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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 12/30/25. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Information Disclosure Statement
The information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 6-8, 11-17, and 46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schoess et al. (US 2019/0192066 A1, hereinafter Schoess).
For claim 1, Schoess discloses a wound monitoring and/or therapy system (Fig 9) ([0071-0092]), comprising inter alia:
a wound dressing (201) configured to be positioned over a wound (Fig 9) ([0071-0092]), the wound dressing comprising a stretchable substrate ([0038, 0071, 0100]) supporting a plurality of electronic components (circuitry of 201) and a plurality of electronic connections (circuitry connections of 201) that connect at least some of the plurality of electronic components (Fig 9) ([0071-0092]),
the plurality of electronic components comprising a plurality of sensors (173, 182, 205) (Fig 9) ([0071-0092]) configured to obtain measurement data of at least one of the wound or periwound (Fig 9) ([0071-0092]), and
the plurality of electronic components comprising at least one controller (171) positioned on a circuit board (substrate of 201) (Fig 9) ([0071-0092]), the at least one controller configured to control at least some of the plurality of sensors (Fig 9) ([0071-0092]), the circuit board comprising a reinforced material (substrate of 201) and configured to accommodate flexure (flexible substrate of [0038]) such that circuit board operates without failure when the circuit board is flexed as a result of strain on the wound dressing (Fig 9) ([0071-0092]).
For claim 6, Schoess discloses the system of claim 1, wherein the wound dressing further includes an antenna (175) configured to communicate measurement data to a remote computing device (Fig 9) ([0071-0092]).
For claim 7, Schoess discloses the system of claim 1, further comprising a power source (169) positioned on the stretchable substrate (Fig 9) ([0071-0092]), the power source configured to power the plurality of electronic components (Fig 9) ([0071-0092]).
For claim 8, Schoess discloses the system of claim 7, wherein the power source is not enclosed in a separate casing or enclosure (Fig 9) ([0071-0092]).
For claim 11, Schoess discloses the system of claim 1, wherein the at least one controller is configured to be activated by one or more of: flexing the wound dressing, activating an activation switch, bursting a bubble of conductive material, charging a transistor, initiating a magnetic trigger, or triggering a piezoelectric element (Fig 9) ([0071-0092]).
For claim 12, Schoess discloses the system of claim 1, wherein the system is not configured to be physically connected to an external controller that controls any of the plurality of sensors or receives any of the measurement data (Fig 9) ([0071-0092]).
For claim 13, Schoess discloses the system of claim 1, wherein the stretchable substrate comprises a plurality of perforations ([0100-0101]) configured to allow fluid to pass through the stretchable substrate.
For claim 14, Schoess discloses the system of claim 1 further comprising a negative pressure source ([0098]) configured to be fluidically connected to the wound dressing, the negative pressure source configured to supply negative pressure to the wound ([0098]).
For claim 15, Schoess discloses the system of claim 1 further comprising: a control device (220) (Fig 9) ([0071-0092], especially smartphone [0090]) including at least one controller (130) configured to obtain the measurement data from the plurality of sensors and a power source (smartphone) ([0071-0092]) configured to provide power to the at least one controller and the plurality of sensors, the at least one controller and power source enclosed in an enclosure (Fig 9) ([0071-0092], especially smartphone exterior [0090]).
For claim 16, Schoess discloses the system of claim 15, wherein the enclosure comprises a first portion (Fig 9) ([0071-0092], especially smartphone [0090]) supporting the at least one controller and the power source and a second portion (150) (Fig 9) ([0071-0092]) configured to be attached to at least one pin ([0091]) positioned on the first portion.
For claim 17, Schoess discloses the system of claim 15, wherein the enclosure is configured to substantially shield the at least one controller from at least one of electromagnetic interference (EMI) or electrostatic discharge (ESD) (Fig 9) ([0071-0092], especially smartphone [0090]).
For claim 46, Schoess discloses the system of claim 1, wherein the plurality of electronic connections and the plurality of sensors comprises stretchable material (flexibility in [0038]) ([0038, 0071, 0100]).
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.
Claim(s) 2-5, 45, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoess in view of Arora et al. (US 9,516,758 B2, hereinafter Arora).
For claim 2, Schoess discloses the system of claim 1, except for explicitly disclosing the reinforced material of the circuit board comprises a wafer subjected to compression prior to placement of the wafer on the stretchable substrate in order to increase resiliency of the wafer of the circuit board to flexing. Arora teaches stretchable electronics with physical sensors (102) (Cols 3-8), including reinforced material of the circuit board (PDMS) (Cols 3-8) comprises a wafer (PDMS) (Cols 3-8) subjected to compression prior to placement of the wafer on the stretchable substrate (602) in order to increase resiliency of the wafer of the circuit board to flexing (Cols 3-8). Schoess and Arora are both considered to be analogous to the claimed invention because they are in the same field of medical sensing substrates. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoess to incorporate the teachings of Arora to provide a known stretchable electronics alternative configuration to Schoess substrate because doing so would aid in providing a stretchable electronic physiological sensor that is less susceptible to electronics failure while being worn on an individual being monitored.
