Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges receipt of Applicants’ Response, filed 22 December 2025. Claim 1 is amended therein. Claims 7, 15, 16, 21, 23 – 25, and 28 remain withdrawn as being directed to a non-elected invention (see below). Accordingly, claims 1 – 6, 13, 18, 20, and 30 - 35 are available for active consideration.
Claim Issues
The claim set that Applicants submitted with the Response filed on 22 December 2025 provides claim identifiers (“Original,” “Currently Amended,” “Previously Presented,” etc.) for each of the claims in the set. For claims 7, 15, and 16, the claim identifier used is “Previously Presented.” However, as set forth in the Action of 1 October 2025, claims 7, 15, and 16 have been withdrawn as being directed to a non-elected invention based on Applicants’ species election. Consequently, the appropriate identifier for these claims is “Withdrawn.” See MPEP § 1893.01(a)(4). Appropriate correction is required.
Information Disclosure Statement
The Examiner has considered the information disclosure statement (IDS) filed 22 December 2025, which is now of record in the file.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejection set forth in the Action of 1 October 2025 is hereby withdrawn in light of Applicants’ amendment of the claims, and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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.
The Examiner directs Applicants’ attention to the fact that the instant rejection applies the same references as applied in previous rejections of the claims pursuant to 35 U.S.C. § 103. However, the teachings of these references are applied in a manner different from how those teachings were applied in prior rejections, necessitated by Applicants’ amendment of claim 1, thus constituting a new basis of rejection.
Claims 1 – 6, 13, 18, 20, and 30 - 35 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 5,718,909 to Forsgren, A. and A. Lundblad, issued 17 February 1998 (“Forsgren ‘909”), in view of US 2016/0192652 A1 to Hope, P., published 7 July 2016 (“Hope ‘652”), and EP 3 015 538 A1 to Andersen, J., published 5 April 2016 (“Andersen EP ‘538”), as evidenced by Applicants’ specification.
The Invention As Claimed
Applicants claim a device comprising cellulose as a carrier material, and a combination of lactoferrin and a lectin (such as WGA/wheat germ agglutinin; cf. claim 1. ii)), as a binding agent, wherein the binding agent is attached to the carrier material via one, or more, covalent bonds, wherein the one or more covalent bonds has been created by treating the carrier with an oxidizing agent to produce acid and/or aldehyde groups and subsequently contacting the treated carrier with the binding agent, such that the binding agent is linked to the carbohydrate-based polymer by the one or more covalent bonds, and the binding agent can bind to a microbe, wherein the device comprises a fluid in which the cellulose is dissolved, suspended, dispersed, emulsified, or otherwise carried, wherein the device further comprises an antiseptic, wherein the carrier material is in the form of a wipe, wherein the carrier material further comprises a buffer, and wherein the device is sterilized.
The Teachings of the Cited Art
Forsgren ‘909 discloses a sheet of nonwoven material that can be used as cleansing product in the form of a wet tissue for effective removal of bacteria, particularly type 1 piliated E. coli, wherein, by interaction with bacteria, an effective removal of the bacteria from the cleaning site is achieved by the bacteria being bound to the sheet (see Abstract), wherein the nonwoven material comprises from 5 to 50% wgt cellulose (see Col. 10, ll. 19 – 20), wherein the sheet contains an active component/[binding agent] interacting with the bacteria that are to be removed (see Col. 3, ll. 41 – 43), wherein binding to the sheet can be achieved by dipping the sheet in a solution containing the active component, which component is sucked up into the material and, after drying of the material, remains there (see Col. 3, ll. 3 – 8), wherein the sheets are then used as tissues for wiping the hands, in connection with personal hygiene, or the like (see Col. 10, ll. 42 – 44), and wherein two piliated (type 1) E. coli strains 382 and 373 bind strongly to mannoside substituted non-woven tissue (see Col. 11, ll. 52 – 54; see also FIG. 4). The reference does not disclose a device with the combination of lactoferrin and WGA as the binding agent/active component, or a device further comprising an antibiotic, or a device with carrier material further comprising a buffer, or a device that is sterilized. The teachings of Hope ‘652 and Andersen EP ‘558 remedy those disclosures.
