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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 10, 2026 has been entered.
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 15 and 17 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 15 recites the limitation "the first plurality of supports and/or second plurality of supports" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the second plurality of supports" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
(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, 12, 15, 17, 19 and 51-53 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al. (US 2015/0196431).
With reference to claim 1, Dunn et al. (hereinafter “Dunn”) discloses an apparatus for managing fluid at a tissue site [0009], comprising:
first and second layers including inner and outer surfaces placed above and below a first plurality of supports (i.e., stabilizing structure) in a stacked relationship where each layer may include foam [0023] wherein the layers define a fluid pathway therebetween (see stabilizing structure shown in figures);
an aperture (106) configured to provide fluid communication between the at least one fluid pathway and the tissue site; and
a port configured to provide fluid communication between the at least one fluid pathway and a negative-pressure source as set forth in [0083].
As to claim 12, Dunn discloses an apparatus further comprising a first barrier between the inner surface of the first layer and an inner surface of the second layer, wherein the at least one fluid pathway comprises a first fluid pathway and a second fluid pathway formed by the first barrier as set forth in [0095].
With reference to claim 15, Dunn discloses an apparatus wherein the first plurality of supports and/or second plurality of supports are configured to support the first fluid pathway to resist collapse under negative pressure as set forth in [0114].
As to claim 17, Dunn discloses an apparatus wherein the first plurality of supports are coupled to the second plurality of supports as shown in the figures, see especially figure 3B which shows a first plurality of supports (1711) coupled (1702) to a second plurality of supports (1713).
With reference to claim 19, Dunn discloses an apparatus wherein the first layer further comprises a slot between and separating the first fluid pathway and the second fluid pathway as set forth in [0101].
As to claim 51, Dunn discloses an apparatus wherein the first plurality of supports are substantially perpendicular to the inner surface of the first layer as set forth in figure 3B and in figure 8A where the supports are positioned both horizontally and vertically which would allow at least one support to be substantially perpendicular to any surface placed upon it.
Regarding claim 52, Dunn discloses an apparatus wherein the first plurality of supports extend inward from the inner surface of the first layer as set forth in [0023] where Dunn discloses that the structure is enclosed by the porous material.
With reference to claim 53, Dunn discloses an apparatus wherein the first plurality of supports comprise a plurality of standoffs as set forth in [0092].
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 16 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al. (US 2015/0196431).
With reference to claim 16, Dunn teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Dunn and claim 16 is the explicit recitation that the first plurality of supports are coupled to the second layer.
It would have been obvious to one of ordinary skill in the art at the time of the invention to couple the first plurality of supports of Dunn to the second layer of Dunn because Dunn recognizes that the foam material may surround the entire stabilizing structure and may include upper and lower layers and the joining of the support to the upper and/or lower layer provides added protection, function, stability and structure to the device.
Additionally, it is noted that it has been held the joining to two elements that have previously been disclosed as separate is considered to be within the level of ordinary skill in the art.
With reference to claim 28, Dunn discloses an apparatus for managing fluid at a tissue site [0009], comprising:
first and second layers including inner and outer surfaces placed above and below a first plurality of supports (i.e., stabilizing structure) in a stacked relationship where each layer may include foam (see [0023] where the genus foam is taught and would include the species of closed cell foam) wherein the layers define a fluid pathway therebetween (See stabilizing structure shown in figures);
an aperture (106) configured to provide fluid communication between the at least one fluid pathway and the tissue site; and
a port configured to provide fluid communication between the at least one fluid pathway and a negative-pressure source as set forth in [0083].
The difference between Dunn and claim 28 is the explicit recitation that the first and second layers are coupled around a perimeter and that the second layer is a substantially flat sheet.
It would have been obvious to one of ordinary skill in the art at the time of the invention to couple the first and second layers around a perimeter and to provide substantially flat sheets because Dunn discloses that the foam material may surround the entire stabilizing structure and providing a substantially flat sheet and joining of the layers around the perimeter would provide additional protection, function, stability and structure to the device.
Claims 18 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al. (US 2015/0196431) and further in view of Mercer et al. (US 2018/0214315).
With reference to claim 18, Dunn teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Dunn and claim 18 is the explicit recitation that the apparatus further comprises an affixation surface located on the outer surface around the aperture.
Mercer et al. (hereinafter “Mercer”) teaches an analogous apparatus further comprising an affixation surface (132) located on the outer surface around the aperture as shown in figure 4b.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the aperture of Dunn with the affixation surface as taught by Mercer in order to provide an improved interface for fluid connection as taught by Mercer in [0061].
With reference to claim 26, Dunn teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Dunn and claim 26 is the explicit recitation that the apparatus further comprises a valve.
Mercer discloses an apparatus wherein one or more of the at least one fluid pathway comprises a valve as set forth in [0081].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the apparatus of Dunn with a valve as taught by Mercer in order to control fluid flow as taught by Mercer in [0081 and 0087].
With reference to claim 27, Dunn teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Dunn and claim 27 is the explicit recitation that the apparatus further comprises a bulb element configured to collapse to be substantially flat with the outer surface when experiencing negative pressure, and to project outward in the absence of negative pressure.
Mercer teaches an analogous apparatus including a bulb element (1002) configured to collapse to be substantially flat with the outer surface when experiencing negative pressure, and to project outward in the absence of negative pressure as set forth in [0115-0117].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the apparatus of Dunn with a bulb as taught by Mercer in order to control fluid flow as taught by Mercer in [0115-0117].
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al. (US 2015/0196431) and further in view of Blott et al. (US 2009/0254054).
With reference to claims 24-25, Dunn teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Dunn and claims 24-25 is the explicit recitation that the at least one fluid pathway is coated with an anticoagulant agent (cl. 24) or a hydrophobic surface treatment (cl. 25).
Blott et al. (hereinafter “Blott”) teaches an analogous apparatus including at least pathway coated with an anticoagulant agent (cl. 24) or a hydrophobic surface treatment as set forth in [0213].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the pathway of Dunn with the anticoagulant coating or hydrophobic surface treatment as taught by Blott in order to provide the benefit of growth factors, enzymes and/or other proteins as taught by Blott in [0213].
Allowable Subject Matter
Claims 13-14, 20, 22-23 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 33-35 are allowed.
Response to Arguments
Applicant’s arguments with respect to claims 1, 12-20, 22-28, 33-35 and 51-53 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781