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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), 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 3, 4, 6, 7, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the thermoplastic material" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the concentration of the PVA" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the polyol compound" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the concentration of the glycerol" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the electrodes" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, 6-7, 10-13, and 22 in the reply filed on 07/08/2025 is acknowledged.
Claims 14-19, 25, 26, 28, 29, 31, 32, 35-38, 40, 42, and 44-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/08/2025.
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.
Claim(s) 1-3, 6, 10-13, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burton (US 6903243).
Regarding Claim 1, Burton discloses a wound dressing (10, Fig. 1) for application against a wound site of a subject (abstract, Col. 1 lines 55-65, Col. 10 lines 36-61, Col. 12 lines 52-62), the wound dressing (10, Fig. 1) comprising:
a transparent (abstract, Col. 4 lines 55-59), moisture absorbing layer (absorbent layer 24, Fig. 1) having a wound side (bottom, Fig. 1) and an opposed outer side (top, Fig. 1); and
an adhesive layer (pressure sensitive adhesive 30, Fig. 1) that is connected to at least a portion of the wound side (bottom, Fig. 1) of the moisture absorbing layer (24, Fig. 1; adhesive 30 is connected to the wound side of layer 24 via the intervening layers), wherein the adhesive layer (30, Fig. 1) facilitates attachment of the wound dressing (10, Fig 1) to a non-wounded perimeter of the wound site (Col. 10 lines 36-61);
wherein the moisture absorbing layer (24, Fig. 1) absorbs moisture from the wound site, without swelling, to promote healing of the wound site (Col. 6 lines 12-18, Col. 7 lines 29-47; the absorbent layer 24 is fully capable of absorbing some moisture from the wound without swelling occurring, and a thicker or larger layer 24 will allow more moisture to be absorbed before the dressing begins to swell; additionally, all wounds are different with some wounds only producing exudate/moisture for a very short duration of time, so the dressing is fully capable of being used with a very small wound that produces a very small amount of exudate for a very short duration of time and then left on for an extended period of time after the dressing ceases to absorb as the wound is no longer producing moisture).
Regarding Claims 2, 3, and 6, Burton discloses the moisture absorbing layer (24, Fig. 1) comprises a thermoplastic material such as polyvinyl alcohol (Col. 4 lines 55-60, Col. 5 lines 26-31) and a polyol compound such as glycerol (Col. 8 line 62 – Col. 9 line 9).
Regarding Claim 10, Burton discloses the moisture absorbing layer (24, Fig. 1) remains transparent after absorbing liquid from the wound site (abstract).
Regarding Claim 11, Burton discloses the moisture absorbing layer (24, Fig. 1) absorbs liquid from the wound site, without swelling, for a period of about 1 hour to about 14 days following contact of the wound dressing with the wound site (Col. 6 lines 12-18, Col. 7 lines 29-47; the absorbent layer 24 is fully capable of absorbing some moisture from the wound without swelling occurring, and a thicker or larger layer 24 will allow more moisture to be absorbed before the dressing begins to swell; the size of the layer can be selected to allow the dressing to absorb moisture for at least 1 hour without swelling occurring; additionally, all wounds are different with some wounds only producing exudate/moisture for a very short duration of time, so the dressing is fully capable of being used with a very small wound that produces a very small amount of exudate for a very short duration of time and then left on for an extended period of time after the dressing ceases to absorb as the wound is no longer producing moisture).
Regarding Claim 12, Burton discloses the moisture absorbing layer (24, Fig. 1) includes one or more bioactive agents for delivery into tissue comprising the wound site or a surrounding non-wound site (Col. 8 lines 53-61; an antioxidant can be considered a bioactive agent).
Regarding Claim 13, Burton discloses the moisture absorbing layer (24, Fig. 1) is free of any exogenous conductive elements (Col. 4 line 54 – Col. 9 line 21; exogenous conductive elements like those mentioned in Applicant’s specification are not present within the absorbent layer 24).
Regarding Claim 22, Burton discloses a method for healing a wound site of a subject, the method comprising:
applying the wound dressing (10, Fig. 1) of Claim 1 over the wound site (abstract, Col. 1 lines 55-65, Col. 10 lines 36-61, Col. 12 lines 52-62); and
leaving the wound dressing (10, Fig. 1) over the wound site for a period of time until the wound site is healed (Col. 12 lines 52-62).
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) 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Burton (US 6903243) in view of Taylor et al (US 2016/0095759).
Regarding Claim 4, Burton is silent whether the concentration of the PVA in the moisture absorbing layer is about 1 to 5 wt%.
Taylor teaches an absorbent article, thus being in the same field of endeavor, with a hydrophilic hydrogel adhesive composition that can have 2-5 wt% PVA (¶ [0046-0047]).
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 concentration of PVA in the moisture absorbing article of Burton to be about 1 to 5 wt%, as taught by Taylor, since Taylor indicates that absorbent hydrogel materials are well known in the art to be able to have a PVA concentration within the range of 1 and 5 wt%.
Regarding Claim 7, Burton is silent whether the concentration of the glycerol in the moisture absorbing layer is about 3 to 15 wt%.
Taylor teaches an absorbent article with a hydrophilic hydrogel adhesive composition that can have 5-40, or 15-25 wt% glycerol (¶ [0049]).
Therefore, it would have been obvious to modify the concentration of glycerol in the moisture absorbing article of Burton to be 5-40, or 15-25 wt%, as taught by Taylor, since Taylor indicates that absorbent hydrogel materials are well known in the art to be able to have a glycerol concentration within the ranges of 5-40 or 15-25 wt%.
However, Burton/Taylor does not explicitly disclose the concentration of the glycerol in the moisture absorbing layer is about 3 to 15 wt%.
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 glycerol concentration of Burton/Taylor to be from 5-40 wt% to 3 to 15 wt% as applicant appears to have placed no criticality on the claimed range (see ¶ [0132] of the published specification indicating the concentration of glycerol “can” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
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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