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 Arguments
Applicant’s amendment filed 10/16/2025 is accepted and entered. Applicant’s amendments to the claims have overcome the previous 112 rejections and the previous 112 rejections have been withdrawn.
Applicant’s arguments with respect to claim(s) 1, 11, and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
(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) 11, 13, 14, 18, and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azocar (US 9480830).
Regarding Claim 11, Azocar discloses an oxygen scavenging dressing (10, Figs. 1 and 5) comprising:
an oxygen scavenging layer (43, Fig. 5);
one or more additional layers (moisture/exudate absorbing layers 56, 56’ and barrier layer 58, Fig. 5); and
a film layer (combination of gas impermeable encasement 24 and cuff 20, Figs. 1 and 5) configured to seal with a patient’s skin (Col. 9 lines 38-55) and define an inner volume (chamber 42, Figs. 1 and 5) within which the oxygen scavenging layer (43, Fig. 5) and the one or more additional layers (56, 56’, and 58, Fig. 5) are positioned;
wherein the oxygen scavenging layer (43, Fig. 5) is exposed to liquid within the inner volume (42, Fig. 5) and configured to remove oxygen from within the inner volume (42, Fig. 5) to draw a negative pressure within the oxygen scavenging dressing (10, Figs. 1 and 5; Col. 5 line 62 – Col. 6 line 10, Col. 9 lines 29-37; since the oxygen scavenging layer removes oxygen from the air/exudate, it will also draw at least a small amount of negative pressure within the dressing due to the removal of oxygen).
Regarding Claim 13, Azocar discloses the oxygen scavenging dressing (10, Figs. 1 and 5) is configured to be positioned on a patient’s face (Col. 8 lines 63-66 indicate the dressing can be accommodated to fit other body parts, and therefore is fully capable of being configured for use on a patient’s face).
Regarding Claim 14, Azocar discloses the film layer (20 and 24, Figs. 1 and 5) comprises an adhesive (54, Fig. 6) along an underside configured to seal with the patient’s skin (Col. 9 lines 38-55).
Regarding Claim 18, Azocar discloses the oxygen scavenging layer (43, Fig. 5) comprises an iron compound (55, Fig. 5) configured to remove oxygen from within the inner volume (Col. 5 line 62 – Col. 6 line 10, Col. 9 lines 35-37).
Regarding Claim 20, Azocar discloses the oxygen scavenging layer (43, Fig. 5) comprises two or more sections (anterior portion 26 and posterior portion 28, Fig. 1) configured to be selectively deployed to customize a negative pressure capability of the oxygen scavenging dressing (10, Figs. 1 and 5; the two sections can be considered to be selectively deployed and therefore could customize the negative pressure capability of the dressing).
Regarding Claim 21, Azocar discloses a method for passively drawing a negative pressure at a dressing (10, Fig. 1), the method comprising:
providing a dressing (10, Fig. 1) including an oxygen scavenging material (43, Fig. 5), a film layer (combination of 24 and 20, Figs. 1 and 5), and one or more other layers (56, 56’, and 58, Fig. 5);
adhering the dressing (10, Fig. 1) to a patient’s skin over an incision or a wound to define a sealed inner volume (42, Fig. 5) and expose the oxygen scavenging material (43, Fig. 5) to liquid within the internal volume (42, Fig. 5; Col. 9 lines 29-57); and
drawing a negative pressure within the sealed inner volume (42, Fig. 5) by scavenging oxygen within the sealed inner volume (42, Fig. 5) at the oxygen scavenging material (43, Fig. 5; Col. 5 line 62 – Col. 6 line 10, Col. 9 lines 29-37; since the oxygen scavenging layer removes oxygen from the air/exudate, it will also draw at least a small amount of negative pressure within the dressing due to the removal of oxygen).
Regarding Claims 22 and 23, Azocar discloses selectably fluidly coupling one or more additional sections of oxygen scavenging material with the sealed inner volume to further decrease the negative pressure, and selectively deploying two or more sections of the oxygen scavenging material to customize a negative pressure capability of the dressing (anterior portion 26 and posterior portion 28, Fig. 1; the two sections can be considered to be selectively deployed and therefore could customize the negative pressure capability of the dressing).
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.
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.
Claim(s) 1-5, 8-10, 12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Azocar (US 9480830) in view of Middaugh et al (US 2019/0091382).
