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 .
Response to Arguments
Applicant's arguments filed 23JUN2026 have been fully considered but they are not persuasive.
Regarding the second check valve of Michaels (Claims 1, 11, and 15), Applicant’s arguments are not persuasive. When actuated, the valve prevents flow from passing through and is considered to fulfill the claim limitation as written. Furthermore, the primary therapy unit as cited is a vacuum pump which is not capable of causing any form of ingress through the valve.
Regarding Claim 15, Applicant’s arguments are not persuasive. Coulthard provides clear teachings of modification of a valve to retain pressure and increase reliability, which could reasonably be incorporated into the device of Michaels as previously cited. Modification of one valve type for another is considered well-known in the art.
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) 1, 2, and 5-9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20090005747 A1 (Michaels et al.).
Regarding Claim 1, Michaels teaches an apparatus (10) (the entire system shown generally in Fig. 1) for managing fluid for negative-pressure treatment of a tissue site [Abstract], the apparatus comprising:
a fluid reservoir (30) configured to be fluidly coupled between the tissue site and a primary therapy unit (at least 44), the fluid reservoir having a variable volume in response to a change of pressure within the fluid reservoir (the container expanding and contracting based on pressure applied as described in [0090] and shown in Fig. 8);
a first fluid passage (141) fluidly coupled to the fluid reservoir (as seen in Fig. 20) and configured to fluidly couple the fluid reservoir to the tissue site (connecting via 134);
a first check valve (within 134 as described in [0109]) configured to prevent egress from the fluid reservoir to the tissue site through the first fluid passage ([0109] describing the valve preventing release of material);
a second fluid passage (Michaels Annotated Figs. 20 and 21) fluidly coupled to the fluid reservoir and configured to fluidly couple the fluid reservoir to the primary therapy unit (149 being a vacuum passageway which provides vacuum via the therapy unit) [0114]; and
a second check valve (146) configured to prevent ingress to the fluid reservoir from the primary therapy unit through the second fluid passage [0114].
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Michaels Annotated Figs. 20 and 21
Regarding Claim 2, Michaels is considered to teach the first check valve (Michaels Annotated Figs. 20 and 21) and the second check valve (146) are configured to open at a therapeutic level of negative pressure, as flow would be required for suction to applied, thereby causing the valves to be open.
Regarding Claims 5-7, Michaels further teaches a third fluid passage (145) comprising a first end (Michaels Annotated Figs. 20 and 21) fluidly coupled to the first fluid passage and a second end (Michaels Annotated Figs. 20 and 21) fluidly coupled to the second fluid passage; wherein:
the first check valve (Michaels Annotated Figs. 20 and 21) is disposed between the first fluid passage (141) and the first end; and the second check valve (146) is disposed between the second fluid passage and the second end (Michaels Annotated Figs. 20 and 21); wherein:
the first fluid passage and the first end of the third fluid passage are configured to be coupled to a tissue interface (via 134 as previously described); and
the second fluid passage and the second end of the third fluid passage are configured to be coupled to a negative-pressure source (being fluidly coupled for application of vacuum).
Regarding Claim 8, Michaels further teaches the fluid reservoir (30) is configured to contract if negative pressure increases in the fluid reservoir and to expand if negative pressure decreases in the fluid reservoir (vacuum being applied externally to expand the reservoir within the housing, while application of atmospheric pressure causes the reservoir to reduce in size [0090].
Regarding Claim 9, Michaels further teaches the fluid reservoir (230, corresponding to 30 of Claim 1) [0128] is defined by a housing (215) and a piston (280) disposed within the housing [0131].
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.
Claim(s) 3, 4, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michaels in view of US 20160015873 A1 (Robinson et al.).
Regarding Claims 3 and 4, Michaels fails to teach the specific operating pressures used in the device, teaching operation at a predetermined working pressure [0023].
Robinson teaches an apparatus for managing fluid wherein the first check valve (134) and the second check valve (132) are configured to open at a therapeutic level of negative pressure (a differential of less than about 125 mmHg causing operation of the valves during operation [0053, 0055], therapeutic level defined to vary between 5 mmHg and 300 mmHg [0026]), and is therefore considered to be configured to open if negative pressure in the fluid reservoir is greater than zero mmHg or greater than 50 mmHg.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the undisclosed pressure of Michaels with those taught by Robinson as therapeutic pressures vary according to treatment requirements [Robinson 0026].
Regarding Claims 17 and 18, Michaels fails to teach the specific operating pressures used in the device, teaching operation at a predetermined working pressure [0023].
Robinson teaches an apparatus for managing fluid wherein the first check valve (134) and the second check valve (132) are configured to open at a therapeutic level of negative pressure (a differential of less than about 125 mmHg causing operation of the valves during operation [0053, 0055], therapeutic level defined to vary between 5 mmHg and 300 mmHg [0026]), and is therefore considered to be configured to open if negative pressure in the fluid reservoir is greater than zero mmHg or greater than 50 mmHg.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the undisclosed pressure of Michaels with those taught by Robinson as therapeutic pressures vary according to treatment requirements [Robinson 0026].
Claim(s) 11, 13, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michaels, as evidenced by US 20160325026 A1 (Yarger).
