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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Action is responsive to the Reply filed on 19 November 2025 (“Reply”). As directed in the Reply:
Claims 1-8, 10, and 13 have been amended;
Claims 17-20 have been and/or remain cancelled; and
Claims 21-24 have been added.
Thus, Claims 1-16 and 21-24 are presently pending in this application.
Applicant’s amendments to the Abstract and Claim 13 are sufficient to overcome the objections from the previous Action and are therefore withdrawn.
Response to Arguments
Applicant’s arguments with respect to Claims 1 and 8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Concerning the objections to the Specification and Claims, repeated below, Applicant baldly opines (Reply, pg. 9, item B) that the text beginning at [0068] are not claims; yet, they have the exact same format, and include the exact same text, as the formal claims appearing at the end of the specification. Now even more problematic is that the claims appearing at the end of the Specification have been amended, while those presented in the Specification at [0068] have not, adding to a reader’s confusion. The U.S. patent system is full of examples of how to avoid this simple problem, see, e.g., U.S. Patent No. 11,376,028 and the documents listed in search result L104 (see the attached Search Results), derived from IDSs Applicant has filed.
Correction is required.
Information Disclosure Statement (IDS)
The IDS filed 19 November 2025 fails in part to comply with one or more sections of 37 C.F.R. § 1.98(a); see the prior Action for a reproduction of its requirements.
copy located in file, not listed: WO 2020/055908, CA 3017779, WO 2011/082319, WO 2007/035885.
listed, no copy provided: HK 1162287, IN 2021147016648, IN 201837038624.
Applicant is reminded that each IDS, as a self-contained unit, must fully comply with all of the provisions of 37 C.F.R. § 1.98(a) on the date it is filed to ensure consideration of the information cited therein.
Specification
The disclosure is objected to because of the following informalities: the “examples” at [0068] are plainly the prior claims re-presented, and thus invites confusion as to which set of claims are those under examination; alternatively, they are the claims, and do not appear at the end of the Specification, and thus fail to satisfy 37 C.F.R. § 1.75(a). For examination purposes, the ‘claims’ appearing at the end of the Specification have been treated as the claims of the application.
Appropriate correction is required.
Claim Objections
Claims 1-20 are objected to because of the following informalities: all the prior claims are duplicated in the Specification at [0068], which is not at the end of the Specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claims 1, 2, 4, 6, and 7 are rejected under 35 U.S.C. 103 as being obvious over U.S. Patent App. Pub. No. 2021/0361428, by Dixon (“Dixon”) in view of U.S. Patent App. Pub. No. 2020/0281720, by Jackson et al. (“Jackson”)
Dixon discloses a catheter and system substantially as claimed by Applicant, as follows.
Claim 1: A catheter assembly (Figs. 47A-C, 49B, 50A, 62A, comprising: an aspiration catheter (1114) defining a lumen (2602) and including:
a proximal region (right end in Fig. 62A); and
a distal region including a deflectable member (Figs. 47A-C, 62C; 1025, including spine 2040), wherein the deflectable member includes
a proximal ring (Figs. 48A, 50B, #1806);
a distal ring configured to be fixedly attached to a pull wire (1904; pull wire not claimed, but passim); and
a tube portion extending between the proximal and distal rings (Figs. 48A, 50B), wherein the tube portion includes a plurality of openings (1036) extending therethrough to define a plurality of ribs (1038), and wherein the ribs are configured to flex away from each other when the pull wire is pulled proximally (ribs 1038 separate when the tube is flexed in a manner very well known in the art).
Dixon does not, however, describe the further inclusion of a side port fluidly coupled to the lumen of the aspiration catheter, wherein the side port is configured to be fluidly coupled to an aspiration source configured to aspirate the lumen of the aspiration catheter.
