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
`
`01/04/2024
`
`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
`
`01/04/2024
`
`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):
`
`dgodzisz@hdp.com
`troymailroom @hdp.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-5,7-8,10-12,14-20,23-24 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`5a) Of the above claim(s) _ is/are withdrawn from consideration.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) 1-5,7-8,10-12, 14-20,23-24 and 26 is/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 20231227
`
`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 07 December 2023.
`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: 17/281,668
`Art Unit: 3781
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA 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.
`
`Continued Examination Under 37 CFR 1.114
`
`A request for continued examination under 37 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 set forth 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. Applicant's
`
`submission filed on 12/07/2023 has been entered.
`
`Response to Arguments
`
`Applicant’s amendmentsfiled 12/07/2023 have been accepted.
`
`Applicant's argumentsfiled 12/07/2023 have been fully considered but they are not persuasive.
`
`Applicant argues that wound cover 40 of Weston cannotbeinterpreted as having a dual layer structure.
`
`However, Weston §][0055] states that the protrusions 60 may be constructed of a different material
`
`than cover 40, whichclearly implies a dual layer structure, since the layer including the protrusions 60
`
`may be constructed of a different material having its own thickness and pliability than the cover 40
`
`(Weston 4[0055-0056]).
`
`Additionally, Applicant argues that cover 40 cannotbe interpreted as having a dual layer
`
`structure because Weston states in §[0054] that the plurality of protrusions 60 are embeddedin the
`
`cover 40. However, the claim is written broadly enough that the cover 40 and protrusions 60 of Weston
`
`are still capable of being interpreted as having a dual layer structure. Furthermore, Wu in view of
`
`Robinson is relied upon as teaching the dual layer structure, and Weston is merely relied upon to teach
`
`that the layers may havesimilar profiles and dimensions. In light of the combination of
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 3
`
`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 dependentclaims.
`
`Claim Rejections - 35 USC § 103
`
`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 ordinaryskill 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 contentsofthe prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinentart.
`
`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 owned as 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.
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 4
`
`Claims 1-5, 8, 10-12, 14-19, 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 further in view of
`
`Weston (US 20040073151 A1).
`
`Regarding Claim 1, Wu discloses 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]) and
`
`defining a fluid path (device 100 may be configured to create and maintain a fluidic pathway 4][0041])
`
`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 second end (proximal port 125, Fig 1), anda
`
`longitudinal axis (conduit body 105 has a longitudinal axis extending between 125 and 115,Fig 1);
`
`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 morelocations along the device 100 such as
`
`within the tubing 130, on a 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 (Deformation of the
`
`exterior wall of the indicator 230 can result in a change fromafirst profile to a second profile. The
`
`relative position of the exterior wall between the first profile and the second profile can be indicative of
`
`an amountof pressure delivered to the wound site. 4[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 a second barrier coupled to the first barrier, the second barrier formed from a second
`
`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 throughthe indicator ports.
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 5
`
`However, Robinson teaches a reduced pressure therapy dressing, thus from the same field of
`
`endeavor, with indicator ports (port aperture 120, Fig 1), and a second barrier (flexible member 138, Fig
`
`1) coupled to the first 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 made of 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 136is aligned with aperture
`
`120, Fig 1) and configured to elastically deform in response to a reduction in pressure (Upon being
`
`subjected to at least threshold reduced pressurethat 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 pressure is uniformly distributed and to indicate the
`
`presenceand location of clogs within the fluid path, and to reduceor eliminate vacuum lock associated
`
`with the delivery conduit and reduced pressure source (4][0041)]).
`
`Therefore, it would have been obvious to one ofordinaryskill 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
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 6
`
`be advantageous since a plurality 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 reduceor eliminate vacuum lock associated with the deliver conduit and reduced
`
`pressure source (as motivated by Robinson 4][0041]).
`
`Wu/Robinson is 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, with a 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/Robinson to havelayers
`
`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.
