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 § 112(b)
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 1-7 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 1 calls for “A foley catheter sponge assembly being positionable around a foley catheter tube … said device comprising…” This language is ambiguous because it uses two terms, “assembly” and “device” to describe the same feature. Examiner suggests to choose only one of these terms.
Claim 6 recites similar language in its preamble and should be revised likewise.
Claim 1 further calls for “A foley catheter sponge assembly … said device comprising: a foley catheter having a tube and a balloon …” This language is ambiguous because it implies that the device which is positionable around the foley catheter also includes the foley catheter.
Claim 6 recites similar redundant language about a foley catheter and should be revised likewise.
Claim 7 calls for “…inserting a foley catheter into a female patient's urethra in a manner that complies with standard medical practices…” This language is ambiguous because the claim does not specify any objective steps, physical structures or compositions related to the medical practices.
The meaning of this phrase cannot be easily determined from the level of ordinary skill in the art, since medical regulations and standards vary between different regions. This phrase also raises a question of whether other accessories (e.g. sterilizing wipes, gloves, lubricant, a sterile drape etc.) must accompany the catheter.
Claims 2-5 are rejected for depending on a rejected parent claim.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 4, 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Challa; Pranav (US 20230009148 A1) in view of Reddy; Usha (US 20160022509 A1).
Regarding claim 1, Challa discloses a foley catheter sponge assembly being positionable around a foley catheter tube at a strategic location to secure a balloon of the foley catheter against the bladder wall (¶ [0002], an anti-microbial coated urethral plug to reduce catheter associated urinary tract infections (“CAUTI”); ¶ [0017] FIG. 1 … The urethral plug 100);
said device comprising: a foley catheter having a tube and a balloon (¶ [0018], urinary catheter 50; ¶ [0026], Further details and embodiments of catheterization kits and methods of use thereof can be found, in US 2017/0216558, which is incorporated by reference in its entirety into this application; ¶ [0028], The retention balloon can be inflated in the bladder by injecting the sterile liquid from the syringe of sterile liquid into the catheter through an inflation port);
a sponge (¶ [0005], [0021] In an embodiment, the urethral plug 100 is formed of … polyvinyl chloride (PVC), polyurethane (PU), “memory foam,” silicone rubber, foam rubber);
having a longitudinal split integrated into said sponge thereby facilitating said tube of said foley catheter to be positioned in said sponge for securing said sponge on said tube (¶ [0019], the plug 100 further includes a slit 112 extending longitudinally from the plug lumen 110, through the plug body 102 to an outer surface thereof and is configured to allow the catheter 50 to pass laterally or transversely therethrough);
said sponge being strategically located with respect to said balloon wherein said sponge is configured to rest against a female patient's urethra when said tube is inserted into the female patient's urethra thereby securing said balloon against the female patient's bladder wall to inhibit said balloon from floating in the female patient's bladder (¶ [0020] FIG. 2 shows a cross-sectional view of the urethral plug 100, including a urinary catheter 50, and disposed within an entrance of a urethra 40; ¶ [0028], Once inflated, the clinician may gently pull the catheter 50 until the inflated balloon is snug against the bladder neck);
said sponge being comprised of an antimicrobial material wherein said sponge is configured to inhibit the development of a urinary tract infection in the female patient (¶ [0005], The coating may include at least one of a hydrogel coating, an antimicrobial coating such as a silver ion coating and/or a chlorhexidine coating, an antibiotic coating, a medicinal coating, or any other coating suitable for minimizing HAI and improving patient comfort; ¶ [0029], As disclosed herein, the plug 100 can further include anti-microbial coatings and/or textures to further mitigate the introduction of pathogens that cause CAUTI infections);
said sponge being comprised of a fluid absorbent material wherein said sponge is configured to absorb urine that leaks from the female patient's urethra thereby enhancing cleanliness for the female patient (¶ [0005], [0021] In an embodiment, the urethral plug 100 is formed of … polyvinyl chloride (PVC), polyurethane (PU), “memory foam,” silicone rubber, foam rubber).
Regarding the sponge being strategically located with respect to said balloon in order to inhibit the balloon from floating, Challa pulls the catheter (¶ [0028], Once inflated, the clinician may gently pull the catheter 50 until the inflated balloon is snug against the bladder neck) and then pushes the sponge assembly towards the patient’s urethral opening (¶ [0020] FIG. 2 shows a cross-sectional view of the urethral plug 100, including a urinary catheter 50, and disposed within an entrance of a urethra 40). After arranging the balloon at the bladder neck and the sponge at the urethral opening, the catheter and its balloon will be unable to move in either direction.