Jackson relates to intravascular heart valve prosthesis delivery systems, like Dixon, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Jackson teaches that such systems can be provided with a side port (1107 in Fig. 11) fluidly coupled to the lumen of the aspiration catheter ([0085]), wherein the side port is configured to be fluidly coupled to an aspiration source configured to aspirate the lumen of the aspiration catheter (fluidly upstream of valve 1118, the device is fully capable of being coupled as claimed), so that the lumen can be bled of air prior to insertion into the patient, thus reducing or eliminating the possibility of the introduction of air emboli into the patient.
It 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, to further include, in Dixon’s vascular prosthetic delivery system, a side port fluidly coupled to the lumen of the aspiration catheter, wherein the side port is configured to be fluidly coupled to an aspiration source configured to aspirate the lumen of the aspiration catheter, because Jackson teaches doing so in a very closely related system, to inhibit the introduction of air emboli into the patient.
Claim 2: (The catheter assembly of claim 1) wherein the tube portion includes a spine ([0158]; 2040) extending in a direction between the proximal and distal rings, wherein the ribs extend away from the spine, and wherein the spine is configured to extend generally parallel to and over the pull wire (id.).
Claim 4: (The catheter assembly of claim 1,) further comprising an intermediate region between the proximal and distal regions, wherein the proximal region and the intermediate region include a braid of wires extending therethrough (2401; [0205]).
Claim 6: (The catheter assembly of claim 1) wherein the tube portion extends along a longitudinal axis in a relaxed state, and wherein the openings extend circumferentially about the longitudinal axis and generally parallel to one another in the relaxed state (Figs. 66-68).
Claim 7: (The catheter assembly of claim 1) wherein the proximal ring includes an annular member (2502, 2511) configured to slidably receive the pull wire therethrough (pull wire not claimed; pull wires 1135, 1136 extend through the pull wire tubes).
Claims 8, 9, 11-14, and 21-24 are rejected under 35 U.S.C. 103 as being obvious over Dixon in view of Jackson, optionally further in view of U.S. Patent App. Pub. No. 2015/0359547, by Vale et al. (“Vale”)
Dixon and Jackson together describe a system substantially as claimed by Applicant; see above concerning Claim 1, the features of which overlap significantly with those of Claim 8.
Claim 8: A clot removal system (Figs. 47A-C, 49B, 50A, 62A), comprising:
an aspiration catheter (24, 1114, 1124) defining a lumen (2602) including a proximal region (right end in Fig. 62A) and a distal region (Fig. 62C, including spine 2040), wherein the distal region includes a deflectable member (1025);
a handle coupled to the proximal region of the aspiration catheter ([0220], 5901, 5902, and the handles disclosed in the document incorporated by reference), wherein the handle includes an actuator (5901, 5902);
a pull wire (1135) extending between the actuator and the deflectable member (Fig. 62C), wherein actuation of the actuator is configured to pull the pull wire to deflect the deflectable member to deflect the distal region of the aspiration catheter relative to the proximal region (ribs 1038 separate when the tube is flexed in a manner very well known in the art);
a side port (Jackson, 1107) between an aspiration source and the aspiration catheter (Figs. 11, 14), wherein the aspiration source is configured to aspirate the lumen of the aspiration catheter.
While Jackson discloses a flange on the proximal end of its fluid line 1107, upstream of its valve 1108, which appears to be a Luer-type connection flange, Dixon and Jackson do not, however, expressly disclose the further inclusion of an aspiration source fluidly upstream of the side port.
The Examiner takes Official Notice that, in the fields of medical aspirators, it is widely common to use a syringe to aspirate fluid from a fluid lumen of a body inserted conduit, such as Jackson’s, because syringes are very widely available in a surgical suite, inexpensive, easily manipulated by the practitioner, and because they are often translucent or transparent, give the practitioner a visual indicator when fluid has been aspirated from the lumen.
