DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 11/21/2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/21/2025 has been entered.
Status of Claims
Claims 27-28, 31-36, 40-44, and 46-47 are pending in the application.
Claims 27-28, 31-36, 40-44, and 46-47 are examined on the merits.
Information Disclosure Statement
The new information disclosure statements (IDS) submitted on 11/21/2025 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 filed on 11/21/2025 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that Askem/Kenny does not disclose the claimed limitations “a peristaltic pump disposed on the outer occlusive layer” and “a tube disposed on the outer occlusive layer” because Askem does not disclose a peristaltic pump and the peristaltic pump and the tube of Kenny are not disposed on the outer occlusive layer. The arguments are found persuasive. New reference Bharti (US PGPUB 20150250931) is applied to teach “a peristaltic pump disposed on the outer occlusive layer” and a concept of using a micropump in a wound dressing system to effectively draw wound fluid or exudate away from the wound bed, or deliver fluids to the wound bed, without the need for an external pressure source and having a portable wound dressing and micropump system (Abstract). From these teachings of Bharti, a person having ordinary skill in the art would have recognized that Bharti suggests that components of the micropump (a pump inlet and a pump outlet) or any connectors to the micropump are disposed on the outer layer of the wound dressing. Even though the peristaltic pump and the tube of Kenny are not disposed on the outer occlusive layer, Kenny is only applied to teach “a flange elbow connector disposed on the outer occlusive layer”, “the tube comprising a first end and a second end, wherein the tube is connected to the peristaltic pump between the first end and the second end of the tube, wherein the first end of the tube is connected to the flange elbow connector, and the tube comprises a one-way valve for maintaining negative pressure within the area around the wound” because Bharti already discloses the concept of having the peristaltic pump and the tube disposed on the outer occlusive layer.
Applicant argues that Blott fails to teach or suggest “a tube disposed on the occlusive layer, the tube comprising a first end and a second end, wherein the tube is connected to the peristaltic pump between the first end and the second end of the tube, wherein the first end of the tube is connected to the flange elbow connector, and the tube comprises a one-way valve for maintaining negative pressure within the area around the wound”. Applicant’s arguments are not found persuasive. Blott is only applied to teach a concept of having a pump removably secured to an outer layer of a wound dressing. Examiner does not apply Blott to teach the claimed limitations “a tube disposed on the occlusive layer, the tube comprising a first end and a second end, wherein the tube is connected to the peristaltic pump between the first end and the second end of the tube, wherein the first end of the tube is connected to the flange elbow connector, and the tube comprises a one-way valve for maintaining negative pressure within the area around the wound” since Bharti/Kenny discloses these claimed limitations.
With respect to the claim rejection(s) under 35 U.S.C. § 112(b), applicant's amendment(s) to the claim(s) has/have overcome the claim rejection(s).
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) 27-28, 31-36, and 43-44 is/are rejected under 35 U.S.C 103 as being unpatentable over Bharti (US PGPUB 20150250931) in view of Kenny (US PGPUB 20090281526) and Blott (US PGPUB 20070167926).
Regarding claim 27, Bharti discloses a mechanical vacuum dressing (a wound system 300: ¶0205 and Fig. 15) comprising:
a base (a pressure sensitive adhesive 106: ¶0205 and Fig. 15) for releasable fixation to tissue surrounding a wound (the adhesive is releasable: ¶0106);
absorptive material carried by the base (a wound packing 110: ¶0076, 0204, and Fig. 15) and configured to contact the wound and receive exudates from the wound (¶0076);
an outer occlusive layer connected to the base for sealing an area around the wound (a backing layer 104: ¶0017, 0205, and Fig. 15).
Bharti further discloses an orifice 126 made through layers (104+106) that communicates with a pump inlet opening 125 and the pump inlet opening 125 disposed on the outer occlusive layer 104 (¶0205 and Fig. 15), but does not disclose a flange elbow connector disposed on the outer occlusive layer. Bharti also discloses a peristaltic pump disposed on the outer occlusive layer (a micropump/peristaltic 320: ¶0109, 0205, and Fig. 15), but does not disclose a tube is connected to the peristaltic pump, the tube disposed on the outer occlusive layer, the tube comprising a first end and a second end, wherein the tube is connected to the peristaltic pump between the first end and the second end of the tube, wherein the first end of the tube is connected to the flange elbow connector, and the tube comprises a one-way valve for maintaining negative pressure within the area around the wound.
