DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Request for Continued Examination (RCE), filed 4 September 2026, in the matter of Application N° 17/997,414. Said documents have been entered on the record. The Examiner further acknowledges the following:
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 4 September 2026 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-23 are pending, where claims 2-5, 8-10, and 13-23 remain withdrawn from consideration.
No additions, amendments, or cancellations to the claims filed 11 February 2026 have been made. No new matter has been added.
Thus, claims 1, 6, 7, 11, and 12 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 4 March 2026 since the art that was previously cited continues to read on the previously recited limitations.
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 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. Applicants are 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, 6, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Guay (US Pre-Grant Publication Nº 2001/0003600 A1).
As amended, the instantly claimed invention is directed to an antiviral filament comprising an antiviral polymer. The antiviral polymer comprises a base polymer and an antiviral agent uniformly incorporated into the base polymer or present in domains dispersed in a matrix of the base polymer.
Guay discloses producing a bilayer substrate wherein said substrate can be in the form of coaxial filaments having a sheath/core arrangement. See ¶[0008]-¶[0009].
Paragraph [0027] discloses that one polymer is used to form a sheath around another polymer (sheath/core), with available suitable polymers being disclosed in ¶[0025]. Paragraph [0031], for instance discloses that the fibers may be made of starch, a disclosure which is considered to support a showing that the sheath and core are prepared using the same material.
Paragraph [0033] discloses suitable active ingredients that may be used and includes chlorhexidine and chlorhexidine salts. Paragraph [0037] discloses that the active ingredient is uniformly distributed across the entire length and width of the textured article (i.e., fiber).
Based on the teachings of Guay, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 6, 11, and 12 under 35 USC 103(a) as being unpatentable over the combined teachings of Guay et al. have been fully considered, but they are not persuasive.
Applicants traverse the rejection on the grounds that Guay does not disclose the recited active agent as being uniformly dispersed within the base polymer and cites ¶[0037], ¶[0031], and ¶[0007] as supporting evidence.
The Examiner, in response, respectfully disagrees and submits that the cited paragraphs instead affirm the Examiner’s position. As discussed in the previous action, ¶[0027] and ¶[0031] teach that the core-sheath structure will employ a polymer to form both and that the sheath is formed of a polymer (e.g., starch).
Paragraph [0007] establishes that the active ingredient is also possibly mixed with starch, pectin, or cellulose.
Thus, the disclosure of ¶[0037] whereby the active ingredient is uniformly distributed across the entire length and width of the article is considered to teach that the active ingredient (e.g., chlorhexidine or salts thereof) is dispersed within the coating polymer (e.g., starch), which is uniformly or non-uniformly distributed.
Consequently, the instantly claimed invention does not compositionally or structurally distinguish itself from the teachings of Guay.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
Claims 1, 6, 7, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Migihiro et al. (JP 2018071007A; machine translation provided and cited).
As amended, the instantly claimed invention is directed to an antiviral filament comprising an antiviral polymer. The antiviral polymer comprises a base polymer and an antiviral agent uniformly incorporated into the base polymer or present in domains dispersed in a matrix of the base polymer.
Migihiro discloses antibacterial/antiviral fibers formed from quaternary ammonium salts and polyester fibers (see e.g., Abstract).
Paragraph [0016] further defines the fibers as possessing a core-sheath structure whereby the polymers of the fibers represent, most preferably, more than 90% by weight or more of the fiber.
Paragraph [0014] defines the quaternary ammonium salt antiviral compound as being present in the fiber in a range of 0.05% to 1.00% owf (on the weight of the fiber). Regarding the uniformity of the applied antiviral, the reference does not expressly use the terms “uniform” or “homogeneous,” but does disclose that the quaternary ammonium compound is applied in the form of an aqueous solution in which the fibers are soaked. This is interpreted by the Examiner as the polymeric fibers absorbing a solution (i.e., a uniform aqueous solution) of the antiviral compound.
