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 .
Status of Claims
As directed by the amendment filed on 26 June 2024: claim(s) 8 & 10 have been amended, claim(s) 13-20 have been cancelled. Thus, claims 1-12 are presently pending.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 & 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tazoe (US 20040236292 A1) in view of Okabe et al. (US 20040254547 A1).
Regarding Claim 1, Tazoe discloses a female external urinary device ("automatic urine disposal device" [0020]; FIG. 1) comprising:
a core ("urine receptacle 1" [0021]; FIG. 1), the core comprising a non-absorbent material ("outer sheet 4 is a liquid-impermeable, non-breathable thin sheet" [0024]) having a plurality of urine-receiving apertures ("urine drainage pores 125a" [0064]; FIGs. 11-12), the core comprising a suction channel ("urine drainage tube (a first urine drainage means) 11a" [0032]; FIG. 10(a)) communicating with a suction aperture ("urine drainage port 4b" [0032]; FIG. 10(a)) and including a reservoir ("urine tank 21" [0033]) fluidically communicating with said suction channel ("other end of the urine drainage tube 11 b passes through the lid 22 of the urine tank 21" [0033]; FIG. 1 );
a fabric cover that at least partially covering said core and said absorbent layer ("top sheet 2 is made of a soft, flexible material, such as a non-woven fabric" [0021]; FIG. 7(a)).
Tazoe fails to specify an absorbent layer disposed externally with respect to said core. However, Okabe teaches an automatic urine disposal device wherein an absorbent layer disposed externally with respect to said core ("urine absorbent sheet 6 is provided to absorb urine which has not been collected by the support sheet 5" [0021]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Tazoe to incorporate the teachings of Okabe to prevent “urine from wetting the wearer's clothes or bedding and also preventing urine from coming in contact with the wearer's skin” ([0021]).
Regarding Claim 5, Tazoe discloses the core includes an inner core section and an outer core section adjacent to the inner core section ([0021-0026]; FIG. 10(a)), wherein the suction aperture is formed in the outer core section ("perforated urine drainage tube unit 115 is located at the bottom part of the urine absorbent material" [0063]), wherein the outer core section includes an outer channel portion that interfaces an inner channel portion of the inner core section to at least partially define the suction channel therebetween, and wherein the inner channel portion is at least partially defined by ribs that terminate at the reservoir [0063-0066]; FIG. 11).
Regarding Claim 6, Tazoe discloses suction channel being defined in part by a first rib and a second rib within said core ("one end of three perforated urine drainage tubes 125 are connected with a common tube 126" [0063]; FIG. 11), the urinary device further including a spout ("one-touch joint 13" [0032]; FIG. 10(a)) communicating with said suction channel ("joint 13 connects the other end of the urine drainage tube 11a" [0032]; FIG. 10(a)).
Claim(s) 2-3 & 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tazoe/Okabe in view of Wada et al. (US 20110040267 A1).
Regarding Claims 2-3, Tazoe discloses the core extending partially outside of said fabric cover (see FIG. 11) but fails to specify said core including at least one strap retainer; specify said core including an area of hook or loop material. However, Wada teaches a urine suction device (see Abstract) wherein said core including at least one strap retainer ("mechanical fastener 304" [0046]; FIG. 2); an area of hook or loop material ("urine suction device 102 is fixed to an inner side of a crotch belt segment 301 as a part of a T-shaped belt 300, for example, by pressure-sensitive adhesive or a mechanical fastener known by the trade name "Velcro"" ([0046]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device to incorporate the teachings of Wada to ensure “contact with the wearer's urethral orifice and peripheral region thereof as the urine suction device 102 is put on the wearer's body” ([0057]).
Regarding Claim 7, Tazoe/Okabe fails to specify a pelvic belt secured to said urinary device, said urinary device including at least one strap retainer and said pelvic belt including a strap securing said pelvic belt to said urinary device, the urinary device further including an area of hook or loop material and the pelvic belt further including an area of mating hook or loop material. However, Wada teaches a pelvic belt secured to said urinary device ("urine suction device 102 is fixed to an inner side of a crotch belt segment 301 as a part of a T-shaped belt 300" [0046]; FIG. 2), said urinary device including at least one strap retainer ("mechanical fastener 304" [0046]; FIG. 2) and said pelvic belt including a strap ("crotch belt segment 301" [0046]; FIG. 2) securing said pelvic belt to said urinary device ([0046]), the urinary device further including an area of hook or loop material and the pelvic belt further including an area of mating hook or loop material ("urine suction device 102 is fixed to an inner side of a crotch belt segment 301 as a part of a T-shaped belt 300, for example, by pressure-sensitive adhesive or a mechanical fastener known by the trade name "Velcro"" [0046]). Therefore, it would have been obvious to modify the device to ensure “contact with the wearer's urethral orifice and peripheral region thereof as the urine suction device 102 is put on the wearer's body” ([0057]).
