DETAILED ACTION
The Examiner acknowledges the amendments received 04 November 2025. Claims 1-12 are cancelled; claims 22-24 are entered; claims 13-24 are pending.
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, see “Remarks”, filed 04 November 2025, with respect to the rejection(s) of claim(s) 13-21 under 25 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of DiLorenzo.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Interpretation
The Examiner acknowledges the further structures delineated by the Applicant for the claimed elements in the Response received 04 November 2025.
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: “the stimulation system” in claim 13.
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.
The Examiner draws attention to possible structures, or their functional equivalents, as provided in the Applicant’s Published Application. Par. 0027 outlines the broad structures encompassed by the “stimulation system”, whereas par. 0100 and Figure 5 (plus accompanying par. 0113-0118) delineates specific examples of various embodiments for the “stimulation system”. Therefore, the Examiner considers the “stimulation system” as claimed to correspond to “a pulse generator configured to deliver a first series of electrical signals and a second series of electrical signals to the electrode” and “a non-transitory computer-readable medium configured to store sensor data indicative of one or more non-electrical heart activity properties in response to delivering the first series of electrical signals and the second series of electrical signals to the electrode, and a processor configured to determine a selected magnitude of the first parameter and a selected magnitude of the second parameter based at least partially on the sensor data.” (par. 0027). Further structures that, for the purposes of prior art rejections, could encompass the “stimulation system” as claimed include “an input/output connector” (par. 0113), “microprocessor”, “pulse control output generator” (par. 0114), “storage device” (par. 0115) etc.
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 13-24 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. Claim 13 recites the limitation "the stimulation system" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that the amendments received 04 November 2025 are insufficient to overcome this rejection.
Claim Rejections - 35 USC § 103
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 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 13-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ternes et al (U.S. 2008/0147140) in view of DiLorenzo (U.S. 7,403,820). Ternes discloses (par. 0058-0059) delivering a first series of electrical signals to an electrode (par. 0057), the first series (Figures 12-13; par. 0055; 1208, 1308) comprising a first plurality of electrical signals (“’normal’ VNM therapies” and “’normal brady therapies”), each of the first plurality of electrical signals comprising a plurality of parameters, each of the first plurality of electrical signals of the first series differing from one another by a magnitude of a first parameter of the plurality of parameters; selecting a magnitude of the first parameter; after delivering the first series of electrical signals to the electrode, delivering, via the stimulation system (Figure 16), a second series (1211A-B, 1212, 1213, 1311A-B, 1312, 1313) of electrical signals to the electrode, the second series comprising a second plurality of electrical signals (“non-sustained atrial VNM therapies”, “non-sustained atrial brady therapies”, etc.), each of the second plurality of electrical signals comprising the plurality of parameters, each of the second plurality of electrical signals of the second series differing from one another by a magnitude of a second parameter of the plurality of parameters, the second parameter different than the first parameter (e.g. “A simple burst pattern with one burst duration and burst interval can continue periodically for a programmed period or can follow a more complicated schedule. The programmed pattern of bursts can be more complicated, composed of multiple burst durations and burst interval sequences.”); selecting a magnitude of the second parameter; and determining a therapeutic neuromodulation signal to be delivered, the therapeutic neuromodulation signal including the selected magnitude of the first parameter and the selected magnitude of the second parameter (par. 0060). Ternes also discloses sensing heart rate (par. 0057 and 0076) in closed loop mode for parameter selection.
Ternes discloses the claimed invention except for a hierarchical selection of stimulation parameters. DiLorenzo, however, discloses (col. 4, line 51-col. 5, line 4) a method of weighting parameter values in order to converge automatically upon an optimal treatment. Ternes and DiLorenzo both disclose systems for selecting stimulation parameters for neurostimulation based on detected conditions. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ternes’ heart activity sensing system with DiLorenzo’s order of parameter selection in order to “[expedite] achievement of satisfactory treatment of the patient, reducing the time and number of interactions, typically in physician visits, endured by the patient.”
Regarding claim 14, Ternes discloses (par. 0058-0060) the first parameter comprises one of current, frequency, or duty cycle, and wherein the second parameter comprises a different one of current, frequency, or duty cycle.
Regarding claim 15, Ternes discloses (par. 0058-0060) the first parameter is one of the following: a polarity, a pulsing mode, a pulse width, an amplitude, a frequency, a phase, a voltage, a current, a duration, an inter-pulse interval, a duty cycle, a dwell time, a sequence, a wavelength, or a waveform, and wherein the second parameter is a different one of the following: a polarity, a pulsing mode, a pulse width, an amplitude, a frequency, a phase, a voltage, a current, a duration, an inter-pulse interval, a duty cycle, a dwell time, a sequence, a wavelength, or a waveform.
Regarding claim 16, Ternes discloses (par. 0071-0072; Figure 17-18) the first sensor data and the second sensor data are received from a sensor positioned in a body cavity.
Regarding claim 17, Ternes discloses (par. 0057) the first sensor data and the second sensor data comprise at least one of a pressure property, an acceleration property, an acoustic property, a temperature, or a blood chemistry property.
Regarding claim 18, Ternes discloses (par. 0071-0072; Figure 17-18) the first and second sensor data is received from a sensor in a body cavity.
Regarding claim 19, Ternes discloses (par. 0071-0072; Figures 17-18) the electrode is positioned in a blood vessel.
Regarding claim 20, Ternes discloses (Figures 13; par. 0055 and 0058-60) after delivering the second series of electrical signals to the electrode, delivering, via the stimulation system, a third series (1316) of electrical signals to the electrode, the third series comprising a third plurality of electrical signals (“post- arrhythmia VNM therapy”, ”post-arrhythmia brady therapy”), each of the third plurality of electrical signals comprising the plurality of parameters, each of the third plurality of electrical signals of the third series differing from one another by a magnitude of a third parameter of the plurality of parameters, the third parameter different than the first parameter and the second parameter; and selecting a magnitude of the third parameter; and wherein the therapeutic neuromodulation signal includes the selected magnitude of the third parameter. DiLorenzo discloses (col. 4, line 51-col. 5, line 4) the hierarchical selection of therapy parameters.
Regarding claim 21, Ternes discloses (par. 0057 and 0071-0072) the first sensor data, the second sensor data, and the third sensor data are received from a sensor positioned in a body cavity, wherein the first sensor data, the second sensor data, and the third sensor data comprise at least one of a pressure property, an acceleration property, an acoustic property, a temperature, or a blood chemistry property, and wherein the electrode is positioned in a blood vessel.
Regarding claim 22, Ternes discloses (par. 0027) the desired heart activity response comprises increased heart contractility.
Regarding claim 23, DiLorenzo discloses (col. 37, lines 12-35) the comparison comprises an iterative method comprising making comparisons until a limit is found at which a difference is negligible.
Regarding claim 24, DiLorenzo discloses (col. 11, line 46-col. 12, line 8) the first parameter comprises current and the second parameter comprises frequency.
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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792