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 .
Response to Amendment
This office action is in response to the amendment filed on 2/23/2026. Currently claims 1-9 and 11-20 are pending.
Response to Arguments
Applicant’s arguments, see pg. 9, filed 2/23/2026, with respect to the previous objection of the drawings have been fully considered and are persuasive. The previous objection of the drawings has been withdrawn.
Applicant's arguments filed 2/23/2026, with respect to the previous objection of claim 20 have been fully considered but they are not persuasive. In particular, applicant has neither amended claim 20, nor addressed why the objection of claim 20 is improper. Therefore, the objection will be maintained.
Applicant’s arguments, see pg. 9, filed 2/23/2026, with respect to the previous rejection under 35 USC 112(b) of claim 17 have been fully considered and are persuasive. The previous rejection under 35 USC 112(b) of claim 17 has been withdrawn.
Applicant’s arguments, see pgs. 9-14, filed 2/23/2026, with respect to the previous rejection(s) of:
claim(s) 1-5 rejected under 35 USC 103 as being unpatentable over Nakamura
claim(s) 6 and 8 rejected under 35 USC 103 as being unpatentable over Nakamura in view of Toth
Claims(s) 9 and 16 as being unpatentable over Nakamura in view of Toth in view of Singh
claim(s) 7 rejected under 35 USC 103 as being unpatentable over Nakamura in view of Koblish in view of Toth
claim(s) 18-19 rejected under 35 USC 103 as being unpatentable over Nakamura in view of Toth
claim(s) 20 rejected under 35 USC 103 as being unpatentable over Nakamura in view of Toth in view of Singh
have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the additional reference of Nezhat et al (US 6123701) as outlined below.
Applicant’s arguments, see pg. 12-13, filed 2/23/2026, with respect to the previous rejection(s) of:
Claim(s) 9 and 11-14 as being unpatentable over Calderon in view of Singh
Claim(s) 15 as being unpatentable over Calderon in view of Singh in view of Aina-Mumuney
Claim(s) 17 as being unpatentable over Calderon in view of Singh in view of Maalouf
have been fully considered but they are not persuasive.
Applicant has amended claims 9 and 12 to include “obtaining a feature related to a peristaltic activity of the non-pregnant uterus based at least partly on said first digital data and on said second digital data” and “generating a pattern related to a peristaltic activity of the non-pregnant uterus based on the first digital data and second digital data corresponding to the non-pregnant uterus” respectively which were originally in claims dependent to claims 9 and/or 12. Applicant argues that the references of Calderon, Singh, and Toth either individually or combined as outline in previous non-final mailed on 12/1/2025 fail to disclose these limitations of claims 9 and 12 as amended [see pgs. 12-13 filed on 2/23/2026].
This response is not persuasive because it is not commensurate to the scope of the claims. “A feature” and “a pattern” are fairly broad terms and there doesn’t appear to be a special definition for these terms in the disclosure. Additionally, the feature or pattern only need to be “related” in some way to peristaltic activity which again adds additional broadness to the limitation being claimed. Para 28 of applicant’s specification received on 9/20/2022 (hereafter referred to as applicant spec) states:
“The electromyogram may represent a predicted or characterized peristaltic activity cycle of the individual or a portion thereof.”
And para 38 of Applicant spec states:
“FIG. 6 is an example of an electromyogram and a calculated signal for representation of peristaltic activity according to further aspects of the invention”
And para 48 of Applicant spec states:
“The analog signals may be transmitted to a display means, such as a monitor or screen, for visualization (which may be referred to as an electromyogram).”
These sections appear to explain an electromyogram as being a visualization of analog signals and an electromyogram as being at the very least related to peristaltic activity. Thus, an electromyogram is understood to show a pattern and a feature that is at the very least related to peristaltic activity as claimed. Thus, by modifying Calderon with that of Singh as outlined below and in the previous office action one would obtain EMG data related to both that the follicular phase and the luteal phase. Since EMG data is at least related to characterized peristaltic activity, a pattern and a feature as claimed is understood to be taught by Calderon in view of Singh as claimed. Even claim 11 (which further clarifies) a feature of claim 9 is still fairly broad and understood to be disclosed by EMG as outlined in the previous and current rejections, as an EMG can at least provide peaks in muscle contractions (i.e. note the claim only recites the broader peaks rather than something more specific like the global peaks) which are understood to be shown on EMG. Thus, while the grounds of rejection have been updated to reflect the amended language, the grounds of rejection are substantially similar to the previous non-final. However, it should be noted that while claim 11 is disclosed as discussed above as the claims is currently written, some of the more specific examples given in claim 11 for a feature are not disclosed by EMG data. For example, mean intensity and mean contraction intensity are not disclosed by EMG data alone as disclosed Calderon in view of Singh. Thus, if applicant has support and can further clarify features and/or pattern, applicant could potentially overcome the current grounds of rejection depending on the language used.
Claim Objections
Claim 20 is objected to because of the following informalities:
The limitation:
“a probe comprising;
Should be changed to:
“a probe comprising:”
Also, when amending, please double check spelling and grammar for any possible minor issues that might have been missed.
Appropriate correction is required.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et al (US 20190223755) hereafter known as Nakamura in view of Nezhat et al (US 6123701) hereafter known as Nezhat.
Independent claim:
Regarding claim 1:
A probe for measuring uterine muscle activity in a non-pregnant uterus [see Figs. 2 and 5 and para 49… “FIG. 5 is a schematic representation of the picture of the uterine cavity measurement probe illustrated in FIG. 2.”], the probe comprising:
an elongate member [see Fig. 5 element 42 and para 66… “a substantially flexible rod-shaped member 42”];
a reference electrode having a rounded tip arranged at a distal end of the elongate member [see Fig. 5 element 44 and para 66… “redox potential difference electrode 44”];
a uterine internal orifice sensing electrode arranged concentrically with the reference electrode [see Figs. 2 and 5 element 46d and para 66… “the impedance electrodes 46a, 46b, 46c, and 46d”]; and
one or more uterine cavity wall sensing electrodes arranged between the reference electrode and the uterine internal orifice sensing electrode [see Fig. 5 element 46a-4c and para 66… “impedance electrodes 46a, 46b, 46c”];
wherein adjacent electrodes among the reference electrode, the one or more uterine cavity wall sensing electrodes and the uterine internal orifice sensing electrode are separated by an interelectrode distance along a longitudinal axis of the probe [see sections of element 42 separating elements 44 and 46], and
However, Nakamura fails to explicitly or implicitly disclose that “the probe is configured such that, in use, the reference electrode is in contact with a fundus of the uterus while the uterine internal orifice sensing electrode is in contact with a uterine internal orifice, the uterine internal orifice being a cervical opening area” as claimed.
Nakamura further discloses modifying the diameter of the probe according to the diameter of the subject’s uterine cavity [see para 66… “The diameter of the rod-shaped member 42 is φ2.5 mm that is the almost same as the diameter of the uterine cavity of the human body and however, may be changed according to the diameter of the subject's uterine cavity.”].
Nezhat discloses in the analogous art of electrode device procedures in the uterus [see Col. 10 lines 25-35…“Referring now to FIG. 6, a pair of electrodes 100 and 110 which are configured especially for engaging the exterior surface of a uterus is illustrated.”] that a known placement of an electrode at the uterine internal office is specifically at the cervical opening [see Col. 11 lines 45-60… “Optionally, an electrode may also be placed within the cervical opening as illustrated in FIG. 13. The electrode may be a conventional rod-type electrode and may act as the common or return electrode in the electrosurgical treatment.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura to size the diameter of the probe such that the reference electrode is in contact with a fundus of the uterus while the uterine internal orifice sensing electrode is in contact with a uterine internal orifice as claimed because this is a subset of different sizing of the diameters of the probe relative to the user disclosed by Nakamura.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Nakamura by configuring the probe so that the electrode at the uterine internal orifice is specifically at a cervical opening area because as taught by Nezhat this is a known configuration for electrode devices used in uterus procedures.
