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 Objections
Claims 1-12 are objected to because of the following informalities:
Claims 1, 5, 7-8, and 11 each have the limitation of a tube having a lumen and the moving element having a lumen, the lumen crossing the entire section of the moving element and having a membrane. While the context of the claim limitations makes clear the lumen of the moving element is the one with the membrane, examiner recommends language that differentiates the lumen of the tube and the lumen of the moving element for the sake of clarity.
Claims 1 and 7 recite the limitation of “the index and middle fingers” and “the thumb finger”. While it is apparent that these limitations are more so to indicate how the device is gripped, examiner recommends rewriting the limitations to have antecedent basis, such as reciting -allow an index finger and a middle finger- and -while a thumb finger-.
Moreover, claims 1 and 7 recite a narrative limitation of “a firm, natural and ergonomic grip”, which is unclear as to what structure the limitation provides. Examiner recommends removing this limitation, since a “firm, natural grip and ergonomic grip” does not necessarily add to the structure of the device.
Further, the preambles of claims 1-12 should read -A urinary catheter- and -A urinary catheter according to claim [claim number]- as opposed to “Urinary catheter” and “Urinary catheter according to claim [claim number]”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 5, 7-8, and 11 each recite “a main body at the end whereof opposite the bladder connection area”. There does not appear to be sufficient antecedent basis for this limitation. For the purpose of examination, the limitation will be interpreted as -a main body at an end whereof opposite a bladder connection area –
Moreover, claims 1, 5, 7-8, and 11 each recite “the longitudinal section”. There does not appear to be sufficient antecedent basis for this limitation. For the purpose of examination, the limitation will be interpreted as -a longitudinal section-
Further, claims 1, 5, 7-8, and 11 each recite “the moving element is provided with a relief at the end-. There does not appear to be sufficient antecedent basis for this limitation. For the purpose of examination, the limitation will be interpreted as -moving element is provided with a relief at an end-
Claims 1 and 5 recite the limitation “both reliefs are at the same end of the slide valve”. There does not appear to be sufficient antecedent basis for this limitation. For the purpose of examination, the limitation will be interpreted as -both reliefs are at a same end of the slide valve-
Claims 2, 6, 8, and 11 all recite the limitation of a plug that “prevents the slide valve from moving involuntarily and a membrane position of the slide valve to be fixed in the urinary catheter”. While the claim as written appears to suggest the plug prevents the membrane position of the slide valve to be fixed, as best understood by the examiner in light of the specification the plug is meant to prevent the slide valve from moving involuntarily and allow the membrane position of the slide valve to be fixed (see instant specification publication, paragraph 0047). For the purpose of examination, the limitation will be interpreted as the plug preventing involuntary movement and allows fixing of the membrane position.
Claims 2, 6, 8, and 11 also recite “rigid plug made and arranged to fit into the end of the tube, at the end opposite to the end where the reliefs are located”, There does not appear to be sufficient antecedent basis for this limitation. For the purpose of examination, the limitation will be interpreted as -rigid plug made and arranged to fit an end of the tube, at an end opposite to an end where the reliefs are located”
Claims 2-4, 6, 9, and 12 are rejected by virtue of being dependent on rejected independent claims.
Claim 12 is rejected by virtue of being dependent on claim 11.
