DETAILED ACTION
Notice of Pre-AIA 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 .
Response to Amendment
The amendment filed July 31st, 2025 has been entered. Claims 1-4, 6-13, 18-21, and 23 remain pending in the application. Claims 22 and 24 have been cancelled. Examiner withdraws 112(b) rejection previously set forth in the Non-Final Office Action mailed May 8th, 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first release liner and second release liner of claim 21 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 21 states that there is a “first release liner” and a “second release liner”, however the specification only provides support for a single release liner which has either one or two parts [0025].
Claim Rejections - 35 USC § 102
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.
(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, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 6-13, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Axel Eckstein et al. (US 20110152798 – hereinafter Eckstein).
Regarding claim 1, Eckstein teaches a cutting aid device for use with a negative pressure wound therapy (NPWT) system (Abstract), comprising:
a holding section (“placing the cutting-to-size element on the wound or alternatively holding the cutting-to-size element at a close distance, for example, at a distance of 2 cm, above the wound”; Para. [0084]); and
a contact section comprising a top surf ace connected to the holding section, and a bottom
surface having an adhesive (“the transparent film has a self-adhesive coating at least on its
second side facing the first side, so that the cutting-to-size element can be adhesively fixed to the side of the wound dressing that faces away from the wound during use”; Para [0019]);
wherein the holding section (Fig. 3, Gripping Strips 13 and 14) is configured to extend vertically outward at an angle from the top surface of the contact section.
Regarding claim 2, Eckstein teaches the cutting aid device of claim 1 (see rejection of claim 1 above), wherein the bottom surface of the contact section with the adhesive is configured to contact a top surface of a drape of the NPWT system (“the transparent film has a self-adhesive coating at least on its second side facing the first side, so that the cutting-to-size element can be adhesively fixed to the side of the wound dressing that faces away from the wound during use”; Para [0019]).
Regarding claim 4, Eckstein teaches the cutting aid device of claim 1 (see rejection of claim 1 above), wherein the cutting aid device has a die cut two dimensional profile that is configured to be folded to form a three dimensional profile. Eckstein teaches a cutting to size element that comprises a film (two dimensional profile) which can be folded to form a three dimensional profile.
Regarding claim 6, Eckstein teaches the cutting aid device of claim 1 (see rejection of claim 1 above), wherein the cutting aid device has a three dimensional profile. As set forth in MPEP 2113, product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps.
Regarding claim 7, Eckstein teaches the cutting aid device of claim 1 (see rejection of claim 1 above), wherein the bottom surface of the contact section is reusable. Eckstein’s cutting to size element can be used multiple times.
Regarding claim 8, Eckstein teaches the cutting aid device of claim 1 (see rejection of claim 1 above), wherein the adhesive comprises a double-sided tape with a polypropylene film carrier and an acrylic pressure sensitive adhesive (“The transparent film is preferably a polymer film, in particular, a film made of polyurethane, polyester, polypropylene, polyethylene, polyamide, polyvinyl chloride, polyorganosiloxane (silicone) or a mixture of these…On the second side opposite the first side, the cutting-to-size element comprises a self -adhesive coating”; Para. [0070]).
Regarding claim 9, Eckstein teaches A kit for use with a negative pressure wound therapy (NPWT) system (“Further, the invention provides a ready-to-use set for vacuum wound therapy”; Para. [0079]), the kit comprising:
a package defining a sterilized interior environment (“A further advantage is that all components of the set used in the region of the wound can be provided already sterilized ”; Para. [0082]); and
the cutting aid device of claim 1 (see rejection of claim 1 above) disposed within the sterilized interior environment (“In a further preferred embodiment, a cutting-to-size element is provided for use in vacuum therapy in the treatment of a wound produced by a skin grafting ”; Para. [0083]).
Regarding claim 10, Eckstein teaches the kit of claim 9 (see rejection of claim 9 above), further comprising a dressing layer disposed within the sterilized interior environment, wherein the dressing layer is configured to be placed on top of a wound area (“The advantage of ready-to-use sets is that the vacuum dressing can be applied in a standardized and uncomplicated manner”; Para. [0082]).
