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
`
`17/281,668
`
`03/31/2021
`
`Christopher Brian LOCKE
`
`PO01658US02PCT
`
`1000
`
`60402
`
`7590
`
`07/03/2024
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 20
`Troy, MI 48098
`
`EXAMINER
`
`FLYNN, TIMOTHY LEE
`
`Para NONE
`
`3781
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`07/03/2024
`
`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)
`
`

`

`Application No.
`Applicant(s)
`17/281,668
`LOCKE et al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`TIMOTHY L FLYNN
`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 04 April 2024.
`C) A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)[¥) This action is FINAL.
`2b) (J 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.
`
`Disposition of Claims*
`1-5,7-8,10-11,19-20 and 26 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`CL] Claim(s)__is/are allowed.
`Claim(s) 1-5,7-8,10-11,19-20 and 26is/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://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)(J accepted or b)( 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)7) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.1.) Certified copies of the priority documents have been received.
`2.2) 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 20240626
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA orAIA Status
`
`The presentapplication,filed on or after March 16, 2013, is being examined under the first
`
`inventorto file provisions of the AIA.
`
`Response to Arguments
`
`Applicant’s amendments filed 04/04/2024 have been accepted. Claims 12, 14-18, 24, and 24 are
`
`canceled. Claims 1-5, 7-8, 10-11, 19-20, and 26 are pending.
`
`Applicant's argumentsfiled 04/04/2024 have been fully considered but they are not persuasive.
`
`Applicant argues that Wu/Robinson/Weston does not teach the amended limitations of claim 1
`
`wherein the first barrier comprises, “a first layer formed from a film” and “ a second layer sealed to the
`
`first layer to define a fluid path between thefirst layer and the second layer, the second layer formed
`
`froma film,” stating that the upper cover 215 and lower base 210 of Wu, which read on thefirst and
`
`second layers of the first barrier are not formed from a film. However, Dictionary.com defines a film as
`
`“athin sheet of any material.”
`
`|.”
`
`Thus, the upper cover 215 and lower base 210 of Wu meet the
`
`requirements of the claim as set forth below.
`
`Applicant argues that Wu/Robinson/Weston does not teach the amendedlimitations of claim 1
`
`wherein,“a plurality of standoffs formed by at least one of thefirst layer and the second layer,” stating
`
`that the support structures 205 of Wu protrude from a middle layer 207 rather than the first layer or the
`
`second layer (215 and 210 of Wu, respectively). However, Wu [0048] states that the support structures
`
`205 may beintegrated with or coupled to the inner walls of the conduit body 105, which includes layers
`
`215 and 210. Thus, the support structures 205 being integrated or coupled to layer 215 or 210 of Wu
`
`meet the requirements of the claimas set forth below.
`
`Applicant argues that one of ordinary skill would not combine the dressing valve 136 of
`
`Robinson with the pressure indicators of Wu because the connector body 123 of Robinson includes a
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 3
`
`receptacle 134 that would prevent application of negative pressure, and that the size of connector body
`
`123 would not motivate one to combine Robinson with Wu. However, the combination is drawn to the
`
`dressing valve 136 only, not the entire connector body 123, so the size of connector body 123 would not
`
`prevent the combination from being made. Additionally, the receptacle 134 is merely a connector toa
`
`reduced pressure delivery conduit, and thus would not prevent application of negative pressure when
`
`coupled to a negative pressure source as intended (Robinson 4][0023]). Additionally, since only the
`
`dressing valve 136 of Robinson is combined with thefirst barrier of Wu, the receptacle 134 would not
`
`necessarily be included in the combination. Thus, the rejection is maintained as set forth below.
`
`Applicant again argues that wound cover 40 of Weston cannot be interpreted as having a dual
`
`layer structure. However, the examiner maintains that Weston 4[0055] states that the protrusions 60
`
`may be constructed of a different material than cover 40, which clearly implies a dual layer structure,
`
`since the layer including the protrusions 60 may be constructed of a different material having its own
`
`thickness, pliability, or color that is different than the cover 40, (Weston 4[0055-0058)).
