www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/292,979
`
`05/11/2021
`
`Benjamin A. PRATT
`
`P001704US02PCT
`
`8266
`
`60402
`
`7590
`
`09/24/2024
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 20
`Troy, MI 48098
`
`EXAMINER
`
`DEL PRIORE, ALESSANDRO R
`
`Para NONE
`
`3781
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/24/2024
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`IPDocketing @ Solventum.com
`dgodzisz@hdp.com
`troymailroom @hdp.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-10,12,18-20 and 43-54 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 43-54 is/are withdrawn from consideration.
`() Claim(s)__is/are allowed.
`Claim(s) 1-10,12 and 18-20is/are rejected.
`[) Claim(s)__ is/are objectedto.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10)2) The specification is objected to by the Examiner.
`11)M The drawing(s) filed on 5/11/2021 is/are: a)¥) accepted or b)C) objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`Priority under 35 U.S.C. § 119
`12)2) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)() None ofthe:
`b)( Some**
`a) All
`1.1.) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*“ See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`2) (J Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240919
`
`Application No.
`Applicant(s)
`17/292,979
`PRATTet al.
`
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`
`ALESSANDRO R DEL PRIORE|3781 Yes
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1) Responsive to communication(s) filed on 8/26/2024.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)(2) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`The presentapplication, filed on or after March 16, 2013,
`
`is being examined underthe
`
`first inventor to file provisions of the AIA.
`
`Continued Examination Under 37 CFR 1.114
`
`A request for continued examination under37 CFR 1.114, including the fee set forth in
`
`37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible
`
`for continued examination under 37 CFR 1.114, and the fee setforth in 37 CFR 1.17(e) has been
`
`timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR
`
`1.114.
`
`The amendmentfiled 8/26/2024 has beenentered: Claims 1-10, 12, 18-20, and 43-54
`
`remain pending in the presentapplication. Claims 11, 13- 17 and 21-42 are cancelled and claim
`
`1 is currently amended. Claims 43-54 remain withdrawn. Claim 1 is amended and claims 1-10,
`
`12, and 18-20 are examined on the merits.
`
`Response to Arguments
`
`Applicant’s arguments with respect to claim(s) 1 have beenconsidered but are moot
`
`because the new ground of rejection does not rely on any reference applied in the prior
`
`rejection of record for any teaching or matter specifically challenged in the argument.
`
`Locke’114 remains as the primary reference in rejecting the present claims, for
`
`disclosing a majority of the claimed invention.
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 3
`
`Brandolini is being introduced as a secondary referencein the present rejection for
`
`disclosing and/or rendering obvious the newly amended limitations of claim 1.
`
`Locke, Beyrle and Locke’606 remain in the present rejection for disclosing and/or
`
`rendering obvious the limitations of the dependent claims.
`
`Applicant’s arguments regarding the dependent claims overcoming the rejection of
`
`record on at least the same grounds as claim 1 are similarly moot.
`
`Claim Rejections - 35 USC § 103
`
`In the event the determination of the status of the application as subjectto AIA35
`
`U.S.C. 102 and 103 (or as subjectto pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction
`
`of the statutory basis (i.e., changing from AIA to pre-AlA) forthe 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 forthin 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.
`
`Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et
`
`al. (US 2012/0143114 A1), hereinafter Locke’114,
`
`in view of Brandolini et al (US
`
`2021/0290837 A1).
