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 .
Detailed Action
Status of Application
1. Applicant’s arguments/remarks filed 24 March 2026 are acknowledged. Claims 1, 28, 31, and 43-45 are currently pending. Claims 2-27, 29-30, and 32-42 have been cancelled. Claims 1 and 43 have been amended. Claims 1, 28, 31, and 43-45 are examined on the merits within.
Withdrawn Rejections
2. Applicant’s arguments, filed 24 March 2026, with respect to the 35 U.S.C. 112(a) Rejection have been fully considered and are persuasive. The 35 U.S.C. 112(a) Rejection of claims 1, 28, 31, and 43-45 has been withdrawn. The 35 U.S.C. 103 Rejection of French in view of Gabbay et al. and Baldacci has been modified to also include the teachings of Bruder et al.
New Rejections
Claim Rejections – 35 U.S.C. 112(b)
3. 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.
4. Claims 1, 28, 31, and 43-45 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. Claim 1 recites “consisting of disposing a fabric containing infused copper in proximity to an affect eyelid of the subject”. The claim further states “a middle layer that is not in direct contact with the subject, and a bottom layer, and wherein the middle layer is made of a yarn consisting of the infused copper.” Since the amendment clarifies that the copper is not in direct contact with the subject, it is unclear how “proximate” the phrase “in proximity to an affected eyelid of the subject” would be. Are the symptoms of blepharitis or dry eye reduced by laying an eye mask on a night stand close by the subject or does the fabric need to be in physical contact with the subject even though the copper itself does not have to be in direct contact. Clarification is requested. Claim 43 is included in this rejection for the same ambiguity.
Claim Rejections – 35 U.S.C. 103
6. 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.
7. Claims 1, 28, 31, and 43-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over French (WO2012/007723) in view of Gabbay et al. (J. Industrial Textiles, 2006), Bruder et al. (U.S. Patent No. 9,445,939) and Baldacci (WO2016/162795).
French teaches bed sheets, wound dressings, face masks, anti-wrinkle devices, clothing fabrics, etc. comprising copper with antimicrobial properties. See abstract. A fabric structure includes a multilayer fabric with an outer shell of woven fabric, a thermally insulating wadding, copper mesh and an inner lining. See pages 32-33. Figure 15 shows a multilayer fabric 71. There is an outer shell 72 of a conventional woven. Next to the outer shell 72 is a layer of thermally insulating wadding 73, followed by a layer of the copper mesh 1 or the combination mesh 54. In this case, there is also an inner lining 74 of silk, artificial silk or the like, for comfort. See page 33. Metallic wire may be twisted together with natural or artificial polymer fibers to form composite fibers which are formed into a woven mesh. See page 4. Thus the copper mesh layer is copper and woven with polymers.
French does not teach treating blepharitis or dry eye or an amount of 0.05 to 4.5% copper.
Gabbay et al. teach that impregnating or coating cotton or polyester fibers with cationic copper endows them with potent broad-spectrum antibacterial, antiviral, antifungal and anti-mite properties. The technology allows for introduction of copper oxide treated fibers into woven and non-woven fabrics. The fabrics contain 3-10% copper impregnated fibers. See abstract. The fibers can be made of polyester, polypropylene, polyethylene, polyurethane, polyolefin, cotton (cellulose) or nylon fibers. See page 325. Yarn with treated fibers were used. See page 328. Polypropylene based fabrics were made with 3% copper. See page 329. Fabrics include sheets, pillow covers, mattress covers, etc. See abstract.
Bruder et al. teach providing moisture therapy to a subject by applying a moist therapy compress against a treated body portion. The moist therapy compress includes a fluid-permeable shell, a flexible backing fastened to the shell to define an enclosure and hydrophilic zeolite fill granules loosely contained within the enclosure. See abstract. The present invention relates generally to medical treatment devices and therapeutic methods, and more particularly to moist-heat therapy compresses and wound dressings, and to a wound dressing and/or heat-therapy compress containing antimicrobial metal(s) providing a germ and microbial free environment within the article and treated areas. See column 1, lines 20-26. The antimicrobial agent is copper. See claim 14. The outer shell comprises a synthetic fabric. See claim 2.
Baldacci teaches the combination of pyrrolidone carboxylic acid (PCA) with at least one additional active ingredient for use in the treatment of ocular diseases. See abstract. Addition of copper sulfate to PCA surprisingly resulted in synergistic effect of ocular treatment especially in the case of inflammations and/or infections of the cornea of bacterial origin. See page 12. The composition may be in the form of a spray to treat blepharitis due to dryness. See page 9. The formulation can also be a cream, ointment or gel. See page 9. The additional active ingredient, i.e., copper, is present in an amount of 0.0005% to 0.2%. See page 10.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to apply a multilayer fabric containing copper in the proximity of an eyelid as an antibiotic to treat blepharitis. One would have been motivated, with a reasonable expectation of success, because French teaches the antimicrobial effectiveness of copper applied to multilayer structures wherein copper is present in an inner layer, Gabbay et al. teach the effective antibiotic properties of copper when applied to fabric, such as pillow cases, which come in close proximity to the eye, Bruder et al. teach the antimicrobial effectiveness of copper without being in direct contact to a subject, and Baldacci teaches the use of copper to provide synergistic effect when treating dry eye and blepharitis. The content of yarn in fabric is a matter of routine optimization based on the desired properties and intended use of the fabric. It would have been well within the purview of the skilled artisan to modify the amount of copper based on known effective amounts to provide antimicrobial properties to fabric as taught by Gabbay et al.
Response to Arguments
Applicant’s arguments filed 24 March 2026 have been fully considered but they are not persuasive.
8. Applicants argued, “French does not teach the antimicrobial effectiveness of copper applied to multilayer structure wherein copper is present in an inner layer. The therapeutic effect of copper is by contact with the skin of the wearer. Gabbay also teaches direct contact.”
In response to applicant’s arguments, French specifically teaches multilayers, wherein the inner layer comprises copper and polymer in a fiber mesh, while also providing antimicrobial effectiveness. Thus French shows the antimicrobial effectiveness of a product wherein copper is in an internal layer and not in direct contact. However, the prior art of Bruder et al. was provided to show that copper contains it’s antimicrobial effectiveness even when it is not in direct contact with the user. The moist therapy compress includes a fluid-permeable shell, a flexible backing fastened to the shell to define an enclosure and hydrophilic zeolite fill granules loosely contained within the enclosure. See abstract. The present invention relates generally to medical treatment devices and therapeutic methods, and more particularly to moist-heat therapy compresses and wound dressings, and to a wound dressing and/or heat-therapy compress containing antimicrobial metal(s) providing a germ and microbial free environment within the article and treated areas. See column 1, lines 20-26. Thus there would be a reasonable expectation of success that copper within the inner layer, not having direct contact with the user, would maintain its antimicrobial effectiveness. Both French and Gabbay teach copper containing products with antibacterial properties attributed to the copper. Balducci teaches synergistic effect observed when adding copper to PCA. The formulation was used to treat blepharitis, which can be caused by bacteria. Thus, it would have been well within the purview of the skilled artisan to administer copper without PCA for the treatment of blepharitis or dry eye with a reasonable expectation of success due to its synergistic affect in Balducci and already known antimicrobial properties taught by French and Gabbay.
Thus these rejections are maintained.
Conclusion
9. 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.
Correspondence
10. No claims are allowed at this time.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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