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 .
Specification
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
The abstract of the disclosure is objected to because:
The first sentence lacks an article for the phrase “subject”.
The second sentence lacks articles for the phrase “blood sample”, “dialyser”, “first blood bypass tube”, and “second blood bypass tube”.
The third sentence lacks articles for the phrase “first sensor and second sensor”.
The fourth sentence lacks articles for the phrase “dialyser”, “first and second dialysate tube”.
The fourth sentence also lacks a subject-verb grammatical structure.
The fifth sentence lacks articles for the phrase “third sensor and fourth sensor”.
The sixth sentence lacks articles for the phrase “blood sample” and “concentration”.
The last sentence lacks an article for the phrase “blood sample”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: please also insert the publication numbers and dates of the applications mentioned in the Related Applications section.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “blood sample” is missing an article like “the”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: the limitation “the dialyzer” should be spelled either like the earlier recitations of “dialyser” or they should all be changed to the “dialyzer” spelling for consistency type purposes. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the limitation “by signal acquisition unit” is missing an article such as “a”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the limitation “the collected weight” should be rewritten as “the weight that is collected”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the limitation “the acquired BP signal, BCG signal” should be rewritten as “the BP and BCG signal that is acquired”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the limitation “weigh” on line 7 is misspelled. Examiner suggests “weight”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the limitations “initial and end point” and “electrolytes imbalance condition” are missing an article like “an”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: the limitations “ratio” and “volume” are missing an article like “a”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the limitation “hemolysis condition” is missing an article like “a”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the phrase “wherein a fifth sensor” is missing a verb-like structure. For example, “comprising” substituted for “wherein” would be appropriate. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the limitation “subject” on line 2 is missing an article like “a”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the limitation “blood sample” on lines 13-14 is missing an article like “a”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the limitation “one or more metabolic content” on line 19 is grammatically improper. Appropriate correction is required.
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 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 the limitation “one or more electrolytes and metabolic content”.
Claim 1 recites the limitation “the blood”. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the identified variations”. It is not clear if this limitation is the same as “variations” recited earlier in the claim or not.
Claim 3 recites the limitation “dialysate fluid”. It is not clear if this limitation is the same limitation as “dialysate fluid” already recited in Claim 1, or if it is a different limitation altogether.
Claim 5 recites the limitation “the blood fluid”. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “concentration of metabolic content in the blood sample and the dialysis fluid”. It is not clear if this limitation is the same limitation as “dialysate fluid” already recited in Claim 1, or if it is a different limitation altogether.
Claim 8 recites the limitation “hemodialysis”. It is not clear if this limitation is the same as “personalized hemodialysis” as in Claim 7 or Claim 1, or something different.
Claim 9 recites the limitation “removal”. It is not clear if this limitation is the same as “removal” recited in Claim 1, or a different “removal” limitation.
Claim 10 recites the limitation “hemodialysis”. It is not clear if this limitation is the same as “personalized hemodialysis” as in Claim 1, or something different.
Claim 11 recites the limitation “personalized hemodialysis”. It is not clear if this limitation is the same as “personalized hemodialysis” as in Claim 1, or something different.
Claim 11 recites the limitation “blood fluid rate” on lines 4-5. It is not clear if this limitation is the same as “blood fluid rate” as on line 4, or something different.
Claim 11 recites the limitation “variations”. It is not clear if this limitation is the same as “variations” recited in Claim 1, or not.
Claim 11 recites the limitation “hemodialysis” on lines 13 & 15. It is not clear if this limitation is the same as “personalized hemodialysis” as in Claim 1, or something different.
Claim 12 recites the limitation “the concentration of the one or more electrolytes in blood sample” on lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the concentration of the metabolic content” on lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the concentration of the one or more electrolytes in dialysis fluid” on lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the concentration of the metabolic content in the dialysate fluid” on lines 9-10. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the concentration” once each on lines 11 & 13. It is not clear if this limitation is the same as both “concentrations” indicated on lines 3-4 & 5-6, and on lines 7-8 & 9-10, or not.
Claim 12 recites the limitation “one or more electrolytes and metabolic content” on line 13. It is not clear if these are the same or different from the limitations recited on lines 8 & 10 or not.