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 4
`
`Regarding claim 1, Locke’114 teaches a wound therapy system (Fig. 1; Abstract)
`
`comprising:
`
`a canister configured to contain fluid removed from a wound site (fluid container 122;
`
`qs 35-36);
`
`a conduit having a first end coupled to the canister and a second end operably coupled
`
`to the wound site (conduit 118 can be seenin Fig. 1 coupled to the reservoir 122, andtoa
`
`tissue site through interface 110; 4s 34-36), wherein an interior volume of the conduitis
`
`defined by a single lumen providing the only fluid path between the canister and the wound
`
`site (Fig. 1 shows one lumen serving as the only fluid path between the canister and the wound
`
`site);
`
`whereinan interior volume of the canister and an interior volume of the conduit define
`
`a negative pressurecircuit (4s 34-36 describe how the conduit and canister and connected and
`
`transfer fluid and negative pressure; thus they would define an interior volume of a negative
`
`pressurecircuit);
`
`a pump fluidly operably coupled to the wound site via the conduit and configured to
`
`apply negative pressure to the woundsite via the negative pressure circuit (reduced pressure
`
`source 124; described in 4s 35-37);
`
`a pressure indicator configured to indicate a pressure within the negative pressure
`
`circuit (4] 37 describes the pressurein eachtissue site is displayed on user interface 126 and
`
`also alarms are generated with respect to pressure source 124); and
`
`a controller (4Js 37-39 describe a processing unit) configured to:
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 5
`
`store a baseline pressure decay curve representing a change in pressure within the
`
`negative pressure circuit fora first negative pressure to a predetermined threshold pressure
`
`over a first period of time (4138 describes a threshold pressure),
`
`generate a second pressure decay curve by operating the pump to apply a second
`
`applied negative pressure equal to the first negative pressure to the negative pressurecircuit (J
`
`38) and measuring a change in pressure overa second period of time within the negative
`
`pressure circuit during which the pressure within the negative pressure circuit increases from
`
`the second applied negative pressure to the threshold pressure(Js 38-39 also describes
`
`comparing the generated decay curve to the standard curve will distinguish between slough
`
`and granulation tissue);
`
`compare the second pressure decay curve to the baseline pressure decay curve; and
`
`generate an alert in response to detecting that a difference between the second pressure decay
`
`curve and the baseline pressure decay curve exceeds a predetermined first variance threshold
`
`(ls 38-39).
`
`Locke’114 does not explicitly teach the single lumen providing the only flow path to the
`
`wound site.
`
`Brandolini teaches a wound dressing system (Figs. 4A-4B; Abstract), thus being in the
`
`same field of endeavor, comprising a pressure sensor within the canister (q] 162 indicates
`
`pressure sensorsbeing in the inlet, canister connection, in the canister or in the dressing).
`
`It would have been obvious to one of ordinary skill in the art before the effectivefiling
`
`date of the claimed invention to have modified the pressure sensors of Locke’114 to be
`
`distributed as taught by Brandolini (e.g. in the inlet, canister connection, within the canister, at
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 6
`
`the wound dressing, etc.). Doing so would thus comprise a single lumen providing the onlyfluid
`
`path to the wound site as the sensors of Brandolini do not utilize dedicated pressure lumens.
`
`Doing so would be advantageous in mitigating the effects of errant pressure readings (4 162 of
`
`Brandolini).
`
`Regarding claim 6, Locke’114 further discloses the baseline pressure decay curve stored
`
`by the controller is generated based on measuring pressure decay within the negative pressure
`
`circuit prior to an initial use of the wound therapy system to provide negative pressure therapy
`
`to the wound site (4] 38 describes a threshold pressure).
`
`Further, “[E]ven though product-by-process claims are limited by and defined by the
`
`process, determination of patentability is based on the productitself. The patentability of a
`
`product does not dependon its method of production. If the product in the product-by-
`
`process claim is the same as or obvious from a product of the prior art, the claim is
`
`unpatentable eventhough the prior product was made by a different process." In the instant
`
`case, the baseline pressure decay curve of Locke’114 appearsidentical to the pressure decay
`
`curve as claimed, and the means of generation does not appear to change how the resulting
`
`baseline curve is used. See MPEP 2113.
`
`Claims 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Locke’114
`
`and Brandolini, as applied to claim 1 above, and further in view of Locke et al. (US
`
`2013/0144227 A1), hereinafter Locke.
`
`Regarding claim 2, the combination of Locke’114 and Brandolini does not explicitly
`
`disclose, wherein, in response to generating the alert, the controller is further configured to:
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 7
`
`generate a third pressure decay curve by operating the pump to apply a third applied
`
`negative pressure equal to the first negative pressure circuit and measuring a changein
`
`pressure over a third period of time within the negative pressure circuit during which the
`
`pressure within the negative pressurecircuit increases from the third applied negative pressure
`
`to the threshold pressure; and
`
`comparethe third pressure decay curve to the second pressure decay curve.
