DETAILED ACTION
Response to Amendment
The amendment filed June 15, 2026, has been entered. Claims 1, 13-15, and 17 have been amended and claim 3 has been cancelled. Claims 1, 2, 4-9, 11-28 are currently pending in the application.
Response to Arguments
Applicant's arguments filed June 15, 2026, have been fully considered but they are not persuasive. Regarding Applicant’s arguments as to the transition section and the inner member being in a proximal section should overcome the cited prior art, the Examiner respectfully disagrees. As depicted below in the annotated figure, the distal end of the outer member can be broken into a proximal segment that receives the inner member as claimed. The claim does not require the proximal section to be adjacent to the terminal proximal end of the device or in any other manner which might prevent such an interpretation. For this reason, the rejection is maintained as set forth below.
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, 2, 5-9, 11, 16, 19, 22-25, 27, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samson et al. (US 2004/0158191).
Regarding claim 1, Samson et al. (henceforth Samson) discloses (Figure 2) a catheter system for infusing a chilled fluid into a subject (¶ [0031] discloses the delivery of hypothermically chilled fluid into the subject), comprising: an outer elongate member (48, Figure 2) sized for insertion into a body cavity of a subject and having a proximal section, a distal section, and a transition section disposed between (seen in Figure 2 wherein the distal end forms a conical taper to the narrower terminal distal end; see annotated figure below wherein the “distal end” of the outer member can be broken into proximal and distal sections with the transition region therebetween as claimed), and in fluid communication with, a proximal section and a distal section of the outer elongate member (Figure 2), said distal section being an infusion lumen (¶ [0032]; the supply lumen 24a provides fluid for exiting the distal end of outer catheter 48 via distal port 22a); an inner elongate member (46) extending within the proximal section of the outer elongate member (Figure 2) and having an input lumen permitting fluid to flow in a forward direction from a proximal end of the inner elongate member to a distal end of the outer elongate member and into the body cavity (¶ [0032] and Figure 2; fluid flows from the fluid source through the supply lumen and out the distal end of the outer member via port 22a and into the body cavity), wherein a distal end of the inner elongate member is located in the proximal section of the outer elongate member (see annotated figure below); and a return lumen (26a) extending within the proximal section of the outer elongate member and outside the input lumen and permitting fluid to flow in a reverse direction from the transition section to a proximal end of the outer elongate member (fluid flows from the inner member 46 and there is some reverse flow (represented by element 58) back through the return lumen; ¶ [0032]), wherein a lumen of the transition section provides sufficient flow resistance to urge a first portion of fluid flowing out of the input lumen in the forward direction to flow into the return lumen in the reverse direction while a second portion of the fluid flowing out of the input lumen in the forward direction flows out of the distal end of the outer elongate member (¶ [0032] discloses this function; the fluid from the supply lumen flows out the distal end of the outer catheter and some fluid, which is halted via the tapered section, will flow back into the return lumen as claimed; the inner member is adjusted relative to the outer member to set the desired proportion of flow entering the return lumen; see portion wherein “…the distal end of the tubular member 46 can interact with the taper 50 to control the flow of fluid thereby.” In this manner, the taper provides the flow resistance as claimed based on the distance of the distal end of 46 relative to the taper).
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Regarding claim 2, Samson further discloses a cooling device that cools (i) the fluid entering the input lumen and (ii) fluid exiting the return lumen (see e.g., ¶ [0031] and Figure 1; the supply fluid and the return fluid are cooled via heat exchanger 38 and the return fluid is recycled throughout the procedure).
Regarding claim 5, Samson further discloses wherein an inner diameter of the transition section lumen distally is smaller than an inner diameter of the transition section lumen proximally (¶ [0032]; Figure 20, section 50 is tapered from the proximal end to the distal end).
Regarding claim 6, Samson further discloses wherein an inner diameter of the transition section lumen tapers (50) such that the inner diameter of the transition section lumen becomes progressively smaller distally than proximally (it’s tapered as in Figure 2; ¶ [0032]).
Regarding claim 7, Samson further discloses wherein the body cavity is a blood vessel (see e.g., ¶ [0030] which discloses utilizing the coronary arteries as the perfusion location).
Regarding claim 8, Samson further discloses wherein the inner elongate member (46) is unsecured within the outer elongate member (48; see ¶ [0032] which discloses moving the inner elongate member relative to the outer elongate member to vary the flow through the distal port of the outer member; this relative movement can only be achieved via an unsecured relative cooperation between the two elements).
Regarding claim 9, Samson further discloses wherein the return lumen (26a) is coaxial with the input lumen (24a; it can be seen in Figure 2 that the supply and return lumens are coaxial as claimed).