Vale relates to vascular occlusion aspiration systems and is therefore from an art which is the same as, or very closely related to, those of Applicant’s claims. Optionally, Vale expressly discloses that a syringe (111) can be used to aspirate ([0083]) a lumen of a catheter through a side port (unlabeled in Figs. 1, 11a), to remove the contents of the lumen prior to removing the device from the patient, and as an art recognized device suitable for the intended, and predictable, purpose of catheter aspiration. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
It 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, to further include, in Dixon/Jackson’s vascular prosthetic delivery system, a syringe as a source of aspiration, because syringes are widely used in medical systems for aspiration; Vale specifically discloses using a syringe for aspirating a catheter lumen; and syringes are as an art recognized device suitable for the intended, and predictable, purpose of catheter aspiration.
Claim 9: (The clot removal system of claim 8) wherein the aspiration catheter extends along an axis, and wherein the actuation of the actuator is configured to deflect the distal region of the aspiration catheter away from the axis by about 90 degrees or greater ([0173]).
Claim 11: (The clot removal system of claim 8) wherein the deflectable member has a tubular shape that extends along a longitudinal axis (see Fig. 51), and wherein the deflectable member includes
(a) a spine ([0158]; 2040) extending parallel to the longitudinal axis and
(b) a plurality of ribs (1038) extending from the spine and circumferentially about the longitudinal axis.
Claim 12: (The clot removal system of claim 11) wherein the deflectable member has a distal portion and a proximal portion, and wherein the pull wire (1035) is attached to the distal portion of the deflectable member (Fig. 62).
Claim 13: (The clot removal system of claim 12) wherein the actuation of the actuator is configured to pull the distal portion proximally relative to the proximal portion (Fig. 62).
Claim 14: (The clot removal system of claim 12) wherein the ribs (10398) define a plurality of openings (1036) therebetween, and wherein the actuation of the actuator is configured pull the distal portion of the deflectable member proximally relative to the proximal portion to bend the spine and increase a size of the openings (Fig. 62).
Claim 21: (The clot removal system of claim 8,) further comprising a hemostasis valve (Jackson, 1114 and [0091]) coupled to a proximal portion of the handle (Figs. 11, 12), wherein the hemostasis valve is configured to be actuated to an at least partially unsealed position to provide fluid access to the lumen of the aspiration catheter (as is the nature of Tuohy Borst adapters).
Claim 22: (The clot removal system of claim 21) wherein the side port is coupled to the handle distal to the hemostasis valve (id.).
Claim 23: (The clot removal system of claim 8) wherein the side port includes a fluid control device (Jackson, 1108) movable between a first position in which the aspiration source is fluidly decoupled from the lumen of aspiration catheter and a second position in which the aspiration source is fluidly coupled to the lumen of the aspiration catheter (bleed valve 1108 is movable between open and closed positions, being a valve).
Claim 24: (The clot removal system of claim 8) wherein the aspiration source comprises a syringe (see discussion above concerning Claim 8 and the further inclusion of a syringe as an aspiration source, optionally in view of Vale).
Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Dixon and Jackson, optionally further in view of Vale, as applied to Claims 1 and 8, above.
Dixon and Jackson (and Vale) together describe a device substantially as claimed by Applicant; see above. They are silent about the exact size of Dixon’s delivery catheter and thus do not, however, expressly describe that the aspiration catheter has a diameter of 20 French or greater (Claims 3 and 10).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Dixon to be 20 French or greater, 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.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Dixon would not operate differently with the claimed size and, as the delivery of a prosthetic Mitral valve requires a delivery sheath large enough for the prosthetic valve, and Mitral valves naturally are different sizes (from those of infants to those of very large adult), requiring a broad range of sizes of delivery sheaths, the device would function appropriately having the claimed size. Further, Applicant assigns no criticality to the size limitation, indicating simply that the size limitation “can” be one of several sizes (Specification @ [0036], reciting numerous sizes for the catheter, with 20 French being only one of many).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Dixon and Jackson (and Vale) as applied to Claims 4 and 8 above, and further in view of U.S. Patent App. Pub. No. 2021/0322166, by von Oepen et al. (“von Oepen”).
