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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/3/24 is being considered by the examiner.
Claim Objections
Claim 13 is objected to because of the following informalities: the limitation of “a cardiac resynchronization therapy, CRT, device or an implantable cardioverter defibrillator, ICD, device” should recite -- a cardiac resynchronization therapy (CRT) device or an implantable cardioverter defibrillator (ICD) device— for clarity purposes (see ¶100 of the US PGPub version of the application). Appropriate correction is required.
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:
stimulation generating unit in claims 1, 4, and 11;
control unit in claims 1-3, 5, 9, and 12;
multiple sensor units in claim 6; and
processing unit in claim 15.
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.
For a stimulation generating unit in claims 1, 4, 8, and 11, the specification discloses “the stimulation generating unit comprises a first signal generator associated with the first pair of electrodes for generating the first stimulation signal and outputting the first stimulation signal to the first pair of electrodes and wherein the stimulation generating unit comprises a second signal generator associated with the second pair of electrodes for generating the second stimulation signal and outputting the second stimulation signal to the second pair of electrodes” (see ¶73 of the US PGPub version of the application). Therefore, the Examiner is interpreting the stimulation generating unit to be a first signal generator associated with the first pair of electrodes and a second signal generator associated with the second pair of electrodes, or equivalents thereof.
For a control unit in claims 1-3, 5, 9, and 12, the specification discloses “the control unit 160 may be implemented as a general-purpose processing unit, such as a central processing unit (CPU), which may execute the instructions of one or more computer programs in order to control the generation and timing of control signals” (see ¶161 of the US PGPub version of the application) and “the control unit 160 may further comprise a memory storing the application program and storing settings for controlling the generation and timing of control signals” (see ¶162 of the US PGPub version of the application). Therefore, the Examiner is interpreting the control unit to be a general-purpose processing unit, such as a central processing unit (CPU) and memory, or equivalents thereof.
For multiple sensor units, the specification discloses “the electrical signal sensor comprises electrodes configured to be arranged at the location of the heart for detecting electrical signals conducted in the location of the heart” (see ¶71 of the US PGPub version of the application). Therefore, the Examiner is interpreting the multiple sensor units to be electrodes, or equivalents thereof.
For processing unit, the specification discloses “a general-purpose processing unit, such as a central processing unit (CPU)” (see ¶161 of the US PGPub version of the application) and “a specifically designed processing unit, such as an Application-Specific Integrated Circuit (ASIC) or a Field-Programmable Gate Array (FPGA)” (see ¶163 of the US PGPub version of the application). Therefore, the Examiner is interpreting the processing unit to be a general-purpose processing unit, such as a central processing unit (CPU), a specifically designed processing unit, such as an Application-Specific Integrated Circuit (ASIC) or a Field-Programmable Gate Array (FPGA), or 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.
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 4, 10, and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 4, the phrase "such as" in line 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In claim 10, the limitation of “the stimulation signals” in line 6 seems unclear. It remains unclear which combination of stimulation signals are being referred to as there is a first stimulation signal, a second stimulation signal, and a respective stimulation signal. For the purpose of examination, the Examiner is interpreting “the stimulation signals” to be referring to a plurality of the respective stimulation signal.
Regarding claim 13, the phrase "such as" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claim 14 is directed to statutory subject matter as the claims recite a method for controlling conduction of an electrical signal in a heart. The Examiner notes that claim 15 does not fall within at least one of the four categories of patent eligible subject matter because it recites a computer program product per se. MPEP 2106.03(I) states “a product claim to a software program that does not also contain at least one structural limitation (such as a "means plus function" limitation) has no physical or tangible form, and thus does not fall within any statutory category.” To narrow the claim to those embodiments that fall within a statutory category, the claim can be amended to positively recite the processing unit as a structural limitation.
Step 2A, Prong One
Regarding claim 14, the recited steps are directed to certain methods of organizing human activity and a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (II) and (III)).
Regarding claim 14, the limitation of “outputting one or more control signals for controlling a first stimulation signal and a second stimulation signal in dependence of the determined timing” is a process, as drafted, covers performance of the limitation that are directed to organizing human activity (managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions). For example, this limitation is nothing more than a medical professional verbally communicating instructions on one or more control signals for controlling a first stimulation signal and a second stimulation signal in dependence of the determined timing.
