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 .
In light of the amendments to the claims filed 06/24/2026 in which claims 1 and 11 were amended, claims 1, 3-9, 11, and 13-19 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims priority to U.S. Provisional 63/157,034 filed on 03/05/2021.
Claims 1, 3-9, 11, and 13-19 receive priority to the prior-filed application, filed on 03/05/2021.
Response to Arguments
Rejections of the Claims under 35 U.S.C. 103
Applicant’s arguments filed 06/24/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding amended claims 1 and 11, the applicant asserts on pg. 8-9 that the prior art to Weber, McMaster, Song, Barda, Abraham, or Solazzo fail to disclose the newly amended limitations: “wherein the wireless transmission module is configured to provide an alarm that the peripheral device is silent.”
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully notes that the prior art was not used in the previous Office Action filed 05/19/2026. While the prior art to Weber, McMaster, Song, Barda, Abraham, and Solazzo fail to disclose the newly added limitations, the amendments to the independent claims have necessitated new grounds of rejection in view of Yue as explained below.
Claim Interpretation
The Examiner recognizes claim 1 as comprising "product-by-process" limitations. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claim(s) 1 requires the diaper to comprise the following structural elements in addition to those in the claims from which they depend: an array of sensors integrally connected to a substrate of the diaper.
In the prior art rejection in this Office action, Examiner considers claim(s) 1 to be met when a reference teaches these structural limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-9, 11, and 13-19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 11 have been amended to recite the limitation, “wherein the wireless transmission module is configured to provide an alarm that the peripheral device is silent”. The applicant’s specification (para. 0046) provides support for the wireless communication system including a local alarm to alert the caregiver “via the peripheral device” that the peripheral device is silent or away from the caregiver.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, 6-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US/2022/409443 A1 to Weber, and further in view of CN/109549782 A to Yue, US/2008/0266117 A1 to Song, and WO/2011/156862 A1 to Barda.
Regarding claim 1, Weber discloses a smart diaper system (Fig. 4) comprising:
a diaper (Fig. 4, diaper 100);
an embedded sensor array (Fig. 4, sensor array 32), fixed to the diaper (para. 0146 ln. 1-4; para. 0161 ln. 1-9; Claim 21), including at least one sensor configured to detect a stimuli (para. 0142; para. 0160 ln. 1-13); and
a wireless transmission module operably connected to the embedded sensor array (para. 0141 ln. 1-8; para. 0146; para. 0147 ln. 1-5; para. 0157; Fig. 4, transmitter 36 as a part of reusable part 20), configured to transmit a signal to a peripheral device (para. 0156 ln. 1-8);
wherein, in response to detecting a stimuli, the embedded sensor array communicates with the wireless transmission module to transmit a signal to the peripheral device corresponding to the detected stimuli (para. 0156; para. 0157; para. 0178 ln. 4-14),
wherein the embedded sensor array consists of printed sensors printed directly on a substrate of the diaper (para. 0017; para. 0161 ln. 1-13), wherein the substrate featuring the embedded sensor array becomes an integral part of the diaper (para. 0131; para. 0161 ln. 1-13),
wherein at least one of the printed sensors includes a respiration rate sensor (para. 0160); and
where the configuration of the embedded sensor array is customizable as to the at least one sensor provided (para. 0015, providing multiple sensor types is advantageous in that it enables detection and observation of various body parameters related to the wearer, increasing efficiency and functionality of the absorbent article; para. 0174, discloses multiple optional sensors that may be provided in the sensor array and multiple optional parameters that the sensor array may sense).
Weber differs from the instantly claimed invention in that Weber fails to disclose that the wireless transmission module is configured to provide an alarm that the peripheral device is silent.
Yue teaches a urination monitoring system comprising an integrated light and buzzer system connected to the wireless transmission module. This light and buzzer system provides timely alerts when phone connection is lost, which eliminates the need for constant phone monitoring and prevents missed alarms (para. 10-11, 17, 22, and 27, light and buzzer system alerts when phone connection is lost, such as when a phone is powered off and silent).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the wireless transmission module of Weber to be configured to provide an alarm that the peripheral device is silent as taught by Yue, because Yue teaches that this eliminates the need for constant phone monitoring and prevents missed alarms (para. 10-11, 17, 22, and 27, light and buzzer system alerts when phone connection is lost, such as when a phone is powered off and silent).
Further, Weber differs from the instantly claimed invention in that Weber fails to disclose wherein the screen printed sensors are interconnected to at least one signal conditioning circuit, the at least one signal conditioning circuit configured to eliminate redundant data generated through exposure of the screen printed sensors to the surrounding environment.
