DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 2 , 11, 16, and 17 are objected to because of the following informalities:
“EMG” in claim 2 line 1 and claim 16 line 9 should recite “electromyogram (EMG)”.
“Z=min(M,N)” in claim 11 line 6 and claim 19 line 7 should recite “Z=minimum(M,N).
Appropriate correction is required;
“at least one a uterine” in claim 17 line 2 should recite “at least one uterine”.
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: transforming/displaying using a/the computing device in claims 11-14.
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.
The computing device is defined, in para. [0149, 0151, 0153, 0155-0158], as a desktop computer, a laptop computer, a personal digital assistant (PDA), a cellular phone, a smartphone, a tablet, a phablet, wearable electronics, smartwatch, or other web-based connectable equipment or mobile devices, a processor and computer-readable media.
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 12-14, 15, 19, and 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.
Claim 12 (claims 13-14 by virtue of dependency) recites the limitation "the function" in line 4. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a function”.
Claim 12 (claims 13-14 by virtue of dependency) recites the limitation "the kth" in line 5. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a kth”.
Claim 19 recites the limitation "the function" in line 10. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a function”.
Claim 19 recites the limitation "the kth" in line 11. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a kth”.
Claim 12 line 4 and claim 19 line 10 recite “G” in the limitation “f(G,ΦB)”. It is unclear what variable/ parameter G defines/represents. Examiner suggests reciting what variable/ parameter G defines/represents in the claims.
Claim 13 line 4 and claim 19 line 15 recite “T” in the limitation “di=
U
.
,
i
T
ΦB.”. It is unclear what variable/ parameter T defines/represents. Examiner suggests reciting what variable/ parameter G defines/represents in the claims.
Claim 15 line 3 and claim 20 line 3 recite the limitation “RPI geometry”. It is unclear what RPI is an acronym for. Examiner suggests reciting what RPI is an acronym for.
Claim Rejections - 35 USC § 101
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 1 and 16 follows.
STEP 1
Regarding claims 1 and 16, the claim recites a series of steps or acts. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
providing an atlas comprising a reference body surface-uterus geometry;
transforming the plurality of patient-specific sensor positions to a patient-specific body surface-uterus geometry by projecting the plurality of patient-specific sensor positions onto the reference body surface-uterus geometry of the atlas;
reconstructing a plurality of uterine electrical signals based on the plurality of EMG signals and the patient-specific body surface-uterus geometry.
set forth a judicial exception. These steps describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (transforming, reconstructing) and/ or mathematical concepts (including mathematical relationships, mathematical formulas or equations, and mathematical calculations) (transforming, reconstructing). Thus, the claims are drawn to Certain Methods of Organizing Human Activity, Mental Processes, and/or Mathematical Concepts which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claims fail to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claims 1 and 16, respectively, recite positioning a plurality of sensors on a body surface of the patient, obtaining a plurality of patient-specific sensor positions corresponding to the plurality of sensors using a 3D optical scanner and obtaining a plurality of EMG signals using the plurality of sensors, which is merely adding insignificant pre-solution activity to the judicial exception (MPEP 2106.05(g)). The positioned plurality of sensors, obtained plurality of patient-specific sensor positions, and EMG signals does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the positioned plurality of sensors, obtained plurality of patient-specific sensor positions and EMG signals, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
positioning a plurality of sensors on a body surface of the patient;
obtaining a plurality of patient-specific sensor positions corresponding to the plurality of sensors using a 3D optical scanner;
obtaining a plurality of EMG signals using the plurality of sensors
The positioning and obtaining steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the positioning and obtaining steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Regarding claims 1 and 16, the plurality of sensors and 3D Optical scanner recited in the claim are generic sensors/scanners (as evidenced by the non-patent literature of record - Gaia Amaranta Taberna et al 2019 J. Neural Eng. 16 026020; Cheng, L.K., Sands, G.B., French, R.L. et al. Rapid construction of a patient-specific torso model from 3D ultrasound for non-invasive imaging of cardiac electrophysiology. Med. Biol. Eng. Comput. 43, 325–330 (2005). https://doi.org/10.1007/BF02345808) configured to perform pre-solutional data gathering activity. Furthermore, according to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2, 14-15, and 20 are directed to insignificant pre-solution activity and insignificance extra-solution activity, i.e. mere data gathering and data outputting steps necessary to perform the abstract idea and claims 3-13 and 17-19 are directed to more abstract ideas (mental processes and/or mathematical concepts (reconstructing, transforming, classifying)), which does not add anything significantly more. Regarding claims 10-14 and 19, according to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
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 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.
