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
Claim Rejections 35 U.S.C. 101
Applicant’s arguments (AA) filed on 12/12/25 have been fully considered. Without conceding to Applicant’s arguments, the pending rejection under 35 U.S.C. 101 has been reconsidered and withdrawn.
Claim Rejections 35 U.S.C 103
Applicant's arguments (AA) filed 12/12/25 have been fully considered but they are not persuasive for the reasons discussed below.
Applicant argues that it would not be reasonable to modify Gillberg’s electrode-based system with Tais inductive coils. Examiner respectfully disagrees, the sensor of Gillberg and the sensor of Tai are functionally equivalent given that they both non-invasively monitor ventricular function. Examiner asserts that one of ordinary skill in the art looking to design a system to non-invasively monitor ventricular function would turn to either Gillberg or Tai for inspiration, because of their functional equivalence.
Applicant argues that neither Gillberg nor Tai provide any motivation for a person of ordinary skill in the art to replace the electrode-based sensing measurement with an eddy-current measurement. As discussed above, Examiner asserts that one of ordinary skill in the art would turn to either Gillberg or Tai for inspiration because of their functional equivalence. Examiner notes that this motivation (i.e., functional equivalence) is independent of any explicit motivation discussed in either Gillberg or Tai.
Claim Interpretation
While not necessarily unclear, it is conceivable that the following terms could be interpreted in ways other than the manner in which they are interpreted herein. Accordingly, Examiner seeks correction or confirmation of the following claim interpretations.
Regarding the limitation “a controller configured to receive the at least one ventricular state information to adjust the at least one ventricular control parameter of the blood flow assist pump of the ventricular assist device”, Examiner notes that the limitation “to adjust” does not actually require the ventricular assist system to perform an adjustment. Nevertheless, upon reconsideration, Examiner believes Applicant is trying to require that the pump be adjusted based on the “received at least one ventricular state information”. Accordingly, the limitation “a controller configured to receive the at least one ventricular state information to adjust the at least one ventricular control parameter of the blood flow assist pump of the ventricular assist device” will be interpreted as requiring the following: “a controller configured to receive the at least one ventricular state information, and based thereon, adjust the at least one ventricular control parameter of the blood flow assist pump of the ventricular assist device”.
Claim Objections
Claim 6 is rejected to because of the following informalities. Appropriate correction is required.
In re claim 6,
The limitation “wherein prior to the coil performs the eddy current induction measurement”, is grammatically incorrect.
The limitation “and wherein a signal parameter of a first electromagnetic signal for the eddy current induction measurement corresponds to one of the at least one leading electromagnetic signal with an largest response” should read “and wherein a signal parameter of a first electromagnetic signal for the eddy current induction measurement corresponds to one of the at least one leading electromagnetic signal with a largest response”.
Although “largest” is a synonym for “maximum”, Examiner recommends amending the limitation “…to one of the at least one leading electromagnetic signal with an largest response”, to “…to one of the at least one leading electromagnetic signal with a maximum response”, to match the language used in the specification (Applicant’s specification, [0037]).
35 U.S.C. 112(f)
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitations 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 limitations are:
In re claim 9: “depth detection component”
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid 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, 3, 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Gillberg et al. (US 2019/0298903) in view of Tai et al. (US 11,475,987).
In re claim 1, Gillberg discloses a ventricular assistant system (abstract; FIG. 1), comprising:
a ventricular state sensor (FIG. 2: 110; [0046]: “electrode apparatus”) including:
a sensing component (112); and
a control module (140) operatively coupled to the sensing component (FIG. 2),
wherein the control module includes:
a signal generating unit ([0041, 0042]; part of the control module (140) responsible for “implementing one or more exemplary methods and/or processes”) coupled to the sensing component (FIG. 2) and configured to drive the sensing component to perform a measurement on a ventricle of a subject ([0050, 0052]; and
a processor [0041, 0044] coupled to the sensing component (FIG. 2) and configured to derive, at least one ventricular state information ([0037]: “heartbeat”) of the subject through the measurement; and
a ventricular assist device (FIG. 8: 151; [0032]: “LVAD apparatus” 151 includes a “LVAD” 150 and “LVAD controller” 152) operatively coupled to the ventricular state sensor (FIG. 1; coupled via the LVAD controller), wherein the ventricular assist device includes:
a blood flow assist pump (150) ; and
a controller (151) configured to receive the at least one ventricular state information (FIG. 4: 202, 204; [0060]) to adjust at least one ventricular control parameter (CP) of the blood flow assist pump of the ventricular assist device (210; [0064]: “pump speed”).