Regarding claim 2, see Fig. 2 and para 66 of Nakamura [see “the impedance electrodes 46a, 46b, 46c, and 46d are arranged with a predetermined interval therebetween on the surface of the rod-shaped member 42” and “the impedance electrodes 46 coat a portion around the axial line O2-O2 of the rod-shaped member 42”] which describe electrodes on a rod shaped member (i.e. a cylindrical shape) and being concentric around the O2 axis.
Regarding claim 3-5:
Nakamura discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above. Additionally, Nakamura discloses a single reference electrode [see Fig. 5 element 44 of Nakamura] and a single uterine internal orifice sensing electrode [see Fig. 5 element 46d of Nakamura] as recited by claim 5.
However, Nakamura is silent as to the geometric enter point of the reference electrode relative to the geometric center point of the uterine internal office sensing electrode, also Nakamura discloses an interelectrode distances of 4mm and 6 mm [see para 69… “In FIG. 5, lengths L1, L3, L5, and L7 of the impedance electrodes 46 each are 4.0 mm, an interval L2 between the impedance electrodes 46a and 46b, and an interval L6 between the impedance electrodes 46c and 46d each are 4.0 mm, and an interval L4 between the impedance electrodes 46b and 46c is 6.0 mm.”] and recites only 3 uterine cavity wall sensing electrodes [see Fig. 5 elements 46a, 46b, and 46c]. Thus, Nakamura fails to disclose “wherein a geometrical center point of the reference electrode and a geometrical center point of the uterine internal orifice sensing electrode are longitudinally separated by a distance of 33.0 to 40.0 mm” as recited by claim 3, “wherein the interelectrode distance is 4.3 to 4.7 mm” as recited by claim 4 or “seven uterine cavity wall sensing electrodes” as recited by claim 5.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the both the number and position of electrodes such that “wherein a geometrical center point of the reference electrode and a geometrical center point of the uterine internal orifice sensing electrode are longitudinally separated by a distance of 33.0 to 40.0 mm”, “wherein the interelectrode distance is 4.3 to 4.7 mm” and “seven uterine cavity wall sensing electrodes” by optimization through routine experimentation because absent unpredictable results the adjustment of the exact number and exact placement of the electrodes (including the center points) relative to one another and the body to obtain a strong measurement is a known method to yield a predictable result of a stronger and/or clearer signal.
Claim(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of Nezhat in view of Toth et al (US 20150289929) hereafter known as Toth.
Regarding claim 6:
Nakamura in view of Nezhat discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above and “the uterine internal orifice and the uterine cavity wall sensing electrodes are cylindrical electrodes and are arranged concentrically with the reference electrode” [see Fig. 2 and para 66 of Nakamura… see “the impedance electrodes 46a, 46b, 46c, and 46d are arranged with a predetermined interval therebetween on the surface of the rod-shaped member 42” and “the impedance electrodes 46 coat a portion around the axial line O2-O2 of the rod-shaped member 42” which describe electrodes on a rod shaped member (i.e. a cylindrical shape) and being concentric around the O2 axis. ]
However, Nakamura in view of Nezhat discloses a straight elongate member and thus fails to disclose “wherein the elongate member has a Coronary Sinus curvature”.
Toth discloses in the analogous art of stimulation to a uterus [see para 67… “and/or alter the sensitivity of an organ in a body to a stimulus, to alter neural communication between an organ and a neural circuit, and/or to treat a cancerous tumor. A non-limiting list of organs include a gall bladder, a kidney, a small intestine, a stomach, a large intestine, a spleen, a pancreas, a bladder, an adrenal gland, a prostate, a lung, a uterus, or the like.”] that probes with elastic material able to take specific curvature shapes (i.e. a configuration capable of having a coronary sinus curvature) provide the advantage of enabling an increased range of movement during procedures [see para 202… “one or more probes may be sufficiently hyper elastic (e.g. formed from a memory alloy material, a superelastic material, pseudo elastic, etc.) so as to effectively deploy from a very small deployment tube and expand outward to larger tissue areas over which to monitor/treat. Such a configuration may be advantageous in so far as a small number of unit sizes may be suitable for treating a wide range of anatomical structures. In addition, the designed curvature and form of a probe may be substantially chosen so as to further enable a wide deployable range of movement during a procedure.”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura in view of Nezhat’s probe’s elongate member by using an elastic material able to take specific curvature shapes (i.e. a configuration capable of having a coronary sinus curvature) similarity to that disclosed by Toth as this will provide the advantage of increased range of movement.
Independent claim:
Regarding claim 8:
A kit comprising a probe for measuring uterine muscle activity in a non-pregnant uterus [see Figs. 2 and 5 and para 49… “FIG. 5 is a schematic representation of the picture of the uterine cavity measurement probe illustrated in FIG. 2.”], the probe comprising:
an elongate member [see Fig. 5 element 42 and para 66… “a substantially flexible rod-shaped member 42”];
a reference electrode having a rounded tip arranged at a distal end of the elongate member [see Fig. 5 element 44 and para 66… “redox potential difference electrode 44”];
a uterine internal orifice sensing electrode arranged concentrically with the reference electrode [see Figs. 2 and 5 element 46d and para 66… “the impedance electrodes 46a, 46b, 46c, and 46d”]; and
one or more uterine cavity wall sensing electrodes arranged between the reference electrode and the uterine internal orifice sensing electrode [see Fig. 5 element 46a-4c and para 66… “impedance electrodes 46a, 46b, 46c”];
wherein adjacent electrodes among the reference electrode, the one or more uterine cavity wall sensing electrodes and the uterine internal orifice sensing electrode are separated by an interelectrode distance along a longitudinal axis of the probe [see sections of element 42 separating elements 44 and 46].
However, Nakamura fails to explicitly or implicitly disclose that “the probe is configured such that, in use, the reference electrode is in contact with a fundus of the uterus while the uterine internal orifice sensing electrode is in contact with a uterine internal orifice”, “a cannula that is configured to cover at least a portion of the probe during an insertion of the probe into the non-pregnant uterus, the uterine internal orifice being a cervical opening area” as claimed.
Nakamura further discloses modifying the diameter of the probe according to the diameter of the subject’s uterine cavity [see para 66… “The diameter of the rod-shaped member 42 is φ2.5 mm that is the almost same as the diameter of the uterine cavity of the human body and however, may be changed according to the diameter of the subject's uterine cavity.”].
Nezhat discloses in the analogous art of electrode device procedures in the uterus [see Col. 10 lines 25-35…“Referring now to FIG. 6, a pair of electrodes 100 and 110 which are configured especially for engaging the exterior surface of a uterus is illustrated.”] that a known placement of an electrode at the uterine internal office is specifically at the cervical opening [see Col. 11 lines 45-60… “Optionally, an electrode may also be placed within the cervical opening as illustrated in FIG. 13. The electrode may be a conventional rod-type electrode and may act as the common or return electrode in the electrosurgical treatment.”]
