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 view of the amendments to the claims filed 09/12/2025 in which claims 17-19 and 28-30 were amended, claims 17-33 are pending in the instant application and, in view of the reply to restriction filed 11/20/2024 in which claims 25-32 were withdrawn, claims 17-24 and 33 are examined on the merits herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/12/2025 has been entered.
Priority
The instant application is a 371 of PCT/DK2020/050383 filed 12/18/2020 which claims priority to DKPA/2019/70788 filed on 12/18/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 17-33 receive priority to the prior-filed application, filed on 12/18/2019.
Response to Arguments
Rejections of the Claims under 35 U.S.C. 102 and 103
Applicant's arguments filed 09/12/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
The applicant asserts on pg. 7-8 that the prior art to Marsiquet and Luckemeyer fail to disclose the newly added limitations to claim 17: detect, after a first time-delay, one or more additional short-circuiting events across two or more electrodes of the first and/or second plurality of electrodes; determine, based on the first time-delay between the short-circuiting event and the one or more additional short-circuiting events, a propagation of the exudate uptake pattern: and indicate the propagation of the exudate uptake pattern based on a second region corresponding to the one or more additional short-circuiting events.
In response to the applicant’s arguments, the examiner acknowledges the applicant’s argument and respectfully notes that the prior art to Marsiquet and Luckemeyer were not used in the previous Office Action filed 06/12/2025 to read on the newly added limitations. The newly added limitations have necessitated new grounds of rejection in view of Marsiquet and Larkin.
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 17-24 and 33 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.
Claim 17 requires that the monitor device is configured to detect one or more additional short-circuiting events across two or more electrodes of the first and/or second plurality of electrodes after a first time-delay and to determine a propagation of the exudate uptake pattern based on the first time-delay between the “short-circuiting events” and the one or more additional short-circuiting events. The short-circuiting events are previously recited as a short-circuiting event across a primary and a secondary electrode of the first plurality of electrodes and a short-circuiting event across a primary and a secondary electrode of the second plurality of electrodes. The newly added limitations read as though the monitor device is configured to determine the propagation of the exudate uptake pattern based on a first-time delay between either of the previously recited short-circuiting events and an additional short-circuiting event occurring in either of the first or second plurality of electrodes. The applicant’s specification provides support only for the system to determine the propagation of the exudate uptake pattern based on a first-time delay between a short-circuiting event occurring in either of the first and second plurality of electrodes and the other of the first and second plurality of electrodes, such that the time-delay is based on the time between short-circuiting events occurring on either side of the absorbent core layer/first material (Applicant’s specification: pg. 17:9-19:7; pg. 20:32-21:9; pg. 26:26-27:19; pg. 32:6-33:4). Therefore, the Applicant’s specification does not provide support for the breadth of the claim.
Claims 18-24 and 33 are rejected for depending upon a rejected base claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-24 and 33 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation “determine, based on the first time-delay between the short-circuiting event” in ln.25. This limitation is indefinite in that it is unclear which short-circuiting event the limitation is referring to as previously recited in the claim. For the sake of compact prosecution, the examiner is treating the limitation as though the short-circuiting event refers to either of the previously recited short-circuiting events.
Claims 18-24 and 33 are rejected for depending upon a rejected base claim.
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 17-24 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over US/2015/0018792 A1 to Marsiquet in view of US/2010/0305530 A1 to Larkin.
