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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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.
Claims 6 and 9-14 are 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 6 recites the following limitations
"the amplitude" in line 5
“said measured current amplitude” in lines 7-8
“the supply” in line 8
“the motor” in lines 9 and 11*
“the effect” in line 12
“the measured amplitude” in line 13
“the effect of the no-load current” in liens 14-15
“the measured amplitude of the current” in line 16
“the no-load current” in line 18
“said negative pressure value” in line 19
There is insufficient antecedent basis for these limitations in the claim.
*It is noted that the claim recites both “the electric motor” and “the motor”. For the sake of clarity, consistency is recommended.
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.
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 2022/0226559) and further in view of WO 2022/073762.
With reference to claim 6, Locke et al. (hereinafter “Locke”) discloses an apparatus (100) for controlling a negative pressure level prevailing at a wound site [0009],
the apparatus including an electrically powered device [0062], a constant voltage source [0096], an air pump [0062], current monitor [0074], a processor [00019], and a switch [0164], characterized in that the apparatus includes a temperature sensor as set forth in [0098].
The remaining limitations require that the structural elements are capable of performing a specific function.
Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In this case, the elements as recited are identical to that disclosed by Locke. As such, the elements of Locke are fully capable of performing the functions as claimed.
One of ordinary skill in the art would have been motivated to program the system of Locke as desired because Locke acknowledges that the negative pressure control algorithm may be programmed to generate an alarm based on the occurrence of a predetermined number of alerts as set forth in [0122].
Additionally, WO 2022/073762 (hereinafter “Laitenberger”) teaches an analogous negative pressure wound therapy system that includes a sensor configured to measure temperature of the negative pressure system, circuitry configured to control operation of the negative pressure source responsive to temperature measured by the sensor and a programmable controller configured to control operation of the source responsive to the temperature measured and set forth in the abstract. The temperature measured by the first sensor can be indicative of a temperature of the negative pressure source, and The controller can be configured to control operation of the negative pressure source independently of the electronic control circuitry as set forth in [0003].
The controller can also independently (or, in some cases, additionally to the circuitry 2080) perform one or more remedial actions responsive to the temperature, and the sensors can sense or monitor temperature of one or more of the one or more electronics components and/or of the patient as set forth in [0069].
Laitenberger also provides the system with a switch that can be configured to permit activation of the negative pressure source wherein the switch can be configured to be deactivated responsive to a determination that the temperature measured by at least one of the first sensor or the second sensor satisfies a predetermined temperature [0006]. The invention also includes a switch that can be used as an on/off button to stop and start the operation of the pump and/or electric components as set forth in [0035].
It would have been obvious to one of ordinary skill in the art at the time of the invention to program the system of Locke using the parameters suggested by Laitenberger in order to control operation of the negative pressure source independently of the electronic control circuitry as taught by Laitenberger in the abstract.
As to claim 10, Locke modified teaches the invention substantially as claimed as set forth in the rejection of claim 6.
The difference between Locke and claim is the explicit recitation that the apparatus includes a housing in which the constant voltage source, the processor, the electric motor and the air pump are mounted.
Laitenberger teaches an analogous negative pressure wound therapy system that includes a housing in which the constant voltage source, the processor, the electric motor and the air pump are mounted as set forth in [0039] and as shown in figure 3.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the elements within a single housing in order to reduce components to facilitate portability and increase convenient usage.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 2022/0226559) in view of WO 2022/073762 and further in view of WO 2021/024164.
With reference to claim 9, Locke modified teaches the invention substantially as claimed as set forth in the rejection of claim 6.
The difference between Locke modified and claim 9 is the provision that the apparatus includes first and second housings each containing specific elements and a connector arrangement connecting the first and second housing.
WO 2021/024164 (hereinafter ‘164) Features an analogous apparatus that includes the first housing and a second housing with a connector arrangement between the two housings as shown in figure 2.
As discussed in [0050] of ‘164 one housing includes a pump unit and the other housing includes an actuator unit. The pump unit includes the pump and an actuation surface as discussed in [0052] and in [0070]. The actuator unit may include a circuit board and a power supply as discussed in [0054].
