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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/20/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 03/05/2026 have been fully considered but are not persuasive or are moot in view to a new grounds of rejection.
Applicant argues, “…there may be a need to, relatively quickly, distinguish between true anemia and fluid overload in patients and provide an indication of which condition a patient may be suffering from, thereby facilitating the administration by a clinician of the appropriate treatment for the condition of the patient. A device capable of detecting anemia, and differentiating true anemia from fluid overload, may improve patient management by enabling earlier detection and treatment of the underlying cause of the anemia. Thus, the "outputting, by the processing circuitry to an external device and for use by a clinician in determining a treatment for the patient, an indication of the measure of hematocrit, and the indication true anemia" is a practical application as it facilitates a clinician differentiating between true anemia and fluid overload, detecting true anemia earlier than otherwise, and administering the proper treatment for true anemia.”
Examiner respectfully disagrees. The recited, “outputting, by the processing circuitry to an external device and for use by a clinician in determining a treatment for the patient, an indication of the measure of hematocrit, and the indication of fluid overload or the indication true anemia” is directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process information and then output the results of the above identified abstract ideas. Additionally, the recited outputting is neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception. In other words, the breadth of the recited “outputting” is such that it substantially encompasses all applications of the recited exception (such as moving information around).
Additionally, regarding the limitation, “for use by a clinician in determining a treatment for the patient”, Examiner respectfully asserts that under broadest reasonable interpretation, the recited limitation does not require that treatment is provided to a patient after it is determined. Therefore, the recited clinician determining a treatment for a patient is interpreted as a mental process, specifically a clinician reading an output and making a determination for treatment, without requiring the clinician to actually provide the treatment.
There is nothing in the claims which shows how the recited limitations amounts to a particular prophylaxis or integrates the abstract ideas into a practical application.
Applicant argues, “Moreover, the subject matter of amended claim 1 is an improvement to a computer or other technology as detailed in Applicant's specification. For example, paragraph [0005] of Applicant's specification as filed states, "Hematocrit is a relatively important parameter for managing patients with heart failure and other chronic diseases. …"In some examples, external device 21 may receive from PCD 110 an indication of a measurement of hematocrit, an indication of true anemia, or an indication of fluid overload, which a clinician may use to guide treatment of patient 114."…. "As discussed above, true anemia and fluid overload require different treatments. For example, treatment for true anemia may depend on pathophysiology, for example, intravenous administration of iron in the case of iron deficiency. Treatment for fluid overload may include, for example, the administration of diuretics to the patient. Therefore, it may be desirable to be able to distinguish or discriminate between true anemia and fluid overload and to output an indication of which condition patient 114 may have in order to guide a clinician in administering the appropriate treatment."
Examiner respectfully states that although the present application discloses an improvement to measuring hematocrit and true anemia to require different treatments, there is still nothing in the claims which shows how the recited limitations amounts to a particular prophylaxis or integrates the abstract ideas into a practical application
Applicant argues, “the Table 2 of Lefkov in paragraph [0018] reproduced below clearly shows that the diagnoses of increased or decreased thoracic fluid do not rely on or result from any change in intracardiac impedance, even though a change intracardiac impedance is shown in Table 2. Instead, they are based entirely on changes in intrathoracic impedance. Note that the first four rows involve only a change in intrathoracic impedance, while the last three rows involve only a change in intracardiac impedance.”
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).
Examiner respectfully states that Lefkov is used to teach the following limitations:
the second impedance comprising an intrathoracic impedance;
determining, by the processing circuitry, a relative change in intracardiac impedance compared to a baseline intracardiac impedance;
determining, by the processing circuitry, a relative change in intrathoracic impedance compared to a baseline intrathoracic impedance.
Specifically, Examiner respectfully asserts that Lefkov is not used to teach “diagnoses of increased or decreased thoracic fluid do not rely on or result from any change in intracardiac impedance”.
Applicant argues, “There is not a specific mention of any comparison in paragraph [0012] of any impedance. While paragraph [0028] of Skrabal may suggest that a change in impedance in limbs, arms, or legs together with "the impedance change on the thorax" may provide an evaluation of the power of the heartbeat, this has nothing to do with an intracardiac impedance (the first impedance), a relative change in the intracardiac impedance, a comparison of the relative change in the intracardiac impedance to the relative change in the intrathoracic impedance, or even the output of an indication of true anemia.”
