DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed April 21, 2026.
Status of Claims
1. Claims 1-7, 9, 11 and 12 are pending and currently under consideration for patentability.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on April 21, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-7, 9, 11 and 12 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. Braga et al. (US PGPUB 2009/0240218 A1) is newly presented as the primary reference of rejection, below. Hartwell and the additional prior art references of the most recent Office action remain in the present rejection as secondary references.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claim(s) 1-4, 6, 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Braga et al. (US PGPUB 2009/0240218 A1) in view of Hartwell et al. (US PGPUB 2019/0282738 A1).
5. With regard to claim 1, Braga discloses a canister (collection canister, 118) for negative pressure wound therapy (wound therapy system, 100; abstract; [0043]; [0047]; [0052]; Figs. 1A, 1B), the canister (118) comprising: a housing (un-numbered walls of 118) defining an interior volume (internal chamber, 176) for storing fluid aspirated from a wound during provision of negative pressure wound therapy ([0058]), the housing (of 118) sized to be removably coupled (via “insertion of first coupling segment or latch 124 within locking slot 130”) with a pump assembly (subatmospheric pressure mechanism, 104 including vacuum source, 164; [0061-0062]); and an electronic circuitry (“electronic, electrical and pneumatic components”; actuator or motor, 166 and power source, 168) at least partially enclosed by the housing (partially enclosed by top wall of 118; Fig. 1B; [0054]).
However, while Braga suggests that alternate embodiments may include complimentary sensors for detecting attachment which in turn signal control circuitry to activate a power source ([0100]), Braga fails to explicitly disclose that the electronic circuitry comprising: a memory configured to store data related to one or more parameters of the canister; a transceiver configured to wirelessly communicate with the pump assembly; and a processing circuitry connected to the memory and the transceiver, the processing circuitry configured to store the data in the memory and cause the transceiver to provide at least some of the data stored in the memory responsive to a request from the pump assembly.
Within the same field of endeavor, namely negative pressure wound therapy, Hartwell discloses a negative pressure wound therapy device (100; abstract; Figs. 1-4; [0032]; [0037]), the device comprising: a housing (defined by cover layer, 113 and “wound contact layer”, not shown) defining an interior volume (including absorbent material, 112) for storing fluid aspirated from a wound during provision of negative pressure wound therapy ([0032]; [0037]), the housing (113) coupled with a pump assembly (“negative pressure source”; [0032]; [0034]); and an electronic circuitry (within electronics area, 161; Fig. 1; also see electrical schematics, 300; Fig. 3) at least partially enclosed by the housing (113 and contact layer; [0033-0034]), the electronic circuitry comprising: a memory (memory, 350) configured to store data related to one or more parameters of the canister (“remaining fluid capacity of the canister”; [0062]; [0067]; [0075]); a transceiver (wireless communications processor, 320; Fig. 3) configured to wirelessly communicate with the pump assembly (via wireless communications device or WCD, 210; Fig. 2; [0048]; [0071-0072]; [0076]); and a processing circuitry (interface processor or controller, 310; “processors… can include logic circuitry”; [0093]) connected to the memory (350) and the transceiver (320; Fig. 3), the processing circuitry (310) configured to store the data in the memory (350; [0066-0068]) and cause the transceiver (320) to provide at least some of the data stored in the memory (350) responsive to a request from the pump assembly (via 210; [0018]; [0049-0052]; [0075]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the electronic circuitry disclosed by Braga to include a memory, transceiver and processing circuitry, similar to that disclosed by Hartwell, in order to provide the pump assembly with wireless control and data storage, where the pump assembly is configured to receive operating data responsive to at least one of an occurrence of an event, an expiration of a time interval, or a request transmitted by the processing circuitry, and output the received operating data, as suggested by Hartwell in paragraphs [0004-0005].
6. With regard to claims 2-4, Braga, as modified by Hartwell above, discloses the electronic circuitry as required be claim 1. While Hartwell discloses that the memory (350) is further configured to store code for updating firmware or software of the pump assembly (“firmware and/or software upgrades”; [0086]; [0089]) and store an indication ([0060-0062]) for the pump assembly (of 220) to determine that firmware or software should be updated with the code and configured to be executed by the processing circuitry (310; [0086]; [0012-0014]; [0054]; [0067]; [0075]; [0089-0090]), Braga and Hartwell fail to explicitly disclose that the indication comprises a version of firmware of software stored in the memory.
However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the electronic circuitry disclosed by Braga in view of Hartwell to store a version of firmware of software indicator in the memory, in order to allow for a user or caregiver to be alerted or notified of a new version of firmware or software being available, as suggested by Hartwell in paragraph [0086].
7. With regard to claim 6, Braga, as modified by Hartwell above, discloses the electronic circuitry as required be claim 1. While Hartwell discloses that the data comprises canister capacity stored in the memory (350) for negative pressure wound therapy ([0012]; [0014]; [0054]; [0079]; [0089-0090]), Hartwell fails to explicitly disclose that the canister capacity is stored in the memory prior to the canister being used.
However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the electronic circuitry disclosed by Braga in view of Hartwell to store the canister capacity in the memory prior to the canister being used, in order for the size of canister to be known to the system prior to therapy, so that the remaining fluid capacity of the canister can be accurately determined, as suggested by Hartwell in paragraph [0062].
8. With regard to claim 9, Braga, as modified by Hartwell above, discloses the electronic circuitry as required be claim 1. Braga further discloses that the electronic circuitry further comprises a power source comprising a battery(168) configured to supply power to the pump assembly (164) and actuator/motor (166; Fig. 1B; [0054]; [0056]).
