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
`
`16/618,682
`
`12/02/2019
`
`T. Blane SANDERS
`
`P001672USO1PCT
`
`9078
`
`60402
`
`7590
`
`10/04/2023
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 300
`
`Troy, MI 48098
`
`EXAMINER
`
`TRAN, NHU
`
`3781
`
`10/04/2023
`
`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.
`16/618,682
`Examiner
`NHU Q TRAN
`
`Applicant(s)
`SANDERSetal.
`Art Unit
`AIA (FITF) Status
`3781
`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 09/08/2023.
`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 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.
`
`Disposition of Claims*
`1-26 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 13-26 is/are withdrawn from consideration.
`[) Claim(s)__ is/are allowed.
`Claim(s) 1-12 is/are rejected.
`S)
`) © Claim(s)____is/are objected to.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`“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)C) The specification is objected to by the Examiner.
`11)M The drawing(s) filed on 12/02/2019 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)0) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)() None ofthe:
`b)( Some**
`a)C) All
`1.2 Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have beenreceived 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) (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)
`
`(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 20230926
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 2
`
`DETAILED CORRESPONDENCE
`
`Note: This office action is in response to communication filed on 09/08/2023.
`
`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), wasfiled 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 beentimely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
`
`09/08/2023 has been entered.
`
`Status of Claims
`
`Claim(s) 1-26 is/are pending in the application.
`
`Claim(s) 1-12 is/are examined on the merits.
`
`Response to Arguments
`
`Applicant's arguments/remarksfiled on 08/24/2023 have been considered, but
`
`they are not persuasive.
`
`Applicant argues that Locke does not disclose “the plurality of struts of the
`
`porous foam configured to directly contact the tissue site” because Locke teaches
`
`inclusion of NTSAMD material whereas claimed invention does not. First, Applicant’s
`
`claim does not exclude incorporation of NTSAMD material. Thus, the presence of
`
`NTSAMD material in the struts of Locke does not patentably differentiate Applicant’s
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 3
`
`struts from Locke’s disclosed struts. Second, the basis of rejection is not based on
`
`eliminating/excluding the NTSAMD material from the struts of Locke. Third, {0074-0075
`
`of Locke read:
`
`[0074] The struts 1219 of the open-cell reticulated foam 1217 illustrated in FIGS. 12 and
`
`13 provide the necessary structure for creating microstrain at the tissue site 1201 when
`
`reduced pressure treatment is provided. Like the nodes described herein, the struts
`
`1219 may be formed from or coated with at least one NTSAMD material. The struts
`
`1219 may be unimorph-, bimorph-, or uniform-configured as previously described. For
`
`example, a unimorph-configured strut 1219a may include an active portion 1223 that is
`
`coated with the NTSAMD material and aninactive portion 1225 that is not coated.
`
`Alternatively, a bimorph-configured strut 12196 mayinclude two active portions,afirst
`
`that includes a first NTSAMD material and a second that includes a second NTSAMD
`
`material. As another alternative, a uniform-configured strut 1219c may be providedin
`
`which the entire strut 1219c is coated with or formed from a single NTSAMD material.
`
`[0075] During reduced pressure treatment, as reduced pressure is removed from the
`
`sealed space beneath drape 1210, the drape 1210 presses on the open-cell reticulated
`
`foam 1217 urging the foam 1217 toward the tissue site 1201. Some of the struts 1219 of
`
`the open-cell reticulated foam 1217 contact the tissue site 1201, and these struts 1219
`
`provide a point load to the tissue site 1201 thereby creating a particular distribution of
`
`microstrain across the tissue site 1201. When a stimulus is provided by a stimulus
`
`source 1231 to the dressing filler 1206, the deformation of the NTSAMD material and
`
`movementof struts 1219 permits a spatial redistribution of the point loads applied by the
`
`struts 1219 to the tissue site 1201. This in turn creates a different microstrain profile (i.e.
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 4
`
`the distribution of microstrain) at the tissue site 1201 and helps prevent adhesion of new
`
`tissue growth to the dressing filler 1206.
