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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference signs mentioned in the description: “155”, “772”, “889”, “897”, “983”, “992”, and “995”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: “890” and “982”. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference characters in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 1-2, 4-9, 11-12, 15, 34-35, 37-38, 41-43, and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spargo (WO 2019113634 A1).
Regarding claim 1, Spargo teaches a method for cleaning at least one interior lumen of a medical device (abstract) comprising: mixing a liquid with a powder to form a slurry (providing a suspension of solid particles in a liquid (page 4 paragraph 7); and applying at least one flow of fluid to a portion of the slurry to propel the portion of the slurry through the at least one interior of the medical device (flowing the suspension along surface to remove contaminants, page 4 paragraph 7, and surface is the interior of a medical instrument, page 4 paragraph 8).
Regarding claim 2, Spargo teaches apportioning the liquid-powder mixture into the portion based at least on a fluidic resistance of at least a proximal section of the at least one lumen (flow rate used is the maximum allowable as determined by the pressure rating of the instrument, page 5 paragraph 3).
Regarding claim 4, Spargo teaches wherein applying at least one flow of fluid to a portion of the slurry comprises: providing the portion of the slurry to a delivery chamber (Figure 2 selected paste mixture flows to valve “109” through line “108”); and applying the at least one flow of fluid in the delivery chamber to accelerate the portion of the slurry prior to delivery of the portion of the slurry to the at least one interior lumen (flow may be fed through the endoscope in a manner interspersed with one or more other liquid flows, page 10 paragraph 1).
Regarding claim 5, Spargo teaches wherein applying the at least one flow of fluid in the delivery chamber comprises: applying a first flow of fluid in the delivery chamber and a second flow of fluid in the delivery chamber (flow may be pulsed, page 10 paragraph 1).
Regarding claim 6, Spargo teaches delivering a fluid flow through the at least one interior lumen without any portion of the slurry (valve is closed to the flow of any paste but in open communication with water or other aqueous solutions, page 9 paragraph 1).
Regarding claim 7, Spargo teaches mixing the powder with the liquid in at least one holding chamber (paste is premixed in a cartridge, page 8 paragraph 5), wherein the at least one holding chamber is in fluid communication with one or more delivery chambers (Figure 2 cartridges “101” and “102” flow paste to valve “109” through line “108”).
Regarding claim 8, Spargo teaches drawing the portion of the slurry from the at least one holding chamber to at least one of the one or more delivery chambers (paste from each cartridge flows down the lines to the valves, page 8 paragraphs 6-7, and conveyable paste may be conveyed by way of reduced pressure or suction, page 7 paragraph 7).
Regarding claim 9, Spargo teaches pumping the portion of the slurry from the at least one holding chamber to at least one of the one or more delivery chambers (paste is forced from the cartridge with plungers or linear drivers, page 8 paragraph 6).
Regarding claim 11, Spargo teaches wherein mixing the powder with the liquid to form the slurry comprises: providing excessive powder relative to the liquid such that undissolved powder is suspended in the slurry (carrier fluid is selected to not dissolve or only provide minimal dissolution of solid particles to provide a suitably stable suspension of solid particles, page 7 paragraph 2).
Regarding claim 12, Spargo teaches wherein mixing the powder with the liquid to form the slurry comprises: mixing sodium bicarbonate with water (solid particles are crystals of sodium bicarbonate, page 5 paragraph 5, and one useful paste is 1/3 water, page 5 paragraph 10).
Regarding claim 15, Spargo teaches all aspects of the current invention except wherein the at least one interior lumen is a fluidically complex lumen having at least a first section (endoscopes have internal chambers for delivering air and water, providing suction, and allowing forceps access and channels can bifurcate or join from two into one, page 1 paragraph 7), and wherein the second section has a second internal dimension that is smaller than the first internal dimension (suction/biopsy lumens are larger while air/water channels are smaller, page 2 paragraph 8).
