DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 05/26/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, the foreign patent documents JP-2020536666, JP-H0420305, and JP-2002306486 listed in the submitted IDS are missing and therefore not considered.
Response to Amendment
The amendment filed 04/27/2026 has been entered. New claims 43-44 have been added. Claims 1-20 and 43-44 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 01/28/2026.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Newly cited reference Law (US4742829) teaches the argued upon feature, wherein the argued upon feature is a grip configured to prevent free rotation of the ultrasound array relative to the elongated probe and to define a scanning direction. Law similarly teaches a transvaginal ultrasound probe (10) (Figs. 1-2, Abstract). Law teaches the probe (10) includes a housing (16) for housing a transducer array (17), a shaft (14), and a handle (18), i.e. a grip (Figs. 1-4, Column 2 lines 40-55). Law teaches the transducer assembly, i.e. transducer array (17) and its housing (16), is fastened to an end of the shaft (14) (Claim 1, Column 1 lines 61-66). Law teaches the shaft (14) or elongated body is bonded to the housing (16) and the handle (18) (Figs. 3-4, Column 3 lines 38-42). Law therefore teaches wherein the handle (18) is rigidly connected to the transducer array (17) via the shaft (14), thereby preventing free rotation of the transducer array relative to the elongated probe (10). Moreover, Law teaches wherein the imaging field of view is provided by rotating the probe (10) (Abstract, Column 1 line 65 – Column 2 line 1, Column 3 lines 30-33). Law therefore further teaches wherein the handle (i.e. grip) is configured to define a scanning direction, wherein rotation of the probe is provided by rotating or manipulating the handle/grip. Law discloses no use of motors or the like to provide rotation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to have the handle/grip be rigidly connected to the transducer as taught by Law (Figs. 1-4, Claim 1, Column 1 lines 61-66, Column 2 lines 40-55, Column 3 lines 38-42). Through this rigid connection, manual rotation of the probe, via the handle, may provide a desired imaging field of view as recognized by Law (Abstract).
Applicant argues that the invention of Prisant is directed towards a user sitting on a ball while the probe is positioned within the user’s vagina.
In response, examiner points out that ball is only present in some exemplary embodiments, and not the embodiment in which the examiner cited, which is the embodiment shown in figures 9A-9D rather than figures 13A-13D. The user therefore does not sit on the probe as alleged by the applicant, at least not the probe as shown in figures 9A-9D.
Applicant argues Prisant does not, and would have no need to, teach the amended feature since Prisant’s scanner (ultrasound array) is rotatable within a socket as explained in ¶ [0286] of Prisant.
Examiner respectfully disagrees. In ¶ [0286], it is recited “In some embodiments, the scanner 906 is movable within a socket 910”. Therefore, not all embodiments is the scanner 906 movable within the socket 910.
Applicant further argues Prisant explicitly teaches stabilization and prevention of probe movement, which is contrary to current claim 1 that relies on user manipulation of probe orientation.
Examiner agrees that Prisant teaches stabilization and prevention of probe movement. However, examiner points out stabilization is only provided in some embodiments (¶ [0043], “According to some embodiments, the probe is stabilized within the body cavity…”) and is only an aspect of some embodiments (¶ [0055], “An aspect of some embodiments relates to stabilizing a position of an ultrasound probe within a body cavity…”). The intended purpose of Prisant’s invention is therefore not stabilization as it is not required by all embodiments. Therefore, Prisant may be freely modified by, for example, Law above such that the modified combination of Prisant in view of Law results in a grip angularly configured to prevent free rotation of the ultrasound array relative to the elongated probe and to define a scanning direction; the modification of Prisant with the teachings of Law would not result in the invention of Prisant being inoperable for its intended purpose.
Accordingly, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Prisant (US20240268784) in view of Law (US4742829).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “a tip”. It is unclear what this “tip” is of. For purposes of examination, claim 3 will be interpreted to mean “The device of claim 1, further comprising a probe tip, wherein the probe tip is detachable, disposable, or single use” which is consistent with the language of the amended claims filed 02/20/2024.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4-7, 10-12, 14-17, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Prisant (US20240268784, provisional priority filed in US on 06/11/2021) in view of Law (US4742829).
