Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
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.
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Claims 18-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12097095. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent containthe limitations about the sampling rate in the independent claims and is thus more specific, in effect making the invention of pending claims 18-37 a "species" of the "generic" invention of instant claims 1-14. Further, the limitation of “duration of time” in the patented claims and “proportion of time” in the instant claims appear to be the same since there is no recitation regarding what period the “proportion” of time is relative to. In addition, the fluid flow path instantly recited would be part of the wound in the patented claims since the wound area would necessarily be part of the fluid flow path. It has been held that the generic invention is "anticipated" by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Regarding instant claim 18-37, claims 1-14 of the reference patent discloses all the limitations of instant claims 18-37.
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 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 negatived 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.
Claims 18-20, 24-28, 32-33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Svedman (US 2011/0015593) in view of Karpowicz (US 2007/0219532).
Regarding claim 18, Svedman discloses a method of operating a negative pressure wound therapy device, the method comprising, by a controller (14, [0038]) of the negative pressure wound therapy device:
operating a source of negative pressure of the negative pressure wound therapy device in a first mode via a fluid flow path (path from pumps 18/20 to the wound 11) to provide negative pressure to a wound covered by a wound dressing ([0024], [0042]), the source of negative pressure configured to be fluidically connected to the wound ([0049]);
determining pressure in the fluid flow path ([0047], [0042], sensors 42/34 can measure either pressure from pump to reservoir which would still be part of the fluid flow path and the pressure at the wound which is still part of the fluid flow path due to the fluid flowing to the wound by necessity); comparing the pressure to a target negative pressure ([0024]); at a first time in response to determining that the target negative pressure has not been established at the wound, continue operating the source of negative pressure in the first mode ([0058], [0024-0025], pressure is compared by microprocessor and leads to decision to continue applying pressure or to stop); and indicating a presence of a leak in response to determining a proportion of time during which the source of negative pressure has been activated over a time period satisfies a threshold indicative of a leak ([0054], a duration of two minutes is used to detect whether the pump has established pressure, and if not maintained a leak alarm results, the claims do not recite what the proportion is relative to and thus Examiner interprets this proportion of the time as synonymous with duration).
Svedman does not explicitly teach that the maintenance mode is uses less power than the first. It would have been obvious to a person of ordinary skill in the art at the time the invention was made to operate the maintenance mode at a lower power since the power draw for the pump is lower ([0024-0025]) and to conserve the power of the device since Svedman already contemplates using DC motor power ([0045]).
Svedman does not teach wherein at a second time in response to determining that the target negative pressure has been established at the wound, operating the negative pressure source in the second mode comprises cycling the source of negative pressure on and off to maintain the target negative pressure at the wound.
Karpowicz discloses a negative pressure would therapy method in the same field of endeavor as the Applicant. Karpowicz teaches wherein operating the negative pressure source (104 and 103) in a mode comprises cycling the source of negative pressure on and off to maintain the target negative pressure at the wound ([0088]).
Karpowicz utilizes the cyclic pressure application to provide constant desired pressure at the wound site ([0088]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the Svedman device with Karpowicz mode in order to provide desired pressures at the wound site.
Regarding claims 19-20, Svedman does not teach in the second mode, in response to determining that the pressure at the wound is more positive than the target negative pressure, activating the source of negative pressure to deliver negative pressure to the wound (claim 19), activating the source of negative pressure for one cycle (claim 20).
Karpowicz further teaches in the second mode, in response to determining that the pressure at the wound is more positive than the target negative pressure, activating the source of negative pressure to deliver negative pressure to the wound ([0088]), activating the source of negative pressure for one cycle ([0088])
Karpowicz utilizes the cyclic pressure application to provide constant desired pressure at the wound site ([0088]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the Svedman device with Karpowicz mode in order to provide desired pressures at the wound site.
Regarding claim 24, Svedman discloses maintaining a pressure in the range of -70 mmHg and -150 mmHg ([0053]).
