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 Objections
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n).
Claims 11-13, which are dependent upon claim 9, are separated by claim 10 which is not dependent upon claim 9.
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 2 and 12 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 claim 2, it is unclear if the non-invasive means was intended to be positively recited, or if the applicant is simply referring to how the information was obtained.
In claim 12, it is unclear what the phrase, “…to be measured input to the input unit,” is intended to mean, possibly due to grammatically awkward wording.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Limitations pertaining to who uses the device, fail to further limit the structure of the apparatus. Further, it is unclear if the applicant is attempting to positively recite a structural limitation --that the control unit is further configured to process the recited elapsed time when determining the disease risk (e.g., such as disclosed in par. 0106)-- or if the applicant is simply stating that the control unit considers such a time period to be potentially suitable input. The examiner suggests deleting the phrase “to be measured input to the input unit.” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the mentally performable tasks of estimating an intracardiac pressure that is applied to an inside of a heart or blood vessel near the heart on the basis of cardiac function-related information, and calculating an adjusted value of the intracardiac pressure according to variation factor information.
This judicial exception is not integrated into a practical application because there are no improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a); there is no application or use of
a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo; there is no application of the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b); there is no transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and there is no application or use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the particular technological environment of cardiac monitoring, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of the acquisition unit, input unit, and control unit represent insignificant extra-solution activity required in order to gather the data necessary (i.e., the cardiac function-related information and the load information) in order to make and execute the estimation and adjustment calculations. These elements are generic in nature and function in their usual capacity, alone and in combination, to collect information and execute control based on said information.
The use of data acquisition/ input units to collect cardiac information is WURC in cardiac monitoring systems, as is the combination of data acquisition/input units and generic control units. The applicant discloses that that control device may be a general-purpose computer (pars. 0039, 0048), with the measurement/input unit comprising standard equipment (e.g., ECG, sphygmomanometers, phonocardiogram microphones, etc., pars. 0034-0037).
Regarding claim 2, note the comment made above in the rejection under §112. The obtainment of information that is measured by a non-invasive means is considered insignificant data gathering. The applicant discloses that the invention may include either invasive or non-invasive means to collect data (par. 0034), with the invention relying upon, and residing within, the mentally performable abstract idea independent of the data source. Both invasive and non-invasive means to gather cardiac data are WURC in the cardiac monitoring art and are commercially available.
Claims 3-13 contain no new additional elements beyond that already discussed above, with limitations concerning the type of information collected representing insignificant data collection necessary to perform the abstract idea.
Regarding claims 14-20, substantially similar comments made in the rejection of claims 2-13 apply here as well. Specifically regarding the additional element of a non-transitory computer-readable element in claim 20, such a means is insignificant as it merely serves as the storage upon which the abstract idea resides. Such storage is further WURC as discussed by the applicant in par. 0050.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 10, 14-18 and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Westphal et al. (Westphal: Pub. No. 2022/0293906).
Regarding claim 1, Westphal discloses an intracardiac pressure estimation device comprising: an acquisition unit (Fig. 3, element 82 and associated sensor circuitry for detecting physiological data such as EGM/ECG activity, body motion, pressure and the like, par. 0069) configured to obtain cardiac function-related information related to a cardiac function (e.g., left ventricular pressure, pulmonary or arterial pressure); an input unit configured to receive an input of load information indicating a load applied to a body of a person to be measured when the cardiac function-related information is measured (sensed electrical activity, activity, posture, respiration, impedance, etc., pars. 0044, 0047-0050, 0080, 0110, 0145, etc., where sensed physiological information is input to digital signal processing circuitry, DSP and other requisite input processing circuitry on a beat-by-beat basis); and a control unit 80 configured to estimate an intracardiac pressure that is a pressure applied to an inside of a heart or to a blood vessel near the heart on a basis of the cardiac function-related information (various above mentioned cardiac pressures estimated based on input information, Fig. 6C, pars. 0024, 0047, 0050, etc.), obtain variation factor information that is information indicating a variation factor that may affect the intracardiac pressure and includes the load information, and calculate an adjusted value of the intracardiac pressure on a beat-by-beat basis according to the variation factor information (calibration/adjustment, based on variation of estimates based on load information, from measured pressure, pars. 0053, 0105, 0106, 0128).
Regarding claim 2, note at least pars. 0006, 0027, 0052 which pertain to the use of non-invasive data acquisition in implantable or external devices.
Regarding claim 3, see par. 0004.
Regarding claim 4, see par. 0006.
Regarding claim 5, the acquisition of information pertaining to the EGM or ECG, activity, motion, heart sounds, vibration, oxygen saturation, etc., is considered to constitute at least one of biological information of the person to be measured, environmental information, and presence of absence of a daily life activity of the person to be measured and a time elapsed after the activity is performed.
Regarding claim 6 (with related commentary applying to claim 18), the adjusted or calibrated value can be said to depend on at least the magnitude of the load (the first physiological signal representing an intermediate or indirect measurement of pressure data) as, for example, with an increased or decreased detected motion or activity (i.e., represented by an increased or decreased magnitude in the signal level, as with any mechanosensory device such as an accelerometer) because an increase in motion or activity would be inherently reflected in the magnitude of the signal.
Regarding claim 10, Westphal monitors for cardiac maladies and abnormalities that may cause a decline in the patient’s health in order to make therapy determinations which, according to the method, are based on the adjusted value of the intracardiac pressure (par. 0109). A pressure indicative of a condition that may cause a person to be at future risk, is treated.
Related comments to those made above apply to substantially similar claims 14-17.
Regarding claim 20, see element 70, Fig. 3, and par. 0072.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cho ‘057 includes posture information or activity levels along with cardiac motion or vibration in order to facilitate interpretation of hemodynamic data for pressure estimation. Eigler ‘836 discloses a system for noninvasively calibrating implanted pressure sensors using less-invasive airway pressure. Wenzel ‘597 indirectly estimates left arterial pressure and includes calibration to adjust the estimate for increased accuracy. The system may be non-invasive. Gutfinger ‘083 estimates left ventricular pressure non-invasively. An ‘930 estimates systemic diastolic pressure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
July 11, 2026
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