`
`In addition, Fig. 13 of Locke clearly shows that the disclosed/shown struts 1219
`
`are made of a porous foam. Based on the sentence “Some of the struts 1219 of the
`
`open-cell reticulated foam 1217 contact the tissue site 1201” in 0075 and Fig. 13
`
`Locke alone explicitly disclose/meet Applicant’s claimed limitation “plurality of struts of
`
`the porous foam configured to directly contact the tissue site’. Additionally, based on the
`
`explicit teachings of 0074-0075 and Fig. 13 of Locke above, a person having ordinary
`
`skill in the art would readily understand/recognize that the disclosed/shown struts 1219
`
`are made of a porous foam even when they are formed from NTSAMD material or when
`
`they are coated with the NTSAMD. Thefirst requirement of Locke’s struts is to be
`
`formed of open-cell reticulated foam. A person having ordinary skill in the art would
`
`understand that no struts can be formed without the foam. Even when the
`
`disclosed/shown struts 1219 are coated with the NTSAMD, Lockeexplicitly teaches that
`
`at least some of the struts such as “1219a mayinclude an active portion 1223 that is
`
`coated with the NTSAMD material and an inactive portion 1225 that is not coated’. As
`
`such, a person having ordinary skill in the art would understand that at least the struts
`
`“1219a” directly contact with the tissue site via the uncoated/inactive portions.
`
`In
`
`addition, Locke teaches that inactive portion 1225 is not coated with NTSAMD material
`
`(see annotated Fig. 13 below). The uncoated portions 1225 indicated by cleaner cell
`
`outlines are in the periphery of the coated portion 1223 which are delineated by jagged
`
`lines. Furthermore, Locke discloses in the embodiment of Fig. 12 that nodes are cell
`
`struts associated with an open-cell reticulated foam (Y0009). An inactive portion 1025 of
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 5
`
`the nodeorcell strut 1019a i.e., without NTSAMD material directly contacts the tissue
`
`site 1001 (see annotated Figs. 10-11 below). For at least these reasons, the presence
`
`of NTSAMD in the struts of Locke does not prevent the struts of Locke from being of a
`
`porous foam, does not prevent at least some of struts of Locke from contacting the
`
`tissue site, and does not prevent at least some of struts of Locke from meeting the
`
`claimed limitation.
`
`For at least the reason set forth above, Applicant’s arguments against Locke are
`
`not found persuasive and therefore, Locke discloses “the plurality of struts of the porous
`
`foam configured to directly contact the tissue site’ (see rejection of claim 1 below).
`
`a Ussue site
`
`\ Annotated
`
`| FIG. 11
`1004
`
`
`Annotated
`
`FIG. 10 |
`
`
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 6
`
`OWS | FIG. 13
`uncoated/inactive
`f
`
`[1225 portion
`
`1217 ‘ \ coated
`
`4293 Peer
`
`
`a tissue site
`4201
`
`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 groundof
`
`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
`
`the same under either status.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that
`
`the claimed invention is not identically disclosed as set forth in section
`
`102, if the differences between the claimed invention and the prior art are
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 7
`
`such that the claimed invention as a whole would have been obvious
`
`before the effectivefiling date of the claimed invention to a person having
`
`ordinary skill
`
`in the art to which the claimed invention pertains.
`
`Patentability shall not be negated by the manner in which the invention
`
`was made.
`
`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 present in the application indicating
`
`obviousness or nonobviousness.
`
`Claim(s) 1-10 is/are rejected under 35 U.S.C 103 as being unpatentable over
`
`Locke (US PGPUB 20130072850) in view of Olson (US PGPUB 20100069863).
`
`Regarding claim 1, Locke discloses a system (a system 1200: §0072 and Figs.
`
`12-13) for stimulating tissue growth at a tissue site (0072), comprising:
`
`a porous foam (a dressing filler 1206 comprising an open-cell, reticulated foam
`
`1217: 40073 and Fig. 12) comprising an exterior-facing surface (a surfacethat is
`
`contacted to a cover/drape 1210 : 40072 and Fig. 12), a tissue contact surface (a
`
`surface that is contacted to a tissue site 1201: 40072 and Fig. 12), and a plurality of
`
`struts (a plurality of struts 1219: 0073 and Fig. 13) positioned at the tissue contact
`
`surface (some of the struts 1219 contact the tissue site 1201: 40075 and Figs. 12-13),
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 8
`
`the plurality of struts of the porous foam configured to directly contact the tissue site and
`
`to create tissue deformation at the tissue site (some of the struts 1219 contactthe tissue
`
`site 1201 and these struts 1219 provide a point load to the tissue site 1201: 40075;
`
`therefore, the struts 1219 are capable of creating tissue deformation at the tissue site);
`
`a moisture barrier (a cover or drape 1210: 40072 and Fig. 12) configured to cover
`
`the exterior-facing surface of the porous foam (40072 and Fig. 12);
`
`wherein the porous foam (1206+1217) is configured to provide a contact force at
`
`least between the plurality of struts and the tissue site to create the tissue deformation
`
`without the application of a reduced pressure (some of the struts 1219 contact the
`
`tissue site 1201 and these struts 1219 provide a point load to the tissue site 1201:
`
`0075; therefore, the porous foam is capable of providing a contactforce at least
`
`between the plurality of struts and the tissue site to create the tissue deformation
`
`without the application of a reduced pressure; and since the taught porous foam and the
`
`claimed porous foam are patentably indistinct in terms of structure, the taught porous
`
`foam is considered/expected to be capable of providing a contact force at least between
`
`the plurality of struts and the tissue site to create the tissue deformation without the
`
`application of a reduced pressure; See MPEP § 2112.01 (I).