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 1-5 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Raudins (US 20190015012 A1 – cited by IDS 1/9/25) in view of Calderon (US 20090062683 A1 - cited by IDS 1/9/25).
Regarding claim 1, Raudins discloses a method for imaging electrode geometry in a patient (Abstract, para. [0002]), the method comprising: providing an atlas comprising a reference body surface geometry (“template ... body of atlases for a plurality of different body shapes ... body atlas ... torso ... geometry”, para. [0058], fig. 7); positioning a plurality of sensors on a body surface of the patient (step 16, fig. 1 & as seen in figs. 8-9, “process of placing electrodes are placed on the body at 16”, para. [0028, 0055]); obtaining a plurality of patient-specific sensor positions corresponding to the plurality of sensors using a 3D optical scanner (steps 210-216, fig. 7, “range imaging device ... 3D scanning device ... optical imaging is performed”; “optical imaging is performed to digitize the electrodes on the body surface, demonstrated at 18 ... three-dimensional surface geometry of the torso is acquired based on the imaging at 18”; “3D electrode and surface geometry 216”, para. [0021-0022, 0029-0030]); and transforming the plurality of patient-specific sensor positions to a patient-specific body surface geometry by projecting the plurality of patient-specific sensor positions onto the reference body surface geometry of the atlas (as seen in fig. 12, generate geometry data 152/202; “electrode locations on the body surface and the anatomical envelope are registered in a common coordinate system”; “projected”; “reconstructed three-dimensional surface model 700 of a torso showing electrode marker locations ... electrode geometry ... registered with the body surface ... geometry computed”, para.[0041, 0046, 0057, 0061, 0068], steps 218 & 202 in fig. 7).
Raudins does not disclose a method for imaging uterine contractions in a patient and a body-surface uterus geometry.
However, Calderon directed to three-dimensional monitoring (e.g., measuring, imaging and displaying) of myographic activity, such as that of the uterus) discloses a method for imaging uterine contractions in a patient (“3D image of muscle contraction, in particular uterine myographic activity”, para. [0006, 0029]) and body-surface uterus geometry (as seen in fig. 2, “uterus ... 3D image of muscle contraction”, para. [0015, 0025-0029]). Calderon further discloses fiducial markers 62 placed or marked on the patient near the EMG sensors and that positions and orientation of the fiducial markers 62 may be sensed by position sensing system 22, such as by optical means (para. [0026-0027]).
Upon reading Calderon, one skilled in the art would have understood the uterus, as a contractile muscle, to be similar to the heart in that contractions of the uterus are directly proportional to the underlying electrical activity of the muscle. The frequency, duration and magnitude of a uterine contraction are directly proportional respectively to the frequency, duration and propagation of action potentials in the myometrium and other muscle cells associated with movement of the uterus (Calderon, paragraph [0003]) and as such one skilled in the art would understand the methodologies of Raudins could be adapted and used to further understand and noninvasively characterize myometrial contractions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins such that the method for imaging electrode geometry is adapted for imaging uterine contractions in a patient and provides body-surface uterus geometry, in view of the teachings of Calderon, as this would aid in three-dimensional monitoring of myographic activity of the uterus.
Regarding claim 2, Raudins, as modified by Calderon hereinabove, discloses the method of claim 1, the method further comprising obtaining a plurality of signals using the plurality of sensors (“one or more electrodes ... array 764 ... measuring electrical activity”, para. [0073, 0075-0077], Claim 12). Raudins, as modified by Calderon hereinabove, does not disclose the method further comprising obtaining a plurality of EMG signals using the plurality of sensors.
However, Calderon directed to an electromyogram (EMG) system operative to sense electromyographic activity discloses obtaining a plurality of EMG signals using the plurality of sensors (“measuring electromyographic activity ... EMG sensors 30”; “electrical signals are output from each EMG sensors 30 for each channel”, para. [0025, 0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon hereinabove, such that the method further comprising obtaining a plurality of EMG signals using the plurality of sensors, in view of the teachings of Calderon, as such a modification would have been merely a substitution of the one or more electrodes of Raudins for the EMG sensors of Calderon and would aid in obtaining electrical signals for three-dimensional monitoring of myographic activity of the uterus.
