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 .
Response to Amendment
The amendment filed 2/17/2026 has been entered: Claims 1-12 and 14-30 are pending in the present application. Claims 1, 6, 10, 15, 19, and 22-23 are currently amended. Claims 1-12 and 14-30 are examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12, 14-18, and 19-26 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.
With respect to claims 1-12 and 14-18:
Collinson remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention.
Previously uncited portions of Collinson are being introduced in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claim 1.
With respect to claims 19-26:
Collinson remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention.
Ruchti is being introduced as a secondary reference in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claim 19.
Armstrong, Allen, and Duesterhoft remain in the present rejection for disclosing and/or rendering obvious the limitations of the claims.
Applicant's arguments with respect to claims 28 and 29 have been fully considered but they are not persuasive.
Applicant argues the rejection of claim 28 refers to elements not recited in claim 28. However, the rejection still covers all elements as required by Applicant’s claim. Thus, Applicant’s request for a new non-final office action is not persuasive.
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 19-27 are 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 19 now recites “usage data” of specifically the pneumatic pump, and of additional particular elements (replacement processor, transceiver, etc.). Applicant’s specification does not provide support for particular usage data beyond being from the therapy unit (¶ 7 of Applicant’s specification).
Claims 20-27 are rejected via their dependency on claim 19.
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 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.
Claims 1-7, 11, 14-17, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Collinson et al. (US 2015/0182677 A1), in view of Armstrong et al. (US 2018/0308578 A1),
Regarding claim 1, Collinson teaches a system for treating a tissue site comprising:
an absorbent wound dressing (Fig. 1; Abstract and ¶s 111 and 115-120 describes absorbent layer 2110) comprising:
a tissue interface (¶ 106 describes wound packing material) configured to be positioned adjacent the tissue site (¶s 106-107), and
a cover (lower surface 2101) comprising:
a base layer (contact layer 2104) configured to be positioned adjacent the tissue site (¶ 107-112),
an absorbent member disposed over the base layer (absorbent layer 2110)
a cover sealing member disposed over the bas over the absorbent member (backing layer 2140) and
an adhesive layer positioned between the cover sealing member and the base layer and configured to couple the cover sealing member to the base layer and the tissue site (¶ 113 describes the contact layer comprising adhesive on upper and lower surfaces, the upper adhesive being configured to provide integrity to the dressing thus being configured to couple the cover sealing member to the base layer and the tissue site).
and therapy unit (therapy unit 150 in Figs. 1 and 2C), the therapy unit comprising a pneumatic pump configured to be fluidly coupled to the dressing (coupled via port 120; see ¶s 22, 39, and 105).
Collinson does not explicitly teach:
a first processor operatively coupled to the pneumatic pump, the first processor configured to receive data from the pneumatic pump and generate operational data of the pneumatic pump, and
a first transceiver operatively coupled to the first processor, the first processor and first transceiver configured to transmit operational data of the pneumatic pump to a remote device;
wherein the remote device comprises a second transceiver configured to receive the operational data transmitted by the first receiver, the second processor and the third transceiver configured to transmit the operational data of the pneumatic pump to a monitoring center,
In the same field of endeavor, Armstrong teaches a system for treating tissue comprising a wound dressing, fluid conduit, and therapy unit comprising a pump (Fig. 1; Abstract).
