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 .
Information Disclosure Statement
The information disclosure statement, filed July 10, 2025 and May 26, 2026, were received and entered into the record. However, it is impractical for the examiner to review the references thoroughly with the number of references cited in this case. By initializing each of the cited references on the accompanying 1449 forms, the examiner is merely acknowledging the submission of the cited references and indicating that only a cursory review has been made of the cited references.
MPEP § 2004.13 states: It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant's attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aft 'd, 479 F.2d 1338, 178 USPQ 577 (Sth Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Claim Objections
Claims 30-31 are objected to because of the following informalities: the limitation of “clam 21” should be amended to read “claim 21”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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) 21-22, 24, 27, 29 and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stevens (US 4,923,462, hereinafter “Stevens”).
Referring to claim 21, Stevens discloses a clot treatment system (see entire reference), comprising:
an aspiration catheter 10 (Figs. 1-3, Figs. 2-4 are reproduced below) defining a lumen (Fig. 4) and having a distal portion and a proximal portion;
a hub 20 (Fig. 3, col. 4, lns. 55-58) coupled to the proximal portion of the aspiration catheter 10 and configured to provide access to the lumen of the aspiration catheter;
a side port coupled to the hub (Figs. 2-3 show side port 54 of rotating adapter 56 is coupled to hub 20. Col. 5, lns. 25-30: “A conventional rotating adapter 56 coupled to the "Y" connector 52 has a leur fitting 57 that engages the leur hub 20 of the angiographic catheter 10.”) and fluidly coupled to the lumen of the aspiration catheter;
an aspiration source configured to be coupled to the side port and configured to aspirate the lumen of the aspiration catheter (Stevens inherently discloses an aspiration source (col. 3, lns. 25-31: “One additional advantage is the ability to apply suction to the catheter to remove deposits that have been dislodged by the rotating head. Alternately suction can be applied during intervals when the rotatable head is withdrawn from or pulled back inside the angiographic catheter.”));
a valve insert (rotating adapter 56 as shown in Figs. 2-3) configured to be releasably coupled to the hub 20, wherein the valve insert defines an insertion lumen, and wherein the valve insert is actuatable between a first position in which the insertion lumen is sealed and a second position in which the insertion lumen is unsealed (col. 6, lns. 9-25: “A seal 80 (FIG. 9) inside the connector 52 prevents the saline/dye solution that is pumped into the catheter 10 via the side-arm 54 from leaking from the connector 52… The plastic bushing 82 is then heat fused to the "Y" connector 52 to position the seal 80 within the connector 52. The drive catheter is then free to slide back and forth through the connector 52 but fluid injected through the side branch 54 does not leak from the connector 52.”); and
a clot treatment device (drive catheter 50, which include drive wire 62 and sheath 64, as shown in Figs. 4) configured to be inserted through the hub and the lumen of the aspiration catheter (Figs. 2 and 4. “The catheter 10 is positioned next to an entry way to the deposits 90 and the drive catheter 50 inserted until the rotatable head 66 approaches the distal end of the catheter 10.” (col. 6, lns. 60-65)).
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Referring to claim 22, Stevens discloses the clot treatment system of claim 21 wherein the valve insert 80 comprises a hemostasis valve (col. 6, lns. 9-25: “A seal 80 (FIG. 9) inside the connector 52 prevents the saline/dye solution that is pumped into the catheter 10 via the side-arm 54 from leaking from the connector 52… The plastic bushing 82 is then heat fused to the "Y" connector 52 to position the seal 80 within the connector 52. The drive catheter is then free to slide back and forth through the connector 52 but fluid injected through the side branch 54 does not leak from the connector 52.”).
Referring to claim 24, Stevens discloses the clot treatment system of claim 21 wherein the clot treatment device 50 is configured to be inserted through the hub and the lumen of the aspiration catheter when the valve insert is decoupled from the hub (Figs. 2-3, col. 5, lns. 19-30).
