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 07/31/2026 regarding the 35 U.S.C. § 103 rejections have been fully considered and are persuasive.
Applicant’s arguments filed 07/31/2026 regarding the 35 U.S.C. § 101 rejections have been fully considered but are not persuasive.
Applicant argues, “a person cannot mentally control processing circuitry to measure a first impedance or a second impedance. Therefore, the amended claims are not directed to a mental process.”
Examiner respectfully states that the above recited limitation is directed to insignificant extra solution activities. Specifically, the above recited limitation is directed towards pre-solution activity (see MPEP §2106.05(g)) since it’s used to obtain information about the user to provide an output of true anemia.
Further, regarding Applicant’s arguments that the amended claims are not directed to a mental process, Examiner respectfully disagrees.
As demonstrated below (Claim Rejections - 35 USC 101, In re claim 1), claims 1, 11, and 21 indeed discloses limitations directed to mental processes, specifically limitations directed to comparing, analyzing, and organizing information for use in determining a treatment.
Applicant argues, “the claims are directed to specific technological methods, medical device systems, and non-transitory computer-readable media for accurately detecting true anemia in vivo. The claims require controlling an implantable medical device to measure both an intracardiac impedance and an intrathoracic impedance using processing circuitry, calculating relative changes in both impedances compared to baselines, and comparing these relative changes to each other to determine an indication of true anemia based on the intracardiac change being greater than the intrathoracic change.”
Regarding the limitations directed to
“an implantable medical device comprising at least three electrodes,
wherein
at least two of the electrodes are located within a heart of a patient and
at least one of the electrodes is located outside the heart of the patient,
external clinical device”
see Blomqvist et al (US 2009/0118666), which teaches
an implantable medical device [0041] comprising at least three electrodes [0041-0042],
wherein
at least two of the electrodes are located within a heart of a patient [0042] and
at least one of the electrodes is located outside the heart of the patient [0042], and
an external clinical device ([0052]: data may be transmitted to a programmer i.e. external clinical device or a patient; [0057].
Thus, the limitations directed to the implantable medical device comprising three electrodes and an external clinical device are well-understood, routine, and conventional, as evidenced by the reference above.
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.
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.
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.
Applicant argues, “moreover, the outputting of amended claim 1 is to an external clinician device. This is not "so broad as to encompass all application of the [alleged] recited exception." Therefore, the claims integrate any alleged abstract idea into a practical application and are not directed to a judicial exception under Step 2A.”
Examiner respectfully disagrees. Although the outputting is done to an external clinician device, the recited “outputting, by the processing circuitry to an external clinician 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” is interpreted as merely processing information and then outputting 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).
Further, there is nothing in the claims which show how outputting the above recited limitations integrates the judicial exception into a practical application.
Applicant argues, “This specific combination solves the technical problem of in vivo hematocrit measurement inaccuracies caused by fluid overload in a new way, allowing the processing circuitry and the clinician to distinguish true anemia from fluid overload. This goes far beyond merely applying an abstract idea on a generic computer or mere data gathering. As such, claim 1 is directed to statutory subject matter. Independent claims 11 and 21 are similarly directed to statutory subject matter.”
Examiner respectfully states that although the present application discloses an improvement in vivo hematocrit measurement inaccuracies caused by fluid overload in a new way, 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 Office Action has not shown that the subject matter of claims 2-4 and 12-14 are mental processes practically performed in the human mind.”
Examiner respectfully states that, as discussed above, claims 1, 11, and 21 recite mental processes practically performed in the human mind. Further, there is nothing in claims 2-4 and 12-14 which shows how the recited limitations amounts to a particular prophylaxis or integrates the abstract ideas into a practical application.
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 of operating an implantable medical device, a device, and a non-transitory computer-readable media including instructions, respectively. 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:
an implantable medical device comprising at least three electrodes,
wherein at least two of the electrodes are located within a heart of a patient and at least one of the electrodes is located outside the heart of the patient,
processing circuitry…,
controlling, by processing circuitry, the implantable medical device to measure a first impedance associated with the heart of the patient, the first impedance comprising an intracardiac impedance;
controlling, by the processing circuitry, the implantable medical device to measure 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 clinician 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 additionally 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 additionally recites the following additional elements:
Non-transitory computer-readable media including instructions
The following limitations:
“controlling, by processing circuitry, the implantable medical device to measure a first impedance associated with the heart of the patient, the first impedance comprising an intracardiac impedance;
controlling, by the processing circuitry, the implantable medical device to measure 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).
Regarding the limitation, “outputting, by the processing circuitry to an external clinician 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.
Regarding the limitations directed to
“an implantable medical device comprising at least three electrodes,
wherein
at least two of the electrodes are located within a heart of a patient and
at least one of the electrodes is located outside the heart of the patient,
external clinical device”
see Blomqvist et al (US 2009/0118666), which teaches
an implantable medical device [0041] comprising at least three electrodes [0041-0042],
wherein
at least two of the electrodes are located within a heart of a patient [0042] and
at least one of the electrodes is located outside the heart of the patient [0042], and
an external clinical device ([0052]: data may be transmitted to a programmer i.e. external clinical device or a patient; [0057].
Thus, the limitations directed to the implantable medical device comprising three electrodes and an external clinical device are well-understood, routine, and conventional, as evidenced by the reference above.
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).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The closes prior art is 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] of operating an implantable medical device [0017, 0041] comprising at least three electrodes [0422], wherein at least two of the electrodes are located within a heart of a patient [0042] and at least one of the electrodes is located outside the heart of the patient [0042], the method comprising:
controlling, by processing circuitry (fig. 2: combination of 27 and 29; [0043-0044]) of the implantable medical device (20), to measure a first impedance [0025] associated with the heart of the 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);
controlling, by the processing circuitry, the implantable medical device to measure 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 clinical device [0052, 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”
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 limitations, “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”, The prior art does not teach a motivation of obviousness for modifying the disclosed prior art to include the limitations mentioned above. It would not have been obvious to one of ordinary skill in the art to modify the proposed combination, to provide the above recited limitations.
In re claim 11, see in re claim 1 above.
In re claim 21, see in re claim 1 above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
