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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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) 1-3, 9-12, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elbadry (US 20190358387).
Regarding claim 1, Elbadry discloses a method comprising:
accommodating, by an apparatus (device 6800 in fig. 68), a dialysate drain bag or drain line in a predetermined position (fluid conduit 6830 in fig. 68; paragraph 137 discloses the conduit is a drain line), the dialysate drain bag or drain line comprising spent dialysate (paragraph 137);
emitting, by a light source of the apparatus, light through the dialysate drain bag or drain line (paragraph 131 discloses a light emitter);
sensing, by a light sensor of the apparatus, light emitted through the dialysate drain bag or drain line (paragraph 131 discloses “detectors”); and
determining, by the apparatus, a risk of peritonitis based at least on the light sensed by the light sensor (paragraph 9 discloses sensor data is used to monitor peritonitis; paragraph 134 discloses a controller of the device 6800 estimating total particle concentration and leukocyte concentration from the sensor data; paragraph 244 discloses a cloudy dialysate solution from particle/leukocyte elevation is indicative of peritonitis).
Regarding claim 2, Elbadry discloses determining the risk of peritonitis comprising measuring turbidity of the spent dialysate (paragraph 273 discloses converting the sensor output to Formazin Turbidity Units).
Regarding claim 3, Elbadry discloses determining the risk of peritonitis comprising estimating a proportion of white blood cells in the spent dialysate (paragraph 239 discloses measuring white blood cell count or activity).
Regarding claim 9, Elbadry discloses analyzing the spent dialysate comprising transmitting data to a server (paragraph 133 discloses transmitting data to a database server)and receiving an analysis result from the server (paragraph 104 discloses receiving summarized data from the server to display to the user).
Regarding claim 10, Elbadry discloses a non-transitory computer-readable medium containing thereon instructions for analyzing spent dialysate (paragraph 133 discloses a controller having a processor and a memory), the instructions instructing at least one processor to:
control a light source to emit a light through spent dialysate in a dialysate drain bag or dialysate drain line (paragraph 133 discloses the controller controls the sensor; paragraph 131 discloses emitting light through conduit 6830 in fig. 68 via a light emitter; paragraph 137 discloses the conduit is a drain line);
receive an indication of one or more characteristics of the light from a light sensor situated opposite the light source (paragraph 138 discloses a light detector arranged 180 degrees from the emitter; paragraph 134 discloses receiving light data); and
determine, based on the one or more characteristics of the light, a risk of peritonitis (paragraph 9 discloses sensor data is used to monitor peritonitis; paragraph 134 discloses a controller of the device 6800 estimating total particle concentration and leukocyte concentration from the sensor data; paragraph 244 discloses a cloudy dialysate solution from particle/leukocyte elevation is indicative of peritonitis).
Regarding claim 11, Elbadry discloses the instructions further instruct the at least one processor to determine the risk of peritonitis based on a turbidity of the spent dialysate, the turbidity of the spent dialysate being determined at least in part based on the one or more characteristics of the light (paragraph 273 discloses converting light data to Formazin Turbidity Units).
Regarding claim 12, Elbadry discloses wherein the instructions further instruct the at least one processor to determine the risk of peritonitis based at least in part
on a proportion of white blood cells in the spent dialysate, the proportion of white blood cells being based at least in part on the one or more characteristics of the light (paragraph 239 discloses measuring white blood cell count or activity).
Regarding claim 18, Elbadry discloses the instructions further instruct the at least one processor to transmit the one or more characteristics of the light to a server (paragraph 133 discloses transmitting data to a database server), and receive an analysis of the one or more characteristics of the light from the server (paragraph 104 discloses receiving summarized data from the server to display to the user).
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) 4-6, 8, 13-15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elbadry, as applied to claim 1 above, and further in view of Yu (US 20200405243).
Regarding claim 4, Elbadry discloses all of the claimed limitations set forth in claim 1, as discussed above, and further discloses that polymorphonuclear cells is suggestive of an infection (paragraph 279). However, Elbadry does not teach or disclose determining the risk of peritonitis comprises estimating a proportion of polymorphonuclear cells in the spent dialysis.
Yu teaches using an optical sensor to estimate a proportion of polymorphonuclear cells in the spent dialysis (paragraph 217). Since Elbadry discloses that polymorphonuclear cells is suggestive of an infection (paragraph 279), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Elbadry to have the risk of peritonitis determination be further dependent on a proportion of polymorphonuclear cells in the spent dialysis since Yu teaches that this test can assist in determining the root cause of elevated leukocyte levels (paragraph 217).
Regarding claim 5, in the modified method of Elbadry, Yu discloses the proportion of polymorphonuclear cells in the spent dialysate comprising analyzing light scattering data obtained by the light sensor (paragraph 217; paragraph 87 discloses scattering).