Regarding claims 17-19, Marsiquet discloses (Claim 17) a wound dressing system configured to determine an exudate uptake pattern of a wound dressing (para. 0050; para. 0065; para. 0095; Fig. 1-2, wound dressing system), the wound dressing system comprising:
a wound dressing extending in an appliance plane (Fig. 1-2, wound dressing 1 extending along an appliance plane horizontally), the wound dressing comprising:
an absorbent structure layer having a proximal side and a distal side (Fig. 1-2, absorbent structure 4 having a lower distal side and an upper proximal side),
a proximal electrode assembly comprising a first plurality of electrodes, and
a distal electrode assembly comprising a second plurality of electrodes (para. 0022, two networks of electrodes are arranged in the form of a grid; para. 0087-0088, ai first network of electrodes, bi second network of electrodes; para. 0033, the detection system may be disposed on both sides of absorbent structure 4; para. 0081, the two networks of electrodes, ai and bi, may be disposed on either side of absorbent structure 4), the proximal electrode assembly and the distal electrode assembly being layered and spaced apart by a first material in a direction normal to the appliance plane (para. 0022, two networks of electrodes are arranged in the form of a grid; para. 0087-0088, ai first network of electrodes, bi second network of electrodes; para. 0033, the detection system may be disposed on both sides of absorbent structure 4; para. 0081, the two networks of electrodes, ai and bi, may be disposed on either side of absorbent structure 4; ai and bi spaced apart by the material of the absorbent structure in a vertical direction), wherein the first material comprises a plurality of through-going openings that each have a corresponding intersection of an electrode of the proximal electrode assembly and an electrode of the distal electrode assembly (para. 0022, two networks of electrodes are arranged in the form of a grid; para. 0087-0088, ai first network of electrodes, bi second network of electrodes; para. 0033, the detection system may be disposed on both sides of absorbent structure 4; para. 0081, the two networks of electrodes, ai and bi, may be disposed on either side of absorbent structure 4; ai and bi spaced apart by the material of the absorbent structure in a vertical direction; para. 0035, absorbent structure 4 may be entirely formed from open cell polyurethane foam which would be considered to comprise a plurality of through-going openings that may each terminate at least near an intersection of the two networks of electrodes, ai and bi; para. 0019-0020, pores of absorbent structure 4 may be obstructed on the face directed toward the wound except in admission zones [areas of moisture diffusion into the absorbent structure] which take up less than 20% of the total area of the absorbent structure, such that the pores provided only in the admission zones may be considered the through-going openings); and
a monitor device configured to:
detect a short-circuiting event across a primary and a secondary electrode of the first plurality of electrodes and a short-circuiting event across a primary and a secondary electrode of the second plurality of electrodes;
determine a first region of the wound dressing, wherein the first region is a region wherein the short-circuited primary and secondary electrodes of the first plurality of electrodes and the short-circuited primary and secondary electrodes of the second plurality of electrodes overlap in the direction normal to the appliance plane,
and indicate an exudate uptake pattern of the wound dressing based on at least the first region (para. 0027, measurements occur between two consecutive electrodes in a network; para. 0030, measurement system determines impedance between a plurality of consecutive pairs of electrodes; para. 0043-0047, level of saturation is based on a peak voltage measured across the terminals as a quantity representative of the electrical impedance between two electrodes and in succession between various successive pairs of electrodes; para. 0065, measurement system 30 performs calculations from the data provided by the electrode networks; para. 0083-0095, method of measurement: electrodes make electrical contact with 4 absorbent structure and when absorbent structure 4 is permeated with moisture locally between two adjacent electrodes, either ai and ai+1 or bi and bi+1, the impedance between the electrodes changes such that the change may be detected by measuring an electrical quantity, either Ai or Bi becoming 1, at the terminals of the electrodes [detection of short-circuiting events between primary and secondary electrodes], if the short-circuits between the networks of electrodes overlap in the vertical direction, the system determines that the coefficient of the matrix at that point is 1 which represents a wet zone of absorbent structure 4 [determination of the first region], wet zones are visualized in a number of ways such as a percentage value or a map [indication of exudate uptake pattern]; para. 0113, Ai or Bi corresponds to the value of voltage measured for each pair of electrodes; Fig. 1, measurement system 30; Fig. 4 showing exudate uptake pattern measurement in a plurality of regions).
Marsiquet differs from the instantly claimed invention in that Marsiquet fails to disclose wherein the monitor device is configured to:
(Claim 17) detect, after a first time-delay, one or more additional short-circuiting events across two or more electrodes of the first and/or second plurality of electrodes; determine, based on the first time-delay between the short-circuiting event and the one or more additional short-circuiting events, a propagation of the exudate uptake pattern: and indicate the propagation of the exudate uptake pattern based on a second region corresponding to the one or more additional short-circuiting events;
(Claim 18) wherein the monitor device is further configured to assign a first timestamp to the short-circuiting event across the primary electrode and the secondary electrode of the first plurality of electrodes and to assign a second timestamp to the short-circuiting event across the primary electrode and the secondary electrode of the second plurality of electrodes, and to determine a second time- delay between said short-circuiting events based on said assigned first and second timestamps; and
(Claim 19) wherein the monitor device is configured to indicate the exudate uptake pattern of the wound dressing based on at least the first region and the second time-delay.
