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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 04/15/2026 has been entered.
Claims dated 12/15/25 are under review.
Claims 1-6, 8-10, 12,14-16 and 20-23 are pending; Claims 7, 11, 13 and 17-19 were cancelled.
The IDS dated 04/15/2026 has been reviewed and JP 3157107U has been applied below.
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.
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.
Claims 1-6, 8-10, 12,14-16 and 20-23 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.
Claims 1 and 20, recite a unit for the median pore size that is not understood or recognized by the Office-“median pore size less than or equal to 0.25 um.” This could be a typographical error as well. However, the scope of the claim is unclear and thus indefinite as the unit of measure is unclear.
Claims 2-6, 8-10, 12,14-16 and 21-23 are objected to as being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-6, 8-10, 12,14-16 and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP3157107U issued to Tsukahara et al. in view of USPUB 20100299805A1 issued to Graneto.
Regarding Claims 1 and 20, where Applicant seeks a disposable, protective article comprising a composite of a free-standing, hydrophobic, breathable, polyolefin-based web with a median pore size less than or equal to 0.25 µm and a non-woven material joined to at least one major surface of the polyolefin-based web, wherein the polyolefin-based web comprises a thickness of 9 microns to 30 microns, wherein the protective article comprises a gown comprising two sleeves and a thumb hole in each sleeve; Applicant is directed to Tsukahara et al., teach making disposable protective garment having both blood barrier properties, virus barrier properties, breathability, and flexibility. The disposable protective garment includes a composite sheet. [abstract, ¶ 7-8]. The composite can be PE or PP nonwoven fabric (example 1) / microporous polyethylene film /nonwoven fabric [¶ 25]. The first nonwoven serves as Applicant’s web. The layers are joined together by means of heat sealing or adhesives [¶ 25]. The thickness of the nonwoven is about 15-40 μm.
The composite sheet includes a web of polyethylene terephthalate fibers and a nonwoven fabric partially bonded to via heat to it. [abstract, ¶¶ 10, 15-17].
Tsukahara et al., teach making disposable protective garment but do not specifically teach protective article comprises a gown comprising two sleeves and a thumb hole in each sleeve.
This is remedied by Graneto.
Graneto is from the same art of endeavor as he too teaches making disposable medical garments made from nonwovens [¶0021].
Graneto teaches making disposable medical garments, such as gowns (10) which include sleeves (30 and 32). In various embodiments, sleeves 30 and 32 each include thumb holes 60 through which the wearer's thumb is inserted and hand holes 62 through which the four fingers are inserted.
Therefore, a person having ordinary skill in the art before the effective filing date of the invention would have found it obvious to have used the composite of Tsukahara et al. modified with the structure of a gown with thumbholes and sleeves, as they both teach making disposable protective garments. One would have been motivated to do so as thumb holes, hand holes, and tie straps give the sleeves a glove-like quality and operate to prevent the sleeves from creeping up the arm of the wearer. Such features not only operate to make the gown more pleasant to wear, but help reduce the spreading of germs, viruses, and the like, by providing substantially complete arm coverage [¶ 0016].
Tsukahara et al., and Graneto teach breathable (hence porous) disposable protective garments but do not specifically teach that the median pore size less than or equal to 0.25 µm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the hydrophobic, breathable microporous polyethylene film [see ¶’s 0014, 0023, 0028, 0030] the invention to have optimized the pore size within the composite, since it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that the claimed weight is critical and has unexpected results. In the present invention, one would have been motivated to optimize the pore size to control breathability yet create a suitably strong and flexible laminate.
Regarding Claim 2, where Applicant seeks that the disposable, protective article of claim 1, in which the non-woven material comprises polyethylene terephthalate, polypropylene, cellulose, glass, or combinations thereof; Applicant is directed to abstract, ¶¶ 10, 15-17 of Tsukahara et al. where the composite sheet includes a polyethylene terephthalate fibers.
