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 1-5 and 7-18 are currently pending. Claims 1, 4, 13, and 16 are currently amended. Claims 6 and 19 are cancelled. No new subject matter is added.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 and 7-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4- 13, 15, and 19 of U.S. Patent No. 12070545, as shown in the chart below. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations in the current claims are found in the patented claims. Patented Claim 1 recites more details than current claim 1, i.e. wherein a blockage of the negative pressure applied by the pump to the wound site through the first chamber causes the negative pressure indicated by the pressure indicator to differ from the negative pressure applied by the pump.
Current Claim #
1
2
3
4
5
7
8
9
10
Patented Claim #
1
1
1
2
4
6
7
8
9
Current Claim #
11
12
13
14
15
16
17
18
Patented Claim #
10
11
1
2
1
12
13
15
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.
Claims 1-4, 7, 10-11, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hall (US 20100262095 A1) in view of Locke et al. (US 20080234641 A1), hereinafter referred to as “Locke”, and in further view of Karpowicz et al. (US 20110077605 A1).
Regarding Claim 1, Hall teaches a wound therapy system (see Abstract) comprising:
a first chamber (a waste receptacle (not shown) associated with the vacuum pump 26, see Paragraph [0044]) configured to be fluidly coupled to a dressing (24) at a wound site (10) through a primary conduit (conduit 22);
a second chamber (small plastics material housing 36) configured to be fluidly coupled to the dressing (24) at the wound site separately from the first chamber (see Figure 1) through a secondary conduit (short conduit portion 30), the second chamber configured to controllably leak air into the second chamber at a controlled leak rate through a filter (an air bleed is admitted through the filter element 42 into the wound cavity 17 thus stimulating a fluid flow through the wound cavity 17 and through the conduit 22 towards the pump 26 so keeping the conduit 22 unblocked and free flowing, see Paragraph [0044]; Control of bleed rate may be achieved by control of the area of the filter through which bleed air may be admitted see Paragraph [0018]-[0019]); and
a pump (26) configured to apply negative pressure to the wound site through the first chamber (through conduit portion 22) and to remove air from the second chamber through the dressing at an air removal rate greater than the controlled leak rate (in operation vacuum pump is turn on and vacuum is created in the wound cavity 17, see Paragraph [0044]; it is to be understood that the vacuum pump generates negative pressure at greater rate than the controlled air leak to maintain proper pressure within the dressing and allow wound exudate to flow towards pump 26).
However, Hall does not explicitly disclose wherein a portion of the filter is exposed through an external wall of the second chamber.
Karpowicz teaches a pump system (10) for applying negative pressure to a wound (see Abstract) comprising a second chamber (housing of air vent 32, see Figure 2) configured to be fluidly coupled to the dressing at the wound site separately from the first chamber through a secondary conduit (coupled to the wound packing 12 through tube 14), the second chamber configured to controllably leak air into the second chamber at a controlled leak rate through a filter (he system described herein uses a reference airflow, as may be provided by a calibrated filter or porous plug 34 , see Paragraph [0059]), and wherein a portion of the filter is exposed through an external wall of the second chamber (porous plug 34 is exposed through the external wall of air vent 32, see Figure 2).
Hall and Karpowicz are analogous art because both teach a wound therapy system with a filter.
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 filter of Hall and further include a portion of the filter is exposed through an external wall of the second chamber, as taught by Karpowicz. Karpowicz teaches , a calibrated vent, such as the porous vent (32, 34) is a preferred reference for airflow rate because it provides a larger and more stable flow rate that masks variations in the permeation flow, see Paragraph [0062]).
Hall and Karpowicz teaches all of the limitation as taught above. However, Hall and Karpowicz do not explicitly disclose a pressure indicator fluidly coupled to the second chamber between the filter and a portion of the secondary conduit at a location remote from the dressing and configured to indicate a negative pressure in the second chamber.
Locke teaches a reduce pressure dressing (see Abstract; Figure 1) comprising a reduced pressure source (110) applied to tissue site (105) using source tube (130) and delivery tube (135); a pressure indicator (controller 170 directs indicator 180 to emit a signal in response to the actual reduced pressure at tissue site 105, as measured by pressure sensor 155, see Paragraph [0068]) fluidly coupled to a second chamber between the filter and a portion of the secondary conduit at a location remote from the dressing (pressure sensor may be directly or indirectly coupled to other remotely located components of reduced pressure treatment system 100, see Paragraph [0056]; therefore could be placed between the filter and a portion of the secondary conduit of Hall) and that detects the reduced pressure at tissue site (105) via control tube (160).
