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 § 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-3, 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20180369603 to Tore et al. (hereinafter “Tore”).
Regarding claim 1. Tore discloses a urinary catheter having a proximal end and a distal end (para 0088, “catheter device 10” “proximal end 14”, “distal end 10”), the urinary catheter comprising: an outer tubular member having a proximal end and a distal end (para 0088, balloons 18, 20, fig 2); an inflatable member disposed on the outer tubular member (para 0092, balloons 18, 20, fig. 2-5), the outer tubular member and inflatable member being configured to be inserted into a patient's urinary bladder by way of the urethra (para 0088-0089 “a portion of the catheter body 12 are within a body cavity or hollow organ of a patient's body”, “the catheter device is adapted for use with the bladder”, para 0059-0060 “inserted through the urethra”); a source of liquid operably coupled to the outer tubular member configured to direct liquid under pressure to inflate the patient's urinary bladder (para 0013, “balloon, inflated by water”; para 0062-0063 “fluid reservoir for inflation of the balloon(s)”); and a red-light source configured to emit red light to illuminate the patient's urinary bladder (para 0094 “red light”, figs 4-5, see para 0029, 0031, etc.), wherein the red-light source is sufficiently strong to transmit light through the urinary bladder to permit an observer to directly visualize an outer portion of the illuminated bladder from within the abdominal or pelvic cavity using a separate visualization device situated in the abdominal or pelvic cavity (para 0105 “[] well-positioned to illuminate the majority of the bladder wall 73”; the claim as recited does not provide any details regarding the separate visualization device, and as written does not require the separate visualization device. The claim only states that the claimed device would enable such visualization).
Regarding claim 2. The urinary catheter of Claim 1, wherein the red-light source is configured to direct red light through the inflatable member (para 0094 “Each of the three parts 22, 24, 26 of the array of light emitting elements includes multiple LEDs … red light”, figs 2-5, see para 0029, 0031, etc.).
Regarding claim 3. Tore discloses the urinary catheter of Claim 1, wherein the red-light source is disposed inside of the inflatable member and is configured to direct red light through the inflatable member (para 0094 “Each of the three parts 22, 24, 26 of the array of light emitting elements includes multiple LEDs … red light”, figs 2-5, see para 0029, 0031, etc.).
Regarding claim 8. Tore discloses the urinary catheter of Claim 1, wherein the red-light source is configured to deliver light in a red visible wavelength range between 675 nm and 725 nm in wavelength (para 0094 “635 nm”, 0028-0031, claim 47).
Regarding claim 9. Tore discloses a method comprising: providing a urinary catheter according to Claim 1; introducing the urinary catheter into a patient's urinary bladder by way of the urethra; directing a pressurized liquid through the urinary catheter to inflate the patient's urinary bladder; inflating the inflatable member inside of the patient's urinary bladder; and illuminating the red-light source to direct light through the inflated inflatable member to illuminate the bladder (para 0088-0089 “a portion of the catheter body 12 are within a body cavity or hollow organ of a patient's body”, “the catheter device is adapted for use with the bladder”, para 0059-0060 “inserted through the urethra”, para 0094 “Each of the three parts 22, 24, 26 of the array of light emitting elements includes multiple LEDs … red light”, figs 2-5, see para 0029, 0031, etc.).
Regarding claim 10. Tore discloses the method of Claim 9, further comprising directly visualizing an outer portion of the patient's urinary bladder from within the abdominal or pelvic cavity using a separate visualization device situated in the abdominal or pelvic cavity (para 0105 “[] well-positioned to illuminate the majority of the bladder wall 73”; the claim as recited does not provide any details regarding the separate visualization device, and as written does not require the separate visualization device. The claim only states that the claimed device would enable such visualization).
Regarding claim 11. Tore discloses the method of Claim 9, further comprising performing a diagnostic procedure wherein the diagnostic procedure is performed ex-vivo after images have been collected of the patient's urinary bladder (fig 1; the claim as recited does not provide any details regarding diagnostic procedure. As written and under its BRI, any diagnostic procedure that could be performed ex-vivo would read over the claimed limitation. Here, any operation of the device using the controller 70 would read over the claimed limitation).
Regarding claim 12. The method of Claim 11, wherein the diagnostic procedure is performed in real time while the urinary catheter is inside the patient's urinary bladder (para 0100).
