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 .
Status of Claims
Claims 1-19 and 25 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Feb. 11, 2025; Mar. 3, 2025; Oct. 28, 2025; and Nov. 11, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 5 and 12 limitation “wherein the stimulation circuit begins a first stimulation pulse of the stimulation pulse train a third predetermined number of cycles of the clock signal after the beginning of a previous sensing of the signal in response to the start signal” should be changed to --wherein the stimulation circuit begins a first stimulation pulse of the stimulation pulse train at a third predetermined number of cycles of the clock signal after the beginning of a previous sensing of the signal in response to the start signal -- for clarity.
Claims 8 and 25 limitation of “wherein the sensing circuit comprises a first counter to count cycles of the clock signal and begin to sense the signal and reset the first counter in response to the count of the first counter equaling a first predetermined number of cycles of the clock signal” should be changed to --wherein the sensing circuit comprises a first counter to count cycles of the clock signal, and wherein the sensing circuit begins to sense the signal and resets the first counter in response to the count of the first counter equaling a first predetermined number of cycles of the clock signal-- for clarity.
Claims 9 and 25 limitation of “wherein the stimulation circuit comprises a second counter to count cycles of the clock signal and begin a stimulation pulse and reset the second counter in response to the count of the second counter equaling a second predetermined number of cycles of the clock signal” should be changed to --wherein the stimulation circuit comprises a second counter to count cycles of the clock signal, and wherein the stimulation circuit begins a stimulation pulse and resets the second counter in response to the count of the second counter equaling a second predetermined number of cycles of the clock signal-- for clarity.
Claim 13 limitation “wherein the sensing circuit senses a physiologic signal of the patient beginning a fourth predetermined number of cycles after the beginning of a previous stimulation pulse of the stimulation pulse train” should be changed to --wherein the sensing circuit begins to sense for a physiologic signal of the patient at a fourth predetermined number of clock cycles after the beginning of a previous stimulation pulse of the stimulation pulse train-- for clarity.
Claim Interpretation
In all claims, “clock signal” refers to a signal that can generated by a clock with repeating frequency.
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.
Claim limitation(s) is/are: “an event detector to generate…” in claims 5 and 12 and all dependent claims thereof. MPEP2181(I)(A) states “The following are examples of structural terms that have been found not to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6: "circuit," "detent mechanism," "digital detector," "reciprocating member," "connector assembly," "perforation," "sealingly connected joints," and "eyeglass hanger member."” Therefore, “an event detector” does not invoke 112(f) and is being interpreted as a digital detector.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 18 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The following limitation is directed to parts of the claimed device encompassing a human: “wherein the nerve innervates the tongue and soft palate of the patient”. As such, claim 18 would encompass the claimed device to include a human subject. Applicant is suggested to amend the claim to --wherein the stimulation pulse train outputted to a nerve of a patient is configured to innervate the tongue and soft palate of the patient--.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-7, and 11-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolea (US 20140228905 A1, published Aug. 18, 2014, hereinafter referred to as “Bolea”).
Regarding claim 1, Bolea teaches a device (Fig. 63B “INS circuit 1130” ¶[0462] (INS = Implanted Neurostimulator System)) comprising: a clock to generate a clock signal (Fig. 63B “real-time clock” ¶[0462]; and “real-time clock provides the basic time base (32 KHz) for the INS circuit 1130 as well as a clock (year, day, hour, minute, second) which can be used to control the scheduled delivery of therapy” ¶[0463]); a sensing circuit (Fig. 63B “sensing circuits to monitor respiration via the RSLs 1200” ¶[0462] (RSL = respiration sensing lead)) to periodically sense a signal based on the clock signal; and a stimulation circuit (Fig. 63B “controlling the delivery of output stimuli via the STLs 1300” ¶[0462] (STL = stimulation lead)) to output a stimulation pulse train relative to the periodic sensing of the signal based on the clock signal (“One method of stimulating and sensing using the same lead is to interleave a sensing period within the stimulation pulse bursts during the duty cycle. In other words, the sensing period may occur between pulses within the stimulation pulse train. This approach may be used with electrodes/leads that directly stimulate and alternately sense on a nerve involved with inspiration or on a muscle involved with inspiration or a combination of the two.” ¶[0421] therefore, the sensing circuit measures at a periodic time and the pulse train occurs at a periodic time based on the sensing and since the clock can be used to control delivery of therapy, it is also capable of controlling the sensing signal).