Regarding claim 3, Raudins, as modified by Calderon hereinabove, discloses the method of claim 2, the method further comprising reconstructing a plurality of uterine electrical signals based on the plurality of EMG signals and the patient-specific body surface-uterus geometry (fig. 12, “ reconstructed three-dimensional surface model 700”; “electrical activity that is reconstructed with respect to a geometric surface”, para. [0068, 0077], Claim 12).
Regarding claim 4, Raudins, as modified by Calderon hereinabove, discloses the method of claim 2, the method further comprising transforming the plurality of EMG signals into at least one uterine potential map based on the patient-specific body surface-uterus geometry (“mapping system 762 ... graphical maps ... demonstrating determined electrical activity that is reconstructed with respect to a geometric surface”; “electroanatomic maps”, para. [0077-0078, 0082]).
Regarding claim 5, Raudins, as modified by Calderon hereinabove, discloses the method of claim 4, the method further comprising transforming the at least one uterine potential map into at least one uterine electrogram and/or at least one isochrone map (“reconstruct epicardial potentials and to provide electrograms and isochrones”; “reconstructed electrograms ... algorithms that can be implemented by electrogram reconstruction 780 ... those disclosed in U.S. Pat. Nos. 7,983,743 and 6,772,004”, para. [0003, 0078, 0082]).
Regarding claim 16, Raudins discloses a method for imaging electrode geometry in a patient (Abstract, para. [0002]), the method comprising: providing an atlas comprising a reference body surface geometry (“template ... body of atlases for a plurality of different body shapes ... body atlas ... torso ... geometry”, para. [0058], fig. 7); positioning a plurality of sensors on a body surface of the patient (step 16, fig. 1 & as seen in figs. 8-9, “process of placing electrodes are placed on the body at 16”, para. [0028, 0055]); obtaining a plurality of patient-specific sensor positions corresponding to the plurality of sensors using a 3D optical scanner (steps 210-216, fig. 7, “range imaging device ... 3D scanning device ... optical imaging is performed”; “optical imaging is performed to digitize the electrodes on the body surface, demonstrated at 18 ... three-dimensional surface geometry of the torso is acquired based on the imaging at 18”; “3D electrode and surface geometry 216”, para. [0021-0022, 0029-0030]); transforming the plurality of patient-specific sensor positions to a patient-specific body surface geometry by projecting the plurality of patient-specific sensor positions onto the reference body surface geometry of the atlas (as seen in fig. 12, generate geometry data 152/202; “electrode locations on the body surface and the anatomical envelope are registered in a common coordinate system”; “projected”; “reconstructed three-dimensional surface model 700 of a torso showing electrode marker locations ... electrode geometry ... registered with the body surface ... geometry computed”, para.[0041, 0046, 0057, 0061, 0068], steps 218 & 202 in fig. 7).
Raudins does not disclose a method for imaging uterine contractions in a patient and a body surface-uterus geometry, obtaining a plurality of EMG signals using the plurality of sensors; and reconstructing a plurality of uterine electrical signals based on the plurality of EMG signals and the patient-specific body surface-uterus geometry.
However, Calderon discloses directed to three-dimensional monitoring (e.g., measuring, imaging and displaying) of myographic activity, such as that of the uterus) discloses a method for imaging uterine contractions in a patient (“3D image of muscle contraction, in particular uterine myographic activity”, para. [0006, 0029]), body-surface uterus geometry (as seen in fig. 2, “uterus ... 3D image of muscle contraction”, para. [0015, 0025-0029]), and obtaining a plurality of EMG signals using the plurality of sensors. Calderon further discloses fiducial markers 62 placed or marked on the patient near the EMG sensors and that positions and orientation of the fiducial markers 62 may be sensed by position sensing system 22, such as by optical means (para. [0026-0027]).
