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 .
Status of Claims
Claims 1-20 are pending and examined on the merits.
Information Disclosure Statement
The two information disclosure statements (IDS’s) submitted on 10/11/2023 were filed before the mailing date of the First Office Action on the Merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 2, 7, 11, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murphy (U.S. Pre Grant Pub. No. 2012/0165715 A1).
Regarding claim 1, Murphy teaches: A dressing (see at least Abstract), comprising:
a patient interface layer (see skin adhesive layer 40 in para. [0027] and Fig. 3) defining an opening (see para. [0034] and Fig. 3);
a first fastening layer coupled to the patient interface layer (see base layer 30 in Fig. 3 and para. [0027]);
a second fastening layer (see top adhesive layer 60 in Fig. 3 and para. [0027]) detachably coupled to the first fastening layer (as broadly recited, the top adhesive layer 60 is detachably coupled to the base layer 30 at least because a user can detach the two layers from each other) such that the second fastening layer can be separated from and reattached to the first fastening layer while still forming a substantially airtight seal with the first fastening layer (as broadly recited, a user can detach and reattach the layers while still forming a substantially airtight seal due to the presence of adhesives on the top adhesive layer 60; see para. [0027]); and
an upper cover coupled to the second fastening layer and covering the opening (see top layer 80 in Fig. 3 and para. [0027]).
Regarding claim 2, Murphy teaches the invention as discussed above in claim 1. Additionally, Murphy teaches wherein at least a portion of the first fastening layer extends into the second fastening layer when the first fastening layer is pressed against the second fastening layer (as broadly recited, when the two layers 30, 60 are pressed against one another, the portion of the first fastening layer in contact with the second fastening layer extends into the second fastening layer).
Regarding claim 7, Murphy teaches the invention as discussed above in claim 1. Additionally, Murphy teaches wherein the first fastening layer is disposed along a perimeter of the opening (as broadly recited, the first fastening layer 30 has a perimeter around opening 36 which couples to the area outside the opening on layer 40; therefore, the claim is anticipated; see Fig. 3; see also para. [0044]).
Regarding claim 11, Murphy teaches the invention as discussed above in claim 1. Additionally, Murphy teaches wherein one end of the upper cover is permanently bonded to the patient interface layer (as broadly recited, when the layers are attached together as in Fig. 1, the upper cover 80 is permanently bonded to the patient interface layer 40 by way of adhesives; see para. [0027]).
Regarding claim 16, Murphy teaches A method of making a dressing (see at least para. [0027, 0069]), comprising:
providing a patient interface layer (see skin adhesive layer 40 in para. [0027] and Fig. 3) defining an opening (see para. [0034] and Fig. 3);
providing a first fastening layer (see base layer 30 in Fig. 3 and para. [0027]);
joining the first fastening layer to the patient interface layer (see at least para. [0027] and Fig. 3);
providing an upper cover sized to cover the opening (see top layer 80 in Fig. 3 and para. [0027]);
providing a second fastening layer (see top adhesive layer 60 in Fig. 3 and para. [0027]);
joining the second fastening layer to the upper cover (see at least para. [0027] and Fig. 3); and
coupling the upper cover to the patient interface layer by pressing the second fastening layer against the first fastening layer (see at least para. [0027] and Fig. 3) to form a selectively releasable and reclosable access system (as broadly recited, the top adhesive layer 60 is selectively releasable and reclosable to the base layer 30 at least because a user can detach the two layers from each other) that provides a substantially airtight seal between the first fastening layer and the second fastening layer (a substantially airtight seal is created due to the presence of adhesives on the top adhesive layer 60; see para. [0027]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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 ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-6, 8-9, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (U.S. Pre Grant Pub. No. 2012/0165715 A1) in view of Hsu (U.S. Pre Grant Pub. No. 2005/048921 A1).
Regarding claims 3 and 5, Murphy teaches the invention as discussed above in claim 1. However, Murphy fails to explicitly teach that the first fastening layer includes a strip, as required by the claim.
Hsu teaches an analogous wound care device (see Abstract) comprising a strip of detachable affixation mechanisms 108 to allow a device cover 106 to be detachably affixed to a device frame 104 (see para. [0041] and Fig. 1). Hsu further teaches that a Ziploc fastener can be used (see para. [0041]). By including a Ziploc type fastener, on the first and second fastening layers (which are considered to be the plurality of stems), the first and second fastening layers are mechanically fastened when pressure is applied to one of the layers against the other layer (as applied to claim 3). Additionally, the Ziploc type fastener on the first and second fastening layers are of the male and female interlocking type (as applied to claim 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Murphy to incorporate the teachings of Hsu by including a strip extending along a perimeter portion of the opening, the strip comprising a plurality of stems that are configured to mechanically fasten the first fastening layer to the second fastening layer when the first fastening layer is pressed against the second fastening layer at least in order to allow for the detachable affixation of two or more layers of the dressing thus allowing a layer to be removed without affecting the adhesion between a layer and a patient’s skin, as taught by Hsu (see para. [0041]).