Regarding claim 34, Spargo teaches at least one delivery chamber fluidically connected to at least one interior lumen of an apparatus (paste flows to valve with pressure sensor to ensure paste flows at an optimal speed to endoscope, page 8 paragraphs 7): at least one of a valve or a pump configured to provide an apportioned amount of a liquid powder mixture to the at least one delivery chamber (valves maintained to control the flow of the paste through the various channels of the endoscope, page 8 paragraph 8); and a delivery mechanism configured to apply at least one flow of fluid to the apportioned amount of the liquid powder mixture in the at least one delivery chamber to propel the apportioned amount of the liquid powder mixture through the at least one interior lumen (paste is forced from cartridges by plungers or linear drivers and pressure sensor is connected to control mechanism to control the linear drivers, page 8 paragraphs 6-7).
Regarding claim 35, Spargo teaches a control sub-system configured to determine the apportioned amount of the liquid-powder mixture based on a fluidic resistance of at least a proximal section of the at least one interior lumen (flow rate used is the maximum allowable as determined by the pressure rating of the instrument, page 5 paragraph 3, and pressure sensor can be connected to a control mechanism, page 8 paragraph 7).
Regarding claim 37, Spargo teaches wherein the at least one delivery mechanism is configured to apply a first flow of fluid in the at least one delivery chamber and a second flow of fluid in the delivery chamber (flow may be fed through the endoscope in a manner interspersed with one or more other liquid flows and flow may be pulsed, page 10 paragraph 1).
Regarding claim 38, Spargo teaches a holding chamber wherein the holding chamber is a consumable component that is configured to be mechanically decoupled from the system (paste is premixed and provided contained in a cartridge, page 8 paragraph 5).
Regarding claim 41, Spargo teaches wherein the system is configured to create a pressure difference between a holding chamber and the at least one delivery chamber to draw the apportioned amount of the liquid-powder mixture from the holding chamber to the at least one delivery chamber (paste from cartridge flow under pressure down the lines to the valves with pressure feedback from the valves to the linear drives to control flow, page 8 paragraphs 6-7).
Regarding claim 42, Spargo teaches a distribution manifold fluidly connected between the at least one delivery chamber and the at least one interior lumen (Figure 2 vales “112” and “113” split fluid flow between multiple chambers of the lumen “114”, “115”, and “116”).
Regarding claim 43, Spargo teaches wherein the delivery mechanism is configured to apply a flow of at least one of compressed air or water to the apportioned amount of the liquid-powder mixture in the at least one delivery chamber (flow may be fed through the endoscope in a manner interspersed with one or more other liquid flows, page 10 paragraph 1).
Regarding claim 49, Spargo teaches wherein the at least one delivery chamber comprises first and second delivery chambers each separately fluidically connected to a holding chamber (Figure 2 valves “112” and “113” in configuration to control the flow of paste from cartridges “101” and “102” through various channels of the lumen “114”, “115”, and “116”).
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.
Claims 3 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Spargo in view of Coughlin (US 20030121532 A1).
Regarding claim 3, Spargo teaches all aspects of the current invention as described above except wherein mixing the liquid with the powder to form the slurry comprises: introducing the liquid into a consumable holding the powder. However, Coughlin teaches introducing the liquid into a container holding the powder (Figure 3 water is supplied “30” into container “12” for slurry “44” and mixed with stir bar “14”), and Spargo teaches a consumable container (paste is premixed in a cartridge, page 8 paragraph 5).
Spargo and Coughlin are considered analogous to the current invention because all are in the field of biofilm removal methods. Therefore, it would have been obvious to one of ordinary skill in the art to combine the paste cartridge taught by Spargo with the introduction of liquid into the powder because Spargo teaches that flowing water into the compartment will allow the slurry to be conveyed through the tubing connecting the container and the instrument (paragraph [0085]).
Regarding claim 39, Spargo teaches all aspects of the current invention including a holding chamber (paste is premixed and provided contained in a cartridge, page 8 paragraph 5), but does not teach wherein the holding chamber is configured to retain a powder, and wherein the system is configured to deliver a fluid to the holding chamber for mixing with the powder to form the liquid-powder mixture (Figure 3 water is supplied “30” into container “12” for slurry “44” and mixed with stir bar “14”).
