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 .
Response to Arguments
Applicant's arguments filed April 29, 2026 have been fully considered but they are not persuasive. Amendments to the current set of claims have not significantly changed the scope of the claimed invention, and the previous prior art rejection has been modified to still read upon the claimed invention. A second Non-Final rejection has been made to clarify stances on the merits.
On pages 9-11 of the Remarks section, as indicated by the page number at the bottom of each page, Applicant discusses the previous objections and 112(b) rejections, detailing the amendments made to overcome them. In response, the Examiner has withdrawn almost all of the objections and 112 rejections, except for the ones still listed in this Action.
On pages 11-12, Applicant begins arguments against the previous 103 prior art rejection of independent Claim 1, involving primary reference Rovatti et al., (“Rovatti”, US 2021/0015990), and secondary reference Brandl et al., (“Brandl”, US 2011/0208105). First, Applicant summarizes the claimed invention, arguing that the cited references do not disclose the invention, and then summarizes the disclosure of Rovatti. Then, Applicant argues that Rovatti does not disclose directly obtaining metabolic content concentration in a blood sample or obtaining concentrations of metabolic content at both the inlet and the outlet of a dialysis using first and second sensors as in Claim 1. However, the Examiner notes that Rovatti explicitly discloses two different sensors 50 upstream and downstream of the dialyzer in the blood lines, in which the sensors 50 explicitly measure hemoglobin, (See paragraph [0037] of Rovatti in which paragraph [0040] is a subset of this paragraph and states measuring hemoglobin), and according to the instant Specification in page 1, lines 16-19, and Figure 4A/4B, this is a form of metabolic content. The Examiner finds this remark unpersuasive.
On page 13, Applicant argues that Rovatti does not disclose measuring metabolic content concentrations of the dialysate fluid flowing into and out of the dialyser as in Claim 1. The Examiner notes that the current phrasing in the claim states “a concentration of one or more electrolytes and metabolic content”. The Examiner has interpreted this to mean “one or more” of “electrolytes and metabolic content”. Thus, only one of either electrolytes and metabolic content is required. The Examiner finds this remark unpersuasive for this reason. Furthermore, the Examiner notes that sensor or probe 106 measures the buffer concentration on the dialysate side/line, (See paragraph [0202], Rovatti). The Examiner interprets buffer to read upon metabolic content because the various buffers that can be selected are known to metabolize in the human body, such as bicarbonate, acetate, and lactate. The Examiner finds this argument unpersuasive.
Next, Applicant argues that Rovatti does not teach “to identify variations in the concentration obtained…”. Applicant argues that Rovatti does not measure metabolic content, and that it cannot identify variations of such. Again, the Examiner notes that the current phrasing in the claim states “a concentration of one or more electrolytes and metabolic content”. The Examiner has interpreted this to mean “one or more” of “electrolytes and metabolic content”. Thus, only one of either electrolytes and metabolic content is required. The Examiner finds this remark unpersuasive for this reason. Also, the Examiner notes that sensor or probe 106 measures the buffer concentration on the dialysate side/line, (See paragraph [0202], Rovatti). The Examiner interprets buffer to read upon metabolic content because the various buffers that can be selected are known to metabolize in the human body, such as bicarbonate, acetate, and lactate. The Examiner finds this argument unpersuasive. In addition, any inherent changes in the value of the buffer or of hemoglobin etc. will inherently result in variations in the measurements occurring.
Then, on pages 13-14, Applicant argues that Brandl does not correct the deficiencies of Rovatti, and does not compare blood and dialysate electrolyte and metabolic content concentrations. The Examiner notes that Brandl is not used to disclose the limitations in question. Rather, Brandl discloses a feature of the various “bypass tubes” in combination with Rovatti. As a result, this argument is a piecemeal analysis, and thus unpersuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant concludes that the combination of Rovatti and Brandl does not disclose independent Claim 1 for the reasons already stated. However, the Examiner disagrees for the reasons stated above in this response, finding the remarks unpersuasive.
On page 14, Applicant argues that Rovatti does not disclose the claim features of dependent Claim 2, particularly the second sensor measuring metabolic content in the blood sample. Here, the claim requires metabolic content to be measured, but as stated above, Rovatti does disclose “metabolic content” for the blood side. Rovatti explicitly discloses two different sensors 50 upstream and downstream of the dialyzer in the blood lines, in which the sensors 50 explicitly measure hemoglobin, (See paragraph [0037] of Rovatti in which paragraph [0040] is a subset of this paragraph and states measuring hemoglobin), and according to the instant Specification in page 1, lines 16-19, and Figure 4A/4B, this is a form of metabolic content.
