DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 20-37 are 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.
Regarding Claims 20-22, the use of the term “dry impedance” is not understood in the context of the Claims and Specification. The term “dry impedance” does not appear to have a widely known and accepted definition. While Applicant may act as their own lexicographer, the Specification does not provide a clear and concise definition for the term. As detailed below, the Specification presents several possible meanings for the term. For the purpose of examination, the term will be treated as measuring impedance.
“External device 12 may retrieve the sensor data to perform a risk assessment for patient 4 and/or to determine intra-dialytic fluid volume estimate(s) and/or inter- dialytic fluid volume estimates using impedance data (e.g., measurements) recorded during an inter-dialytic period between dialysis sessions (which may be known as dry impedance and/or wet impedance, respectively).” [0039]
“In general, the dry impedance is a target impedance (e.g., level) that is determined at an end of the dialysis session, for example, when patient 4 has reached their ideal hydration state” [0049]
“The dry impedance may be a measurement (e.g., value (in ohms)) determined from impedance data collected during and/or after the previous dialysis session” [0083]
“In one example, the dry impedance may be representative of a (e.g., target) dry weight“ [0083]
“Alternatively, the dry impedance may be set to a default value for at least an initial dialysis session” [0085]
“an estimated (target) dry impedance 308 may be determined based on impedance data as a more accurate replacement for fluid volume” [0101]
“The estimated dry impedance for any point-in-time may be based on fluid accumulation estimates from previous impedance measurements and possibly, other factors including a day of week and other diagnostic information” [0101]
Regarding Claim 20, the limitation “the impedance data for at least one fluid volume comprises impedance measurements for at least two of an extravascular space, an intravascular space, or an interstitial space” is not understood in the context of the Specification and Claims and is therefore indefinite. The extravascular space is understood to include all fluid compartments outside of the blood vessels and therefore would include interstitial spaces. Furthermore, the means for producing these measurements is not positively recited. As an example, a device measuring impedance with at least two electrodes which is placed on the heart would provide impedance data from an extravascular space and an interstitial space.
Claims 23-37 are rejected based on their dependency.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 20-31, 35, and 37-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20150149096 A1 (Soykan).
Regarding Claim 20, Soykan teaches a medical system (Fig. 12) comprising:
one or more medical devices (1305) configured to collect physiological parameter data of a patient [0281], wherein the physiological parameter data comprises impedance data corresponding to at least one fluid volume in the patient [0295], and the impedance data for at least one fluid volume comprises impedance measurements for at least two of an extravascular space, an intravascular space, or an interstitial space ([0262] describing the use of four electrodes, where impedance data may be collected between any two of said electrodes, and with said device being placed on the heart, it is considered to comprise measurements from an extravascular space and interstitial space); and
processing circuitry (1306) [0281] configured to:
determine a dry impedance for the patient having a dialysis session based on the physiological parameter data [0295]; and
generate output data indicating the dry impedance for presentation to a clinician [0295].
Regarding Claim 21, Soykan further teaches to determine the dry impedance, the processing circuitry is configured to:
determine an estimate of the dry impedance based on impedance data collected at least one of during or after a previous dialysis session [0290]; and
compare the dry impedance to at least one of impedance data collected between the dialysis session and the previous dialysis session or impedance data collected during the dialysis session [0290].
Regarding Claim 22, Soykan further teaches the processing circuitry is configured to generate dialysis parameter data for controlling at least one of the dialysis session or a next dialysis session based on the dry impedance wherein the dry impedance is established as a target for impedance data collected during the dialysis session [0285].
Regarding Claim 23, Soykan further teaches the processing circuitry is configured to:
determine a risk level to the patient from undergoing a dialysis session based on the physiological parameter data [0242] (Fig. 2); and
generate output data indicating the risk level for presentation to the clinician [0242].
Regarding Claim 24, Soykan further teaches the processing circuitry is configured to generate dialysis parameter data for controlling the dialysis session based on the risk level [0285-0286].
Regarding Claim 25, Soykan further teaches the physiological parameter data comprises physiological parameter data collected during the dialysis session, and the dialysis parameter data comprises updated dialysis parameter data [0281].
Regarding Claim 26, Soykan further teaches the dialysis parameter data comprises an amount of the fluid volume to remove in the dialysis session [0295].
Regarding Claim 27, Soykan further teaches the dialysis parameter data comprises at least one of a blood flow rate, fluid removal rate, an ultra-filtration rate, a duration of the dialysis session, or a temperature [0295].
