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 .
Election/Restrictions
Claims 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11-4-25.
Applicant’s election without traverse of 1-22 in the reply filed on 11-4-25 is acknowledged.
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 1-22 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.
Claim 1 recites “wherein the control unit is configured to analyze the captured image data and, based on a deterioration in the image quality of the captured image data, to output control instructions to the cleaning module automatically or manually by an operator and/or at predetermined time intervals”. This phrasing is unclear because it presents multiple alternative conditions without making clear which particular combinations are within the metes and bounds of the claimed invention. For instance, is it presenting three alternative options for outputting control instructions to automatically activate a fluid pulse, manual activate a fluid pulse, or activate a fluid pulse at predetermined time interval. Alternatively, the limitations could be presenting two alternatives for outputting control instructions, automatic or manually and either of the automatic or manual instructions include cleaning at predetermined time intervals. Additionally, the claim language allows for embodiments including “the control unit is configured to ... output control instructions to the cleaning module manually by an operator” this embodiment is unclear as to if the control unit is generating instructions for an operator to follow or if the operator is deciding the instructions for the control unit to send to the cleaning module based on the image quality. Therefore, one of ordinary skill in the art cannot determine with reasonable certainty what specific functions a control unit must have to fall within the claim limitations.
Regarding claims 3-8, 10 and 22, the phrase "preferably" renders the claim(s) indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The remaining claims are rejected as being dependent on an indefinite claim.
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(s) 1-13 and 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banik et al. US 2006/0069306 (US’306) (cited in the IDS filed 6-21-24).
Regarding claim 1, US’306 teaches a device for cleaning at least one window arranged at the distal end of an endoscope (an endoscopic imaging system including automated cleaning of an imaging system of the endoscope, abstract) comprising:
an image capture device having at least one optical window for capturing image data and at least one further window for illuminating an object space using an illumination device (an image sensor such as a CMOS imager, optical lens assembly 270, light sources such as a number of LEDs, lenses 260 and 262 that cover the illumination sources, para. 16, 29-30, see fig. 3-4a-b),
at least one cleaning module comprising at least one fluid channel and at least one nozzle which is designed to clean and/or dry the at least one optical window (flush cap 256 that directs water across the lens of an image sensor, gas delivery lumen terminates at directional port 256, para. 28-29, see fig. 4a);
and a control unit (image processor 114 and/or the processor and servo control unit 108, para. 28, see fig. 2),
wherein the control unit is configured to analyze the captured image data (Upon advancing single-use endoscope 18, images are produced by the image sensor at the distal tip of the endoscope and analyzed by the image processor 114, para. 28) and,
based on a deterioration in the image quality of the captured image data, to output control instructions to the cleaning module automatically or manually by an operator to activate a fluid pulse for cleaning the at least one optical window (the image processor 114 and/or the processor and servo control unit 108 to determine if either irrigation is required, the gas delivery lumen terminates at directional port 256, that directs the irrigation liquid over a lens 270 of the imaging sensor. With the endoscopic imaging system 10, any obstructions that interfere with the endoscopic procedure are automatically detected. Washing or lens cleaning routines are initiated upon command by the system control software or may be initiated by an operator command received via user interface 16, para. 28 and 37),
wherein the fluid pulse is adjustable by at least one cleaning parameter by means of the control unit, wherein the at least one cleaning parameter is selected from a group comprising: a total cleaning duration (wash routines may include, for example, a continuous spray, a pulsating jet, and a large bolus wash. Sequential mixtures of fluids or gases can be augmented with aeration and/or additives. Additives are added into the irrigant solution, either singularly or in combination, upon operator command using user interface 16 or as directed by preprogrammed wash routines or based on an analysis of signals produced from the image sensor and/or the one or more environmental sensors 245, para. 37, therefore the total cleaning time is either preprogramed or based on operator commands).
Regarding claim 2, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the at least one nozzle is detachably connected to the at least one fluid channel and is selected from a group comprising: flat jet nozzle (distal cap 250 includes directional port or flush cap 256 that directs water across the lens of an image sensor, cap 256 has a flat top, para. 29, see fig. 3 and 4A).
Regarding claim 3, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the cleaning parameters for the fluid used in each case are adjustable by means of the control unit such that the pulse duration is at most 3000 milliseconds (ms), preferably at most 2000 ms (washing or lens cleaning routines are initiated upon command by the system control software or may be initiated by an operator command received via user interface 16. Wash routines may include, for example, a continuous spray, a pulsating jet, and a large bolus wash. Sequential mixtures of fluids or gases can be augmented with aeration and/or additives. Additives are added into the irrigant solution, either singularly or in combination, upon operator command using user interface 16 or as directed by preprogrammed wash routines or based on an analysis of signals produced from the image sensor, para. 37, therefore the control unit is configured to allow the user to input any desired cleaning routine, applicants’ recitation of the processing conditions following “the cleaning parameters for the fluid used in each case are adjustable by means of the control unit” reads on the intended use of the control unit and since the control unit can be used by the operator to input any desired cleaning parameters, the process conditions read as the intended use).