Examiner respectfully disagrees. Skrabal [0012] teaches using an impedance curve remote from the heart in addition to an impedance curve on the thorax to estimate biochemical parameters. Under broadest reasonable interpretation, the recited “comparison” requires an evaluation of both and at least an indirect comparison where both are evaluated against one another to estimate the biochemical parameters.
Additionally, Skrabal [0045] teaches that changes in comparison to previous findings can be recorded and identified [0045], therefore a comparison of the data must be made at some point.
Skrabal further teaches that impedance change with heartbeat is used together with the impedance change on the thorax [0028-0029], and that the impedance measurement must be done to where a differentiation between the volume change with the heartbeat at the thorax and in the limbs is possible [0032].
Applicant argues, “Moreover, one skilled in the art would simply not arrive at the subject matter of claim 1 at the priority date of the current application when consulting the cited references…the subject matter of claim 1 does not relate to obtaining information about activity of the heart… One of ordinary skill in the art viewing Lefkov, would view the use of the change in intracardiac impedance to determine fluid overload or true anemia as unnecessary and wasteful of processing power.”
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Blomqvist teaches a desire to obtain heart activity relating to impedance measurement (Blomqvist: [0024]) as well as information regarding fluid volume (Blomqvist: [0008]) so that different conditions can be monitored or detected (Blomqvist: [0008]), and Skrabal teaches that measuring impedance from two different measuring distances is used to obtain information about activity of the heart (Skrabal: [0010, 0012]), and that measuring impedance from two locations provides an excellent parameter for fluid overload (Skrabal: [0012]).
Further, Blomqvist teaches that patient suffering from congestive heart failure (CHF) often have pulmonary edema [0007], which is caused by an accumulation of fluid [0007], and that pulmonary edema is an effective indicator of CHF [0007].
Lefkov teaches an impedance waveform being broken into components of intrathoracic impedance and intracardiac impedance [0128], and that thoracic impedance can be used to detect progression of pulmonary edema [0072, 0122-0123] by detecting a change in thoracic fluid [0018, 0106-0107, 0138]. Lefkov further teaches that calibration can occur by using a reference impedance [0137] and that heart rate signal from the intracardiac impedance can be used to evaluate impedance values [0016, 0073].
Thus, someone of ordinary skill in the art at the time the instant invention was filed would modify the determining taught by Blomqvist with the teachings of Skrabal and Lefkov, so they could obtain more information used for detecting or monitoring various conditions, as taught above.
Applicant argues, “the remote impedance of Skrabal is remote from the heart (a limb, an arm, a leg), and therefore certainly not an intracardiac impedance.”
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).
Examiner respectfully asserts that although Skrabal does not teach an intracardiac impedance, Skrabal does teach comprising a first impedance comprising a remote impedance ([0012]: impedance from libs remote to heart), and a second impedance comprising an intrathoracic impedance ([0012]: impedance from thorax).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-15, and 17-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Claims 1, 11, and 21 are directed to a method, a device, and a non-transitory computer-readable media including instructions. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claim 1 recites the following claim limitations:
“determining, by the processing circuitry and based on the first impedance and the second impedance, a measure of hematocrit;
determining, by the processing circuitry, a relative change in the intracardiac impedance compared to a baseline intracardiac impedance;
determining, by the processing circuitry, a relative change in intrathoracic impedance compared to a baseline intrathoracic impedance; and
comparing, by the processing circuitry, the relative change in the intracardiac impedance to the relative change in the intrathoracic impedance;
determining, by the processing circuitry and based on the relative change in intracardiac impedance being greater than the relative change in the intrathoracic impedance, an indication of true anemia
…a clinician in determining a treatment for the patient”,
which are directed to mental processes, since a person can read the first and second impedance values to analyze and organize information to determine a measure of hematocrit, as well as changes which are used to detect true anemia, which are then used to determine a treatment.
In re claim 11 and 21, see in re claim 1 above.
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind, i.e., using pen and paper (i.e. mental processes).
