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
An amendment was filed on 12/17/2025. Claims 1-9 remain withdrawn, claims 1-11 and 20 have been amended, and claim 17 has been canceled. Currently, claims 1-16 and 18-23 are pending with claims 1-9 being withdrawn from consideration, and claims 10-16 and 18-23 are being examined on the merits.
Terminal Disclaimer
The terminal disclaimer filed on 01/05/2026 with respect to patent # 11,707,602 has been considered. As such, the double patenting rejections made on 09/30/2025 have been withdrawn.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not fully persuasive and/or are moot in light of new prior art.
In response to applicant’s arguments that Cross does not teach in indwelling urinary catheter, the applicant’s argument is considered persuasive. However, Cawood (US 4449971) is now utilized to cure the deficiency.
In response to the applicant’s argument that the prior art does not teach a flexible elongated tube having one end connected to the catheter and an opposite end connected to the tubular sleeve of the reservoir through at least one annual barrel proximate to the opposite end, the examiner notes newly cited Denton (US 20140194839) to cure this deficiency.
In response to the applicant’s arguments that Vernon cannot teach a pressure sensor on the outer surface of said inner strip in the central portion and configured to contact the catheter user’s leg due to the leg being a more solid substrate for more accurate readings, the examiner respectfully disagrees.
Examiner argues that relocating the pressure sensor to the inner strip as opposed to the standard location in Vernon would have been obvious as it would not change the operation of the device. See MPEP 2144(VI)(C). The applicant’s statement that the claimed placement would provide additional benefit appears to be conclusory and not supported by evidence within the instant specification. See MPEP 716.01(c). As such, Examiner asserts that Vernon can be further modified for the pressure sensor to be relocated to the inner strip.
Priority
This application is a Continuation in Part of application 16/555,111, which was filed on 08/29/2019. However, certain claim limitations, notably in claims 12-13 and 15-18 appear to be new matter with respect to the previous application, and as such do not appear to have priority for 08/29/2019. For the purpose of examination, however, priority to the previous application will be assumed to be present.
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)(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.
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.
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cross in view of Cawood (US 4449971), and further in view of Kay (US 20060079854) and Vernon (US 8075538 ).
Regarding claim 10, Cross discloses a urinary catheter system comprising:
an indwelling catheter having a tip inserted into a person’s bladder (the context of the device being used with a urinary catheter implies a tip of a catheter for insertion into a user’s bladder), said tip having an opening through which urine from the bladder flows into the catheter (as urine is intended to fill the bag from the catheter, the catheter is implied to have an opening where urine passes through)
a urine reservoir constructed to wrap around and attach to a catheter user’s lower leg above the ankle (fig. 1, urine collection vessel V wraps around leg above the ankle), comprising:
inner and outer overlapping, elongated strips of flexible, water-impermeable material having a central portion and opposed end portions (“Referring now to figures 2 and 3, the device comprises a pair of like sheets of plastics material of which an inner one 19 lies in use against the leg of the patient and an outer one 20 faces outward from the leg), said strips having a longitudinal length and a transverse width (fig. 2, vessel V has a longitudinal length and transverse length)
an internal urine cavity formed in the central portion between said strips by a sealed periphery comprising upper and lower longitudinal seams and left and right lateral seams (fig. 2, internal cavity defined by the sheets, sealed by seams on all 4 sides)
first and second inter-engageable fasteners formed at opposed, lengthwise ends of said strips (fig. 2, upper stud 25 as a first fastener and a series of eyes 26 as a second fastener, or vice versa)
a flexible elongated tube having one end connected to said catheter and an opposite end connected to said urine reservoir (fig. 1, flexible elongate tube running up patient’s leg with connection between vessel V and the catheter in the patient).
Cross is silent to an indwelling catheter having a tip inserted into a person’s bladder, said tip having an opening through which urine from the bladder flows into the catheter, wherein the strips of material are water-impermeable, and fails to teach a pressure sensor fixed to the outer surface of said inner strip in the central potion and configured to contact the catheter user’s leg during expansion of the urine reservoir.
However, Cawood teaches an indwelling urinary catheter (13) having a tip for being inserted into a person’s bladder (fig. 2, catheter 13 with a distal end for placement within a patient’s bladder, abstract), said tip having an opening (19) through which urine from the bladder flows into the catheter (fig. 2, inlet 19 at distal end).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross such that it includes an indwelling catheter having a tip inserted into a person’s bladder, said tip having an opening through which urine from the bladder flows into the catheter, as taught by Cawood, for the purpose of providing a suitable structure known in the art for draining urine from the patient (see Cawood, abstract).
