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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Long; Justin Alexander et al. (US 20220087871 A1, published earlier as WO 2020159677 A1).
Regarding claim 1, Long discloses a tissue interface for use in an abdominal cavity (¶ [0002], abdominal negative pressure therapy systems; ¶ [0027] FIG. 1 is a simplified functional block diagram of an example embodiment of a therapy system 100; ¶ [0029], As illustrated in the example of FIG. 1, the dressing 110 may comprise or consist essentially of a tissue interface 120, a cover 125, or both in some embodiments; ¶ [0068] FIG. 7 is a schematic view of an example of the tissue interface 120 applied to a tissue site that comprises an abdominal cavity 705);
the tissue interface comprising: a first contact layer comprising a first plurality of perforations (¶ [0057], FIG. 4, the tissue interface 120 generally includes a first contact layer 405, a second contact layer 410, and a spacer layer 415 … For example, as illustrated in FIG. 4, the first contact layer 405 and the second contact layer 410 may have fenestrations 420);
a second contact layer comprising a second plurality of perforations (¶ [0057], FIG. 4, the tissue interface 120 generally includes a first contact layer 405, a second contact layer 410, and a spacer layer 415 … For example, as illustrated in FIG. 4, the first contact layer 405 and the second contact layer 410 may have fenestrations 420);
a spacer layer disposed between the first contact layer and the second contact layer (¶ [0057], FIG. 4, the tissue interface 120 generally includes a first contact layer 405, a second contact layer 410, and a spacer layer 415; ¶ [0058], The spacer layer 415 may be a flexible foam in some examples); and
a plurality of location tags configured to be located by an identifier tool and to be positioned in a plurality of treatment areas within the abdominal cavity (¶ [0061] FIG. 5 also illustrates a plurality of sensors 530 that may be associated with tissue interface 120 of FIG. 4. … the sensors 530 are positioned in different regions, zones, or areas within the abdominal cavity; ¶ [0072] FIG. 8 … The sensor 530 may comprise a temperature sensor that is a component of either the pressure sensor 816 or the humidity sensor 818. The sensor 530 is capable of two-way wireless communication with therapy device 800, which may be, for example, an iPad, a PC, or another similar device; ¶ [0079], Once the tissue interface 120 is in place, the operator registers in 1010 the locations or regions of the sensors 530A-530F in the abdominal cavity).
Long teaches all features of claim 1 in a single embodiment. Long exchanges the labels “first” and “second” for the contact layers but otherwise discloses all the same physical elements and their arrangements and functions.
Regarding claim 12, Long discloses a tissue interface kit (¶ [0002], [0027] FIG. 1 … system 100; ¶ [0029], tissue interface 120; ¶ [0068] FIG. 7 … tissue interface 120 applied to a tissue site that comprises an abdominal cavity 705);
comprising: a tissue interface (¶ [0029], FIG. 1, the dressing 110 may comprise or consist essentially of a tissue interface 120, a cover 125, or both in some embodiments);
comprising: a first contact layer comprising a first plurality of perforations; a second contact layer comprising a second plurality of perforations; a spacer layer disposed between the first contact layer and the second contact layer (¶ [0057], FIG. 4, the tissue interface 120 generally includes a first contact layer 405, a second contact layer 410, and a spacer layer 415 … For example, as illustrated in FIG. 4, the first contact layer 405 and the second contact layer 410 may have fenestrations 420); and
a plurality of location tags disposed between the first contact layer and the second contact layer and configured to be positioned in a plurality of treatment areas within an abdominal cavity; and an identifier tool configured to sense a location of one of the plurality of location tags of the tissue interface at each of the treatment areas (¶ [0061] FIG. 5 also illustrates a plurality of sensors 530 that may be associated with tissue interface 120 of FIG. 4. … the sensors 530 are positioned in different regions, zones, or areas within the abdominal cavity; ¶ [0072] FIG. 8 … The sensor 530 may comprise a temperature sensor that is a component of either the pressure sensor 816 or the humidity sensor 818. The sensor 530 is capable of two-way wireless communication with therapy device 800, which may be, for example, an iPad, a PC, or another similar device; ¶ [0079], Once the tissue interface 120 is in place, the operator registers in 1010 the locations or regions of the sensors 530A-530F in the abdominal cavity).