Step 2A, Prong 2:
Claim 1 recites the following additional elements:
processing circuitry…,
determining, by processing circuitry of a device, a first impedance associated with a heart of a patient, the first impedance comprising an intracardiac impedance;
determining, by the processing circuitry, a second impedance associated with the heart of the patient, the second impedance comprising an intrathoracic impedance;
outputting, by the processing circuitry to an external device and for use by a clinician in determining a treatment for the patient, an indication of the measure of hematocrit, and the indication of true anemia
Claim 11 recites the following additional elements:
a memory configured to store a first impedance and a second impedance
processing circuity communicatively coupled to the memory
Claim 21 recites the following additional elements:
Non-transitory computer-readable media including instructions
The following limitations:
“determining, by processing circuitry of a device, a first impedance associated with a heart of a patient, the first impedance comprising an intracardiac impedance” and
determining, by the processing circuitry, a second impedance associated with the heart of the patient, the second impedance comprising an intrathoracic impedance”
are interpreted as insignificant extra solution activities. Specifically, the above recited limitations are directed towards pre-solution activity (see MPEP §2106.05(g)) since they’re used to obtain information about the user to provide an output (i.e. mere data gathering).
Additionally, there is nothing in the claims which show how outputting the above recited limitations integrates the judicial exception into a practical application.
Regarding the limitation, “outputting, by the processing circuitry to an external device and for use by a clinician in determining a treatment for the patient, an indication of the measure of hematocrit, and the indication of true anemia”, Examiner respectfully asserts that these limitations are directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process information and then output the results of the above identified abstract ideas. Additionally, the recited outputting is neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception. In other words, the breadth of the recited “output” is such that it substantially encompasses all applications of the recited exception (such as moving information around).
Additionally, regarding the limitation, “for use by a clinician in determining a treatment for the patient”, Examiner respectfully asserts that under broadest reasonable interpretation, the recited limitation does not require that treatment is provided to a patient after it is determined.
There is nothing in the claims which show how outputting the above recited limitations integrates the judicial exception into a practical application.
34. Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or a technological solution to a technological problem.
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer.
Further, the limitations:
processing circuitry
memory
non-transitory computer-readable media including instructions
are directed toward generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field.
Accordingly, the combination of these additional elements is no more than insignificant extra solution activity. Thus, the abstract ideas are not integrated into a practical application.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed with respect to Step 2A, Prong 2 above, the additional elements in the claim amount to no more than insignificant extra solution activity and applying the exception in a general way, as well as establishing an environment for which data is gathered.
Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
Thus, none of the claims 1-5, 7-15, and 17-23 amount to significantly more than the abstract idea itself. Accordingly, claims 1-5, 7-15, and 17-23 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al., MPEP §2106.04(a)(2), MPEP §2106.04(d)(2),and MPEP §2106.05(g).
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 5,7-9, 10-12, 15, 17-19, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Blomqvist et al. (US 2009/0118666) in view of Lefkov et al. (US 2008/0300504) in view of Skrabal (US 2015/0374256) in view of Zhang et al. (US 2010/0249865).
In re claim 1, Blomqvist discloses a method [0002] comprising:
determining, by processing circuitry (fig. 2: combination of 27 and 29; [0043-0044]) of a device (20), a first impedance [0025] associated with a heart of a patient ([0042]: impedance circuit 29 is positioned within a heart of a patient),
the first impedance comprising an intracardiac impedance ([0041-0042]: impedance measurements may be between a tip and ring of an atrial lead or ventricular lead i.e. between electrodes in electrodes in a ventricle or atrium);
determining, by the processing circuitry, a second impedance [0025] associated with the heart of the patient [0042];
determining, by the processing circuitry and based on the first impedance and the second impedance, a measure of hematocrit ([0025]: first and second impedance measurement session determine a phase shift which calculates amount of hematocrit);
determining, by the processing circuitry an indication of fluid overload an indication of fluid overload ([0008]: impedance is used to determine intracellular fluid volume which would provide an indication of fluid overload); and
outputting, by the processing circuitry [0043, 0025] to an external device [0057] and for use by a clinician in determining a treatment for the patient [0057], an indication of
the measure of hematocrit ([0025]: first and second impedance measurement session determine a phase shift which calculates amount of hematocrit are outputted; [0057]: hematocrit used to check patient condition and determine if change is needed), and
the indication of fluid overload ([0007-0008]: determining intracellular fluid volume is an output that must be analyzed to monitor different conditions).
