www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`16/918,682
`
`07/01/2020
`
`Christopher Brian LOCKE
`
`P001182US04CON
`
`5599
`
`60402
`
`7590
`
`01/02/2025
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 20
`Troy, MI 48098
`
`EXAMINER
`
`TANNER, JOCELIN C
`
`Para NONE
`
`3771
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`01/02/2025
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`IPDocketing @ Solventum.com
`dgodzisz@hdp.com
`troymailroom @hdp.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`Applicant(s)
`16/918,682
`LOCKE et al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`JOCELIN C TANNER
`3771
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`
`
`1) Responsive to communication(s) filed on 20 November 2024.
`C) A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)[¥) This action is FINAL.
`2b) (J This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)(2) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`1-2,4-5,7-25 and 27-28 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`CL] Claim(s)__is/are allowed.
`Claim(s) 1-2,4-5,7-25 and 27-28 is/are rejected.
`(] Claim(s)__ is/are objectedto.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)(J accepted or b)( objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`Priority under 35 U.S.C. § 119
`12)7) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.1.) Certified copies of the priority documents have been received.
`2.2) Certified copies of the priority documents have been received in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*“ See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`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)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20241226
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 2
`
`DETAILED ACTION
`
`This Office Action is in response to the Amendmentfiled 20 November 2024.
`Claim(s) 1-2, 4-5, 7-25, 27-28 are currently pending. The Examiner acknowledges the
`amendmentsto claim(s) 1 and 2, and cancelled claim(s) 3, 6 and 26.
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`The present application, filed on or after March 16, 2013, is being examined
`
`underthe first inventor to file provisions of the AIA.
`
`Claim Interpretation
`
`2.
`
`The claims in this application are given their broadest reasonable interpretation
`
`using the plain meaning of the claim language in light of the specification as it would be
`
`understood by oneof ordinary skill in the art. The broadest reasonable interpretation of
`
`a claim element (also commonly referred to as a claim limitation) is limited by the
`
`description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth
`
`paragraph, is invoked.
`
`As explained in MPEP § 2181, subsection I, claim limitations that meet the
`
`following three-prongtest will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35
`
`U.S.C. 112, sixth paragraph:
`
`(A)—the claim limitation uses the term “means”or “step” or a term used as a substitute
`
`for “means” that is a generic placeholder (also called a nonce term or a non-
`
`structural term having no specific structural meaning) for performing the claimed
`
`function;
`
`(B)
`
`the term “means”or “step” or the generic placeholder is modified by functional
`
`language, typically, but not always linked by the transition word “for” (e.g.,
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 3
`
`“means for’) or another linking word or phrase, such as “configured to” or “so
`
`that”: and
`
`(C)
`
`the term “means”or“step” or the generic placeholder is not modified by sufficient
`
`structure, material, or acts for performing the claimed function.
`
`Use of the word “means”(or “step”) in a claim with functional language creates a
`
`rebuttable presumption that the claim limitation is to be treated in accordance with 35
`
`U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim
`
`limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth
`
`paragraph, is rebutted when the claim limitation recites sufficient structure, material, or
`
`acts to entirely perform the recited function.
`
`Absenceof the word “means”(or “step”) in a claim creates a rebuttable
`
`presumption that the claim limitation is not to be treated in accordance with 35 U.S.C.
`
`112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim
`
`limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth
`
`paragraph, is rebutted whenthe claim limitation recites function without reciting
`
`sufficient structure, material or acts to entirely perform the recited function.
`
`Claim limitations in this application that use the word “means”(or “step”) are
`
`being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph,
`
`except as otherwise indicated in an Office action. Conversely, claim limitations in this
`
`application that do not use the word “means”(or “step”) are not being interpreted under
`
`35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise
`
`indicated in an Office action.
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 4
`
`Claim Objections
`
`1.
`
`Claim(s) 7 is/are objected to becauseofthe following informalities: Please
`
`change “less than 1” to “less than about 1”. Appropriate correction is required. It has
`
`been acknowledgedthat the claimedlimitations were present in the claims on the
`
`applicationfiling date of 1 July 2020, thus is not new matter.
`
`Double Patenting
`
`3.