Spargo and Coughlin are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to one of ordinary skill in the art to combine the paste cartridge taught by Spargo with the introduction of liquid into the powder because Spargo teaches that flowing water into the compartment will allow the slurry to be conveyed through the tubing connecting the container and the instrument (paragraph [0085]).
Regarding claim 40, the combination of Spargo and Coughlin teaches all aspects of the current invention including a motor for use in mixing the fluid with the powder to form the liquid0powder mixture (container is agitated by magnetic stirring bar driven by magnetic stirrer, paragraph [0079], Coughlin).
Claims 16-18, 33, 45, 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Spargo in view of Alemana (WO 2020077406 A1).
Regarding claim 16, Spargo teaches all aspects of the current invention except modulating at least one attribute of the portion of the slurry at a transition from the first section of the at least one interior lumen to the second section of the at least one interior lumen. However, Alemana teaches modulating at least one attribute of the portion of the slurry at a transition from the first section of the at least one interior lumen to the second section of the at least one interior lumen (flow rate is individually altered to proceed through each internal channel at a preselected volumetric flow rate, paragraph [00116]).
Spargo and Alemana are considered analogous to the current invention because all are in the field of biofilm removal methods. Therefore, it would have been obvious to combine the biofilm removal method taught by Spargo with the alteration of fluid attributes taught by Alemana because Alemana teaches this will ensure that the fluid creates enough shear force to remove the biofilm without exceeding the maximum internal pressure limit of each channel (paragraph [00116]).
Regarding claim 17, the combination of Spargo and Alemana teaches wherein the second section is connected to the first section via a fluidic chamber (Figure 2 fluid flows from consumable unit “18”to the medical device “12” via the cleaning apparatus “10” using the cleaning pumps “20”, Alemana), and wherein the method comprises: modulating the at least one attribute of the portion of the slurry at the fluidic chamber (each cleaning pump is individually controllable and connected to one or more internal channels of the medical device, paragraph [0069], Alemana).
Regarding claim 18, the combination of Spargo and Alemana teaches wherein modulating the at least one attribute of the portion of the slurry comprises: increases a ratio of fluid to powder of the portion of the slurry (flow rate of water through each cleaning pump is individually adjusted to the required flow rate through the respective internal channel, paragraph [00113]).
Regarding claim 33, Spargo teaches all aspects of the current invention except wherein the portion is delivered to the first section with a first configuration, and wherein the method comprises: modifying the portion to a second configuration at a transition from the first section of the at least one lumen to the second section of the at least one lumen. However, Alemana teaches wherein the portion is delivered to the first section with a first configuration, and wherein the method comprises: modifying the portion to a second configuration at a transition from the first section of the at least one lumen to the second section of the at least one lumen (cleaning apparatus may be provided with several combined primary and secondary transfer conduit assemblies, paragraph [0082], and flow rate is individually altered to correspond to the ideal volumetric flow and pressure for the respective internal channel, paragraph [00116]).
Spargo and Alemana are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to combine the biofilm removal method taught by Spargo with the alteration of fluid attributes taught by Alemana because Alemana teaches this will ensure that the fluid creates enough shear force to remove the biofilm without exceeding the maximum internal pressure limit of each channel (paragraph [00116]).
Regarding claim 45, Spargo teaches all aspects of the current invention including wherein the at least one interior lumen is a fluidically complex lumen having at least a first section with a first internal dimension and a second section fluidically connected in series with the first section (endoscopes have internal chambers for delivering air and water, providing suction, and allowing forceps access and channels can bifurcate or join from two into one, page 1 paragraph 7), and wherein the second section has a second internal dimension that is smaller than the first internal dimension (suction/biopsy lumens are larger while air/water channels are smaller, page 2 paragraph 8), but does not teach wherein the system comprises a fluid delivery connector configured to deliver a fluid at a transition of the at least one interior lumen from the first internal dimension to the second internal dimension to modulate at least one attribute of the apportioned amount of the liquid-powder mixture at the transition of the at least one interior lumen from the first internal dimension to the second internal dimension. However, Alemana teaches wherein the system comprises a fluid delivery connector configured to deliver a fluid at a transition of the at least one interior lumen from the first internal dimension to the second internal dimension to modulate at least one attribute of the apportioned amount of the liquid-powder mixture at the transition of the at least one interior lumen from the first internal dimension to the second internal dimension (flow rate is individually altered to proceed through each internal channel at a preselected volumetric flow rate, paragraph [00116]).
