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
`
`03/20/2024
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 20
`Troy, MI 48098
`
`EXAMINER
`
`BASET, NASHEHA
`
`Para NONE
`
`3771
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`03/20/2024
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`dgodzisz@hdp.com
`troymailroom @hdp.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`Applicant(s)
`16/918,682
`LOCKE et al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`NASHEHA BASET
`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 December 14, 2023.
`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*
`1-27 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`C} Claim(s)__ is/are allowed.
`Claim(s) 1-27 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 20240314
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA orAIA Status
`
`The presentapplication,filed on or after March 16, 2013, is being examined under the first
`
`inventorto file provisions of the AIA.
`
`Response to Amendmentand Status of the Claims
`
`This office action is in response to the remarksfiled on December 14, 2023.
`
`In response to the amendmentfiled December 14, 2023, claim1 is amended, claims 1-27 are
`
`pending. Examiner notes that the double patenting rejection of the office action dated 09/21/2023
`
`should not be held in abeyance.
`
`Claim Rejections - 35 USC § 102
`
`Inthe event the determination of the status of the application as subject to AIA 35 U.S.C. 102
`
`and 103 (or as subject to pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory
`
`basis (i.e., changing from AIA to pre-AlA) 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 made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(a}(1) the claimed invention was patented, described ina printed publication, or in public use, on sale,
`or otherwise available to the public before the effective filing date of the claimed invention.
`
`Claims 1-3, 6, 9, 14-16, 18, and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being
`
`anticipated by Dunn et al(WO 2014014922A1), herein after Dunn.
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 3
`
`Claim 1. Dunn teaches a dressing for closing an opening through a surfaceof a tissue site, the
`
`dressing comprising: a tissue interface (system 100, comprising wound packer 102 figures 1, 3A-D and
`
`21A-27B paragraph 0081), comprising: a contracting layer (stabilizing structure or wound packer 102,
`
`figure 1; element 1701, figure 3A-D; element 2100 figures 21A-B paragraphs0081, 0083, 0087, and
`
`0132), the contracting layer comprising a plurality of holes (material such as foam or polymers, see
`
`paragraph 0081;cells or holes in between the stabilizing structures of 1701 and 2100; cells 2102,
`
`figure 21 paragraph0132) extending through the contracting layer to form a void space(interior space
`
`of the wound packer), anda protective layer configured to be positioned between the contracting layer
`
`and at least a portion of the surface of the tissue site surrounding the opening (organ protection layer
`
`paragraphs0083 and 0092, “...anon-or minimally-adherent organ protection layer(notillustrated)
`
`may be applied overany exposed viscera.”
`
`“maybe placed into contactwith at least the bottom
`
`nt
`
`portion of the wound.” As the claim limitation requires the protective layer to be positioned on at
`
`least a portion of the surface of the tissue site surrounding the opening, being placed overany
`
`exposedviscera is considered to bea portion ofa surface of tissue surrounding the opening in the
`
`broadest reasonable interpretation of the word surfacein application to surrounding the opening, if
`
`the opening is the viscera and viscerais tissue. Whether the organ protection layer be placed over or
`
`onthe bottom part of the wound, itis contacting surface tissue surrounding the opening and not
`
`within the wound itself as the wound packer would be inserted within the wound and sealed with the
`
`drape, see paragraph 0083.); anda sealing drape (drape 104; paragraph 0081 and 0083) configured to
`
`cover the tissue interface to form a sealed space (paragraphs 0081 and 0083).
`
`Claim 2. Dunn teaches the device as taughtin the rejection of claim 1 above. Dunn continues to
`
`teach wherein the plurality of holes have a perforation shape factor and a strut angle {all holes
`
`inherently have a perforation shape factor and astrut angle, paragraphs 0092, 0132-0133) configured
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 4
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`to cause the plurality of holes to collapse in a direction substantially perpendicular to the opening
`
`(paragraphs 0083, 0092, and 0132-0133), and wherein the contracting layer generatesa closing force
`
`substantially parallel to the surface of the tissue site to close the opening in response to an application
`
`of negative pressure (paragraphs 0083, 0092 and 0132-0133).
