DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of t/e previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/7/2026 has been entered.
Status of Application
The Examiner acknowledges receipt of the amendments filed on 1/7/2026 wherein claim 1 has been amended.
Claims 1-3 and 6-14 are presented for examination on the merits. The following rejections are made.
Information Disclosure Statement
The information disclosure statement filed 5/14/2026 has been considered.
Response to Applicants’ Arguments
Applicant’s amendments/arguments filed 1/7/2026 overcome the rejection of claims 1-3, 6, 7 and 9-13 made by the Examiner under 35 USC 103 over Green et al. (EP 1287197) in view of DiLucco et al. (US 2004/0082239). This rejection is withdrawn as the claims have been amended to require that the coating material is impermeable to the biologically therapeutic active compound.
Applicant’s amendments/arguments filed 1/7/2026 overcome the rejection of claim 8 made by the Examiner under 35 USC 103 over Green et al. (EP 1287197) in view of DiLucco et al. (US 2004/0082239) further in view of Lidocaine MSDS. This rejection is withdrawn for the reasons noted under section 5.
Applicant’s amendments/arguments filed 1/7/2026 overcome the rejection of claim 13 made by the Examiner under 35 USC 103 over Green et al. (EP 1287197) in view of DiLucco et al. (US 2004/0082239) further in view of Sehm (US 5221722). This rejection is withdrawn for the reasons noted under section 5.
Applicant’s amendments filed 1/7/2026 cancelling claim 15 renders moot the rejection made by the Examiner under 35 USC 103 over Green et al. (EP 1287197) in view of DiLcco et al. (US 2004/0082239) further in view of Chang et al. CN102247316).
New Rejections, Necessitated by Amendment
Claim Rejections - 35 USC § 112
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.
Claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites, “…wherein the at least one yarn is intermittently masked” and “…wherein the at least one treated yarn is unmasked”. This appears to be a product-by-process limitation but also reads as if the yarn is to have a masked portion and unmasked portion. It is unclear if the yarn in the final product is to have a masked and unmasked portion, or if the yarn is to have no masked portion as the mask has been removed (unmasked). For purposes of examination, the Examiner is interpreting the limitation as product-by-process limitations wherein the yarn does not contain a masking portion. Clarification is requested.
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.
Claims 1-3, 6, 7 and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (EP 1287197; of record) in view of Di Lucco et al. (US 2004/0082239; of record), Hosoi et al. (JP 2004/195348; translation provided; of record) and Chang et al. (CN 102247316; translation provided; of record).
Green describes yarns and fabrics having a durable non-electrically conductive topically applied metal-based finish wherein a substrate, such as a yarn, is treated with a finish composition and then treated with a binder formulation (i.e. a coating) (see abstract and claim 1) (see instant claims 1). The yarn is to be used in various textiles such as apparel (‘article of clothing’) (see instant claim 1).
The finish composition applied to the yarn comprises an antimicrobial metal compound (i.e. antiseptic, antifungal) (see [0006]) (see instant claim 1) and the binder formulation may be crosslinked imidazolidinones and acrylic polymers (see [0006]) (see instant claims 7 and 8). It is noted that the binder is to exhibit no water solubility (water-insoluble) and be hydrophobic (see [0024, 0027]) (see instant claims 6 and 8).
Green’s treated yarn may be knit/woven into a fabric with non-treated yarns (see [0034]) (see instant claim 1). The treated yarn may be woven together with untreated yarn wherein the yarn fibers are selected from natural fibers such as cotton, wool, synthetic fibers such as polyesters, polyamides, polyurethanes, etc. in any combination, mixtures or blend (see [0009]) (see instant claim 13). Thus, Green describes a fiber material which would be considered air-covered (possess an elastic fiber) as the coated fiber may be combined with other fibers having elastomeric properties, e.g. polyurethane
Green’s yarn possesses superior wash durability wherein the metal finish is retained in the yarn after at least 10 washes (see [0006]) such that after 30 washes 70% of the antimicrobial metal particles are retained thereby retaining antimicrobial activity (see [0033]) (see instant claims 10 and 12). It would be reasonable to conclude that if the material is capable of retaining the agent during washing that it would be capable of retaining the agent when being worn.
In all, Green discloses a yarn to be fashioned in to a textile wherein the yarn comprises a polymer comprising a biologically beneficial active compound (e.g. an antimicrobial metal) wherein the textile retains an effective amount of the biologically beneficial active compound after multiple wash cycles.
Green fails to teach the article of clothing being configured to release a biologically therapeutic agent to the skin.