`
`Locke discloses a wound therapy system (Fig. 1; Abstract), thus being in the same field
`
`of endeavor, comprising:
`
`a canister configured to contain fluid removed from a wound site (fluid reservoir 134; qs
`
`44 and 50);
`
`a conduit having a first end coupled to the canister and a second end operably coupled
`
`to the wound site (conduits 126 can be seenin Fig. 1 coupled to the therapy unit 128 which
`
`contains reservoir 134, and to tissue sites 102 through interfaces 120; 4s 36 and 40); and
`
`a controller (Fig. 2 shows controller 136; {Js 9, and 44-46 describes the controller)
`
`configured to:
`
`store a baseline pressure decay curve representing a change in pressure within the
`
`negative pressure circuit fora first negative pressure to a predetermined threshold pressure
`
`over a first period of time (4 93 describes a median or standard decay pattern),
`
`generate a second pressure decay curve by operating the pump to apply a second
`
`applied negative pressure equal to the first negative pressure to the negative pressurecircuit (4
`
`93 generating a second decay pattern, i.e. second decay curve) and measuring a changein
`
`pressure over a second period of time within the negative pressure circuit during which the
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 8
`
`pressure within the negative pressure circuit increases from the second applied negative
`
`pressure to the threshold pressure (493 also describes comparing the generated decay pattern
`
`to the standard pattern and determining variation) ;
`
`compare the second pressure decay curve to the baseline pressure decay curve; and
`
`generate an alert in response to detecting that a difference between the second pressure decay
`
`curve and the baseline pressure decay curve exceedsapredetermined first variance threshold
`
`(4] 93 indicates the controller triggers an alert based on the variance between pressure decay
`
`patterns).
`
`Locke further discloses, wherein, in response to generating the alert, the controller is
`
`configured to:
`
`generate a third pressure decay curve by operating the pump to apply a third applied
`
`negative pressure equal to the first negative pressure to the negative pressurecircuit and
`
`measuring a change in pressure over a third time period within the negative pressure circuit
`
`during which the pressure within the negative pressure circuit increases from the third applied
`
`negative pressure to the threshold pressure; and compare the third pressure decay curve to the
`
`second pressure decay curve (the end of 4] 93 indicates additional measurements can be taken
`
`subsequentan initial measurement and alert to confirm the leakage of a channel).
`
`It would have been obvious to one of ordinary skill in the art before the effectivefiling
`
`date of the claimed invention to have modified the controller of Locke’114 and Brandolini to
`
`generate a third pressure decay curveas taught by Locke. Doing so would thus comprise the
`
`controller being further configured to:
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 9
`
`generate a third pressure decay curve by operating the pump to apply a third applied
`
`negative pressure equal to the first negative pressure circuit and measuring a changein
`
`pressure over a third period of time within the negative pressure circuit during which the
`
`pressure within the negative pressurecircuit increases from the third applied negative pre ssure
`
`to the threshold pressure; and
`
`comparethe third pressure decay curve to the second pressure decay curve.
`
`Doing so would be advantageous in more accurately confirming the presence of a leak
`
`(9 93 of Locke).
`
`Regarding claim 8, the combination of Locke’114 and Brandolini does not explicitly
`
`teach the detected difference between the second pressure decay curve and the baseline
`
`pressure decay curve comprises a difference in slop e between the baseline and second
`
`pressure decay curve.
`
`Locke discloses a wound therapy system (Fig. 1; Abstract), thus being in the same field
`
`of endeavor, comprising:
`
`a canister configured to contain fluid removed from a wound site (fluid reservoir 134; 4s
`
`44 and 50);
`
`a conduit having a first end coupled to the canister and a second end operably coupled
`
`to the wound site (conduits 126 can be seenin Fig. 1 coupled to the therapy unit 128 which
`
`contains reservoir 134, and to tissue sites 102 through interfaces 120; 4s 36 and 40); and
`
`a controller (Fig. 2 shows controller 136; {Js 9, and 44-46 describes the controller)
`
`configured to:
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 10
`
`store a baseline pressure decay curve representing a change in pressure within the
`
`negative pressurecircuit fora first negative pressure to a predetermined threshold pressure
`
`over a first period of time (4 93 describes a median or standard decay pattern),
`
`generate a second pressure decay curve by operating the pump to apply a second
`
`applied negative pressure equal to the first negative pressure to the negative pressurecircuit (|
`
`93 generating a second decay pattern, i.e. second decay curve) and measuring a changein
`
`pressure over a second period of time within the negative pressurecircuit during which the
`
`pressure within the negative pressure circuit increases from the second applied negative
`
`pressure to the threshold pressure (493 also describes comparing the generated decay pattern
`
`to the standard pattern and determining variation);
`
`compare the second pressure decay curve to the baseline pressure decay curve; and
`
`generate an alert in response to detecting that a difference between the second pressure decay
`
`curve and the baseline pressure decay curve exceedsa predetermined first variance threshold
`
`(4] 93 indicates the controller triggers an alert based on the variance between pressure decay
`
`patterns).