Regarding claim 19, Long discloses a method of placing a tissue interface into an abdominal cavity (claim 11. A method for applying negative-pressure therapy to an abdominal cavity; ¶ [0002], [0005] New and useful systems, apparatuses, and methods for remote monitoring in a negative-pressure therapy environment; ¶ [0027] FIG. 1 … system 100; ¶ [0029], tissue interface 120; ¶ [0068] FIG. 7 … tissue interface 120 applied to a tissue site that comprises an abdominal cavity 705);
comprising: inserting the tissue interface into the abdominal cavity (¶ [0068] FIG. 7 … tissue interface 120 applied to a tissue site that comprises an abdominal cavity 705);
the tissue interface comprising: a first contact layer comprising a first plurality of perforations; a second contact layer comprising a second plurality of perforations; a spacer layer disposed between the first contact layer and the second contact layer (¶ [0057], FIG. 4, the tissue interface 120 generally includes a first contact layer 405, a second contact layer 410, and a spacer layer 415 … For example, as illustrated in FIG. 4, the first contact layer 405 and the second contact layer 410 may have fenestrations 420); and
a plurality of location tags disposed between the first contact layer and the second contact layer; locating, with an identifier tool, each location tag of the plurality of location tags to determine an orientation of the tissue interface in the abdominal cavity (¶ [0061] FIG. 5 also illustrates a plurality of sensors 530 that may be associated with tissue interface 120 of FIG. 4. … the sensors 530 are positioned in different regions, zones, or areas within the abdominal cavity; ¶ [0072] FIG. 8 … The sensor 530 may comprise a temperature sensor that is a component of either the pressure sensor 816 or the humidity sensor 818. The sensor 530 is capable of two-way wireless communication with therapy device 800, which may be, for example, an iPad, a PC, or another similar device; ¶ [0079], Once the tissue interface 120 is in place, the operator registers in 1010 the locations or regions of the sensors 530A-530F in the abdominal cavity); and
adjusting the orientation of the tissue interface to place the tissue interface in a plurality of treatment areas within the abdominal cavity (¶ [0048] In operation, the tissue interface 120 may be placed within, over, on, or otherwise proximate to a tissue site. If the tissue site is a wound, for example, the tissue interface 120 may partially or completely fill the wound, or it may be placed over the wound; ¶ [0062], Alternatively, the sensors 530 may be removably attached to the spacer layer 415, thereby enabling the positions of the sensors 530 to be customized by moving the sensors 530 to target specific zones in the abdominal cavity).
Regarding claims 2-3, 5-11 and 13-17, Long discloses a tissue interface, kit and method wherein the spacer layer comprises a central portion and a plurality of appendages radiating from the central portion and configured to extend to a plurality of zones within the abdominal cavity (¶ [0058], In the example of FIG. 4, the spacer layer 415 has a star profile having a plurality of appendages, such as spacer legs 425, coupled to and radiating from a central body 430);
wherein the plurality of location tags are disposed between the plurality of appendages of the spacer layer (¶ [0062], In still other embodiments, the sensors 530 may not be mounted on spacer layer 415 at all but may instead, be fixedly or removably attached between the spacer legs 425, such as in one of more of the flow paths 520);
wherein each location tag of the plurality of location tags is encoded with a unique identifier (¶ [0078] FIG. 9 … Each of the sensors 530A-503F comprises a unique sensor identifier (ID) value that enables therapy device 800 to determine the identity of each sensor 530A-530F and to establish a dedicated bi-directional communication link to each sensor 530A-530F. For example, sensor 530A ID may be a unique binary value associated with sensor 530A, sensor 530B ID may be a unique binary value associated with sensor 530B, and so forth);
wherein the plurality of location tags are disposed between the first contact layer and the second contact layer and isolated from the abdominal cavity by the first contact layer and the second contact layer (¶ [0062] In the exemplary embodiment in FIG. 5, the sensors 530 are mounted on the spacer layer 415; ¶ [0067], In the exemplary embodiment in FIG. 6, the sensors 530 are mounted at various spaced-apart points of the spacer layer 415; ¶ [0069] In the example of FIG. 7 … A plurality of sensors 530 are disposed on the surface of spacer layer 415, beneath second contact layer 410);