Regarding claim 14, the limitation of “determining a timing of an interferential stimulation signal in relation to the conduction of the electrical signal in the heart” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional receiving a print out of an electrical signal of the heart and analyzing it to determine a timing of an interferential stimulation signal.
Step 2A, Prong Two
For claim 14, the judicial exception is not integrated into a practical application. In particular, claim 14 recites “receiving input from an electrical signal sensor configured to detect conduction of the electrical signal in the heart; and outputting one or more control signals for controlling a first stimulation signal and a second stimulation signal in dependence of the determined timing.” The step of receiving input from an electrical signal sensor configured to detect conduction of the electrical signal in the heart amounts to nothing more than pre-solution activity of data gathering. The outputting step amounts to post-solution activity. The Examiner notes that the controlling is not positively recited and is intended use. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional element of receiving input from an electrical signal sensor configured to detect conduction of the electrical signal in the heart amounts to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the receiving input from an electrical signal sensor configured to detect conduction of the electrical signal in the heart is recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20030149456 (¶23-conventional pacemaker where one grouping of the electrodes of lead providing connections for sensing and a second set of electrodes of the multi-electrode cardiac lead providing connections for pacing or other cardiac stimulation),US 20060136004 (¶97-the ICD device utilizes a conventional lead/electrode system for (optionally) right atrial and right ventricular sensing and pacing, with defibrillation electrodes combined onto the right ventricular lead), US 20240042220 (¶2-conventional implantable cardioverter defibrillators (ICDs) include or are attached to intracardiac electrodes by transvenous leads), and US 20050288717 (¶6-a conventional cardiac pacemaker includes the main body of the cardiac pacemaker (generator), lead wires, and electrodes that transmit a stimulating pulse to the myocardium). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claim 15, the limitations of claims 14 further define the limitations already indicated as being directed to the abstract idea.
Claim 15 recites a computer program product to a non-statutory subject matter as set forth above. However, if claim 15 is amended to fall within a statutory category, claim 15 is further ineligible because it is recited at a high-level of generality and amount to nothing more than parts of a generic computer.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-10, and 14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Feinstein (US 10485977 filed on 6/28/18 as cited in the IDS).
Regarding claim 1, Feinstein teaches an apparatus for controlling conduction of an electrical signal in a heart (col. 9, line 55-col. 10-line 6), said apparatus comprising: a stimulation generating unit configured to generate a first stimulation signal and a second stimulation signal, wherein the first stimulation signal has a first frequency and the second stimulation signal has a second frequency (col. 5, lines 61-67-a plurality of electrodes in electrical communication with the stimulation power supply, the plurality of electrodes supplying transcutaneous electrical impulses when supplied power by the stimulation power supply. The plurality of electrodes comprises at least two electrodes supplying transcutaneous electrical impulses at two different frequencies; col. 8 and lines 60-62-IFC therapy generally utilizes two medium frequency currents which pass through the tissues simultaneously; col. 8, line 65-col. 9, line 3-the exact frequency of the resultant beat frequency can be controlled by the input frequencies. For example, if one current is at about 4000 Hz and the other current is at about 3900 Hz, the resultant beat frequency would be at about 100 Hz); a first pair of electrodes configured to be arranged in relation to a location in the heart in which conduction of the electrical signal is to be controlled, wherein the first pair of electrodes is configured to receive the first stimulation signal (col. 9 and lines 6-8-a first pair of electrodes (18.sup.1, 18.sup.2) supplies transcutaneous electrical impulses at a first frequency (represented by solid lines); col. 6 and lines 53-59- a first electrode supplying transcutaneous electrical impulses at a first frequency and a second electrode supplying transcutaneous electrical impulses at a second frequency different than the first frequency, the transcutaneous electrical impulses provided at the first and second frequencies giving rise to a first beat impulse having a first interference frequency stimulating a first area of a heart of the patient; Fig. 2); a second pair of electrodes configured to be arranged in relation to the location in the heart in which conduction of the electrical signal is to be controlled, wherein the second pair of electrodes is configured to receive the second stimulation signal (col. 9 and lines 9-11-a second pair of electrodes (18.sup.3, 18.sup.4) supplies transcutaneous electrical impulses at a second frequency (represented by dashed lines) different than the first frequency; col. 6 and lines 60-67-a third electrode supplying transcutaneous electrical impulses at a third frequency and a fourth electrode supplying transcutaneous electrical impulses at a fourth frequency different than the third frequency, the transcutaneous electrical impulses provided at the third and fourth frequencies giving rise to a second beat impulse having a second interference frequency stimulating a second area of the heart of the patient; Fig. 2), wherein the first and second pairs of electrodes are configured to form an interferential stimulation signal in the location of the heart based on the first and second stimulation signals (col. 7 and lines 50-57-the electrodes (18.sup.1,18.sup.2 . . . 