Toth discloses in the analogous art of stimulation to a uterus [see para 67… “and/or alter the sensitivity of an organ in a body to a stimulus, to alter neural communication between an organ and a neural circuit, and/or to treat a cancerous tumor. A non-limiting list of organs include a gall bladder, a kidney, a small intestine, a stomach, a large intestine, a spleen, a pancreas, a bladder, an adrenal gland, a prostate, a lung, a uterus, or the like.”] using a cannula to help deploy a probe with electrodes into a user’s body [see para 52… “a cannula including a lumen through which a fluid and/or a surgical tool may be passed, including a distal tip and a control end, the distal tip thereof shaped and dimensioned so as to fit within the lumen, the cannula shaped and dimensioned so as to extend from an entry site on the body into the lumen; and one or more probes configured with a tip, the probes deploy-ably coupled with the distal tip of the cannula, electrically, mechanically, and/or fluidly coupled to the control end of the elongate member, the tip of the probe shaped so as to penetrate into and/or through a wall of the lumen upon deployment from the cannula, one or more of the probes including one or more electrodes, electrically coupled to the probe”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura to size the diameter of the probe such that the reference electrode is in contact with a fundus of the uterus while the uterine internal orifice sensing electrode is in contact with a uterine internal orifice as claimed because this is a subset of different sizing of the diameters of the probe relative to the user disclosed by Nakamura.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Nakamura by configuring the probe so that the electrode at the uterine internal orifice is specifically at a cervical opening area because as taught by Nezhat this is a known configuration for electrode devices used in uterus procedures.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Nakamura in view of Nezhat by including a cannula configured to provide a lumen to through which to introduce the probe into the body similarity to that disclosed by Toth (i.e. thereby reciting “a cannula that is configured to cover at least a portion of the probe during an insertion of the probe into the non-pregnant uterus”) because this is a known way to introduce a probe with electrodes into the body.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of Nezhat as applied to claim 1 above, and further in view of Koblish et al (US 20140058375) hereafter known as Koblish in view of Toth.
Regarding claim 7:
Nakamura in view of Nezhat discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Nakamura in view of Nezhat is silent as to many of the details of the probe and therefore fails to disclose “a probe handle portion and a mechanism for adjustment of the distance between the reference electrode and the uterine internal orifice sensing electrode, wherein the mechanism is selected from the group consisting of: a telescopic extension mechanism allowing for displacement of the uterine internal orifice sensing electrode along the elongate member within a predefined extension of the elongate member, a slidably arranged uterine internal orifice sensing electrode on the elongate member such that the uterine internal orifice sensing electrode can be displaced along a length of the elongate member; and a constellation or fan configuration mechanism, wherein a plurality of elongate members comprising sensing electrodes are arranged so as to expand in a balloon- like manner inside the uterine cavity”.
Another embodiment of Nakamura discloses an elongate member comprising sensing electrodes arranged so as to expand in a balloon-like manner inside the uterine cavity for the purpose of bringing the electrodes into contact with the wall being measured [see Fig. 1 elements 20a-20c (i.e. sensing electrodes), element 18 (elongate member) and para 11… “a main body (balloon 18 in this embodiment) stretchable and expandable in at least a vagina wall direction after insertion into a vagina by air injection thereinto; four electrodes arranged substantially in a line around the surface of the main body with a predetermined interval therebetween, the electrodes being brought into contact with the vagina wall as the main body expands and stretches”]
Koblish discloses in the analogous art of electrode probes [see abstract… “A medical system includes a medical probe including an elongated member having a distal end, a metallic electrode mounted to the distal end of the elongated member, and a plurality of microelectrodes embedded within, and electrically insulated from, the metallic electrode.”] that including a handle assembly (i.e. probe handle portion) provides the advantage of making it easier to manipulate the device [see para 51… “The handle assembly 30 comprises a handle 32 composed of a durable and rigid material, such as medical grade plastic, and ergonomically molded to allow a physician to more easily manipulate the electrophysiology catheter 14.”].
Toth discloses in the analogous art of stimulation to a uterus [see para 67… “and/or alter the sensitivity of an organ in a body to a stimulus, to alter neural communication between an organ and a neural circuit, and/or to treat a cancerous tumor. A non-limiting list of organs include a gall bladder, a kidney, a small intestine, a stomach, a large intestine, a spleen, a pancreas, a bladder, an adrenal gland, a prostate, a lung, a uterus, or the like.”] including an interface that allows regions of the probe to slide relative to the rest of the elongate device (i.e. “a mechanism for adjustment of the distance between the reference electrode and the uterine internal office sensing electrode” and “a slidably arranged uterine internal orifice sensing electrode on the elongate member such that the uterine internal orifice sensing electrode can be displaced along a length of the elongate member”) to help with the positioning of the device relative to the lumen wall in which the device is placed [see para 108… “The elongate member may include and/or interface with one or more probes, at least a region of one or more of the probes slide-ably coupled to the elongate member so as to advance from the elongate member in a direction towards an associated lumen wall (e.g. radially, circumferentially, axially, combinations thereof, or the like). At least one probe may include an electrode, a needle, a fluid delivery aspect, combinations thereof, or the like.”]
It would have been obvious to further modify Nakamura in view of Nezhat by including an additional elongate member sensing electrodes that is arranged so as to expand in a balloon-like manner inside the uterine cavity similarly to the other embodiment disclosed by Nakamura (i.e. thereby reciting “wherein a plurality of elongate members comprising sensing electrodes are arranged so as to expand in a balloon- like manner inside the uterine cavity”) for the purpose of bringing the electrodes into contact with the wall being measured.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura in view of Nezhat by including a probe handle portion similarity to that disclosed by Koblish because this would provide the advantage of easier manipulation of Nakamura’s device by a user.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura in view of Nezhat in view of Koblish by including an interface that allows regions of the probe to slide relative to the rest of the elongate device similarity to that disclosed by Toth as will help further the positioning of the electrode relative to the rest of the wall of the uterine.
Claim(s) 9 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderon et al (US 20160345817) hereafter known as Calderon in view of Singh et al (US 20150313892) hereafter known as Singh.
Independent claim:
Regarding claim 9
A method of acquiring information of uterine muscle activity in a non-pregnant uterus [see claim 8…. “A method comprising using the vaginal speculum of claim 1 to generate signals indicative of electromyographic activity in a vagina, cervix, or uterus” and claim 9… “processing said signals to determine treatment of menstrual-related pain for non-pregnant women” and claim 1…. “Apparatus comprising: a vaginal speculum comprising a spreading element and at least two electromyographic sensors, at least one of said electromyographic sensors being mounted in or on said spreading element, said electromyographic sensors operative to generate signals indicative of electromyographic activity in a vagina, cervix, or uterus.”], the method comprising the steps of:
generating sets of analog signals based on electrical activity of uterine muscle sensed internally in a non-pregnant uterus [see claim 8…. “generate signals indicative of electromyographic activity in a vagina, cervix, or uterus”] including during menstruation [see para 4… “determination of a characteristic of uterine contractions, determination of intra-uterine pressure correlated to electromyographic activity, treatment of menstrual-related pain for non-pregnant women,” determining characteristics of uterine contractions and treating menstrual-related pain implies determining characteristic of uterine contractions during menstruation]
generating digital data from the sets of analog signals [see para 16… “The signals from the surface EMG sensors 16 are sent to an electrical connector 18 (such as via wired connection 19 or wireless connection, e.g., Bluetooth) which is in electrical communication with an EMG monitor or processor 20, such as the EUM-100 Pro system, commercially available from OB Tools Ltd., Israel. The EMG monitor can determine the presence, effectiveness, frequency and intensity of uterine contractions.”]