Claim 12 recites the limitation “the identified variations”. It is not clear if this limitation is the same as “variations” recited earlier in the claim or not.
Claim 13 recites the limitation “the dialyzer”. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “haemodialysis” on line 14. It is not clear if this limitation is the same as “haemodialysis” on line 4, or not. Examiner interprets it to be the same.
Claim 14 recites the limitation “dialysis” on line 22. It is not clear if this limitation is the same as “personalized haemodialysis”, or “haemodialysis”, as recited earlier in the claim, or not.
Claim 14 recites the limitation “personalised haemodialysis” on line 23. It is not clear if this limitation is the same as “personalized haemodialysis” on line 1, or not. Examiner interprets it to be the same.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “unit” coupled with functional language but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “signal acquisition unit”, “weight acquisition unit”, “decision and control device” in claim 7 and “a Blood Pressure (BP) and Ballistocardiograph (BCG) signal acquisition unit”, “a Photoplethysmography (PPG) signal acquisition unit”, “a weight acquisition unit”, “an optical spectral metabolic estimation device”, “a decision and control device” in claim 14. Examiner indicates that these limitations are modified by enough descriptors associated with each “unit” or “device” to require enough structure to associate with each recitation.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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) 1, 2, 9, 11 & 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovatti et al., (“Rovatti”, US 2021/0015990; the earlier publication and filing dates of the PCT application are relied upon), in view of Brandl et al., (“Brandl”, US 2011/0208105).
Regarding Claims 1, 2, 9, 11, Rovatti discloses a method of providing personalised haemodialysis for a subject, (See Abstract, Rovatti), the method comprising: obtaining, by a haemodialysis filtering device, concentration of one or more electrolytes and of metabolic content in a blood sample of a subject flowing into a dialyser and out of the dialyser using a first sensor and a second sensor configured in the haemodialysis filtering device respectively, (Sensors 50 upstream and downstream of Dialyzer 2, See Figure 2, See paragraph [0130], [0037] & [0042]); obtaining, by the haemodialysis filtering device, concentration of one or more electrolytes and metabolic content in a dialysate fluid flowing into the dialyser and out of the dialyser through a first dialysate tube and a second dialysate tube respectively, (Line 19 and Line 13 connected to Dialyzer 2, See Figure 2), wherein the first dialysate tube and the second dialysate tube are arranged to pass through a third sensor and a fourth sensor configured in the haemodialysis filtering device respectively, (Sensor 109 and Sensor 112, See Figure 2, See paragraph [0202], [0203], [0243]); identifying, by the haemodialysis filtering device, variations in the concentration obtained for the one or more electrolytes and the metabolic content in the blood sample with respect to the concentration obtained for one or more electrolytes and metabolic content in the dialysate fluid, respectively, (See paragraph [0044]/[0045] & [0236]); and performing, by the haemodialysis filtering device, removal of the one or more electrolytes and the metabolic content from the blood based on the identified variations, (See paragraph [0016], [0024], [0256]).
Rovatti does not disclose passing the blood sample through a first blood bypass tube and a second blood bypass tube respectively, wherein the first blood bypass tube and the second blood bypass tube are arranged in the first sensor and the second sensor.
Brandl discloses passing the blood sample through a first blood bypass tube and a second blood bypass tube respectively, (Line 632a/632b redirect blood sample from main conduit, See Figure 6c, See paragraph [0132]), wherein the first blood bypass tube and the second blood bypass tube are arranged in the first sensor and the second sensor, (Sensors 630 and 631 on lines 623a or 632b, See Figure 6c, See paragraph [0132]; the sensors on the blood side of Rovatti are each modified by one sensor apparatus). Additional features of this embodiment are included as part of the overall combination.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Rovatti by incorporating passing the blood sample through a first blood bypass tube and a second blood bypass tube respectively, wherein the first blood bypass tube and the second blood bypass tube are arranged in the first sensor and the second sensor as in Brandl in order to provide for the most…continuous detection of the ion concentration as possible” while “the sensor can be recalibrated”, (See paragraph [0047], Brandl).