`
`Additionally, Applicant argues that cover 40 cannot be interpreted as having a dual layer
`
`structure because Westonstates in 4 [0054] that the plurality of protrusions 60 are embedded in the
`
`cover 40. However, the examiner maintains that the claimis written broadly enough that the cover 40
`
`and protrusions 60 of Weston arestill capable of being interpreted as having a dual layer structure.
`
`Furthermore, Wuin view of Robinson is relied upon as teaching the dual layer structure, and Westonis
`
`merely relied upon to teachthat the layers may havesimilar profiles and dimensions. In light of the
`
`combination of Wu/Robinson/Weston, it would be obvious to one of ordinary skill to have dual layers
`
`having similar profiles and dimension in order to simplify manufacturing.
`
`Applicant did not specifically argue the dependent claims.
`
`Claim Rejections - 35 USC § 103
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 4
`
`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 skillin 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.
`
`This application currently names joint inventors. In considering patentability of the claims the
`
`examiner presumesthat the subject matter of the various claims was commonly ownedas of the
`
`effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised
`
`of the obligation under 37 CFR 1.56 to point out the inventor and effectivefiling dates of each claim that
`
`was not commonly ownedas of the effective filing date of the later invention in order for the examiner
`
`to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art
`
`against the later invention.
`
`Claims 1-5, 8, 10-11, 19, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Wu (US 20130144230 A1) in view of Robinson (US 20110224633 A1), and furtherin view of Weston
`
`(US 20040073151 A1).
`
`Regarding Claim 1, Wu disclosesa fluid conductor (conduit body 105, Fig 5), comprising:
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page5S
`
`a first barrier (combination of upper cover 215 and base 210, Fig 5) formed fromafirst fluid -
`
`impermeable material (conduit body 105 can be made of polyethylene or polyurethane 4][0046]), the
`
`first barrier comprising:
`
`a first layer formed fromafilm (215 is formed from a film, defined asathin layer of any
`
`material, Fig 5);
`
`a second layer (210, Fig 5) sealedto thefirst layer to define a fluid path between thefirst layer
`
`and the second layer (device 100 may be configured to create and maintain a fluidic pathway,
`
`specifically between layers 215 and 210 4[0041][0050]), the second layer formed from a film (210 is
`
`formed fromafilm, defined as a thin layer of any material, Fig 5);
`
`the fluid path having a first end (distal port 115, Fig 1. Figs 1 and S show the same device, with
`
`Fig 5 illustrating the different layers that make up conduit body 105. Distal port 115, proximal port 125,
`
`and device 100, are presentin both figures, but they are unlabeled in Fig 5), a secondend (proximal port
`
`125, Fig 1), and a longitudinal axis (conduit body 105 has a longitudinal axis extending between 125 and
`
`115, Fig 1);
`
`and a plurality of standoffs (support structures 205, Fig 7A) formed byat least one ofthe first
`
`layer and the second layer (support structures 205 may be integrated with or coupled to the inner walls
`
`of the conduit body 105, which includes layers 215 and 210 4[0048]), the plurality of standoffs disposed
`
`in the fluid path (The support structures 205 prevent or mitigate collapse of the channel 200 upon
`
`application of internal vacuum, external pressure to or compression of the conduit body 105 4[0047)).
`
`and a plurality of pressure indicators (both ports 115 and 125 may include pressure indicators
`
`230, Fig 5. The indicator 230 can be positioned in one or more locations along the device 100 suchas
`
`within the tubing 130, ona region of the conduit body 105, near the distal port 115 or proximal port 125
`
`4[0057]) configured to elastically deform in response to a reduction in pressure (Defor mation of the
`
`exterior wall of the indicator 230 can result in a change fromafirst profile to a second profile. The
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 6
`
`relative position of the exterior wall between thefirst profile and the second profile can be indicative of
`
`an amount of pressure delivered to the woundsite. [0058]).
`
`Wuis silent regarding the first barrier and second barrier having similar profiles and dimensions,
`
`indicator ports distributed linearly along the first barrier parallel to and in fluid communication with the
`
`fluid path; and asecond barrier coupled to the first barrier, the second barrier formed from asecond
`
`fluid-impermeable material defining a plurality of pressure indicators aligned with the indicator ports
`
`and configured to elastically deform in response to a reduction in pressure through the indicator ports.
