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 November 21st, 2025 has been entered. Claims 1, 4, 9-11, 15 have
been amended. Claims 6-8, 28 are now cancelled. Claims 1-5, 9-15, 17-20, 29, 31 are now pending in the application. The previous 35 USC 112 (b) rejection of claims 4, 8, and 11 are withdrawn in light of Applicant's amendment.
Response to Arguments
Applicant's arguments filed 11/21/25 have been fully considered but they are not persuasive.
Applicant submits that claim 1 is not anticipated by Bowe (US 20150342682 A1, hereinafter Bowe) in view of the present amendments because Bowe does not teach or suggest an endoscopic device with an outer housing surrounding an interstitial space, wherein said endoscopic device comprises at least one interstitial flow opening(s) configured to deliver fluid or suction through said interstitial space, nor a computer system configured to optimize the irrigation and suction flowrate for a particular endoscope and/or subject. However, the examiner argues that Bowe does teach these features as can be referenced in the following prior art rejection in compliance with 35 U.S.C. 102.
Moreover, the applicant submits that considering a combination of Bowe and Shelton, one of ordinary skill in the art would not arrive at the systems of the presently claimed invention, however, the examiner argues that a combination between these two prior art references would be obvious with Bowe as a primary reference and Shelton as a teaching reference which provides a more sophisticated irrigation system that can be compatible with the invention disclosed in Bowe.
Applicant’s arguments with respect to claim(s) 2-5, 9-15, 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 § 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.
Claim 1-3, 9, 12-15, 17-20 are rejected under rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bowe (US 20150342682 A1).
Regarding Claim 1, Bowe discloses
A system (pulsed aspiration system 17, FIG. 4), comprising:
an endoscopic device (catheter 2, FIG. 1), comprising:
an outer housing (outer jacket 4, FIG. 1) surrounding an interstitial space,
wherein said endoscopic 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);
b) a suction component (vacuum pump 18, FIG. 4) and/or an irrigation component (par. 2 discloses system of improved irrigation and containment, par. 41 discloses use of peristaltic pump); and
c) 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
d) a computer system configured to optimize the irrigation and suction flowrate for a particular endoscope and/or subject (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).
Regarding Claim 2, Bowe discloses
The system of claim 1, wherein said suction component and said irrigation
component are pressure and/or flowrate controlled (par. 117-119 disclose CPU controlling vacuum pressure).
Regarding Claim 3, Bowe discloses
The system of claim 1, 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 9, Bowe discloses
The system of claim 1, 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 endoscope (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 discloses
The system of claim 1, 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 12, Bowe discloses
The system of claim 1, 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 discloses
The system of claim 12, 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 discloses
The system of claim 12, 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 discloses
The system of claim 1, 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 discloses
The system of claim 1, 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 discloses
The system of claim 17, 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 discloses
The system of claim 18, 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 discloses
The system of claim 17, wherein said irrigation and suction flowrate calibration component comprises a pressure sensor (par. 119 discloses pressure sensor in communication with pulse width modulator).
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) 4, 5, and 11 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 4, Bowe discloses all of the elements of the current invention
disclosed in claim 1, however, Bowe does not disclose wherein said irrigation component is selected from a pressure chamber, a gravity bag, a pressure bag, a peristaltic pump, and a combination thereof.
Shelton teaches an analogous system (100, FIG. 1) having an endoscopic device (medical device 110; par. 60 discloses medical device is endoscope), a suction component (Suction Source 120) and/or an irrigation component (Irrigation Source 130), a clog detection and removal component (Clog Controller 161), and a computer system (control module 160, FIG. 1) configured to optimize the irrigation and suction flowrate for a particular endoscope and/or subject (par. 68-70 disclose control module can monitor and automatically apply suction and irrigation based on what is required, i.e. optimization). The irrigation component (130) can be a container where irrigation fluid is pressurized, i.e. a pressure bag [0063], wherein the irrigation flow rate is adjustable [0057, 0068]. Moreover, the clog controller (161) can alternate between an application of irrigation fluid and an application of suction pressure to unclog an obstructed channel [0073].
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 a system capable of utilizing and controlling both suction and irrigation to perform operations and unclogging of obstructed channels when clogs are detected [Shelton - 0073].
Regarding Claim 5, Bowe discloses all of the elements of the current invention
disclosed in claim 1, however, Bowe does not disclose wherein said irrigation component is configured to provide irrigation at a flowrate between 0-60 ml/minute.
Shelton teaches an analogous system (100, FIG. 1) having an endoscopic device (medical device 110; par. 60 discloses medical device is endoscope), a suction component (Suction Source 120) and/or an irrigation component (Irrigation Source 130), a clog detection and removal component (Clog Controller 161), and a computer system (control module 160, FIG. 1) configured to optimize the irrigation and suction flowrate for a particular endoscope and/or subject (par. 68-70 disclose control module can monitor and automatically apply suction and irrigation based on what is required, i.e. optimization). The irrigation component (130) can be a container where irrigation fluid is pressurized, i.e. a pressure bag [0063], wherein the irrigation flow rate is adjustable [0057, 0068]. Moreover, the clog controller (161) can alternate between an application of irrigation fluid and an application of suction pressure to unclog an obstructed channel [0073].
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 a system capable of utilizing and controlling both suction and irrigation to perform operations and unclogging of obstructed channels when clogs are detected [Shelton - 0073].
Regarding Claim 11, Bowe discloses all of the elements of the current invention disclosed in claim 10, however, Bowe does not disclose 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, and vibrating or actuating said endoscope to shake loose the clog.
Shelton teaches an analogous system (100, FIG. 1) having an endoscopic device (medical device 110; par. 60 discloses medical device is endoscope), a suction component (Suction Source 120) and/or an irrigation component (Irrigation Source 130), a clog detection and removal component (Clog Controller 161), and a computer system (control module 160, FIG. 1) configured to optimize the irrigation and suction flowrate for a particular endoscope and/or subject (par. 68-70 disclose control module can monitor and automatically apply suction and irrigation based on what is required, i.e. optimization). The irrigation component (130) can be a container where irrigation fluid is pressurized, i.e. a pressure bag [0063], wherein the irrigation flow rate is adjustable [0057, 0068]. Moreover, the clog controller (161) can alternate between an application of irrigation fluid and an application of suction pressure to unclog an obstructed channel [0073].
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 a system capable of utilizing and controlling both suction and irrigation to perform operations and unclogging of obstructed channels when clogs are detected [Shelton - 0073].
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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