Upon reading Calderon, one skilled in the art would have understood the uterus, as a contractile muscle, to be similar to the heart in that contractions of the uterus are directly proportional to the underlying electrical activity of the muscle. The frequency, duration and magnitude of a uterine contraction are directly proportional respectively to the frequency, duration and propagation of action potentials in the myometrium and other muscle cells associated with movement of the uterus (Calderon, paragraph [0003]) and as such one skilled in the art would understand the methodologies of Raudins could be adapted and used to further understand and noninvasively characterize myometrial contractions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins such that the method for imaging electrode geometry is adapted for imaging uterine contractions in a patient, provides body-surface uterus geometry, and obtains a plurality of EMG signals using the plurality of sensors, in view of the teachings of Calderon, as such a modification would have been merely a substitution of the one or more electrodes of Raudins for the EMG sensors of Calderon and would aid in obtaining electrical signals for three-dimensional monitoring of myographic activity of the uterus.
Raudins, as modified by Calderon hereinabove, further discloses reconstructing a plurality of uterine electrical signals based on the plurality of EMG signals and the patient-specific body surface-uterus geometry (fig. 12, “ reconstructed three-dimensional surface model 700”; “electrical activity that is reconstructed with respect to a geometric surface”, para. [0068, 0077], Claim 12). .
Regarding claim 17, Raudins, as modified by Calderon hereinabove, discloses the method of claim 16, wherein reconstructing the plurality of uterine electrical signals produces at least one a uterine electrogram and/or at least one isochrone map (“reconstruct epicardial potentials and to provide electrograms and isochrones”; “reconstructed electrograms ... algorithms that can be implemented by electrogram reconstruction 780 ... those disclosed in U.S. Pat. Nos. 7,983,743 and 6,772,004”, para. [0003, 0078, 0082]).
Claims 6, 10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Raudins in view of Calderon, as applied to claims 2, 5, and 16 above, and further in view of Rudy (US 6772004 B2).
Regarding claim 6, Raudins, as modified by Calderon hereinabove, discloses the method of claim 5. Raudins, as modified by Calderon hereinabove, discloses the method further comprising transforming the at least one isochrone map into at least one summary parameter.
However, Rudy directed to a system and method for non-invasive electrocardiographic imaging discloses at least one isochrone map and transforming the at least one isochrone map into at least one summary parameter (“Isochrones ... slow activation spread ... 47 and 69 m-sec ... patterns of activation”, col. 10 lines 52 - col. 11 line 7 & col. 13 line 42-col. 14 line 67, figs. 17-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon hereinabove, such that the method further comprises transforming the at least one isochrone map into at least one summary parameter, in view of the teachings of Rudy, as this would aid in representing the patterns of activation and enabling significant information about the entire activation sequence to be seen at one glance.
Regarding claim 10, Raudins, as modified by Calderon hereinabove, discloses the method of claim 2 and the plurality of EMG signals (see claim 2 above, Calderon, para. [0025, 0031]). Raudins, as modified by Calderon hereinabove, does not disclose wherein the plurality of EMG signals comprises a body surface potential map ΦB.
However, Rudy directed to a system and method for non-invasive electrocardiographic imaging discloses the plurality of signals comprises a body surface potential map ΦB (“electrical potentials are measured ... electrode vest ... body surface potential map is generated”; “BSPMs were obtained with the 224-electrode vest and mapping system”, Abstract, col. 4 lines 9-32 & col 16 lines 30-43, claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon hereinabove, such that the plurality of EMG signals comprises a body surface potential map ΦB, in view of the teachings of Rudy, as this would aid in representing the distribution of electrical potentials over the body surface.
Regarding claim 18, Raudins, as modified by Calderon hereinabove, discloses the method of claim 16 and the plurality of EMG signals (see claim 16 above, Calderon, para. [0025, 0031]). Raudins, as modified by Calderon hereinabove, does not disclose wherein the plurality of EMG signals comprises a body surface potential map ΦB.
However, Rudy directed to a system and method for non-invasive electrocardiographic imaging discloses the plurality of signals comprises a body surface potential map ΦB (“electrical potentials are measured ... electrode vest ... body surface potential map is generated”; “BSPMs were obtained with the 224-electrode vest and mapping system”, Abstract, col. 4 lines 9-32 & col 16 lines 30-43, claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon hereinabove, such that the plurality of EMG signals comprises a body surface potential map ΦB, in view of the teachings of Rudy, as this would aid in representing the distribution of electrical potentials over the body surface.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Raudins in view of Calderon and Rudy, as applied to claim 6 above, and further in view of Gosh (US 20140371808 A1).
Regarding claim 7, Raudins, as modified by Calderon and Rudy hereinabove, discloses the method of claim 6. Raudins, as modified by Calderon and Rudy hereinabove, does not disclose wherein the at least one summary parameter includes activation ratio, activation duration, synchronized ratio, slow conduction ratio, and/or median propagation speed.