Regarding claim 11, Eckstein teaches the kit of claim 10 (see rejection of claim 10 above), further comprising a drape layer disposed within the sterilized interior environment, the drape layer configured for placement on top of the dressing layer (“package element within which said air-impermeable cover material, said element for functional connection of the wound space to a source of vacuum, said liquid permeable wound dressing and said cutting-to-size element are accommodated in a sterilized condition thereof”; Claim 16).
Regarding claim 12, Eckstein teaches the kit of claim 11 (see rejection of claim 11 above), wherein the bottom surface of the contact section is configured to contact a top surface of the drape layer (“the transparent film has a self-adhesive coating at least on its second side facing the first side, so that the cutting-to-size element can be adhesively fixed to the side of the wound dressing that faces away from the wound during use”; Para [0019]).
Regarding claim 13, Eckstein teaches the kit of claim 12 (see rejection of claim 12 above), wherein the adhesive on the bottom surface of the contact section comprises a double-sided tape with a polypropylene film carrier and an acrylic pressure sensitive adhesive.
Regarding claim 18, Eckstein teaches a method of cutting a drape for use with a negative pressure wound therapy device (“A further object of the invention is a method for vacuum therapy of wounds comprising the steps”; Para. [0084]), the method comprising:
placing a cutting aid device on the drape, wherein the cutting aid device comprises (“further comprises a cutting-to-size element for the liquid-permeable wound dressing. The cutting-to-size element comprises a transparent film with a first and a second side. The first side of the transparent film can be written on, so that the outline of the wound can be traced onto the cutting-to-size element. Furthermore, at least on its second side facing the first side, the transparent film has a self-adhesive coating so that the cutting-to-size element can be adhesively fixed to the side of the wound dressing that faces away from the wound during use”; Para. [0084]):
a holding section (“placing the cutting-to-size element on the wound or alternatively holding the cutting-to-size element at a close distance, for example, at a distance of2 cm, above the wound”; Para. [0084]; and
a contact section comprising a top surf ace connected to the holding section, and an adhesive bottom surface (“further comprises a cutting-to-size element for the liquid-permeable wound dressing. The cutting-to-size element comprises a transparent film with a first and a second side. The first side of the transparent film can be written on, so that the outline of the wound can be traced onto the cutting -to-size element. Furthermore, at least on its second side facing the first side, the transparent film has a self- adhesive coating so that the cutting-to-size element can be adhesively fixed to the side of the wound dressing that faces away from the wound during use”; Para. [0084]), wherein the holding section (Fig. 3, Gripping Strips 13 and 14) is configured to extend vertically outward at an angle from the top surface of the contact section;
lifting up the cutting aid device to lift up a portion of the drape; and cutting the lifted portion of the drape. (“adhesively fixing the cutting-to-size element to the side of a liquid-permeable dressing facing away from the wound, cutting the liquid-permeable wound dressing to size with the cutting-to-size element, wherein the outline traced is followed when cutting to size”; Para. [0084]).
Regarding claim 19, Eckstein teaches the method of claim 18 (see rejection of claim 18 above), further comprising applying adhesive force on a top surface of the drape by contacting the bottom surf ace of the contact section to the top surface of the drape (“Furthermore, at least on its second side facing the first side, the transparent film has a self-adhesive coating so that the cutting-to-size element can be adhesively fixed to the side of the wound dressing that faces away from the wound during use”; Para. [0084]).
Regarding claim 20, Eckstein teaches the method of claim 18, further comprising removing the lifted portion of the drape to define a hole through the drape by adhering the lifted portion of the drape to the bottom surface of the contact section. (“Finally, the combination of the wound dressing and cutting-to-size element can be cut to size along the traced outline of the wound, wherein a sterilized pair of scissors is preferably used for cutting to size”; Para. [0021]). Eckstein implies that once the drape and cutting to size element are cut that they stay connected and are removed from the excess drape material to reveal a hole through the leftover drape material.
