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 .
Response to Amendment
The amendments filed 20th April 2026 have been entered. Claims 1-4, 8, 12-14, 17-21 are pending.
Response to Arguments
Applicant’s arguments with respect to the prior art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Information Disclosure Statement
It is noted that the Information Disclosure Statement (IDS) submissions (see attachments) are extremely long, citing well over 750 references for consideration. The Examiner has considered the references submitted as part of the Information Disclosure Statements, but has found the majority have no relevance to patentability. Applicants are encouraged to provide a concise explanation of the information if Applicants are aware of document(s) or a section of a document that is highly relevant to patentability. See MPEP 609.04(a)(III) and MPEP 2004.13:
Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.
…
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the references have been considered in a cumulative manner. The Examiner further notes that numerous cited references appear to have little or no relevance at all to the claimed invention, many of which do not even mention urinary collection devices. Most of the references are directed towards generic additional elements which are not relevant to the claimed invention, unrelated patent prosecution documents, unrelated/irrelevant non-patent literature and dictionary definitions (such as ‘tube’ and ‘abut’).
Examiner notes Applicant’s statement regarding Information Disclosure Statements in Remarks dated 20th April 2026: ‘Applicant wishes to make clear that the number of references cited therein does not reflect any attempt to “bury” references, nor has applicant submitted “a mountain of largely irrelevant material.” Instead, Applicant has made a good faith effort to submit all references that have come to its attention and that fall within categories that might arguably render the references material, so that the Examiner may have the benefit of all possibly material information and so as to preclude any allegation that Applicant has not fully complied with its duty of candor and good faith.’. Applicant includes “bury” and “a mountain of largely irrelevant material” in quotations within their statement, implying that the quoted language was alleged by Examiner in the previous action applied, dated 22nd December 2025. However, no such language was stated by Examiner within the office action. Examiner merely highlighted findings in the extensive IDS that had been submitted, and encouraged review of MPEP 609.04(a)(III), MPEP 2004.13, and proper compliance with 37 CFR 1.56 (b). Examiner has included similar findings within this action.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1 is objected to because of the following informalities:
Claim 1, ‘interior chamber to with a portion…’ in lines 4-5, should likely read ‘interior chamber with a portion…’.
Appropriate correction is required.
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) 1, 2, 4, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170281399 A1 to VanMiddendorp et al. (hereinafter, VanMiddendorp) in view of US 20160374848 A1 to Sanchez et al. (hereinafter, Sanchez)
Regarding Claim 1, VanMiddendorp discloses a fluid collection device (Sanchez: Abstract)(VanMiddendorp: Abstract), comprising:
a fluid impermeable barrier () at least partially defining an interior chamber and an opening through which the interior chamber is exposed to an external environment ()(VanMiddendorp: Para. [0036]; Para. [0039]; Note: the exterior of the sleeve and cup combined are considered to be the fluid impermeable barrier, the collection chamber being the interior chamber; Para. [0017] ‘The sleeve defines a first open end disposed adjacent, but external to the female user's external urethral opening’);
one or more retention components configured for retaining the portion of the fluid permeable body over the urethra at least proximate to the labia of the wearer by engaging with one or more of legs, pelvis, or buttocks of the wearer (VanMiddendorp: Para. [0046] ‘the sleeve 12 can be contoured along one or both of the longitudinal and lateral axes 20, 22 to facilitate fitting and adhering the sleeve 12 to the user's body. The flange 27 forming the interface surface 26 can be contoured to define a surface that generally corresponds to the curvature of the female anatomy adjacent to the urethral orifice.’; Para. [0056]),
wherein the one or more retention components include a mounting frame affixed to the fluid impermeable barrier (VanMiddendorp: Para. [0070]; Para. [0071]; ‘undergarment 170’),
the mounting frame having a semi-rigid or rigid body with a shape that at least partially complements one or more anatomical features of the wearer (VanMiddendorp: Para. [0071]; ‘undergarment 170’); and
a conduit extending into the interior chamber (VanMiddendorp: Para. [0039] ‘The collection chamber 32 is fluidly connected with an outlet 34 through which urine in the collection chamber 32 can drain from the collection chamber 32 and exit the urinary device 10 through a drain 40.’; Para. [0041]).
While VanMiddendorp does disclose a fluid permeable body positioned at least partially within the interior chamber to extend across at least a portion of the opening and enabling draining of the urine (VanMiddendorp: Para. [0039]; Para. [0040] ‘the outlet 34 can be disposed in the wall 30 on the side of the lateral axis 22 adjacent the posterior end 16, as illustrated, to facilitate draining of the urine in the collection chamber 32.’). VanMiddendorp does not explicitly disclose a portion of the fluid permeable body extending convexly across at least a portion of the opening and that configured to be disposed over a urethra proximate to labia of a wearer and wick fluid away from the opening.