18n) are particularly configured to employ interferential current (IFC) therapy, while the controller (12) and the one or more sensors (16) are configured to provide feedback and/or targeting capabilities to monitor the heartbeat of the patient and/or ensure that the stimulating currents are directed to the appropriate areas of the patient's body to achieve the desired results; col. 9 and lines 4-11-FIG. 2, an exemplary arrangement of electrodes employing IFC therapy is shown applied to the epidermis (52) of a patient (50). In this example, a first pair of electrodes (18.sup.1, 18.sup.2) supplies transcutaneous electrical impulses at a first frequency (represented by solid lines) and a second pair of electrodes (18.sup.3, 18.sup.4) supplies transcutaneous electrical impulses at a second frequency (represented by dashed lines) different than the first frequency), wherein a difference between the first frequency and the second frequency defines a beat frequency of the interferential stimulation signal for controlling conduction of the electrical signal in the location in the heart (col. 8, line 60-col. 9, line 3-IFC therapy generally utilizes two medium frequency currents which pass through the tissues simultaneously. They are set up so that their paths cross; and in simple terms they interfere with each other. This interference gives rise to an interference or beat frequency, which has the characteristics of low-frequency stimulation. The exact frequency of the resultant beat frequency can be controlled by the input frequencies. For example, if one current is at about 4000 Hz and the other current is at about 3900 Hz, the resultant beat frequency would be at about 100 Hz); an electrical signal sensor configured to detect conduction of the electrical signal in the heart (Fig. 1-sensors 16; col. 6 and lines 3-5-a sensor in communication with the controller provides data to the controller indicative of cardiac contractions of the patient); and a control unit configured to receive input from the electrical signal sensor and configured to control output of the first and the second stimulation signals for controlling a timing of the interferential stimulation signal in relation to the conduction of the electrical signal in the heart (Fig. 1-controller 12; col. 6 and lines 3-8-a sensor in communication with the controller provides data to the controller indicative of cardiac contractions of the patient, and at least one of a timing and an intensity of the transcutaneous electrical impulses is varied by the controller based at least in part upon the data indicative of cardiac contractions of the patient; col. 7 and lines 51-57-employ interferential current (IFC) therapy, while the controller (12) and the one or more sensors (16) are configured to provide feedback and/or targeting capabilities to monitor the heartbeat of the patient and/or ensure that the stimulating currents are directed to the appropriate areas of the patient's body to achieve the desired results).
Regarding claim 2, Feinstein teaches the apparatus according to claim 1. However, Feinstein does not explicitly teach wherein the control unit is configured to control output of the first and the second stimulation signals for controlling the interferential stimulation signal to block conduction of the electrical signal in the heart.
Snell teaches wherein the control unit is configured to control output of the first and the second stimulation signals for controlling the interferential stimulation signal to block conduction of the electrical signal in the heart (¶38-the outputs of the atrial and ventricular sensing circuits 244, 246 are connected to the microcontroller 220, which, in turn, is able to trigger or inhibit the atrial and ventricular pulse generators 222, 224, respectively, in a demand fashion in response to the absence or presence of cardiac activity in the appropriate chambers of the heart; ¶20-intersection of two AC signals with (a frequency offset) along a first pathway and a second pathway creates an interferential beat frequency of that depends on the offset (e.g., from about 30 hertz to about 120 hertz) that can be utilized for atrial defibrillation and/or atrial preconditioning; ¶31).
Therefore, 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 invention of Feinstein to include wherein the control unit is configured to control output of the first and the second stimulation signals for controlling the interferential stimulation signal to block conduction of the electrical signal in the heart of Snell in order for detecting patient conditions and determining desirable times to administer various therapies such as pacing, defibrillation and/or in vivo dispensing of pharmaceuticals (Snell, ¶34).
