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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8 in the reply filed on 01/28/2026 is acknowledged.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/28/2026.
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 Hartwell (Pub. No.: US 2010/0280422 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) fluidly coupled to 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); and
A negative-pressure port fluidly coupled to the fluid inlet of the pump (¶ 0162).
Gordon fails to disclose that the pressure transducer is fluidly coupled to the ambient environment; and the device comprising an atmospheric pressure measurement port.
Hartwell teaches (fig. 10A) a negative-pressure therapy device (apparatus 400, abstract) and thus in the same field of endeavor, comprising:
A pump (402);
A pressure transducer (second pressure sensor 430) fluidly coupled to the ambient environment (via valve 432, ¶ 0071) and the pump (second pressure sensor 430 is fluidly coupled to pressure sensing conduit 424, “T” piece 420 and aspirant conduit 408 which is fluidly coupled to pump 402, ¶ 0071; and
An atmospheric pressure measurement port (characterized by valve 432, ¶ 0071);
The pressure transducer and atmospheric pressure measurement port being configured to indicate a blockage (¶ 0073).
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 such that the pressure transducer is fluidly coupled to the ambient environment; and comprises an atmospheric pressure measurement port, as taught by Hartwell, in order to provide indication of a blockage (¶ 0073).
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 Hartwell disclose wherein the pressure transducer is fluidly coupled to the atmospheric pressure measurement port by a fluid path isolated from the interior space (Hartwell, see pressure sensing conduit 424, ¶ 0071).
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);
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), the pressure relief valve configured to prevent excessive negative pressures from being applied by the apparatus to the wound of the user (¶ 0175).
Gordon in view of Hartwell disclose wherein the pressure transducer is fluidly coupled to the atmospheric pressure measurement port by a fluid path isolated from the interior space (Hartwell, see pressure sensing conduit 424, ¶ 0071).
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 Hartwell, as applied to claim 1 above, and further in view of Joshi et al. (Pub. No.: US 2007/0265586 A1).
Regarding claim 2, Gordon in view of Hartwell fail to disclose wherein the formed front layer and the formed rear layer are formed from polyurethane.
Joshi teaches (fig. 6) a negative-pressure therapy device (wound therapy device 20, abstract) and thus in the same field of endeavor, comprising a housing (220), wherein the housing is formed from polyurethane (¶ 0031), the housing being suitable for application of negative pressure (¶ 0031).
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 Hartwell such that they are formed from polyurethane, as taught by Joshi, as such materials are suitable for application of negative pressure (Joshi, ¶ 0031).
Claim(s) 3 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gordon in view of Hartwell, 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 Hartwell 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 Hartwell 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 Hartwell 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 Hartwell 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. Earl et al. (Pub. No.: US 2020/0337905 A1) discloses a negative-pressure therapy device. Allen et al. (Pub. No.: US 2012/0136325 A1) discloses a negative-pressure therapy device.
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
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781