Larkin teaches a tampon saturation monitoring system (Fig. 4, tampon saturation monitoring system) comprising
(Claim 17) a monitor device (Fig. 4, signal processor 14; para. 0051) configured to:
detect an amount of saturation of the tampon (Fig. 8; para. 0051-0056, moment T1);
detect, after a first time-delay, an additional amount of saturation of the tampon (Fig. 8; para. 0051-0056, moment T2 [progressive moments TN]);
determine, based on the first time-delay between the first saturation signal and the second saturation signal, a propagation of the saturation (Fig. 8; para. 0051-0056, estimated progression curve is based on the time DTX between moments T1 and T2 [and progressive moments TN] and the amount of saturation sensed): and
indicate the propagation of the saturation based on a second region corresponding to the additional amount of saturation of the tampon (Fig. 8; para. 0051-0056, estimated progression curve is based on the time DTX between moments T1 and T2 [and progressive moments TN] and the amount of saturation sensed);
(Claim 18) wherein the monitor device is further configured to assign a first timestamp to the first saturation signal and to assign a second timestamp to the second saturation signal, and to determine a second time-delay between said saturation signals based on said assigned first and second timestamps (Fig. 8; para. 0051-0056, estimated progression curve is based on the time DTX between moments T1 and T2 [and progressive moments TN] and the amount of saturation sensed); and
(Claim 19) wherein the monitor device is configured to indicate the saturation of the tampon based on at least the first region and the second time-delay (Fig. 8; para. 0051-0056, estimated progression curve is based on the time DTX between moments T1 and T2 [and progressive moments TN] and the amount of saturation sensed); and
wherein this configuration of the monitor allows for the system to update a saturation forecast of the tampon with a reduced margin of error such that a user of the tampon saturation monitoring system can monitor saturation progress with a precision that increases as the tampon reaches its fluid absorption limit at which the wetting response signal may have a maximum amplitude (para. 0031; para. 0054).
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 monitor device of Marsiquet to be configured in the manner as claimed and as taught by Larkin, because Larkin teaches that this configuration of the monitor allows for the system to update a saturation forecast of the tampon with a reduced margin of error such that a user of the tampon saturation monitoring system can monitor saturation progress with a precision that increases as the tampon reaches its fluid absorption limit at which the wetting response signal may have a maximum amplitude (para. 0031; para. 0054).
Regarding claim 20, the cited prior art suggests the invention of claim 17. Marsiquet further discloses: wherein the electrodes of the first plurality of electrodes are mutually parallel and extending in a first direction (Fig. 3, ai first plurality of electrodes parallel to each other and extending in a first direction), and wherein the electrodes of the second plurality of electrodes are mutually parallel and extending in a second direction (Fig. 3, bi second plurality of electrodes parallel to each other and extending in a second direction), and wherein the first direction and the second direction are non-parallel (Fig. 3 showing ai and bi first and second plurality of electrodes extending perpendicularly to one another).
Regarding claim 21, the cited prior art suggests the invention of claim 17. Marsiquet further discloses: wherein the first material is at least a portion of the absorbent structure layer (para. 0022, two networks of electrodes are arranged in the form of a grid; para. 0087-0088, ai first network of electrodes, bi second network of electrodes; para. 0033, the detection system may be disposed on both sides of absorbent structure 4; para. 0081, the two networks of electrodes, ai and bi, may be disposed on either side of absorbent structure 4; ai and bi spaced apart by the material of absorbent structure 4 in a vertical direction).
Regarding claim 22, the cited prior art suggests the invention of claim 17. Marsiquet further discloses: wherein the first material is a spacer element (para. 0022, two networks of electrodes are arranged in the form of a grid; para. 0087-0088, ai first network of electrodes, bi second network of electrodes; para. 0033, the detection system may be disposed on both sides of absorbent structure 4; para. 0081, the two networks of electrodes, ai and bi, may be disposed on either side of absorbent structure 4; ai and bi spaced apart by the material of absorbent structure 4 which may be considered a spacer element as being between the networks of electrodes).
