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
The Amendment filed June 9th, 2026 has been entered. Claims 1, 4, 9 and 11 have
been amended. Claims 6-8, 21-28, 30 and 32-36 are presently cancelled. Claims 1-5, 9-15, 17-20, 29, 31 are now pending in the application, with claims 29 and 31 withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 9, 12-15 and 17-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim 1 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.
Claim 1 recites the limitation "said ureteroscope device" in its first appearance. There is insufficient antecedent basis for this limitation in the claim. Although the examiner recognizes that this is in reference to the ureteroscope, the language of “device” alludes to a potentially separate aspect of the invention, therefore, the examiner nonetheless suggests amending the claim language.
Examiner’s Comments
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
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.
Claim(s) 1-5, 9-15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowe (US 20150342682 A1) in view of Shelton et al. (US 20200187768 A1, hereinafter Shelton).
Regarding Claim 1, Bowe discloses
A system (pulsed aspiration system 17, FIG. 4) for ureteroscopic treatment of a kidney stone, comprising:
an ureteroscope (catheter 2, FIG. 1, par. 101 discloses catheter provided with plurality of
optical fibers, i.e. imaging means), comprising:
an outer housing (outer jacket 4, FIG. 1) surrounding an interstitial space (lumen 14, FIG. 2) defined between said outer housing and an inner working channel of said ureteroscope (par. 100 discloses guidewire lumen, i.e. inner working channel, provided between outer jacket and inner band, therefore, lumen would be defined between the channel and the lumen at one point or another),
wherein said ureteroscope device comprises at least one interstitial flow opening(s) (inner lumen 14, FIG. 1) configured to deliver fluid or suction through said interstitial space (par. 101 discloses inner lumen connected to aspiration system; par. 102 discloses inner lumen is provided inside lumen); and
a pressure sensor configured to measure intrarenal pressure during operation of said ureteroscope (par. 119 discloses pressure sensor which outputs signals, i.e. measured pressure, to CPU of system);
a suction component (vacuum pump 18, FIG. 4) configured to remove irrigation fluid and
stone fragments or stone dust from said renal collecting system (fluid collection jar 21 + filter 24, FIG. 4; par. 41 discloses vacuum pump used to aspirate and move material, par. 117 discloses removal of fluid from patients with suction component; par. 114-115 disclose fluid collection jar in fluid communication with the vacuum pump); and
a clog detection and removal component (par. 45 discloses clogging detection and alert
means),
wherein said clog detection and removal component comprises one or more clog
detectors selected from
a weight scale or load cell that measures the rate change in weight of a collection canister (par. 47 discloses load cell for measuring the weight of an aspirate collection feature, such as a sampling jar),
a flowmeter in a part of an aspiration tube,
an ultrasonic wave flowmeter,
a photo resistor shining light through said aspiration tubing, and
a pressure monitor; and
a computer system (CPU + pulse width modulator 20, FIG. 4) configured to calibrate
irrigation and suction flowrates for a particular ureteroscope and/or subject by (par. 117-119 disclose CPU controlling vacuum pressure provided by vacuum pump, as well as, other devices such as flow sensors and/or pressure sensors, i.e. capable of controlling irrigation devices/ systems, moreover, CPU also controls pulse width modulator):
i) measuring intrarenal pressure over time during irrigation and/or suction via said pressure sensor (par. 119 discloses pressure sensor outputs signals, i.e. measurement values, to CPU which controls pulse width modulator);
ii) extrapolating the measured intrarenal pressure over time to determine an anticipated steady-state intrarenal pressure (par. 117 discloses pulse width modulator controls pulse pressure and rate at which it increases/ decreases, and it may be manually or automatically adjusted for desired pulse patters, the automatic adjustment being based on parameters stored in a CPU, i.e. extrapolation using known values); and
iii) selecting irrigation and suction parameters that increase irrigation flow for clearing stone fragments or stone dust and improving visualization while maintaining the anticipated steady-state intrarenal pressure below a predetermined pressure threshold (par. 117 discloses pulse width modulator can provide optimal suction based on the application, par. 119 discloses CPU transmits output signals to computer readable medium and adjusts solenoid valve parameters, i.e. irrigation flow, based on those signals such as pressure sensor measurements, i.e. irrigation and suction are optimized based on desired pressure).
However, Bowe does not disclose an irrigation component configured to deliver irrigation fluid through said interstitial space into a renal collecting system.
Shelton teaches an analogous system (100, FIG. 1) having an endoscopic device (endoscope/ medical device 110, FIG. 1), a suction component (Suction Source 120, FIG. 1), an irrigation component (Irrigation Source 130, FIG. 1), a clog detection and removal component (Clog Controller 161, FIG. 1), and a control module (160, FIG. 1, i.e. computer system) that monitors and automatically applies suction and irrigation based on what is required, i.e. optimization [0060, 0068-0070]. The irrigation component (130) that functions to provide irrigation fluid to a working channel (111, FIG. 1, i.e. interstitial space) into an anatomical site (i.e. renal collecting system) of the kidney [0060, 0063].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the system of Bowe with the irrigation device of Shelton in order provide an improved system capable of intuitively and automatically utilizing and controlling both suction and irrigation to perform operations and unclogging of obstructed channels when clogs are detected [Shelton - 0073].
