DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 05/12/2026.
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) 14-31 is/are pending in the application.
Claim(s) 14-31 is/are examined on the merits.
Information Disclosure Statement
The new information disclosure statements (IDS) submitted on 05/12/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the new information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments/remarks filed on 05/12/2026 have been fully considered.
Applicant argues that Ingram does not disclose “at least some of the plurality of projections having tapered end disposed within the plurality of recesses”. The argument is not found persuasive. Ingram discloses the interior surface of the walls 148 of the through holes 140 may taper toward the center 150 of the through-holes 140 (¶0077). Thus, at least some of the plurality of projections will have tapered end when disposing within the plurality of recesses.
Applicant argues that there is no motivation to combine Ingram and Robinson. The argument is not found persuasive. Since Ingram discloses the desire of promoting granulation of tissue by providing through-holes 140 while Robinson disclose to provide recesses 212 and projections 216 to enhance granulation of tissue, a person having ordinary skill in the art would have been motivated to includes projections and holes to enhance granulation of tissue and a person having ordinary skill in the art would have recognized that holes and projections further promotes/strengthen granulation of tissue and thereby further promote healing of the wound.
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 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.
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) 26-27 and 31 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Ingram (US PGPUB 20150320434).
Regarding claim 26, Ingram discloses a method of debridement (Abstract and Claim 1), the method comprising:
positioning a contact layer adjacent a tissue site (a contact layer (108+110) adjacent a tissue site 103: ¶0033; Figs. 1 and 6-8), the contact layer comprising:
a side configured to be positioned adjacent to the tissue site (a side 110 configured to be positioned adjacent to a tissue site 103: ¶0055 and Fig. 6),
a plurality of recesses in the side (a plurality of through-holes 140: ¶0070 and Figs. 6-8);
a plurality of projections disposed within one or more of the recesses (bosses 137 disposed within one or more of the recesses 140: ¶0092 and Fig. 8), at least one of the plurality of projections protruding into at least one of the plurality of recesses of the contact layer (¶0092 and Fig. 8); and
applying negative pressure to the tissue site (¶0061 and 0092), wherein the plurality of recesses are configured to collapse from a relaxed position to a contracted position in response to the negative pressure (the through-holes 140 collapse from a relaxed position to a contracted position in response to negative pressure: ¶0010) to allow macro-deformation at the tissue site (¶0091) and acceptance of slough from the tissue site (¶0005, 0055, and 0057).
Regarding claim 27, Ingram further discloses the contact layer comprises an open cell foam (the contact layer (108+110) comprises an open cell foam: ¶0045-0046).
Regarding claim 31, Ingram further discloses positioning a cover layer adjacent to the contact layer (a drape 106 positioned adjacent to the contact layer (108+110): ¶0033; Figs. 1 and 6-7).
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) 14-18 and 28-30 is/are rejected under 35 U.S.C 103 as being unpatentable over Ingram (US PGPUB 20150320434) in view of Robinson (US PGPUB 20120143113).
Regarding claim 14, Ingram discloses a debridement apparatus (a therapy system 100: ¶0061 and Fig. 1) comprising:
a manifold ((108+110): ¶0010, 0033, 0045-0046; Figs. 1 and 6-8) having a side configured to be positioned adjacent to a tissue site (a side 110 configured to be positioned adjacent to a tissue site 103: ¶0055 and Fig. 6);
a plurality of recesses in the side (a plurality of through-holes 140: ¶0070 and Figs. 6-8); and
a plurality of projections disposed within one or more of the recesses (bosses 137 disposed within one or more of the recesses 140: ¶0092 and Fig. 8), wherein the plurality of recesses are configured to collapse from a relaxed position to a contracted position in response to negative pressure (the through-holes 140 collapse from a relaxed position to a contracted position in response to negative pressure: ¶0010).
Ingram does not disclose at least some of the plurality of projections have a tapered end disposed within the plurality of recesses; however, Ingram suggests the interior surface of the walls 148 of the through holes 140 may taper toward the center 150 of the through-holes 140 (¶0077). Thus, at least some of the plurality of projections will have tapered end when disposing within the plurality of recesses.
In the same field of endeavor, wound dressings, Robinson discloses a wound healing apparatus 206 for promoting granulation and epithelialization at a tissue site (Abstract and ¶0055). Robinson also discloses at least one of the projections (one of the projections 216: ¶0055 and Fig. 4A) protruding into at least one of the plurality of recesses (one of the recesses 212: ¶0055 and Fig. 4A) in the wound apparatus 206 at ambient pressure. Robinson further discloses/suggests at least some of the plurality of projections 216 have a tapered end disposed within the plurality of holes 212 (216 can be any shape and is disposed within 212: ¶0056 and Fig. 4A; wherein 216 have a tapered end disposed within 212 in Fig. 4A) for the benefit of inducing microstrains and microstresses at the tissue site for promoting granulation and epithelialization (¶0055-0056).
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 debridement apparatus of Ingram in view of Robinson by providing a tapered end for at least some of the plurality of projections, in order to induce microstrains and microstresses at the tissue site for promoting granulation and epithelialization, as suggested in ¶0055-0056 of Robinson.
Regarding claim 15, Ingram/Robinson does not disclose at least some of the plurality of projections substantially fill some of the recesses; however, Robinson suggests that the projections 216 have any shape or size. A person having ordinary skill in the art would have understood that having at least some of the plurality of projections substantially fill some of the recesses yields the predictable result of inducing microstrains and microstresses at the tissue site for promoting granulation and epithelialization.
Absent a showing of criticality, 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 debridement apparatus of Ingram in view of Robinson by providing at least some of the plurality of projections substantially fill some of the recesses, in order to induce microstrains and microstresses at the tissue site for promoting granulation and epithelialization, as suggested in ¶0055-0056 of Robinson.