It would have been obvious to one of ordinary skill in the art at the time of the invention to include the system in separate housings for benefit of separating the circuitry and electronic elements from the remaining elements, such as the pump, which may potentially come into contact with bodily fluids. This arrangement also allows for elements, such as the pump which may be disposable, to be disposed of with less disturbance to the permanent elements such as the circuitry and power supply.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 2022/0226559) in view of WO 2022/073762 and further in view of Gregory et al. (US 2021/0121609).
With reference to claim 11, Locke modified teaches the invention substantially as claimed as set forth in the rejection of claims 6 and 10.
The difference between Locke modified and claim 11 is the provision that the apparatus includes an exudate collecting container, with which the housing is releasably engageable, the air pump including an inlet which is in air communication with an interior of the container, and a suction port which, in use, is connected to the wound site and which is in air communication with the interior of the container.
Gregory et al. (hereinafter “Gregory”) teaches an analogous negative pressure therapy system that includes a container (220) with which the housing (230) is releasably engageable [0033], with an air pump including an inlet (252) that in air communication with an interior of the container (figure 2C), and a suction port and a suction port (154) which, in use, is connected to the wound site and which is in air communication with the interior of the container as set forth in [0029].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the apparatus of Lock modified with the container as taught by Gregory in order to provide the system with a means positioned in the fluid flow path to store at least some of the aspirated fluid as taught by Gregory in [0009].
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 2022/0226559) in view of WO 2022/073762 and Gregory et al. (US 2021/0121609) and further in view of Miller (US 8,439,894)
With reference to claim 12, Locke modified teaches the invention substantially as claimed as set forth in the rejection of claims 6 and 10-11.
The difference between Locke modified and claim 12 is the provision that the container includes an upper and lower part.
Initially, one of ordinary skill in the art would have been motivated to substitute the container of Locke modified as desired since it has been held that the substitution of one type of container for another is considered to be within the level of ordinary skill in the art. The purpose of the container is to ultimately collect exudate and Locke modified provides such a container for the same purpose as set forth in the rejection of claim 11.
Alternatively, Miller teaches an analogous negative pressure negative device that includes a two chamber internal storage chamber is set forth in the abstract. The container of Miller includes a manifold that is in air communication with the lower part as shown in figure 2. Miller discloses in the abstract that an impermeable layer separates the upper and lower chambers while allowing the upper and lower part to remain engaged as set forth in figure 2.
It would have been obvious to one of ordinary skill in the art to substitute the chamber as taught by Locke modified with the two chamber configuration as taught by Miller in order to keep the wound dry and promote healing is taught by Miller in the abstract.
Regarding claim 13, Locke modified teaches the invention substantially as claimed as set forth in the rejection of claims 6 and 10-12.
The difference between Locke modified and claim 13 is the provision that the
assembly includes an odour neutralizing filter inside the manifold.
Miller teaches an analogous negative pressure negative device that includes an filter (28) inside the manifold as shown in figure 2.
While Miller does not explicitly recite that the filter is an odor neutralizing filter, the filter prevents the passage of fluids (col. 5, lines 1-8), and would therefore at least reduce odor.
Additionally, the substitution of one type of filter for another is considered to be within the level of ordinary skill in the art.
It would have been obvious to one of ordinary skill in the art to provide the assembly of Locke modified with filter as taught by Miller in order to keep the wound dry and promote healing is taught by Miller in the abstract.
Regarding claim 14, Locke modified teaches the invention substantially as claimed as set forth in the rejection of claims 6 and 10-13.
The difference between Locke modified and claim 14 is the provision that the
said insert includes a plurality of air passages which place the manifold in air communication with the interior of the lower part.
Miller teaches an analogous negative pressure negative device that includes a plurality of air passages (30,35) which place the manifold in air communication with the interior of the lower part as shown in figure 11.
It would have been obvious to one of ordinary skill in the art to provide the assembly of Locke modified with air passages as taught by Miller in order to keep the wound dry and promote healing is taught by Miller in the abstract.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781