`
`Locke discloses the moisture barrier (the cover or drape 1210: 40072 and Fig.
`
`12), but does not disclose the material of the moisture barrier or disclose that the
`
`moisture barrier is configured to trap moisture at the tissue site.
`
`In the same field of endeavor, wound dressings, Olson discloses a reduced
`
`pressure treatment system 100 comprising a dressing 102 and a dressing material 106
`
`(§0014-0015 and Figs. 1-2). Olson further discloses a sealing member 106 that is made
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 9
`
`from polyurethane, EVAfilm or silicones for the benefits of providing a fluid seal over the
`
`dressing to maintain reduced pressure at a desired reduced pressure and providing an
`
`impermeable or semi-permeable elastomeric seal ((O022 and 0062).
`
`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 moisture barrier of Locke by
`
`selecting/using polyurethane, EVAfilm, or silicones as a material, similar to that
`
`disclosed by Olson, in order to provide a fluid seal over the dressing to maintain
`
`reduced pressure at a desired reduced pressure and provide an impermeable or semi-
`
`permeable elastomeric seal, as suggested in 40022 and 0062 of Olson and asit has
`
`been held that the selection of a known material based onits suitability for its intended
`
`use supports a prima facie obviousness determination (See MPEP § 2144.07). Further,
`
`one would have been motivated to select the material of polyurethane, EVAfilm, or
`
`silicones to be a material of a moisture barrier in a wound dressing for the purpose of
`
`providing a fluid seal over the dressing to maintain reduced pressure at a desired
`
`reduced pressure and providing an impermeable or semi-permeable elastomeric seal.
`
`Since the moisture barrier of Locke in view of Olson is madeof polyurethaneorsilicone
`
`which is the same material as the moisture barrier in 40028 of the instant application;
`
`the moisture barrier of Locke in view of Olson is capable of trapping moisture at the
`
`tissue site.
`
`Locke does not disclose the porous foam being formed of a hydrophobic material
`
`configured to preventfluid absorption within the porous foam such that the porous foam
`
`is entirely non-absorbent.
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 10
`
`Olson further discloses a technique of providing/disposing hydrophobic porous
`
`layers/materials (214+220: 40033, 0040 and Fig. 2) above the tissue site 207 (0078) for
`
`the benefits of keeping liquids away from the tissue site, reducing or preventing the lateral
`
`spread of the liquid along the interface between the tissue-interface layer and the surface
`
`of the tissue site, and thereby further preventing or reducing maceration of the tissue at
`
`or near the tissue site (0078).
`
`Examiner further notes that there are only two types of porous foam: hydrophobic
`
`and hydrophilic porous foams.
`
`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 porous foam of Lockein view of
`
`Olson by making the porous foam hydrophobic, similar to that disclosed by Olson, in
`
`order to keep liquids away from the tissue site, reduce or preventthe lateral spread of
`
`the liquid along the interface between the tissue-interface layer and the surface of the
`
`tissue site, and thereby further prevent or reduce maceration of the tissue at or near the
`
`tissue site, as suggested in 40078 of Olson and asit has been held that the use of
`
`known technique to yield predictable result is prima facie obvious (See MPEP § 2143(I)
`
`(C & G)). Therefore, the porous foam of Lockein view of Olson is capable of preventing
`
`fluid absorption within the porous foam such that the porous foam is entirely non-
`
`absorbent.
`
`Regarding claims 2-3, Locke in view of Olson disclosesall the limitations as
`
`discussed above for claim 1.
`
`Lockein view of Olson further discloses wherein the porous foam is configured
`
`to remain at the tissue site for at least 3 days or wherein the porous foam is configured
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 11
`
`to remain at the tissue site between 3 days to 7 days(since the taught porous foam and
`
`the claimed porous foam are patentably indistinct in terms of structure, the taught
`
`porous foam is considered/expected to be capable of remaining at the tissue site for at
`
`least 3 days or remaining at the tissue site between 3 days to 7 days; See MPEP §§
`
`2112.01 (I), 2114 (I)-(Il) and 2115).
