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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the magnetographic system including the plurality of magnetic field sensors and the calculation unit must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claims 3 and 13 are objected to because of the following informalities: claim 3 and 13 recite “M is the monopolarity, i the sensor index and bi the magnetic field gradient” however this should be read as “M is the monopolarity, i is the sensor index and bi is the magnetic field gradient. 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:
“a calculation unit being configured to determine” in claim 12 and “the calculation unit is configured to calculate” in claim 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The calculation unit is described on page 21 of the specification by reciting “The calculation unit may, for example, be an integrated circuit, a Personal Computer or other programmable apparatus, or part thereof”. Therefore for examination purposes the calculation unit will be interpreted as a personal computer.
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 1-20 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 claims 1 and 12, claims 1 and 12 recite “determining, using the magnetic field data measured by the at least one magnetic field sensor”. However “the magnetic field data” has not been previously defined therefore it lacks antecedent basis and it is unclear what the magnetic field data is referring to. For examination purposes the limitation will be read as “determining, using magnetic field data measured by the at least one magnetic field sensor”.
Dependent claims are also rejected due to their dependency.
Regarding claims 9, 19, and 20, each of claims 9, 19, and 20 recite “wherein the individual membranous or cytosolic ionic current is the Ito.” Claims 9, 19, and 20 do not define Ito and independent claim 1 also does not define Ito therefore it is unclear what the current Ito is referring to. Pg. 12 line 14 of the current application recites “Ito = transient outward potassium current”. Therefore for examination purposes the claim will be interpreted as “wherein the individual membranous or cytosolic ionic current is the transient outward potassium current (Ito).”
Claim 17 is unclear under 35 USC 112(b), since a claim which purports to be both machine and process is ambiguous and therefore does not particularly point out and distinctly claim the subject matter of the invention. Ex parte Lyell, 17 USPQ2d 1548 (1990). It is unclear if claim 19 is a method claim or an apparatus claim.
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.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim recites software per se.
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.
Claims 1, 6, 7, 8, 10, 12, and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kandori (US 20040210127).
Regarding claims 1, 12, and 17, Kandori discloses a magnetographic method ([0002] – “The present invention relates to a biomagnetic measurement technique detecting a very weak magnetic field such as a magnetocardiogram and a magnetoencephalogram”), the method comprising the following steps: [claim 1]
a magnetographic system (Abstract – “The biomagnetic measurement apparatus”, Fig. 1), comprising, a plurality of magnetic field sensors (Fig. 2, [0037] – “The detection coils 8 are integrated with the SQUID sensors”)…and a calculation unit (Abstract – “The biomagnetic measurement apparatus including an operating circuit for magnetometer, and means collecting output data of the operating circuit for magnetometer, has means calculating a current vector at time t”, [0036] – “computer 6”) [claim 12]
a data carrier comprising a computer program for carrying out the method of claim 1 (Abstract – “The biomagnetic measurement apparatus including an operating circuit for magnetometer, and means collecting output data of the operating circuit for magnetometer, has means calculating a current vector at time t”, [0036] – “computer 6”). [claim 17]
a) measuring, at least at one given point in time or over at least one given time period, at least one component of a biomagnetic field at least at one position above a tissue or organ of a subject using at least one magnetic field sensor ([0039] – “The top figure of FIG. 4 shows an overlapped waveform 11 of magnetic field waveforms in which the magnetocardiogram waveforms (the grid map 9) of 64 channels shown in FIG. 3 are overlapped with each other on one trace to be displayed”, [0030] – “A biomagnetic measurement apparatus of an embodiment of the present invention in which when a plane in parallel with a plane contacted with the surface of a chest”, [0037] – “The detection coils 8 are integrated with the SQUID sensors”), and
b) determining, using the magnetic field data measured by the at least one magnetic field sensor, an individual membranous or cytosolic ionic current in the tissue or organ ([0043] – “FIG. 5 is a schematic diagram showing the cell-membrane ionic current”, [0030] – “current vectors from magnetic fields produced from a heart and absolute values of the current vectors are calculated at a plurality of measurement points (x, y)”), wherein the determination step is computer-implemented (Abstract – “The biomagnetic measurement apparatus including an operating circuit for magnetometer, and means collecting output data of the operating circuit for magnetometer, has means calculating a current vector at time t”, [0036] – “computer 6”).
Regarding claim 6, Kandori further discloses wherein the determination of the rotational behavior of the measured biomagnetic field involves the determination of a change of the field map angle and/or the maximum current angle ([0015] – “a current vector (Ix (t), Iy (t)) at time t and an absolute value of the current vector (Ixy (t)={square root}{(Ix (t))2+I (t))2}) is calculated at time ti (i=0, 1, . . . , n)”, one with ordinary skill in the art would find it obvious that the variations in the angle of the current vector over time would show any rotational behavior).
