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 of Claims
Claim(s) 14-31 is/are pending in the application.
Claim(s) 14-31 is/are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/12/2023, 05/24/2024, 07/16/2024, 09/18/2024, 11/26/2024, 11/03/2025, 11/19/2025, and 01/13/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
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) 14, 16, 19-21, 25-27, and 31 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Ingram (US PGPUB 20150320434).
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).
Regarding claim 16, Ingram further discloses the manifold comprises an open cell foam (¶0045-0046).
Regarding claim 19, Ingram discloses a method of debridement (Abstract; ¶0119-0124; and Claim 1), the method comprising:
positioning a contact layer adjacent a tissue site (a contact layer 110 adjacent a tissue site 103: ¶0033, 0120; Figs. 1, 6-8, and 16), the contact layer comprising a plurality of holes (a plurality of through-holes 140: ¶0070 and Figs. 6-8);
positioning a retainer layer over the contact layer (a retainer layer 108: ¶0033, 0120; Figs. 1, 6-8, and 16), the retainer layer comprising a plurality of projections extending from a surface of the retainer layer (bosses 137 extending from a surface of 108: ¶0092 and Fig. 8), at least one of the plurality of projections configured to protrude into at least one of the plurality of holes of the contact layer (¶0092 and Fig. 8); and
applying negative pressure to the tissue site (¶0061, 0092, and 0121), wherein the plurality of holes 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 20, Ingram further discloses wherein the retainer layer is more compressible than the contact layer (during negative pressure therapy, the contact layer 110 does not compress and the retainer layer 108 compresses: ¶0090; therefore, the retainer layer 108 is more compressible than the contact layer 110).
Regarding claim 21, Ingram further discloses the retainer layer or contact layer comprises an open cell foam (the contact layer comprises an open cell foam: ¶0045-0046).
Regarding claim 25, Ingram further discloses positioning a cover layer adjacent to the retainer layer (a drape 106 positioned adjacent to the retainer layer 108: ¶0033; Figs. 1 and 6-7).
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 configured to protrude 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) 15, 17-18, 22-24, 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 15, Ingram does not disclose at least some of the plurality of projections have a tapered end disposed 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 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 modified the debridement apparatus of Ingram/Robinson 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 modified the debridement apparatus of Ingram/Robinson in view 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 22, 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 23, Ingram further discloses at least one of the plurality of holes 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 holes 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 24, Ingram fails to explicitly disclose the retainer layer comprises a 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 retainer layer 108 may be a 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 retainer 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).
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).
Conclusion
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
/JESSICA ARBLE/Primary Examiner, Art Unit 3781