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
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.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bryan (US 6,872,196).
Regarding claim 1, Bryan discloses a device (10; Figures 1-4) capable of managing shunt bleeds, comprising: a strap (21/24); a dome part (11; col. 2, lines 55-56); and an adhesive (20; col. 3, lines 3-9), wherein the adhesive is applied to attach the dome part on top of a shunt and tightly seal the dome part to the patient's skin so that blood cannot escape from the dome (col. 3, lines 3-9 and 22-29; it is capable of covering and sealing around a shunt and preventing blood from escaping the dome).
Regarding claim 5, the dome part is plastic (col. 2, lines 57-58).
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.
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 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Bryan (US 6,872,196) in view of Walls et al. (US 8,338,657).
Regarding claims 2 and 3, Bryan fails to disclose that the device comprises a label having a field to indicate the date and time the device was placed.
Walls et al. disclose a similar device for covering a wound (col. 3, lines 39-41; the wound covering devices of Bryan and Walls et al. being within Applicant’s field of covering a body penetration formed by a shunt). Walls et al. further disclose a label (25 or 26) on the device containing a field to indicate the date and time the device was placed or other useful information (col. 4, lines 7-13; Figure 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the label of Walls et al. on the device of Bryan in order to record the date and time the device was placed or other useful information.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bryan (US 6,872,196) in view of Raniere (US 2014/0305446).
Regarding claim 4, Bryan is silent as to any specific adhesive that is used and therefore fails to disclose that the adhesive is Tegaderm.
Raniere discloses a device (Figure 2A) for protecting a skin region (¶[0003]) having a dome (30A, domed devices for protecting skin being reasonably pertinent to Applicant’s problem of protecting a shunt site with a domed device) and further teaches securing the dome to skin using Tegaderm as an adhesive layer (¶[0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Raniere to have used Tegaderm as the adhesive for securing the device of Bryan to skin since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771