Cross does not teach wherein the strips of material are water-impermeable, and fails to teach a pressure sensor fixed to the outer surface of said inner strip in the central potion and configured to contact the catheter user’s leg during expansion of the urine reservoir.
However, Kay teaches a urine collection reservoir made of fluid-impervious material (paragraph 0034)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross such that the strips of material are water-impermeable, as taught by Kay, for the purpose of providing a suitable structure that allows for a fluid-tight urine containment area (see Kay, paragraph 0034).
Cross does not teach a pressure sensor fixed to the outer surface of said inner strip in the central potion and configured to contact the catheter user’s leg during expansion of the urine reservoir.
However, Vernon teaches wherein a pressure sensor is applied to an outer surface of an outer strip of the bag (fig. 1, pressure sensor 73 on flap 71 to press against bag 1)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross such that a pressure sensor is applied to an outer surface of an outer strip of the bag, as taught by Vernon, for the purpose of providing a suitable structure that can determine if the bag is full and needs to be emptied (see Vernon, col. 6, lines 56-63)
Cross, as modified by Vernon, does not teach wherein the pressure sensor is fixed to the outer surface of said inner strip in the central portion and configured to contact the catheter user’s leg during expansion of the urine reservoir.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross in view of Vernon such that the pressure sensor is fixed to the outer surface of said inner strip in the central portion and configured to contact the catheter user’s leg during expansion of the urine reservoir, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In this instance, the pressure sensor of the instant specification versus the pressure sensor of Vernon rely on the bag expanding against the pressure sensor to determine whether or not a bag is full. Relocating the sensor of Vernon in a similar location would provide a predictable result.
Regarding claim 11, Cross discloses wherein said urine reservoir has a length sufficient to connect end-to-end at said fasteners and to completely surround a user’s lower leg (fig. 1, vessel V has a length to connect end-to-end to connect the fasteners in fig. 2 to completely surround a lower leg)
Regarding claim 12, Cross discloses wherein said urine reservoir has multiple fasteners arranged at different lengthwise portions to change the connected circumference of said urine reservoir (fig. 2, multiple eyes 26 to change the circumference by having different points connected to stud 25).
Regarding claim 13, Cross discloses wherein said fasteners comprise male tabs (fig. 2, male tabs as stubs 25 and 30) formed at one end and complimentary-shaped and sized female slits formed at the other end (fig. 2, eyes 26 and 32 to connect to stubs 25 and 30 respectively)
Regarding claim 14, Cross discloses wherein the walls of said urine reservoir are corrugated in the central portion forming said urine cavity (figs. 2-3, corrugations formed by vertical weld lines).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cross in view of Cawood, Kay, and Vernon, and further in view of Ba (CN 208852089).
Regarding claim 15, Cross does not teach wherein the corrugated walls of said urine reservoir have lengthwise-extending pleats so that the reservoir can and expand and contract in the widthwise direction as urine enters and exits said cavity. The lengthwise direction will be interpreted as left-to-right direction, and the widthwise direction will be interpreted as expansion in the up-and-down direction.
However, Ba teaches a urine collection bag (abstract) that is corrugated with left-to-right extending pleats (fig. 1, bag 10 with corrugated walls) so that the reservoir can expand and contract in the up-and-down direction as urine enters and exits said cavity (the bag is configured to be folded, and thus is implied to be flexible, and the background notes that bag expansion and contraction conventionally made for inaccurate calculation of urine volume, which the invention seeks to fix).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross such that the corrugated walls of said urine reservoir have lengthwise-extending pleats so that the reservoir can and expand and contract in the widthwise direction as urine enters and exits said cavity, as taught by Ba, for the purpose of providing a suitable structure that conveniently sets calculation of urine volume and allows the bag to be conveniently folded (see translation of Ba, abstract).
Regarding claim 16, Cross discloses wherein the end portions are not corrugated (fig. 2, end portions 4 and 29 are not corrugated).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cross in view of Cawood, Kay, and Vernon, and further in view of Vaillancourt (US 4904248).
Regarding claim 18, Cross does not teach the device including a cushion extending along the lower longitudinal seam.
However, Vaillancourt teaches wherein a cushion extending along a periphery of a device that is in contact with a patient is a known practice in the art (abstract)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross such that it includes a cushion extending along the lower longitudinal seam, as suggested by Vaillancourt, for the purpose of providing a suitable material that is soft and non-irritating when in contact with the skin of a patient (see Vaillancourt, abstract).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cross (GB 2153231) in view of Cawood, and further in view of Denton (US 20100094173).