Regarding claim 1, Prisant teaches a device (902) adapted to self-monitor follicles and to assess a thickness of an endometrium of a subject, the device (902) comprising an elongated probe (904) provided with an ultrasound array (906) located at its distal end (Fig. 9A, [0057], [0059], “In some embodiments, the transducer comprising an array of transducer elements”, [0130], “According to some embodiments, the system is used for follicle monitoring”, [0162], “the ultrasound probe is configured to allow self-examination”, [0167], [0201], “detects and measures the ultrasound images and translate them into numerical data such as but not limited to ovaries, endometrial thickness, ovarian follicles…”, [0286]) and
a grip (908) angularly configured for gripping by a user during a self-monitoring activity (Fig. 9A, [0098], “According to some embodiments, the system is a comprehensive system, allowing a patient to self-perform a vaginal or rectal examination, without any particular skills”, [0150], [0162], “the ultrasound probe is configured to allow self-examination”, wherein figure 9A shows the handle 908 angled with respect to the probe body 904),
an axis of symmetry of the grip (908) being at an angle with respect to an axis of symmetry of said elongated probe (904) (Fig. 9A, annotated figure 9A shown below for clarity).
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However, Prisant fails to teach wherein the grip is configured to prevent free rotation of the ultrasound array relative to the elongated probe and to define a scanning direction.
In an analogous transvaginal ultrasound probe field of endeavor, Law teaches such a feature.. Law similarly teaches a transvaginal ultrasound probe (10) (Figs. 1-2, Abstract). Law teaches the probe (10) includes a housing (16) for housing a transducer array (17), a shaft (14), and a handle (18), i.e. a grip (Figs. 1-4, Column 2 lines 40-55). Law teaches the transducer assembly, i.e. transducer array (17) and its housing (16), is fastened to an end of the shaft (14) (Claim 1, Column 1 lines 61-66). Law teaches the shaft (14) or elongated body is bonded to the housing (16) and the handle (18) (Figs. 3-4, Column 3 lines 38-42). Law therefore teaches wherein the handle (18) is rigidly connected to the transducer array (17) via the shaft (14), thereby preventing free rotation of the transducer array relative to the elongated probe (10). Moreover, Law teaches wherein the imaging field of view is provided by rotating the probe (10) (Abstract, Column 1 line 65 – Column 2 line 1, Column 3 lines 30-33). Law therefore further teaches wherein the handle (i.e. grip) is configured to define a scanning direction, wherein rotation of the probe is provided by rotating or manipulating the handle/grip. Law discloses no use of motors or the like to provide rotation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to have the handle/grip be rigidly connected to the transducer as taught by Law (Figs. 1-4, Claim 1, Column 1 lines 61-66, Column 2 lines 40-55, Column 3 lines 38-42). Through this rigid connection, manual rotation of the probe, via the handle, may provide a desired imaging field of view as recognized by Law (Abstract).
Regarding claim 2, Prisant in view of Law teaches the invention as claimed above in claim 1.
Prisant further teaches wherein the device (902) is adapted to be coupled to a hand-held device (406) (Figs. 4A & 4C, [0053], “In some embodiments, the device coupled to the probe comprises at least one of a, wearable device for example a smartwatch or a smart band, a virtual personal assistant device, a cellular phone”, [0175], [0189], [0200], [0202], wherein the probe being configured to send and receive data from a cellular phone comprises the device being adapted to be coupled to a hand-held device (phone); and figure 4C shows information flow between the probe and a phone).
Regarding claim 4, Prisant in view of Law teaches the invention as claimed above in claim 1.
Prisant further teaches wherein electronics (312) that operate the ultrasound array (310) and image acquisition and transferring elements (328) are housed within a body (304) of the device (Fig. 3A, [0163-0164], [0168], [0175], wherein figure 3A is a block diagram of an ultrasound probe according to embodiments of the invention).
Regarding claim 5, Prisant in view of Law teaches the invention as claimed above in claim 1.
