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
`
`08/27/2024
`
`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
`
`08/27/2024
`
`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):
`
`IPDocketing @ Solventum.com
`dgodzisz@hdp.com
`troymailroom @hdp.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-28 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`5a) Of the above claim(s) _ is/are withdrawn from consideration.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) 1-28is/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){¥ The drawing(s) filed on July 1, 2020 is/are: a) accepted or b)(j 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)£) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`_—_c)L) None ofthe:
`b)L) Some**
`a)Q) All
`1.1) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No. |
`3.2.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*“ See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`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 20240722
`
`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 June 13, 2024.
`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) 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.
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 2
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`DETAILED ACTION
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`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), was filed 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 been timely paid, the
`
`finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's
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`submission filed on June 13, 2024 has been entered.
`
`Response to AmendmentandStatus of the Claims
`
`This office action is in response to the remarksfiled on June 13, 2024.
`
`In response to the amendmentfiled June 13, 2024, claim 28 is new,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.
`
`Specification
`
`The specification is objected to asfailing to provide proper antecedent basis for the claimed
`
`subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(0). Correction of the following is required:
`
`Claim 7 lines 7-8 recites “wherein the perforation shape factor of the hole is less than about 1. Although
`
`values supporting more than about 1 is present in paragraph 0062, values of less than about 1, or
`
`regarding this language, for the perforation shape factor of the hole is not disclosed in the instant
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`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 3
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`specifications. The specification lacks antecedentbasis for the claimed limitation. The word “about”
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`broadens the interpretation for how any value below1is interpreted. It can be seen that there is a
`
`range for more than about 1 is present in paragraph 0062 in the specifications, but not for “less than
`
`about 1”. For examination purposes, the examiner is interpreting this as any value less than 1 .
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out
`and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claims 2-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second paragraph, as
`
`being indefinite for failing to particularly point out and distinctly claim the subject matter which the
`
`inventor or a joint inventor (or for applications subject to pre-AlA 35 U.S.C. 112, the applicant), regards
`
`as the invention.
`
`Claim 2 recites “wherein the plurality of holes have a perforation shape factor and a strut angle
`
`configured to cause the plurality of holes to collapse in a direction substantially perpendicular to the
`
`opening”. The terms “perforation shape factor” and “strut angle” are not standard terms in the art and
`
`have not been defined by the disclosure, but rather merely exemplified. Therefore, the metes and
`
`bounds of the claim as written are unclear. For example, the specification paragraph 0062 states that
`
`“the perforation shape factor may represent an orientation of the hole 128 relative to the first
`
`orientation line 127 and the second orientation line 129. Generally, the perforation shape factor is a
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`ratio of a ratio of % a maximum length of the hole 128 that is parallel to the second orientation line to %
`
`a maximum length of the hole 128 that is parallel to the first orientation line 127”.
`
`It is noted that this
`
`definition is based on generalities and examples. Further, the examples and generalities given are based
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`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 4
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`on first orientation line 127 and second orientation line 129.
`
`In the specification paragraph 0060 various
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`examples of what the orientation lines are also given. As the claim does not clearly identify if the shape
`
`perforation factor claimedis the same as exemplified in paragraph 0062, nor doesit clearly identify
`
`which orientation lines are used for its definition, the scope of the claim is unclear.
`
`It is noted that the
`
`term “strut angle”, also recited in claim 2 is also unclear for substantially the same reasons. The term is
`
`discussedin the specification paragraph 0063 and is exemplified as being relative to the first orientation
`
`line. For the purpose of examination, the term will be considered as encompassing at least one distance
`
`from the center of a hole towards the perimeter in a ratio to another distance from the center of the
`
`hole to the perimeter as this is consistent with the disclosure (see for example Paragraphs 0060 and
`
`0062, and Figure 3, line 144 and 146). The “strut angle” will be considered as a line connecting the
`
`center of adjacent rows, relative to any orientation line, as this is consistent with the disclosure
`
`(paragraphs 0060 and 0063).
`
`It is noted that although claims 3 and 6 appear to define one term or the
`
`other, both terms have not been defined in one claimed limitation.