Regarding claim 15. Tore discloses the method of Claim 9, further comprising performing a therapeutic procedure using the urinary catheter (para 0058).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tore as applied to claims above, and further in view of WO2014043586A1 to Greenberg et al.
Regarding claim 13. The method of Claim 11, but fails to disclose wherein the diagnostic procedure includes a cystoscopy.
Greenberg, from a similar field of endeavor teaches providing an inflatable catheter to be used in cystoscopy. It would have been obvious before the filing date of the claimed invention to modify the disclosure of Tore with the teachings of Greenberg to provide the predictable result of performing cystoscopy.
Regarding claim 14. Tore as modified by Greenberg renders obvious the method of Claim 11, wherein the diagnostic procedure includes continuous cystoscopy during a parallel procedure (Greenberg, abstract, para 0028).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tore as applied to claims above, and further in view of US 20160361120 to Brinkmann.
Regarding claim 16. Tore discloses the method of Claim 15, but fails to disclose wherein the therapeutic procedure includes delivering a beneficial agent including at least one of a medicament and a therapeutic dose of light in a preselected wavelength band at a preselected intensity to a location inside the bladder or inside the ureter or kidney.
Brinkmann, from a similar field of endeavor teaches using a catheter system to treat kidney stones and providing delivering a beneficial agent to a location inside the bladder or inside the ureter or kidney (para 0127-0128). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Tore with the teachings of Brinkmann to provide the predictable result of treating kidney stones.
Regarding claim 17. Tore as modified by Brinkmann renders obvious the method of Claim 16, wherein the light includes laser light (Brinkmann, para 00104, 0107).
Regarding claim 18. Tore as modified by Brinkmann renders obvious the method of Claim 17, wherein the laser light is used to fracture a kidney stone (Brinkmann, para 00104, 0107).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tore as applied to claims above, and further in view of US 20090208143 to Yoon.
Regarding claim 19. Tore discloses the method of Claim 9, but fails to disclose further comprising detecting a bladder tumor by collecting images of an inner surface of the bladder, and comparing the images with a library of tissue samples.
Yoon, from a similar field of endeavor teaches imaging the surface of a bladder to detect problems such as cancer (para 0080) and bi-dictionary coupled to a computer workstation and to interactive display monitor to display the images (para 0110; which would allow for comparing images to previously studied images). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Tore with the teachings of Yoon to provide the predictable result of diagnosing the patient.
Regarding claim 20. Tore discloses the method of Claim 9, but fails to disclose further comprising detecting a carcinoma in situ lesion.
Yoon, from a similar field of endeavor teaches a carcinoma in situ lesion (para 0009, 0080). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Tore with the teachings of Yoon to provide the predictable result of examining the tumors.
Double Patenting
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US11918360B1. Although the claims at issue are not identical, they are not patentably distinct from each other. See details below.
1. A urinary catheter
1. A diagnostic method for evaluating a urinary bladder, comprising:
an outer tubular member having a proximal end and a distal end; an inflatable member disposed on the outer tubular member the outer tubular member and inflatable member being configured to be inserted into a patient's urinary bladder by way of the urethra
introducing a urinary catheter having a proximal end and a distal end into a patient's urinary bladder by way of the urethra, the urinary catheter including an outer tubular member including an inflatable member disposed thereon, and a stylet that is slidably disposable within a passage defined in the outer tubular member;
inflatable member
inflating the inflatable member inside of the bladder;
a source of liquid operably coupled to the outer tubular member configured to direct liquid under pressure to inflate the patient's urinary bladder
inflating the bladder with a liquid to enhance visualization of an inner surface of the bladder;
a red-light source configured to emit red light to illuminate the patient's urinary bladder
illuminating a red-light source through the inflatable member to illuminate the bladder; and
wherein the red-light source is sufficiently strong to transmit light through the urinary bladder to permit an observer to directly visualize an outer portion of the illuminated bladder from within the abdominal or pelvic cavity using a separate visualization device situated in the abdominal or pelvic cavity
directly visualizing an outer portion of the illuminated bladder from within the abdominal or pelvic cavity using a separate visualization device situated in the abdominal or pelvic cavity.
2. The urinary catheter of Claim 1, wherein the red-light source is configured to direct red light through the inflatable member.