Regarding claim 11, Samson further discloses wherein a cross-sectional area of the return lumen (26a) is greater than a cross-sectional area of the input lumen (24a; it can be seen in Figure 2 that the entire inner member is located within the return lumen and is therefore smaller than the return lumen).
Regarding claim 16, Samson further discloses wherein the respective cross-sectional areas of the return lumen (26a) and input lumen (24a) are configured using a recirculation-to-input area ratio parameter so as to provide a desired total flow rate of the catheter system (¶ [0032], the total flow rate is a function of the relative position of the distal end of inner member 46 with respect to the taper 50; this includes the cross-sections of the inner and outer elements), wherein the recirculation-to-input area ratio is defined as the cross-sectional area of the return lumen compared to the cross-sectional area of the input lumen (Samson discloses in ¶ [0032] that the amount of fluid recirculated via return lumen 26a is a function of the relative distance of the distal end of the inner member relative to the transition section; in this manner, the ratio of return flow is a function of the inner member cross-sectional area, the outer member cross-sectional area, and the distance of the end of the inner member relative to the outer member transition area; these parameters are considered to meet the claim limitation as currently set forth; the inner and outer member diameters set the base flow rate and the distance of the end of the inner member relative to the transition section controls the total return flow volume; this also results in a changing effective diameter of the outer member based on the location of the inner member to the transition section).
Regarding claim 19, Samson further discloses a placement mechanism to assist in positioning the inner elongate member (46) within the outer elongate member at a desired position so as to affect a desired flow rate of the chilled fluid into the body cavity or a target region of the subject (while no specific structure is disclosed by Samson, ¶ [0032] discloses that the inner member is “longitudinally shiftable relative to the outer tubular member…” which provides sufficient support that some placement mechanism is provided for shifting the inner member as claimed; this could be some insertion device or is broad enough to be a section of inner member 26 graspable by a user).
Regarding claim 22, Samson discloses a method of infusing a chilled fluid into a subject in need thereof, said method comprising: providing a catheter system according to claim 1 (see rejection of claim 1 above); inserting the distal end of the outer elongate member (48) of the catheter system into the subject (via placement in the coronary arteries as per ¶ [0030]; see Figure 1, the system is located in the aortic arch/root); and infusing a chilled fluid into the subject through the input lumen of the catheter system (¶ [0031] discloses delivering hypothermically-cooled fluid).
Regarding claim 23, Samson discloses a catheter system for use in infusing a chilled fluid into a subject in need thereof, wherein the catheter system according to claim 1 is provided (see rejection above for claim 1); inserting the distal end of the outer elongate member (48) of the catheter system into the subject (e.g., Figure 1; ¶ [0031], it’s located inside the patient); and infusing a chilled fluid into the subject through the input lumen of the catheter system (¶ [0031]; hypothermically-cooled fluid is introduced).
Regarding claim 24, Samson discloses the catheter system of claim 1, and further discloses a chiller device that cools (i) the fluid infused into the input lumen (see e.g., ¶ [0031] and Figure 1; the supply fluid and the return fluid are cooled via heat exchanger 38 and the return fluid is recycled throughout the procedure).
Regarding claim 25, Samson further discloses a saline source (e.g., ¶ [0046] discloses a standard IV saline bag as the fluid source), a fluid delivery pump device (¶ [0046] discloses an external pump for delivering the fluid; Figure 1, element 36), an accumulator (e.g., Figure 1, element 40 is a filtration/debubbling device which may be considered an accumulator), wherein the chiller is a heat exchanger (¶ [0046] discloses that the saline is pumped through a heat exchanger as a thermoelectric cooler for cooling; Figure 1, element 38).
Regarding claim 27, Samson discloses a method of delivering chilled fluids to an organ or tissue of a subject in need thereof, comprising: providing a cooling system according to claim 24 (see rejection above for claim 24); inserting the distal end of the outer elongate member (48) of the cooling system into the body cavity of the subject (see Figure 1; ¶ [0030]); and delivering a chilled fluid to an organ or tissue of the subject through the input lumen of the catheter system (see ¶¶ [0030]-[0031] which disclose infusing hypothermically-cooled fluid into the body cavity).
Regarding claim 28, Samson discloses a cooling system for use in delivering chilled fluids to an organ or tissue of a subject in need thereof, wherein the cooling system according to claim 24 is provided (see rejection of claim 24 above), the distal end of the outer elongate member is inserted into a body cavity of the subject (Figure 1; ¶ [0030] locates the outer elongate member in the patient’s vasculature); and a chilled fluid is delivered to an organ or tissue of the subject through the input lumen of the catheter system (¶ [0031] discloses infusing a hypothermically-cooled fluid during treatment).