Dixon and Jackson (and optionally Vale) describe a device substantially as claimed by Applicant; see above. As noted above and concerning Claim 15, Dixon also describes:
an intermediate region between the proximal and distal regions (any portion between the two regions already defined);
an inner liner (2402) extending through the proximal, intermediate, and distal regions;
a braid of wires extending through the proximal and intermediate regions over the inner liner (2401; [0205]); and
an outer liner extending through the proximal, intermediate, and distal regions over the inner liner and the braid (2301), wherein the deflectable member is positioned between the inner and outer liners in the distal region (Fig. 51).
It does not, however, describe that the intermediate region includes a wire coiled around the braid, with the outer liner positioned around the coiled wire.
Von Oepen relates to reinforced catheter shafts for transluminal navigation through tortuous body passages and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Von Oepen teaches that, in the construction of the reinforcement of such catheters, a braid reinforcement can be augmented by a coiled wire, so that the catheter shaft can benefit from the different torque transmission and lateral stability afforded by each of the braid and the coil and thus make the catheter shaft more capable of navigating a patient’s vasculature. Its coil is, however, positioned radially inside of its braid, but von Oepen does not attribute any important function to this particular orientation of the two reinforcing elements in the catheter shaft.
It has been held that, in the absence of evidence to the contrary, the reversal of two parts in a prior art device does not impart patentability. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification.). Similarly, the rearrangement of parts also does not. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
It 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, to construct Dixon/Jackson/Vale’s catheter shaft such that the intermediate region includes a wire coiled around the braid, with the outer liner around the coiled wire, because von Oepen teaches including both a wire coil and a braid in the same portion of a catheter shaft, so that the catheter shaft can benefit from the different torque transmission and lateral stability afforded by each of the braid and the coil and thus make the catheter shaft more capable of navigating a patient’s vasculature; and, placing the coil around the braid instead of the braid around the coil is, based on the current record, an unpatentable reversal and/or rearrangement of two parts of a device.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dixon, Jackson, optionally Vale, and von Oepen as applied to Claim 15 above, and further in view of U.S. Patent App. Pub. No. 2018/0304040, by Jalgaonkar et al. (“Jalgaonkar”).
Dixon, Jackson, optionally Vale, and von Oepen together describe a device substantially as claimed by Applicant; see above. In addition, Dixon’s distal region includes a proximal transition region (Fig. 50B, near 2008), a distal tip region (near 2006), and a deflectable region between the proximal transition region and the distal tip region (the portion between), the deflectable member is positioned in the deflectable region (at least the center of the cut tube portion is capable of deflecting).
They do not, however, describe that the outer liner has a first hardness in the proximal transition region, a second hardness in the deflectable region, and a third hardness in the distal tip region, and the second hardness is less than the first hardness and less than the third hardness.
Jalgaonkar relates to reinforced catheters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Jalgaonkar teaches that the outer liner (24) of such a catheter can be designed so that it has a first hardness in the proximal transition region, a second hardness in the deflectable region, and a third hardness in the distal tip region, and the second hardness is less than the first hardness and less than the third hardness ([0147], including the indication that the distalmost portion of the outer liner is harder than the portion immediately proximal), so that the outer liner “contribute[s] to the desired stiffness profile of catheter body” (id.) and “while also increasing the hardness about distal opening 13 to resist geometric deformation when distal opening 13 (FIG. 1) of catheter body 12 is engaged with a guide member, which may help support the navigation of catheter body 12 through vasculature”.
It 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, to design Dixon/Jackson/Vale/von Oepen Dixon’s outer liner so that it has a first hardness in the proximal transition region, a second hardness in the deflectable region, and a third hardness in the distal tip region, and the second hardness is less than the first hardness and less than the third hardness, so that the outer liner contributes to the desired stiffness profile of the catheter, and to resist deformation of the distalmost opening when another medical instrument is passed through the catheter’s lumen.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, being a representative sample of documents disclosing the widespread utilization of a side port and hemostatic valve at the proximal end of catheter handles.
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 Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/08/2026