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 .
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2014/0316378 to Magnenat et al. (Magnenat hereinafter).
Regarding claim 1, Magnenat teaches a therapeutic delivery system, comprising: a cannula (see e.g. paragraph 49) configured to deliver a therapeutic (product, see e.g. paragraph 1) into an anatomical region, the cannula having an internal lumen (part of fluid path discussed in paragraph 9); a pumping system (9) coupled to the cannula, the pumping system being inline of a therapeutic flow pathway (fluid path, paragraph 9) between a therapeutic source (of product, not illustrated) and the cannula, the pumping system configured to drive the therapeutic from the therapeutic source and toward the cannula (see e.g. paragraph 9, “administration of a solution such as insulin”).
Regarding claim 2, Magnenat teaches a tubing (behind 5, see Fig. 9, as discussed in paragraph 49, re “channel”).
Regarding claim 3, Magnenat teaches a tubing (behind 5, see Fig. 9, as discussed in paragraph 49, re “channel”).
Regarding claim 6, Magnenat teaches direct connection to the cannula (via tracks 8).
Claim(s) 1-6, 8-12, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2012/0209240 to Gray (Gray hereinafter).
Regarding claim 1, Gray teaches a therapeutic delivery system (see Fig. 3), comprising: a cannula (5010, see paragraph 238, “an infusion device 5010 – for example, a cannula”) configured to deliver a therapeutic fluid (see e.g. paragraph 12) into an anatomical region, the cannula having an internal lumen; a pumping system (16) coupled to the cannula, the pumping system being inline of a therapeutic flow pathway (310) between a therapeutic source (20) and the cannula, the pumping system configured to drive the therapeutic from the therapeutic source and toward the cannula.
Regarding claims 2 and 3, Gray teaches tubing (310) as part of the fluid pathway.
Regarding claim 4, Gray teaches a therapeutic source (20).
Regarding claim 5, Gray teaches a device holding therapeutic fluid (reservoir 20, see e.g. paragraph 237).
Regarding claim 6, Gray teaches that the pumping system may be directly attached to the cannula (see e.g. Fig. 69B).
Regarding claim 8, Gray teaches an outer housing defining a fill chamber (2350, see e.g. Fig. 15C-D); an inlet (see Fig. 28, left of 21) to the fill chamber, wherein the inlet provides fluid communication between the therapeutic source and the fill chamber via an input tubing (310); an outlet (see Fig. 28, left of 22) from the fill chamber, wherein the outlet provides fluid communication between the fill chamber and the cannula via an output tubing (310); an input valve (21, see paragraph 300) coupled to the inlet, wherein the input valve regulates flow from the input tubing into the fill chamber such that the input valve permits fluid flow into the fill chamber and blocks fluid flow out of the fill chamber via the input tubing; an output valve (22) coupled to the outlet, wherein the output valve regulates flow from the fill chamber into the output tubing such that the output valve permits fluid flow out of the fill chamber and blocks fluid flow into the fill chamber via the outlet tubing; a mechanism (54) coupled to the fill chamber, wherein the mechanism causes a pressure differential that draws fluid via the inlet into the fill chamber and pushes fluid out of the fill chamber via the outlet.
Regarding claim 9, Gray teaches that the mechanism is a plunger piston (54, see paragraph 348).
Regarding claim 10, Gray teaches that the mechanism may be diaphragm (2356).
Regarding claim 11, Gray teaches that the pumping system (16) and cannula (5010) share a common structure (such as tubing 310 or casing x, y).
Regarding claim 12, Gray teaches that the therapeutic is pressurized at least to approximately atmospheric pressure before entering the fill chamber.
Regarding claim 19, Gray teaches a common structure (x, y).
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(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Magnenat.
Regarding claims 4 and 5, Magnenat teaches the limitations of claim 1 from which these claims depend, but does not explicitly teach a therapeutic source. However, since Magnenat teaches a pump for applying a product, one of ordinary skill in the art would plainly expect a therapeutic source to be present, including some sort of device for holding the therapeutic. Furthermore, the examiner takes official notice that such structures are well known in the art, based on his personal experience of April 2019 and earlier. As such, to any extent to which Magnenat does not teach a therapeutic source and device for holding therapeutic, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to use such a device in order to supply the product of that reference.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray in view of US Pre-Grant Publication 2006/0173412 to Susi (Susi).
Regarding claim 7, Gray teaches the limitations of claim 1 from which claim 7 depends but does not teach the limitations of MRI compatibility. Susi teaches another infusion apparatus generally, and particularly teaches that MRI compatibility is necessary during the use of MRI technology (paragraphs 11-12) in order to avoid interference with the imaging. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide the infusion set and pump of Gray as MRI compatible components as taught by Susi in order to prevent interference with MRI imaging.
Claim(s) 13-15 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray in view of U.S. Patent 1,643,744 to Lowenfield.
Regarding claim 13, Gray teaches the limitations of claim 1 as discussed above, and also teaches an outer housing defining a fill chamber (2350, see e.g. Fig. 15C-D); an inlet (see Fig. 28, left of 21) to the fill chamber, wherein the inlet provides fluid communication between the therapeutic source and the fill chamber via an input tubing (310); an outlet (see Fig. 28, left of 22) from the fill chamber, wherein the outlet provides fluid communication between the fill chamber and the cannula via an output tubing (310), as well as a mechanism (54). Gray does not teach a single valve operating as the intake and outlet valve. Lowenfield teaches another medical fluid device generally (see.e.g. col. 1, ln. 1-3) and particularly teaches a valve (c, see col. 1 ln.19-32) which has one or more openings through which fluid can flow from the input tubing into the fill chamber when the valve is in a first position (end of upstroke, see col. 1, ln. 19-32), and wherein the valve blocks fluid flow out of the fill chamber via the output tubing when the valve is in the first position; and wherein the single valve transitions to a second position wherein the fluid can flow from the fill chamber into the output tubing via the opening, and wherein the single valve blocks fluid flow into the fill chamber via the outlet tubing when the single valve is in the second position (end of downstroke, see col. 1, ln. 19-32). Lowenfield thus teaches a valve system in accordance with the claimed invention. Since Gray differs from the invention of claim 13 only in the structure of the inlet/outlet valving, and corresponding structure is taught by Lowenfield, it would have been obvious to those of ordinary skill in the art at the time of the effective filing date to use a slide valve as taught by Lowenfield in place of the valves of Gray as the mere substitution of one inlet/outlet valving arrangement for another.
Regarding claim 14, Lowenfield teaches sliding.
Regarding claim 15, Gray teaches that the pumping system (16) and cannula (5010) share a common structure (such as tubing 310 or casing x, y).
Regarding claim 17, Gray teaches that the mechanism (54) pushes fluid into at least a downstream portion of the fill chamber (2350).
Regarding claim 18, Gray teaches that the mechanism sucks fluid into the fill chamber (paragraph 323).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray in view of US Pre-Grant Publication 2007/0060974 to Lozano (Lozano).
Regarding claim 16, Gray teaches the limitations of claim 1 as discussed above, but does not teach a transcranial infusion. Lozano teaches another infusion device generally, and particularly teaches that a transcranial path (522A) may be used for infusion (paragraph 20). Lozano teaches that this is useful to treat various disorders (paragraph 21). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a transcranial infusion path as taught by Lozano with the system of Gray in order to treat various disorders.
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 7 January 2026