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the “right to exclude” granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
`
`patenting rejection is appropriate where the conflicting claims are not identical, but at
`
`least one examined application claim is not patentably distinct from the reference
`
`claim(s) because the examined application claim is either anticipated by, or would have
`
`been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46
`
`USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
`
`Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timelyfiled terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actualor provisional rejection based on nonstatutory
`
`double patenting provided the reference application or patent either is shown to be
`
`commonly owned with the examined application, or claims an invention made as a
`
`result of activities undertaken within the scopeof a joint research agreement. See
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 5
`
`MPEP § 717.02 for applications subject to examination underthe first inventor tofile
`
`provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146et seq.for
`
`applications not subject to examination underthe first inventor to file provisions of the
`
`AlA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
`
`The filing of a terminal disclaimer byitself is not a complete reply to a
`
`nonstatutory double patenting (NSDP)rejection. A complete reply requires that the
`
`terminal disclaimer be accompanied by a reply requesting reconsideration of the prior
`
`Office action. Even where the NSDP rejection is provisional the reply must be complete.
`
`See MPEP § 804, subsection |.B.1. For a reply to a non-final Office action, see 37 CFR
`
`1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A requestfor
`
`reconsideration while not provided for in 37 CFR 1.113(c) maybefiled afterfinal for
`
`consideration. See MPEP §§ 706.07(e) and 714.13.
`
`The USPTOInternet website contains terminal disclaimer forms which may be
`
`used. Please visit www.uspto.gov/patent/patents-forms. The actualfiling date of the
`
`application in which the form is filed determines what form (e.g., PTO/SB/25,
`
`PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal
`
`Disclaimer maybefilled out completely online using web-screens. An eTerminal
`
`Disclaimer that meets all requirements is auto-processed and approved immediately
`
`upon submission. For more information about eTerminal Disclaimers, refer to
`
`www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
`
`4.
`
`Claims 1 and 2 are rejected on the ground of nonstatutory double patenting
`
`as being unpatentable over claims 1 and 9 of U.S. Patent No. US 10736788 (Locke
`
`et al.) in view of Jaeb et al. (US 2009/0227969A1).
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 6
`
`5.
`
`Although the claims at issue are notidentical, they are not patentably distinct
`
`from each other becausethe application claims of the US Application No. 16/918682
`
`require the protective layer is configured to extend beyond the contracting layerinto
`
`contact with a portion of the sealing drape.
`
`6.
`
`Patent claims 1 and 9 of the US Application No. 16/918682 recites a dressing for
`
`closing an opening through a surfaceof a tissue site (Claim 1, Col 23; lines 8-9),
`
`the dressing comprising: a tissue interface, comprising: a contracting layer, the
`
`contracting layer (Claim 1, Col 23; line 17) comprising a plurality of holes
`
`extending through the contracting layer to form a void space (Claim 1, Col 23;
`
`lines 20-21), and a protective layer configured to be positioned between the
`
`contracting layer and the tissue site (Claim 9, Col 24; lines 1-3); and a sealing
`
`drape configured to cover the tissue interface to form a sealed space (Claim 1, Col
`
`23; lines 9-10). In the same field of endeavor, wound dressings, Jaebet al. teaches a
`
`tissue interface including a contracting layer (224; Fig. 2) having a plurality of holes
`
`extending therethrough and a protective layer (222) positioned between the contracting
`
`layer and at least a portion of the surface of the tissue site surrounding the opening. A
`
`sealing drape (244) is configured to cover the tissue interface and the protective layeris
`
`configured to extend beyond the contracting layer into contact with a portion of the
`
`sealing drape [0076-0078, 0095; Fig. 2]. Therefore, it would have been obvious to one
`
`of ordinary skill in the art before the effectivefiling date of the claimed invention to have
`
`provided the protective layer of the application claims of the US Application No.
`
`16/918682 with the ability to extend beyond the contracting layer into contact with a
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 7
`
`portion of the sealing drape, as taught by Jaebetal., to provide means for securing the
`
`dressing to the tissue site and maintaining a seal around the tissue site [0095,0076].
`
`7.
