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
This Office action is in response to the applicant’s communication filed 11/26/2025.
Status of the claims:
Claims 1, 3, 6, 8, 11, 14, 15, 18, and 20 are pending in the application.
Claims 1 and 14 are amended.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6, 11, 14, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zook et al (US 2009/0088786 A1) (previously cited) in view of Condon (US 5,188,596).
Regarding claim 1, Zook discloses a method for use in a cystostomy (abstract, paragraphs [0003], [0012], [0038], and Figs. 1 – 12) comprising:
providing a medical instrument (cystostomy apparatus 10) for use in executing an inside-out cystostomy procedure (transurethral suprapubic procedure) (paragraphs [0003], [0038], and Figs. 1, 9 – 13), said inside-out cystostomy procedure involving first operating said medical instrument in relation to a first procedure pathway, through a urethra of said patient to a bladder of said patient (paragraph [0038]), and second operating said medical instrument to form a second procedure pathway from a first position, where a distal portion of said medical instrument is inside of said bladder, and a second position, where said distal portion of said medical instrument is outside of an abdominal wall of a patient (paragraph [0038] and shown in Figs. 9 – 13) (Examiner’s note: as stated in paragraph [0038] the cutting tip pierces the skin as it moves outwardly from the abdomen), said medical instrument (cystostomy apparatus 10) including an instrument body (cystostomy apparatus 10) having a proximate portion (proximal portion 28) and a distal portion (distal portion 30) (paragraph [0039] and Fig. 1);
wherein said first operating involves advancing said medical instrument on said first procedure pathway through said urethra to said bladder paragraph [0038]);
wherein said medical instrument comprises a structure supporting (connector 71) a retractable blade (cutting tip 20) that is extendable from within the open interior (within sound 12) of said medical instrument (paragraphs [0038], [0044], and Figs. 7 and 12) and said second operating involves advancing said retractable cutting blade from said first position to said second position (paragraph [0038] and Figs. 12 – 13).
However, Zook is silent regarding (i) an optical assembly supported on said instrument body, said optical assembly including a tip cap mounted to the distal potion of said instrument, the tip cap including an optical lens and a light source, (ii) wherein the tip cap is within an open interior of said medical instrument, (iii) the optical element and light source are directed forwardly in relation to said distal portion of said instrument body, for use in providing image information for a volume forward of said distal portion of said instrument body and illumination of said volume forward of said distal portion of said instrument body, respectively, (iv) connecting said medical instrument to a display device for displaying images based on said image information, (v) first using said display device for monitoring said first operating, and (vi) second using said display device for monitoring said second operating.
As to (i) – (iv), Condon teaches a medica device comprising a urethral catheter (catheter 22; which is equated to the “sound 12” of Zook) and an optical assembly (fiberoptic endoscope/bundle 20) mounted in the interior of the distal end of the medical device (Fig. 1), the optical assembly (fiberoptic assembly/ bundle 20) comprising a tip cap (lens 27) including a lens (lens 27) and a light source (light source / video camera) directed forwardly from said distal portion of said instrument for providing image information and illumination of a volume forward of said distal portion, respectively, (col. 5 lines 4 – 30 and Fig. 1) (Examiner’s note: both the light and the optical lens are directed forward in relation to the distal portion of the instrument body – shown in Fig. 1), wherein the medical instrument (catheter 22; which is equated to the “sound 12” of Zook) is connected to a display (display / video monitor) for displaying images based on said image information (col. 5 lines 20 – 30) for the purpose of viewing the insertion process of the system (col. 4 lines 7 – 15).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the medical device of Zook to include an optical assembly with a cap and display device, based on the teachings of Condon, for the purpose of viewing the insertion process of the system (col. 4 lines 7 – 15 – Condon). Furthermore, with respect to (iii), (v), and (vi) it would be obvious to have the optical assembly (i.e., the optical element and the light source) directed forward of the distal portion of the device of Zook so that the operator can accurately drive the system through the pathway by visualizing the pathway in front of the device and, further, it would be obvious to use the display device with the optical assembly to monitor both the traversing of the device through the urethra into the bladder and the advancing of the cutting tip through the abdominal wall to outside the skin for the purpose of ensuring the accurate traversing of the device through the body and ensuring the puncturing of the abdominal wall occurs at the desired location.
