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 Arguments
Applicant’s amendments and arguments, filed 8 October 2025, with respect to the rejections of the claims, as amended, over Geiger and Anand have been fully considered and are partially persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Geiger, Anand, and Vase, as presented below.
Applicant argues that the combination of Geiger and Anand lack controller based modulation of CSF flow direction, temporal flexibility, a therapeutic kit, or controller logic. The Examiner has added the Vase reference to disclose the use of bidirectional control and controller logic.
With regard to claim 10, Geiger and Anand disclose the claimed device; recitation drawn to the operation of the device is not afforded patentable weight to a device claim.
Applicant did not argue claims 2-4 and 14-16 separately.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over US 10,272,188 to Geiger et al in view of US 9,682,193 to Anand et al, further in view of US 2017/0096549 to Vase et al.
In the Specification and figures, Geiger and Anand suggest the apparatus as claimed by Applicant. With regard to claim 10, Geiger discloses a pump 206 that provides directional flow, catheters 102/202, 104/204, an access port 244, a controller, and sensors connected to the pump, suggesting couplings. Anand discloses an antisense oligonucleotide material. Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.
With regard to recitation of flow directions, 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.
Claims 1-9 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,272,188 to Geiger et al in view of US 9,682,193 to Anand et al, further in view of US 2017/0096549 to Vase et al.
In the specification and figures, Geiger discloses a system and method for treating a patient substantially as disclosed by Applicant. With regard to claims 1-8, Geiger discloses a method of treating a patient comprising the steps of coupling a fluid channel between a patient’s lumbar region 104/204 and a brain ventricle 102/202, wherein the fluid channel has an access port 242/244 and a pump 206 with a controller, actively pumping CSF between the lumbar and the ventricle, with the option of adding a drug via port 244 (see Geiger FIGS 1-2, column 3, line 59 to column 4, line 67). Geiger does not disclose the use of antisense oligonucleotide material. However, Anand discloses a CSF treatment method comprising the infusion of a bolus of antisense oligonucleotide material into the CSF of a patient, which may be followed up with pulsatile delivery (see Anand column 3, lines 37-45, 57-60). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use antisense oligonucleotide material as disclosed by Anand in the method disclosed by Geiger, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP § 2144.07.
With regard to oscillating the directional flow through the pump, Vase discloses a CSF fluid treatment loop 100 with catheters 104, pump 116, and the steps of removing fluid through one catheter and returning it through a second catheter (see Vase FIG 2 and accompanying text). Vase further discloses that the fluid flow may be stopped (at which time natural flow processes dictate the direction of flow) or reversed in order to provide control over fluid flow characteristics (see ¶0078-0079, 145). It would have been within the skill of a person with ordinary skill in the art at the time of filing to stop or reverse the fluid flow, as taught by Vase, in the method suggested by Geiger and Anand in order to allow the user complete control over fluid flow characteristics. The prior art 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 Geiger, Anand, and Vase.
With regard to claims 9, 13, 17-19 Geiger illustrates a closed-loop system, suggesting the coupling steps claimed by Applicant (see also rejections of claims 1, 5-7 above).
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 20 October 2025