www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`16/754,183
`
`04/07/2020
`
`STEVEN B. HEINECKE
`
`79466US004
`
`3378
`
`3M INNOVATIVE PROPERTIES COMPANY
`PO BOX 33427
`ST. PAUL, MN 55133-3427
`
`CARREIRO, CAITLIN ANN
`
`ART UNIT
`
`3786
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`03/17/2022
`
`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):
`
`LegalUSDocketing@mmm.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`22-39 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`5a) Of the above claim(s) ___ is/are withdrawn from consideration.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) 22-39 is/are rejected.
`S)
`) © Claim(s)____is/are objected to.
`Cj) Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://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 4/7/2020 is/are: a)(] accepted or b)¥) objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)Z) 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)X) All
`1.2 Certified copies of the priority documents have been received.
`2.2) Certified copies of the priority documents have been received in Application No.
`3.2.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`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) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20220304
`
`Application No.
`Applicant(s)
`16/754, 183
`HEINECKE etal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`CAITLIN CARREIRO
`3786
`Yes
`
`
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133}.
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1) Responsive to communication(s) filed on 4/7/2020.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)L) This action is FINAL. 2b)¥)This action is non-final.
`3)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4\0) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 2
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`DETAILED ACTION
`
`In the preliminary amendmentfiled 4/7/2020, Applicant cancelled claims 1-21 and
`
`added new claims 22-39. Currently, claims 22-39 are pending in the application.
`
`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.
`
`Specification
`
`A substitute specification excluding the claims is required pursuant to 37 CFR 1.125(a)
`
`for at least the following reason:
`
`Applicantfiled two different specifications on 4/7/2020 — one specification is 18 pages
`
`long and appearsto be a description of the claimed invention while the other specification is 25
`
`pages long and is directed to an unrelated invention (entitled “Self Contained Monitor and
`
`System for Use”). It appears that the 25 page-long specification is from WO 2019/084156 and
`
`was filed in error. It has been assumed for purposes of examination that Applicant intended for
`
`the 18 page specification filed 4/7/20 be considered (and this is the version the Office will
`
`consider at this time). However,clarification is necessary and a substitute specification should
`
`be filed in order to make the record clear as to which specification should be examined for this
`
`application.
`
`A substitute specification must not contain new matter. The substitute specification
`
`must be submitted with markings showing all the changes relative to the immediate prior
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 3
`
`version of the specification of record. The text of any added subject matter must be shown by
`
`underlining the added text. The text of any deleted matter must be shown bystrike-through
`
`except that double brackets placed before and after the deleted characters may be used to
`
`show deletion of five or fewer consecutive characters. The text of any deleted subject matter
`
`must be shown by being placed within double brackets if strike-through cannot be easily
`
`perceived. An accompanying clean version (without markings) and a statement that the
`
`substitute specification contains no new matter must also be supplied. Numbering the
`
`paragraphs of the specification of record is not considered a change that must be shown.
`
`Additionally, the lengthy specification has not been checked to the extent necessary to
`
`determine the presence of all possible minor errors. Applicant’ s cooperation is requested in
`
`correcting any errors of which applicant may become awarein the specification.
`
`Drawings
`
`New corrected drawings in compliance with 37 CFR 1.121(d) are required in this
`
`application for at least the following reason:
`
`Twodifferent sets of drawings werefiled on 4/7/2020 — one set includes 14 drawing
`
`sheets and does not correspond to the subject matter of the present application; the other set
`
`of drawings includes 9 drawing sheets and appearstoillustrate the claimed subject matter.It
`
`has been assumed for purposes of examination that Applicant intended for the drawings with 9
`
`sheets to be examined in this application and that the drawings with 14 sheets werefiled in
`
`error. However, Applicant needs to clarify which drawings are to be considered and if the 14-
`
`sheet group of drawings was filed in error, Applicant should specifically direct the Office to
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 4
`
`CANCEL the drawings which werefiled in error (i.e. figures 1A-21B) and file replacement
`
`drawing sheets showing the correct drawingsin order to clarify the record.