Regarding claim 20, Cross discloses a catheter system comprising:
a) an indwelling, catheter having a tip designed for insertion into a catheter user's bladder, said tip having an opening through which urine from the bladder passes into the catheter,
b) a flexible reservoir (V) extending around the person's ankle and having walls bounding an interior compartment (fig. 1, vessel V, while around the leg above the ankle, is capable of being utilized around the person’s ankle); and
c) a flexible, elongated tube having one end connected to tubing and an opposite end connected to the reservoir (fig. 1 shows a tube up the person’s leg to connect to vessel V and the catheter within the patient, with fig. 2 showing urine inlet tube 22), the tube being hollow for conducting urine in the catheter through the tube into the compartment of the reservoir (fig. 2 shows urine inlet tube 22 to allow urine into the vessel); wherein one of the walls of the reservoir is a bottom wall that engages and rests on a top of the person's foot in use to resist downward movement of the reservoir as the reservoir is filled with urine (fig. 2 shows a bottom wall of the reservoir that is capable of resting on a top of a person’s foot).
Cross does not teach an indwelling, catheter having a tip designed for insertion into a catheter user's bladder, said tip having an opening through which urine from the bladder passes into the catheter, and a tubular sleeve extending from a top of the walls, wherein the catheter is connected to the tubular sleeve of the reservoir through at least one annular barrel proximate to the opposite end.
However, Cawood teaches an indwelling urinary catheter (13) having a tip for being inserted into a person’s bladder (fig. 2, catheter 13 with a distal end for placement within a patient’s bladder, abstract), said tip having an opening (19) through which urine from the bladder flows into the catheter (fig. 2, inlet 19 at distal end).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross such that it includes an indwelling catheter having a tip inserted into a person’s bladder, said tip having an opening through which urine from the bladder flows into the catheter, as taught by Cawood, for the purpose of providing a suitable structure known in the art for draining urine from the patient (see Cawood, abstract).
Cross, as modified by Cawood, does not teach a tubular sleeve extending from a top of the walls, wherein the catheter is connected to the tubular sleeve of the reservoir through at least one annular barrel proximate to the opposite end.
However, Denton teaches a tubular sleeve extending from a wall (see annotated fig. 1 below, with bottom half of telescopic portion 134 serving as the tubular sleeve), wherein the catheter (118) is connected to the tubular sleeve of the reservoir (138) through at least one annular barrel proximate to the opposite end (see annotated fig. 1 below, serving as another portion of the telescopic portion 134).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross in view of Cawood such that a tubular sleeve extends from a wall, wherein the catheter is connected to the tubular sleeve of the reservoir through at least one annular barrel proximate to the opposite end, as taught by Denton, for the purpose of providing a suitable structure that can lengthen or shorten the drain path between the container and the catheter (paragraph 0020), thus allowing for more customizable length depending on the patient’s needs.
Cross, as modified by Cawood and Denton, is silent to wherein the tubular sleeve extends from a top wall of the walls.
However, because Cross appears to have its respective tubing attachable to a top wall of the walls (fig. 2, inlet tube 22 extending from a top wall of the walls of the bag), It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross in view of Cawood and Denton such that the tubular sleeve extends from a top wall of the walls, for the purpose of providing a suitable structure that grants the benefits cited in Denton while remaining consistent with the structure of Cross.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Cross in view of Cawood and Denton, and further in view of Washington (US 20170079571).
Regarding claim 21, Cross does not teach a flexible drain pipe having an inlet end in fluid communication with the compartment of the reservoir, and an outlet end movable between a raised position above the bottom wall and a lowered position below the bottom wall.
However, Washington teaches a urinary collection system (abstract) with a flexible drain pipe (116) that has an inlet end in fluid communication with the compartment of the reservoir (fig. 2, drain tube 116 connected with an inlet end near valve 138), and an outlet end (140) moveable between a raised position above the bottom wall and a lowered position below the bottom wall (fig. 2, raised position where drain spigot 140 is above the bottom portion, and has a portion where spigot 140 is outside the pocket 152 to be below the bottom wall).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross such that it comprises a flexible drain pipe having an inlet end in fluid communication with the compartment of the reservoir, and an outlet end movable between a raised position above the bottom wall and a lowered position below the bottom wall, as taught by Washington, for the purpose of providing a suitable structure that allows a user to stow away the spigot when not in use (see Washington, paragraph 0026).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Cross in view of Cawood and Denton, and further in view of Vernon.