Armstrong also teaches a first processor operatively coupled to a pump (¶ 7 indicates the controller controls the negative pressure source; e.g. UI processor 310 or pump control processor 370 in Fig. 3), the processor configured to receive data from the pump and generate operational data of the pump (¶ 7 indicates recording operational a data; it is implicit this data must at some point be received from the pump); and
a first transceiver operatively coupled to the first processor (¶ 41 describes both wired and wireless capability using a transceiver such as antenna 340), the first processor and the first transceiver configured to transmit the operational data of the pump to a remote device (¶ 41; ¶ 7 also describes transmitting the operational data to a remote computer);
wherein the remote device comprises a second transceiver configured to receive the operational data transmitted by the first receiver (¶ 47 indicates the remote device can be in the form of a smartphone, which implicitly have several transceivers such as for Bluetooth, WIFI, or cellular communication; ¶ 41 indicates multiple wireless protocols including cellular connectivity and internet connectivity, as well as being used for compliance monitoring), and a third transceiver (¶s 47 and 41, as previously stated, a smart phone would implicitly have several transceivers to operate multiple wireless protocols), and a third transceiver configure to transmit the operational data to a monitoring center (¶ 47 also indicates the computer 410 communicates with a remote computer or server 440 via the cloud 430 and also using multiple remote computers which all comprise web interfaces; further, “the cloud” comprises a remote device itself implicitly requiring transceivers to send and receive data in which the computer 410 serves as the monitoring center).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Collinson to comprise the transceivers, processor, and remote device of Armstrong. Doing so would predictably allow for receiving, generating, processing, and transmitting operational data of the pump to remote device and monitoring center. Doing so would be advantageous in facilitating patient compliance and would allow for remote monitoring and therapy adjustment (¶ 41 of Armstrong).
Further, the limitations of “the first transceiver configured to transmit the operational data of the pneumatic pump to a remote device”, “a second transceiver configured to receive the operational data transmitted by the first transceiver, and a third transceiver configured to transmit the operational data to a monitoring center”, and the first transceiver “being further configured to receive the operational data of the pneumatic pump and a specifically-selected treatment protocol from the remote device” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2114. Thus, if a prior art structure is capable of performing the function recited the claim, then it meets the claim. In the instant case, the device of Collinson and Armstrong teaches all the structure as claimed, including the transceivers, and thus would be configured to transmit to a remote device and monitoring center as claimed (as the primary function of a transceiver is to transmit data).
Regarding claim 2, Collinson further teaches the absorbent wound dressing fluidly coupled to the therapy unit by a fluid conduit (Figs. 1 and 3B; Abstract and ¶s 13; ¶s 105 and 225 describe the conduit), the fluid conduit comprises a flexible non-woven material sealed between a plurality of occlusive layers (Fig. 35 shows conduit spacer layer 3520 between occlusive layers 3510 and 3540; ¶ 229 indicates polyethylene, ¶ 248 indicates the spacer layer can be made of a non-woven fabric; ¶ 225 indicates how the conduit of Fig. 35 may be used with any of the described wound dressings).
Regarding claim 3, Collinson further discloses the plurality of occlusive layers comprise polyurethane (¶ 228).
Regarding claim 4, Collinson further teaches a connection interface configured to fluidly connect the fluid conduit to the top of the absorbent wound dressing (Fig. 35; element 3541; ¶ 226).
Regarding claim 5, Collinson further teaches the conduit being low profile (Fig. 35) comprising a receiving end (at element 3541) and a transmitting end (at element 3522) separated by a length (i.e. the space between elements 3525/3541 and 3522), the low profile conduit further comprising a manifold comprising a plurality of fibers defining a plurality of fluid communication voids through the manifold (spacer, i.e. manifold, 3520 is comprised by fibers which for a plurality of fluid communication voids, as seen in Figs. 40a - 40b; ¶s 248 - 252).
Regarding claim 6, Collinson further teaches the fibers engaging one another when the conduit is exposed to a force and wherein the plurality fluid communication voids are adapted to provide fluid communication through the low profile conduit when exposed to force (¶s 229 and 249 indicate the material resists collapsing such that there is still space for effective transmission of negative pressure and fluids).
Regarding claim 7, Collinson further teaches a conduit interface adapted to be fluidly coupled to the receiving end of the low profile conduit (Fig. 3A, element 2150).
Regarding claim 11, Collinson further teaches the length of the fluid conduit does not include a tube (Fig. 35 shows the length of the conduit between the entry port 3541 and exit port 3522 does not include a tube, instead relying on the spacer material).
Regarding claim 14, Collinson further teaches the absorbent layer has a superabsorbent material (¶s 13, 15 and 115).