Blomqvist fails to disclose
the second impedance comprising an intrathoracic impedance;
determining, by the processing circuitry, a relative change in the intracardiac impedance compared to a baseline intracardiac impedance;
determining, by the processing circuitry, a relative change in the intrathoracic impedance compared to a baseline intrathoracic impedance; and
comparing, by the processing circuitry, the relative change in the intracardiac impedance to the relative change in intrathoracic impedance;
determining, by the processing circuitry and based on the relative change in the intracardiac impedance being greater than the relative change in the intrathoracic impedance, an indication of true anemia; and
outputting, by the processing circuitry to an external device and for use by a clinician in determining a treatment for the patient, an indication of the measure of hematocrit, and the indication true anemia.
Lefkov teaches an implantable medical device (fig. 1: 10) that measures impedance [0006-0007], and teaches
wherein
first impedance [0007] comprises an intracardiac impedance ([0007]: intracardiac impedance is between left and right ventricles; [0010]: intracardiac impedance is between electrodes in a ventricle; [0048]),
second impedance [0007] comprises an intrathoracic impedance ([0007]: intrathoracic impedance is measured between an implantable medical device case and an intracardiac electrode i.e. either a left or a right ventricular electrode; [0047]: implantable medical device has a case that serves as a large surface electrode; [0048]), and
an output comprises an indication of fluid overload ([0018]: detects increase or decrease of thoracic fluid which would provide an indication of fluid overload of the thoracic fluid was too high; [0023-0027]) or an indication of true anemia, further comprising:
determining, by processing circuitry [0007, 0021], a relative change in intracardiac impedance compared to a baseline intracardiac impedance ([0072]: in all cases, an earlier reference value is compared to a recent value, which includes intracardiac impedance);
determining, by the processing circuitry, a relative change in intrathoracic impedance compared to a baseline intrathoracic impedance ([0072]: in all cases, an earlier reference value is compared to a recent value, which includes intrathoracic impedance).
Lefkov further teaches an impedance waveform being broken into components of intrathoracic impedance and intracardiac impedance [0128], and that thoracic impedance can be used to detect progression of pulmonary edema [0072, 0122-0123] by detecting a change in thoracic fluid [0018, 0106-0107, 0138]. Lefkov further teaches that calibration can occur by using a reference impedance [0137] and that heart rate signal from the intracardiac impedance can be used to evaluate impedance values [0016, 0073].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the determining taught by Blomqvist, to provide the second impedance comprising an intrathoracic impedance; determining, by the processing circuitry, a relative change in intracardiac impedance compared to a baseline intracardiac impedance; determining, by the processing circuitry, a relative change in intrathoracic impedance compared to a baseline intrathoracic impedance, as taught by Lefkov, because the thoracic impedance can be used to detect progression of pulmonary edema by detecting a change in thoracic fluid, heart rate signal from the intracardiac impedance can be used to evaluate impedance values, and because calibration can be done with a reference impedance.
Regarding the limitations,
“comparing, by the processing circuitry, the relative change in intracardiac impedance to the relative change in intrathoracic impedance,
determining, by the processing circuitry and based on the relative change in the intracardiac impedance being greater than the relative change in the intrathoracic impedance”
Skrabal teaches an analogous method of analyzing impedance of a body [0003], and teaches
wherein
first impedance comprises a remote impedance ([0012]: impedance from libs remote to heart),
second impedance comprises an intrathoracic impedance ([0012]: impedance from thorax), and
an output comprises an indication of fluid overload [0012],
further comprising:
determining, by processing circuitry ([0012]: portion of ECG device which measured impedance from the heart and impedance on the thorax), a relative change in remote impedance compared to a baseline remote impedance ([0045]: impedance can be measured overtime to detect a change therefore baseline remote impedance is the previous remote impedance measured; [0029]: impedance change with heartbeat);
determining, by the processing circuitry, a relative change in intrathoracic impedance compared to a baseline intrathoracic impedance ([0045]: impedance can be measured overtime to detect a change therefore baseline intrathoracic impedance is the previous intrathoracic impedance measured; [0029]: impedance change with heartbeat on the thorax); and
comparing, by the processing circuitry, the relative change in remote impedance to the relative change in remote impedance
([0045]: changes in comparison to previous findings can be identified, which includes changes in remote impedance and intrathoracic impedance; [0012]: remote impedance and intrathoracic impedance are compared; [0028-0029]: impedance change with heartbeat is used together with impedance change on the thorax),
wherein determining the indication of fluid overload [0012] comprises determining the indication of fluid overload based on the comparison [0012].