Regarding claim 7, Kandori further discloses wherein the at least one component of the biomagnetic field is measured at a plurality of positions above the tissue or organ of the subject using a plurality of magnetic field sensors, each sensor of the plurality of magnetic field sensors being arranged at one of the positions of the plurality of positions above the tissue or organ of the subject ([0030] – “A biomagnetic measurement apparatus of an embodiment of the present invention in which when a plane in parallel with a plane contacted with the surface of a chest”, [0037] – “The detection coils 8 are integrated with the SQUID sensors”, Fig. 2).
Regarding claim 8, Kandori further discloses wherein the individual membranous or cytosolic ionic current is an individual membranous or cytosolic ionic current of or during an action potential at the cell membrane of a cell or multiple cells (Figs. 4 and 5, Fig. 4 shows individual current vectors and Fig. 5 shows the relation between a cell-membrane ionic current, a ventricular muscle action potential).
Regarding claims 10 and 15, Kandori further discloses wherein the component of the magnetic field is the z-component of the magnetic field ([0033] – “a plurality of detection coils detecting, when a plane in parallel with a plane contacted with a living body is xy plane and an axis vertical to the (x, y) plane is z, element Bz in z direction of a magnetic field produced from the living body, and a data collection device collecting detected signal data of the element Bz in the z direction”).
Regarding claim 14, Kandori further discloses wherein the magnetographic system is a magnetocardiographic system ([0002] – “The present invention relates to a biomagnetic measurement technique detecting a very weak magnetic field such as a magnetocardiogram and a magnetoencephalogram”, Abstract – “The biomagnetic measurement apparatus”).
Regarding claim 16, Kandori further discloses comprising a computer being or comprising the calculation unit (Abstract – “The biomagnetic measurement apparatus including an operating circuit for magnetometer, and means collecting output data of the operating circuit for magnetometer, has means calculating a current vector at time t”, [0036] – “computer 6”).
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.
Claims 2, 3, 4, 11, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kandori (US 20040210127) as applied to claims 1 and 12 above, and further in view of Ehrlen (EP 3308703 B1).
Regarding claim 2, Kandori discloses all the elements of the claimed invention as cited in claim 1.
Conversely Kandori does not teach wherein the determination of the individual membranous or cytosolic ionic current in the tissue or organ involves the determination of the magnetic polarity or rotational behavior of the measured biomagnetic field.
However Ehrlen discloses wherein the determination of the individual membranous or cytosolic ionic current in the tissue or organ involves the determination of the magnetic polarity or rotational behavior of the measured biomagnetic field ([0008] – “Determining, using the magnetic field data measured by the plurality of magnetic field sensors, the monopolarity of the magnetic field at at least one given point in time or over at least one given time period”).
Ehrlen is an analogous art considering it is in the field of magnetocardiography.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the determination of magnetic polarity of Ehrlen to achieve the same results. One would have motivation to combine because it “provides a measure for indicating the presence and the severity of cardiac muscle tissue disorder” (Ehrlen – [0009]).
Regarding claim 3, Kandori and Ehrlen disclose all the elements of the claimed invention as cited in claims 1 and 2.
Conversely Kandori does not teach wherein the monopolarity of the magnetic field at at least one given point in time or over at least one given time period is determined, the monopolarity of the magnetic field representing a measure for the deviation of the magnetic field from a dipolar shape, and wherein the monopolarity of the magnetic field is calculated by the following formula
M
=
∑
b
i
∑
b
i
wherein M is the monopolarity, i the sensor index and bi the magnetic field gradient measured by the i-th magnetic field sensor.
However Ehrlen discloses wherein the monopolarity of the magnetic field at at least one given point in time or over at least one given time period is determined, the monopolarity of the magnetic field representing a measure for the deviation of the magnetic field from a dipolar shape ([0008] – “the monopolarity of the magnetic field at at least one given point in time or over at least one given time period…the monopolarity of the magnetic field representing a measure for the deviation of the magnetic field from a dipolar shape”), and wherein the monopolarity of the magnetic field is calculated by the following formula (1)
M
=
∑
b
i
∑
b
i
wherein M is the monopolarity, i the sensor index and bi the magnetic field gradient measured by the i-th magnetic field sensor (Paragraph [0008] recites the claimed equation and “wherein M is the monopolarity, i the sensor index and bi the magnetic field gradient measured by the i-th magnetic field sensor”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the determination of monopolarity of Ehrlen to achieve the same results. One would have motivation to combine because it “provides a measure for indicating the presence and the severity of cardiac muscle tissue disorder” (Ehrlen – [0009]).
