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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/16/2026 has been entered.
Response to Amendment
Applicant’s amendment of claim 1 is acknowledged by the Examiner.
Claims 1,3,5,7,9,15,21,24-26,34-35,37,43-46,51-55,58-59,61-64 and 72 are pending in the application with claims 34-35,37,43-46,51-55,58-59,61-64 and 72 being withdrawn from consideration, and claims 1,3,5,7,9,15,21 and 24-26 subject to examination.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on the reference of Locke ‘509 as a primary reference as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll et al. (US 2020/0155359 A1) (hereinafter Carroll) in view of Locke et al. (US 2020/0121509 A1) (hereinafter Locke ‘509).
In regards to claim 1, Carroll discloses A dressing (102; see [0041]; see figure 9) for treating a tissue site with negative pressure (see [0041]), comprising:
a foam member (107; see [0041]; see figure 1a) comprising a single layer of open-cell foam (107 comprises a single layer of open cell foam 108; see [0054]) including both a felted portion (110; see [0041]; see figure 9; 110 may be a felted foam (see [0118])) and a non-felted portion (108; see [0054]; see figure 9), the felted portion extending a depth into a surface of the foam member (107; see figure 1a that 110 extends a depth into 107);
a second plurality of perforations (140; see [0080]; see figure 9) formed through the felted portion (110; see figure 9), at least one of the second plurality of perforations exposed to the tissue site (see [0080]; see figure 6); and
a cover (106; see [0041]; see figure 1) comprising a film and an adhesive (see [0057]), the film disposed over the foam member (107) around the foam member (see figure 1).
Carroll does not disclose a sealing layer comprising a treatment aperture and a first plurality of perforations around the treatment aperture, the felted portion configured to contact the tissue site through the treatment aperture;
the at least one of the second plurality of perforations exposed to the tissue site through the treatment aperture; and
the adhesive of the cover disposed adjacent to the first plurality of perforations.
However, Locke ‘509 teaches an analogous dressing for treating a tissue site with negative pressure (110; see [0044]; see figure 9) comprising: a foam member (205, 210, and 215 taken together given the three layers are bonded to one another (hereinafter referred to as foam member); see [0044]; see figure 9) having an analogous tissue contacting portion (215) which comprises a second plurality of perforations (225; see [0088]; see figure 9) formed through the first portion (215) and a cover (125; see [0044]; see figure 9) comprising a film (elastomeric film; see [0056]) and an adhesive (255; see [0091]; see figure 9); wherein the dressing comprises:
a sealing layer (905; see [0101]; see figure 9) comprising a treatment aperture (915; see [0103]; see figure 9) and a first plurality of perforations (920; see [0103]; see figure 9) around the treatment aperture (915), the tissue contacting portion (215) configured to contact the tissue site through the treatment aperture (915; see figure 9)
at least one of the second plurality of perforations (225) exposed to the tissue site through the treatment aperture (915; see figure 11); and
the adhesive (255) of the cover (125) disposed adjacent to the first plurality of perforations (920; see [0108]) for the purpose of providing a sealing layer formed from a soft, pliable material suitable for providing a fluid seal with a tissue site (see [0101]) which allows the dressing to provide a sealed therapeutic environment proximate to a tissue site, can provide an effective and reliable seal against challenging anatomical surfaces, such as an elbow or heel, at and around a tissue site, and may permit re-application or re-positioning, to correct air leaks caused by creases and other discontinuities in the dressing which may increase the efficacy of the therapy and reduce power consumption in some embodiments (see [0124]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dressing as disclosed by Carroll and to have included the sealing layer which comprises a treatment aperture and first plurality of perforations as taught by Locke ‘509 in order to have provided an improved dressing that would add the benefit of providing a sealing layer formed from a soft, pliable material suitable for providing a fluid seal with a tissue site (see [0101]) which allows the dressing to provide a sealed therapeutic environment proximate to a tissue site which can provide an effective and reliable seal against challenging anatomical surfaces, such as an elbow or heel, at and around a tissue site, and may permit re-application or re-positioning, to correct air leaks caused by creases and other discontinuities in the dressing which may increase the efficacy of the therapy and reduce power consumption in some embodiments (see [0124]).
