DETAILED ACTION
This Office Action is in response to the amendment filed December 5, 2025. Claims 4-7, 10, 12-20 and 24 have been amended, and claim 9 has been cancelled.
Claims 1-8 and 10-24 are pending.
In response to the amendment, the objections to claims 4-19 and 24 in the Office Action of 06/05/25 have been withdrawn.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 24 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 24, “The method” lacks proper antecedent basis. Applicant is advised to amend the claim to depend from method claim 20.
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.
Claim(s) 1 and 20 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2015/0231314 (hereinafter “Robinson et al.”).
Regarding claim 1, Robinson et al. discloses systems and methods for increasing absorbent capacity of a dressing that anticipates Applicant’s presently claimed invention. More specifically, Robinson et al. discloses a wound care device (reduced pressure system 100, see Fig. 1 and para. [0019]) comprising; a first portion (upstream layer 128, see para. [0019]) that is configured to be applied over and external to a wound (see Fig. 1, which shows upstream layer 128 applied over and external to tissue site 102); said first portion comprising a first fluid absorbent material (absorbent 126, see para. [0019]); a second portion (manifold 110, see Fig. 1) comprising a second fluid absorbent material (see para. [0042]) and having a proximal end and a distal end (see Fig 1, the proximal end being the top end of 110 and the distal end being the bottom end of 110), wherein the proximal end is in fluid communication with said first portion (see para. [0056] which discloses the upstream layer 128 and the downstream layer 130 may also wick fluids from the tissue site 102 into absorbent 126 and wherein the distal end is configured to be positioned within the wound in a subcutaneous skin layer (see Fig 1, which shows 110 being positioned within a tissue site 102 adjacent the subcutaneous layer, It must be noted that a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex Parte Masham, 2 USPQ2d 1647 (Bd. Pal. App. & Inter. 1987); in the instant case manifold 110 is capable of being positioned within the subcutaneous layer since the manifold 110 is shown to extend distally past the dermis 120); and a reservoir (constituted by the space between 128 and 130) operatively coupled to the first portion (space between 128 and 130 that holds 126, see Fig 1 and para. [0019]; the space between upstream layer 128 and downstream layer 130 is considered to be a reservoir, such that it holds absorbent 126, and the absorbent 126 is capable of holding fluid), wherein the reservoir is configured to contain a medicament (the recitation “configured to contain a medicament" is considered an intended use recitation; it must be noted that a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex Parte Masham, 2 USPQ2d 1647 (Bd. Pal. App. & Inter. 1987); in the instant case the identified reservoir is fully capable of containing a medicament since the reservoir can contain a medicament held by absorbent 126 that has been suctioned from the tissue site 102 via the reduced pressure source 106, further taught in para. [0021]); wherein said first portion comprises a central portion to which said proximal end of said second portion is coupled (see Fig. 1 and para. [0019]; the proximal end of manifold 110 is shown to be coupled to a central portion of upstream layer 128), and wherein said first portion is adapted to form a cover over the wound when said distal end of said second portion is positioned within the wound (see Fig 1 and para. [0019]; upstream layer 128 is shown to form a cover over tissue site 102 when manifold 110 is positioned within tissue site 102); wherein the first fluid absorbent material has a first fluid-absorbing characteristic (see Fig 1 and para [0054]-[0056], which discloses upstream layer 128 is made of Libeltex TDL2 and can wick fluids from tissue site 102) and the second fluid absorbent material has a second fluid-absorbing characteristic different from the first fluid absorbing characteristic (see Fig 1 and para. [0042], which discloses the manifold 110 is can be made of V.A.C. WhiteFoam, which is reasonably considered to have a different fluid-absorbing characteristic than that of the upstream layer 128, which comprises a different material, see para. [0054]-[0055]); and wherein the first and second-fluid absorbent materials are configured to wick liquids from the second portion to the first portion to facilitate removal of fluid and potentially infectious materials from the subcutaneous skin layer (see Fig. 1 and para. [0042], which discloses manifold 110 is taught to wick fluid away from the tissue site 102; further, upstream layer 128 is taught to wick fluids from the tissue site, see para. [0056]).