Regarding claim 15, Armstrong further teaches a battery supply (¶ 33 indicates an internal battery); wherein the first processor and the first transceiver are configured to transmit a status of the battery supply (¶ 44 describes how battery level can be monitored and wireless transmitted); wherein a second processor and the second transceiver are configured to receive the status of the battery supply and wherein the second processor and the display screen are configured to display alert on the display screen in response to the status of the battery supply indicating a charge level of the battery supply decreasing below a threshold (¶s 54, 57, and 61 describe how battery status is displayed; ¶ 47 indicates the remote device can be in the form of a smartphone, which implicitly has a display and processor, used for alarms and other operational data, which would include battery status as previously stated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified , the combination of Collinson, Armstrong, and Duesterhoft to specifically comprise the battery and second processor and transceiver of Armstrong. Doing so would thus comprise a battery supply wherein a second processor and second transceiver are configured to receive the status of the battery supply and wherein the second processor and the display screen are configured to display alert on the display screen in response to the status of the battery supply indicating a charge level of the battery supply decreasing below a threshold. Doing so would be obvious and have the advantage of allowing operation without a power jack (¶ 33 of Armstrong) and would serve to alert and inform a remote user of the battery level so the device can be charged.
Regarding claim 16, Armstrong further teaches the remote device comprising a user input (¶ 47 describes the remote device may be used to adjust therapy settings, and also describes laptops and smartphones, which implicitly have a user input; also see Fig. 6), wherein a second processor and second transceiver(the processor and transceiver are implicit to the devices described in ¶ 47) are configured to transmit a stop signal in response to a command received from the user input, wherein the first transceiver is configured to receive the stop signal, and wherein the first processor is configured to deactivate the pneumatic pump in response to the first transceiver receiving the stop signal (Fig. 6 and ¶s 58-61 describe how the pump is connected to a remote computer; ¶ 61 explicitly describes how user input in the form of unauthorized pump registration causes a pump exception action, which includes cycling the pump off).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified, the combination Collinson, Armstrong, and Duesterhoft to specifically comprise the second processor and second transceiver configured to transmit a stop signal in response to a command received from the user input, wherein the first transceiver is configured to receive the stop signal, and wherein the first processor is configured to deactivate the pneumatic pump in response to the first transceiver receiving the stop signal. Doing so would be obvious and have the advantage of allowing operation without a power jack (¶ 33 of Armstrong) and would serve to alert and inform a remote user of the battery level so the device can be charged.
Further, doing so would be obvious to enable wireless control of the device (e.g. ¶ 41 of Armstrong describes how wired and wireless connectivity are analogous; ¶ 30 describes a manual power button). In the instant case, the mobile device stop signal performs the same function as the manual power button. See MPEP 2106.05(a) which discusses computer improvements.
Regarding claim 17, Armstrong further teaches the remote device comprising a display screen (a display screen is implicit to the devices described in ¶ 47) and the display screen and second processor are configured to display an alert related to a fluid flow indicated by the operational data (¶ 47 indicates the remote device used for alarms; ¶ 28 gives canister full or disconnected conduit as example alarms, both of which are related to fluid flow).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified , the combination of Collinson, Armstrong, and Duesterhoft to specifically comprise the display screen of Armstrong. Doing so would have the advantage of allowing operation without a power jack (¶ 33 of Armstrong) and would serve to alert and inform a remote user of the battery level so the device can be charged (i.e. when used with the second processor, second transceiver, and battery supply of Armstrong).
Regarding claim 30, Collinson further teaches the absorbent wound dressing comprises:
a tissue interface configured to be positioned adjacent the tissue site (wound contact layer 210 in Fig. 3A; ¶ 107); and
a cover comprising:
a base layer configured to be positioned adjacent the tissue interface (transmission layer 2105);
an absorbent member disposed over the base layer (absorbent layer 2110);
a sealing member disposed over the absorbent member (backing layer 2140; ¶ 111); and
an adhesive layer configured to couple the sealing member to the base layer and the tissue site (adhesive sealing strips 210 in Fig. 2D; ¶ 58).