Regarding Claim 28, Soykan further teaches to determine the risk level, the processing circuitry is configured to:
determine a risk level of an adverse effect occurring in the patient from the dialysis session [0094].
Regarding Claim 29, Soykan further teaches to generate the output data, the processing circuitry is configured to:generate the output data based on a determination that the risk level satisfies at least one criterion [0099].
Regarding Claim 30, Soykan further teaches the one or more medical devices are configured to collect impedance data at a first rate during an inter-dialytic period between the dialysis session and a prior dialysis session and a second rate during an intra-dialytic period during the dialysis session ([0090]-[0092] describes adjusting measurement frequency based on the physiological data, wherein adjusting frequency during one period would necessarily cause it to differ from a second period).
Regarding Claim 31, Soykan further teaches the processing circuitry is further configured to:
determine a net filtration rate based on impedance measurements for the interstitial space and impedance measurements for the intravascular space for at least one of an inter-dialytic period between the dialysis session and a prior dialysis session or an intra-dialytic period during the dialysis session ([0295] describing the use of impedance data to adjust filtration rate, with [0307] noting the filtration rate as a measured parameter).
Regarding Claim 35, Soykan further teaches the processing circuitry is further configured to: determine a net filtration rate based on impedance measurements for the interstitial space and the physiological parameter data of another physiological parameter indicative of fluid volume in the intravascular space [0285]-[0286].
Regarding Claim 37, Soykan further teaches the physiological parameter data further comprises electrocardiogram data, tachyarrhythmia data, heart sound data, activity data, and posture data [0172] [0285].
Regarding Claim 38, Soykan teaches a method performed by processing circuitry (1306) [0281] of a medical system having one or more medical devices (1305) configured to collect physiological parameter data of a patient [0281], the method comprising:
determining a risk level [0086] [0216] to the patient from undergoing a dialysis session based on the physiological parameter data [0216], wherein the physiological parameter data comprises impedance data corresponding to at least one fluid volume in the patient [0295], and the impedance data for at least one fluid volume comprises impedance measurements for at least two of an extravascular space, an intravascular space, or an interstitial space ([0262] describing the use of four electrodes, where impedance data may be collected between any two of said electrodes, and with said device being placed on the heart, it is considered to comprise measurements from an extravascular space and interstitial space); and
generating output data indicating the risk level for presentation to a clinician [0216].
Regarding Claim 39, Soykan further teaches:
generating dialysis parameter data for controlling the dialysis session based on at least one of the physiological parameter data or the risk level [0283] [0286].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 32, 33, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soykan in view of US 20210093220 A1 (Sarkar et al.).
Regarding Claims 32 and 33, Soykan fails to explicitly teach the one or more medical devices comprise a first medical device configured to measure impedance for the interstitial space and a second medical device configured to measure impedance for the intravascular space.
Sarkar teaches a medical system wherein the one or more medical devices ((10) and (12)) comprise a first medical device configured to measure impedance for the interstitial space and a second medical device configured to measure impedance for the intravascular space ([0056]-[0057] describing the use of impedance measurements);
Wherein the first medical device comprises an insertable cardiac monitor configured to measure impedance for the interstitial space [0112].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Soykan to incorporate the medical devices measuring impedance in the interstitial space and intravascular space in order to monitor health conditions of the patient [Sarkar 0056].
Regarding Claim 36, Soykan fails to teach the another physiological parameter comprises at least one of an electrocardiogram morphology parameter or a heart sound parameter.
Sarkar teaches the another physiological parameter comprises at least one of an electrocardiogram morphology parameter or a heart sound parameter [0073].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Soykan to incorporate the multiplex switching of Sarkar which allows for the same electrodes to be used for both impedance and ECG measurements [Sarkar 0073].
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soykan evidenced by Medtronic Reveal Specification Sheet.
Soykan further teaches the insertable cardiac monitor (1302) (Figs. 11 and 12) comprises:
a housing (1205) configured for subcutaneous implantation in the patient, a first electrode (1203) at or proximate to the first end (Fig. 11), and a second electrode (1204) at or proximate to the second end (Fig. 11), and wherein the insertable cardiac monitor is configured to measure impedance for the interstitial space via the first electrode and the second electrode [0260].
Soykan teaches use of a device such as the Medtronic Reveal, having a housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end (having a length of 44.8 mm), a width less than the length (7.2 mm), and a depth less than the width (4.0 mm) (Medtronic Reveal Product Specifications).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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/HANS KALIHER/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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