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 .
Status of Claims
Claims 16-22 and 24-36 are pending and currently under consideration for patentability.
Claims 16 and 26 have been amended.
Claim 23 has been cancelled.
Claim 36 has been added.
Response to Arguments
Applicant's arguments filed 3/6/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 16-35 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.
In response to the argument that the rejection regarding, Thirstrup further teaches an electronic control system configured for detection of degree of wetness at the proximal surface based on an electrical signal from the electrode structure, though a humidity sensor is not directly mentioned, a sensor that detects the degree of wetness is equivalent as humidity is defined as “a quantity representing the amount of water vapour in the atmosphere or in a gas”. Since humidity is defined as the measure of water vapor in the air, it would be obvious to try since “detection or wetness” has the broadest reasonable interpretation including “detecting water vapor in the air.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 16-26 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thirstrup (US 2010030167 A1) in view of Zdeblick (US 20160324442 A1) and in view of Zamanzadeh (US 20050034985 A1).
Regarding Claim 16, Thirstrup teaches a base plate (1) for an ostomy appliance, the base plate (1) (figures 1a, 1c, 3c, 3d) forming a proximal surface configured to be attached to the skin surface of a user (2) and defining a stoma-receiving opening (3) from the proximal surface through the base plate (1), the base plate (1) comprising: an electrode structure comprising at least two electrodes (28) extending in a recess structure(space between 26 and 27 in figure 3d), wherein the recess structure is in the proximal surface (paragraph [0046]), and defines a first volume, v, which exceeds a second volume, v2, of the electrode structure to thereby define a free space with a third volume, v3, around the electrode structure in the recess structure (paragraph [0050], [0061-0062], [0068-0077], [0093-0095]) (Annotated Figure 3c),
Thirstrup fails to explicitly teach exposing at least a part of the electrode structure to the skin surface of the user. Zdeblick teaches a wearable receiver system that teaches exposing at least a part of the electrode structure to the skin surface of the user (paragraph [0105, 0106]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrode structure of Thirstrup exposing at least a part of the electrode structure to the skin surface of the user, similar to Zdeblick in order to maintain low impedance in the system (as motivated by Zdeblick, paragraph [0106]).
The combination fails to teach an electronic control system configured to process an electrical signal from the electrode structure to detect, based a resistance between the at least two electrodes, humidity at the proximal surface of the base plate.
Zamanzadeh teaches sensors to detect wetness, an electronic control system configured to process an electrical signal from the electrode structure to detect, based a resistance between the at least two electrodes, humidity at the proximal surface of the base plate (paragraph [0037]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the base plate of Thirstrup with an electronic control system configured to process an electrical signal from the electrode structure to detect, based a resistance between the at least two electrodes, humidity at the proximal surface of the base plate, similar to Zamanzadeh to control the resistance between electrodes.
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Regarding Claim 17, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 16. Thirstrup further teaches wherein the recess structure has a Gaussian cross-sectional shape (figure 3a-3c).
Regarding Claim 18, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 16. Thirstrup further teaches the proximal surface comprises an adhesive surface portion (paragraph [0029]).
Regarding Claim 19, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 18. Thirstrup further teaches wherein the recess structure (space between 26 and 27 in figure 3d) is provided in the adhesive surface portion (23) (paragraph [0095])
Regarding Claim 20, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 19. Thirstrup further teaches wherein the electrode structure (28) is fixed in the recess structure (figure 3d) by adhesive properties of the adhesive surface portion (paragraph [0095]).
Regarding Claim 21, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 16. Thirstrup further teaches wherein the third volume v3 is equal to or larger than the second volume v2 (Annotated Figure 3c).
Regarding Claim 22, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 16. Thirstrup further teaches a backing layer (paragraph [0029]: “dressing” and “bandage” are considered the backing layer) covering at least a covered portion of the proximal surface, the recess structure and electrode structure being in the covered portion (paragraph [0085]).
