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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 March 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 30 March 2026. As directed by the amendment: claims 1 and 24 have been amended, claims 6, 11, and 21-23 have been canceled. Thus claims 1-5, 7-10, 12-20, and 24-25 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 30 March 2026, with respect to the rejection(s) of the claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Waller et al. (US 2016/0317359 A1) which teaches applying an adhesive composition as a liquid under a dressing.
Claim Objections
Claim 1 is objected to because of the following informalities: the word “comprise” in line 28 should instead recite “comprises”. 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.
Claims 1-5, 7-10, 12-20, and 24-25 are 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 1 recites the limitation "the securement strength" in line 23. There is insufficient antecedent basis for this limitation in the claim. It is further unclear what the securement strength is referring to, securement of the catheter or of the dressing. For the purpose of examination, this is interpreted as the securement strength of the catheter to the patient.
Claims 2-5, 7-10, 12-20, and 24-25 are rejected as being dependent on, and failing to cure the deficiencies of, rejected independent claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 7-10, 12-16, 18-20, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2019/0143081 A1), hereinafter Zhang, in view of Bailey et al. (US 20090149814 A1), hereinafter Bailey, Waller et al. (US 2016/0317359 A1) and McCullen et al. (US 11,033,655 B1).
Regarding claim 1, Zhang discloses a method for securing a vascular access device which has a tube that has been inserted into a vascular system of a patient at a vascular access point, the method comprising: applying a first amount of a radiation-sterilized cyanoacrylate adhesive composition over the vascular access point ([0067]); allowing the first amount of the radiation-sterilized cyanoacrylate adhesive composition to cure to create a first cured radiation-sterilized cyanoacrylate adhesive composition ([0020]), wherein the first cured radiation- sterilized cyanoacrylate adhesive composition provides a water-resistant seal barrier ([0067]), a hemostatic effect on the vascular access point ([0065]), an antimicrobial function to immobilize and eliminate bacteria at and around the vascular access point ([0066]), and secures the insertion tube to the vascular access site ([0067]); applying a second amount of the radiation-sterilized cyanoacrylate adhesive composition under a portion of the vascular access device at a site remote from the vascular access point ([0020]); and allowing the second amount of the radiation-sterilized cyanoacrylate adhesive composition to cure and secure the vascular access device to the patient with a secured strength ([0020]); further applying a conventional dressing product ([0107]), wherein the radiation-sterilized cyanoacrylate adhesive composition provides effective securement for at least 3 days ([0109] “The average adhesion strength for securing BD Autoguard catheters using the composition in the applicator 190 at 3 days after application is 3.38 lbf.”).
Zhang fails to disclose the first cured radiation-sterilized cyanoacrylate adhesive composition is transparent, wherein the radiation- sterilized cyanoacrylate adhesive composition is applied as a liquid beneath the conventional dressing product, wherein the radiation sterilizable cyanoacrylate adhesive composition is compatible with the conventional dressing product and the securement strength is stronger than the radiation-sterilized cyanoacrylate adhesive composition or the conventional dressing product used alone, and the radiation-sterilized cyanoacrylate adhesive composition comprise cyanoacrylate monomer having a purity of at least 97% by weight.
Bailey teaches a transparent adhesive tape ([0089]). It would have been obvious to one of ordinary skill in art before the effective filing date of the invention to have modified the first amount of cured radiation-sterilized cyanoacrylate adhesive composition to be transparent as taught by Bailey as doing so would provide visible inspection underneath the first amount of cured radiation-sterilized cyanoacrylate adhesive composition as taught by Bailey in [0089].