Also, Calderon is directed to determining characteristics of uterine contractions and treating menstrual-related pain [see para 4… “The system of the invention has many applications, such as without limitation, determination of a characteristic of uterine contractions, determination of intra-uterine pressure correlated to electromyographic activity, treatment of menstrual-related pain for non-pregnant women”] and collecting electromyographic activity of the uterus contractions from the signals [see claim 8 of Calderon... “generate signals indicative of electromyographic activity in a vagina, cervix, or uterus”]
However, beyond determining uterine characteristics during menstruations, Calderon fails to specify what phases of menstruations are analyzed including whether this analyzation occurs during the luteal phase and/or follicular phase. Therefore, Calderon fails to disclose “generating a first set of analog signals based on electrical activity of uterine muscle sensed internally in a non-pregnant uterus during a luteal phase of a menstrual cycle”, “generating a second set of analog signals based on electrical activity of uterine muscle sensed internally in the same non-pregnant uterus during a follicular phase of the menstrual cycle”, “generating first digital data from the first set of generated analog signals”, “generating second digital data from the second set of generated analog signals” or “obtaining a feature related to a peristaltic activity of the non-pregnant uterus based at least partly on said first digital data and on said second digital data”.
Singh discloses in the analogous art of diagnosing and/or treating uterine pain [see para 5… “The uterus frequently contracts throughout the entire menstrual cycle, and these contractions have been termed endometrial waves or contractile waves” and para 144….“Accordingly, an object of the invention is to provide methods and compositions for the treatment of pain associated with primary and secondary dysmenorrhea which provide effective control of pain”] that during menstruation contractions are known to occur and change in frequency and amplitude including during both the luteal phase and the follicular phases [see para 5… “In the early follicular phase, these contractions occur once or twice per minute and last 10-15 seconds with a low amplitude of usually 30 mmHg. The frequency increases to 3-4 per minute towards ovulation. During the luteal phase, the frequency and amplitude decrease, possibly to facilitate any implantation.”] and that these contractions are known to be responsible for the pain experienced during menstruation [see para 7… “These uterine contractions continue as they squeeze the old, dead endometrial tissue through the cervix and out of the body through the vagina. These contractions, and the resulting temporary oxygen deprivation to nearby tissues, are responsible for the pain or “cramps” experienced during menstruation.”]
Since Calderon is directed to determining characteristics of uterine contractions and treating menstrual-related pain and Singh discloses the characteristics of contractions (a reason for the pain) differ depending on the phase of menstruation including differences in the follicular phase and the luteal phase, it would have been obvious to modify Calderon to generate EMG data (i.e. generating analog signals based on electrical activity) and process the EMG data (i.e. generating digital data) as a set for each different phase of the menstruation cycling including that of both the luteal phase and follicular phase (i.e. thereby reciting “generating a first set of analog signals based on electrical activity of uterine muscle sensed internally in a non-pregnant uterus during a luteal phase of a menstrual cycle”, “generating a second set of analog signals based on electrical activity of uterine muscle sensed internally in the same non-pregnant uterus during a follicular phase of the menstrual cycle”, “generating first digital data from the first set of generated analog signals”, “generating second digital data from the second set of generated analog signals” and since EMG is also produced from the signals as discussed above, a featured related to peristaltic activity of the uterus based on the first and second digital data is obtained as claimed is recited as well) because one of ordinary skill would expect this more specific data on contractions based on each phase to provide a more accurate depiction on the characteristics of the contractions which would aid in better diagnostic and subsequent pain treatment.
Independent claim:
Regarding claim 12:
A method of acquiring information of uterine muscle activity in a non-pregnant uterus [see claim 8…. “A method comprising using the vaginal speculum of claim 1 to generate signals indicative of electromyographic activity in a vagina, cervix, or uterus” and claim 9… “processing said signals to determine treatment of menstrual-related pain for non-pregnant women” and claim 1…. “Apparatus comprising: a vaginal speculum comprising a spreading element and at least two electromyographic sensors, at least one of said electromyographic sensors being mounted in or on said spreading element, said electromyographic sensors operative to generate signals indicative of electromyographic activity in a vagina, cervix, or uterus.”], the method comprising the steps of:
generating a first set of analog signals based on electrical activity of uterine muscle sensed internally in a non-pregnant uterus [see claim 8…. “generate signals indicative of electromyographic activity in a vagina, cervix, or uterus”] including during menstruation [see para 4… “determination of a characteristic of uterine contractions, determination of intra-uterine pressure correlated to electromyographic activity, treatment of menstrual-related pain for non-pregnant women,” determining characteristics of uterine contractions and treating menstrual-related pain implies determining characteristic of uterine contractions during menstruation]
generating digital data from the sets of analog signals [see para 16… “The signals from the surface EMG sensors 16 are sent to an electrical connector 18 (such as via wired connection 19 or wireless connection, e.g., Bluetooth) which is in electrical communication with an EMG monitor or processor 20, such as the EUM-100 Pro system, commercially available from OB Tools Ltd., Israel. The EMG monitor can determine the presence, effectiveness, frequency and intensity of uterine contractions.”]
Also, Calderon is directed to determining characteristics of uterine contractions and treating menstrual-related pain [see para 4… “The system of the invention has many applications, such as without limitation, determination of a characteristic of uterine contractions, determination of intra-uterine pressure correlated to electromyographic activity, treatment of menstrual-related pain for non-pregnant women”] and collecting electromyographic activity of the uterus contractions [see claim 8 of Calderon... “generate signals indicative of electromyographic activity in a vagina, cervix, or uterus”].
However, beyond determining uterine characteristics during menstruations, Calderon fails to specify what phases of menstruations are analyzed including whether this analyzation occurs during the luteal phase and/or follicular phase. Therefore, Calderon fails to disclose “generating a first set of analog signals based on electrical activity of uterine muscle sensed internally in a non-pregnant uterus during a luteal phase of a menstrual cycle”, “generating a second set of analog signals based on electrical activity of uterine muscle sensed internally in the same non-pregnant uterus during a follicular phase of the menstrual cycle”, “generating first digital data from the first set of generated analog signals”, “generating second digital data from the second set of generated analog signals” or “generating a pattern related to a peristaltic activity of the non-pregnant uterus based on the first digital data and second digital data corresponding to the non-pregnant uterus”, or “generating a pattern related to a peristaltic activity of the non-pregnant uterus based on the first digital data and second digital data corresponding to the non-pregnant uterus”
Singh discloses in the analogous art of diagnosing and/or treating uterine pain [see para 5… “The uterus frequently contracts throughout the entire menstrual cycle, and these contractions have been termed endometrial waves or contractile waves” and para 144….“Accordingly, an object of the invention is to provide methods and compositions for the treatment of pain associated with primary and secondary dysmenorrhea which provide effective control of pain”] that during menstruation contractions are known to occur and change in frequency and amplitude including during both the luteal phase and the follicular phases [see para 5… “In the early follicular phase, these contractions occur once or twice per minute and last 10-15 seconds with a low amplitude of usually 30 mmHg. The frequency increases to 3-4 per minute towards ovulation. During the luteal phase, the frequency and amplitude decrease, possibly to facilitate any implantation.”] and that these contractions are known to be responsible for the pain experienced during menstruation [see para 7… “These uterine contractions continue as they squeeze the old, dead endometrial tissue through the cervix and out of the body through the vagina. These contractions, and the resulting temporary oxygen deprivation to nearby tissues, are responsible for the pain or “cramps” experienced during menstruation.”]
Since Calderon is directed to determining characteristics of uterine contractions and treating menstrual-related pain and Singh discloses the characteristics of contractions (a reason for the pain) differ depending on the phase of menstruation including differences in the follicular phase and the luteal phase, it would have been obvious to modify Calderon to generate EMG data (i.e. generating analog signals based on electrical activity) and process the EMG data (i.e. generating digital data) as a set for each different phase of the menstruation cycling including that of both the luteal phase and follicular phase (i.e. thereby reciting “generating a first set of analog signals based on electrical activity of uterine muscle sensed internally in a non-pregnant uterus during a luteal phase of a menstrual cycle”, “generating a second set of analog signals based on electrical activity of uterine muscle sensed internally in the same non-pregnant uterus during a follicular phase of the menstrual cycle”, “generating first digital data from the first set of generated analog signals”, “generating second digital data from the second set of generated analog signals” and since EMG is also produced from the signals as discussed above, a pattern related to peristaltic activity of the uterus based on the first and second digital data is generated as claimed is recited as well) because one of ordinary skill would expect this more specific data on contractions based on each phase to provide a more accurate depiction on the characteristics of the contractions which would aid in better diagnostic and subsequent pain treatment.