Regarding claim 2, Bolea teaches wherein the stimulation pulse train comprises a plurality of stimulation pulses, and wherein an interval between the periodic sensing of the signal and a stimulation pulse of the stimulation pulse train is constant (Fig. 63B “The stimulation output circuits deliver bursts of biphasic stimulation pulses to either STL 1300. These bursts may be synchronized to the sensed respiratory waveform.” ¶[0465]).
Regarding claim 4, Bolea teaches wherein the stimulation pulse train comprises a plurality of stimulation pulses (Fig. 63B “The stimulation output circuits deliver bursts of biphasic stimulation pulses to either STL 1300. These bursts may be synchronized to the sensed respiratory waveform.” ¶[0465]), and wherein the stimulation circuit is to output each stimulation pulse of the plurality of stimulation pulses every second predetermined number of cycles of the clock signal (“real-time clock provides the basic time base (32 KHz) for the INS circuit 1130 as well as a clock (year, day, hour, minute, second) which can be used to control the scheduled delivery of therapy” ¶[0463] therefore, as this is functional language and the stimulation circuit is capable of outputting the stimulation pulses based on the clock signal, it is capable of stimulating at every predetermined number of cycles).
Regarding claims 5 and 12, Bolea teaches a device which is an implanted medical device (Fig. 63B “INS circuit 1130” ¶[0462] (INS = Implanted Neurostimulator System)) comprising: a clock to generate a clock signal (Fig. 63B “real-time clock” ¶[0462]; and “real-time clock provides the basic time base (32 KHz) for the INS circuit 1130 as well as a clock (year, day, hour, minute, second) which can be used to control the scheduled delivery of therapy” ¶[0463]); a sensing circuit (Fig. 63B “sensing circuits to monitor respiration via the RSLs 1200” ¶[0462] (RSL = respiration sensing lead)) to sense a physiological signal of a patient beginning every first predetermined number of cycles of the clock signal; an event detector to generate a start signal in response to detecting a physiologic event of the patient (Fig. 63B “electronic circuitry 1130 contained in the INS 1100 enables…determination of the trigger point for stimulation” ¶[0457]; “The Default Algorithm block represents one or more pre-set trigger algorithms pre-programmed into the INS or physician programmer. The default algorithm used at a specific point in time while delivering therapy may be selected from a library of pre-set algorithms. The selection of the algorithm can be made automatically by the INS based on: patient sleep position (position sensor), heart rate (detectable through the impedance measuring system) or respiration rate. Clinical evidence supports that the algorithm used to predict the onset of inspiration may be dependent on sleep position, sleep state or other detectable conditions of the patient.” ¶[0329]); and a stimulation circuit to output a stimulation pulse train to a nerve of a patient, the stimulation pulse train comprising a plurality of stimulation pulses (Fig. 63B “The stimulation output circuits deliver bursts of biphasic stimulation pulses to either STL 1300. These bursts may be synchronized to the sensed respiratory waveform.” ¶[0465] this is on an implantable nerve stimulator), each stimulation pulse beginning every second predetermined number of cycles of the clock signal, wherein the stimulation circuit begins a first stimulation pulse of the stimulation pulse train at a third predetermined number of cycles of the clock signal after the beginning of a previous sensing of the signal in response to the start signal (“real-time clock provides the basic time base (32 KHz) for the INS circuit 1130 as well as a clock (year, day, hour, minute, second) which can be used to control the scheduled delivery of therapy” ¶[0463] and “During a session, the start of stimulation may be delayed by a programmable delay, subject to patient preference.” ¶[0516] therefore, as this claim limitation is functional language and the stimulation circuit is capable of outputting the stimulation pulses based on the clock signal, it is capable of stimulating at every predetermined number of cycles starting when indicated to start).
Regarding claim 6, Bolea teaches wherein the first predetermined number equals the second predetermined number.