`
`The corrected drawings are required in reply to the Office action to avoid abandonment
`
`of the application. The requirement for corrected drawingswill not be held in abeyance.
`
`Claim Objections
`
`Claim 27 is objected to because of the following informalities: “the opposing edges”
`
`should be “the pair of opposing edges”. Appropriate correction is required.
`
`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 moreclaims 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 23-24, 33 and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA),
`
`second paragraph,as beingindefinite 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 23 recites the limitation "the first portion" in line 2. There is insufficient
`
`antecedent basis for this limitation in the claim.
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 5
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`Claim 24 recites the limitation "the first portion and the second portion"in line 1. There
`
`is insufficient antecedent basis for this limitation in the claim.
`
`Claim 24 recites the limitation "the entire backing perimeter"in line 2. There is
`
`insufficient antecedent basis for this limitation in the claim.
`
`Claim 33 recites the limitation "the tubing slot length"in line 2. There is insufficient
`
`antecedent basis for this limitation in the claim.
`
`Claim 33 recites: a maximum tubing slot width...that is equal to or greater than 5
`
`percent of the tubing slot length”in lines 2-3 but does not recite an upper limit to the range
`
`and thus is an open-ended range which creates ambiguity with respect to the metes and
`
`bounds of the claimed subject matter claimed and thus renders the scope of the claim
`
`indefinite. The claimed rangeis not supported in the original filed specification because a
`
`search of the specification discloses that "the tubing slot may, in one or more embodiments,
`
`have a maximum tubing slot width measured transverse to the tubing slot length that is equal
`
`to or greater than 5 percent, 10 percent, 15 percent or 20 percent of the tubing slot length”
`
`(specification page 9 lines 14-36) but there is no disclosure of the upper limit or maximum
`
`width measurement that would be possible. Therefore, claim 33 is ambiguous and is rejected
`
`under 35 U.S.C. 112 (b).
`
`Claim 37 recites: a moisture vapor transmission rate of at least 300 g/m?/24 hours..." in
`
`line 2 but does not recite an upper limit to the range of moisture vapour transmission rate and
`
`thus is an open-ended range which creates ambiguity with respect to the metes and bounds of
`
`the claimed subject matter claimed and thus renders the scope of the claim indefinite. The
`
`claimed rangeis not supported in the original filed specification because a search of the
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 6
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`specification discloses that "the adhesive coated film transmits moisture vapor at a rate of at
`
`least 300 g/m2/24 hrs/37 C/100-10% RH, more preferably at least 700 g/m?/24 hrs/37 C/100-
`
`10% RH, and mostpreferably at least 2000 g/m?/24 hrs/37 C/100- 10% RH”(specification page
`
`13 lines 9-12), but there is no disclosure of an upper limit or maximum value that is possible.
`
`Therefore. claim 37 is ambiguous and is rejected under 35 U.S.C. 112 (b).
`
`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 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.
`
`Claim(s) 22 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
`
`Heinecke et al (US 2016/0015570) (hereinafter “Heinecke ‘570”).
