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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63,593,951, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In particular, the limitations of “performing a safety action based on fulfillment of the menstrual condition” in claim 1; “the safety action includes at least one of providing a notification on a user device or providing a notification at the menstrual hygiene product” in claim 6; “the safety action includes releasing medicine at the menstrual hygiene product” in claim 7; and “performing a safety action based on an occurrence of the menstrual condition” do not have adequate support or enablement identified in the provisional application 63,593,951.
The effective filing date of the instant Application is determined to be October 24, 2024.
Drawings
The drawings filed on October 24, 2024 are accepted.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19, line 3: “the computer-readable media” should be corrected to –the one or more non-transitory computer-readable media--.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-8 are directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claims 19-20 are drawn to a “non-transitory computer-readable medium” which describes one of the four statutory categories, i.e., a manufacture.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1 and 19 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: “determining a menstrual characteristic based on the data; and monitoring the menstrual characteristic for a menstrual condition”.
In claims 1 and 19, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper. If a person were to visually examine, i.e., perform an observation, the data from the sensor, either in a printout or an electronic format, the person would be able to identify the menstrual characteristic based on the data, determine a menstrual condition and track the data over time (i.e., “monitor” as claimed) based on the menstrual characteristic. There is nothing recited in the claim to suggest an undue level of complexity in how the menstrual characteristic is determined and how the menstrual condition is monitored. Therefore, a person would be able to perform the identification and selection mentally.
Prong Two: Claims 1, 9 and 19 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recite additional steps of (1) providing a menstrual hygiene product including a sensor; and obtaining data from the menstrual hygiene product including data from the sensor; (2) performing a safety action based on fulfillment/occurrence of the menstrual condition; and (3) Claim 19 further recites a processor and a non-transitory computer-readable media.
The step (1) and (3) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
The step (2) represents merely an insignificant post-solution activity. More specifically, the Specification defines "a safety action", in part, to include mere notification to a user which is merely an insignificant post-extra solution activity of displaying data. The Specification however further discloses the safety action may also including administering medicine, which may integrate the judicial exception into a practical application under Step 2A, Prong Two. However, generically reciting the administration of a medicine, without specificity is not adequate to integrate the judicial exception into a practical application. Applicant is encouraged to add further specificity (as is supported by the original Specification) to the administration step in order to establish integration. See Vanda memo.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to perform an action based on the abstract idea, while generically implementing it in a high level of generality. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the monitoring is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 19 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of (1) providing a menstrual hygiene product including a sensor; and obtaining data from the menstrual hygiene product including data from the sensor; (2) performing a safety action based on fulfillment/occurrence of the menstrual condition; and (3) Claim 19 further recites a processor and a non-transitory computer-readable media. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
For similar reasons set forth in Step 2A, Prong Two above, these additional elements do not provide an inventive concept under Step 2B.
Accordingly, these additional steps amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
Describing further the menstrual characteristic (claims 3 and 5);
Describing further the menstrual condition (claim 4);
Describing further the safety action (claims 6);
Describing further abstract idea of identifying a baseline and the deviation from it (claims 8 and 20).
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
describing further sensing data (claim 2);
describing further the safety action being releasing a drug (claim 7), with claim 16 further reciting that such an action of releasing a drug is in response to one of the three conditions. The step of “releasing medicine” does not provide any information as to how the medicine is released, or what the medicine is, but instead covers any possible treatment that a medical professional decides as a safety action. As such, there are no meaningful constrains on the releasing step such that the particular medicine or prophylaxis consideration would apply because it is not limited to any particular manner or type of medicine to be release. The claims recite The limitation is at most an instruction to “apply” the judicial exception, hence is considered merely an insignificant post-solution activity.
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 6, 9, 11, 13, 15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al., US 2013/0331666 A1, hereinafter Miller.