Regarding Claim 2, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 1, and Bowe further discloses
wherein said suction component are pressure and/or flowrate controlled (par. 117-119 disclose CPU controlling vacuum pressure).
Shelton further teaches wherein said irrigation component are pressure and/or flowrate controlled (par. 68 discloses irrigation is flow rate controlled).
Regarding Claim 3, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 1, and Bowe further discloses
wherein said suction component comprises a volumetric peristaltic pump (par. 41 discloses peristaltic pump would replace vacuum pump, i.e. suction pump is volumetric peristaltic pump).
Regarding Claim 4, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 1, and Shelton further teaches
wherein said irrigation component is selected from a pressure chamber,
a gravity bag,
a pressure bag (par. 63 discloses irrigation source can be a container wherein irrigation fluid is pressurized, i.e. pressure bag),
a peristaltic pump, and
a combination thereof.
Regarding Claim 5, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 1, and Shelton further teaches
wherein said irrigation component is configured to provide irrigation at a flowrate between 0-60 ml/minute (par. 68 discloses irrigation source can provide completely adjustable irrigation flow rates, i.e. capable of being between 0-60 ml/minute).
Regarding Claim 9, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 1, and Bowe further discloses
wherein said clog detectors are located downstream from said suction component,
upstream of said suction component,
within a fluid collection canister,
below said fluid collection canister,
before or after the volumetric pump,
within the fluid collection canister,
below the collection canister,
within said ureteroscope (par. 44 discloses clogging detection means which detects clogging in aspiration tube/ catheter, par. 99-101 disclose laser excimer system provided in catheter, par. 114 discloses catheter is interconnected to excimer laser system, par. 120 discloses excimer laser system provides for clogged aspiration detection system, i.e. clog detector is within endoscope device), or
a combination thereof.
Regarding Claim 10, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 1, and Bowe further discloses
wherein said clog detection and removal component further comprises a clog removal component (par. 54 discloses clog detection means allows the user to take corrective measures, i.e. clog removal).
Regarding Claim 11, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 10, and Bowe further discloses
wherein said clog removal component is configured to respond to the presence of a clog by taking one or more actions selected from reducing the irrigation pressure/flowrate to minimize a rise in intra renal pressure;
increasing the irrigation pressure/flowrate;
momentarily stopping/reversing the flow of the suction channel to unclog any fragments that clogged the tip of the device;
alarming a user (par. 54 discloses alert means which indicate to a user the presence of a clog and to take corrective measures, i.e. clog removal), and
vibrating or actuating said ureteroscope to shake loose the clog.
Regarding Claim 12, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 1, and Bowe further discloses
wherein said system monitors the number of clogs and/or the severity of said clogs over time (par. 49 discloses system can discern severity of clogging based on pressure exceeding threshold).
Regarding Claim 13, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 12, and Bowe further discloses
wherein if the number and/or severity of the clogs is above a preset threshold, the system alerts a user and/or decreases the normal suction flowrate (par. 49 discloses the system can discern severity of clogging based on pressure exceeding a threshold and emit a corresponding warning).
Regarding Claim 14, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 12, and Bowe further discloses
wherein if the number and/or severity of the clogs is below a preset threshold, the system increases the normal suction flowrate (par. 49 discloses the system can discern severity of clogging based on pressure exceeding a threshold since aspiration pressure increases when the aspiration tube is blocked until the threshold is reached).
Regarding Claim 15, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 1, and Bowe further discloses
wherein said clog detection and removal component is automated or manually controlled (Par. 54 discloses clog detection means is automated and can allow for manual correction).
Regarding Claim 17, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 1, and Bowe further discloses
wherein said system further comprises an irrigation and suction flowrate calibration component (Pulse width modulator(s) 20, FIG. 4, par. 116 discloses pulse width modulator(s) provides for automatic control and varied application of vacuum pressure).
Regarding Claim 18, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 17, and Bowe further discloses
wherein said irrigation and suction flowrate calibration component is configured to
a) measure intrarenal pressure during irrigation and/or suction (par. 119 discloses pressure sensor in communication with pulse width modulator);
b) extrapolate the intrarenal pressure to determine the anticipated steady state pressure (par. 117 discloses pulse width modulator controls pulse pressure and rate at which is increases/ decreases, and it may be manually or automatically adjusted for desired pulse patters, the automatic adjustment being based on parameters stored in a CPU, i.e. extrapolation using known values); and
c) predict optimal suction and/or irrigation parameters that maintain a target intrarenal pressure for said system (par. 117 discloses pulse width modulator can provide optimal suction based on the application).
Regarding Claim 19, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 18, and Bowe further discloses
wherein said irrigation and suction flowrate calibration component is further configured to adjust input pressure and/or flowrate to maintain said intrarenal pressure at said optimal steady state intrarenal pressure during use of said system (par. 117 discloses pulse width modulator can adjust pressure to provide optimal suction based on the application).
Regarding Claim 20, Bowe, as previously modified by Shelton, discloses all of the elements of the current invention disclosed in claim 17, and Bowe further discloses
wherein said irrigation and suction flowrate calibration component comprises a pressure sensor (par. 119 discloses pressure sensor in communication with pulse width modulator).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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