Claims 19-26, are rejected under 35 U.S.C. 103 as being unpatentable over Collinson, in view of Armstrong, Allen et al. (US 2012/0136325 A1), Duesterhoft et al. (US 2013/0271278 A1), and Ruchti et al. (WO 2011/075687 A1)
Regarding claim 19, Collinson teaches a system for treating a tissue site comprising an absorbent wound dressing (Fig. 1; Abstract) a fluid conduit (Fig. 35; ¶ 225), and a therapy unit comprising a pneumatic pump (¶s 22 and 39).
Collinson does not explicitly teach:
a first processor operatively coupled to the pneumatic pump, the first processor configured to receive data from the pneumatic pump and generate operational data of the pneumatic pump, and
a first transceiver operatively coupled to the first processor, the first processor and first transceiver configured to transmit operational data of the pneumatic pump to a remote device;
wherein the remote device comprises a second transceiver configured to receive the operational data transmitted by the first receiver, and a third transceiver, the second processor and the third transceiver configured to transmit the operational data of the pneumatic pump to a monitoring center,
coupling the pneumatic pump it to skin of a patient having the tissue site, or
receiving, at a replacement pneumatic pump, the transmitted usage data of the pneumatic pump, the replacement therapy unit comprising a replacement pneumatic pump, a replacement processor operatively coupled to the replacement pneumatic pump, and a replacement transceiver operatively coupled to the replacement processor.
In the same field of endeavor, Armstrong teaches a system for treating tissue comprising a wound dressing, fluid conduit, and pneumatic pump (Fig. 1; Abstract).
Armstrong also teaches a first processor operatively coupled to a pump (¶ 7 indicates the controller controls the negative pressure source; e.g. UI processor 310 or pump control processor 370 in Fig. 3), the processor configured to receive data from the pump and generate operational data of the pump (¶ 7 indicates recording operational a data; it is implicit this data must at some point be received from the pump); and
a first transceiver operatively coupled to the first processor (¶ 41 describes both wired and wireless capability using a transceiver such as antenna 340), the first processor and the first transceiver configured to transmit the operational data of the pump to a remote device (¶ 41; ¶ 7 also describes transmitting the operational data to a remote computer);
wherein the remote device comprises a second transceiver configured to receive the operational data transmitted by the first receiver (¶ 47 indicates the remote device can be in the form of a smartphone, which implicitly have several transceivers such as for Bluetooth, WIFI, or cellular communication; ¶ 41 indicates multiple wireless protocols including cellular connectivity and internet connectivity, as well as being used for compliance monitoring), and a third transceiver (¶s 47 and 41, as previously stated, a smart phone would implicitly have several transceivers to operate multiple wireless protocols).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Collinson to comprise the transceivers, processor, and remote device of Armstrong. Doing so would predictably allow for receiving, generating, processing, and transmitting operational data of the pump to remote device. Doing so would be advantageous in facilitating patient compliance and would allow for remote monitoring and therapy adjustment (¶ 41 of Armstrong) , and a third transceiver configure to transmit the operational data to a monitoring center (¶ 47 also indicates the computer 410 communicates with a remote computer or server 440 via the cloud 430 and also using multiple remote computers which all comprise web interfaces; further, “the cloud” comprises a remote device itself implicitly requiring multiple transceivers to send and receive data in which the computer 410 serves as the monitoring center).
The combination of Collinson and Armstrong still do not explicitly teach coupling the pneumatic pump to skin of a patient having the tissue site or receiving, at a replacement pneumatic pump, the transmitted usage data of the pneumatic pump, the replacement therapy unit comprising a replacement pneumatic pump, a replacement processor operatively coupled to the replacement pneumatic pump, and a replacement transceiver operatively coupled to the replacement processor.