`
`Claim 3. Dunn teachesthe device as taught in the rejection of claim 2 above. Dunn continues to
`
`teach wherein the strut angle is an angle between a line connecting centers of holes in adjacent rows
`
`and an orientation line perpendicular to a direction of the closing force (paragraphs 0083, 0087,0092
`
`and 0132-0133).
`
`Claim 6. Dunn teachesthe device as taught in the rejection of claim 2 above. Dunn continues to
`
`teach wherein the perforation shape factor of a hole of the plurality of holes is a ratio of a first line
`
`segment toa secondline segment, the first line segment extending from a center of the hole toa
`
`perimeter of the hole in a direction perpendicular to a direction of the closing force and the secondline
`
`segment extending from a center of the hole toa perimeter of the hole in a direction parallel to the
`
`direction of the closing force (paragraphs 0087 and 0132).
`
`Claim 9. Dunn teaches the device as taughtin the rejection of claim 1 above. Dunn continues to
`
`teach wherein the plurality of holes are formed in two or more parallel rows, as this can be best seenin
`
`figure 3B where the plurality of holes are formedin parallel rows (figures 3A-3B, 1701 has
`
`openings/holesthat are parallel; see figure 21 A; cells 2102 are parallel rows).
`
`Claim 14. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn continues
`
`to teach wherein a shape of each hole of the plurality of holes is hexagonal (paragraph 0133).
`
`Claim 15. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn continues
`
`to teach wherein a shapeof each hole ofthe plurality of holes is elliptical (oblong or oval paragraph
`
`0133).
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page5S
`
`Claim 16. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn continues
`
`to teach wherein a shape of each hole of the plurality of holes is circular (paragraph 0119-0120).
`
`Claim 18. Dunn teaches the device as taughtin the rejection of claim 1 above. Dunn continues
`
`to teach wherein the contracting layer comprises a felted foam (“compressed or "felted" reticulated
`
`foam’, paragraph 0099).
`
`Claim 21. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn continues
`
`to teach wherein the contracting layer comprises a thermoplastic polyurethane (paragraphs 0099, 0104
`
`0109, 0113, 0134).
`
`Claim 22. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn teachesthe
`
`wall (of the contracting layer/stabilizing structure) may have a height “at least about 15mm”(paragraph
`
`0142).
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections
`
`set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is
`not identically disclosed as set forthin section 102, if the differences between the claimed invention
`and the prior art are such that the claimed invention as a whole would have been obvious before the
`effective filing date of the claimed invention to a person having 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 as follows:
`
`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.
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 6
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`This application currently names joint inventors. In considering patentability of the claims the
`
`examiner presumesthat the subject matter of the various claims was commonly owned as of the
`
`effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised
`
`of the obligation under 37 CFR 1.56 to point out the inventor and effectivefiling dates of each claim that
`
`was not commonly ownedas of the effective filing date of the later invention in order for the examiner
`
`to consider the applicability of 35 U.S.C. 102(b)(2}(C) for any potential 35 U.S.C. 102(a)(2) prior art
`
`against the later invention.
`
`Claims 4-5, 7-8, 10-13, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable
`
`over Dunn etal (WO 2014014922 A1), herein after Dunn.
`
`Claim 4. Dunn teaches the device as taughtin the rejection of claim 3 above. Dunn does not
`
`teach wherein the strut angle is about 90 degrees. Dunnteach beams 1700 and walls 2104 which create
`
`the plurality of holes can be adjusted at different positions (paragraphs 0087 and 0132). Dunn also
`
`teaches that the strut angle is a result effective variable wherein the strut angle can affect the ability to
`
`collapse around the wound (paragraphs0087 and 0132). It would have been obvious to one of ordinary
`
`skill in the art before the effective filing date of the invention to make the strut angle about 90 degrees
`
`in order tochange the amountof force required for the hole to collapse, since it has been held that
`
`where the general conditions of a claim are disclosed in the prior art, discovering the optimum or
`
`workable rangesinvolves only routine skill in the art. Inre Aller, 105 USPQ 233.