Additional Disclosures Included:
Claim 2: The method as claimed in claim 1, wherein the first sensor measures variations in the concentration of the one or more electrolytes in blood sample, (Sensors 50 upstream and downstream of Dialyzer 2, See Figure 2, See paragraph [0130], [0037] & [0042]; Rovatti), and the second sensor measures variations in the concentration of the metabolic content in the blood sample, (Sensors 630/631, See Figure 6c, See paragraph [0007], [0050]-[0052]; Brandl).
Claim 9: The method as claimed in claim 1, wherein removal of the one or more electrolytes and the metabolic content comprises controlling respective valves based on the variations, (See paragraph [0132] & [0134], Brandl).
Claim 11: The method as claimed in claim 1, wherein providing personalized hemodialysis for the subject further comprising identifying adequacy of hemodialysis by: setting blood fluid rate and dialysate fluid rate as predefined proportion to blood fluid rate, (See paragraph [0120], [0121], Rovatti); obtaining variations in the concentration obtained for the metabolic content in the blood sample with respect to the concentration obtained for the metabolic content in the dialysate fluid, (See paragraph [0143], Rovatti; See paragraph [0132], Brandl); evaluating a target factor based on ratio between volume of the dialysate fluid to the blood sample, (See paragraph [0232], Rovatti; See paragraph [0053], [0076], Brandl); comparing the target factor with a previous target factor, (See paragraph [0232], Rovatti; See paragraph [0053], [0076], Brandl), wherein performing one of: storing the target factor and continuing the haemodialysis when the target factor is greater than the previous target factor; or indicating to stop the haemodialysis when the target factor is lesser or equal to the previous target factor, (See paragraph [0053], Brandl).
Regarding Claim 12, Rovatti discloses a haemodialysis filtering device for providing personalised haemodialysis for a subject, (See Abstract, Rovatti), comprising: a first sensor configured to measure variations in the concentration of the one or more electrolytes in blood sample; a second sensor configured to measure variations in a concentration in the blood sample, (Sensors 50 upstream and downstream of Dialyzer 2, See Figure 2, See paragraph [0130], [0037] & [0042]); obtaining, by the haemodialysis filtering device, concentration of one or more electrolytes and metabolic content in a dialysate fluid flowing into the dialyser and out of the dialyser through a first dialysate tube and a second dialysate tube respectively, (Line 19 and Line 13 connected to Dialyzer 2, See Figure 2), a third sensor configured to measure variations in the concentration of the one or more electrolytes in dialysate fluid; a fourth sensor configured to measure variations in the concentration of the metabolic content in the dialysate fluid, (Sensor 109 and Sensor 112, See Figure 2, See paragraph [0202], [0203], [0243]); and a computing unit for identifying variations in the concentration obtained for the one or more electrolytes and the metabolic content in the blood sample with respect to the concentration obtained for one or more electrolytes and metabolic content in the dialysate fluid, respectively, (See paragraph [0044]/[0045] & [0236]); wherein removal of the one or more electrolytes and the metabolic content from the blood sample is performed based on the identified variations, (See paragraph [0016], [0024], [0256]).
Rovatti does not disclose the second sensor configured to measure variations in the concentration of the metabolic content in the blood sample.
Brandl discloses the second sensor configured to measure variations in the concentration of the metabolic content in the blood sample, (Sensors 630/631, See Figure 6c, See paragraph [0007], [0050]-[0052]; Brandl). Additional features of this embodiment are included as part of the overall combination.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Rovatti by incorporating the second sensor configured to measure variations in the concentration of the metabolic content in the blood sample as in Brandl in order to provide for the most…continuous detection of the ion concentration as possible”, (See paragraph [0047], Brandl).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovatti et al., (“Rovatti”, US 2021/0015990; the earlier publication and filing dates of the PCT application are relied upon), in view of Brandl et al., (“Brandl”, US 2011/0208105), in further view of Pouchoulin et al., (“Pouchoulin”, US 2019/0134290).
Regarding Claim 3, modified Rovatti discloses the method as claimed in claim 1, wherein the third sensor measures variations in the concentration of the one or more electrolytes in dialysate fluid, (See paragraph [0266], Rovatti), but does not disclose that the fourth sensor measures variations in the concentration of the metabolic content in the dialysate fluid.
