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 .
Claim Rejections - 35 USC § 102
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 4-10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mathews (US 2021/0106468 A1).
With regard to claim 1, Mathews teaches a dressing for use with a catheter assembly, comprising: a base defining a perimeter and an interior, the base comprising a bottom surface configured to contact skin of a patient and comprising a first opening in the perimeter (Fig. 1A member 120); and a cover portion attached to the base and configured to cover a site of a catheter insertion, the cover portion comprising a second opening (Fig. 1A member 112), the second opening configured to align with the first opening in the base when the dressing is applied to the patient's skin (Fig. 1A), wherein the perimeter defines a shape that is not a square and wherein portions of the base defining the first opening are arranged such that the portions form an oblique angle (Fig. 1A member 120, there is a single perimeter with a single opening as further explained in the response to arguments below).
With regard to claim 2, the full catheter is not shown but the dressing is capable of forming such a seal.
With regard to claim 4, see [0030].
With regard to claims 5 and 6, see Fig. 1A member 118 which can be considered to have two sections one on either side of the openings.
With regard to claim 7, see [0031].
With regard to claim 8, see Fig. 1A, there is no defined shape.
With regard to claims 9 and 10, see 126 (Fig. 1A).
Claim Rejections - 35 USC § 103
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.
Claim(s) 11-13, 15-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2016/0000363 A1) in view of Mathews (US 2021/0106468 A1).
With regard to claim 11, Jones et al. teach a kit, comprising: at least one package (Fig. 6 member 610) containing: a catheter assembly comprising: a catheter adapter (Fig. 6 member 630), comprising: a distal end (Fig. 6 member 630); a proximal end (Fig. 6 member 630); a lumen arranged between and in fluid communication with the distal end and the proximal end (Fig. 6 member 630); a port arranged between the proximal end and the distal end at an angle relative to the lumen (Fig. 6 member 630, shown in more detail in Fig. 1, opening at the junction between 130 and 140); a conduit in fluid communication with the port (Fig. 6 member 630, shown in more detail in Fig. 1, conduit 130); and a catheter arranged at the distal end of the catheter adapter and in fluid communication with the lumen (Fig. 6 member 630); and a dressing (Fig. 6 member 660). Jones et al. teach a dressing may be used but do not disclose details of the dressing. However, Mathews teaches a dressing having a base defining a perimeter and an interior, the base comprising a bottom surface configured to contact skin of a patient and comprising a first opening in the perimeter (Fig. 1A member 120); and a cover portion attached to the base and configured to cover a site of a catheter insertion, the cover portion comprising a second opening (Fig. 1A member 112), the second opening configured to align with the first opening in the base when the dressing is applied to the patient's skin (Fig. 1A), wherein the perimeter defines a shape that is not a square and wherein portions of the base defining the first opening are arranged such that the portions form an oblique angle (Fig. 1A member 120, there is a single perimeter with a single opening as further explained in the response to arguments below). The dressing is beneficial to secure the catheter in place and also provides indicia ([0012]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a dressing in Jones et al. as in Mathews as Mathews teach this to be beneficial to provide indicia and yields the same predictable result of securement.
With regard to claims 12 and 13, when the dressing is applied it is able to forms a seal as recited.
With regard to claim 15, see [0030] of Mathews.
With regard to claims 16 and 17, see Fig. 1A of Mathews member 118 which can be considered to have two sections one on either side of the openings.
With regard to claim 18, see [0031] of Mathews.
With regard to claim 20, see 126 (Fig. 1A of Mathews).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2016/0000363 A1) in view of Mathews (US 2021/0106468 A1) as applied to claim 11 above, and further in view of Helm et al. (US 2019/0247623 A1).
With regard to claim 19, Jones et al. and Mathews teach a device substantially as claimed. The dressing as provided by Mathews does not explicitly show the interior to have substantially the same shape as the catheter adapter. However, Helm et al. teach using a piece under the adhesive cover to fit the shape of the adapter for securement (Fig. 8, [005], [0098]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the shape of the interior of the dressing as provided by Mathews combined with Jones et al. to be substantially the same as the catheter adapter as Helm et al. teach this is beneficial for securement.
Response to Amendment
The amendments to the drawings and specification are sufficient to overcome the previous objections.
Response to Arguments
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive. The base identified in Matthews has a perimeter which is clearly not square and only has one opening which necessarily has portions which form an oblique angle. The perimeter and opening are features inherent to the indicated base. The claim broadly recites “portions”, an oblique angle could be derived from any “portions” as there are no frames of reference provided for the angle other than it is formed by “portions.” There is nothing that indicates what planes or surfaces of such portions are considered. Applicant refers to 124 which is in portion 112, as noted 112 is relied upon as the cover not the base so an opening of the cover would not be considered as the opening of the base. 120 clearly has its own separate opening. The opening of the base and cover are aligned. Annotated Reference Figures are provided below for Applicant’s reference showing an outlined portion of the perimeter in the area of the opening from which portions forming an oblique angle are readily apparent.
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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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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