`
`Locke further discloses the detected difference between the second pressure decay
`
`curve and the baseline pressure decay curve comprises a difference in slope between the
`
`baseline and second pressure decay curve(4 93 indicates the ramp up pattern; Figs. 7 and 8
`
`show differences in slope and time of the pressure curves).
`
`It would have been obvious to one of ordinary skill in the art before the effectivefiling
`
`date of the claimed invention to have modified the controller of Locke’114 and Brandolini to
`
`detect the difference between pressure decay curves as taught by Locke. Doing so would thus
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 11
`
`comprise the detected difference between the second pressure decay curve and the baseline
`
`pressure decay curve comprising a difference in slope between the baseline pressure decay
`
`curve anda slope of the second pressure decay curve. Doing so would be advantageous in more
`
`accurately confirming the presence of a leak (4] 93 of Locke).
`
`Claims 3-4, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Locke’114, Brandolini, and Locke, as applied to claim 2 above, in view of Beyrle et al. (EP
`
`3187204 A1), hereinafter Beyrle.
`
`Regarding claim 3, the combination of Locke’114, Brandolini, and Locke does not
`
`explicitly teach the controller is further configured to generate a blockage alarm in response to
`
`detecting that a difference between the third pressure decay curve and the second pressure
`
`decay curve exceeds a predetermined variance threshold.
`
`Beyrle teaches a method of determining a blockage condition, thus being in the same
`
`field of endeavor, by comparing pressure curves (4s 22-23 how multiple instances, i.e. second
`
`and third decay curves, of pressure over time is measuredand an alarm is triggered; 127 further
`
`describe howan initial pressure is generated and compared with a threshold).
`
`It would have been obvious to one of ordinary skill in the art before the effectivefiling
`
`date of the claimed invention to have modified the device of Locke’114, Brandolini, and Locke
`
`to explicitly trigger a blockage alarm in response to measuring a second and third pressure
`
`decay curve, and detecting that a difference between the second and third decay curves exceed
`
`a predetermined variance threshold. Doing so would be obvious to provide the advantage of
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 12
`
`alerting a user that a blockage is detected, and also in confirming the condition (4s 11 and 22 of
`
`Beyrle).
`
`Regarding claim 4, the combination of Locke’114, Brandolini, and Locke does not
`
`explicitly disclose the controller configured to generate a leakage alarm in response to
`
`detecting that a difference between the third pressure decay curve and the second pressure
`
`decay curve exceeds a predetermined second variance threshold.
`
`In the same field of endeavor, Beyrle teaches a method of determining a pressure
`
`condition by comparing pressure curves (4/s 22-23 how multiple instances,i.e. second and third
`
`decay curves, of pressure over time is measured and an alarm is triggered; 127 further describe
`
`how an initial pressure is generated and compared with a threshold), and making subsequent
`
`comparisons before triggering an alarm (4s 22-24).
`
`It would have been obvious to one of ordinary skill in the art before the effectivefiling
`
`date of the claimed invention to have modified the device of Locke’114 and Locke to explicitly
`
`trigger a leakage alarm in response to measuring a second and third pressure decay curve, and
`
`detecting that a difference betweenthe second and third decay curves exceeda predetermined
`
`variance threshold. Doing so would be obvious to provide the advantage of confirming the
`
`condition before alerting a user to reducefalse positives ({/s 11 and 22 of Beyrle).