Additionally, it should be understood that Zook and Condon are known references in the art that teach a medical instrument guided through the urethra (abstract, paragraphs [0003], [0012], [0038], and Figs. 1 – 12 — Zook ; abstract, col. 5 lines 4 – 65, and Fig. 1); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Zook to include an optical assembly (optical fiber endoscope assembly/ bundle 20) as all of the clamed elements were known in the prior art and one skilled in the art could have combined the known elements as claimed, by known methods, with no change in their respective functions; and the combination would have been predictable and resulted in the system of Zook being able to perform the procedure in the manner claimed. The Examiner notes the rejection above is based on KSR, 550 U.S. at 416, 82 USPQ2d at 1395 rational A, outlined in MPEP 2143.
Regarding claim 3, as discussed above, it would be obvious to modify the system and method of Zook to incorporate an optical assembly therein based on the teachings of Condon. Additionally, the combination makes obvious wherein said second using of the display device (video monitor – Condon) involves monitoring movement of a device (sound 12 – Zook) supported on said medical instrument (cystostomy apparatus 10 – Zook) relative to said bladder of said patient for the purpose of having continuous visualization of the procedure, thereby providing the accurate insertion and movement of the device (sound 12 – Zook) through the male urethra (Examiner’s note: paragraph [0038] of Zook discusses the movement of the sound 12 (i.e., the device) relative to the bladder and the abstract of Condon teaches using the optical fiber endoscope to view the pathway through the urethra. Therefore, the combination encompasses the claimed limitations above).
Regarding claim 6, as discussed above, it would be obvious to modify the system and method of Zook to incorporate an optical assembly therein based on the teachings of Condon. Additionally, Zook discloses wherein said medical instrument (cystostomy apparatus 10) further comprises a catheter(catheter 26) supported on said instrument body for draining fluid from said patient (Examiner’s note: as stated in paragraph [0053] catheter 26 attaches to the sound 12 and is used to drain the bladder).
Regarding claim 11, as discussed above, it would be obvious to modify the system and method of Zook to incorporate an optical assembly therein based on the teachings of Condon. Additionally, Zook discloses wherein said medical instrument (cystostomy apparatus 10) further comprises a catheter (catheter 26) (paragraph [0038] and Fig. 14).
Regarding claim 14, Zook discloses an apparatus (cystostomy apparatus 10) for use in a cystostomy (abstract, paragraphs [0003], [0012], [0038], and Figs. 1 – 12) comprising:
a medical instrument including an instrument body (cystostomy apparatus 10) having a proximate portion (proximal portion 28) and a distal portion (distal portion 30) (paragraphs [0038 – 0039] and Figs. 1 – 2), and said medical instrument being operative for performing an inside-out medical procedure involving first operating said medical instrument relative to a first procedure pathway, through a urethra of said patient to a bladder of said patient and second operating said medical instrument to form a second procedure pathway from a first position, where said distal portion is inside a bladder of said patient, to a second position, where said distal portion is outside of an abdominal wall of said patient (paragraph [0038] and Figs. 9 – 14);
wherein said medical instrument comprises a structure supporting (connector 71) a retractable blade (cutting tip 20) that is extendable from within the open interior (within sound 12) of said medical instrument (paragraphs [0038], [0044], and Figs. 7 and 12) and said second operating involves advancing said cutting end from said first position to said second position (paragraph [0038] and Figs. 12 – 13).
However, Zook is silent regarding (i) an optical assembly supported on said instrument body, said optical assembly including a tip cap mounted to the distal potion of said instrument, the tip cap including an optical lens and a light source directed forwardly in relation to said distal portion of said instrument body, for use in providing image information for a volume forward of said distal portion of said instrument body and for directing light forwardly from said distal portion of said instrument body, respectively, (ii) wherein the tip cap is within an open interior of said medical instrument, (iii) a display device for displaying images based on said image information, and (iv) said image information corresponding to said movement of said first operating and said second operating.