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 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 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Axel Eckstein et al. (US 20110152798 – hereinafter Eckstein).
Regarding claim 3, Eckstein does not teach the cutting aid device of claim 2, wherein the adhesive on the bottom surface of the contact section has a peel strength of about 45N/mm. However it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of such that the adhesive on the bottom surface of the contact section has a peel strength of about 45N/mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Eckstein would not operate differently. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the peel strength “may” be within the claimed range (specification pp. [0024]).
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Gregory Cooksey et al. (US 20120285560 – hereinafter Cooksey) in view of John Nguyen et al. (US 10010393 – hereinafter Nguyen).
Regarding claim 21, Cooksey teaches a method of making a sheet material which could be used as a cutting aid device for use with a negative pressure wound therapy (NPWT) system, comprising:
providing a two-dimensional sheet material (“a sheet of material, preferably an elastic material such as poly(dimethylsiloxane) ("PDMS"), is attached to the top adhesive surface of the tape as a membrane”; Para. [0044])
forming a first fold line between the first holding section and the second holding section, and a second fold line between the first holding section and the first contact section, and a third fold line between the second holding section and the second contact section (“An alternative embodiment of the invention comprises arranging the fold lines to form a three dimensional shape by folding the material along the fold lines to form a three dimensional object comprised of the material ”; Para. [0087]);
applying an adhesive to the first side of the elongated shape to cover the first contact section, and the second contact section and at least one of the first holding portion and the second holding portion (“a sheet of material, preferably an elastic material such as poly(dimethylsiloxane) ("PDMS"), is attached to the top adhesive surface of the tape as a membrane”; Para. [0044]);
applying a first release liner (Fig. 7, liner) over at least one of the first holding section and the second holding section; and applying a second release liner (Fig. 7, 2nd liner) over the first contact section and the second contact section that are separately removable from the first release liner ([0044] and [0047] – removed separately).
However, Cooksey is silent regarding Cutting an elongated shape from the sheet material, the elongated shape having a first side and a second side, and defining a first holding section and a second holding section and a first contact section and a second contact section.
Nguyen teaches Cutting an elongated shape from the sheet material, the elongated shape having a first side and a second side, and defining a first holding section and a second holding section and a first contact section and a second contact section (“cutting the sheet material to a desired shape”; Col. 25 lines 8-9).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to use the step of cutting sheet material as taught by Nguyen in the method taught by Cooksey in order to create “a desired shape” (Col. 25 lines 8-9).
Regarding claim 23, Cooksey in view of Nguyen teaches the method of claim 21 (see rejection of claim 21 above), Cooksey further teaches a method wherein the adhesive comprises a double-sided tape with a polypropylene film carrier and an acrylic pressure sensitive adhesive (“In the preferred embodiment illustrated in FIG. 1, double-sided tape is used”; Para. [0041]).
Response to Arguments
Applicant's arguments filed 7/31/2025 have been fully considered but they are not persuasive.
Regarding claims 1 and 18, Applicant asserts that Eckstein does not teach “wherein the holding section is configured to extend vertically outward at an angle from the top surface of the contact section”. However, it can be seen in the rejections of claims 1 and 18 above that Eckstein does teach this limitation, as gripping portions 13 and 14 extend generally vertically and at an angle.
Regarding claim 21, Applicant asserts that Cooksey in view of Nguyen does not teach “applying a first release liner over at least one of the first holding section and the second holding section; and applying a second release liner over the first contact section and the second contact section that are separately removable from the first release liner”. However, Cooksey is shown to teach in the rejection of claim 21 a first liner and a second liner, each attached to different portions of the invention and each being separately removable from one another (Fig. 7).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLA LORRAINE KEENA whose telephone number is (571)272-1806. The examiner can normally be reached 7:30am - 5:00 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Boyer Ashley can be reached at (571) 272-4502. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLA L KEENA/Examiner, Art Unit 3724 /BOYER D ASHLEY/Supervisory Patent Examiner, Art Unit 3724
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