Allen teaches a negative pressure wound dressing system (apparatus 100 in Fig. 1; Abstract) comprising an adhesive layer disposed on the pneumatic pump to couple the pneumatic pump to the skin of a patient (¶ 82 describes adhesive tapes or otherwise).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Collinson and Armstrong to comprise the adhesive layer of Allen. Doing so would thus comprise the adhesive layer configured to couple the pneumatic pump to the skin of a patient having a tissue site. Doing so would be advantageous in comfortably securing the pump assembly to the patient for improved portability (¶ 82 of Allen).
The combination of Collinson, Armstrong, and Allen still do not explicitly receiving, at a replacement pneumatic pump, the transmitted usage data of the pneumatic pump, the replacement therapy unit comprising a replacement pneumatic pump, a replacement processor operatively coupled to the replacement pneumatic pump, and a replacement transceiver operatively coupled to the replacement processor.
Duesterhoft discloses an electronically monitored wound dressing (Fig. 5; Abstract), thus being in the same field of endeavor, where the therapy unit and wound dressing are a combined unit that transmits wirelessly to a transceiver (dressing combination unit 125; ¶s 59-60 describe how the wound dressing and appurtenance may not be separable, and may be disposed of/replaced together; ¶ 89 describe the wireless communication between the wound dressing and a remote transceiver; Fig. 8) that is replaced and continues function (¶ 70).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified method of using the device of Collinson and Armstrong to replace the therapy unit as necessary. Doing so would also wherein the replacement therapy unit receives transmitted usage data of the therapy unit (as the replacement unit would need to function in the same way as the initial unit and Duesterhoft teaches two way communication). Doing so would be obvious to properly care for different types of wounds (¶ 70 of Duesterhoft).
The combination of Collinson, Armstrong, Allen, and Duesterhoft still do not explicitly the usage data being for the pneumatic pump, the replacement therapy unit comprising a replacement pneumatic pump, a replacement processor operatively coupled to the replacement pneumatic pump, and a replacement transceiver operatively coupled to the replacement processor.
In addressing the same problem as Applicant, the problem being informatic provisions for the ensuring of continuous care with medical devices, Ruchti teaches a medical system (Fig. 4; Abstract) which utilizes backups of the required patient specific variables such that the first medical system may be replaced with a second medical system (i.e. usage data; ¶s 6, 36, 46, 69).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Collinson, Armstrong, Allen, and Duesterhoft to transfer the all patient system variables to a replacement device, as taught by Ruchti. Doing so would thus comprise the usage data being for the pneumatic pump, the replacement therapy unit comprising a replacement pneumatic pump, a replacement processor operatively coupled to the replacement pneumatic pump, and a replacement transceiver operatively coupled to the replacement processor. Doing so would be advantageous in improved workflow, reducing user error, and enabling a desired therapy outcome (¶ 20 of Ruchti).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). As such, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti teaches all the claimed structure, and further teaches a method of treating a tissue site and transmitting and monitoring usage data as claimed.
Regarding claim 20, Armstrong further teaches the remote device comprising a user input (¶ 47 describes the remote device may be used to adjust therapy settings, and also describes laptops and smartphones, which implicitly have a user input; also see Fig. 6) to remotely control the therapy unit (¶ 47 describes adjusting therapy settings; Fig. 6 and ¶s 58-61 describe how the pump is connected to a remote computer to control the pump)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified , the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti to comprise a user interface to receive remote inputs to remotely control the therapy unit as taught by Armstrong. Doing so would be obvious and have the advantage of allowing a remote user to monitor and control the device, particularly for troubleshooting (¶s 47-48 of Armstrong).
Further, doing so would be obvious to enable wireless control of the device (e.g. ¶ 41 of Armstrong describes how wired and wireless connectivity are analogous). In the instant case, wirelessly controlling the device from a mobile device performs the same function as controlling the device locally. See MPEP 2106.05(a) which discusses computer improvements.
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). As such, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti teaches all the claimed structure, and further teaches a method of controlling the device remotely as claimed.
Regarding claim 21, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti substantially disclose the invention of claim 19.
