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 .
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) 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (US2019/0076009A1).
Re claim 25, Yang et al. teach a method of reprocessing an internal channel of a medical device (Abstract) comprising detecting with at least one sensor a predetermined condition (i.e. fluidic parameter of at least one fluid line (i.e. lumen). Paragraph 32 teaches a sensor 42 in fluid communication with each flush line for sensing excessive pressure in the flush line. Any excessive pressure or lack of flow sensed maybe indicative of a partial or complete blockage in an endoscope channel (200) in which each flush line is connected to. Paragraph 39 further teaches that flow rates in lines 30 can be monitored by pressure sensors 42 to check for blockages in the endoscope. Paragraph 49 further teaches monitoring the pressure to determine the presence of leaks. Once the fluidic parameter is measured (flow rate, pressure, leak detection) a cleaning cycle is performed (paragraphs 51-52) comprising a pre-rinse, wash/detergent step and a post rinse, wherein the pre-rinse or rinse and the wash cycle each read on the either the fluid having a first reprocessing parameter or a fluid having a second reprocessing parameter, wherein the fluids are different from each other. Specifically, the "reprocessing parameter" is broadly interpreted to read on any property of the fluid. Therefore, a wash cycle having a detergent solution (i.e. enzymatic detergent solution, paragraph 52) has a first reprocessing parameter (i.e. chemical composition for example) which is different from a prerinse/rinse solution (paragraph 55, warm water) having a second reprocessing parameter (i.e. chemical composition) which is different from the first solution. Applicant's reprocessing parameter is read broadly as any variable of the fluid, which could be the chemical composition, density, concentration for example). Paragraph 28 teaches reprocessing system of Fig. 2 that may be used to decontaminate endoscopes and other medical devices that include channels or lumens. In summary, Yang et al. teach measuring at least one fluidic parameter (pressure, flow rate, leak detection) and reprocessing (i.e. cleaning )the lumen based on at least one the fluidic parameter, such a pressure or flowrate which is indicative of a blockage or leak.
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.
Claim(s) 34-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US2019/0076009A1) in view of Spargo et al. (US2021/0189300).
Yang et al. teach the rinsing, washing and disinfecting the endoscope (paragraphs 51, 52, 57).
Yang et al. fail to teach reprocessing the lumen with a liquid powder mixture. Claim 34 is broadly interpreted as dividing the mixture into several portions and delivering at least one portion to the lumen. Spargo et al. teach a method of cleaning an interior lumen of an endoscope with a liquid suspension of solid particles (abstract) for purposes of removing biofilm contaminants present therein. Paragraphs 38 and 52 teaches a suspension which flows like a fluid. In reference to the limitations of apportioning the liquid/powder mixture into one or more apportioned amounts, the limitations read broadly on delivering a predetermined amount of the suspension into the interior of the lumen, the limitations of which are taught by Spargo et al. Specifically, Spargo et al. teach a premixed amount of paste (i.e. apportioned amount) is provided into a cartridge and placed in line with the endoscope and pumped through the lumen (paragraphs 65-66). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yang et al. to include a liquid powder mixture, as taught by Spargo et al., for purposes of performing the same function of effectively cleaning/disinfecting the lumen of the endoscope.
Re claims 35-39, Yang et al. in view of Spargo et al. do not teach determining the number of one or more amounts, the velocity or timing based one the at least one measured fluid parameter. Applicant’s limitations are directed to processing parameters during a cleaning process. Yang et al. teach washing, rinsing and disinfecting based on the fluidic parameter of flow rate and pressure, as an indicator of blockage. Absent of a showing of criticality and/or unexpected results, it would have been obvious to one of ordinary skill in the art to adjust processing parameters such as the number and amount/concentration of the solution, flow rate (i.e. velocity), and timing of the cleaning/disinfecting/washing solution being delivered into the lumen in order to effectively clear/clean any blockages and contaminants, such as biofilm, present in the interior of the lumen.
Claim(s) 40-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US2019/0076009A1) in view of Crawford et al. (US2018/0001009).
Yang et al. teach measuring fluidic parameters comprising flow rate and pressure, but fails to
teach fluidic resistance. Crawford et al. teach pressure sensor mounted at the end of a patient line to detect a blockage (occlusion) (abstract). Paragraph 30 teaches whether the blockage (occlusion) is caused by a pressure differential. Paragraphs 35, 89 and 224 teaches another embodiment wherein the determination of a blockage in a medical tube is based on a change in flow rate over time, or a measure of fluidic resistance. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method of Yang et al. to include equivalent fluidic parameters, besides pressure and flow rate, as taught by Crawford et al., for purposes of detecting a blockage in the medical tube. Re claims 41 and 43, the limitations are broadly interpreted as determining which channels are blocked based on the fluidic resistance. In the absence of a showing of criticality and/or unexpected results, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to measure the fluidic parameter in each line/channel/tubing to determine if a blockage is present such that cleaning can be performed. Re claim 42, paragraph 35 of Crawford et al. teach measuring the fluidic resistance of a catheter over time by detecting a transient component. The limitations of a specific gravity are met because specific gravity is a chemical property of any component, and therefore the component inherently has a know specific gravity. In reference to measuring pressure, refer to both the teachings of Yang et al. and Crawford et al. (paragraph 30), as discussed previously. Additionally, paragraph 35 of Crawford et al. teach determining the volumetric flow rate over time, as well as measurements of pressure and fluidic resistance. Re claim 44, determining the existence of a blockage is a measure of the integrity of the lumen, and therefore the limitations are met by both references. Re claim 45, Crawford et al. do not teach comparing the fluidic resistance to a nominal range. The claim is broadly interpreted as comparing the measured value to a threshold (i.e. reference value). In the absence of a showing of criticality and/or unexpected results, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to compare the fluidic resistance to reference value, in order to detect whether a blockage has occurred.
Response to Arguments
9. The rejection of the claims under 112, first paragraph is withdrawn in view of the newly amended claims. However, the claims are now rejected in view of Yang et al. for the reasons set forth above.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sharidan Carrillo whose telephone number is (571)272-1297. The examiner can normally be reached M-F, 7:00am-4:00pm.
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Sharidan Carrillo
Primary Examiner
Art Unit 1711
/Sharidan Carrillo/Primary Examiner, Art Unit 1711 bsc
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