Claim(s) 3, 5, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll in view of Locke ‘509 as applied to claim 1 above, and further in view of Long et al. (US 2023/0038460 A1) (hereinafter Long).
In regards to claim 3, Carroll as now modified by Locke’ 509 discloses the invention as discussed above.
Carroll as now modified by Locke’ 509 does not explicitly disclose wherein the non-felted portion has a density in a range of about 1.3 lb/ft3 to about 1.6 lb/ft3, and wherein the felted portion has a density in a range of about 2.6 lb/ft3 to about 16 lb/ft3.
However, Long teaches an analogous foam member (210; see [0074]; see figure 2a) for use in an analogous dressing (110; see [0046]; see figure 16) for treating a tissue site with negative pressure (see [abstract]); the foam member (210) having an analogous felted portion (215; see [0094] in reference to an embodiment where only 215 is felted; see figure 2a) and a non-felted portion (220; see [0094]; figure 2a) wherein the non-felted portion (220) has a density in a range of about 1.3 lb/ft3 to about 1.6 lb/ft3 (see [0089] in reference to the pre-felted foams having a density of about 1.3 lb/ft3 to about 1.6 lb/ft3) and wherein the felted portion (215) has a density in a range of about 2.6 lb/ft3 to about 16 lb/ft3 (see [0092] in reference to felted 215 having a density in a range of about 2.6 lb/ft3 to about 16 lb/ft3) for the purpose of providing foam member for better resisting the compressive effects and maintaining fluid flow when under negative pressure (see [0092]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the felted and non-felted portions of the foam member as disclosed by Carroll as now modified by Locke’ 509 and to have formed the non-felted portion of the foam member with a density in a range of about 1.3 lb/ft3 to about 1.6 lb/ft3 and the felted portion of the foam member with a density in a range of about 2.6 lb/ft3 to about 16 lb/ft3 as taught by Long in order to have provided an improved foam member that would add the benefit of providing a foam member with a density for better resisting the compressive effects while maintaining fluid flow when under negative pressure (see [0092]).
In regards to claim 5, Carroll as now modified by Locke’ 509 discloses the invention as discussed above.
Carroll further discloses wherein the non-felted portion (108) has an average pore size in a range of about 400 micrometers to about 600 micrometers (see [0054]) and wherein the felted portion (110) has an average pore size in a range of about 50 micrometers to about 300 micrometers (pore size less than 600 microns).
While the pore size less than about 600 microns fully encompasses the claimed range of about 50 micrometers to about 300 micrometers, Carroll as now modified by Locke’ 509 does not explicitly disclose wherein the felted portion has an average pore size in a range of about 50 micrometers to about 300 micrometers.
However, Long teaches an analogous foam member (210; see [0074]; see figure 2a) for use in an analogous dressing (110; see [0046]; see figure 16) for treating a tissue site with negative pressure (see [abstract]); the foam member (210) having an analogous felted portion (215; see [0094] in reference to an embodiment where only 215 is felted; see figure 2a) and a non-felted portion (220; see [0094]; figure 2a); wherein the felted portion (215) has an average pore size in a range of about 50 micrometers to about 300 micrometers (see Long [0092] in reference to the felted foam having an average pore size in a range of 40 to about 300 microns, with regards to the lower end of 40 microns, 40 microns is considered to be about 50 microns (micrometers) and thus is considered to meet the claimed language) for the purpose of providing sufficient pore size for maintaining fluid flow when under negative pressure (see [0092]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the felted portion of the foam member as disclosed by Carroll as now modified by Locke ‘509 as to have formed the felted portion with an average pore size in a range of about 50 micrometers to about 300 micrometers as taught by Long in order to have provided an improved felted portion which would add the benefit of providing a sufficient pore size for maintaining fluid flow when under negative pressure (see [0092]).