Regarding claim 23, the cited prior art suggests the invention of claim 17. Marsiquet further discloses: wherein the monitor device is further configured to detect one or more additional short-circuiting events across two or more electrodes of the first and/or second plurality of electrodes (para. 0027, measurements occur between two consecutive electrodes in a network; para. 0030, measurement system determines impedance between a plurality of consecutive pairs of electrodes; para. 0043-0047, level of saturation is based on a peak voltage measured across the terminals as a quantity representative of the electrical impedance between two electrodes and in succession between various successive pairs of electrodes; para. 0065, measurement system 30 performs calculations from the data provided by the electrode networks; para. 0083-0095, method of measurement: electrodes make electrical contact with absorbent structure 4 and when absorbent structure 4 is permeated with moisture locally between two adjacent electrodes, either ai and ai+1 or bi and bi+1, the impedance between the electrodes changes such that the change may be detected by measuring an electrical quantity, either Ai or Bi becoming 1, at the terminals of the electrodes [detection of short-circuiting events between primary and secondary electrodes], if the short-circuits between the networks of electrodes overlap in the vertical direction, the system determines that the coefficient of the matrix at that point is 1 which represents a wet zone of absorbent structure 4 [determination of the first region], wet zones are visualized in a number of ways such as a percentage value or a map [indication of exudate uptake pattern]; para. 0113, Ai or Bi corresponds to the value of voltage measured for each pair of electrodes; Fig. 1, measurement system 30; Fig. 4 showing exudate uptake pattern measurement in a plurality of regions).
Regarding claim 24, the cited prior art suggests the invention of claim 23. Marsiquet further discloses: wherein the monitor device is further configured to indicate a propagation of the exudate uptake pattern of the wound dressing based on the detection of one or more additional short-circuiting events across two or more electrodes of the first and/or second plurality of electrodes (para. 0027, measurements occur between two consecutive electrodes in a network; para. 0030, measurement system determines impedance between a plurality of consecutive pairs of electrodes; para. 0043-0047, level of saturation is based on a peak voltage measured across the terminals as a quantity representative of the electrical impedance between two electrodes and in succession between various successive pairs of electrodes; para. 0065, measurement system 30 performs calculations from the data provided by the electrode networks; para. 0083-0095, method of measurement: electrodes make electrical contact with absorbent structure 4 and when absorbent structure 4 is permeated with moisture locally between two adjacent electrodes, either ai and ai+1 or bi and bi+1, the impedance between the electrodes changes such that the change may be detected by measuring an electrical quantity, either Ai or Bi becoming 1, at the terminals of the electrodes [detection of short-circuiting events between primary and secondary electrodes], if the short-circuits between the networks of electrodes overlap in the vertical direction, the system determines that the coefficient of the matrix at that point is 1 which represents a wet zone of absorbent structure 4 [determination of the first region], wet zones are visualized in a number of ways such as a percentage value or a map [indication of exudate uptake pattern]; para. 0113, Ai or Bi corresponds to the value of voltage measured for each pair of electrodes; Fig. 1, measurement system 30; Fig. 4 showing exudate uptake pattern measurement in a plurality of regions).
Regarding claim 33, the cited prior art suggests the invention of claim 17.
The prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein each through-going opening of the through-going openings is offset from a corresponding electrode intersection.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the instant application to have the through-going openings offset from the electrode intersections since there are only a finite number of predictable solutions (i.e. at or offset from). Marsiquet discloses in embodiments wherein the networks of electrodes are placed on the same side of the absorbent structure that the networks of electrodes are electrically insulated from one another at their intersections (para. 0022; para. 0079) and fails to disclose a solution for sufficiently electrically insulating the intersections of the networks of electrodes from each other in embodiments wherein the networks of electrodes are placed on either side of the absorbent structure. Thus, making the through-going openings offset from the electrode intersections would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that the product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under §103." See MPEP 2143.
Conclusion
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.
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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
28 September 2026