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson.
Regarding claim 4, Samson discloses the claimed invention substantially as set forth above for claim 1, with respect to the tapering transition section. Samson fails to explicitly disclose an inner diameter of the transition section lumen being smaller than an inner diameter of the input lumen. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Samson to form the tapering portion of the outer member lumen with a smaller dimension than that of the inner elongate member input lumen since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. See Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Samson would not operate differently with the claimed diameter of the outer member since its function is to deliver fluid from the input lumen through the output lumen while providing some resistance to flow. This function would be maintained even with a reduced diameter portion. Furthermore, it appears that no criticality has been placed on the claimed relative dimensions, indicating that “In certain embodiments of catheter system, inner diameter of transition section lumen distally is smaller than inner diameter of input lumen (see instant ¶ [0075]; it’s an optional feature which is not considered critical to the function of all embodiments).
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson in view of Chu (US 2019/0298572).
Regarding claim 12, Samson discloses the claimed invention substantially as set forth above for claim 1 but fails to explicitly disclose the resistance member in the input lumen.
Chu teaches (Figures 78-79) a medical fluid delivery device (650) comprising a lumen (651) and a resistance member (wire 640) for increasing resistance to fluid flow within the lumen (¶¶ [0298]- [0302] disclose the wire as being used for restricting flow through the conduit).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the input lumen of Samson to comprise the resistance member of Chu to provide additional means of adjustably controlling flow through the input lumen during a procedure, as taught by Chu. In this manner, the flow rate through the output port can be fine-tuned via the resistor and relative location of the inner member relative to the distal end of the outer member to prevent injury/damage to the tissue receiving the fluid (e.g. barotrauma).
Regarding claim 13, Chu further teaches wherein the resistance member (640) is adjustable to vary resistance to fluid flow within the input lumen (e.g., ¶ [0300] discloses adjusting the restrictor to control flow through the device).
Regarding claim 14, Chu further teaches wherein the resistance member (640) has multiple outer diameters (see ¶ [0298] which discloses the restrictor as tapered with a cross-section that decreases from the proximal end to the distal end) and is adjustable such that positioning any of its outer diameters within the lumen results in differing resistances to fluid flow within the input lumen (see ¶ [0300] which discloses the restrictors as adjustable based on how far its inserted into the lumen; see also ¶ [0302] which discloses adjusting flow by removing a length of the restrictor from the conduit to decrease resistance).
Regarding claim 15, Chu further discloses wherein the resistance member comprises a wire (¶ [0298], it’s a tapered wire) that extends at least partially along the length of the lumen (651; Figure 79).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson in view of Griffin et al. (US 2005/0124918).
Regarding claims 17 and 18, Samson discloses the claimed invention substantially as set forth above for claim 16 but fails to explicitly disclose the recirculation-to-input area ratio ranges of from about 0.9 to about 2.3 or 1.3 for catheters having an inner diameter of about 0.085 inches or less. Samson is concerned, however, with optimizing flow through the distal port of the outer member based upon parameters related to the inner member (see ¶ [0032] which discloses shifting the inner member relative to the outer member to vary the open area of the return lumen available to provide return flow through the device). In this manner, the device of Samson explicitly describes a function of the device is to vary the recirculation-to-input area during use to achieve the desired flow through the device. This area is a function of the diameters of the inner and outer members and the distance of the inner member distal end relative to the outer member tapered portion (50). Therefore, the recirculation area and lumen diameters of the catheters (which provide the base flow rate) are intended to be optimized to achieve the desired flow during use. It appears that one of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in modifying the Samson reference to achieve the claimed recirculation-to-input area ratios, as it involves only adjusting a dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Samson by adjusting the inner elongate member relative to the outer elongate member to achieve the desired recirculation-to-input area ratio since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As noted, Samson still fails to disclose the inner diameters of the catheters of the system.
Griffin et al. (henceforth Griffin) discloses a coaxial catheter system (e.g., Figure 4) for use in the aortic arch (see e.g., ¶¶ [0003]-[0004]) wherein both catheters comprise inner diameters smaller than 0.085 inches (as per ¶ [0041], the inner diameter of inner layer 30 is about 0.058 inches; and as per ¶¶ [0043]-[0044], the inner diameter of the outer member 28 can be equal to the outer diameter of the inner member or be formed in the range from 0.0675 inches to 0.0690 inches).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Samson to comprise the claimed lumen diameters of Griffin since Griffin discloses that such catheter diameters are known for use in procedures passing through the aortic arch. The cited combination would retain the utility of the return lumen based upon the larger diameter lumen of the outer member of Griffin and so the claimed recirculation-to-input area could be achieved even with both catheters in the claimed range.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson in view of Williams et al. (US 6,214,016).