Regarding claim 4, Murphy teaches the invention as discussed above in claim 3. Additionally Hsu teaches wherein the strip further comprises a pressure sensitive adhesive disposed in between adjacent ones of the stems (para. [0041] teaches that a light adhesive can be used as a detachable affixation mechanism).
Regarding claim 6, Murphy teaches the invention as discussed above in claim 1. Additionally Hsu teaches wherein the first fastening layer includes both a non-adhesive-based mechanical fastener and an adhesive material (see para. [0041]).
Regarding claim 8, Murphy teaches the invention as discussed above in claim 1. However, Murphy fails to explicitly teach wherein the first fastening layer comprises a first fastening strip and a second fastening strip positioned on an opposite side of the opening as the second fastening strip, as required by the claim.
Hsu teaches wherein the first fastening layer comprises a first fastening strip and a second fastening strip positioned on an opposite side of the opening as the second fastening strip (see for example the perimeter of the detachable affixation mechanism 108 in Fig. 1 having four strips surrounding a wound 102), and wherein the first fastening strip and the second fastening strip are each oriented in a direction that is substantially parallel to a longest dimension of the opening (see Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Murphy to incorporate the teachings of Hsu by including multiple strips for the detachable affixation mechanism at least in order for the device to remain in comfortable adherence to a patient's skin, which may fold or twist with movement of a patient, as taught by Hsu (see para. [0028]).
Regarding claim 9, Murphy teaches the invention as discussed above in claim 8. Additionally Murphy teaches a gel adhesive that is disposed between the patient interface layer and the upper cover (para. [0037] teaches a hydrogel polymeric composition). Additionally, in the device of Murphy in view of Hsu, the gel adhesive extends between the first fastening strip and the second fastening strip at least because the gel adhesive is disposed between the first fastening strip and the second fastening strip.
Regarding claims 17 and 18, Murphy teaches the method as discussed above in claim 16. However, Murphy fails to explicitly teach wherein joining the first fastening layer to the patient interface layer comprises positioning a strip along a perimeter portion of the opening, and bonding the strip to the patient interface layer, as required by the claim.
Hsu teaches an analogous wound care device (see Abstract) comprising a strip of detachable affixation mechanisms 108 to allow a device cover 106 to be detachably affixed to a device frame 104 (see para. [0041] and Fig. 1). Hsu further teaches that a Ziploc fastener can be used (see para. [0041]). By including a Ziploc type fastener, on the first and second fastening layers (which are considered to be the plurality of stems), the first and second fastening layers are mechanically fastened when pressure is applied to one of the layers against the other layer (as applied to claim 17). Additionally, the Ziploc type fastener on the first and second fastening layers are of the male and female interlocking type (as applied to claim 18).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Murphy to incorporate the teachings of Hsu by including a strip extending along a perimeter portion of the opening, the strip comprising a plurality of stems that are configured to mechanically fasten the first fastening layer to the second fastening layer when the first fastening layer is pressed against the second fastening layer at least in order to allow for the detachable affixation of two or more layers of the dressing thus allowing a layer to be removed without affecting the adhesion between a layer and a patient’s skin, as taught by Hsu (see para. [0041]).
Regarding claim 19, Murphy teaches the method as discussed above in claim 16. However, Murphy fails to explicitly teach wherein joining the first fastening layer to the patient interface layer comprises: positioning a first fastening strip along a direction that is substantially parallel to a longest dimension of the opening; joining the first fastening strip to the patient interface layer on a first side of the opening; joining a second fastening strip to a second side of the opening opposite the first side; and applying a gel adhesive to the patient interface layer to substantially fill a gap between the first fastening strip and the second fastening strip, as required by the claim.
Hsu teaches wherein joining the first fastening layer to the patient interface layer comprises:
positioning a first fastening strip along a direction that is substantially parallel to a longest dimension of the opening (see for example the perimeter of the detachable affixation mechanism 108 in Fig. 1 having four strips surrounding a wound 102);
joining the first fastening strip to the patient interface layer on a first side of the opening (see for example Fig. 1);
joining a second fastening strip to a second side of the opening opposite the first side (see for example Fig. 1); and
applying a gel adhesive to the patient interface layer to substantially fill a gap between the first fastening strip and the second fastening strip (para. [0041] teaches the use of adhesives).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Murphy to incorporate the teachings of Hsu by including multiple strips for the detachable affixation mechanism at least in order for the device to remain in comfortable adherence to a patient's skin, which may fold or twist with movement of a patient, as taught by Hsu (see para. [0028]).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (U.S. Pre Grant Pub. No. 2012/0165715 A1) in view of Edwards (U.S. Pre Grant Pub. No. 2022/0079815 A1).
Regarding claim 10, Murphy teaches the invention as discussed above in claim 1. However, Murphy fails to explicitly teach an absorbent material disposed between the upper cover and the patient interface layer, as required by the claim.
Edwards teaches an analogous partially transparent dressing (see Abstract) comprising an absorbent material (see absorbent layer 417 in para. [0043] and Fig. 1) disposed between the upper cover and the patient interface layer (see Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Murphy to incorporate the teachings of Edwards by including an absorbent material disposed between the upper cover and the patient interface layer at least in order to absorb and remove wound exudate from a wound, as taught by Edwards (see para. [0043]). Additionally, when the absorbent material is included in the device of Murphy, the absorbent material is substantially aligned with the opening at least because a skilled artisan would place the absorbent material adjacent the opening of Murphy.
