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
`
`09/24/2021
`
`Christopher Brian LOCKE
`
`P001742US02PCT
`
`7319
`
`EXAMINER
`
`TRAN, NHU
`
`3781
`
`05/25/2023
`
`ELECTRONIC
`
`17/442,815
`
`60402
`
`7590
`
`05/25/2023
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 300
`
`Troy, MI 48098
`
`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.
`17/442,815
`Examiner
`NHU Q TRAN
`
`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 09/24/2021.
`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 incorporated into 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.
`
`1,4-6,10,12,18-19,22,31,35,45-46,51,53,55-56,58,61,63-67 and 69-70 is/are pending in the
`
`
`
`Disposition of Claims*
`5)
`Claim(s)
`application.
`is/are withdrawn from consideration.
`5a) Of the above claim(s)
`(9 Claim(s) _ is/are allowed.
`Claim(s) 1,4-6,10,12,18-19,22,31,35,45-46,51,53,55-56 ,58,61,63-67 and 69-70 is/are rejected.
`CG Claim(s) _ is/are objectedto.
`8)
`9) © 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.
`
`) ) ) )
`
`6 7
`
`Application Papers
`10)C The specification is objected to by the Examiner.
`11) The drawing(s) filed on 09/24/2021 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)D) None ofthe:
`b)7) Some**
`a)D All
`1.1) Certified copies of the priority documents have been received.
`2.) Certified copies of the priority documents have been received in Application No.
`3.2.) 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)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`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 20230518
`
`

`

`Application/Control Number: 17/442,815
`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.
`
`Status of Claims
`
`Claim(s) 1, 4-6, 10, 12, 18-19, 22, 31, 35, 45-46, 51, 53, 55-56, 58, 61, 63-67,
`
`and 69-70 is/are pending in the application.
`
`Claim(s) 1, 4-6, 10, 12, 18-19, 22, 31, 35, 45-46, 51, 53, 55-56, 58, 61, 63-67,
`
`and 69-70 is/are examined on the merits.
`
`Priority
`
`Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e)
`
`or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
`
`Information Disclosure Statement
`
`The information disclosure statement(s) (IDS) submitted on 09/24/2021 and
`
`12/12/2022 in compliance with the provisions of 37 CFR 1.97. Accordingly, the
`
`information disclosure statement(s) has/nave been considered by the examiner.
`
`Claim Objections
`
`Claim 46 is objected to because of the following informalities:
`
`e Claim 46, “a spacer disposed between the fluid passage and the cover”
`
`should read -- a spacer disposed between the at least one fluid passage
`
`and the cover --.
`
`Appropriate correction is required.
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 3
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`
`(bo) CONCLUSION.—The specification shall conclude with one or more
`
`claims particularly pointing out and distinctly claiming the subject matter
`
`which the inventor or a joint inventor regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`
`The specification shall conclude with one or moreclaims particularly
`
`pointing out and distinctly claiming the subject matter which the applicant
`
`regards ashis invention.
`
`Claim(s) 51, 63, and 64 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112
`
`(pre-AlA), second paragraph, as being indefinite for failing to particularly point out and
`
`distinctly claim the subject matter which the inventor or a joint inventor (or for
`
`applications subject to pre-AlA 35 U.S.C. 112, the applicant), regards as the invention.
`
`Claim 51 recites the limitation “a screen removably attached to the cover and
`
`that is optically occlusive” whichis indefinite. It is unclear which structures/materials of
`
`the screen provide/make the “screen removable attached to the cover” and “optically
`
`occlusive”. The limitation has been examined belowasif it read -- a screen
`
`[[rerRevably]] attached to the cover [[andthatis-opticalh-occlusive] --.
`
`Claim 63 recites the limitation “a screen removably disposed over the cover,
`
`wherein the screen is visually occlusive” whichis indefinite. It is unclear which
`
`structures/materials of the screen provide/make the “screen removably disposed over
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 4
`
`the cover” and “visually occlusive”. The limitation has been examined below asif it read
`
`-- a screen [[remevably]| disposed over the cover [[andthatisvisuallyocclusivel] --.
`
`Claim 64 recites the limitation “the first polymer film and the second polymer film
`
`each have an exposed perimeter” whichis indefinite.
