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 .
Claims 1-24 are cancelled. Claims 34-40 are withdrawn. Claims 25-33 and 41-44 are hereby under examination.
Election/Restrictions
Claims 34-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/14/2026.
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 sensing module, signal processing module, and processor module in claim 25 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Describe the structure, material, or acts that correspond to signal processing module, and processor module in claim 25, a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f).
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.
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: sensing module, signal processing module, and processor module in claim 25.
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.
sensing module is interpreted as a patch, electrical sensor, sensing electrodes and its equivalents.
Signal processing module is merely described in functions, lacking structural disclosure ([0182]).
Processor module is merely described in functions, lacking structural disclosure ([0043])
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25, 27-28, 32, and 41-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The structures of signal processing module and processor module is not disclosed in the specification. The means plus function is not being supported by an enabling disclosure because the person skilled in the art would not know how to make and use the invention without a description of elements to perform the function.
Claims 26, 29-31 and 33 are rejected due to their dependencies on the rejected claims.
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 25, 27-28, 32, and 41-44 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.
As to claims 25, 27-28, 32, and 41-44, claim limitation “signal processing module” and “processor module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. No association between the structure and the function can be found in the specification. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 26, 29-31 and 33 are rejected due to their dependencies on the rejected claims.
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 25-33 and 41-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 25-33 and 41-44 are directed to a “system”, which describes one of the four statutory categories of patentable subject matter, i.e., a machine
Step 2A of the subject matter eligibility test (see MPEP 2106.04)
Prong one: Claims 25-33 and 41-44 recite abstract idea, as follows:
…receive electrical activity measurements…and isolate from the electrical activity measurements a signal comprising a slow wave contractility frequency representative of the target pelvic structure…receive as an input the plurality of signals comprising a slow wave contractility frequency representative of the target pelvic structure; generate a data profile of the subject comprising the plurality of signals representative of the slow wave contractility frequency of the target pelvic structure in the subject at the plurality of spaced-apart time points during the subject's hormonal cycle; compare the data profile with a database comprising reference data profiles of reference subjects with or without the endocrine disorder, in which each reference data profile comprises a plurality of signals representative of the slow wave contractility frequency of the target pelvic structure in the reference subject at a plurality of spaced-apart time points during the reference subject's hormonal cycle; and output the endocrine disorder status of the subject based on the comparison, wherein when the subject is female the hormonal cycle is the menstrual cycle and when the subject is male the hormonal cycle is any 24-hour period. (claim 25)
Based on the broadest reasonable interpretation, receiving electrical activity measurements, isolating a signal comprising slow wave contractility frequency, generating a data profile, comparing the data profile with a database, outputting the endocrine disorder can be done mentally with the aid of a pen and paper. A person can receive the electrical activity measurements on a piece of paper and either graphically or mathematically isolate a signal comprising slow wave contractility, and generate a data profile by drawing or writing down the data associated with a subject, compare the data profile visually or mathematically with a hand-written database on paper, output the endocrine disorder verbally.
Prong two: Claims 25-33 and 41-44 do not include additional elements that integrate the abstract into a practical application.
The additional elements are as follows:
sensing module
signal processing module
processor module
Reciting a computer or computer components (signal processing module and processor module) simply amounts to reciting a general processor to perform general functions of a computer as above to perform the mental processes of receiving electrical activity measurements, isolating a signal comprising slow wave contractility frequency, generating a data profile, comparing the data profile with a database, outputting the endocrine disorder are mere instructions to apply the judicial exception to general technology. Such elements do not integrate the exception into a practical application since they are merely instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Therefore, claims 25-33 and 41-44 are ineligible at step 2A, prong two.
Step 2B of the subject matter eligibility test (see MPEP 2106.05)
Reciting a computer or computer components (signal processing module and processor module) simply amounts to reciting a general processor to perform general functions of a computer as above to perform the mental processes of receiving electrical activity measurements, isolating a signal comprising slow wave contractility frequency, generating a data profile, comparing the data profile with a database, outputting the endocrine disorder are mere instructions to apply the judicial exception to general technology.