Hall, Karpowicz, and Locke are all analogous art because both teach a negative pressure 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 second conduit of modified Hall and further include a pressure sensor configured to indicate a negative pressure in the second chamber, as taught by Locke. Locke teaches the pressure sensor is beneficial because cost, weight, and power consumption are minimized is through the use of only one sensor to measure pressure. As previously mentioned, traditional systems typically use two pressure sensors, one to measure pressure at the tissue site and one to measure pressure at the reduced pressure source. However, the elimination of the pressure sensor measuring pressure at the reduced pressure source allows significant reductions in the amount of electronic circuitry required and also the amount of power consumed by the system (see Paragraph [0095]).
Regarding Claim 2, Modified Hall teaches all of the limitations as discussed above in claim 1 and Locke further teaches wherein a blockage of the negative pressure applied by the pump to the wound site through the first chamber causes the negative pressure indicated by the pressure indicator to differ from the negative pressure applied by the pump (controller 170 determines a responsiveness of the actual reduced pressure at tissue site 105, as measured by pressure sensor 155, to an increase/decrease in the generated reduced pressure from reduced pressure source 110 to determine a block condition, see Paragraph [0067], [0073],and [0074]) and Hall further teaches wherein the air removal rate causes the negative pressure at the pressure indicator to be substantially equal to the negative pressure applied by the pump before the blockage occurs (the air bleed rate in filter 24 can be controlled, see Paragraph [0019]; it is to be understood the air bleed rate can be controlled in order to allow for a negative pressure at within the tubing 30 to equal the negative pressure applied by the pump).
Regarding Claim 3, Modified Hall teaches all of the limitations as discussed above in claim 1 and Locke further teaches wherein the pressure indicator is located within the second chamber (pressure sensor may be directly or indirectly coupled to other remotely located components of reduced pressure treatment system 100, see Paragraph [0056]; therefore could be placed in the second chamber of Hall).
Regarding Claim 4, Modified Hall teaches all of the limitations as discussed above in claim 1 and Hall further teaches wherein the filter (42) is configured to controllably leak air into the secondary conduit (control of bleed rate may be achieved by control of the area of the filter through which bleed air may be admitted see Paragraph [0018]-[0019]).
Regarding Claim 7, Modified Hall teaches all of the limitations as discussed above in claim 1 and Locke further teaches wherein the pressure indicator (155) is configured to indicate the negative pressure at the pressure indicator (via indicator 180) relative to a plurality of pressure thresholds (the actual reduced pressure, as measured by pressure sensor 155, exceeding the target reduced pressure by a predetermined threshold or not exceeding a predetermined threshold, see Paragraph [0064]).
Regarding Claim 10, Modified Hall teaches all of the limitations as discussed above in claim 1 and Locke further teaches wherein the pressure indicator is an electronic pressure sensor (pressure sensor 155 is a silicon piezoresistive gauge pressure sensor, see Paragraph [0052]).
Regarding Claim 11, Modified Hall teach all of the limitations as discussed above in claim 10 and Locke further teaches wherein the pressure indicator is configured to compare the negative pressure at the pressure indicator to one or more pressure thresholds (the actual reduced pressure, as measured by pressure sensor 155, exceeding the target reduced pressure by a predetermined threshold or not exceeding a predetermined threshold, see Paragraph [0064]) and generate an alarm based on the negative pressure at the pressure indicator relative to one or more pressure thresholds (controller 170 directs indicator 180 to emit a signal in response to the actual reduced pressure at tissue site 105, as measured by pressure sensor 155, being nonresponsive to increasing the generated reduced pressure, see Paragraph [0068]).