Claims 1, 9 and 19. Miller teaches a method of monitoring menstrual fluid for diagnosis and treatment, a menstruation monitoring instrument ([0013]: methods, articles, and systems for the non-intrusive collection, fractionation, and analysis of menstrual fluid; and [0017]: a non-invasive menstrual fluid analyte monitoring system. Some example systems include an absorbent layer, a porous matrix, and an analyte sensor), and a device comprising one or more non-transitory computer readable media configured to store instructions, and a processor coupled to the computer-readable media and configured to execute the instructions to perform operations ([0141]: a detection matrix or display may include one or more electronic components and/or be endowed with operating logic configured to operate the analyte sensor, a microprocessor, a transceiver, and/or other components), comprising:
providing a menstrual hygiene product (501) including a sensor (554) ([0017]: a non-invasive menstrual fluid analyte monitoring system. Some example systems include an absorbent layer, a porous matrix, and an analyte sensor; and [0073]: an analyte sensor may be provided for use with a pre-existing feminine hygiene product. Alternatively, an analyte sensor may be integrated within a feminine hygiene product (e.g., a menstrual pad, tampon, or menstrual cup);
obtaining data from the menstrual hygiene product including data from the sensor; determining a menstrual characteristic based on the data ([0076]: prefilter 102 and sample collection matrix 104 may be coupled to receptacle 106 in a single unit configured for use with a standard menstrual pad, such as a sanitary napkin; [0108]: detection matrix 320 may be a cellulosic or polymer membrane provided with an immobilized detection reagent, a capture reagent, and/or an indicator such as a dye in an anhydrous form; [0112]: as the mixed fluid component flows by capillary action through detection matrix 320, a reaction product may interact with the indicator to produce a visible indication of target analyte presence; and [0117]: as a visible reaction product is formed on the bottom of detection matrix 320, it may be deposited on display 326. Alternatively, one or more indicators may be coupled to display 326 and may produce a visible indication of target analyte presence/concentration);
monitoring the menstrual characteristic for a menstrual condition ([0113]: an analyte sensor to measure cholesterol essentially…may be provided in a feminine hygiene product to monitor cholesterol via menstrual fluid); and
performing a safety action based on fulfillment of the menstrual condition ([0061]: An analyte sensor may be configured to convey the presence or absence of a target analyte as either a “positive” or “negative” result. Analyte sensors may venerate a visible signal…to indicate that the analyte was detected in the tested sample. An analyte sensor may generate such a signal in response to detection of the analyte at any concentration above a minimum threshold concentration. For example, an analyte sensor may produce a color deposit in response to the detection of triglycerides at any concentration equal to or greater than 150 mg/dL. Alternatively, an analyte sensor may generate a “positive” signal in response to detection of the analyte at any concentration, without a minimum threshold. For example, an analyte sensor may produce a color deposit in response to the detection of a toxin at any concentration).
Claims 3-4 and 17-18. Miller further teaches that
the menstrual characteristic includes at least one of blood loss, saturation level of the menstrual hygiene product, time that the menstrual hygiene product has been in use, a presence of biomarkers in the menstrual fluid, presence of pathogens, or blood clot size (claims 3 and 17), and the menstrual condition includes at least one of: a blood loss threshold, a saturation threshold, a time threshold, a presence of a specific biomarker in the menstrual fluid, a blood clot size threshold, or a medication release time (claims 4 and 18) ([0061]: an analyte sensor may generate such a signal in response to detection of the analyte at any concentration above a minimum threshold concentration. For example, an analyte sensor may produce a color deposit in response to the detection of triglycerides at any concentration equal to or greater than 150 mg/dL. Alternatively, an analyte sensor may generate a “positive” signal in response to detection of the analyte at any concentration, without a minimum threshold. For example, an analyte sensor may produce a color deposit in response to the detection of a toxin at any concentration; and [0032] teaches a list of biomarkers).
Claim 6. Miller further teaches that
the safety action includes at least one of providing a notification on a user device or providing a notification at the menstrual hygiene product ([0061]: An analyte sensor may be configured to convey the presence or absence of a target analyte as either a “positive” or “negative” result. Analyte sensors may venerate a visible signal…to indicate that the analyte was detected in the tested sample.).
Claim 11. Miller further teaches
a processor incorporated in the menstrual hygiene product, the processor being communicatively coupled to the sensor wherein the processor is configured to transmit the data collected by the sensor to a user device ([0141]: a detection matrix or display may include one or more electronic components and/or be endowed with operating logic configured to operate the analyte sensor, a microprocessor, a transceiver, and/or other components) – a transceiver transmits and receives data.