Regarding claim 4, Kandori and Ehrlen disclose all the elements of the claimed invention as cited in claims 1, 2, and 3.
Conversely Kandori does not teach wherein a dipolarity D of the magnetic field is calculated with the following formula (2)
D
=
1
-
M
D being the dipolarity, and M being the monopolarity.
However Ehrlen discloses wherein a dipolarity D of the magnetic field is calculated with the following formula (2)
D
=
1
-
M
D being the dipolarity, and M being the monopolarity ([0012] – “A perfect dipolar shape of a magnetic field would result in an axially symmetric isocontour map plotted from measured data of a plurality of sensors, e.g. axial gradiometers, positioned directly above the magnetic field source and oriented in the z-axis using standard heart coordinates. A shift to a more monopolar shape, i.e. a magnetic field having a higher monopolarity, would result in an axially asymmetric isocontour map, where, for example, the majority of the sensors of a plurality of magnetic field sensors positioned directly above the magnetic field source would measure negative or positive values”, [0023] – “The above formula provides a monopolarity score lying between 0 (zero, no monopolarity) and 1 (one, complete monopolarity)”, therefore one with ordinary skill in the art would find it obvious that to measure the dipolarity it can be found by taking 1-M with M being the monopolarity).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the determination of monopolarity and dipolarity of Ehrlen to achieve the same results. One would have motivation to combine because it “provides a measure for indicating the presence and the severity of cardiac muscle tissue disorder” (Ehrlen – [0009]).
Regarding claim 11, Kandori discloses all the elements of the claimed invention as cited in claim 1.
Conversely Kandori does not teach wherein the subject is a mammal.
However Ehrlen discloses wherein the subject is a mammal (0018] – “The term "subject" as used herein refers preferably to a vertebrate, further preferred to a mammal, and most preferred to a human”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the subject being a mammal of Ehrlen to achieve the same results. One would have motivation to combine because the behaviors of a healthy heart of mammals are the most commonly known.
Regarding claim 13, Kandori discloses all the elements of the claimed invention as cited in claim 12.
Conversely Kandori does not teach wherein the calculation unit is configured to calculate the monopolarity of the magnetic field by the following formula (1)
M
=
∑
b
i
∑
b
i
wherein M is the monopolarity, i the sensor index and bi the magnetic field gradient measured by the i-th magnetic field sensor, or the dipolarity of the magnetic field by the following formula (2):
D
=
1
-
M
D being the dipolarity, and M being the monopolarity.
However Ehrlen discloses wherein the calculation unit is configured to calculate the monopolarity of the magnetic field by the following formula (1)
M
=
∑
b
i
∑
b
i
wherein M is the monopolarity, i the sensor index and bi the magnetic field gradient measured by the i-th magnetic field sensor (Paragraph [0008] recites the claimed equation and “wherein M is the monopolarity, i the sensor index and bi the magnetic field gradient measured by the i-th magnetic field sensor”), or the dipolarity of the magnetic field by the following formula (2):
D
=
1
-
M
D being the dipolarity, and M being the monopolarity ([0012] – “A perfect dipolar shape of a magnetic field would result in an axially symmetric isocontour map plotted from measured data of a plurality of sensors, e.g. axial gradiometers, positioned directly above the magnetic field source and oriented in the z-axis using standard heart coordinates. A shift to a more monopolar shape, i.e. a magnetic field having a higher monopolarity, would result in an axially asymmetric isocontour map, where, for example, the majority of the sensors of a plurality of magnetic field sensors positioned directly above the magnetic field source would measure negative or positive values”, [0023] – “The above formula provides a monopolarity score lying between 0 (zero, no monopolarity) and 1 (one, complete monopolarity)”, therefore one with ordinary skill in the art would find it obvious that to measure the dipolarity it can be found by taking 1-M with M being the monopolarity).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the determination of monopolarity and dipolarity of Ehrlen to achieve the same results. One would have motivation to combine because it “provides a measure for indicating the presence and the severity of cardiac muscle tissue disorder” (Ehrlen – [0009]).
Regarding claim 18, Kandori discloses all the elements of the claimed invention as cited in claim 1.
Conversely Kandori does not teach wherein the subject is a human.
However Ehrlen discloses wherein the subject is a human (0018] – “The term "subject" as used herein refers preferably to a vertebrate, further preferred to a mammal, and most preferred to a human”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the subject being a human of Ehrlen to achieve the same results. One would have motivation to combine because the behaviors of a healthy heart of humans are the most commonly known.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kandori (US 20040210127) and Ehrlen (EP 3308703 B1) as applied to claim 4 above, and further in view of Petrovich (RU 2551918 C1) machine translation.
