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 1-4, 7-12, 14-18, 20, 21, 39-42, and 57-59 and 63-65 are currently pending. Claims 14-16, 21, 39-42, and 57-59 have been previously withdrawn. Claims 5, 6, 13, 19, 22-38, 43-56, and 60-62 were previously cancelled. Claim 1 is currently amended. Claims 63-65 are newly added. No new subject matter is added.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/11/2025 has been entered.
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 1-4, 7-12, 17-18, 20, and 63-65 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn ‘225 (US 20140180225 A1) in view of Simmons et al. (US 20110224630 A1), hereinafter referred to as “Simmons” and in further view of Brownhill et al. (WO 2017195038 A1), hereinafter referred to as Brownhill”.
Regarding Claim 1, Dunn ‘225 teaches a dressing (100/300) for treating an open abdominal cavity with negative pressure (see Figures 1A, 3B, 5, 13, and 14; Paragraph [0063], [0106], and [0107]), the dressing comprising:
a viscera contact layer (negative pressure drainage/fluid management component 301, see Figure 14) configured to communicate a negative pressure to viscera (tube 121 connects the device 300 to a single pump for applying a negative pressure to the wound closure and wound treatment components, see Paragraph [0082]) and configured to form flow paths for a fluid through the viscera contact layer (wound closure device can have a bottom surface 115 with pores 116 for fluid to flow through, see Figure 1F);
a fluid manifold (filler material 102, see Paragraph [0058]) configured to be disposed adjacent to the viscera contact layer (disposed adjacent to component 301, see Figure 14, note reference number 104 is pointing to tissue grasping surface as explained in [0058]) and configured to communicate a negative pressure to a tissue (applying a negative pressure to the filler material 102, see Paragraph [0063]) and capable of forming flow paths for a fluid (filler material 102 is porous open cell foam that has pores for fluid flow, see Paragraph [0057]).
However, Dunn ‘225 does not explicitly disclose a spacer manifold enclosed by the viscera contact layer and the spacer manifold including a plurality of spacer legs extending from a central body; a first leg of the plurality of spacer legs and a second leg of the plurality of spacer legs.
Simmons teaches a wound dressing system (100, see Figures 1-3 and 7) comprises a spacer manifold (125) enclosed by a viscera contact layer (first contact layer 120 and second contact layer 118, see Figure 7), the spacer manifold including a plurality of spacer legs extending from a central body (plurality of spaced leg members 178, see below) comprising a first leg of the plurality of spacer legs along a first axis (see below), a second leg of the plurality of spacer legs along a second axis (see below), a central body along a third axis (see below), wherein at least one of the first axis and the second axis are different from the third axis (the
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first and second axis being different from the third axis, see below).
Dunn ‘225 and Simmons are analogous art because both deal with an abdominal wound dressing.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the spacer layer of Dunn ‘225 and further include the spacer layer to be enclosed in the visceral contact layer and include a plurality of spacer legs with a first and second leg, as taught by Simmons. Simmons teaches the spacer legs would allow control of the direction of the reduced pressure (see Paragraph [0048]).
Modified Dunn ‘225 teaches all of the limitations above. However, Modified Dunn ‘225 do not explicitly disclose and at least one sensor configured to acquire data associated with strain in one or more of the fluid manifold and the viscera contact layer, a first sensor of the at least one sensor disposed on a first leg, a second sensor of the at least one sensor disposed on a second leg, and a third sensor of the at least one sensor extending between two legs and across the central body.
Brownhill teaches a system for applying negative-pressure therapy to an abdominal cavity (a negative pressure wound therapy apparatus, see Paragraph [0001]; Figure 1), the system comprising:
a spacer layer (transmission layer 226 comprises a 3D polyester spacer fabric layer, see Paragraph [0054]), the spacer layer configured to extend to a plurality of different zones within the abdominal cavity (the area of layer 226 extends to different zones of the abdominal cavity, see Figure 2A-C);
at least one sensor (sensor array portion 301 having a number of sensors, see Paragraph [0087]) configured to acquire data associated with strain in one or more of the fluid manifold and the viscera contact layer (the sensor elements can be mounted to the internal flexible frame 108 of manifold 102 to measure wound closure force or strain, see Paragraph [0106]) a first sensor of the at least one sensor disposed on a first leg (one or more sensors can be arranged or deployed in alternative or additional ways such as a strip or string and encapsulated within other components of the wound dressing such as the absorbent layer or spacer layer, see Paragraph [0086] and [0091]; Figures 3C-H; see below), a second sensor of the at least one sensor disposed on a second leg (one or more sensors can be arranged or deployed in alternative or additional ways such as a strip or string and encapsulated within other components of the wound dressing such as the absorbent layer or spacer layer, see Paragraph [0086] and [0091]; Figures 3C-H; see below), and a third sensor of the at least one sensor extending between two of the legs and across the central body (one or more sensors can be arranged or deployed in alternative or additional ways such as a strip or string and encapsulated within other components of the wound dressing such as the absorbent layer or spacer layer, see Paragraph [0086] and [0091]; Figures 3C-H; see below).
