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 07/08/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed on 06/18/2026 has been entered. Claims 1 and 9 have been amended. Claims 2-3, 5-8, 10-13 are in the original/previously presented form. Claims 4 and 14-37 are cancelled. Claim 12 has been withdrawn from examination by the examiner as not being drawn to the elected species of FIGS. 4A-4C. This decision comes from the Applicant’s Remarks, where on page 8, the Applicant states “the hingedly, rotatably, or pivotally coupled handle is not a feature specified in the elected claims directed to the elected species of FIGS. 4A-4C. Rather, claim 12, which recites this feature, depends on claim 1 and is directed to an optional configuration.”. Claim 12 may be rejoined later. Thus, claims 1-3, 5-11, and 13 remain pending in the application.
Drawings
The amendment to the drawings was received on 06/18/2026. Applicant addressed all previous objections. The drawings are acceptable.
Specification
The amendment to the specification was received on 06/18/2026. Applicant addressed all previous objections. The specification is acceptable.
Claim Objections
The amendments to the claims were received on 06/18/2026. Applicant addressed all previous objections to the claims.
Claims 8 and 9 are objected to because of the following informalities: Both claims 8 and 9 use the language “wherein one or both of”. The use of “one or both of” leads to an indefinite interpretation of the claim as it presents such a broad understanding of what limitations are being claimed. The examiner suggests modifying the claims to add specificity by explicitly selecting either “one” or “both”, not the two together. For the purposes of examination, the examiner will interpret any use of “one or both of” within the claims to mean “one, the other, or both”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The claim states “the handle is formed of a first material having a substantially rigid, or resilient, material properties and including a second material…”. The wrong tense of “include” is used. The examiner suggests modifying the claim to state “the handle is formed of a first material having a substantially rigid, or resilient, material properties and includes a second material” to fix grammatical errors. Appropriate correction is required.
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, 2, 5, 6, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Chow et al. (United States Patent Application Publication No. US 2016/0242862 A1; herein, Chow), and further in view of Bierman et al. (United States Patent Application Publication No. US 2014/0249478 A1; herein, Bierman).
Regarding claim 1, Chow discloses a catheter containment device (FIGS. 7-11, medical device management unit 90) for retaining a portion of a catheter placement system (FIG. 10, medical device 65), comprising:
a body (base piece 95); and
a handle coupled to the body and configured to be grasped by a digit of a clinician (FIGS. 9 and 10, hand held portion 153).
Chow does not disclose the body defining a channel extending longitudinally along a first axis between a first end and a second end, the channel configured to retain the portion of the catheter placement system, and having an opening extending longitudinally between the first end and the second end of the channel and configured to allow ingress or egress along a second axis extending at an angle to the first axis of the channel.
However, Bierman teaches the body defining a channel (channel 140) extending longitudinally along a first axis between a first end and a second end ([0072], “channel 140 extends on the underside of the body member 130 in a longitudinal direction”; FIG. 3 and FIG. 4, channel 140 extends from distal end 125 to proximal end 127 of the retainer body 130), the channel configured to retain the portion of the catheter placement system (FIG. 5), and having an opening (FIG. 3, lower opening 150) extending longitudinally between the first end and the second end of the channel (FIG. 1 and FIG. 3, lower opening 150 seen covering entire distance of channel 140) and configured to allow ingress or egress along a second axis extending at an angle to the first axis of the channel ([0051], “This access opening allows ingress or egress of the medical article. The medical article can be installed or removed from the underside of the retainer via this access opening.”; [0128], “the connector fitting 300 (see FIG. 5) is inserted through the opening 150 and into the central channel 140 of the body member 130”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the body disclosed by Chow to include a channel and opening of the channel that extend between a first and second end as taught by Bierman in order to inhibit any transverse or lateral motion of the catheter placement system relative to the body ([0111]), excluding the necessary ingress and egress motion of the catheter placement system through the opening.
Regarding claim 2, in the modified device of Chow, Chow discloses wherein the portion of the catheter placement system includes one of a catheter body, catheter hub, extension leg, luer lock, or guidewire (FIG. 11, medical device 65).