Claim 13. Miller further teaches that
the sensor is a part of an array of sensors, wherein the array of sensors are incorporated into the menstrual hygiene product ([0050]: a detection matrix may be provided with a plurality of surface-bound detection reagents and/or capture reagents. In some examples, a detection matrix may be provided with a plurality of different detection/capture reagents immobilized in one or more shapes….the shapes may be arranged on/in the detection matrix in rows and/or columns to form an array. For example, a detection matrix may be provided with twenty detection/capture reagents).
Claim 15. Miller further teaches that
the menstrual hygiene product is at least one of a tampon, a sanitary pad, period underwear, or a menstrual cup ([0073]: an analyte sensor may be provided for use with a pre-existing feminine hygiene product. Alternatively, an analyte sensor may be integrated within a feminine hygiene product (e.g., a menstrual pad, tampon, or menstrual cup)).
Claims 1-6, 9-15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brief et al., US 2017/0150917 A1, hereinafter Brief.
Claim 1. Brief teaches a method of monitoring menstrual fluid for diagnosis and treatment ([0030]: FIG,1 shows the components of a feminine hygiene product to monitor blood flow during a menstrual cycle; [0067]: FIG.12 is a flowchart of a method to monitor a blood flow during a menstrual cycle of a user), comprising:
providing a menstrual hygiene product (100) including a sensor ([0030]: FIG.1 shows the components of a feminine hygiene product to monitor blood flow during a menstrual cycle. The feminine hygiene product, such as a tampon, a panty liner, a sanitary napkin, a sanitary brief, a menstrual cup, etc, includes…a string 140…The string encloses a plurality of conductive wires coupled to a sensor disposed within the absorbent part 130);
obtaining data from the menstrual hygiene product including data from the sensor; determining a menstrual characteristic based on the data ([0030]: A wearable device 110 is coupled to the string 140 and receives data from the sensor regarding an amount of blood associated with the menstrual cycle of a user);
monitoring the menstrual characteristic for a menstrual condition ([0030]: FIG.1 shows the components of a feminine hygiene product to monitor blood flow during a menstrual cycle; and [0067]: FIG.12 is a flowchart of a method to monitor a blood flow during a menstrual cycle of a user); and
performing a safety action based on fulfillment of the menstrual condition ([0049]: the remote processor performs various functions, such as…analyzing the smooth data and/or data, and/or the historical data to generate various notifications to the user…The remote processor sends notifications to a display associated with the processor,…The display generates a visual message corresponding to the notification, the visual message comprising at least one of a textual message, an image, a graph, or a video; and [0057]: FIGS.7A-7C show an example of a notification to the user…an average amount of time elapsed before the feminine hygiene product is fully saturated…an amount of saturation associated with the feminine hygiene product…approximate time when the feminine hygiene product needs to be changed…an expected start and end of the next menstrual cycle).
Claim 2. Brief further teaches that
the data includes at least one of image data generated from an image of the menstrual hygiene product, weight data indicating a weight of the menstrual hygiene product, time data indicating a length of time that the menstrual hygiene product has been in use, resistance data indicating a resistance of the sensor, conductivity data indicating conductivity in the sensor, viscosity data indicating viscosity in the sensor or biological data of the menstrual fluid ([0041]: When the absorbent part of the tampon 300 is dry, the current flowing between the probe pair 310 is low, meaning that the ohmic resistance is high. The conductance between the probe pair when the absorbent part of the tampon is dry is known before the tampon is inserted in the body. As the absorbent part of the tampon receives more blood, the conductance changes, e.g., the ohmic resistance between the probe pair decreases, allowing more electric current to flow between the probe pair because blood is conductive; and [0057]: FIG.7A represents a correspondence between a day of the week and an average amount of time elapsed before the feminine hygiene product is fully saturated…Message 710 in FIG.7C associated with the mobile device shows an approximate time when the feminine hygiene product needs to be changed).
Claims 3-4. Brief further teaches that
the menstrual characteristic includes at least one of blood loss, saturation level of the menstrual hygiene product, time that the menstrual hygiene product has been in use, a presence of biomarkers in the menstrual fluid, presence of pathogens, or blood clot size (claims 3 and 17), and the menstrual condition includes at least one of: a blood loss threshold, a saturation threshold, a time threshold, a presence of a specific biomarker in the menstrual fluid, a blood clot size threshold, or a medication release time (claims 4 and 18) ([0057]: Display 710 in FIG.7B associated with the mobile device shows an amount of saturation associated with the feminine hygiene product. Message 720 in FIG.7C associated with the mobile device shows an approximate time when the feminine hygiene product needs to be changed).