Di Lucco describes a fiber material for providing controlled active agent delivery wherein the fiber is comprised of a fiber forming component and an active agent/positive dispensing carrier combination (see abstract). The fiber material may be configured in to clothing such as swimwear and pants (see abstract and [0040]). The clothing materials are structured such that upon wearing they release the active agent to the skin thereby improving conditions of the skin in the treated/contacted areas (see [0003, 0006]) (see instant claims 1, 2 and 11). The result of improving the condition of the skin suggests that the active compound is capable of being delivered in an amount effective to improve the condition of the skin. Exemplified active agents for release to the skin include lidocaine and benzocaine (see [0006]) (see instant claim 3). Di Lucco states that their material can be used to treat various skin conditions such as wounds and rash as well as skin diseases (see [0040]) (see instant claim 9). Thus, it would have been obvious to modify Green’s garment such that it comprised biologically therapeutic agents such as lidocaine and/or benzocaine for release to the skin so as to improve the condition of the skin as taught by Di Lucco. See MPEP 2143(I)(A) which states that combining prior art elements according to known elements to yield predictable results is indicia of obviousness. See also MPEP 2144.06(I) which states that combining equivalents known for the same purpose is supportive of obviousness.
Green (and Di Lucco) fail to teach the coating applied to their fiber as being applied intermittently.
From the outset, it is the Examiner’s view that the coating pattern applied to the fiber of Green’s yarn would be considered obvious as an adjustable parameter. See MPEP 2144.04(V)(D). That is, the amount of coating applied to the yarn is directly related to the amount of active contained which ultimately relates to how much active is contained by and released from the yarn. One of ordinary skill in the art would be capable of modifying Greens’ yarn to vary the coating parameters, e.g. thickness, continuousness, etc., so as to identify a coated yarn material best suited to the end goal. In any case, Hosoi is cited to show that intermittent coatings are obvious from a prior art perspective. Hosoi is directed to fabrics and cloth which have been coated to provide release benefits wherein the coating is provided intermittently. The material of Hosoi has a continuous coating and an intermittent coating atop (see [0001, 0008] and claims). Thus, the choice to apply the active coating as a continuous coating or an intermittent coating would have been obvious as such were known to exist in drug release fabric materials as the time of filing.
Regarding the limitation recited by claim 1, “…wherein the at least one yarn is intermittently masked” and “…wherein the at least one treated yarn is unmasked”, this appears to be a product-by-process limitation as it provides a means for how the intermittent coating is created. See MPEP 2113 which states that “…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.”
Green and Di Lucco fail to teach the treated yarn as being partially coated with a coating material that is impermeable to the biologically therapeutic active compound.
Chang describes a hydrophobic coating layer for the controlled release of drug loaded fibers. Chang teaches that providing a coating layer on to the loaded fiber prolongs the active lifetime of the fiber while controlling the release rate of release of drug from the fiber (see abstract). Chang teaches that their coating prevents water molecules from entering the fiber and carrying out the drug to the external environment and so drug release and surface wettability has a direct relationship and by preventing water from entering the fiber prevents the drug from being released from the fiber (see [0008]) (see instant claim 1). Thus, as water cannot enter the fiber to carry the drug out from the fiber, the surface coating can be said to be impermeable to the biologically therapeutic active compound. It would have been obvious to provide this coat, partially or entirely, to the fiber of Green/Di Lucco with a reasonable expectation for success in controlling the rate of drug release and extend the active lifetime of the fiber. See MPEP 2143(I)(D).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (EP 1287197; of record) in view of Di Lucco et al. (US 2004/0082239), Hosoi et al. (JP 2004/195348; translation provided) and Chang et al. (CN 102247316; translation provided; of record) as applied to claims 1-3, 6, 7 and 9-13 above, and further in view of Lidocaine MSDS (2012, 5 pgs).
Green, Di Lucco and Chang fail to teach the active agent being crystalline, semi-crystalline or an amorphous solid
Lidocaine MSDS teaches that lidocaine exists as a crystalline solid (see page 3). Thus, it would have been obvious that the lidocaine of Di Lucco would exist as a crystalline solid.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (EP 1287197; of record) in view of Di Lucco et al. (US 2004/0082239), Hosoi et al. (JP 2004/195348; translation provided) and Chang et al. (CN 102247316; translation provided; of record) as applied to claims 1-3, 6, 7 and 9-13 above, and further in view of Sehm (US 5221722).
Green fails to teach their crosslinked polymers as exhibiting negligible swelling or no swelling in water.
Sehm is directed to composition that contain crosslinked acrylate polymers. Sehm teaches that these crosslinked polymers do not exhibit swelling when combined with water (see abstract and claim 1). Thus, it would be reasonable to expect that the crosslinked polymer of the prior art would exhibit the same property given the structure is overlapping (e.g. crosslinked polyacrylate).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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