Regarding claim 5, in the modified device of Chow, Chow discloses wherein the body (base piece 95) includes a first channel (FIG. 7, trenches 112) extending along a first axis of the channel, and a second channel (additional trenches 112 as shown in FIG. 7) extending along third axis at an angle to the first axis of the channel (trenches are at a zero angle relative to each other).
Regarding claim 6, in the modified device of Chow, Chow discloses wherein an inner diameter of the channel is equal to or slightly smaller than an outer diameter of the portion of the catheter placement system ([0056], “…trenches 112 of unit 90 preferably comprise depths at least equal to the circumference of the medical device 65 that is being managed during the procedure.”).
Regarding claim 11, in the modified device of Chow, Chow discloses wherein the handle is a ring defining an aperture and configured to receive one or more digits therethrough (FIG. 10, thumb loop 150).
Regarding claim 13, in the modified device of Chow, Chow discloses wherein the handle extends from the body at an angle relative to the first axis of the channel (FIG. 7).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chow in view of Bierman as applied to claim 1 above, and further in view of Nakajima (United States Patent Application Publication No. US 2004/0102739 A1).
Regarding claim 7, in the modified device of Chow, Chow does not disclose wherein a width of the opening of the channel is smaller than an outer diameter of the portion of the catheter placement system. However, Nakajima teaches wherein a width of the opening of the channel is smaller than an outer diameter of the portion of the catheter placement system ([0066], “…opening 9 which has a diameter slightly smaller than that of the tube and through which the flexible tube 8 of the winged needle can be passed.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified openings of the channels as disclosed by Chow to have smaller widths than the outer diameter of the catheter placement system, such as a tube, as taught by Nakajima in order that the catheter placement system is supported through the opening while not hindering passage through the channel ([0014]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chow in view of Bierman as applied to claim 1 above, and further in view of Brellis et al. (United States Patent Application Publication No. US 2020/0398450 A1; herein, Brellis).
Regarding claim 8, in the modified device of Chow, Chow does not disclose wherein one or both of the body and the handle is formed of a substantially rigid, or resilient material selected from a group consisting of a plastic, polymer, metal, alloy, or composite. However, Brellis teaches wherein one or both of the body and the handle is formed of a substantially rigid, or resilient material selected from a group consisting of a plastic, polymer, metal, alloy, or composite ([0059], “…a first material of which the rest of the handle body 26 is made. For example, the first material may be made of plastic.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified body and/or handle disclosed by Chow to be formed of a rigid material such as plastic as taught by Brellis in order to provide strength and less elasticity to the handle ([0018]).
Regarding claim 9, in the modified device of Chow, Chow does not disclose wherein one or both of the body and the handle is formed of a flexible, malleable, or elastically deformable material selected from a group consisting of a plastic, polymer, elastomer, rubber, silicone rubber, metal, alloy, shape memory material, super-elastic material, Nitinol, composite. However, Brellis teaches wherein one or both of the body and the handle is formed of a flexible, malleable, or elastically deformable material selected from a group consisting of a plastic, polymer, elastomer, rubber, silicone rubber, metal, alloy, shape memory material, super-elastic material, Nitinol, composite ([0059], “The handle body 26 further comprises an elastic portion 42…the second material may be a rubber.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified body and/or handle disclosed by Chow to be formed of an elastic material such as rubber as taught by Brellis in order to form a grip finger area for a user, allowing a good handling of the handle ([0059]).
Regarding claim 10, in the modified device of Chow, Chow does not disclose wherein the handle is formed of a first material having a substantially rigid, or resilient, material properties and including a second material disposed thereon having a relatively softer, or more flexible material properties. However, Brellis teaches wherein the handle is formed of a first material having a substantially rigid, or resilient, material properties and including a second material disposed thereon having a relatively softer, or more flexible material properties ([0059], handle body is formed of a first, more rigid, material and a second, more elastic, material). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified handle disclosed by Chow to be formed of both rigid and elastic materials as taught by Brellis in order to provide strength and less elasticity to the handle ([0018]), while also providing a grip finger area for a user, allowing a good handling of the handle ([0059]).
Response to Arguments
Applicants’ arguments, see pages 9-12 of Remarks, with respect to claim 1, have been considered but are moot because the arguments do not apply in view of the present rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lundgaard et al. (United States Patent Application Publication No. US 2007/0142785 A1) is considered relevant prior art with regards to a securement device having both a channel and opening.
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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