For claim 3, Schoess discloses the system of claim 1, except for explicitly disclosing the reinforced material of the circuit board comprises a pre-strained wafer. Arora teaches stretchable electronics with physical sensors (102) (Cols 3-8), including the reinforced material of the circuit board comprises a pre-strained wafer (Cols 3-8). Schoess and Arora are both considered to be analogous to the claimed invention because they are in the same field of medical sensing substrates. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoess to incorporate the teachings of Arora to provide a known stretchable electronics alternative configuration to Schoess substrate because doing so would aid in providing a stretchable electronic physiological sensor that is less susceptible to electronics failure while being worn on an individual being monitored.
For claim 4, Schoess discloses the system of claim 1, except for explicitly disclosing the wound dressing comprises a coating covering the circuit board and at least some of the plurality of electronic components and at least some of the plurality of electronic connections, and wherein the reinforced material of the circuit board has been reinforced by the coating compressing the reinforced material of the circuit board by shrinking when being applied to the wound dressing. Arora teaches stretchable electronics with physical sensors (102) (Cols 3-8), including the wound dressing comprises a coating (Cols 3-8) covering the circuit board and at least some of the plurality of electronic components and at least some of the plurality of electronic connections (Cols 3-8), and wherein the reinforced material of the circuit board has been reinforced by the coating compressing the reinforced material of the circuit board by shrinking when being applied to the wound dressing (Cols 3-8). Schoess and Arora are both considered to be analogous to the claimed invention because they are in the same field of medical sensing substrates. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoess to incorporate the teachings of Arora to provide a known stretchable electronics alternative configuration to Schoess substrate because doing so would aid in providing a stretchable electronic physiological sensor that is less susceptible to electronics failure while being worn on an individual being monitored.
For claim 5, Schoess discloses the system of claim 4, wherein the coating is hydrophobic and/or biocompatible ([0100]) (Fig 12).
For claim 45, Schoess discloses the system of claim 1, except for explicitly disclosing the wound dressing further comprises a non- stretchable material positioned on the stretchable substrate and configured to support the plurality of electronic components, and wherein at least some of the plurality of sensors are not stretchable and configured to remain in a same location of the wound when the circuit board is flexed. Arora teaches stretchable electronics with physical sensors (102) (Cols 3-8), including the substrate further comprises a non- stretchable material positioned on the stretchable substrate and configured to support the plurality of electronic components (Cols 3-8), and wherein at least some of the plurality of sensors are not stretchable and configured to remain in a same location of the wound when the circuit board is flexed (Cols 3-8). Schoess and Arora are both considered to be analogous to the claimed invention because they are in the same field of medical sensing substrates. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoess to incorporate the teachings of Arora to provide a known stretchable electronics alternative configuration to Schoess substrate because doing so would aid in providing a stretchable electronic physiological sensor that is less susceptible to electronics failure while being worn on an individual being monitored.
For claim 47, Schoess disclsies the system of claim 4, except for explicitly disclosing the reinforced material is positioned on the stretchable substrate, and wherein the coating encapsulates the stretchable substrate and the reinforced material. Arora teaches stretchable electronics with physical sensors (102) (Cols 3-8), including the reinforced material is positioned on the stretchable substrate (Cols 3-8), and wherein the coating encapsulates the stretchable substrate and the reinforced material (Cols 3-8). Schoess and Arora are both considered to be analogous to the claimed invention because they are in the same field of medical sensing substrates. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoess to incorporate the teachings of Arora to provide a known stretchable electronics alternative configuration to Schoess substrate because doing so would aid in providing a stretchable electronic physiological sensor that is less susceptible to electronics failure while being worn on an individual being monitored.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoess in view of Stivoric et al. (US 2017/0156594 A1, hereinafter Stivoric).
For claim 9, Schoess discloses the system of claim 7, except for wherein the substrate comprises first and second portions, wherein the power source comprises an anode supported by the first portion of the substrate and a cathode supported by the second portion of the substrate, and wherein the power source further comprises an electrolyte layer positioned between the anode and cathode. Schoess contemplates a variety of means for providing power to power module on the flexible substrate, including at least battery, RF energy delivery and NFC electromagnetic induction ([0071-0092]). Schoess is silent with respect to the particular construction details of power module (169) and/or the battery. However, in the same field of flexible electronic substrates for sensing physiological characteristics, Stivoric teaches a battery (135) powering a flexible substrate (314) comprises first and second portions, wherein the power source comprises an anode (Fig 8) ([0140-0141]) supported by the first portion of the substrate and a cathode (Fig 8) ([0140-0141]) supported by the second portion of the substrate, and wherein the power source further comprises an electrolyte layer positioned between the anode and cathode ([0140-0141]). Thus, at the time of invention it would have been obvious to one of ordinary skill in the art to modify the known alternative powering configuration taught by Stivoric with the power configuration of Schoess to achieve the predictable results of powering a skin disposed, flexible sensor apparatus for detecting physiological parameters.