On pages 15-16, Applicant argues against independent Claim 12, which is similar to independent Claim 1. Applicant argues that Rovatti does not “measure metabolic content concentration in the blood at all”. The Examiner disagrees, pointing to the sensors 50 on the blood side which explicitly measure hemoglobin, (See paragraph [0037] of Rovatti in which paragraph [0040] is a subset of this paragraph and states measuring hemoglobin), and according to the instant Specification in page 1, lines 16-19, and Figure 4A/4B, this is a form of metabolic content. The Examiner finds this remark unpersuasive.
Applicant also argues that while Rovatti discloses dialysate conductivity sensors on the dialysate side/line of the unit, these measurements are associated with sodium concentration, concluding that Rovatti does not disclose measuring variations in concentration of electrolytes with a sensor or metabolic content with another sensor. The Examiner finds that sodium is a well-known electrolyte, so measuring the sodium conductivity is a measurement of the electrolytes as claimed. The Examiner also finds that sensor 106 measures the value of the buffer in the dialysate, and notes that buffer is a metabolizable substance in the human body, and thus reads upon metabolic content, (See paragraph [0202], [0203], Rovatti). The Examiner also takes the position that any inherent change in the values measured, results in the measurement and identification of variations in said measurements or values. The Examiner finds these remarks unpersuasive as a result.
On pages 15-16, Applicant argues against Brandl regarding these alleged deficiencies. The Examiner notes that Brandl is not relied upon for these limitations, so these remarks are considered moot.
On page 16, Applicant argues that the combination of Rovatti and Pouchoulin does not disclose dependent Claim 3, and measuring metabolic content in the dialysate. The Examiner finds that Rovatti itself discloses measuring metabolic content in the dialysate such as buffer, (See paragraph [0202], [0203], Rovatti), thus this remark is unpersuasive.
On page 17, Applicant argues that the secondary references used in the prior art rejections of dependent Claims 4, 5 & 13 do not make up for the alleged deficiencies of Rovatti and Brandl. The Examiner finds these remarks moot because of the reasons stated above.
On pages 17-18, Applicant argues that the secondary references used in the prior art rejections of dependent Claims 6 do not explicitly use PPG-based uremia estimation. However, the Examiner notes that the rejection is a combination of different disclosed features from Goldstein and Ou Yang in which Goldstein explicitly discloses estimating or monitoring uremia using the various disclosed measurement techniques, and Ou Yang connects the conversion of using blood pressure to monitor uremia, in which Ou Yang uses PPG to measure blood pressure. The Examiner finds this remark unpersuasive.
On page 18, Applicant argues that the secondary references used in the prior art rejections of dependent Claims 7 & 8 do not make up for the alleged deficiencies of Rovatti and Brandl. Applicant also argues that Halperin does not disclose using BP and BCG acquisitions and body weight measurement with a decision control device that takes one or more actions for providing personalized haemodialysis to a subject. The Examiner notes that paragraph [0694] of Halperin explicitly uses the vitals of a patient to determine whether to provide dialysis to the patient. Furthermore, the Examiner notes that Halperin uses BP and BCG acquisitions to determine the vitals of the patient in paragraphs [0026] & [0456]. Additionally, Halperin uses body weight measurements to determine the heart rate and BCG, (See paragraph [0726] & [0727], Halperin). The Examiner finds these remarks unpersuasive.
On page 19, Applicant argues that the secondary reference used in the prior art rejections of dependent Claim 10 does not make up for the alleged deficiencies of Rovatti and Brandl. Furthermore, Applicant argues that Roger does not disclose computing an 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 as in claim 10. The Examiner notes that measuring the ECG signal inherently has a starting point and an end point over the duration of time it is measured. The Examiner finds this argument unpersuasive.
On pages 19-22, Applicant argues against the previous prior art rejection of independent Claim 14. Applicant argues that Rovatti does not disclose estimating metabolic content in the blood sample or dialysis fluid. The Examiner notes that the claim does not explicitly require sensors on the blood side or dialysis side measuring the metabolic content in the same manner as in Claims 1 & 12. Furthermore, the Examiner points to the remarks above demonstrating how Rovatti discloses measuring metabolic content. This argument is unpersuasive. Applicant also argues that Rovatti does not teach various measurement systems or devices that are claimed. The Examiner notes that these limitations are disclosed in other secondary references so this remark is piecemeal. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Then, Applicant argues that the various secondary references Roger, Ou Yang, Halperin, and Szamosfalvi do not disclose various measurement systems and devices claimed. Again, the Examiner notes that these limitations are disclosed in the other secondary references as listed in the prior art rejection below so this remark is piecemeal. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner notes that Halperin in paragraph [0694] explicitly uses the vitals of a patient to determine whether to provide dialysis to the patient. Additionally, Szamosfalvi does not need to disclose ECG, BP, BCG, PPG and weight acquisition units because these are disclosed in the other references, and they are all directed towards dialysis technologies. This remark also applies toward Roger and Ou Yang. Thus, these remarks as a whole are unpersuasive.
