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 .
Status of the Claims
The amendment filed 04/28/2025 has been entered. At entry, claims 1-9 and 11-16 are pending and under consideration.
Claim Objections
Claim 84 is objected to because of the following informalities:
Claim 84 line 5 recites “the atmospheric air” which should read “atmospheric air”
Claim 84 lines 9-10 recites “the atmosphere” which should read “atmosphere”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 93 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 93 recites “the housing further comprises at least one vent hole” which renders the claim indefinite. For instance, dependent claim 91 recites “a cavity comprising an opening”, and further recites that “wherein an air flow out of the opening of the housing”. Thus, claim 91 already requires an opening in the housing through which air exits the housing. Accordingly, it is unclear if the “at least one vent hole” corresponds to the previously recited opening of the housing as set forth in claim 91 or refers to an additional opening distinct from the previously recited opening. In an effort to compact prosecution, the “at least one vent hole” is interpreted as corresponding to the previously recited opening of the housing.
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.
Claims 84-86 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Askem et al (US 20150174304 A1) in view of Risk al (US 20020198504 A1)
Regarding claim 84, Askem substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A apparatus (figures 12-13, dressing kit 230) for delivering negative pressure wound therapy comprising:
a first layer (figure 12a, backing layer 244);
a pump (figure 12a, pump assembly 232 having a fluid inlet and a fluid outlet ([0287, 0288 and 0295] upstream, e.g, port of the pump and downstream of the pump);
a pressure sensor ([0380] pressure sensor) fluidly coupled to the atmospheric air and the pump;
a second layer (figure 12a, wound contact layer 246 best seen in figure 10a) configured to be coupled to the first layer to form an interior space having the pressure sensor and the pump disposed therein (figure 12b, the backing layer 244 and the wound contact layer 246 are coupled together about their perimeters to define an interior space containing the pump assembly and the pressure sensor);
a pump exhaust mechanism ([0287] exhaust valve and/or filter positioned over the pump 232 and coupled to pump downstream configured to allow fluid from the pump downstream exhausted to the atmosphere) fluidly coupled to the fluid outlet of the pump and configured to allow fluid from the fluid outlet of the pump to be exhausted to atmosphere;
a negative pressure inlet mechanism ([0287 0288] filter or valves fluidly coupled to the upstream of the pump assembly 232) fluidly coupled to the fluid inlet of the pump;
wherein the pressure sensor is configured to measure the atmospheric air through a port in fluid communication with the atmosphere air.
Askem does not teach the pressure sensor fluidly coupled to the atmospheric air and the pump; and
wherein the pressure sensor is configured to measure the atmospheric air through a port in fluid communication with the atmosphere air.
In the same field of endeavor, namely a reduced pressure apparatus and methods, Risk teaches the pressure sensor (figure 27 and [0099 and 0126], pressure sensor 124 is fluidly coupled to the atmospheric air and the pump through fluid lines 854, 858, 860 862) fluidly coupled to the atmospheric air and the pump; and
wherein the pressure sensor (figure 27 [0126], pressure sensor 124 is configured to measure the atmospheric air through pressure port 852) is configured to measure the atmospheric air through a port in fluid communication with the atmosphere air.
Therefore, 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 Askem, to incorporate the teachings of Risk and provides the pressure sensor as claimed for the purpose of providing means to calibrate the pressure sensor for accurate pressure measure as taught by Risk ([0126]).
Regarding claim 85, Askem, as modified by Risk, teaches the apparatus of claim 84.
The combination further teaches wherein the pump exhaust mechanism is configured to exhaust air from the pump out of a vent hole in the second layer (Askem; [0287] “the backing layer 244 can be positioned over the pump 232, with an exhaust valve and/or filter to prevent pathogens, bacteria, odors, or other contaminants from leaving the pump” the valve or filter necessarily requires and occupies an opening in the backing layer, and configured to exhaust air from the pump out of an opening in the backing layer)
Regarding claim 86, Askem, as modified by Risk, teaches the apparatus of claim 85.