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 5 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Luque González (US 20150202407)
Regarding claim 5, Luque González discloses Urinary catheter (abstract) comprising a main body (fig. 1, tube 12) at the end whereof opposite the bladder connection area is a slide valve (fig. 1, tip 16 to be inserted into the bladder, valve 22 at the opposite end), the slide valve being provided with a tube consisting of an elongated hollow element having a lumen and provided with a moving element located inside the tube (fig. 3 and 4a, valve 22 shown consisting of a hollow body with a lumen to hold an actuating element 40), wherein the moving (40) element is longer than the tube such that one of two ends of the moving element is always visible and accessible by protruding from one of the ends of the tube (fig. 5A shows one end protruding, fig. 5B and 5C shows another end protruding)), wherein the moving element consists of an elongated part provided with a narrowing in the longitudinal section (fig. 5C, releasing section 46 as a narrowing) and a lumen (fig. 5C, wherein a lumen is defined by the cross section where fluid passes by releasing section 46), the lumen crossing the entire section of the moving element, wherein at one of the ends of the lumen there is a surface wherein a membrane composed of a flexible sheet that only allows the passage of flow of air but not flow of urine is housed (fig. 5A, membrane section 50 that discharges air but not liquid, paragraph 0039. Paragraph 0039 also alludes to air passing through the membrane, thus suggesting a lumen that houses the membrane), wherein the moving element (40) is mounted movable with respect the main body (38) such that;
- in an open position of the slide valve, the narrowing (46) coincides with a urine flow channel (fig. 5C shows the assembly in the open condition, where releasing section 46 lets liquid flow past it, paragraph 0035),
- in a membrane position of the slide valve, the lumen having the membrane coincides with the urine flow channel such that it allows the flow of air and prevents the flow of urine from passing through the lumen (fig. 5B shows the assembly in the membrane position, where membrane section 50 lets air be discharged but prevents liquid flow, paragraph 0039), and
- in a closed position of the slide valve, the moving element blocks the urine flow channel such that it prevents the flow of urine and air from passing through the urine channel (fig. 5A shows the assembly in the closed position, where closing section 42 prevents fluid flow, paragraph 0037).
and wherein the moving element (40) is provided with a relief at one end that when visible corresponds to an open position of the slide valve (fig. 5C shows a portion as upper end 48 of actuating element 40 as a relief), and the tube is provided with another relief (see annotated fig. 5A below), and both reliefs are at the same end of the slide valve and close to each other in a closed position of the slide valve (see annotated fig. 5A below).
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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 1, 3-4 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Luque González in view of Douglass (US 20130324975), and further in view of T-Control (hereinafter Rethink) and Allard (US 20180093089).
Regarding claim 1, Luque González discloses a urinary catheter (abstract) comprising a main body (fig. 1, tube 12) at the end whereof opposite the bladder connection area is a slide valve (fig. 1, tip 16 to be inserted into the bladder, valve 22 at the opposite end), the slide valve (22) being provided with a tube consisting of an elongated element, hollow and having a lumen and a moving element located inside the tube (fig. 3 and 4a, valve 22 shown consisting of a hollow body with a lumen to hold an actuating element 40), and consists of an elongated part (fig. 5A shows the actuating element 40 as elongated) provided with a narrowing in the longitudinal section (fig. 5C, releasing section 46 as a narrowing) and a lumen (fig. 5C, wherein a lumen is defined by the cross section where fluid passes by releasing section 46), wherein the lumen crosses the entire section of the moving element wherein at one of the ends of the lumen there is a surface wherein a membrane composed of a flexible sheet that only allows the passage of flow of air but not flow of urine is housed (fig. 5A, membrane section 50 that discharges air but not liquid, paragraph 0039. Paragraph 0039 also alludes to air passing through the membrane, thus suggesting a lumen that houses the membrane);
wherein the moving element is longer than the tube (fig. 5a shows actuating element 40 longer than the receiving section 38) such that one of two ends of the moving element is always visible and accessible by protruding from one of the ends of the tube (fig. 5A shows one end protruding, fig. 4B shows another end protruding),
- wherein the moving element is provided with a relief at the end that when visible corresponds to an open position of the slide valve (fig. 5C shows a portion as upper end 48 of actuating element 40 as a relief), and the tube is provided with another relief (see annotated fig. 5A below), and both reliefs are at the same end of the slide valve and close to each other in a closed position of the slide valve (see annotated fig. 5A below).
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Luque González is silent to where the tube is made of rigid material, and wherein the moving element comprises two chromatically differentiated parts, and does not teach wherein the slide valve is provided with curved surfaces made and arranged to allow the index and middle fingers hold the main body to make a firm, natural and ergonomic grip of the urinary catheter while the thumb finger press the moving element to move said moving element to the open position or to the closed position of the slide valve.
