DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 89-108 are pending and examined on the merits.
Claims 1-88 are canceled.
Information Disclosure Statement
No information disclosure statement (IDS) was submitted by Applicant.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 89-90 and 92-98 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Buan (U.S. Pre Grant Pub. No. 2009/0299306 A1) in view of Ichiro (U.S. Patent No. 3,435,944 A).
Regarding claim 89, Buan teaches A sterile negative pressure wound therapy device (see at least Abstract; the device is considered sterile at least before use on a patient) comprising:
a housing (see housing 102 in para. [0034]);
a negative pressure source (see at least para. [0034]) supported by the housing (see para. [0034]) and configured to be connected via a fluid flow path to a wound dressing that covers a wound (see at least para. [0035]), the negative pressure source configured to provide negative pressure to the wound via the fluid flow path (see para. [0035 and 0037]);
an inlet (see port 14 in para. [0035]) and an outlet supported by the housing (see para. [0037] teaching a check valve 110 for preventing a flow of positive pressure; the area into which the check valve 110 is connected to the pump is considered to be an outlet), the inlet and outlet being in fluid communication with the negative pressure source (see at least para. [0035 and 0037]);
a first valve (see quick release valve 18 in para. [0035]) supported by the housing (see para. [0035]; since port 14 is included on the housing 102, the quick release valve 18 is also considered to be supported by the housing; see Fig. 1) and configured to control a flow of a fluid through the inlet (see para. [0035]); and
a second valve (see solenoid valve 118 in para. [0039]) supported by the housing (see para. [0039]) and configured to control a flow of a fluid through the outlet (see para. [0039]).
However, Buan fails to explicitly teach wherein each of the first and second valves is configured to permit a flow of fluid at a flow rate between 0.1 mL/min and 10 mL/min when closed to allow a sterilization gas to penetrate into the housing, as required by the claim.
Ichiro teaches an analogous medical device to be sterilized (see col. 1, lines 24-39) by introducing sterilizing gas such as ethylene oxide into the interior after the device has been mounted (see col. 1, lines 42-45). Ichiro further teaches that sterilizing gases permeate at the rate of about 1 mL/min (see col. 2, line 72 thru col. 3, line 5).
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 device of Buan to incorporate the teachings of Ichiro by configuring each of the first and second valves to permit a flow of fluid at a flow rate between 0.1 mL/min and 10 mL/min when closed to allow a sterilization gas to penetrate into the housing at least because it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); see also MPEP 2144.05(I). In the instant case, since Ichiro teaches a flow rate within the claimed range, such claimed range is obvious.
Regarding claim 90, Buan in view of Ichiro teaches the invention as discussed above in claim 89. Additionally, Buan teaches further comprising a one-way flow valve supported by the housing (see at least para. [0037]) and being in fluid communication with the inlet and the negative pressure source (para. [0037] teaches that the check valve 110 prevents flow from the pump module to the dressing), the one-way flow valve being configured to prevent the flow of fluid toward the inlet (see at least para. [0037])
Regarding claim 92, Buan in view of Ichiro teaches the invention as discussed above in claim 89. Additionally, while Ichiro teaches that sterilizing gases permeate at the rate of about 1 mL/min (see col. 2, line 72 thru col. 3, line 5), it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); see also MPEP 2144.05(I). Therefore, one of ordinary skill in the art would have found the claimed ranges obvious.
Regarding claim 93, Buan in view of Ichiro teaches the invention as discussed above in claim 89. Additionally, Buan teaches further comprising a plurality of indicators positioned at least partially on an exterior surface of the housing (see buttons 218 at least in Fig. 5 and para. [0046]), the plurality of indicators comprising:
a first indicator configured to indicate a leak condition in the fluid flow path (para. [0011] teaches that a user can program the device to display relevant operational information including current settings and error messages; therefore, one of the buttons can be a first indicator to indicate a leak); and
a second indicator configured to indicate a remaining capacity of a power source (para. [0011] teaches that a user can program the device to display relevant operational information including current settings and error messages; therefore, one of the buttons can be a second indicator to indicate a remaining capacity of a power source).
Regarding claim 94, Buan in view of Ichiro teaches the invention as discussed above in claim 93. Additionally, Buan teaches wherein the plurality of indicators comprises a third indicator (see for example one of the buttons in Fig. 5) configured to indicate that the negative pressure source has been activated (para. [0011] teaches that a user can program the device to display relevant operational information including current settings and error messages; therefore, one of the buttons can be a third indicator that indicates that the negative pressure source has been activated).
Regarding claim 95, Buan in view of Ichiro teaches the invention as discussed above in claim 89. Additionally, Buan teaches further comprising a switch (see button 212 in Fig. 5 and para. [0046]) positioned at least partially on an exterior surface of the housing, wherein the switch is a sole switch configured to manipulated by a user to activate and deactivate the negative pressure source (see para. [0046]).