Dependent claims
Regarding claims 11 and 13, as outlined in claims 9 and 12 above and cited in claim 8 of Calderon [see “generate signals indicative of electromyographic activity in a vagina, cervix, or uterus”], the sets of data collected by Calderon in view of Singh includes electromyographic or EMG data which recites claim 13 and amplitudes (i.e peak muscle contraction intensity) and contraction durations as recited by claim 11.
Regarding claim 14, as discussed in claim 12 above and cited in claim 8 of Calderon [see “generate signals indicative of electromyographic activity in a vagina, cervix, or uterus”], the sets of data collected by Calderon in view of Singh are electromyographic or EMG data which is understood to provide an electromyogram based on the pattern. Additionally, para 4 of Calderon [see “measurement of electromyographic activity in the uterus for IVF re-introduction of fertilized eggs when the uterus is non-active to prevent rejection of fetuses”] discloses using this EMG data to determine when to apply IVF re-introduction of fertilized eggs. This when to apply IVF re-introduction of fertilized eggs is at least a time when there is a high probability implantation is high which is understood to recite “determining, based on the pattern, a time window during which a probability of embryo implantation is higher than a predefined threshold”
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of Toth in view of Singh.
Independent claim
Regarding claim 9:
Nakamura discloses:
A method of acquiring information of uterine muscle activity in a non-pregnant uterus [see abstract of Nakamura… “A non-invasive and accurate vagina evaluation device and uterine evaluation devices are provided that measure the receptivity (uterine implantation capacity) of the mother's body to a fertilized egg implanting itself into the uterus.” And “four or two impedance electrodes arranged with a predetermined interval therebetween in an insertion direction of the main body and brought into contact with an endometrium of the uterine cavity to measure a uterine endometrial impedance generated between the endometrium and each of the electrodes.” The endometrial impedance is at least information of uterine muscle activity and as it is implied that the egg is not yet implanted it is understood that the uterus is non-pregnant], the method comprising the steps of:
generating a first set of analog signals based on electrical activity of uterine muscle sensed internally in a non-pregnant uterus [see para 12 of Nakamura… “electrodes arranged on the surface of the main body can be brought into contact with the vaginal wall. The four electrodes are arranged substantially in a line, and the interval between the electrodes is fixed irrespective of expansion and stretching of the main body, achieving proper measurement according to a four-electrode method, which is mentioned below.” And para 77… “Each experimental group was examined more than 6 times.” 1 of these 6 times examined with the measurement signals from the electrodes being a first set of analog signals]
generating a second set of analog signals based on electrical activity of uterine muscle sensed internally in the same non-pregnant uterus [see para 12 of Nakamura…“electrodes arranged on the surface of the main body can be brought into contact with the vaginal wall. The four electrodes are arranged substantially in a line, and the interval between the electrodes is fixed irrespective of expansion and stretching of the main body, achieving proper measurement according to a four-electrode method, which is mentioned below.” And para 77… “Each experimental group was examined more than 6 times.” 1 of these 6 times examined is at least a second time window and each measurement signal from the electrodes is at least a second analog signal]
However, Nakamura fails fully to disclose:
“generating a first set of analog signals based on electrical activity of uterine muscle sensed internally in a non-pregnant uterus during a luteal phase of a menstrual cycle;
generating a second set of analog signals based on electrical activity of uterine muscle sensed internally in the same non-pregnant uterus during a follicular phase of the menstrual cycle;
generating first digital data from the first set of generated analog signals; and
generating second digital data from the second set of generated analog signals; and
obtaining a feature related to a peristaltic activity of the non-pregnant uterus based at least partly on said first digital data and on said second digital data.”
as claimed.
Toth discloses in the analogous art of stimulation to a uterus [see para 67… “and/or alter the sensitivity of an organ in a body to a stimulus, to alter neural communication between an organ and a neural circuit, and/or to treat a cancerous tumor. A non-limiting list of organs include a gall bladder, a kidney, a small intestine, a stomach, a large intestine, a spleen, a pancreas, a bladder, an adrenal gland, a prostate, a lung, a uterus, or the like.”] including a processor coupled to sensory electrodes for the purpose of assessing the functionality of the tissue (i.e. this assessment is understood to include generating digital data based on the received analog data… thereby reciting “generating first digital data from the first set of generated analog signals” and “generating second digital data from the second set of generated analog signals”) [see para 166… “one or more circuits and/or processors included in a system in accordance with the present disclosure may be coupled to a sensory electrode and may be configured to assess functionality of one or more regions of target tissue in the vicinity of the sensory electrode”] and specifically collecting EMG activity to help further monitor locations within the body [see para 394… “The method may include, monitoring one or more local physiological signals (e.g. an evoked potential, a neurological activity, MSNA, EMG, MMG, sympathetic tonal change, etc.) in accordance with the present disclosure at one or more measurement locations within and/or along an outer wall of the organ/lumen to determine one or more reference signals”]
Singh discloses in the analogous art of diagnosing and/or performing procedures related to the contractions of the uterus during the menstruation cycle [see para 2… “Dysmenorrhea (or dysmenorrhoea) is a gynecological medical condition of pain during menstruation that interferes with daily activities, as defined by, The American Congress of Obstetricians and Gynecologists (ACOG). Still, dysmenorrhea is often defined simply as menstrual pain, or at least menstrual pain that is excessive.” And para 5… “The uterus frequently contracts throughout the entire menstrual cycle, and these contractions have been termed endometrial waves or contractile waves” and para 144….“Accordingly, an object of the invention is to provide methods and compositions for the treatment of pain associated with primary and secondary dysmenorrhea which provide effective control of pain”] that during menstruation contractions are known to occur and change in frequency and amplitude including during both the luteal phase and the follicular phases [see para 5… “In the early follicular phase, these contractions occur once or twice per minute and last 10-15 seconds with a low amplitude of usually 30 mmHg. The frequency increases to 3-4 per minute towards ovulation. During the luteal phase, the frequency and amplitude decrease, possibly to facilitate any implantation.”] which changes the conditions of the tissue in and around the uterus [see para 7… “These uterine contractions continue as they squeeze the old, dead endometrial tissue through the cervix and out of the body through the vagina. These contractions, and the resulting temporary oxygen deprivation to nearby tissues, are responsible for the pain or “cramps” experienced during menstruation.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura by including a processor that performs the step of assessing the impedance sensors similarly to that of Toth and to record EMG activity similarly to that of Toth this would provide greater information about the uterine activity and help in monitoring the body, respectively which one of ordinary skill would expect to allow for greater accuracy in determining a receptivity ( or uterine implantation capacity) of the mother's body to a fertilized egg implanting itself into the uterus.
It would have been obvious to modify Nakamura in view of Toth to generate the analog and digital signals as a set for each different phase of the menstruation cycling including that of both the luteal phase and follicular phase (i.e. thereby fully reciting the missing steps and since EMG is also produced from the signals as discussed above, a feature related to peristaltic activity of the uterus based on the first and second digital data is obtained as claimed is recited as well) similarly to that disclosed by Singh because one of ordinary skill would expect data based on each phase to provide a more accurate depiction on the characteristics of the tissue of the environment thereby providing a more accurate prediction of a fertilized egg implanting itself into the uterus.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of Toth in view of Singh as applied to claim 9 above, and further in view of Nezhat.