As previously stated, Armstrong teaches using a remote device to transmit usage data from the therapy unit toa monitoring center (¶ 47 also indicates the computer 410 communicates with a remote computer or server 440 via the cloud 430 and also using multiple remote computers which all comprise web interfaces; further, “the cloud” comprises a remote device itself implicitly requiring multiple transceivers to send and receive data in which the computer 410 serves as the monitoring center).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Collinson to comprise the transceivers, processor, and remote device of Armstrong. Doing so would predictably allow for receiving, generating, processing, and transmitting operational data of the pneumatic pump to remote device and monitoring center. Doing so would be advantageous in facilitating patient
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). As such, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti teaches all the claimed structure, and further teaches a method of transmitting usage data as claimed.
Regarding claim 22, Armstrong further teaches remotely troubleshooting one or more identified issues with the therapy unit/pump or absorbent dressing based on the transmitted usage data (¶ 48 in particular; also see ¶ 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti to remotely troubleshoot issues with the therapy unit as taught by Armstrong. Doing so would be obvious to enable a third party to remotely correct issues with therapy.
Further, doing so would be obvious to enable wireless control of the device (e.g. ¶ 41 of Armstrong describes how wired and wireless connectivity are analogous; ¶ 57 describes general troubleshooting). Troubleshooting remotely achieves the same result as troubleshooting locally. See MPEP 2106.05(a) which discusses computer improvements.
Regarding claim 23, Collinson further teaches the method step of replacing the dressing (¶ 110). Further, the therapy units of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti would inherently replaceable.
Regarding claim 24, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti substantially disclose the invention of claim 23.
Collinson further teaches replacing the dressing after certain time periods, such as when the canister is full (¶ 110).
Duesterhoft further discloses an electronically monitored wound dressing (Fig. 5; Abstract) that is replaced every 3 days based on the direction of a caregiver and on the type of wound (¶ 70).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified method of using the device of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti to replace the therapy unit as necessary, such as every 3 days. Doing so would be obvious to properly care for different types of wounds (¶ 70 of Duesterhoft).
Regarding claim 25, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti substantially disclose the invention of claim 23.
Collinson further teaches replacing the dressing after certain time periods, such as when the canister is full (¶ 110).
Duesterhoft further discloses an electronically monitored wound dressing (Fig. 5; Abstract) that is replaced every 7 days based on the direction of a caregiver and on the type of wound (¶ 70).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti to replace the therapy unit as necessary, such as every 7 days (which falls within, and thus anticipates, the claimed range). Doing so would be obvious to properly care for different types of wounds (¶ 70 of Duesterhoft).
Regarding claim 26, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti substantially disclose the invention of claim 23.
Armstrong further teaches replacing portions of the therapy unit following a low battery status of the therapy unit (¶s 28, 57, and 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti to specifically comprise low battery alerts and replaceable battery of Armstrong. Doing so would be obvious and have the advantage of allowing operation without a power jack (¶ 33 of Armstrong).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). As such, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti teaches all the claimed structure, and further replacing the therapy unit as claimed.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Collinson, Armstrong, and Duesterhoft as applied to claim 5 above, and further in view of Braga et al. (US 2010/0324516 A1).
Regarding claim 8, the combination of Collinson, Armstrong, and Duesterhoft substantially discloses the invention of claim 5. Collinson further teaches the plurality of fibers comprise a plurality of horizontal fibers (¶s 250 and 252). They do not explicitly teach the fibers being oriented substantially in a longitudinal direction along the length of the low profile conduit.
In the same field of endeavor, Braga teaches a low-profile conduit (Fig. 3; ¶ 46) in which fibers are oriented substantially in a longitudinal direction along the length of the low profile conduit (Fig. 3, element 42; ¶ 49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the horizontal fibers of Collinson, Armstrong, and Duesterhoft to be oriented substantially in a longitudinal direction along the length of the low profile conduit. Doing so would predictably allow for analogous flow through the conduit and would be advantageous in encouraging flow in the direction of the fibers (recognized in ¶s 18 and 50 of Braga) and also to prevent collapsing of the conduit (¶ 49).