Regarding claim 5, Kandori and Ehrlen disclose all the elements of the claimed invention as cited in claims 1, 2, 3, and 4.
Conversely Kandori does not teach wherein at least one of the monopolarity M and the dipolarity D determined over a period of time are multiplied with an averaged root mean square value calculated for the magnetic field data measured over the period of time.
As cited above Ehrlen discloses the Monopolarity M and the Dipolarity D ([0008], [0012], [0023]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the determination of monopolarity and dipolarity of Ehrlen to achieve the same results. One would have motivation to combine because it “provides a measure for indicating the presence and the severity of cardiac muscle tissue disorder” (Ehrlen – [0009]).
Conversely Kandori and Ehrlen do not teach wherein […magnetic field] determined over a period of time are multiplied with an averaged root mean square value calculated for the magnetic field data measured over the period of time.
However Petrovich wherein […magnetic field] determined over a period of time are multiplied with an averaged root mean square value calculated for the magnetic field data measured over the period of time ([0008] – “root mean square corrected value of the magnetic field strength is determined”, [0010] – “where H<sub>w</sub> is the root mean square corrected value of the magnetic field strength”, [0011] – “H<sub>i</sub> - root mean square magnetic field strength”, [0013] – “A<sub>D</sub> - decade normalization factor”, [0021] – “The root-mean-square corrected value of the intensity is the value of the magnetic field intensity averaged over the frequency in the decade frequency bands”).
Petrovich is an analogous art considering it is in the field of measuring a magnetic field.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the determination of the corrected magnetization of Petrovich to achieve the same results. One would have motivation to combine because “the obtained root mean square corrected value of the magnetic field intensity affecting a person in a given ten-day band is compared with the value of its maximum permissible level and, if it is exceeded, the possibility of developing unfavorable changes in a person’s health is predicted.” (Petrovich – [0020]).
Claims 9, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kandori (US 20040210127) as applied to claim 1 above, and further in view of June-Bum Kim NPL 2013 “Channelopathies” and Lome NPL 2022 “ECG Basics QRS Complex”.
Regarding claims 9, 19, and 20, Kandori discloses all the elements of the claimed invention as cited in claim 1.
Kandori further discloses wherein the method is a magnetocardiographic method ([0002] – “The present invention relates to a biomagnetic measurement technique detecting a very weak magnetic field such as a magnetocardiogram”), the tissue being heart tissue or the organ being the heart of a subject ([0009] – “a magnetic field produced from a heart is detected”).
Conversely Kandori does not teach wherein the individual membranous or cytosolic ionic current is an individual membranous or cytosolic ionic current of or during an action potential at the cell membrane of a myocardial cell or multiple myocardial cells, and wherein the at least one time period preferably includes or consists of the last 40, 37, and 35 milliseconds of the QRS complex, and wherein the individual membranous or cytosolic ionic current is the Ito.
However June-Bum Kim discloses wherein the individual membranous or cytosolic ionic current is an individual membranous or cytosolic ionic current of or during an action potential at the cell membrane of a myocardial cell or multiple myocardial cells (Fig. 4 shows a comparison of an action potential with measured potassium and calcium currents), and wherein the at least one time period preferably includes or consists of the last 40, 37, and 35 milliseconds of the QRS complex, and wherein the individual membranous or cytosolic ionic current is the Ito (Fig. 4 shows a comparison of an action potential, the measured potassium and calcium currents, and an ECG signal, as seen in Fig. 4 Ito mainly occurs in the last half of QRS complex, as cited below in the tertiary reference a normal duration of the QRS complex is between 0.08 and 0.1 seconds therefore one with ordinary skill in the art would find it obvious to use a time period of the last 40, 37, and 35 milliseconds to measure the transient outward potassium current (Ito)).
June-Bum Kim is an analogous art considering it is in the field of electrical currents of the heart tissue.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the measurement of ionic current within a particular time period of June-Bum Kim to achieve the same results. One would have motivation to combine because it would allow one to identify potassium channel disfunction which could help one make a diagnosis.
Tertiary reference Lome discloses the duration of the QRS complex (pg. 1 – “The normal duration (interval) of the QRS complex is between 0.08 and 0.10 seconds — that is, 80 and100 milliseconds”, therefore as recited above one with ordinary skill in the art would recognize from the teachings of Lome and Fig. 4 of June-Bum Kim that a time period of the last 40, 37, and 35 milliseconds can be used to measure the transient outward potassium current (Ito)).
Lome is an analogous art considering it is in the field of cardiac measurements.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kandori to incorporate the QRS duration of Lome to achieve the same results. One would have motivation to combine because it would provide a knowing of when to take measurements of the inward and outward currents.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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