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 § 103
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 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.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk (U.S. Pub. 2018/0263752 A1, hereinafter “Pinchuk”) in view of Allen et al (U.S. Pub. 2014/0364835 A1, hereinafter “Allen”), further in view of Watanabe et al (U.S. Pub. 2014/0094777 A1, hereinafter “Watanabe”).
Regarding claim 9, Pinchuk discloses a method of delivering a therapeutic agent into a target issue through a target vessel, comprising:
a) advancing a distal end of a system (see, e.g., 1200 in Figs. 24-26) for temporarily occluding a blood vessel, into the target vessel (see para [0063], disclosing advancing the occluder to a treatment site), the system comprising:
i) a flexible tubular member (combination of 1202 and 1208; see Fig. 24) having a proximal end 1210 (see Fig. 24) and a distal end 1212 (see Fig. 24), an infusion lumen 320 extending between the proximal and distal ends, the infusion lumen having a distal orifice 1258 (see Fig. 25) at the distal end, and
ii) an expandable occluder 1214 (see Fig. 24 and para [0096] disclosing that the occluder 1214 automatically expands in view of inherent outward spring bias of the filter) comprising a distal fluid permeable portion 1236 (see para [0096] disclosing that the distal portion 126 is free of a polymeric filter, and otherwise appears in Fig. 24 to permit fluid to flow through the braids of the occluder) and mounted at the distal end 1212 of the flexible tubular member, the distal end of the flexible tubular member extending through the expandable occluder such that the orifice is positioned distal of the expandable occluder (as clearly shown in Figs. 24-26);
b) expanding the expandable occluder within the target vessel to block blood flow past the occluder within the vessel (see para [0063], disclosing fully opening the occluder so that the occluder contacts the vessel wall so that a large pressure differential is generated between the proximal and distal sides of the occluder);
c) then infusing a therapeutic agent through the infusion lumen and out of the distal orifice into the vessel distal of the occluder (see para [0063] disclosing infusing an infusate through the orifice of the inner catheter to a location distal of the occluder), and
g) leaving the expandable occluder expanded post-infusion for at least a dwell time (see para [0064]).
Pinchuk does not appear to disclose:
a first pressure sensor positioned proximal to the distal fluid permeable portion of the expandable occluder (as per section (a)(iii));
a second pressure sensor positioned proximal to the expandable occluder (as per section (a)(iv));
measuring a first fluid pressure distal of the expandable occluder in the target vessel with the first pressure sensor, wherein the first pressure sensor is in fluid communication with a portion of the target vessel distal of the occluder and noise from turbulent flow generated by infusion of the therapeutic agent is prefiltered from the first pressure sensor (as per section (d));
measuring a second fluid pressure proximal of the expandable occluder in the target vessel with the second pressure sensor (as per section (e)); and
controlling the infusion of the therapeutic agent through the infusion lumen based on the first fluid pressure and the second fluid pressure (as per section (f)).
Allen discloses a system for delivering a therapeutic agent to a blood vessel of a patient, comprising an expandable occluder 1110 (see Fig. 36) inserted into a target blood vessel, a first pressure sensor 1112 located distally of the occluder (see Fig. 36) that measures a first fluid pressure of blood in the vessel exposed to the occluder by being in fluid communication with the portion of the vessel distal of the occluder, and a second pressure sensor 1114 located proximally of the occluder (see Fig. 36) that measures a second fluid pressure of blood in the vessel exposed to the occluder (see para [0148]).
Allen further discloses controlling the infusion of the therapeutic agent through the infusion lumen based on the first fluid pressure and the second fluid pressure (see para [0148], disclosing the two pressure sensors described above being used to monitor and control “injection pressure”—this term is understood to mean pressure of injection of, for example, a therapeutic embolic agent, as disclosed in para [0013]). Allen teaches that it is desirable to control the injection pressure to avoid retrograde reflux of drug backward over the catheter (see para [0013]).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the method of Pinchuk to provide the first and second pressure sensors in the claimed configuration and performing the method steps according to sections (d), (e) and (f), in order to avoid retrograde reflux of drug backward over the catheter, as taught in Allen (see Allen at para [0013]), with a reasonable expectation of success.
