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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06DEC2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The specification recites:
[0040] stimulation electromagnetic signal (EMS1) can be improved. The stimulation emitting coil 121 can also limit the divergence of the stimulation electromagnetic signal (MS1) through a shielding component. For example, a shielding component can be set around the stimulation emitting coil 121 to block the stimulation electromagnetic signal (MS1) and reduce the risk of affecting other circuit components, medical devices, or other stimulation emitting coils 121 (if there are multiple stimulation emitting coils).
The stimulation electromagnetic signal is recited as both (EMS1) and (MS1). The terminology should be consistent throughout the specification.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "110" and "130" have both been used to designate a component in both Figure 4 and Figure 5. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-11 are 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).
Claims 1 & 3 recite “electrode is arranged at a cardiac sensing area of the subject” in lines 14 and 8 respectively. The claims should instead recite “electrode is configured to be arranged at a cardiac sensing area of the subject”. Claims 2 & 4-11 are rejected for depending upon the rejected claims 1 & 3.
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.
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 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:
“Shielding component” in Claim 8:
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. Claim limitation “shielding component”, has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they use a generic placeholder “component” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. A review of the specification shows that the as-filed specification discloses:
[0015] In an embodiment, the sensing module further includes a shielding component at least arranged at a first side of the sensing emitting coil. Wherein the shielding component at least shields a portion of the sensing electromagnetic signal emitted toward to a first direction.
[0040] The stimulation emitting coil 121 can also limit the divergence of the stimulation electromagnetic signal (MS1) through a shielding component. For example, a shielding component can be set around the stimulation emitting coil 121 to block the stimulation electromagnetic signal (MS1) and reduce the risk of affecting other circuit components, medical devices, or other stimulation emitting coils 121 (if there are multiple stimulation emitting coils).
[0051] The divergence of sensing electromagnetic signal (EMS2) emitted by the sensing emitting coil 111 can be limited by a shielding component. For example, the shielding component can be set around the sensing emitting coil 111 to block the sensing electromagnetic signal (EMS2) and reduce the risk of affecting other circuit components, medical devices, or other sensing emitting coils 111 (if there are multiple sensing emitting coils 111).
Which does not seem to disclose any corresponding structures for performing the function of shielding as recited in claim 8 (see the rejection under 35 U.S.C. 112(a) below. For the purpose of examination, the “shielding component” is interpretated as any type of reflective and/or insulative component.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 8:
For the limitation of “shielding component”, the specification provides the following.
[0015] In an embodiment, the sensing module further includes a shielding component at least arranged at a first side of the sensing emitting coil. Wherein the shielding component at least shields a portion of the sensing electromagnetic signal emitted toward to a first direction.
[0040] The stimulation emitting coil 121 can also limit the divergence of the stimulation electromagnetic signal (MS1) through a shielding component. For example, a shielding component can be set around the stimulation emitting coil 121 to block the stimulation electromagnetic signal (MS1) and reduce the risk of affecting other circuit components, medical devices, or other stimulation emitting coils 121 (if there are multiple stimulation emitting coils).
[0051] The divergence of sensing electromagnetic signal (EMS2) emitted by the sensing emitting coil 111 can be limited by a shielding component. For example, the shielding component can be set around the sensing emitting coil 111 to block the sensing electromagnetic signal (EMS2) and reduce the risk of affecting other circuit components, medical devices, or other sensing emitting coils 111 (if there are multiple sensing emitting coils 111).
MPEP 2163(II)(A)(3)(a)(ii)states the following:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
The as-filed specification does not adequately disclose species that would be representative of the entire genus of “shielding component” as claimed since the specification does not even disclose a single species representing the “shielding component.” Since a representative number of adequately described species are not disclosed for the limitation of “shielding component”, as-filed specification lacks adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
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 1-3, 6-7, 9, & 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hastings et al. (US Publication No. 20160175599).