Challa lacks a pair of adhesive pads. Reddy discloses an absorbent article for use with an indwelling catheter (¶ [0006], [0038] FIG. 1A … absorbent article 100);
said device comprising: a foley catheter having a tube (¶ [0038], an absorbent article 100 is configured to accommodate a urinary catheter and its associated tubing);
a sponge (¶ [0027], The absorbent core may comprise any material or combination of materials … including tissue wraps and tissue laminates, absorbent foams, absorbent sponges; ¶ [0039], The absorbent article 100 optionally comprises an absorbent core, not shown, disposed between the top sheet 102 and the back sheet 104);
having a longitudinal split integrated into said sponge thereby facilitating said tube of said foley catheter to be positioned in said sponge for securing said sponge on said tube (¶ [0042] The absorbent article 100 further comprises a reclosable opening 120, which extends from the aperture 110 to an edge of the absorbent article 100);
said sponge being comprised of a fluid absorbent material wherein said sponge is configured to absorb urine that leaks from the female patient's urethra thereby enhancing cleanliness for the female patient (¶ [0027], The absorbent core may comprise any material or combination of materials which is capable of absorbing and retaining liquids such as urine, feces, and other body exudates); and
a pair of adhesive pads, each of said pair of adhesive pads being positioned in said longitudinal split thereby facilitating each of said pair of adhesive pads to adhere to said tube of said foley catheter when said tube is inserted into said longitudinal split thereby securing said sponge to said tube (¶ [0030], Suitable fasteners include, for example, tape, adhesive, hook and loop closures, hook and hook closures, and tongue and groove fasteners; ¶ [0032] In another embodiment, the sides of the reclosable opening are held in the closed configuration by virtue of a fastener, which is disposed along an edge of the first side, the second side, or both sides of the reclosable opening … the fastener is selected from the group consisting of adhesive, hook and loop closures (e.g., Velcro®), tongue and groove closures, and combinations thereof; ¶ [0043] The absorbent article 100 further comprises a fastener 130, disposed along an edge of the first side 120A, second side 120B, or both sides 120A and 120B of the reclosable opening 120. In the instant embodiment, the fastener 130 comprises adhesive or hook and loop-type closures that traverse the reclosable opening 120 and hold the sides 120A and 120B in the closed configuration … the entire length of the sides 120A and 120B may comprise a fastener 130, such as adhesive or mating sides of a hook and loop-type closure or a tongue and groove closure, such that the entire length of the reclosable opening 120 may be secured in the closed configuration; ¶ [0044] FIG. 1B … The fastener 130 traverses the reclosable opening 120 in a perpendicular manner, thus holding the reclosable opening 120 in a closed configuration. In specific embodiments, the fastener 130 comprises adhesive or hook and loop-type closures).
Regarding the ability for the adhesive pads to inhibit said balloon from displacing from the female patient's bladder wall, this rejection combines Challa with Reddy’s adhesive pads by arranging Reddy’s adhesive pads on Challa’s slit 112. The combined device will secure Challa’s sponge on the catheter and prevent it from moving along the catheter. Reddy retains a pad against a catheter and also prevents fluids from bypassing the pad (¶ [0041], In one embodiment, the aperture edge 112 is configured to support the catheter and substantially hold the catheter in proper position). One would be motivated to modify Challa with Reddy’s adhesive pads to more securely fasten the sponge and prevent leaks. Therefore, it would have been obvious to modify Challa with Reddy’s adhesive pads in order to more securely retain a sponge along a catheter.