Pouchoulin discloses that the fourth sensor measures variations in the concentration of the metabolic content in the dialysate fluid, (See Abstract and paragraph [0049], Pouchoulin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating that the fourth sensor measures variations in the concentration of the metabolic content in the dialysate fluid as in Pouchoulin in order to rely pon “one or parameters indicative of the progress of the treatment so as to be able, where appropriate, to modify the treatment conditions that were initially fixed or to at least inform the patient and the medical personnel about the effectiveness of the treatment”, (See paragraph [0004], Pouchoulin).
Claim(s) 4 & 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovatti et al., (“Rovatti”, US 2021/0015990; the earlier publication and filing dates of the PCT application are relied upon), in view of Brandl et al., (“Brandl”, US 2011/0208105), in further view of Lee, (US 5,330,420).
Regarding Claim 4, modified Rovatti discloses the method as claimed in claim 1, but does not disclose further comprising detecting by a fifth sensor configured in the hemodialysis filtering device, hemolysis condition of the blood sample flowing through a third blood bypass tube into the dialyzer.
Lee discloses further comprising detecting by a fifth sensor configured in the hemodialysis filtering device, hemolysis condition of the blood sample flowing through a third blood bypass tube into the dialyzer, (Device with Shell 10 and Compartment 12 with Inlet Port 14 from extracorporeal path and Outlet Port 16 returning to extracorporeal path, See Figure 1, See column 2, lines 49-53, See column 3, lines 23-37 and See column 1, lines 12-14, 20-26; Examiner interprets adding this measurement device which takes blood from main extracorporeal path and returns it and which is recirculated through the dialyzer and patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating detecting by a fifth sensor configured in the hemodialysis filtering device, hemolysis condition of the blood sample as in Lee because “the breaking of blood cells is deleterious”, (See column 1, lines 16-17, Lee), and “hemolyzed blood is dangerous to the patient”, (See column 1, lines 37-38, Lee), so it provides a device “that can continuously detect hemolysis that may be developing in a blood path”, (See column 2, lines 26-28, Lee).
Regarding Claim 13, modified Rovatti discloses e hemodialysis filtering device as claimed in claim 12, but does not disclose wherein a fifth sensor configured for detecting hemolysis condition of the blood sample flowing through a third blood bypass tube into the dialyzer.
Lee discloses wherein a fifth sensor configured for detecting hemolysis condition of the blood sample flowing through a third blood bypass tube into the dialyzer, (Device with Shell 10 and Compartment 12 with Inlet Port 14 from extracorporeal path and Outlet Port 16 returning to extracorporeal path, See Figure 1, See column 2, lines 49-53, See column 3, lines 23-37 and See column 1, lines 12-14, 20-26; Examiner interprets adding this measurement device which takes blood from main extracorporeal path and returns it and which is recirculated through the dialyzer and patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating a fifth sensor configured for detecting hemolysis condition of the blood sample flowing through a third blood bypass tube into the dialyzer as in Lee because “the breaking of blood cells is deleterious”, (See column 1, lines 16-17, Lee), and “hemolyzed blood is dangerous to the patient”, (See column 1, lines 37-38, Lee), so it provides a device “that can continuously detect hemolysis that may be developing in a blood path”, (See column 2, lines 26-28, Lee).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovatti et al., (“Rovatti”, US 2021/0015990; the earlier publication and filing dates of the PCT application are relied upon), in view of Brandl et al., (“Brandl”, US 2011/0208105), in further view of Szamosfalvi et al., (“Szamosfalvi”, US 2008/0015487).
Regarding Claim 5, modified Rovatti discloses the method as claimed in claim 1, but does not disclose wherein obtaining the concentration of the metabolic content in the blood fluid and the dialysate fluid comprises: causing a laser light source to excite light beams on the blood sample and the dialysate fluid drawn from the first blood bypass tube and the first dialysate tube respectively; providing optical signals by a fibre optics tube based on the light beams; detecting by a prism one or more spectrums based on the optical signals; and obtaining by a spectrograph detector concentration of metabolic content in the blood sample and the dialysate fluid based on the one or more spectrums.