Modified Dunn ‘225 and Brownhill are analogous art because both deal with a negative pressure wound therapy system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first leg, second leg, and central body of Modified Dunn ‘225 and further include the a first sensor on the first leg, a second sensor on the second leg, and a third sensor on the central body, as taught by Brownhill. Brownhill teaches that sensors are utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound. Collecting data from the wounds that heal well, and from those that do not, can provide useful insights towards identifying measurements or measurands to indicate one or more conditions, including whether a wound is on a healing trajectory, whether the dressing needs to be adjusted,
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whether therapy parameters needs to be adjusted, or the like (see Paragraph [0084]).
Regarding Claim 2, Modified Dunn ‘225 teaches all of the limitations as disclosed above in claim 1. However, Modified Dunn ‘225 does not explicitly disclose wherein the data comprises changes in capacitance based on deformation of the at least one sensor.
Brownhill teaches a wound dressing (100, see Figure 2A-B; see abstract) comprising a number of sensors incorporated onto or into a wound contact layer, which may be a perforated wound contact layer (see Paragraph 0085]), wherein the sensor data comprises changes in capacitance based on deformation of the at least one sensor (sensor may comprise a strain sensor such as a strain gauge, see Paragraph [0087] and [0093]; strain gauges gathers data based on measured electrical resistance varying with changes in strain or deformation/displacement).
Modified Dunn ’225 and Brownhill are analogous art because both deal with a negative pressure wound therapy system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sensor of Modified Dunn ‘225 and further include wherein the at least one sensor is a strain gauge wherein the data comprises changes in capacitance based on deformation of the sensor, as taught by Brownhill. Brownhill teaches that sensors are utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound. Collecting data from the wounds that heal well, and from those that do not, can provide useful insights towards identifying measurements or measurands to indicate one or more conditions, including whether a wound is on a healing trajectory, whether the dressing needs to be adjusted, whether therapy parameters needs to be adjusted, or the like (see Paragraph [0084]).
Regarding Claim 3, Modified Dunn ‘225 teaches all of the limitations as disclosed above in claim 1. However, Modified Dunn ‘225 does not explicitly disclose wherein the at least one sensor comprises a polymer that changes in size and/or in shape in the presence of an electric field.
Brownhill teaches a wound dressing (100, see Figure 2A-B; see abstract) comprising a number of sensors incorporated onto or into a wound contact layer, which may be a perforated wound contact layer (see Paragraph 0085]), wherein the at least one sensor comprises a polymer that changes in size and/or in shape in the presence of an electric field (the sensor may be an electroactive polymer, see Paragraph [0124]; electroactive polymers is a polymer that exhibits a change in size or shape when stimulated by an electric field).
Modified Dunn ‘225 and Brownhill are analogous art because both deal with a negative pressure wound therapy system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sensor of Modified Dunn ‘225 and further include wherein the at least one sensor is an electroactive polymer wherein the data comprises changes in capacitance based on deformation of the sensor, as taught by Brownhill. Brownhill teaches that sensors are utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound. Collecting data from the wounds that heal well, and from those that do not, can provide useful insights towards identifying measurements or measurands to indicate one or more conditions, including whether a wound is on a healing trajectory, whether the dressing needs to be adjusted, whether therapy parameters needs to be adjusted, or the like (see Paragraph [0084]).
Regarding Claim 4, Modified Dunn ‘225 teaches all of the limitations as disclosed above in claim 1. However, Modified Dunn ‘225 does not explicitly disclose wherein the at least one sensor comprises a stretchable capacitor.
Brownhill teaches a wound dressing (100, see Figure 2A-B); see abstract) comprising a number of sensors incorporated onto or into a wound contact layer, which may be a perforated wound contact layer (see Paragraph 0085]), wherein the at least one sensor comprises a stretchable capacitor (the sensor may be an electroactive polymer, see Paragraph [0124]; electroactive polymers is a polymer that exhibits a change in size or shape when stimulated by an electric field).
Modified Dunn ‘225 and Brownhill are analogous art because both deal with a negative pressure wound therapy system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sensor of Modified Dunn ‘225 and further include wherein the at least one sensor is an electroactive polymer wherein the data comprises changes in capacitance based on deformation of the sensor, as taught by Brownhill. Brownhill teaches that sensors are utilized in order to monitor characteristics of a wound as it heals or to identify one or more risk factors or conditions that may precipitate a wound. Collecting data from the wounds that heal well, and from those that do not, can provide useful insights towards identifying measurements or measurands to indicate one or more conditions, including whether a wound is on a healing trajectory, whether the dressing needs to be adjusted, whether therapy parameters needs to be adjusted, or the like (see Paragraph [0084]).
