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 statements (IDS) submitted on 06/05/2026 and 03/10/2026 were considered by the examiner.
Drawings
The drawings were received on 03/10/2026. The replacement drawings are objected to under 35 U.S.C. §132(a) because they introduce new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the indicator strip 150’ being located at a center of the ribs 380 of Fig. 13B.
Applicant is required to cancel the new matter in the reply to this Office Action.
The Examiner suggests submitting replacement drawings which revert Fig. 13B to its original form. Additionally, if Fig. 13B is reverted to its original form, the previous objection under 37 CFR § 1.84 for not showing every feature of the invention specified in the claims will not be raised. The previous drawings objections were withdrawn in light of MPEP 1893.03(f).
Claim Objections
Claim 116 is objected to because of the following informalities:
Claim 116, line 2: “a material comprising the body of the device” is grammatically awkward and should be replaced with –a material which at least partially forms the body of the device–.
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.
Claims 104 and 107 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0113500 A1 (Hwang ‘500) (previously cited) in view of CN 107049587 A1 (Guo) and US 2018/0140458 A1 (Brockway).
With regards to claim 104, Hwang ‘500 teaches a vaginal insert device configured for placement in a vagina (Fig. 2 and ¶ [0040] depict a menstrual cup 100; ¶ [0042] depicts the menstrual cup 100 mounted in the vagina), the vaginal insert device comprising:
a body that extends from an open top end to a closed bottom end (Fig. 2 depicts the menstrual cup 100 having a body extending from an open top end and a closed bottom end), the body comprising an upper portion having an interior (Fig. 2 and ¶ [0040] depict a an upper portion of the menstrual cup 100 having a storage part 120 and a space for receiving the cartridge 140), with the interior being configured to collect a vaginal fluid or vaginal tissue (¶ [0035] depicts the storage part 120 formed to store menstrual blood therein); and
a sensor embedded within the body of the device and configured to detect a property of the vaginal fluid or vaginal tissue collected within the interior of the upper portion of the body of the device (Fig. 2 depicts the cartridge 140 embedded within the body of the menstrual cup 100; ¶ [0041] depicts the cartridge 140 is capable of testing menstrual blood contained in the storage part 140; ¶ [0039] discloses the cartridge being used for obtaining, from the menstrual blood, biometric information such as genetic information, protein information, and the like).
Hwang ‘500 is silent regarding whether the sensor is located within a rib of the body.
In the same field of endeavor of menstrual cups, Guo teaches a sensor located with a rib of a body (Fig. 1 depict the sensor 22 being located within a protrusion (i.e., a rib); Page 10 of the attached translation indicates that the sensor 22 can identify a blood colour, pH value, and concentration of bacteria). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embedded sensor of Hwang ‘500 to incorporate that it is located within a rib of the body as taught by Guo. Because both locations are suitable for sensing parameters of blood, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent regarding whether the rib extends across the interior and is connected to an interior wall.
In the same field of endeavor of menstrual cups, Brockway teaches a body comprising a rib that extends across the interior and is connected to an interior wall (Fig. 1 and ¶¶ [0033], [0042]-[0043] depict a menstrual cup 10 having a wall structure 20 with ridges 44 that extend across an interior of the cup). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rib of the body of the above combination to incorporate that the rib that extends across the interior and is connected to an interior wall as taught by Brockway. The motivation would have been to provide more than one degree or level of deformation of the open top for unsealing the menstrual cup from the from the walls of the vagina (¶ [0045] of Brockway). Additionally or alternatively, it would have been the simple substitution of one rib for another to obtain predictable results.
With regards to claim 107, Hwang ‘500 teaches a microchip configured to communicate the property to a user or a medical professional (¶ [0055] depicts a wireless communication module for transmitting data to the cartridge reader or a user terminal. The Examiner asserts that the wireless communication module necessarily includes a microprocessor or microchip)
Claims 105-106 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang ‘500 in view of Guo and Brockway, as applied to claim 104 above, and further in view of WO 2017/015767 A1 (Murison) (cited by Applicant).
With regards to claim 105, the above combination is silent regarding whether the sensor is a reagent, an indicator strip, an electrical sensor, a receptor, or nano-technology.