However, Douglass teaches a catheter valve with a valve body made of rigid material (paragraph 0051)
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 Luque González such that the tube is made of rigid material, as taught by Douglass, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 125 USPQ 416.
Luque González is silent to wherein the moving element comprises two chromatically differentiated parts, and does not teach wherein the slide valve is provided with curved surfaces made and arranged to allow the index and middle fingers hold the main body to make a firm, natural and ergonomic grip of the urinary catheter while the thumb finger press the moving element to move said moving element to the open position or to the closed position of the slide valve.
However, Rethink teaches a moving element with two chromatically differentiated parts (see figures in Open vs Closed configurations, with the open configuration showing a green side and a closed position showing a red side). While the attached non-patent literature has been processed in black and white, the original publication shows the colors green and red. The original publication can be accessed via Wayback machine using https://www.rethinkmedical.es/our-solution.html, on August 07, 2020.
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 Luque González such that the moving element comprises two chromatically differentiated parts, as taught by Rethink, for the purpose of providing a suitable additional means of differentiating between the two modes at a glance.
Luque González does not teach wherein the slide valve is provided with curved surfaces made and arranged to allow the index and middle fingers hold the main body to make a firm, natural and ergonomic grip of the urinary catheter while the thumb finger press the moving element to move said moving element to the open position or to the closed position of the slide valve.
However, Allard teaches a valve with curved surfaces (15) made and arranged to allow index and middle fingers to hold the body to make a firm, natural and ergonomic grip of the urinary catheter while the thumb finger can press the means of opening the valve from the open and closed position (fig. 2 shows curved areas as gripping means 15, fig. 1 shows these gripping means in relationship to plug 3. It appears that one of ordinary skill in the art would be capable of using their index and middle fingers to grip two gripping means 15 and use their thumb to move the plug 3).
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 Luque González such that the slide valve is provided with curved surfaces made and arranged to allow the index and middle fingers hold the main body to make a firm, natural and ergonomic grip of the urinary catheter while the thumb finger press the moving element to move said moving element to the open position or to the closed position of the slide valve, as taught by Allard, for the purpose of providing a suitable structure that allows a user to grasp the valve more efficiently (see Allard, paragraph 0075).
Regarding claim 4, Luque González discloses wherein the moving element (40) is mounted movable with respect the main body (38) such that;
- in an open position of the slide valve, the narrowing (46) coincides with a urine flow channel (fig. 5C shows the assembly in the open condition, where releasing section 46 lets liquid flow past it, paragraph 0035),
- in a membrane position of the slide valve, the lumen having the membrane coincides with the urine flow channel such that it allows the flow of air and prevents the flow of urine from passing through the lumen (fig. 5B shows the assembly in the membrane position, where membrane section 50 lets air be discharged but prevents liquid flow, paragraph 0039), and
- in a closed position of the slide valve, the moving element blocks the urine flow channel such that it prevents the flow of urine and air from passing through the urine channel (fig. 5A shows the assembly in the closed position, where closing section 42 prevents fluid flow,, paragraph 0037).
Regarding claim 10, Luque González does not teach wherein a half of the moving element has a first chromatic differentiated part, and the other half of the moving element has a second chromatic differentiated part.
However, Rethink teaches wherein a half of the moving element has a first chromatic differentiated part, and the other half of the moving element has a second chromatic differentiated part (see figures in Open vs Closed configurations, with the open configuration showing a green side and a closed position showing a red side). While the attached non-patent literature has been processed in black and white, the original publication shows the colors green and red. The original publication can be accessed via Wayback machine using https://www.rethinkmedical.es/our-solution.html, on August 07, 2020.
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 Luque González such that a half of the moving element has a first chromatic differentiated part, and the other half of the moving element has a second chromatic differentiated part, as taught by Rethink, for the purpose of providing a suitable means of allowing a user to differentiate between different settings at a glance.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Luque González in view of Douglass, Rethink, and Allard, and further in view of Funamura (US 20070265581) and Svensson (US 4306705).
