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 .
Response to Amendment
The amendment filed 01/06/2026 has been entered. Amendments to claims 1 is acknowledged. Claims 1-20 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 discloses the limitation “wherein the first section is centered on a first axial position located at a first distance from the distal end of said probe body, the first distance being comprised between 6 and 8 cm, and the second section is centered on a second axial position located at a second distance from the distal end of said probe body, the second distance being comprised between 2.5 and 3.5 cm.”, which repeats the limitation disclosed in claim 1: “said first section is centered on a first axial position located at a first distance from the distal end of the probe body, the first distance ranging between 6 cm and 8 cm,… said second section is centered at a second axial position located at a second distance from the distal end of the probe body, the second distance ranging between 2.5 cm and 3.5 cm,” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5, 10-13, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (US 20210259605 A1), hereinafter Nielsen, in view of Madill (“Quantification of abdominal and pelvic floor muscle synergies in response to voluntary pelvic floor muscle contractions”).
Regarding claim 1, Nielsen discloses a system for monitoring pelvic floor muscle (PFM) contractions performed by a subject (abstract, Fig 14: pelvic floor contraction), notably a female individual, the system comprising: a pelvic floor probe device (100) configured to be positioned within the vaginal canal and in contact with the internal vaginal surface of the subject (Fig 13 element 200), said probe comprising a body extending along a main axis with a distal end and proximal end (Fig 13 element 260 as the distal end to 250 at the proximal end), an external surface (Fig 13 element 220), and at least three sections (Fig 13 elements 260 and sections surrounding elements 1-8), a first section (106) being at the proximal end of the probe for contacting the midzone area of the vaginal canal (Fig 13 the section from sensors 6-8), said first section is centered on a first axial position located at a first distance from the distal end of the probe body (Fig 13 element 6-8), the first distance ranging between 6 cm and 8 cm ([0102]: “the array of sensors has a total length of 80 mm”, wherein the first section located near 250 is a maximum of 8 cm from the distal end), a second section (108) being positioned at the distal end of the probe for contacting the distal zone of the vaginal canal (Fig 13 the section from sensors 1-4), said second section is centered at a second axial position located at a second distance from the distal end of the probe body (Fig 13 the section from sensors 1-4 distance from distal end), the second distance ranging between 2.5 cm and 3.5 cm (Fig 13 sensors 1-4, [0102]: “total length of 80 mm”, wherein the section occupies less than or up to half of the length of the body per Fig 14 and [0104-106]: “The tail 250 of the device is located at the entrance of the vagina, the introitus… During PFM contractions the greatest increase in pressure was in the region of the PFM, shown by the sensors placed approximately 3.5 cm from the introitus (for 3 out of the 4 subjects”, wherein the greatest increases were from sensors 4-6), each of said first and second sections having a bulbous shape (Fig 13 wherein the sections have a bulbous shape) and being separated from each other by a waist section ([0079]: “the substructure 1 has a membrane attached to or moulded about either side, so that the openings 2 become chambers within which individual pressure sensing devices are housed. The material from which the membranes are formed (for example a silicone or similar material)” [0089]: “As shown in that figure, the substructure 1 of the apparatus has been moulded over or otherwise incorporated in a flexible biocompatible material to provide chambers 7… two alternative embodiments of the pressure sensor apparatus are shown in FIG. 12… Here the retention contour is similar to that described above,” Wherein the substructure 1 is incorporated within the different protruding regions shown in Fig 12 and subsequently 13, and Fig 13 wherein the waist section is formed in between the bulbous section by the membrane) providing decoupling of sensing between the first sensor housed in the first section and the second sensor housed in the second section ([0079] : “thus the sensing devices are independently isolated in separate chambers. The chambers are designed to be substantially mechanically isolated from each other. For example, the pathway or wall regions between adjacent chambers are selected to provide a pressure resistant barrier or pathway between adjacent chambers. Preferably the barrier provides mechanical isolation which is sufficient to substantially prevent pressure changes in one chamber affecting pressure in the adjacent chamber”, [0089], wherein substructure 1 is incorporated in the embodiment), and a third section (104) arranged at the proximal end of the device (Fig 13 element 250 to 240), the third section (104) being separated from the first section (106) by a base waist portion (105) (Fig 13 area around base of element 8), the first section comprising at least a first sensor adapted for measuring the pressure applied by the internal vaginal surface to the external surface of the probe at the midzone area of the vaginal canal ([0094]: “The pressure sensor of the present invention is a mobile intra-vaginal pressure sensing device (IVPSD), to continuously measure the vaginal pressure profile for evaluating the PFM performance.”, Fig 14 graphs 1-4), and the second section comprising at least a second sensor adapted for measuring the pressure applied by the internal vaginal surface to the external surface of the probe at a distal zone ([0101]: “having an array of eight pressure sensors 230 (individually numbered 1 to 8”, Fig 14 graphs 1-4), said first sensor and said second sensor operating independently, having distinct and non-overlapping sensing areas along the main axis ( [0079]: “Thus the sensing devices are independently isolated in separate chambers. The chambers are designed to be substantially mechanically isolated from each other.”, [0089], wherein the chambers is incorporated in the embodiment, Fig 14 graphs 1-4, wherein the pressures are measured individually along the length of the device/canal); a data processing module (202) ([0080]: “processing/measuring device 4”) configured to determine a first differential vaginal pressure ([0103]: “the rate of pressure change was also computed.”) in the midzone area of the pelvic floor cavity denoted APmz (Fig 14 from sensors 3-5) and a second differential pressure in the distal zone area denoted APdt ([0106]: “showed the greatest pressure increase at the most distal sensors… The greatest rate of pressure change was 605 mmHg/s”), first and a second differential pressures serving as reference pressure values sensed in a relaxed state of the user ([0103]: “Vaginal pressures profiles were recorded for all tasks. Baseline pressures were recorded prior to each task”).