Regarding claim 96, Buan in view of Ichiro teaches the invention as discussed above in claim 95. Additionally, Buan teaches further comprising a controller supported by the housing (see at least para. [0011]) and programmed to:
monitor a duration of time following an initial activation of the device (para. [0011] teaches that a user can program the device to display relevant operational information including current settings and error messages; therefore, the control unit is programmed to monitor a duration of time following initial activation of the device);
in response to manipulation of the switch by the user, activate the negative pressure source to cause provision of negative pressure by the negative pressure source (para. [0045-0046] teach that the control unit includes button 212 which is a power button; therefore, when the power button 212 is actuated, the control unit activates the negative pressure source; see also para. [0041]); and
in response to a determination that the duration of time has reached a lifetime threshold, disable provision of negative pressure by the negative pressure source (para. [0011] teaches that a user can program the device to display relevant operational information including current settings and error messages; additionally, para. [0044] teaches that batteries can be used to power the device; therefore, a determination that a duration of time has reached a lifetime threshold can be determining that the battery is depleted causing the device to power down).
Regarding claim 97, Buan in view of Ichiro teaches the invention as discussed above in claim 96. Additionally, Buan teaches wherein the initial activation comprises connection of a power source (para. [0012] teaches that the apparatus may include a power source for the pump; therefore, initial activation is not possible without connection of a power source for the pump).
Regarding claim 98, Buan in view of Ichiro teaches the invention as discussed above in claim 96. Additionally, Buan teaches further comprising a plurality of indicators positioned at least partially on the exterior surface of the housing (see display 210 in para. [0047] and Fig. 5), wherein the controller is further programmed to indicate with the plurality of indicators that the duration of time has reached the lifetime threshold (para. [0011] teaches that a user can program the device to display relevant operational information including current settings and error messages).
Claim 91 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Buan (U.S. Pre Grant Pub. No. 2009/0299306 A1) in view of Ichiro (U.S. Patent No. 3,435,944 A), as applied above to claim 89, and further in view of Heaton (U.S. Pre Grant Pub. No. 2007/0219512 A1).
Regarding claim 91, Buan in view of Ichiro teaches the invention as discussed above in claim 89. Additionally, Buan teaches further comprising a pressure sensor (see para. [0037]) configured to monitor pressure in the fluid flow path (see para. [0040]). However, neither Buan nor Ichiro explicitly teach a manifold as required by the claim.
Heaton teaches an analogous negative pressure wound therapy device (see Abstract) comprising a distribution manifold (see 24 in Fig. 1) supported by a housing (see reduced pressure adapter 22 in Fig. 4; as broadly recited, the manifold 24 is supported by reduced pressure adapter 22 at least because para. [0048] teaches that reduced pressure adapter 22 is adhered to the distribution manifold; additionally, the claim does not necessarily require that the negative pressure wound therapy device comprise the manifold, rather that it supports the manifold), the manifold comprising a first port (see communication line between port 22 and first pressure measurement 40a in Fig. 12) in fluid communication with a pressure sensor (see Fig. 12), a second port in fluid communication with the negative pressure source (see communication line between port 22 and negative pressure pump 38 in Fig. 12), and a third port in fluid communication with the inlet (see for example unlabeled central aperture in Fig. 2).
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 device of Buan in view of Ichiro to incorporate the teachings of Heaton by including a manifold supported by the housing and that comprises a first port in fluid communication with a pressure sensor, a second port in fluid communication with the negative pressure source, and a third port in fluid communication with the inlet at least in order to separate lumens in the reduced pressure device such that the manifold becomes a barrier between sensing lumens and a reduced pressure path, as taught by Heaton (see para. [0044]), which would better control, distribute, and combine fluids.
Claim 99 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Buan (U.S. Pre Grant Pub. No. 2009/0299306 A1) in view of Ichiro (U.S. Patent No. 3,435,944 A), as applied above to claim 89, and further in view of Fink (U.S. Pre Grant Pub. No. 2008/0082059 A1).
Regarding claim 99, Buan in view of Ichiro teaches the invention as discussed above in claim 96. However, neither Buan nor Ichiro explicitly teach that the lifetime threshold comprises at least ten days, as required by the claim.
Fink teaches an analogous negative pressure wound therapy device (see Abstract). Fink further teaches that the power source has a life capacity of 20-40 days (see para. [0045]).
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 device of Buan in view of Ichiro to incorporate the teachings of Fink by making the lifetime threshold comprise at least ten days at least because it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); see also MPEP 2144.05(I).
Claims 100-103 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Buan (U.S. Pre Grant Pub. No. 2009/0299306 A1) in view of Ichiro (U.S. Patent No. 3,435,944 A), as applied above to claim 89, and further in view of Lazarus (U.S. Patent No. 4,128,173 A).
Regarding claim 100, Buan in view of Ichiro teaches the invention as discussed above in claim 89. However, neither Buan nor Ichiro explicitly teach a sterile packaging as required by the claim.