Regarding claims 9-10, Collinson further teaches the vertical and horizontal fiber layers may be used in conjunction with one another (¶ 248 indicates a top and bottom layer with different patterns). Thus, Collinson teaches a plurality of horizontal fibers (¶s 250 and 252) and a plurality of vertical fibers oriented substantially normal relative to the plurality of horizontal fibers (¶s 248 and 249 i.e. would also be substantially normal to the length of the low-profile conduit, as per claim 9),
wherein the plurality of longitudinal fibers and plurality of vertical fibers engage with one another when the low profile conduit is exposed to a force and wherein the plurality of fluid communication voids are adapted to provide fluid communication through the low profile conduit when exposed to force (¶ 248 indicate the two layers are engaged with one another; ¶s 229 and 249 indicate the material resists collapsing such that there is still space for effective transmission of negative pressure and fluids).
Collinson does not explicitly teach the plurality of horizontal, the plurality of longitudinal fibers being oriented in a longitudinal direction along the length of the conduit.
In the same field of endeavor, Braga teaches a low-profile conduit (Fig. 3; ¶ 46) in which a plurality of fibers are oriented substantially in a longitudinal direction along the length of the low profile conduit (Fig. 3, element 42; ¶ 49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the plurality of horizontal fibers of Collinson, Armstrong, and Duesterhoft to be oriented substantially in a longitudinal direction along the length of the low profile conduit. Doing so would thus comprise (claim 9) the plurality of vertical fibers oriented substantially normal relative to the length of the low-profile conduit, and also (claim 10) the plurality of longitudinal fibers oriented substantially in a longitudinal direction along the length of the low-profile conduit; and a plurality of vertical fibers oriented substantially normal relative to the plurality of longitudinal fibers. Doing so would predictably allow for analogous flow through the conduit and would be advantageous in encouraging flow in the direction of the plurality of fibers (recognized in ¶s 18 and 50 of Braga) and also to prevent collapsing of the conduit (¶ 49). Further, doing so would be obvious as Collinson recognizes using layers with different fiber orientations (¶ 248).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Collinson, Armstrong, and Duesterhoft as applied to claim 5 above, and further in view of Wu et al. (US 2013/0144230 A1).
Regarding claim 12, the combination of Collinson, Armstrong, and Duesterhoft substantially disclose the invention of claim 5. Collinson further teaches a first sealing member and a second sealing member (Fig. 35, elements 3510 and 3540). They do not explicitly teach the second sealing layer including an adhesive layer on an external, tissue-facing surface.
In the same field of endeavor, Wu teaches a wound therapy device with a low profile conduit (Fig. 5; Abstract) and an adhesive layer on an external tissue facing surface of the second layer (Fig. 5, element 110; ¶ 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second sealing member of Collinson, Armstrong, and Duesterhoft to comprise the adhesive layer of Wu. Doing so would predictably allow for the conduit to be secured to the body of a user or other areas. Doing so would be advantageous in preventing relative movement between the conduit and underlying skin surface (recognized in ¶ 41 of Wu).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable Collinson, Armstrong, and Duesterhoft as applied to claim 1 above, and further in view of Tam et al. (US 2016/0220175 A1).
Regarding claim 18, the combination does not explicitly disclose an integrated inductive coil adapted to provide a charge to a power supply of the therapy unit.
In the same field of endeavor, Tam teaches a patient monitoring system integrated with a wound dressing (Fig. 1; Abstract and ¶ 38) comprising a power supply rechargeable through induction (¶ 37).
it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Collinson, Armstrong, and Duesterhoft to comprise the wireless charging mechanism of Tam. Doing so would be advantageous to enable charging without the need for exposed electrical ports.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Collinson, Armstrong, Allen, Duesterhoft, and Ruchti as applied to claim 23 above, and further in view of Lloyd et al. (US 3,572,340 A).
