DETAILED ACTION
Claims 1-4, 7-15, and 19-23 are pending. Of these, claims 12-15 are withdrawn as directed to a nonelected invention. Therefore, claims 1-4, 7-11, and 19-23 are under consideration on the merits.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/09/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/9/26 was filed prior to the mailing date of a first Action on the merits after the filing of an RCE. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Status of the Rejections
The 103 rejections are revised in view of the amendment.
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 1-4, 7-11 and 20-23 are rejected under 35 U.S.C. 103 as unpatentable over Huang et al. (Biomaterials 141 (2017) 296-313; of record in IDS) in view of Dai et al. (ACS Appl. Mater. Interfaces 2016, 8, 25798-25807; of record in IDS).
As to claims 1-4, 7-11, and 20-23, Huang discloses an antimicrobial agent comprising a selenium nanoparticle functionalized with EDC and NHS amine linkers that conjugate an antimicrobial peptide (UBI29-41) to the nanoparticles via a covalent linkage (claim 10) (Abstract and Section 2.2). Since the covalently linked antimicrobial peptide is within the scope of dependent claim 10, the antimicrobial peptide is “superficially located” as required by claim 1. The nanoparticles are formed in an aqueous solution (a “carrier” of claim 11)(Section 2.2). Huang teaches that the nanoparticles are spherical (claim 2) and have a diameter of 52 nm, which is within the ranges of claims 3 and 20 (first paragraph of Section 3.1). Huang further teaches coating a ruthenium complex onto the nanoparticles resulting in particles having a size of 78 nm, which is within the range of claim 21. Id. Additionally, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Huang teaches that the selenium nanoparticles enhanced the stability of the antimicrobial peptide and also caused the composition to specifically target bacterial infection and that the purpose of the reuthenium complex is to impart synergistic antimicrobial activity (Abstract).
Regarding the limitation of claim 1 that the antimicrobial agent is “consisting essentially of” the selenium nanoparticle core and one or more superficially located antimicrobial peptides, for the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." MPEP 2111.03. See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 ("PPG could have defined the scope of the phrase 'consisting essentially of' for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention."). See also AK Steel Corp. v. Sollac, 344 F.3d 1234, 1240-41, 68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003) (Applicant's statement in the specification that "silicon contents in the coating metal should not exceed about 0.5% by weight" along with a discussion of the deleterious effects of silicon provided basis to conclude that silicon in excess of 0.5% by weight would materially alter the basic and novel properties of the invention. Thus, "consisting essentially of" as recited in the preamble was interpreted to permit no more than 0.5% by weight of silicon in the aluminum coating.); In re Janakirama-Rao, 317 F.2d 951, 954, 137 USPQ 893, 895-96 (CCPA 1963). If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of "consisting essentially of," applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant's invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See also Ex parte Hoffman, 12 USPQ2d 1061, 1063-64 (Bd. Pat. App. & Inter. 1989) ("Although 'consisting essentially of' is typically used and defined in the context of compositions of matter, we find nothing intrinsically wrong with the use of such language as a modifier of method steps. . . [rendering] the claim open only for the inclusion of steps which do not materially affect the basic and novel characteristics of the claimed method. To determine the steps included versus excluded the claim must be read in light of the specification. . . . [I]t is an applicant's burden to establish that a step practiced in a prior art method is excluded from his claims by 'consisting essentially of' language.").
Here, there is no evidence of record that the antimicrobial agent of Huang comprises any ingredient that would materially affect the basic and novel characteristics of the claimed composition. Therefore, “consisting essentially of” is currently being interpreted as equivalent to “comprising.”
As to claims 1-4, 7-11, and 20-23, Huang does not further expressly disclose that the antimicrobial peptide is the elected species of claims 1 and 7)(i.e., ε-poly-L-lysine), and which is electrostatically adsorbed (claim 8) or hydrogen bonded (claim 9) to the selenium nanoparticle core.
Dai discloses silver nanoparticles comprising ε-poly-L-lysine for use as antimicrobial agents that promote wound healing, and teaches that ε-poly-L-lysine is a naturally occurring polypeptide that itself has anti-infection activity along with good biocompatibility (Abstract and paragraph bridging pages 25798-25799). Dai teaches the use of ε-poly-L-lysine having a molecular weight of 7000 Da, which corresponds to a peptide having approximately 48 lysine residues, which is within the range of claims 4 and 22-23 (“Materials” paragraph on page 25799).