Regarding claim 4, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the cleaning parameters for the respective fluid used and depending on the respective nozzle geometry used can be adjusted by means of the control unit such that the total cleaning time is less than or equal to 3000 milliseconds (ms), preferably 2000 ms (as discussed above, regarding claim 3, the control unit is configured to allow the user to input any desired cleaning routine, the process conditions recited, read as the intended use of the nozzle and the apparatus is independent of the intended use).
Regarding claim 5, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein a fluid channel diameter is the same size or up to at most 20% larger than the nozzle cross section (the gas delivery lumen terminates at directional port 256, that directs the insufflation gas and/or irrigation liquid over a lens 270, para. 28, therefore the channel diameter would be approximately equate to the connecting opening of the directional port, which would be within the range of the same size or up to at most 20%), and the cleaning module is connectable to a device for generating pressure or a pressure line (pump 145 and supplies water and manifold 140 controls the supply of irrigation fluid, air and vacuum to various tubes or lumens, para. 24, see fig. 2) in order to direct a closed fluid jet, under high pressure onto the optical window for cleaning after activation of the fluid pulse of the cleaning module (directional port 256 directs fluid across the lens, as discussed above, with regard to claim 1)
Regarding claim 6, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the fluid comprises a liquid and the liquid fluid volume or fluid volumes predetermined for cleaning is or are less than 5 mL, preferably less than 3 mL, and the pressure in a fluid supply line is at least 0.5 bar, preferably 2.5 bar (as discussed above, regarding claim 3, the control unit is configured to allow the user to input any desired cleaning routine, the process conditions recited, read as the intended use of the apparatus and the apparatus is independent of the intended use).
Regarding claim 7, US’306 teaches the device of claim 6 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the liquid fluid is a physiologically safe and biocompatible liquid (water, para. 29).
Regarding claim 8, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the fluid is liquid and/or gaseous and the cleaning can be controlled with several fluid pulses with a duration of a few milliseconds up to at most 1000 ms, preferably with a duration in a range of 200-800 ms (water or gas can be directed to cleaning the lens, para. 28-29, as discussed above, regarding claim 3, the control unit is configured to allow the user to input any desired cleaning routine, the process conditions recited, read as the intended use of the apparatus and the apparatus is independent of the intended use).
Regarding claim 9, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the fluid is gaseous, wherein the fluid velocity of the gaseous fluid volume or volumes is less than 15 centilitres per second and the maximum pressure in the fluid supply line is 3 bar (gas can be directed to cleaning the lens, para. 28-29, as discussed above, regarding claim 3, the control unit is configured to allow the user to input any desired cleaning routine, the process conditions recited, read as the intended use of the apparatus and the apparatus is independent of the intended use).
Regarding claim 10, US’306 teaches the device of claim 8 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the gaseous fluid is physiologically harmless and biocompatible (an inert gas such as carbon dioxide, nitrogen, air, etc., para. 24-28).
Regarding claim 11, US’306 teaches the device of claim 9 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the cleaning using the gaseous fluid can be controlled by the control unit continuously with fluid pulses at intervals each with a duration of at most 1000 ms or continuously (as discussed above, regarding claim 3, the control unit is configured to allow the user to input any desired cleaning routine, the process conditions recited, read as the intended use of the apparatus and the apparatus is independent of the intended use).
Regarding claim 12, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein a fluid outside the cleaning module can be conveyed by at least one pumping device or a gas source by means of a supply line into the body cavity and through a discharge line out of the body cavity and the device furthermore comprises a pressure sensor for measuring the intracorporeal pressure, wherein the control unit controls the intracorporeal pressure in an event- controlled and/or time-controlled manner at least during the duration of a cleaning by means of a control of the at least one pumping device or a control of a pressure regulator (overpressure valve) such that the intracorporeal pressure does not exceed a predetermined maximum limiting value (when performing the washing routine, the system control software may take into consideration measurements obtained from the one or more environmental sensors 245 included in the single-use endoscope 18. For example, measurements of the size of the colon cavity, thickness of the colon wall, pressure within the colon, or other factors such as temperature, pH, etc. can be obtained from the one or more environmental sensors 245 and used to adjust the volume or rate of delivery and/or aspiration of liquid supplied or the composition of the washing liquid can be adjusted based on the measurements obtained, para. 36).
Regarding claim 13, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the nozzle can be fixedly positioned at a predetermined distance relative to the optical window so that the fluid jet is directed over the entire external geometry of the optical window (the nozzle opening is a port of cap 250 that directs water across the lens, para. 29).