Regarding claim 27, the combination of Collinson, Armstrong, Allen, Duesterhoft, and Ruchti substantially disclose the invention of claim 23.
The combination does not explicitly teach the therapy unit is exchanged without removing the absorbent dressing.
In the same field of endeavor, Lloyd teaches a wound dressing (Fig. 1; Abstract) in which the treatment unit is replaced regularly (Col. 9, line 2 - Col. 10, line 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified , the combination of Collinson, Armstrong, and Allen to specifically to replace the therapy unit without removing the dressing as taught by Lloyd. Doing so would be obvious and have the advantage of maintaining good aseptic conditions (Col. 9, line 2 - Col. 10, line 19 of Lloyd).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). As such, the combination of Collinson, Armstrong, and Lloyd teaches all the claimed structure, and further replacing the therapy unit as claimed.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable Armstrong et al. (US 2018/0308578 A1) in view of Allen.
Regarding claim 28, Armstrong teaches a therapy unit for treating a tissue site (Fig. 1; Abstract), comprising:
a negative-pressure source having a surface (¶s 7 and 21; Figs. 2A-C show the negative-pressure source in a housing with multiple surfaces), and
a processor operatively coupled to the negative-pressure source (¶ 7 indicates the controller controls the negative pressure source; e.g. UI processor 310 or pump control processor 370 in Fig. 3), the processor configured to:
receive input related to the delivery of negative pressure from the negative pressure source to the tissue site (¶ 7 indicates recording operational a data; it is implicit this data must at some point be received from the pump);
generate output information related to the delivery of negative pressure from the negative-pressure source to the tissue site (¶s 4 and 39-41 describe how the processors can generate and store data on memory), and
transmit the output information from the first transceiver of the therapy unit to a mobile device via a first network, the first network adapted to allow communications between the first transceiver of the therapy unit and a second transceiver of the mobile device (¶ 41 describes both wired and wireless capability using a transceiver such as antenna 340; ¶ 41 describes several mobile devices which would implicitly have a second transceiver as well as several networks; ¶ 7 also describes transmitting the operational data to a remote computer); and
receive the output information with the first transceiver of the therapy unit from the second transceiver of the mobile device via the first network (¶s 44, 47-50 describe how the computer in the form of a mobile device can be used to send data/software back to the pump assembly and that the processor downloads operational data)
wherein the mobile device is adapted to:
receive, at the second transceiver of the mobile device, the output information; display information related to the delivery of negative pressure from the negative-pressure source to the tissue site (¶ 47 indicates the remote device can be in the form of a smartphone, which implicitly have a display, and can be used to monitor and control the pump and device), and
collect instructions from a user related to operational parameters of the therapy unit (¶ 47 specifically indicates adjusting therapy settings from the remote device) and
Armstrong does not explicitly teach an adhesive layer and coupling the therapy unit to skin of a patient having the tissue site or the mobile device adapted to transmit the output information from the third transceiver of the mobile device to a therapy replacement negative-pressure source.
Allen teaches a negative pressure wound dressing system (apparatus 100 in Fig. 1; Abstract) comprising an adhesive layer disposed on the therapy unit to couple the therapy unit to the skin of a patient (¶ 82 describes adhesive tapes or otherwise).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Collinson and Armstrong to comprise the adhesive layer of Allen. Doing so would thus comprise the adhesive layer configured to couple the therapy unit to the skin of a patient having a tissue site. Doing so would be advantageous in comfortably securing the pump assembly to the patient for improved portability (¶ 82 of Allen).
Further, the limitations of “the mobile device adapted to…” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2114. Thus, if a prior art structure is capable of performing the function recited the claim, then it meets the claim. In the instant case, the device of Armstrong and Allen teaches all the structure as claimed, including the mobile device and transceivers, and thus would be configured to transmit to a mobile device and monitoring center as claimed.
Regarding claim 29, Armstrong further teaches the input information comprises the instructions from the user communicated from the mobile device (¶ 47 indicates the mobile device used to change therapy settings).
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 ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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