Claim 5. Brief further teaches that
at least one of the blood loss or the saturation level is determined based on at least one of the weight data or the resistance data ([0041]: When the absorbent part of the tampon 300 is dry, the current flowing between the probe pair 310 is low, meaning that the ohmic resistance is high. The conductance between the probe pair when the absorbent part of the tampon is dry is known before the tampon is inserted in the body. As the absorbent part of the tampon receives more blood, the conductance changes, e.g., the ohmic resistance between the probe pair decreases, allowing more electric current to flow between the probe pair because blood is conductive).
Claim 6. Brief further teaches that
the safety action includes at least one of providing a notification on a user device or providing a notification at the menstrual hygiene product ([0049]: the remote processor performs various functions, such as…analyzing the smooth data and/or data, and/or the historical data to generate various notifications to the user…The remote processor sends notifications to a display associated with the processor,…The display generates a visual message corresponding to the notification, the visual message comprising at least one of a textual message, an image, a graph, or a video).
Claim 9. Brief teaches a menstruation monitoring instrument ([0030]: FIG,1 shows the components of a feminine hygiene product to monitor blood flow during a menstrual cycle; [0067]: FIG.12 is a flowchart of a method to monitor a blood flow during a menstrual cycle of a user), comprising:
a menstrual hygiene product (100) and a sensor incorporated in the menstrual hygiene product ([0030]: FIG.1 shows the components of a feminine hygiene product to monitor blood flow during a menstrual cycle. The feminine hygiene product, such as a tampon, a panty liner, a sanitary napkin, a sanitary brief, a menstrual cup, etc, includes…a string 140…The string encloses a plurality of conductive wires coupled to a sensor disposed within the absorbent part 130),
the sensor being configured to collect data from the menstrual fluid contacting the menstrual hygiene product ([0030]: A wearable device 110 is coupled to the string 140 and receives data from the sensor regarding an amount of blood associated with the menstrual cycle of a user).
Claim 11. Brief further teaches
a processor incorporated in the menstrual hygiene product, the processor being communicatively coupled to the sensor wherein the processor is configured to transmit the data collected by the sensor to a user device ([0045]: The internal electronic unit includes a wireless transceiver to send the smooth data and/or data to a remote processor for further analysis; and [0049]: the remote processor can be associated with a mobile device, a wearable device…The mobile device can be a tablet, a cell phone, a personal digital assistant, etc).
Claim 13. Brief further teaches that
the sensor is a part of an array of sensors, wherein the array of sensors are incorporated into the menstrual hygiene product ([0050]: FIG.3D shows a tampon with a plurality of internal sensors and a plurality of strings…The plurality of internal sensors includes plurality of probe pairs…A plurality of conductive wires connects to the probe pairs) – in FIG.3D, the probe pairs form the “array of sensors” as claimed.
Claim 14. Brief further teaches that
the data includes at least one of image data generated from an image of the menstrual hygiene product, weight data indicating a weight of the menstrual hygiene product, time data indicating a length of time that the menstrual hygiene product has been in use, resistance data indicating a resistance of the sensor, conductivity data indicating conductivity in the sensor, viscosity data indicating viscosity in the sensor or biological data of the menstrual fluid ([0041]: When the absorbent part of the tampon 300 is dry, the current flowing between the probe pair 310 is low, meaning that the ohmic resistance is high. The conductance between the probe pair when the absorbent part of the tampon is dry is known before the tampon is inserted in the body. As the absorbent part of the tampon receives more blood, the conductance changes, e.g., the ohmic resistance between the probe pair decreases, allowing more electric current to flow between the probe pair because blood is conductive; and [0057]: FIG.7A represents a correspondence between a day of the week and an average amount of time elapsed before the feminine hygiene product is fully saturated…Message 710 in FIG.7C associated with the mobile device shows an approximate time when the feminine hygiene product needs to be changed).
Claim 15. Brief further teaches that
the menstrual hygiene product is at least one of a tampon, a sanitary pad, period underwear, or a menstrual cup ([0030]: FIG.1 shows the components of a feminine hygiene product to monitor blood flow during a menstrual cycle. The feminine hygiene product, such as a tampon, a panty liner, a sanitary napkin, a sanitary brief, a menstrual cup, etc, includes…a string 140…The string encloses a plurality of conductive wires coupled to a sensor disposed within the absorbent part 130).