However, Sanchez teaches a fluid permeable body positioned at least partially within the interior chamber to with a portion of the fluid permeable body extending convexly across at least a portion of the opening and configured to be disposed over a urethra proximate to labia of a wearer and wick fluid away from the opening (Sanchez: Para. [0009], [0121-0122]; Figs. 34 & 35).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system of VanMiddendorp by adhering the design of the fluid permeable body extending convexly across a portion of the opening and urine transport means to wick fluid away from the opening as taught by Sanchez to conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly (Sanchez: Para. [0121]).
Regarding Claim 2, VanMiddendorp in view of Sanchez discloses the fluid collection device of claim 1, VanMiddendorp does not explicitly disclose a fluid permeable membrane, and a fluid permeable support, wherein the fluid permeable membrane is disposed over at least a portion of the fluid permeable support.
However, Sanchez teaches wherein the fluid permeable body includes a fluid permeable membrane (Sanchez: Para. [0121-0122]; Figs. 34 & 35, item 1830) and
a fluid permeable support (Sanchez: [0121-0122]; Figs. 34 & 35, item 1840),
wherein the fluid permeable membrane is disposed over at least a portion of the fluid permeable support (Sanchez: Para. [0122] ‘The permeable membrane 1830 can be pulled over the permeable support 1840.’; Figs. 34 & 35).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system of VanMiddendorp by adhering the design of the fluid permeable body extending convexly across a portion of the opening and urine transport means to wick fluid away from the opening as taught by Sanchez to conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly (Sanchez: Para. [0121]).
Regarding Claim 4, VanMiddendorp in view of Sanchez discloses the fluid collection device of claim 1, VanMiddendorp further discloses wherein the one or more retention components include a pressure sensitive adhesive disposed on a front facing surface of the fluid impermeable barrier around at least some of the opening (VanMiddendorp: Para. [0046] ‘the sleeve 12 can be contoured along one or both of the longitudinal and lateral axes 20, 22 to facilitate fitting and adhering the sleeve 12 to the user's body. The flange 27 forming the interface surface 26 can be contoured to define a surface that generally corresponds to the curvature of the female anatomy adjacent to the urethral orifice.’; Para. [0054-0056]).
Regarding Claim 12, VanMiddendorp in view of Sanchez discloses the fluid collection device of claim 1, VanMiddendorp further discloses wherein the mounting frame includes a T-shape extending from a longitudinal axis of the fluid impermeable barrier and fluid permeable body (VanMiddendorp: Para. [0071]; Figs. 11 & 12; Note: the undergarment is configured to pass the cup and abut the sleeve, and from the opening, naturally including a T-shape longitudinally extending along a longitudinal axis of the fluid impermeable barrier and fluid impermeable body).
Regarding Claim 13, VanMiddendorp in view of Sanchez discloses the fluid collection device of claim 12, VanMiddendorp further discloses wherein the mounting frame includes one or more attachment components include one or more of an adhesive, hook and loop fasteners, weights, or fasteners thereon (VanMiddendorp: Para. [0072] ‘The undergarment 170 optionally includes fasteners 180 associated with the second portion 174 to facilitate dressing and removing the undergarment 170 from the female user's body. Non-limiting examples of suitable fasteners 180 includes buttons, snaps, hooks, and hook-and-loop tape.’).
Regarding Claim 14, VanMiddendorp in view of Sanchez discloses the fluid collection device of claim 1, VanMiddendorp further discloses wherein the semi-rigid or rigid body is shaped to contour a pubic region of the wearer (VanMiddendorp: Para. [0070] ‘The undergarment 170 can include a first portion 172 that is adapted to extend at least partially between the female user's legs when worn by the female user…’; Para. [0071]; ‘undergarment 170’).
Claim(s) 3 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over VanMiddendorp in view of Sanchez in further view of US 20110040271 A1 to Rogers.
Regarding Claim 3, VanMiddendorp in view of Sanchez discloses the fluid collection device of claim 1, VanMiddendorp does not explicitly disclose wherein the one or more retention components include a shape of the fluid impermeable barrier and fluid permeable body, wherein the shape includes indentations in sides of the fluid impermeable barrier and fluid permeable body to accommodate surfaces of inner thighs of the wearer.