Further, Pinchuk does not appear to disclose that the dwell time recited in section (g) occurs “post-infusion … sufficient for transport of the therapeutic agent through a wall of the target vessel and into the target tissue.”
Watanabe discloses a device for delivering a medication to a vessel (see Abstract), and teaches that it is desirable to maintain the device in an occluded position post-infusion for a dwell time sufficient for perfusion of therapeutic agent, i.e., transport of the agent through the wall of the target vessel and into the target tissue, in order to prevent washout of the medicament or unwanted exposure of same in the body (see Abstract, paras [0003], [0020], [0023], [0028]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Pinchuk, according to the teaching in Watanabe, in order to leave the expandable occluder expanded post-infusion for a dwell time sufficient for transport of the therapeutic agent through the wall of the target vessel and into the target tissue, in order to prevent washout of the unperfused medicament and/or unwanted exposure of same in the body.
Examiner notes that claim 9 recites that “noise from turbulent flow generated by infusion of the therapeutic agent is prefiltered from the first pressure sensor”, which appears to be implicit in the combination of Pinchuk and Allen. Specifically, the first pressure sensor would be located on the proximal side of the partially porous occluder of Pinchuk; therefore, it appears that noise from the turbulent flow generated by infusion of the therapeutic agent on the distal side of the occluder would be “prefiltered” by the physical geometry of the occluder.
Regarding claim 10, it appears that infusion of the therapeutic agent would implicitly modify a pressure gradient in the target vessel between the first and second fluid pressure sensors of the combination of Pinchuk and Allen, based on the infusion of therapeutic agent occurring distal to the occluder, and the pressure gradient would at least in part affect the transport of the therapeutic agent (see Figs. 9-11, for example, showing the differential pressure on opposing sides of the occluder that is used to perfuse vessels of different sizes based on the differential).
Regarding claim 11, Allen discloses real-time monitoring of the pressure gradient, interpreted to mean while the infusion of fluid is occurring, based on the teaching in Allen that that the pressure sensors are used to monitor and control injection pressure at the same time (see para [0148]).
Claims 12, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk, in view of Allen, further in view of Watanabe, further in view of Dedrick et al (U.S. Pat. 3,946,734, hereinafter “Dedrick”).
Regarding claims 12, 13 and 15, it is noted that Pinchuk, in view of Allen and Watanabe, does not appear to disclose that dwell time is determined, at least in part, based on the diffusion rate of a molecule of the therapeutic agent, where the diffusion rate of the molecule is predicted, at least in part, by the molecular mass of the molecule, and the transport rate of the therapeutic agent is determined, at least in part, by osmotic characteristics of the therapeutic agent in the target vessel.
Dedrick discloses that it may be desirable to use diffusion rate of a therapeutic agent (which is inherently predicted in part by the molecular mass and osmotic characteristics of the agent) to determine how much of the therapeutic agent is diffused into surrounding body tissue in a given time unit (see col. 1, line 60 to col. 2, line 3).
A skilled artisan would have found it obvious at the time of the invention to determine the amount of agent desired to diffused based on the diffusion rate during a set period of time based on the diffusion rate of a molecule of the therapeutic agent, based on the teaching in Dedrick, and to use the amount of agent to determine the dwell time that the occluder is open, with a reasonable expectation of success.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk, in view of Allen, further in view of Watanabe, further in view of Huang et al (U.S. Pub. 2017/0166598 A1, hereinafter “Huang”).
Regarding claim 14, it is noted that Pinchuk, in view of Allen and Watanabe, does not appear to disclose that one of the at least one therapeutic agent at least partially replaces the oxygen and/or nutrient requirements of the target tissue.
Huang discloses a method of infusing a pharmaceutically active drug by intravascular means (see para [0547]), and further discloses that it is known in the art for the drug to be infused with an agent that at least partially replaces oxygen and/or nutrients in target tissue, such as Ringer’s solution (see para [0113]).
A skilled artisan would have found it obvious to modify the method of Pinchuk so that the at least one therapeutic agent at least partially replaces the oxygen and/or nutrient requirements of the target tissue, such as by the delivery of the drug with Ringer’s solution, as taught in Huang, as Ringer’s solution was a well-known pharmaceutically acceptable carrier for delivering drugs intravascularly without destroying the pharmacological activity of the drug (see Huang, at para [0113]).