Regarding Claim 7, Modified Dunn ‘225 teaches all of the limitations as disclosed above in claim 1. However, Modified Dunn ‘225 does not explicitly disclose a wireless transmitter coupled to the at least one sensor.
Brownhill teaches a wound dressing (100, see Figure 2A-B; see abstract) comprising a number of sensors incorporated onto or into a wound contact layer, which may be a perforated wound contact layer (see Paragraph 0085]), and a wireless transmitter coupled to the at least one sensor (the sensors are configured to communicate wirelessly, see last line of Paragraph [0090]).
Modified Dunn ‘225 and Brownhill are analogous art because both deal with a negative pressure wound therapy system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the at least one sensor of Modified Dunn ‘225 and further include a wireless transmitter coupled to the sensor, as taught by Brownhill. Brownhill teaches that sensors can wireless communicate to prevent contact with liquids to protect the sensor from damage (see Paragraph [0090]).
Regarding Claim 8, Dunn ‘225 further teaches wherein another of the at least one sensor is coupled to the fluid manifold (sensor array 301 can include sensor 320,322 coupled to manifold 102, see Figure 14 and 15).
Regarding Claim 9, Modified Dunn ‘225 teaches all of the limitations, as discussed above in claim 1 and Brownhill further teaches wherein the spacer manifold (221) is configured to communicate the negative pressure to the tissue (interior space or chamber of dressing 100 may comprise additional structures that may be adapted to distribute or transmit negative pressure, see Paragraph [0048]) and configured to form flow paths for the fluid (absorbent layer 221 is configured to distribute fluid throughout the layer via a wicking action so that fluid is drawn from the wound site and stored throughout the absorbent layer, see Paragraph [0058]).
Regarding Claim 10, Modified Dunn ‘225 teaches all of the limitations as discussed above in claim 9 and Brownhill further teaches wherein the spacer manifold comprises open- cell foam (absorbent layer 221 comprises a foam or super-absorbent material to wick fluids through the layer, see Paragraph [0057]-[0058]).
Regarding Claim 11, Dunn ‘225 further teaches wherein the fluid manifold comprises open- cell foam (manifold 102 is an open cell foam, see Paragraph [0057]).
Regarding Claim 12, Modified Dunn ‘225 teaches all of the limitations, as discussed above in claim 1 and Simmons further teaches wherein the viscera contact layer comprises a polymer sheet (viscera contact layer 118, 120 are formed from liquid impermeable material such as a polymer sheet, see Paragraph [0021]) forming openings configured to allow fluid to pass through the viscera contact layer (fenestrations 122, 124) and wherein the fluid manifold is configured to fluidly communicate with the tissue and spacer manifold through at least some of the openings in the viscera contact layer (fenestrations allow fluids to enter the space between the plurality of liquid-impermeable layers and move directly or indirectly towards a reduced-pressure source through the tissue and manifold 126, see Figure 1; Paragraph [0038]).
Regarding Claim 17, Dunn ‘225 further teaches wherein the viscera contact layer (301) comprises a periphery (periphery of layer 301) and a central area (center of layer 301), and the sensor (320,322) is configured to acquire data associated with strain along one or more axes of the central area (measure pressure at the bottom of panel 301 at the central area, see Figure 14).
Regarding Claim 18, Modified Dunn ‘225 teaches all of the limitations as disclosed above in claim 1. However, Modified Dunn ‘225 does not explicitly disclose wherein a location of the at least one sensor is capable of being detected when the dressing is delivering negative pressure to the abdominal cavity.
Brownhill teaches a wound dressing (100, see Figure 2A-B; see abstract) comprising a number of sensors incorporated onto or into a wound contact layer, which may be a perforated wound contact layer (see Paragraph [0085]), wherein a location of the at least one sensor is capable of being detected when the dressing is delivering negative pressure to the abdominal cavity (the sensor array, arrangement, or package can register itself with electromagnetic tags placed on or near the wound, which can assist with positioning and rotating the sensors correctly with respect to the tags and the wound, see Paragraph [0092]).
Modified Dunn ‘225 and Brownhill are analogous art because both deal with a negative pressure wound therapy system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the at least one sensor of Modified Dunn ‘225 and further a location of the sensor is capable of being detected when the dressing is delivering negative pressure to the abdominal cavity, as taught by Brownhill. Brownhill teaches that this information can be used to assess positioning of the sensors or to facilitate proper positioning when the sensors are replaced (for example, when dressing is discarded) (see Paragraph [0092]).