Regarding Claim 13, Hall teaches a wound therapy system (see Abstract) comprising:
a primary conduit (conduit portion 22) configured to be fluidly coupled between a first chamber (a waste receptacle (not shown) associated with the vacuum pump 26, see Paragraph [0044]) and a dressing (24) at a wound site (10);
a secondary conduit (short conduit portion 30) configured to be fluidly coupled between a second chamber (small plastics material housing 36) and the dressing (24) at the wound site separately from the primary conduit (see Figure 1), the secondary conduit including a controlled air leak into the secondary conduit at a controlled leak rate through a filter (an air bleed is admitted through the filter element 42 into the wound cavity 17 thus stimulating a fluid flow through the wound cavity 17 and through the conduit 22 towards the pump 26 so keeping the conduit 22 unblocked and free flowing, see Paragraph [0044]; Control of bleed rate may be achieved by control of the area of the filter through which bleed air may be admitted see Paragraph [0018]-[0019]); and
a pump (26) configured to apply negative pressure to the wound site through the primary conduit and to remove air from the secondary conduit through the dressing (24) at an air removal rate greater than the controlled leak rate (in operation vacuum pump is turn on and vacuum is created in the wound cavity 17, see Paragraph [0044]; it is to be understood that the vacuum pump generates negative pressure at greater rate than the controlled air leak to maintain proper pressure within the dressing and allow wound exudate to flow towards pump 26).
However, Hall does not explicitly disclose wherein a filter exposed to ambient air at an external wall of the second chamber.
Karpowicz teaches a pump system (10) for applying negative pressure to a wound (see Abstract) comprising a second chamber (housing of air vent 32, see Figure 2) configured to be fluidly coupled to the dressing at the wound site separately from the first chamber through a secondary conduit (coupled to the wound packing 12 through tube 14), the second chamber configured to controllably leak air into the second chamber at a controlled leak rate through a filter (the system described herein uses a reference airflow, as may be provided by a calibrated filter or porous plug 34 , see Paragraph [0059]), and wherein the filter is exposed to ambient air at an external wall of the second chamber (porous plug 34 is exposed through the external wall of air vent 32, see Figure 2).
Hall and Karpowicz are analogous art because both teach a wound therapy system with a filter.
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 filter of Hall and further include a portion of the filter is exposed through an external wall of the second chamber, as taught by Karpowicz. Karpowicz teaches , a calibrated vent, such as the porous vent (32, 34) is a preferred reference for airflow rate because it provides a larger and more stable flow rate that masks variations in the permeation flow, see Paragraph [0062]).
Hall and Karpowicz teach all of the limitations as discussed above. However, Hall and Karpowicz do not explicitly disclose a pressure indicator fluidly coupled to the secondary conduit between the filter the dressing and configured to indicate a negative pressure in the secondary conduit.
Locke teaches a reduce pressure dressing (see Abstract; Figure 1) comprising a reduced pressure source (110) applied to tissue site (105) using source tube (130) and delivery tube (135); a pressure sensor (155) between the filter and the dressing (pressure sensor 155 may be located anywhere on reduced pressure treatment system 100, see Paragraph [0056]; therefore could be placed between the filter and dressing of Hall) and that detects the reduced pressure at tissue site (105) via control tube (160).
Hall, Karpowicz, and Locke are all analogous art because both teach a negative pressure 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 second conduit of Modified Hall and further include a pressure sensor, as taught by Locke. Locke teaches the pressure sensor is beneficial because cost, weight, and power consumption are minimized is through the use of only one sensor to measure pressure. As previously mentioned, traditional systems typically use two pressure sensors, one to measure pressure at the tissue site and one to measure pressure at the reduced pressure source. However, the elimination of the pressure sensor measuring pressure at the reduced pressure source allows significant reductions in the amount of electronic circuitry required and also the amount of power consumed by the system (see Paragraph [0095]).
Regarding Claim 14, Modified Hall teaches all of the limitations of claim 13 and Hall further teaches wherein the filter (42) is fluidly coupled to the secondary conduit (30) and configured to controllably leak air into the secondary conduit (Control of bleed rate may be achieved by control of the area of the filter through which bleed air may be admitted see Paragraph [0018]-[0019]).
Regarding Claim 15, Modified Hall teaches all of the limitations of claim 13 and Hall further teaches wherein the air removal rate causes the negative pressure at the pressure indicator to be substantially equal to the negative pressure applied by the pump before the blockage occurs the air bleed rate in filter 24 can be controlled, see Paragraph [0019]; it is to be understood the air bleed rate can be controlled in order to allow for a negative pressure at within the tubing 30 to equal the negative pressure applied by the pump). Locke further teaches a blockage of the negative pressure applied by the pump to the wound site through the primary conduit causes the negative pressure indicated by the pressure indicator to differ from the negative pressure applied by the pump (controller 170 determines a responsiveness of the actual reduced pressure at tissue site 105, as measured by pressure sensor 155, to an increase/decrease in the generated reduced pressure from reduced pressure source 110 to determine a block condition, see Paragraph [0067], [0073],and [0074]).