As to claims 1-4, 7-11, and 20-23, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the antimicrobial agent of Huang to comprise ε-poly-L-lysine as the antimicrobial peptide instead of, or in addition to, the UBI29-41 antimicrobial peptide taught by Huang, because Dai expressly teaches that ε-poly-L-lysine is another example of an antimicrobial peptide that is suitable for linking to metal nanoparticle to produce an antimicrobial composition that is useful in wound healing, such that the skilled artisan reasonably would have expected that ε-poly-L-lysine could be used successfully as an antimicrobial peptide in the metal nanoparticles of Huang. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Regarding claims 8-9, the skilled artisan would recognize that ε-poly-L-lysine has a positive electrostatic charge as well as hydroxyl and amine groups, such that it is capable of electrostatic adsorption onto the selenium core as well as engaging in hydrogen bonding interactions with the selenium core. The skilled artisan would further recognize that while Huang discloses that the selenium nanoparticle comprises a linker to form a covalent bond with the antimicrobial peptide, some of the ε-poly-L-lysine molecules will interact with the selenium core via hydrogen bonding and electrostatic interactions as they come into contact with the cores during the synthesis step of the selenium-peptide nanoparticles.
Claim 19 is rejected under 35 U.S.C. 103 as unpatentable over Huang et al. (Biomaterials 141 (2017) 296-313) in view of Dai et al. (ACS Appl. Mater. Interfaces 2016, 8, 25798-25807) as applied to claims 1-4, 7-11, and 20-23 above, and further in view of Agarwal et al. (US Pat. Pub. 2015/0283287).
The teachings of Huang and Dai are relied upon as discussed above, but they do not further expressly disclose an article incorporating the antimicrobial agent and which is the elected species of article of claim 19, i.e., a wound dressing.
Agarwal discloses compositions for wound healing comprising a wound dressing (paragraphs 1, 45, and 231), and teaches that the composition may comprise particles comprising an antimicrobial such as selenium (paragraph 223), wherein the particles may have a size of at least 100 nm (paragraph 224).
As to claim 19, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the selenium nanoparticle-containing antimicrobial agent of Huang and Dai as combined supra by incorporating the antimicrobial agent onto the surface of a wound dressing, because Agarwal teaches that particles comprising an antimicrobial such as selenium are useful for imparting antimicrobial activity to wound dressing when incorporated therein, such that the skilled artisan reasonably would have expected that the antimicrobial agent of Huang and Dai also would be useful in imparting antimicrobial activity to wound dressings.
Response to Applicant’s Arguments
Applicant argues that claim 1 as amended recites that the antimicrobial agent consists essentially of a selenium nanoparticle (seNP) core and one or more superficially located antimicrobial peptides, and argues that tables 1-2 of the specification clearly show that the claimed invention is an effective antimicrobial agent in the absence of any other antimicrobial agent. Applicant claims that the amended claim language excludes the presence of other antimicrobial agents such as the ruthenium complexes taught by Huang. Applicant further argues that the ruthenium complexes are essential to the Huang invention because Huang’s data shows that there is no meaningful antimicrobial efficacy observed with the selenium nanoparticle/peptide unless they are further functionalized with the ruthenium complexes.
In response, and as discussed in the revised rejection, it is Applicant’s burden to demonstrate that the cited art comprises an additional element that is excluded by the “consisting essentially of” language because it would materially alter the characteristics of the invention. In the AK Steel Corp. v. Sollac, case cited in the rejection, supra, the specification stated that "silicon contents in the coating metal should not exceed about 0.5% by weight" and discussed the deleterious effects of silicon such that it was concluded that silicon in excess of 0.5% by weight would materially alter the basic and novel properties of the invention and was excluded by "consisting essentially of" language in the claim.
Here, while Applicant states that the specification shows that the claimed invention is effective as an antimicrobial in the absence of other antimicrobial agents such as the ruthenium complexes taught by Huang, the characteristic of the present invention is that a composition comprising selenium nanoparticle along with an associated antimicrobial peptide exhibits antimicrobial activity. There is no evidence that including a ruthenium complex in the claimed composition would impair this characteristic antimicrobial activity of the invention. The present specification does not teach that a ruthenium complex should not be included or would be harmful to the claimed invention. In fact, since Huang teaches that the inclusion of a ruthenium complex enhances the antimicrobial activity of the nanoparticles, the skilled artisan would expect that the antimicrobial activity of the claimed invention would be enhanced with the inclusion of the ruthenium complex.
Conclusion
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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