`
`Claim 5. Dunn teachesthe device as taught in the rejection of claim 3 above. Dunn does not
`
`teach wherein the strut angle is less than about 90 degrees. Dunn teach beams 1700 and walls 2104
`
`which create the plurality of holes can be adjusted at different positions (paragraphs 0087 and 0132).
`
`Dunn also teaches that the strut angle is a result effective variable wherein the strut angle can affect the
`
`ability to collapse around the wound (paragraphs 0087 and 0132). It would have been obvious to one of
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 7
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`ordinary skill in the art before the effective filing date of the invention to make the strut angle less than
`
`90 degreesin order to change the amountof force required for the hole tocollapse, since it has been
`
`held that where the general conditions of a claim are disclosedin the prior art, discovering the optimum
`
`or workable rangesinvolves only routine skill in the art. Inre Aller, 105 USPQ 233.
`
`Claim 7. Dunn teaches the device as taughtin the rejection of claim 6 above. Dunn does not
`
`teach wherein the perforation shape factorof the hole is less than about 1. Dunn teaches the beams
`
`1700 or walls 2104 that create the plurality of holes canbe adjusted at different positions (paragraphs
`
`0087 and 0132). Dunn alsoteaches that the perforation shape factoris a result effective variable,
`
`wherein the perforation shapefactor can affect the ability to collapse around the wound (paragraphs
`
`0087 and 0132). It would have been obvious to oneof ordinary skill in the art before the effective filing
`
`date of the invention to make the perforation shape factor of each hole less than about 1, for the
`
`purpose of changing the amountof force required for the holes tocollapse, since it has been held that
`
`where the general conditions of a claim are disclosed in the prior art, discovering the optimum or
`
`workable rangesinvolves only routine skill in the art. Inre Aller, 105 USPQ 233.
`
`Claim 8. Dunn teachesthe device as taught in the rejection of claim 6 above. Dunn does not
`
`teach wherein the perforation shape factor of the hole is more than about 1. Dunn teaches the beams
`
`1700 or walls 2104 that create the plurality of holes canbe adjustedat different positions (paragraphs
`
`0087 and 0132). Dunn alsoteaches that the perforation shape factoris a result effective variable,
`
`wherein the perforation shapefactor can affect the ability to collapse around the wound (paragraphs
`
`0087 and 0132). It would have been obvious to one of ordinary skill in the art before the effective filing
`
`date of the invention to make the perforation shape factor of each hole more than about 1, for the
`
`purpose of changing the amountof force required for the holes tocollapse, since it has been held that
`
`where the general conditions of a claim are disclosed in the prior art, discovering the optimum or
`
`workable rangesinvolves only routine skill in the art. Inre Aller, 105 USPQ 233.
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 8
`
`Claim 10. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn does not
`
`teach wherein the plurality of holes have an average effective diameter of about 5 mm. Dunn teaches
`
`“the width may be between about 1mm to 30mm, 2mm to 25mm, 4mm to 20mm, 6mm to 18mm, 8mm
`
`to 16mm,or 10mm to 14 mm,, preferably about 10.8mm. These measurements may apply to any
`
`stabilizing structure described in this section or elsewhere in this specification” (paragraph 0143-0144).
`
`It would have been obvious to one of ordinaryskill in the art before the effective filing date of the
`
`invention to make the plurality of holes have an average effective diameter of about 5mm, for the
`
`purpose of changing the structural strength required for the collapse, since it has been held that where
`
`the general conditions of aclaim are disclosed in the prior art, discovering the optimum or workable
`
`rangesinvolves only routine skill in the art. Inre Aller, 105 USPQ 233.