Skrabal further teaches that measuring impedance from two different measuring distances is used to obtain information about activity of the heart [0010, 0012].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the determining yielded by the proposed combination, to provide comparing, by the processing circuitry, the relative change in intracardiac impedance to the relative change in intrathoracic impedance and determining, by the processing circuitry and based on the relative change in the intracardiac impedance, an indication of fluid overload, as taught by the comparison between the change in remote impedance and the change in intrathoracic impedance of Skrabal, because measuring impedance from two different measuring distances is used to obtain information about activity of the heart.
The proposed combination would be for the device of Blomqvist to provide wherein the first impedance is based on the intracardiac impedance and wherein the second impedance is based on the intrathoracic impedance, as taught by Lefkov, and for the comparison between the change in intracardiac impedance and the change in intrathoracic impedance be used to determine an indication of fluid overload, as taught by the comparison between change in remote impedance and change in intrathoracic impedance in Skrabal.
Regarding the limitation, “determining, by the processing circuitry and based on…the intracardiac impedance…, an indication of true anemia”, Zhang teaches detecting hematocrit [0052] from intracardiac impedance ([0052]: blood impedance detects hematocrit), and teaches wherein the intracardiac impedance is used to detect true anemia ([0052]: blood parameters include blood impedance which detect anemia), which is outputted by a processing circuitry to an external device [0053] for use by a clinician in determining a treatment for the patient ([0052-0053]: patient-external device may be linked to patient-sensors and provide patient information), so that cardiac therapy is adjusted accordingly ([0082]: diagnostics used to adjust cardiac therapy).
Zhang further teaches that thoracic impedance [0061] may be used in combination with intracardiac impedance through a comparison to detect a higher priority alert [0061].
Thus, similar to how the proposed combination yielded in re claim 1 uses comparing the relative change in intracardiac impedance to the relative change in intrathoracic impedance to detect fluid overload, at the time the instant application was filed it would be obvious to try to provide wherein the indication comprises an indication of true anemia, and outputting, by the processing circuitry to an external device and for use by a clinician in determining a treatment for the patient, an indication true anemia, since Zhang teaches that intracardiac impedance is used to detect anemia so treatment is adjusted accordingly, and also because Zhang teaches that thoracic impedance and intracardiac impedance may be used to detect higher priority alerts.
Regarding the limitation, “determining, by the processing circuitry and based on the relative change in the intracardiac impedance being greater than the relative change in the intrathoracic impedance, ”, Examiner respectfully asserts that at the time the instant application was filed it would be obvious to try to provide determining, by the processing circuitry and based on the relative change in the intracardiac impedance being greater than the relative change in the intrathoracic impedance,
In re claim 2, Blomqvist discloses further comprising:
determining, by the processing circuitry, a first complex impedance [0025] based on the first impedance [0025],
wherein the first impedance is determined at a first frequency [0025]; and
determining, by the processing circuitry, a second complex impedance [0025] based on the second impedance [0025],
wherein the second impedance is determined at a second frequency [0025],
wherein determining the measure of hematocrit comprises determining the measure of hematocrit based on
the first complex impedance [0025] and
the second complex impedance [0025].
In re claim 5, the proposed combination yields further comprising: calibrating, by the processing circuitry, the measure of hematocrit ([0017]: present hematocrit is determined i.e. calibrated based on at least one hematocrit value).
In re claim 7, regarding the limitations, “wherein the determining the intracardiac impedance comprises determining the intracardiac impedance between electrodes in a ventricle or atrium”, see the proposed combination yielded in re claim 1 above (as taught by Blomqvist).
In re claim 8, regarding the limitations, “wherein the determining the intrathoracic impedance comprises determining the intrathoracic impedance between
an electrode in
a ventricle or
atrium and
a device housing electrode,”
see the proposed combination yielded in re claim 1 above (as taught by Lefkov).
In re claim 9, regarding the limitation, “wherein the relative change in intracardiac impedance is greater than or equal to the relative change in intrathoracic impedance and wherein the indication comprises an indication of true anemia”, see in re claim 1 above.
In re claim 19, regarding the limitation, “wherein the relative change in intracardiac impedance is greater than or equal to the relative change in intrathoracic impedance and wherein the indication comprises an indication of true anemia”, see in re claim 1 above.
In re claim 10, the proposed combination fails to yield wherein the relative change in intracardiac impedance is less than the relative change in intrathoracic impedance and wherein the indication comprises an indication of fluid overload.