Szamosfalvi discloses wherein obtaining the concentration of the metabolic content in the blood fluid and the dialysate fluid comprises: causing a laser light source to excite light beams on the blood sample and the dialysate fluid drawn from the first blood bypass tube and the first dialysate tube respectively, (See paragraph [0083], [0939], Szamosfalvi); providing optical signals by a fibre optics tube based on the light beams, (See paragraph [0793], [0830], Szamosfalvi); detecting by a prism one or more spectrums based on the optical signals; and obtaining by a spectrograph detector concentration of metabolic content in the blood sample and the dialysate fluid based on the one or more spectrums, (See paragraph [0794], [0830], Szamosfalvi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating wherein obtaining the concentration of the metabolic content in the blood fluid and the dialysate fluid comprises: causing a laser light source to excite light beams on the blood sample and the dialysate fluid drawn from the first blood bypass tube and the first dialysate tube respectively; providing optical signals by a fibre optics tube based on the light beams; detecting by a prism one or more spectrums based on the optical signals; and obtaining by a spectrograph detector concentration of metabolic content in the blood sample and the dialysate fluid based on the one or more spectrums as in Szamosfalvi in order to “allow automated, frequent measurements without the need for a complex sampling apparatus” and “an additional benefit is that specific analytes can also be detected…safely and in a sterile fashion”, (See paragraph [0083], Szamosfalvi).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovatti et al., (“Rovatti”, US 2021/0015990; the earlier publication and filing dates of the PCT application are relied upon), in view of Brandl et al., (“Brandl”, US 2011/0208105), in further view of Goldstein et al., (“Goldstein”, US 2020/0187838), in further view of Ou Yang et al., (“Ou Yang”, US 2009/0149762).
Regarding Claim 6, modified Rovatti discloses the method as claimed in claim 1 further comprising estimating concentration of uremia in the blood sample by: emitting light rays to a blood flow tube arranged between a Near Infrared (NIR) LED source and a photodiode detector; converting the light rays projected from the NMR LED source as digital PPG signals; and estimating the uraemia concentration in the blood sample based on the PPG signals.
Goldstein discloses further comprising estimating concentration of uremia in the blood sample by: emitting light rays to a blood flow tube arranged between a Near Infrared (NIR) LED source and a photodiode detector, and having the light rays projected from the NMR LED source (See paragraphs [0081] & [0082], Goldstein).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating further comprising estimating concentration of uremia in the blood sample by: emitting light rays to a blood flow tube arranged between a Near Infrared (NIR) LED source and a photodiode detector as in Goldstein in order to employ a type of dialysis therapy “for the removal of solutes from the blood of the patient while safely managing fluid levels” and “the patient is exhibiting signs of uremia, pH imbalance and/or electrolyte imbalance”, (See paragraph [0059] & [0060], Goldstein), while monitoring the kidney, (See paragraph [0081], Goldstein).
Modified Rovatti does not disclose converting digital PPG signals; and estimating the uraemia concentration in the blood sample based on the PPG signals.
Ou Yang discloses converting digital PPG signals; and estimating the uraemia concentration in the blood sample based on the PPG signals, (See paragraph [0005], [0013], & Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating converting digital PPG signals; and estimating the uraemia concentration in the blood sample based on the PPG signals as in Ou Yang so that “the user easily obtains their health condition without having to refer to a normal blood table”, (See paragraph [0032], Ou Yang).
Claim(s) 7 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovatti et al., (“Rovatti”, US 2021/0015990; the earlier publication and filing dates of the PCT application are relied upon), in view of Brandl et al., (“Brandl”, US 2011/0208105), in further view of Halperin et al., (“Halperin”, US 2008/0275349).
Regarding Claim 7, modified Rovatti discloses the method as claimed in claim 1 but does not disclose wherein measuring body weight by: acquiring BP and BCG signals by signal acquisition unit; collecting one of continuous or periodic weight using a weight acquisition unit, wherein variation in weight of the subject is calculated between the collected weight with a predefined reference weight; providing the acquired BP signal, BCC signal, and the variation in weigh to a decision and control device for taking one or more actions for providing personalized hemodialysis to the subject.