Song teaches a diaper comprising sensors wherein the sensors are interconnected to a signal conditioning circuit, the at least one signal conditioning circuit configured to prepare the signals for processing by at least filtering or smoothing (para. 0026; para. 0041; Fig. 1B).
Barda teaches a diaper comprising sensors wherein the sensors are connected to a processor that is configured to smooth the sensor signals to reduce the noise within the signal (pg. 29 ln. 18-29), similar to the signal conditioning circuit of Song.
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system suggested by Weber to comprise a signal conditioning circuit interconnected to the sensors as taught by Song and Barda, because Song teaches that a signal conditioning circuit processes a signal by at least filtering or smoothing (para. 0041), and Barda teaches that smoothing sensor data reduces the noise to consequently capture the important pattern of the signal and make the signal differentiable for detection (pg. 29 ln. 18-29), which would increase detection accuracy.
Regarding claim 3, the cited prior art suggests the invention of claim 1. Weber further discloses wherein the embedded sensor array is bendable, foldable, and stretchable with conformal integration capability onto nonplanar surface (para. 0086; para. 0146; para. 0160 ln. 1-13; para. 0173 ln. 5-8; Fig. 4 showing sensor array 32 on both disposable 10 and reusable part 20, both of which are meant to be folded and flexible when worn by a user).
Regarding claim 4, the cited prior art suggests the invention of claim 1. Weber further discloses wherein the embedded sensor array detects human body temperature (para. 0142 ln. 4-12; para. 0160 ln. 1-13; para. 0174).
Regarding claim 6, the cited prior art suggests the invention of claim 1. Weber further discloses wherein the embedded sensor array detects wetness of the diaper as an indication about amount of liquid inside the diaper (para. 0142 ln. 1-3; para. 0161 ln. 1-9).
Regarding claim 7, the cited prior art suggests the invention of claim 1. Weber further discloses wherein the embedded sensor array detects real-time respiration rate of the smart diaper wearer (para. 0160 ln. 1-13).
Regarding claim 9, the cited prior art suggests the invention of claim 1. Weber further discloses wherein the signal transmitted by the wireless transmission module to the peripheral device is a short range wireless signal (para. 0156 ln. 1-8; para. 0159 ln. 1-6).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Weber, Yue, Song and Barda as applied above, and further in view of U.S. Patent no. 8698641 A1 to Abraham.
Regarding claim 5, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the embedded sensor array detects the presence and/or absence of volatile organic compounds present in the human waste.
Abraham teaches an embedded sensor array (Fig. 11, sensor array 200) comprising sensors to detect the presence and/or absence of volatile organic compounds present in the human waste to provide further information about the type of insult (col. 14 ln. 15-63; Fig. 11, electronic nose sensor 240).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the embedded sensor array of the cited prior art to further comprise a sensor for detecting volatile organic compounds present in human waste as taught by Abraham, because Abraham teaches that the gases associated with a urine insult and a feces insult are different, and providing an electronic nose sensor of their invention may provide further information about the insult such that a false positive check may not be sent to a user (col. 14 ln. 15-63).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Weber, Yue, Song, and Barda as applied above, and further in view of U.S. Patent no. 8471715 A1 to Solazzo.
Regarding claim 8, the cited prior art suggests the invention of claim 1. Weber discloses wherein the wireless transmission module is configured to be selectively detachable from the disposable part of the diaper (para. 0171; transmitter 36 as a part of reusable part 20); however, Weber further discloses that the electronic system or at least one element of the electronic system may be included in a device separated from the re-usable part and the disposable part, in a manner such that it is mechanically connected to the absorbent article (para. 0018; para. 0141, electronic system 22 comprises transmitter 36).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the wireless transmission module is configured to be selectively detachable from the entirety of the diaper.
Solazzo teaches a wireless transmission module (Fig. 2, wireless transmitter 13) configured to be selectively detachable from the diaper for re-use of the transmission module (col. 7 ln. 48-54).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the wireless transmission module of the cited prior art to be selectively detachable from the diaper as taught by Solazzo, because Weber discloses that at least one part of the electronic system can be included in a device separated from the re-usable and disposable parts of the diaper (para. 0018) and Solazzo teaches that selective detachment allows for re-use of the transmission module (col. 7 ln. 48-54) similarly to the preferred embodiment of Weber wherein the transmitter is provided in the re-usable part.