Regarding the above recited limitations, Examiner respectfully asserts that at the time the instant application was filed it would be obvious to try to provide wherein the relative change in intracardiac impedance is less than the relative change in intrathoracic impedance and wherein the indication comprises an indication of fluid overload. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the proposed combination yielded in re claim 1 above yields wherein the relative change can be used to provide an indication, such as an indication of fluid overload, and also since the claimed relative change is not disclosed as being crucial or unexpected.
In re claim 11, Blomqvist discloses a device (fig. 2: 20) comprising:
memory (31) configured to store a first impedance [0025, 0057] and a second impedance [0025, 0057], each associated with a heart of a patient (see in re claim 1 above); and
processing circuity (see in re claim 1 above) communicatively coupled to the memory (fig. 2; [0043]).
Regarding the limitation, “processing circuity communicatively…configured to:
determine a first impedance associated with a heart of a patient, the first impedance comprising an intracardiac impedance;
determine a second impedance associated with the heart of the patient, the second impedance comprising an intrathoracic impedance;
determine, based on the first impedance and the second impedance, a measure of hematocrit;
determine a relative change in the intracardiac impedance compared to a baseline intracardiac impedance;
determine a relative change in the intrathoracic impedance compared to a baseline intrathoracic impedance;
compare the relative change in the intracardiac impedance to the relative change in intrathoracic impedance;
determine, based on the relative change in intracardiac impedance being greater than the relative change in the intrathoracic impedance, an indication of true anemia; and
output, to an external device and for use by a clinician in determining a treatment for the patient, an indication of the measure of hematocrit, and the indication true anemia,”
see in re claim 1 above.
In re claim 12, regarding the limitation, “wherein the processing circuitry is further configured to:
determine a first complex impedance based on the first impedance,
wherein the first impedance is determined at a first frequency; and
determine a second complex impedance based on the second impedance,
wherein the second impedance is determined at a second frequency,
wherein the determination of the measure of hematocrit is based on the first complex impedance and the second complex impedance”,
see in re claim 2 above.
In re claim 15, regarding the limitation, “wherein the processing circuitry is further configured to: calibrate the measure of hematocrit”, see in re claim 5 above.
In re claim 17, regarding the limitation, “wherein the processing circuitry is further configured to determine the intracardiac impedance between electrodes in a ventricle or atrium”, see in re claim 7 above.
In re claim 18, regarding the limitation, “wherein the processing circuitry is further configured to determine the intrathoracic impedance between an electrode in a ventricle or atrium and a device housing electrode”, see in re claim 8 above.
In re claim 20, regarding the limitation, “wherein the relative change in intracardiac impedance is less than the relative change in intrathoracic impedance and wherein the indication comprises an indication of fluid overload”, see in re claim 10 above.
In re claim 21, Blomqvist discloses non-transitory computer-readable media [0019, 0032] including instructions [0019, 0043].
Regarding the limitation, “…instructions, which, when executed, cause processing circuitry of a device to:
determine a first impedance associated with a heart of a patient, the first impedance comprising an intracardiac impedance;
determine a second impedance associated with the heart of the patient, the second impedance comprising an intrathoracic impedance;
determine, based on the first impedance and the second impedance, a measure of hematocrit;
determine a relative change in the intracardiac impedance compared to a baseline intracardiac impedance;
determine a relative change in the intrathoracic impedance compared to a baseline intrathoracic impedance;
compare the relative change in the intracardiac impedance to the relative change in the intrathoracic impedance;
determine, the relative change in the intracardiac impedance being greater than the relative change in the intrathoracic impedance, an indication of true anemia; and
output, to an external device and for use by a clinician in determining a treatment for the patient, an indication of the measure of hematocrit, and the indication true anemia”,
see in re claim 1 above.
In re claim 22, the proposed combination yields (all mapping directed to Blomqvist unless otherwise stated) regarding the limitations, “wherein the intracardiac impedance is a first intracardiac impedance,
the intrathoracic impedance is a first intrathoracic impedance,
the measure of hematocrit is a first measure of hematocrit, and
the treatment is a first treatment”,
see the proposed combination yielded in re claim 1 above.
