DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 06/29/2026.
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 of Claims
Claim(s) 56-65, 67, and 69-70 are pending in the application.
Claim(s) 56-65, 67, and 69-70 are examined on the merits.
Response to Arguments
Applicant’s arguments/remarks filed on 06/29/2026 have been fully considered.
Applicant argues that the combination of Locke’662 and Locke’342 does not disclose “a first layer comprising a plurality of standoffs and at least one fluid passage concentrically aligned with the aperture in the cover”. The argument is not persuasive. Locke’662 discloses a first layer (a third layer 220: ¶0052 and Fig. 2) comprising a plurality of standoffs (blister 270: ¶0068, Figs. 2, and 6-7) and at least one fluid passage (apertures 275 are configured to allow fluid transfer through the film 220: ¶0068 and Fig. 2) concentrically aligned with the aperture in the cover (see annotated Fig. 2 below). Thus, Locke’662 discloses the claimed invention.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 62 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 62 recites the limitation “the dressing interface is configured to be sized” which was not described in the specification. There is no mention in the specification of different sizes of the dressing interface.
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 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.
Claim(s) 56-62, 64-65, 67, and 69 is/are rejected under 35 U.S.C 103 as being unpatentable over Locke (US PGPUB 20180353662) in view of Locke (US PGPUB 2018033342).
Regarding claim 56, Locke’662 discloses a dressing (a dressing 102: ¶0030 and Fig. 2) for treating a tissue site with negative pressure (Abstract and ¶0030), the dressing (102) comprising:
a cover (a cover 106: ¶0042 and Fig. 2) having an aperture (an aperture 294: ¶0080 and Fig. 2);
a first layer (a third layer 220: ¶0052 and Fig. 2) comprising a plurality of standoffs (blister 270: ¶0068, Figs. 2, and 6-7) and at least one fluid passage (apertures 275 are configured to allow fluid transfer through the film 220: ¶0068 and Fig. 2) concentrically aligned with the aperture in the cover (see annotated Fig. 2 below);
a second layer (a second layer 210: ¶0052 and Fig. 2) comprising a plurality of openings (slots 260: ¶0065-0066 and Fig. 2); and
a third layer (a first layer 205: ¶0052 and Fig.2);
wherein the cover, the first layer, the second layer, and the third layer are assembled in a stacked relationship with the first layer and the second layer disposed between the cover and the third layer (Figs. 2 and 8), the aperture in the cover is fluidly coupled to at least one fluid passage in the first layer (¶0080 and Fig. 2), and the standoffs are disposed adjacent to the second layer (¶0068 and Fig. 7).
Locke’662 does not disclose the third layer comprising a treatment aperture and at least some of the openings in the second layer are exposed through the treatment aperture.
In the same field of endeavor, wound dressing, Locke’342 discloses a dressing 110 comprising a tissue interface 120 (¶0057 and Fig. 2) and wherein the tissue interface comprising a first layer 205, a second layer 210, and a third layer 215 (¶0057 and Fig. 2). Locke’342 further discloses the second layer 210 comprising openings (slots 220: ¶0069-0070 and Fig. 2), the third layer 215 comprising a treatment aperture 230 (¶0073 and Fig. 2), and wherein at least some of the openings are exposed through the treatment aperture (¶0084 and Fig. 4) for the benefit(s) of providing an open area for delivery of negative pressure and passage of wound fluid through the second layer and the first layer (¶0100). Locke ‘342 discloses that the disclosed aperture and openings arrangement provides an open area for delivery of negative pressure and wound fluid passage (¶0100).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Locke in view of Locke’342 by incorporating a treatment aperture in the third layer and having at least some of the openings are exposed through the treatment aperture, in order to provide an open area for delivery of negative pressure and passage of wound fluid through the second layer and the first layer, as taught by ¶0100 of Locke’342.
Regarding claim 57, Locke’662 further discloses the standoffs form a plurality of spaces between the first layer and the second layer (the standoffs 270 protrude towards or face the second film 210 and are formed of raised formations: ¶0068 and Figs. 6-7; thus, the standoffs 270 form/create a plurality of spaces between the first film 220 and the second film 210).
Regarding claim 58, Locke’662 does not disclose the treatment aperture forms a frame around at least some of the openings and more than one of the openings are exposed through the treatment aperture.
Locke’342 further discloses the treatment aperture 230 forms a frame around at least some of the openings 220 and more than one of the openings 220 are exposed through the treatment aperture (Fig. 4) for the benefit of providing an open area for delivery of negative pressure and passage of wound fluid through layers (¶0100).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Locke’662 in view Locke’342 by having the treatment aperture form a frame around at least some of the fluid restrictions 220 and having more than one of the openings exposed through the treatment aperture, in order to provide an open area for delivery of negative pressure and passage of wound fluid through layers, as taught by ¶0100 of Locke’342.
Regarding claim 59, Locke’662/Locke’342 discloses the claimed invention except for the rearrangement of the standoffs (270) and the openings (260).
However, Locke’662 discloses/suggests arranging the openings 260 in adjacent rows offset so that the spacing between the openings will increase density of the openings according to therapeutic requirements (¶0081). Locke’662 implicitly discloses that the standoffs 270 can be offset from each other (¶0068: the pitch and the spacing of the standoffs 270 differ across the surface of the layer 220). From the teachings of Locke’662, a person having ordinary skill in the art with the knowledge of fluid dynamic would understand/recognize that the arrangement of standoffs relative to the openings adjusts the fluid flow through the wound dressing and arranging at least some of the standoffs offset from the openings would increase fluid flow through the wound dressing. Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wound dressing of Locke’662/Locke’342 by rearranging the standoffs and the openings so that at least some of the standoffs are offset from the openings, in order to increase fluid flow in the wound dressing according to therapeutic requirements, as it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art. See MPEP § 2144.04 (VI) (C). Further, Applicant places no criticality on the arrangement of the standoffs and the openings, indicating simply that at least some of the standoffs may be offset from the fluid restrictions (¶0010 and 0087 of Applicant’s published application).