Halperin discloses wherein measuring body weight by: acquiring BP and BCG signals by signal acquisition unit, (See paragraph [0026], [0456], Halperin); collecting one of continuous or periodic weight using a weight acquisition unit, wherein variation in weight of the subject is calculated between the collected weight with a predefined reference weight, (See paragraph [0726] & [0727], Halperin); providing the acquired BP signal, BCC signal, and the variation in weigh to a decision and control device for taking one or more actions for providing personalized hemodialysis to the subject, (See paragraph [0694], Halperin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating wherein measuring body weight by: acquiring BP and BCG signals by signal acquisition unit; collecting one of continuous or periodic weight using a weight acquisition unit, wherein variation in weight of the subject is calculated between the collected weight with a predefined reference weight; providing the acquired BP signal, BCC signal, and the variation in weigh to a decision and control device for taking one or more actions for providing personalized hemodialysis to the subject as in Halperin so it “identifies changes in vital signs…that indicate that a subject may need dialysis treatment or other intervention”, (See paragraph [0694], Halperin).
Additional Disclosures Included:
Claim 8: The method as claimed in claim 7, wherein the one or more actions comprises generating alarms for either continuation or stop of hemodialysis for the subject, (See paragraph [0041], Brandl and/or paragraph [0676], Halperin).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovatti et al., (“Rovatti”, US 2021/0015990; the earlier publication and filing dates of the PCT application are relied upon), in view of Brandl et al., (“Brandl”, US 2011/0208105), in further view of Roger et al., (“Roger”, US 2008/0195060).
Regarding Claim 10, modified Rovatti discloses the method as claimed in claim 1, but does not disclose wherein computing initial and end point of a plurality of waves of an ECG signal for checking electrolytes imbalance condition and generating one or more control signals for hemodialysis.
Roger discloses wherein computing initial and end point of a plurality of waves of an ECG signal for checking electrolytes imbalance condition, (See paragraph [0128], Roger), and generating one or more control signals for hemodialysis, (See paragraph [0132], Roger).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating wherein computing initial and end point of a plurality of waves of an ECG signal for checking electrolytes imbalance condition and generating one or more control signals for hemodialysis as in Roger because the “electrocardiogram…may show…changes in the electrical activity of the heart caused by an electrolyte imbalance in the body” in which “these parameters may be useful during dialysis”, (See paragraph [0128], Roger), such that it allows for “key cardiovascular parameters to be monitored during dialysis, which may have beneficial effects on the dialysis therapy”, (See paragraph [0132], Roger).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovatti et al., (“Rovatti”, US 2021/0015990; the earlier publication and filing dates of the PCT application are relied upon), in view of Roger et al., (“Roger”, US 2008/0195060), in further view of Ou Yang et al., (“Ou Yang”, US 2009/0149762), in further view of Halperin et al., (“Halperin”, US 2008/0275349), in further view of Szamosfalvi et al., (“Szamosfalvi”, US 2008/0015487).
Regarding Claim 14, Rovatti discloses a hemodialysis apparatus for providing personalized hemodialysis to subject, the hemodialysis apparatus comprises: a dialysing sensing device, (See Abstract and Sensors 50 upstream and downstream of Dialyzer 2, See Figure 2, See paragraph [0130], [0037] & [0042]), comprising: an extracorporeal blood circuitry connected to the subject for drawing blood sample from the subject for haemodialysis and pushing back to the subject, (Blood Withdrawal Line 6/Blood Return Line 7, See Figure 1, See paragraph [0198]); a dialysis fluid circuitry configured for preparing dialysate solution, (Fresh Dialysis Line 19 and Spent Dialysate Line 13, See Figure 1, See paragraph [0200]); a dialyser connected to the dialysis fluid circuitry for receiving the dialysate solution and the blood sample from the extracorporeal blood circuitry, (Dialyzer 2, See Figure 1, See paragraph [0197]); a decision and control device configured for receiving inputs, (Control Unit 10, See paragraph [0199]); and a haemodialysis filtering device for providing personalised haemodialysis to the subject, (Apparatus 1, See Figure 1, See paragraphs [0196]-[0198]).