Hope ‘652 discloses an anti-pathogen device useful as a wound dressing, an antibiotic sock, a mastitis cup, a tampon, or a window, door or bed cover, the device comprising a carrier, a pathogen-binding component, and a binding intermediate attached to the carrier to facilitate binding of the pathogen-binding component to the carrier by forming a pathogen-binding construct with the pathogen-binding component, wherein the pathogen binding construct is lactoferrin, and wherein a carbohydrate binder binds the pathogen binding construct to the carrier (see Abstract), wherein the binding affinity of the pathogen-binding component for a pathogen is increased, in addition to the pathogen-binding component being advantageously attached to a carrier (see ¶[0011]), wherein the binding intermediate comprises a protein component attached to the carrier (see ¶[0020]), wherein the pathogen-binding construct comprises an oligosaccharide component and a protein component (see ¶[0022]), wherein the carrier comprises a cloth comprising cotton (see ¶[0024]; see also ¶[0103]), wherein the cotton cloth is impregnated with a binder, such as a carbohydrate polymer that acts as a reactive organic-inorganic binder, and the cloth is impregnated with an anti-microbial, such as silver particles (see ¶[0025]), wherein the protein component/[binding agent] may be denatured prior to attaching the component to the carrier by exposure to a detergent, by using a phosphate buffered saline (PBS), or exposure to heat (see ¶[0057]), wherein the device functions as an anti-bacterial device (see ¶[0073]), wherein the device captures viruses, bacteria, or other pathogens by providing a pathogen-binding component and using the carrier to retain the pathogen, whilst delivering other factors or components (on the carrier) to the pathogen that might neutralize or kill the pathogen (see ¶[0137]), wherein, of the plant lectins, WGA has been identified as a suitable protein for mimicking the binding of influenza HA (see ¶[0187]), and wherein the device is in the form of a lactoferrin-adsorbed cloth (see ¶[203]).
Andersen EP ‘538 discloses a disinfection and/or cleaning article comprising a cloth of a nonwoven textile material containing at least 30% by weight of cellulose that is impregnated with a aqueous disinfectant composition that comprises one or more non-ionic or amphoteric disinfecting agents, one or more surfactants, a nonfoaming solvent, and a complexing agent (see Abstract; see also ¶[0024]), wherein the article comprises a composition comprising N,N-bis (aminopropyl) lauryl amine as the non-ionic disinfectant, in combination with lauryldimethylamine oxide as a surfactant (see ¶[0035]), and wherein, in testing antibiotic efficacy on a floor surface, wipes were sterilized in an autoclave (see ¶¶[0117] – [0119]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare sheets of nonwoven material for used as a cleansing product in the form of a wet tissue for effective removal of bacteria, wherein, by interaction with bacteria, removal of the bacteria from the cleaning site is achieved by the bacteria being bound to the sheet, wherein the nonwoven material comprises from 5 to 50% wgt cellulose, wherein the sheet contains an active component/[binding agent] interacting with the bacteria that are to be removed, wherein binding the active component/[binding agent] to the sheet can be achieved by dipping the sheet in a solution containing the active component, which component is sucked up into the material and, after drying of the material, remains there, wherein the sheets are then used as tissues for wiping the hands, in connection with personal hygiene, or the like, as taught by Forsgren ‘909, and wherein the sheets comprise, in addition to the carrier, a pathogen-binding construct to facilitate binding of the pathogen to the carrier, wherein the pathogen binding construct comprises lactoferrin and/or a lectin, such as WGA, wherein the lactoferrin is formulated as a denatured form of the protein by phosphate buffered saline (PBS), wherein the carrier is impregnated with silver particles as an anti-microbial [antibiotic] component, wherein the device captures viruses, bacteria, or other pathogens by providing a pathogen-binding component and using the carrier to retain the pathogen, as taught by Hope ‘652, and wherein the device is sterilized in an autoclave before use, as taught by Andersen EP ‘538. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Hope ‘652 to the effect that sheets with lactoferrin as a component of the pathogen-binding construct function to effectively remove and/or destroy bacterial pathogens on contact with the sheets/devices, and by the disclosure that WGA mimics the binding of influenza HA (see ¶[0187]). With respect to claim 30, which claim recites a limitation to the carrier comprising a buffer, the Examiner notes that Applicants’ specification, at ¶[0084], states that “the binding agent can be formulated in a buffered solution.” It is the Examiner’s position that the disclosure of Hope ‘652, directed to the binding agent being formulated as a denatured protein with phosphate buffered solution (see ¶[0057]), resulting in an anti-microbial sheet comprising a buffer.