Regarding claim 16, Ingram further discloses the manifold comprises an open cell foam (¶0045-0046).
Regarding claim 17, Ingram does not disclose the plurality of projections are complementary to the plurality of recesses.
Robinson further discloses/suggests providing at least one of the projections (one of the projections 216: ¶0055 and Fig. 4A) protruding into at least one of the plurality of holes (one of the recesses 212: ¶0055 and Fig. 4A) in the wound apparatus 206 at ambient pressure for the benefit of inducing microstrains and microstresses at the tissue site for promoting granulation and epithelialization (¶0055). From these teachings, a person having ordinary skill in the art would have recognized/deduced that providing/having the plurality of projections complementary to the plurality of recesses yields the predictable result of inducing microstrains and microstresses at the tissue site for promoting granulation and epithelialization.
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 debridement apparatus of Ingram in view of Robinson by making/having the plurality of projections that is complementary to the plurality of recesses, in order to induce microstrains and microstresses at the tissue site for promoting granulation and epithelialization, as suggested in ¶0055 of Robinson.
Regarding claim 18, Ingram further discloses at least one of the plurality of recesses has a diameter between 5 mm and 15 mm (the holes 140 have diameter between 5 mm and 20 mm: ¶0070 and 0079; thus, the taught diameter range is within the claimed range; See MPEP § 2131.03) for the benefits of providing through-holes based on the size of debris, allowing debris to pass through the manifold, and influencing fluid movement in the manifold (¶0079).
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 debridement apparatus of Ingram by selecting diameter of at least one of the plurality of recesses within the claimed range, in order to provide through-holes based on the size of debris, allow debris to pass through the manifold, and influence fluid movement in the manifold, as suggested in ¶0079 of Ingram and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
Regarding claim 28, Ingram does not disclose one or more of the plurality of projections have a ragged outer surface.
Robinson further discloses that the plurality of projections 216 have a ragged outer surface (a sufficiently rough and uneven surface: ¶0056) for the benefit of promoting granulation (¶0056).
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 plurality of projections of Ingram in view of Robinson by making/providing ragged/uneven outer surfaces, in order to promoting granulation, as suggested in ¶0056 of Robinson.
Regarding claim 29, Ingram further discloses at least one of the plurality of recesses has a diameter between 5 mm and 15 mm (the holes 140 have diameter between 5 mm and 20 mm: ¶0070 and 0079; thus, the taught diameter range is within the claimed range; See MPEP § 2131.03) for the benefits of providing through-holes based on the size of debris, allowing debris to pass through the manifold, and influencing fluid movement in the manifold (¶0079).
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 plurality of recesses of Ingram/Robinson in view of Ingram by selecting the diameter within the claimed range, in order to provide through-holes based on the size of debris, allow debris to pass through the manifold, and influence fluid movement in the manifold, as suggested in ¶0079 of Ingram and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
Regarding claim 30, Ingram further discloses the contact layer comprises a foam (¶0045-0046).
Ingram fails to explicitly disclose the foam having an average pore size between 10 and 80 pores per inch.
An average pore size between 10 - 80 pores per inch is equivalent to an average pore size between 254 - 317.5 microns when converted to microns of a single pore.
Ingram further discloses the foam having pore sizes in a range of 60 microns to 2000 microns (¶0046; thus, the taught pore size range overlaps with the claimed range; See MPEP § 2131.03) for the benefit of providing a pore size according to needs of a prescribed therapy (¶0046).
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 contact layer of Ingram/Robinson in view of Ingram by selecting average pore size within the claimed range, in order to provide a pore size according to needs of a prescribed therapy, as suggested in ¶0046 of Ingram and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
Allowable Subject Matter
Claim(s) 19-25 is/are allowed.
The closest prior arts of record are Ingram (US PGPUB 20150320434), Locke (US PGPUB 20130072850), and Robinson (US PGPUB 20120143113).
Ingram discloses a method of debridement, the method comprising positioning a contact layer adjacent a tissue site and the contact layer comprising a plurality of holes. Although Ingram further discloses positioning a plurality of projections into corresponding holes of the plurality of holes, Ingram fails to disclose the plurality of projections coupled to and extending from a retainer layer and applying negative pressure to the tissue site after positioning the plurality of projections. The plurality of projections of Ingram is formed when applying a negative pressure to the dressing.
Locke discloses a plurality of projections extending from a base of a dressing filler at ambient pressure; however, Locke does not disclose a contact layer comprising a plurality of holes and positioning the plurality of projections into corresponding holes of the plurality of holes. In addition, there is no motivation to modify the dressing of Locke to incorporate a contact layer comprising a plurality of holes and to position the plurality of projections into corresponding holes of the plurality of holes. There is not an apparent/obvious reason/motivation for this modification as this modification increases the complexity of the system in the prior art in terms of structure, function, and design (See MPEP §2143.01 (IV)).
Robinson discloses positioning a contact layer adjacent a tissue site, wherein the contact layer comprising a plurality of holes and positioning a plurality of projections into corresponding holes of the plurality of holes. Robinson fails to disclose the plurality of projections coupled to and extending from a retainer layer. In addition, there is no motivation to modify the dressing of Robinson to have the plurality of projections coupled to and extending from a retainer layer. There is not an apparent/obvious reason/motivation for this modification as this modification increases the complexity of the system in the prior art in terms of structure, function, and design (See MPEP §2143.01 (IV)).
No other prior art was located that fairly suggested the claimed invention in whole or in part, along with the requisite motivation for combining to render the claimed invention obvious.
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
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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