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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 23, 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on February 17, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 5, 9, and 17 are objected to because of the following informalities:
Claim 5 recites “device according to any claim 1”, should read “device according to claim 1” for clarity.
Claim 9 recites “the materials of the compressible pad”, should read “the material of the compressible pad” for clarity of the antecedent basis established in claim 8.
Claim 17 recites “the needle extends from away from”, should read “the needle extends away from” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites the limitation "the method according to claim 1". There is insufficient antecedent basis for this limitation in the claim, as claim 1 is not a method claim. For examining purposes, claim 19 is interpreted to depend from claim 17, which is a method claim.
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.
Claims 1-4, 6-8, and 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over Howell et al. (US 20150224285), hereinafter Howell, in view of Bailey et al. (US 20090149814), hereinafter Bailey.
Regarding claim 1, Howell discloses a stabilization device for a cannula (Fig. 27-31, securement device 500 for catheter 200), comprising: first and second portions (Fig. 30 and Annotated Fig. 27, first and second lateral anchor pad 104 portions), a first side (Fig. 5 and 30, upper surface 105) and an opposing second side (Fig. 5 and 30, opposing lower surface 106), and a first edge (Annotated Fig. 27, first edge) and opposing second edge (Annotated Fig. 27, opposing second edge); a compressible pad (Fig. 5 and 27-31 an [0094], retainer 101/102 which is made of an elastomer and is thus compressible (examiner notes; disclosure of Howell utilizes both character numbers 101 and 102 interchangeably when referring to the retainer)) having a tapered notch (Fig. 27, tapered recess 108), the notch having a wide end and a narrow end (Fig. 27, recess 108 has a wide end and narrow end), wherein the wide end is disposed adjacent an edge of the compressible pad and at the first edge of the device between the first and second portions (Annotated Fig. 27, wide end of recess 108 is disposed adjacent the edge of retainer 101 and at the first edge of device 500, between the first and second anchor pad 104 portions); an adhesive disposed on the second side at least on the first and second portions of the stabilization device (Annotated Fig. 27, Fig. 30, and [0087], adhesive is disposed on lower surface 106 which includes the regions of first and second anchor pad 104 portions); and a securement strip (Fig. 27-31 and 41, flap 510) attached to the first side of the first portion of the stabilization device (Annotated Fig. 27 and [0119], flap 510 is attached to first anchor pad portion on upper surface 105), wherein the securement strip is configured to extend over the notch in the compressible pad to the second portion, and is attachable to the first side of the second portion of the stabilization device (Fig. 39-41 and [0124, 0129], flap 510 extends over retainer 101 and its recess 108 to the second anchor pad 104 and is attached to the upper surface of the second anchor pad portion when in the closed position).
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Annotated Fig. 27 of Howell
Howell fails to disclose wherein the wide end is disposed at the edge of the compressible pad. However, Bailey discloses wherein the wide end is disposed at the edge of the compressible pad (Fig. 2, relief 28b has a wide end of the relief disposed at the edge of the mount 12b).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell to incorporate the disclosures of Bailey and modify tapered notch such that the wide end is disposed at the edge of the compressible pad. Doing so would allow the tapered notch to receive the larger rounder portion of the catheter and/or the catheter hub for stabilization of the catheter (Bailey, [0042-0044]).
Regarding claim 2 and Howell, in view of Bailey, Howell further discloses the stabilization device according to claim 1, wherein the device comprises a backing strip (Fig. 27 and 30, anchor pad 104), and the first and second portions, first side and opposing second side, and first and opposing second edges of the stabilization device are part of the backing strip (Annotated Fig. 27, first and second anchor pad 104 portions, upper surface 105 and lower surface 106, and first and second edge are part of anchor pad 104).
Regarding claim 3 and Howell, in view of Bailey, Howell further discloses the stabilization device according to claim 2, wherein the compressible pad is disposed on the first side of the backing strip (Fig. 5, 27 and 30, retainer 101 is disposed on upper surface 105 of anchor pad 104), and the adhesive is disposed on the second side of the backing strip for adhesion to a skin of a patient (Fig. 30 and [0087], adhesive is disposed on lower surface 106 of anchor pad 104).
Regarding claim 4 and Howell, in view of Bailey, Howell further discloses the stabilization device according to claim 1, wherein the first and second portions, first side and the opposing second side, and first and second edges of the stabilization device are part of the compressible pad (Fig. 27 and [0119], flap 510, anchor pad 104, and retainer 101/102 may be one integral piece, therefore the first and second anchor pad 104 portions, upper surface 105 and lower surface 106, and first and second edge are part of retainer 101/102), and the adhesive is disposed on the second side of the first and second portions of the compressible pad for adhesion to skin of a patient (Annotated Fig. 27, Fig. 30, and [0087], adhesive is disposed on lower surface 106 which includes the regions of first and second anchor pad 104 portions).
Regarding claim 6, Howell, in view of Bailey, discloses the stabilization device according to claim 1, as explained above. Howell is silent to wherein the notch has a rounded narrow end. However, Bailey further discloses wherein the notch has a rounded narrow end (Fig. 2, relief 28d shows tapered relief with a rounded shape (similar to rounded relief 28a), therefore, narrow end of relief 28d is rounded).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to further incorporate the disclosures of Bailey and modify the notch to have a rounded narrow end. Doing so would provide the notch with both the semi-circular shape the best allows for receipt of the catheter and/or hub while also providing the wider opening at the upper portion of the relief for receiving the larger rounder portion of the catheter and/or the catheter hub (Bailey. [0043-0044]).
Regarding claim 7, Howell, in view of Bailey, discloses the stabilization device according to claim 1, as explained above. Howell is silent to wherein the compressible pad has a depth and a width, and the ratio of the depth of the compressible pad to the width of the wide end of the notch is 1:1 to 1:5. However, Bailey further discloses wherein the compressible pad has a depth (Fig. 2, mount depth/height 32) and a width (Fig. 2, mount width 34), and the ratio of the depth of the compressible pad to the width of the wide end of the notch is 1:1 to 1:5 (Fig. 2 and [0050], mount may have a depth 32 of 3/8 in and a width 34 of 3/4 in; which gives a depth to width ratio of 1:2).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to further incorporate the disclosures of Bailey and modify the compressible pad to have a depth and a width, and the ratio of the depth of the compressible pad to the width of the wide end of the notch is 1:1 to 1:5. Doing so would provide a compressible pad with dimensions that optimize the performance of the mount and provide sufficient space for a tape/cover to surround the inserted catheter/hub to provide the best utility and least interference (Bailey, [0047-0050]).
Regarding claim 8, Howell, in view of Bailey, discloses the stabilization device according to claim 1, as explained above. Howell is silent to wherein the compressible pad comprises a material selected from foam, fabric and a compressible non-porous material. However, Bailey further discloses wherein the compressible pad comprises a material selected from foam ([0091], mount comprises a foam material), fabric and a compressible non-porous material.
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to further incorporate the disclosures of Bailey and modify the compressible pad to comprise a material selected from foam, fabric and a compressible non-porous material. Doing so would provide a material that provides no absorption of liquids and thus no hosting of bacteria in the compressible pad (Bailey, [0092]).
Regarding claim 10, Howell, in view of Bailey, discloses the stabilization device according to claim 8, as explained above. As noted above, Howell fails to disclose wherein the compressible pad comprises a foam, and is thus silent to wherein the compressible pad comprises a closed cell foam. However, Bailey further discloses wherein the compressible pad comprises a closed cell foam ([0091], mount comprises a closed cell foam material).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to further incorporate the disclosures of Bailey and modify the compressible pad to comprise a closed cell foam. Doing so would provide a material that provides no absorption of liquids and thus no hosting of bacteria in the compressible pad (Bailey, [0092]).
Regarding claim 11 and Howell, in view of Bailey, Howell further discloses the stabilization device according to claim 2, wherein the backing strip comprises a continuous web of material, a fabric, a foam, and a paper ([0085-0086], anchor pad 104 comprises a foam).
Regarding claim 12 and Howell, in view of Bailey, Howell further discloses the stabilization device according to claim 2, wherein the backing strip comprises a polymeric material ([0086], anchor pad 104 may comprise a polyethylene foam, which is a polymeric material).
Regarding claim 13 and Howell, in view of Bailey, Howell further discloses the stabilization device according to claim 1, wherein the adhesive is selected from a silicone ([0087], lower surface 106 adhesive may be a silicone adhesive), an acrylic, a hydrocolloid, a hydrogel, a rubber adhesive and a polyurethane.
Regarding claim 14, Howell, in view of Bailey, discloses the stabilization device according to claim 1, as explained above. Howell fails to disclose wherein the compressible pad comprises two layers. However, Baliey further discloses wherein the compressible pad comprises two layers (Fig. 2, Mount 12E comprises two layers of mounts).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to further incorporate the disclosures of Bailey and modify the compressible pad to comprise two layers. Doing so would provide a taller/steeper compressible pad, which may be desired to optimize the performance of the compressible pad in certain procedures (Bailey, [0045-0047]).
Regarding claim 15 and Howell, in view of Bailey, Howell further discloses the stabilization device according to claim 14, wherein the tapered notch is a stepped notch (Fig. 3, recess 108 is configured with a stepped reduction in width portion 114, thus making a stepped recess).
Regarding claim 16 and Howell, in view of Bailey, Howell further discloses the stabilization device according to claim 1, further including a release liner on the adhesive (Fig. 30 and [0125], liners 520 and 521 cover the adhesive on lower surface 106).
Regarding claim 17 and Howell, in view of Bailey, Howell further discloses a method of securing a cannula to a patient (Figs. 33-41), comprising: inserting a needle of a cannula into a blood vessel of a patient ([0083], cannula is first inserted into patient vessel), adhering the stabilization device according to claim 1 on a skin of the patient (Fig. 34 and [0128], securement device 500 is adhered to patient's skin), placing the cannula into the tapered notch of the stabilization device (Fig. 33, catheter/cannula 200 is placed into recess 108 of retainer 102), and extending the securement strip over the cannula and the notch, such that it is adhered to the first side of both the first and second portions of the stabilization device (Figs. 39-40 and [0129], flap 510 is extended over catheter/canula 200 and recess 108, then adhered to opposite lateral anchor pad 104 portion, such that it is adhered to the top surface of both later anchor pad 104 portions).
Howell fails to disclose wherein the cannula is placed in the tapered notch such that the needle extends from away from the wide end of the notch. However, Bailey further discloses wherein the cannula is placed in the tapered notch such that the needle extends from away from the wide end of the notch (Fig. 2, tapered relief 28b is configured such that a needle end of the catheter/cannula extends away from the wide end of the tapered relief 28b).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to further incorporate the disclosures of Bailey and modify the notch to have taper wherein the wide end is at the upper portion so that a method of using the device may include wherein the cannula is placed in the tapered notch such that the needle extends from away from the wide end of the notch. Doing so would allow the tapered notch to receive the larger rounder portion of the catheter and/or the catheter hub for stabilization of the catheter (Bailey, [0042-0044]).
Regarding claim 18, Howell, in view of Bailey, discloses the method according to claim 15, as explained above. Howell is silent to wherein the cannula comprises a cannula hub from which the needle of the cannula extends, and the cannula hub is placed in the tapered notch. However, Bailey further discloses wherein the cannula comprises a cannula hub from which the needle of the cannula extends (Fig. 7 and [0069-0070], catheter comprises hub 16, from which shank 50 (which carriers needle 70) extends), and the cannula hub is placed in the tapered notch (Fig. 2 and [0044], catheter hub 16 is placed in tapered relief 28b).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to further incorporate the disclosures of Bailey and modify the method to include wherein the cannula comprises a cannula hub from which the needle of the cannula extends, and the cannula hub is placed in the tapered notch. Doing so would allow the tapered notch to receive the larger catheter hub for stabilization of the catheter (Bailey, [0042-0044]).
Regarding claim 19, Howell, in view of Bailey, discloses the method according to claim 1, as explained above wherein the cannula comprises tubing, and the tubing is placed in the tapered notch (Fig. 2 and 4 and [0042-0044], catheter 14, which comprises a tubing 52, may be configured to be placed within the relief 28 of mount 12).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to further incorporate the disclosures of Bailey and modify the method to include wherein the cannula comprises tubing, and the tubing is placed in the tapered notch. Doing so would allow the notch to receive the catheter for stabilization of the catheter and provide a lower/more distributed stress at the skin of the user (Bailey, [0040,0042-0043]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Howell (US 20150224285), in view of Bailey (US 20090149814), as applied to claim 1 above and further in view of Clavijo et al. (US 20200246592), hereinafter Clavijo.
Regarding claim 5, Howell, in view of Bailey, discloses the stabilization device according to any claim 1.
Howell, in view of Bailey, fails to disclose wherein the notch has an angle of between 5 to 140 degrees. However, Clavijo discloses wherein the notch has an angle of between 5 to 140 degrees (Fig. 2B, 5 and [0055], notch 116a follows the angled alignment of platform 110, which is provided at an 8.5 deg. Angle, therefore the notch 116 has an 8.5 deg. Angle relative to the skin surface).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to incorporate the disclosures of Clavijo and modify the notch to have an angle of between 5 to 140 degrees. Doing so would provide the catheter at an appropriate insertion angle while minimizing the risk of kinking in the catheter tube and also minimizes pistoning at the insertion site (Clavijo, [0055]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Howell (US 20150224285), in view of Bailey (US 20090149814), as applied to claim 1 above and further in view of Aronzon (US 20230133259).
Regarding claim 9, Howell, in view of Bailey, discloses the stabilization device according to claim 8.
Howell, in view of Bailey, fails to disclose wherein the materials of the compressible pad comprises a polymer selected from polyalkylene (e.g. polyethylene, polypropylene), halogenated polyalkylene (e.g. chlorosulphonated polyethylene), silicone, ethylene vinyl alcohol polymer, polychloroprene (neoprene), styrene butadiene, polystyrene, natural rubber, butyl rubber, nitrile rubber, hydrogenated nitrile, ethylene propylene diene, fluoroelastomer rubber, polyurethane (e.g. a microcellular polyurethane), polyurea, polyimide, polyvinylchloride, hydrocolloid and hydrogel. However, Aronzon discloses wherein the materials of the compressible pad comprises a polymer selected from polyalkylene (e.g. polyethylene, polypropylene), halogenated polyalkylene (e.g. chlorosulphonated polyethylene), silicone, ethylene vinyl alcohol polymer, polychloroprene (neoprene), styrene butadiene, polystyrene, natural rubber, butyl rubber, nitrile rubber, hydrogenated nitrile, ethylene propylene diene (Fig. 3-4 and [0018-0019], body 102 may be constructed of EPDM (ethylene propylene diene monomer) material), fluoroelastomer rubber, polyurethane (e.g. a microcellular polyurethane), polyurea, polyimide, polyvinylchloride, hydrocolloid and hydrogel.
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Howell, in view of Bailey, to incorporate the disclosures of Aronzon and modify the compressible pad to comprise a polymer selected from polyalkylene (e.g. polyethylene, polypropylene), halogenated polyalkylene (e.g. chlorosulphonated polyethylene), silicone, ethylene vinyl alcohol polymer, polychloroprene (neoprene), styrene butadiene, polystyrene, natural rubber, butyl rubber, nitrile rubber, hydrogenated nitrile, ethylene propylene diene, fluoroelastomer rubber, polyurethane (e.g. a microcellular polyurethane), polyurea, polyimide, polyvinylchloride, hydrocolloid and hydrogel. Doing so would provide a compressible pad which is readably cleanable and/or resists absorption of bodily or other fluids, making it well suited for use in an operation (Aronzon, [0019]).
Conclusion
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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