Regarding Claim 23, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 16. Thirstrup further teaches an electronic control system configured for detection of degree of wetness at the proximal surface based on an electrical signal from the electrode structure. Thirstrup fails to explicitly teach that humidity is detected from the electrodes. However, since humidity is defined as the measure of water vapor in the air, it would be obvious to try since “detection or wetness” has the broadest reasonable interpretation including “detecting water vapor in the air.
Regarding Claim 24, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 16. Thirstrup further teaches wherein the proximal surface extends in an interface plane (22), and the electrode structure (28) extends at a distance from the interface plane (figures 3d).
Regarding Claim 25, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 24. Thirstrup further teaches wherein at least one of the electrodes has a cross-sectional dimension being smaller than the distance from the interface plane to the electrode (figure 3d) .
Regarding Claim 26, Thirstrup further teaches an ostomy appliance comprising:
a base plate (1) forming a proximal surface configured to be attached to the skin surface of a user (2) and defining a stoma-receiving opening (3) from the proximal surface through the base plate, the base plate (1) comprising: an electrode structure comprising at least two electrodes (28) extending in a recess structure (space between 26 and 27 in figure 3d) wherein the recess structure is in the proximal surface of the base plate and defines a first volume, v, which exceeds a second volume, v2, of the electrode structure to thereby define a free space with a third volume, v3, around the electrode structure in the recess structure (annotated figure 3c); and a collection bag attached in communication with the stoma-receiving opening (paragraph [0029]).
Thirstrup fails to explicitly teach exposing at least a part of the electrode structure to the skin surface of the user. Zdeblick teaches and electrode and ostomy plate that includes exposing at least a part of the electrode structure to the skin surface of the user (paragraph [0105, 0106]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the base plate of Thirstrup so at least a part of the electrode structure to the skin surface of the user similar to Zdeblick in order to maintain low impedance in the system (as motivated by Zdeblick, paragraph [0106]).
The combination fails to teach an electronic control system configured to process an electrical signal from the electrode structure to detect, based a resistance between the at least two electrodes, humidity at the proximal surface of the base plate.
Zamanzadeh teaches sensors to detect wetness, an electronic control system configured to process an electrical signal from the electrode structure to detect, based a resistance between the at least two electrodes, humidity at the proximal surface of the base plate (paragraph [0037]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the base plate of Thirstrup with an electronic control system configured to process an electrical signal from the electrode structure to detect, based a resistance between the at least two electrodes, humidity at the proximal surface of the base plate, similar to Zamanzadeh to control the resistance between electrodes.
Regarding Claim 31, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 26. Thirstrup further teaches wherein the recess structure has a Gaussian cross-sectional shape (figures 3a-3d).
Regarding Claim 32, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 26. Thirstrup further teaches wherein the proximal surface comprises an adhesive surface portion (paragraph [0033]).
Regarding Claim 33, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 32. Thirstrup further teaches wherein the recess structure is provided in the adhesive surface portion (paragraph [0095]).
Regarding Claim 34, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 33. Thirstrup further teaches wherein the electrode structure is fixed in the recess structure by adhesive properties of the adhesive surface portion (paragraph [0097]).
Regarding Claim 36, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 16. Thirstrup further teaches wherein processing the electrical signal comprises evaluating a change in the resistance based on a predetermined value to detect a presence of liquid at the base plate.
The combination fails to teach wherein processing the electrical signal comprises evaluating a change in the resistance based on a predetermined value to detect a presence of liquid at the base plate.
Zamanzadeh teaches sensors to detect wetness, a wherein processing the electrical signal comprises evaluating a change in the resistance based on a predetermined value to detect a presence of liquid at the base plate. (paragraph [0037]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the base plate of Thirstrup with wherein processing the electrical signal comprises evaluating a change in the resistance based on a predetermined value to detect a presence of liquid at the base plate similar to Zamanzadeh to control the resistance between electrodes.
Claim(s) 27- 30 are rejected under 35 U.S.C. 103 as being unpatentable over Thirstrup (US2010030167A1) in view of Zdeblick (US 20160324442 A1) in view of Zamanzadeh (US 20050034985 A1) in view of Davis (US 20160158056A1).