`
`Claims 1, (11, 12), (11, 13) is/are rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over claim(s) 1, 7, 8 of U.S. Patent No. US
`
`10736788 (Lockeetal.) in view of Jaeb et al. (US 2009/0227969A1).
`
`8.
`
`Although the claims at issue are notidentical, they are not patentably distinct
`
`from each other becausethe application claims of the US Application No. 16/918682
`
`require the protective layer is configured to extend beyond the contracting layerinto
`
`contact with a portion of the sealing drape and a protective layer configured to be
`
`positioned between the contracting layer and the tissue site.
`
`9.
`
`Patent claim(s) 1, 7, and 8 of Lockeetal. recites a dressing for closing an
`
`opening through a surfaceof a tissue site (Claim 1 Col 23 lines 8-9), the dressing
`
`comprising: a tissue interface, comprising: a contracting layer, the contracting layer
`
`(Claim 1, Col 23; line 17) comprising a plurality of holes extending through the
`
`contracting layer to form a void space (Claim 1, Col 23; lines 20-21), and a sealing
`
`drape configured to cover the tissue interface to form a sealed space (Claim 1, Col
`
`23; lines 9-10). The contracting layer is formed from a foam material having a firmness
`
`factor, wherein the firmness factor is a ratio of density of the foam material in a
`
`compressedstate to a density of the foam material in an uncompressed state. The
`
`firmness factor is about 5 (claims 11, 12) and the firmness factor is about 3 (claims 11,
`
`13).
`
`In the samefield of endeavor, wound dressings, Jaebet al. teaches a tissue
`
`interface including a contracting layer (224; Fig. 2) having a plurality of holes extending
`
`therethrough and a protective layer (222) positioned between the contracting layer and
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 8
`
`at least a portion of the surface of the tissue site surrounding the opening. A sealing
`
`drape (244) is configured to coverthe tissue interface and the protective layeris
`
`configured to extend beyond the contracting layer into contact with a portion of the
`
`sealing drape [0076-0078, 0095; Fig. 2]. The protective layer is configured to be
`
`positioned between the contracting layer and the tissue site (Fig. 2). Therefore, it would
`
`have been obvious to one of ordinary skill in the art before the effectivefiling date of the
`
`claimed invention to have provided the protective layer of the application claims of the
`
`US Application No. 16/918682 with the ability to extend beyond the contracting layer
`
`into contact with a portion of the sealing drape, as taught by Jaebet al., to provide
`
`means for securing the dressing to the tissue site and maintaining a seal around the
`
`tissue site [0095,0076].
`
`10.
`
`Claim(s) (1, 3, 5, 11-13, 17), 14, 15, 16, 22 is/are rejected on the ground of
`
`nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 7, 4 of
`
`U.S. Patent No. US 9974694 (Locke ‘694) in view of Jaeb et al. (US
`
`2009/0227969A1).
`
`11.
`
`Although the claims at issue are notidentical, they are not patentably distinct
`
`from each other becausethe application claims of the US Application No. 16/918682
`
`requires the protective layer to be configured to extend beyond the contracting layerinto
`
`contact with a portion of the sealing drape and a protective layer configured to be
`
`positioned between the contracting layer and the tissue site.
`
`12.
`
`Patent claim(s) 1, 5, 6, 7 and 4 of Locke ‘694 recites a dressing for closing an
`
`opening through a surfaceof a tissue site (Claim 1, col 23; lines 8-9), the dressing
`
`comprising: a tissue interface, comprising: a contracting layer (Claim 1, col 23; line
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 9
`
`17), the contracting layer comprising a plurality of holes extending through the
`
`contracting layer to form a void space(claim 1, col 23; lines 22-25), anda
`
`protective layer (claim 1, col 23; line 15) configured to be positioned between the
`
`contracting layer and at least a portion of the surface of the tissue site surrounding the
`
`opening (claim 1, col 23; lines 15-16); and a sealing drape configured to cover the
`
`tissue interface to form a sealed space(claim 1, col 23; lines 10-11). The contracting
`
`layer is formed from a foam material having a firmness factor, wherein the firmness
`
`factor is a ratio of density of the foam material in a compressed state to a density of the
`
`foam material in an uncompressedstate. The firmness factor is about 5 (claims 11, 12)
`
`and the firmness factor is about 3 (claims 11, 13), the contracting layer is formed of
`
`compressed foam (claim 17). The shape of each hole is hexagonal, elliptical or circular
`
`(claims 14-16) and the contracting layer has a thickness of about 15mm (claim 22).