`
`With respect to claim 22, Heinecke ‘570 discloses a medical dressing (100) comprising:
`
`a backing layer (300) comprising a first major surface and a second major surface
`
`opposite the first major surface (upper/lower surfaces shown in fig 2), the backing layer (300)
`
`comprising a backing perimeter (inherent structural feature, perimeter is shown in fig 1);
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 7
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`an adhesive (200) on the second major surface of the backing layer (shown in fig 2);
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`a release layer removably secured to the adhesive (para [0060]);
`
`a support material (400) secured to the backing layer (para [0021]), wherein the support
`
`material is less elastic than the backing layer (para [0050]), and wherein the support material
`
`comprises a support perimeter (inherent structural feature) spaced inwardly from the backing
`
`perimeter (as shown in fig 2) such that the backing layer (300) forms a border between the
`
`support perimeter and the backing perimeter (overhang region of backing 300 that extends
`
`beyond the outer perimeter of layer 400 shown in fig 2); and
`
`a tubing slot formed through the first and second major surfaces of the backing layer
`
`(slot shown in fig 1; identified in the annotated fig 1 below; the slot appears to pass through all
`
`the layers of the dressing and is interpreted as having such a configuration in order for the
`
`bandage to accommodate an inserted iv catheter as intended — see i.e. para [0020] which
`
`describes that the dressing is used to cover an iv catheter), wherein the tubing slot extends
`
`from a receiving end that interrupts the backing perimeter of the backing layer to a terminal
`
`end located within the backing layer (as shown in fig 1), the tubing slot comprising a pair of
`
`opposing edges extending from the receiving end to the terminal end of the tubing slot (parallel
`
`sides defining the slot in fig 1), and wherein the pair of opposing edges of the tubing slot
`
`interrupt the support perimeter of the support material (as shown in fig 1), and further wherein
`
`at least a portion of each opposing edge of the pair of opposing edges is coincident with a
`
`tubing slot edge of the support material (the slot appears to pass through all the layers of the
`
`dressing and is interpreted as having such a configuration in order for the bandage to
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 8
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`accommodate an inserted iv catheter as intended — see i.e. para [0020] which describes that
`
`the dressing is used to cover an iv catheter).
`
`ANNOTATEDFIG 1 of Heinecke et al (US 2016/0015570)
`
`
`
`With respect to claim 36, Heinecke ‘570 discloses the invention as claimed (see rejection
`
`of claim 22) and also discloses that the medical dressing further comprises support material
`
`adhesive on a surface of the support material that faces away from the backing layer (adhesive
`
`200 covers the entire surface 120 which is the surface of the support material 400 that faces
`
`away from the backing layer 300 as shown in figure 2; see para [0022]).
`
`Claim Rejections - 35 USC § 103
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 9
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`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 for the rejection will not be considered a new ground of rejection if the
`
`prior art relied upon, and the rationale supporting the rejection, would be the same under
`
`either status.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
`
`rejections set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is
`not identically disclosed as set forth in section 102,if the differences between the claimed invention
`and the prior art are 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 ordinaryskill 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 obviousnessor
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`nonobviousness.
`
`This application currently names joint inventors. In considering patentability of the
`
`claims the examiner presumes that the subject matter of the various claims was commonly
`
`ownedas ofthe 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
`
`effective filing dates of each claim that was not commonly owned as ofthe effective filing date
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`

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`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 10
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`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 22-32, 35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Plewset al (WO 95/20415) in view of Heinecke et al (US 6607799).
`
`With respect to claim 22, Plews discloses a medical dressing (dressing 10) comprising:
`
`a backing layer (body portion 30 comprising flexible sheet 90) comprising a first major
`
`surface and a second major surface opposite the first major surface (upper/lower surfaces
`
`shown in fig 2a), the backing layer comprising a backing perimeter (inherent physical
`
`characteristic of a flexible sheet of material; the perimeter of the layers forming the dressing
`
`are shown in fig 1);
`
`an adhesive (70) on the second major surface of the backing layer (shown in fig 2a);
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`a release layer removably secured to the adhesive (release sheet 50 shown in fig 2a);
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`support material (support layer 60) secured to the backing layer (shown in fig 2a),
`
`wherein the support material is less elastic than the backing layer (pg 2 lines 29-30; pg 12 lines
`
`10-13), wherein the support material comprises a support perimeter (inherent physical
`
`characteristic of a layer of material in a dressing; the perimeter of the layers forming the
`
`dressing are shown in fig 1); and
`
`a tubing slot formed through the first and second major surfaces of the backing layer
`
`(slot shown in fig 1), wherein the tubing slot extends from a receiving end that interrupts the
`
`backing perimeter of the backing layer to a terminal end located within the backing layer (as
`
`shown in fig 1), the tubing slot comprising a pair of opposing edges (parallel straight regions
`
`120; fig 1) extending from the receiving end to the terminal end of the tubing slot (as shown in
`
`

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`Application/Control Number: 16/754,183
`Art Unit: 3786
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`Page 11
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`fig 1), and wherein the pair of opposing edgesof the tubing slot interrupt the support perimeter
`
`of the support material (the slot extends all the way to the outermost perimeter edgeof the
`
`dressing thereby interrupting the perimeter ofall the layers, including the perimeter of the
`
`support layer 60), and further wherein at least a portion of each opposing edge of the pair of
`
`opposing edges is coincident with a tubing slot edge of the support material (each layer stacked
`
`to form the dressing as shown in fig 2a is interpreted as having a slot defined by parallel edges
`
`that are identical to edges 120 in fig 1 wherein the edges of the slot in each layer are aligned in
`
`order to provide an opening that passes through the entire thickness of the dressing in order to
`
`provide a slot that is capable of fitting around a connector for a cannula or catheter as intended
`
`— see pg 9 lines 25-33).