Regarding claim 60, Locke further discloses the first layer (220) comprising a plurality of fluid passages adjacent to the standoffs (apertures 275: ¶0068 and Fig. 10).
Regarding claim 61, Locke further discloses the first polymer film, the second polymer film, and the third layer are transparent (¶0106), but does not disclose the cover is transparent.
Locke’342 further discloses/suggests a cover 125 is transparent (¶0083) for the benefit of allowing visibility of apertures of the third layer 215 (¶0083).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the dressing of Locke in view of Locke’342 by making the cover transparent, in order to allow visibility of the wound dressing layers, as taught by ¶0083 of Locke’342.
Regarding claim 62, Locke’662 further discloses a spacer (a manifold 225: ¶0071 and Fig. 2) and a dressing interface (a dressing interface 292: ¶0080 and Fig. 2), wherein the spacer disposed between the aperture in the cover and the first layer (the spacer 225 is disposed between the aperture 294 and the first layer 220: Fig. 2), and the dressing interface is configured positioned coextensive with the spacer (Fig. 2).
Locke’662/Locke’342 does not disclose the dressing interface is configured to be sized. However, a person having ordinary skill in the art would have understood/recognized different sizes of the dressing interface are used to accommodate different dressing dimensions, sizes of tissue sites, shapes of tissue interface, and fluid flow requirements.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the dressing of Locke’662 by providing different sizes for the dressing interface, motivated by the desires to accommodate different dressing dimensions, sizes of tissue sites, shapes of tissue interface, and fluid flow requirements; and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)). Thus, the dressing interface of Locke’662 is configured to be sized.
Regarding claim 64, Locke’662 further discloses the first layer and the second layer each have an exposed perimeter (Fig. 2).
Regarding claim 65, Locke’662 further discloses the cover and the third layer enclose the first layer and the second layer (the cover 106 and the third layer 205 enclose the first layer 220 and the second layer 210: Fig. 2).
Regarding claim 67, Locke’662 discloses an apparatus (a therapy system 100: ¶0028 and Fig. 1) for treating a tissue site with negative pressure (¶0028), the apparatus (100) comprising:
a dressing (a dressing 102: ¶0030 and Fig. 2) according to claim 56; and
a negative pressure source (104) fluidly coupled to the dressing (¶0030).
Regarding claim 69, Locke’662/Locke’342 discloses the dressing of claim 56 (see rejection of claim 56 above).
Locke’662 further discloses a negative pressure source (104) fluidly coupled to the dressing (¶0030).
Since the dressing of Locke’662/Locke’342 meets the structural limitations of the claimed dressing, it follows naturally that the structure suggested by Locke’662 and Locke’342 will perform the method steps as presented by Applicant. Thus, Locke’662/Locke’342 further discloses a method of treating a tissue site with negative pressure, the method comprising: applying the dressing of claim 56; applying negative pressure to the tissue site through the dressing; and observing the tissue site through the dressing (¶0014).
Claim(s) 63 and 70 is/are rejected under 35 U.S.C 103 as being unpatentable over Locke (US PGPUB 20180353662) in view of Locke (US PGPUB 20180353342), as applied to claim 56 above, and further in view of Mumby (US PGPUB 20140249495).
Regarding claim 63, Locke’662/Locke’342 does not disclose a screen disposed over the cover and the screen is visually occlusive.
In the same field of endeavor, wound dressing, Mumby discloses a wound dressing 2100 comprising a cover layer 2140 (¶0375 and Fig. 5A). Mumby further discloses/suggest having a masking or obscuring layer 2107 (¶0375) for the benefit of reducing the visibility of unsightly exudates while allowing clinical judgment on the state of the dressing (¶0191). Mumby also discloses/suggest having the masking or obscuring layer 2107 positioned adjacent to the cover layer 2140 or positioned adjacent to any other dressing layer desired (¶0375).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the dressing of Locke’662 in view of Mumby by incorporating a screen disposed over the cover, in order to reduce the visibility of unsightly exudates while allowing clinical judgment on the state of the dressing, as suggested in ¶0191 of Mumby.
Regarding claim 70, Locke’662/Locke’342 discloses the dressing of claim 56 (see rejection of claim 56 above).
Locke’662/Locke’342 does not disclose a screen configured to obscure the tissue site.
Mumby further discloses/suggest having a masking or obscuring layer 2107 (¶0375) for the benefit of reducing the visibility of unsightly exudates while allowing clinical judgment on the state of the dressing (¶0191).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the dressing of Locke’662 in view of Mumby by incorporating a screen configured to obscure the tissue site, in order to reduce the visibility of unsightly exudates while allowing clinical judgment on the state of the dressing, as taught by ¶0191 of Mumby.
Since the dressing of Locke’662 in view of Locke’342 and Mumby meets the structural limitations of the claimed dressing, it follows naturally that the structure suggested by Locke’662 in view of Locke’342 and Mumby will perform the method steps as presented by Applicant. Thus, Locke’662 in view of Locke’342 and Mumby further discloses a method of treating a tissue site with negative pressure, the method comprising: applying the dressing of claim 56; applying negative pressure to the tissue site through the dressing; removing the screen; observing the tissue site through the dressing; and replacing the screen to obscure the tissue site.
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 NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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