With respect claims 31 – 33, directed to the methods used to sterilize the devices, and new claims 34 and 35, directed to methods used to form covalent bonds to the carrier material, it is the Examiner’s position that such limitations effectively render the claims product-by-process claims, wherein the recited process steps do not serve to distinguish the claimed invention from the prior art. See MPEP § 2113:
Even 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.
Furthermore, the new limitation added to claim 1 in the most recent amendment is directed to the chemical processing steps used to form covalent bonds between the binding agent and the carrier material. This limitation, therefore, also effectively renders claim 1 a product-by-process claim wherein the process-related limitations do not serve to distinguish the claimed composition over the prior art. See above.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 6, 13, 18, 20, and 30 – 35 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered the arguments that Applicants submitted with their Response filed 22 December 2025, but does not find them persuasive. Applicants first assert the following:
The presently claimed device forms strong, permanent bonds between the carrier and the binding agents which advantageously (a) prevents the binding agents from being lost over time and (b) ensures that target biotoxins, viruses, microbes, and microbial components will be more strongly retained on the device / carrier material, and less likely to be transferred to a subsequent surface (see paragraph [0083] of the present application as originally filed). The instantly claimed device therefore exhibits improved safety, efficacy, stability, and longevity when compared to a device such as that taught in Forsgren which does not employ covalent bonding between the carrier and the binding agent.
However, it is the Examiner’s position that the alleged advantages of the composition of the invention bear little relevance to the question of patentability of an invention claimed as a composition of matter. Such inventions are examined with respect to their compositional and structural characteristics, and not to what they do. Furthermore, as has been pointed previously, Applicants’ arguments in this regard are largely directed to shortcomings of the cited references taken individually, and not to what the references, taken as a whole, would teach or suggest to the skilled practitioner. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this regard, Applicants argue that Hope ‘652, a secondary obviousness reference, discloses only that “the protein component of a binding intermediate (i.e. a glycoprotein, e.g. lactoferrin) as being attached to the carrier by adsorption.” Although Applicants accurately cite to a disclosure from the reference, it is the Examiner’s position that Applicants are not correctly interpreting the disclosure, in that the disclosure is properly read, logically and grammatically, to refer to loading of protein component, and not to the chemical processes that would occur once the component is loaded into the carrier material. It is these chemical processes that would occur in a composition in accord with the teachings of the combination of cited references that would lead to the type of interaction as claimed by Applicants. Consequently, it is the Examiner’s position that the devices disclosed by the reference, comprising cotton cloth with lactoferrin and WGA as the binding agent, would necessarily result in binding of the agent to the cloth in the same manner as that disclosed and claimed by Applicants, absent some indication to the contrary. In arguing that “Hope [‘652] does not teach or suggest any such pre-treatment steps to chemically activate the carrier,” Applicants fail to take into account, as addressed above, that process-related limitations in a claim directed to a composition of matter do not serve to distinguish the invention over the teachings of prior art references unless those process steps result in a composition that is structurally or compositionally different from compositions prepared by different process methods.
Accordingly, based on the above discussion, Applicants’ arguments are unpersuasive, and claims 1 – 6, 13, 18, 20, and 30 – 35 stand rejected as obvious pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
CONCLUSION
Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The Examiner can normally be reached on M - F 8:30 a.m. - 5:00 p.m.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619