`
`Claim Rejections - 35 USC § 102
`
`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102
`
`and 103 (or as subject to pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory
`
`basis (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 in a printed publication, or in public use, on sale,
`or otherwise available to the public before the effective filing date of the claimed invention.
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`

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`Application/Control Number: 16/918,682
`Art Unit: 3771
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`Page 5
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`(a)(2) the claimed invention was described in a patent issued under section 151, or in an application
`for patent published or deemed published under section 122(b), in which the patent or application, as
`the case may be, namesanother inventor and was effectively filed before the effective filing date of
`the claimed invention.
`
`Note: The term “tissue site” has been defined in the instant specification, paragraph 0035, as
`
`referring to a wound or a defect located on or within tissue; and may also refer to areas of any tissue
`
`that are not necessarily wounded or defective but are instead areas which it may be desirable to add or
`
`promote growth of additional tissue.
`
`Claims 1-6, 9, 11, 14, 17-18, 21 and 28 is/are rejected under 35 U.S.C. 102(a){1) and 35 U.S.C.
`
`102(a)(2) as being anticipated by Dunn et al (WO 2014014922 A1), herein after Dunn.
`
`It is noted that Dunn teaches several different embodiments which anticipate the claims.
`
`In a first embodiment, system 100, paragraph 0081-0086, Figure 1, Dunn anticipatesclaims1,
`
`9, 11, and 28 as follows:
`
`Claim 1. Dunn teachesa dressing for closing an opening through a surface ofa tissue site, the
`
`dressing comprising: a tissue interface (system 100, comprising wound packer 102 figure 1 paragraph
`
`0081), comprising: a contracting layer (stabilizing structure or wound packer 102 described as
`
`comprising porous material such as foam and may comprise one or more embodimentsof the wound
`
`closure device, figure 1 paragraphs 0081, 0083), the contracting layer comprising a plurality of holes
`
`(porous material such as foam or polymers, see paragraph 0081) extending through the contracting
`
`layer to form a void space (interior space of the wound packer as the pores would create the void
`
`space), and a 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 paragraph
`
`
`0083, “...a non- or minimally-adherent organ protection layer (notillustrated) may be applied over any
`
`
`exposedviscera.” Being placed over any exposed viscera is considered to be a portion of a surface of
`
`tissue surrounding the openingin the broadest reasonable interpretation of the word surface in
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 6
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`application to surrounding the opening, if the openingis the viscera and viscerais tissue. If the organ
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`protection layer is placed over the wound,it is contacting surface tissue surrounding the opening and
`
`not within the wounditself as the wound packer would beinserted within the wound and sealed with
`
`the drape, see paragraph 0083); and a sealing drape (drape 104; paragraph 0081 and 0083) configured
`
`to coverthe tissue interface to form a sealed space (paragraphs 0081 and 0083). It is noted that the
`
`claimed limitation in the preamble “for closing an opening through a surfaceofa tissue site” is intended
`
`use and thus is only considered as it breatheslife and meaning into the claims, and would only require a
`
`product capable of performing the claimed use. As discussed above, the product of Dunn would be
`
`capable of performing the use as claimed, and thus the product of Dunn encompassesthe product as
`
`claimed.
`
`Claim 9. Dunn teachesthe device as taughtin the rejection of claim 1 above. Dunn continues to
`
`teach wherein the plurality of holes are formed in two or moreparallel rows(as in the perimeter region,
`
`one row would be the wound packer and another parallel row to this would be the perimeter or on
`
`top of any wound closure device, creating two parallel rowsof plurality of holes; paragraph 0081).
`
`Claim 11. Dunn teaches the device as taughtin the rejection of claim 1 above. Dunn teaches
`
`wherein the contracting layer is formed from a foam material having a firmness factor (the foam used
`
`by Dunn inherently hasa firmnessfactor as it collapses when negative pressure is applied; paragraph
`
`0085), wherein the firmnessfactor is a ratio of density of the foam material in a compressed state to a
`
`density of the foam material in an uncompressed state (as this would be calculated as the ratio of the
`
`density of the foam material used by Dunn in a compressedstate to a density of the foam material in
`
`used by Dunn in an uncompressedstate, as all foam would have an inherent density depending on the
`
`compression factors, as Dunn recites the application of multiple levels of pressure applied to the foam
`
`in paragraph 0085).