In the same field of endeavor of vaginal insert devices, Murison teaches a sensor being a reagent, an indicator strip, an electrical sensor, a receptor, or nano-technology (Figs. 1A, 1B and ¶ [0019] depict a sensor array 118 comprising a collection of one or more sensors, wherein the sensors may include a heated post/film/strip with thermistors, a capacitive sensor, a resistive sensor, an optical reflectometry sensor, a magnetic level gauge, an acoustic sensor, an accelerometer, a pressure sensor, a temperature sensor, a light detector, a blood flow sensor, a bioelectricity sensor, a gas/organic compound sensor, etc. Fig. 1B depicts the sensing array including strips affixed to and/or lining the reservoir wall 110, wherein ¶ [0019] discloses those one or more sensor(s) that require coupling to the collected menstrual fluid to yield quantifications relating to the menstrual fluid (e.g., volume, flow rate, color, pH, viscosity, temperature, hormone concentrations, etc.); also see Claim 8 regarding the strip). It would have been obvious for one of ordinary skill in the art to have substituted the sensor of Hwang ‘500 of the above combination with the sensor of Murison. Because both elements are capable of measuring biometrics (¶ [0019] of Murison; ¶ [0039] of Hwang ‘500), it would have been the substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to gather further biometric data and provide a more complete diagnostic picture of the patient.
With regards to claim 106, the above combination is silent regarding whether the property is a pH value, a presence of a bacteria, a presence of a microbe, a vitamin level, an ovulation level, a hormone level, a temperature, a pelvic floor or muscle strength, a sexually transmitted disease, a yeast infection, a nonsexually transmitted infection, abnormal cells, interstitial cystitis, or an abnormality in vaginal fluid or tissue.
In the same field of endeavor of vaginal insert devices, Murison teaches a sensor configured to detect a property of vaginal fluid vaginal tissue, the property being a pH value, a hormone level, an abnormality in vaginal fluid or tissue. (¶ [0019] discloses those one or more sensor(s) that require coupling to the collected menstrual fluid to yield quantifications relating to the menstrual fluid (e.g., volume, flow rate, color, pH, viscosity, temperature, hormone concentrations, etc.). It would have been obvious for one of ordinary skill in the art to have substituted the sensor of Hwang ‘500 of the above combination with the sensor of Murison. Because both elements are capable of measuring biometrics (¶ [0019] of Murison; ¶ [0039] of Hwang ‘500), it would have been the substitution of one known equivalent element for another to obtain predictable results.
Claim 108 is rejected under 35 U.S.C. 103 as being unpatentable over Hwang ‘500 in view of Guo and Brockway, as applied to claim 107 above, and further in view of US 2018/0199874 A1 (Hwang ‘874) (previously cited)
With regards to claim 108, the above combination is silent regarding whether the microchip is configured to communicate via Bluetooth®, Wi-Fi, or radio waves such that the property is communicated to a mobile device or computer.
In the same field of endeavor of vaginal insert devices, Hwang ‘874 teaches a microchip configured to communicate via Bluetooth®, Wi-Fi, or radio waves such that the property is communicated to a mobile device or computer (Fig. 2 and ¶¶ [0046]- [0049] depict a control unit 400 configured to externally transmit a signal via a communication unit 350, wherein the communication unit 350 uses a means of communication such as Bluetooth, infrared rays, Zigbee, Wi-Fi, etc.). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microchip of Hwang ‘500 of the above combination to incorporate configurations for communicating via Bluetooth®, Wi-Fi, or radio waves such that the property is communicated to a mobile device or computer, as taught by Hwang ‘874. Because both configurations are capable of wireless communications to an external device(¶ [0055] of Hwang ‘500; ¶ [0046] of Hwang ‘874), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 110, 111, and 113 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang ‘500 in view of Guo and Brockway, as applied to claim 104 above, and further in view of US 2018/0184976 A1 (Kuniavsky) (Previously cited).
With regards to claim 110, the above combination is silent whether the sensor provides a visual indication of the property.