Regarding claim 6, in the modified method of Elbadry, Elbadry discloses estimating fluorescence intensity at one or more of a plurality of wavelengths or a plurality of spectrums (paragraphs 13 and 14 discloses measuring optical absorption, equated to the claimed intensity, at a plurality of wavelengths; paragraph 410 discloses an example light source is fluorescent light).
Regarding claim 8, Elbadry discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose obtaining a baseline light reading for the light sensor, determining the risk of peritonitis comprising determining a difference between the baseline light reading and the light emitted through the dialysate drain bag or drain line.
Yu teaches a similar method comprising disclose obtaining a baseline light reading for the light sensor (paragraph 185 discloses obtaining a baseline optical measurement), and determining a difference between the baseline light reading and the light emitted through the dialysate drain bag or drain line (paragraph 185 discloses subtracting the baseline measurement from subsequent optical measurements). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Elbadry to include the step of obtaining a baseline light reading for the light sensor, determining the risk of peritonitis comprising determining a difference between the baseline light reading and the light emitted through the dialysate drain bag or drain line. Yu teaches that this allows for ambient light noise to be removed from optical measurements for more accurate results (paragraph 185).
Regarding claim 13, Elbadry discloses all of the claimed limitations set forth in claim 10, as discussed above, but does not teach or disclose the instructions further instruct the at least one processor to estimate a proportion of polymorphonuclear cells in the spent dialysate.
As discussed above, Yu teaches using an optical sensor to estimate a proportion of polymorphonuclear cells in the spent dialysis (paragraph 217). Since Elbadry discloses that polymorphonuclear cells is suggestive of an infection (paragraph 279) and that the processor controls the sensor and processes sensor data (paragraph 133), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Elbadry to have the instructions further instruct the at least one processor to estimate a proportion of polymorphonuclear cells in the spent dialysate since Yu teaches that this test can assist in determining the root cause of elevated leukocyte levels (paragraph 217).
Regarding claim 14, in the modified medium of Elbadry, Yu discloses the instructions further instruct the at least one processor to determine the proportion of polymorphonuclear cells based on light scattering data of the light (paragraph 217).
Regarding claim 15, in the modified medium of Elbadry, Elbadry discloses the instructions further instruct the at least one processor to estimate a fluorescence intensity at one or more wavelengths of one or more spectrums of light (paragraph 133 discloses the processor controls the optical sensor; paragraph 14 discloses measuring optical absorption, indicative of light intensity, at a plurality of wavelengths; paragraph 410 discloses fluorescent lamps as a type of light emitter).
Regarding claim 17, Elbadry discloses all of the claimed limitations set forth in claim 10, as discussed above, but does not teach or disclose the instructions further instruct the at least one processor to obtain a baseline reading from the light sensor and determine the risk of peritonitis by determining a difference between the baseline reading and the one or more characteristics of the light emitted through the spent dialysate.
As discussed above, Yu teaches the step of obtaining a baseline light reading for the light sensor (paragraph 185 discloses obtaining a baseline optical measurement), and determining a difference between the baseline light reading and the light emitted through the dialysate drain bag or drain line (paragraph 185 discloses subtracting the baseline measurement from subsequent optical measurements). Since Elbadry teaches that the processor controls the sensor (paragraph 133), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the instructions further instruct the at least one processor to obtain a baseline reading from the light sensor and determine the risk of peritonitis by determining a difference between the baseline reading and the one or more characteristics of the light emitted through the spent dialysate since. Yu teaches that this allows for ambient light noise to be removed from optical measurements for more accurate results (paragraph 185).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elbadry, as applied to claim 1 above, and further in view of Karopadi (US 20200020445).
Regarding claim 7, Elbadry teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose determining a weight of the dialysate drain bag, determining the risk of peritonitis being further based on the weight of the dialysate drain bag.
Karopadi teaches that the weight of a dialysate drain bag can indicate a medical problem (paragraph 58). Since Elbadry teaches that multiple factors can be used to determine peritoneal risk (paragraph 364), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Elbadry to include the steps of determining a weight of the dialysate drain bag, determining the risk of peritonitis being further based on the weight of the dialysate drain bag since Karopadi teaches that this data is useful in determining if patient treatment needs to be modified (paragraph 58).
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 16, the closest prior art is Elbadry and Karopadi, as discussed above. Karopadi discloses receiving an indication of a weight of a dialysate drain bag and determining a health condition may be present based on the weight of the drain bag (paragraph 58). However, Karopadi discloses determining the weight of the entire drain bag and does not teach or disclose determining a dialysate weight based on the weight of the drain bag, as required by the claim.
Conclusion
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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