Nielsen fails to disclose the data processing module (202) is configured to calculate at a given time at least one ratio APmz/APdt and compare it to a threshold value (c1).
Madill discloses a method to quantify the relative levels of pressure between pelvic floor muscles and abdominal muscles (abstract). Madill further discloses the data processing module is configured to calculate at least one ratio APmz/APdt (Table 2, wherein F values are a ratio, see https://sixsigmastud yguide.com/f- distributionf-statistic-f-test/ below) and compare it to a threshold value (Table 2, significance level).
Nielsen further discloses wherein the data processing module is in communication with a user device to notify, in the case the ratio is lower than said first threshold value, an occurrence of a suboptimal pelvic floor muscle contraction ([0092]: “Transmission to a mobile device supports realtime feedback on the pressure profile during different conditions in the anatomical cavity in which the apparatus is located”, as modified by Madill).
It would have been obvious to a person of ordinary art in the skill to modify the system disclosed by Nielsen to include the ratios as disclosed by Madill and to further use that ratio in comparison to the threshold value in order to further provide detail about the muscle synergy between abdominal and PFM muscles (Madill introduction paragraph 6).
Regarding claim 2, Nielsen further discloses wherein the pelvic floor probe device (100) extends along a main axis (X) (Fig 13), wherein the first sensor exhibits a main direction of sensing along a first transverse direction (W1) ([0081]: “the pressure sensing device 3 that is housed in each chamber can sense the pressure in the immediate environment,” wherein the device can sense pressures in all surrounding directions), and the second sensor exhibits a main direction of sensing along a second transverse direction (Y2) ([0081]), wherein said second transverse direction is substantially perpendicular to the first transverse direction ([0081] wherein by nature of encompassing the entire device the range of sensing overlaps and can be perpendicular), and preferably, first and second transverse directions (W1,Y2) are substantially perpendicular to the main axis (X) ([0081]).
Regarding claim 3, Nielsen further discloses wherein said first section (106) is separated from said second section (108) by a waist section (107) said waist section having a cross-section (D7) in size less than 75% of the size of a cross-section (D6) of said first section (106) (Fig 13, wherein the dips between sections are less than 75%) and wherein the waist section exhibits flexure compliance to allow a misalignment of said second section (108) relative to the said first section (106) ([0079]: “may be formed from a relatively inert flexible material such as silicone or a material having similar properties”).
Regarding claim 5, Nielsen further discloses wherein the third section (104) has an oblong transverse cross-section with a larger dimension along a base orientation noted WO, which is parallel to the first transverse direction (W1) (Fig 13), whereby the user is induced to place the device with the base orientation aligned with her anteroposterior direction (Fig 10).
Regarding claim 8, Nielsen further discloses wherein the first section (106) comprises two complementary first shells (11,12), which, when assembled, form the bulbous body ([0080]: “The substrate 5 has a membrane in the top side and a second membrane in the bottom side and the pressure sensing device will respond to pressure on either membrane.”), with a first assembly joint arranged generally on a plane perpendicular to the first transverse direction W1 (Fig 5 showing a mould for an upper and lower half).
Regarding claim 9, Nielsen further discloses wherein the second section (108) comprises two complementary second shells (21,22), which, when assembled, form the bulbous body ([0080], wherein the second half of the two shells covers the second section), with a second assembly joint arranged generally on a plane perpendicular to the second transverse direction Y2 (Fig 5).
Regarding claim 10, Nielsen further discloses wherein the first section (106) exhibits a substantially circular cross section (D6) (Fig 13), with an outer diameter no greater than 30 mm ([0102]: “maximum width of 20 mm”).
Regarding claim 11, Nielsen further discloses wherein said first and second sensors are electronic sensors chosen among electromechanical sensors or pressure sensors or force sensors. ([0086]: “The MS5611-01BA sensor is a high-resolution altimeter sensor from MEAS Switzerland with SPI and I2C bus interface”).