However, Gosh directed to evaluating the electrical activation patterns of the heart discloses isochrone or other activation maps (para. [0054]) and at least one summary parameter including activation ratio, activation duration, synchronized ratio, slow conduction ratio, and/or median propagation speed (“standard deviation of the activations-times (SDAT) ... index of electrical dyssynchrony is a range of activation times (RAT) ... index of electrical dyssynchrony ... percentage of late activation (PLAT)”, para. [0062-0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon and Rudy hereinabove, such that the at least one summary parameter includes activation ratio, activation duration, synchronized ratio, slow conduction ratio, and/or median propagation speed, in view of the teachings of Gosh, as this would aid in computing indices of electrical dyssynchrony.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Raudins in view of Calderon, Rudy, and Gosh, as applied to claim 7 above, and further in view of Young (US 20160242671 A1 – cited by IDS 1/9/25).
Regarding claim 8, Raudins, as modified by Calderon, Rudy, and Gosh hereinabove, discloses the method of claim 7. Raudins, as modified by Calderon, Rudy, and Gosh hereinabove, does not disclose the method further comprising classifying a labor status of the patient based on at least one of the at least one uterine potential map, the at least one uterine electrogram, the at least one isochrone map, and the at least one summary parameter.
However, Young directed to determining the status of labor in a pregnant subject using a method of recording using multichannel uterine electromyography (uEMG) (Absract, para. [0022]) discloses classifying a labor status of the patient based on at least one of the at least one uterine potential map, the at least one uterine electrogram, the at least one isochrone map, and the at least one summary parameter (“combination of frequency, strength, and uterine coordination (synchronization) provides a more complete assessment of uterine contractility and labor status”; “the synchronization of the regional contractions of the uterus—when combined with contraction frequency and strength measurements can be used to accurately predict both true and false labor”, para. [0006, 0022, 0026, 0113-0114]).
Upon reading Young, one skilled in the art would have understood the uterus, as a contractile muscle, to be similar to the heart in that the direct pathway between each pair of electrodes is a good approximation of the activity of the tissue directly between the electrodes and as exemplified by the standard (cardiac) EKG, it is possible to probe specific regions of electrically active tissue by judicious placement of skin electrode leads (Young, para. [0110-0115]). As such one skilled in the art would understand the methodologies of Raudins could be adapted and used to further understand and noninvasively measure the degree of uterine contraction coordination.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon, Rudy, and Gosh hereinabove, such that the method further comprises classifying a labor status of the patient based on at least one of the at least one uterine potential map, the at least one uterine electrogram, the at least one isochrone map, and the at least one summary parameter, in view of the teachings of Young, as this would aid in providing a more complete assessment of uterine contractility and labor status for accurately predicting both true and false labor.
Regarding claim 9, Raudins, as modified by Calderon, Rudy, Gosh, and Young hereinabove, discloses the method of claim 8. Raudins, as modified by Calderon, Rudy, Gosh, and Young hereinabove, does not disclose wherein the labor status of the patient includes early labor, late labor, preterm birth, or labor arrest.
However, Young directed to determining the status of labor in a pregnant subject using a method of recording using multichannel uterine electromyography (uEMG) (Absract, para. [0022]) discloses wherein the labor status of the patient includes early labor, late labor, preterm birth, or labor arrest (“determining ... subject in true labor or false labor”; “determining the stage of labor”; “first stage labor, second stage labor, or third stage labor”; “premature labor”; “failure-to-progress in labor”, para. [0006]).
Upon reading Young, one skilled in the art would have understood the uterus, as a contractile muscle, to be similar to the heart in that the direct pathway between each pair of electrodes is a good approximation of the activity of the tissue directly between the electrodes and as exemplified by the standard (cardiac) EKG, it is possible to probe specific regions of electrically active tissue by judicious placement of skin electrode leads (Young, para. [0110-0115]). As such one skilled in the art would understand the methodologies of Raudins could be adapted and used to further understand and noninvasively measure the degree of uterine contraction coordination.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon, Rudy, and Gosh hereinabove, such that the labor status of the patient includes early labor, late labor, preterm birth, or labor arrest, in view of the teachings of Young, as this would aid in determining the status of labor in a pregnant subject.