Claims 11, 13-14, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US/2022/409443 A1 to Weber, and further in view of US/2020/0008299 A1 to Tran, CN/109549782 A to Yue , US/2008/0266117 A1 to Song, and WO/2011/156862 A1 to Barda.
Regarding claim 11, Weber discloses a method for manufacturing a smart diaper (para. 0177-0178), the method comprising:
providing a diaper (para. 0177; Fig. 4, diaper 100);
providing an embedded sensor array (para. 0178; Fig. 4, sensor array 32), including at least one sensor configured to detect a stimuli (para. 0142; para. 0160 ln. 1-13);
wherein the embedded sensor array consists of printed sensors printed directly on a substrate of the diaper (para. 0017; para. 0161 ln. 1-13),
wherein the substrate featuring the embedded sensor array becomes a fixed integral part of the diaper (para. 0131; para. 0146 ln. 1-4; para. 0161 ln. 1-13; Claim 21), and
where the configuration of the embedded sensor array is customizable as to the at least one sensor provided (para. 0015, providing multiple sensor types is advantageous in that it enables detection and observation of various body parameters related to the wearer, increasing efficiency and functionality of the absorbent article; para. 0174, discloses multiple optional sensors that may be provided in the sensor array and multiple optional parameters that the sensor array may sense);
wherein at least one of the printed sensors includes a respiration rate sensor (para. 0160);
providing a wireless transmission module operably connected to the embedded sensor array (para. 0178; para. 0141 ln. 1-8; para. 0146; para. 0147 ln. 1-5; para. 0157; Fig. 4, transmitter 36 as a part of reusable part 20), configured to transmit a signal to a peripheral device (para. 0156 ln. 1-8), and
operably connecting the embedded sensor array with the wireless transmission module to transmit a signal to the peripheral device corresponding to the detected stimuli (para. 0178; para. 0156; para. 0157; para. 0178 ln. 4-14; para. 0141 ln. 1-8; para. 0146; para. 0147 ln. 1-5; Fig. 4, transmitter 36 as a part of reusable part 20).
Weber differs from the instantly claimed invention in that Weber fails to disclose wherein the embedded sensor array consists of screen printed sensors printed directly on a thermal transfer substrate for thermal lamination onto the diaper, wherein upon thermal lamination of the thermal transfer substrate featuring the embedded sensor array the embedded sensor array becomes an integral part of the diaper.
Tran teaches an embedded sensor array consisting of screen printed sensors printed directly on a thermal transfer substrate for thermal lamination onto the diaper which takes advantage of roll-to-roll processing that is considered to be advantageous for larger area processing (para. 0006; para. 0024; para. 0090-0094, electrically conductive material may be screen printed onto a carrier film/thermal transfer substrate), wherein upon thermal lamination of the thermal transfer substrate featuring the embedded sensor array, the embedded sensor array becomes a fixed integral part of the diaper (para. 0094, an adhesive, dielectric material, and electrically conductive material can be adhered to a substrate upon applying heat and pressure to a carrier film).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to have modified the provision of the embedded sensor array of Weber such that it comprises thermal lamination of the screen printed sensors by a roll-to-roll process as taught by Tran, because Tran teaches a similar final product to the final product of Weber in that the sensors are directly fixed and integral with the diaper (para. 0094; Fig. 5e), and that providing the screen printed sensors on a thermal transfer substrate for subsequent thermal lamination onto the diaper takes advantage of roll-to-roll processing, which is advantageous for larger area processing (para. 0006; para. 0024; para. 0090-0094; Fig. 5e).
Further, Weber differs from the instantly claimed invention in that Weber fails to disclose that the wireless transmission module is configured to provide an alarm that the peripheral device is silent.
Yue teaches a urination monitoring system comprising an integrated light and buzzer system connected to the wireless transmission module. This light and buzzer system provides timely alerts when phone connection is lost, which eliminates the need for constant phone monitoring and prevents missed alarms (para. 10-11, 17, 22, and 27, light and buzzer system alerts when phone connection is lost, such as when a phone is powered off and silent).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the wireless transmission module of Weber to be configured to provide an alarm that the peripheral device is silent as taught by Yue, because Yue teaches that this eliminates the need for constant phone monitoring and prevents missed alarms (para. 10-11, 17, 22, and 27, light and buzzer system alerts when phone connection is lost, such as when a phone is powered off and silent).
Further still, Weber differs from the instantly claimed invention in that Weber fails to disclose wherein the screen printed sensors are interconnected to at least one signal conditioning circuit, the at least one signal conditioning circuit configured to eliminate redundant data generated through exposure of the screen printed sensors to the surrounding environment.