Regarding claim 3, Luque González does not teach wherein the elongated part of the moving element comprises an elliptical cross section, said elliptical elongated part of the moving element is mounted movable inside the elongated element of the tube and said elongated element of the tube having also an elliptical cross section, wherein the lumen having the membrane is circular in section and crosses the entire section of the moving element according to an axis parallel to the minor axis of the ellipse that constitutes the section of said moving element.
However, Funamura teaches a valve wherein the valve body and the chamber hosting said valve body can both be an ellipse shape such that they have an elliptical cross section (paragraph 0050, “rotation in the direction around the axis of the valve body can be prevented by formation of the shape of the outer circumferential surface of the valve body and the inner circumferential surface of the chamber as a polygonal shape such as an ellipse, square or triangle.”)
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 Luque González such that wherein the elongated part of the moving element comprises an elliptical cross section, said elliptical elongated part of the moving element is mounted movable inside the elongated element of the tube and said elongated element of the tube having also an elliptical cross section, as taught by Funamura, for the purpose of preventing unwanted rotation (see Funamura, paragraph 0050).
Luque González does not teach wherein the lumen having the membrane is circular in section and crosses the entire section of the moving element according to an axis parallel to the minor axis of the ellipse that constitutes the section of said moving element.
However, Svensson teaches circular openings for fluid drainage along a minor axis of an oblong section (fig. 9 shows the circular aperture 34 within the rectangular slide 32 going through the smaller axis of the shape)
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 Luque González such that the lumen having the membrane is circular in section and crosses the entire section of the moving element according to an axis parallel to the minor axis of the ellipse that constitutes the section of said moving element, as taught by Svensson, for the purpose of providing a suitable orientation that minimizes the length of the valve along the axis of the main body of the catheter by accommodating the bulk of the movable body along the width dimension. Moreover, the exact shape of the opening, absent persuasive evidence, does not appear critical to the claimed invention. See MPEP 2144.04(IV)(B).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Luque González in view of Allard.
Regarding claim 7, Luque González discloses Urinary catheter (abstract) comprising a main body (fig. 1, tube 12) at the end whereof opposite the bladder connection area is a slide valve (fig. 1, tip 16 to be inserted into the bladder, valve 22 at the opposite end), the slide valve being provided with a tube consisting of an elongated hollow element having a lumen and provided with a moving element located inside the tube (fig. 3 and 4a, valve 22 shown consisting of a hollow body with a lumen to hold an actuating element 40), wherein the moving (40) element is longer than the tube such that one of two ends of the moving element is always visible and accessible by protruding from one of the ends of the tube (fig. 5A shows one end protruding, fig. 5B and 5C shows another end protruding)), wherein the moving element consists of an elongated part provided with a narrowing in the longitudinal section (fig. 5C, releasing section 46 as a narrowing) and a lumen (fig. 5C, wherein a lumen is defined by the cross section where fluid passes by releasing section 46), the lumen crossing the entire section of the moving element, wherein at one of the ends of the lumen there is a surface wherein a membrane composed of a flexible sheet that only allows the passage of flow of air but not flow of urine is housed (fig. 5A, membrane section 50 that discharges air but not liquid, paragraph 0039. Paragraph 0039 also alludes to air passing through the membrane, thus suggesting a lumen that houses the membrane), wherein the moving element (40) is mounted movable with respect the main body (38) such that;
- in an open position of the slide valve, the narrowing (46) coincides with a urine flow channel (fig. 5C shows the assembly in the open condition, where releasing section 46 lets liquid flow past it, paragraph 0035),
- in a membrane position of the slide valve, the lumen having the membrane coincides with the urine flow channel such that it allows the flow of air and prevents the flow of urine from passing through the lumen (fig. 5B shows the assembly in the membrane position, where membrane section 50 lets air be discharged but prevents liquid flow, paragraph 0039), and
- in a closed position of the slide valve, the moving element blocks the urine flow channel such that it prevents the flow of urine and air from passing through the urine channel (fig. 5A shows the assembly in the closed position, where closing section 42 prevents fluid flow, paragraph 0037).
