Prosecution Insights
Last updated: April 18, 2026
Application No. 18/397,897

CONTROL OF WOUND CLOSURE AND FLUID REMOVAL MANAGEMENT IN WOUND THERAPY

Non-Final OA §103§112§DP
Filed
Dec 27, 2023
Examiner
TRAN, NHU
Art Unit
3781
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Smith & Nephew Inc.
OA Round
1 (Non-Final)
69%
Grant Probability
Favorable
1-2
OA Rounds
3y 0m
To Grant
95%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allow Rate
84 granted / 122 resolved
-1.1% vs TC avg
Strong +26% interview lift
Without
With
+26.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
35 currently pending
Career history
157
Total Applications
across all art units

Statute-Specific Performance

§101
1.3%
-38.7% vs TC avg
§103
51.5%
+11.5% vs TC avg
§102
12.5%
-27.5% vs TC avg
§112
26.7%
-13.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 122 resolved cases

Office Action

§103 §112 §DP
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. Status of Claims Claim(s) 2-21 is/are pending in the application . Claim(s) 2-21 is/ are examined on the merits . Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Information Disclosure Statement The information disclosure statement (s) (IDS) submitted on 01/11/2024 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement (s) has /have been considered by the examiner. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim(s) 2-11 and 14-21 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim(s) 2 recites the limitation “ a controller programmed to: … using the rate of fluid removal, determine a volume of fluid removed from the wound over a duration of time” which was not described in the specification. T he specification only discloses the controller configured to determine a volume or rate of fluid removed from the wound (¶ 0023 and 0030 ). There is no mention in the specification of using the rate of fluid removal to determine a volume of fluid removed from the wound over a duration of time and having the controller programmed . Claim(s) 2- 11 is/are rejected as being dependent from claim 2 and therefor including all the limitation thereof. Claim(s) 14 recites the limitation “using the rate of fluid removal, determine a volume of fluid removed from the wound over a duration of time” which was not described in the specification. T he specification only discloses a controller programmed to determine a volume or rate of fluid removed from the wound (¶ 0023 and 0030 ). There is no mention in the specification of using the rate of fluid removal to determine a volume of fluid removed from the wound over a duration of time and having the controller programmed. Claim(s) 14-21 is/are rejected as being dependent from claim 14 and therefor including all the limitation thereof. Claim Interpretation In claim s 2 and 14 , the limitation s “ volume of fluid removed from the wound over a duration of time ” and “rate of fluid removed ” are interchangeable (in view of at least ¶0022 of Applicant’s published application). In addition, a person having ordinary skill in the art would have understood/recognized the “rate of fluid removed” is the same as the “volumed of fluid removed over a duration of time”. 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. 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 3-5 and 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 28, 30, 33-34, and 37 of U.S. Patent No. 11395873. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 28, 30, 33-34, and 37 of the reference patent contain a wound therapy apparatus comprising a negative pressure source configured to provide negative pressure via a fluid flow path to a wound of a patient covered by a wound dressing and to remove fluid from the wound; and a controller configured to : monitor a rate of fluid removal from the wound during provision of negative pressure by the negative pressure source, determine the rate of fluid removal causes a volume of fluid being removed from the wound of the patient to meet or exceed a volume of fluid being provided to the patient and provide a notification that the volume of fluid being removed from the wound of the patient meets or exceeds the volume of fluid being provided to the patient. The scope of the claimed limitations in the reference patent encompasses the claimed limitations in the instant application. Regarding instant claim 3 , claim 28 of the reference patent discloses all of the limitations of instant claim 3. Examiner notes that the scope of the claimed “fluid volume threshold” encompasses “volume of fluid being provided to the patient”. Thus, the disclosed “volume of fluid being provided to the patient” in the reference patent reads on the claimed “fluid volume threshold”. Thus, instant claim 3 and claim 28 of the reference patent are coextensive in scope. Regarding instant claim 4 , claim 30 of the reference patent discloses all of the limitations of instant claim 4. Regarding instant claim 5 , claim 33 of the reference patent discloses all of the limitations of instant claim 5. Regarding instant claim 7 , claim 34 of the reference patent discloses all of the limitations of instant claim 7. Regarding instant claim 8 , claim 37 of the reference patent discloses all of the limitations of instant claim 8. 