DETAILED ACTION
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 .
Response to Amendment
Applicant’s response filed on September 30, 2026 has been entered. No claim amendments have been made. As such, Claims 1-20 are currently pending in the application.
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 1-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,268,544 to Court et al. (“Court”) in view of U.S. Patent Application Publication No. 2014/0065092 to Bastos et al. (“Bastos”).
With regard to Claims 1, 5-11, 14-16, 18, and 20, Court discloses a wound dressing comprising a mixture of textile fibers and gel forming fibers, wherein the dressing is a knitted fabric comprising support yarn and in-laid yarn. See, e.g., Abstract, entire document. Court discloses that the “wound dressing of the present invention may be made by spinning or twisting gel-forming [fibers] and textile [fibers] together to form the in-laid yarn and then warp knitting using a yarn consisting of textile [fibers] as the pillar yarn to form a gauze, bandage or stocking.” Column 2, line 65 – column 3, line 2. Court teaches that the textile fiber can comprise polypropylene and the gel-forming fiber can comprise alginate twisted together to provide cohesion of the fibers in the formed yarn, Example 1, column 3, line 60 – column 4, line 32, with the alginate fiber being a semi-synthetic polysaccharide fiber. Court does not disclose that the synthetic textile fiber includes nanoparticles dispersed therein. Bastos is also related to fiber or filaments useful in textile article medical devices, such as wound dressings. See, e.g., Abstract, paragraphs [0019] to [0021], entire document. Bastos teaches that fibers or filaments comprising a polymer matrix can be provided with inorganic fillers uniformly dispersed therein to provide properties of absorption and/or emission in the far-infrared region, which can improve skin cicatrization. Paragraphs [0031] and [0032]. Bastos discloses that the inorganic filler can include elements such as titanium, silicon, magnesium, barium, calcium, or sodium, paragraphs [0041] to [0047], and have nano-sized dimensions. Paragraphs [0060] and [0061]. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to provide the synthetic textile fiber disclosed by Court with nanoparticles comprising at least one element selected from the group consisting of Au, Ag, Ti, Ge, Zn, Al, Mg, Si, Cu, Ca, Fe, Ba, K, Na, Mn, Ni, Ga, Pt, and combinations thereof, in order to provide the fiber with absorption and/or emission in the far-infrared region in order to improve skin cicatrization of the wound dressing, as shown to be known in the art by Bastos. With regard to Claim 2, Court discloses using 3 denier fiber. Column 3, line 61 – column 4, line 1. With regard to Claims 3 and 4, Court discloses using a staple fiber length of 40 mm. Column 4, line 1. With regard to Claims 12 and 13, Court discloses the in-laid yarn comprises 0% to 80% of textile fiber and 20% to 100% of gel-forming fiber. Column 3, lines 6-11. In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. M.P.E.P. 2144.05. With regard to Claim 19, Court discloses that chitosan fibers can be used in the wound dressing, column 2, line 39, which would provide hemostatic features to the wound dressing. Additionally, Bastos teaches the inorganic fillers provide hemostatic abilities to the wound dressing. Paragraphs [0010] and [0011].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Court in view of Bastos as applied to Claim 16 above, and further in view of U.S. Patent No. 6,087,549 to Flick (“Flick”).
With regard to Claim 17, the combination of Court with Bastos does not disclose using metallic yarn in the wound dressing. Flick is also related to wound dressing materials formed using fibers to provide a textile construction. See, e.g., Abstract, entire document. Flick teaches that metallized fiber can be used in conjunction with non-metallized fiber to provide antimicrobial properties to a wound dressing. Column 3, lines 18-26 and column 5, lines 1-6. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to provide a metallic yarn into the textile product taught by the combination of Court with Bastos in order to provide antimicrobial features to the wound dressing in a predictable fashion, as shown to be known in the art by Flick.
Response to Arguments
Applicant's arguments filed September 30, 2026, along with the arguments presented in the Rule 132 Declaration of Zhe Yu Wu (“the Wu Declaration”) have been fully considered but they are not persuasive.