Regarding Claim 11, Michaels teaches a system (10) for treating a tissue site with negative pressure, the system comprising:
a housing (215) (Fig. 29) and a piston (280) defining a fluid chamber (230);
a first fluid passage (141) fluidly coupled to the fluid chamber (as seen in Fig. 20) and configured to fluidly couple the fluid chamber to the dressing (connecting via 134 as previously described);
a first check valve (within 134 as described in [0109]) configured to prevent egress from the fluid chamber to the dressing through the first fluid passage([0109] describing the valve preventing release of material);
a second fluid passage (Michaels Annotated Figs. 20 and 21) fluidly coupled to the fluid chamber (Fig. 20);
a negative-pressure source (44) configured to be coupled to the fluid chamber through the second fluid passage [0114]; and
a second check valve (146) configured to prevent ingress to the fluid chamber from the negative-pressure source through the second fluid passage [0114].
While not directly taught, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Michaels to include a dressing configured to be disposed adjacent to the tissue site as surgical procedures necessitate a dressing of some kind, as evidenced by Yarger which teaches the inclusion of dressings during surgical suction [Yarger 0006].
Regarding Claim 13, Michaels further teaches the fluid reservoir (30) is configured to contract if negative pressure increases in the fluid reservoir and to expand if negative pressure decreases in the fluid reservoir (vacuum being applied externally to expand the reservoir within the housing, while application of atmospheric pressure causes the reservoir to reduce in size [0090].
Regarding Claim 16, Michaels is considered to teach the first check valve (Michaels Annotated Figs. 20 and 21) and the second check valve (146) are configured to open at a therapeutic level of negative pressure, as flow would be required for suction to applied, thereby causing the valves to be open.
Claim(s) 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michaels in view of US 20170326277 A1 (Huang).
Regarding Claim 10, Michaels teaches a spring-controlled valve which allows for movement of the piston, but fails to explicitly teach a piston spring coupled to the piston and configured to expand the variable volume of the fluid reservoir if negative pressure in the fluid reservoir decreases.
Huang teaches a negative pressure system [Abstract] wherein a piston spring (9) coupled to the piston (4) and configured to expand the variable volume of the fluid reservoir (S2) if negative pressure in the fluid reservoir decreases [0009].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reservoir of Michaels to incorporate the piston spring system of Huang to allowed for controlled expansion of the reservoir [Huang 0035].
Regarding Claim 14, Michaels teaches a spring-controlled valve which allows for movement of the piston, but fails to explicitly teach a piston spring coupled to the piston and configured to expand the variable volume of the fluid reservoir if negative pressure in the fluid reservoir decreases.
Huang teaches a negative pressure system [Abstract] wherein a piston spring (9) coupled to the piston (4) and configured to expand the variable volume of the fluid reservoir (S2) if negative pressure in the fluid reservoir decreases [0009].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reservoir of Michaels to incorporate the piston spring system of Huang to allowed for controlled expansion of the reservoir [Huang 0035].
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michaels in view of US 20090030402 A1 (Adahan).
Regarding Claim 12, Michaels further teaches
a pressure sensor (vacuum level indicator 59) [0072];
a third fluid passage (145) comprising a first end (Michaels Annotated Figs. 20 and 21) configured to be fluidly coupled to the dressing (via 134) and a second end configured to be fluidly coupled to the pressure sensor (being fluidly coupled to 134 and the vacuum source); and
Michaels teaches use of a vacuum indicator and vacuum regulator to control pressure [0120], but fails to teach a controller configured to operate the negative-pressure source based on input from the pressure sensor.
a controller configured to operate the negative-pressure source based on input from the pressure sensor.
Adahan teaches a pressure sensor [0039]; and
a controller (300) configured to operate the negative-pressure source based on input from the pressure sensor to maintain a predetermined negative pressure [0038, 0041].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manual control taught by Michaels to incorporate the controller-based pressure control of Adahan to maintain a predetermined negative pressure [Adahan 0038, 0041].
Claim(s) 15, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michaels in view of US 20150018784 A1 (Coulthard et al.).
Regarding claim 15, Michaels fails to explicitly teach the second check valve is configured to maintain a therapeutic level of negative pressure in the fluid chamber if the negative-pressure source is separated from the fluid chamber.
Coulthard teaches a system for treating a tissue site with negative pressure [0108] wherein the valve is configured to maintain a therapeutic level of negative pressure in the fluid chamber if the negative-pressure source is separated from the fluid chamber [0109].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Michaels to incorporate the valve and vent design of Coulthard to allow the system to continue operation after disconnection from a negative pressure source [Coulthard 0109], thereby increasing reliability.
Regarding Claims 19 and 20, Michaels in view of Coulthard teaches the device of claim 15, which when operated would necessarily involve the claimed method. Michaels is therefore considered to teach a method of treating a tissue site with negative pressure, the method comprising: disposing a dressing adjacent to the tissue site; providing a fluid management unit comprising: a housing, a piston defining a fluid chamber in the housing, a first fluid passage fluidly coupled to the fluid chamber, a first check valve configured to prevent egress from the fluid chamber through the first fluid passage, a second fluid passage fluidly coupled to the fluid chamber, and a second check valve configured to prevent ingress to the fluid chamber through the second fluid passage; fluidly coupling the fluid chamber to the dressing through the first check valve; fluidly coupling a negative-pressure source to the fluid chamber through the second check valve; and applying a therapeutic level of negative-pressure from the negative-pressure source to the fluid chamber, further comprising separating the negative-pressure source from the fluid chamber, whereby the second check valve closes to maintain a therapeutic level of negative pressure in the fluid chamber and the fluid chamber receives fluid from dressing through the first check valve, further comprising separating the negative-pressure source from the fluid chamber, whereby the second check valve closes to maintain a therapeutic level of negative pressure in the fluid chamber and the fluid chamber receives fluid from dressing through the first check valve.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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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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/HANS KALIHER/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