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) 2, 4 - 6 , 10-11, 14, and 16- 1 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Askem (US PGPUB 20150051560) in view of Toth (US PGPUB 20170065751). Regarding claim 2 , Askem discloses a wound therapy apparatus (a reduced pressure wound treatment apparatus 100 comprising a pump assembly 104: ¶0032, 0044, and Fig. 1) comprising: a negative pressure source (source of negative pressure 1090: ¶0045 and Fig. 3) configured to provide negative pressure via a fluid flow path to a wound of a patient covered by a wound dressing (a wound dressing 102: ¶0032 and 0041) and to remove fluid from the wound (¶0041) ; and a controller programmed to (a controller 1160 : ¶0030, 0044, and Fig. 3): monitor a rate of fluid removal from the wound during provision of negative pressure by the negative pressure source (¶0030, 0047, and 0109) , using the rate of fluid removal, determine a volume of fluid removed from the wound over a duration of time (¶0024, 0030 and 0047: determine rate of flow of fluid aspirated from wound), provide a notification (providing indication, alarms reflecting operating conditions to a user : ¶0031). Askem does not disclose the controller programmed to determine that the volume of fluid removed from the wound over the duration of time satisfies a fluid volume threshold and provide a notification responsive to determining that the volume of fluid removed from the wound over the duration of time satisfies the fluid volume threshold . In the same field of endeavor, wound therapy apparatus, Toth discloses a wound therapy apparatus (a wound assessment system 14: Abstract, ¶0041, and Fig. 1) comprising a controller to analyze values of one or more physiological parameters and to provide an alert or an alarm to patient (¶0050, 0119, and Fig. 1C) for the benefits of obtaining an assessment of wound exudate and providing treatment guideline based on the assessment (a processor 15: ¶0006, 0040, 0050, and Fig. 1C). Tod further discloses the parameters are flow rate of wound exudates or volume (¶0079 and Claim 5). Thus, Tod implicity discloses the controller configured to determine that the volume of fluid removed from the wound over the duration of time satisfies a fluid volume threshold and provide a notification responsive to determining that the volume of fluid removed from the wound over the duration of time satisfies the fluid volume threshold . It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Askem in view of Toth by programming the controller to determine that the volume of fluid removed from the wound over the duration of time satisfies a fluid volume threshold and provide a notification responsive to determining that the volume of fluid removed from the wound over the duration of time satisfies the fluid volume threshold , in order to obtain an assessment of wound exudate and provide treatment guideline based on the assessment, as suggested in ¶0006 of Toth. Regarding claim 4 , Askem does not disclose the controller is further programmed to monitor the rate of fluid removal from a weight of fluid aspirated from the wound. Toth further discloses the apparatus is configured to monitor and detect weight of exudate for the benefits of providing information for determining rate of exudate removal from wound site and monitor ing wound progression (¶0067). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Askem /Toth in view of Toth by having the controller being programmed to monitor the rate of fluid removal from a weight of fluid aspirated from the wound , in order to provide information for determining rate of exudate removal from wound site and monitor wound progression , as suggested in ¶0067 of Toth. Regarding claim 5 , Askem further discloses a canister configured to store fluid removed from the wound (¶0032) . Askem does not disclose the controller is further programmed to monitor the rate of fluid removal based on a level of fluid in the canister. Toth further discloses the apparatus is configured to monitor the rate of fluid removal based on a level of fluid in the canister for the benefits of providing information for determining rate of exudate removal from wound site and monitor ing wound progression (¶0042-0044 and 0067). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Askem /Toth in view of Toth by having the controller being programmed to monitor the rate of fluid removal based on a level of fluid in the canister , in order to provide information for determining rate of exudate removal from wound site and monitor wound progression , as suggested in ¶0067 of Toth. Regarding claim 6 , Askem further discloses a pressure sensor configured to monitor pressure in the fluid flow path (a pressure sensor 1070: ¶0045) , wherein the controller is programmed to monitor the rate of fluid removal based on monitoring pressure variations in the fluid flow path using output of the pressure sensor (¶0030 and 0045) . Regarding claim 10 , Askem further discloses the duration of time is part of a starting phase of treating the wound with negative pressure (¶0008-0009) . Regarding claim 11 , Askem implicitly discloses the controller is further programmed to cause the negative pressure source to decrease a level of negative pressure provided by the negative pressure source responsive to determining that the volume of fluid removed from the wound over the duration of time satisfies the fluid volume threshold (monitoring duty cycle of source of negative pressure to indicate rate of flow through the system and reflect a level of activity of the source of negative pressure : ¶0024 and 0030) . Regarding claim 14 , Askem discloses a method of operating a negative pressure wound therapy apparatus (¶0024), the method comprising: monitor a rate of fluid removal from the wound during provision of negative pressure by the negative pressure source (¶0030, 0047, and 0109) , using the rate of fluid removal, determine a volume of fluid removed from the wound over a duration of time (¶0024, 0030 and 0047: determine rate of flow of fluid aspirated from wound) , provide a notification (providing indication, alarms reflecting operating conditions to a user : ¶0031). wherein the method is performed by a controller (a controller 1160 : ¶0030, 0044, and Fig. 3). Askem does not disclose the method steps of determi ning that the volume of fluid removed from the wound over the duration of time satisfies a fluid volume threshold and provid ing a notification responsive to determining that the volume of fluid removed from the wound over the duration of time satisfies the fluid volume threshold . In the same field of endeavor, wound therapy apparatus, Toth discloses a wound therapy apparatus (a wound assessment system 14: Abstract, ¶0041, and Fig. 1) comprising a controller to analyze values of one or more physiological parameters and to provide an alert or an alarm to patient (¶0050, 0119, and Fig. 1C) for the benefits of obtaining an assessment of wound exudate and providing treatment guideline based on the assessment (a processor 15: ¶0006, 0040, 0050, and Fig. 1C). Tod further discloses the parameters are flow rate of wound exudates or volume (¶0079 and Claim 5). Thus, Tod implicity discloses the controller configured to determine that the volume of fluid removed from the wound over the duration of time satisfies a fluid volume threshold and provide a notification responsive to determining that the volume of fluid removed from the wound over the duration of time satisfies the fluid volume threshold . It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Askem in view of Toth by programming the controller to determine that the volume of fluid removed from the wound over the duration of time satisfies a fluid volume threshold and provide a notification responsive to determining that the volume of fluid removed from the wound over the duration of time satisfies the fluid volume threshold , in order to obtain an assessment of wound exudate and provide treatment guideline based on the assessment, as suggested in ¶0006 of Toth. Regarding claim 16 , Askem implicitly discloses decreasing a level of negative pressure provided by the negative pressure source responsive to determining that the volume of fluid removed from the wound over the duration of time satisfies the fluid volume threshold (monitoring duty cycle of source of negative pressure to indicate rate of flow through the system and reflect a level of activity of the source of negative pressure : ¶0024 and 0030) . Regarding claim 17 , Askem does not disclose monitoring the rate of fluid removal comprising monitoring the rate of fluid removal from a weight of fluid aspirated from the wound. Toth further discloses the apparatus is configured to monitor and detect weight of exudate for the benefits of providing information for determining rate of exudate removal from wound site and monitor ing wound progression (¶0067). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Askem /Toth in view of Toth by having the controller being programmed to monitor the rate of fluid removal from a weight of fluid aspirated from the wound , in order to provide information for determining rate of exudate removal from wound site and monitor wound progression , as suggested in ¶0067 of Toth. Regarding claim 18 , Askem further discloses monitoring one or more characteristic of pressure in a fluid flow path configured to connect the negative pressure source to the wound (a pressure sensor 1070 is used to monitor characteristic of pressure in a fluid flow path: ¶0045 and Fig. 3) , and wherein monitoring the rate of fluid removal is performed using the one or more characteristic of pressure (¶0030 and 0045) . Claim(s) 7- 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Askem (US PGPUB 20150051560) in view of Toth (US PGPUB 20170065751) , as applied to claim 6 above, and further in view of Jaecklein (US PGPUB 20160184496). Regarding claim s 7 -8 , Askem /Toth does not disclose the controller is further programmed to monitor the level of fluid in