`
`

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`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 7
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`Claim 28. Dunn teaches the device as taughtin the rejection of claim 1 above. Dunn continues
`
`to teach wherein the protective layer is configured to be positioned over the opening (organ protection
`
`layer paragraphs 0083, “...a non- or minimally-adherentorgan protection layer (notillustrated) may
`
`be applied overany exposed viscera.”; as the instant invention and claims are regarding an apparatus
`
`and not a methodofuse, one of ordinary skill could position the protective layer over the opening).
`
`In a second embodiment, system of the structure 1701, Figures 3A-3D, paragraphs 0087-0092,
`
`Dunn anticipates claims 1-6, 9, 14, and 28 as follows:
`
`Claim 1. Dunn teachesa dressing for closing an opening through a surface ofa tissue site, the
`
`dressing comprising: a tissue interface (stabilizing structure 1701 comprising the porous material such
`
`as foam of paragraph 0092), comprising: a contracting layer (stabilizing structure 1701 as it is capable
`
`of collapsing; paragraph 0087) the contracting layer comprising a plurality of holes extending through
`
`the contracting layer to form a void space ( as the holes would bethe voids of space within the beams
`
`that create the stabilizing structure 1701, and the plurality of holes can be seen to be present
`
`extending through thelayer in figures 3A-3D; paragraph 0087), and a protective layer (“organ
`
`protection layer” paragraph 0092) configured to be positioned between the contracting layer and at
`
`least a portion of the surface of the tissue site surrounding the opening (as one could place the organ
`
`protection layer between the tissue, as it states that it may be placed into contact with at least the
`
`bottom portion of the wound,and the contracting layer; paragraph 0092); and a sealing drape
`
`(“drape” paragraph 0092) configured to cover the tissue interface to form a sealed space (as it may be
`
`sealed over the skin surrounding the woundandeffectuate woundclosure; paragraph 0092).
`
`Claim 2. Dunn teaches the device as taughtin the rejection of claim 1 above. Dunn teaches
`
`wherein the plurality of holes (see cells or holes in between the stabilizing structures of 1701 created
`
`by the struts 1703 and 1705in figure 3A-3B; paragraph 0087) have a perforation shape factor and a
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 8
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`strut angle (all holes inherently have a perforation shape factor and a strut angle which would be
`
`created by the struts 1703 and 1705 and multiple rowsof this embodiment, but Dunn discloses as the
`
`struts meet, they maybein right angles to each otherto create planar support structures 1702, orin
`
`other configurations such as honeycomb, and multiple planar support structures 1702 maybe joined
`
`together to form thestabilizing structure; paragraphs 0087 and 0092) configured to causethe plurality
`
`of holes to collapse in a direction substantially perpendicular to the opening (as the structure’s holes’
`
`openings can be from anydirection, any direction, best seen in figure 3A-3D,it could collapse in a
`
`direction perpendicular to the horizontal openings; see figures 3A-3D and paragraphs 0087 and 0092),
`
`and wherein the contracting layer generates a closing force substantially parallel to the surface of the
`
`tissue site to close the opening in response to an application of negative pressure (as the negative
`
`pressureis applied, the closing force would be parallel as it would collapse inward, causing the tissue
`
`of the wound to cometogetherin a parallel direction and close the opening, see paragraphs 0087,
`
`0088, and 0092 regarding direction of the collapse and the contracting layer, porous foam,
`
`surroundingthetissuesite).