As to (i) – (iii), Condon teaches a medica device comprising a urethral catheter (catheter 22; which is equated to the “sound 12” of Zook) and an optical assembly (fiberoptic endoscope/bundle 20) mounted in the interior of the distal end of the medical device (Fig. 1), the optical assembly (fiberoptic assembly/ bundle 20) comprising a tip cap (lens 27) including a lens (lens 27) and a light source (light source / video camera) directed forwardly from said distal portion of said instrument for providing image information and illumination of a volume forward of said distal portion, respectively, (col. 5 lines 4 – 30 and Fig. 1) (Examiner’s note: both the light and the optical lens are directed forward in relation to the distal portion of the instrument body – shown in Fig. 1), wherein the medical instrument (catheter 22; which is equated to the “sound 12” of Zook) is connected to a display (display / video monitor) for displaying images based on said image information (col. 5 lines 20 – 30) for the purpose of viewing the insertion process of the system (col. 4 lines 7 – 15).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the medical device of Zook to include an optical assembly with a cap and display device, based on the teachings of Condon, for the purpose of viewing the insertion process of the system (col. 4 lines 7 – 15 – Condon). Furthermore, with respect to (iv) it would be obvious to have the optical assembly (i.e., the optical element and the light source) directed forward of the distal portion of the device of Zook so that the operator can accurately drive the system through the pathway by visualizing the pathway in front of the device and, further, it would be obvious to use the display device with the optical assembly to monitor both the traversing of the device through the urethra into the bladder and the advancing of the cutting tip through the abdominal wall to outside the skin for the purpose of ensuring the accurate traversing of the device through the body and ensuring the puncturing of the abdominal wall occurs at the desired location.
Additionally, it should be understood that Zook and Condon are known references in the art that teach a medical instrument guided through the urethra (abstract, paragraphs [0003], [0012], [0038], and Figs. 1 – 12 — Zook ; abstract, col. 5 lines 4 – 65, and Fig. 1); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Zook to include an optical assembly (optical fiber endoscope assembly/ bundle 20) as all of the clamed elements were known in the prior art and one skilled in the art could have combined the known elements as claimed, by known methods, with no change in their respective functions; and the combination would have been predictable and resulted in the system of Zook being able to perform the procedure in the manner claimed. The Examiner notes the rejection above is based on KSR, 550 U.S. at 416, 82 USPQ2d at 1395 rational A, outlined in MPEP 2143.
Regarding claim 15, as discussed above, it would be obvious to modify the system and method of Zook to incorporate an optical assembly therein based on the teachings of Condon. Additionally, the combination makes obvious wherein said display device (video monitor – Condon) is operative for monitoring movement of a device (sound 12 – Zook) supported on said medical instrument (cystostomy apparatus 10 – Zook) relative to said bladder of said patient for the purpose of having continuous visualization of the procedure, thereby providing accurate insertion and movement through the male urethra (Examiner’s note: paragraph [0038] of Zook discusses the movement of the sound 12 (i.e., the device) relative to the bladder and the abstract of Condon teaches using the optical fiber endoscope to view the pathway through the urethra. Therefore, the combination encompasses the claimed limitations above).
Regarding claim 18, as discussed above, it would be obvious to modify the system and method of Zook to incorporate an optical assembly therein based on the teachings of Condon. Additionally, Zook discloses wherein said medical instrument (cystostomy apparatus 10) further comprises a line (catheter 26) supported on said instrument body for draining fluid from said patient (Examiner’s note: as stated in paragraph [0053] catheter 26 attaches to the sound 12 and is used to drain the bladder).
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zook et al (US 2009/0088786 A1) (previously cited) in view of Condon (US 5,188,596), as applied to claims 1 and 14 above, respectively, and further in view of Barnett (US 2011/0054326 A1) (previously cited).
Regarding claims 8 and 20, as discussed above, the combination of Zook and Condon teaches the method of claim 1.
However, the combination of Zook and Condon is silent regarding (i) operating said medical device to supply a gel at said distal portion of said medical instrument.
As to the above, Barnett, in a filed reasonably pertinent to the particular problem with which applicant was concerned with, namely a medical device for direct visualization of internal lumens of the body, teaches a medical device (endoscope device 100; which equates to cystostomy apparatus 10 of Zook) with an optical assembly (camera; which equates to the optical assembly of Condon used with the system and method of Zook) and operating the medical device to supply a gel at the distal portion thereof for the purpose of improving the illumination of the target size, thereby allowing the camera to better visualize the area (paragraphs [0026], [0030], and [0040]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system and method of Zook in view of Condon, based on the teachings of Barnett, to incorporate supplying a gel to the distal end of the medical device for the purpose of improving the illumination of the target size, thereby allowing the camera to better visualize the area (paragraph [0026] – Barnett).
Response to Arguments
Applicant’s arguments filed 03/10/2026, with respect to the rejection of claims 1, 3 – 6, 8, 11, 14 – 18, and 20 under Zook and Molnar have been considered and found to be persuasive. However, a new rejection has been set forth above under Zook and Condon.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771