Specification
The abstract of the disclosure is objected to because it contains more than 150 words. 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, not just the application numbers.
Appropriate correction is required.
Claim Objections
Claim 7 is objected to because of the following informalities: the limitation “the collected weight” should be rewritten as “the weight”. 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.
Claim 14 is 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 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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Rovatti et al., (“Rovatti”, US 2021/0015990; the earlier publication and filing dates of the PCT application are relied upon).
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 a concentration of the one or more electrolytes in a 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 a concentration of one or more electrolytes in a dialysate fluid; a fourth sensor configured to measure variations in a concentration of metabolic content in the dialysate fluid, (One of Sensors 107, 109 & 112, and also Sensor 106, See Figure 2, 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 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 variations identified, (See paragraph [0016], [0024], [0040], [0042], [0256]).
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) 1-3, 9 & 11 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 1-3, 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, a concentration of one or more electrolytes and of a 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], [0040] & [0042]); obtaining, by the haemodialysis filtering device, a 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, (One of Sensors 107, 109 & 112, and also Sensor 106, 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 the one or more electrolytes and the 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 sample based on the variations identified, (See paragraphs [0016], [0024], [0202], [0203], [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 the 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, (One of Sensors 50, See Figure 2, See paragraphs [0037]-[0042], Rovatti; hemoglobin concentration changes are metabolic content; and Sensors 630/631, See Figure 6c, See paragraph [0007], [0050]-[0052]; Brandl).
Claim 3: The method as claimed in claim 1, wherein the third sensor measures variations in the concentration of the one or more electrolytes in the 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, (See paragraph [0202], [0203], Rovatti).
Claim 9: The method as claimed in claim 1, wherein the 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 personalised haemodialysis for the subject further comprising identifying adequacy of haemodialysis by: setting a blood fluid rate and a dialysate fluid rate as a predefined proportion to the blood fluid rate, (See paragraph [0120], [0121], Rovatti); obtaining the 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 a ratio between a 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).
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 haemodialysis filtering device, a hemolysis condition of the blood sample flowing through a third blood bypass tube into the dialyser.
Lee discloses further comprising detecting by a fifth sensor configured in the haemodialysis filtering device, a hemolysis condition of the blood sample flowing through a third blood bypass tube into the dialyser, (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 further comprising detecting by a fifth sensor configured in the haemodialysis filtering device, a hemolysis condition of the blood sample flowing through a third blood bypass tube into the dialyser 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 the haemodialysis filtering device as claimed in claim 12, but does not disclose further comprising a fifth sensor configured for detecting a hemolysis condition of the blood sample flowing through a third blood bypass tube into a dialyser.
Lee discloses wherein a fifth sensor configured for detecting a hemolysis condition of the blood sample flowing through a third blood bypass tube into a dialyser, (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 a hemolysis condition of the blood sample flowing through a third blood bypass tube into a dialyser 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 sample 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 the concentration of the 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 the concentration of the 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 sample 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 the concentration of the 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 but does not disclose further comprising estimating concentration of uraemia 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 uraemia 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 uraemia 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 further comprising measuring body weight by: acquiring BP and BCG signals by a 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 that is collected with a predefined reference weight; providing the BP signal, and BCC signal that is acquired, and the variation in weigh to a decision and control device for taking one or more actions for providing personalised haemodialysis to the subject.
Halperin discloses further comprising measuring body weight by: acquiring BP and BCG signals by a 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 that is collected with a predefined reference weight, (See paragraph [0726] & [0727], Halperin); providing the BP signal, and BCC signal that is acquired, and the variation in weigh to a decision and control device for taking one or more actions for providing personalised haemodialysis 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 further comprising measuring body weight by: acquiring BP and BCG signals by a 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 that is collected with a predefined reference weight; providing the BP signal, and BCC signal that is acquired, and the variation in weigh to a decision and control device for taking one or more actions for providing personalised haemodialysis 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 haemodialysis 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 further comprising computing an initial and an end point of a plurality of waves of an ECG signal for checking electrolytes imbalance condition and generating one or more control signals for haemodialysis.
Roger discloses wherein computing an initial and an 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 haemodialysis, (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 an initial and an end point of a plurality of waves of an ECG signal for checking electrolytes imbalance condition and generating one or more control signals for haemodialysis 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 haemodialysis apparatus for providing personalised haemodialysis to subject, the haemodialysis 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 a 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 a 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
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