`
`Claim 3. Dunn teaches the device as taughtin the rejection of claim 2 above. Dunn continues to
`
`teach wherein the strut angle (see claim 2, as Dunn’s strut angle is interpreted in accordance with the
`
`specifications paragraph 0063) is an angle (see interpreted “strut angle” in the annotated figure
`
`below) between a line (see interpreted “first line” in the annotated figure below for a diagonal line
`
`created by the holes diagonal from one another in adjacent rows OR “second line” for holes
`
`orientated directly above one another in adjacent rows) connecting centers of holes (represented as
`
`the exaggerated black dots in the centersof the holes in the annotatedfigure below) in adjacent rows
`
`and an orientation line (see interpreted “orientation line” in the annotated figure below)
`
`perpendicular to a direction of the closing force (see interpreted “direction of closing force” in the
`
`annotatedfigure below,as the structure 1701 would compress so that the planar support structures
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`

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`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 9
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`1702 come closer to one another, paragraphs 0087 and 0092)(as the struts would meetat right
`
`angles, and other configurations, and two or more support structures which are planes of 2D holes
`
`create 3D holes when they are joined together adjacently, see figure 3A for example, using the beams
`
`at the angles wherein the holes would be perpendicular, see figure 3D, when the direction of the
`
`closing force is on top and arrangedto collapse downward, the orientation line is interpreted as the
`
`axis that would be interpreted as going horizontally through the device as that would create the
`
`perpendicular angle to the closing force best seen by the general orientation ofthe struts in figure 3D;
`
`see paragraphs 0087 and 0092 regarding arrangementofstruts, planes, and collapse when closing
`
`force is applied).
`
`Line trut Angle of the
`
`
`bottom hele and
`
`
`“the diagonal hole
`
`
`:
`
`
`
`Sing Angie of
`the bottom
`hole and the
`
`
`
`hole directly
`above it
`
`Orientation
`
`Claim 4. Dunn teachesthe device as taughtin the rejection of claim 3 above. Dunn continues to
`
`teach wherein the strut angle is about 90 degrees (best seen in annotated figure 3D above,as the strut
`
`

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`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 10
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`angle is created between the interpreted “second line” and the “orientation line”, as the angle
`
`created by these lines can be seen to be about 90 degrees).
`
`Claim 5. Dunn teachesthe device as taughtin the rejection of claim 3 above. Dunn continues to
`
`teach wherein the strut angle is less than about 90 degrees (best seen in annotatedfigure 3D above, as
`
`the strut angle is created between the interpreted “first line” and the “orientation line”, as the angle
`
`created by these lines can be seen to beless than 90 degrees).
`
`Claim 6. Dunn teaches the device as taughtin the rejection of claim 2 above. Dunn continues to
`
`teach wherein the perforation shape factor (interpreted as how the hole is shaped of Dunn, see the
`
`limitation regardingthe ratio thatis following, see figure 3D below) of a hole of the plurality of holes is
`
`a ratio of a first line segment to a second line segment (interpreted as the ratio between the twoline
`
`segmentsofthe hole seen in figure 3D below), the first line segment extending from a center of the
`
`hole to a perimeter of the hole in a direction perpendicular to a direction of the closing force (see
`
`Interpreted direction of the Closing Force and Interpreted First Line Segment, as they are arranged ina
`
`perpendicular manner in annotated figure 3D below) and the second line 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 the Closing Force and Interpreted Second Line Segment, as they are
`
`arrangedin a perpendicular manner in annotated figure 3D below) (See paragraphs 0087 regarding
`
`the struts 1703 and 1705; please note that the word “segment”is presentin “line segment”, therefore
`
`boththe first and the second line segments are segmentsof the greater lines of the holes, see zoomed
`
`and annotatedfigure 3D below).
`
`

`

`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 11
`
`
`
`interpreted First
`
`
`interpreted
`Line Segment
`Direction of the
`
`
`seat at ae
`
`ne tat a
`Closing Farce
`
`
` Seeece aoe erelee agen nr ee
`
`
`Reta
`nescenceee
`ana
`Serene Ate
`
`
`
`
`
`interpreted
`Second Line
`
`segment
`
`melee
`
`eat
`
`araey
`neineee
`
`
`
`Fig. 3D Zoomed
`and Annotated ents ¥
`epee ne
`
`roe
`. ¥
`
`Claim 9. Dunn teachesthe device as taughtin the rejection of claim 1 above. Dunn continues to
`
`teach wherein the plurality of holes are formed in two or moreparallel rows (best seen in the full figure
`
`3D, as two or moreparallel rowsof the plurality of holes can be seen goingin the x, y, and z axis).