Rovatti does not disclose a support structure in which the subject is laid down during haemodialysis, an Electrocardiography (ECG) acquisition unit connected to the subject through one or more ECG electrodes for acquiring ECG signals of the subject; a Blood Pressure (BP) and Ballistocardiography (BCG) signal acquisition unit connected to the subject for monitoring the BP of the subject; a Photoplethysmography (PPG) signal acquisition unit connected to a PPG sensor attached to the subject for monitoring urea in blood of the subject; and a weight acquisition unit comprising one or more sensors connected to the subject for monitoring weight of the subject; an optical spectral metabolic estimation device for estimating concentration of one or more metabolic content in the blood sample and dialysate fluid; the decision and control device receiving the inputs from the ECG acquisition unit, the BP and BCG signal acquisition unit, the PPG signal acquisition unit, and the weight acquisition unit to assist in dialysis.
Roger discloses an Electrocardiography (ECG) acquisition unit connected to the subject through one or more ECG electrodes for acquiring ECG signals of the subject, (See paragraph [0128], Roger), the decision and control device receiving the inputs from the ECG acquisition unit, (See paragraph [0132], [0079], Roger).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating an Electrocardiography (ECG) acquisition unit connected to the subject through one or more ECG electrodes for acquiring ECG signals of the subject and the decision and control device receiving the inputs from the ECG acquisition unit as in Roger because the “electrocardiogram…may show…changes in the electrical activity of the heart caused by an electrolyte imbalance in the body” in which “these parameters may be useful during dialysis”, (See paragraph [0128], Roger), such that it allows for “key cardiovascular parameters to be monitored during dialysis, which may have beneficial effects on the dialysis therapy”, (See paragraph [0132], Roger).
Ou Yang discloses a Photoplethysmography (PPG) signal acquisition unit connected to a PPG sensor attached to the subject for monitoring urea in blood of the subject, the decision and control device receiving the inputs from the PPG signal acquisition unit (See paragraph [0005], [0013], [0028], & Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating a Photoplethysmography (PPG) signal acquisition unit connected to a PPG sensor attached to the subject for monitoring urea in blood of the subject, the decision and control device receiving the inputs from the PPG signal acquisition unit as in Ou Yang so that “the user easily obtains their health condition without having to refer to a normal blood table”, (See paragraph [0032], Ou Yang).
Halperin discloses a support structure in which the subject is laid down during haemodialysis, (See Abstract, See paragraph [0140], [0694], Halperin), a Blood Pressure (BP) and Ballistocardiography (BCG) signal acquisition unit connected to the subject for monitoring the BP of the subject, (See paragraph [0026], [0456], Halperin); a weight acquisition unit comprising one or more sensors connected to the subject for monitoring weight of the subject, (See paragraph [0726] & [0727], Halperin); and the decision and control device receiving the inputs from the BP and BCG signal acquisition unit, and the weight acquisition unit to assist in dialysis, (See paragraph [0694], Halperin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating a support structure in which the subject is laid down during haemodialysis, a Blood Pressure (BP) and Ballistocardiography (BCG) signal acquisition unit connected to the subject for monitoring the BP of the subject, a weight acquisition unit comprising one or more sensors connected to the subject for monitoring weight of the subject and the decision and control device receiving the inputs from the BP and BCG signal acquisition unit, and the weight acquisition unit to assist in dialysis as in Halperin so it “identifies changes in vital signs…that indicate that a subject may need dialysis treatment or other intervention”, (See paragraph [0694], Halperin).
Szamosfalvi discloses an optical spectral metabolic estimation device for estimating concentration of one or more metabolic content in the blood sample and dialysate fluid, (See paragraph [0083], [0793], [0794], [0830], [0939], Szamosfalvi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Rovatti by incorporating an optical spectral metabolic estimation device for estimating concentration of one or more metabolic content in the blood sample and dialysate fluid as in Szamosfalvi in order to “allow automated, frequent measurements without the need for a complex sampling apparatus” and “an additional benefit is that specific analytes can also be detected…safely and in a sterile fashion”, (See paragraph [0083], Szamosfalvi).
Conclusion
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779