Regarding claim 1, Hastings discloses a cardiac stimulation device (Hastings Title “leadless cardiac stimulation systems), comprising: a sensing module (Hasting Figure 1 Pacing Controller 40 combined with the seed electrodes 20 and transmitter 50) configured to measure at least one cardiac state of a subject (Hastings ¶0054 “Generally, the pacing controller 40 includes circuitry to sense and analyze the heart's electrical activity, and to determine if and when a pacing electrical pulse needs to be delivered and by which of the seeds 20. The sensing capability may be made possible by having sense electrodes included within the physical assembly of the pacing controller 40.”); and a stimulation module (Hastings Figure 1 which depicts a general stimulation module including wireless stimulation components driven by a transceiver 50 and pacing controller 40 where the stimulation module encompasses the seeds 20, transmitter 50, antenna 60, and pacing controller 40) coupled to the sensing module(Hastings ¶0055 “The transmitter 50—which is in communication with, and is controlled by, the pacing controller 40—drives an RF signal onto the antenna 60. In one embodiment, the transmitter 50 provides both 1) a charging signal to charge the electrical charge storage devices contained within the seeds 20 by inductive coupling, and 2) an information signal, such as a pacing trigger signal, that is communicated to a selected one or more of the seeds 20, commanding that seed to deliver its stored charge to the adjacent tissue.” Showing that the components are in communication and where the examiner maintains that the Pacing controller 40 provides both sensing and stimulation capabilities), including: a stimulation emitting coil (Hastings Antenna 60 which provides a wireless stimulation signal to the receiving coils in seed electrodes 20); a stimulation control circuit coupled to the stimulation emitting coil (Hastings Figure 1 Pacing Controller 40; ¶0055 “The transmitter 50—which is in communication with, and is controlled by, the pacing controller 40—drives an RF signal onto the antenna 60. In one embodiment, the transmitter 50 provides both 1) a charging signal to charge the electrical charge storage devices contained within the seeds 20 by inductive coupling, and 2) an information signal, such as a pacing trigger signal, that is communicated to a selected one or more of the seeds 20, commanding that seed to deliver its stored charge to the adjacent tissue.”); wherein the stimulation control circuit is configured to drive the stimulation emitting coil to emit a stimulation electromagnetic signal based on the at least one cardiac state (Hastings ¶0054 “Generally, the pacing controller 40 includes circuitry to sense and analyze the heart's electrical activity, and to determine if and when a pacing electrical pulse needs to be delivered and by which of the seeds 20.”; ¶0055 “The transmitter 50—which is in communication with, and is controlled by, the pacing controller 40—drives an RF signal onto the antenna 60. In one embodiment, the transmitter 50 provides both 1) a charging signal to charge the electrical charge storage devices contained within the seeds 20 by inductive coupling, and 2) an information signal, such as a pacing trigger signal, that is communicated to a selected one or more of the seeds 20, commanding that seed to deliver its stored charge to the adjacent tissue.”); and a stimulation receiver including a stimulation receiving coil (Hastings ¶0053 “In one embodiment, each of the seeds 20 has an internal coil that is inductively coupled with an external power source coil to charge an electrical charge storage device contained within the seed 20, and also has a triggering mechanism to deliver stored electrical charge to adjacent heart tissue.”)and a stimulation electrode (Hastings Figure 1 Seed electrodes 20 as described in ¶0053); wherein the stimulation receiving coil is configured to receive the stimulation electromagnetic signal to generate a stimulation voltage provided to the stimulation electrode (Hastings ¶0053 “In one embodiment, each of the seeds 20 has an internal coil that is inductively coupled with an external power source coil to charge an electrical charge storage device contained within the seed 20, and also has a triggering mechanism to deliver stored electrical charge to adjacent heart tissue.”); wherein the stimulation electrode is arranged at a cardiac stimulation area of the subject (Hastings ¶0053 “The system 10 includes a number of wireless electrode assemblies 20, herein referred to simply as “seeds.” The seeds 20 are implanted within chambers of the heart 30.”); and wherein the stimulation voltage is provided to the cardiac stimulation area through the stimulation electrode (Hastings ¶0053 “FIG. 1 shows a general depiction of such a system 10 and an external programming device 70. The system 10 includes a number of wireless electrode assemblies 20, herein referred to simply as “seeds.” The seeds 20 are implanted within chambers of the heart 30. In this example, there are eight seeds 20, there being one implanted in the left atrium 32, three implanted in the left ventricle 34, one implanted in the right atrium 36, and three implanted in the right ventricle 38. In one embodiment, each of the seeds 20 has an internal coil that is inductively coupled with an external power source coil to charge an electrical charge storage device contained within the seed 20, and also has a triggering mechanism to deliver stored electrical charge to adjacent heart tissue.”).