The proposed combination yields (all mapping directed to Blomqvist unless otherwise stated)
the method comprising:
determining, by the processing circuitry, a third impedance associated with the heart of the patient ([0023]: impedance measurement session is repeated, therefore there would be a third impedance),
the third impedance comprising a second intracardiac impedance [0023, 0041-0042];
determining, by the processing circuitry, a fourth impedance [0023, 0025] associated with the heart of the patient [0023, 0042],
determining, by the processing circuitry and based on the third impedance and the fourth impedance, a second measure of hematocrit ([0025]: first and second impedance measurement session determine a phase shift which calculates amount of hematocrit; [0023]: measurement would be repeated);
outputting, by the processing circuitry to an external device, and for use by a clinician in determining a second treatment for the patient, an indication of the second measure of hematocrit and the indication of fluid overload (see in re claim 1 above, where the output would be repeated for the second measurement session [0023]).
The proposed combination fails to yield
the fourth impedance comprising a second intrathoracic impedance;
determining, by the processing circuitry, a relative change in the second intracardiac impedance compared to the baseline intracardiac impedance;
determining, by the processing circuitry, a relative change in the second intrathoracic impedance compared to the baseline intrathoracic impedance; and
comparing, by the processing circuitry, the relative change in the second intracardiac impedance to the relative change in the second intrathoracic impedance;
determining, by the processing circuitry and based on the relative change in the second intracardiac impedance being less than or equal to the relative change in the second intrathoracic impedance, an indication of fluid overload.
Blomqvist teaches that the impendence measurement session may be repeated at predetermined intervals of time [0023], so a sequence of hematocrit values over time can be obtained [0023] and stored [0023], so a trend can be determined and monitored [0023].
At the time the instant application was filed it would be obvious to try to provide wherein the method yielded in re claim 1 above was repeated a second time to provide wherein the fourth impedance comprising a second intrathoracic impedance; determining, by the processing circuitry, a relative change in the second intracardiac impedance compared to the baseline intracardiac impedance; determining, by the processing circuitry, a relative change in the second intrathoracic impedance compared to the baseline intrathoracic impedance; and comparing, by the processing circuitry, the relative change in the second intracardiac impedance to the relative change in the second intrathoracic impedance; determining, by the processing circuitry and based on the relative change in the second intracardiac impedance being less than or equal to the relative change in the second intrathoracic impedance, an indication of fluid overload, as taught by Blomqvist because the impendence measurement session may be repeated at predetermined intervals of time so a sequence of hematocrit values over time can be obtained and stored to provide a trend that can be determined and monitored.
In re claim 23, regarding the limitations,
“wherein the intracardiac impedance is a first intracardiac impedance,
the intrathoracic impedance is a first intrathoracic impedance,
the measure of hematocrit is a first measure of hematocrit, and
the treatment is a first treatment, and
wherein the processing circuitry is further configured to:
determine a third impedance associated with the heart of the patient,
the third impedance comprising a second intracardiac impedance;
determine a fourth impedance associated with the heart of the patient,
the fourth impedance comprising a second intrathoracic impedance;
determine, based on the third impedance and the fourth impedance, a second measure of hematocrit;
determine a relative change in the second intracardiac impedance compared to the baseline intracardiac impedance;
determine a relative change in the second intrathoracic impedance compared to the baseline intrathoracic impedance;
compare the relative change in the second intracardiac impedance to the relative change in the second intrathoracic impedance;
determine, based on the relative change in the second intracardiac impedance being less than or equal to the relative change in the second intrathoracic impedance an indication of fluid overload; and
output, to an external device and for use by a clinician in determining a second treatment for the patient, an indication of the second measure of hematocrit, and the indication of fluid overload”,
see in re claim 22 above.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Blomqvist et al. (US 2009/0118666) in view of Lefkov et al. (US 2008/0300504) in view of Skrabal (US 2015/0374256) in view of Zhang et al. (US 2010/0249865) in view of Bauer-Espindola et al. (US 2016/0091482).
In re claim 3, Blomqvist discloses further comprising: determining, by the processing circuitry, a phase shift ([0058]: phase shift is dependent on frequency which changes AC current as well as impedance [0025]; [0054]: impedance is based on output voltage and input current) between an input current ([0016]: applied current; [0054]) and an output voltage ([0016]: sensed voltage; [0054]) to calculate
a real resistive ([0064]: impedance vector contains real resistive component of the impedance) and
an imaginary reactance ([0064]: impedance vector contains imaginary reactance component of the impedance).
Blomqvist fails to disclose determining, by the processing circuitry, a phase shift between an input current and an output voltage to calculate
a real admittance and
an imaginary admittance.