The combination further teaches further comprising a filter (Askem; [0287] the filter in fluid communication with the opening in the backing layer and configured to filter the air exhausted from the pump) in fluid communication with the vent hole and configured to filter the air exhausted from the pump to the atmosphere.
Regarding claim 89, Askem, as modified by Risk, teaches the apparatus of claim 85.
The combination further teaches wherein the fluid inlet of the pump (Askem; [0287 and 0288] a port in the pump 232 is in fluid communication with the interior space through the filter or valve) and the negative pressure inlet mechanism are fluidly coupled to the interior space.
Claim 88 is rejected under 35 U.S.C. 103 as being unpatentable over Askem et al (US 20150174304 A1) in view of Risk al (US 20020198504 A1,), and in further view of Joshi et al (US 20070265585 A1).
Regarding claim 88, Askem, as modified by Risk and Locke, teaches the apparatus of claim 85.
The combination does not expressly teach wherein the fluid outlet of the pump is fluidly coupled to the vent hole by a fluid path that is isolated from the interior space
In the same field of endeavor, namely a device for wound therapy, Joshi teaches wherein the fluid outlet of the pump is fluidly coupled to the vent hole by a fluid path that is isolated from the interior space (figure 6, outlet of pump 234 is fluidly coupled to hole of housing by outlet 235 isolating from the interior space within device 210).
Therefore, 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 Askem, as modified by Risk, to incorporate the teachings of Joshi and provides the fluid outlet as claimed, and one of skill in the art motivated to do so, for the purpose of facilitating venting exhaust out of the interior space.
Claim 90 is rejected under 35 U.S.C. 103 as being unpatentable over Askem et al (US 20150174304 A1) in view of Risk al (US 20020198504 A1,) and Joshi et al (US 20070265585 A1), and in further view of Pratt et al (20160067392).
Regarding claim 90, Askem, as modified by Risk and Joshi, teaches the apparatus of claim 88.
The combination does not teach wherein the pump exhaust mechanism comprises a chamber coupled to the fluid outlet of the pump.
In the same field of endeavor, namely a tissue treatment systems, Pratt teaches wherein the pump exhaust mechanism (figure 16 and [0070], chamber 1604 is coupled to exhaust port 1612 of the vacuum pump 1606) comprises a chamber coupled to the fluid outlet of the pump.
Therefore, 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 Askem, as modified by Risk and Joshi, to incorporate the teachings of Pratt and provide the pump exhaust mechanism as claimed for the purpose of attenuate exhaust noise from the pump as taught by Pratt ([0006]).
Claims 91-94 are rejected under 35 U.S.C. 103 as being unpatentable over Fujisaki (US 20170112974 A1) in view of Locke (US 20180021178 A1).
Regarding claim 91, Fujisaki teaches a apparatus for interfacing a negative pressure source with a wound dressing disposed on a wound, the apparatus comprising:
a housing (figure 8, housing 22) comprising:
a cavity (figure 8, cavity formed under housing 22) comprising an opening (figure 8, vent hole 26 configured to fluidly communicate with the wound dressing 10 through the pump 36 and filter 40 ) configured to fluidly communicate with the dressing;
a filter at least partially covering the cavity of the housing, wherein the filter is air permeable;
an enclosure (figure 8, enclosure of pump unit 20c at least defined by housing 22 and air flow out of the vent hole 26) defined by the housing and the filter, wherein an air flow out of the opening of the housing (figure 8, exhaust of the pump flow out of the vent hole 26) is configured to pass through the filter; and
a sensor (figure 8 and [0019], pressure sensor 34 is configured to sense the pressure within the dressing) received within the enclosure and configured to sense at least one parameter associated with the wound.
Fujisaki does not teach the housing comprising a filter at least partially covering the cavity of the housing, wherein the filter is air permeable; and
the enclosure defined by the housing and the filter, and the air flow out of the opening of the housing is configured to pass through the filter.