Regarding claim 2, claim 1 is anticipated by Hastings. Hastings further discloses wherein the sensing module (Hasting Figure 1 Pacing Controller 40) includes: a sensing emitting coil (Hastings Figure 3 Transmit/Receive Circuitry 308); and a sensing control circuit coupled to the sensing emitting coil (Hastings ¶0068 Referring to FIG. 3, control computer 310 ); wherein the sensing control circuit is configured to drive the sensing emitting coil to emit a sensing electromagnetic signal to the subject’s cardiac position, and receive a first inductive signal induced by a feedback electromagnetic signal (Hastings ¶0068 “Referring to FIG. 3, an embodiment of the controller/transmitter 240 and associated loop antenna 260 is shown in block diagram form. Included within the pacing controller 240 is: …ECG sensing electrodes 304 and associated sensing circuitry 306; circuitry 308 for transmitting firing commands to the implanted seeds, transmitting status information to the external programmer, receiving control instructions from the external programmer and receiving power to recharge the battery; and a computer 310 that is programmed to control the overall functioning of the pacing control implant. In alternative embodiments, antenna 260 may receive signals from the individual seeds 220 containing information regarding the local ECG at the site of each seed,”) ; and wherein the sensing control circuit is further configured to determine the at least one cardiac state based on the first inductive signal (Hastings ¶0054 “Generally, the pacing controller 40 includes circuitry to sense and analyze the heart's electrical activity, and to determine if and when a pacing electrical pulse needs to be delivered and by which of the seeds 20. The sensing capability may be made possible by having sense electrodes included within the physical assembly of the pacing controller 40.”).
Regarding claim 3, claims 1 & 2 are anticipated by Hastings. Hastings further discloses wherein the sensing module (Hasting Figure 1 Pacing Controller 40) further includes: a sensing receiving coil (Hastings Figure 3 Transmit/Receive Circuitry 308); and a sensing electrode (Hastings ¶0054 “The sensing capability may be made possible by having sense electrodes included within the physical assembly of the pacing controller 40”; ¶0069 “FIG. 4 is a schematic diagram of an example wireless electrode assembly, or seed, 420, which may serve as the seeds 20 or 220 as shown in either FIG. 1 or FIGS. 2A-B. The seed 420 includes, firstly, a receiver coil 410 that is capable of being inductively coupled to a magnetic field source generating a time-varying magnetic field at the location of coil 410, such as would be generated by the transmitter 50 and the antenna 60 shown in FIG. 1.”); wherein the sensing receiving coil is coupled to the sensing electrode, and configured to receive the sensing electromagnetic signal and generate the feedback electromagnetic signal (Hastings Figure 4 Receiver coil 410 as shown integrated into a wireless electrode schematic; Hastings ¶0068 “ECG sensing electrodes 304 and associated sensing circuitry 306;” where the associated sensing circuitry can be shown in example Figure 4.); wherein the sensing electrode is arranged at a cardiac sensing area of the subject; and wherein the sensing electrode is configured to adjust at least one electrical parameter of the sensing coil for generating the feedback electromagnetic signal based on the at least one cardiac state (Hastings ¶0076 “ The controller/transmitter device 240 may have a pair of sensing electrodes on its surface to detect the subcutaneous electrocardiogram (ECG), or it may contain multiple electrodes to provide a more detailed map of electrical activity from the heart. This local ECG signal sensed by the controller/transmitter device 240 may be used to trigger the onset of seed pacing when the patient has a functioning sinus node. In any case, the signals sensed by the controller/transmitter device 240 are used to monitor ECG signals from the paced heart. In some cases, these ECG signals, or other physiologic sensor input signals, may be used to adjust or adapt the timing of firing of the pacing seeds 220.”).
Regarding claim 6, claim 2 is anticipated by Hastings. Hastings further discloses wherein the sensing control circuit (Hastings ¶0068 Referring to FIG. 3, control computer 310 ) includes a frequency adjustment unit coupled to the sensing emitting coil (XXXX); and wherein frequency adjustment unit is configured to adjust a frequency of the sensing electromagnetic signal (Hasting ¶0076 “ The controller/transmitter device 240 may have a pair of sensing electrodes on its surface to detect the subcutaneous electrocardiogram (ECG), or it may contain multiple electrodes to provide a more detailed map of electrical activity from the heart. This local ECG signal sensed by the controller/transmitter device 240 may be used to trigger the onset of seed pacing when the patient has a functioning sinus node. In any case, the signals sensed by the controller/transmitter device 240 are used to monitor ECG signals from the paced heart. In some cases, these ECG signals, or other physiologic sensor input signals, may be used to adjust or adapt the timing of firing of the pacing seeds 220.”).