Claims 17-18. Brief further teaches that
the menstrual characteristic includes at least one of blood loss, saturation level of the menstrual hygiene product, time that the menstrual hygiene product has been in use, a presence of biomarkers in the menstrual fluid, presence of pathogens, or blood clot size (claims 3 and 17), and the menstrual condition includes at least one of: a blood loss threshold, a saturation threshold, a time threshold, a presence of a specific biomarker in the menstrual fluid, a blood clot size threshold, or a medication release time (claims 4 and 18) ([0057]: Display 710 in FIG.7B associated with the mobile device shows an amount of saturation associated with the feminine hygiene product. Message 720 in FIG.7C associated with the mobile device shows an approximate time when the feminine hygiene product needs to be changed).
Claim 19. Brief teaches a device comprising one or more non-transitory computer readable media configured to store instructions, and a processor coupled to the computer-readable media and configured to execute the instructions to perform operations ([0045]: FIG.3B shows the tampon with an internal sensor and an internal electronic unit…the internal electronic unit can include a processor to analyze the data…The internal electronic unit includes a wireless transceiver to send the smooth data and/or data to a remote processor for further analysis; and [0049]: the remote processor performs various functions, such as…storing the smooth data and/or data in a database; and [0079]: the user device includes a processor for running the analytic module, and a memory associated with the processor), the operations comprising:
obtaining data included data collected from a sensor ([0030]: A wearable device 110 is coupled to the string 140 and receives data from the sensor regarding an amount of blood associated with the menstrual cycle of a user);
determining a menstrual characteristic based on the data; monitoring the menstrual characteristic for a menstrual condition ([0030]: FIG.1 shows the components of a feminine hygiene product to monitor blood flow during a menstrual cycle; and [0067]: FIG.12 is a flowchart of a method to monitor a blood flow during a menstrual cycle of a user); and
performing a safety action based on an occurrence of the menstrual condition ([0049]: the remote processor performs various functions, such as…analyzing the smooth data and/or data, and/or the historical data to generate various notifications to the user…The remote processor sends notifications to a display associated with the processor,…The display generates a visual message corresponding to the notification, the visual message comprising at least one of a textual message, an image, a graph, or a video; and [0057]: FIGS.7A-7C show an example of a notification to the user…an average amount of time elapsed before the feminine hygiene product is fully saturated…an amount of saturation associated with the feminine hygiene product…approximate time when the feminine hygiene product needs to be changed…an expected start and end of the next menstrual cycle).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Brief in view of Waldhorn et al., WO 2009144696 A1, hereinafter Waldhorn.
Claims 7 and 16. Brief teaches all the limitations of claims 1 and 19.
Brief does not teach that the safety action includes releasing medicine at the menstrual hygiene product, and the medicine is released in response to at least one of the following: the sensor contacting menstrual fluid; or a signal to dispense medicine being received at the processor; or the processor receiving data from the sensor indicating that a menstrual condition has been fulfilled.
However, in an analogous wearable absorbent article-based fluid monitoring field of endeavor, Waldhorn teaches that
the safety action includes releasing medicine at the menstrual hygiene product, and the medicine is released in response to at least one of the following: the sensor contacting menstrual fluid; or a signal to dispense medicine being received at the processor; or the processor receiving data from the sensor indicating that a menstrual condition has been fulfilled (p.8, ¶-4: it is another object of the present invention to provide the absorbing pad as defined above, additionally comprising an electrically or chemically triggered release valve that releases said medication at a rate that is correlated with the degree of saturation sensed by said interconnected saturation sensor).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method or device of Brief employ such features associated with the safety action including releasing medicine at the menstrual hygiene product, and the medicine being released in response to at least one of the following: the sensor contacting menstrual fluid; or a signal to dispense medicine being received at the processor; or the processor receiving data from the sensor indicating that a menstrual condition has been fulfilled as taught in Waldhorn for the advantage of controlling the degree of saturation as the medication is released at a rate that is correlated with the degree of saturation, as suggested in Waldhorn, p.8, ¶-4.
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Brief in view of Heirman et al., US 2022/0233363 A1, hereinafter Heirman.
Claims 8 and 20. Brief teaches all the limitations of claims 1 and 19.