In regards to claim 7, Carroll as now modified by Locke ‘509 discloses the invention as discussed above.
Carroll as now modified by Locke ‘509 does not explicitly disclose wherein the non-felted portion has a free volume of about 90%, and wherein the felted portion has a free volume in a range of about 9% to about 45%.
However, Long teaches an analogous foam member (210; see [0074]; see figure 2a) for use in an analogous dressing (110; see [0046]; see figure 16) for treating a tissue site with negative pressure (see [abstract]); the foam member (210) having an analogous felted portion (215; see [0094] in reference to an embodiment where only 215 is felted; see figure 2a) and a non-felted portion (220; see [0094]; figure 2a); wherein the non-felted portion (220) has a free volume of about 90% (see [0084]), and wherein the felted portion (215) has a free volume in a range of about 9% to about 45% (see [0092] in reference to the felted foam having a free volume in a range of about 9% to about 45%) for the purpose of providing a non-felted portion which is suitable for many therapy applications (see [0084]) and a felted portion which better resists the compressive effects and better maintains fluid flow when under negative pressure (see [0092]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-felted and felted portions of the foam member as disclosed by Carroll as now modified by Locke ‘509 and to have formed the non-felted portion with a free volume of about 90% and the felted portion with a free volume in a range of about 9% to about 45% as taught by Long in order to have provided an improved non-felted portion and felted portion that would add the benefit of providing a non-felted portion which is suitable for many therapy applications (see [0084]) and a felted portion which better resists the compressive effects and better maintains fluid flow when under negative pressure (see [0092]).
In regards to claim 9, Carroll as now modified by Locke ‘509 discloses the invention as discussed above.
Carroll as now modified by Locke ‘509 does not disclose wherein the non-felted portion has an average porosity in a range of about 40 pores per inch to about 50 pores per inch, and wherein the felted portion has an average porosity in a range of about 80 pores per inch to about 500 pores per inch.
However, Long teaches an analogous foam member (210; see [0074]; see figure 2a) for use in an analogous dressing (110; see [0046]; see figure 16) for treating a tissue site with negative pressure (see [abstract]); the foam member (210) having an analogous felted portion (215; see [0094] in reference to an embodiment where only 215 is felted; see figure 2a) and a non-felted portion (220; see [0094]; figure 2a); wherein the non-felted portion (220) has an average porosity in a range of about 40 pores per inch to about 50 pores per inch (see [0089] in reference to the pre-felted foam 220 having an average porosity in a range of about 40 pores per inch to about 50 pores per inch), and wherein the felted portion (215) has an average porosity in a range of about 80 pores per inch to about 500 pores per inch (see [0092] in reference to the felted foam 215 having an average porosity in a range of about 80 pores per inch to about 500 pores per inch) for the purpose of for the purpose of providing foam member for better resisting the compressive effects and maintaining fluid flow when under negative pressure (see [0092]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the felted and non-felted portions of the foam member as disclosed by Carroll as now modified by Locke ‘509 and to have formed the non-felted portion of the foam member with an average porosity in a range of about 40 pores per inch to about 50 pores per inch, and the felted portion of the foam member with an average porosity in a range of about 80 pores per inch to about 500 pores per inch as taught by Long in order to have provided an improved foam member that would add the benefit of providing a foam member with a density for better resisting the compressive effects while maintaining fluid flow when under negative pressure (see [0092]).
Claim(s) 15, 21, and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll in view of Locke ‘509 as applied to claim 1 above, and further in view of Locke et al. (US 2020/0085629 A1) (hereinafter Locke ‘629).
In regards to claim 15, Carroll as now modified by Locke ‘509 discloses the invention as discussed above.
Carroll further discloses wherein each perforation of the second plurality of perforations (140) is formed through the felted portion (110; see figure 6).
Carroll as now modified by Locke ‘509 does not disclose wherein each perforation of the second plurality of perforations is a slot formed through the felted portion.