`
`Claim 14. Dunn teaches the device as taught in the rejection of claim 1 above. Dunn teaches
`
`wherein a shapeof each hole (see cells or holes in between the stabilizing structures of 1701 created
`
`by the struts 1703 and 1705in figure 3A-3B; paragraph 0087)of the plurality of holes is hexagonal
`
`(paragraph 0087 states honeycomb configurations are possible; merriam-webster.com defines
`
`honeycomb as “a mass of hexagonal waxcells built by honeybeesin their nest to contain their brood
`
`and stores of honey; something that resembles a honeycomb in structure or appearance especially: a
`
`strong lightweight cellular structural material” therefore honeycomb configurations of the holes
`
`created by the beams would be hexagonal).
`
`Claim 28. Dunn teaches the device as taughtin the rejection of claim 1 above. Dunn continues
`
`to teach wherein the protective layer is configured to be positioned over the opening(as the instant
`
`

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`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 12
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`invention and claims are regarding an apparatus and not a methodof use, oneofordinary skill could
`
`position the protective layer over the opening; as one could place the organ protection layer between
`
`the tissue, as it states that it may be placed into contact with at least the bottom portion of the
`
`wound,and the contracting layer; paragraph 0092).
`
`In a third embodiment, system of the structure 1101, Figures 8A-8E, paragraphs 0098-0108,
`
`Dunn anticipates claims 1-6, 9, 17-18, 21, and 28 as follows:
`
`Claim 1. Dunn teachesa dressing for closing an opening through a surface ofa tissue site, the
`
`dressing comprising: a tissue interface (stabilizing structure 1100 comprising porous material such as
`
`“felted” reticulated foam; paragraph 0098-0099), comprising: a contracting layer (stabilizing structure
`
`1100 asit is configured to collapse; paragraph 0098), the contracting layer comprising a plurality of
`
`holes extending through the contracting layer to form a void space (as the holes would bethe voids of
`
`space within the strips 1102 and 1104 thatcreate the stabilizing structure 1100, and the plurality of
`
`holes can be seen to be present extending throughthe layer best in figure 8C-8D; paragraphs 0099-
`
`0101), and a protective layer (“organ protection layer” paragraph 0107) configured to be positioned
`
`between the contracting layer and at least a portion of the surface of the tissue site surrounding the
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`opening (as one could place the organ protection layer between thetissue,as it states that it may be
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`placed into contact with at least the bottom portion of the wound, and the contracting layer;
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`paragraph 0107); and a sealing drape configured to cover the tissue interface to form a sealed space
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`(drape, as the drapeis disclosed to be covering the wound andissue interface in order for the
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`pressure to be exerted onit; paragraph 0099).
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`Claim 2. Dunn teachesthe device as taughtin the rejection of claim 1 above. Dunn teaches
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`wherein the plurality of holes (see cells or holes in between the stabilizing structure 1101 created by
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`the strips 1102 and 1104 bestin figure 8C-8D; paragraphs 0099-0101) have a perforation shape factor
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`

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`Application/Control Number: 16/918,682
`Art Unit: 3771
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`Page 13
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`and a strut angle (all holes inherently have a perforation shape factor and a strut angle which would
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`be created by each ofthe strip portions 1102 and 1104 of the respective holes and multiple rows of
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`this embodiment, but Dunn disclosesas the strips meet at the notches 1106 and 1108, they may be in
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`right angles to each other to create planar support structures 1101; paragraphs 0099-0102) configured
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`to cause the plurality of holes to collapse in a direction substantially perpendicular to the opening
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`(parallel collapse against the tissue and perpendicular collapse to the opening of this embodimentis
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`disclosed in paragraph 0105), and wherein the contracting layer generates a closing force substantially
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`parallel to the surface of the tissue site to close the opening in response to an application of negative
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`pressure (as the negative pressure Is applied, the closing force would be parallel in order for the
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`collapse to be oriented to go in a direction generally parallel with the orientation of the collagen and
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`other fibrous tissue, causing the tissue of the wound to come together in a parallel direction and close
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`the opening, see paragraphs 0103-0105 regardingdirection of the collapse and thestabilizing
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`structure, porous foam, surroundingthe tissue site).