Regarding claims 25, Svedman discloses the monitoring of pressure through the use of the pressure sensors ([0023-0024]). It follows naturally that the measuring of pressure sensor would occur asynchronously with the operation of the negative pressure since the measurement would need to occur before apply negative pressure ([0023-0024 which states the device measures pressure first and then applies negative pressure).
Regarding claim 26, Svedman discloses a negative pressure wound therapy apparatus comprising: a source of negative pressure (18, figure 1, [0045]) configured to provide negative pressure via a fluid flow path (path from pumps 18/20 to the wound 11) to a wound covered by a wound dressing (11), the source of negative pressure configured to be fluidically connected to the wound ([0024-0025]);
a pressure sensor (42/34) configured to determine pressure in the fluid flow path ([0047], [0042], sensors can measure either pressure from pump to reservoir which would still be part of the fluid flow path and the pressure at the wound which is still part of the fluid flow path due to the fluid flowing to the wound by necessity); and
a controller (14) configured to:
operate the source of negative pressure in a first mode ([0024]);
determine pressure in fluid flow path based on the readings of pressure obtained by the sensor;
compare the pressure at the wound to a target negative pressure ([0024], [42], [0047]);
in response to determining that the target negative pressure has not been established at the wound, continue operating the source of negative pressure in the first mode ([0024-0025]);
and indicating a presence of a leak in response to determining a proportion of time during which the source of negative pressure has been activated over a time period satisfies a threshold indicative of a leak ([0054], a duration of two minutes is used to detect whether the pump has established pressure, and if not maintained a leak alarm results, the claims do not recite what the proportion is relative to and thus Examiner interprets this proportion of the time as synonymous with duration).
Svedman does not explicitly teach that the maintenance mode is uses less power than the first. It would have been obvious to a person of ordinary skill in the art at the time the invention was made to operate the maintenance mode at a lower power since the power draw for the pump is lower ([0024-0025]) and to conserve the power of the device since Svedman already contemplates using DC motor power ([0045]).
Svedman does not teach in response to determining that the target negative pressure has been established at the wound wherein operating the negative pressure source in the second mode comprises cycling the source of negative pressure on and off to maintain the target negative pressure at the wound.
Karpowicz discloses a negative pressure would therapy method in the same field of endeavor as the Applicant. Karpowicz teaches teach in response to determining that the target negative pressure has been established at the wound wherein operating the negative pressure source (104 and 103) in the second mode comprises cycling the source of negative pressure on and off to maintain the target negative pressure at the wound ([0088]).
Karpowicz utilizes the cyclic pressure application to provide constant desired pressure at the wound site ([0088]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the Svedman device with Karpowicz mode in order to provide desired pressures at the wound site.
Regarding claim 27-28, Svedman does not teach in the second mode, in response to determining that the pressure at the wound is more positive than the target negative pressure, activating the source of negative pressure to deliver negative pressure to the wound (claim 27), activating the source of negative pressure for one cycle (claim 28).
Karpowicz further teaches in the second mode, in response to determining that the pressure at the wound is more positive than the target negative pressure, activating the source of negative pressure to provide negative pressure to the wound ([0088]), activating the source of negative pressure for one cycle ([0088]).
Karpowicz utilizes the cyclic pressure application to provide constant desired pressure at the wound site ([0088]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the Svedman device with Karpowicz mode in order to provide desired pressures at the wound site.
Regarding claim 32, Svedman discloses maintaining a pressure in the range of -70 mmHg and -150 mmHg ([0053]).
Regarding claim 33, Svedman discloses the monitoring of pressure through the use of the pressure sensors ([0023-0024]). It follows naturally that the measuring of pressure sensor would occur asynchronously with the operation of the negative pressure since the measurement would need to occur before apply negative pressure ([0023-0024 which states the device measures pressure first and then applies negative pressure).
Claims 22-23, 30-31 and 34-35 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Svedman in view of Karpowicz further in view of Gordon (US 2010/0278518).