Regarding claim 22, Cross does not teach a stocking worn on the person's leg and surrounding and enclosing the reservoir to hold the reservoir against the person's leg atop the person's foot, and also enclosing the outlet end to hold the outlet end in the raised position, the stocking having an openable fastener.
However, Vernon teaches a stocking (fig. 2, sleeve 5) worn on a person’s leg and surrounding and enclosing the reservoir to hold the reservoir against the person’s leg (fig. 2 shows sleeve 5 enclosing bag 1, also see fig. 1). Moreover, the outlet end may be enclosed in this stocking to hold the outlet in the raised position (fig. 1, wand 81 can be raised over the bottom of bag 1 and enclosed in the stocking underneath the flap 7). Further, the stocking has an openable fastener (fig. 1, hook material 77 to fit flap 71 over bag 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross such that it includes a stocking worn on the person's leg and surrounding and enclosing the reservoir to hold the reservoir against the person's leg atop the person's foot, and also enclosing the outlet end to hold the outlet end in the raised position, the stocking having an openable fastener, as taught by Vernon, for the purpose of providing a suitable structure that can incorporate a pressure sensor to determine if a bag is full (see Vernon, col. 6, lines 56-63).
Regarding claim 23, Cross does not teach a stocking worn on the person's leg and having a foldable neck to form a cuff that surrounds and holds the reservoir between the cuff and the neck, and also enclosing the outlet end in the raised position, the stocking having an openable fastener.
However, Vernon teaches a stocking worn on a person’s leg with a foldable neck (fig. 1, neck of sleeve 5 is foldable with flap 71 being folded) that forms a cuff that surrounds and holds the reservoir between the cuff and the neck (fig. 1, cuff to hold the bag 1 formed by base of the sleeve and the flap 71, the cuff defined by the top of the folded assembly). Moreover, the outlet end may be enclosed in this stocking to hold the outlet in the raised position (fig. 1, wand 81 can be raised over the bottom of bag 1 and enclosed in the stocking underneath the flap 7). Further, the stocking has an openable fastener (fig. 1, hook material 77 to fit flap 71 over bag 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Cross such that it includes a stocking worn on the person's leg and having a foldable neck to form a cuff that surrounds and holds the reservoir between the cuff and the neck, and also enclosing the outlet end in the raised position, the stocking having an openable fastener, as taught by Vernon, for the purpose of providing a suitable structure that can incorporate a pressure sensor to determine if a bag is full (see Vernon, col. 6, lines 56-63).
Allowable Subject Matter
Claim 19 would be allowable if rewritten or amended to overcome the rejection(s) non-statutory double patenting set forth in this Office action.
Regarding claim 19, the closest prior art of record, Miller (US 20150051588), discloses a catheter system comprising:
a) an indwelling, catheter having a tip designed for insertion into a catheter user's bladder, said tip having an opening through which urine from the bladder passes into the catheter,
b) a flexible reservoir constructed to extend around a user’s ankle with walls bounding an interior compartment
c) flexible tubing connecting said catheter in fluid communication with each of said reservoirs to conduct urine from said catheter into the compartment of said reservoirs;
Miller does not teach wherein said catheter including a catheter wall defining at least one pocket for the retention of lubricant including a pocket opening defined on a surface of the catheter wall and a cavity extending into the catheter wall, wherein a first portion of the pocket opening overhangs the cavity and a second portion of the pocket opening does not overhang the cavity to create an asymmetrical parabolic shaped cavity; a pair of flexible reservoirs, each of which is constructed to extend around the catheter user's ankle and has walls bounding an interior compartment, wherein said reservoirs rest on the top of each of the user's feet to resist downward movement of the reservoir as the reservoir is filled with urine.
Hutzler (EP 0795339) teaches the use of lubricant pockets for a catheter, but fails to teach the specific structure of the lubricant pockets as claimed, notably that a first portion of the pocket opening overhangs the cavity and a second portion for the pocket opening does not overhang the cavity to create an asymmetrical parabolic shaped cavity.
Kaldany (US 6659996) teaches a device for delivering a substance that includes pockets with overhangs around the pocket opening, but fails to teach wherein a first portion of the pocket opening overhangs the cavity and a second portion of the pocket opening does not overhang the cavity to create an asymmetrical parabolic shaped cavity.
Torres- Leon teaches a pair of reservoirs, and Cross teaches wherein said reservoirs rest on the top of each of the user's feet to resist downward movement of the reservoir as the reservoir is filled with urine, but does not cure the above deficiencies.
For these reasons, claim 19 is allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781