Waller et al. teaches applying a convention dressing product ([0064] “The barrier device is configured to receive a percutaneous medical device and retain the medical device in a substantially fixed position with respect to the percutaneous incision”), wherein a cyanoacrylate adhesive composition ([0195] “the bioadhesive is a composition that includes a cyanoacrylate”) is applied as a liquid beneath a conventional dressing product ([0207] “a flowable adhesive composition that hardens at a skin-barrier device interface, skin-medical device interface, and/or barrier device-medical device interface. Such flowable adhesive compositions can be liquids, gels, pastes, and the like. The flowable composition can be placed onto the skin, barrier device, and medical device at an interface therebetween, which is usually at, adjacent, or proximal with the percutaneous incision.”) wherein the radiation sterilizable cyanoacrylate adhesive composition is compatible with the conventional dressing product ([0190] “the adhesive composition can be compatible with the barrier device”) and the securement strength is stronger than the radiation-sterilized cyanoacrylate adhesive composition or the conventional dressing product used alone ([0198] “The adhesive composition can be configured so as to produce and maintain strong glue-skin, glue-barrier device, and glue-catheter adhesive interfaces.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the conventional dressing product of Zhang to include the adhesive composition applied as a liquid beneath it as taught by Waller et al. because it is “providing a barrier against contaminants and microbes as well as holding and retaining the medical device in a substantially fixed position such that the medical device does not move into and/or out of the incision” [0064].
McCullen et al. teaches cyanoacrylate adhesive composition comprise cyanoacrylate monomer (Col 7 lines 13-18 “an adhesive compound or mixture of compounds based on cyanoacrylate monomers. Partial polymers (i.e., oligomers) of such cyanoacrylates are also encompassed within this definition. A preferred cyanoacrylate for use in this invention is octyl-2-cyanoacrylate (2-OCA)”) having a purity of at least 97% by weight (Claim 2 “wherein said 2-octyl cyanoacrylate monomer has a purity of 99% by weight or greater.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the first and second amounts of cured radiation-sterilized cyanoacrylate adhesive composition of modified Zhang to comprise the cyanoacrylate monomer having a purity of at least 97% by weight as taught by McCullen et al. to as to prevent premature polymerization of the monomer and prevent the need for substantial amounts of stabilizers (Col 2 lines 21-27).
Regarding claim 3, Zhang as modified above teaches the method of claim 1. Zhang further teaches the vascular access device is a catheter and the first and second amounts of cured radiation-sterilized cyanoacrylate adhesive composition further inhibit complications associated with catheter insertion selected from a group consisting of catheter dislodgement, catheter infiltration, catheter migration, catheter occlusion, catheter-related phlebitis, and catheter-related infections (infections - [0096]).
Regarding claim 4, Zhang as modified above teaches the method of claim 1. Zhang further teaches the first cured radiation-sterilized cyanoacrylate adhesive composition further prevents bleeding at the vascular access point ([0065]).
Regarding claim 5, Zhang as modified above teaches the method of claim 1. Zhang further teaches the first and second amounts of cured radiation- sterilized cyanoacrylate adhesive composition further immobilize bacteria at and around the vascular access point ([0021], [0066]).
Regarding claim 7, Zhang as modified above teaches the method of claim 1. Zhang further teaches the portion of the vascular access device under the second amount of the radiation-sterilized cyanoacrylate adhesive composition is wings or a catheter hub (catheter hub - [0026]).
Regarding claim 8, Zhang as modified above teaches the method of claim 1. Zhang further teaches the secured strength of the secured vascular access device to the patient is greater than 3 lbf (5.01 lbf; [0107]).
Regarding claim 9, Zhang as modified above teaches the method of claim 1. Zhang further teaches the secured strength of the secured vascular access device to the patient is greater than 5 lbf (5.01 lbf; [0107]).
Regarding claim 10, Zhang as modified above teaches the method of claim 1. Zhang further teaches the vascular access device is selected from a group consisting of: intravenous (IV) catheters; peripheral venous catheters (PVCs), central venous catheters (CVCs), peripherally inserted central catheters (PICCs), arterial catheters, urinary catheters, and dialysis catheters ([0026]).