`
`However, Robinson teaches a reduced pressure therapy dressing, thus fromthe same field of
`
`endeavor, withindicator ports (port aperture 120, Fig 1), and a second barrier (flexible member 138,Fig
`
`1) coupled to thefirst barrier (sealing member 114, Fig 1), the second barrier (138, Fig 1) formed from a
`
`second fluid-impermeable material (connector body 123 and flexible member 138 may be formed or
`
`molded as an integral member. [0042] Connector body 123 may be made from polyurethane 4[0032]
`
`and thus 138 may be madeof polyurethane as well) defining a pressure indicator (dressing valve 136
`
`may indicate a reduced pressure state. Upon being subjected to at least threshold reduced pressure that
`
`is delivered to the interior of the dressing valve 136, the flexible member 138 collapses and seals the
`
`port aperture 120. 4[0042]) aligned with the indicator ports (dressing valve 136 is aligned with aperture
`
`120, Fig 1) and configuredto elastically deform in response to a reduction in pressure (Upon being
`
`subjected to at least threshold reduced pressure that is delivered to the interior of the dressing valve
`
`136, the flexible member 138 collapses and seals the port aperture 120. 4|[0042]) through the indicator
`
`ports (reduced pressureis delivered to dressing valve 136 through port aperture 120 4|[0040]), in order
`
`to indicate to the user or physician if negative pressureis uniformly distributed and to indicate the
`
`presence andlocation of clogs within the fluid path, and to reduce or eliminate vacuum lock associated
`
`with the delivery conduit and reduced pressure source (4][0041]).
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 7
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to modify the device of Wu to substitute the pressure indicator
`
`structure of Robinson for the pressure indicator structure of Wu. The combination of the conduit having
`
`a first impermeable barrier and a plurality of pressure indicators of Wu with the second impermeable
`
`barrier and aperture of the pressure indicator of Robinson would result in a device having two
`
`impermeable barriers with apertures distributed linearly along the first barrier and in fluid
`
`communication with the fluid path, where each aperture is associated with a single elastically
`
`deformable pressure indicator formed from the second impermeable barrier. The resulting device would
`
`be advantageoussinceaplurality of pressure indicators would indicate to the user or physician if
`
`negative pressure is uniformly distributed and would indicate the presence and location of clogs within
`
`the fluid path, and to reduce or eliminate vacuum lock associated with the deliver conduit and reduced
`
`pressure source (as motivated by Robinson 4[0041]).
`
`Wu/Robinsonis silent regarding the first barrier and second barrier having similar profiles and
`
`dimensions.
`
`However, Weston teaches a reduced pressure treatment system, thus from the same field of
`
`endeavor, witha wound cover that is interpreted as having a dual layer structure wherein both layers
`
`have similar profiles and dimensions (bottom layer of wound cover 40 not including protrusions 60, and
`
`top layer is the portion of the layer including protrusions 60 and remaining surface 43 Fig 5A-D since
`
`having the layers be of similar profiles and dimensions would allow for simpler manufacturing 4][0054)).
`
`Therefore,it would have been obvious to modify the barriers of Wu/Robinsonto have layers
`
`with similar profiles and dimensions a taught by Weston,in order to allow for simpler manufacturing.
`
`Regarding Claim 2, Wu/Robinson/Weston teachesthe claimed limitations as set forth above for
`
`Claim 1.
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 8
`
`Robinson teachesthat the plurality of pressure indicators comprisesblisters or raised channels
`
`(Fig 1 of Robinson showsa raised configuration of 136) in the second barrier (138, Fig 1), which would
`
`provide a visualor tactile indication whether sufficient reduced pressure is achieved.
`
`Therefore, the combination of Wu/Robinson/Weston alsoteaches that the plurality of pressure
`
`indicators comprises blisters or raised channels in the second barrier, which would provide a visual or
`
`tactile indication whether sufficient reduced pressure is achieved.
`
`Regarding Claim 3, Wu/Robinson/Weston teachesthe claimed limitations as set forth above for
`
`Claim 1.
`
`Robinson teachesthat each of the plurality of pressure indicators (pressure indicators 230 of
`
`Wu,Fig 5) is aligned with only one of the indicator ports (aperture 120 of Robinson, Fig 1) in order to
`
`indicate to the user or physician if negative pressure is uniformly distributed and to indicate the
`
`presence and location of clogs within the fluid path and to reduce or eliminate vacuum lock associated
`
`with the deliver conduit and reduced pressure source (][0041]).
