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 in the reply filed on June 9, 2026 is acknowledged.
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 12 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.
Regarding claim 12, the limitation “the apparatus comprises a canisterless apparatus” renders the claim indefinite. On page 2, line 30; page 7, line 8; page 20, line 9; and page 21, line 7 of the filed specification the apparatus itself is described as canisterless, not as comprising a canisterless apparatus. It is unclear what exactly “canisterless apparatus” is intended as, especially as the housing and negative pressure source are claimed, and the housing encloses the vacuum source and would be canisterless (see current application, Figures 5A-5C).
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.
Claim(s) 1-4, 7, 10, 12, 16, 20, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Risk, JR. et al. (US 2002/0198504) in view of Bushko et al. (US 2017/0354768).
Regarding claim 1, Risk, JR. discloses a negative pressure wound therapy apparatus (see Figs. 1, 14) comprising: a housing 4; at least one negative pressure source 110 supported by the housing (see Fig. 3, 6, 14; par. 99), the at least one negative pressure source configured to aspirate, via a fluid flow path, fluid from a wound covered by a wound dressing (see Figs. 1, 3, 6-7, 27, par. 74); a switch positioned on an exterior surface of the housing (see par. 117, 137-138 disclosing exterior surface on which setting of pressure can be accomplished via selection of enter button 1022 to make selection); and a controller 803 configured to operate the at least one negative pressure source (see Fig. 27, par. 9, 20, 117), the controller further configured to, in a first mode: responsive to receiving a first user input via the switch, operate the at least one negative pressure source to aspirate fluid from the wound at a first fluid flow rate (see par. 137); and responsive to receiving, via the switch, a second user input subsequent to receiving the first user input, operate the at least one negative pressure source to aspirate fluid from the wound at a second fluid flow rate (see par. 138).
Risk, JR. does not disclose the second fluid flow rate greater than the first fluid flow rate, though Risk, JR. discloses increasing the desired negative pressure setting, and therefore the second negative pressure setting being greater than the first negative pressure setting (see par. 137-138). However, Bushko discloses increasing a setpoint of negative pressure leading to the negative pressure source having a higher level of activity with the pump motor turning faster to reach and maintain the lower negative pressure setpoint (see par. 71). Official notice is taken that a pump motor turning controls the flow rate coming from the pump motor turning, and therefore the pump motor turning faster would result in an increased flow rate in such a situation. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the increase in a setpoint of negative pressure lead to a higher level of activity with the pump motor turning faster to reach and maintain the lower negative pressure setpoint, as disclosed by Bushko, in situations in which a negative pressure setting is increased, such an increase disclosed by Risk, JR., which would predictably result in the required increased negative pressure setting and increased negative pressure that would therefore result in the second fluid flow rate being greater than the first fluid flow rate.
Regarding claim 2, Risk, JR. and Bushko disclose the limitations of claim 1 above and Risk, JR. further discloses the switch is the only switch positioned on the exterior surface of the housing and configured to activate and deactivate provision of negative pressure wound therapy (see Fig. 40, par. 137-138, button 1022 on left side due to other side being off would be the only switch as it is the only button that allows for enter to be pressed and switched to providing/deactivating the negative pressure wound therapy).
Alternatively, Bushko discloses a negative pressure wound therapy apparatus provided for a single wound (see Fig. 1). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the apparatus be for a single wound, and therefore have one screen instead of dual screens, Bushko disclosing such a single wound treatment apparatus that would predictably result in providing negative pressure wound therapy to a wound. This would allow for a smaller device that is easier to transport and use when only one wound treatment is required.
Regarding claim 3, Risk, JR. and Bushko disclose the limitations of claim 1 above and Risk, JR. discloses increasing the desired negative pressure setting, and therefore a third negative pressure setting can be input, the third negative pressure setting being greater than the second negative pressure setting (see par. 137-138). Bushko discloses increasing a setpoint of negative pressure leading to the negative pressure source having a higher level of activity with the pump motor turning faster to reach and maintain the lower negative pressure setpoint (see par. 71). Official notice is taken that a pump motor turning controls the flow rate coming from the pump motor turning, and therefore the pump motor turning faster would result in an increased flow rate in such a situation. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the increase in a setpoint of negative pressure lead to a higher level of activity with the pump motor turning faster to reach and maintain the lower negative pressure setpoint, as disclosed by Bushko, in situations in which a negative pressure setting is increased, such an increase disclosed by Risk, JR., which would predictably result in the required increased negative pressure setting and increased negative pressure that would therefore result in the third fluid flow rate being greater than the second fluid flow rate.