In the same field of endeavor, wound dressing with pump, Kenny discloses an NPWT apparatus 10 comprising a wound dressing 12 and a vacuum source 40 (¶0060, 0066-0067, and Fig. 1A). Kenny further teaches to have a fluid tube 36 comprising a first end 38 and a second end (44+46) (¶0064 and Fig. 1A), a flange elbow connector secured to an outer layer 24 of the wound dressing 12 (a vacuum port 30 having a flange 34: ¶0064), and the first end 38 of tube 36 connected to the flange elbow connector 30 for the benefit of facilitating connection of the wound dressing to the fluid tube (¶0064). Kenny further discloses the vacuum source 40 is a peristaltic pump (¶0067 and Fig. 1A). In addition, Kenny discloses the tube 36 connected to the peristaltic pump (Fig. 1A), the peristaltic pump is in between the first end and the second end of tube 36 (Fig. 1A), and the first end 38 of tube 36 connected to the flange elbow connector 30 for the benefit of providing a fluid flow path between the wound dressing and a canister via the peristaltic pump (¶0068 and 0071). Kenny also discloses the tube 36 comprising a one-way valve (¶0065: a one-way valve is in line with tube 36) for the benefit of permitting exudates to flow in one direction only and away from the wound dressing (¶0065).
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 Bharti in view of Kenny by incorporating a flange elbow connector disposed on the outer occlusive layer, incorporating a tube comprising a first end and a second end, wherein the tube comprising a one-way valve for maintaining negative pressure within the area around the wound, connecting the tube to the peristaltic pump, connecting the first end of the tube to the flange elbow connector, and arranging the peristaltic pump in between the first end and the second end of tube, in order to facilitate connection of the wound dressing to a negative pressure source via a fluid tube, provide a fluid flow path between the wound dressing and a canister via the peristaltic pump, and permit exudates to flow in one direction only and away from the wound dressing, as suggested in ¶0064-0065, 0068, and 0071 of Kenny. Since the peristaltic pump of Bharti/Kenny disposed on the outer occlusive layer (a micropump/peristaltic 320: ¶0109, 0205, and Fig. 15) and the flange elbow connector disposed on the outer occlusive layer, the tube is also disposed on the outer occlusive layer.
Bharti/Kenny does not disclose the pump is removably secured to the outer occlusive layer.
In the same field of endeavor, wound dressing, Blott discloses a medical wound dressing for cleansing wounds (¶0001). Blott further teaches to removably secure (releasably attaching: ¶0486) a peristaltic pump to a backing layer (3: ¶0468, 0471, and Fig. 12b).
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 Bharti/Kenny in view of Blott by having the pump removably secured to the outer occlusive layer, motivated by the desires to be able to remove/exchange the pump during maintenance or when the pump is broken.
Regarding claim 28, Bharti discloses providing a mechanical vacuum dressing (a wound system 300: ¶0205 and Fig. 15) comprising:
a base (a pressure sensitive adhesive 106: ¶0205 and Fig. 15) for releasable fixation to tissue surrounding a wound (the adhesive is releasable: ¶0106);
absorptive material carried by the base (a wound packing 110: ¶0076, 0204, and Fig. 15) and configured to contact the wound and receive exudates from the wound (¶0076);
an outer occlusive layer connected to the base for sealing an area around the wound (a backing layer 104: ¶0017, 0205, and Fig. 15);
positioning the mechanical vacuum dressing against tissue so that the absorptive material carried by the base contacts the wound (¶0205 and Fig. 15).
Bharti further discloses an orifice 126 made through layers (104+106) that communicates with a pump inlet opening 125 and the pump inlet opening 125 disposed on the outer occlusive layer 104 (¶0205 and Fig. 15), but does not disclose a flange elbow connector disposed on the outer occlusive layer. Bharti also discloses a peristaltic pump disposed on the outer occlusive layer (a micropump/peristaltic 320: ¶0109, 0205, and Fig. 15), but does not disclose a tube is connected to the peristaltic pump, the tube disposed on the outer occlusive layer, the tube comprising a first end and a second end, wherein the tube is connected to the peristaltic pump between the first end and the second end of the tube, wherein the first end of the tube is connected to the flange elbow connector, and the tube comprises a one-way valve for maintaining negative pressure within the area around the wound.