Regarding claim 3, Feinstein teaches the apparatus according to claim 1, wherein the control unit is configured to control output of the first and the second stimulation signals for controlling the interferential stimulation signal to trigger conduction of the electrical signal in the heart (col. 7 and lines 2-15-employing interferential current therapy comprises…varying at least one of a timing and an intensity of the transcutaneous electrical impulses based at least in part upon the data indicative of cardiac contractions of the patient; col. 7 and lines 51-57-employ interferential current (IFC) therapy, while the controller ( 12 ) and the one or more sensors ( 16 ) are configured to provide feedback and/or targeting capabilities to monitor the heartbeat of the patient and/or ensure that the stimulating currents are directed to the appropriate areas of the patient's body to achieve the desired results).
Regarding claim 5, Feinstein teaches the apparatus according to claim 1, wherein the control unit is configured to store a model for determining the timing of the interferential stimulation signal in relation to the input from the electrical signal sensor (col. 13 and lines 43-50-model is then used with other data in the memory ( 24 ) of device ( 10 ) to generate a computer assisted plan (at 122 ), including the location for initial placement of the electrodes ( 18 ), as well as data indicative of the frequencies of the interferential currents to be generated to create the beat impulse(s) having the interference frequency/frequencies desired for the particular application; col. 6 and lines 22-26-the timing of the transcutaneous electrical impulses is varied based at least in part upon the data indicative of cardiac contractions of the patient such that electrical stimulation is applied to the cardiac muscle during an absolute refractory period of the heartbeat cycle) or the control unit is configured to trigger output of the first and second stimulation signals based on detection of conduction of the electrical signal in the heart (col. 7 and lines 2-15-employing interferential current therapy comprises…varying at least one of a timing and an intensity of the transcutaneous electrical impulses based at least in part upon the data indicative of cardiac contractions of the patient; col. 7 and lines 51-57-employ interferential current (IFC) therapy, while the controller ( 12 ) and the one or more sensors ( 16 ) are configured to provide feedback and/or targeting capabilities to monitor the heartbeat of the patient and/or ensure that the stimulating currents are directed to the appropriate areas of the patient's body to achieve the desired results).
Regarding claim 6, Feinstein teaches the apparatus according to claim 1, wherein the electrical signal sensor comprises multiple sensor units configured to detect electrical signals in multiple locations in the heart (col. 6 and lines 19-26-the plurality of electrodes are disposed so as to stimulate heart contractions at predetermined times during a heartbeat cycle. In certain of these embodiments, the timing of the transcutaneous electrical impulses is varied based at least in part upon the data indicative of cardiac contractions of the patient such that electrical stimulation is applied to the cardiac muscle during an absolute refractory period of the heartbeat cycle; Fig. 3).
Regarding claim 7, Feinstein teaches the apparatus according to claim 1, wherein the electrical signal sensor comprises electrodes configured to be arranged at the location of the heart for detecting electrical signals conducted in the location of the heart (col. 6 and lines 3-5-a sensor in communication with the controller provides data to the controller indicative of cardiac contractions of the patient; col. 6 and lines 19-26-the plurality of electrodes are disposed so as to stimulate heart contractions at predetermined times during a heartbeat cycle. In certain of these embodiments, the timing of the transcutaneous electrical impulses is varied based at least in part upon the data indicative of cardiac contractions of the patient such that electrical stimulation is applied to the cardiac muscle during an absolute refractory period of the heartbeat cycle; col. 10 and lines 46-48-the electrodes may be automatically activated to generate and vary the stimulus until a desired heart rate is achieved; Fig. 3).