`
`Claim 11. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn does not
`
`teach wherein the contracting layer is formed from a foam material having a firmness factor, wherein
`
`the firmness factor is a ratioof density of the foam material in a compressed state toa density of the
`
`foam material in an uncompressed state. Dunn does teach theuse of foam (paragraph 0081)for the
`
`wound packer 102 (instant application’s contracting layer, see claim 1). In an alternate embodiment,
`
`Dunn teaches “By reducing the overall density, the structure will be more readily collapsible. Thus, the
`
`use of a lower density structure with less foam may allow for greater wound closure as sucha structure
`
`is more readily collapsible. Conversely, the use of a higher density structure with more foam may beless
`
`collapsible.” (paragraph 0224). It would have been obvious to one of ordinaryskill in the art before the
`
`effective filing date of the invention to make the contracting layer from a foam material, inherently
`
`having a firmness factor, wherein the ideal firmness is determined by the density of the structure in
`
`order to be moreorless collapsible to its ideal conditions, since it has been held that where the general
`
`conditions of a claimare disclosedin the prior art, discovering the optimum or workable rangesinvolves
`
`only routine skill in the art. Inre Aller, 105 USPQ 233.
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 9
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`Claim 12. Dunn teaches the device as taught in the rejection of claim 11 above. Dunn does not
`
`teach wherein the firmness factor is about 5. Dunn teaches “By reducing the overall density, the
`
`structure will be more readily collapsible. Thus, the use of a lower density structure with less foam may
`
`allow for greater wound closure as such a structure is more readily collapsible. Conversely, the use of a
`
`higher density structure with more foam may beless collapsible.” (paragraph 0224). It would have been
`
`obvious to one of ordinary skill in the art before the effective filing date of the invention to make the
`
`contracting layer have the ideal firmness, wherein the ideal firmness is determined by the density of the
`
`structure in order to be moreor less collapsible to its ideal conditions, since it has been held that where
`
`the general conditions of aclaim are disclosed in the prior art, discovering the optimum or workable
`
`rangesinvolves only routine skill in the art. Inre Aller, 105 USPQ 233.
`
`Claim 13. Dunn teaches the device as taught in the rejection of claim 11 above. Dunn does not
`
`teach wherein the firmness factor is about 3. Dunn teaches “By reducing the overall density, the
`
`structure will be more readily collapsible. Thus, the use of a lower density structure with less foam may
`
`allow for greater wound closure as such a structure is more readily collapsible. Conversely, the use of a
`
`higher density structure with more foam may beless collapsible.” (paragraph 0224). It would have been
`
`obvious to one of ordinary skill in the art before the effective filing date of the invention to make the
`
`contracting layer have the ideal firmness, wherein the ideal firmness is determined by the density of the
`
`structure in order to be moreor less collapsible to its ideal conditions, since it has been held that where
`
`the general conditions of aclaim are disclosed in the prior art, discovering the optimum or workable
`
`rangesinvolves only routine skill in the art. Inre Aller, 105 USPQ 233.
`
`Claim 17. Dunn teaches the device as taught in the rejection of claim 1 above. The current
`
`embodiment does not teach wherein the contracting layer comprises a compressed foam. In an
`
`alternate embodiment, Dunn continues to teach an alternative embodiment wherein the contracting
`
`layer comprises a compressed foam (“compressed or "felted" reticulated foam”, paragraph0100), as it
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 10
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`could preferably withstand pressure applied to a top or bottom edge. Therefore one of ordinaryskill in
`
`the art before the effective filing date of the invention could create a contracting layer with foam in
`
`order to achieve the desirable density for collapsibility (paragraph 0224).
`
`Claim 20. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn continues
`
`to teach wherein the contracting layer comprises a thermoplastic elastomer, as rubber is a known
`
`elastomer (paragraph 0134), to assist with creating morerigid walls than the remainder of the device.
`
`Therefore one of ordinaryskill in the art before the effectivefiling date of the invention could modify
`
`the current embodiment of Dunn with the teachings of the alternate embodiment’s use of
`
`rubber/elastomer in order to achieve the desired rigidity needed for controlled collapsing and collapsing
`
`resistance.