`
`Regarding claim 10, the combination of Locke’114, Brandolini, Locke, and Beyrle
`
`substantially discloses the invention of claim 4. Beyrle further teaches the detected difference
`
`between the third pressure decay curve and the second pressure decay curve comprises at
`
`least one of a differentslope and a differenttime period betweenthe second and third
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 13
`
`pressure decay curves (4s 12 and 94 describes monitoring a difference in pressure drop over
`
`the same period of time, i.e. slope).
`
`Regarding claim 12, the combination of Locke’114, Brandolini, Locke, and Beyrle
`
`substantially discloses the invention of claim 4. Locke further discloses the detected difference
`
`between the second pressure decay curve and the baseline pressure decay curve comprises a
`
`difference in slope between the baseline and second pressure decaycurve ( 4] 93 indicates the
`
`ramp up pattern; Figs. 7 and 8 show differences in slope and time of the pressure curves).
`
`It would have been obvious to one of ordinary skill in the art before the effectivefiling
`
`date of the claimed invention to have modified the controller of Locke’114, Locke, and Beyrle to
`
`detect the difference between pressure decay curves as taught by Locke. Doing so would thus
`
`comprise the detected difference between the second pressure decay curve and the baseline
`
`pressure decay curve comprising a difference in slope between the baseline pressure decay
`
`curve anda slope of the second pressure decay curve. Doing so would be advantageous in more
`
`accurately confirming the presence of a leak (4] 93 of Locke).
`
`Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Locke’114 and
`
`Brandolini, as applied to claim 1 above, in view of Beyrle.
`
`Regarding claim 5, the combination of Locke’114 and Brandolini does not explicitly
`
`teach:
`
`in response to detecting that the second pressure decay curve is substantially the same
`
`as the baseline pressure decay curve, the controller is further configured to follow a
`
`predetermined time interval:
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 14
`
`generate a third pressure decay curve by operating the pump to apply a third applied
`
`negative pressure equal to the first negative pressure to the negative pressure circuit and
`
`measuring a change in pressure over a third time period with the negative pressure circuit
`
`during which the pressure within the negative pressure circuit increases from the third applied
`
`negative pressure to the threshold pressure; and
`
`compare the third pressure decay curve to the baseline pressure decay curve
`
`Beyrle teaches a method of determining a pressure condition by comparing pressure
`
`curves ({/s 22-23 how multiple instances, i.e. second and third decay curves, of pressure over
`
`time is measured to regularly monitor pressure conditions; 127 further describe howan initial
`
`pressure is generated and compared with a threshold), thus being in the same field of
`
`endeavor, and in responseto detecting that the second pressure decay curveis substantially
`
`the same as the baseline pressure decay curve, the controller is furtherconfigured to follow a
`
`predetermined time interval:
`
`generate a third pressure decay curve by operating the pump to apply a third applied
`
`negative pressure equal to the first negative pressure to the negative pressurecircuit and
`
`measuring a change in pressure over a third time period with the negative pressure circuit
`
`during which the pressure within the negative pressure circuit increases from the third applied
`
`negative pressure to the threshold pressure; and
`
`compare the third pressure decay curve to the baseline pressure decay curve ( 4 22 describes
`
`how blockage detection is executed at regular intervals).
`
`It would have been obvious to one of ordinaryskill in the art before the effective filing
`
`date of the claimed invention to have modified the device of Locke’114 and Brandolini to
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 15
`
`repeat pressure decay curve measurementsat regular intervals. Doing so would thus comprise
`
`the controller configured to generate and compare subsequent pressure decay curves. Doing so
`
`would be obvious to provide the advantage of continuously monitoring for abnormal pressure
`
`conditions (Js 11 and 22 of Beyrle).
`
`Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Locke’114 ,
`
`Brandolini and Locke as applied to claim 8 above,in view of Beyrle.
`
`Regarding claim 9, the combination of Locke’114, Brandolini, and Locke does not
`
`explicitly teach:
`
`the variance threshold being approximately between 5% and 15%.