Regarding claim 8, Feinstein teaches the apparatus according to claim 1, wherein the stimulation generating unit comprises a first signal generator associated with the first pair of electrodes for generating the first stimulation signal (col. 5 and lines 60-65-a stimulation power supply in communication with the controller and a plurality of electrodes in electrical communication with the stimulation power supply, the plurality of electrodes supplying transcutaneous electrical impulses when supplied power by the stimulation power supply; col. 9 and lines 6-8-a first pair of electrodes (18.sup.1, 18.sup.2) supplies transcutaneous electrical impulses at a first frequency (represented by solid lines)) and outputting the first stimulation signal to the first pair of electrodes (col. 5, line 63-col. 6, line 3-the plurality of electrodes supplying transcutaneous electrical impulses when supplied power by the stimulation power supply. The plurality of electrodes comprises at least two electrodes supplying transcutaneous electrical impulses at two different frequencies, the transcutaneous electrical impulses provided at two different frequencies giving rise to at least one beat impulse having an interference frequency); and wherein the stimulation generating unit comprises a second signal generator associated with the second pair of electrodes for generating the second stimulation signal (col. 5 and lines 60-65-a stimulation power supply in communication with the controller and a plurality of electrodes in electrical communication with the stimulation power supply, the plurality of electrodes supplying transcutaneous electrical impulses when supplied power by the stimulation power supply; col. 9 and lines 9-11-a second pair of electrodes (18.sup.3, 18.sup.4) supplies transcutaneous electrical impulses at a second frequency (represented by dashed lines) different than the first frequency) and outputting the second stimulation signal to the second pair of electrodes (col. 5, line 63-col. 6, line 3-the plurality of electrodes supplying transcutaneous electrical impulses when supplied power by the stimulation power supply. The plurality of electrodes comprises at least two electrodes supplying transcutaneous electrical impulses at two different frequencies, the transcutaneous electrical impulses provided at two different frequencies giving rise to at least one beat impulse having an interference frequency).
Regarding claim 9, Feinstein teaches the apparatus according to claim 1, wherein the control unit is configured to control modulation of the interferential stimulation signal by modulating the first frequency and/or the second frequency (col. 9 and lines 40-41-the electrodes vary the beat frequency) and/or by modulating a time instant for start of the first stimulation signal and/or a time instant for start of the second stimulation signal (col. 6 and lines 22-26-the timing of the transcutaneous electrical impulses is varied based at least in part upon the data indicative of cardiac contractions of the patient such that electrical stimulation is applied to the cardiac muscle during an absolute refractory period of the heartbeat cycle).
Regarding claim 10, Feinstein teaches the apparatus according to claim 1, further comprising a set of additional electrodes (col. 11, line 66-col. 12, line 3-additional pairs of electrodes may be employed to produce additional beat impulses at the same or different beat frequencies as those described above, depending on the particular application of the device (10); col. 7 and lines 46-47-a plurality of electrodes ( 18 1 , 18 2 . . . 18 n ); Fig. 1-there can be any number of electrodes), wherein the set of additional electrodes comprises at least two pairs of electrodes configured to be arranged in relation to an additional location in the heart (col. 11, line 66-col. 12, line 3-additional pairs of electrodes may be employed to produce additional beat impulses at the same or different beat frequencies as those described above, depending on the particular application of the device (10); Fig. 1-there can be any number of electrode pairs; col. 7 and lines 63-65-various options are possible for electrode ( 18 1 , 18 2 . . . 18 n ) placement, as well as types of electrodes used; Fig. 3), wherein each pair of electrodes is configured to receive a respective stimulation signal for forming an interferential stimulation signal in the additional location of the heart based on the stimulation signals (col. 11, line 66-col. 12, line 3-additional pairs of electrodes may be employed to produce additional beat impulses at the same or different beat frequencies as those described above, depending on the particular application of the device ( 10 ); col. 7 and lines 50-52-the electrodes ( 18 1 , 18 2 . . . 18 n ) are particularly configured to employ interferential current (IFC) therapy; col. 7 and lines 63-65-various options are possible for electrode ( 18 1 , 18 2 . . . 18 n ) placement, as well as types of electrodes used; Fig. 3).
Regarding claim 14, Feinstein teaches a method for controlling conduction of an electrical signal in a heart, said method comprising: receiving input from an electrical signal sensor configured to detect conduction of the electrical signal in the heart (Fig. 1-sensors 16; col. 6 and lines 3-5-a sensor in communication with the controller provides data to the controller indicative of cardiac contractions of the patient); determining a timing of an interferential stimulation signal in relation to the conduction of the electrical signal in the heart (col. 6 and lines 22-26-the timing of the transcutaneous electrical impulses is varied based at least in part upon the data indicative of cardiac contractions of the patient such that electrical stimulation is applied to the cardiac muscle during an absolute refractory period of the heartbeat cycle; col. 7 and lines 7-9-the transcutaneous electrical impulses provided at two different frequencies giving rise to at least one beat impulse having an interference frequency; time is inversely related to frequency); and outputting one or more control signals for controlling a first stimulation signal and a second stimulation signal in dependence of the determined timing (Fig. 1-controller 12; col. 6 and lines 3-8-a sensor in communication with the controller provides data to the controller indicative of cardiac contractions of the patient, and at least one of a timing and an intensity of the transcutaneous electrical impulses is varied by the controller based at least in part upon the data indicative of cardiac contractions of the patient; col. 7 and lines 51-57-employ interferential current (IFC) therapy, while the controller (12) and the one or more sensors (16) are configured to provide feedback and/or targeting capabilities to monitor the heartbeat of the patient and/or ensure that the stimulating currents are directed to the appropriate areas of the patient's body to achieve the desired results).