In a system relevant to the problem of detecting properties of a vaginal fluid (¶ [0032] of Kuniavsky), Kuniavsky teaches a sensor capable of being used with a menstrual cup (¶ [0046] sensors may need to be printed, directly, onto the inner surface of the menstrual cups to make contact with the menstrual fluid), wherein the sensor provides a visual indication of a property of vaginal fluid (¶ [0095] depicts a printed pattern of various chemically color-changing materials, wherein a particular substance can react with a particular color-changing material; ¶ [0096] and Fig. 10B depict the color-changing materials being multiple parallel strip). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor of Hwang ‘500 of the above combination with the color-changing strips as taught by Kuniavsky. Because both elements are capable of detecting biometric information (¶¶ [0039], [0049] of Kuniavsky; ¶ [0039] of Hwang ‘500), it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to make the property easier to detect with the eye.
With regards to claim 111, the above combination teaches or suggests the vaginal insert device of claim 110, wherein the sensor is an indicator strip and the visual indication is a change in color of the indicator strip (see the above combination in view of Kuniavsky; ¶ [0096] and Fig. 10B of Kuniavsky depict the color-changing materials being multiple parallel strips, which form an indicator strip).
With regards to claim 113, the above combination teaches or suggests the sensor is embedded within the rib of the body of the vaginal insert device (Fig. 2 of Hwang ‘500 depicts the cartridge 140 is embedded within a wall of the body of the menstrual cup; Fig. 1 of Guo depicts the sensor located within the rib).
The above combination is silent regarding whether the sensor is an indicator strip.
In a system relevant to the problem of detecting properties of a vaginal fluid (¶ [0032] of Kuniavsky), Kuniavsky teaches a sensor capable of being used with a menstrual cup (¶ [0046] sensors may need to be printed, directly, onto the inner surface of the menstrual cups to make contact with the menstrual fluid), wherein the sensor is an indicator strip (¶ [0095] depicts a printed pattern of various chemically color-changing materials, wherein a particular substance can react with a particular color-changing material; ¶ [0096] and Fig. 10B depict the color-changing materials being a test strip). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor of Hwang ‘500 of the above combination with the indicator strip as taught by Kuniavsky. Because both elements are capable of detecting biometric information (¶¶ [0039], [0049] of Kuniavsky; ¶ [0039] of Hwang ‘500), it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to make the property easier to detect with the eye.
Claim 116 is are rejected under 35 U.S.C. 103 as being unpatentable over Hwang ‘500 in view of Guo and Brockway, as applied to claim 104 above, and in view of US 2013/0331666 A1 (Miller) (previously cited)
With regards to claim 116, the above combination is silent regarding whether the sensor is formed of a material comprising the body of the device.
In a system relevant to the problem of detecting properties of a vaginal fluid, Miller teaches a sensor formed of a material comprising a body of a device (¶ [0092] discloses a reagent (e.g., an antibody to a target analyte, coupled to a colored polymer particle) being a material which comprises at least a portion of a sample collection matrix 206). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the body of the device of the above combination to incorporate a reagent as taught by Miller. The motivation would have been to integrate the device with the sensor, thereby making the device easier to use.
Response to Arguments
Drawing Objections
The replacement drawings were objected to under 35 U.S.C. §132(a) because they introduce new matter into the disclosure The Examiner suggests submitting replacement drawings which revert Fig. 13B to its original form. Additionally, if Fig. 13B is reverted to its original form, the previous objection under 37 CFR § 1.84 for not showing every feature of the invention specified in the claims will not be raised. The previous drawings objections were withdrawn in light of MPEP 1893.03(f).
Claim Objections
In view of the claim amendments filed 03/10/2026, the previous claim objections were withdrawn. There are new grounds of claim objections.
Claim Rejections under 35 U.S.C. §112
In view of the claim amendments filed 03/10/2026, the claim objections were withdrawn.
Prior Art Rejections
Applicant' s amendment and arguments filed 03/10/2026 with respect to the 35 USC 103 rejections set forth in the Non-Final Rejection mailed 12/22/2025 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 Guo and Brockway. Hwang ‘500 is silent regarding whether the sensor is located within a rib of the body and whether the rib extends across the interior and is connected to an interior wall but Guo and Brockway discloses these features. Therefore, the previously applied 103 rejection has been modified to incorporate the teachings of Guo and Brockway.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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