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 .
Election/Restrictions
Applicant's election with traverse of Group 1 in the reply filed on 5/26/2026 is acknowledged. The traversal is on the ground(s) that Group 1 and II should not be restricted because the method claims are directed to the manufacture of the product claims and that there is a special technical feature. This is not found persuasive because the apparatus and the method of manufacturing said product require different search strategies and separate analyses of prior art while looking for different features. Furthermore, the shared technical feature is not special because even though the claims both contain a substantially planar impermeable barrier and base which is contemplated by Sharma et al. (US 20230020563 A1).
The requirement is still deemed proper and is therefore made FINAL.
Claims 34, 37-38, 40, 44-46, 48-49, 51-52, 54, 56-57, 59-64, 66 and 68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim.
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 (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 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 person shall be entitled to a patent unless –
(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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sharma et al. (US 20230020563 A1).
Regarding claim 1, Sharma discloses a fluid collection device (1, fig. 1C), comprising: a fluid impermeable barrier (104’) at least partially defining a chamber (104) within the fluid collection device (1), at least a portion of the fluid impermeable barrier (104’) being substantially planar (fig. 2B) and extending at least partially between a proximal end region (16, para. [0079], fig. 1E) of the fluid collection device and a distal end region (5, para. [0079], fig. 1E) of the fluid collection device (fig. 1A-1D, 2B); and
a base (104”) secured to the fluid impermeable barrier (para. [0091]) and at least partially defining the chamber (104) and an opening (3’) in fluid communication with the chamber and sized to receive at least a portion of a penis therethrough (para. [0091]), at least a portion the base being substantially planar (fig. 2B) and including at least a first layer (102”) including at least a nonwoven fabric (87, para. [0110, 0114]) extending at least partially between the proximal end region and the distal end region (flow directors made of fibers 87 are within first fluid compartment 102, para. [0106], fig. 4C), the first layer including a first inner (55b) portion and a first outer portion (56b, para. [0103]).
Regarding claim 2, Sharma discloses the device of claim 1 and further discloses a port (24”) positioned proximate to the distal end (5, para. [0079], fig. 1E) region of the fluid collection device (fig. 1C), the port defining an aperture configured to be fluidly coupled to a tube (24) effective to provide fluid communication between the chamber (104) and the tube (24, para. [0084]), wherein the opening (3’) is positioned proximate to the proximal end region (16, fig. 1E).
Allowable Subject Matter
Claims 3-4, 9, 11-12, 14-15, 17, 19, 25, 29, 31, and 34 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 4, 9, 11-12, 14-15, 17, 19. 25, 29, 31, and 34 are objected to based on their dependency off claim 3.
The following is a statement of reasons for the indication of allowable subject matter: no prior art alone nor in combination discloses a fluid collection device with a base that has a first and second layer wherein the second layer has a fluid permeable multilayer fabric between the first layer, and a chamber formed by a fluid impermeable barrier. Further, the device has an opening sized to receive a penis therethrough and extends through both the first and second layer. Sharma does not disclose every limitation of claim 3 and rearranging the layers to align with the claimed invention would not have been obvious nor would it have the necessary disclosure in an additional reference to support such a modification. Although Sharma discloses a nonwoven material within the first compartment and could arguably be considered a permeable multilayer fabric, but distinct, separate layers are required and are not contemplated by Sharma.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 20 August 2026
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