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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/17/25 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Helm (US 2020/0398039). Helm discloses:
103 obviousness rejection used due to combination of embodiments [0116]. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of Helm.
A catheter dressing system comprising: a dressing device, comprising: an adhesive plate portion 1040, comprising: a top layer of a conformable material (Fig. 22c, top layer unlabeled but comprising the chamber portion extending upward from 1040); and a first circumferential seal opening (chamber portion extending upward from 1040, Fig. 22c) disposed through the top layer; and a mating body portion (chamber portion extending upward from 1040, Fig. 22c) coupled to the adhesive plate portion, comprising: a gasket portion 1031, comprising a second circumferential seal opening (opening at 1031, Fig. 22c) disposed through the gasket portion; and a chamber (chamber portion extending upward from 1040, Fig. 22c) comprising an internal surface; and a central connector, comprising: a barrel member 2447 (Fig. 24c) comprising a proximal end and configured to be disposed within the chamber through the first circumferential seal opening; a male connector configured to fluidly couple to a hub of an inserted medical device; and a mounting shaft 2431 extending proximally from the barrel member and configured to be disposed through the second circumferential seal opening (Fig. 24d).
the adhesive plate portion is configured to provide a first circumferential seal around the first circumferential seal opening when the adhesive plate portion is applied to a patient’s skin. See [0014, last 4 sentences]
the gasket portion and the proximal end are configured to engage when the central connector is disposed within the chamber to provide a second circumferential seal around the second circumferential seal opening. See Fig. 24c
the adhesive plate portion and the mating body portion comprise a unibody construct. See [0014, last 2 sentences]
the mating body portion comprises a flange configured to couple the mating body portion to the adhesive plate portion. [0188]
the mating body portion comprises a window section configured to allow visualization of a catheter insertion site. [0131]
the window comprises a moisture vapor permeable material. [0011,0127]
the adhesive plate portion further comprises an adhesive layer disposed on a bottom surface of the top layer. See [0014, last 2 sentences]
the barrel member comprises an external contour configured to match an internal contour of the chamber. [0161]
the mounting shaft comprises a stop flange configured to capture the gasket portion between the stop flange and the proximal end. [0186]
a compression collar engagable with the mounting shaft and configured to apply a compressive force to the gasket portion. See Fig. 24d, [0198]
an extension tubing set comprising: a tubing coupled to the mounting shaft at a distal end of the tubing; and a connector coupled to a proximal end of the tubing. See Fig. 24a
a gasket disposed between the gasket portion and the proximal end and over the mounting shaft. 2447, see Fig. 24a, d
claims 14-20 further taught as described above with claims 1-13
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 9:00am-5:30pm est.
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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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/DEANNA K HALL/Primary Examiner, Art Unit 3783