Luque González does not teach wherein the slide valve is provided with curved surfaces made and arranged to allow the index and middle fingers hold the main body to make a firm, natural and ergonomic grip of the urinary catheter while the thumb finger press the moving element to move said moving element to the open position or the closed position of the slide valve.
However, Allard teaches a valve with curved surfaces (15) made and arranged to allow index and middle fingers to hold the body to make a firm, natural and ergonomic grip of the urinary catheter while the thumb finger can press the means of opening the valve from the open and closed position (fig. 2 shows curved areas as gripping means 15, fig. 1 shows these gripping means in relationship to plug 3. It appears that one of ordinary skill in the art would be capable of using their index and middle fingers to grip two gripping means 15 and use their thumb to move the plug 3).
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 Luque González such that the slide valve is provided with curved surfaces made and arranged to allow the index and middle fingers hold the main body to make a firm, natural and ergonomic grip of the urinary catheter while the thumb finger press the moving element to move said moving element to the open position or to the closed position of the slide valve, as taught by Allard, for the purpose of providing a suitable structure that allows a user to grasp the valve more efficiently (see Allard, paragraph 0075).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Luque González in view of Douglass, Rethink, and Allard, and further in view of Taylor (WO 2021198672).
Regarding claim 9, Luque González discloses the main body made of silicone (paragraph 0009), but does not teach wherein the main body is made of transparent silicone or equivalent plastic material to allow the flow of urine to be seen.
However, Taylor teaches wherein the main body of a catheter is made of transparent silicone to allow the flow of urine to be seen (paragraph 0066).
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 Luque González such that the main body is made of transparent silicone or equivalent plastic material to allow the flow of urine to be seen, as taught by Taylor, for the purpose of providing a material that allows a light generator to transmit through the body more efficiently for the sake of sterilization (see Taylor, paragraph 0080)
Allowable Subject Matter
Claims 2, 6, and 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 2, Luque González does not teach a rigid plug made and arranged to fit into the end of the tube, at the end opposite to the end where the reliefs are located, such that said plug prevents the slide valve from moving involuntarily and a membrane position of the slide valve to be fixed in the urinary catheter.
While many slide valves in the art have stops to prevent the movable part of the valve from exiting the assembly when going from the rightmost position to the leftmost position (such as stop 32 in fig. 1 of Christensen [US 7802824] and end caps 154/155 in fig. 1 of Chen [US 7802824]), this would not fairly teach a plug that locks in a membrane position of the slide valve of Luque González. The movable element of Luque González is made such that the membrane position is the middle position, and as such these stops would not lock in a membrane position. While rearranging the elements of the slide member of Luque González such that the membrane position is the leftmost or rightmost position is possible in order for the stops to lock the membrane position, this would have a substantial enough change on the function of the device such that said change would not be fairly obvious.
Svensson teaches a slide valve that has a means of locking from multiple positions (fig. 21, resilient arm 85 formed with finger piece to interact with notches 86). However, not only would such a piece not be a rigid plug, as the arm needs to be resilient to move from position to position, such an assembly would prevent one of the two ends of the moving element being always visible by protruding from one of the ends of the tube.
Frezza (EP 0576380) similarly teaches a pusher that would go between multiple positions for a slide valve, but fails to reconcile that teaching with the limitation of claim 1 wherein one of the two ends of the moving element being always visible by protruding from one of the ends of the tube.
For these reasons, claim 2 contains allowable subject matter.
Claim 6 contains allowable subject matter for similar reasons as described in the analysis of claim 2 below
Claim 12, as described below, is allowable by virtue of being dependent on independent claim 11.
Claims 8 and 11 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 8 and 11 would be allowable for similar reasons described in claim 2 above, notably due to containing the same limitations as claim 2.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 5712705879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781
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