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 .
Information Disclosure Statement(s)
The information disclosure statement(s) (IDSs) submitted on 6/15/23; 9/10/24; and 2/23/26, listing about 269 pages of references, is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Claims
Claims 1-22 are pending in the application, with claims 1-16 under consideration and claims 17-22 withdrawn.
Election/Restriction
Applicant's election without traverse of Group I claims 1-16 in the 2/23/26 response is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Group II claims 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. A complete reply to a final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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 2, 3, 7, 8, 10, 11, 13, and 14 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 pre-AIA the applicant regards as the invention. Claim 2,ll.4 and claim 10,ll.6, are considered indefinite for the recitation of “an opening” as it is unclear whether the recited opening is the same or different from “an opening” as recited in claim 1, ll.4; and claim 9,ll.4. Appropriate correction is required, e.g., reciting “a first opening” in claims 1 and 9; and reciting “a second opening” in claims 2 and 10, as well as dependent claims 3, 7, 8, 11, 13, and 14, which recite “the opening”. Claim 5,ll.5 is considered indefinite for the recitation of “a distal portion” as it is unclear whether the recited distal portion is the same or different from “a distal portion” as recited in claim 4, ll.2. Appropriate correction is required, e.g., reciting “a first distal portion” in claim 4; and “a second distal portion” in claim 5.
See MPEP 2173.05.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Godinez (US 11,504,265 B2).
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As to independent claims 1 and 9, and dependent claim 13, Godinez teaches a fluid collection device, (urinary collection device 31; Fig.1,3,9; Col.2-Col.6; Abstract, incorporated herein) comprising:
a fluid impermeable barrier 40/42/46/52/53 (Fig.3,9) having an elongated shape (Fig.3) with a proximal region 40 (obverse face 40 of proximal layer 53; Fig.9; Col.3,ll.5-7) and a distal region 41 (reverse face 41 of distal layer 52; Fig.9; Col.3,ll.7-8), the fluid impermeable barrier including a first impermeable layer 53 (fluid impermeable reverse outer layer 53 Fig.9) and a second impermeable layer 52 (fluid impermeable obverse outer layer 52 Fig.9) (Fig.9,3;Col.3,ll.19-29) opposite to the first impermeable layer 53 (Fig.1,3,9) and defining an opening 46 (obverse opening 46 first/obverse outer layer 53 Fig.3;Col.3,ll.11-12), the first impermeable layer 53 and the second impermeable layer 52 at least partially defining a chamber therebetween (as chamber between layers 53 and 52 holding fluid permeable/absorbing core 44 Fig.3,9; Col.3,ll.19-29)
[claims 1 and 13] the chamber including a pocket portion that extends distally from the opening 46 between the first impermeable layer 53 and the second impermeable layer 52 (pocket portion as portion of impermeable barrier forming pocket between layers 53 and 52 extending between edges of opening 46 and outer edge of outer seam 56 between layers 53 and 52 within chamber holding liquid permeable core 44; Fig.3,9; Col.3,ll.8,20-21,26-28), wherein the opening 46 is sized and positioned to cover substantially all of the vulva of a user (Col.2,ll.52-53);
[claim 9] wherein the second impermeable layer 52 includes a distal portion having the chamber absent therefrom (Fig.9, e.g., the portion as the conduit 35, as claimed below); a porous material 44 (core 44;Fig.3,9; Col.3,ll.9) disposed in the chamber such that the porous material extends across the opening 46 and is positioned in the pocket portion of the chamber (Fig.3,9,as presented above) [claim 1] the porous material 40 being configured to space the first impermeable layer 53 from the second impermeable layer 52 in the pocket portion of the chamber (Fig.9,3, as presented above); [claim 9] one or more fluid permeable materials 60 (as fabric layer 60 as distal portion of core 44 Fig.9; Col.3,ll.30-33) covering substantially all of the distal portion of the fluid impermeable barrier 53 (within distal side of chamber with distal cover as second layer 53 Fig.9); andand a conduit 35 (as conduit/tube 35 between 53 and 52 Fig.9; Col.2,ll.58-Col.3,ll.1; Col.3,ll.8-10,14-18) extending through the proximal region 40 into the chamber (between 52 and 54 Fig.1,3,9) and including an inlet (as opening in impermeable barrier for conduit/tube 35 Fig.9,3) disposed in (Fig.3,9) the pocket portion of the chamber (within pocket portion of chamber (as presented above) Fig.3,9; Col.2,ll.58-Col.3,ll.1; Col.3,ll.8-10,14-18).
