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
Applicant’s response dated 04 November 2025 to the previous Office action dated 04 June 2025 is acknowledged. Claims 1-20 are pending in the application.
Election/Restrictions
Applicant’s election without traverse of invention I (claims 1-14) in the reply filed on 04 November 2025 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04 November 2025.
Claims 1-14 are under current consideration.
Information Disclosure Statement
One of the information disclosure statements filed 03 August 2023 merely repeats documents listed in the other IDS filed 03 August 2023, and thus it is marked through as duplicating such documents.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Rice et al. (US 2021/0113748 A1; published 22 April 2021).
Regarding claim 1, Rice et al. discloses a wound dressing 100 comprising a wound interface layer 110 welded to a film layer 130 along separation-lines 151 having compression/compaction resulting from the welding (paragraph [0083]), reading on the claimed wound-cleansing pad comprising a first scrubbing element and a backing element and a first plurality of welds.
Further regarding claim 1, Rice et al. further illustrates wound dressing 100 wherein wound interface layer 110 has a top side and a bottom side (Fig. 3A), reading on the claimed first top side and first back side of the first scrubbing element; and film layer 130 has a top side and a bottom side (Fig. 3A), reading on the claimed front side and rear side of the backing element; and the separation-line 151 welds connect the bottom side of the wound interface layer 110 to the top side of the film layer 130 (Fig. 3A), reading on the claimed first plurality of welds connecting the first back side of the first scrubbing element to the front side of the backing element; and the separation-lines 151 have compression/compaction at the welds on the top side of the wound interface layer 110 (Fig. 3A; paragraph [0083]), reading on the claimed first plurality of welds creating a first surface texture on the first top side of the first scrubbing element.
Further regarding claim 1, Rice et al. further discloses that the wound interface layer 110 has the ability to disrupt debris at the wound site (paragraph [0065]), which reads on the claimed wound-cleansing pad and first scrubbing element.
Further regarding claim 1, Rice et al. further discloses that the wound interface layer 110 may be formed from foam such as GRANUFOAM or V.A.C. VERAFLO foam (paragraph [0063]) which are reticulated foams (paragraph [0072]), and the layers of the wound dressing 100 have porosity (paragraph [0097]), reading on the claimed first scrubbing element being comprised of a first reticulated foam material having a first porosity.
Regarding claim 2, Rice et al. discloses that the film layer 130 may be a polyurethane or polyethylene film that is substantially impermeable to liquid (paragraph [0075]), which reads on the claimed backing element being comprised of a polymeric film that provides a barrier layer that blocks liquid materials from passing through the first back side of the first scrubbing element.
Regarding claims 3-4, Rice et al. illustrates that the separation-lines 151 divide the wound interface layer 110 up into various sections (Fig. 3A; Figs. 4A-4D; paragraph [0093]), which in conjunction with the disclosures discussed above regarding claim 1 reads on the claimed second scrubbing element having a second top side and a second back side, wherein the second scrubbing element is comprised of a second reticulated foam material having a second porosity; and a second plurality of welds connecting the second back side of the second scrubbing element to the front side of the backing element, wherein the second plurality of welds creates a second surface texture on the second top side of the second scrubbing element.
Regarding claims 5-6 and 8, Rice et al. discloses a negative pressure pump configured to reduce pressure at wound site 15 by removing air from wound site 15 (paragraph [0055]) via removed fluid tubing 50b (paragraph [0056]) which attaches to the top of wound dressing 100 (Fig. 1), which reads on the claimed port connected to the backing element in a manner that allows a gas to be passed through the port and the first scrubbing element, and the claimed port being connected to a source of negative pressure, and the claimed port connected to the backing element and connected to a source of negative pressure in a manner that allows a negative pressure to be applied through the first scrubbing element.
Regarding claim 7, Rice et al. discloses that he film layer 130 may be adapted to elastically deform (paragraph [0076]) and separation-lines 151 may have weakened portions 153 (paragraph [0080]), which reads on the claimed first plurality of welds including at least one weld designed to accommodate bending of the backing element.
Regarding claim 9, see the discussion above regarding claims 1-2, 5-6, and 8.