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.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Feinstein in view of Rhodes (US 20150080984 filed on 9/13/13).
Regarding claim 4, Feinstein teaches the apparatus according to claim 1, wherein the stimulation generating unit is configured to generate a pulse of the first stimulation signal (col. 9 and lines 6-8-a first pair of electrodes ( 18 1 , 18 2 ) supplies transcutaneous electrical impulses at a first frequency (represented by solid lines)) and a pulse of the second stimulation signal (col. 9 and lines 9-11-a second pair of electrodes ( 18 3 , 18 4 ) supplies transcutaneous electrical impulses at a second frequency (represented by dashed lines) different than the first frequency) for forming an interferential stimulation signal (col. 5 and lines 27-33-IFC therapy utilizes two or more medium frequency currents which pass through body tissues simultaneously. They are set up so that their paths cross; and in simple terms they interfere with each other (hence the name “interferential” current therapy). This interference gives rise to an interference or beat frequency, which has the characteristics of low-frequency stimulation). However, Feinstein does not explicitly teach the interferential signal having a duration of not more than two periods of the beat frequency, such as a single period or half a period of the beat frequency.
Rhodes teaches the interferential signal having a duration of not more than two periods of the beat frequency, such as a single period or half a period of the beat frequency (¶28-the patient is briefly subjected to no carrier frequency or frequencies or beat frequency or frequencies for a short period, the patient is subjected to a series of tests, initially using different beat frequencies in an attempt to determine an effective, optimum or ideal combination of parameters that produce a desired effect on the autonomic nervous system and thereby determine a preferred treatment regimen. This may be accomplished by using one of the carrier frequencies and delivering a series of pulses in a first range, such as 1-10 pulses/second, the standard interferential module 16 produces a sweep of beats in this range in the following repeating pattern: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, changing every second).
Rhodes relates to a method and apparatus for determining effective treatment parameters in an electrical interferential system (¶2).
Therefore, 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 invention of Feinstein to include the interferential signal having a duration of not more than two periods of the beat frequency, such as a single period or half a period of the beat frequency of Rhodes in order to obtain more efficient treatment parameters, shorten the time to determine these parameters, require less experienced personnel and rely on patients or their caregivers to determine effective parameters, the responses of the patient may be entered into software designed to obtain better parameters (Rhodes, ¶5).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Feinstein in view of Wichner (US 20140194949 filed on 1/4/13).
Regarding claim 11, Feinstein teaches the apparatus according to claim 1, wherein each pair of electrodes is arranged on a flexible, elongate carrier (col. 12 and lines 18-27-the pads/electrodes may be formed with an adhesive on one side, such that the pads/electrodes can be affixed to the patient's skin. If desired, the pads/electrodes can be incorporated into or onto to an article of clothing (e.g., a robe or vest), a surgical drape or the like, a medical device, such as a splint, cast or other immobilization device, a wheelchair, a hospital bed, etc. The pads/electrodes can also take the form of a thin, flexible electrical circuit, such as in the nature of a temporary tattoo formed of an electrically conductive material; Figs. 2-3). However, Feinstein does not explicitly teach wherein the carrier comprises wires for connecting each electrode to the stimulation generating unit.
Wichner teaches wherein the carrier comprises wires for connecting each electrode to the stimulation generating unit (¶66-a lead 622 may comprise a cable or wire to conduct an electrical signal from a device that generates the electrical signal to electrode pad 620. Similarly, a lead 627 may comprise a cable or wire to conduct an electrical signal to electrode pad 625. Leads 622 and 627 may both connect into a port (e.g., 250) of a device such as 200, for example; ¶36-applications of electrical energy (e.g. for muscle stimulation, cellular regeneration, physical or mental diagnosis, and so on) may involve a power source, a signal generator, at least two electrodes, and leads (e.g., cables, wires, conductors, and so on); ¶73).