In the same field of endeavor, wound dressing with pump, Kenny discloses an NPWT apparatus 10 comprising a wound dressing 12 and a vacuum source 40 (¶0060, 0066-0067, and Fig. 1A). Kenny further teaches to have a fluid tube 36 comprising a first end 38 and a second end (44+46) (¶0064 and Fig. 1A), a flange elbow connector secured to an outer layer 24 of the wound dressing 12 (a vacuum port 30 having a flange 34: ¶0064), and the first end 38 of tube 36 connected to the flange elbow connector 30 for the benefit of facilitating connection of the wound dressing to the fluid tube (¶0064). Kenny further discloses the vacuum source 40 is a peristaltic pump (¶0067 and Fig. 1A). In addition, Kenny discloses the tube 36 connected to the peristaltic pump (Fig. 1A), the peristaltic pump is in between the first end and the second end of tube 36 (Fig. 1A), and the first end 38 of tube 36 connected to the flange elbow connector 30 for the benefit of providing a fluid flow path between the wound dressing and a canister via the peristaltic pump (¶0068 and 0071). Kenny also discloses the tube 36 comprising a one-way valve (¶0065: a one-way valve is in line with tube 36) for the benefit of permitting exudates to flow in one direction only and away from the wound dressing (¶0065).
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 Bharti in view of Kenny by incorporating a flange elbow connector disposed on the outer occlusive layer, incorporating a tube comprising a first end and a second end, wherein the tube comprising a one-way valve for maintaining negative pressure within the area around the wound, connecting the tube to the peristaltic pump, connecting the first end of the tube to the flange elbow connector, and arranging the peristaltic pump in between the first end and the second end of tube, in order to facilitate connection of the wound dressing to a negative pressure source via a fluid tube, provide a fluid flow path between the wound dressing and a canister via the peristaltic pump, and permit exudates to flow in one direction only and away from the wound dressing, as suggested in ¶0064-0065, 0068, and 0071 of Kenny. Since the peristaltic pump of Bharti/Kenny disposed on the outer occlusive layer (a micropump/peristaltic 320: ¶0109, 0205, and Fig. 15) and the flange elbow connector disposed on the outer occlusive layer, the tube is also disposed on the outer occlusive layer.
Bharti/Kenny does not disclose the pump is removably secured to the outer occlusive layer.
In the same field of endeavor, wound dressing, Blott discloses a medical wound dressing for cleansing wounds (¶0001). Blott further teaches to removably secure (releasably attaching: ¶0486) a peristaltic pump to a backing layer (3: ¶0468, 0471, and Fig. 12b).
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 Bharti/Kenny in view of Blott by having the pump removably secured to the outer occlusive layer, motivated by the desires to be able to remove/exchange the pump during maintenance or when the pump is broken.
Thus, Bharti/Kenny/Blott further discloses all method steps for providing negative pressure wound therapy below:
connecting the peristaltic pump to the occlusive layer; and
using the peristaltic pump to provide suction to the area around the wound so as to pull exudates from the wound and into the absorptive material.
Regarding claim 31, Bharti further discloses the base comprises a flexible material having an opening (the base 106 has an opening 126 and is made of polymers, silicones or rubber-based adhesives: ¶0194 and 0205; a person having ordinary skill in the art would have understood that polymers, silicones, or rubber is flexible material; thus, Bharti discloses the claimed invention).
Regarding claim 32, Bharti further discloses the flexible material comprises an adhesive (¶0205).
Regarding claim 33, Bharti further discloses a peel-away liner removably disposed on the adhesive (¶0197-0198).
Regarding claim 34, Bharti further discloses the absorptive material is disposed in the opening in the base (the absorptive material 110 is disposed in the opening 126 in the base 106 when the absorptive material 110 is bonded to the base layer 106: ¶0205, 0211, and Fig. 15).
Regarding claim 35, Bharti further discloses the absorptive material comprises at least one from the group consisting of a woven dressing, a non-woven dressing, and a foam dressing (non-woven or foam: ¶0190).
Regarding claim 36, Bharti further discloses the absorptive material comprising at least one from the group consisting of antimicrobials, growth factors and other healing agents (¶0018).
Regarding claim 43, the one-way valve of Bharti/Kenny/Blott prevents air from passing through the peristaltic pump mechanism and into the wound (see rejection of claim 27 above and ¶0065 of Kenny).
Regarding claim 44, Bharti further discloses removing a release liner from the base before positioning the mechanical vacuum dressing against tissue (¶0197-0199; A person having ordinary skill in the art would have understood that the release liner is configured to be removed in order to attach the adhesive layer to the patient).
Claim(s) 40 is/are rejected under 35 U.S.C 103 as being unpatentable over Bharti (US PGPUB 20150250931) in view of Kenny (US PGPUB 20090281526) and Blott (US PGPUB 20070167926, as applied to claim 27 above, and as evidenced by Gourlay (US PGPUB 20190184076).
Regarding claim 40, Bharti further discloses exudates are pulled from the wound by the pump to create suction within the absorptive material (¶0107 and 0204).
Bharti further discloses the peristaltic pump (¶0109 and 0205), but Bharti/Kenny/Blott does not disclose exudates are pulled from the wound by rotating the peristaltic pump to provide suction.