Furthermore, it is noted that this is similar to applicant’s invention in that multiple clicks lead to increases of a setting in the apparatus (see current application, Fig. 6 in which each click causes user input for a switch to increase flow rate provided by the pump).
Regarding claim 4, Risk, JR. and Bushko disclose the limitations of claim 3 above and Risk, JR. further discloses the controller is configured to operate the at least one negative pressure source to aspirate the fluid at the first, second, or third flow rate during establishing a target negative pressure level at the wound (see rejections of claims 1 and 3, par. 137-138).
Regarding claim 7, Risk, JR. and Bushko disclose the limitations of claim 1 above and Risk, JR. further discloses the first fluid flow rate corresponds to a default fluid flow rate for establishing a target negative pressure level at the wound following initiation of negative pressure wound therapy (see par. 137, default setting).
Regarding claim 8, Risk, JR. and Bushko disclose the limitations of claim 1 above and Risk, JR. further discloses the at least one negative pressure source comprises first and second negative pressure sources 110, the first negative pressure source configured to aspirate fluid from the wound at the first fluid flow rate (see Fig. 27 having two negative pressure sources 110).
Regarding claim 10, Risk, JR. and Bushko disclose the limitations of claim 1 above and Risk, JR. further discloses the switch comprises a button (see Fig. 29, button 1022).
Regarding claim 12, Risk, JR. and Bushko disclose the limitations of claim 1 above but as described above do not disclose the apparatus comprises a canisterless apparatus, as Risk, JR. discloses the use of canisters (see Fig. 14).
Bushko discloses a negative pressure wound therapy apparatus with a pump being a canisterless pump assembly, meaning that exudate is collected in the wound dressing or is transferred via a tube for collection to another location, or alternatively can include or support a canister (see par. 18). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the apparatus be a canisterless apparatus, as Bushko discloses such an apparatus being a well-known alternative to having a canister and such a configuration would predictably result in the withdrawal of fluids/exudates from a wound using negative pressure wound therapy.
Regarding claim 16, Risk, JR. and Bushko disclose the limitations of claim 1 and Risk, JR. discloses the controller is further configured to, in a second mode responsive to receiving a third user input, operate the at least one negative pressure source to provide negative pressure to the wound at a third negative pressure rate; and responsive to receiving a fourth user input subsequent to the fourth user input, operate the at least one negative pressure source to provide negative pressure to the wound at a fourth negative pressure rate lower than the third negative pressure rate (see par. 89, 136-141, modes can be switched and allow for additional pressures, which include third and fourth inputs, along with a decrease in pressure related to those inputs, which would result in rates as claimed).
Regarding claim 20, Risk, JR. and Bushko disclose the limitations of claim 16, and Risk, JR. further discloses the controller is configured to operate the negative pressure source to provide negative pressure to the wound at the third negative pressure rate or the fourth negative pressure rate during establishing a target negative pressure level at the wound (see 89, 136-141, setting target negative pressures).
Regarding claim 26, Risk, JR. discloses a method of operating a negative pressure wound therapy apparatus comprising: operating at least one negative pressure source in a first mode to aspirate, via a fluid flow path, fluid from a wound covered by a wound dressing (see Figs. 1, 3, 6-7, 27, par. 74, 136-141), the operating comprising at a first time: responsive to receiving a first user input, operating the at least one negative pressure source to aspirate fluid from the wound at a first fluid flow rate (see par. 137, change in pressure requires flow rate); and at a second time: responsive to receiving a second user input subsequent to receiving the first user input, operating the at least one negative pressure source to aspirate fluid from the wound at a second fluid flow rate (see par. 138, change in pressure requires flow rate), wherein the method is performed under control of a controller (see Fig. 27, par. 9, 20, 117, controller 803).
Risk, JR. does not disclose the second fluid flow rate greater than the first fluid flow rate, though Risk, JR. discloses increasing the desired negative pressure setting, and therefore the second negative pressure setting being greater than the first negative pressure setting (see par. 137-138). However, Bushko discloses increasing a setpoint of negative pressure leading to the negative pressure source having a higher level of activity with the pump motor turning faster to reach and maintain the lower negative pressure setpoint (see par. 71). Official notice is taken that a pump motor turning controls the flow rate coming from the pump motor turning, and therefore the pump motor turning faster would result in an increased flow rate in such a situation. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the increase in a setpoint of negative pressure lead to a higher level of activity with the pump motor turning faster to reach and maintain the lower negative pressure setpoint, as disclosed by Bushko, in situations in which a negative pressure setting is increased, such an increase disclosed by Risk, JR., which would predictably result in the required increased negative pressure setting and increased negative pressure that would therefore result in the second fluid flow rate being greater than the first fluid flow rate.