Applicant argues that Example 2 of the present invention demonstrates an unexpected result that a hemostatic dressing manufactured from the bioenergetic mixed twisted filaments of the present invention can achieve rapid hemostasis with arterial bleeding in a very short time because it is generally recognized that far-infrared radiation promoted blood circulation. Applicant notes that the Wu Declaration shows greater fibrin formation, demonstrating a higher hemostatic effect. The Examiner disagrees. First, it is noted that if the Applicant intends to rely on examples in the specification or in a submitted declaration or to show non-obviousness, then Applicant should clearly state how the examples of the present invention are commensurate in scope with the claims and how the comparative examples are commensurate in scope with the applied prior art. Neither condition is satisfied. Example 2 of the present application is limited to an instance in which polyvinylpyrrolidone-coated gold nanocores are provided with a shell coating of tetraethoxysilane and blended with a resin of polyethylene terephthalate in a fixed ratio to form filaments having a fiber fineness of 1.5 denier and a length of 38 mm. Example 2 does not disclose the size of the particles used with the resin. These first filaments are mixed with chitosan second filaments in a weight ratio of 1:4 to form the yarn. Example 2 is not commensurate in scope with the materials recited in Claim 1 or the parameters of Claim 1 and its dependent claims. For example, Claim 1 does not limit the first polymer matrix material to polyethylene terephthalate. Also, Claim 1 does not limit the nanoparticles to being formed of gold. Rather, Claim 1 recites that “the nanoparticles comprise element(s) selected from the group consisting of Au, Ag, Ti, Ge, Zn, Al, Mg, Si, Cu, Ca, Fe, Ba, K, Na, Mn, Ni, Ga, Pt, and combinations thereof.” How is the data of Example 2 representative for all of these materials? Moreover, Claim 1 does not limit the size of the filaments to being 1.5 denier with a length of 38 mm. The filaments of Claim 1 have no such limitations. Claim 1 embraces any amount of the nanoparticles, in any amount of the resin, along with any amount of second filaments, but Example 2 does not provide such an expansive amount of data. Furthermore, Claim 1 does not limit the second filament material to being chitosan. In fact, even the dependent claims of the present invention recite limitations that are broader in scope than anything defined by the single example of the Specification, Example 2. The comparative example is also not commensurate in scope with the cited prior art. Neither Court nor Bastos are limited to embodiments in which the wound dressing material contains only chitosan fibers. Why should a commercial chitosan-containing gauze be compared to Court, which teaches a wound dressing comprising a mixture of textile fibers and gel forming fibers, wherein the dressing is a knitted fabric comprising support yarn and in-laid yarn? Why should a commercial chitosan-containing gauze be compared to Bastos, which teaches filaments comprising a polymeric matrix and incorporating inorganic fillers having absorption and/or emission in the 2 to 20 microns far-infrared region? Second, Example 2 does not demonstrate any kind of unexpected result. Bastos teaches that particles that provide emission and/or absorption of infrared radiation improve the speed, effectiveness, and quality of cicatrization. Paragraphs [0028] to [0031]. Increasing blood circulation provides the beneficial effect of moving biological materials necessary for healing to the wound site. Paragraph [0011]. As such, Example 2 of the present invention fails to demonstrate any unexpected result.
Applicant argues that none of Court, Bastos, or Flick teach that the bioenergetic mixed twisted filament of the present invention comprises nanoparticles capable of emitting far-infrared radiation. The Examiner disagrees. Bastos teaches “yarns, fibers or filaments comprising a polymeric matrix and inorganic fillers which are uniformly dispersed in the polymeric matrix and have properties of absorption and/or emission in the far-infrared region ranging from 2 microns to 20 microns for improving skin cicatrization.” Paragraph [0031]. The inorganic fillers disclosed by Bastos satisfy the limitations of the nanoparticles emitting far-infrared radiation recited in Claim 1.
Applicant argues that Court does not teach or provide technical guidance for incorporating nanoparticles capable of emitting far-infrared radiation into the wound dressing. In response to Applicant's arguments against the references individually, 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 instance, Bastos teaches incorporating nanoparticles capable of emitting far-infrared radiation into the wound dressing.
Applicant argues that Bastos never address any hemostatic effect, let alone rapid hemostasis for massive bleeding caused by arterial injuries. However, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Additionally, Bastos notes that the first objective of the body’s repair process is to stop bleeding, paragraph [0011], which is, itself, a hemostatic effect. Moreover, the present claims are not directed to a method, nor do they related to a methodology of treating massive bleeding caused by arterial injuries. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that Flick does not cure the deficiencies of Court and Bastos. However, it is the Office’s position that those references are not deficient in the manner argued by Applicant.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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JEREMY R. PIERCE
Primary Examiner
Art Unit 1789
/JEREMY R PIERCE/Primary Examiner, Art Unit 1789