`
`Therefore, the combination of Wu/Robinson/Weston alsoteaches that each of the plurality of
`
`pressureindicatorsis aligned with only one of the indicator ports in order to indicate to the user or
`
`physician if negative pressure is uniformly distributed and to indicate the presence and location of clogs
`
`within the fluid path and to reduce or eliminate vacuum lock associated with the deliver conduit and
`
`reduced pressure source (as motivated by Robinson 4][0041)).
`
`Regarding Claim 4, Wu/Robinson/Weston is silent whether each of the plurality of pressure
`
`indicators has a length of about 10 millimeters to about 30 millimeters, a width of about 2 millimeters to
`
`about 4 millimeters, and a height of about 1 millimeter to about 3 millimeters.
`
`It would have been obvious to cause the device of Wu/Robinson to have each of the plurality of
`
`pressure indicators to have a lengthof about 10 millimeters to about 30 millimeters, a width of about 2
`
`millimeters to about 4 millimeters, and a height of about 1 millimeter to about 3 millimeters since it has
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 9
`
`been held that “where the only difference between the prior art and the claims was a recitation of
`
`relative dimensions of the claimed device and a device having the claimed relative dimensions would
`
`not perform differently than the prior art device, the claimed device was not patentably distinct from
`
`the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert.
`
`denied, 469 U.S. 830, 225 SPQ 232 (1984) (MPEP 2144.04 IV(A)). In the instant case, the device of
`
`Wu/Robinson would not operate differently with the claimed dimensions. Further, applicant places no
`
`criticality on the range claimed, indicating simply that the dimensions “may” be within the claimed
`
`ranges (specification 4][00135]).
`
`Regarding Claim 5, Wu/Robinson/Weston is silent regarding a gap between each ofthe plurality
`
`of pressure indicators, whereinthe gap has a length of about 5 millimeters to about 10 millimeters.
`
`It would have been obvious to cause the device of Wu/Robinson to have a gap between each of
`
`the plurality of pressure indicators, wherein the gap has a length of about 5 millimeters to about 10
`
`millimeters since it has been held that “where the only difference between the prior art and the claims
`
`was a recitation of relative dimensions of the claimed device and a device having the claimed relative
`
`dimensions would not perform differently than the prior art device, the claimed device was not
`
`patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777
`
`(Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984) (MPEP 2144.04 IV(A)). In the instant
`
`case, the device of Wu/Robinson would not operate differently with the claimed length. Further,
`
`applicant places no criticality on the range claimed, indicating simply that the length “may” be within
`
`the claimed ranges(specification 4][00135]).
`
`Regarding Claim 8, Wu/Robinson/Weston teachesthe claimed limitations as set forth above for
`
`Claim 1.
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 10
`
`Robinson teachesthat each of the indicator ports (aperture 120, Fig 1) comprises an aperture in
`
`the first barrier, which would indicate to the user or physician if negative pressureis uniformly
`
`distributed and would indicate the presence and location of clogs within the fluid path.
`
`Therefore, Wu/Robinson/Weston teachesthat each of the indicator ports comprises an
`
`aperture in the first barrier, which would indicate to the user or physician if negative pressureis
`
`uniformly distributed and would indicate the presence andlocation of clogs within the fluid path.
`
`Regarding Claim 10, Wu/Robinson/Westonis silent whether the indicator ports are distributed
`
`along the first barrier with a spacing of about 10 millimeters to about 30 millimeters.
`
`It would have been obvious to cause the device of Wu/Robinson to have the indicator ports
`
`distributed along the first barrier with a spacing of about 10 millimeters to about 30 millimeters since it
`
`has been held that “where the only difference betweentheprior art and the claims was a recitation of
`
`relative dimensions of the claimed device and a device having the claimed relative dimensions would
`
`not perform differently than the prior art device, the claimed device was not patentably distinct from
`
`the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777(Fed. Cir. 1984), cert.
`
`denied, 469 U.S. 830, 225 SPQ 232 (1984) (MPEP 2144.04 IV(A)). In the instant case, the device of
`
`Wu/Robinson would not operate differently with the claimed spacing. Further, applicant places no
`
`criticality on the range claimed, indicating simply that the spacing “may” be within the claimed ranges
`
`(specification 4][00132)).