However, Rogers teaches wherein the one or more retention components include a shape of the fluid impermeable barrier and fluid permeable, wherein the shape includes indentations in sides of the fluid impermeable barrier and fluid permeable body to accommodate surfaces of inner thighs of the wearer (Rogers: Para. [0043] ‘The sides of the urine catchment device 100, as best seen in FIG. 10B, form concave recesses 340, 360 just above the bulges 280, 300, generally midway between the top and bottom of the urine catchment device 100. These concave recesses 340, 360 are shaped to compliment and engage the inside shape of the female user's thighs to enable the surfaces of the recesses 340, 360 to be fitted and comfortably gripped by the inner thighs of the female user to keep the device 100 in the operative position as shown in FIGS. 5 and 6.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the one or more retention components of VanMiddendorp to include indentations to accommodate surfaces of inner thighs of the wearer as taught by Rogers for comfort (Rogers: Para. [0043] ‘The sides of the urine catchment device 100, as best seen in FIG. 10B, form concave recesses 340, 360 just above the bulges 280, 300, generally midway between the top and bottom of the urine catchment device 100. These concave recesses 340, 360 are shaped to compliment and engage the inside shape of the female user's thighs to enable the surfaces of the recesses 340, 360 to be fitted and comfortably gripped by the inner thighs of the female user to keep the device 100 in the operative position as shown in FIGS. 5 and 6.’).
Regarding Claim 17, VanMiddendorp in view of Sanchez discloses the fluid collection device of claim 1, VanMiddendorp does not explicitly disclose a spring member.
However, Rogers further discloses wherein the mounting frame is configured as a spring member having a size and shape to provide inward force when the spring member is forced open (Rogers: Para. [0062]; Fig. 20).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the retention components of VanMiddendorp to include a spring member to provide inward force as taught by Rogers as a known element using known methods to provide predictable results, in this case to provide retention of the urine collector to the skin of the wearer, and further to cooperate with anatomical detail, optimize spring action, and promote comfort into the design of the device (Rogers: Para. [0062] ‘Shape, curvature, width, thickness, and other characteristics of the spring 1420 or any corresponding spring utilized with the present invention may be varied in configuration or constituency or both to cooperate with anatomical detail, to optimize spring action, and to promote comfort.’).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over VanMiddendorp in view of Sanchez in further view of US 20070270716 A1 to Wu et al. (hereinafter, Wu).
Regarding Claim 8, VanMiddendorp in view of Sanchez discloses the fluid collection device of claim 1, VanMiddendorp does not explicitly disclose wherein the one or more retention components include one or more protrusions sized, shaped, and positioned on the fluid impermeable barrier to fit an anatomical feature within a gluteal cleft of the wearer.
However, Wu teaches wherein the one or more retention components include one or more protrusions sized, shaped, and positioned on the fluid impermeable barrier to fit an anatomical feature within a gluteal cleft of the wearer (Wu: Para. [0033] ‘referring to FIG. 5, the tapered edge 104 in the rear is located in front of the anus 20, so as to prevent any infection by bacteria.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the fluid impermeable barrier of VanMiddendorp to include the protrusion sized, shaped, and positioned on the fluid impermeable barrier to fit an anatomical feature within a gluteal cleft of the wearer as taught by Wu in order to aid in preventing bacterial infection (Wu: Para. [0033] ‘FIG. 5, the tapered edge 104 in the rear is located in front of the anus 20, so as to prevent any infection by bacteria. As to the collecting cup 10, it has been ergonomically designed to form a slanted angle to apply to the genital position of females.’).
Claim(s) 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over VanMiddendorp in view of Sanchez in view of Rogers and in further view of EP 4494611 A2 to Davis et al. (hereinafter, Davis).
Regarding Claim 18, VanMiddendorp in view of Sanchez in further view of Rogers discloses the fluid collection device of claim 17, VanMiddendorp in view of Sanchez in further view of Rogers does not explicitly disclose wherein the spring member includes a longitudinal member that extends along a longitudinal axis of the fluid impermeable barrier, the longitudinal member having an arcuate shape that contours a pubic region and perineal region of the wearer.