`
`It is unclear how “the first polymer
`
`film and the second polymer film each have an exposed perimeter” when the first
`
`polymer film and the second polymer film are enclosed between the cover 106 and the
`
`third layer 215 (¢0011, 0091, Figs. 2, and 5 of instant specification). In addition, it is
`
`unclear which structures/features of the cover and the third layer provide the exposed
`
`perimeters of the first polymer film and the second polymer film. The limitation has been
`
`examined below asif it read -- the first polymer film and the second polymer film each
`
`have [[an-expesed]] a perimeter --.
`
`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-AIA 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.
`
`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 madein this Office action:
`
`A person shall be entitled to a patent unless —
`
`(a)(1) the claimed invention was patented, describedin a printed
`
`publication, or in public use, on sale, or otherwise available to the public
`
`before the effective filing date of the claimed invention.
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 5
`
`This application currently names joint inventors. In considering patentability of the
`
`claims the examiner presumes that the subject matter of the various claims was
`
`commonly ownedasof the effective filing date of the claimed invention(s) absent any
`
`evidenceto 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
`
`ownedasofthe effectivefiling 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.
`
`Claim 1, 4-5, 10, 45-46, 53, 55, 61, 66-67, and 69 is rejected under 35 U.S.C
`
`102(a)(1) as being anticipated by Locke (US PGPUB 20180353662 — of record).
`
`Regarding claim 1, Locke discloses a dressing (a dressing 102: (0030 and Fig.
`
`2) for treating a tissue site with negative pressure (Abstract and 40030), the dressing
`
`(102) comprising:
`
`a first polymer film (a third layer 220 is formed of a polyurethane film: (O086 and
`
`Fig. 2) comprising a plurality of standoffs (blister 270: (0068, Figs. 2, and 6-7); and
`
`a second polymer film (a second layer 210 comprises a non-porous polymer film:
`
`0060 and Fig. 2) disposed adjacent to the standoffs in the first polymer film (the
`
`standoffs 270 protrude towards or face the second film 210: 40068 and Fig. 2; thus, 210
`
`is disposed adjacent to the standoffs 270), the second polymer film (210) including a
`
`plurality of fluid restrictions (fluid restrictions 260: (0065 and Fig. 2).
`
`Regarding claim 4, Locke discloses all the limitations as discussed abovefor
`
`claim 1.
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 6
`
`Locke further discloses the first polymer film and the second polymer film allow
`
`visualization of the tissue site (220 and 210 comprise transparent materials to allow
`
`visualization of the tissue site to a user throughout the wearduration of the dressing:
`
`q0106).
`
`Regarding claim 5, Locke discloses all the limitations as discussed abovefor
`
`claim 1.
`
`Lockefurther discloses the plurality of standoffs form a plurality of spaces
`
`between the first polymer film and the second polymer film (the standoffs 270 protrude
`
`towards or face the second film 210 and is formed of raised formations: 40068 and Figs.
`
`6-7; thus, the standoffs 270 form a plurality of spaces between the first film 220 and the
`
`second film 210).
`
`Regarding claim 10, Locke discloses all the limitations as discussed above for
`
`claim 1.
`
`Lockefurther discloses the first polymer film (220) further comprises apertures
`
`(apertures 275: ¥O0068, Figs. 2, and 7) formed in portions of the first polymer film
`
`between the standoffs (apertures 275 is formed in the portions ofthe first film 220 that
`
`are between the standoffs 270: 40087 and Fig. 7).
`
`Regarding claim 45, Locke discloses all the limitations as discussed above for
`
`claim 1.
`
`Locke further discloses at least one fluid passage through the first polymer film
`
`(apertures 275 are configuredto allow fluid transfer through the film 220: (0068 and Fig.
`
`2); and a cover disposed over the first polymer film (a cover 106 is configured to
`
`disposed over the first polymer film 220 (¢0076 and Fig. 10).
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 7
`
`Regarding claim 46, Locke discloses all the limitations as discussed above for
`
`claim 45.
`
`Locke further discloses a spacer (a fourth layer 225: (0052 and Fig. 2) disposed
`
`between the at leastfluid passage and the cover (Fig. 2), wherein the spacer comprises
`
`a manifold (0071).
`
`Regarding claim 53, Locke discloses all the limitations as discussed above for
`
`claim 1.
`
`Lockefurther disclosesa layer of gel (a first layer 205 comprises a gel: 40053
`
`and Fig. 2) disposed adjacent to the second polymer film opposite the first polymer film
`
`((0052 and Fig. 2), the layer of gel having perforations (apertures 240: 40055 and Fig.