Nakamura in view of Toth in view of Singh discloses all the limitations of claim 9 as outlined above and:
wherein the electrical activity inside a non-pregnant uterus is sensed with a probe [see Figs. 2 and 5 and para 49 of Nakamura … “FIG. 5 is a schematic representation of the picture of the uterine cavity measurement probe illustrated in FIG. 2.”] comprising:
an elongate member [see Fig. 5 element 42 and para 66 of Nakamura… “a substantially flexible rod-shaped member 42”];
a reference electrode having a rounded tip arranged at a distal end of the elongate member [see Fig. 5 element 44 and para 66 of Nakamura … “redox potential difference electrode 44”];
a uterine internal orifice sensing electrode arranged concentrically with the reference electrode [see Figs. 2 and 5 element 46d and para 66 of Nakamura … “the impedance electrodes 46a, 46b, 46c, and 46d”]; and
one or more uterine cavity wall sensing electrodes arranged between the reference electrode and the uterine internal orifice sensing electrode [see Fig. 5 element 46a-4c and para 66 of Nakamura … “impedance electrodes 46a, 46b, 46c”];
wherein adjacent electrodes among the reference electrode, the one or more uterine cavity wall sensing electrodes and the uterine internal orifice sensing electrode are separated by an interelectrode distance along a longitudinal axis of the probe [see sections of element 42 separating elements 44 and 46 of Nakamura], and
However, Nakamura in view of Toth in view of Singh fails to explicitly or implicitly disclose that “the probe is configured such that, in use, the reference electrode is in contact with a fundus of the uterus while the uterine internal orifice sensing electrode is in contact with a uterine internal orifice, the uterine internal orifice being a cervical opening area”.
Nakamura further discloses modifying the diameter of the probe according to the diameter of the subject’s uterine cavity [see para 66… “The diameter of the rod-shaped member 42 is φ2.5 mm that is the almost same as the diameter of the uterine cavity of the human body and however, may be changed according to the diameter of the subject's uterine cavity.”]
Nezhat discloses in the analogous art of electrode device procedures in the uterus [see Col. 10 lines 25-35…“Referring now to FIG. 6, a pair of electrodes 100 and 110 which are configured especially for engaging the exterior surface of a uterus is illustrated.”] that a known placement of an electrode at the uterine internal office is specifically at the cervical opening [see Col. 11 lines 45-60… “Optionally, an electrode may also be placed within the cervical opening as illustrated in FIG. 13. The electrode may be a conventional rod-type electrode and may act as the common or return electrode in the electrosurgical treatment.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura in view of Toth in view of Singh to size the diameter of the probe such that the reference electrode is in contact with a fundus of the uterus while the uterine internal orifice sensing electrode is in contact with a uterine internal orifice as claimed because this is a subset of different sizing of the diameters of the probe relative to the user disclosed by Nakamura.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Nakamura in view of Toth in view of Singh by configuring the probe so that the electrode at the uterine internal orifice is specifically at a cervical opening area because as taught by Nezhat this is a known configuration for electrode devices used in uterus procedures.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderon in view of Singh as applied to claim 12 above, and further in view of Aina-Mumuney et al (US 20150216472) hereafter known as Aina-Mumuney.
Calderon in view of Singh discloses the invention substantially as claimed including all the limitations of claim 12. Also, as discussed in claim 12 above and cited in claim 8 of Calderon [see “generate signals indicative of electromyographic activity in a vagina, cervix, or uterus”], the sets of data collected by Calderon in view of Singh are electromyographic or EMG data which is understood to provide an electromyogram based on at least one pattern and based on para 4 of Calderon [see “measurement of electromyographic activity in the uterus for IVF re-introduction of fertilized eggs when the uterus is non-active to prevent rejection of fetuses”] Calderon in view of Singh discloses using this EMG data to determine when to apply IVF re-introduction of fertilized eggs. This when to apply IVF re-introduction of fertilized eggs is at least a time when there is a high probability implantation is high which is understood to recite “determining, based on the at least one pattern of uterine peristalsis, a time window during which a probability of embryo implantation is higher than a predefined threshold”.
However, Calderon in view of Singh is silent as to how the time window is determined and communicated and therefore fails to disclose “providing at least one visual indicator in said electromyogram to indicate said time window” as recited by claim 15.
Aina-Mumuney discloses in the analogous art of EMG diagnostics of uterine activity [see abstract… “Methods for detecting uterine and/or cervical activity in a subject are disclosed which comprise positioning a "uterine/cervical activity monitor" or "UCAM" within the subject,” and para 34… “one embodiment of the UCAM used with the methods of the present invention, the first and second electrodes 104, 106 may comprise electromyography electrodes (hereinafter referred to as "EMG electrodes"). Electromyography (EMG) is a technique used for evaluating and recording electrical activity produced by muscles, for example the smooth muscle of the cervix, uterus and/or abdomen of a pregnant patient. (See FIG. 5 old, a chart illustrating the electrical activity of an example muscle using EMG). Alternatively, the device and methods can detect cervical and/or uterine activity using other types of biocompatible sensors.”] that a known way to determine a likelihood for success of in-vitro fertilization (i.e. a time window during which a probability of embryo implantation is higher than a predefined threshold) is to compare waveforms to normative controls of subject having successful IVF procedures (i.e. a visual indicator) [see para 84… “the method for prognosing the likelihood of success of in-vitro fertilization in a subject, the waveforms of the signals of the cervical and/or vaginal activities are compared to normative controls of subjects having successful IVF procedures”]
Since Calderon in view of Singh is silent as to how the time window is determined and Aina-Mumuney discloses a known way is to compare waveforms to normative controls of subject having successful IVF procedures, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Calderon in view of Singh by comparing their EGM waveform to a normative controls of subject having successful IVF procedures (i.e. a visual indicator in said electromyogram to indicate said time window) as this is a known way to identify the time window.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderon in view of Singh as applied to claim 9 above, and further in view of Maalouf et al (US 20030125635) hereafter known as Maalouf.
Calderon in view of Singh discloses the invention substantially as claimed including all the limitations of claim 9 as outlined above. Also, Calderon in view of Singh discloses collecting EMG signals [see claim 8…. “generate signals indicative of electromyographic activity in a vagina, cervix, or uterus”]
However, Calderon in view of Singh is silent as many of the details of the sampling frequency of the EMG signals and thus fails to disclose “downsampling and/or decimating the signals such that a signal bandwidth of 0.01 to 30 Hz is obtained, wherein downsampling and/or decimating the signals comprises filtering with a bandpass filter, a low-pass filter, a high-pass filter, or any combination thereof; and filtering the downsampled and/or decimated signals to obtain a frequency band between 0 to 4 Hz.” As recited by claim 17.
Maalouf discloses in the analogous art of EMG signal data of uterine contractions [see para 1… “The present invention relates generally to reducing the noise in physiological signals. In particular the present invention relates to monitoring the medical condition of a woman in labor and to reducing the signal noise while processing abdominal surface electromyogram (EMG) signal data for the purpose of uterine contraction monitoring.”] collecting two inputs of EMG signals summing them and filtering the signals (i.e. using at least one of a bandpass filter, a low-pass filter, a high-pass filter) for the purpose of reducing noise signal [see abstract… “A signal processor is coupled to the EMG1 sensor and the EMG2 sensor. The signal processor processes the EMG1 input signal and the EMG2 input signal with a filter and sum technique to generate an EMG1 reduced noise signal that represents a magnitude of at least one contraction event and periodicity of a set of multiple contraction events.”] to obtain a sampling frequency of 4 Hz for the purpose of reducing signal noise [see para 36…. “Both the EMG1 reduced noise signal 60 as depicted in FIG. 5 and the EMG2 reduced noise signal 70 as depicted in FIG. 6 were generated when the digitized representation of the EMG1 input signal 4 and the digitized representation of the EMG2 input signal 6 sampling frequency was four (4) Hz.”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Calderon in view of Singh by collecting two EMG signals summing and filtering the signals and to collect the signals at a sampling frequency for 4 Hz similarly to that disclosed by Maalouf (i.e. thereby reciting claim 17) because this will reduce the signal noise of the EMG signals.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of Nezhat as applied to claim 1 above, and further in view of Toth.