`
`Plews further discloses that a border is formed between the support perimeter and the
`
`backing perimeter (as shown in fig 2a the support layer 60 overlaps and extends beyond the
`
`perimeter edge of the sheet 90 thereby defining a border) but does notdisclose that the
`
`support perimeter is spaced inwardly
`
`from the backing
`
`perimeter such that the backing layer
`
`forms a border between the support perimeter and the backing perimeter.
`
`Heinecke teaches an adhesive dressing 110 (fig 4) which includes a backing layer 112, an
`
`adhesive 114, a release liner removably secured to the adhesive (liner 116) and a support
`
`material secured to the backing layer (handle 118 secured to backing 112; col 9 lines 46-49)
`
`wherein the support material comprises a support perimeter (inherent physical characteristic;
`
`outermost peripheral edges of handle 118 shown in fig 4 and identified in the annotated figure
`
`below) and the backing layer comprises a backing perimeter (inherent physical characteristic;
`
`outer edges of the sheet of material forming the backing; one side of the perimeter is defined
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 12
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`by edge 113 shown in fig 4); wherein the support perimeter is spaced inwardly from the backing
`
`perimeter (as shown in fig 4 handle 118 overlaps backing 112 such that one perimeter edgeis
`
`spaced inwardly from edge 113 of backing 112) such that the backing layer forms a border
`
`between the support perimeter and the backing perimeter (as identified in the annotated
`
`figure below). It would have been obvious to one having ordinaryskill in the art, before the
`
`effective filing date of the invention, to have modified the support of Plewsto be sized so that
`
`the perimeter is spaced inwardly from the backing perimeter to form a border between the
`
`support perimeter and backing perimeter as taught in Heinecke in order to provide added
`
`structural stability and rigidity at the border region where the layers overlap and to provide
`
`attachment between the twolayers only along the defined border region (rather than across
`
`the entire surface of the backing) for easier removal of the support layer from the backing after
`
`application to a user. Additionally, such a modification would have been obvious to one having
`
`ordinary skill in the art before the effective filing date of the invention because such a
`
`modification would have involved a mere changein the size of a component whichis generally
`
`recognized as being within the level of ordinary skill in the art.
`
`ANNOTATEDFIG 4 of Heinecke et al (US 6607799)
`
`

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`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 13
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`
`
`“HO
`
`fa LSnaretecnsanantsaSrohanSAARebro
`
`With respect to claim 23, Plews in view of Heinecke discloses the invention substantially
`
`as Claimed (see rejection of claim 22) and Plews further discloses that the receiving end of the
`
`tubing slot is located proximate a midpoint of the first portion of the backing perimeter (as
`
`shown in fig 1 one end of the slot is provided proximate a midpoint of one side of the perimeter
`
`of the dressing which, inherently, will correspond to a midpoint of the side of the backing
`
`perimeter located on that side of the dressing).