2. The method of claim 1, wherein the red-light source is disposed inside of the inflatable member.
3. The urinary catheter of Claim 1, wherein the red-light source is disposed inside of the inflatable member and is configured to direct red light through the inflatable member.
3. The method of claim 2, wherein the red-light source is disposed on the stylet, and further wherein light is directed from the stylet, and through the inflatable member.
5. The urinary catheter of Claim 4, wherein the stylet includes a steerable distal tip region and an imaging device disposed at a distal end thereof to receive images.
4. The method of claim 1, wherein the stylet includes a steerable distal tip region and an imaging device disposed at a distal tip thereof to receive images.
6. The urinary catheter of Claim 5, wherein the stylet further includes forward illumination to direct light through a distal end thereof, and further wherein the red-light source is arranged along a length of the stylet to illuminate the inflatable member.
5. The method of claim 4, wherein the stylet further includes forward illumination to direct light through a distal end thereof, and further wherein the red-light source is arranged along a length of the stylet to illuminate the inflatable member.
7. The urinary catheter of Claim 4, wherein at least one of the stylet and the lumen includes a lubricious coating along its length.
6. The method of claim 1, wherein at least one of the stylet and the passage includes a lubricious coating along its length.
8. The urinary catheter of Claim 1, wherein the red-light source is configured to deliver light in a red visible wavelength range between 675 nm and 725 nm in wavelength.
7. The method of claim 1, wherein the red-light source is configured to deliver light in a red visible wavelength range between 675 nm and 725 nm in wavelength.
11. The method of Claim 9, further comprising performing a diagnostic procedure wherein the diagnostic procedure is performed ex-vivo after images have been collected of the patient's urinary bladder.
8. The method of claim 1, further comprising performing a diagnostic procedure wherein the diagnostic procedure is performed ex-vivo after images have been collected of the bladder.
12. The method of Claim 11, wherein the diagnostic procedure is performed in real time while the urinary catheter is inside the patient's urinary bladder.
9. The method of claim 8, wherein the diagnostic procedure is performed in real time while the urinary catheter is inside the patient.
13. The method of Claim 11, wherein the diagnostic procedure includes a cystoscopy.
10. The method of claim 8, wherein the diagnostic procedure includes a cystoscopy.
14. The method of Claim 11, wherein the diagnostic procedure includes continuous cystoscopy during a parallel procedure.
11. The method of claim 8, wherein the diagnostic procedure includes continuous cystoscopy during a parallel procedure.
15. The method of Claim 9, further comprising performing a therapeutic procedure using the urinary catheter.
12. The method of claim 1, further comprising performing a therapeutic procedure using the urinary catheter.
16. The method of Claim 15, wherein the therapeutic procedure includes delivering a beneficial agent including at least one of a medicament and a therapeutic dose of light in a preselected wavelength band at a preselected intensity to a location inside the bladder or inside the ureter or kidney.
13. The method of claim 12, wherein the therapeutic procedure includes delivering a beneficial agent to a location inside the bladder or inside the ureter or kidney.
16. The method of Claim 15, wherein the therapeutic procedure includes delivering a beneficial agent including at least one of a medicament and a therapeutic dose of light in a preselected wavelength band at a preselected intensity to a location inside the bladder or inside the ureter or kidney.
14. The method of claim 13, wherein the beneficial agent includes a medicament.
16. The method of Claim 15, wherein the therapeutic procedure includes delivering a beneficial agent including at least one of a medicament and a therapeutic dose of light in a preselected wavelength band at a preselected intensity to a location inside the bladder or inside the ureter or kidney.
15. The method of claim 13, wherein the beneficial agent includes a therapeutic dose of light in a preselected wavelength band at a preselected intensity.
17. The method of Claim 16, wherein the light includes laser light.
16. The method of claim 15, wherein the light includes laser light.
18. The method of Claim 17, wherein the laser light is used to fracture a kidney stone.
17. The method of claim 16, wherein the laser light is used to fracture a kidney stone.
19. The method of Claim 9, further comprising detecting a bladder tumor by collecting images of an inner surface of the bladder, and comparing the images with a library of tissue samples.
18. The method of claim 1, further comprising detecting a bladder tumor by collecting images of an inner surface of the bladder, and comparing the images with a library of tissue samples.
20. The method of Claim 9, further comprising detecting a carcinoma in situ lesion.
19. The method of claim 1, further comprising detecting a carcinoma in situ lesion.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796