`
`Patent claim 1 of Locke ‘694 recites the dressing of instant claim 5, wherein the strut
`
`angle is about 30-70 degrees, which encompassesthe range of less than about 90
`
`degrees (claim 1, col 23; line 30-31). Patent claim 1 of Lock ‘694 recites the dressing
`
`of instant claim 3, wherein the strut angle is claimed (claim 1, col 23; line 30-31). ‘694
`
`does not explicitly claim the strut angle as an angle betweenaline connecting centers
`
`of holes in adjacent rows and anorientation line perpendicular to a direction of the
`
`closing force, however, as the same term “strut angle” is used, one would expectthis to
`
`encompassthe same definition, and therefore be at least obvious.
`
`13.
`
`In the same field of endeavor, wound dressings, Jaeb et al. teaches a tissue
`
`interface including a contracting layer (224; Fig. 2) having a plurality of holes extending
`
`therethrough and a protective layer (222) positioned between the contracting layer and
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 10
`
`at least a portion of the surface of the tissue site surrounding the opening. A sealing
`
`drape (244) is configured to cover the tissue interface and the protective layeris
`
`configured to extend beyond the contracting layer into contact with a portion of the
`
`sealing drape [0076-0078, 0095; Fig. 2]. The protective layer is configured to be
`
`positioned between the contracting layer and the tissue site (Fig. 2). Therefore, it would
`
`have been obvious to one of ordinary skill in the art before the effectivefiling date of the
`
`claimed invention to have provided the protective layer of the application claims of the
`
`US Application No. 16/918682 with the ability to extend beyond the contracting layer
`
`into contact with a portion of the sealing drape, as taught by Jaebetal., to provide
`
`means for securing the dressing to the tissue site and maintaining a seal around the
`
`tissue site [0095,0076].
`
`Claim Rejections - 35 USC § 102
`
`1.
`
`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 (i.e., changing from AIA to pre-AlA) 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 undereither status.
`
`2.
`
`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 personshall 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 effectivefiling date of the claimed
`invention.
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 11
`
`3.
`
`Claim(s) 1, 19 and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being
`
`anticipated by Adie et al. (US 2011/0282309A1, “Adie”).
`
`4.
`
`Regarding claim 1, Adie discloses a dressing for closing an opening through a
`
`surface of a tissue site. The dressing includes a tissue interface including a contracting
`
`layer (105; [0180]) having a plurality of holes extending through the contracting layer to
`
`form a void space (Fig. 24). A protective layer (102) is capable of being positioned
`
`between the contracting layer and at least a portion of the surface of the tissue site
`
`surrounding the opening. A sealing drape (140; [0156]) is capable of covering the tissue
`
`interface to form a sealed space. The protective layer extends beyond the contracting
`
`layer into contact with a portion of the sealing drape (Fig. 1B).
`
`5.
`
`Regarding claim 19, Adie discloses that the contracting layer includes a 3D
`
`spacerfabric [0139].
`
`6.
`
`Regarding claim 28, Adie discloses that the protective layer is capable of being
`
`positioned over the opening (Fig. 1B).
`
`7.
`
`Claim(s) 1, 11, 17 and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being
`
`anticipated by Jaebet al. (US 2009/0227969A1, “Jaeb”).
`
`8.
`
`Regarding claim 1, Jaeb discloses a dressing for closing an opening through a
`
`surface of a tissue site. The dressing includes a tissue interface including a contracting
`
`layer (224; [0044, 0059]) having a plurality of holes extending through the contracting
`
`layer to form a void space(Fig. 2). A protective layer (222) is capable of being
`
`positioned between the contracting layer and at least a portion of the surface of the
`
`tissue site surrounding the opening. A sealing drape (244; [0076, 0078, 0095)) is
`
`capable of covering the tissue interface to form a sealed space. The protective layer
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 12
`
`extends beyondthe contracting layer into contact with a portion of the sealing drape
`
`(Fig. 2).
