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 .
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered.
Regarding the objection to the drawings, Applicant’s arguments have been considered and are persuasive. the amendments to the claim overcome the drawing objection and therefore the objection is withdrawn.
Regarding the 103 rejections over Freedman in view of Corley, Applicant’s arguments have been considered and are not persuasive. Applicant argues that Freedman teaches a negative pressure wound dressing, and therefore teaches against the present claims where the flexible base is sized and configured to be positioned in a formed subcutaneous pocket and the irrigation lumens being configured to generate a fluid vortex. This argument is not convincing. The claim language “sized and configured to be positioned in a formed subcutaneous pocket” is interpreted to be an intended use limitation. The device of Freedman is of a size that is capable of being inserted into a subcutaneous pocket. Freedman discloses that the device can be of varying sizes, in particular 3, 6 or 12 inches in diameter (col. 9, lines 57-63). While Applicant does not disclose a specific size of the claimed invention, the intended use is insertion in a breast pocket and therefore it is understood that the device would be sized similarly to that of Freedman based on the range of sizes of the human breast. The examiner agrees that Freedman does not specifically disclose a vortex, as this was originally part of claim 6 which was addressed by Blott in the prior office action. However, Freedman does disclose irrigation fluid delivered to the application site to remove wound debris (col. 4, lines 43-46) and therefore does not teach away from a vortex as movement of the irrigation fluid would assist in debridement.
Applicant further argues that both Corley and Freedman teach against the current claims as any irrigation is specifically limited to the side of the wound dressing affixed to the skin. This argument is not convincing.
Claim Objections
Claims 6, 13-15, 17, 18, 20 are objected to because of the following informalities:
Claim 6 recites “suction portion” in line 2. This should be “suction port”.
Claims 13-15, 17, 18, 20 recite “irrigation tube(s)” and “irrigation lumen(s)”. these terms should be consistent throughout the claim or the claims should be amended such that it’s clear that both elements have proper antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al (US 8,974,428) in view of Corley (WO 2012/138514 A1) in view of Blott et al (KR 2007/0122546 A). For ease of discussion, citations below refer to machine translation of Blott provided herewith.
Regarding claim 1, the limitation “subcutaneous irrigation system” is interpreted to be an intended use limitation wherein the scope of the limitation is an irrigation system capable of being deployed subcutaneously. Freedman teaches an irrigation system that is sized such that it is capable of being deployed in a subcutaneous pocket. Freedman discloses that the system comprises a flexible base (fig. 1B) comprising a plurality of irrigation lumens 115 (col. 13, lines 15-20; figs. 1B, 1C) ; and a hub 121 coupled to the flexible base (figs. 1B, 1C), the hub comprising an inlet port (fig. 1B: upper part of port connected to irrigation tubing 108; col. 9, lines 25-27), an outlet tube 109 (fig. 1B; col. 9, lines 30-33), and a suction port (fig. 1B: part of port connected to outflow/vacuum tubing), wherein the plurality of irrigation lumens extend radially away from the hub (figs. 1B, 1C).
Claim 1 further calls for a plurality of size adjustment channels configured to remove a predefined amount of the flexible base. Freedman discloses that the size of the base can be trimmed to match the size of the treatment area (col. 9, lines 57-61), but fails to disclose size adjustment channels. Corley teaches a dressing for delivery and removal of therapeutic materials including a base, wherein the base includes a plurality of size adjustment channels 58/60 that allow the clinician to tear the base at discrete locations as needed to conform the base to the size needed (page 12, lines 8-17; fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base of Freedman to include a plurality of size adjustment channels as taught by Corley so that the clinician can tear the base as needed to achieve the size that is appropriate for the particular application site.
Claim further calls for the plurality of irrigation lumens are configured to generate a vortex flow of irrigation fluid within the subcutaneous pocket. As noted above, “within the subcutaneous pocket” is interpreted to be an intended use limitation. The device of Freedman is capable of being inserted into a subcutaneous pocket and providing irrigation thereto. Blott teaches an irrigation device wherein the irrigation lumens are configured to generate a vortex flow of irrigation fluid to increase the rate of cellular movement within the treatment site (page 7, middle of page). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the irrigation lumens of Freedman to achieve a desired irrigation fluid flow pattern, such as a vortex as taught by Blott to provide an increased force to move the tissues within the treatment site to the outflow lumens.
Regarding claim 2, Freedman discloses one or more holes extending from each irrigation lumen of the plurality of irrigation lumen through the flexible base (fig. 1E).
Regarding claim 3, Freedman discloses that the hub is integrated with the flexible base (fig. 1C: the hub is sandwiched between layers of the base thereby forming an integral unit).
Regarding claim 4, Freedman discloses that the hub is configured to distribute fluid through the plurality of irrigation lumens (col. 13, lines 20-23).
Regarding claim 5, in the combination described above with regard to claim 1, the perimeter of the flexible base is configured to be reduced by the one or more size adjustment channels (Freedman teaches that the perimeter is cut away to achieve the desired size; Corley teaches size adjustment channels providing areas to tear away concentric outer edges to achieve the desired size).
Regarding claim 6, Freedman discloses that the suction port is positioned on an opposite side of the flexible base from the plurality of irrigation lumens such that the irrigation fluid flow from the irrigation lumens to the suction port (fig. 1B).
Regarding claim 9, Freedman discloses that each irrigation lumen of the of the plurality of irrigation lumens extend in straight line (fig. 1B).
Regarding claim 10, Freedman discloses that the plurality of irrigation lumens extend radially from the hub (fig. 1B).
Regarding claim 12, the limitation “wherein the flexible base is configured to be inserted into a breast pocket” is interpreted to be an intended use limitation. The base of Freedman is flexible and size such that it is capable of being inserted into a breast pocket.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Corley as applied to claim 1 above, and further in view of Martin (US 7,883,494).
Claim 11 differs from Freedman in calling for a flow control valve configured to adjust a flow rate of irrigation fluid. Martin teaches an irrigation system wherein a flow control valve is configured to adjust a flow rate of the irrigation fluid so that a balance of fluid can be maintained within the treatment site thereby ensuring that over pressurization does not occur (col. 5, lines 15-23; col. 32, lines 54-58). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Freedman to include a flow control valve as taught by Martin to provide an equilibrium of fluid within the treatment location.
Allowable Subject Matter
Claims 7, 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 13-21 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: see prior Office action for reasons for allowance.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783