Spargo and Alemana are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to combine the biofilm removal method taught by Spargo with the alteration of fluid attributes taught by Alemana because Alemana teaches this will ensure that the fluid creates enough shear force to remove the biofilm without exceeding the maximum internal pressure limit of each channel (paragraph [00116]).
Regarding claim 47, the combination of Spargo and Alemana teaches all aspects of the current invention including wherein the second section is connected to the first section via a fluidic chamber (Figure 2 fluid flows from consumable unit “18”to the medical device “12” via the cleaning apparatus “10” using the cleaning pumps “20”, Alemana), and wherein the fluid delivery connector is configured to fluidically connect to the fluidic chamber (Figure 2 main feed line “40” connects the consumable fluid unit “18” to the cleaning apparatus “10”, Alemana).
Regarding claim 48, the combination of Spargo and Alemana teaches all aspects of the current invention including wherein the fluidic delivery connector is configured to bifurcate the fluidic chamber into a first chamber and a second chamber (cleaning apparatus may be provided with several combined primary and secondary transfer conduit assemblies, paragraph [0082]), and wherein the fluid delivery connector is configured to separately deliver the fluid to the first chamber and the second chamber (supply lines are split into primary and secondary supply lines, paragraph [0079]).
Claims 21 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Spargo in view of Miller (US 20230375268 A1).
Regarding claim 21, Spargo teaches all aspects of the current invention except wherein the delivery chamber comprises a frustoconical shaped interior surface, and wherein applying the at least one flow of fluid delivery chamber to accelerate the portion of the slurry comprises: applying the at least one flow of fluid in the at least one delivery chamber to cause the portion to rotate along the frustoconical shaped interior surface. However, Miller teaches wherein the delivery chamber comprises a frustoconical shaped interior surface (variable pressure region may include a partial venturi shape or parabolic shape, paragraph [0150]), and wherein applying the at least one flow of fluid delivery chamber to accelerate the portion of the slurry comprises: applying the at least one flow of fluid in the at least one delivery chamber to cause the portion to rotate along the frustoconical shaped interior surface (shape changes the pressure and creates an acceleration of the fluid, paragraph [0152]).
Spargo and Miller are considered analogous to the current invention because all are in the field of lumen cleaning methods. Therefore, it would have been obvious to one of ordinary skill in the art to combine the lumen cleaning method taught by Spargo with the curved shape interior surface taught by Miller because Miller teaches it advantageously increases the fluid friction force applied to the internal wall of the lumen (abstract).
Regarding claim 36, Spargo teaches all aspects of the current invention except wherein the at least one delivery chamber comprises a frustoconical shaped interior surface, and wherein the delivery mechanism is configured to apply the at least one flow of fluid in the at least one delivery chamber so that the apportioned amount of the liquid-powder mixture spins along the frustoconical shaped interior surface. However, Miller teaches wherein the at least one delivery chamber comprises a frustoconical shaped interior surface (variable pressure region may include a partial venturi shape or parabolic shape, paragraph [0150]), and wherein the delivery mechanism is configured to apply the at least one flow of fluid in the at least one delivery chamber so that the apportioned amount of the liquid-powder mixture spins along the frustoconical shaped interior surface (shape changes the pressure and creates an acceleration of the fluid, paragraph [0152]).
Spargo and Miller are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to one of ordinary skill in the art to combine the lumen cleaning method taught by Spargo with the curved shape interior surface taught by Miller because Miller teaches it advantageously increases the fluid friction force applied to the internal wall of the lumen (abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA ROSE SARANTAKOS whose telephone number is (703)756-5524. The examiner can normally be reached Mon-Fri 7:00-4:00.
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799