However, Locke ‘629 teaches an analogous foam portion (205 and 210; see [0054]; see figure 2) comprising an analogous wound contacting surface (210; see [0054]; see figure 2), and an analogous sealing layer (215; see [0054]; see figure 2), the sealing layer (215) comprising a first plurality of perforations (235; see [0068]; see figure 2), and the wound contacting surface (210) comprising a second plurality of perforations (220; see [0064]; see figure 9); wherein each perforation of the second plurality of perforations (220) is a slot formed through the wound contacting surface (210; see [0065]) for the purpose of functioning as imperfect valves that substantially reduce liquid flow in a normally closed or resting state, and can expand or open wider in response to a pressure gradient to allow increased liquid flow (see [0065]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second plurality of perforations of the felted portion as disclosed by Carroll as now modified by Locke ‘509 and to have formed each perforation as a slot formed through the felted portion as taught by Locke ‘629 in order to have provided an improved second plurality of perforations that would add the benefit of functioning as imperfect valves that substantially reduce liquid flow in a normally closed or resting state, and can expand or open wider in response to a pressure gradient to allow increased liquid flow (see [0065]).
In regards to claim 21, Carroll as now modified by Locke ‘509 and Locke ‘629 discloses the invention as discussed above.
Carroll as now modified by Locke ‘509 and Locke ‘629 does not disclose further comprising a third plurality of perforations formed through the felted portion, wherein each perforation of the third plurality of perforations is a slot formed through the felted portion, wherein each perforation of the second plurality of perforations is parallel to a first direction, and wherein each perforation of the third plurality of perforations is parallel to a second direction.
However, Locke ‘629 further teaches further comprising a third plurality of perforations (910 of 220; see [0099]; see figure 9) formed through the wound contacting surface (210; see [0099]), wherein each perforation of the third plurality of perforations (910) is a slot formed through the wound contacting surface (210; see [0099]), wherein each perforation of the second plurality of perforations (905 of 220) is parallel to a first direction (see figure 9), and wherein each perforation of the third plurality of perforations (910) is parallel to a second direction (see figure 9).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the felted portion as disclosed by Carroll as now modified by Locke ‘509 and Locke ‘629 and to have included the third plurality of perforations in addition to the second plurality of perforations through the felted portion which extends along first and second directions as further taught by Locke ‘629 in order to have provided an improved felted portion that would add the benefit of providing additional perforations for communicating negative pressure to a wound site, thereby increasing the therapeutic benefits of the negative pressure at the wound site.
In regards to claim 24, Carroll as now modified by Locke ‘509 and Locke ‘629 discloses the invention as discussed above.
Carroll as now modified by Locke ‘629 further discloses wherein the second plurality of perforations (905 of Locke ‘629) is arranged in a first pattern of rows (see Locke ‘629 figure 9), and wherein the third plurality of perforations (910 of Locke ’629) is arranged in a second pattern of rows (see Locke ’629 figure 9).
In regards to claim 25, Carroll as now modified by Locke ‘509 and Locke ‘629 discloses the invention as discussed above.
Carroll as now modified by Locke ‘629 further discloses wherein the first direction is orthogonal to the second direction (see Locke ’629 [0104]).
In regards to claim 26, Carroll as now modified by Locke ‘509 and Locke ‘629 discloses the invention as discussed above.
Carroll as now modified by Locke ‘629 further discloses wherein the foam member (107 of Carroll) comprises an edge (see Carroll figure 9), and the first direction is parallel to the edge (see Locke ‘629 figure 9 that the first direction of 905 is parallel to the edge of 210 and thus, when included into 107 of Carroll, would be similarly parallel to the edge of 107 of Carroll).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Karim et al. (US 2015/0306273 A1) which discloses an analogous negative pressure wound system (10; see [0044]; see figure 1) which teaches the use of a foam wound contacting layer (16; see [0045]; see figure 2) wherein the wound contacting layer is selected from either closed-cell foams or felted mats, both of which can include wicking materials, hydrophobic materials, and hydrophilic materials (see [0054]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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