`
`Robinson teaches that the plurality of pressure indicators comprise blisters or raised channels
`
`(Fig 1 of Robinson showsa raised configuration of 136) in the second barrier (138, Fig 1), which would
`
`provide a visual or tactile indication whether sufficient reduced pressureis achieved.
`
`Therefore, the combination of Wu/Robinson/Weston also teaches that the plurality of pressure
`
`indicators comprise blisters or raised channels in the second barrier, which would provide a visual or
`
`tactile indication whether sufficient reduced pressureis achieved.
`
`Regarding Claim 3, Wu/Robinson/Weston teachesthe claimed limitations as set forth above for
`
`Claim 1.
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 7
`
`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 pressureis uniformly distributed and to indicate the
`
`presence and location of clogs within the fluid path and to reduceor eliminate vacuum lock associated
`
`with the deliver conduit and reduced pressure source (4][0041)).
`
`Therefore, the combination of Wu/Robinson/Weston also teaches 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 reduceor 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 eachofthe plurality of
`
`pressure indicators to have 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 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 dimensions. Further, applicant places no
`
`criticality on the range claimed, indicating simply that the dimensions “may” be within the claimed
`
`ranges(specification 4[00135]).
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 8
`
`Regarding Claim 5, Wu/Robinson/Weston is silent regarding a gap between each ofthe plurality
`
`of pressure indicators, wherein the 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.
`
`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 pressure is 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
`
`aperturein 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.
`
`Regarding Claim 10, Wu/Robinson/Weston is 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 havethe indicator ports
`
`distributed along the first barrier with a spacing of about 10 millimeters to about 30 millimeters since it
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 9
`
`has been held that “where the only difference betweenthe 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 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
`
`polyurethane or polyethylene (conduit body 105 can be made of polyethylene or polyurethane 4][0046]).
`
`Regarding Claim 12, Wu further discloses the first barrier (combination of 215 and 210, Fig 5)
`
`comprisesa first layer (215, fig 7A) and a second layer (210, Fig 7A) sealed to the first layer (conduit
`
`body 105 can have a multilayer structure as shownin Fig 5, where two or more components may be
`
`bonded together by adhesive 4][0048]) to define the fluid path (channel 200, Fig 7A) betweenthe first
`
`layer (215, Fig 7A) and the second layer (210, Fig 7A).
`
`Regarding Claim 14, Wu further discloses a manifold (plurality of support structures 205, Fig
`
`7A) disposed between the first layer (215, Fig 7A) and the second layer (210, Fig 7A).
`
`Regarding Claim 15, Wu further discloses at least one of the first layer (215, Fig 7A) and the
`
`second layer (210, Fig 7A) comprise a plurality of bubbles or blisters (support structures 205, Fig 7A can
`
`be rounded or semi-spherical, 4[0048]) configured to support 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)).
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 10
`
`Regarding Claim 16, Wu further discloses open-cell foam or a textile (The support structure
`
`205 can include a fabric or other material having open channels running therethrough 4[0048])
`
`disposed between the first layer (215, Fig 7A) and the second layer (210, Fig 7A).
`
`Regarding Claim 17, Wufurther discloses that the first fluid-impermeable material is a polymer
`
`(conduit body 105 can be made of polyethylene or polyurethane 4][0046]).
`
`Regarding Claim 18, Wu further discloses that the first barrier (combination of 215 and 210,
`
`Fig 7A) comprises a tube (Fig 7A showsa flattened tube configuration).
`
`Regarding Claim 19, Wu/Robinson/Weston teachesthe claimed limitations as set forth above
`
`for Claim 1.