Referring to claim 27, Stevens discloses the clot treatment system of claim 21 wherein the clot treatment device 50 is further configured to be inserted through the valve insert 56, and wherein the valve insert is configured to seal against the clot treatment device in the second position (col. 6, lns. 9-25: “A seal 80 (FIG. 9) inside the connector 52 prevents the saline/dye solution that is pumped into the catheter 10 via the side-arm 54 from leaking from the connector 52… The plastic bushing 82 is then heat fused to the "Y" connector 52 to position the seal 80 within the connector 52. The drive catheter is then free to slide back and forth through the connector 52 but fluid injected through the side branch 54 does not leak from the connector 52.”).
Referring to claim 29, Stevens discloses the clot treatment system of claim 21 wherein the clot treatment device is configured to be moved within the aspiration catheter 10 while the aspiration source aspirates the lumen of the aspiration catheter (col. 7, lns. 1-11; claim 8).
Referring to claim 30, Stevens discloses the clot treatment system of clam 21 wherein the valve insert 52 is configured to releasably lock to the hub 20 (Figs. 2-3, col. 5, lns. 25-30: “A conventional rotating adapter 56 coupled to the "Y" connector 52 has a leur fitting 57 that engages the leur hub 20 of the angiographic catheter 10.”).
Claim(s) 21-22, 25, 27-28, 31, 33-38 and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffin et al. (US 2016/0157873, hereinafter “Griffin”).
Referring to claim 21, Griffin discloses a clot treatment system (see entire reference), comprising:
an aspiration catheter 12 (Figs. 1-7, Fig. 6 is reproduced below) defining a lumen 16 (Fig. 6) and having a distal portion and a proximal portion;
a hub (collection chamber 22 and body portion 44 as shown in Fig. 6) coupled to the proximal portion of the aspiration catheter 12 and configured to provide access to the lumen of the aspiration catheter;
a side port 28 coupled to the hub (Fig. 6, para. [0021] “In use, suction is applied to a suction port 28 that is located along the collection chamber 22.”) and fluidly coupled to the lumen of the aspiration catheter;
an aspiration source configured to be coupled to the side port and configured to aspirate the lumen of the aspiration catheter (para. [0021]);
a valve insert (cap 20, which includes valve 52, as shown in Figs. 1-7) configured to be releasably coupled to the hub (Fig. 6 shows cap 20 is coupled to collection chamber 22 and Fig. 7 shows cap 20 is released from proximal end of collection chamber 22), wherein the valve insert defines an insertion lumen, and wherein the valve insert is actuatable between a first position in which the insertion lumen is sealed and a second position in which the insertion lumen is unsealed (para. [0024]: “The second seal 52 may be generally aligned with the lumen 16 of the shaft 12 to allow medical devices to extend through the catheter 10 while the cap 20 is closed.”); and
a clot treatment device configured to be inserted through the hub and the lumen of the aspiration catheter (para. [0024]: “The second seal 52 may be generally aligned with the lumen 16 of the shaft 12 to allow medical devices to extend through the catheter 10 while the cap 20 is closed.” (emphasis added). Paragraph [0024] also discloses a guidewire is extended through the catheter 10. Thus, the “medical device” and guidewire are interpreted as a clot treatment device).
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Referring to claim 22, Griffin discloses the clot treatment system of claim 21 wherein the valve insert (cap 20) comprises a hemostasis valve 52 (Figs. 6-7).
Referring to claim 25, Griffin discloses the clot treatment system of claim 21, further comprising a guide wire configured to be inserted through the hub and the lumen of the aspiration catheter, wherein the valve insert (cap 20) is configured to seal against the guidewire in the second position (para. [0024]).
Referring to claim 27, Griffin discloses the clot treatment system of claim 21 wherein the clot treatment device is further configured to be inserted through the valve insert (cap 20), and wherein the valve insert is configured to seal against the clot treatment device in the second position (para. [0024]).
Referring to claim 28, Griffin discloses the clot treatment system of claim 21 but fails to disclose the aspiration source comprises a syringe (para. [0021]: “Various suction sources, such as a syringe or a vacuum machine, may be attached to the hose 30 or valve 32.”).
Referring to claim 31, Griffin discloses the clot treatment system of claim 21 wherein the hub comprises a valve 18 (Figs. 6-7, paras. [0019]-[0020]).