Brief further teaches
establishing a baseline for the menstrual characteristic ([0048]: the processor associated with the external electronics unit stores the measurement as a baseline for comparison with future electronic current measurements).
Brief does not teach that the menstrual condition includes a deviation from the baseline for the menstrual characteristic.
However, in an analogous wearable absorbent article-based fluid monitoring field of endeavor, Heirman teaches
establishing a baseline for the menstrual characteristic; and wherein the menstrual condition includes a deviation from the baseline for the menstrual characteristic ([0262]: The article condition is permanently monitored by the system, at least with a certain time interval or when a change of at least one real-time indicator is triggering to determine the article condition with an updated status. This allows to compare previous extrapolation (or interpolation) of the warning condition with the real evolution of it and to change to prioritization when necessary; and FIG.21).
In addition, as the menstrual hygiene product is meant to be used to collect menstrual blood, the menstrual characteristic at the clean state of the product, i.e., at the very initial time point of use, is the baseline. The quantity of the characteristics derived from the sensor data is the deviation from such a baseline when the hygiene product has no blood collected.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method or device of Brief employ such features associated with establishing a baseline for the menstrual characteristic; and wherein the menstrual condition includes a deviation from the baseline for the menstrual characteristic as taught in Heirman for the advantage of providing a real-time prioritization of the action when necessary, as suggested in Heirman, [0262].
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Brief in view of Carney et al., US 2015/0206151 A1, hereinafter Carney.
Claim 10. Brief teaches all the limitations of claim 9.
Brief does not teach a camera incorporated in the menstrual hygiene product, or an external camera, the camera being configured to capture images of the menstrual fluid contacting the menstrual hygiene product.
However, in an analogous wearable absorbent article-based fluid monitoring field of endeavor, Carney teaches
a camera incorporated in the menstrual hygiene product, or an external camera, the camera being configured to capture images of the menstrual fluid contacting the menstrual hygiene product ([0104]: FIG,5 illustrates a used hygiene product 12 in form of an incontinence protector comprising an area 13 of absorbed fluid. The mobile device 1 captures an image of the product 12 by means of the image capturing device 3 of the mobile device, preferably during illumination of the product 12 by a light source 10 of the mobile deice 1, e.g., an integrated camera flash. By analyzing the colour and/or light intensity information of the pixels of the captured image, a degree of utilization of the absorbed product can be determined).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the instrument of Brief employ such features associated with an external camera, the camera being configured to capture images of the menstrual fluid contacting the menstrual hygiene product as taught in Carney for the advantage of “determining a degree of utilization of the absorbed product” in Carney, [0104].
Claim 12. As applied to claim 9, Brief teaches
Brief further teaches
a processor incorporated in the menstrual hygiene product and communicatively coupled to the sensor, the processor being configured to transmit the data collected by the sensor to a user device ([0045]: FIG.3B shows the tampon with an internal sensor and an internal electronic unit…the internal electronic unit can include a processor to analyze the data…The internal electronic unit includes a wireless transceiver to send the smooth data and/or data to a remote processor for further analysis; [0049]: the remote processor can be associated with a mobile device, a wearable device…The mobile device can be a tablet, a cell phone, a personal digital assistant, etc…the remote processor performs various functions, such as receiving the smooth data and/or data from the wearable device via the wireless connection, storing the smooth data and/or data in a database; and [0079]: the user device includes a processor for running the analytic module, and a memory associated with the processor).
Since the processor incorporated in the menstrual hygiene product wirelessly communicates with the mobile device, when Brief and Carney are combined, the processor would remain communicating with the mobile device and all its components, including the cameral taught by Carney.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Waldhorn et al., WO 2009144696 A1.
Larkin et al., WO 2011/126497 A1.
Hwang et al., WO2017/010800A1.
Wang et al., CN 105596138 A.
Ishikawa et al., JP 2013132518 A.
Contente et al., US 5,295,984.
Larkin et al., US 7,806,882 B1.
Davis et al., US 2015/0087935 A1.
Mukherjee et al., “MenstruLoss: Sensor for menstrual blood loss monitoring”. Proc. ACM Interact. Mob. Wearable Ubiquitous Technol., Vol. 3, No. 2, June 2019.
Each one of the above cited prior arts teaches various menstrual hygiene products coupled with various sensors coupled with a processor to characterize menstrual conditions.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798