Regarding claim 18:
Nakamura discloses:
A method of acquiring information of uterine peristaltic activity in a non-pregnant uterus [see abstract of Nakamura… “A non-invasive and accurate vagina evaluation device and uterine evaluation devices are provided that measure the receptivity (uterine implantation capacity) of the mother's body to a fertilized egg implanting itself into the uterus.” And “four or two impedance electrodes arranged with a predetermined interval therebetween in an insertion direction of the main body and brought into contact with an endometrium of the uterine cavity to measure a uterine endometrial impedance generated between the endometrium and each of the electrodes.” The endometrial impedance is at least information of uterine peristalsis], comprising:
placing electrical activity sensing means inside the uterine cavity of a non- pregnant uterus to sense the electrical activity of the uterine muscle during a first time window, thereby generating at least one first analog signal [see para 12 of Nakamura…
“electrodes arranged on the surface of the main body can be brought into contact with the vaginal wall. The four electrodes are arranged substantially in a line, and the interval between the electrodes is fixed irrespective of expansion and stretching of the main body, achieving proper measurement according to a four-electrode method, which is mentioned below.” And para 77… “Each experimental group was examined more than 6 times.” 1 of these 6 times examined is at least a first time window and each measurement signal from the electrodes is at least a first analog signal];
placing electrical activity sensing means inside the uterine cavity of a non- pregnant uterus to sense the electrical activity of the uterine muscle during a second time window, thereby generating at least one second analog signal [see para 12 of Nakamura…“electrodes arranged on the surface of the main body can be brought into contact with the vaginal wall. The four electrodes are arranged substantially in a line, and the interval between the electrodes is fixed irrespective of expansion and stretching of the main body, achieving proper measurement according to a four-electrode method, which is mentioned below.” And para 77… “Each experimental group was examined more than 6 times.” 1 of these 6 times examined is at least a second time window and each measurement signal from the electrodes is at least a second analog signal];
wherein placing the electrical activity sensing means comprise placing the probe of claim 1 [see rejection claim 1 above];
However, Nakamura fails to disclose:
“generating first digital data from the at least one first analog signal;
generating second digital data from the at least one second analog signal; and
characterizing the uterine activity of the non-pregnant uterus by obtaining at least one feature based on the first and second digital data,
wherein placing electrical activity sensing means inside the uterine cavity of a
non-pregnant uterus comprises placing the probe such that the reference
electrode is in contact with a fundus of the uterus while the uterine internal
orifice electrode is in contact with a uterine internal orifice electrode is in contact with a fundus of the uterus while the uterine internal orifice electrode is in contact with a uterine internal orifice, the uterine internal orifice being a cervical opening area.”
Nakamura further discloses modifying the diameter of the probe according to the diameter of the subject’s uterine cavity [see para 66… “The diameter of the rod-shaped member 42 is φ2.5 mm that is the almost same as the diameter of the uterine cavity of the human body and however, may be changed according to the diameter of the subject's uterine cavity.”].
Nezhat discloses in the analogous art of electrode device procedures in the uterus [see Col. 10 lines 25-35…“Referring now to FIG. 6, a pair of electrodes 100 and 110 which are configured especially for engaging the exterior surface of a uterus is illustrated.”] that a known placement of an electrode at the uterine internal office is specifically at the cervical opening [see Col. 11 lines 45-60… “Optionally, an electrode may also be placed within the cervical opening as illustrated in FIG. 13. The electrode may be a conventional rod-type electrode and may act as the common or return electrode in the electrosurgical treatment.”]
Toth discloses in the analogous art of stimulation to a uterus [see para 67… “and/or alter the sensitivity of an organ in a body to a stimulus, to alter neural communication between an organ and a neural circuit, and/or to treat a cancerous tumor. A non-limiting list of organs include a gall bladder, a kidney, a small intestine, a stomach, a large intestine, a spleen, a pancreas, a bladder, an adrenal gland, a prostate, a lung, a uterus, or the like.”] including a processor coupled to sensory electrodes that assesses the sensory data (i.e. this assessment is understood to include generating digital data based on the analog data… thereby reciting “generating first digital data from the at least one first analog signal; generating second digital data from the at least one second analog signal; and characterizing the uterine activity of the non-pregnant uterus by obtaining at least one feature based on the first and second digital data”) for the purpose of assessing the functionality of the tissue [see para 166… “one or more circuits and/or processors included in a system in accordance with the present disclosure may be coupled to a sensory electrode and may be configured to assess functionality of one or more regions of target tissue in the vicinity of the sensory electrode”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura to size the diameter of the probe such that the reference electrode is in contact with a fundus of the uterus while the uterine internal orifice sensing electrode is in contact with a uterine internal orifice as claimed because this is a subset of different sizing of the diameters of the probe relative to the user disclosed by Nakamura.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Nakamura by configuring the probe so that the electrode at the uterine internal orifice is specifically at a cervical opening area because as taught by Nezhat this is a known configuration for electrode devices used in uterus procedures.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura in view of Nezhat by including a processor and assessing the impedance sensors similarity to that of Toth as this provide greater information about the uterine activity which one of ordinary skill would expect to allow for greater accuracy in determining a receptivity (uterine implantation capacity) of the mother's body to a fertilized egg implanting itself into the uterus.
Regarding claim 19:
generating at least one pattern of uterine peristalsis [see abstract of Nakamura… “A non-invasive and accurate vagina evaluation device and uterine evaluation devices are provided that measure the receptivity (uterine implantation capacity) of the mother's body to a fertilized egg implanting itself into the uterus.” And “four or two impedance electrodes arranged with a predetermined interval therebetween in an insertion direction of the main body and brought into contact with an endometrium of the uterine cavity to measure a uterine endometrial impedance generated between the endometrium and each of the electrodes.” The endometrial impedance is at least a pattern of uterine peristalsis];
and determining, based on the at least one pattern of uterine peristalsis, a time window during which a probability of embryo implantation is higher than a predefined threshold [see abstract of Nakamura… “A non-invasive and accurate vagina evaluation device and uterine evaluation devices are provided that measure the receptivity (uterine implantation capacity) of the mother's body to a fertilized egg implanting itself into the uterus.” The times at which receptivity is the highest when measured is at least a time window as claimed.]
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of Nezhat in view of Toth in view of Singh.