In the same field of endeavor, namely a reduced pressure system, Locke teaches the housing comprising a filter (figure 1 and [0056] air permeable odor filter 177 covering the interior space of the electronic pouch 116) at least partially covering the cavity of the housing, wherein the filter is air permeable; and
the enclosure defined by the housing and the filter, and the air flow out of the opening of the housing is configured to pass through the filter ([0056]).
Therefore, 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 Fujisaki to incorporate the teachings of Locke and provide the apparatus as claimed for the purpose of preventing the apparatus from emitting odor from the wound as taught by Locke ([0056])
Regarding claim 92, Fujisaki, as modified by Locke, teaches the apparatus of claim 91.
The combination further teaches comprising a printed circuit board (Fujisaki; figure 8, substrate 28) received within the enclosure and wherein the sensor is coupled to and disposed on the printed circuit board (Fujisaki; figure 8, sensor 34 is disposed on the substrate 28).
The combination does not expressly teaches the substrate is a printed circuit board.
In the same field of endeavor, namely a reduced pressure system, Locke teaches the substrate is formed from a printed circuit board ([0056]).
Therefore, 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 Fujisaki, as modified by Locke, to incorporate the teachings of Locke and provide the printed circuit board as claimed, and one of skill in the art motivated to do so, for the purpose of electrically wiring electrical components of the negative pressure wound dressing system.
Regarding claim 93, Fujisaki, as modified by Locke, teaches the apparatus of claim 91.
The combination further teaches wherein the housing further comprises at least one vent hole (Fujisaki; figure 8, opening 26 extending through the housing 23 and fluidly communicating with the enclosure) extending therethrough and fluidly communicating with the enclosure.
Regarding claim 94, Fujisaki, as modified by Locke, teaches the apparatus of claim 91.
The combination further teaches wherein the sensor is a pressure sensor, and wherein the at least one parameter is a negative pressure (Fujisaki; [0048 and 0055]).
Allowable Subject Matter
Claim 87 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: No prior art, alone or in combination, could be found to teach (claim 84 and 87) a pressure sensor fluidly coupled to the atmospheric air and the pump; wherein the pressure sensor is configured to measure the atmospheric air through a port in fluid communication with the atmosphere air; and the pressure sensor is fluidly coupled to the port in fluid communication with the atmosphere air by a fluid path isolated from the interior space. The closest prior art Askem et al (US 20150174304 A1) and Risk al (US 20020198504 A1) teaches the device as claimed except for “the pressure sensor is fluidly coupled to the port in fluid communication with the atmosphere air by a fluid path isolated from the interior space”. For example, Risk teaches the pressure sensor coupled to the atmospheric air and the pump, and the sensor is configured to measure the atmospheric air through a port in fluid communication with the atmosphere air (figure 27 [0126], pressure sensor 124 is configured to measure the atmospheric air through pressure port 852) and also measures pressure within the interior space of the dressing, and therefore Risk fails to teach the pressure sensor is fluidly coupled to the port by a fluid path isolated from the interior space. Locke (US 20140005618 A1) cures the deficiency of the combination above and teaches the pressure sensor is fluidly coupled to the port by a fluid path isolated from the interior space (figures 1 b-d, first sensor 126a comprising strain gauge 131 is fluidly coupled to ambient air by a fluid path formed on reduced pressure interface 132a/b), but Locke fails to teach the pressure sensor fluidly coupled to the pump.
It would have not have been obvious to one of ordinary skill in the art to combine the prior art above to yield the claimed limitation as Askem and Risk teach pressure sensors disposed within and in fluid communication with an interior space, whereas Locke does not teach the sensor is fluidly coupled to the pump. Examiner found Locke does not provide sufficient teaching or motivation to modify Askem or Risk to arrive at the claimed arrangement. There is not an apparent/obvious reason/motivation for this modification as this modification increases the complexity of the system in the prior art in terms of structure, function, and design without an improvement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tumey et al (US 20180021178 A1) Pratt et al (US 20240238504 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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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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/SETH HAN/ Examiner, Art Unit 3781
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