`
`2) fluidly coupled with at least some ofthe fluid restrictions (apertures 240is fluidly
`
`coupled with at least some ofthe fluid restrictions 260: 40083 and Fig. 5).
`
`Regarding claim 55, Locke discloses all the limitations as discussed above for
`
`claim 1.
`
`Locke further discloses the standoffs comprise blisters, bubbles, cells, bosses, or
`
`a combination thereof (qO068-0069).
`
`Regarding claim 61, Locke discloses all the limitations as discussed above for
`
`claim 56.
`
`Locke further discloses the cover, the first polymer film, the second polymer film,
`
`and the third layer are transparent (40106).
`
`Regarding claim 66, Locke discloses a dressing (a dressing 102: 40030 and Fig.
`
`2) for treating a tissue site with negative pressure (Abstract and 40030), the dressing
`
`(102) comprising:
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 8
`
`a cover (a cover 106: 40042 and Fig. 2) having an aperture (an aperture 294:
`
`40080 and Fig. 2);
`
`a first layer (a third layer 220: (0052 and Fig. 2) comprising a plurality of
`
`standoffs (blister 270: J0068, Figs. 2, and 6-7) and at least one fluid passage (apertures
`
`275 are configured to allow fluid transfer through the film 220: YO0068 and Fig. 2);
`
`a second layer (a second layer 210: 40052 and Fig. 2) comprising a plurality of
`
`slots (fluid restrictions comprise slots 260: J0066 and Fig. 2); and
`
`a third layer (a first layer 205: (0052 and Fig.2) comprising a plurality of
`
`apertures (aperture 240: 40055 and Fig. 2);
`
`wherein the cover,the first layer, the second layer, and the third layer are
`
`assembled in a stacked relationship with the first layer and the second layer disposed
`
`between the cover and the third layer (Figs. 2 and 8), at least some of the slots are
`
`exposed through the plurality of apertures in the third layer (0083 and Fig. 5), the
`
`aperture in the cover is fluidly coupled to at least one fluid passage in the first layer
`
`((O080 and Fig. 2), and the standoffs are disposed adjacent to the second layer (¢0068
`
`and Fig. 7).
`
`Regarding claim 67, Locke discloses an apparatus (a therapy system 100:
`
`40028 and Fig. 1) for treating a tissue site with negative pressure (40028), the
`
`apparatus (100) comprising:
`
`a dressing (0030 and Fig. 2) according to claim 1; and
`
`a negative pressure source (104) fluidly coupled to the dressing (¢0030).
`
`Regarding claim 69, Locke discloses the dressing of claim 1 (see rejection of
`
`claim 1 above).
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 9
`
`Locke further discloses a negative pressure source (104) fluidly coupled to the
`
`dressing (0030).
`
`Since the dressing of Locke meets the structural limitations of the claimed
`
`dressing, it will inherently perform the method steps as claimed (See MPEP § 2112.02
`
`(1)). Thus, Locke further discloses a method of treating a tissue site with negative
`
`pressure, the method comprising: applying the dressing of claim 1; applying negative
`
`pressure to the tissue site through the dressing; and observing the tissue site through
`
`the dressing.
`
`Claim Rejections - 35 USC § 103
`
`In the event the determination of the status of the application as subject to AIA 35
`
`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103)is incorrect, any
`
`correction of the statutory basis for the rejection will not be considered a new ground of
`
`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
`
`the same under either status.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
`
`obviousnessrejections 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 effectivefiling date of the claimed invention to a person having
`
`ordinaryskill in the art to which the claimed invention pertains.
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 10
`
`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 asfollows:
`
`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 presentin the application indicating
`
`obviousness or nonobviousness.
`
`Claim(s) 6, 12, 18-19, 22, 31, and 35 is/are rejected under 35 U.S.C 103 as
`
`being unpatentable over Locke (US PGPUB 20180353662).
`
`Regarding claim 6, Locke discloses all the limitations as discussed abovefor
`
`claim 5.
`
`Locke discloses the claimed invention exceptfor the rearrangement of the
`
`standoffs and the fluid restrictions.
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to have modified the wound dressing of Locke by
`
`rearranging the standoffs and the fluid restrictions so that at least some of the standoffs
`
`are offset from the fluid restrictions, motivated by the desires to improve negative
`
`pressure therapeutic effect, as it has been held that a mere rearrangement of element
`
`without modification of the operation of the device involves only routine skill in the art.