Regarding claim 10, see the discussion above regarding claims 5-6 and 8-9.
Regarding claim 11, Rice et al. illustrates the separation-lines 151 having compression/compaction at the welds on the top side of the wound interface layer 110 and the separation-lines 151 as parallel lines (Fig. 3A; paragraph [0083]), which reads on the claimed surface texture being parallel lines.
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.
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) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rice et al. in view of Dunn et al. (US 2019/0231944 A1; published 01 August 2019).
Regarding claims 12-13 as they refer to claim 9, Rice et al. discloses a wound dressing 100 comprising a wound interface layer 110 welded to a film layer 130 along separation-lines 151 having compression/compaction resulting from the welding (paragraph [0083]), reading on the claimed wound-cleansing pad comprising a first scrubbing element and a backing element and a first plurality of welds.
Further regarding claims 12-13 as they refer to claim 9, Rice et al. further illustrates wound dressing 100 wherein wound interface layer 110 has a top side and a bottom side (Fig. 3A), reading on the claimed first top side and first back side of the first scrubbing element; and film layer 130 has a top side and a bottom side (Fig. 3A), reading on the claimed front side and rear side of the backing element; and the separation-line 151 welds connect the bottom side of the wound interface layer 110 to the top side of the film layer 130 (Fig. 3A), reading on the claimed first plurality of welds connecting the first back side of the first scrubbing element to the front side of the backing element; and the separation-lines 151 have compression/compaction at the welds on the top side of the wound interface layer 110 (Fig. 3A; paragraph [0083]), reading on the claimed first plurality of welds creating a first surface texture on the first top side of the first scrubbing element.
Further regarding claims 12-13 as they refer to claim 9, Rice et al. further discloses that the wound interface layer 110 has the ability to disrupt debris at the wound site (paragraph [0065]), which reads on the claimed wound-cleansing pad and first scrubbing element.
Further regarding claims 12-13 as they refer to claim 9, Rice et al. further discloses that the wound interface layer 110 may be formed from foam such as GRANUFOAM or V.A.C. VERAFLO foam (paragraph [0063]) which are reticulated foams (paragraph [0072]), and the layers of the wound dressing 100 have porosity (paragraph [0097]), reading on the claimed first scrubbing element being comprised of a first reticulated foam material having a first porosity.
Further regarding claims 12-13 as they refer to claim 9, Rice et al. discloses that the film layer 130 may be a polyurethane or polyethylene film that is substantially impermeable to liquid (paragraph [0075]), which reads on the claimed backing element being comprised of a polymeric film that provides a barrier layer that blocks liquid materials from passing through the first back side of the first scrubbing element.
Further regarding claims 12-13 as they refer to claim 9, Rice et al. discloses a negative pressure pump configured to reduce pressure at wound site 15 by removing air from wound site 15 (paragraph [0055]) via removed fluid tubing 50b (paragraph [0056]) which attaches to the top of wound dressing 100 (Fig. 1), which reads on the claimed port connected to the backing element in a manner that allows a gas to be passed through the port and the first scrubbing element.
Further regarding claim 13 as it refers to claim 11, Rice et al. illustrates the separation-lines 151 having compression/compaction at the welds on the top side of the wound interface layer 110 and the separation-lines 151 as parallel lines (Fig. 3A; paragraph [0083]), which reads on the claimed surface texture being parallel lines.
Further regarding claims 12-13, Rice et al. does not disclose that the reticulated foam material has a porosity of approximately 20 or 35 pores-per-inch as claimed.
Dunn et al. discloses devices to treat a wound with negative pressure (paragraph [0002]) wherein wound securing material therein can be reticulated foam having a porosity in the range of 10-60 ppi (paragraph [0079]), which reads on the claimed reticulated foam material having porosity of approximately 20 or 35 pores-per-inch.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rice et al. and Dunn et al. by using reticulated foam having porosity of 10-60 ppi as suggested by Dunn et al. as the reticulated foam in the wound dressing of Rice et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a reticulated foam therein that is known to be suitable for use in wound treatment devices as suggested by Dunn et al. given that Rice et al. teaches use of reticulated foam therein. Such porosity of 10-60 ppi overlaps the claimed ranges of approximately 20 and approximately 35 pores-per-inch, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rice et al. in view of Wibaux et al. (US 2010/0322996 A1; published 23 December 2010).