Claims 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Raudins in view of Calderon, as applied to claim 1 above, further in view of Yoon (US 20100215235 A1), and further in view of Xu (X. G. Xu, V. Taranenko, J. Zhang, and C. Shi, “A boundary-representation method for designing whole-body radiation dosimetry models: Pregnant females at the ends of three gestational periods-RPI-P3, -P6 and -P9,” Phys. Med. Biol., vol. 52, no. 23, pp. 7023-7044, December 2007).
Regarding claim 15, Raudins, as modified by Calderon hereinabove, discloses the method of claim 1. Raudins further discloses that template selection can also be enhanced in response to previous medical imaging for a given patient and in response to the template selection and user input the corresponding torso and cardiac envelope geometry can be generated at 208 and stored in memory (para. [0058]).
Raudins, as modified by Calderon hereinabove, does not disclose wherein providing the atlas comprising the reference body surface-uterus geometry includes obtaining a 3D scan of the patient and projecting the 3D scan to an RPI geometry.
However, Yoon directed to the identification of body landmarks from three-dimensional (3D) human body scans discloses obtaining a 3D scan of the patient and projecting the 3D scan to a geometry (“3D-scanned body”; “best-matched part-meshes were projected onto the unmarked body to obtain the required landmarks”; “scanning a plurality of three-dimensional scans of a subject body, a human body (S200)”, para. [0039, 0073, 0078-0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon hereinabove, such that providing the atlas comprising the reference body surface-uterus geometry includes obtaining a 3D scan of the patient and projecting the 3D scan to a geometry, in view of the teachings of Yoon, as this would aid in automatic landmarking of a 3D-scanned body (para. [0073]) to provide a customized model of anatomy that defines a body surface.
Raudins, as modified by Calderon and Yoon hereinabove, does not disclose an RPI geometry.
However, Xu directed to a project to adopt the BREP modeling approach to systematically design whole-body radiation dosimetry models: a pregnant female and her fetus at the ends of three gestational periods of 3, 6 and 9 months discloses RPI geometry (Abstract, “finalized RPI-P models”, fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon and Yoon hereinabove, to further comprise RPI geometry, in view of the teachings of Xu, as such a modification would have been merely a substitution of the templates of Raudins for the RPI-P models of Xu, and would aid in providing 3D surface geometries of pregnant females.
Regarding claim 20, Raudins, as modified by Calderon hereinabove, discloses the method of claim 16. Raudins further discloses that template selection can also be enhanced in response to previous medical imaging for a given patient and in response to the template selection and user input the corresponding torso and cardiac envelope geometry can be generated at 208 and stored in memory (para. [0058]).
Raudins, as modified by Calderon does not disclose wherein providing the atlas comprising the reference body surface-uterus geometry includes obtaining a 3D scan of the patient and projecting the 3D scan to an RPI geometry.
However, Yoon directed to the identification of body landmarks from three-dimensional (3D) human body scans discloses obtaining a 3D scan of the patient and projecting the 3D scan to a geometry (“3D-scanned body”; “best-matched part-meshes were projected onto the unmarked body to obtain the required landmarks”; “scanning a plurality of three-dimensional scans of a subject body, a human body (S200)”, para. [0039, 0073, 0078-0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon hereinabove, such that providing the atlas comprising the reference body surface-uterus geometry includes obtaining a 3D scan of the patient and projecting the 3D scan to a geometry, in view of the teachings of Yoon, as this would aid in automatic landmarking of a 3D-scanned body (para. [0073]) to provide a customized model of anatomy that defines a body surface.
Raudins, as modified by Calderon and Yoon hereinabove, does not disclose an RPI geometry.
However, Xu directed to a project to adopt the BREP modeling approach to systematically design whole-body radiation dosimetry models: a pregnant female and her fetus at the ends of three gestational periods of 3, 6 and 9 months discloses RPI geometry (Abstract, “finalized RPI-P models”, fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raudins, as modified by Calderon and Yoon hereinabove, to further comprise RPI geometry, in view of the teachings of Xu, as such a modification would have been merely a substitution of the templates of Raudins for the RPI-P models of Xu, and would aid in providing 3D surface geometries of pregnant females.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kalinin (US 20160338611 A1) directed to systems and methods for noninvasive and/or invasive imaging of cardiac electrical activity using numerical reconstruction of cardiac action potentials.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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