Wichner relates to an apparatus and method for providing electrotherapeutic signals to a patient (¶2).
Therefore, 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 invention of Feinstein to include wherein the carrier comprises wires for connecting each electrode to the stimulation generating unit of Wichner in order to provide electrotherapeutic signals to a patient (Wichner, ¶2).
Claims 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Feinstein in view of Grossman (US 20170216594 filed on 10/8/15).
Regarding claim 12, Feinstein teaches the apparatus according to claim 1, further comprising a sensor for detecting information relating to functionality of the heart (Feinstein, col. 6 and lines 3-5-a sensor in communication with the controller provides data to the controller indicative of cardiac contractions of the patient) and to receive and analyze the information detected by the sensor and to provide input to the control unit for adapting control by the control unit (Feinstein, col. 6 and lines 3-8-a sensor in communication with the controller provides data to the controller indicative of cardiac contractions of the patient, and at least one of a timing and an intensity of the transcutaneous electrical impulses is varied by the controller based at least in part upon the data indicative of cardiac contractions of the patient). However, Feinstein does not explicitly recite a processor.
Grossman teaches a processor (¶172-microprocessor, central processing unit, signal processing circuitry).
Grossman relates generally to stimulation of biological tissue, including interferential stimulation of a brain (¶2). Grossman further teaches that in some use scenarios of this invention, interferential stimulation is targeted at particular regions of the heart (¶15).
Therefore, 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 invention of Feinstein to include a processor of Grossman in order to control the operation of, or interface with, hardware components of a current drive or voltage drive, including any waveform generators; to perform any other calculation, computation, program, algorithm, computer function or computer task; to receive signals indicative of human input; to output signals for controlling transducers for outputting information in human perceivable format; and to process data, to perform computations, to execute any algorithm or software, and to control the read or write of data to and from memory devices (Grossman, ¶166).
Regarding claim 15, Feinstein teaches claim 14. However, Feinstein does not explicitly recite a computer program product comprising computer-readable instructions such that when executed on a processing unit, the computer program product will cause the processing unit to perform the method.
Grossman teaches a computer program product comprising computer-readable instructions such that when executed on a processing unit, the computer program product will cause the processing unit to perform the method (¶167-one or more computers are programmed to perform any and all calculations, computations, programs, algorithms, computer functions and computer tasks described or implied above. For example, in some cases: (a) a machine-accessible medium has instructions encoded thereon that specify steps in a software program; and (b) the computer accesses the instructions encoded on the machine-accessible medium, in order to determine steps to execute in the program; ¶172).
Therefore, 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 invention of Feinstein to include a computer program product comprising computer-readable instructions such that when executed on a processing unit, the computer program product will cause the processing unit to perform the method of Grossman in order to perform any and all calculations, computations, programs, algorithms, computer functions and computer tasks (Grossman, ¶167) and perform interferential stimulation (Grossman, Abstract).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Feinstein in view of Snell (US 20100114207 filed on 11/5/08).
Regarding claim 13, Feinstein teaches the apparatus according to claim 1. However, Feinstein does not explicitly teach wherein the apparatus is configured to be implanted in a body of a subject, such as the apparatus forming part of a cardiac resynchronization therapy, CRT, device or an implantable cardioverter defibrillator, ICD, device.
Snell teaches wherein the apparatus is configured to be implanted in a body of a subject, such as the apparatus forming part of a cardiac resynchronization therapy, CRT, device or an implantable cardioverter defibrillator, ICD, device (¶9-an implantable medical device (IMD), such as implantable cardioverter-defibrillator (ICD); ¶34).
Snell generally pertains to cardiac related therapy and particularly to interferential cardiac preconditioning and depolarization (¶1).
Therefore, 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 invention of Feinstein to include wherein the apparatus is configured to be implanted in a body of a subject, such as the apparatus forming part of a cardiac resynchronization therapy, CRT, device or an implantable cardioverter defibrillator, ICD, device of Snell in order to detect patient conditions and determine desirable times to administer various therapies such as pacing, defibrillation and/or in vivo dispensing of pharmaceuticals (Snell, ¶34).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20110125225: cardiac stimulation can be achieved by using interferential technique (¶42).
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/LAURA HODGE/Examiner, Art Unit 3792
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