wherein the identifier tool is configured to locate each location tag of the plurality of location tags separately from another location tag of the plurality of location tags (¶ [0078] FIG. 9 … Each of the sensors 530A-503F comprises a unique sensor identifier (ID) value that enables therapy device 800 to determine the identity of each sensor 530A-530F);
wherein the identifier tool is configured to locate one of the location tags of the plurality of location tags when the identifier tool is within a sensing distance thereof (¶ [0073], The wireless communication chip in wireless communications module 822 may comprise an integrated device that implements Bluetooth® Low Energy wireless technology);
wherein the plurality of location tags are further configured to collect treatment data associated with the plurality of treatment areas within the abdominal cavity; wherein the treatment data comprises at least one of a pressure in the abdominal cavity, a temperature in the abdominal cavity, a pH in the abdominal cavity, or a presence of fluid in the abdominal cavity (¶ [0072] FIG. 8 … The sensor 530 may comprise a housing 810 that contains a circuit board (not shown) on which are mounted a pressure sensor 816, a humidity sensor 818, a pH sensor 820, a front-end amplifier 821, a communications module 822, and a power source 824. The sensor 530 may comprise a temperature sensor that is a component of either the pressure sensor 816 or the humidity sensor 818);
wherein the plurality of location tags are configured to communicate the treatment data with the identifier tool (¶ [0072], In some embodiments, the therapy device 800 may be a stand-alone device that simply monitors sensors 530 and displays values to an operator. In other embodiments, therapy device 800 may communicate with controller 130 to transmit the measured pressure, humidity, and pH to controller 130);
wherein the identifier tool comprises a handheld device comprising a locator and an indicator (¶ [0008], The system may include a wireless transceiver in some examples, which may to a tablet device or smartphone; ¶ [0061], The sensors 530 may be capable of transmitting and receiving signals wirelessly, which can enable the sensors to be remotely monitored and controlled by an external device (e.g., iPad or similar tablet device); ¶ [0072], The sensor 530 is capable of two-way wireless communication with therapy device 800, which may be, for example, an iPad, a PC, or another similar device);
wherein the indicator is configured to actuate when the locator is within a sensing distance of one of the location tags of the plurality of location tags (¶ [0073], The wireless communication chip in wireless communications module 822 may comprise an integrated device that implements Bluetooth® Low Energy wireless technology);
wherein the identifier tool comprises a smart phone configured to communicate with each location tag of the plurality of location tags (¶ [0008], The system may include a wireless transceiver in some examples, which may to a tablet device or smartphone; ¶ [0072], The sensor 530 is capable of two-way wireless communication with therapy device 800, which may be, for example, an iPad, a PC, or another similar device);
wherein the identifier tool is configured to display the treatment data of one of the location tags of the plurality of location tags when the identifier tool is within a sensing distance thereof (¶ [0079], Once the tissue interface 120 is in place, the operator registers in 1010 the locations or regions of the sensors 530A-530F in the abdominal cavity. In this manner, the parameter values registered by the sensors 530A-530F may be associated with specific regions within the abdominal cavity; ¶ [0085] Temperature—In one variant, the therapy system can be configured to determine the temperature at multiple discrete points in the abdominal cavity by use of remote temperature sensors in sensors 530. This can be particularly useful as multiple, discretely-located temperature sensors are able to form a de facto temperature gradient field identifying any higher temperatures or potential sources and locations of infection. This can even be presented via a graphic on the therapy device 800 as a field thus helping the operator locate the zone or area of potential intra-abdominal infection).
