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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 3-4 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claims recite the garment is worn by the user which then encompasses the human body as well.
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.
Claim(s) 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2013/0331666 in view of Naseri et al. US 2021/0236097.
Regarding claim 14, Miller discloses a menstrual pad, comprising:
a layered assembly ([FIG. 3a, 3b]) having a translucent polymer layer ([¶118] layer 328 on layer 326), a surface layer ([¶98] layer 306), an absorbent layer ([¶98] layer 304), a waterproof layer ([¶104] barrier),
a lateral flow assay test strip embedded in the layered assembly ([¶118] layer 320 is a matrix assay), wherein the translucent polymer layer covers a first portion of the lateral flow assay test strip, and the translucent polymer layer exposes a second portion of the lateral flow assay test strip ([¶115-118] layer 326 covers 320 except for the exposed portion over the detection matrix 320);
wings ([¶95] wings 346); and
clasps for closing wings ([¶96] fasteners 348).
Miller discloses a backing layer but not specifically an anti-microbial backing layer. Naseri teaches a similar menstrual pad with detection elements that has an anti-microbial backing layer ([¶121] antimicrobial treatments can be added to layers). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Miller with the teachings of Naseri order to inhibit microbial growth and enhance preservation of the test strip ([¶121]).
Regarding claim 15, Miller discloses translucent polymer layer is made from a hydrophobic polymer ([¶46] the layers can have a hydrophobic coating).
Regarding claim 16, Miller does not specifically disclose the translucent polymer layer is made from polyisoprene. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use the polymer polyisoprene because Applicant has not disclosed that polyisoprene provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Miller, and applicant' s invention, to perform equally well with either the translucent polymer or paper taught by Miller or the claimed polyisoprene because both layers would perform the same function of being a translucent polymer layer equally well.
Therefore, it would have been prima facie obvious to modify Miller to obtain the invention as specified in the claim because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Miller.
Regarding claim 17, Miller discloses the second portion of the lateral flow assay test strip includes a collection pad at a first end of the lateral flow assay test strip ([¶105] section 338).
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2013/0331666 in view of Naseri et al. US 2021/0236097 further in view of Long et al. US 2008/0269706.
Regarding claim 1, Miller discloses a garment, comprising:
a layered assembly ([FIG. 3a, 3b]) having a translucent polymer layer ([¶118] layer 328 on layer 326), a surface layer ([¶98] layer 306), an absorbent layer ([¶98] layer 304), a waterproof layer ([¶104] barrier),
a lateral flow assay test strip embedded in the layered assembly ([¶118] layer 320 is a matrix assay), wherein the translucent polymer layer covers a first portion of the lateral flow assay test strip, and the translucent polymer layer exposes a second portion of the lateral flow assay test strip ([¶115-118] layer 326 covers 320 except for the exposed portion over the detection matrix 320);
Miller discloses a backing layer but not specifically an anti-microbial backing layer. Naseri teaches a similar menstrual pad with detection elements that has an anti-microbial backing layer ([¶121] antimicrobial treatments can be added to layers). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Miller with the teachings of Naseri order to inhibit microbial growth and enhance preservation of the test strip ([¶121]).
Miller does not disclose a first hip strap extending from a first corner of the layered assembly to a second corner of the layered assembly; and a second hip strap extending from a third corner of the layered assembly to a fourth corner of the layered assembly. However, Long discloses an absorbent garment with testing array that does have hip straps ([¶42][FIG.1]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Miller with the hip straps of Long in order to have an adjustable and secure waistband ([¶36-39]).
Regarding claim 2, Miller disclose wings ([¶95] wings 346); and
clasps for closing wings ([¶96] fasteners 348).
Regarding claim 3, Miller discloses when the garment is worn by a user, extends from below the user’s abdomen, across the user’s groin, and to the user’s lower back ([FIG.3a]).
Regarding claim 4, Long teaches the first hip strap and the second hip strap, when the garment is worn by a user, hang on the user’s hips ([FIG.6]).
Regarding claim 5, Miller discloses the translucent polymer layer is bonded to the surface layer and the lateral flow assay test strip to seal the lateral flow assay test strip in the layered assembly ([¶75,76,104]).
Regarding claim 6, Long teaches the lateral flow assay test strip is enclosed in a plastic casing ([¶29-31] the test strip can be completely encased in the plastic film).
Regarding claim 7, Long teaches the first hip strap and the second hip strap are adjustable in length ([¶36] the hip straps are elastic).
Regarding claim 8, Miller discloses translucent polymer layer is made from a hydrophobic polymer ([¶46] the layers can have a hydrophobic coating).
Regarding claim 9, Miller does not specifically disclose the translucent polymer layer is made from polyisoprene. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use the polymer polyisoprene because Applicant has not disclosed that polyisoprene provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Miller, and applicant' s invention, to perform equally well with either the translucent polymer or paper taught by Miller or the claimed polyisoprene because both layers would perform the same function of being a translucent polymer layer equally well.
Therefore, it would have been prima facie obvious to modify Miller to obtain the invention as specified in the claim because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Miller.
Regarding claim 10, Miller discloses the second portion of the lateral flow assay test strip includes a collection pad at a first end of the lateral flow assay test strip ([¶105] section 338).
Regarding claim 11, Long teaches the lateral flow assay includes a sample pad; and fluidically connecting the collection pad to the sample pad ([¶51] sample pad 16 and connects to collection pad 102).
Long does not specifically disclose the fluidic connection is nanotubes. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use nanotubes because Applicant has not disclosed that nanotubes provide an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Long, and Applicant' s invention, to perform equally well with either the microfluidic channels ([¶47]) of Long or the claimed nanotubes because both would perform the same function of carrying the fluid sample.
Regarding claim 12, Long teaches the lateral flow assay test strip further includes: conjugate pad ([¶51]); results reading area having a test line and a control line ([¶53] detection zone 20 and control zone 22); and wick pad ([¶50] absorbent pad 18).
Regarding claim 13, Long discloses the nanotubing is filled with a buffer ([¶63] a buffer can be included in the flow assay or applied to the assay).
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2013/0331666 in view of Naseri et al. US 2021/0236097 and Wang CN 201064525.
a layered assembly ([FIG. 3a, 3b]) having a translucent polymer layer ([¶118] layer 328 on layer 326), a surface layer ([¶98] layer 306), an absorbent layer ([¶98] layer 304), a waterproof layer ([¶104] barrier),
a lateral flow assay test strip embedded in the layered assembly ([¶118] layer 320 is a matrix assay), wherein the translucent polymer layer covers a first portion of the lateral flow assay test strip, and the translucent polymer layer exposes a second portion of the lateral flow assay test strip ([¶115-118] layer 326 covers 320 except for the exposed portion over the detection matrix 320);
wings ([¶95] wings 346); and
clasps for closing wings ([¶96] fasteners 348).
Miller discloses a backing layer but not specifically an anti-microbial backing layer. Naseri teaches a similar menstrual pad with detection elements that has an anti-microbial backing layer ([¶121] antimicrobial treatments can be added to layers). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Miller with the teachings of Naseri order to inhibit microbial growth and enhance preservation of the test strip ([¶121]).
Miller does not specifically disclose that the device has a translucent organdy fabric layer. Wang discloses a similar sanitary pad that has a transparent silk-thin soft cotton surface (see FIG.2 and the description in the translation of figure 2). Wang does not specifically disclose organdy fabric but at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use organdy because Applicant has not disclosed that organdy itself provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Wang, and applicant' s invention, to perform equally well with either the transparent thin cotton taught by Wang or the claimed organdy because both are well known sheer cotton fabrics that would perform the same function of allowing viewing of the test strip equally well considering their translucency.
Therefore, it would have been prima facie obvious to modify Miller in view of Wang to obtain the invention as specified in the claim because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Wang.
Regarding claim 20, Naseri teaches the antimicrobial fabric layer covers the layered assembly and the wings ([¶121] antimicrobial treatments can be added to layers).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2013/0331666 in view of Naseri et al. US 2021/0236097 and Wang CN 201064525 further in view of Chen US 2010/0137822.
Regarding claim 19, Miller does not specifically disclose the antimicrobial fabric layer comprises a charcoal bamboo fiber fabric layer. Chen teaches a similar sanitary napkin that has a bamboo charcoal layer ([¶10]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Miller with the bamboo charcoal layer of Chen in order to have a sterilization and deodorization layer ([¶10]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791