Gillberg does not disclose:
a coil configured to transmit a first electromagnetic signal and receive a second electromagnetic signal;
a signal generating unit coupled to the coil and configured to drive the coil to transmit the first electromagnetic signal and receive the second electromagnetic signal to perform an eddy current induction measurement on a ventricle of a subject; and
a processor coupled to the coil and configured to derive, in response to receiving the second electromagnetic signal, at least one ventricular state information of the subject through the eddy current induction measurement; and
Tai discloses an analogous ventricular state sensor (FIG. 4: 400) that includes a coil (410) coupled to a control module (405: “processing circuitry”). Tai further discloses using the control model to drive the coil to perform an eddy current induction measurement of a subject’s ventricles (col. 6, lines 18-27; col. 2, lines 3-14). Tai discloses using the induction measurement to derive information regarding the state of the ventricles such as heartbeat (FIG. 8; col. 12, lines 48-49), heart rate (FIG. 9; col. 12, lines 61-67) and ejection fraction (FIG. 11; col. 13, lines 49-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ventricular state sensor of Gillberg to include a coil and associated circuitry configured to drive the coil to transmit a first electromagnetic signal and receive a second electromagnetic signal to perform an eddy current induction, as taught by Tai. One would have been motivated to make this modification because the ventricular state sensor of Tai is functionally equivalent to the ventricular state sensor of Gillberg. Moreover, one of ordinary skill in the art would have the ability to choose the ventricular state sensor (i.e., that of Tai or Gillberg) that would best meet their needs.
In re claim 3, the proposed combination yields (all mapping directed to Tai),
wherein a computer system is configured to calculate the at least one ventricular state information according to a difference between first electromagnetic signal and the second electromagnetic signal (col. 6, lines 24-39; col. 5, lines 61-67).
The proposed combination does not yield
wherein the processor of the control module is configured to calculate the at least one ventricular state information.
As stated above (In re claim 3), Tai discloses a computer system responsible for analyzing measurement data collected by the control module to calculate ventricular state information (col. 5, lines 61-67). Tai further discloses the control module including a microcontroller (440) has both a processor and memory (col. 8, lines 55-56).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the proposed combination, to calculate the ventricular state information using the processor of the control module. One would have been motivated to make this modification because having the control module calculate the ventricular state information would eliminate the need for an external computer system.
In re claim 5, the proposed combination yields (all mapping directed to Gillberg), wherein the at least one ventricular control parameter includes a pumping speed of the blood flow assist pump ([0067]: “LVAD pumping speed”).
In re claim 9, the proposed combination yields (all mapping directed to Tai) wherein the ventricular state sensor further includes:
a depth detection component (col. 11, line 60 - col. 12, line 3: “number of coils”) configured to
output a detection signal (col. 11, line 60 - col. 12, line 3: “magnetic field) to the ventricle of the subject and
provide a depth information corresponding to the ventricle of the subject to the control module (col. 11, line 60 - col. 12, line 3).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gillberg et al. (US 2019/0298903) in view of Tai et al. (US 11,475,987) in view of Yakobson et al. (US 2021/0361965).
In re claim 6, the proposed combination does not yield
wherein prior to the coil performs the eddy current induction measurement, the coil is further configured to output at least one leading electromagnetic signal;
wherein each of the at least one leading electromagnetic signal corresponds to a signal parameter; and
wherein a signal parameter of a first electromagnetic signal for the eddy current induction measurement corresponds to one of the at least one leading electromagnetic signal with an largest response.
