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 .
Election/Restrictions
Applicant's election without traverse of invention I in the reply filed on July 20, 2026 is acknowledged.
Claims 234-241 have been canceled by the Response to Election/Restriction filed on July 20, 2026. Accordingly, claims 222-233 are pending and under examination.
Information Disclosure Statement
Three information disclosure statements, filed November 19, 2024, 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 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) 222-225 and 230-231 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakano (US 2018/0344349, hereinafter “Nakano”) in view of Soeda et al. (US 2014/0336684, hereinafter “Soeda”).
Referring to claim 222, Nakano discloses a tissue-removing catheter (Figs. 1 and 5) comprising:
an elongate catheter body (sheath 116 and drive shaft 114 as shown in Figs. 2A-2B. Shaft 262 as shown in Fig. 5, para. [0046]) having a proximal end portion and a distal end portion;
ablation burr 102 (Figs. 1-2B, para. [0029]) adjacent the distal end portion of the catheter body and configured to rotate about a rotational axis, the ablation burr having an abrasive outer surface configured to remove tissue from a body lumen (para. [0037]: “One way of accomplishing this result is to provide the distal-most end portion 136, the intermediate portion 138 and the proximal end portion 140 of the treatment member 102 with a coating that helps facilitate the grinding of the substance in the body lumen. An example of the coating is a diamond grind coating.”);
a driver (para. [0041]: “During operation of the medical device 100, the treatment member 102 is rotated by operation of the motor 128 to grind the substance 30 in the body lumen 10 (e.g., stenosis in the blood vessel).” Para. [0046]: “Although not shown, the handle 200 preferably also houses a power supply section, which can include source of power, for example, a battery, or a connection to a power source to operate the motor and other related electrical components in connection with the high-speed drive source 210 and the low-speed drive source 250.”) operatively coupled to the ablation burr and configured to drive rotation of the ablation burr about the rotational axis;
a user control configured to actuate the driver, wherein the user control is operable by a user to actuate the driver (second activation switch 280 as shown in Fig. 5. In paragraphs [0046]-[0049] Nakano discloses second activation switch in “ON” position in order to activate the first activation switch 270);
a driver regulator (first activation switch 270 as shown in Fig. 5, paras. [0046]-[0049]) configured to selectively operate the driver in a first mode, in which a first operation of the user control actuates the driver to continuously drive rotation of the ablation burr, and a second mode, in which the first operation of the user control actuates the driver to drive a discrete burst of rotation of the ablation burr (para. [0048]: “Thus, the first activation switch 270 causes a revolution type action, for example, continuous rotation, intermittent rotation, or wiper-like action of the treatment member or flushing, aspiration, or sealing of the medical device 100.” (emphasis added)).
Nakano discloses the invention substantially as claimed except for disclosing a mode selector in communication with the driver regulator and configured to allow a user to select between the first and second modes of the driver.
In the same field of endeavor, which is a tissue-removing catheter, Soeda discloses a mode selector in communication with the driver regulator and configured to allow a user to select between the first and second modes of the driver (Fig. 1, para. [0087]: “When the user judges that the atheroma 51 is relatively soft, the user further moves the shaft 22 while the knob 75 (FIG. 1) is being set to "1" to press the cutting portion 21 against the atheroma 51 to excise the atheroma 51. When the user judges that the atheroma 51 is hard, the user turns the knob 75 to any one of "2" to "6" according to the hardness degree to increase the rotation speed (unloaded state) of the direct-current motor M.”).
In view of Soeda’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 incorporated the teaching s of Soeda to the system of Nakano to provide a mode selector in communication with the switch 270 allow the user to select between the continuous rotation, intermittent rotation, and wiper-like action of the treatment member.
Referring to claim 223, Nakano/Soeda discloses a tissue-removing catheter as set forth in claim 222, wherein in the first mode of the driver regulator, the user control (second activation switch 280) functions as an alternate action switch (in paragraphs [0046]-[0049] Nakano discloses second activation switch 280 in “ON” position in order to activate the first activation switch 270. “in accordance with an exemplary embodiment, the activation switch can have a first position (i.e., “OFF”) and a second position (i.e., “ON”). The drive shaft 212 rotates in the “ON” position until the activation switch 280 is placed in the “OFF” position (i.e., until the rotation button is pressed again or switch to the “OFF” position), which will prevent unintended operation by differentiating the interface of control to the first activation switch 270.” (para. [0047]).
Referring to claim 224, Nakano/Soeda discloses a tissue-removing catheter as set forth in claim 222, wherein in the first mode of the driver regulator, a second operation of the user control (second activation switch 280 moved to “OFF” position to stop the drive shaft), which is performed after the first operation of the user control, stops the driver from driving rotation of the ablation burr (“in accordance with an exemplary embodiment, the activation switch can have a first position (i.e., “OFF”) and a second position (i.e., “ON”). The drive shaft 212 rotates in the “ON” position until the activation switch 280 is placed in the “OFF” position (i.e., until the rotation button is pressed again or switch to the “OFF” position), which will prevent unintended operation by differentiating the interface of control to the first activation switch 270.” (para. [0047]).
Referring to claim 225, Nakano/Soeda discloses a tissue-removing catheter as set forth in claim 222, wherein the discrete burst of rotation of the ablation burr has a duration of less than about 5 seconds (Nakano fails to disclose the duration of the intermittent rotation. Examiner contends that it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to configure the system of Nakano to allow the user to perform the intermittent rotation with many durations, including a duration of less than about 5 seconds, based on the user’s preferences.)
Referring to claim 230, Nakano/Soeda discloses a tissue-removing catheter as set forth in claim 222, wherein the user control comprises a push button (in the rejection of claim 222 above the second activation switch 280 as shown in Fig. 5 has been interpreted as a user control. Attention is directed to Fig. 5. It appears that the second activation switch 280 is a push button. In alternative, in paragraphs [0046]-[0049] Nakano discloses second activation switch in “ON” position in order to activate the first activation switch 270. Examiner contends that a button switch to allow the user press on the button to activate the first activation switch 270 and press on the button again to deactivate the first activation switch 270 is old and well known in the art).
Claim 231 (Original): A tissue-removing catheter as set forth in claim 222, further comprising: a handle (Fig. 5) operatively connected to the catheter body and defining a guidewire lumen through which a guidewire is passable to the elongate catheter body; and a guidewire brake on the handle for selectively applying a braking force to the guidewire that inhibits the guidewire from moving relative to the handle (Fig. 5, para. [0054]: “In accordance with an exemplary embodiment, the handle 200 can also include the wire fixation unit 290, which is configured to fix, for example, the guidewire 115 during grinding operations of the stenosis 30, such that that guidewire 115 does not move and is secured during the operation and/or procedure.”).
Allowable Subject Matter
Claims 226-229 and 232-233 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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