Such elements do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in 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 in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Therefore, claims 25-33 and 41-44 are ineligible at step 2B.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 25, 27-28, 30-31, 33, and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over US20170157397A1 (Lockwood et. al), hereto referred as Lockwood, and in view of US20200196958A1 (Penders et. al), hereto referred as Penders
As to claim 25, Lockwood teaches a system to determine status of an endocrine disorder in a subject characterised by abnormal contractility activity of a target pelvic structure (Lockwood, [0007], “The sensing component can be configured to detect at least one physiological parameter associated with the obstetric or gynecological disorder”, [0026], “endometriosis”), the system comprising:
a sensing module to measure electrical activity of the subject's pelvis at a plurality of spaced- apart time points during the subject's hormonal cycle (Lockwood, [0053], “sensing component 22 can comprise an electrode”; the examiner notes that sensing at any time is part of a hormonal cycle);
a signal processing module configured to receive electrical activity measurements from the sensing module (Lockwood, Fig. 8, sensing component 22) and isolate from the electrical activity measurements a signal comprising a slow wave contractility frequency representative of the target pelvic structure (Lockwood, [0069], “uterine contractions”; [0078], “the detected level(s) of electrical activity can then be relayed to the controller 24”; [0023], “In further instances, the term can refer to the frequency”; the examiner notes, the electrical activity is interpreted as uterine contractions in frequency); and
a processor module operably connected to the signal processing module and configured to: receive as an input the plurality of signals comprising a slow wave contractility frequency representative of the target pelvic structure (Lockwood, Fig. 8, controller 24, the controller is operably connected to sensing component 22);
generate a data profile of the subject comprising the plurality of signals representative of the slow wave contractility frequency of the target pelvic structure in the subject at the plurality of spaced-apart time points during the subject's hormonal cycle (Lockwood, [0061], “the controller 24 can be configured to record and store data indicative of…activity in the subject”; the examiner interpreted the stored data as the data profile of the subject);
compare the data profile with a database comprising reference data profiles of reference subjects with or without the endocrine disorder, in which each reference data profile comprises a plurality of signals representative of the slow wave contractility frequency of the target pelvic structure in the reference subject at a plurality of spaced-apart time points during the reference subject's hormonal cycle (Lockwood, [0078], “Where the detected level(s) is/are within an abnormal range (e.g., at an elevated or decreased level as compared to a control or baseline)”); and
output the endocrine disorder status of the subject based on the comparison, wherein when the subject is female the hormonal cycle is the menstrual cycle and when the subject is male the hormonal cycle is any 24-hour period (Lockwood, [0078], “Where the detected level(s) is/are within an abnormal range (e.g., at an elevated or decreased level as compared to a control or baseline), the controller 24 can cause the power source 16 to deliver an electrical signal”; the examiner notes, the controller causing the power source to deliver electrical signal is a cause of outputting the endocrine disorder status from the controller).
However, Lockwood does not necessarily teach that reference data profile comprises a plurality of signals. Penders teaches a similar art of uterine activity monitoring. Penders teaches that reference data profile comprises a plurality of signals (Penders, [0065], “the one or more references include one or more of: a database”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lockwood in view of Penders to include that reference data profile comprises a plurality of signals because Lockwood already teaches using reference data to compare, and having plurality of signals would allow comparing pluralities of data to the reference.
As to claim 27, Lockwood does not teach the details of the signal processing module. However, Penders teaches the signal processing module comprises a filter configured to isolate a signal (Penders, "signals are: sensed by the sensors 12; amplified, filtered, digitized and/or otherwise processed by the electronic circuit 15"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Lockwood in view of Penders to include the signal processing module comprises a filter configured to isolate a signal comprising a slow wave contractility frequency representative of the target pelvic structure because Lockwood already teaches signal processing slow wave contractility frequency representative of the target pelvic structure, and Penders supplies the details of signal processing.
As to claim 28, Lockwood does not teach the processor module is configured to receive as an additional input a plurality of measurements of at least one non-electrical hormonal cycle parameter taken at a plurality of time points during the subject's hormonal cycle, wherein the generated data profile of the subject comprises the electrical contractility parameter measurements representative of the target pelvic structure and the non-electrical hormonal cycle parameter measurements. Penders teaches processor module is configured to receive as an additional input a plurality of measurements of at least one non-electrical hormonal cycle parameter (Penders, [0184], "a maternal skin or body temperature"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Lockwood in view of Penders to include processor module is configured to receive as an additional input a plurality of measurements of at least one non-electrical hormonal cycle parameter taken at a plurality of time points during the subject's hormonal cycle, wherein the generated data profile of the subject comprises the electrical contractility parameter measurements representative of the target pelvic structure and the non-electrical hormonal cycle parameter measurements because Lockwood already teaches the component of plurality of measurements taken at a plurality of time points and generating a data profile comprising the electrical contractility parameter measurements representative of the target pelvic structure, and Penders suggests to include at least one non-electrical hormonal cycle parameter, which would increase the accuracy of diagnosis due to more helpful data being added, as suggested by Penders (Penders, [0209, “the plurality of maternal characteristics additionally or alternatively is monitored over time and correlated to the plurality of uterine electrical activity characteristics”).