Regarding Claim 16, Hall teaches a method for detecting a blockage in a wound therapy system (intended use), the method comprising:
fluidly coupling a first chamber (a waste receptacle (not shown) associated with the vacuum pump 26, see Paragraph [0044]) to a dressing (24) at a wound site (10) with a primary conduit (conduit portion 22);
operating the pump to apply negative pressure to the wound site via the first chamber, the primary conduit and the dressing (see Paragraph [0044]);
fluidly coupling a second chamber (small plastics material housing 36) to the dressing at the wound site with a secondary conduit (short conduit portion 30) separate from the primary conduit (see Figure 1);
controllably leaking air into the secondary conduit at a controlled leak rate through a filter (an air bleed is admitted through the filter element 42 into the wound cavity 17 thus stimulating a fluid flow through the wound cavity 17 and through the conduit 22 towards the pump 26 so keeping the conduit 22 unblocked and free flowing, see Paragraph [0044]; Control of bleed rate may be achieved by control of the area of the filter through which bleed air may be admitted see Paragraph [0018]-[0019]);
wherein operating the pump removes air from the secondary conduit through the dressing at an air removal rate greater than the controlled leak rate (in operation vacuum pump is turn on and vacuum is created in the wound cavity 17, see Paragraph [0044]; it is to be understood that the vacuum pump generates negative pressure at greater rate than the controlled air leak to maintain proper pressure within the dressing).
However, Hall does not explicitly disclose wherein a filter exposed to ambient air at an external wall of the second chamber.
Karpowicz teaches a pump system (10) for applying negative pressure to a wound (see Abstract) comprising a second chamber (housing of air vent 32, see Figure 2) configured to be fluidly coupled to the dressing at the wound site separately from the first chamber through a secondary conduit (coupled to the wound packing 12 through tube 14), the second chamber configured to controllably leak air into the second chamber at a controlled leak rate through a filter (the system described herein uses a reference airflow, as may be provided by a calibrated filter or porous plug 34 , see Paragraph [0059]), and wherein the filter is exposed to ambient air at an external wall of the second chamber (porous plug 34 is exposed through the external wall of air vent 32, see Figure 2).
Hall and Karpowicz are analogous art because both teach a wound therapy system with a filter.
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 filter of Hall and further include a portion of the filter is exposed through an external wall of the second chamber, as taught by Karpowicz. Karpowicz teaches , a calibrated vent, such as the porous vent (32, 34) is a preferred reference for airflow rate because it provides a larger and more stable flow rate that masks variations in the permeation flow, see Paragraph [0062]).
Hall and Karpowicz teaches all of the limitations above. However, Hall and Karpowicz do not explicitly disclose using a pressure indicator to indicate a negative pressure in the secondary conduit between the filter and the dressing; and detecting a blockage in response to the negative pressure indicated by the pressure indicator differing from the negative pressure applied by the pump.
Locke teaches a reduce pressure dressing (see Abstract; Figure 1) comprising a reduced pressure source (110) applied to tissue site (105) using source tube (130) and delivery tube (135); fluidly coupling a pressure indicator (155) to the dressing (pressure sensor 155 may be located anywhere on reduced pressure treatment system 100, see Paragraph [0056]; therefore could be placed on the dressing); using the pressure indicator to indicate a negative pressure in the secondary conduit between the filter and the dressing (pressure sensor 155 detects the reduced pressure at tissue site 105 via control tube 160, see Paragraph [0053]); and detecting a blockage in response to the negative pressure indicated by the pressure indicator differing from the negative pressure applied by the pump (controller 170 directs indicator 180 to emit a signal in response to the actual reduced pressure at tissue site 105, as measured by pressure sensor 155, being nonresponsive to increasing the generated reduced pressure, see Paragraph [0068]-[0070]).
Hall, Karpowicz, and Locke are all analogous art because both teach a negative pressure 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 second conduit of Modified Hall and further include a pressure sensor to detect a blockage, as taught by Locke. Locke teaches the pressure sensor is beneficial because cost, weight, and power consumption are minimized is through the use of only one sensor to measure pressure. As previously mentioned, traditional systems typically use two pressure sensors, one to measure pressure at the tissue site and one to measure pressure at the reduced pressure source. However, the elimination of the pressure sensor measuring pressure at the reduced pressure source allows significant reductions in the amount of electronic circuitry required and also the amount of power consumed by the system (see Paragraph [0095]).