Yakobson discloses an electronic patch (FIG. 1: 10) with a coil (5). The current in the coil produces an electromagnetic field (FIG. 3: 17) that extends through a patient’s body to promote healing (abstract). Yakobson further discloses a method of calibrating the patch (before treatment) to ensure the electromagnetic field delivered has the appropriate pulse shape and pulse width to promote healing [0163]. Yakobson discloses the calibration method involving outputting a leading signal (1006: “pulses of known current”) corresponding to a signal parameter ([0163]: “pulse width”). This calibration processes makes it such that electromagnetic signal delivered after calibration will induce the maximum therapeutic response (1012: field having “specified value”). Yakobson further discloses a control module (7) to adjust a passive component ([0154]: “capacitor”), to change the signal parameters of the leading signal ([0154]: pulse generating circuit adjusts the voltage across the capacitor and coil).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the eddy current measurement of the proposed combination, such that before the coil performs the eddy current induction measurement, the coil further outputs at least one leading electromagnetic signal; each of the at least one leading electromagnetic signal corresponds to a signal parameter; a signal parameter of a first electromagnetic signal for the *eddy current induction measurement corresponds to one of the at least one leading electromagnetic signal with an optimal response, as taught by Yakobson. One would have been motivated to make this modification because body composition varies from patient to patient, making it crucial to have a way to identify optimal signal parameters for each patient (Yakobson, [0183]).
*Examiner notes that Yakobson does not disclose an eddy current induction measurement. However as discloses above (In re claim 6), it is apparent that modifying the eddy current induction measurement of the proposed modification with the calibration process taught by Yakobson would yield wherein “a first electromagnetic signal for the eddy current induction measurement corresponds to one of the at least one leading electromagnetic signal…”
In re claim 7,the proposed combination yields (all mapping directed to Yakobson), wherein the control module further includes an adjustable passive component ([0154]: “capacitor”; see modification above (In re claim 6)) coupled to the coil; the processor of the control module is further configured to adjust the impedance of the adjustable passive component to adjust the signal parameter of each of the at least one leading electromagnetic signal ([0171]: “communication link” can be used to adjust parameters of operation including “pulse repetition rate or field amplitude”; As known by one of ordinary skill in the art, adjusting the frequency of pulse across a capacitor changes its impedance).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gillberg et al. (US 2019/0298903) in view of Tai et al. (US 11,475,987) in view of Leijssen et al. (US 2019/0343417).
In re claim 8, the proposed combination does not yield wherein the ventricular state sensor further includes:
an isolation layer
formed by an electromagnetic shielding material, configured to be disposed between the coil and the subject, and
having a gap for allowing a first portion of the first electromagnetic signal directed toward the ventricle of the subject to pass therethrough; and
the isolation layer is configured to block a second portion of the first electromagnetic signal that does not pass the gap.
Leijssen discloses an analogous inductive sensor used to non-invasively investigate properties of the human body [0001]. As disclosed by Leijssen, the inductive sensor includes an electromagnetic shield (FIG. 3: 36; [0159]: “shield”) arranged between a coil (10) and a subject [0159]. Leijssen further discloses the electromagnetic shield containing a gap (40) which allows a first portion ([0159]: “magnetic field component”) of an electromagnetic signal directed toward the subject (FIG. 1) to pass through while blocking a second portion ([0159]: “electric field component”) of the electromagnetic signal [0159].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ventricular state sensor of the proposed combination, to include an isolation layer formed by an electromagnetic shielding material, configured to be disposed between the coil and the subject and having a gap a first portion of the first electromagnetic signal directed toward the ventricle of the subject to pass therethrough; and the isolation layer is configured to block a second portion of the first electromagnetic signal that does not pass the gap, as taught by Leijssen. One would have been motivated to make this modification because adding an isolation layer would improve the signal-to-noise ratio (Leijssen, [0125]).
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 OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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