`
`With respect to claim 24, Plewsin view of Heinecke discloses the invention substantially
`
`as Claimed (see rejection of claim 22) and Plews further discloses that the backing perimeter
`
`has first and second portions (i.e. one portion located abovethe slit and the other located
`
`below the slit shown in fig 1) the first portion and the second portion of the backing perimeter
`
`occupy the entire backing perimeter outside of the receiving end of the tubing slot (the first and
`
`

`

`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 14
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`second portions extend along the entire edge above and below the opening at the receiving
`
`end of the slot as shown in fig 1).
`
`With respect to claim 25, Plewsin view of Heinecke discloses the invention substantially
`
`as Claimed (see rejection of claim 22) and Plewsfurther discloses that the tubing slot comprises
`
`a pair of opposing edges extending from the receiving end to the terminal end of the tubing slot
`
`(edges 120 shown in fig 1), and wherein the support material (60) comprises a pair of opposing
`
`support material slot edges (layer 60 is the top layer of the dressing as shown in fig 2a and thus
`
`is interpreted as including edges 120 defining the slot as shown in fig 1) coincident with at least
`
`a portion of the pair of opposing edges of the tubing slot (each layer stacked to form the
`
`dressing as shown in fig 2a is interpreted as having a slot defined by parallel edges that are
`
`identical to edges 120 in fig 1 wherein the edges of the slot in each layer are aligned in order to
`
`provide an opening that passes through the entire thickness of the dressing in order to provide
`
`a slot that is capable offitting around a connector for a cannula or catheter as intended — see
`
`pg 9 lines 25-33).
`
`With respect to claim 26, Plewsin view of Heinecke discloses the invention substantially
`
`as Claimed (see rejection of claim 22) and Plewsfurther discloses that the tubing slot comprises
`
`a pair of opposing edges extending from the receiving end to the terminal end of the tubing slot
`
`(edges 120 shown in fig 1), and wherein the support material (60) comprises a pair of opposing
`
`support material slot edges (layer 60 is the top layer of the dressing as shown in fig 2a and thus
`
`is interpreted as including edges 120 defining the slot as shown in fig 1) coincident with all of
`
`the pair of opposing edges (each layer stacked to form the dressing as shown in fig 2ais
`
`interpreted as having a slot defined by parallel edges that are identical to edges 120 in fig 1
`
`

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`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 15
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`wherein the edges of the slot in each layer are aligned in order to provide an opening that
`
`passes through the entire thickness of the dressing in order to provide a slot that is capable of
`
`fitting around a connector for a cannula or catheter as intended — see pg 9 lines 25-33).
`
`With respect to claim 27, Plews in view of Heinecke discloses the invention substantially
`
`as Claimed (see rejection of claim 26) and Plewsfurther discloses that the support material
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`(support layer 60) is coincident with all of the opposing edges of the tubing slot (each layer
`
`stacked to form the dressing as shown in fig 2a is interpreted as having a slot defined by parallel
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`edges that are identical to edges 120 in fig 1 wherein the edges of the slot in each layer are
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`aligned in order to provide an opening that passes through the entire thickness of the dressing
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`in order to provide a slot that is capable offitting around a connector for a cannula or catheter
`
`as intended — see pg 9 lines 25-33).
`
`With respect to claim 28, Plewsin view of Heinecke discloses the invention substantially
`
`as Claimed (see rejection of claim 22) and Plews further discloses that the support material
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`(support layer 60) completely surrounds the tubing slot (as shown in fig 1).
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`With respect to claim 29, Plewsin view of Heinecke discloses the invention substantially
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`as Claimed (see rejection of claim 22) and Plews further discloses that the support material is
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`attached to the first major surface or second major surface of the backing layer (pg 12 lines 14-
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`16; see also fig 2a).