Regarding claims 22-23 and 30-31, Svedman and Karpowicz do not disclose wherein determining the pressure at the wound comprises averaging a plurality of pressures at the wound (claim 22 and 30) and wherein comparing the pressure at the wound to the target negative pressure comprises comparing the average pressure to the target negative pressure (claim 23 and 31).
Gordon discloses suction devices in the same field of endeavor as the Applicant. Gordon teaches determining the pressure at the wound comprises averaging a plurality of pressures at the wound and wherein comparing the pressure at the wound to the target negative pressure comprises comparing the average pressure to the target negative pressure ([0070]).
Gordon minimizes jitter and noise by averaging pressure values ([0070]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Svedman with the averaging values of Gordon in order to minimize jitter and noise.
Regarding claim 34, Svedman discloses a negative pressure wound therapy apparatus comprising: a source of negative pressure (18, figure 1, [0045]) configured to provide negative pressure via a fluid flow path (path from pumps 18/20 to the wound 11) to a wound covered by a wound dressing (11), the source of negative pressure configured to be fluidically connected to the wound ([0024-0025]);
a pressure sensor (42/34) configured to determine pressure at the fluid flow path ([0047], [0042], sensors can measure either pressure from pump to reservoir which would still be part of the fluid flow path and the pressure at the wound which is still part of the fluid flow path due to the fluid flowing to the wound by necessity); and
a controller (14) configured to:
operate the source of negative pressure in a first mode ([0024]);
compare the pressure at the wound to a target negative pressure ([0024], [42], [0047]);
in response to determining that the target negative pressure has not been established at the wound, continue operating the source of negative pressure in the first mode ([0024-0025]);
Svedman does not explicitly teach that the maintenance mode is uses less power than the first. It would have been obvious to a person of ordinary skill in the art at the time the invention was made to operate the maintenance mode at a lower power since the power draw for the pump is lower ([0024-0025]) and to conserve the power of the device since Svedman already contemplates using DC motor power ([0045]).
Svedman does not teach in response to determining that the target negative pressure has been established at the wound wherein operating the negative pressure source in the second mode comprises cycling the source of negative pressure on and off to maintain the target negative pressure at the wound and determine pressure in fluid flow path based on an average of readings of pressure obtained by the sensor.
Karpowicz discloses a negative pressure would therapy method in the same field of endeavor as the Applicant. Karpowicz teaches teach in response to determining that the target negative pressure has been established at the wound wherein operating the negative pressure source (104 and 103) in the second mode comprises cycling the source of negative pressure on and off to maintain the target negative pressure at the wound ([0088]).
Karpowicz utilizes the cyclic pressure application to provide constant desired pressure at the wound site ([0088]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the Svedman device with Karpowicz mode in order to provide desired pressures at the wound site.
Svedman and Karpowicz does not teach determine pressure based on an average of readings of pressure obtained by the sensor.
Gordon discloses suction devices in the same field of endeavor as the Applicant. Gordon teaches determining the pressure at the wound comprises averaging a plurality of pressures at the wound and wherein comparing the pressure at the wound to the target negative pressure comprises comparing the average pressure to the target negative pressure ([0070]).
Gordon minimizes jitter and noise by averaging pressure values ([0070]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Svedman with the averaging values of Gordon in order to minimize jitter and noise.
Regarding claim 35, Svedman discloses indicating a presence of a leak in response to determining a proportion of time during which the source of negative pressure has been activated over a time period satisfies a threshold indicative of a leak ([0054], a duration of two minutes is used to detect whether the pump has established pressure, and if not maintained a leak alarm results, the claims do not recite what the proportion is relative to and thus Examiner interprets this proportion of the time as synonymous with duration).
Regarding claim 37, Svedman discloses the monitoring of pressure through the use of the pressure sensors ([0023-0024]). It follows naturally that the measuring of pressure sensor would occur asynchronously with the operation of the negative pressure since the measurement would need to occur before apply negative pressure ([0023-0024 which states the device measures pressure first and then applies negative pressure).
Allowable Subject Matter
Claims 21, 29 and 36 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 allowable subject matter of the sampling rates are the same as the parent Applications.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached on M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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