`
`See MPEP § 2144.04(VI) (C). In re Japikse, 181 F.2d 1019,86 USPQ 70 (CCPA 1950).
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 11
`
`Further, Applicant places no criticality on the arrangement of the standoffs and the fluid
`
`restrictions, indicating simply that at least some of the standoffs may be offset from the
`
`fluid restrictions (¥0010 and 0087 of instant specification).
`
`Regarding claim 12, Locke discloses all the limitations as discussed above for
`
`claim 1.
`
`Lockefurther discloses the first polymer film (220) further comprises apertures
`
`(aperture 275: 40087 and Fig. 7) adjacent to the standoffs (0087 and Fig. 7), the
`
`apertures having a width in a range of 0.5 millimeters to 1.5 millimeters (the apertures
`
`275 have a length between about 0.5 mm and 2.0 mm: 40087; thus, the taught width
`
`range overlaps the claimed width range).
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to have modified the dressing of Locke by selecting
`
`the width of the apertures within the claimed range asit has been held that a prima facie
`
`case of obviousness exists when the claimed ranges overlap with ranges disclosed by
`
`the prior art. See MPEP § 2144.05(I). in re Wertheim, 541 F.2d 257, 191 USPQ 90
`
`(CCPA 1976); in re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
`
`Further, Applicant places no criticality on the range claimed, indicating simply that the
`
`apertures may have a width between about 0.5 mm and 1.5 mm (40100 of instant
`
`specification).
`
`Regarding claim 18, Locke discloses all the limitations as discussed above for
`
`claim 1.
`
`Locke further discloses the second polymer film (210) has a thicknessin a range
`
`of about 50 microns to about 100 microns (the second film 210 has a thickness between
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 12
`
`20 microns to 100 microns: 0064; thus, the taught thickness range overlaps the
`
`claimed thickness range).
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to have modified the dressing of Locke by selecting
`
`the thickness of the secondfilm within the claimed range asit has been held that a
`
`prima facie case of obviousness exists when the claimed ranges overlap with ranges
`
`disclosed by the prior art. See MPEP § 2144.05(I). fn re Wertheim, 541 F.2d 257, 191
`
`USPQ 90 (CCPA 1976); in re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir.
`
`7990). Further, Applicant places no criticality on the range claimed, indicating simply
`
`that a thickness of about 50 microns to about 100 microns maybesuitable for some
`
`examples ({0060 of instant specification).
`
`Regarding claim 19, Locke discloses all the limitations as discussed abovefor
`
`claim 1.
`
`Locke further discloses the fluid restrictions are fenestrations in the second
`
`polymer film (the fluid restrictions 260 comprises perforations or linear slots in the
`
`second film 210: 40065-0066), wherein the fenestrations each have a length of about 2
`
`millimeters to about 5 millimeters (the perforations or linear slots have a length less than
`
`4 millimeters and at least 2 millimeters: (0066; thus, the taught length range is within
`
`the claimed length range). See MPEP § 2131.03. Further, Applicant places no criticality
`
`on the range claimed, indicating simply that the fluid restrictions 230 may comprise or
`
`consistof linear slots having a length less than 4 millimeters and the length maybe at
`
`least 2 millimeters (¢0067 of instant specification).
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 13
`
`Regarding claim 22, Locke discloses all the limitations as discussed above for
`
`claim 1.
`
`Locke further discloses the second polymer film (210) has a thickness between
`
`20 microns to 100 microns (0064), but does not discloses the second polymer film
`
`(210) has a thicknessin a range of about 200 microns to about 300 microns. However,
`
`a person having ordinary skill in the art would have understood that the thickness of the
`
`second polymer film varies according to needs of a prescribed therapy.
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to have modified the dressing of Locke by selecting
`
`the thicknessof the second film within the claimed range asit has been held that a
`
`prima facie case of obviousness exists when the claimed ranges overlap with ranges
`
`disclosed by the prior art. See MPEP § 2144.05(I). in re Wertheim, 541 F.2d 257, 191
`
`USPQ 90 (CCPA 1976); in re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir.
`
`7990). Further, Applicant places no criticality on the range claimed, indicating simply
`
`that a thickness of about 200 microns to about 300 microns maybesuitable for some
`
`examples (¥0061 of instant specification).
`
`Regarding claim 31, Locke discloses all the limitations as discussed abovefor
`
`claim 1.
