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 .
Claim Objections
Claim 8 is objected to because of the following informalities: “the needle” should be “the catheter needle” for consistency. Appropriate correction is required.
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.
Claim(s) 1, 3, 4, 6, 8, and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tollini (US 2007/0135769 A1) in view of Marshel (US 6,267,115 B1).
With regard to claims 1, 4, and 10-15, Tollini teaches a method of securely inserting a catheter in a vessel of a patient, the method comprising: applying an anchor pad on a patient's skin, adjacent to the vessel, wherein the anchor pad is formed of flexible, biocompatible, non-adhesive material that contacts the skin without adhesive attachment (Fig. 1 member 12, [0055], there is no adhesive between the contact between the base of 12 and the skin); inserting a catheter needle through the skin and into the vessel such that a portion of the catheter needle overlies the anchor pad (Fig. 1, [0038]). Tollini do not disclose wrapping around the anchor and catheter needle. However, Marshel teaches using a transparent plastic wrap tightly around a patient’s limb to protect an IV site from contaminants (abstract, Figs. 1 and 2, Col. 5 lines 12-13, 20-21, Col. 6 lines 1-8). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a wrap in Tollini as Marshel teaches this is beneficial to protect the insertion site from contaminants. As the wrap is placed tightly around it would cover the catheter with compression and enclosure.
With regard to claim 3, as the anchor and outer covering are made of the same materials as listed (see claims 6 and 12) they are expected to have the same peel strength. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. As a variety of materials are listed one of ordinary skill would be able to select a material as desired.
With regard to claim 6, see [0055].
With regard to claim 8, see Fig. 1.
Claim(s) 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tollini (US 2007/0135769 A1) and Marshel (US 6,267,115 B1) as applied to claim 1 above, and further in view of Ofek et al. (US 2021/0228765 A1).
With regard to claims 2 and 9, Tollini teaches a device substantially as claimed but does not disclose an antimicrobial patch. However, Ofek et al. teach using an antimicrobial pad over the insertion site which may include chlorhexidine base, chlorhexidine gluconate, or silver-sulfadiazine to promote healing at the insertion site ([0013], Fig. 3 member 12, [0032]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an antimicrobial pad in Tollini as Ofek et al. teach this is beneficial to promote healing.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tollini (US 2007/0135769 A1) and Marshel (US 6,267,115 B1) as applied to claim 1 above, and further in view of Buttaravoli (US 3,918,446).
With regard to claim 5, Tollini teaches the device may be processed for sterility ([0065]) but does not disclose a bacteriostatic or bactericidal agent. However, Buttaravoli teaches foam pads for retaining a catheter which may contain a bacteriostatic to prevent bacteria from reaching the insertion site (Col. 3 lines 60-65). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a bacteriostatic agent in the anchor of Tollini as Buttaravoli teaches this is beneficial to protect the insertion site from bacteria.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tollini (US 2007/0135769 A1) and Marshel (US 6,267,115 B1) as applied to claim 1 above, and further in view of Aronzon (US 2023/0133259 A1).
With regard to claim 7, Tollini teaches the anchor may be a variety of shapes and configurations ([0053]) but do not disclose explicit dimensions. However, Aronzon teaches an anchor for a catheter which may have an area of about 9 to 12 square inches ([0017]) resulting in a length and width of about 3 inches and a thickness of at least .125 inches ([0018]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have dimensions in Tollini as Aronzon teach such are effective for providing retention space for a catheter and would yield the same predictable result. One of ordinary skill would be able to dimension the anchor based on the patient placement and instrument being placed.
Response to Arguments
Applicant's arguments filed October 29, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments to Tollini, though Tollini uses tape the pad base is in direct contact with the skin without adhesive attachment. Applicant argues that including a wrap would require a complete redesign and negate the function of Tollini, as combined with Marshel the wrap is able to be placed around the device of Tollini and would not require a change in structure. Applicant argues adhesive is required to attached to the skin, however, as noted Velco may also be used. The material is the same as applicant and is tightly wrapped around the patient which results in compression and enclosure. The function is also maintained as the catheter is still inserted into the body. The benefit of providing a water-proof covering provides sufficient motivation and also results in securement. The previous objections and rejections under 35 U.S.C. 112 are withdrawn in light of the amendments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited references are exemplary of catheter securements without adhesive.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783