Regarding Claim 1, Azocar discloses an oxygen scavenging dressing (10, Figs. 1 and 5) comprising:
a patient interface layer (barrier layer 58, Fig. 5);
an absorbent layer (moisture/exudate absorbing layer 56, Fig. 5);
a layer that is liquid permeable (moisture/exudate absorbing layer 56’, Fig. 5)
an oxygen scavenging layer (43, Fig. 5); and
a film layer (combination of gas impermeable encasement 24 and cuff 20, Figs. 1 and 5) configured to seal with a patient’s skin (Col. 9 lines 38-55) and define an inner volume (chamber 42, Figs. 1 and 5) within which the patient interface layer (58, Fig. 5), the absorbent layer (56, Fig. 5), the liquid permeable layer (56’, Fig. 5), and the oxygen scavenging layer (43, Fig. 5) are positioned.
Azocar is silent whether the liquid permeable layer is a foam layer that is liquid permeable.
Middaugh teaches a wound dressing, thus being in the same field of endeavor, with a wicking element (34, Fig. 3) that absorbs exudate away from the wound site (¶ [0030]) where the wicking element (34, Fig. 3) is made of foam (¶ [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the liquid permeable layer of Azocar to be made of foam, as Middaugh teaches that foam absorbent layers are well known in the art of wound dressings for absorbing wound exudates (¶ [0030]). Additionally, it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Regarding Claim 2, Azocar further discloses the oxygen scavenging layer (43, Fig. 5) is configured to remove oxygen from within the inner volume (42, Fig. 5) of the oxygen scavenging dressing (10, Figs. 1 and 5) to draw a negative pressure within the oxygen scavenging dressing (10, Figs. 1 and 5; Col. 5 line 62 – Col. 6 line 10, Col. 9 lines 29-37; since the oxygen scavenging layer removes oxygen from the air/exudate, it will also draw at least a small amount of negative pressure within the dressing due to the removal of oxygen).
Regarding Claim 3, Azocar further discloses the oxygen scavenging dressing (10, Figs. 1 and 5) is configured to be positioned on a patient’s face (Col. 8 lines 63-66 indicate the dressing can be accommodated to fit other body parts, and therefore is fully capable of being configured for use on a patient’s face).
Regarding Claim 4, Azocar further discloses the film layer (20 and 24, Figs. 1 and 5) comprises an adhesive (54, Fig. 6) along an underside configured to seal with the patient’s skin (Col. 9 lines 38-55).
Regarding Claims 5, 16, and 17, Azocar further discloses the patient interface layer (58, Fig. 5) abuts the patient’s skin (Col. 6 lines 44-54).
Azocar/Middaugh is silent whether the absorbent layer is positioned directly between the foam layer and the patient interface layer, and wherein the foam layer is positioned directly between the oxygen scavenging layer and the absorbent layer.
However, it has been held that the mere rearrangement of parts is an obvious matter of design choice (see MPEP 2144.04). Therefore, it would have been obvious to rearrange the order of the layers of Azocar/Middaugh to have the absorbent layer positioned directly between the foam layer and the patient interface layer, and wherein the foam layer is positioned directly between the oxygen scavenging layer and the absorbent layer.
Regarding Claims 8 and 9, Azocar further discloses the oxygen scavenging layer (43, Fig. 5) comprises an iron compound (55, Fig. 5) configured to remove oxygen from within the inner volume (Col. 5 line 62 – Col. 6 line 10, Col. 9 lines 35-37).
Regarding Claim 10, Azocar further discloses the oxygen scavenging layer (43, Fig. 5) comprises two or more sections (anterior portion 26 and posterior portion 28, Fig. 1) configured to be selectively deployed to customize a negative pressure capability of the oxygen scavenging dressing (10, Figs. 1 and 5; the two sections can be considered to be selectively deployed and therefore could customize the negative pressure capability of the dressing).
Regarding Claim 12, Azocar further discloses a patient interface layer (58, Fig. 5), an absorbent layer (56, Fig. 5), and a liquid permeable layer (56’, Fig. 5).
Azocar is silent whether the liquid permeable layer is a foam layer that is liquid permeable.
Middaugh teaches a wound dressing, thus being in the same field of endeavor, with a wicking element (34, Fig. 3) that absorbs exudate away from the wound site (¶ [0030]) where the wicking element (34, Fig. 3) is made of foam (¶ [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the liquid permeable layer of Azocar to be made of foam, as Middaugh teaches that foam absorbent layers are well known in the art of wound dressings for absorbing wound exudates (¶ [0030]). Additionally, it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Regarding Claim 15, Azocar further discloses the patient interface layer (58, Fig. 5) abuts the patient’s skin (Col. 6 lines 44-54).
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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