Regarding claim 20, Long further discloses collecting treatment data associated with the abdominal cavity from each location tag of the plurality of location tags using the identifier tool (¶ [0008], The system may include a wireless transceiver in some examples, which may to a tablet device or smartphone; ¶ [0072], The sensor 530 is capable of two-way wireless communication with therapy device 800, which may be, for example, an iPad, a PC, or another similar device);
locating a unique identifier of each of the plurality of location tags at each of the plurality of treatment areas using the identifier tool (¶ [0079], Once the tissue interface 120 is in place, the operator registers in 1010 the locations or regions of the sensors 530A-530F in the abdominal cavity);
assigning the treatment data to each of the plurality of treatment areas using the unique identifier; and outputting, with the identifier tool, the treatment data at each of the plurality of treatment areas (¶ [0085], the therapy system can be configured to determine the temperature at multiple discrete points in the abdominal cavity by use of remote temperature sensors in sensors 530 … to form a de facto temperature gradient field).
Since Long displays a temperature gradient field, this necessarily requires that the identifier tool uses both the unique identifier and treatment data from each tag located at each of the plurality of treatment areas. In other words, without a combination of both unique IDs, location data and treatment data, the tool could not produce a heatmap.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Long; Justin Alexander et al. (US 20220087871 A1) in view of Duesterhoft; Paul et al. (US 20130271278 A1).
Regarding claim 4, Long discloses a plurality of location tags that communicate wirelessly (¶ [0073], The wireless communication chip in wireless communications module 822 may comprise an integrated device that implements Bluetooth® Low Energy wireless technology … the nRF51822 chip available from Nordic Semiconductor).
Long does not explicitly disclose NFC devices. Duesterhoft discloses a system for monitoring a wound dressing (¶ [0004], [0058], appurtenance 120; ¶ [0065] The appurtenances 120 described herein can be useful in conjunction with an affixed wound dressing as a combination unit 125);
comprising a tag, wherein the tag is a near field communication (NFC) device (¶ [0081], The at least one transmitter included in the appurtenance 120 can include a near field communication (NFC) device. The appurtenance 120 can include a transmission unit. The transmission unit can include a transmitter and a receiver. The transmission unit can include an RFID unit. The transmission unit can include a near field communication (NFC) device; ¶ [0092], A local unit 540 can include a radio-frequency identification (RFID) receiver. A local unit 540 can include a near field communication (NFC) device; ¶ [0109], US Patent Application No. 2009/0243813 to Smith at al., titled "Wireless Programming of Non-Volatile Memory with Near-Field UHF Coupling," … incorporated herein by reference).
Duesterhoft transfers information with a widely known wireless protocol that consumes very low energy. One would be motivated to modify Long with Duesterhoft’s NFC device since Long suggests to use other wireless protocols (¶ [0067], The sensors 530 may be wireless-capable sensors; ¶ [0073], The wireless communications module 822 may be implemented with other wireless technologies suitable for use in the medical environment). Therefore, it would have been obvious to modify Long with Duesterhoft’s NFC device in order to transmit data with another low-energy protocol.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Long; Justin Alexander et al. (US 20220087871 A1).
Regarding claim 18, Long discloses a kit wherein each location tag has a unique identifier, and the identifier tool is configured to detect the unique identifier (¶ [0078] FIG. 9 … Each of the sensors 530A-503F comprises a unique sensor identifier (ID) value that enables therapy device 800 to determine the identity of each sensor 530A-530F and to establish a dedicated bi-directional communication link to each sensor 530A-530F);
when the identifier tool is within a sensing distance thereof (¶ [0073], Bluetooth® Low Energy wireless technology).
Long does not explicitly configure the identifier tool to display the unique identifier of one of the location tags of the plurality of location tags. However, Long discloses that the identifier tool receives unique identifiers as binary values (¶ [0078]), and that the tags’ locations form a map or graphical layout (¶ [0085], the therapy system can be configured to determine the temperature at multiple discrete points … multiple, discretely-located temperature sensors are able to form a de facto temperature gradient field).
Long also requires an operator to register the tags’ locations during a setup phase (¶ [0079], Once the tissue interface 120 is in place, the operator registers in 1010 the locations or regions of the sensors 530A-530F in the abdominal cavity). Here, Long suggest a need to confirm each tag’s unique binary identifier. A skilled artisan would have been able to modify Long’s identifier tool by adding a confirmation or query feature where the operator can check each tag’s ID. For example, during the setup phase, the smartphone app can display each tag’s ID along with other parameters.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Duesterhoft; Paul et al. US 20130274629 A1
Allin; Boyd D. et al. US 20140298927 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights