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 .
Double Patenting
Claims 24, 25, 29, and 35 of this application is patentably indistinct from claims 2, 6, and 10 of Application No. 17977220. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 10, and 15 of U.S. Patent No. 12161533. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant device is directed to a system comprising a single wound dressing featuring the same characteristics of the issued ‘533 device, namely a wound dressing configured to be positioned over a wound, the wound dressing comprising electronic circuitry; and a negative pressure wound therapy device comprising: a negative pressure source configured to provide negative pressure to the wound via a fluid flow path connecting the negative pressure source to the wound dressing; and a controller configured to operate the negative pressure source, wherein the electronic circuitry is configured to: monitor a dressing usage indicating a time duration during which the wound dressing has been in use; and communicate to the controller a dressing identifier unique to the electronic circuitry, the dressing usage, and a dressing usage threshold limit for the wound dressing, and wherein the controller is configured to: determine that the dressing usage satisfies the dressing usage threshold limit; and responsive to determining that the dressing usage satisfies the dressing usage threshold limit, provide an indication that the wound dressing should be replaced..
Instant Claim
US 12,161,533 Claim
24, 25
2
29
10
35
15
Claims 26-28, 30-34, and 36-43 are rejected based on their dependency.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 24, 29, 30, 34, 35, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200330662 A1 (Hartwell et al.).
Regarding Claim 24, Hartwell teaches a negative pressure wound therapy system (Fig. 15A), comprising:
a wound dressing (2300) configured to be positioned over a wound [0002], the wound dressing comprising an electronic circuitry [0118]; and
a negative pressure wound therapy device (2100) comprising:
a negative pressure source (2206A) [0104] configured to provide negative pressure to the wound via a fluid flow path connecting the negative pressure source to the wound dressing [0104]; and
a controller (2200) configured to operate the negative pressure source [0099], wherein the electronic circuitry is configured to:
monitor a dressing usage indicating a time duration during which the wound dressing has been in use [0086];
communicate to the controller a dressing identifier unique to the electronic circuitry ([0110] teaching it being specific to the dressing and usage), the dressing usage [0110], and a dressing usage threshold limit for the wound dressing [0110], and
wherein the controller is configured to:
determine that the dressing usage satisfies the dressing usage threshold limit (the described timer [0110]); and
responsive to determining that the dressing usage satisfies the dressing usage threshold limit, provide an indication that the wound dressing should be replaced (after exceeding the timer [0110]).
Regarding Claims 29 and 30, Hartwell further teaches the controller is further configured to automatically adjust one or more operational parameters of the negative pressure wound therapy device based on the dressing identifier, namely an alarm threshold [0113].
Regarding Claim 34, Hartwell further teaches monitoring an operational lifetime of the device, wherein upon completion of said lifetime, the device will cease to operate [0110]. As Hartwell also teaches indicators (204) which indicate the status and operation of the device, Hartwell is considered to teach the dressing usage threshold limit is shorter than the operational lifetime of the wound dressing (as the device would indicate it is running and has therefore not reached the operational lifetime).
Regarding Claim 35, Hartwell teaches a negative pressure wound therapy system (Fig. 15A) wherein through use would entail the method comprising:
by an electronic circuitry [0118] supported by a wound dressing (2300):
monitoring a dressing usage indicating a time duration during which the wound dressing has been in use for provision of negative pressure wound therapy to a wound [0110]; and
communicating to a controller (2200) of a negative pressure wound therapy device (2100) a dressing identifier unique to the electronic circuitry [0110], the dressing usage [0110], and a dressing usage threshold limit for the wound dressing [0110]; and
by the controller:
determining that the dressing usage satisfies the dressing usage threshold limit [0086, 0110]; and
responsive to determining that the dressing usage satisfies the dressing usage threshold limit, providing an indication that the wound dressing should be replaced [0110].
Regarding Claim 40, Hartwell further teaches the controller is further configured to adjust a leak alarm threshold based on a leak rate of a controlled leak of the wound dressing indicated by the dressing identifier [0116].
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) 25, 26, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200330662 A1 (Hartwell et al.) in view of US 20100022990 A1 (Karpowicz et al.).
Regarding Claim 25, Hartwell further teaches the electronic circuitry comprises a pressure sensor (2033) [0100] configured to monitor pressure proximal to the wound [0073].
Hartwell fails to teach monitoring a time duration during which the wound dressing has been in use based on detecting an initial attainment of the negative pressure set point in the fluid flow path
Karpowicz teaches a negative pressure wound therapy system (Abstract) wherein the device monitors a time duration during which the wound dressing has been in use based on detecting an initial attainment of the negative pressure set point in the fluid flow path, and communicate to the controller the time duration [0077] (as the tracking of compliant time is a measure of the time above the minimum negative pressure setpoint).
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 time measurement of Hartwell with the time measurement of Karpowicz to ensure the timer accurately reflects the in-use time of the device.
Regarding Claim 26, Hartwell fails to teach monitoring a time duration during which the wound dressing has been in use based on detecting an initial attainment of the negative pressure set point in the fluid flow path
Karpowicz teaches a negative pressure wound therapy system (Abstract) wherein the device monitors a time duration during which the wound dressing has been in use based on detecting an initial attainment of the negative pressure set point in the fluid flow path, and communicate to the controller the time duration [0077] (as the tracking of compliant time is a measure of the time above the minimum negative pressure setpoint).
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 time measurement of Hartwell with the time measurement of Karpowicz to ensure the timer accurately reflects the in-use time of the device.
Regarding Claim 36, Hartwell teaches the pressure sensors provide measurements which are used to control the device [0084] and is therefore considered to teach the initial attainment of the negative pressure set point in the fluid flow path is made based on one or more readings of the pressure sensor.
Hartwell fails to teach monitoring a time duration during which the wound dressing has been in use based on detecting an initial attainment of the negative pressure set point in the fluid flow path
Karpowicz teaches a negative pressure wound therapy system (Abstract) wherein the device monitors a time duration during which the wound dressing has been in use based on detecting an initial attainment of the negative pressure set point in the fluid flow path, and communicate to the controller the time duration [0077] (as the tracking of compliant time is a measure of the time above the minimum negative pressure setpoint).
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 time measurement of Hartwell with the time measurement of Karpowicz to ensure the timer accurately reflects the in-use time of the device.
Regarding Claim 37, Hartwell fails to teach monitoring a time duration during which the wound dressing has been in use based on detecting an initial attainment of the negative pressure set point in the fluid flow path
Karpowicz teaches a negative pressure wound therapy system (Abstract) wherein the device monitors a time duration during which the wound dressing has been in use based on detecting an initial attainment of the negative pressure set point in the fluid flow path, and communicate to the controller the time duration [0077] (as the tracking of compliant time is a measure of the time above the minimum negative pressure setpoint).
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 time measurement of Hartwell with the time measurement of Karpowicz to ensure the timer accurately reflects the in-use time of the device.
Claim(s) 32, 33, and 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200330662 A1 (Hartwell et al.) in view of US 20100022990 A1 (Karpowicz et al.). and further in view of US 20120136325 A1 (Allen et al.).
Regarding Claims 32 and 33, Hartwell teaches the ability to pause the timer [0097], but fails to teach the electronic circuitry is further configured to pause monitoring the time duration during which the wound dressing has been in use responsive to receiving an indication from the controller that provision of negative pressure by the negative pressure source has been interrupted or to resume monitoring the time duration during which the wound dressing has been in use responsive to receiving an indication from the controller that provision of negative pressure by the negative pressure source has been resumed..
Allen teaches a negative pressure wound therapy device wherein the electronic circuitry (1040) is further configured to pause monitoring the time duration during which the at least one wound dressing has been in use responsive to receiving an indication from the controller that provision of negative pressure by the negative pressure source has been interrupted, (as exemplified by a pause in the chosen run time of the device upon a change in measured pressure) [0069, 0070].
Allen further teaches the electronic circuitry (1040) is configured to measure time
of dressing usage [0063] and features a pause feature [0025] which temporarily
suspends or pauses operation [0066]. Through monitoring time, suspending usage for a
measured time and then resuming operation, the teachings of Allen correspond to the
claimed “resume monitoring the time duration during which the at least one wound
dressing has been in use responsive to receiving an indication from the controller that
provision of negative pressure by the negative pressure source has been resumed.”
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 timer of Hartwell in view of Karpowicz with the timer pausing operations of Allen in order to more accurately reflect the operational runtime of the device.
Regarding Claim 41, Hartwell teaches the ability to pause the timer [0097], but fails to teach automatically adjusting the one or more operational parameters of the negative pressure wound therapy device further based on at least one of an average pressure or a flow rate received from the electronic circuitry.
Allen teaches a negative pressure wound therapy device wherein the electronic circuitry (1040) is further configured to pause monitoring the time duration during which the at least one wound dressing has been in use responsive to receiving an indication from the controller that provision of negative pressure by the negative pressure source has been interrupted, (as exemplified by a pause in the chosen run time of the device upon a change in measured pressure, this being considered to represent a change in flow rate) [0069, 0070].
Allen further teaches the electronic circuitry (1040) is configured to measure time
of dressing usage [0063] and features a pause feature [0025] which temporarily
suspends or pauses operation [0066]. Through monitoring time, suspending usage for a
measured time and then resuming operation, the teachings of Allen correspond to the
claimed “resume monitoring the time duration during which the at least one wound
dressing has been in use responsive to receiving an indication from the controller that
provision of negative pressure by the negative pressure source has been resumed.”
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 timer of Hartwell in view of Karpowicz with the timer pausing operations of Allen in order to more accurately reflect the operational runtime of the device.
Regarding Claims 42 and 43, Hartwell teaches the ability to pause the timer [0097], but fails to teach receiving an indication from the controller that provision of negative pressure wound therapy has been stopped; and pausing monitoring the time duration during which the wound dressing has been in use responsive to receiving the indication that provision of negative pressure wound therapy has been stopped.
Allen teaches a negative pressure wound therapy device wherein the electronic circuitry (1040) is further configured to pause monitoring the time duration during which the at least one wound dressing has been in use responsive to receiving an indication from the controller that provision of negative pressure by the negative pressure source has been interrupted, (as exemplified by a pause in the chosen run time of the device upon a change in measured pressure) [0069, 0070].
Allen further teaches the electronic circuitry (1040) is configured to measure time
of dressing usage [0063] and features a pause feature [0025] which temporarily
suspends or pauses operation [0066]. Through monitoring time, suspending usage for a
measured time and then resuming operation, the teachings of Allen correspond to the
claimed “receiving an indication from the controller that provision of negative pressure wound therapy has been stopped; and pausing monitoring the time duration during which the wound dressing has been in use responsive to receiving the indication that provision of negative pressure wound therapy has been stopped”, as well as “receiving an indication from the controller that provision of negative pressure wound therapy has been resumed; and resuming monitoring the time duration during which the wound dressing has been in use responsive to receiving the indication that provision of negative pressure wound therapy has been resumed”.
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 timer of Hartwell in view of Karpowicz with the timer pausing operations of Allen in order to more accurately reflect the operational runtime of the device.
REASONS FOR ALLOWANCE
Claims 27, 28, 31, 38, and 39 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: US 20200330662 A1 (Hartwell et al.) in view of US 20100022990 A1 (Karpowicz et al.) are the closest prior art of record.
Hartwell teaches the systems of Claims 24 and 35, but fails to teach the controller is further configured to, responsive to determining that the dressing usage satisfies the dressing usage threshold limit: determine that the wound dressing has been replaced with another wound dressing responsive to detecting that a dressing usage during which the another wound dressing has been in use indicates that the another wound dressing is at or near a beginning of being in use.
While detection of the need to replace a dressing is well-known in the art, Hartwell is fails to teach determining that the wound dressing has been replaced with another wound dressing responsive to detecting that a dressing usage during which the another wound dressing has been in use indicates that the another wound dressing is at or near a beginning of being in use, alone or in combination.
Karpowicz teaches a negative pressure wound therapy system wherein the device monitors a time duration during which the wound dressing has been in use based on detecting an initial attainment of the negative pressure set point in the fluid flow path, and communicate to the controller the time duration. Karpowicz similarly fails to teach the claimed sequence of steps required during dressing change and is therefore considered to fail to teach the claimed device, alone or in combination.
Conclusion
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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/HANS KALIHER/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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