Regarding claim 12, Nielsen discloses the first distance ranging between 6 cm and 8 cm ([0102]: “the array of sensors has a total length of 80 mm”, wherein the first section located near 250 is a maximum of 8 cm from the distal end), and said second section is centered at a second axial position located at a second distance from the distal end of the probe body (Fig 13 the section from sensors 1-2), the second distance ranging between 2.5 cm and 3.5 cm (Fig 13 sensors 1-2, [0102]: “total length of 80 mm”, wherein the section occupies less than half of the length of the body),
Regarding claim 13, Nielson further discloses the pelvic floor probe comprises a fluid-tight envelope (8) ([0090]: “The sheath may provide protection from moisture ingress to the electronics and keep the pressure sensor assembly clean”), said envelope being made of a biocompatible elastomer, preferably a medical grade silicon. ([0090]: “the sheath will be of a thin flexible material such as silicone rubber or latex.”)
Regarding claim 17, Nielsen further discloses a computer device configured to communicate with the data processing module of the probe device to convey the output generated by the data processing module to the computer device ([0092]: “Transmission to a mobile device supports realtime feedback on the pressure profile during different conditions in the anatomical cavity in which the apparatus is located, for example during a pelvic floor exercise when the device is located in an intra-abdominal or intra-vaginal cavity.”), wherein the probe device further comprises a transmitter configured to send the output data generated by the data processing module to the computer device ([0091]: “this may comprises a transmission means such as a Bluetooth™ module for example”).
Regarding claim 18, Madill further discloses the data processing module is further configured to register a set of differential pressures data APmz(k) and APdt(k) of sample points (k) during a voluntary pelvic floor muscle contraction (2.3 paragraph 2), wherein said data processing module is configured to calculate a result ratio function RRF defined as RRF (k)= Func (APmz (k) /APdt (k)), where RFF(k) is a series of numbers (3.1 paragraph 1), each number being representative of a quality of the pelvic floor muscle contraction (3.1 paragraph 3).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nielsen in view of Madill in further view of Shim (US 20100174218), hereinafter Shim in further view of Guay (US 20200281516 A1).
Nielsen and Madill disclose the system of claim 1, but fails to disclose the pelvic floor probe device (100) comprises a first battery cell lodged in the first section (106) and a second battery cell lodged in the second section (108).
Shim discloses a pelvic probe system (abstract) wherein the pelvic floor probe device (Figure 1A element 10) comprises a first battery cell ([0197]:” provided with a battery disposed inside the first or second unit 21, 22”) lodged in the first section (Figure 1A element 21).
As Nielsen does not specify a power source, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Nielsen to include the battery lodged in the first section as disclosed by Shim in order to provide power to the device.
Shim fails to specify and a second battery cell lodged in the second section (108).
Guay discloses Guay a pelvic floor probe device (abstract) comprises a second battery cell lodged in the second section (Figure 3 element 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to combine the battery cell within the first section as disclosed by Nielsen modified by Shim to obtain with the known battery cell within the second section as disclosed by Guay with the battery within the predictable result of providing power to the system. The battery cells within each of the prior art system function to provide power separately, and in combination performs the same function as they do individually. Furthermore, as the battery may exist in either the first or second section as per Shim ([0197]), the location of the battery cell is not critical to the function of the device.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nielsen in view of Madill in view of Murison (US 2017070787), hereinafter Murison.
Regarding claim 7, Nielsen and Madill disclose the system of claim 1. However, Nielsen as modified by Madill fails to disclose discloses the first section and second section are attached together by a link ring arranged at the waist section, the link ring being encompassed by a collar.
Murison discloses a pressure sending device able to be inserted into the vagina (abstract) with a first section (Figure 8b element 20) and a second section (Figure 8b element 12) wherein the first section and second section are attached together by a link ring (Figure 9 element 68) arranged at the waist section, the link ring being encompassed by a collar (Figure 9 element 72).
It would have been obvious to a person of ordinary skill in the art to modify the system disclosed by Nielsen to include the link ring disclosed by Murison in order to ensure secure attachment of the different sections.
Allowable Subject Matter
Claims 14-16 and 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments about Guay on pages 9-11, these arguments are considered moot as the new rejection necessitated by claim amendments does not rely on Guay as a primary reference.
Applicant argues on page 11 of Remarks that the data processing in Madill does not consider real time measurements. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Nielsen clearly discloses the capability of determining real time measurements (see rejection above). Additionally, MPEP 2183 states that a prior art element is equivalent when (A) The prior art element performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000). While Madill is interested in discerning the differences between contractions based on position, they do so by evaluating the strength of the contractions (i.e. the quality) during the performed exercises (Madill abstract).
Applicant argues on pages 12 and 13 that Nielsen does not teach the amended claim limitation regarding decoupling of the sensors. However, Nielsen discloses both the first and second distances (see rejection above) and decoupling. Nielsen para [0079]: "Thus the sensing devices are independently isolated in separate chambers. The chambers are designed to be substantially mechanically isolated from each other…. Preferably the barrier provides mechanical isolation which is sufficient to substantially prevent pressure changes in one chamber affecting pressure in the adjacent chamber". Nielson specifically discloses isolation of sensing chambers, allowing for pressure changes in one section from affecting changes in the next. The section as such is decoupled from the other sections, and further allows for decoupled sensing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
De Laat et al. (US 20210137444 A1) – discloses a pelvic device with multiple shells and compartments
12, THIS ACTION IS MADE FINAL. 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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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791