Regarding claim 20, Samson discloses the claimed invention substantially as set forth above for claim 19 but fails to disclose the placement mechanism as marker bands on each of the inner and outer elongate members.
Williams et al. (henceforth Williams), teaches (Figure 12) an inner elongate member (46) comprising a plurality of marker bands (82) and an outer elongate member (44) comprises a plurality of marker bands (80) which can be used together to determine the relative insertion distance of the inner member relative to the outer member.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Samson to comprise marker bands on the inner and outer members, as taught by Williams, to allow a user a means of determining how far into the outer member the inner member has been inserted during a procedure. This is relevant to Samson as the insertion distance of the inner member relative to the outer member controls the fluid flow out of the outer member during use.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson in view of Williams, and further in view of Sakal et al. (US 2005/0137574).
Regarding claim 21, Samson/Williams teach the claimed invention substantially as set forth above for claim 20 but fail to disclose the tubing stop for assisting in positioning.
Sakal et al. (henceforth Sakal) teaches that is it known to use tubing stops on medical catheter devices to control the depth of insertion of one element relative to another (see e.g., ¶ [0036]; the stop element may comprise a knob or an integrally formed element on the catheter 40 for preventing the catheter from extending beyond a desired distance).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the placement mechanism (shaft of inner element of Samson) to comprise the stop element of Sakal to provide a means of preventing the inner member from extending beyond the contact depth of the inner member with the transition section of the outer member of Samson during use, as taught by Sakal. In this manner, when applied to the device of Samson/Williams, the stop may also act as an indicator that the distal end of the inner member is abutting the transition section thereby alerting the user that the full volume of fluid is flowing into the patient and there is no return flow).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson in view of Burnett et al. (US 2007/0106247).
Regarding claim 26, Samson discloses the claimed invention substantially as set forth above for claim 24, and further discloses an elevated fluid source (¶ [0031], Figure 1; supply reservoir 34; ¶ [0046] discloses an IV saline bag, which would be elevated even if not hanging from an IV hook, as it will not be located on the ground during an infusion procedure and would still be at least partially elevated if it were). A bubble trap (40; ¶ [0031]), and a fluid delivery pump device (Figure 1, element 36; ¶ [0031]). Samson fails to explicitly disclose the chiller as a cooling unit that includes a bladder, or the waste container.
The instant disclosure at ¶ [0089] cites two different known, commercially available, recirculation chillers comprising bladders which meet the claim limitation and were in commercial use as of the filing of the disclosure (see e.g., Wayback Machine pulling https://tetech.com/product/cp-031/ as early as September 26, 2015). Therefore, said disclosure is considered to constitute prior art which anticipates the cooling unit of claim 26. See e.g., MPEP 2129 which states: “A statement by an applicant in the specification or made during prosecution identifying the work of another as "prior art" is an admission which can be relied upon for both anticipation and obviousness determinations, regardless of whether the admitted prior art would otherwise qualify as prior art under the statutory categories of 35 U.S.C. 102. Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1354, 66 USPQ2d 1331, 1337 (Fed. Cir. 2003); Constant v. Advanced Micro-Devices Inc., 848 F.2d 1560, 1570, 7 USPQ2d 1057, 1063 (Fed. Cir. 1988).” For this reason, it would have been obvious to one of ordinary skill in the art at the time of filing to utilize the disclosed cold plate cooler of TE Technology with the system of Samson, as the instant disclosure recognizes that such a chilling unit, which comprises a bladder, is known to be suitable for use in invasive vascular cooling procedures such as that performed by Samson. Such a known cooling device would have been an obvious choice to one of ordinary skill in the art when modifying the system of Samson to utilize a known industry cooling assembly comprising the claimed structure.
Samson still fails to explicitly recite the waste container; however, Burnett et al. (henceforth Burnett) teaches a hypothermic fluid infusion system which utilizes a waste container (80) for receiving used fluid during a procedure (Figures 1 and 2d; ¶¶ [0048] and [0085]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Samson to include the waste container of Burnett to provide a means of storing used cooling fluid for procedures not requiring constant circulation as taught by Burnett. In this manner, the waste fluid may be safely stored outside the patient while providing the additional utility of remaining a heat sink for cooled fluid in the reservoir as taught by Burnett (¶ [0085]).
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.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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