www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/281,668
`
`03/31/2021
`
`Christopher Brian LOCKE
`
`P001658US02PCT
`
`1000
`
`60402
`
`7590
`
`03/02/2023
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 300
`
`Troy, MI 48098
`
`EXAMINER
`
`FLYNN, TIMOTHY LEE
`
`3781
`
`03/02/2023
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`Thetime 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)
`
`

`

`Office Action Summary
`
`Application No.
`17/281,668
`Examiner
`TIMOTHY L FLYNN
`
`Applicant(s)
`LOCKE etal.
`Art Unit
`3781
`
`AIA (FITF) Status
`Yes
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of 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 09 February 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)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on__; the restriction requirement and election have been incorporatedinto this action.
`4)\0) 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*
`1-5,7-8,10-12,14-20,23-24 and 26 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`Claim(s)
`is/are allowed.
`s) 1-5,7-8,10-12,14-20,23-24 and 26 is/are rejected.
`Claim(s
`1) Claim(s)__is/are objectedto.
`Cj} 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)( The specification is objected to by the Examiner.
`11) The drawing(s) filed on 31 March 2021 is/are: a)(¥) 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)1) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`_—_c)L) None ofthe:
`b)L) Some**
`a)Q) All
`1.2) Certified copies of the priority documents have been received.
`2.2 Certified copies of the priority documents have been received in Application No.
`3.4.) 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)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20230221
`
`

`

`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.
`
`Claim Rejections - 35 USC § 102
`
`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102
`
`and 103 (or as subject to pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory
`
`basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and
`
`the rationale supporting the rejection, would be the same under either status.
`
`a.
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form
`
`the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale,
`or otherwise available to the public before the effective filing date of the claimed invention.
`
`(a)(2) the claimed invention was described in a patent issued under section 151, or in an application
`for patent published or deemed published under section 122(b), in which the patent or application, as
`the case may be, names another inventor and was effectively filed before the effective filing date of
`the claimed invention.
`
`Claims 23-24 are rejected under35 U.S.C. 102(a)(1) as being anticipated by Wu (US
`
`20130144230 A1).
`
`Regarding Claim 23, Wu discloses A fluid conductor (conduit body 105, Fig 5) for use treating a
`
`tissue site with negative pressure ([abstract]), the fluid conductor (105, Fig 5) comprising: a fluid path
`
`(channel 200, Figs 4, 7A [0044] device 100 may be configured to create and maintain a fluidic pathway
`
`4[0041]) between 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) and a second end (proximal port
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 3
`
`125, Fig 1); and a plurality of pressure indicators (pressure indicator 230, Fig 5. The indicator 230 can be
`
`positioned in one or more locations along the device 100 such as within the tubing 130, onaregion of
`
`the conduit body 105, near the distal port 115 or proximal port 125 4[0057]) configured to indicate a
`
`pressure state (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])
`
`between the first end (115, Fig 1) and the second end (125,Fig 1).
`
`Regarding Claim 24, Wudiscloses that the fluid path (channel 200, Figs 4, 7A 4][0044]) has a
`
`height and a width thatis substantially greater than the height (Figs 4 and 7A show cross sections of
`
`conduit 105, wherein the width of the channel 200 is substantially greater than the height).
`
`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 pertinent art.
`
`4. Considering objective evidence present in the application indicating obviousness or
`
`nonobviousness.
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 4
`
`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 effective filing 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, 10-12, 14-19, and 26 are rejected under 35 U.S.C. 103 as being unpatentable
`
`over Wuin view of Robinson (US 20110224633 A1).
`
`Regarding Claim 1, Wudiscloses 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 (pressure indicator 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 responseto 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. §[0058])
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 5
`
`Wuis silent regarding 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 responseto a reduction in
`
`pressure through the 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
`
`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 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 useror physician if negative pressure is uniformly distributed and to indicate the
`
`presenceand location of clogs within the fluid path.
`
`Therefore, it would have been obvious to one of ordinaryskill in the art before the effective
`
`filing date of the claimed invention to modify the device of Wu to have 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
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 6
`
`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 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.
`
`Regarding Claim 2, Wu/Robinson teachesthe claimed limitations as set forth above for Claim 1.
`
`Robinson teachesthat 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 pressure is achieved.
`
`Therefore, the combination of Wu/Robinson also teachesthat 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 pressure is achieved.
`
`Regarding Claim 3, Wu/Robinson 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
`
`presenceand location of clogs within the fluid path.
`
`Therefore, the combination of Wu/Robinson also teaches that eachof the plurality of pressure
`
`indicators is 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.
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 7
`
`Regarding Claim 4, Wu/Robinson 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 ofthe 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 betweenthe prior art and the claims was a recitation of
`
`relative dimensions of the claimed device and a device having the claimedrelative 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). 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 is silent regarding a gap between each of the 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). In the instant case, the device of
`
`Wu/Robinson would not operate differently with the claimed length. Further, applicant places no
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 8
`
`criticality on the range claimed, indicating simply that the length “may” be within the claimed ranges
`
`(specification 4[00135)).
`
`Regarding Claim 8, Wu/Robinson teachesthe claimed limitations as set forth abovefor 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 teachesthat each of the indicator ports 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.
`
`Regarding Claim 10, Wu/Robinson 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
`
`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 claimedrelative 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). 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 disclosesthe 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
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 9
`
`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) between the 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 betweenthe 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]).
`
`Regarding Claim 16, Wufurther 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 betweenthe first layer (215, Fig 7A) and the second layer (210, Fig 7A).
`
`Regarding Claim 17, Wu further 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 teachesthe claimed limitations as set forth above for Claim 1.
`
`Robinson teachesan adhesive (bonds 402 may be used to connect the 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 teaches an adhesive between the second barrier
`
`and the first barrier.
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 10
`
`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 (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
`
`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 (pressure indicator 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 responseto 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. §[0058])
`
`configured to 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]).
`
`