Prisant further teaches wherein the device is adapted to transmit a raw ultrasound image or a signal representative thereof to a hand-held device that includes electronic processing components and a display ([0059], wherein the images acquired are ultrasound images, [0200], “…for transferring images and/or measurements to external devices…In some embodiments, it is configured to send and receive data from a cellular phone”, wherein a cellular phone comprises a hand-held device that includes electronic processing components and a display).
Regarding claim 6, Prisant in view of Law teaches the invention as claimed above in claim 5.
Prisant further teaches wherein data received by the hand-held device include information indicative of a positioning of a probe tip relative to a desired location in the subject’s body ([0050], wherein the images include a target or desired location in the subject’s body, i.e. uterus, ovary, follicle, [0200], wherein the images are sent to a cellular phone; since the ultrasound transducer is positioned at the probe tip, ultrasound images of a target are indicative of a positioning of the probe tip relative to the target since the coordinate origin of the image is the tip of the probe).
Regarding claim 7, Prisant in view of Law teaches the invention as claimed above in claim 1.
Prisant further teaches wherein the hand-held device is connected to a monitoring device via wire or wirelessly ([0053], wherein the system includes the ultrasound probe, “the device coupled to the probe comprises at least one of a, wearable device for example a smartwatch or a smart band, a virtual personal assistant device, a cellular phone device or any other device functionally coupled to the probe via wires or via wireless communication”, [0090], “the system is configured to monitor reproductive health”, wherein the ultrasound probe device comprises a monitoring device).
Regarding claim 10, Prisant in view of Law teaches a method for self-monitoring ([0098], [0150], [0162], [0316]) the follicles and to assess a thickness of an endometrium of a subject ([0130], “the system is used for follicle monitoring”, [0201], “detects and measures the ultrasound images and translate them into numerical data such as but not limited to ovaries, endometrial thickness, ovarian follicles”), comprising allowing a subject to obtain specific ultrasound images using the device (902) of claim 1, based on the probe’s orientation (Figs. 9A-9D, [0162], “the ultrasound probe is configured to allow self-examination, for example self-scanning of tissue within a body cavity. by the female subject”, [0286]).
Regarding claim 11, Prisant in view of Law teaches the invention as claimed above in claim 10.
Prisant teaches the invention further comprising monitoring natural ovulation ([0093], “tracking of ovulatory cycles”, [0185], “determining a time period until ovulation”, [0272], “predicted time to ovulation”, [0302], “the system is used to provide indications and/or predictions regarding at least one of, number of eggs in an ovary, maturation of an egg within a follicle, release of an egg from a follicle”).
Regarding claim 12, Prisant in view of Law teaches the invention as claimed above in claim 10.
Prisant teaches the invention further comprising performing an offline scan by the subject ([0008], “Optionally, a network connection is provided as well”, wherein a network connection is not provided comprises the device being offline, and, [0045], [0150], wherein self-examination is performed without an expert comprises performing an offline scan by the subject, [0162], “self-scanning of tissue within a body cavity. by the female subject”).
Regarding claim 14, Prisant in view of Law teaches a system (402) (Fig. 4A, [0188]) for self-monitoring ([0098], [0150], [0162], [0316]) follicles and to assess a thickness of an endometrium of a subject ([0130], “the system is used for follicle monitoring”, [0201], “detects and measures the ultrasound images and translate them into numerical data such as but not limited to ovaries, endometrial thickness, ovarian follicles”), the system (402) (Fig. 4A, [0188]) comprising:
a) a device (902) according to claim 1 (Figs. 9A-9D, see claim 1 above);
b) instruction displayable to said subject to obtain specific ultrasound images using a smart device (406), based on an orientation of the elongated probe ([0053], [0071], [0125], [0210], wherein providing visual indications comprises displaying instructions, [0156], “In some embodiments, the indication is generated based on signals received from at least one position and/or orientation sensor of the probe”, [0161], wherein indications comprising how to modify parameters of the scanning session, i.e. position/orientation of the probe, in order to proceed/continue with the scanning session comprises instructions to obtain specific ultrasound images, [0053], “the device coupled to the probe comprises at least one of a, wearable device for example a smartwatch or a smart band, a virtual personal assistant device, a cellular phone device”, [0189-0190], wherein smartwatches, smart bands, cellular devices (i.e. smartphone), and computers comprise smart devices);
c) at least one communication channel adapted to transmit the acquired ultrasound images, or data representative thereof, to a remote location (410) (Fig. 4A, [0191], [0193], [0235], [0239], [0249]).
