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 § 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) 1-7 and 10-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2025/0143914 A1 to Rothberg.
As to claim 1, Rothberg discloses a urine collection device for collecting an uncontaminated urine sample from a pre-continent or an incontinent user, the urine collection device comprising:
a receptacle (see Fig 4B-C, element 450) configured to be placed within a nappy or an incontinence pad of the user to receive and retain a urine sample collected from the user in use (Examiner notes that the receptacle may be placed on the inside of such an article given its proximity to the genitalia of the user), wherein the receptacle comprises:
a receiving portion for receiving the urine sample, the receiving portion comprising an opening configured to engage with a human body portion surrounding external genitalia of the user, thereby enabling urine exiting the body of the user to be captured directly in use (see Fig 4C, element 464);
a reservoir for retaining the received urine sample in use (see Fig 4C, element 462);
an outlet for draining the retained urine sample in use, the opening being larger than the outlet (see Fig 4C, element 468); and
wherein the receptacle has a greater height dimension at a forward-facing end than a rearward-facing end, and wherein the outlet is positioned at the rearward-facing end (see Fig 4B-C).
As to claims 3-4, Rothberg further discloses wherein the reservoir comprises a substantially flat base, wherein the outlet is in alignment with the substantially flat base (see Fig. 4C).
As to claim 5, Rothberg further discloses wherein the receptacle comprises at least one overflow opening for releasing excess urine in use (Fig 4B, element 478).
As to claim 6, Rothberg further discloses a mesh guard at the receiving portion for separating the urine collected in the reservoir from the external genitalia of the user in use (see Fig 4C, element 472).
As to claim 7, Rothberg further discloses a mesh guard at the receiving portion for separating the urine collected in the reservoir from the external genitalia of the user in use and wherein the at least one overflow opening is located between the mesh guard and the reservoir (see Fig 4C, element 472).
As to claim 10, Rothberg further discloses wherein the urine collection device further comprises a tube, a first end of the tube being connected to the outlet, for directing the retained urine sample away from the reservoir in use (see Fig 4C, element 474).
As to claim 11, Rothberg further discloses a mesh guard at the receiving portion for separating the urine collected in the reservoir from the external genitalia of the user in use, wherein the receptacle, the mesh guard and/or the tube comprises a flexible material (see [0058]).
As to claim 12, Rothberg further discloses wherein the flexible material of the receptacle has a variable degree of flexibility characteristic and the degree of flexibility of the receptacle at the receiving portion is greater than the degree of flexibility of the receptacle at the reservoir (see Fig 4C – the combined tube and first panel 458 is inherently less flexible at the base where it is joined than the top where the base 458 is not joined) .
As to claim 13, Rothberg further discloses a mesh guard at the receiving portion for separating the urine collected in the reservoir from the external genitalia of the user in use (see Fig 4C, element 472), wherein the receptacle, the mesh guard and/or the tube comprises medical-grade silicone (see [0028]).
As to claim 14, Rothberg further discloses a collection container, a second end of the tube being connected to the collection container, for collecting the urine sample in use and the first end of the tube is sealed to the outlet and the second end of the tube is sealed to the collection container (see Fig 1B).
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.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg.
As to claim 2, Rothberg fails to mention the dimensions of the Rothberg device and thus it does not disclose wherein the receptacle is between approximately 10cm and approximately 17cm in length, between approximately 4cm and approximately 10cm in width, and between approximately 3cm and approximately 8cm in height.
However, given the known dimensions of users, such shapes would have been obvious to one of ordinary skill in the art in order to achieve the predictable result that is a good fit for the user. See also MPEP 2144.04(IV)(A-B).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg in view of US 2023/0087775 A1 to Paunescu.
As to claims 8-9, Rothberg discloses a porous (mesh) material disposed in the device, but does not disclose the means by which it is fastened in place. In a similar device, Paunescu discloses
a mesh guard attached to the receptacle using a press fit fitting, wherein the receptacle comprises at least one engagement clip and the mesh guard comprises at least one support clip for attaching the mesh guard to the receptacle (see Fig 4, elements 170, 178, and 184 and [0085]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to attach the porous material of Rothberg using the clips of Paunescu in order to achieve the predictable result that is a resusable and reliable connection between the porous material and the receptacle.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg in view of US 2017/0079571 A1 to Washington.
As to claims 15-20, the details of the collection container are not shown and thus Rothberg does nod disclose wherein the collection container comprises an non-return inlet valve at an inlet end of the collection container; wherein the collection container further comprises a non-return outlet valve at an outlet end of the collection container; a stop tap for controlling flow of the collected urine sample out of the collection container in use; wherein the collection container comprises an object support structure for mounting the collection container to a nearby object in use; wherein the object support structure comprises a flat-fold hook; wherein the collection container comprises a user support structure for mounting the collection container to an item of clothing of user in use.
However, in a similar invention Washington discloses wherein the collection container comprises an non-return inlet valve at an inlet end of the collection container (see Fig 1, element 36); wherein the collection container further comprises a non-return outlet valve at an outlet end of the collection container (see Fig 1, element 38); a stop tap for controlling flow of the collected urine sample out of the collection container in use (see Fig 1, element 38 and [0021]); wherein the collection container comprises an object support structure for mounting the collection container to a nearby object in use (see Fig 1, element 20); wherein the object support structure comprises a flat-fold hook (see Fig 1, element 20); wherein the collection container comprises a user support structure for mounting the collection container to an item of clothing of user in use (see Fig 1, element 22). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the sample acquisition device of Rothberg with the collection container features of Washington in order to achieve the predictable result of controlling the flow of the sample fluid in the collection vessel while making the device easy to mount and use for the user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-F, 830am-5pm.
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/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791