Regarding Claim 17, Modified Hall teaches all of the limitations of claim 16 and Hall further teaches coupling the filter (42) to the secondary conduit (30) and controllably leaking the air into the secondary conduit via the filter (control of bleed rate may be achieved by control of the area of the filter through which bleed air may be admitted, see Paragraph [0018]-[0019]).
Regarding Claim 18, Modified Hall teaches all of the limitations of claim 16 and Locke further teaches
comparing the negative pressure at the pressure indicator to one or more pressure thresholds (controller 170 determines a responsiveness of the actual reduced pressure at tissue site 105, as measured by pressure sensor 155, to an increase in the generated reduced pressure from reduced pressure source 110, see Paragraph [0067] and [0074]); and
generating an alarm based on the negative pressure at the pressure indicator relative to one or more pressure thresholds (controller 170 directs indicator 180 to emit a signal in response to the actual reduced pressure at tissue site 105, as measured by pressure sensor 155, being nonresponsive to increasing the generated reduced pressure, see Paragraph [0068]).
Claims 5 and 8-9 is rejected under 35 U.S.C. 103 as being unpatentable over Hall, Karpowicz, and Locke as applied to claim 1 above, and further in view of Askem et al. (WO 2013136181 A2), hereinafter referred to as “Askem”.
Regarding Claim 5, Modified Hall teaches all of the limitations as discussed above in claim 1. However, Modified Hall does not explicitly disclose wherein the pressure indicator is configured to physically deform or collapse responsive to the negative pressure at the pressure indicator.
Askem further teaches Askem teaches a reduce pressure wound dressing (see Abstract, Figure 66) comprising: a pressure indicator (pressure indicator 1270) fluidly coupled to a second chamber between the filter (the one or more pressure indicators can be supported in any desired location on the dressing, see Paragraph [0291] and individually formed, see Paragraph [0296]; therefore could be placed between the filter and dressing of Hall) and the dressing and configured to indicate a negative pressure in the second chamber (it would be understood that the negative pressure in the second chamber would be equal to the negative pressure in the dressing since they are fluidly connected); and wherein the pressure indicator (1270) is configured to physically deform or collapse responsive to the negative pressure at the pressure indicator (see Paragraph [0290]).
Modified Hall and Askem are analogous art because both teach a negative pressure 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 wound dressing of Modified Hall and further include wherein the pressure indicator is configured to physically deform or collapse responsive to the negative pressure at the pressure indicator, as taught by Askem. Askem teaches the pressure indicator permits the user to visually inspect the level of reduced pressure (see Paragraph [0294]).
Regarding Claim 8, Modified Hall teaches all of the limitations as discussed above in claim 7. However, Modified Hall does not explicitly disclose wherein the plurality of pressure thresholds comprise at least a low pressure threshold and a high pressure threshold such that the pressure indicator indicates whether the negative pressure at the pressure indicator is: within a first negative pressure range below the low pressure threshold; within a second negative pressure range between the low pressure threshold and the high pressure threshold; and within a third negative pressure range above the high pressure threshold.
Askem teaches a reduce pressure wound dressing (see Abstract, Figure 66) comprising: a pressure indicator (pressure indicator 1270) fluidly coupled to a second chamber between the filter (the one or more pressure indicators can be supported in any desired location on the dressing, see Paragraph [0291] and individually formed, see Paragraph [0296]; therefore could be placed between the filter and dressing of Hall) and the dressing and configured to indicate a negative pressure in the second chamber (it would be understood that the negative pressure in the second chamber would be equal to the negative pressure in the dressing since they are fluidly connected); and wherein the plurality of pressure thresholds comprise at least a low pressure threshold and a high pressure threshold (a depressed or collapsed position when a threshold level of reduced pressure is present under the overlay and an extended or inflated position when no pressure or less than the threshold pressure is present under the overlay, see Paragraph [0295]) such that the pressure indicator indicates whether the negative pressure at the pressure indicator is:
within a first negative pressure range below the low pressure threshold (an extended or inflated position when no pressure or less than the threshold pressure is present, see Paragraph [0295]);
within a second negative pressure range between the low pressure threshold and the high pressure threshold (the pressure indicators 1270 can also define intermediate positions, see Paragraph [0295]); and
within a third negative pressure range above the high pressure threshold (a depressed or collapsed position when a threshold level of reduced pressure is present, see Paragraph [0295].
