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 05/22/2026 has been entered. Claims 1-2, 5-6 have been amended. Claim 21 is cancelled. Claims 1-20 remain pending in this application. Claims 9-20 are withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not Gordon in view of Hartwell for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made over Gordon in view of newly cited Locke.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. (Pub. No.: US 2020/0000983 A1) in view of Locke et al. (Pub. No.: US 2014/0005618 A1).
Regarding claim 1, Gordon discloses (fig. 1-12) a negative pressure therapy device (10/200, ¶ 0161) comprising:
A formed front layer (front moulding 232);
A pump (44/248) having a fluid inlet (see inlet connected to entry/suction port 30, 216) and a fluid outlet (see outlet connected to exhaust port 54/408) (¶ 0162);
A pressure transducer (pressure sensor 46/440) including a second port fluidly coupled to the fluid inlet of the pump (¶ 0162, ¶ 0175);
A formed rear layer (back moulding 234) configured to be coupled to the formed front layer to form an interior space having the pressure transducer and the pump disposed therein (¶ 0173);
An exhaust port (54/408) fluidly coupled to the fluid outlet of the pump (¶ 0162);
A negative-pressure port fluidly coupled to the fluid inlet of the pump (¶ 0162).
Gordon fails to disclose that the pressure transducer including a first port fluidly coupled to the ambient environment outside the negative-pressure therapy device; wherein the first port of the pressure transducer is fluidly coupled to the ambient environment by a fluid path isolated from the interior space.
Locke teaches (fig. 1, 3) a negative-pressure therapy device (system 100, abstract) and thus in the same field of endeavor comprising: a pressure transducer (first sensor 126) including a first port coupled to the ambient environment outside the negative-pressure therapy device (fig. 1A-1D, ¶ 0046) and a second port fluidly coupled to a fluid inlet of a pump (¶ 0046, second port is fluidly coupled to tissue site which is fluidly coupled to pump, fig. 3), wherein the first port of the pressure transducer is fluidly coupled to the ambient environment by a fluid path isolated from an interior space (fig. 1, ¶ 0046), wherein the pressure transducer is configured indicate a reduced pressure status (¶ 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure transducer of Gordon such that it includes a first port fluidly coupled to the ambient environment outside the negative-pressure therapy device; wherein the first port of the pressure transducer is fluidly coupled to the ambient environment by a fluid path isolated from the interior space, as taught by Locke, in order to provide a pressure sensor that indicates a reduced pressure status (Locke ¶ 0047).
Regarding claim 4¸ Gordon discloses a manifold (dressing 14) fluidly coupled to the pump, the pressure transducer, and the negative-pressure port (fig. 1-2, ¶ 0162).
Regarding claim 5, Gordon in view of Locke fail to disclose an ambient pressure conduit having a first end coupled with the first port and a second end coupled to the ambient environment, the second end of the ambient pressure conduit defining an atmospheric pressure measurement port.
However, Gordon discloses a conduit (444) having a first end coupled with the second port and a second end coupled to the fluid inlet of the pump, the second end of the conduit defining a measurement port (fig. 11, ¶ 0175), such conduit allowing for fluid communication (fig. 11, ¶ 0175).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure transducer of Gordon in view of Locke such that it includes an ambient pressure conduit having a first end coupled with the first port and a second end coupled to the ambient environment, the second end of the ambient pressure conduit defining an atmospheric pressure measurement port, as suggested by Gordon, as such conduits allow for fluid communication (fig. 11, ¶ 0175).
Regarding claim 6, Gordon discloses wherein:
The fluid outlet of the pump is fluidly coupled to the exhaust port by a fluid path that is isolated from the interior space (fig. 1-2); and
Wherein the fluid inlet of the pump and the negative pressure port are fluidly coupled to the interior space (see pressure relief valve 448, ¶ 0175).
Regarding claim 7, Gordon discloses wherein the fluid path between the fluid outlet and the exhaust port comprises a chamber (silencer system 50) fluidly coupled to the fluid outlet on a first end and to the exhaust port on a second end (¶ 0162).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gordon in view of Locke, as applied to claim 1 above, and further in view of Rodrigues (Pub. No.: US 2022/0168491 A1).