Independent claim
Regarding claim 20
Nakamura discloses:
A system for measuring electrical activity of a uterine muscle in a non-pregnant uterus [see abstract… “A non-invasive and accurate vagina evaluation device and uterine evaluation devices are provided that measure the receptivity (uterine implantation capacity) of the mother's body to a fertilized egg implanting itself into the uterus.”], the system comprising:
a probe [see Figs. 2 and 5 element 40 and para 49… “FIG. 5 is a schematic representation of the picture of the uterine cavity measurement probe illustrated in FIG. 2.”] comprising;
an elongate member [see Fig. 5 element 42 and para 66… “a substantially flexible rod-shaped member 42”];
a reference electrode having a rounded tip arranged at a distal end of the elongate member [see Fig. 5 element 44 and para 66… “redox potential difference electrode 44”];
a uterine internal orifice sensing electrode arranged concentrically with the reference electrode [see Figs. 2 and 5 element 46d and para 66… “the impedance electrodes 46a, 46b, 46c, and 46d”]; and
one or more uterine cavity wall sensing electrodes arranged between the reference electrode and the uterine internal orifice sensing electrode [see Figs. 2 and 5 element 46a-4c and para 66… “impedance electrodes 46a, 46b, 46c”];
wherein adjacent electrodes among the reference electrode, the one or more uterine cavity wall sensing electrodes and the uterine internal orifice sensing electrode are separated by an interelectrode distance along a longitudinal axis of the probe [see sections of element 42 separating elements 44 and 46], and
generating a first set of analog signals based on electrical activity of the uterine muscle sensed internally in a non-pregnant uterus, the electrically activity of the uterine muscle being sensed by the reference electrode, the one or more uterine cavity wall sensing electrodes and the uterine internal orifice sensing electrode of the probe [see para 12 of Nakamura… “electrodes arranged on the surface of the main body can be brought into contact with the vaginal wall. The four electrodes are arranged substantially in a line, and the interval between the electrodes is fixed irrespective of expansion and stretching of the main body, achieving proper measurement according to a four-electrode method, which is mentioned below.” And para 77… “Each experimental group was examined more than 6 times.” The measurement signals from 1 of these 6 examined times is at least a first set of analog signals]
generating a second set of analog signals based on electrical activity of the uterine muscle sensed internally in the same non-pregnant uterus, the electrically activity of the uterine muscle being sensed by the reference electrode, the one or more uterine cavity wall sensing electrodes and the uterine internal orifice sensing electrode of the probe [see para 12 of Nakamura…“electrodes arranged on the surface of the main body can be brought into contact with the vaginal wall. The four electrodes are arranged substantially in a line, and the interval between the electrodes is fixed irrespective of expansion and stretching of the main body, achieving proper measurement according to a four-electrode method, which is mentioned below.” And para 77… “Each experimental group was examined more than 6 times.” The measurement signals from 1 of these 6 examined times is at least a second set of analog signals];
However, Nakamura fails to fully disclose “the probe is configured such that, in use, the reference electrode is in contact with a fundus of the uterus while the uterine internal orifice sensing electrode is in contact with a uterine internal orifice, the uterine internal orifice being a cervical opening area;” or “a processor that is communicatively connected to the probe, the processor configured with instructions which when executed cause the processor to carry out a method comprising the steps of:
generating a first set of analog signals based on electrical activity of the uterine muscle sensed internally in a non-pregnant uterus during a luteal phase of a menstrual cycle, the electrically activity of the uterine muscle being sensed by the reference electrode, the one or more uterine cavity wall sensing electrodes and the uterine internal orifice sensing electrode of the probe;
generating a second set of analog signals based on electrical activity of the uterine muscle sensed internally in the same non-pregnant uterus during a follicular phase of the menstrual cycle, the electrically activity of the uterine muscle being sensed by the reference electrode, the one or more uterine cavity wall sensing electrodes, the uterine internal orifice sensing electrode of the probe;
generating first digital data from the first set of generated analog signals; and
generating second digital data from the second set of generated analog signals.”
Nakamura further discloses modifying the diameter of the probe according to the diameter of the subject’s uterine cavity [see para 66… “The diameter of the rod-shaped member 42 is φ2.5 mm that is the almost same as the diameter of the uterine cavity of the human body and however, may be changed according to the diameter of the subject's uterine cavity.”].
Nezhat discloses in the analogous art of electrode device procedures in the uterus [see Col. 10 lines 25-35…“Referring now to FIG. 6, a pair of electrodes 100 and 110 which are configured especially for engaging the exterior surface of a uterus is illustrated.”] that a known placement of an electrode at the uterine internal office is specifically at the cervical opening [see Col. 11 lines 45-60… “Optionally, an electrode may also be placed within the cervical opening as illustrated in FIG. 13. The electrode may be a conventional rod-type electrode and may act as the common or return electrode in the electrosurgical treatment.”]
Toth discloses in the analogous art of stimulation to a uterus [see para 67… “and/or alter the sensitivity of an organ in a body to a stimulus, to alter neural communication between an organ and a neural circuit, and/or to treat a cancerous tumor. A non-limiting list of organs include a gall bladder, a kidney, a small intestine, a stomach, a large intestine, a spleen, a pancreas, a bladder, an adrenal gland, a prostate, a lung, a uterus, or the like.”] including a processor coupled to sensory electrodes that assesses the data from the electrodes for the purpose of assessing the functionality of the tissue (i.e. this assessment is understood to include generating digital data based on the analog data… thereby reciting “generating first digital data from the at least one first analog signal; generating second digital data from the at least one second analog signal; and characterizing the uterine activity of the non-pregnant uterus by obtaining at least one feature based on the first and second digital data”) [see para 166… “one or more circuits and/or processors included in a system in accordance with the present disclosure may be coupled to a sensory electrode and may be configured to assess functionality of one or more regions of target tissue in the vicinity of the sensory electrode”].
Singh discloses in the analogous art of diagnosing and/or performing procedures related to the contractions of the uterus during the menstruation cycle [para 2… “Dysmenorrhea (or dysmenorrhoea) is a gynecological medical condition of pain during menstruation that interferes with daily activities, as defined by, The American Congress of Obstetricians and Gynecologists (ACOG). Still, dysmenorrhea is often defined simply as menstrual pain, or at least menstrual pain that is excessive.” And para 5… “The uterus frequently contracts throughout the entire menstrual cycle, and these contractions have been termed endometrial waves or contractile waves” and
para 144….“Accordingly, an object of the invention is to provide methods and compositions for the treatment of pain associated with primary and secondary dysmenorrhea which provide effective control of pain”] that during menstruation contractions are known to occur and change in frequency and amplitude including during both the luteal phase and the follicular phases [see para 5… “In the early follicular phase, these contractions occur once or twice per minute and last 10-15 seconds with a low amplitude of usually 30 mmHg. The frequency increases to 3-4 per minute towards ovulation. During the luteal phase, the frequency and amplitude decrease, possibly to facilitate any implantation.”] which changes the conditions of the tissue in and around the uterus [see para 7… “These uterine contractions continue as they squeeze the old, dead endometrial tissue through the cervix and out of the body through the vagina. These contractions, and the resulting temporary oxygen deprivation to nearby tissues, are responsible for the pain or “cramps” experienced during menstruation.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura to size the diameter of the probe such that the reference electrode is in contact with a fundus of the uterus while the uterine internal orifice sensing electrode is in contact with a uterine internal orifice as claimed because this is a subset of different sizing of the diameters of the probe relative to the user disclosed by Nakamura.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Nakamura by configuring the probe so that the electrode at the uterine internal orifice is specifically at a cervical opening area because as taught by Nezhat this is a known configuration for electrode devices used in uterus procedures.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Nakamura in view of Nezhat by including a processor that performs the method of assessing the impedance sensors similarity to that of Toth as this provide greater information about the uterine activity which one of ordinary skill would expect to allow for greater accuracy in determining a receptivity (uterine implantation capacity) of the mother's body to a fertilized egg implanting itself into the uterus.
It would have been obvious to modify Nakamura in view of Nezhat in view of Toth to generate the analog and digital signals as a set for each different phase of the menstruation cycling including that of both the luteal phase and follicular phase (i.e. thereby fully reciting a processor configured as claimed) because one of ordinary skill would expect data based on each phase to provide a more accurate depiction on the characteristics of the tissue of the environment thereby providing a more accurate prediction of a fertilized egg implanting itself into the uterus.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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