Regarding the limitation of wherein the first predetermined number equals the second predetermined number, this is further limiting functional language and, the recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the device of Bolea contains all of the structural components of the claim, is capable of sensing the signal based on cycles of the clock signal, and is therefore capable of sensing it at a predetermined number of cycles which can be set to equal the second predetermined number; see MPEP 2114(I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2s at 1432.
Regarding claim 7, Bolea teaches wherein the first predetermined number is an integer multiple or an integer divisor of the second predetermined number.
Regarding the limitation of wherein the first predetermined number is an integer multiple or an integer divisor of the second predetermined number, this is further limiting functional language and, the recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the device of Bolea contains all of the structural components of the claim, is capable of sensing the signal based on cycles of the clock signal, and is therefore capable of sensing it at a predetermined number of cycles which can be an integer multiple or an integer divisor of the second predetermined number; see MPEP 2114(I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2s at 1432.
Regarding claim 11, Bolea teaches wherein the sensing circuit continues to sense the signal between stimulation pulse trains (“Nerves innervating muscles that are involved with inspiration, such as the hypoglossal nerve, have been shown to have greater electrical activity during apnea or hypopnea. This signal cannot be easily measured while simultaneously stimulating the same nerve. One method of stimulating and sensing using the same lead is to interleave a sensing period within the stimulation pulse bursts during the duty cycle. In other words, the sensing period may occur between pulses within the stimulation pulse train. This approach may be used with electrodes/leads that directly stimulate and alternately sense on a nerve involved with inspiration or on a muscle involved with inspiration or a combination of the two. The approach may allow sensing of apnea/hypopnea, as well as therapeutic stimulation.” ¶[0421]).
Regarding claim 13, Bolea teaches wherein the sensing circuit senses a physiologic signal of the patient beginning a fourth predetermined number of cycles after the beginning of a previous stimulation pulse of the stimulation pulse train.
Regarding the limitation of the sensing circuit senses a physiologic signal of the patient beginning a fourth predetermined number of cycles after the beginning of a previous stimulation pulse of the stimulation pulse train, the recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the device of Bolea contains all of the structural components of the claim, is capable of sensing the signal based on cycles of the clock signal, and is therefore capable of sensing it at the claimed predetermined number of cycles; see MPEP 2114(I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2s at 1432.
Regarding claim 14, Bolea teaches wherein the third predetermined number of cycles is less than the fourth predetermined number of cycles.
Regarding the limitation of wherein the third predetermined number of cycles is less than the fourth predetermined number of cycles, the recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the device of Bolea contains all of the structural components of the claim, is capable of sensing the signal based on cycles of the clock signal, and is therefore capable of sensing it at the claimed predetermined number of cycles; see MPEP 2114(I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2s at 1432.
Regarding claim 15, Bolea teaches wherein the physiologic event of the patient comprises inspiration or expiration (“Stimulation is generated by an implantable neurostimulator (INS) 1100, synchronized with inspiration as measured by the respiration sensing lead (RSL) 1200 using bio-impedance, and delivered to the hypoglossal nerve by a stimulation lead (STL) 1300.” ¶[0423]).
Regarding claim 16, Bolea teaches wherein the physiologic signal comprises a muscle signal (“The respiration sensing lead 1200 is designed to measure bio-impedance” ¶[0432] and “Changes in impedance are calculated by dividing the change in voltage by the excitation current, which correspond to movement of the diaphragm and lung to produce a signal indicative of respiratory activity.” ¶[0437]).
Regarding claim 17, Bolea teaches wherein each stimulation pulse of the stimulation pulse train comprises a cathodic portion and an anodic portion (“The excitation signal may comprise a 10 Hz biphasic constant current pulse, with the positive and negative phases of each biphasic pulse” ¶[0461]).
Regarding claim 18, Bolea teaches wherein the nerve innervates the tongue and soft palate of the patient (“a nerve electrode may be attached to a specific branch of the hypoglossal nerve innervating the genioglossus muscle” for the tongue ¶[0162] and “activation of the genioglossus serves to apply tension to the styloglossus and the glossopharyngeal aspects of the superior pharyngeal constrictor muscle” ¶[0688]).
