art for silver nano-particles and the selection of a useful shape for the methods, uses and kits of the present disclosure can be made by a person skilled in the art” ([0063]).
Thus, Noble teaches a composition of citrate or PVP capped silver nanoparticles having antimicrobial activity, substantially identical to those of claims 17 and 18.
However, Noble does not teach explicitly that the citrate or PVP capped silver nanoparticles impart a color change that can be used to determine antimicrobial activity.
Karandikar pertains to the production and use of silver nanoparticles (Title, Abstract). Karandikar teaches that “nanoparticle compositions of the present invention can be used in other compositions where an antimicrobial environment or antifouling environment is desired or where a reduction in microbial growth, or a reduction in odor would be useful” ([0014]).
Karandikar teaches that the silver nanoparticles cause a characteristic visible color change ([0027]: “Upon nanoparticle formation, the metal nanoparticles may impart a characteristic color to the treated surface or article. For example, silver nanoparticles impart a characteristic yellow to yellow amber color, depending on the concentration of nanoparticles present”). In various embodiment, Karandikar teaches that treating materials with the silver nanoparticles results in a darkening color change and imparts antimicrobial activities (see e.g. [0193]; “Following treatment, it imparted faint yellow color that after 24h turned to orange red. The color change indicated the presence of silver nanoparticles in the catheter walls. It was found to [be] antimicrobial in 24h bacterial challenge test.”, see also the examples of [0194], [0198], and [0202]).
Thus, to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, it would have been prima facie obvious that when using the antimicrobial citrate or PVP-capped silver nanoparticles taught in Noble, that the presence of the silver nanoparticles at a suitable concentration to impart antimicrobial activity can be determined by a visible colorimetric change, according to the teachings of Karandikar.
One would have been motivated to use the color change taught in Karandikar to determine whether antimicrobial silver nanoparticles were present on a surface, because Karandikar teaches that the yellow-brown color imparted by an analogous silver nanoparticle solution is correlated or predictive of the antimicrobial (antibacterial) activity. Thus the color change and the antimicrobial activity are both properties of silver nanoparticles known to the art. The citrate-capped silver nanoparticles and the PVP-capped silver nanoparticles taught in Noble appear to have all of the claimed structural features of the instant claim 17. Because Karandikar teaches that silver nanoparticles impart a darkening color change when applied to an item for which antimicrobial activity is desirable, it is obvious that those of Noble would impart an analogous colorimetric change, indicative of a suitable concentration.
Indeed, the disclosure of these darkening color changing properties of in the instant specification ([0094] and [0097]) is further evidence that the structures taught in Noble, which appear to be structurally identical to those instantly claimed, would possess the same color changing functional properties. Thus, the functions, both explicit and implicit, of the prior art nanoparticles appear to be inclusive of those appreciated in the instant disclosure as being present (see MPEP 2112.02 at Ex parte Novitski, in reference to reference-silent functioning of biological materials providing anticipation of the functions based upon the material itself, noting the reference of “Dart” therein did not appreciate the claimed function but still anticipated the function based on the inherent function of the material, and that the Applicant’s disclosure appreciating the function upon usage thereof as further evidence of the presence of the function).
Regarding claim 18, Noble teaches that the silver nanoparticles may be silver nano-prisms (i.e. thus prismatic silver nanoparticles) and Noble teaches a variety of silver nano-particle shapes are known in the art and the selection of a useful shape for the desired method can be made by a person skilled in the art. Thus, the selection of the silver nanoprism would amount to a matter of judicious selection among known materials and shapes in the art. Any benefits, although not presently recited in the claim, imparted by the selection of the known nanoprism shape would have been discovered as a manner of routine optimization, as Noble teaches different shapes may be beneficial depending on the desired method (thus the shape is a known result-effective variable).
From the teachings of the cited references, it is apparent that there would have been a reasonable expectation of success in combining the teachings therein to arrive at the claimed invention because both Noble and Karandikar pertain to the use of silver nanoparticles as antimicrobial agents, and each teach structural and functional properties of these nanoparticles.
Therefore, the invention of claims 11, 17, and 18 would have been prima facie obvious over the combined teachings of Noble and Karandikar, especially in the absence of evidence to the contrary.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bertucci (US PGPub No. 20070275472) teaches a method for testing for presence of silver metal or silver salt antimicrobial agents on a surface of substrate, comprising contacting the substrate with a dye solution, wherein the dye solution comprises a dye selected to provide a detectable differential color change in the dye solution contacted substrate for a substrate having silver metal or silver salt on a surface thereof (Abstract, claim 1).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW TERRY MOEHLMAN whose telephone number is (571)270-0990. The examiner can normally be reached M-F 9am-5pm EST.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655