Regarding claim 20, Robinson et al. disclose systems and methods for increase absorbent capacity of a dressing that anticipates Applicant’s disclosed invention. More specifically, Robinson et al. necessarily discloses a method of manufacturing a wound care device by providing system (100) shown in Fig. 1, the method comprising: providing a first portion (upstream layer 128) comprising a first fluid absorbent material having a first fluid-absorbing characteristic (constituted by Libeltex TDL2, which wicks fluid from tissue site 102); providing a second portion (manifold 110) comprising a second fluid absorbent material (constructed from White Foam) having a second fluid-absorbing characteristic that is different from the first fluid-absorbing characteristic (the two different absorbent materials necessarily have different absorbing characteristics, see para. [0054-0055]), the second portion having a proximal end (the side furthest away from the tissue site) and a distal end (the side closest to the tissue site), wherein the first and second fluid absorbent materials are configured to wick liquids from the second portion to the first portion to facilitate removal of fluid and potentially infectious materials from the subcutaneous skin layer (see Fig. 1 and para. [0042], which discloses manifold 110 is taught to wick fluid away from the tissue site 102; further, upstream layer 128 is taught to wick fluids from the tissue site, see para. [0056]; thus fluid, such as wound exudate and potentially infectious materials is first absorbed from the wound site by manifold 110 and then fluid is absorb upstream layer 128; coupling the second portion to a central portion of the first portion such that the proximal end of the second portion is in fluid communication with said first portion (as can read from para. [0020], the components of the reduced-pressure therapy system may be couple directly or indirectly to each other; further, manifold 110 is positioned in the center of upstream layer 128, see Fig. 1); and coupling a reservoir to the first portion (the designated reservoir portion is fluidly coupled to the upstream layer).
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.
Claim(s) 2 and 3 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. in view of U.S. Patent Application No. 2018/0140814 (“Pratt et al.”).
Regarding claims 2 and 3, Robinson et al. discloses the wound care device of claim 1, except that the device further comprises said medicament, wherein the medicament is a pain killer.
However, Pratt et al. in the disclosure of an analogous system teaches it is known to couple an instillation system (116) to a reduced-pressure therapy system (110) either directly (see Fig. 2) or indirectly (see Fig. 1). The fluid introduced to the tissue site may be medicine such as antibiotics, anti-fungals, antiseptics, analgesics, or other similar substances, to aid in the treatment of a tissue site (see para. [0004]).
It would have been obvious to one having ordinary skill in the art to have modified the system of Robinson et al. to have included an instillation system coupled directly to the reduced-pressure system of Robinson et al., as in Fig. 2 of Pratt et al., or indirectly coupled to the system of Robinson et al., as in Fig. 1 of Pratt et al., and thereby providing the identified reservoir with a medicament, such as an analgesic in order to aid in treatment of a tissue site by reducing pain.
Claim(s) 21 and 22 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. in view of Pratt et al.
Regarding claim 21, modified Robinson et al. discloses the method of claim 20, except that the method further comprises providing said medicament to said reservoir.
However, Pratt et al. in the disclosure of an analogous system teaches it is known to couple an instillation system (116) to a reduced-pressure therapy system (110) either directly (see Fig. 2) or indirectly (see Fig. 1). The fluid introduced to the tissue site may be medicine such as antibiotics, anti-fungals, antiseptics, analgesics, or other similar substances, to aid in the treatment of a tissue site (see para. [0004]).
It would have been obvious to one having ordinary skill in the art to have modified the system of Robinson et al. to have included an instillation system coupled directly to the reduced-pressure system of Robinson et al., as in Fig. 2 of Pratt et al., or indirectly coupled to the system of Robinson et al., as in Fig. 1 of Pratt et al., and thereby providing the identified reservoir with a medicament, such as an analgesic in order to aid in treatment of a tissue site by reducing pain.
Regarding claim 22, Robinson et al. discloses the method of claim 20, except further comprising soaking said second portion in said medicament. However, Pratt et al. in the disclosure of an analogous system teaches it is known to couple an instillation system (116) to a reduced-pressure therapy system (110) either directly (see Fig. 2) or indirectly (see Fig. 1). The fluid introduced to the tissue site may be medicine such as antibiotics, anti-fungals, antiseptics, analgesics, or other similar substances, to aid in the treatment of a tissue site (see para. [0004]).
It would have been obvious to one having ordinary skill in the art to have modified the system of Robinson et al. to have included an instillation system coupled directly to the reduced-pressure system of Robinson et al., as in Fig. 2 of Pratt et al., or indirectly coupled to the system of Robinson et al., as in Fig. 1 of Pratt et al., and thereby providing the identified reservoir with a medicament, and during use, each layer of the wound care device will receive the installation fluid including medicament will be soaked with the medicament.
Claim(s) 4 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. in view of Pratt et al. as applied to claim 3 above, and in further view of U.S. Patent Application No. 2015/0080787 (“Blott et al.”)
Regarding claim 4, modified Robinson et al. disclose the wound care device of claim 3, except wherein the medicament includes a specific type of analgesic such as at least one of Ketamine, Marcaine and lidocaine.
However, Blott et al. in the disclosure of an analogous system (see Fig. 1) teaches is it is known to provide analgesics, such as lidocaine (see para. [0206]). It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used lidocaine as the analgesic in modified Robinson et al. because of its well known use for providing fast-acting pain relief.