Song teaches a diaper comprising sensors wherein the sensors are interconnected to a signal conditioning circuit, the at least one signal conditioning circuit configured to prepare the signals for processing by at least filtering or smoothing (para. 0026; para. 0041; Fig. 1B).
Barda teaches a diaper comprising sensors wherein the sensors are connected to a processor that is configured to smooth the sensor signals to reduce the noise within the signal (pg. 29 ln. 18-29), similar to the signal conditioning circuit of Song.
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method suggested by Weber, Tran, and Yue to comprise a signal conditioning circuit interconnected to the sensors as taught by Song and Barda, because Song teaches that a signal conditioning circuit processes a signal by at least filtering or smoothing (para. 0041), and Barda teaches that smoothing sensor data reduces the noise to consequently capture the important pattern of the signal and make the signal differentiable for detection (pg. 29 ln. 18-29), which would increase detection accuracy.
Regarding claim 13, the cited prior art suggests the method of claim 11. Weber further discloses wherein the embedded sensor array is bendable, foldable, and stretchable with conformal integration capability onto nonplanar surface (para. 0086; para. 0146; para. 0160 ln. 1-13; para. 0173 ln. 5-8; Fig. 4 showing sensor array 32 on both disposable 10 and reusable part 20, both of which are meant to be folded and flexible when worn by a user).
Regarding claim 14, the cited prior art suggests the method of claim 11. Weber further discloses wherein the embedded sensor array detects human body temperature (para. 0142 ln. 4-12; para. 0160 ln. 1-13; para. 0174).
Regarding claim 16, the cited prior art suggests the method of claim 11. Weber further discloses wherein the embedded sensor array detects wetness of the diaper as an indication about amount of liquid inside the diaper (para. 0142 ln. 1-3; para. 0161 ln. 1-9).
Regarding claim 17, the cited prior art suggests the method of claim 11. Weber further discloses wherein the embedded sensor array detects real-time respiration rate of the smart diaper wearer (para. 0160 ln. 1-13).
Regarding claim 19, the cited prior art suggests the method of claim 11. Weber further discloses wherein the signal transmitted by the wireless transmission module to the peripheral device is a short range wireless signal (para. 0156 ln. 1-8; para. 0159 ln. 1-6).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Weber, Tran, Yue, Song, and Barda as applied above, and further in view of U.S. Patent no. 8698641 A1 to Abraham.
Regarding claim 15, the cited prior art suggests the method of claim 11; however, the prior art differs from the instantly claimed invention in that they fail to disclose wherein the embedded sensor array detects the presence and/or absence of volatile organic compounds present in the human waste.
Abraham teaches an embedded sensor array (Fig. 11, sensor array 200) comprising sensors to detect the presence and/or absence of volatile organic compounds present in the human waste to provide further information about the type of insult (col. 14 ln. 15-63; Fig. 11, electronic nose sensor 240).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the embedded sensor array of the cited prior art to further comprise a sensor for detecting volatile organic compounds present in human waste as taught by Abraham, because Abraham teaches that the gases associated with a urine insult and a feces insult are different, and providing an electronic nose sensor of their invention may provide further information about the insult such that a false positive check may not be sent to a user (col. 14 ln. 15-63).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Weber, Tran, Yue, Song, and Barda as applied above, and further in view of U.S. Patent no. 8471715 A1 to Solazzo.
Regarding claim 18, the cited prior art suggests the method of claim 11. Weber discloses wherein the wireless transmission module is configured to be selectively detachable from the disposable part of the diaper (para. 0171; transmitter 36 as a part of reusable part 20); however, Weber further discloses that the electronic system or at least one element of the electronic system may be included in a device separated from the re-usable part and the disposable part, in a manner such that it is mechanically connected to the absorbent article (para. 0018; para. 0141, electronic system 22 comprises transmitter 36).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the wireless transmission module is configured to be selectively detachable from the entirety of the diaper.
Solazzo teaches a wireless transmission module (Fig. 2, wireless transmitter 13) configured to be selectively detachable from the diaper for re-use of the transmission module (col. 7 ln. 48-54).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the wireless transmission module of the cited prior art to be selectively detachable from the diaper as taught by Solazzo, because Weber discloses that at least one part of the electronic system can be included in a device separated from the re-usable and disposable parts of the diaper (para. 0018) and Solazzo teaches that selective detachment allows for re-use of the transmission module (col. 7 ln. 48-54) similarly to the preferred embodiment of Weber wherein the transmitter is provided in the re-usable part.
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 1 September 2026
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