Regarding Claim 27, Thirstrup further teaches a method of manufacturing a base plate for detecting leakage, the method comprising:
providing a base plate (1) with a proximal surface configured to be attached to the body and defining a stoma-receiving opening (3) from the proximal surface through the base plate(1) (figures 1a, 1c, 3c, 3d),
providing an electrode structure (28) comprising at least two electrodes; and pressing the electrode structure into the proximal surface to thereby define a recess structure (space between 26 and 27 in figure 3d) in the proximal surface that receives the electrode structure, the recess structure thereby defining a first volume, vl, which exceeds a second volume, v2, of the electrode structure, thereby defining a free space with a third volume, v3, around the electrode structure in the recess structure (Annotated Figure 3c).
Thirstrup fails to explicitly teach exposing at least a part of the electrode structure to the skin surface of the user. Zdeblick teaches and electrode and ostomy plate that includes exposing at least a part of the electrode structure to the skin surface of the user (paragraph [0105-0106]]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the base plate of Thirstrup so at least a part of the electrode structure to the skin surface of the user , similar to Zdeblick in order to maintain low impedance in the system (as motivated by Zdeblick, paragraph [0106]).
Thirstrup further teaches the electrodes are places on the surface via printing (paragraph [0150]). However, Thirstrup fails to teach wherein pressing the electrode structure into the proximal surface to thereby define a recess structure in the proximal surface for the electrode structure. Davis teaches a leak detector sensor for the stoma wherein the step of creating fractures in the coating of the electrodes may comprise creating successive troughs at spaced intervals in the coating of the electrodes by laser ablation of the coating, exposing the surface of the respective electrode in the troughs, whereby the transmission of heat along the length of the respective electrode during the creation of a respective trough results in the partial melting of the coating surrounding a previously ablated adjacent trough which recovers the previously exposed surface of the electrode, fractures arising in the remelted coating as it solidifies as a consequence of the previous thermal degradation of the coating (paragraph [0017]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Thirstrup in view of Davis so the electrodes are securely attached and the location of the electrodes is detectable from both sides of the base plate.
Regarding Claim 28, Thirstrup in view of Davis teaches the base plate according to claim 27. The combination further teaches wherein the step of pressing the electrode structure into the proximal surface is carried out to cause elastic deformation of a first part (first electrode) of the base plate (Davis, paragraph [0017]).
Regarding Claim 29, Thirstrup in view of Zdeblick and Zamanzadeh and Davis teaches the base plate according to claim 27. The combination further teaches wherein the step of pressing the electrode structure into the proximal surface is carried out to cause elastic deformation of a second part (second electrode) of the base plate (Davis, paragraph [0017]).
Regarding Claim 30, Thirstrup further teaches wherein the step of applying a pressure sensitive adhesive to at least a part of the proximal surface prior to the step of pressing the electrode structure into that part of the proximal surface (adhesive is how electrodes are applied in Thirstrup, so it would be obvious that in order to press the electrodes such as in Davis, the adhesive must already be applied)
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Thirstrup (US2010030167A1) in view of Zdeblick (US 20160324442 A1) Zamanzadeh (US 20050034985 A1) in view of Cappellari (WO 2012025456 A1).
Regarding Claim 35, Thirstrup in view of Zdeblick and Zamanzadeh teaches the base plate according to claim 26. Thirstrup fails to teach an electronic control system configured for detection of humidity at the proximal surface based on an electrical signal from the electrode structure. Cappellari teaches an electrode system wherein an electronic control system configured for detection of humidity at the proximal surface based on an electrical signal from the electrode structure (page 6, lines 16-30). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrode structure of Thirstrup to detect humidity so monitor for ideal conditions that could impact effectiveness of the device (Cappellari, page 6, lines 16-30).
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 KATE ELIZABETH STRACHAN whose telephone number is (571) 272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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