Claim(s) 5 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. in view of Pratt et al. as applied to claim 2 above, and in further view of Blott et al.
Regarding claim 5, modified Robinson et al. discloses the wound care device of any of claims 2-4 (claim 2), except wherein the medicament includes at least one of a nonsteroidal anti-inflammatory drug, a corticosteroid, an opioid, a muscle relaxant, an anti-anxiety drug, an antidepressant, and an anticonvulsant.
However, Blott et al. in the disclosure of an analogous system (see Fig. 1) teaches is it is known to treat tissue sites with anti-inflammatories, (see para. [0329]) in order to treat inflammation. It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used an anti-inflammatory medicament as the instillation fluid in modified Robinson et al. in order to reduce and/or prevent inflammation at the wound site.
Claim 23 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. in view of Pratt et al. as applied to claim 20, 21 or 22 above, and in further view of U.S. Patent No. 7,790,945 (“Watson, Jr.”).
Regarding claim 23, modified Robinson et al. discloses the method of claim 20, 21 or 22, except forming a perforation in part of the wound care device. However, Watson, Jr. in the disclosure of an analogous reduced pressure dressing (10, see Figs. 2 and 3) necessarily teaches a method of manufacturing by providing wound dressing (10) comprising dressing layers (24, 26), a suction member (12) for connection to a source of vacuum pressure. As shown in Fig. 18, each absorptive layer 26 preferably comprises an upper sheet and a lower sheet 126 quilted together with a trapping sheet therebetween (see col. 3, lines 42-45). With respect to Fig. 3, a round absorptive quilted layer (30) is shown having a plurality of perforations (38) in order to facilitate the sizing of the layer.
In view of Watson et al., it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have provided Robinson et al. with perforations in order to facilitate sizing of the device.
Allowable Subject Matter
Claims 6-8 and 10-19 are allowed.
The closest prior art is that of Robinson et al. which discloses all features of claim 6 except “wherein the reservoir is configured to come into fluid communication with the second portion when a wall of the reservoir is ruptured”. Neither Robinson et al. nor the other cited prior art teach or fairly suggest to one alone or in combination a rupturing a wall of the reservoir.
Remaining claims 7-8 and 10-19 are allowable by virtue of their dependence on an allowable base claim.
Claim 24 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed December 5, 2005 have been fully considered but they are not persuasive. Applicant primarily argues the following”:
The cited art fails to disclose, teach, or suggest "wherein the first fluid absorbent material has a first fluid-absorbing characteristic and the second fluid absorbent material has a second fluid-absorbing characteristic different from the first fluid-absorbing characteristic; and wherein the first and second fluid absorbent materials are configured to wick liquids from the second portion to the first portion to facilitate removal of fluid and potentially infectious materials from the subcutaneous skin layer," as recited in claim 1. As discussed hereinabove, Robinson explicitly states paragraph [0042] states "In some embodiments, such as embodiments in which the manifold 110 may be made from a hydrophilic material, the manifold 110 may also wick fluid away from a tissue site while continuing to distribute reduced pressure to the tissue site." and in paragraph [0056] states "The upstream layer 128 and the downstream layer 130 may also wick fluids from the tissue site 102 into the absorbent 126."
The Office disagrees. Robinson et al. discloses the first fluid absorbent material has a first fluid-absorbing characteristic (see Fig 1 and para [0054]-[0056], which discloses upstream layer 128 is made of Libeltex TDL2 and can wick fluids from tissue site 102) and the second fluid absorbent material has a second fluid-absorbing characteristic different from the first fluid absorbing characteristic (see Fig 1 and para. [0042], which discloses the manifold 110 is can be made of V.A.C. WhiteFoam, which is reasonably considered to have a different fluid-absorbing characteristic than that of the upstream layer 128 and which comprises a different material, see para. [0054]-[0055]). Further, the first and second-fluid absorbent materials are configured to wick liquids from the second portion to the first portion to facilitate removal of fluid and potentially infectious materials from the subcutaneous skin layer (see Fig. 1 and para. [0042], which discloses manifold 110 is taught to wick fluid away from the tissue site 102; further, upstream layer 128 is taught to wick fluids from the tissue site, see para. [0056]). Thus, Robinson et al. anticipates claims 1 and 20.
While the Office has indicated claim 6 and its dependent claims as allowable, the Office does not agree that Robinson et al. fails to teach “wherein the first fluid absorbent material has a first fluid-absorbing characteristic and the second fluid absorbent material has a second fluid-absorbing characteristic different from the first fluid-absorbing characteristic; and wherein the first and second fluid absorbent materials are configured to wick liquids from the second portion to the first portion to facilitate removal of fluid and potentially infectious materials from the subcutaneous skin layer”.
No arguments have been provided for claims 2-5 and 21-23.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786