the canister using one or more characteristics of pressure in the fluid flow path and wherein the one or more characteristics of pressure comprises a magnitude of pressure signals, and the magnitude of pressure signals increases as the level of fluid in the canister increases. In the same field of endeavor, negative pressure therapy apparatus, Jaecklein discloses a negative pressure wound therapy apparatus including a controller configured to determine a level of exudate in a canister (Abstract). Jaecklein further discloses the controller configured to monitor the level of fluid in the canister using one or more characteristics of pressure in the fluid flow path (¶0007-0008) and to monitor the level of fluid in the canister from an activity level of the negative pressure source (¶0011-0012) and the one or more characteristics of pressure comprises a magnitude of pressure signals, and the magnitude of pressure signals increases as the level of fluid in the canister increases (¶0006-000 9 ) for the benefit of determining a level of exudate in the canister irrespective of an intensity of a leak present in a fluid flow path (¶000 9 ). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Askem /Toth in view of Jaecklein by having the controller being programmed as claimed , in order to determine a level of exudate in the canister irrespective of an intensity of a leak present in a fluid flow path , as suggested in ¶000 9 of Jaecklein . Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Askem (US PGPUB 20150051560) in view of Toth (US PGPUB 20170065751) , as applied to claim 5 above, and further in view of Jaecklein (US PGPUB 20160184496). Regarding claim 9 , Askem /Toth does not disclose the controller is programmed to monitor the level of fluid in the canister using an activity level of the negative pressure source, and wherein the negative pressure source comprises an actuator and the activity level of the negative pressure source corresponds to a speed of the actuator. In the same field of endeavor, negative pressure wound therapy apparatus, Jaecklein discloses a negative pressure wound therapy apparatus includes a controller configured to determine a level of exudate in a canister based at least in part on one or more characteristics of pressure signals generated by a negative pressure source and monitored by a pressure sensor (Abstract). Jaecklein further discloses the controller configured to monitor the level of fluid in the canister using one or more characteristics of pressure in the fluid flow path (¶0004 and 0007) and to monitor the level of fluid in the canister from an activity level of the negative pressure source (¶0012) for the benefit of determining a level of exudate in the canister irrespective of an intensity of a leak present in a fluid flow path (¶0007). Jaecklein also discloses the negative pressure source comprises an actuator and the activity level of the negative pressure source corresponds to a speed of the actuator (vacuum pump motor: ¶0059) for the benefit of measuring and/or monitoring activity of the negative pressure source. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Askem /Toth in view of Jaecklein by configuring the processor to monitoring the level of fluid in the canister using an activity level of the negative pressure source and incorporating an actuator in the negative pressure source , in order to determine a level of exudate in the canister irrespective of an intensity of a leak present in a fluid flow path and measuring and/or monitoring activity of the negative pressure source , as suggested in ¶0007 and 0059 of Jaecklein . Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Askem (US PGPUB 20150051560) in view of Toth (US PGPUB 20170065751) , as applied to claim 2 above, and further in view of Hartwell (US PGPUB 20170007751). Regarding claim s 12 -13 , Askem further discloses the controller is programmed to monitor the rate of fluid removal based on monitoring pressure changes in the fluid flow path (¶0024 , 0045 , and 0047 ) . Askem /Toth does not disclose the wound dressing compris ing a stabilizing structure configured to be inserted into the wound; collapse of the stabilizing structure as a result of provision of negative pressure causes one or more changes of pressure in the fluid flow path and the stabilizing structure is configured to collapse more in a horizontal plane than in a vertical plane perpendicular to the horizontal plane. In the same field of endeavor, wound dressing system, Hartwell discloses a negative pressure wound treatment apparatus comprising a wound dressing (¶0023-0026 and Fig. 1). Hartwell further discloses the wound dressing comprising a stabilizing structure 1701 (¶0085 and Figs. 4A-D) to facilitate closure of the skin surrounding the wound (¶0083) and wherein the stabilizing structure configured to collapse more within a horizontal plane than within a vertical plane to apply a horizontal force to the skin surrounding the wound when the wound dressing is placed under negative pressure (¶0023-0026) . It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Askem /Toth in view of Hartwell by incorporating a stabilizing structure configured to collapse more in a horizontal plane than in a vertical plane perpendicular to the horizontal plane , in order to facilitate closure of the skin surrounding the wound and apply a horizontal force to the skin surrounding the wound when the wound dressing is placed under negative pressure , as suggested in ¶00 23-0026 and 00 83 of Hartwell. Claim(s) 19-2 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Askem (US PGPUB 20150051560) in view of Toth (US PGPUB 20170065751) , as applied to claim 14 above, and further in view of Jaecklein (US PGPUB 20160184496). Regarding claim s 19-20 , Askem further discloses a canister configured to store fluid removed from the wound (¶0032). Askem does not disclose monitoring the level of fluid in the canister using one or more characteristics of pressure in the fluid flow path and wherein the one or more characteristics of pressure comprises a magnitude of pressure signals, and the magnitude of pressure signals increases as the level of fluid in the canister increases. Jaecklein further discloses the controller configured to monitor the level of fluid in the canister using one or more characteristics of pressure in the fluid flow path (¶0007-0008) and to monitor the level of fluid in the canister from an activity level of the negative pressure source (¶0011-0012) and the one or more characteristics of pressure comprises a magnitude of pressure signals, and the magnitude of pressure signals increases as the level of fluid in the canister increases (¶0006-0009) for the benefit of determining a level of exudate in the canister irrespective of an intensity of a leak present in a fluid flow path (¶0009). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Askem /Toth in view of Jaecklein by having the controller being programmed as claimed, in order to determine a level of exudate in the canister irrespective of an intensity of a leak present in a fluid flow path , as suggested in ¶0009 of Jaecklein . Regarding claim 21 , Askem does not disclose monitoring a level of fluid in the canister using an activity level of the negative pressure source, and wherein the negative pressure source comprises an actuator and the activity level of the negative pressure source corresponds to a speed of the actuator. Jaecklein further discloses the controller configured to monitor the level of fluid in the canister using one or more characteristics of pressure in the fluid flow path (¶0004 and 0007) and to monitor the level of fluid in the canister from an activity level of the negative pressure source (¶0012) for the benefit of determining a level of exudate in the canister irrespective of an intensity of a leak present in a fluid flow path (¶0007). Jaecklein also discloses the negative pressure source comprises an actuator and the activity level of the negative pressure source corresponds to a speed of the actuator (vacuum pump motor: ¶0059) for the benefit of measuring and/or monitoring activity of the negative pressure source. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Askem /Toth in view of Jaecklein by configuring the processor to monitoring the level of fluid in the canister using an activity level of the negative pressure source and incorporating an actuator in the negative pressure source , in order to determine a level of exudate in the canister irrespective of an intensity of a leak present in a fluid flow path and measuring and/or monitoring activity of the negative pressure source , as suggested in ¶0007 and 0059 of Jaecklein . Allowable Subject Matter The following is a statement of reasons for the indication of allowable subject matter: Claim(s) 2 and 15 is/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 closest prior art s of record are Askem (US PGPUB 20150051560) and Toth (US PGPUB 20170065751) . Regarding claims 2 and 15 , Askem /Toth fails to disclose the fluid volume threshold being indicative of a volume of fluid being provided to the patient over the duration of time. There is not an apparent/obvious reason/motivation to choose the fluid volume threshold of Askem /Toth to be a volume of fluid being provided to the patient over the duration of time. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NHU Q TRAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2032 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Thursday 8:00-5:00 (PST) . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT SARAH AL-HASHIMI can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-7159 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NHU Q. TRAN/ Examiner, Art Unit 3781 /PHILIP R WIEST/ Primary Examiner, Art Unit 3781
Read full office action

Prosecution Timeline

Dec 27, 2023
Application Filed
Mar 18, 2026
Non-Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
69%
Grant Probability
95%
With Interview (+26.1%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 122 resolved cases by this examiner. Grant probability derived from career allow rate.

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