`
`With respect to claim 30, Plewsin view of Heinecke discloses the invention substantially
`
`as Claimed (see rejection of claim 22) and Plewsfurther discloses that the tubing slot comprises
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`a second tubing slot, wherein the second tubing slot is formed through the first and second
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`major surfaces of the backing layer (each layer stacked to form the dressing as shown in fig 2ais
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`

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`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 16
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`interpreted as having a slot defined by parallel edges that are identical to edges 120 in fig 1
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`wherein the edges of the slot in each layer are aligned in order to provide an opening that
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`passes through the entire thickness of the dressing in order to provide a slot that is capable of
`
`fitting around a connector for a cannula or catheter as intended — thus,a first tubing slot is
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`formed in layer 60 and a second tubing slot is interpreted as being formed in layer 90; see pg 9
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`lines 25-33) wherein the second tubing slot extends from a receiving end that interrupts the
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`backing perimeter of the backing layer to a terminal end located within the backing layer (the
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`tubing slot in the layer 90 is interpreted as having the same configuration as the slot in layer 60
`
`which includes these features as shown in fig 1), the second tubing slot comprising a pair of
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`opposing edges extending from the receiving end to the terminal end of the second tubing slot
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`(the tubing slot in the layer 90 is interpreted as having the same configuration as the slot in
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`layer 60 which includes opposing edges 120 as shown in fig 1).
`
`With respect to claim 31, Plews in view of Heinecke discloses the invention substantially
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`as Claimed (see rejection of claim 22) and Plewsfurther discloses that the tubing slot comprises
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`a slit formed through the backing layer (the aperture is in the form of an elongate slot and can
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`be formed by punching out or cutting the shape from the dressing — see pg 9 lines 25-33 and pg
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`10 lines 5-10; cutting the slot is interpreted as providing a “slit”).
`
`With respect to claim 32, Plews in view of Heinecke discloses the invention substantially
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`as Claimed (see rejection of claim 22) and Plewsfurther discloses that the tubing slot comprises
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`a plurality of perforations formed through the backing layer (page 10 lines 5-10).
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`With respect to claim 35, Plewsin view of Heinecke discloses the invention substantially
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`as Claimed (see rejection of claim 22) but Plews does not disclose that the adhesive covers only
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`

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`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 17
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`a portion of the second major surface of the backing layer. Heinecke, however, teaches
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`application of adhesive in a pattern on the backing in order to achieve a high relative rate of
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`moisture vapor transmission (col 5 lines 28-36; pattern coating of adhesive is interpreted as
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`application of adhesive in a series of lines/gaps to form a pattern thereby leaving some areas of
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`the backing uncovered). Thus, it would have been obvious to one havingordinaryskill in the art,
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`before the effective filing date of the invention, to have applied the adhesive in Plewsina
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`pattern so that the adhesive covers only a portion of the second major surface of the backing
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`layer, as taught by Heinecke, in order to improve the moisture vapor transmission rate of the
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`backing.
`
`With respect to claim 37, Plews in view of Heinecke discloses the invention substantially
`
`as Claimed (see rejection of claim 22) and Plewsfurther discloses that the backing layer is
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`transparent and is impermeable to liquid and can transmit moisture vapor at a rate of at least
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`300 g/m’/24 hrs at 37° C./100-10% RH (pg 7 lines 1-12; pg 12 lines 21-25).
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`Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Plewset al (WO
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`95/20415) in view of Heinecke et al (US 6607799) and further in view of Heineckeet al (US
`
`5738642) (hereinafter “Heinecke ‘642”).
`
`With respect to claim 34, Plewsin view of Heinecke discloses the invention substantially
`
`as Claimed (see rejection of claim 22) but does not disclose that the support material comprises
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`an inner perimeter defining a window within the support material, wherein the backing layer
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`extends over the window.
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`

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`Application/Control Number: 16/754,183
`Art Unit: 3786
`
`Page 18
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`Heinecke ‘642, however, teaches an analogous dressing which includes a support
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`material in the form of a carrier 170 (fig 1) configured as a frame having an inner perimeter
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`with a windowin the center of the carrier (as shown in fig 1) wherein the backing layer (14)
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`extends over the window(as shown in