Regarding claim 15, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the optical window is an endoscope (as discussed above, with regard to claim 1) and wherein the at least one illumination device comprises LEDs (light emitting diodes) (LED’s, para. 16); wherein the illumination device is integrally connected to the endoscope (para. 30, see fig. 2-4); and wherein the endoscope is selected from a group having the following image capture devices: a CMOS image sensor (CMOS imager, para. 16).
Regarding claim 16, US’306 teaches the device of claim 15 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the at least one image capture device having at least one illumination device is designed to be insertable and exchangeable in a shaft (the heat exchanger 280 comprises a semi-circular section having a concave recess 282 into which a cylindrical lens assembly 270 is fitted, para. 30 fig. 4a), and the control unit has a memory and a processor for image recognition and optics recognition in order to recognize the image capture device and to transmit stored cleaning parameters, depending on the recognized image capture device, to the cleaning module for cleaning activation (an image analysis program that is executed by a processor on the imaging board 114 or the processor and servo control unit 108 analyzes the image signals to determine if it is necessary to employ a wash routine in the patient or to clean the lens of the endo scope 18. If the image analysis program determines that a lens cleaning or wash routine should be initiated the control software application activates one or more valves controlling the manifold to deliver an irrigation liquid and vacuum aspiration to the endoscope, para. 33).
Regarding claim 17, US’306 teaches the device of claim 1 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the cleaning module is part of a kit; and wherein the kit further comprises: a pressure sensor for measuring the intracorporeal pressure (environmental sensors 245 included in the single-use endoscope 18 can measure the size of the colon cavity, thickness of the colon wall, pressure within the colon, or other factors such as temperature, pH, etc., para. 36, fig. 3).
Regarding claim 18, US’306 teaches the device of claim 17 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the kit comprises at least one of a shaft (distal shaft portion 120, para. 22, see fig. 2).
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.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over US’306 as applied to claim 1 above, and further in view of Khettal et al. US 2018/0360298 (US’298).
Regarding claim 14, US’306 teaches the device of claim 19 for cleaning a window at the end of an endoscope.
US’306 does not teach wherein the optical window is formed by an at least partially convex surface.
US’298 teaches an objective lens for an endoscope has an object-side lens element including a plane-convex rod lens and an image-side lens element including a biconvex lens arranged at the image-side end of the objective lens (abstract). The lens element allows a simple and compact structure with high optical quality is achieved (para. 11).
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 system of US’306 to include wherein the optical window is formed by an at least partially convex surface because US’298 teaches it allows a simple and compact structure with high optical quality is achieved and use of known technique to improve similar methods in the same way is obvious, see MPEP 2141 III (C).
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(s) 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banik et al. US 2006/0069306 (US’306) (cited in the IDS filed 6-21-24).
Regarding claim 19, US’306 teaches a modular system comprising a device according to claim 1 (as discussed above with regard to claim 1),
the modular system furthermore comprising a shaft having a proximal and a distal end (shown in fig. 2, the single-use endoscope 18 has a distal shaft portion 120, para. 22) and
at least one receptacle for at least one further component, wherein the component is selected from the following group comprising: at least one working channel extending through the shaft from proximal to distal (as shown in FIG. 3, the distal end of the single-use endoscope 18 includes a distal cap 250 having a number of openings on its front face. The openings include an opening to a working channel 252 and an opening 254 for a low pressure lavage lumen, whereby a stream of liquid can be delivered through the endoscope to remove debris or obstructions from the patient, para. 29, see fig. 2-4).
Regarding claim 20, US’306 teaches the device of claim 19 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the cleaning module and/or the components are designed as disposable items (single-use imaging endoscope 18 is a single-use flexible tube that contains one or more lumens for the purpose of performing endoscopic procedures and facilitating the insertion and extraction of fluids, gases, and/or medical devices into and out of the body, para. 16).
Regarding claim 21, US’306 teaches the device of claim 19 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the cleaning module and/or the components are detachably connected to another the image capture device (fig. 4a shows the image capture device 290 is a separate component from the cap including the nozzle opening, para. 29-30)
Regarding claim 22, US’306 teaches the device of claim 19 for cleaning a window at the end of an endoscope. US’306 further teaches wherein the outer diameter of the shaft is configured such that the image capture device having at least one illumination device and having the cleaning module is receivable by an access system to the body cavity (the invention essentially provides an improved method for providing irrigating fluid to a distal end of an endoscope or to a surgical site, para. 2-16, therefore, US’306 teaches that the endoscope would be capable of being received in an access system of the body).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN FLANAGAN BERGNER whose telephone number is (571)270-1133. The examiner can normally be reached M-F 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joshua Allen can be reached at 571-270-3176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN F BERGNER/Primary Examiner, Art Unit 1713
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