Regarding claim 12, Zhang as modified above teaches the method of claim 1. Zhang further teaches the cyanoacrylate monomer comprises a cyanoacrylate with straight chain or branched chain alkyl or alkoxyalkyl groups having 4 to 20 carbon atoms, including but not limited to, 2-octyl cyanoacrylate, dodecyl cyanoacrylate, undecyl cyanoacrylate, decyl cyanoacrylate, butyl cyanoacrylate, nonyl cyanoacrylate, heptyl cyanoacrylate, hexyl cyanoacrylate, pentyl cyanoacrylate, propyl cyanoacrylate, ethyl cyanoacrylate, 2-ethylhexyl cyanoacrylate, methyl cyanoacrylate, 3- methoxybutyl cyanoacrylate, 2-butoxyethyl cyanoacrylate, 2-isopropoxyethyl cyanoacrylate, or 1-methoxy-2-propyl cyanoacrylate, or a combination thereof (2-octyl cyanoacrylate; [0071]).
Regarding claim 13, Zhang as modified above teaches the method of claim 1. Zhang further teaches the radiation-sterilized cyanoacrylate adhesive composition is stabilized by free radical stabilizers and anionic stabilizers ([0087]).
Regarding claim 14, Zhang as modified above teaches the method of claim 1. Zhang further teaches the radiation-sterilized cyanoacrylate adhesive composition is sterilized by irradiation methods and/or chemical sterilization methods (irradiation - [0079]).
Regarding claim 15, Zhang as modified above teaches the method of claim 1. Zhang further teaches the radiation-sterilized cyanoacrylate adhesive composition has a shelf life of at least 24 months post sterilization ([0081]) evaluated by real time shelf stability studies ([0082]).
Regarding claim 16, Zhang as modified above teaches the method of claim 1. Zhang further teaches the vascular access device is selected from a group consisting of intravenous (IV) catheters; peripheral venous catheters (PVCs), central venous catheters (CVCs), peripherally inserted central catheters (PICCs), arterial catheters, urinary catheters, and dialysis catheters (IV catheters - [0062]).
Regarding claim 18, Zhang as modified above teaches the method of claim 1. Zhang further teaches the radiation-sterilized cyanoacrylate adhesive is packaged in an applicator (190; fig. 1, [0062]).
Regarding claim 19, Zhang as modified above teaches the method of claim 1. Zhang further teaches the applicator is fabricated from a material that is substantially impermeable to moisture and air ([0057], [0023]).
Regarding claim 20, Zhang as modified above teaches the method of claim 1. Zhang further teaches the radiation-sterilized cyanoacrylate adhesive composition stops bleeding at the vascular access site ([0065]).
Regarding claim 24, Zhang as modified above teaches the method of claim 1. Zhang further teaches the secured strength of the secured vascular access device can be up to 15 lbf (Zhang discloses the radiation-sterilized cyanoacrylate adhesive composition as structurally claimed; therefore the cyanoacrylate adhesive composition is considered capable of providing a secured strength for securing vascular access devices that can be up to 15 lbf).
Regarding claim 25, Zhang as modified above teaches the method of claim 1. Zhang further teaches the radiation-sterilized cyanoacrylate adhesive composition can seal vascular access sites ([0067]) and secure vascular access devices ([0026]) providing antibacterial property ([0096]) and stopping bleeding at or around vascular access sites ([0065]).
Claims 2 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Bailey, Waller et al. and McCullen et al. as applied to claim 1 above, and further in view of O'Sullivan et al. (US 20200038631 A1), hereinafter O’Sullivan.
Regarding claim 2, Zhang as modified above fails to teach the water-resistant seal barrier lasts for more than 3 days.
O’Sullivan teaches a catheter securement device (1; fig. 1) comprising a water-resistant seal barrier ([0160]) comprising adhesive ([0111]), wherein the water-resistant seal barrier lasts for up to seven days ([0117]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the water-resistant seal barrier of Zhang as modified above to last for more than 3 days as doing so would reduce or prevent contact irritant dermatitis as taught in [0117] of O’Sullivan.
Regarding claim 17, Zhang as modified above fails to teach the radiation-sterilized cyanoacrylate adhesive provides securement of the vascular access device to the patient for up to 7 days.
O’Sullivan teaches a catheter securement device (1; fig. 1) providing securement of a vascular access device (9; fig. 1) to a patient for up to seven days ([0120]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the radiation-sterilized cyanoacrylate adhesive to provide securement of the vascular access device to the patient for up to seven days as doing so would reduce or prevent contact irritant dermatitis as taught in [0117] of O’Sullivan.
Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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