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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “medical device” in claim 8 with specification support in paragraph [0042].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sarkar et al (US Pub 2021/0093220 -cited by applicant) in view of Song et al (US Pub 2020/0030612 -cited by applicant).
Re claims 1, 20: Sarkar discloses a system comprising:
a first implantable medical device (IMD) comprising one or more first sensors, the first IMD configured to receive one or more first signals from the one or more first sensors to determine one or more interstitial fluid index values based at least in part on the received first signals [figure 2; 0040; see sensor electrodes of IMD 10 is configured to measure impedance values within the interstitial fluid of patient; IMD 10 may also use the impedance value measurements to determine one or more fluid index values, impedance scores, and/or various thresholds, such as adaptive thresholds, scoring thresholds, weighting factors for thresholds, and/or cardiac risk thresholds]; and
a second IMD comprising one or more second sensors, the second IMD configured to receive one or more second signals from the second sensors to determine one or more intravascular fluid index values based at least in part on the received second signals [0045,0054,0057, 0062; see sensor electrodes other than the first sensor electrodes which determine fluid index values from one or more of the intra-vascular impedance measurements or subcutaneous impedance measurements and which average together fluid index values based intra-vascular impedance and fluid index values based on subcutaneous impedance]; and
processing circuitry configured to detect a health condition status of a patient based at least in part on the interstitial fluid index values and the intravascular fluid index values (fig 3; see 50 and fig 6; see 119 that determines heart condition status).
Further, Sarkar discloses a method of detecting statuses of health conditions including steps of determining interstitial values, determining intravascular values, and detecting a health condition as cited above.
Sarkar discloses all features including that the health condition is based on the fluid index values and that such is compared to a threshold, but does not disclose that the interstitial values and intravascular values are compared to determine the health condition. However, Song teaches of a system and method to determine fluid status from a cardiac electrical signal and impedance signal, wherein a first IMD is implanted subcutaneously to detect interstitial values, a second IMD is implanted to detect intravascular values, and the impedance and cardiac values are compared [0032, 0046, 0095-0099, 0129, figure 7; see that the implantable devices are disclosed as being used together to generate the corresponding impedance and cardiac signals, wherein the calibration and generation of the resulting fluid metric includes comparison and/or correlation between the impedance and cardiac signals; in particular, a comparison involves a correlation between the values for calibration and also involves a correlation between the values in the generation of the fluid metric as the calibrated cardiac signal is updated/verified with the impedance signal]. It would have been obvious to the skilled artisan to modify Sarkar, to compare interstitial and intravascular values as taught by Song, in order to improve accuracy of health condition status determination.
Re claim 2: Sarkar discloses the first IMD is configured to be inserted subcutaneously, the one or more first sensors include electrodes, and the one or more first signals include a sensed subcutaneous impedance (fig 2, 0040; see the electrodes inserted in the subcutaneous space).
Re claim 3: Sarkar discloses one of the electrodes of the first IMD contacts interstitial fluid (fig 2; 0066; see the electrode in the fluid).
Re claim 4: Sarkar discloses the second sensors include electrodes, and the one or more second signals include one or more of a sensed intracardiac impedance or sensed heart sounds (figure 2; 0040; see the impedance measurements of the electrodes).
Re claim 5: Sarkar discloses the second IMD comprises an intracardiac pacemaker [0060; see the pacemaker].
Re claim 6: Sarkar discloses the health condition status comprises at least one of a heart failure level or a risk level of a heart failure event [0158; see that circuitry determines a heart condition status as a heart failure risk status].
Re claims 7, 20: Sarkar discloses to detect the health condition status of the patient based at least in part on the interstitial fluid index values and the intravascular fluid index values, the processing circuitry is configured to: aggregate the interstitial fluid index values and the intravascular fluid index values over a period of time; determine one or more interstitial fluid levels for the period of time based at least in part on the aggregated interstitial fluid index values; determine one or more intravascular fluid levels for the period of time based at least in part on the aggregated intravascular fluid index values; compare the interstitial fluid levels and the intravascular fluid levels; and detect the health condition status of the patient based at least in part on the comparison [0157, 0158; see the circuitry that compares impedance score to risk thresholds to determine a heart condition status, wherein the scores are aggregated over time].
Re claim 8: Sarkar discloses the system includes an external monitoring device configured to sense one or more physiological signals and determine patient related information based on the physiological signals, wherein processing circuitry is further configured to detect the health condition status based at least in part on the comparison and the patient related information (figure 5; see external device 12, external server 94, and computing devices that sense patient related information).
Re claim 9: Sarkar discloses the circuitry is further configured to receive medical records of the patient and detect the health condition status based at least in part on the comparison and on the received medical records (figure 6; see the comparison to reference values).
Re claim 10: Sarkar discloses the circuitry is located in a computing system external from the patient (figure 5; see the external devices).
Re claim 11: Sarkar discloses the circuitry determines the one or more interstitial fluid index values and the one or more intravascular fluid index values [0045, 0054, 0062; see the circuitry that determines the values].
Re claim 12: Sarkar discloses the computing system comprises at least one of a smartphone or a cloud computing system [0102; see the smartphone].
Re claim 13: Sarkar discloses the processing circuitry is located within one of the first IMD or the second IMD (figure 3; see the circuitry).
Re claim 14: Sarkar discloses the second IMD is configured to perform treatment of the patient in response to the detected health condition status [0043; see the electrodes configured to perform therapy].
Re claims 15, 16: Sarkar discloses the circuity is configured to detect the health condition status of the patient based on application of the interstitial fluid index values and the intravascular fluid index values and additional patient parameters to a machine learning model [0009; see the machine learning models with input of the measured values and other patient parameters].
Re claim 17: Sarkar discloses the patient parameters comprises heart sounds sensed by the second IMD [0098; see the heart sounds].
Re claim 18: Sarkar discloses the first IMD comprises an insertable cardiac monitor comprising a housing configured for subcutaneous implantation in a patient, the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end, a width less than the length, and a depth less than the width, wherein the one or more first sensors comprise a first electrode at or proximate to the first end and a second electrode at or proximate to the second end (figure 2; see the dimensions of the housing that is implanted in a patient).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The specification objections and 112 rejections are withdrawn due to amendments.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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