Modified Hall and Askem are analogous art because both teach a negative pressure 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 pressure indicator of Modified Hall and further include wherein the pressure indicators has a plurality of pressure thresholds comprising at least a low pressure threshold and a high pressure threshold such that the pressure indicator indicates whether the negative pressure at the pressure indicator is: within a first negative pressure range below the low pressure threshold; within a second negative pressure range between the low pressure threshold and the high pressure threshold; and within a third negative pressure range above the high pressure threshold, as taught by Askem. Askem teaches the device is configured to provide a visual indication one or more conditions or parameters of the dressing, such as pressure (see Paragraph [0017]).
Regarding Claim 9, Modified Hall teaches all of the limitations as discussed above in claim 8 and Askem further teaches wherein each of the negative pressure ranges corresponds to a different color visible on the pressure indicator (any of the pressure indicators disclosed herein can have two or more different colors to help a user better visualize the position of the indicator, see Paragraph [0311]) such that the pressure indicator indicates:
a first color when the negative pressure at the pressure indicator is within the first negative pressure range (a first colored ring 1432 could be positioned around the protrusion 1433, and the protrusion 1433 can have a similarly colored top surface such that, when the protrusion ) is collapsed, the color of the top 1434 of the protrusion 1433 matches the color surrounding the protrusion so that it is clear that the protrusion is collapsed, see Paragraph [0311]);
a second color when the negative pressure at the pressure indicator is within the second negative pressure range (When less than a sufficient amount of reduced pressure is exerted on the overlay such that the protrusion 1433 extends away from the cover of the overlay, a different colored portion of the protrusion can contrast with the color surrounding the overlay to provide a clear indication to a user that the protrusion 1433 is extended and that a less than optimal amount of reduced pressure is present under the overlay, see Paragraph [0311]; and
a third color when the negative pressure at the pressure indicator is within a third negative pressure rang e(any of the pressure indicators disclosed herein can have two or more different colors to help a user better visualize the position of the indicator, see Paragraph [0311]; it would be reasonable to have a third color indicative of a third state of negative pressure, i.e. when pressure indicator is depressed into the dressing).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hall, Karpowicz and Locke as applied to claim 11 above, and further in view of Coulthard et al. (US 20120109083 A1), hereinafter referred to as “Coulthard”.
Regarding Claim 12, Modified Hall teaches all of the limitations as discussed above in claim 11. However, Modified Hall does not explicitly teaches wherein the pressure indicator comprises a wireless communications interface and is configured to transmit the alarm to an external system or device via the wireless communications interface.
Coulthard teaches dressing for providing reduce pressure to a tissue site on a patient are presented (see Abstract) wherein a pressure indicator (138) comprises a wireless communications interface (the first processor 118 may transmit the pressure message signal via the first RFID antenna 114 to the RFID reader 112. After arriving at the RFID reader 112, the pressure message signal is delivered to the second processor 128., see Paragraph [0056]) and is configured to transmit the alarm to an external system or device via the wireless communications interface (an alarm signal is created by the base unit 110 or by the wireless, reduced-pressure pump 108. The alarm may be a separate audible device, visual alarm, or the micro-pump 116 may function at a different frequency range, e.g., lower, to make an audible noise for the alarm, see Paragraph [0057]).
Modified Hall and Coulthard are analogous art because all teach a negative pressure 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 pressure indicator of Modified Hall and further include wherein the pressure indicator comprises a wireless communications interface and is configured to transmit the alarm to an external system or device via the wireless communications interface, as taught by Coulthard. Coulthard teaches pressure sensing device 138 may prepare a pressure message signal to communicate a measurement of the pressure at the tissue site for further processing by the first processor to develop a pump control signal for activating or deactivating the micro-pump as may be needed (see Paragraph [0056]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 13, and 16 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 12/12/2025 have been fully considered but they are not persuasive.
Specifically Applicant argues the double patenting rejections are rendered moot by at least the amendments. The examiner disagrees because even though the claims at issue are not identical, they are not patentably distinct from each other because all limitations in the current claims are found in the patented claims.
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 ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. 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.
PNG
media_image1.png
200
400
media_image1.png
Greyscale
/PHILIP R WIEST/Primary Examiner, Art Unit 3781