Regarding claim 19, Bolea teaches wherein the implantable medical device is configured to treat sleep disordered breathing (“The embodiments described herein relate to devices, systems and associated methods for treating sleep disordered breathing.” ¶[0003]).
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bond et al. (US 20120109259 A1, published May 3, 2012, hereinafter referred to as “Bond”).
Regarding claim 1, Bond teaches a device (Fig. 1 “Therapy system 10A includes an implantable medical device (IMD) 16A, which is coupled to programmer 24” ¶[0031]) comprising: a clock to generate a clock signal (“IMD 16A includes a system clock (not shown in FIG. 1), according to which it performs sensing and therapy delivery” ¶[0033]; “Clock comparator 104 receives the clock signals from system clock 90 and reference clock 92” ¶[0104]); a sensing circuit (“A proximal portion of the lead may be coupled to a medical device housing, which may contain circuitry such as signal generation and/or sensing circuitry” ¶[0003]) to periodically sense a signal based on the clock signal; and a stimulation circuit (“A proximal portion of the lead may be coupled to a medical device housing, which may contain circuitry such as signal generation and/or sensing circuitry” ¶[0003] ; and Fig.’s 8, and 11 “Processor 80 operates IMD 16 in accordance with system clock 90 (124). For example, processor 80 may control the delivery of stimulation therapy to organs or tissue by signal generator 84 and may control the monitoring of electrical activity of the organs or tissue by electrical sensing module 86 according to the clock cycles of system clock 90.” ¶[0123]) to output a stimulation pulse train relative to the periodic sensing of the signal based on the clock signal (“IMD 16A includes a system clock (not shown in FIG. 1), according to which it performs sensing and therapy delivery” ¶[0033]; “IMD 16A provides pacing pulses to heart 12 based on the electrical signals sensed within heart 12” ¶[0031]).
Regarding claim 3, Bond teaches wherein the sensing circuit is to periodically sense the signal every first predetermined number of cycles of the clock signal.
Regarding the limitation of the sensing circuit is to periodically sense the signal every first predetermined number of cycles of the clock signal, the recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the device of Bond contains all of the structural components of the claim, is capable of sensing the signal based on cycles of the clock signal, and is therefore capable of sensing it at a predetermined number of cycles; see MPEP 2114(I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2s at 1432.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Nelson et al. (US 5292342 A, published Mar. 8, 1994, hereinafter referred to as “Nelson”).
Regarding claim 8, Bolea teaches the device of claim 5. Bolea does not disclose wherein the sensing circuit comprises a first counter to count cycles of the clock signal and begin to sense the signal and reset the first counter in response to the count of the first counter equaling the first predetermined number of cycles of the clock signal.
Nelson’s invention, concerned with the common goal of an implantable medical device driven by clocks, describes a blanking circuit. The blanking decode circuit defines a `blanking interval` which follows every sensed or paced cardiac event. During the blanking interval, the output signal O from blanking circuit 28 goes high; this signal is conducted on line 29 to a DISABLE input of sense amplifier 20. The blanking interval is indicated by a logical high level pulse of the signal on line 29. In this way output signals from sense amplifier 20 are prevented from affecting operation of pacemaker 10. In the presently preferred embodiment of the invention, it is believed that a blanking interval on the order of 100-mSec or so is appropriate. In that case, blanking decode circuit 28 would define the blanking interval as lasting for one 10-Hz clock cycle. It is to be understood that a blanking period comprising a greater number of clock cycle counts may be defined, depending upon the desired length of the blanking interval and the actual oscillation rate of circuit 22 (Col. 6, ln. 38-55).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to count cycles of the clock and sense and reset the counter when reaching a set number of cycles as taught by Nelson in the device of Bolea in order to prevent sensing signals from the operation of the stimulator.
Claims 9 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Nelson, as applied to claim 8 above, and further in view of Keller et al. (US 3557796 A, published Jan. 26, 1971, hereinafter referred to as “Keller”).