Based on the teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 6, 7, 11, and 12 under 35 USC 103(a) as being unpatentable over the combined teachings of Migihiro et al. have been fully considered, but they are not persuasive.
Applicants traverse the rejection on the grounds that Migihiro does not disclose or reasonably suggest the combination of an antiviral agent as being uniformly dispersed within the base polymer as instantly claimed. Applicants further assert that Migihiro’s antiviral compounds are applied after fiber formation by surface treatment methods, and not blended into the polymer melt.
The Examiner, in response, respectfully disagrees and maintains the rejection for the reasons already of record.
Applicants’ remarks suggest that the species didecyldimethylammonium chloride might not exhibit the recited property of having a phase transition temperature in excess of 200ºC. To this, the Examiner respectfully points out that such a species is defined by Applicants as being a representative species of antiviral agent with this property. Thus, while the reference does not define the compound as such, the Examiner maintains that the limitation is met as defined by Applicants. See MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g).
Furthermore, the Examiner respectfully submits that the instant invention is directed to a composition and not the manner in which it is produced. The practiced fibers are disclosed as containing both polyester fiber and antiviral compound (see e.g., Abstract). Further, ¶[0025] discloses that the antiviral agent can be added by post-processing a textile with the antiviral agent and in the same bath as dyeing. The Examiner advances that a bath teaches and suggests that the fibers are soaked, and therefore, the aqueous antiviral solution would be taken up into the matrix of the polymer used to form the fibers.
Lastly, Applicants’ discussion of alleged unexpected results has been thoroughly considered, but is also not persuasive. Of particular note is Applicants’ discussion of the manner in which the fibers are produced, a limitation which is not at issue in any of the rejected claims. Additionally, the purported evidence is not considered to be commensurate in scope with the breadth of the claimed composition.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
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 1 and 6 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Davis et al. (USPN 8,128,954 B2).
As currently amended, the instantly claimed invention is directed to an antiviral filament comprising an antiviral polymer. The antiviral polymer comprises a base polymer and an antiviral agent uniformly incorporated into the base polymer or present in domains dispersed in a matrix of the base polymer.
Davis discloses a fiber comprising one or more polymers and one or more therapeutic agents (see e.g., claim 1). Claim 2 discloses that the therapeutic agent is present at a substantially uniform concentration throughout the width of the fiber. Claims 27-29 disclose that the therapeutic agent is chlorhexidine (i.e., a bisbiguanide).
The reference thus anticipates each of the recited limitations.
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 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. Applicants are 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, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (USPN 8,128,954 B2).
The limitations of claims 1 and 6 are discussed above. The limitations of claim 7 recite that the antiviral agent is present in the polymer in an amount ranging from 0.01% to 2% by weight of the total weight of the polymer.
Davis discloses a fiber comprising one or more polymers and one or more therapeutic agents (see e.g., claim 1). Claim 2 discloses that the therapeutic agent is present at a substantially uniform concentration throughout the width of the fiber. Claims 27-29 disclose that the therapeutic agent is chlorhexidine (i.e., a bisbiguanide).
Regarding the amount of drug loaded into the practiced fiber, Davis additionally teaches that drug loading of the thread, for slower release, is most preferably less than 5%, thereby encompassing the recited range (see col. 17, lines 1-13).
MPEP §2144.05(I) states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. MPEP §2144.05(II)(B) further states that “[i]n order to properly support a rejection on the basis that an invention is the result of ‘routine optimization’, the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range”.
In the instant case, Davis articulates the reasoning and motivation for the skilled artisan to modify the concentration of the drug loaded into the practiced fiber. Put plainly, it is directly correlated with the release rate of the drug of choice; “the release rate of the agent from the thread may be controlled by the ratio of the agent to the polymeric component of the thread” and that “[b]y changing the drug loading, different release rate profiles can be obtained”. “For a slower release profile, drug loading may be … preferably less than 5%.”
Based on the foregoing teachings, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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