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 without traverse of claims 1-13 in the reply filed on 01/16/2026 is acknowledged.
Claims 4 and 14-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/16/2026. Although claim 4 were in the group of claims believed to encompass the elected species as remarked by the applicant, the claims are withdrawn from consideration as they are not directed towards the elected species. Regarding claim 4, the elected species in FIG. 4A-C do not show a singular channel that is able to retain multiple extension legs (as shown in FIG. 5).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/15/2023, 03/25/2024, 11/08/2024, and 01/21/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The listing of references in the specification, specifically paragraph [0071], is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because in FIG. 4C, reference number "216" is used when referring to the second opening. This reference number should be corrected to "216B" in order to properly identify the second opening.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 514A, 514B, 514C, 524A, and 524B. “514” and “524” are both used in the specification as describing a channel and a finger channel, respectively. However, no mention to the sub-parts of these items was made.
The drawings, specifically the elected species FIGS. 4A-4C, are objected to under 37 CFR 1.83(a) because they fail to show how the handle is hingedly, rotatably, or pivotally coupled to the body as described in the specification and claim 12. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: In paragraph [0078], it says "first channel 214B". Based on the context of the paragraph, this should be revised to say "second channel 214B". For the purpose of examination, the examiner will interpret as the suggested correction.
Appropriate correction is required.
Claim Objections
Claim 9 objected to because of the following informalities: The end of the claim appears to be missing a conjunction "...super-elastic material, Nitinol, composite." Based on the structure of claims 8 and 10, the claim should be revised using the conjunction "or". Therefore, the corrected language should read "...super-elastic material, Nitinol, or composite." For the purposes of examination, the examiner will interpret the claim as if the conjunction "or" was used. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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, 2, 5-6, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chow et al. (United States Patent Application Publication No. US 2016/0242862 A1; herein, Chow).
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) defining a channel extending longitudinally along a first axis (FIG. 10, trenches 112), the channel configured to retain the portion of the catheter placement system (FIG. 11), and having an opening extending longitudinally and configured to allow ingress or egress along a second axis extending at an angle to the first axis of the channel (FIG. 11, openings at the ends of either sides of the trenches 112 allow for medical device 65 to pass in one side and out the other); 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).
Regarding claim 2, 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, 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, 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, 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, Chow discloses wherein the handle extends from the body at an angle relative to the first axis of the channel (FIG. 7).
Claim Rejections - 35 USC § 103
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chow as applied to claim 2 above, and further in view of Mitchell et al. (United States Patent Application Publication No. US 2019/0255294 A1; herein, Mitchell).
Regarding claim 3, Chow discloses wherein the body (base piece 95) includes a first channel and a second channel configured to retain (FIG. 7, trenches 112) a portion of the catheter placement system. Chow is silent on the portion of the catheter placement system specifically being a first extension leg and a second extension leg. However, Mitchell teaches a first extension leg and a second extension leg (FIG. 1, extension tubes 29, 30, 31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medical device as disclosed by Chow with the extension tubes as taught by Mitchell in order to administer different treatments simultaneously with the multiple lumens of the extension tubes, rather than the single lumen of the medical device.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chow 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, 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 openings of the trenches as disclosed by Chow to have smaller widths than the outer diameter of a medical device, such as a tube, as taught by Nakajima in order for a more secure fit to be achievable between the trenches and the medical device, reducing the risk of the medical device falling out of place.
Claims 8-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chow 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, 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 base piece or hand held portion disclosed by Chow to be formed of a rigid material such as plastic as taught by Brellis in order that the structure of the device be stiff enough to withstand grasping by a user and have better resistance to deformation.
Regarding claim 9, 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.”). . 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 base piece or hand held portion disclosed by Chow to be formed of an elastic material such as rubber as taught by Brellis in order that the device be able to deform with the grip of the user and remain in handling position, but also reform into its original shape after for reuse.
Regarding claim 10, 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 base piece or hand held portion disclosed by Chow to be formed of both rigid and elastic materials as taught by Brellis in order that the structure of the device be stiff enough to withstand grasping by a user and resistant to complete deformation, while also allowing enough deformation to fit the grip of the user and remain in handling position.
Regarding claim 12, Chow does disclose wherein the handle is hingedly, rotatably or pivotally coupled to the body. However, Brellis teaches wherein the handle is hingedly, rotatably or pivotally coupled to the body (FIG. 9 and 10, [0068], front portion pivots about axis which extends from handle body). 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 hand held portion disclosed by Chow to be pivotally coupled to the body as taught by Brellis in order that additional degrees of freedom be allowed by the hand held portion of the device to react naturally with movements of the user.
Conclusion
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..
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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
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783