Lazarus teaches an analogous medical device that is placed in sterile openable sealed packages for storage and transport (see Abstract).
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 device of Buan in view of Ichiro to incorporate the teachings of Lazarus by enclosing the device of claim 89 in a sterile packaging at least in order to better store and transport the device, as taught by Lazarus (see Abstract).
Regarding claim 101, Buan, in view of Ichiro, and further in view of Lazarus teaches the invention as discussed above in claim 100. Additionally, Lazarus teaches wherein the sterile packaging comprises a first packaging container and a second packaging container (see 10A and 10B in Fig. 1 and col. 7, lines 36-41) configured to be removably coupled with the first packaging container (see broken line 130 in Fig. 1), at least one of the first or second packaging containers including one or more recesses sized to receive the device (see 90, 92, 94 in Fig. 1).
Regarding claim 102, Buan, in view of Ichiro, and further in view of Lazarus teaches the invention as discussed above in claim 101. Additionally, Lazarus teaches wherein at least one of the first and second packaging containers includes one or more recesses sized to receive one or more batteries configured to be inserted into the housing (see 90, 92, 94 in Fig. 1).
Regarding claim 103, Buan, in view of Ichiro, and further in view of Lazarus teaches the invention as discussed above in claim 102. Additionally, Lazarus teaches wherein the device has been sterilized after being positioned in the sterile packaging (see col. 7, lines 52-58).
Claim 104-108 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Buan (U.S. Pre Grant Pub. No. 2009/0299306 A1) in view of Ichiro (U.S. Patent No. 3,435,944 A), as applied above to claim 89, and further in view of Gunther (U.S. Patent No. 3,589,861 A).
Regarding claim 104, Buan, in view of Ichiro, and further in view of Lazarus teaches the invention as discussed above in claim 89. However, neither Buan, Ichiro, nor Lazarus explicitly teach exposing the device to the sterilization gas, wherein the sterilization gas comprises ethylene oxide, as required by the claim.
Gunther teaches an analogous process for sterilizing goods packaged in containers (see Abstract) comprising a sterilization gas that comprises ethylene oxide (see Abstract).
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 device of Buan, in view of Ichiro, and further in view of Lazarus to incorporate the teachings of Gunther by making the sterilization gas comprise ethylene oxide at least because ethylene oxide is well known to be a sterilization gas, as evidenced by its disclosure in Gunther (see at least Abstract).
Regarding claim 105, Buan, in view of Ichiro, further in view of Lazarus, and further in view of Gunther teaches the invention as discussed above in claim 104. However, neither Buan, Ichiro, nor Lazarus explicitly teach placing the device in a chamber and reducing pressure in the chamber relative to atmospheric pressure, as required by the claim.
Gunther teaches further comprising placing the device in a chamber and reducing pressure in the chamber relative to atmospheric pressure (see col. 1, lines 35-43).
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 device of Buan, in view of Ichiro, further in view of Lazarus, and further in view of Gunther to further incorporate the teachings of Gunther by placing the device in a chamber and reducing pressure in the chamber relative to atmospheric pressure at least because Gunther teaches that the package is placed in an environment of a permeable gas (see col. 1, lines 35-43) and one of ordinary skill in the art would have reasonably recognized that reducing the pressure within the chamber will allow the gas to permeate easier and faster through the package.
Regarding claim 106, Buan, in view of Ichiro, further in view of Lazarus, and further in view of Gunther teaches the invention as discussed above in claim 105. Additionally, Gunther teaches further comprising, subsequent to reducing pressure in the chamber, introducing the sterilization gas into the chamber and exposing the device to the sterilization gas for a duration of time (see col. 1, lines 35-43).
Regarding claim 107, Buan, in view of Ichiro, further in view of Lazarus, and further in view of Gunther teaches the invention as discussed above in claim 105. Additionally, Gunther teaches wherein the sterilization gas is introduced into the chamber at a reduced pressure relative to atmospheric pressure (see col. 1, lines 35-43).
Regarding claim 108, Buan, in view of Ichiro, further in view of Lazarus, and further in view of Gunther teaches the invention as discussed above in claim 106. However, neither Buan, Ichiro, nor Lazarus explicitly teach flushing the chamber with nitrogen or air, as required by the claim.
Gunther teaches the use of impermeable gas such as nitrogen to confine the package and prevent inflation of the package (see col. 6, lines 1-7).
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 device of Buan, in view of Ichiro, further in view of Lazarus, and further in view of Gunther to further incorporate the teachings of Gunther by flushing the chamber with nitrogen or air at least in order to confine the package and prevent inflation of the package, as taught by Gunther (see col. 6, lines 1-7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McMichael (U.S. Patent No. 7,401,703 B2) – Surgical Kit with Accessory Item Container.
Randolph (U.S. Pre Grant Pub. No. 2013/0211348 A1) – Systems and Methods for Delivering Fluid to a Wound Therapy Dressing
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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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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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781