Regarding claim 7, Challa discloses a method of securing a foley catheter in a female patient (¶ [0003] Disclosed herein are apparatus and methods for applying a plug to the urinary meatal opening; ¶ [0006] Also disclosed herein is a method of mitigating urinary tract infections associated with a urinary catheter, including providing a urethral plug configured to engage the urinary catheter; ¶ [0025], A non-limiting method of use is described below);
the steps of the method comprising: inserting a foley catheter into a female patient's urethra in a manner that complies with standard medical practices (¶ [0028], With the genitalia cleansed, the clinician can insert the lubricated catheter 50 into the urethra 40 to access the patient's bladder);
positioning a sponge around a tube of said foley catheter; said sponge having a cut which extends through an outer surface of said sponge and is elongated to extend through each of a top surface and a bottom surface of said sponge, said cut insertably receiving said tube of said foley catheter such that said sponge extends along a substantial length of said tube (¶ [0019], the plug 100 further includes a slit 112 extending longitudinally from the plug lumen 110, through the plug body 102 to an outer surface thereof and is configured to allow the catheter 50 to pass laterally or transversely therethrough);
positioning said sponge at a point along said tube such that said sponge rests against the female patient's urethra thereby securing a balloon of said foley catheter against a wall of the female patient's bladder thereby inhibiting said balloon from floating in the female patient's bladder (¶ [0020] FIG. 2 shows a cross-sectional view of the urethral plug 100, including a urinary catheter 50, and disposed within an entrance of a urethra 40; ¶ [0028], Once inflated, the clinician may gently pull the catheter 50 until the inflated balloon is snug against the bladder neck).
Challa does not compress a pair of adhesive pads against the tube. Reddy discloses an absorbent article designed to accommodate indwelling catheters (¶ [0006], [0038], an absorbent article 100 is configured to accommodate a urinary catheter and its associated tubing);
including compressing a pair of adhesive pads against a catheter tube, each of said pair of adhesive pads being positioned in a cut in a sponge against said tube such that said pair of adhesive pads adhesively engages said tube thereby securing said sponge on said tube (¶ [0030], Suitable fasteners include, for example, tape, adhesive, hook and loop closures; ¶ [0032] In another embodiment, the sides of the reclosable opening are held in the closed configuration by virtue of a fastener, which is disposed along an edge of the first side, the second side, or both sides of the reclosable opening … the fastener is selected from the group consisting of adhesive, hook and loop closures (e.g., Velcro®), tongue and groove closures, and combinations thereof; ¶ [0043] The absorbent article 100 further comprises a fastener 130, disposed along an edge of the first side 120A, second side 120B, or both sides 120A and 120B of the reclosable opening 120. In the instant embodiment, the fastener 130 comprises adhesive or hook and loop-type closures that traverse the reclosable opening 120 and hold the sides 120A and 120B in the closed configuration … the entire length of the sides 120A and 120B may comprise a fastener 130, such as adhesive or mating sides of a hook and loop-type closure or a tongue and groove closure, such that the entire length of the reclosable opening 120 may be secured in the closed configuration; ¶ [0044] FIG. 1B … The fastener 130 traverses the reclosable opening 120 in a perpendicular manner, thus holding the reclosable opening 120 in a closed configuration. In specific embodiments, the fastener 130 comprises adhesive or hook and loop-type closures).
Reddy securely retains a pad against a catheter (¶ [0041], In one embodiment, the aperture edge 112 is configured to support the catheter and substantially hold the catheter in proper position). Regarding the rationale and motivation to modify Challa with Reddy’s adhesive pads, see the discussion of claim 1 above.
Regarding claim 2, Challa discloses that the sponge has a top surface and a bottom surface and an outer surface extending between said top surface and said bottom surface; said sponge is elongated between said top surface and said bottom surface (¶ [0004], The urethral plug includes a plug body defining a frustum shape; ¶ [0017] FIG. 1 … The urethral plug 100 includes a plug body 102 that substantially defines a frustum shape, e.g. a frusto-conical shape);
said outer surface is continuously arcuate about said central longitudinal axis of said sponge such that said sponge has a cylindrical shape (¶ [0017], The proximal end 104 and distal end 106 each define a substantially circular cross-sectional shape although it will be appreciated that other closed-curve, polygonal, cross-sectional shapes are also contemplated);
said sponge has a cut extending into said outer surface; said cut being elongated to extend through said top surface and said bottom surface such that said cut defines said longitudinal split (¶ [0019], the plug 100 further includes a slit 112 extending longitudinally from the plug lumen 110); and
said cut is aligned with a central longitudinal axis of said sponge (Figs. 1, 2, lumen 110 substantially aligns with plug’s center axis).
Regarding claim 4, Challa discloses that the cut has a first bounding surface and a second bounding surface each extending between said top surface and said bottom surface of said sponge (¶ [0019], the plug 100 further includes a slit 112 extending longitudinally from the plug lumen 110, through the plug body 102 to an outer surface thereof; ¶ [0029] With the urinary catheter 50 inserted into the patient, a portion of the shaft of the catheter 50 is inserted through the slit 112, into the lumen 110 of the urethral plug 100).