Referring to claim 33, Griffin discloses a system for treating clot material in a vasculature of a patient (see entire reference), comprising:
a catheter (Figs. 1-7, Fig. 6 is reproduced above) defining a lumen and having a distal portion and a proximal portion, wherein the catheter is shaped and sized to be positioned within the vasculature such that the distal portion is proximate to the clot material;
a hub (collection chamber 22 and body portion 44 as shown in Fig. 6) having a proximal portion and a distal portion, wherein the distal portion of the hub is coupled to the catheter;
a side port 28 (Figs. 1-2 and 6-7) coupled to the hub between the proximal portion of the hub and the distal portion of the hub, wherein the side port is fluidly coupled to the lumen of the aspiration catheter ;
an aspiration source (Fig. 6, para. [0021] “In use, suction is applied to a suction port 28 that is located along the collection chamber 22.”) configured to be coupled to the side port and configured to aspirate the lumen of the aspiration catheter; and
a hemostasis valve (cap 20 includes hemostasis valve 52) configured to be releasably coupled to the proximal portion of the hub (Fig. 6 shows cap 20 is coupled to collection chamber 22 and Fig. 7 shows cap 20 is released from proximal end of collection chamber 22), wherein the hemostasis valve is actuatable between (a) a sealed position in which fluid is inhibited from passing through the hemostasis valve from the lumen of the aspiration catheter and (b) an unsealed position in which fluid can at least partially pass through the hemostasis valve from the lumen of the aspiration catheter (para. [0024]: “Once access has been gained with a guidewire, the distal opening 14 may be threaded onto the guidewire, and the catheter 10 may be slid onto the guidewire so that the guidewire extends through the shaft lumen 16, the first seal 18, the collection chamber 22 and the second seal 52. The catheter 10 may then be threaded over the guidewire until the shaft 12 is located within the vein or artery. The guidewire may then be withdrawn from the catheter 10 by pulling the guidewire proximally through the second seal 52.” and “The second seal 52 may be generally aligned with the lumen 16 of the shaft 12 to allow medical devices to extend through the catheter 10 while the cap 20 is closed.”).
Referring to claim 34, Griffin discloses the system of claim 33, further comprising a clot treatment device configured to be inserted through the hemostasis valve, through the hub, and at least partially through the lumen of the aspiration catheter (in paragraph [0007] Griffin discloses the catheter is for treating clot material in a vasculature of a patient. In paragraph [0024] Griffin discloses guidewire and other medical devices extend through the catheter 10 while the cap 20 is closed. The guidewire and other medical devices have been interpreted as clot treatment device).
Referring to claim 35, Griffin discloses the system of claim 34 wherein the clot treatment device is configured to be moved within the aspiration catheter while the aspiration source aspirates the lumen of the aspiration catheter (examiner notes that the aspiration catheter 10 of Griffin is capable of performing the function the clot treatment device (guidewire and other medical devices of Griffin) is configured to be moved within the aspiration catheter while the aspiration source aspirates the lumen of the aspiration catheter).
Referring to claim 36, Griffin discloses the system of claim 34 wherein the hemostasis valve 52 is configured to seal against the clot treatment device in the sealed position (para. [0024]).
Referring to claim 37, Griffin discloses the system of claim 33, further comprising a guide wire configured to be inserted through the hub and the lumen of the aspiration catheter 10, wherein the hemostasis valve 52 is configured to seal against the guidewire in the sealed position (para. [0024]).
Referring to claim 38, Griffin discloses the system of claim 33 wherein the hemostasis valve 52 comprises a rotatable hemostasis valve (examiner notes that the catheter system 10 of Griffin is capable of rotating about a guidewire while valve 52 maintaining a seal around the guidewire).
Referring to claim 40, Griffin discloses the system of claim 33 wherein the hemostasis valve is configured to releasably lock to the proximal portion of the hub (Fig. 6 shows cap 20 is coupled to collection chamber 22 and Fig. 7 shows cap 20 is released from proximal end of collection chamber 22)
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.
Claim(s) 23 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Look et al. (US 2017/0056032, hereinafter “Look”).