`
`9.
`
`Regarding claim 11, Jaeb discloses that the contracting layer is formed from a
`
`foam material [0059], wherein foam has a firmness factor whichis a ratio of density of
`
`the foam material in a compressed state to a density of the foam material in an
`
`uncompressedstate.
`
`10.
`
`Regarding claim 17, Jaeb discloses that the contracting layer is a compressed
`
`foam [0059].
`
`11.
`
`Regarding claim 28, Jaeb discloses that the protective layer is capable of being
`
`positioned over the opening (Fig. 2; [0089)).
`
`Claim Rejections - 35 USC § 103
`
`12.
`
`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
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`correction of the statutory basis (i.e., changing from AIA to pre-AlA) for the rejection will
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`not be considered a new ground ofrejection if the prior art relied upon, and the rationale
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`supporting the rejection, would be the same undereither status.
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`13.
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`The following is a quotation of 35 U.S.C. 103 which forms the basisfor all
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`obviousness rejections set forth in this Office action:
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`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
`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.
`
`14.
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`Claim(s) 2, 4, 5, 7-18, and 20-22 is/are rejected under 35 U.S.C. 103 as being
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`unpatentable over Jaeb in view of Dunn etal. (US 2015/0190288,“Dunn”).
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`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 13
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`15.
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`Regarding claim 2, Jaeb discloses a plurality of holes but does not expressly
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`disclose the plurality of holes having a perforation shape factor and a strut angle
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`configured to causethe plurality of holes to collapsein a direction substantially
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`perpendicular to the opening, wherein the contracting layer generates a closing force
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`substantially parallel to the surface of the tissue site to close the opening in responseto
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`an application of negative pressure, wherein the strut angle is an angle betweena line
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`connecting centers of holes in adjacent rows. In the samefield of endeavor, wound
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`dressings, Dunn teaches a contracting layerincluding a plurality of holes (see cells or
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`holes in between the stabilizing structures of 1701 created by the struts 1703 and
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`1705 in figure 3A-3B; paragraph 0087) that have a perforation shape factor anda
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`strut angle (wherein all holes inherently have a perforation shape factor and a strut
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`angle which would be created by the struts 1703 and 1705 and multiple rows.
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`Dunn teachesasthe struts meet, they maybein right angles to each other to
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`create planar support structures 1702, or in other configurations such as
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`honeycomb, and multiple planar support structures 1702 may be joined together
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`to form the stabilizing structure; paragraphs 0087 and 0092) configured to cause
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`the plurality of holes to collapse in a direction substantially perpendicular to the opening
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`(as the structure’s holes’ openings can be from any direction, as best seen in
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`figure 3A-3D, it could collapse in a direction perpendicular to the horizontal
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`openings; see figures 3A-3D and paragraphs 0087 and 0092). Thus, the contracting
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`layer is capable of generating a closing force substantially parallel to the surface of the
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`tissue site to close the opening in response to an application of negative pressure (as
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`the negative pressure is applied, the closing force would be parallel as it would
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`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 14
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`collapse inward, causing the tissue of the wound to cometogether in a parallel
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`direction and close the opening, see paragraphs 0087, 0088, and 0092 regarding
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`direction of the collapse and the contracting layer, porous foam, surrounding the
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`tissue site).
