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 04/23/2026 is acknowledged.
Claims 40, 43, 44, 47, and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/23/2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Buan et al (US 2022/0241489).
Regarding Claim 21, Buan discloses a pump module (10, Fig. 1) comprising:
a pump (16, Fig. 1) comprising a biasing element (valve 154, Fig. 1; ¶ [0054] indicates the valve can be a spring biased valve) and a pump housing (80, Fig. 1); and
a pump actuation assembly (combination of pull tab 126, packet 130, and removable layer 132, Fig. 1) comprising a sacrificial seal (bond between packing 130 and removable layer 132, Fig. 1) and an actuation device (pull tab 126, Fig. 1) configured to activate the pump (16, Fig. 1) when the sacrificial seal (bond between 130 and 132, Fig. 1) is broken (¶ [0029-0031]).
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) 1-9, 11-12, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buan et al (US 2022/0241489) in view of Locke et al (US 2018/0272052).
Regarding Claims 1-4, Buan discloses a system for negative pressure therapy (10, Fig. 1), the system comprising:
a dressing (14, Fig. 1) configured to be placed adjacent to a tissue site (12, Fig. 2 (¶ [0011]);
a pump (16, Fig. 1) configured to be positioned in fluid communication with the dressing (14, Fig. 1; ¶ [0025-0027]) and to provide negative pressure to the dressing (14, Fig. 1) when activated (¶ [0029-0031]), the pump (16, Fig. 1) comprising a pump housing (80, Fig. 1); and
a pump actuation assembly (combination of pull tab 126, packet 130, and removable layer 132, Fig. 1) comprising a sacrificial seal (bond between packing 130 and removable layer 132, Fig. 1) and an actuation device (pull tab 126, Fig. 1) configured to activate the pump (16, Fig. 1) when the sacrificial seal (bond between 130 and 132, Fig. 1) is broken (¶ [0029-0031]),
wherein the pump housing (80, Fig. 1) comprises a film (upper layer 86, Fig.1; ¶ [0024]) defining at least a portion of a sealed chamber (46, Fig. 1).
Buan is silent regarding a biasing element, wherein the biasing element is configured to generate a variable volume within the pump housing when the pump is activated, wherein the biasing element comprises foam and the pump housing encases the foam, and wherein the foam is configured to move from a compressed state having a first volume prior to activation of the pump to an expanded state having a second volume after activation of the pump, and wherein the second volume is greater than the first volume.
Locke teaches a negative pressure wound dressing, thus being in the same field of endeavor, with a pump (104, Fig. 1) comprising a biasing element (foam block 134, Fig. 1; ¶ [0054]) and a pump housing (film layer 132, Fig. 1), where the biasing element (134, Fig. 1) is configured to generate variable volume within the pump housing (132, Fig. 1; ¶ [0054, 0058-0060]) when the pump is activated (¶ [0059]), wherein the biasing element (134, Fig. 1) comprises foam (¶ [0054]) and the pump housing (132, Fig. 1) comprises a film (132, Fig. 1; ¶ [0054]) defining at least a portion of a sealed chamber (source cavity 138, Fig. 1) that encases the foam (134, Fig. 1); wherein the foam (134, Fig. 1) is configured to move from a compressed state having a first volume prior to activation of the pump to an expanded state having a second volume after activation of the pump, and wherein the second volume is greater than the first volume (¶ [0058-0060, 0066]). This allows for a negative-pressure dressing without the need for conventional electric or mechanical pumps, instead using only the biasing force of a foam block as the means of generating negative pressure.
Therefore, 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 pump of Buan to include a biasing element configured to generate a variable volume within the pump housing when the pump is activated, wherein the biasing element comprises foam, and wherein the foam is configured to move from a compressed state having a first volume prior to activation of the pump to an expanded state having a second volume after activation of the pump, and wherein the second volume is greater than the first volume, as taught by Locke. This allows for a negative-pressure dressing without the need for complex electromechanical or chemical pumps, such as the reactor within Buan. This is further motivated by Buan who indicates in ¶ [0027] the vacuum source can include various types of devices capable of drawing a vacuum.
Regarding Claim 5, Buan further discloses the sacrificial seal (bond between 130 and 132, Fig. 1) comprises a film layer (132, Fig. 1) including a zone of weakness (area without adhesive 134, Fig. 1) and the actuation device (126, Fig. 1) comprises at least one pull tab (126, Fig. 1) configured to stretch the film layer (132, Fig. 1) to form an opening at the zone of weakness (area without adhesive 134, Fig. 1; when the pull tab is pulled, the film layer will stretch until the bond between the film layer and the packet is broken and the film layer peels away from the packet; ¶ [0029-0031]).
Regarding Claim 6, Buan further discloses the at least one pull tab (126, Fig. 1) is coupled to the film layer (132, Fig. 1; ¶ [0029]).
Regarding Claim 7, Buan further discloses the sacrificial seal (bond between 130 and 132, Fig. 1) is moveable from a sealed state to an activated state in which the pump (16, Fig. 1) is activated (¶ [0029-0031]), and wherein the sacrificial seal (bond between 130 and 132, Fig. 1) is closed in the sealed state and open in the activated state (¶ [0029-0031]), and wherein the opening (opening formed when 132 peels away from 130, Fig. 1) is formed through the sacrificial seal (bond between 130 and 132, Fig. 1) in the activated state when the film layer (132, Fig. 1) is stretched to failure at the zone of weakness (area without adhesive 134, Fig. 1; ¶ [0029-0031]).