As to claims 2 and 10, Godinez teaches [claim 10] wherein the one or more fluid permeable materials 60 covering substantially all of the distal portion of the fluid impermeable barrier 53 (Fig.9; as further presented above), or [claim 2] the device, [claims 2,10] further comprises an absorbent material (as knit fabric of 60 Col.3,ll.32-33) secured to the second impermeable layer 52 (as held within impermeable barrier including 2nd layer 52; Fig.9) and covering substantially all of the second impermeable layer 52 (Fig.9) such that the second impermeable layer 53 is positioned between the absorbent material (knit fabric of 60 Fig.9) and the first impermeable layer 53 (Fig.9), the absorbent material (knit fabric of 60) including an opening aligned with and sized and shaped generally complementary to the opening 46 of the second impermeable layer 52 (where (opening as open portion of knit material of 60 aligned with opening 46 of 1st layer 53; Fig.9).
As to claims 3 and 11, Godinez teaches wherein [claim 3] the device further comprises, or [claim 9] wherein the one or more fluid permeable material 60, covering substantially all of the distal portion of the fluid impermeable barrier (53/52 Fig.9), [the fluid permeable material 60] includes the absorbent material (knit fabric; Fig.9;Col.3,ll.32-33) and [claims 1 and 9] a wicking material (as mesh type material Col.3,ll.32-33) secured to the absorbent material 60 and covering substantially all of the absorbent material 61 (Fig.9; Col.3,ll.32-33), such that the absorbent material 61 is positioned between the wicking material (mesh) and the second impermeable layer 53 (Fig.9), the wicking material/mesh covering substantially all of the opening (Fig.9) of the absorbent material 60 and the opening 46 of the second impermeable layer 52 (Fig.9).
As to claim 4, Godinez teaches wherein at least one of the first impermeable layer 52 or the second impermeable layer 53 includes a distal portion (as adjacent outer pocket portion Fig.9) that extends distally from the pocket portion (as flat, attached portion as outer edge of 53 extending downward/distally from pocket portion Fig.9; as presented above) with the chamber being absent from the distal portion (where no chamber where 53 and 52 sealed together as edge 56 inwardly adjacent to pocket portion Fig.9,3), at least one of the absorbent material 60 or the wicking material/mesh covering substantially all of the distal portion (Fig.9).
As to claim 5, Godinez teaches wherein the device further comprises a fluid permeable material 61 (2nd knit fabric layer 61; Fig.9; Col.3,ll.33) secured to the second impermeable layer 53 (Fig.9) and covering substantially all of the second impermeable layer 52 (Fig.9) such that the second impermeable layer 53 is positioned between the fluid permeable material 61 and the first impermeable layer 52, wherein at least one of the first impermeable layer 53 or the second impermeable layer 52 includes a distal portion that extends distally from the pocket portion with the chamber being absent from the distal portion (where no chamber where 53 and 52 sealed together as edge 56 inwardly adjacent to pocket portion Fig.9,3), the fluid permeable material 61 covering substantially all of the distal portion (Fig.9).
As to claims 6, 12, and 15, Godinez teaches wherein the porous material 44 (core 44;Fig.3,9; Col.3,ll.9) includes a first porous layer 60, a second porous layer 61, and a plurality of fibers 62 secured to the first porous layer 60 and the second porous layer 61 (Fig.9), thereby forming an intermediary layer between the first porous layer 60 and the second porous layer 61 (Fig.9; Col.3,ll.32-35).
As to claims 7-8 and 14, Godinez teaches wherein the porous material 44 is disposed in the chamber (Fig.9,3; as further presented above) such that: a plurality of sheets (as upper surfaces of porous layers forming 2 sheets 60,61; Fig.9) of the porous material 44 are disposed in the chamber (between impermeable outer layers 53 and 52; Fig.9) between the opening 46 and the first impermeable layer 53 (Fig.3,9); and
multiple sheets (as at least both surfaces of each of (4 sheets) porous layers 60,61; Fig.9) of the porous material 44 are disposed in the pocket portion of the chamber between the first impermeable layer 53 and the second impermeable layer 52, the multiple sheets of the porous material 44 being greater in number than the plurality of sheet of the porous material (4 v. 2) (Fig.9; Col.3,ll.19-35; multiple sheets as multiple layers Col.3,ll.45-46).
As to claim 16, Godinez teaches wherein the porous material 44 includes a multilayer material (e.g., core 44 comprising layers 60 and 61; Fig.9; Col.3,ll.30-35).
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 Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-58791775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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