Regarding claim 7, claims 1-2 & 6 are anticipated by Hastings. Hastings further discloses wherein the frequency adjustment unit includes a capacitor array configured to adjust an impedance of the sensing emitting coil (Hastings ¶0075 “Subsequent timing of the firing of each additional seed is programmed by the physician at the time of implant. Note that seeds may be programmed not to discharge. For example, an array of seeds may be implanted, but only a subset may be programmed to receive firing commands from the controller 240.” Where each seed contains a ).
Regarding claim 9, claim 1 is anticipated by Hastings. Hastings further discloses wherein the stimulation control circuit (Hastings Figure 1 Pacing Controller 40) includes: a discharge controller (Hastings Figure 1 Transmitter 50) configured to provide a control signal based on the at least one cardiac state (Hastings ¶0055 “The transmitter 50—which is in communication with, and is controlled by, the pacing controller 40—drives an RF signal onto the antenna 60. In one embodiment, the transmitter 50 provides both 1) a charging signal to charge the electrical charge storage devices contained within the seeds 20 by inductive coupling, and 2) an information signal, such as a pacing trigger signal, that is communicated to a selected one or more of the seeds 20, commanding that seed to deliver its stored charge to the adjacent tissue”; ¶0077); a storage capacitor configured to storage a driving voltage (Hastings ¶0018 “The source of electrical energy may be inductively coupled from a source external to the myocardium and stored on a capacitor contained within the wireless electrode. “); and a switch configured to receive the control signal and enable transmitting the driving voltage to the stimulation emitting coil based on the control signal (Hastings ¶0069 “FIG. 4 is a schematic diagram of an example wireless electrode assembly, or seed, 420, which may serve as the seeds 20 or 220 as shown in either FIG. 1 or FIGS. 2A-B. The seed 420 includes, firstly, a receiver coil 410 that is capable of being inductively coupled to a magnetic field source generating a time-varying magnetic field at the location of coil 410, such as would be generated by the transmitter 50 and the antenna 60 shown in FIG. 1.”).
Regarding claim 11, claim 1 is anticipated by Hastings. Hastings further including: a control module (Hastings Figure 1 External Programmer 70) configured to receive the at least one cardiac state and provide a control signal to the stimulation module; wherein the stimulation module is configured to emit the stimulation electromagnetic signal based on the control signal (Hastings ¶0062 “The external programmer 70 may be used to program such parameters as the timing of stimulation pulses in relation to certain sensed electrical activity of the heart, the energy level of stimulation pulses, the duration of stimulation pulse (that is, pulse width), etc. The programmer 70 includes an antenna 75 to communicate with the pacing controller 40, using, for example, RF signals. “).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-5 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hastings et al. (US Publication No. 20160175599) in view of Mercer et al. (US Publication No. 20230023897).
Regarding Claim 4, claims 1-3 are anticipated by Hastings. Hastings does not further disclose wherein the sensing electrode includes a first electrode and a second electrode; and wherein a gap is formed between the first electrode and the second electrode, and the gap is varied by the at least one cardiac state. Mercer in a similar field of endeavor of physiological monitoring teaches wherein the sensing electrode includes a first electrode and a second electrode (Mercer ¶0034 “The plurality of sensing elements may comprise a pair of electrodes. In one example, the impedance sensor may comprises a plurality of electrode pairs, where each pair of electrodes is selectively operable in the sensing mode or treatment mode. “); and wherein a gap is formed between the first electrode and the second electrode, and the gap is varied by the at least one cardiac state (Mercer ¶0035 “The pair of electrodes may be a pair of interdigitated comb electrodes.” Where the gap is formed in the combed structure of an interdigitated electrode and serves as the means for the electrodes to detect signals based on the changes in the distances of the comb fingers.).
Before the effecting filing date, it would have been obvious to one of ordinary skill in the art to use two electrodes with a gap as the sensing electrodes since using a plurality of electrodes with varying distances provides finer information regarding the cardiac states. Therefore, one would integrate the sensing electrode that includes a first electrode and a second electrode wherein a gap is formed between the first electrode and the second electrode, and the gap is varied by the at least one cardiac state of Mercer into the system of Hastings such that Hastings may utilize and interdigital electrode. The purpose of doing this is to increase the signal sensitivity and provide noise reduction, which are achieved using an interdigital electrode since the comb structure provides finer details in cardiac sensing.