`
`Lockefurther discloses the first polymer film has a thickness of about 500
`
`microns (the first polymer film 220 has a thicknessin a range of about 20 to 500
`
`micrometers: 40070; thus, the taught thickness range is within the claimed thickness
`
`range). See MPEP § 2131.03. Further, Applicant places no criticality on the range
`
`

`

`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 14
`
`claimed, indicating simply that the first layer may comprise a film having a thicknessof
`
`about 500 microns (§0093 of instant specification).
`
`Regarding claim 35, Locke discloses all the limitations as discussed above for
`
`claim 1.
`
`Locke further discloses each of the standoffs has a width in a range of about 1
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`millimeter to about 4 millimeters (each of the standoffs 270 has a diameter between
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`approximately 1.0 mm and 3.0 mm: 40086; thus, the taught width range is within the
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`claimed width range). See MPEP § 2131.03.
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`Locke further discloses each of the standoffs has a height in a range of about 1
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`millimeter to about 4 millimeters (each of the standoffs 270 has a height between
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`approximately 0.5 mm and 3.0 mm: 40086; thus, the taught height range overlaps the
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`claimed height range).
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`It would have been obvious to one of ordinary skill in the art before the effective
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`filling date of the claimed invention to have modified the dressing of Locke by selecting
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`the height of each of the standoffs within the claimed range asit has been held that a
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`prima facie case of obviousness exists when the claimed ranges overlap with ranges
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`disclosed by the prior art. See MPEP § 2144.05(I). in re Wertheim, 541 F.2d 257, 191
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`USPQ 90 (CCPA 1976); in re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir.
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`7990). Further, Applicant places no criticality on the range claimed, indicating simply
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`that each of the standoffs may have a height between approximately 1 millimeter and 4
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`millimeters ((0093 of instant specification).
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`Locke further discloses each of the standoffs 270 has a spacing/pitch of
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`approximately 2.0 mm (40086), but does not disclose each of the standoffs have a pitch
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`

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`Application/Control Number: 17/442,815
`Art Unit: 3781
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`Page 15
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`of about 3.5 millimeters to about 4 millimeters. However, a person having ordinary skill
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`in the art would have understood that the a spacing/pitch of each of the standoffs varies
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`according to needs of a prescribed therapy.
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`It would have been obvious to one of ordinary skill in the art before the effective
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`filling date of the claimed invention to have modified the dressing of Locke by selecting
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`the spacing/pitch of each of the standoffs within the claimed range as it has been held
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`that a prima facie case of obviousness exists when the claimed ranges overlap with
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`ranges disclosed bythe prior art. See MPEP § 2144.05(I). in re Wertheim, 541 F.2d
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`257, 191 USPQ 90 (CCPA 1976); in re Woodrulf, 919 F.2d 1575, 16 USPQ2d 1934
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`(Fed. Cir. 1990). Further, Applicant places no criticality on the range claimed, indicating
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`simply that the standoffs may bedistributed acrossthe first layer in a uniform grid or
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`array having a pitch of approximately 3.5 millimeters to about 4 millimeters (0093 of
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`instant specification).
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`Claim(s) 51 and 70 is/are rejected under 35 U.S.C 103 as being unpatentable
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`over Locke (US PGPUB 20180353662) in view of Mumby (US PGPUB
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`20140249495).
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`Regarding claim 51, Locke discloses all the limitations as discussed above for
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`claim 45.
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`Locke does not disclose a screen attached to the cover.
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`In the same field of endeavor, wound dressing, Mumbydiscloses a wound dressing
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`2100 comprising
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`a cover
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`layer 2140
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`(0375 and
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`Fig.
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`5A). Munby further
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`discloses/suggest a technique of having a masking or obscuring layer 2107 positioned
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`

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`Application/Control Number: 17/442,815
`Art Unit: 3781
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`Page 16
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`adjacent to the cover layer 2140 ({0375) for the benefit of allowing clinicians to examine
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`and visually assess the wound area (40051).
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`It would have been obvious to one of ordinary skill in the art before the effective
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`filling date of the claimed invention to have modified the dressing of Locke by
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`incorporating a screen attached to the cover, similar to that disclosed by Mumby, in
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`order to allow clinicians to examine and visually assess the wound area, as suggested
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`in (0375 of Mumby andasit has been held that the use of knowntechnique to yield
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`predictable result is prima facie obvious. See MPEP § 2148(I) (C & G).