Claim(s) 5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Risk, JR. in view of Bushko as applied to claim 1 above, and further in view of Armstrong et al. (US 2017/0216501).
Regarding claim 5, Risk, JR. and Bushko disclose the limitations of claim 1 above and Risk, JR. further discloses the controller is configured to, subsequent to establishing a target negative pressure level at the wound: responsive to receiving a fourth user input via the switch, deactivate the at least one negative pressure source to change aspiration of fluid from the wound (see par. 89, 136, 139, 141 apparatus can be switched to various modes such as intermittent/profile and off in addition to continuous, that would result in pausing).
Risk, JR. does not specifically disclose this change being pausing. However, Armstrong discloses that intermittent therapy can have one of the setpoints be zero, which would pause the pump (see par. 112). It would have been obvious to a person having ordinary skill in the art before the effective filing date to have a setpoint of intermittent therapy be as disclosed by Armstrong, predictably resulting in intermittent negative pressure wound treatment to a patient.
Regarding claim 11, Risk, JR. and Bushko disclose the limitations of claim 1 above and Risk, JR. further discloses another switch configured to activate and change provision of negative pressure wound therapy (see Fig. 29, there are two buttons 1022 that can be used at the same time, par. 89, 136, 139, 141 apparatus can be switched to various modes such as intermittent/profile and off in addition to continuous, that would result in pausing and starting modes).
Risk, JR. does not specifically disclose this change being pausing. However, Armstrong discloses that intermittent therapy can have one of the setpoints be zero, which would pause the pump (see par. 112). It would have been obvious to a person having ordinary skill in the art before the effective filing date to have a setpoint of intermittent therapy be as disclosed by Armstrong, predictably resulting in intermittent negative pressure wound treatment to a patient.
Claim(s) 6, 9, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Risk, JR. in view of Bushko as applied to claims 3, 8, or 16 above, and further in view of Weston et al. (US 2010/0042074).
Regarding claim 6, Risk, JR. and Bushko disclose the limitations of claim 3 but does not disclose at least one negative pressure source comprises an actuator, and wherein the controller is configured to overdrive the actuator to operate the at least one negative pressure source to aspirate fluid from the wound at the second or third fluid flow rate.
Weston discloses at least negative pressure source comprises an actuator (see par. 27, 121-122, pump motor), and wherein the controller is configured to overdrive the actuator to operate the at least one negative pressure source to aspirate fluid from the wound at a fluid flow rate (see par. 27, 64, 76). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include an actuator and controller as disclosed by Weston in order to help with running the pump. As the pump helps provide the flow rate and required negative pressure, it would provide the second or third fluid flow rate.
Regarding claim 9, Risk, JR. and Bushko disclose the limitations of claim 8 but do not disclose the controller is configured to activate the second negative pressure source responsive to the second or third user input to assist the first negative pressure source to aspirate fluid from the wound at the second or third fluid flow rate.
Weston discloses an additional negative pressure source provided and controlled by a controller that is configured to assist a first negative pressure source to aspirate fluid from the wound at a fluid flow rate (see par. 64, 76), the additional negative pressure source may ensure a higher level of safety and product quality by providing pump redundancy to prevent vacuum system failure in the event that a single pump fails, in addition to more efficiently providing increased suction. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have an additional pressure source provided with the first negative pressure source that provides the benefits explained by Weston regarding the additional pump. As this additional source could either act as a backup or help with increased suction, it would work with the first negative pressure source, either replacing it or helping it, to ensure the proper vacuum set, and therefore flow rates, are provided, which would include the second or third fluid flow rates.
Regarding claim 21, Risk, JR. and Bushko disclose the limitations of claim 16 but do not disclose the controller is configured to: responsive to a determination that 1)a duration of time during which the negative pressure source has been providing negative pressure to the wound at the fourth negative pressure rate satisfies a threshold and 2) a target negative pressure level has not been established at the wound, operate the negative pressure source to provide negative pressure to the wound at the third negative pressure rate.
Weston discloses a program/profile used to provide negative pressure in which a controller is configured to: responsive to a determination that 1)a duration of time during which the negative pressure source has been providing negative pressure to the wound at the fourth negative pressure rate satisfies a threshold and 2) a target negative pressure level has not been established at the wound, operate the negative pressure source to provide negative pressure to the wound at the third negative pressure rate (see Fig. 2, par. 21, 31). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the treatment provided by Risk, JR. and Bushko set with two inputs such as that provided in Weston, in order to predictably treat a patient using negative pressure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781
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