Regarding claim 14 as it refers to claim 9, Rice et al. discloses a wound dressing 100 comprising a wound interface layer 110 welded to a film layer 130 along separation-lines 151 having compression/compaction resulting from the welding (paragraph [0083]), reading on the claimed wound-cleansing pad comprising a first scrubbing element and a backing element and a first plurality of welds.
Further regarding claim 14 as it refers to claim 9, Rice et al. further illustrates wound dressing 100 wherein wound interface layer 110 has a top side and a bottom side (Fig. 3A), reading on the claimed first top side and first back side of the first scrubbing element; and film layer 130 has a top side and a bottom side (Fig. 3A), reading on the claimed front side and rear side of the backing element; and the separation-line 151 welds connect the bottom side of the wound interface layer 110 to the top side of the film layer 130 (Fig. 3A), reading on the claimed first plurality of welds connecting the first back side of the first scrubbing element to the front side of the backing element; and the separation-lines 151 have compression/compaction at the welds on the top side of the wound interface layer 110 (Fig. 3A; paragraph [0083]), reading on the claimed first plurality of welds creating a first surface texture on the first top side of the first scrubbing element.
Further regarding claim 14 as it refers to claim 9, Rice et al. further discloses that the wound interface layer 110 has the ability to disrupt debris at the wound site (paragraph [0065]), which reads on the claimed wound-cleansing pad and first scrubbing element.
Further regarding claim 14 as it refers to claim 9, Rice et al. further discloses that the wound interface layer 110 may be formed from foam such as GRANUFOAM or V.A.C. VERAFLO foam (paragraph [0063]) which are reticulated foams (paragraph [0072]), and the layers of the wound dressing 100 have porosity (paragraph [0097]), reading on the claimed first scrubbing element being comprised of a first reticulated foam material having a first porosity.
Further regarding claim 14 as it refers to claim 9, Rice et al. discloses that the film layer 130 may be a polyurethane or polyethylene film that is substantially impermeable to liquid (paragraph [0075]), which reads on the claimed backing element being comprised of a polymeric film that provides a barrier layer that blocks liquid materials from passing through the first back side of the first scrubbing element.
Further regarding claim 14 as it refers to claim 9, Rice et al. discloses a negative pressure pump configured to reduce pressure at wound site 15 by removing air from wound site 15 (paragraph [0055]) via removed fluid tubing 50b (paragraph [0056]) which attaches to the top of wound dressing 100 (Fig. 1), which reads on the claimed port connected to the backing element in a manner that allows a gas to be passed through the port and the first scrubbing element.
Further regarding claim 14, Rice et al. does not disclose that the backing element is comprised of a polyester film that is about 0.076 mm thick as claimed.
Wibaux et al. discloses wound dressings (abstract) wherein a backing layer may be made of liquid impermeable film comprising polyester, polyurethane, or polyethylene (paragraph [0030]) of thickness of about 10-75 µm (paragraph [0031]), which reads on the claimed backing element being comprised of a polyester film that is about 0.076 mm thick.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rice et al. and Wibaux et al. by substituting polyester film of about 10-75 µm thick as suggested by Wibaux et al. for the film layer in the wound dressing of Rice et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a backing film layer therein that is known to be suitable for use in wound dressings as suggested by Wibaux et al. given that Rice et al. teaches use of polyurethane or polyethylene film that is substantially impermeable to liquid therein, and Wibaux et al. teaches that such backing layers can comprise polyurethane or polyethylene or polyester, and also given that it is prima facie obvious to substitute equivalents known for the same purpose (e.g., polyurethane or polyethylene or polyester liquid impermeable backing films known for use in wound dressings) per MPEP 2144.06(II). Such thickness of about 10-75 µm (i.e., about 0.01-0.075) overlaps the claimed range of about 0.076 mm, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617