Regarding Claim 8, Tazoe discloses a method comprising:
providing the urinary device assembly of claim 1 ([0020-0021]; FIG. 1);
securing said urinary device assembly to a female patient by positioning the urinary device assembly in a urine-retaining region ("urine receptacle 1 is worn inside the wearer's (not shown) underwear 41" [0037]; FIG. 5) and aspirating urine away from said urinary device using suction ("vacuum pump 31 with a low suction force can drain urine from the urine absorbent material" [0045]). Tazoe fails to specify positioning the pelvic belt proximal a pelvic area of the patient. However, Wada teaches positioning the pelvic belt proximal a pelvic area of the patient (“come in contact with the wearer's urethral orifice and peripheral region thereof as the urine suction device 102 is put on the wearer's body” [0057]). Therefore, it would have been obvious to modify the device to ensure “contact with the wearer's urethral orifice and peripheral region thereof as the urine suction device 102 is put on the wearer's body” ([0057]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tazoe/Okabe in view of D'Acchioli et al. (US 6551292 B1).
Regarding Claim 4, Tazoe fails to specify a soaker layer, said soaker layer being disposed inwardly with respect to said core and comprising a mixture of a polyester material and a rayon material, the ratio of polyester:rayon ranging from 70:30 to 95:5 in said soaker layer and said soaker layer covering at least a majority of the urine-receiving apertures. However, D'Acchioli teaches a female adult urine management device (see Abstract) including a soaker layer, said soaker layer being disposed inwardly with respect to said core ("bag (11) can comprise one or multiple layers, preferably two or three layers" col. 6 ln. 9-11; FIG. 3) and comprising a mixture of a polyester material and a rayon material ("rayon, polyester" col. 6 ln. 38), the ratio of polyester: rayon ranging from 70:30 to 95:5 in said soaker layer and said soaker layer covering at least a majority of the urine-receiving apertures ("absorbent material (15) may be loosely arranged within the bag (11) or may be secured to the inner layer of the bag (11)" col. 7 ln. 55-57). Therefore, it would have been obvious to modify the device to improve comfort and skin healthiness (col. 6 ln. 51-61).
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Tazoe.
Regarding Claims 9-12, Wada discloses a urinary device assembly for securing to a patient ([0046]; FIG. 2), the urinary device assembly comprising:
a pelvic belt ("T-shaped belt 300" [0046]; FIG. 2); and
a urinary device ("urine suction device 102" [0043]; FIG. 1) releasable securable to the pelvic belt ("urine suction device 102 is fixed to an inner side of a crotch belt segment 301 as a part of a T-shaped belt 300, for example, by pressure-sensitive adhesive or a mechanical fastener known by the trade name "Velcro"" [0046]), the urinary device including:
a core ("urine receiver unit 102a" [0044]; FIG. 4), the core comprising a non-absorbent material ("comprises a plurality of sheet members overlapping one another, i.e., a liquid-impervious leak-preventing sheet 122" [0048]), the core comprising a suction channel ("urine retainer 112" [0045]; FIG. 5) communicating with a suction aperture ("urine outlet 114" [0045]; FIG. 5) and including a reservoir ("urine reservoir 106a" [0044]; FIG. 1) fluidically communicating with said suction channel ("Urine sucked into the urine retainer 112 is further sucked and collected into the urine reservoir 106a via the joint 104 and the guide tube 106" [0045]);
an absorbent layer disposed externally with respect to said core ("liquid-impervious leak-preventing sheet 122, a liquid-pervious but air-permeation retardant sheet 124, a liquid-dispersible sheet 126, a cushion sheet 128" [0048]; FIG. 4); and
a fabric cover that at least partially covering said core and said absorbent layer ("skin-contact sheet 134 may be formed of a soft and liquid-pervious sheet material such as a thermal bond nonwoven fabric" [0057]; FIG. 4);
the urinary device is securable to the pelvic belt via a hook and loop interface ("urine suction device 102 is fixed to an inner side of a crotch belt segment 301 as a part of a T-shaped belt 300, for example, by pressure-sensitive adhesive or a mechanical fastener known by the trade name "Velcro"" [0046]), the urinary device assembly further comprising a spout extending from the urinary device ("joint member 104 adapted to be connected directly to the urine suction device 102" [0044]; FIG. 1), wherein the hook and loop interface is disposed at a first end of the urinary device proximate the spout ("urine suction device 102 is fixed to an inner side of a crotch belt segment 301 as a part of a T-shaped belt 300, for example, by pressure-sensitive adhesive or a mechanical fastener known by the trade name "Velcro"" [0046]; FIG. 2);
at least one tether extending from the pelvic belt to the urinary device at a second end of the urinary device opposite the first end ("crotch belt segment 301 as a part of a T-shaped belt 300" [0046]; FIG. 2);
a conduit ("urine guide tube 106" [0045]; FIG. 1) secured to the spout and in fluidic communication with the suction channel ("urine retainer 112" [0045]; FIG. 5) and the reservoir ("Urine sucked into the urine retainer 112 is further sucked and collected into the urine reservoir 106a via the joint 104 and the guide tube 106" [0045]).
Wada fails to specify the core having a plurality of urine-receiving apertures. However, Tazoe teaches the core having a plurality of urine-receiving apertures ("urine drainage pores 125a" [0064]; FIGs. 11-12). Therefore, it would have been obvious to modify the device suitably drain “urine from a urine drainage port in the outer sheet to a urine tank through a urine drainage tube” ([0010]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights