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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on June 2, 2026 is acknowledged. The traversal is on the grounds that independent claims 1 and 13 both require a base incorporating an integrated structure on its top surface that is mechanically secure with the tubing of a vascular access device. This is not found persuasive because the above characterization generalizes the pegs of claim 1 and the securing members of claim 13 as integrated structures on the top surface of the base. Claims 1 and 13 more specifically claim pegs and securing members such that these claims lack the same or corresponding integrated structures on the top surface of the base.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 2, 2026.
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 1-8 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Payton et al. (Payton) US 4,742,824.
Regarding claim 1, Payton discloses a secondary securement device (patch 10, c 3 ln 1) for a vascular access device (this is being interpreted as merely an intended use that does not result in a structural difference between the claimed invention and the prior art, see MPEP 2111.02) comprising tubing (oxygen tube 30, c 3 ln 15), the secondary securement device comprising: a base (front petal 12, back petal 14 and bottom petal 15, c 3 ln 2-3) including a first end, a second end positioned opposite the first end, a first side, a second side positioned opposite the first side, a top surface, and a bottom surface positioned opposite the top surface, the bottom surface configured to be in contact with a patient's skin surface (see annotated Figs. 1 and 5 below); and a plurality of pegs (posts 22 and 24, c 3 ln 9-11) connected to the base and extending from the top surface of the base, wherein adjacent pegs of the plurality of pegs are configured to secure the tubing of the vascular access device (Fig. 4).
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Regarding claim 2, Payton discloses the secondary securement device of claim 1, wherein the plurality of pegs are arranged into rows and columns (see annotated Fig. 2 above).
Regarding claim 3, Payton discloses the secondary securement device of claim 2, wherein each of the plurality of pegs is engaged with at least one other of the plurality of pegs (see Figs. 1 and 3-4 showing each of the plurality of pegs engaged with at least one other of the plurality of pegs in securing tube 30).
Regarding claim 4, Payton discloses the secondary securement device of claim 1, wherein at least a portion of the plurality of pegs are arranged in pairs (see annotated Fig. 4 above).
Regarding claim 5, Payton discloses the secondary securement device of claim 4, wherein the plurality of pegs are spaced from each other (Fig. 2).
Regarding claim 6, Payton discloses the secondary securement device of claim 1, wherein each of the plurality of pegs comprises a connecting portion (bodies 25, c 3 ln 13) connected to the base and a head portion (heads 26, c 3 ln 13-14) extending from the connecting portion (Fig. 5).
Regarding claim 7, Payton discloses the secondary securement device of claim 6, wherein the head portion is semi-spherical (Fig. 5).
Regarding claim 8, Payton discloses the secondary securement device of claim 6, wherein the head portion is spherical (Fig. 2).
Regarding claim 10, Payton discloses the secondary securement device of claim 1, further comprising first (post 44, c 3 ln 48) and second anchors (adhesive, c 2 ln 66) configured to be secured to the tubing of the vascular access device (Fig. 1).
Regarding claim 11, Payton discloses the secondary securement device of claim 1, wherein the plurality of pegs comprise an elastomeric material (patch 10 is formed of medical grade vinyl, c 2 ln 65, and see Payton 4,66,555 c 4 ln 1-3 that teaches vinyl as an elastomeric material).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Payton in view of McConnel US 4,029,103.
Regarding claim 9, Payton discloses the secondary securement device of claim 6.
Payton does not teach the secondary securement device wherein the connecting portion of each peg comprises a recessed area configured to receive a portion of the tubing of the vascular access device.
However, McConnel teaches an anchoring plate for medical tubes wherein the connecting portion comprises a recessed area (internal curved passageway 13, c 3 ln 27) configured to receive a portion of the tubing of the vascular access device (Fig. 5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the bodies 25 of Payton with a recessed area as taught by McConnel for the purpose of forming an interference fit with the medical tubing to immobilize the medical tubing contained therein, McConnel c 3 ln 30-32.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Payton in view of Bierman US 6,979,320 B2.
Regarding claim 12, Payton discloses the secondary securement device of claim 1, wherein the bottom surface of the base comprises an adhesive surface (adhesive, c 2 ln 66).
Payton does not explicitly teach a liner for the adhesive surface.
However, Bierman teaches an anchoring system wherein the adhesive surface 58 is provided with a liner 68, c 8 ln 35.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the adhesive surface of Payton with a liner as taught by Bierman for the purpose of covering the adhesive surface before use, Payton c 8 ln 35-37.
Conclusion
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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