Regarding Claim 8, Buan/Locke discloses the claimed invention substantially as claimed as set forth above for Claim 1.
Buan further discloses the sacrificial seal (bond between 130 and 132, Fig. 1) is moveable from a sealed state to an activated state in which the pump (16, Fig. 1) is activated (¶ [0029-0031]), and wherein the sacrificial seal (bond between 130 and 132, Fig. 1) is closed in the sealed state and open in the activated state (¶ [0029-0031]), and wherein the opening (opening formed when 132 peels away from 130, Fig. 1) is formed through the sacrificial seal (bond between 130 and 132, Fig. 1) in the activated state when the film layer (132, Fig. 1) is stretched to failure at the zone of weakness (area without adhesive 134, Fig. 1; ¶ [0029-0031]). The combination of Buan/Locke further discloses the biasing element is configured to draw fluid into the pump housing through the opening when the pump is activated (Buan ¶ [0029-0031], Locke ¶ [0054, 0058-0060]).
Regarding Claim 9, Buan further discloses the pump housing (80, Fig. 1) comprises at least one check valve (154, Fig. 1; ¶ [0033-0034]).
Regarding Claim 11, Buan further discloses a port (opening formed by removal of 132, Fig. 1) defined through the pump actuation assembly (combination of 126, 130, and 132, Fig. 1) and configured to enable fluid communication between the dressing (14, Fig. 1) and the pump (16, Fig. 1; the opening in the packet allows for fluid communication between the dressing and the pump through opening 90; ¶ [0022-0023]).
Regarding Claim 12, Buan further discloses the sacrificial seal (bond between 132 and 130, Fig. 1) is positioned in the port (opening formed by removal of 132, Fig. 1) of the pump actuation assembly (126, 130, and 132, Fig. 1).
Regarding Claim 17, Buan/Locke discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Buan/Locke further discloses the pump housing is configured to permit re-activation of the pump to maintain a desired negative pressure at the dressing (the film layer is fully capable of being depressed after the initial activation to provide additional negative pressure to the dressing, see Locke ¶ [0066]).
Regarding Claim 18, Buan further discloses the pump housing (80, Fig. 1) comprises:
a sealed chamber (82, Fig. 1) configured to enclose the biasing element;
a base (84, Fig. 1) configured to be in fluid communication between the dressing (14, Fig. 1) and the sealed chamber (82, Fig. 1); and
at least one exhaust port (102, Fig. 1) configured to provide fluid communication between the sealed chamber (82, Fig. 1) and ambient environment (¶ [0033-0035]).
Regarding Claim 19, Buan further discloses the pump (16, Fig. 1) is coupled to the pump actuation assembly (126, 130, and 132, Fig. 1) an external mounting portion (sealing element 92, Fig. 1) of the pump actuation assembly (126, 130, and 132, Fig. 1), wherein an exterior surface of the external mounting portion (92, Fig. 1) carries a releasable adhesive (¶ [0022]).
Buan/Locke is silent regarding a pump mounting portion of the pump actuation assembly positioned opposite from the external mounting portion.
However, it has been held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04 VI). Therefore, it would have been obvious to one of ordinary skill in the art to duplicate the sealing element of Locke and place it on the opposite side of the opening 90 to provide pump mounting portion surrounding the opening on the interior surface of the inner layer 84 to further improve the fluid tightness of the dressing.
Regarding Claim 20, Buan further discloses the pump (16, Fig. 1) is a first pump (16, Fig. 1) and the pump actuation assembly (126, 130, and 132, Fig. 1) is a first pump actuation assembly (126, 130, and 132, Fig. 1), the system (10, Fig. 1) further comprising at least a second pump and a second pump actuation assembly (¶ [0033-0035]; the mechanical pump assembly can be interpreted as comprising a second pump and a second pump actuation assembly), wherein the second pump is configured to be removed after the dressing (14, Fig. 10 is drawn down to a desired negative pressure (¶ [0033-0035]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buan et al (US 2022/0241489) in view of Locke et al (US 2018/0272052) further in view of Coulthard (US 2015/0057625).
Regarding Claim 13, Buan further discloses the sacrificial seal (bond between 130 and 132, Fig. 1) is positioned in the port (opening in packet 130 when 132 is removed, Fig. 1) and between an external mounting portion (sealing element 92, Fig. 1) of the pump actuation assembly (126, 130, and 132, Fig. 1).
Buan/Locke is silent regarding a pump mounting portion of the pump actuation assembly, and wherein the pump mounting portion and the external mounting portion each comprise a ring of a closed cell foam.
However, it has been held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04 VI). Therefore, it would have been obvious to one of ordinary skill in the art to duplicate the sealing element of Locke and place it on the opposite side of the opening 90 to provide pump mounting portion surrounding the opening on the interior surface of the inner layer 84 to further improve the fluid tightness of the dressing.
Buan/Locke is silent whether the pump mounting portion and the external mounting portion each comprise a ring of closed cell foam.
Coulthard teaches a negative pressure wound dressing, thus being in the same field of endeavor, with a sealing member (254, Fig. 2) that is a sealing ring of closed cell foam (¶ [0047-0048]).
Therefore, it would have been obvious to modify the pump mounting portion and the external mounting portion of Buan/Locke to be a ring of closed cell foam, as taught by Coulthard, as Coulthard indicates that a ring of closed cell foam is a suitable sealing member for use within negative pressure wound dressings.
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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