Referring to claim 23, Stevens discloses the clot treatment system of claim 21 and a seal 80. Stevens fails to disclose the seal 80 is a Tuohy-Borst valve. However, in the same field of endeavor, which is a catheter system for treating a clot in a vessel, Look discloses valve insert 390, which is removably coupled to proximal hub 386 of aspiration catheter 108, includes a Touhy-Borst to provide sealing when guidewire 28 and catheter 391 are inserted into the valve insert 390 (para. [0158]: “The hemostasis valve 389 (e.g., Touhy-Borst, longitudinally spring-loaded seal, etc.) must be adjusted to allow catheter and/or guidewire 28 movement (translation, rotation), but must keep air from being pulled into the lumens during aspiration.”)
Referring again to claim 23, it would have been obvious to one of ordinary skill in the art to substitute seal 80 of Stevens with Touhy-Borst as suggested by Look to prevent leakage and keep air from being pulled into the lumens during aspiration.
Referring to claim 28, Stevens discloses the clot treatment system of claim 21 but fails to disclose the aspiration source comprises a syringe. However, in the same field of endeavor, which is a clot treatment system, Look discloses vacuum source can be a syringe, a vacuum pump or other suitable vacuum source (para. [0142]). In view Look’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a syringe as a vacuum source because syringe always readily available in the operation room.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of McFann et al. (US 2008/0032391, hereinafter “McFann”).
Referring to claim 25, Stevens discloses the clot treatment system of claim 21 but fails to disclose a guide wire configured to be inserted through the hub and the lumen of the aspiration catheter, wherein the valve insert is configured to seal against the guidewire in the second position.
Referring again to claim 25, however, in the same field of endeavor, which is a clot treatment system, McFann discloses it is well known that guidewire is used to facilitate the placement of catheters within the tortuous paths of blood vessel (paras. [0005]-[0006], para. [0006]: “Guidewires are traditionally utilized to negotiate the complex vascular system of a patient to guide a medical device, (e.g. a catheter) to a desired location.”) It would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a guidewire to guide catheter 10 through the tortuous vessel.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens.
Referring to claim 32, Stevens discloses the clot treatment system of claim 21 but fails to disclose wherein the aspiration catheter has a size of at least 16 French. However, clot can be in any vessel in patient. Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have made the catheter 10 with different size, which include catheter with a size equal to 16 French to treat a clot in a vessel that has a diameter larger than 16 French.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Zeroni et al. (US 2012/0109171, hereinafter “Zeroni”).
Referring to claim 26, Griffin discloses the clot treatment system of claim 25 but fails to discloses wherein the clot treatment device is configured to be advanced over the guidewire and through the valve insert.
Referring again to claim 26, however, in the same field of endeavor, which is a clot treatment system, Zeroni discloses using guide wire (“GW” as shown in Fig. 15) for guiding interventional instrument 2 to the clot site (para. [0055]). Zeroni further discloses interventional instrument 2 provides the advantage of using the drill head 4 for crossing a calcified total occlusion (CTO) (paras. [0054]-[0055]). In view of Zeroni’s teaching it would have been obvious to one of ordinary skill in the art to utilize the device of Zeroni with the aspiration catheter of Griffin to provide the ability of crossing a calcified total occlusion in a blood vessel.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Blacker (US 2018/0229008)
Referring to claim 39, Griffin discloses the system of claim 33 but fails to discloses wherein the hemostasis valve comprises a Tuohy- Borst valve. However, in the same field of endeavor, which is a system for treating clot material in a vasculature of a patient, Blacker discloses “Tuohy Borst adapters are known in the art and operate to adjust the size of the opening 205 in the proximal end 204 of the first leg 202 of the y-connector 200 to minimize the risk that fluids may exit the proximal end 204 of the first leg 202. For example, a Tuohy Borst adapter may be used to adjust the size of the opening to zero to stop flow of fluid or may be used to adjust to opening to hold onto or fixate an elongated medical device (e.g., a guidewire) that is passing through it.” (para. [0031])
Referring again to claim 39, in view of Blacker’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have substitute valve 52 of Griffin with a Tuohy Borst adapters since it has been held that substitution of one known component for another to obtain predictable result is old and well known in the art (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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