Regarding claim 9, Bolea and Nelson teach the device of claim 8. Bolea and Nelson do not disclose wherein the stimulation circuit comprises a second counter to count cycles of the clock signal and begin a stimulation pulse and reset the second counter in response to the count of the second counter equaling the second predetermined number of cycles of the clock signal.
Keller’s invention, with the common goal of counting clock cycles, discloses an oscillator driving a binary counter. When the counter reaches a certain count, a signal is provided which causes a cardiac stimulator pulse to be provided. At the same time the counter is reset and again begins counting the oscillator pulses. Additionally, there is disclosed the digital demand concept, in which the counter is reset upon the sensing of a natural heartbeat, and the digital refractory concept, in which the output is inhibited for any certain time after the provision of a cardiac stimulating pulse or the sensing of a natural beat. To provide demand mode operation, the counter is reset in response to spontaneous cardiac signals thereby to prevent stimulation when the heart is functioning normally (Col. 2, ln. 15-18). This type of pacer is often provided with circuitry which simulates the refractory delay period of the heart. The reason for including such delay circuitry is that a spontaneous electrical signal which appears a short time after delivery of an artificial pulse is ineffective to pump blood, either because the natural refractory period of the heart caused the heart to ignore the spontaneous pulse or because the ventricle has not had time following the previous beat to be refilled with blood (Col 1, ln. 33-41).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to count cycles of the clock signal and stimulate the target and reset the counter when the count equals a predetermined number of cycles as taught by Keller in the device of Bolea and Nelson in order to account for an effective time for the stimulation.
Regarding claim 25, Bolea teaches the device of claim 1. Bolea does not teach wherein the sensing circuit comprises a first counter to count cycles of the clock signal and begin to sense the signal and reset the first counter in response to the count of the first counter equaling a first predetermined number of cycles of the clock signal, and wherein the stimulation circuit comprises a second counter to count cycles of the clock signal and begin a stimulation pulse and reset the second counter in response to the count of the second counter equaling a second predetermined number of cycles of the clock signal.
Nelson teaches wherein the sensing circuit comprises a first counter to count cycles of the clock signal and begin to sense the signal and reset the first counter in response to the count of the first counter equaling a first predetermined number of cycles of the clock signal (see claim 8 rejection above).
Bolea and Nelson do not teach wherein the stimulation circuit comprises a second counter to count cycles of the clock signal and begin a stimulation pulse and reset the second counter in response to the count of the second counter equaling a second predetermined number of cycles of the clock signal.
Keller teaches this in claim 9 rejection above.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to count cycles of the clock signal and stimulate the target and reset the counter when the count equals a predetermined number of cycles as taught by Keller in the device of Bolea and Nelson in order to account for an effective time for the stimulation.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea, Nelson, and Keller, as applied to claim 9 above, and further in view of McDonald et al. (US 4275738 A, published Jun. 30, 1981, hereinafter referred to as “McDonald”).
Regarding claim 10, Bolea, Nelson, and Keller teach the device of claim 9. Bolea, Nelson, and Keller do not disclose wherein the count of the first counter is offset with respect to the count of the second counter by the third predetermined number of cycles.
McDonald’s invention, with the common goal of controlling stimulation with two counts and a clock signal, discloses that responsive to the counter reaching a first count for causing a cardiac stimulating pulse to be provided and for resetting the counter means and further responsive to counter means reaching a second count less than the first count at a time after the stimulating pulse is provided for terminating the provision of the stimulating pulse (Col. 3, ln. 33-39). Therefore, the second count is offset from the first count.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to offset the two counters as taught by McDonald in the device of Bolea, Nelson, and Keller in order to provide a time to terminate the action and reset the clock.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Thompson (US 6185454 B1) – discloses counters
Reinke et al. (US 20040059396 A1) – ¶[0074] clock synchronization
Kim et al. (KR 100791634 B1) –A stopwatch for generating a reference clock at a predetermined period and an electric shock unit for outputting an electrical stimulus according to the digital signal and the reference clock
Anderson et al. (US 20210205604 A1) – clock, sensor, and stimulation
Swenson et al. (US 20250256107 A1) – counter and clock
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5:30 and every other F 8-4:30ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.N.C./Patent Examiner, Art Unit 3792
Prosecution Insights