`
`Regarding Claim 11, Wu further discloses that the first fluid-impermeable material is
`
`polyurethaneor polyethylene (conduit body 105 can be made of polyethylene or polyurethane 4][0046]).
`
`Regarding Claim 19, Wu/Robinson/Weston teachesthe claimed limitations as set forth above
`
`for Claim 1.
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 11
`
`Robinson teaches an adhesive (bonds 402 may be used to connect the flexible member 138 to
`
`the connector body 123. Fig 4 4 [0049]) between the second barrier (138, Fig 4) and the first barrier
`
`(combination of 215 and 210, Fig 5 of Wu).
`
`Therefore, the combination of Wu/Robinson/Weston teaches anadhesive between the second
`
`barrier and the first barrier.
`
`Regarding Claim 26, Wu teaches an apparatus for treating a tissue site with negative pressure
`
`(device 100, Fig 1), the apparatus comprising:
`
`A source of negative pressure (The proximal port 125 can connect, for example via tubing 130,
`
`to any of a variety of negative pressure sources (not shown) 4][0041]); a dressing (distal port 115 may
`
`connect to a wound dressing positioned at a wound site 4[0041]) configured to be applied to the tissue
`
`site; and a fluid conductor (conduit body 105, Fig 5), comprising:
`
`a first barrier (combination of upper cover 215 and base 210, Fig 5) formed fromafirst fluid -
`
`impermeable material (conduit body 105 can be made of polyethylene or polyurethane 4][0046]), the
`
`first barrier comprising:
`
`a first layer formed from a film (215 is formed fromafilm, defined as a thin layer of any
`
`material, Fig 5);
`
`a second layer (210, Fig 5) sealedto thefirst layer to define a fluid path between thefirst layer
`
`and the second layer (device 100 may be configured to create and maintain a fluidic pathway,
`
`specifically between layers 215 and 210 4[0041][0050]), the second layer formed from a film (210 is
`
`formed fromafilm, defined as a thin layer of any material, Fig 5);
`
`the fluid path having a first end (distal port 115, Fig 1. Figs 1 and 5 show the same device, with
`
`Fig 5 illustrating the different layers that make up conduit body 105. Distal port 115, proximal port 125,
`
`and device 100, are presentin both figures, but they are unlabeled in Fig 5), a secondend (proximal port
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 12
`
`125, Fig 1), and a longitudinal axis (conduit body 105 has a longitudinal axis extending between 125 and
`
`115, Fig 1);
`
`and a plurality of standoffs (support structures 205, Fig 7A) formed byat least one ofthe first
`
`layer and the second layer (support structures 205 may be integrated with or coupled to the inner walls
`
`of the conduit body 105, which includes layers 215 and 210 4[0048]), the plurality of standoffs disposed
`
`in the fluid path (The support structures 205 prevent or mitigate collapse of the channel 200 upon
`
`application of internal vacuum, external pressure to or compression of the conduit body 105 4[0047)).
`
`and a plurality of pressure indicators (both ports 115 and 125 may include pressure indicators
`
`230, Fig 5. The indicator 230 can be positioned in one or more locations along the device 100 suchas
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`within the tubing 130, ona region of the conduit body 105, near the distal port 115 or proximal port 125
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`4[0057]) configured to elastically deform in response to a reduction in pressure (Deformation of the
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`exterior wall of the indicator 230 can result in a change fromafirst profile to a second profile. The
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`relative position of the exterior wall between thefirst profile and the second profile can be indicative of
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`an amount of pressure delivered to the woundsite. 4][0058])
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`configuredto fluidly couple the dressing to the source of negative pressure (the device 100
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`may be configured to create and maintain a fluidic pathway or channel for the delivery of negative
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`pressure to and removal of exudates from the wound site 4[0041)).
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`Wuis silent regarding the first barrier and second barrier having similar profiles and dimensions,
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`indicator ports distributed linearly along the first barrier parallel to and in fluid communication with the
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`fluid path; and asecond barrier coupled to thefirst barrier, the second barrier formed from asecond
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`fluid-impermeable material defining a plurality of pressure indicators aligned with the indicator ports
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`and configured to elastically deform in response to a reduction in pressure through the indicatorports.