Response to Arguments
Applicant’s arguments, filed in Remarks on 08/06/2026, with respect to claims 9-15 have been considered.
RESPONSE TO REJECTIONS UNDER 35 U.S.C. § 103
Applicant argued that Pinchuk does not teach or suggest step (g) of claim 1 (see Remarks, pg. 7). This argument is moot in view of the new ground of rejection incorporating Watanabe.
Applicant also argued that the Office action “cites to Fig. 36 of Allen and appears to equate pressure sensor 1112 of Allen with the ‘first pressure sensor positioned proximal to the distal fluid permeable portion of the expandable occluder’” (see Remarks, pg. 8).
However, the Office action states that “Allen discloses a first pressure sensor 1112 located distally of the occluder (see Fig. 36) that measures a first fluid pressure of blood in the vessel exposed to the occluder by being in fluid communication with the portion of the vessel distal of the occluder, and a second pressure sensor 1114 located proximally of the occluder (see Fig. 36) that measures a second fluid pressure of blood in the vessel exposed to the occluder” (see Non-Final Rejection dated 02/17/2026, pg. 5, and present Office action, pg. 4). Allen was clearly relied upon for its teaching of a pressure sensor 112 positioned distal to—not proximal to—the distal fluid permeable portion of the expandable occluder.
Applicant also argued that “the inflatable balloon 1110 of Allen cannot include a distal fluid permeable portion as recited by amended claim 9” (see Remarks, pg. 9). However, the Office action did not rely on Allen for teaching an inflatable balloon 1110 that includes a distal fluid permeable portion; the Office action relied on Pinchuk for its teaching of an balloon with a distal fluid permeable portion.
Applicant also argued that Allen does not teach or suggest step (d) of claim 9 (see Remarks, pg. 9). But Allen does, in fact, teach measuring a fluid pressure of the expandable occluder distal of the occluder with the pressure sensor 1112 (see Allen at para [0148]). Although Allen does not explicitly disclose that noise from the turbulent flow is prefiltered from the first sensor, it was noted that this teaching would be impliciti in the combination of Pinchuk and Allen. Specifically, the first pressure sensor would be located on the proximal side of the partially porous occluder of Pinchuk; therefore, it appears that noise from the turbulent flow generated by infusion of the therapeutic agent on the distal side of the occluder would be “prefiltered” by the physical geometry of the occluder.
Applicant also argued that Allen does not teach or suggest step (f) of claim 9 (see Remarks, pg. 10), alleging that Allen does not disclose “how the injection pressure is controlled.” But, as noted in the Office action, Allen does, in fact, disclose the two pressure sensors described above being used to monitor and control “injection pressure.” While it is acknowledged that Allen does not go into great detail about this control, it is nonetheless consistent with Applicant’s claim 9, which also contains no detail about the control beyond that it is “based on the first fluid pressure and second fluid pressure”.
Claims 12, 13, 14 and 15 were alleged to be patentable based on claim 9, but were not specifically argued on the merits of the Office action’s combination of Pinchuk, Allen and Watanabe (see Remarks, pgs. 11-12).
Conclusion
Additional prior art of record is believed to be relevant to Applicant’s claims, but was not relied upon in a rejection:
Vinten-Johansen (U.S. Pat. 7,686,781 B2, hereinafter “Vinten-Johansen”) discloses a catheter adapted for use in passing fluids and medicines therethrough for use in the perfusion or reperfusion of blood or blood-fluid mixtures into the arteries, veins, tissues, conduits, or organs of a patient (see Abstract). Vinten-Johansen teaches that it is desirable to maintain an occluder open within tissue, to pass medication into the space where the occluder is located, and to retain the occluder in place post-infusion “for a specified time” in order to allow “higher concentrations of the desired medications to be used than would otherwise be tolerated if given systemically.” (See col. 6, lines 12-16). After the occluder is retained for the specified time, Vinten-Johansen teaches that it can be deflated, at which time non-perfused volumes can be re-aspirated into the catheter or washed into general circulation (see col. 6, lines 16-19). Vinten-Johansen teaches that this procedure, which is referred to as “elimination of the medications used in the space”, depends on toxicity and side effects of the medications (see col. 6, lines 19-21).
THIS ACTION IS MADE FINAL. 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.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 10/13/2026