`
`Claim(s) 19, 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dunn etal
`
`(WO 2014014922 A1), as applied to claim 1 above,and furtherin view of Adie et al (US 20110282309
`
`A1), herein after Dunn and Adie.
`
`Claim 19. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn does not
`
`teach wherein the contracting layer comprises a 3D spacer fabric. Ina similar field of endeavor of
`
`negative pressure wound therapy, Adie teaches a wound dressing 100 with topical negative therapy
`
`(paragraph 0003 and 0132), wherein the transmission layer (equivalent to Dunn’s contracting layer;
`
`paragraph 0138in Adie) comprises a 3D polyester fabric layer including a top layer as it would provide
`
`open air channels to be maintained to communicate negative pressure over the wound area while also
`
`having a three dimensional structure (paragraph 0138-0139). Therefore, it would have been obvious to
`
`one of ordinary skill in the art before the effective filing date of the invention to modify the contracting
`
`layer to be made of 3D spacer fabric layer since this material was commonly known in the art for use in a
`
`negative pressure treatment procedure and would function equally as well as the disclosed material.
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 11
`
`Claim 24. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn does not
`
`teach wherein the protective layer comprises a perforated film. In a similar field of endeavor of negative
`
`pressure wound therapy, Adie teaches a wound dressing 100 with topical negative therapy (paragraph
`
`0003 and 0132), and discloses a perforated wound contact layer made permeable to liquid and gas; this
`
`perforated wound contact layer can be a polyurethane layer or polyethylene layer or other flexible
`
`layer, and the perforations helps prevent tissue ingrowth into other material of the wound dressing but
`
`alsoallow fluid through (paragraph 0137) encompassing the claimed limitations of the protective layer
`
`comprising a perforated film. Therefore one of ordinary skill in the art before the effective filing date of
`
`the invention could modify the device to include a protective layer comprising a perforated film or layer
`
`in order toallow the layer to be permeable to liquid or gas while also preventing tissue ingrowth into
`
`other material.
`
`Claim 25. Dunn teachesthe device as taught in the rejection of claim 1 above. Dunn does not
`
`teach wherein the protective layer is configured to inhibit irritation of the tissue site. Ina similar field of
`
`endeavorof negative pressure wound therapy, Adie teaches a wound dressing 100 with topical negative
`
`therapy (paragraph 0003 and 0132), and discloses a perforated wound contact layer made permeable
`
`to liquid and gas; this perforated wound contact layer can be a polyurethane layer or polyethylene layer
`
`or other flexible layer, and the perforations helps prevent tissue ingrowth into other material of the
`
`wound dressing but also allow fluid through (paragraph 0137). As inhibiting irritation is functionally
`
`recited, the perforated film (instant application’s protective layer) is capable of inhibiting irritation by
`
`removing the factors that could cause irritation like the earlier disclosed permeability to liquid and gas,
`
`as well as preventing tissue ingrowth. Therefore one of ordinary skill in the art before the effectivefiling
`
`date could modify the wound dressing to have a protective layer comprising a perforated film that is
`
`permeable to liquid and gas but also prevent tissue ingrowth which as a result of the factors would be
`
`capable of inhibiting irritation of the tissue site.