For claim 10, Schoess discloses the system of claim 9, except for wherein the anode is positioned on a first electronic connection of the plurality of electronic connections and the cathode is positioned on a second electronic connection of the plurality of electronic connections. Schoess contemplates a variety of means for providing power to power module on the flexible substrate, including at least battery, RF energy delivery and NFC electromagnetic induction ([0071-0092]). Schoess is silent with respect to the particular construction details of power module (169) and/or the battery. However, in the same field of flexible electronic substrates for sensing physiological characteristics, Stivoric teaches a battery (135) powering a flexible substrate (314) wherein the anode is positioned on a first electronic connection of the plurality of electronic connections and the cathode is positioned on a second electronic connection of the plurality of electronic connections (Fig 8) ([0140-0141]). Thus, at the time of invention it would have been obvious to one of ordinary skill in the art to modify the known alternative powering configuration taught by Stivoric with the power configuration of Schoess to achieve the predictable results of powering a skin disposed, flexible sensor apparatus for detecting physiological parameters.
Response to Arguments
Applicant’s arguments, see page 6, filed 12/30/25, with respect to overcoming the 112(b) rejections in view of the amendments have been fully considered and are persuasive. The 112(b) rejections have been withdrawn.
Applicant’s arguments with respect to claim(s) 2-4 and 45-47 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 12/30/25 with respect to the 102 of Schoess maintained and updated in view of the amendments to claim 1 have been fully considered but they are not persuasive.
Applicant argues Schoess fails to disclose the plurality of electronic components comprising at least one controller positioned on a circuit board, the at least one controller configured to control at least some of the plurality of sensors, the circuit board comprising a reinforced material and configured to accommodate flexure such that circuit board operates without failure when the circuit board is flexed as a result of strain on the wound dressing.
The Examiner respectfully disagrees, and upon further and formal review of Schoess following the interview, the examiner respectfully directs Applicant’s attention to the rejection set forth hereinabove in view of the amendment and art of record.
Schoess is explicitly concerned with and discloses, especially as broadly as structurally claimed and absent any special definition in the instant Specification upon which Applicant does not appear to rely, a circuit board (flexible substrate 201) comprising a reinforced material (flexible substrate 201) and configured to accommodate flexure (substrate 201 is configured to be flexible) such that circuit board operates without failure when the circuit board is flexed as a result of strain on the wound dressing ([0038, 0071-0092, 0100]). Lastly, the positively recited reinforced material does not necessarily structurally require any further “material” or structure beyond or in addition to the circuit board itself.
The Examiner notes Schoess explicitly states at least the following (emphasis added):
[0010] In one exemplary aspect, a system for wirelessly obtaining a moisture measurement is disclosed. The system includes a wireless reader including a transceiver configured to emit and receive radio frequency signals and a coupon. The coupon includes a flexible substrate having a top surface and a bottom surface, at least one electrochemical moisture sensor circuit disposed on the bottom surface of the flexible substrate that is configured to determine a moisture value, an antenna circuit disposed on the top surface of the flexible substrate configured to at least receive the radio frequency signals from the transceiver, and a microcontroller in electronic communication with the antenna circuit and the at least one electrochemical moisture sensor circuit.
[0038] In general, a Wound Moisture Assessment System (hereinafter ‘WMAS’) includes, inter alia, a flexible coupon configured to be placed on, over or about a wound such as, but not limited to, an ulcer. The coupon includes, inter alia, one or more moisture sensors configured to measure moisture in contact with, or in the immediate vicinity of the moisture sensor. The coupon includes requisite electronic circuitry to communicate with a WMAS wireless reader (hereinafter ‘reader’). The reader is configured to energize the coupon and receive measurements from the one or more moisture sensors. Moisture measurements can be analyzed using an analysis module integral with the reader, or, alternatively, moisture measurements can be transmitted to a computing system where analysis of wound moisture data can be processed for visualization, storage, integration with medical health records, transmission to a remote caregiver, or other functions. In a preferred embodiment, data transfer between the reader and coupon, and energization of the coupon by the reader occurs wirelessly. In general, the coupon can be configured with a desired number and type of moisture sensor(s), and a desired modality supporting wireless interrogation of the coupon by the reader.
[0071] Referring now to FIG. 9, a functional illustration of a WMAS 200 is shown according to one embodiment. In this embodiment, wireless communication between the reader and coupon can be accomplished using a digital circuitry schema. For the sake of consistency throughout this disclosure, in the description that follows, reference to coupon, moisture sensor(s), reader and computing device refer to the WMAS components in a general sense as previously described, notwithstanding the differences of the analog and digital components of the reader and coupon in each respective section of this disclosure.
[0100] Some exemplary, non-limiting types of dressings that coupon 101/201 can be integrated with include: tape and foam dressings, where coupon 101/201 can be disposed between the foam layer and the cover layer; transparent films, where coupon 101/201 can be printed directly on the film window; gauze, where coupon 101/201 can be embedded therein or thereon; composites, where coupon 101/201 can be embedded in intermediary layer or printed on the cover layer; and alginate, where coupon 101/201 can be disposed therein or on a secondary dressing.
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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791