However, a person having ordinary skill in the art would have understood/recognized the peristaltic pump works by using rollers to compress the tube as they rotate and creating a vacuum which draws fluid through the tube. As evidenced by Gourlay, peristaltic pumps comprise rollers (¶0036, 0080 and Fig. 1) for the benefit of generating a pumping action (¶0034 and 0086). Thus, the peristaltic pump of Bharti/Kenny/Blott is expected/considered to have rollers and is capable of rotating a portion of the peristaltic pump to provide suction within the absorptive material.
Claim(s) 41-42 is/are rejected under 35 U.S.C 103 as being unpatentable over Bharti (US PGPUB 20150250931) in view of Kenny (US PGPUB 20090281526) and Blott (US PGPUB 20070167926, as applied to claim 27 above, and further in view of Gourlay (US PGPUB 20190184076 – of record).
Regarding claims 41-42, Bharti/Kenny/Blott does not disclose the peristaltic pump comprises a pump outer housing and a pump inner housing, and the pump inner housing is rotatable relative to the pump outer housing and a crank key for rotating the pump inner housing relative to the pump outer housing.
Gourlay further teaches the pump unit 10 comprising a pump outer housing (a cylindrical housing 101: ¶0079 and Fig. 2) and a pump inner housing (pumps 10A and 10B comprising peristaltic rollers: ¶0080 and Fig. 2), and wherein the pump inner housing is rotatable relative to the pump outer housing (¶0079-0080) for the benefit of providing a manually operable pump unit that is suitable for use in situations in which electrical power is not available (¶0092). Gourlay also teaches the pump unit 10 comprising a crank key (a cranked handle or rotatable handle 103: ¶0085, 0092, and Fig. 2) for the benefit of operating the pump unit (¶0085 and 0092).
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 Bharti/Kenny/Blott in view of Gourlay by incorporating a pump outer housing and a pump inner housing for the peristaltic pump, wherein the pump inner housing is rotatable relative to the pump outer housing and providing a crank key, in order to protect pump components, provide a manually operable pump unit that is suitable for use in situations in which electrical power is not available, and provide a handle/tool to operate the pump, as suggested in ¶0092 of Gourlay. Thus, the crank key of Bharti/Kenny/Blott/Gourlay is capable of rotating the pump inner housing relative to the pump outer housing.
Claim(s) 46 is/are rejected under 35 U.S.C 103 as being unpatentable over Bharti (US PGPUB 20150250931) in view of Kenny (US PGPUB 20090281526) and Blott (US PGPUB 20070167926, as applied to claim 28 above, and as evidenced by Gourlay (US PGPUB 20190184076 – of record).
Regarding claim 46, Bharti further discloses exudates are pulled from the wound by the pump to create suction within the absorptive material (¶0107 and 0204).
Bharti further discloses the peristaltic pump (¶0109 and 0205), but Bharti/Kenny/Blott does not disclose the method step of rotating the peristaltic pump to provide suction.
However, a person having ordinary skill in the art would have understood/recognized the peristaltic pump works by using rollers to compress the tube as they rotate and creating a vacuum which draws fluid through the tube. As evidenced by Gourlay, peristaltic pumps comprise rollers (¶0036, 0080 and Fig. 1) for the benefit of generating a pumping action (¶0034 and 0086). Thus, the peristaltic pump of Bharti/Kenny/Blott is expected/considered to have rollers and is capable of rotating a portion of the peristaltic pump to provide suction to the area between the absorptive material and the outer occlusive layer.
Claim(s) 47 is/are rejected under 35 U.S.C 103 as being unpatentable over Bharti (US PGPUB 20150250931) in view of Kenny (US PGPUB 20090281526) and Blott (US PGPUB 20070167926, as applied to claim 28 above, and in view of Gourlay (US PGPUB 20190184076 – of record).
Regarding claim 47, Bharti/Kenny/Blott does not disclose a crank key for rotating the pump inner housing relative to the pump outer housing.
Gourlay further discloses the pump unit 10 comprising a crank key (a cranked handle or rotatable handle 103: ¶0085, 0092, and Fig. 2) for the benefit of operating the pump unit (¶0085 and 0092).
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 vacuum dressing of Bharti/Kenny/Blott in view of Gourlay by incorporating a crank key, in order to provide a handle/tool to operate the pump, as suggested in ¶0085 and 0092 of Gourlay. Thus, the crank key of Bharti/Kenny/Blott in view of Gourlay is capable of rotating a portion of the peristaltic pump.
Conclusion
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/NHU Q. TRAN/Examiner, Art Unit 3781 /JESSICA ARBLE/Primary Examiner, Art Unit 3781