Regarding Claim 3, where Applicant seeks that the disposable, protective article of claim 1, in which the non-woven material is adhesively, thermally, pressure, or ultrasonically joined to the at least one major surface of the polyolefin-based web; Applicant is directed to ¶ 25 of Tsukahara et al. where the layers are joined together by means of heat sealing or adhesives.
Regarding Claim 4, where Applicant seeks that the disposable, protective article of claim 1, wherein the polyolefin-based web has a tortuosity greater than 1.2; Tsukahara et al., do not specifically teach the tortuosity greater than 1.2, however, a skilled artisan would have found it obvious to have arrived at this feature as can be optimized or found by repeated experiments practiced by a person skilled in the art without exercising any leap of ingenuity.
Regarding Claim 5, where Applicant seeks that the disposable, protective article of claim 1, wherein the polyolefin-based web has a porosity of 30% to 70%; Tsukahara et al., provides the teaching that the microporous polyethylene is porous and breathable but does not specifically disclose to what percent. A skilled artisan would have found it obvious to have chosen 30% to 70% depending on how breathable or permeable the final product needed to be.
Regarding Claims 6 and 21, where Applicant seeks that the disposable, protective article of claim 1, wherein the article comprises two-layers joined at the edges of the article; Neither reference teaches that the layers are joined at the edges, but they do teach that the layers are joined. It is the position of the Office that choosing where the layers are joined is arbitrary selection from known alternatives, deemed obvious if it provides no new function or unexpected result.
Regarding Claim 8, where Applicant seeks that the disposable, protective article of claim 1, wherein the polyolefin-based web was made using a dry process; Absent a showing to the contrary, it is Examiner's position that the article of the applied prior art is identical to or only slightly different than the claimed article. 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. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden has been shifted to Applicant to show unobvious difference between the claimed product and the prior art product. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983). The applied prior art either anticipated or strongly suggested the claimed subject matter. It is noted that if Applicant intends to rely on Examples in the specification or in a submitted declaration to show unobviousness, 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.
Regarding Claim 9, where Applicant seeks that the disposable, protective article of claim 1, wherein the polyolefin-based web was made using a wet process; Absent a showing to the contrary, it is Examiner's position that the article of the applied prior art is identical to or only slightly different than the claimed article. 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. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden has been shifted to Applicant to show unobvious difference between the claimed product and the prior art product. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983). The applied prior art either anticipated or strongly suggested the claimed subject matter. It is noted that if Applicant intends to rely on Examples in the specification or in a submitted declaration to show unobviousness, 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.
Regarding Claim 10, where Applicant seeks that the disposable, protective article of claim 1, wherein the polyolefin-based web comprises low density (LDPE), medium density (MDPE), linear low density (LLDPE), high density (HDPE), ultrahigh molecular weight (UHMWPE) polyethylene, polypropylene (PP), polymethyl pentene (TPX), or a mixture thereof; Applicant is directed to ¶ 4, and comparative example 1.
Regarding Claim 12, where Applicant seeks that the disposable, protective article of claim 1, wherein the gown comprises a heat-sealed seam on the back that forms a tear-away seam; Applicant is directed to ¶ 0014 of Graneto, However, a modification could be made to be a tear away seam instead of a tie or a zipper as it is just another means of fastening.
Regarding Claims 14-15; The structure of the gown with the ties and the foldability are taught by Graneto. See figures, specifically 5 and 6.
Regarding Claim 16; See rationale for claim 1 along with Graneto’s teaching of fabrication by cutting the gown shape out of a sheet of the polyolefin-based web.
Regarding Claim 22 and 23; a skilled artisan could have easily altered Tsukahara et al. modified with Graneto’s product having the general knowledge in relevant field of the art in which the final product is to be used in. Tsukahara et al. have embodiments where there are two and three layered structures and Graneto teaches coating the PP web.
Conclusion
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/Arti Singh-Pandey/
Primary Patent Examiner
Art Unit 1759
asp
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