`

`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 11
`
`Wuis silent regarding 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 through the 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
`
`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 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 pressure is delivered to dressing valve 136 through port aperture 120 4[0040)]), in order
`
`to indicate to the useror physician if negative pressure is uniformly distributed and to indicate the
`
`presenceand location of clogs within the fluid path.
`
`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 have 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
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`

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`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 12
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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 aperture is 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.)
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`Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wu/Robinsonin view of
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`Locke (WO 2016182977A1).
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`Regarding Claim 7, Wu/Robinson is silent regarding open-cell foam or gauze configured to bias
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`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 13
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`As the negative pressure decreases in the sealed therapeutic environment, the pressuredifferential
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`across the dressing assembly may decrease and the foam block may gradually expand, reapplying
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`negative pressure at 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/Robinsonin view of
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`Bogie (US 20200061379 A1).
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`Regarding Claim 20, Wu/Robinson is silent regarding a diagnostic port in the first barrier; and a
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`diagnostic indicator operatively coupled to the fluid path through the diagnostic port and at least
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`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 §[0043]); and a diagnostic indicator (plurality of
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`temperature sensors 124, Fig 1 ][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 to include a
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`diagnostic port in the first barrier; and a diagnostic indicator operatively coupled to the fluid path
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`through the diagnostic port and at least partially visible through the second barrier, as taught by Bogie,
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`to determine an infection status of the wound based on a temperature difference (as motivated by
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`Bogie 4[0021]).
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`Conclusion
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`

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`Application/Control Number: 17/281,668
`Art Unit: 3781
`
`Page 14
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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to TIMOTHY LEE FLYNN whosetelephone number is (571)272-8255. The examiner
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`can normally be reached Monday-Friday 7:30-5 ET.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Nicholas Weiss can be reached on 571-270-1775. The fax phone number for the organization wherethis
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`application or proceeding is assigned is 571-273-8300.
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`file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit
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`
`/TIMOTHYL FLYNN/
`Examiner, Art Unit 3781
`
`/JESSICA ARBLE/
`Primary Examiner, Art Unit 3781
`
`