Regarding claim 12, Murphy teaches: a wound dressing with a selective viewing access and reclosure system (see at least Abstract and para. [0010, 0027]), comprising:
a patient interface layer (see skin adhesive layer 40 in para. [0027] and Fig. 3) defining an opening (see para. [0034] and Fig. 3) configured for placement about a patient area of treatment (see para. [0027]);
a top layer (see top layer 80 in Fig. 3 and para. [0027]);
a touch fastener (see top adhesive layer 60 in Fig. 3 and para. [0027]) disposed between the patient interface layer and the top layer (see Fig. 3), the touch fastener configured to detachably couple the patient interface layer to the top layer and form a substantially airtight seal between the patient interface layer and the top layer (as broadly recited, a user can detach and reattach the layers while still forming a substantially airtight seal due to the presence of adhesives on the top adhesive layer 60; see para. [0027]).
However, Murphy fails to explicitly teach that the wound dressing is a negative pressure wound dressing, that the top layer comprises a negative pressure interface, or that a negative pressure source is coupled to the negative pressure interface on the top layer, as required by the claim.
Edwards teaches an analogous partially transparent dressing (see Abstract) comprising a negative pressure wound dressing with a selective viewing access and reclosure system (see at least Abstract and Fig. 8), comprising:
a top layer (see drape 508 in para. [0060] and Fig. 8) sized to cover the opening and comprising a negative pressure interface (as at numeral 510 in Fig. 8); and
a negative pressure source coupled to the negative pressure interface on the top layer (see negative pressure pump 514 in para. [0060] and Fig. 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Murphy to incorporate the teachings of Edwards by including a negative pressure interface on the top layer and coupling a negative pressure source to the negative pressure interface at least in order to increase the healing benefits provided by the dressing, as taught by Edwards (see para. [0060]).
Claims 13-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (U.S. Pre Grant Pub. No. 2012/0165715 A1) in view of Edwards (U.S. Pre Grant Pub. No. 2022/0079815 A1), and further in view of Hsu (U.S. Pre Grant Pub. No. 2005/048921 A1).
Regarding claim 13, Murphy in view of Edwards teaches the invention as discussed above in claim 12. However, Murphy in view of Edwards fails to explicitly teach that the first fastening layer includes a strip, as required by the claim.
Hsu teaches an analogous wound care device (see Abstract) comprising a strip of detachable affixation mechanisms 108 to allow a device cover 106 to be detachably affixed to a device frame 104 (see para. [0041] and Fig. 1). Hsu further teaches that a Ziploc fastener can be used (see para. [0041]). By including a Ziploc type fastener, on the first and second fastening layers (which are considered to be the plurality of stems), the first and second fastening layers are mechanically fastened when pressure is applied to one of the layers against the other layer.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Murphy in view of Edwards to incorporate the teachings of Hsu by including a strip extending along a perimeter portion of the opening, the strip comprising a plurality of stems that are configured to mechanically fasten the first fastening layer to the second fastening layer when the first fastening layer is pressed against the second fastening layer at least in order to allow for the detachable affixation of two or more layers of the dressing thus allowing a layer to be removed without affecting the adhesion between a layer and a patient’s skin, as taught by Hsu (see para. [0041]).
Regarding claim 14, Murphy, in view of Edwards, and further in view of Hsu teaches the invention as discussed above in claim 13. Additionally Hsu teaches wherein the strip further comprises a pressure sensitive adhesive disposed in between adjacent ones of the stems (para. [0041] teaches that a light adhesive can be used as a detachable affixation mechanism).
Regarding claim 15, Murphy, in view of Edwards, and further in view of Hsu teaches the invention as discussed above in claim 12. Additionally Hsu teaches wherein the first fastening layer includes both a non-adhesive-based mechanical fastener and an adhesive material (see para. [0041]).
Regarding claim 20, Murphy in view of Hsu teaches the invention as discussed above in claim 17. However, neither Murphy nor Hsu explicitly teach placing an absorbent material into a recessed area of the upper cover, and aligning the absorbent material with the opening, as required by the claim.
Edwards teaches an analogous partially transparent dressing (see Abstract) comprising an absorbent material (see absorbent layer 417 in para. [0043] and Fig. 1) disposed between the upper cover and the patient interface layer (see Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Murphy in view of Hsu to incorporate the teachings of Edwards by including an absorbent material disposed between the upper cover and the patient interface layer at least in order to absorb and remove wound exudate from a wound, as taught by Edwards (see para. [0043]). Additionally, when the absorbent material is included in the device of Murphy, the absorbent material is substantially aligned with the opening at least because a skilled artisan would place the absorbent material adjacent the opening of Murphy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Roberts (U.S. Patent No. 6,124,520 A) – Window Dressing.
Hathman (U.S. Patent No. 5,086,763 A) – Protective Reclosable Wound Dressing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
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