Challa lacks adhesive pads. Reddy discloses a cut having first and second bounding surfaces (¶ [0042], The reclosable opening 120 has a first side 120A and a second side 120B);
each of said pair of adhesive pads is integrated into a respective one of said first bounding surface and said second bounding surface of said cut; and said pair of adhesive pads is aligned with each other (¶ [0043], For example, in another embodiment not shown, the entire length of the sides 120A and 120B may comprise a fastener 130, such as adhesive or mating sides of a hook and loop-type closure or a tongue and groove closure, such that the entire length of the reclosable opening 120 may be secured in the closed configuration).
A skilled artisan would have been able to modify Challa with Reddy’s adhesive pads by arranging Reddy’s adhesive on the inner surfaces of Challa’s slit 112, to thereby fasten the sponge more securely. Regarding the rationale and motivation to modify Challa with Reddy’s adhesive pads, see the discussion of claim 1 above.
Regarding claim 5, Challa discloses a cut that accommodates the tube so that the sponge fits around the tube (¶ [0019], In an embodiment, the plug 100 further includes a slit 112 extending longitudinally from the plug lumen 110, through the plug body 102 to an outer surface thereof and is configured to allow the catheter 50 to pass laterally or transversely therethrough).
Challa lacks adhesive pads. Reddy discloses a pair of adhesive pads (¶ [0043], For example, in another embodiment not shown, the entire length of the sides 120A and 120B may comprise a fastener 130, such as adhesive or mating sides of a hook and loop-type closure or a tongue and groove closure, such that the entire length of the reclosable opening 120 may be secured in the closed configuration).
Although Reddy does not depict this embodiment, Reddy implies that the continuously-extending adhesive pads adhesively engage the tube when the tube is positioned in the cut.
A skilled artisan would have been able to modify Challa with Reddy’s adhesive pads by extending Reddy’s adhesive pads fully along Challa’s bounding surfaces, including their lower edges.
Regarding the rationale and motivation to modify Challa with Reddy’s adhesive pads, see the discussion of claim 1 above.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Challa and Reddy in view of Fabo; Tomas et al. (US 20100331785 A1).
Regarding claim 3, Challa and Reddy are silent whether the cut has a depth being greater than a radius of said sponge. Fabo discloses an assembly comprising a cut that extends inwardly beyond said central longitudinal axis of a sponge such that said cut has a depth being greater than a radius of said sponge thereby facilitating a tube of a catheter to be aligned with said central longitudinal axis of said sponge when said tube is inserted into said cut (¶ [0060] The dressing 11 according to the embodiment shown in FIG. 7 differs from the dressing shown in FIGS. 1-3 by having secondary slits 20 radially extending from the hole 18 in addition to the primary slit 19 … The secondary slits 20 do not reach the outer edge of the absorbent body but end before reaching said edge; ¶ [0063] In FIG. 9 … Furthermore, there is no hole in the middle of the dressing but a slit 212 crosses the slit 209 a distance from the inner end thereof; ¶ [0064] In FIG. 10 … This dressing 301 differs from dressing 201 shown in FIG. 9 in that a portion projecting from the inner periphery of the stiffening layer is lacking and that instead of one secondary slit crossing the slit 309, two slits 313 are crossing slit 309).
Fabo centers tubes of varying sizes inside a pad (¶ [0060], The advantage by such a construction of the dressing is that the dressing 11 can be accommodated around projecting objects of different sizes and having different cross-sections). One would be motivated to modify Challa and Reddy with Fabo’s extended cuts to accommodate differently sized catheters. Therefore, it would have been obvious to modify Challa and Reddy with Fabo’s extended cuts in order to accommodate catheters of varying diameters.
Claim 6 combines all the features from claims 1-5. This claim is rejected over the combination of Challa, Reddy and Fabo which address all features of these claims, as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gross; James R. US 4784647 A
Kay; Dennis M. US 5207652 A
Chang; Hau H. US 5593389 A
Freeman; Jack B. et al. US 5746723 A
West; Beverley US 20090005750 A1
Weadock; Kevin et al. US 20120203211 A1
Hughett; David et al. US 20170216558 A1
McMichael; Donald US 20200022879 A1
McIntyre; Matthew G. et al. US 20220143363 A1
Whitmore; Caleb Hollis US 20230405278 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781