`
`Beyrle teaches a method of determining a pressure condition, thus being in the same
`
`field of endeavor, by comparing pressure curves (4s 22-23 how multiple instances,i.e. first and
`
`second decay curves,of pressure overtime is measured to regularly monitor pressure
`
`conditions; 127 further describe howan initial pressure is generated and compared with a
`
`threshold), and the threshold being between 10% and 30% (4s 26 and 30)
`
`It would have been obvious to one of ordinary skill in the art before the effectivefiling
`
`date of the claimed invention to have modified the device of Locke’114, Brandolini, and Locke
`
`to have a variance threshold between 10% and 30%. Doing so would be obvious to provide the
`
`advantage of allowing for blockage detection (4/s 11, 22, 26 and 30 of Beyrle).
`
`The combination still does not explicitly teach between approximately 5% and
`
`approximately 15%.
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 16
`
`However, it would have been obvious to one having ordinaryskill in the art before the
`
`effective filing date of the claimed invention to modify the variance threshold from 10% and
`
`30% to approximately 5% and 15% as applicant appears to have placed no criticality on the
`
`claimed range (Js 10 and 17-20 merelyindicate this threshold is “in some embodiments” ) and
`
`since it has beenheld that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges
`
`disclosed by the prior art’ a prima facie case of obviousnessexists.” See MPEP 2133.05 (I).
`
`Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Locke’114, and
`
`Brandolini as applied to claim 1 above, in view of Locke et al. (US 2017/0014606 A1),
`
`hereinafter Locke’606.
`
`Regarding claim 7, the combination of Locke’114 and Brandolini does not explicitly
`
`teach:
`
`a calibrated leak in fluid communication with the negative pressurecircuit, the
`
`calibrated leak configured to allow ambient air to flow into the negative pressure circuit ata
`
`known flow rate and increase a pressure within the negative pressurecircuit.
`
`However, Locke’606 teaches a wound therapy system (Fig. 1; Abstract),thus being in the
`
`same field of endeavor, comprising a calibrated leak in fluid communication with the negative
`
`pressurecircuit, the calibrated leak configured to allow ambient air to flow into the negative
`
`pressure circuit at a known flow rate and increase a pressure within the negative pressure
`
`circuit (Fig. 18, valves 92 and 94; 4Js 92-94).
`
`It would have been obvious to one of ordinaryskill in the art before the effectivefiling
`
`date of the claimed invention to have modified the device of Locke’114 and Brandolini to
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 17
`
`comprise the valves of Locke’606. Doing so would thus comprise a calibrated leak in fluid
`
`communication with the negative pressurecircuit, the calibrated leak configured to allow
`
`ambient air to flow into the negative pressure circuit at a known flow rate and increase a
`
`pressure within the negative pressure circuit. Doing so would be obvious to provide the
`
`advantage of allowing an increasein pressureto clear blockages (4 94 of Locke’606).
`
`Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Locke’114
`
`and Brandolini as applied to claim 1 above, in view of Wilt et al. (US 2014/0299544 A1),
`
`hereinafter Wilt.
`
`Regarding claim 18, the combination of Locke’114 and Brandolini does not explicitly
`
`teach:
`
`the baseline pressure decay curve stored by the controller comprises a plurality of
`
`volume-specific baseline pressure decay curves, each of the volume -specific baseline pressure
`
`decay curves being representative of a changein pressure within a negative pressurecircuit
`
`defined by a specific volume; the controller being configure to determine a volume to the
`
`negative pressure circuit, whereinthe baseline pressure decay curve to which the second decay
`
`curve is compared comprises a volume-specific baseline pressure decay curve corresponding to
`
`the determined volume of the negative pressurecircuit.
`
`In addressing the same problem as Applicant, the problem being the determination of
`
`pressure decaycurves in fluid paths, Wilt teaches a fluid system (Fig. 3A) which uses pressure
`
`decay to determine leakage (1s 347, 942, and 947-949) and also compares pressure data to
`
`

`

`Application/Control Number: 17/292,979
`Art Unit: 3781
`
`Page 18
`
`volume to generate an equation and calibrate the device in calculating pressure differences (Js
`
`1190 and 1192).
`
`It would have been obvious to one of ordinaryskill in the art before the effectivefiling
`
`date of the claimed invention to have modified the device of Locke’114 and Brandolini to store
`
`a plurality of volume-specific baseline pressure decay curves as taught by Wilt. Doing so would
`
`thus comprise the controller comprising a plurality of volume -specific baseline pressure decay
`
`curves, each of the volume-specific baseline pressure decay curves being represen