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 .
Response to Amendments/Arguments
Applicant’s amendments and arguments, filed 30 September 2025, with respect to the rejections of the pending claims, as amended, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of US 2020/0046952 to Vase et al.
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.
Claim 16 recites the limitation “the outlet port” in line 2. There is insufficient antecedent basis for this limitation in the claim. The Examiner is interpreting claim 16 to depend from claim 13.
Claim 17 recites the limitation "the therapeutic material" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 12, 17-21, 24, 25, 34, 37 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0046952 to Vase et al.
In the specification and figures, Vase discloses the method substantially as claimed by Applicant. With regard to claims 1, 12 and 25, Vase discloses the steps of forming a CSF circuit with a pump 36, catheters 44, 48, 46, flowing CSF through the catheter, adding a therapeutic material to the circuit, flowing the CSF through the circuit, measuring a parameter of the CSF fluid, and controlling the method of treatment based on the measured parameters, including drug concentration (see FIG 4, ¶0146, 0202, 0220). The Vase reference itself reflects the level of ordinary skill in the art, and such a skilled artisan would have appreciated that the method claimed could be performed based on the steps outlined by Vase.
With regard to claims 17 and 18, Vase ’952 discloses a CSF circuit with a pump 36, catheters 44, 48, 46, valves, and a flow controller with a monitor (see FIG 4, ¶0004, 0146, 0202, 0220, 0222).
With regard to claims 19-21, 24, Applicant is setting forth the intended use of the claimed apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114. Nonetheless, see the rejections of claims 2-4 and 10, below.
With regard to claims 22-23, Vase ’952 discloses that there may be many sensors, at least one of which may measure CSF pressure, cytokine markers, and drug concentration (see ¶0012, 0219-0220).
With regard to claims 34, 35, 37-39, Vase ’952discloses a medical device comprising catheters 44, 48, 46 with a flow through bore or lumen, valves, CSF monitor/sensors, and a flow controller, pump 36, container 38 and ports for infusing liquid medication (see FIG 4, ¶0146, 0157, 0202, 0222).
With regard to claim 36, Vase does not disclose that manifold 26 comprises multiple outlet ports. However, it has been held that the mere duplication of the parts of an apparatus found in the prior art is not patentably significant unless a new and unexpected result is produced. See MPEP § 2144.04 (VI)(B). In the instant case, a plurality of sampling ports does not provide a new and unexpected result.
Claims 2-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0095649 to Vase et al in view of 2020/0046952 to Vase et al.
In the specification and figures, Vase ’649 discloses the method substantially as claimed by Applicant. With regard to claims 2-3, Vase ’649 discloses the steps of forming a CSF circuit 106 with at least one sensor 114, pump 116, catheters 130, 131, flowing CSF through the catheter, adding a therapeutic material to the circuit, flowing the CSF through the circuit, measuring a parameter (temperature) of the CSF fluid, and controlling the method of treatment based on the measured parameters (see FIG 19, 0074, 0135, 0137, 0140). In particular, Vase ’649 teaches adjusting fluid flow rates to meet a desired goal. Vase ’649 uses temperature as a therapeutic treatment, and teaches that the flow rate may be varied (increased or decreased) in order to reach a desired temperature (see ¶0129-0133, 0144, 0165).
Vase ’649 does not disclose measuring a parameter of the therapeutic material. However, Vase ’952 discloses a CSF shunting method (see rejections above) including adding a therapeutic material to the circuit, flowing the CSF through the circuit, measuring a parameter of the CSF fluid, and controlling the method of treatment based on the measured parameters, including drug concentration, in order to control toxicity (see FIG 4, ¶0146, 0202, 0220). It would have been obvious to a person having ordinary skill in the art to add the monitoring method disclosed by Vase ’952 to the circulation method disclosed by Vase ’649 to control toxicity, as taught by Vase ’952.
With regard to claim 4, Vase ’649 teaches that the catheter flow direction may be reversed, teaching that controlling a flow mate may comprise flow direction reversal (see ¶0080).
With regard to claim 5, Vase ’649 discloses that parameter monitoring may be used to increase, decrease, alter, or maintain a treatment, suggesting the steps claimed by Applicant (see ¶0159).
With regard to claims 6 and 7, Vase ’649 discloses that there may be several sensors within the system, at least one of which may measure CSF pressure, cytokine markers, and drug concentration (see ¶0159, 0175).
With regard to claim 8, Vase ’649 does not specifically disclose “disconnecting” a portion of the circuit from the patient, but does disclose ending treatment, after which the patient would be disconnected (see ¶0157). The change in a fluid flow rate is necessarily made before disconnection because there is no fluid to control if the tubing is disconnected.
With regard to claim 9, Vase ’649 does not specifically disclose “disconnecting” a portion of the circuit from the patient, but does disclose ending treatment, after which the patient would be disconnected (see ¶0157). The change in a fluid flow rate to be used for a new session is not germane to the instantly claimed method, because a new session is hypothetical, and does not limit the scope of the claimed method.
With regard to claim 10, Vase ’649 discloses that the parameters of the system (including flow rate) may be effectuated by processing unit 118, teaching automation (see ¶0144).
With regard to claim 11, it has been held It has been held that the mere duplication of the parts of an apparatus found in the prior art is not patentably significant unless a new and unexpected result is produced. See MPEP § 2144.04 (VI)(B). The same logic holds true for methods. Simple repetition of the steps of a method in two sessions with two different catheters is not patentably distinct from the cited prior art.
Claims 13-16, 26-33 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0095649 to Vase et al in view of 2020/0046952 to Vase et al, further in view of US 2019/0009014 to Chen et al.
In the specification and figures, the cited prior art suggests the method and apparatus substantially as claimed by Applicant (see rejections above). With regard to claims 13, 14, 16, 17, 26-30, the prior art does not disclose a sealable sampling port. Chen discloses a CSF microdialyzer apparatus and method comprising a first and second catheter, pumps 18, 20, and a sample access port 26 comprising a self-sealing membrane (see FIGS 1, 2, ¶0077). Chen discloses that samples may be taken from the port, suggesting the use of
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a container to collect such a sample (see ¶0106). While Vase does not disclose a sample port, the reference does disclose the use of sensors to control the CSF treatment. Chen discloses taking samples, but does not disclose using those samples to control the CSF treatment, rather relying on implanted sensors to control treatment (see ¶0085, 0086). Taken as a whole, one of ordinary skill in the art would be motivated to use a sampling port as disclosed by Chen to monitor the quality of CSF during treatment, as disclosed by Vase, in order to control treatment parameters, as taught by Vase.
With regard to claims 15, 28, 29, it has been held that the mere duplication of the parts of an apparatus found in the prior art is not patentably significant unless a new and unexpected result is produced. See MPEP § 2144.04 (VI)(B). In the instant case, a plurality of sampling ports does not provide a new and unexpected result.
With regard to claim 18, Vase ’649 and ’952 disclose the use of a peristaltic roller pump, a dry pump (see ¶0148).
With regard to claims 19, 20, and 21, see the rejections of claims 2, 3, and 4, respectively, above.
With regard to claims 22, 23, see the rejections of claims 6, 7, respectively, above.
With regard to claims 24, 25, see the rejections of claims 10, 12, respectively, above.
With regard to claim 31, Chen discloses the step of gathering a sample. The step of “for off-site analysis after the end of the CSF session” is a statement of intended use of the collected sample. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114.
With regard to claims 32-33, Vase ’649 and ’952 disclose a housing that may comprise the pump and interface, sensors, and valves (see at lease Vase ’649 FIG 37 and accompanying text, Vase ’952 FIG 4). Chen also discloses a base substrate 10 with pumps 18, 20, a manifold 26 that may receive multiple containers, a guide configured to couple to catheter 14, to the substrate (see FIGS 2-4 and accompanying text). Taken together, references reasonably suggest a CSF management system of claim 17 provided on a base substrate.
Conclusion
Applicant's 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 LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Casler can be reached on 571-272-4956. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 6 October 2025