`
`Regarding claim 4, Locke in view of Olson disclosesall the limitations as
`
`discussed above for claim 1.
`
`Locke further discloses wherein the plurality of struts are exposed atthe tissue
`
`contact surface (some of the struts 1219 contact the tissue site 1201: §0075 and Figs.
`
`12-13).
`
`Regarding claim 5, Locke in view of Olson disclosesall the limitations as
`
`discussed above for claim 1.
`
`Locke further comprises a plurality of voids (the open-cell, reticulated foam
`
`(1206+1217) inherently comprises a plurality of voids arranged between struts 1219:
`
`Figs. 12-13), and wherein the plurality of voids and the plurality of struts are exposed at
`
`the tissue contact surface and configured to engage the tissue site (some of the struts
`
`1219 contact the tissue site 1201: 40075 and Figs. 12-13; therefore, the plurality of
`
`voids and the plurality of struts are exposed at the tissue contact surface and configured
`
`to engage the tissue site).
`
`Regarding claim 6, Locke in view of Olson disclosesall the limitations as
`
`discussed above for claim 1.
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 12
`
`Lockefurther discloses the porous foam comprises a reticulated polyurethane
`
`foam (the dressing filler 1206 comprises a reticulated polyurethane foam 1217: 40073
`
`and Fig. 12).
`
`Regarding claim 7, Locke in view of Olson disclosesall the limitations as
`
`discussed above for claim 1.
`
`Locke further discloses wherein the porous foam (1206+1217) comprises a
`
`thickness (Fig. 12) that is substantially flush with a surface of an epidermis around the
`
`tissue site (the thickness of (1206+1217) is flush/even with a surface of an epidermis
`
`1213 around the tissue site 1201: §0072 and Fig. 12).
`
`Regarding claim 8, Locke in view of Olson disclosesall the limitations as
`
`discussed above for claim 1.
`
`Locke discloses the moisture barrier (the cover or drape 1210: 40072 and Fig.
`
`12) and is configured to be positioned in a sealed space between the moisture barrier
`
`and the tissue site ((0072 and Fig. 12), but does not disclose the material of the
`
`moisture barrier or disclose the moisture barrier comprisingafilm layer.
`
`Olson further discloses a sealing member 106 that is made from polyurethane,
`
`EVAfilm or silicones forthe benefits of providing a fluid seal over the dressing to maintain
`
`reduced pressure at a desired reduced pressure and providing an impermeable or semi-
`
`permeable elastomeric seal (§0022 and 0062).
`
`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 moisture barrier of Locke in
`
`view of Olson by selecting/using polyurethane or EVAfilm as a material, similar to that
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 13
`
`disclosed by Olson, in order to provide a fluid seal over the dressing to maintain
`
`reduced pressure at a desired reduced pressure and provide an impermeable or semi-
`
`permeable elastomeric seal, as suggested in 40022 and 0062 of Olson and asit has
`
`been held that the selection of a known material based onits suitability for its intended
`
`use supports a prima facie obviousness determination (See MPEP § 2144.07). Further,
`
`one would have been motivated to select the material of polyurethane or EVAfilm to be
`
`a material of a moisture barrier in a wound dressing for the purpose of providingafluid
`
`seal over the dressing to maintain reduced pressure at a desired reduced pressure and
`
`providing an impermeable or semi-permeable elastomeric seal. Thus, the moisture
`
`barrier of Locke in view of Olson comprisesafilm layer.
`
`Regarding claim 9, Locke in view of Olson disclosesall the limitations as
`
`discussed above for claim 8.
`
`Locke further discloses wherein the moisture barrier (1210) comprises an
`
`adhesive (an adhesive 1215: 90072 and Fig. 12).
`
`Regarding claim 10, Locke in view of Olson disclosesall the limitations as
`
`discussed above for claim 1.
`
`Locke discloses the moisture barrier (the cover or drape 1210: 40072 and Fig.
`
`12) comprises an adhesive (an adhesive 1215: 40072 and Fig. 12), but does not
`
`disclose the material of the moisture barrier or disclose the moisture barrier comprising
`
`an adhesive film.
`
`Olson further discloses a sealing member 106 that is made from polyurethane,
`
`EVAfilm or silicones for the benefits of providing a fluid seal over the dressing to
`
`

`

`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 14
`
`maintain reduced pressure at a desired reduced pressure and providing an
`
`impermeable or semi-permeable elastomeric seal (f0022 and 0062).