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`Regarding claim 70, Locke discloses the dressing of claim 1 (see rejection of
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`claim 1 above).
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`Locke further discloses a negative pressure source (104) fluidly coupled to the
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`dressing (0030).
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`Locke does not disclose a screen configured to obscurethe tissue site.
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`In the same field of endeavor, wound dressing, Mumbydiscloses a wound dressing
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`2100 comprising
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`a cover
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`layer 2140
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`(0375 and Fig.
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`5A). Munby further
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`discloses/suggest a technique of having a masking or obscuring layer 2107 (¥0375) for
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`the benefit of allowing clinicians to examine and visually assess the wound area (40051).
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to have modified the dressing of Locke by
`
`incorporating a screen, similar to that disclosed by Mumby, in order to allow clinicians to
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`examine and visually assess the wound area, as suggested in §0375 of Mumby and as
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`it has been held that the use of known technique to yield predictable result is prima facie
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`obvious. See MPEP § 2143(I) (C & G).
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`

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`Application/Control Number: 17/442,815
`Art Unit: 3781
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`Page 17
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`Since the dressing of Locke meets the structural limitations of the claimed
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`dressing, it will inherently perform the method steps as claimed (See MPEP § 2112.02
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`(1)). Thus, Locke further discloses a methodof treating a tissue site with negative
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`pressure, the method comprising: applying the dressing of claim 1; applying negative
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`pressure to the tissue site through the dressing; removing the screen; observing the
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`tissue site through the dressing; and replacing the screen to obscurethe tissue site.
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`Claim(s) 56, 58, 61, and 64-65 is/are rejected under 35 U.S.C 103 as being
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`unpatentable over Locke (US PGPUB 20180353662) in view of Locke (US PGPUB
`
`20180353342).
`
`Regarding claims 56 and 58, Lockediscloses all the limitations as discussed
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`abovefor claim 45.
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`Lockefurther disclosesathird layer (a first layer 205: (0055 and Fig. 2); wherein
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`the cover, the first polymer film, the second polymer film, and the third layer are
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`assembled in a stacked relationship with the first polymer film and the second polymer
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`film disposed between the cover and the third layer (Figs. 2 and 8).
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`Lockefurther discloses the third layer 205 comprising apertures 240 (¢0055 and
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`Fig. 2), but does not disclose the third layer 205 comprises a treatment aperture and at
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`least some of the fluid restrictions are exposed through the treatment aperture; and the
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`treatment aperture forms a frame around at least some ofthe fluid restrictions.
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`In the same field of endeavor, wound dressing, Locke’342 discloses a dressing for
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`treating a tissue site with negative pressure (Abstract). Locke’342 further discloses a
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`second layer 210 comprising a plurality of fluid restrictions 220 ((0069 and Fig. 2) anda
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`third layer 215 comprising a treatment aperture 230 (40073 and Fig. 2) wherein a
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`

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`Application/Control Number: 17/442,815
`Art Unit: 3781
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`Page 18
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`substantial number of the fluid restrictions 220 is exposed through the treatment aperture
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`230 (40084 and Fig. 4) and wherein the treatment aperture 230 forms a frame around at
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`least some of the fluid restrictions 220 (Fig. 4) for the benefit of providing an open area
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`for delivery of negative pressure and passage of wound fluid through layers (0100).
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`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to have modified the dressing of Locke by replacing
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`apertures of the third layer with a treatment aperture, similar to that disclosed by
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`Locke’342, in order to provide an open area for delivery of negative pressure and
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`passage of wound fluid through layers, as suggested in 0100 of Locke’342. Thus, the
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`third layer of Locke in view of Locke’342 comprises a treatment aperture and at least
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`some ofthe fluid restrictions are exposed through the treatment aperture; and the
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`treatment aperture forms a frame around at least some ofthe fluid restrictions.
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`Regarding claim 61, Locke in view of Locke’342 discloses all the limitations as
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`discussed abovefor claim 56.
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`Locke further discloses the first polymer film, the second polymer film, and the
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`third layer are transparent (40106), but does not disclose the cover is transparent.
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`Locke’342 further discloses/suggests a cover 125 is transparent ((0083) for the
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`benefit of allowing visibility of apertures of the third layer 215 (40083).
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`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to have modified the dressing of Locke in view of
`
`Locke’34