As to claim 30, Lockwood-Penders teaches the endocrine disorder is endometriosis, the subject is female, and the hormonal cycle is the menstrual cycle (Lockwood, [0026], “endometriosis”).
As to claim 31, Lockwood-Penders teaches to determine whether a non- pregnant female has endometriosis, in which the endocrine disorder is endometriosis, the subject is female, and the hormonal cycle is the menstrual cycle (Lockwood, Fig. 1; the examiner notes, the menstrual cycle is continuous in a female subject).
As to claim 33, Lockwood-Penders teaches the plurality of spaced apart time points during the subject's menstrual cycle (Lockwood, [0023], “In further instances, the term can refer to the frequency at which a nerve or neuron is conducting, propagating, and/or generating one or more action potentials over a given period of time (e.g., seconds, minutes, hours, days, etc.).”). However, Lockwood does not teach plurality of spaced apart time points during the subject's menstrual cycle are days 1, 7, 14 and 21, in which the day 14 measurement may be taken at day 14 +/- 1 day. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lockwood to include that the plurality of spaced apart time points during the subject's menstrual cycle are days 1, 7, 14 and 21, in which the day 14 measurement may be taken at day 14 +/- 1 day because Lockwood already teaches spaced apart time points during the subject's menstrual cycle, and a person of ordinary skills in the art would routinely optimize the specific days as 1, 7, 14 and 21, in which the day 14 measurement may be taken at day 14 +/- 1.
As to claim 41, Lockwood-Penders teaches the signal processing module is configured to amplify and digitize the electrical activity measurements (Penders, [0188], "signals are: sensed by the sensors 12; amplified, filtered, digitized and/or otherwise processed by the electronic circuit 15"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Lockwood in view of Penders to include the signal processing module comprises a filter configured to isolate a signal comprising a slow wave contractility frequency representative of the target pelvic structure because Lockwood already teaches signal processing slow wave contractility frequency representative of the target pelvic structure, and Penders supplies the details of signal processing.
As to claim 42, Lockwood-Penders teaches the signal processing module comprises a filter and isolating slow wave contractility frequency representative of the subject's uterus (Lockwood, [0069], “uterine contractions”; [0078], “the detected level(s) of electrical activity can then be relayed to the controller 24”; [0023], “In further instances, the term can refer to the frequency”; the examiner notes, the electrical activity is interpreted as uterine contractions in frequency). However, Lockwood does not specifically teach the filter is configured to isolate the signal comprising a slow wave contractility frequency representative of the subject's uterus. Penders teaches a filter configured to isolate a signal (Penders, [0190], “band-pass filter”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Lockwood in view of Penders to include isolating the signal comprising a slow wave contractility frequency representative of the subject's uterus because Lockwood already teaches isolating slow wave contractility frequency representative of the subject's uterus and Penders supplies a known method of doing so.
As to claim 43, Lockwood does not teach that the signal processing module is configured to transform the electrical activity measurements into the frequency domain. Penders teaches transforming the electrical activity measurements into the frequency domain (Penders, [0173], “Some embodiments mitigate some or all of the problems discussed above by combining time and frequency domain features”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Lockwood in view of Penders to include transforming the electrical activity measurements into the frequency domain because Lockwood already teaches signal processing electrical activity measurements, and Penders supplies the details of signal processing
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Lockwood and Penders as applied to claim 25 above, and further in view of WO2008144613A1 (Quinones et. al), hereto referred as Quinones.
Claim 25 is taught as above.