Regarding Claim 5, claims 1-4 are obvious over Hastings in view of Mercer. Hastings does not further disclose wherein the first electrode and the second electrode form an interdigital electrode. Mercer further teaches wherein the first electrode and the second electrode form an interdigital electrode (Mercer ¶0035 “The pair of electrodes may be a pair of interdigitated comb electrodes. The pair of electrodes may be configured to conform to a surface of the IMD. For example, where the IMD is a graft or stent, the pair of electrodes may be arranged circumferentially to lie on or in an inner surface of the graft or stent, e.g. in a region where the graft or stent interfaces directly or indirectly with a biological tissue. The examples discussed below demonstrate that the interdigitated electrode configuration provides an environment suitable for both direct contact or contactless method for detecting impedance capable of cell characterisation and delivering energy to cause apoptosis. “).
Before the effecting filing date, it would have been obvious to one of ordinary skill in the art to use two electrodes forming an interdigital electrode as the sensing electrodes since using a plurality of electrodes with varying distances provides finer information regarding the cardiac states and an interdigital electrode provides information regarding the shifting states of the electrodes compared to each other during a heartbeat. Therefore, one would integrate the first electrode and the second electrode which form an interdigital electrode. of Mercer into the system of Hastings such that Hastings utilizes the interdigital electrodes. The purpose of doing this is to increase the signal sensitivity and provide noise reduction, which are achieved using an interdigital electrode since the comb structure provides finer details in cardiac sensing.
Claim 8 is rejected under 35 U.S.C. 103(a) as being unpatentable over Hastings et al. (US Publication No. 20160175599) in view of Maile et al. (US Publication No. 20170203109).
Regarding claim 8, claim 2 is anticipated by Hastings. Hastings does not further disclose a shielding component at least arranged at a first side of the sensing emitting coil; wherein the shielding component at least shields a portion of the sensing electromagnetic signal emitted toward to a first direction. Maile in a similar field of endeavor of a shielding component (Maile ¶0068 “To help improve the recharging capabilities of this system, it may be useful to provide an impedance boundary layer to minimize this reflection. Such a boundary 120 is shown in FIG. 13 and can take on many different embodiments. As a result of including the boundary 120, it can be seen that the incident EM wave front 122 is only partially reflected as a partially reflected EM wave front 126.”) at least arranged at a first side of the sensing emitting coil; wherein the shielding component at least shields a portion of the sensing electromagnetic signal emitted toward to a first direction (Maile Figure 13 showing the sensing device with a shielding boundary layer 120 which affects the reflection of signals from the implanted device.).
Before the effecting filing date, it would have been obvious to one of ordinary skill in the art to utilize a shielding component for the electromagnetic signal since the shield can prevent unwanted noise along with directing the energy in a particular direction for better signal. Therefore, one would integrate the shielding component at least arranged at a first side of the sensing emitting coil; wherein the shielding component at least shields a portion of the sensing electromagnetic signal emitted toward to a first direction of Maile into the system of Hastings for the purpose of noise reduction where the shielding component reduces signal reflections that present as noise.
Claim 10 is rejected under 35 U.S.C. 103(a) as being unpatentable over Hastings et al. (US Publication No. 20160175599) in view of Min et al. (US Patent No. 10252063).
Regarding Claim 10, Claims 1 & 9 are anticipated by Hastings. Hastings does not disclose wherein the stimulation control circuit further includes: a boost circuit configured to receive a supply voltage and boost the supplied power to the driving voltage . Min in a similar field of endeavor of leadless intra-cardiac medical device with built-in telemetry system teaches wherein the stimulation control circuit further includes: a boost circuit configured to receive a supply voltage and boost the supplied power to the driving voltage (Min Column 11 Lines 24-28 “A power conversion unit (not shown) converts RF energy received on telemetry conductor 430 into a power supply signal that can recharge the battery 536 (for example, to a desired voltage range and/or current level).”; Column 17 Lines 50-54 “If the voltage is too low to recharge the battery 536, the voltage may be stepped up to a suitable voltage, such as 3-6 V, for example. If the voltage is sufficient for charging, there is no need to step up the voltage. “).
Before the effecting filing date, it would have been obvious to one of ordinary skill in the art to use a boost circuit as the driving voltage is required to be above a minimum threshold of strength to be an effective stimulation treatment. Because of this, methods for creating ample power without increasing the device size such as by using the boost circuit is favorable. Therefore, one would integrate a boost circuit configured to receive a supply voltage and boost the supplied power to the driving voltage of Min into the system of Hastings for purpose of doing this is to achieve a voltage capable of cardiac pacing.
Conclusion
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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