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 12
`
`Claim 26. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn does not
`
`teach wherein the protective layer is coextensive with the contracting layer. Ina similar field of
`
`endeavorof negative pressure wound therapy, Adie teaches a wound dressing 100 with topical negative
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`therapy (paragraph 0003 and 0132), and discloses a perforated wound contact layer 102 made
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`permeable to liquid and gas; this perforated wound contact layer canbe a polyurethane layer or
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`polyethylene layer or other flexible layer, and the perforations helps prevent tissue ingrowth into other
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`material of the wound dressing but alsoallow fluid through (paragraph 0137-138). Adie alsodiscloses a
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`contracting layer (transmission layer 105 paragraph 0138in Adie). As seenin figure 1A, transmission
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`layer 105 is directly on the perforated wound contact layer 102. Merriam-webster.com defines
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`coextensive as “having the same spatial or temporal scope or boundaries”, and as Adie’s device shows
`
`them layered on each other over the confines of the wound, in the broadest interpretationit is
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`considered to be coextensive. Therefore one of ordinary skill in the art before the effective filing date of
`
`the invention could modify the device of Dunn with a protective layer that is coextensive with the
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`contracting layer as disclosed by Adie in order for prevention of tissue ingrowth, but also for media flow
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`through the layers.
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`Claim 27. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn does not
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`teach wherein the protective layer is laminated to the contracting layer. In a similar field of endeavor of
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`negative pressure wound therapy, Adie teaches a wound dressing 100 with topical negative therapy
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`(paragraph 0003 and 0132), and discloses a perforated wound contact layer 102 made permeable to
`
`liquid and gas and helps prevent tissue ingrowth into other material of the wound dressing but also
`
`allow fluid through {paragraph 0137-138). Adie also discloses a contracting layer (transmission layer
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`105 paragraph 0138in Adie). As seen in figure 1A, transmission layer 105 is directly on the perforated
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`wound contact layer 102, seento be held together with cover layer 140 and extends across the width of
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`the wound dressing, “the cover layer 140 is sealedto the wound contact layer 102 in a border region
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`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 13
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`200 around the circumferenceof the dressing” (paragraph 0156). Merriam-webster.com defines
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`|”
`laminated as “composed of layers of firmly united material”. As Adie discloses cover layer 140 and
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`wound contact layer 102 are sealed, and it is seen in figure 1A that transmission layer 105is directly
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`layered on top of wound contact layer 104, between the sealed cover layer 140 and wound contact layer
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`102, encompassing the claimed limitation. Therefore one of ordinary skill in the art before the effective
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`filing date of the invention could modify Dunn’s device to have a sealed cover layer 140 to the protective
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`wound contact layer 104 with the contracting layer (transmission layer 105) sealedin between to be
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`laminated together in order to create a bacterial barrier during wound healing (paragraph 0156).
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`Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al{WO
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`2014014922 A1), as applied to claim 1 above, and further in view of Wu et al (US 20130144230 A1),
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`herein after Dunn and Wu.
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`Claim 23. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn does not
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`teach wherein the protective layer comprises a mesh. In a similar field of endeavor of reduced or
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`negative pressure wound therapy (paragraph 0004), Wu teaches device 100 with contact surface 135
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`(instant application’s protective layer between the contracting layer, or the support structure 205 of
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`Wu, and thetissuesite) for direct contact with the skin, wherein the contact surface can be made of a
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`variety of materialincluding meshto maintain dryness of the underlying skin for open wounds
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`(paragraph 0055). Therefore one of ordinary skill in the art before the effectivefiling date of the
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`invention could modify the contact surface/protective layer to comprise a mesh in order to keep the
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`treatment area dryfor better wound closure.
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`Double Patenting
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`A rejection based on double patenting of the “same invention” type finds its support in the
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`language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process...
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 14
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`may obtain a patent therefor...” (Emphasis added). Thus, the term “sameinvention,”in this context,
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`means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894);
`
`In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA
`
`1957).
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine grounded
`
`in public policy (a policy reflected in the statute) soas to prevent the unjustified or improper timewise
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`extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple
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`assignees. Anonstatutory double patenting rejection is appropriate where the conflicting claims are not
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`identical, but at least one examined application claim is not patentably distinct from the reference
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`claim(s) because the examinedapplication claim is either anticipated by, or would have been obvious
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`over, the reference claim(s). See, e.g., Inre Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998): Inre
`
`Goodman,11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); Inre Longi, 759 F.2d 887, 225 USPQ 645 (Fed.
`
`Cir. 1985); Inre 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).
`
`Atime