`
`Robinson teaches an adhesive (bonds 402 may be used to connectthe flexible member 138 to
`
`the connector body 123. Fig 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 an adhesive 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 [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]) and
`
`defining a fluid path (device 100 may be configured to create and maintain a fluidic pathway 4][0041])
`
`having a first end (distal port 115, Fig 1. Figs 1 and 5 show the same device, with Fig5illustrating the
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 11
`
`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 second end (proximal port 125, Fig 1), anda
`
`longitudinal axis (conduit body 105 has a longitudinal axis extending between 125 and 115,Fig 1);
`
`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 such as
`
`within the tubing 130, on a 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 (Deformation of the
`
`exterior wall of the indicator 230 can result in a change fromafirst profile to a second profile. The
`
`relative position of the exterior wall between the first profile and the second profile can be indicative of
`
`an amount of pressure delivered to the wound site. 4][0058])
`
`configuredto fluidly couple the dressing to the source of negative pressure (the device 100
`
`may be configured to create and maintain a fluidic pathway or channel for the delivery of negative
`
`pressure to and removal of exudates from the wound site 4][0041]).
`
`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 a second barrier coupled to the first barrier, the second barrier formed from a second
`
`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 throughthe indicator ports.
`
`However, Robinson teaches a reduced pressure therapy dressing, thus from the same field of
`
`endeavor, with indicator ports (port aperture 120, Fig 1), and a second barrier (flexible member 138, Fig
`
`1) coupled to the first 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.4][0042] Connector body 123 may be made from polyurethane 4][0032]
`
`and thus 138 may be made of polyurethane as well) defining a pressure indicator (dressing valve 136
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 12
`
`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
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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 pressurethat 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. 4[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 pressure is uniformly distributed and to indicate the
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`presenceand location of clogs within the fluid path and to reduceor 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 ofordinaryskill 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 advantageous since a plurality of pressure indicators would indicate to the user or physician if
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`negative pressure is uniformly distributed and would indicate the presence and location of clogs within
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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 4][0041)).
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`Wu/Robinson is silent regarding the first barrier and second barrier having similar profiles and
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`dimensions.
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`

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`Application/Control Number: 17/281,668
`Art Unit: 3781
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`Page 13
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`However, Weston teaches a reduced pressure treatment system, thus from the same field of
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`endeavor, with a 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/Robinson to 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 an indication 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 therapy is provided, there may be a natural leakage or decline of negative
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`pressureat the tissue site. As the negative pressure decreasesin the sealed therapeutic environment,
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`the pressure differential across the dressing assembly may decrease and the foam block may gradually
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`expand, reapplying negative pressure at the tissue site ({][0067]).
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`Therefore, it would have been obvious to modify the device of Wu/Robinson to include open-
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`cell foam or gauze configured to bias the pressure indicators, as taught by Locke, becauseif the foam
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`block remains compressed, a patient or clinician may have an indication that the therapy pressure has
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`been reached. The compressed foam block may also act as a pressure reservoir. As negative pressure
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`therapy is provided, there may be a natural leakage or decline of negative pressure at the tissue site.
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`

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`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 14
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`As the negative pressure decreases in the sealed therapeutic environment, the pressure differential
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`across the dressing assembly may decrease and the foam block may gradually expand, reapplying
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`negative pressureat the tissue site (as motivated by Locke 4[0067]).
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`Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wu/Robinson/Weston in
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`view of Bogie (US 20200061379 A1).
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`Regarding Claim 20, Wu/Robinson/Weston is silent regarding a diagnostic port in the first
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`barrier; and a diagnostic indicator operatively coupled to the fluid path through the diagnostic port and
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`at least partially visible through the second barrier.
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`However, Bogie teaches a device for remotely monitoring and treating wounds, thus from the
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`same field of endeavor, with a diagnostic port (holes 126, Fig 1A 4[0043]) in the first barrier (absorbent
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`layer 106 has holes 126 therethrough, Fig 1A 4[0043]); and a diagnostic indicator (plurality of
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`temperature sensors 124, Fig 1 4[0043]) operatively coupled to the fluid path through the diagnostic
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`port (temperature sensors 124 can be positioned within the holes 126 and attached to the underside of
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`the top layer 104, Fig 1A 4[0043]) and at least partially visible through the second barrier (top layer 104
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`is transparent 4[0041] with temperature sensors 124 visible underneath) to determine an infection
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`status of the wound based on a temperaturedifference (][0021]).
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`Therefore, it would have been obvious to modify the device of Wu/Robinson/Weston to include
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`a diagnostic port in the fir