Regarding claim 15, Prisant in view of Law teaches the invention as claimed above in claim 14.
Prisant further teaches wherein the device (902; 302; 404) comprises electronic elements (312) adapted to perform an ultrasound scan (Fig. 3A, [0168-0169]), and electronic elements (328) adapted to allow communication between said device (902; 302; 404) and the smart device (406) (Fig. 3A, [0175-0176], “In some embodiments, the at least one different device comprises a close device that is located in the vicinity of the probe, for example a cellular phone, a computer, a virtual assistant device”, [0189], “In some embodiments, the probe 404 is in communication with the local device using a communication circuitry, for example communication circuitry 328 shown in FIG. 3A”).
Regarding claim 16, Prisant in view of Law teaches the invention as claimed above in claim 15.
Prisant further teaches wherein the smart device is a smartphone, tablet, or laptop ([0053], “a smartwatch or a smart band, a virtual personal assistant device, a cellular phone device”, [0125], “the system generates indications and provides information that can be visualized using computers, tablets, and/or AR/VR solutions”, [0175]).
Regarding claim 17, Prisant in view of Law teaches the invention as claimed above in claim 15.
Prisant further teaches wherein the instructions are printed, displayed, or audible instructions ([0053], “an audio indication, a visual indication”, [0071], [0210]).
Regarding claim 44, Prisant teaches a device (902) adapted to self-monitor follicles and to assess a thickness of an endometrium of a subject ([0130], [0201], [0286]), the device (902) comprising:
an elongated probe (904) provided with an ultrasound array (906) located at its distal end (Figs. 9A-9D, [0057], [0059], “In some embodiments, the transducer comprising an array of transducer elements”, [0130], “According to some embodiments, the system is used for follicle monitoring”, [0162], “the ultrasound probe is configured to allow self-examination”, [0167], [0201], “detects and measures the ultrasound images and translate them into numerical data such as but not limited to ovaries, endometrial thickness, ovarian follicles…”, [0286]); and
a grip (908) (Figs. 9A-9D, [0286]).
However, Prisant fails to teach wherein the ultrasound array is rotationally fixed with respect to said probe.
In an analogous transvaginal ultrasound probe field of endeavor, Law teaches such a feature.. Law similarly teaches a transvaginal ultrasound probe (10) (Figs. 1-2, Abstract). Law teaches the probe (10) includes a housing (16) for housing a transducer array (17), a shaft (14), and a handle (18), i.e. a grip (Figs. 1-4, Column 2 lines 40-55). Law teaches the transducer assembly, i.e. transducer array (17) and its housing (16), is fastened to an end of the shaft (14) (Claim 1, Column 1 lines 61-66). Law teaches the shaft (14) or elongated body is bonded to the housing (16) and the handle (18) (Figs. 3-4, Column 3 lines 38-42). Law therefore teaches wherein the handle (18) is rigidly connected to the transducer array (17) via the shaft (14), thereby preventing free rotation of the transducer array relative to the elongated probe (10). Moreover, Law teaches wherein the imaging field of view is provided by rotating the probe (10) (Abstract, Column 1 line 65 – Column 2 line 1, Column 3 lines 30-33). Law therefore teaches wherein ultrasound array (17) is rotationally fixed with respect to the probe (10). Law discloses no use of motors or the like to provide rotation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to have the ultrasound transducer array be rigidly connected/bonded to the shaft and handle of the probe as taught by Law (Figs. 1-4, Claim 1, Column 1 lines 61-66, Column 2 lines 40-55, Column 3 lines 38-42). Through this rigid connection, manual rotation of the probe, via the handle, may provide a desired imaging field of view as recognized by Law (Abstract).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Prisant (US20240268784) in view of Law (US4742829) as applied to claim 1 above, and further in view of Culjat (US20130060144).