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`16.|Dunn continues to teach that the strut angle (Dunn’s strut angle is interpreted
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`in accordancewith the specifications paragraph 0063) is an angle (see interpreted
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`“strut angle” in the annotated figure below) between a line (see interpreted “first
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`line” in the annotated figure below for a diagonal line created by the holes
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`diagonal from one another in adjacent rows OR “second line” for holes
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`orientated directly above one anotherin adjacent rows) connecting centers of holes
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`(represented as the exaggerated black dots in the centers of the holes in the
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`annotated figure below) in adjacent rows and anorientation line (see interpreted
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`“orientation line” in the annotated figure below) perpendicular to a direction of the
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`closing force (see interpreted “direction of closing force” in the annotated figure
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`below,as the structure 1701 would compresssothat the planar support
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`structures 1702 comecloser to one another, paragraphs 0087 and 0092) (as the
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`struts would meetat right angles, and other configurations, and two or more
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`support structures which are planes of 2D holes create 3D holes when they are
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`joined together adjacently, see figure 3A for example, using the beamsat the
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`angles wherein the holes would be perpendicular, see figure 3D, when the
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`direction of the closing force is on top and arranged to collapse downward, the
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`orientation line is interpreted as the axis that would be interpreted as going
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`horizontally through the device as that would create the perpendicular angle to
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`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 15
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`the closing force best seen by the general orientation of the struts in figure 3D;
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`see paragraphs 0087 and 0092 regarding arrangement of struts, planes, and
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`collapse whenclosing force is applied). The perforation shape factor (interpreted as
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`how the hole is shaped of Dunn, see thelimitation regarding the ratio, see figure
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`3D below)of a hole of the plurality of holes is a ratio of a first line segment to a second
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`line segment (interpreted as the ratio between the two line segments of the hole
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`seenin figure 3D below), the first line segment extending from a center of the hole to a
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`perimeterof the hole in a direction perpendicular to a direction of the closing force (see
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`Interpreted direction of the Closing Force and Interpreted First Line Segment, as
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`they are arranged in a perpendicular manner in annotated figure 3D below) and
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`the secondline segment extending from a center of the hole to a perimeter of the hole
`
`in a direction parallel to the direction of the closing force (see Interpreted Direction of
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`the Closing Force and Interpreted Second Line Segment, as they are arrangedin
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`a perpendicular mannerin annotated figure 3D below) (See paragraphs 0087
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`regarding the struts 1703 and 1705; please note that the word “segment”is
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`presentin “line segment”, therefore boththe first and the second line segments
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`are segmentsof the greater lines of the holes, see zoomed and annotated figure
`
`3D below).
`
`17.
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`Therefore, it would have been obvious to one of ordinary skill in the art before the
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`effective filing date of the claimed invention to have substituted the material of the
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`contracting layer of Jaeb with the material of the contracting layer, as taught by Dunn,
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`as this modification involves the simple substitution of one contracting layer for another
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`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 16
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`for the predictable result of providing means for facilitating migration of liquid from the
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`tissue site.
`
`Direction of
`AL
`Closing Force
`
`’
`;
`
`.
`Second Line
`
`.
`:
`First Line
`
`¥
`
`Orientation
`Line
`
`re diagonal hole
`
`18.
`
`19.
`
`20.
`
`VFOB
`
`Strut Angie of
`the botiam
`hole and the
`hole directly
`above it
`
`
`
`
`
`
`trut Angle of the
`ottorn hole and
`
`Regarding claim 4, the combination of Jaeb and Dunn teachesa deviceincluding
`
`a strut angle that is about 90 degrees (best seen in annotated figure 3D above, as
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`the strut angle is created between the interpreted “second line” and the
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`“orientation line”, as the angle created by these lines can be seen to be about 90
`
`degrees, Dunn).
`
`21.
`
`Regarding claim 5, the combination of Jaeb and Dunn teachesthe strut angle is
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`less than about 90 degrees (best seen in annotated figure 3D above, asthe strut
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 17
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`angle is created between the interpreted “first line” and the “orientation line”, as
`
`the angle created by these lines can be seen to be less than 90 degrees, Dunn).
`
`Interpreted
`Direction of the
`Closing Force
`
`Line Segment
`
`
`
`
`second Line
`Segment
`
`
`interpreted First
`
` Interpreted
`
`Fig. 3D Zoomed
`and Annotated
`
`. Be
`
`10
`
`23.
`
`Regarding claims 7 and8, the combination of Jaeb and Dunn teachesthat the
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`perforation shape factor of the hole is less than about 1 or more than about 1. Dunn
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`teaches wherein a shape of each hole of the plurality of holesis elliptical (the cells
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`2102 may be oblong or oval, and other such shapesofthe stabilizing structure
`
`2100, paragraph 0133). When the oblong or oval shapeis oriented vertically, this would
`
`equate to a perforation shape factor of less than about 1 as the perpendicularline
`
`segmentfrom the center to the perimeterof the hole in the direction perpendicular to the
`
`closing force (when taken to the perimeter closest to the c