`
`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 moisture barrier of Locke in
`
`view of Olson by selecting/using polyurethane, EVAfilm, or silicones as a material,
`
`similar to that disclosed by Olson, in order to provideafluid seal over the dressing to
`
`maintain reduced pressure at a desired reduced pressure and provide an impermeable
`
`or semi-permeable elastomeric seal, as suggested in ¥0022 and 0062 of Olson and asit
`
`has been held that the selection of a known material based on its suitability for its
`
`intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
`
`Further, one would have been motivated to select the material of polyurethane, EVA
`
`film, or silicones to be a material of a moisture barrier in a wound dressing for the
`
`purposeof providing a fluid seal over the dressing to maintain reduced pressure ata
`
`desired reduced pressure and providing an impermeable or semi-permeable
`
`elastomeric seal. Thus, the moisture barrier of Locke in view of Olson comprises an
`
`adhesive film.
`
`Claim(s) 11 is/are rejected under 35 U.S.C 103 as being unpatentable over
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`Locke in view of Olson, as applied to claim 1 above, and further in view of
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`Luckemeyer (US PGPUB 20160015872 — of record).
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`Regarding claim 11, Locke in view of Olson disclosesall the limitations as
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`discussed above for claim 1.
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`Locke/Olson does not disclose wherein the moisture barrier comprises a coating.
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`

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`Application/Control Number: 16/618,682
`Art Unit: 3781
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`Page 15
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`In the same field of endeavor, negative pressure therapy system, Luckemeyer
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`discloses a dressing 102 comprising a cover 108 and a tissue interface 110 (0025 and
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`Fig. 1). Luckemeyerfurther discloses that the cover 108 is coated with an acrylic adhesive
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`for the benefits of improving seal and reducing leaks (40050).
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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 moisture barrier of Locke in
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`view of Olson by incorporating a coating, similar to that disclosed by Luckemeyer,in
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`order to improve seal and reduce leaks, as suggested in §0050 of Luckemeyer.
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`Claim(s) 12 is/are rejected under 35 U.S.C 103 as being unpatentable over
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`Locke in view of Olson, as applied to claim 1 above, and further in view of
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`Hartwell (US PGPUB 20160166744).
`
`Regarding claim 12, Locke in view of Olson disclosesall the limitations as
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`discussed above for claim 1.
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`Locke/Olson does not disclose the porous foam comprises a porosity between
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`about 20 pores per inch to about 80 poresperinch.
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`In an analogous art for being directed to solve the same problem, providing wound
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`packing material for use in negative pressure wound therapy, Hartwell discloses a wound
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`packing material
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`including a reticulated polyurethane foam suitable for use in negative
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`pressure wound therapy (Abstract and §0018). Hartwell further discloses/suggests the
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`foam used in negative pressure wound therapy has porosities in the range 30-60 ppi
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`((0018: the taught porosity overlaps with the claimed range porosity) for the benefits of
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`allowing transmission of the negative pressure to the wound bed and providing sufficient
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`

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`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 16
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`mechanical strength to prevent the negative pressure from substantially collapsing the
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`structure of the foam (40018).
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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 porous foam of Locke in view of
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`Olson by providing/making the porosities between 30-60 ppi, similar to that disclosed by
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`Hartwell,
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`in order to allow transmission of the negative pressure to the wound bed and
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`provide sufficient mechanical strength to prevent the negative pressure from
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`substantially collapsing the structure of the foam, as suggested in §0018 of Hartwell and
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`as it has been held that scaling up or down of an element which merely requires a
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`changein size is generally considered as being within the ordinary skill
`
`in the art (See
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`MPEP § 2144.04 (IV) (A). In addition,
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`it has been held that a prima facie case of
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`obviousness exists when the claimed ranges overlap with ranges disclosed by the prior
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`art. See MPEP § 2144.05 (I).
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`In this case, the claimed porosity range overlap with the
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`ranges disclosed by the prior art, therefore, it would have been obvious to a person of
`
`ordinary skill in the art to reasonably arrive at the same invention by using overlapping
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`ranges.
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`Conclusion
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`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to NHU Q TRAN whosetelephone numberis (571)272-
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`2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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`in-person, and video
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`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
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`

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`Application/Control Number: 16/618,682
`Art Unit: 3781
`
`Page 17
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`/NHU Q. TRAN/
`Examiner, Art Unit 3781
`/KAILH WENG/
`Examiner, Art Unit 3781
`
`