Regarding claim 2, Gordon in view of Locke fail to disclose wherein the formed front layer and the formed rear layer are formed from a flexible polymer film.
Rodrigues teaches (fig. 4A-4B) a negative-therapy device (electronics assembly 400, abstract) and thus in the same field of endeavor, comprising: formed front layer (flexible film 402); and a formed rear layer (plate 401), wherein the formed front layer and the formed rear layer are formed from a flexible polymer film (¶ 0094-¶ 0095) in order to allow the therapy device to be conformable when mounted on a dressing applied to a wound (¶ 0095).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the formed front layer and formed rear layer of Gordon in view of Locke such that they are formed from a flexible polymer film, as taught by Rodrigues, in order to allow the therapy device to be conformable when mounted on a dressing applied to a wound (Rodrigues ¶ 0095).
Claim(s) 3 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gordon in view of Locke, as applied to claim 1 and 7 above, and further in view of Askem et al. (Pub. No.: US 2018/0296397 A1).
Regarding claim 3, Gordon in view of Locke fail to disclose wherein the exhaust port and the fluid outlet are fluidly coupled to the interior space, the exhaust port configured to generate a back pressure to inflate the interior space.
Askem teaches (fig. 4) a negative-pressure therapy device (integrated wound dressing 400) and thus in the same field of endeavor comprising:
A formed front layer (cover layer 419);
A pump (416) having a fluid inlet and a fluid outlet (fig. 4, ¶ 0039);
A formed rear layer (first cover layer 434) configured to be coupled to the formed front layer to form an interior space (chamber 430) having the pump disposed therein (fig. 4);
An exhaust port (see location of filter 420) fluidly coupled to the fluid outlet of the pump (fig. 4, ¶ 0039);
A negative-pressure port (see location of filter 422) fluidly coupled to the fluid inlet of the pump (fig. 4, ¶ 0039);
Wherein the exhaust port and the fluid outlet are fluidly coupled to the interior space (¶ 0039, fig. 4), the exhaust port configured to generate a back pressure to inflate the interior space (¶ 0039) in order to provide a mechanism to drive moisture out of a dressing in an integrated pump/dressing device (¶ 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gordon in view of Locke such that the exhaust port and the fluid outlet are fluidly coupled to the interior space, the exhaust port configured to generate a back pressure to inflate the interior space, as taught by Askem, in order to provide a mechanism to drive moisture out of a dressing in an integrated pump/dressing device (Askem ¶ 0038).
Regarding claim 8, Gordon in view of Locke fail to disclose an outer rear layer disposed over the formed rear layer, the outer rear layer forming the chamber between the outer rear layer and the formed rear layer.
Askem teaches (fig. 4) a negative-pressure therapy device (integrated wound dressing 400) and thus in the same field of endeavor comprising:
A formed front layer (first cover layer 434);
A pump (416) having a fluid inlet (see location of filter 422) and a fluid outlet (see location of filter 421) (fig. 4, ¶ 0039);
A formed rear layer (optional layer 440) configured to be coupled to the formed front layer to form an interior space having the pump disposed therein (¶ 0039, fig. 4);
An exhaust port (see location of filter 420) configured to be coupled to the fluid outlet of the pump (fig. 4, ¶ 0039);
Wherein the fluid path between the fluid outlet and the exhaust port comprises a chamber (chamber 430) fluidly coupled to the fluid outlet on a first end and to the exhaust port on a second end (fig. 4, ¶ 0039); and
An outer rear layer (second cover layer 419) disposed over the formed rear layer (fig. 4), the outer rear layer forming the chamber between the outer rear layer and the formed rear layer (fig. 4, ¶ 0039);
The outer rear layer configured to allow for a mechanism to drive moisture of a dressing in an integrated pump/dressing device (¶ 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gordon in view of Locke such that it comprises an outer rear layer disposed over the formed rear layer, the outer rear layer forming the chamber between the outer rear layer and the formed rear layer, as taught by Askem, in order to provide a mechanism to drive moisture out of a dressing in an integrated pump/dressing device (Askem ¶ 0038).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yao et al. (Pub. No.: US 2012/0053541 A1) discloses a pressure transducer.
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 MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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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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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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