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
Claim1-6 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 3, 2026.
Claim Objections
Claim 11-15 are objected to because of the following informalities:
Claim 11 and 15 depend from claim 7 but the preamble has been changed. Suggested correction would be “The fluid circulation system according to claim 7, which further comprises a connector comprising:”
Claims 12-14 which depend from claim 11 have the same objection.
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.
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.
Claim(s) 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts US 20210052866A1 in view of Vase 20160051801 A1.
Regarding claim 7, Roberts discloses a fluid circulation system configured to inject a fluid into a subarachnoid space and to discharge the fluid in the subarachnoid space from a body of a patient (abstract), the fluid circulation system comprising: a catheter system including a first tube and a second tube, the first tube is configured to be inserted into the subarachnoid space of the patient and to discharge the fluid present in the subarachnoid space out of a body of the patient through a space between the inner cavity of the first tube and an outer side of the second tube ([0138-139, 141] which discloses the removal of CSF through a first lumen and addition of oxygenated fluid through a second lumen); an oxygen supply device configured to oxygenate the fluid ([0168]); and wherein the fluid including cerebrospinal fluid is configured to be discharged from the subarachnoid space of the patient through the inner cavity of the first tube and the oxygenated fluid is injected through the second tube into the subarachnoid space [0138-139, 141].
Roberts fails to disclose the second tube having an outer diameter smaller than an inner diameter of the first tube and is configured to be arranged in an inner cavity of the first tube. Roberts however does disclose the tubes can be separate or in a dual lumen configuration.
Vase teaches a CSF exchange system thereby being in a related field of endeavor as the instant claims and Roberts. Vase teaches a dual lumen system in which a first tube 20 through which a second inner tube 30 is placed into ([0086])
It would have been obvious to use dual lumen specially concentric as suggested by Vase over a generic dual lumen catheter was disclosed by Roberts in order to allow for a single entry hole into the subarachnoid space which will minizine infection risk, would healing, pain, and recovery.
Regarding claim 8, Roberts discloses wherein the fluid circulation system comprises a pump system including at least one pump, the at least one pump configured to inject and/or discharge the fluid ([0119]).
Regarding claim 9, Roberts in view of Vase wherein Vase further discloses an end portion of the second tube is configured to be exposed from an end portion of the first tube in a longitudinal direction of the first tube (Vase- fig 1).
Regarding claim 10, Roberts in view of Vase wherein Vase further discloses wherein the second tube is movable in the inner cavity of the first tube (Vase-[0086]).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts US 20210052866A1 in view of Vase 20160051801 A1 and in further view of Bierman US 6361523 B1.
Regarding claim 15, Roberts and Vase fail to discloses wherein the connector fixture is configured to fix a connector, the connector being connected to the catheter system, and wherein the connector fixture comprises: a body surface attachment portion attached to the body surface of the patient; a tube holding portion configured to hold the first tube; a connector attachment portion to which the connector is attached; and wherein the tube holding portion has a curved portion provided at a portion with which the first tube comes into contact, and the connector attachment portion is configured to adjust an attachment position of the connector along an axial direction of the first tube.
Bierman discloses a medical device holder thereby being drawn to solve the same problem as the instant claim. Bierman discloses a connector (10) which attaches the catheter to the patient’s body. The connector has a body surface attachment (or anchor pad, 12) and a tube holding portion (or retainer, 20) and a connector attachment (or upper surface of the anchor to which the tube connector attaches to. The tube holder has a curved portion to match the tube’s diameter (Col. 6 lines 10-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have used a connector to attach the catheter to the patient to prevent accident dislodgment of the catheter from the patient’s body.
Allowable Subject Matter
Claim 11 and depending claims 12-14 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The cited prior arts of record teach the overall system and a multi tube holder and securement device; however, they fail to teach alone or in combination that there’s a holding device or clamp sized relative to the different diameters of the first and second tube to maintain the position of the a first tube relative to the second tube and an outlet portion which allows a flow path between an inner cavity of the first tube and outer cavity of the second tube residing within the first tube.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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