As to claim 26, Lockwood-Penders teaches that the subject's data profile is correlated with endocrine disorder status (Lockwood, Fig. 7, step 38) and teaches reference data profiles from a population of reference subjects with a known endocrine disorder (Lockwood, [0078], “control or baseline”). However, Lockwood-Penders does not teach employing a classification model generated using reference data profiles from a population of reference subjects with a known endocrine disorder status selected from positive for the disorder, negative for the disorder, risk of developing the disorder, and severity of disorder. Quinones teaches a solution to a relevant art of determining a disorder status (Quinones, abstract, “capable of classifying subjects according to bipolar disorder status”). Quinones teaches employing a classification model generated using reference data profiles from a population of reference subjects with a known disorder status selected from positive for the disorder, negative for the disorder, risk of developing the disorder, and severity of disorder (Quinones, pg. 30, lines 16-17, “A neural network is trained by introducing a population of subjects in which the bipolar disorder status is known”; Pg. 4, lines 28-30, “the presence or absence of the disorder, the risk of developing the disorder, the stage of the disorder”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lockwood-Penders in view of Quinones to include employing a classification model generated using reference data profiles from a population of reference subjects with a known endocrine disorder status selected from positive for the disorder, negative for the disorder, risk of developing the disorder, and severity of disorder as Lockwood-Penders teaches determining endocrine disorder status, and Quinones supplies a method of delivering the status with more useful details.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Lockwood and Penders as applied to claim 28 above, and further in view of US20220005579A1 (Suzuki et. al), hereto referred as Suzuki.
Claim 28 is taught as above.
As to claim 29, Lockwood-Penders teaches measuring non-electrical menstrual cycle parameter and the subject is female (Lockwood, Fig. 1). However, Lockwood-Penders does not necessarily teach the non-electrical menstrual cycle parameter is selected from pain location, pain intensity, pain type, and bleeding occurrence. Suzuki teaches a solution to a relevant problem of measuring non-electrical data. Suzuki teaches menstrual cycle parameter is selected from pain location, pain intensity, pain type, and bleeding occurrence (Suzuki, [0072], “menstrual pain”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lockwood-Penders in view of Suzuki to include a menstrual cycle parameter is selected from pain location, pain intensity, pain type, and bleeding occurrence because doing so would allow better detection of abnormalities, as recognized by Suzuki (Suzuki, [0072], “FIG. 11 is a figure showing an example of a screen for inquiring about the user's troubles”)
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Lockwood and Penders as applied to claim 30 above, and further in view of US5776073A (Garfield et. al), hereto referred as Garfield.
Claim 30 is taught as above.
As to claim 32, Lockwood-Penders teaches the signal processing module is configured to isolate from each electrical activity measurement a signal comprising a slow wave contractility frequency representative of the uterus (Lockwood, [0069], “uterine contractions”; [0078], “the detected level(s) of electrical activity can then be relayed to the controller 24”; [0023], “In further instances, the term can refer to the frequency”; the examiner notes, the electrical activity is interpreted as uterine contractions in frequency);
however, Lockwood-Penders does not teach that slow wave contractility frequency is in the range of 0.00 to 0.05 Hz. Garfield teaches a relevant art of monitoring uterine electrical activity (Garfield, title). Garfield teaches that slow wave contractility frequency is in the range of 0.00 to 0.05 Hz (Garfield, Col. 4, lines 49-51, "For instance, in human beings, the primary frequency range of interest for the identification of uterine contractility from surface abdominal signals is .01 Hz-10 Hz"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lockwood-Penders in view of Garfield to include that slow wave contractility frequency is in the range of 0.00 to 0.05 Hz because Lockwood-Penders already teaches the signal processing module is configured to isolate from each electrical activity measurement a signal comprising a slow wave contractility frequency representative of the uterus, and Garfield supplies the details of slow wave contractility frequency.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Lockwood and Penders as applied to claim 25 above, and further in view of US5716377A (Rise et. al), hereto referred as Rise.
Claim 25 is taught as above.
As to claim 44, Lockwood-Penders teaches the sensing module is configured to measure an EMG signal of the subject’s pelvis (Lockwood, [0068], “other examples of sensors and feedback control techniques that may be employed as part of the present disclosure are disclosed in U.S. Pat. No. 5,716,377”). Rise teaches a solution to a relevant art of using sensors to measure physiological parameters (Rise, Fig. 2, sensor 130). Rise teaches a sensor configured to measure EMG (Rise, col. 4, lines 6-7, "Sensor 130 may detect muscle EMG in one, two or more muscles"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lockwood-Penders to include that sensing module is configured to measure an EMG signal of the subject’s pelvis in view of Rise because Lockwood already considers the types of sensors used by Rise and doing so would allow measurement of muscle movement, as recognized by Lockwood (Lockwood, [0045], “The pelvic diaphragm, the sphincter urethrae and transverse peroneus muscles, and the perineal membrane support the vagina”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791