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`However, Robinson teaches a reduced pressure therapy dressing, thus fromthe same field of
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`endeavor, withindicator ports (port aperture 120, Fig 1), and a second barrier (flexible member 138, Fig
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`Application/Control Number: 17/281,668
`Art Unit: 3781
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`Page 13
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`1) coupled to thefirst barrier (sealing member 114, Fig 1), the second barrier (138, Fig 1) formed froma
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`second fluid-impermeable material (connector body 123 and flexible member 138 may be formed or
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`molded as an integral member. 4[0042] Connector body 123 may be made from polyurethane [0032]
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`and thus 138 may be madeof polyurethane as well) defining a pressure indicator (dressing valve 136
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`may indicate a reduced pressurestate. Upon being subjected to at least threshold reduced pressure that
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`is delivered to the interior of the dressing valve 136, the flexible member 138 collapses and seals the
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`port aperture 120. 4[0042]) aligned with the indicator ports (dressing valve 136 is aligned with aperture
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`120, Fig 1) and configured to elastically deform in response to a reduction in pressure (Upon being
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`subjected to at least threshold reduced pressure that is delivered to the interior of the dressing valve
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`136, the flexible member 138 collapses and seals the port aperture 120. [0042]) through the indicator
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`ports (reduced pressureis delivered to dressing valve 136 through port aperture 120 4][0040]), in order
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`to indicate to the user or physician if negative pressureis uniformly distributed and to indicate the
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`presence and location of clogs within the fluid path and to reduce or eliminate vacuum lock associated
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`with the delivery conduit and reduced pressure source (4][0041]).
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`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
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`filing date of the claimed invention to modify the device of Wu to have substitute the pressure indicator
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`structure of Robinson for the pressure indicator structure of Wu. The combination of the conduit having
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`a first impermeable barrier and a plurality of pressure indicators of Wu with the second impermeable
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`barrier and aperture of the pressure indicator of Robinson would result in a device having two
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`impermeable barriers with apertures distributed linearly along the first barrier and in fluid
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`communication with the fluid path, where each apertureis associated with a single elastically
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`deformable pressure indicator formed from the second impermeable barrier. The resulting device would
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`be advantageoussinceaplurality of pressure indicators would indicate to the user or physician if
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`negative pressureis uniformly distributed and would indicate the presence and location of clogs within
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`Application/Control Number: 17/281,668
`Art Unit: 3781
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`Page 14
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`the fluid path and to reduce or eliminate vacuum lock associated with the delivery conduit and reduced
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`pressure source (as motivated by Robinson §][0041]).
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`Wu/Robinsonis silent regarding the first barrier and second barrier having similar profiles and
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`dimensions.
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`However, Weston teaches a reduced pressure treatment system, thus from the same field of
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`endeavor, witha wound cover that is interpreted as having a dual layer structure wherein both layers
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`have similar profiles and dimensions (bottom layer of wound cover 40 not including protrusions 60, and
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`top layer is the portion of the layer including protrusions 60 and remaining surface 43 Fig 5A-D since
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`having the layers be of similar profiles and dimensions would allow for simpler manufacturing 4][0054)).
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`Therefore,it would have been obvious to modify the barriers of Wu/Robinsonto have layers
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`with similar profiles and dimensions a taught by Weston,in order to allow for simpler manufacturing.
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`Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wu/Robinson /Weston in
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`view of Locke (WO 2016182977 A1).
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`Regarding Claim 7, Wu/Robinson/Weston is silent regarding open-cell foam or gauze
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`configured to bias the pressure indicators.
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`However, Locke teaches a reduced pressure device, thus from the same field of endeavor,
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`wherein open-cell foam or gauze (foam block 134, Fig 1) configured to bias the pressure indicators
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`({[0059]). If the foam block remains compressed, a patient or clinician may have anindication that the
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`therapy pressure has been reached. The compressed foam block may also act as a pressure reservoir.
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`As negative pressure therapyis provided, there may be a natural leakage or decline of negative
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`pressure at the tissue site. As the negative pressure decreases inthe sealed therapeutic environment,
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`the pressure differential across the dressing assembly may decrease and the foam block may gradually