Bauer-Espindola teaches a method for detecting an analyte in a body fluid [0002, 0120], and teaches determining, by processing circuitry [0190], a phase shift [0149] between a current ([0147]: application of a current to the impedance; [0149]) and a voltage ([0147]: may comprise a current-voltage measurement and a voltage-current measurement wherein voltage forms answer signal; [0149]) to calculate
a real admittance ([0149]: real part related to admittance) and
an imaginary admittance ([0149]: imaginary part related to admittance).
Bauer-Espindola further teaches using admittance and a phase to determine a hematocrit value [0150], and that the real/imaginary part may be related to admittance [0149].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the determining taught by Blomqvist, to provide determining, by the processing circuitry, a phase shift between an input current and an output voltage to calculate a real admittance and an imaginary admittance, as taught by Bauer-Espindola, because admittance and phase may be used to determine a hematocrit value.
In re claim 13, regarding the limitation, “wherein the processing circuitry is further configured to: determine a phase shift in an input current and an output voltage to calculate a real admittance and an imaginary admittance”, see in re claim 3 above.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Blomqvist et al. (US 2009/0118666) in view of Lefkov et al. (US 2008/0300504) in view of Skrabal (US 2015/0374256) in view of Zhang et al. (US 2010/0249865) in view of Zielinski et al. (US 2010/0030086) [in view of Petisce (US 2013/0197333)].
In re claim 4, Blomqvist fails to disclose further comprising:
determining, by the processing circuitry, blood conductance based on
the first complex impedance and
the second complex impedance,
wherein the determining the measure of hematocrit is further based on the determined blood conductance.
Regarding the limitations, “determining, by the processing circuitry, blood conductance based on
the first complex impedance and
the second complex impedance”,
Zielinski teaches an implantable medical device (fig. 6: 16) for monitoring cardiovascular parameters [0002] and teaches determining, by processing circuitry (80), blood conductance (fig. 14: 352; [0007]: monitors impedance of a blood vessel; [0126]: conductance is a reciprocal of an impedance waveform and “impedance values” may be understood to include conductance values) based on
first ([0062]: first impedance) complex impedance ([0137]: impedance waveform may be complex; [0065, 0135]) and
second ([0062]: second impedance) complex impedance [0065, 0135, 0137].
Zielinski further teaches that impedance values include conductance values [0126] since blood conductance is considered as a reciprocal of blood impedance [0126], and impedance may be complex to correspond to a real component [0137].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the determining taught by Blomqvist, to provide determining, by the processing circuitry, blood conductance based on the first complex impedance and the second complex impedance, as taught by Zielinski, because impedance values include conductance values since blood conductance is considered as a reciprocal of blood impedance, and impedance may be complex to correspond to a real component.
Regarding the limitation, “wherein the determining the measure of hematocrit is further based on the determined blood conductance”, Blomqvist teaches wherein the determining the measure of hematocrit is based on the determined blood impedance (see in re claim 2 above), and Zielinski teaches that conductance is the reciprocal of impedance, therefore, it’s implied that the proposed combination yields “wherein the determining the measure of hematocrit is further based on the determined blood conductance”.
However, even if the proposed combination fails to explicitly teach “wherein the determining the measure of hematocrit is further based on the determined blood conductance”, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the determining of the proposed combination in view of Petisce to provide wherein the determining the measure of hematocrit is further based on the determined blood conductance, as discussed below.
Petisce teaches adjusting analyte concentration based on measured hematocrit level [0001], and teaches wherein determining measure of hematocrit is further based on the determined blood conductance ([0110]: conductivity i.e. reciprocal of impedance is dependent on hematocrit).
Petisce further teaches that conductivity is dependent on hematocrit [0110], and can be used to correct hematocrit in a blood sample [0110].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the determining yielded by the proposed combination, to provide wherein the determining the measure of hematocrit is further based on the determined blood conductance, as taught by Petisce, because conductivity is dependent on hematocrit and can be used to correct hematocrit in a blood sample.
In re claim 14, regarding the limitations,
“wherein the processing circuitry is further configured to: determine blood conductance based on
the first complex impedance and
the second complex impedance,
wherein the determination of the measure of hematocrit is further based on the determined blood conductance”,
see in re claim 4 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Zielinski et al. (US 2009/0275854) discloses measuring intrathoracic and intracardiac impendence [0002] in an implantable medical device [0002].
Contact
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796 /DAVID HAMAOUI/SPE, Art Unit 3796
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