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`Claim 3. Dunn teaches the device as taughtin the rejection of claim 2 above. Dunn continues to
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`teach wherein the strut angle (see claim 2, as Dunn’s strut angle is interpreted in accordance with the
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`specifications paragraph 0063)is an angle (see interpreted “strut angle” in the annotated figure
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`below) between a line (see interpreted “first line” in the annotated figure below for a diagonal line
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`created by the holes adjacent from one another in adjacent rows OR “second line” for holes
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`orientated directly above one another in adjacent rows) connecting centers of holes (represented as
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`the exaggerated black dots in the centersof the holesin the annotated figure below) in adjacent rows
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`(the first line is created by the dot directly in the adjacent row to the bottom most dot, and the
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`secondline is created by the dot diagonally in the adjacent row to the bottom mostdot; see
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`annotatedfigure below) and an orientation line (see interpreted “orientation line” in the annotated
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`figure below) perpendicular to a direction of the closing force (see interpreted “direction of closing
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`

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`Application/Control Number: 16/918,682
`Art Unit: 3771
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`Page 14
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`force” in the annotated figure below, as the structure 1101 would compress effecting planar support
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`structures 1102 and 1104, paragraphs 0099-0102) (as the strips would meetat right angles, and the 2D
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`strips 1102 and 1104 would create 3D holes when they are joined together, see figure 8A and 8Dfor
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`example, the segmentsofthe strips 1102 and 1104 would be perpendicular where they meet, see
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`figure 8A and 8C-8D, when the direction of the closing force is on top and arrangedto collapse
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`downward,parallel to the collagen and fibrous tissue, paragraph 0105,the orientationline is
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`interpreted as the axis that would be interpreted as going horizontally through the device as that
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`would create the perpendicular angle to the closing force best seen by the general orientation of the
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`struts in figures 8A and 8D; see paragraphs 0099-0102 regarding arrangementof struts, planes, and
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`collapse when closing force is applied).
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`1
`I
`
`III
`
`—
`Directian of
`Closing Farce
`
`First Line
`
`
`Line
`
`m Second
`
`
`
`
`
`
`FS, SA
`
`
`Strut Angle of
`the bottom
`hole and the
`hole directly
`above it
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`
`
`
`
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`Claim 4. Dunn teachesthe device as taughtin the rejection of claim 3 above. Dunn continues to
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`teach wherein the strut/strip angle is about 90 degrees (best seen in annotated figure 8A above, as the
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`strut angle is created between the interpreted “first line” and the “orientation line”, as the angle
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`created by these lines can be seen to be about 90 degrees).
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`

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`Application/Control Number: 16/918,682
`Art Unit: 3771
`
`Page 15
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`Claim 5. Dunn teachesthe device as taughtin the rejection of claim 3 above. Dunn continues to
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`teach wherein the strut angle is less than about 90 degrees (best seen in annotatedfigure 8A above, as
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`the strut angle is created between the interpreted “second line” and the “orientation line”, as the
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`angle created by these lines can be seen to beless than 90 degrees).
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`Claim 6. Dunn teachesthe device as taughtin the rejection of claim 2 above. Dunn continues to
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`teach wherein the perforation shape factor (interpreted as how the hole is shaped of Dunn, see the
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`limitation regardingthe ratio thatis following, see figure 8D below) of a hole of the plurality of holes is
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`a ratio of a first line segment to a second line segment (interpreted as the ratio between the twoline
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`segmentsofthe hole seen in figure 8D below), the first line segment extending from a center of the
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`hole to a perimeter of 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 they are arranged in a
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`perpendicular manner in annotated figure 8D below) and the second line segment extending from a
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`center of the hole to a perimeter of the hole in a direction parallel to the direction of the closing force
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`(see Interpreted Direction of the Closing Force and Interpreted Second Line Segment,as they are
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`arranged in a perpendicular manner in annotated figure 8D below) (See paragraphs 0087 regarding
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`the arrangementand anglesofstrips 1102 and 1104; please note that the word “segment”is present
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`in “line segment”, therefore both the first and the second line s