Regarding Claim 20, Modified Dunn ‘225 teaches all of the limitations as disclosed above in claim 1. However, Modified Dunn ‘225 does not explicitly disclose wherein a location of the at least one sensor is capable of being detected by using one or more of electromagnetic fields, radio frequency, ultrasound, x-rays, and a magnetic field.
Brownhill teaches a wound dressing (100, see Figure 2A-B; see abstract) comprising a number of sensors incorporated onto or into a wound contact layer, which may be a perforated wound contact layer (see Paragraph 0085]), wherein a location of the at least one sensor is capable of being detected by using one or more of electromagnetic fields, radio frequency, ultrasound, x-rays, and a magnetic field (the sensor array, arrangement, or package can register itself with electromagnetic tags placed on or near the wound, which can assist with positioning and rotating the sensors correctly with respect to the tags and the wound, see Paragraph [0092]).
Modified Dunn ‘225 and Brownhill are analogous art because both deal with a negative pressure wound therapy system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the at least one sensor of Modified Dunn ‘225 and further wherein a location of the sensor is capable of being detected by using one or more of electromagnetic fields, radio frequency, ultrasound, x-rays, and a magnetic field, as taught by Brownhill. Brownhill teaches that this information can be used to assess positioning of the sensors or to facilitate proper positioning when the sensors are replaced (for example, when dressing is discarded; see Paragraph [0092]).
Regarding Claim 63, Modified Dunn ‘225 teaches all of the limitations as disclosed above in claim 1 and Brownhill further teaches the first sensor is stretched along the first axis, the second sensor is stretched along the second axis, and the third sensor is stretched along the third axis (one or more sensors can be arranged or deployed in alternative or additional ways such as a strip or string and encapsulated within other components of the wound dressing such as the absorbent layer or spacer layer, see Paragraph [0086] and [0091]; Figures 3C-H; the sensor strips in Brownhill placed on the first, second, and third axis of Simmons respectfully, as described above in the 103 rejection of claim 1).
Regarding Claim 64, Modified Dunn ‘225 teaches all of the limitations as disclosed above in claim 1 and Brownhill further teaches wherein the third sensor is stretched across the central body (one or more sensors can be arranged or deployed in alternative or additional ways such as a strip or string and encapsulated within other components of the wound dressing such as the absorbent layer or spacer layer, see Paragraph [0086] and [0091]; Figures 3C-H; the sensor strips in Brownhill placed on a central body along a third axis of Simmons respectfully, as described above in the 103 rejection of claim 1).
Regarding Claim 65, Modified Dunn ‘225 teaches all of the limitations as disclosed above in claim 1. However, Brownhill further teaches wherein the first sensor, the second sensor, and the third sensor are each associated with a physically and electronically separate circuit (the components in the sensor array can be connected through multiple connections having up to 9 different conductivity terminals, see Paragraph [0116]).
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive.
Specifically, Applicant argues in Claim 1 that the cited prior art does not teach a first sensor of the at least one sensor disposed on a first leg of the plurality of spacer legs on a first axis, a second sensor of the at least one sensor disposed on a second leg of the plurality of spacer legs on a second axis, and a third sensor of the at least one sensor extending between two of the spacer legs and across the central body on a third axis.
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The examiner disagrees that Simmons in view of Brownhill would fail to read on the limitations of the claim. Simmons teaches the plurality of spacer legs having a first second, and third axis associated with a first, second, and third spacer leg (as shown below).
Brownhill teaches an array of sensors that can be positioned in alternative and additional ways such as a strip or string encapsulated within other components of the spacer layer, as described in Paragraphs [0086] and [0091]. Paragraph [0098] also discusses the sensor array portions having linearly extending portions that may extend inward to different locations within an interior of a wound dressing component. Therefore, modifying the first, second, and third spacer legs of Simmons to include a strip of sensors of Brownhill would read on the limitations of the claim.
Specifically, Applicant argues in Claim 1 that Brownhill does not provide motivation to specifically position the first, second and third sensors.
The examiner respectfully disagrees that Brownhill does not provide motivation to specifically position the first, second and third sensors. Paragraph [0087] describes any one or more sensors described herein can be placed or positioned to obtain measurements of any location. For example, a line of Sp02 sensors can allow the sensors to take measurements in the middle of the wound, at the edge or the wound, or on intact skin to measure changes between the various regions. Paragraph [0087] further describes how a larger size of the wound contact layer or sensor array and the multiple sensors can provide more information about the wound area than if the sensor was only placed in the center of the wound or in only one area at a time. Therefore, there is motivation to provide an array of sensors in different regions of the dressing to provide a user to measure changes between various regions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (1/8/2025)Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781