However, Davis teaches a longitudinal member (Davis: Para. [0053] ‘external covering 20… alternatively a fluid impermeable backing formed by a sheet of fluid impermeable material wrapped around an underside of the fluid collection assembly’; Para. [0055] ‘shape retaining element’; Note: The longitudinal member is interpreted as items 20 and 90 combined.) and
the longitudinal member has an arcuate shape that contours a pubic region and perineal region of the wearer (Davis: Para. [0053] ‘external covering 20… a sheet of fluid impermeable material wrapped around an underside of the fluid collection assembly… ’; Note: wrapping around an underside of the elongate fluid collector while extending the longitudinal length of the fluid collector would require an arcuate shape that contours the pubic region and perineal region, due to the combination of Rogers including the spring member into VanMiddendorp.; Para. [0055] ‘the fluid impermeable backing includes a shape retaining element 90 provided in the form of a core integrated into the backing. In various embodiments, the core is a metal core (e.g. aluminum, lead, copper, stainless steel, or any type of soft metal) or a plastic core. For example, in one embodiment, the core of the shape retaining element 90 includes one or more shape memory wires configured to provide a bias to the device 10… the shape retaining element 90 is integrated into the external covering 20 by encasing the shape retaining element 90 in foam of the external covering 20.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the spring member of VanMiddendorp in view of Sanchez in further view of Rogers by adopting the design of an arcuate shaped longitudinal member capable of extending along a longitudinal axis of the fluid impermeable barrier and contouring a pubic and perineal region of the wearer as taught by Davis to aid in shape retention and providing a bias to the device (Davis: Para. [0055] ‘the core of the shape retaining element 90 includes one or more shape memory wires configured to provide a bias to the device 10.’).
Regarding Claim 19, VanMiddendorp in view of Sanchez in view of Rogers and in further view of Davis discloses the fluid collection device of claim 18, VanMiddendorp does not explicitly disclose a spring member.
However, Rogers further discloses wherein the spring member is disposed on or at least partially within at least a portion of the fluid impermeable barrier (Rogers: Para. [0062] ‘The urine catchment device 1400 may incorporate a single member spring 1420 anchored at one end to the rear wall 1440 of the urine collection receptacle 1460. The spring 1420 may elastically bend downwardly against the urine collection receptacle 1460 as the garment such as the briefs B (see FIG. 6) compress thereover.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the retention components of VanMiddendorp to include a spring member disposed on or at least partially within at least a portion of the fluid impermeable barrier as taught by Rogers as a known element using known methods to provide predictable results, in this case to provide retention of the urine collector to the skin of the wearer, and further to cooperate with anatomical detail, optimize spring action, and promote comfort into the design of the device (Rogers: Para. [0062] ‘Shape, curvature, width, thickness, and other characteristics of the spring 1420 or any corresponding spring utilized with the present invention may be varied in configuration or constituency or both to cooperate with anatomical detail, to optimize spring action, and to promote comfort.’).
Regarding Claim 20, VanMiddendorp in view of Sanchez in view of Rogers and in further view of Davis discloses the fluid collection device of claim 18, VanMiddendorp further discloses wherein the mounting frame includes a lateral member that extends substantially perpendicularly to the longitudinal axis of the fluid impermeable barrier (VanMiddendorp: Para. [0071]; Figs. 11 & 12; Note: the portion of the undergarment that is configured to wrap around the front and hips of the wearer are interpreted as lateral members extending perpendicularly to the longitudinal axis of the fluid impermeable barrier) and
the lateral member has an additional arcuate shape that contours a waist region of the wearer (VanMiddendorp: Para. [0071]; Figs. 11 & 12).
Regarding Claim 21, VanMiddendorp in view of Sanchez in view of Rogers and in further view of Davis discloses the fluid collection device of claim 18, VanMiddendorp does not explicitly disclose a spring member.
However, Rogers teaches wherein the spring member extends beyond a first end of the fluid impermeable barrier (Rogers: Fig. 20, item 1420). Rogers does not explicitly teach the spring member extending beyond a second end of the fluid impermeable barrier.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the retention components of VanMiddendorp to include a spring member that extends beyond a first end of the fluid impermeable barrier and rearrange it to extend beyond a second end of the fluid impermeable barrier. This rearrangement of parts would involve adapting the design of the spring member as taught by Rogers and rearranging the size to extend beyond the ends of the fluid impermeable barrier, applying a known element using known methods to provide predictable results, in this case to provide retention of the urine collector to the skin of the wearer, and further to cooperate with anatomical detail, optimize spring action, and promote comfort into the design of the device (Rogers: Para. [0062] ‘Shape, curvature, width, thickness, and other characteristics of the spring 1420 or any corresponding spring utilized with the present invention may be varied in configuration or constituency or both to cooperate with anatomical detail, to optimize spring action, and to promote comfort.’). See MPEP 2144.04, IV. A. (Changes in Size/Proportion) & See MPEP 2144.04, VI. C. (Rearrangement of Parts).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAWN CURTIS BROUGHTON whose telephone number is (571)272-2891. The examiner can normally be reached Monday - Friday, 8am-4pm EST..
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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