Additionally, Hartwell discloses that the electronic circuitry (300; within 161) further comprises a power source ([0034]; [0040]) configured to supply power to at least one of the memory (350), the transceiver (320), or the processing circuitry (310), and wherein the power source comprises one or more of a capacitor or a battery ([0062-0064]).
Accordingly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the power source disclosed by Braga in view of Hartwell to supply power to at least one of the memory, transceiver or processing circuitry, in order to power the system as a whole, with a reasonable expectation of success, as suggested by the power source disclosed by both Braga and Hartwell.
9. With regard to claim 12, Braga, as modified by Hartwell above, discloses the electronic circuitry as required be claim 1. Braga further discloses that alternate embodiments may include complimentary sensors for detecting attachment (indication data) which in turn signal control circuitry to activate a power source ([0100]).
Additionally, Hartwell discloses that the data comprises an indication (“dressing/canister capacity indicator”) that the canister is full (dressing/canister capacity and saturation level data; [0043]; [0062]), the indication ([0060]; [0062]) being stored responsive to a determination that a level of fluid aspirated from the wound has reached a threshold level over a duration of time (internal storage limit; [0074]; [0012-0014]; [0054]; [0067]; [0075]; [0089-0090]).
Accordingly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the data disclosed by Braga in view of Hartwell to be an indication that the canister is full, in order to provide an indication for the user or practitioner to remove and replace the full canister with a new canister which is also connectable through connection means with the housing of the control unit, as suggested by Braga in paragraph [0009].
10. Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Braga in view of Hartwell, as applied to claim 1 above, and further in view of Kim et al. (US PGPUB 2015/0304478 A1).
11. With regard to claim 5, while Hartwell discloses wherein the transceiver (320) is configured to communicate with the computing device (210; Figs. 2, 3; [0048]; [0071-0072]; [0076]), Braga and Hartwell fails to explicitly disclose that the transceiver is configured to communicate with the computing device using near field communication (NFC).
However, within the same field of endeavor (medical device information systems), Kim discloses a method and system for providing information related to medical devices (abstract; Fig. 4), wherein a transceiver is configured to communicate with a computing device (100) using near field communication ([0010]; [0040]; [0067]; [0069]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the means of wireless communication disclosed by Braga in view of Hartwell to be near field communication, as suggested by Kim, in order to utilize well-known means of short-range communication, as suggested by Kim in paragraph [0067], with a reasonable expectation of success.
12. Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Braga in view of Hartwell, as applied to claim 1 above, and further in view of Pan et al. (US PGPUB 2013/0267918 A1).
13. With regard to claim 7, Hartwell discloses that the data comprises a canister orientation (orientation/motion data) or canister fill status (canister capacity) determined during provision of negative pressure wound therapy and stored in the memory (350) during provision of negative pressure wound therapy ([0043]; [0062]).
However, Braga and Hartwell is silent in regard to the canister orientation comprising a flipped orientation determined during provision of negative pressure wound therapy, and wherein storing the flipped orientation in the memory prevents the canister from being used for further provision of negative pressure wound therapy.
In the same field of endeavor (negative pressure wound therapy), Pan discloses a negative pressure wound therapy pump with tilt and fill sensors (abstract; Figs. 1, 2, 8, 9) comprising a canister (20) and data comprises a canister orientation or canister fill status (via fill sensors, 38 and tilt sensor, 39) determined during provision of negative pressure wound therapy and stored in the memory (of microprocessor, 51) during provision of negative pressure wound ([0007-0008]; [0047-0051]), wherein the canister (20) orientation comprises a flipped orientation (“inappropriate orientation” or “not in upright position”) determined during provision of negative pressure wound therapy, and wherein storing the flipped orientation in the memory prevents the canister (20) from being used for further provision of negative pressure wound therapy ([0048-0052]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the canister orientation data disclosed by Braga in view of Hartwell to include a flipped orientation wherein storing the flipped orientation in the memory prevents the canister from being used for further provision of negative pressure wound therapy, similar to that disclosed by Pan, since orientation of the canister is highly critical to prevent fluids from being sensed by the fill sensor prior to being actually full, and such data would allow for operation of the vacuum pump to be terminated when the angle of tilt exceeds a certain allowed maximum, as suggested by Pan in paragraphs [0007-0008].
14. Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Braga in view of Hartwell, as applied to claim 1 above, and further in view of Casady et al. (US PGPUB 2015/0234995 A1).
15. With regard to claim 11, Braga and Hartwell are silent in regard to the data comprises a manufacturing date stored as read only data, wherein the manufacturing date facilitates a determination that shelf life of the canister has not been exceeded.
However, in the same field of endeavor (health care network systems), Casady discloses a real-time recall inventory matching system (abstract; Fig. 1; [0010-0012]; [0029-0032]) including data comprising a manufacturing date stored as read only data, wherein the manufacturing date facilitates a determination that shelf life (expiration date) of a medical product has not been exceeded ([0031]; [0035]; [0043]; [0047-0048]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the stored canister data disclosed by Braga in view of Hartwell to include manufacturing date facilitating determination of shelf life, similar to that disclosed by Casady, in order to utilize and store desirable manufacturer’s information regarding manufacturing date of the canister, so that users and healthcare providers can automatically receive expiration information for subsequent disposal and/or replacement, as suggested by Casady in paragraph [0031].
Conclusion
16. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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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.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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