Regarding claim 3, Prisant in view of Law teaches the invention as claimed above in claim 1.
Prisant teaches the invention further comprising a probe tip (906) (Fig. 9A, [0286]).
However, Prisant fails to teach wherein the probe tip is detachable, disposable, or single use.
In an analogous ultrasound device field of endeavor, Culjat teaches such a feature. Culjat teaches an ultrasound probe (100) including a probe tip (102) having a scanning ultrasound transducer (120) located therein (Figs. 3 & 5, [0042]). Culjat teaches the probe tip (102) may be detachable for cleaning and sterilization (Fig. 6, [0048-0049]). Moreover, Culjat teaches wherein the probe tip may alternatively be disposable for improved sterility ([0049]). Culjat therefore teaches a probe tip which is detachable and/or disposable.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to have the probe tip be detachable and/or disposable as taught by Culjat (Fig. 6, [0048-0049]). The detachable probe tip may be removed for cleaning and sterilization as recognized by Culjat ([0049]). Moreover, the tip being disposable may improve sterility as further recognized by Culjat ([0049]). In addition, probe tips of different types or sizes may be employed by having the probe tip be detachable as recognized by Culjat ([0049]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Prisant (US20240268784) in view of Law (US4742829) as applied to claim 1 above, and further in view of Eugley (US6379305).
Regarding claim 8, Prisant in view of Law teaches the invention as claimed above in claim 1.
However, Prisant fails to explicitly teach wherein a length of a probe shell is between 12 and 30 cm.
In an analogous ultrasound device field of endeavor, Eugley teaches such a feature. Eugley teaches an intravaginal ultrasound probe (1) (Fig. 1, Abstract, Column 4 lines 15-21). Eugley teaches wherein the probe includes an elongated body portion (3) having a length greater than 12.5 cm (Fig. 1, Column 4 lines 30-44). Figure 1 shows wherein the elongated body (3) comprises a probe shell. Eugley therefore teaches wherein a length of a probe shell may be between 12 and 30 cm.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to have the shaft of the probe be greater than 12.5 cm in length as taught by Eugley (Fig. 1, Column 4 lines 30-44). This length may minimize patient discomfort and may enable greater range of manipulation of the probe as recognized by Eugley (Column 4 lines 36-42).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Prisant (US20240268784) in view of Law (US4742829) as applied to claim 1 above, and further in view of Singh (US20160183913).
Regarding claim 9, Prisant in view of Law teaches the invention as claimed above in claim 1.
Prisant teaches the invention further comprising a probe tip (206), the probe tip comprising a diameter (Figs. 9A-9B, [0286], wherein the scanner 906 is located at a probe tip having a diameter as shown in figures 9A-9B).
However, Prisant fails to explicitly teach wherein the diameter of the probe tip is up to 30 mm.
In an analogous ultrasound device field of endeavor, Singh teaches such a feature. Singh teaches an ultrasound probe (10) including transducers positioned at the probe tip (22) (Fig. 1, [0073], [0089-0090]). Singh teaches the probe tip (22) may have a diameter ranging between 1 mm and 50 mm ([0074]), therefore teaching wherein a diameter of a probe tip may be up to 30 mm. Singh further teaches wherein the ultrasound probe (10) may be used for transvaginal imaging ([0205]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to have the diameter of the probe tip be between 1 mm and 50 mm as taught by Singh ([0074]). By having a diameter of such a size, the probe may pass through tissue without tearing or disrupting surrounding anatomy as recognized by Singh ([0074]).
Claims 13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Prisant (US20240268784) in view of Law (US4742829) as applied to claims 10 and 15 above, and further in view of Randall (US20230270389).
Regarding claim 13, Prisant in view of Law teaches the invention as claimed above in claim 10.
However, Prisant fails to teach the invention further comprising performing a healthcare professional online guided scan.
In an analogous self-examination field of endeavor, Randall teaches such a feature. Randall teaches a telemedicine system enabling for remote care for patients when a health professional and patient are not physically present with each other ([0002]). Randall teaches wherein users may perform self-examinations and assisted examinations ([0193]) and wherein patients may examine themselves at home ([0264]). Randall teaches wherein a virtual examination may be performed in which a healthcare professional may guide a patient to move a medical device such as a stethoscope to specific areas to obtain data ([0370]). Randall teaches wherein this is performed using a virtual examination room hosted on a remote web server ([0370]), and therefore comprises performing a healthcare professional online guided scan. Moreover, Randall teaches wherein the medical device may alternatively be an ultrasound device rather than a stethoscope ([0296]). Randall further teaches several examination modes including a self-examination mode and a guided examination mode, i.e. online guided by a healthcare professional (Fig. 21, [0107], [0217], wherein “HPC” in figure 21 should be “HCP” for “healthcare professional” as stated in [0107]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to further include performing an online scan with healthcare professional guidance as recognized by Randall (Fig. 21, [0107], [0217], [0296], [0370]). By doing an online scan, the more experienced healthcare professional may predictably direct a patient to acquire better scans for diagnosis than if they performed the scans themselves.
Regarding claim 18, Prisant in view of Law teaches the invention as claimed above in claim 15.
Prisant further teaches wherein the instructions may be provided remotely ([0192], “the remote device 410 is configured to transmit one or more indications, for example guidance, instructions, reminders, reports, recommendations, feedback and/or results of processing to the local device 406”).
However, Prisant fails to explicitly teach wherein the instructions are provided by a remote healthcare practitioner or technician via a communication channel.
In an analogous self-examination field of endeavor, Randall teaches such a feature. Randall teaches a telemedicine system enabling for remote care for patients when a health professional and patient are not physically present with each other ([0002]). Randall teaches wherein users may perform self-examinations and assisted examinations ([0193]) and wherein patients may examine themselves at home ([0264]). Randall teaches wherein a virtual examination may be performed in which a healthcare professional may guide a patient to move a medical device such as a stethoscope to specific areas to obtain data ([0370]). Randall therefore teaches wherein instructions may be provided by a remote healthcare practitioner. Randall teaches wherein this is performed using a virtual examination room hosted on a remote web server ([0370]), wherein the virtual examination room and/or web server comprises a communication channel. Moreover, Randall teaches wherein the medical device may alternatively be an ultrasound device rather than a stethoscope ([0296]). Randall further teaches several examination modes including a self-examination mode and a guided examination mode, i.e. online guided by a healthcare professional (Fig. 21, [0107], [0217], wherein “HPC” in figure 21 should be “HCP” for “healthcare professional” as stated in [0107]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to further include allowing for instructions to be provided by a remote healthcare professional via a communication channel or remote web server as taught by Randall (Fig. 21, [0107], [0217], [0296], [0370]). The more experienced, remote, healthcare professional may predictably direct/guide a patient to acquire better scans for diagnosis than if they performed the scans themselves at home.
Regarding claim 19, Prisant in view of Law and Randall teaches the invention as claimed above in claim 18.
Prisant further teaches wherein the communication channel adapted to transmit the acquired ultrasound images, or data representative thereof, to a remote location (410), is independent of the communication channel between the remote healthcare practitioner or technician and the subject (Fig. 4A, [0175], [0191], wherein the remote device 410 is a remote computer, with communication paths to the probe 404 and local device 406 for receiving ultrasound images shown in figure 4A, via wireless communication [0053], [0189]; Randall above teaches wherein the communication channel, i.e. virtual examination room, between the remote healthcare practitioner and the subject comprises a unique web-link ([0009], [0370] of Randall); therefore, Prisant in view of Randall teach wherein the communication channels are independent of one another).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Prisant (US20240268784) in view of Law (US4742829) as applied to claim 15 above, and further in view of Mienkina (US20180344286).
Regarding claim 20, Prisant in view of Law teaches the invention as claimed above in claim 15.
However, Prisant fails to teach wherein the invention is adapted to: (a) store one or more baseline image(s) of areas of interest; (b) when a patient performs a self-scan, display the stored image to assist the patient in locating and scanning a correct image.
In an analogous system for self-monitoring follicles field of endeavor, Mienkina teaches such a feature. Mienkina teaches an ultrasound system (100) including a transvaginal ultrasound probe (101) for performing self-examinations at home (Fig. 1, Abstract, [0013], [0017]). Mienkina teaches user interfaces (500; 600) which display a reference image (502; 602), i.e. a baseline image, and a real time image (504; 604) and wherein the user interface may include instructions to guide a user in adjusting the ultrasound probe (Figs. 5-6, [0050], [0053]). Mienkina teaches wherein the reference image is an image of a desired target plane taken during a prior imaging session ([0040], [0048], [0050], [0053]). Mienkina teaches the reference images, i.e. ultrasound image data at the target scan plan acquired during a prior imaging session, are stored ([0015], [0061], “Then, once at the target probe position, the acquired ultrasound image data may be compared to stored ultrasound image data at the target scan plane acquired during a prior imaging session”). Mienkina therefore teaches storing baseline images of areas of interest (reference image at a target scan plane). Mienkina teaches wherein the reference image is used as a guide to assist a user in aligning the real time image to the same scan plane as the reference image (Figs. 5-6, [0015], [0054]). Mienkina therefore teaches when a patient performs a self-scan, i.e. a scan at home, displaying the stored baseline image to assist the patient in locating and scanning a correct image.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to store reference images and to display the reference image side-by-side with real-time images being acquired as taught by Mienkina (Figs. 5-6, [0015], [0050], [0053-0054], [0061]). The reference images may predictably provide an indication to the patient that the current position/orientation of the probe is aligned with the target scan plane which is the reference image as recognized by Mienkina (Fig. 6, [0054]), and the image acquired of the target scan plane may be sent to a remote device accessibly by a clinician for evaluation as further recognized by Mienkina ([0015]).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Prisant (US20240268784) in view of Ramanujam (US20200315444).
Regarding claim 43, Prisant teaches a device (902) adapted to self-monitor follicles and to assess a thickness of an endometrium of a subject ([0130], [0201], [0286]), the device (902) comprising:
an elongated probe (904) provided with an ultrasound array (906) located at its distal end (Figs. 9A-9D, [0057], [0059], “In some embodiments, the transducer comprising an array of transducer elements”, [0130], “According to some embodiments, the system is used for follicle monitoring”, [0162], “the ultrasound probe is configured to allow self-examination”, [0167], [0201], “detects and measures the ultrasound images and translate them into numerical data such as but not limited to ovaries, endometrial thickness, ovarian follicles…”, [0286]); and
a grip (908) (Figs. 9A-9D, [0286]);
wherein the grip (908) and elongated probe (904) include axes of symmetry (Figs. 9A-9D).
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However, Prisant fails to teach wherein an angle between the axis of symmetry of said grip and the axis of symmetry of said elongated probe is at least 100 degrees.
In an analogous transvaginal probe field of endeavor, Ramanujam teaches such a feature. Ramanujam teaches a transvaginal device (100) including a handle (102) and an elongated probe (128) configured for vaginal insertion to visualize the cervix (Figs. 1A-1E, [0068], “…while the image devices described herein are transvaginal…”, [0069]). Ramanujam teaches the handle can be an angle θ of 0 to 90 degrees relative to the probe; for example, the handle can be at an angle θ of 45 degrees relative to the probe (Fig. 1C, [0069]).
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As shown in figures 1A-1C, the handle (102) and elongated probe (128) have corresponding axes of symmetry. When the angle θ is between 0 and 80 degrees, the angle between the axis of symmetry of the handle 102 (grip) and the axis of symmetry of the elongated probe (128) will be at least 100 degrees.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Prisant to have the angle between the handle and elongated probe be at least 100 degrees as taught by Ramanujam (Figs. 1A-1C, [0069]). The angle may enable the user to easily hold the probe while simultaneously performing imaging as recognized by Ramanujam ([0069]); the angle may improve the device’s ergonomics.
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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/TOMMY T LY/ Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/ Supervisory Patent Examiner, Art Unit 3795
07/09/26
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