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 .
Response to Arguments
Applicant’s arguments, see page 6 of 7 through page 7 of 7, filed 07/17/2026, with respect to the rejection(s) of claims 1-20 under 35 U.S.C. §102 & §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. This is due entirely to the amendments to claims 1, 4, and 13. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. §102 & §103 in view of: 1) Anderson et al. (U.S. Patent Application Publication 2014/0100585) for the anticipation rejections, and 2) in further view of Robinson et al. (U.S. Patent 10,463,390) for obviousness. See the rejections below.
Accordingly, this action is made FINAL.
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.
Claims 1-4, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al. (U.S. Patent Application Publication 2014/0100585).
Regarding claims 1, and 4, Anderson et al. disclose a method comprising:
advancing a torque-transmitting coil (“elongate shaft 110” comprising “electromagnetic coil 218,” see [0042] and [0050] and figures 1-14, and torque/stiffness [0038]) of a rotational atherectomy and lithotripsy device into the artery of the patient (see [0007] and figures 1-14);
rotating the torque-transmitting coil so that at least one abrasive burr (the exterior surface of one of the bulbous elements 210, 212, 214, and 216, see [0048] and figures 7A-10A) mounted to the torque-transmitting coil abrades the stenotic lesion material within the artery (see figures 1-14); and
electrically energizing (“electrical energy supplied to the at least one electromagnetic coil 218 is transferred into vibrational energy of the plurality of bulbous elements 210,” see [0057]), and
providing electrical power to a distal end portion of the torque-transmitting coil using one or more power sources to electrically energize the at least one lithotripsy emitter (“electrical energy supplied to the at least one electromagnetic coil 218 is transferred into vibrational energy of the plurality of bulbous elements 210,” see [0057] and figures 1-14, also see the AC source [0052] and [0056]).
Regarding claim 2, Anderson et al. disclose the claimed invention, see figures 1-14.
Regarding claim 3, Anderson et al. disclose the claimed invention, see figures 6A-9.
Regarding claim 10, Anderson et al. disclose the claimed invention, see [0048].
Regarding claim 11, Anderson et al. disclose the claimed invention, see figures 3-14.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (U.S. Patent 10,463,390) in view of Anderson et al. (U.S. Patent Application Publication 2014/0100585).
Regarding claims 1, and 4, Robinson et al. disclose a method of removing stenotic lesion
material from an artery of a patient, the method comprising:
advancing a torque-transmitting coil ("flexible drive shaft 136 includes a torque transmitting coil of one or more helically wound filars," see col. 7 :23-40 and figures 1-19, and alternate/equivalent counterparts in other embodiments) of a rotational atherectomy and lithotripsy device into an artery of the patient (see abstract and figures 11-17)
rotating (see abstract, col. 1: 45 through col. 5 :57 and figures 18-19) the torque transmitting coil so that at least one abrasive burr (a first of "one or more abrasive elements 138," see col. 8:1-51 and figures 1-3 for example, and alternate/equivalent counterparts in other embodiments) mounted to the torque-transmitting coil abrades the stenotic lesion within the artery; and
energizing at least one lithotripsy emitter (a second of "one or more abrasive elements 138," see col. 8:1-51 and figures 1-3 for example, and alternate/equivalent counterparts in other embodiments - that vibrates or reciprocates back and forth repeated, the reciprocation causing acoustic excitation, see col. 21: 14-24 and claim 19) mounted to the torque-transmitting coil to apply acoustic energy to the stenotic lesion within the artery.
Yet Robinson et al. fail to disclose:
1) electrically energizing at least one lithotripsy emitter mounted to the torque-transmitting coil to apply acoustic energy to the stenotic lesion material within the artery, and/or
2) providing electrical power to a distal end portion of the torque-transmitting coil using one or more power sources to electrically energize the at least one lithotripsy emitter.
Like Robinson et al., Anderson et al. disclose a rotational atherectomy and lithotripsy device and method and teach providing the system and method with an electrical power supply in order to electrically activate the lithotripsy emitter (“electrical energy supplied to the at least one electromagnetic coil 218 is transferred into vibrational energy of the plurality of bulbous elements 210,” see [0057], also see the AC source [0052] and [0056]) in order to provide an known and workable manner of electrically activating one or more lithotripsy emitter in order to treat a blood vessel of the patient.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Robinson et al., as taught by Anderson et al., to provide the system and method with an electrical power supply in order to electrically activate the lithotripsy emitter (“electrical energy supplied to the at least one electromagnetic coil 218 is transferred into vibrational energy of the plurality of bulbous elements 210,” see [0057]) in order to provide an known and workable manner of electrically activating one or more lithotripsy emitter in order to treat a blood vessel of the patient.
Regarding claim 2, Robinson et al. disclose the torque-transmitting coil is provided on
an elongated flexible drive shaft of the rotational atherectomy and lithotripsy device (see
figures 1-3).
Regarding claim 3, Robinson et al. disclose the torque-transmitting coil comprises one
or more filars (see abstract, col. 1:47-col. 2:26, and claim 1).
Regarding claim 5, Robinson et al. disclose further comprising conveying fluid along a
central lumen ("inflation lumen through which the inflation fluid can pass," see col. 7:41-
56 and figure 14) defined by the torque-transmitting coil.
Regarding claim 6, Robinson et al. disclose positioning the at least one lithotripsy
emitter in a balloon before advancing the torque-transmitting coil into the artery of the
patient (see "balloon" col. 20:22-36).
Regarding claim 7, Robinson et al. disclose pumping conductive fluid into the balloon
to inflate the balloon before energizing the at least one lithotripsy emitter (see the
inflatable balloon col. 20:22-36).
Regarding claim 8, Robinson et al. disclose pumping the conductive fluid out of the
balloon to deflate the balloon after energizing the at least one lithotripsy emitter (see the
inflatable balloon - which is also deflatable, col. 20:22-36).
Regarding claim 9, Robinson et al. disclose the at least one abrasive burr comprises two
or more abrasive burrs ( a third of the one or more abrasive elements 13 8," see col. 8: 1-51 and figures 1-3 for example, and alternate/equivalent counterparts in other embodiments), and wherein one or more lithotripsy emitters of the at least one lithotripsy emitter are mounted to the torque-transmitting coil between two of the two or more eccentric abrasive burrs (see figures 2-8).
Regarding claim 10, Robinson et al. disclose one or more abrasive burrs of the at least
one abrasive burr are coated with an abrasive media having a first grit, wherein one or
more lithotripsy emitters of the at least one lithotripsy emitter are coated with an abrasive
media having at least one of the first grit and a second grit (see col. 11 :41-54).
Regarding claim 11, Robinson et al. disclose the at least one abrasive burr is mounted
on a distal end portion of the torque-transmitting coil (see figures 1-3 and 15-17).
Regarding claim 12, Robinson et al. disclose advancing the torque-transmitting coil
comprises advancing the torque-transmitting coil through a sheath (sheath 132 see figures
1, and 14-17) fixedly coupled to a handle assembly ("handle assembly 11 O," see figure 1) of the rotational atherectomy and lithotripsy device.
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (U.S. Patent 10,463,390) in view of Ellering et al. (U.S. Patent Application Publication 2022/0265310) in further view of Anderson et al. (U.S. Patent Application Publication 2014/0100585).
Regarding claims 13-14, and 16-17, Robinson et al. disclose a controller ("controller
150," see col. 7:13-21 and figures, 1, and 11-12) comprising:
activate a motor to drive rotation (" electric motor for driving rotations of the drive shaft 136," see col. 12:38-50, col. 18:57 through col. 19:7) of an elongated flexible drive shaft of a rotational atherectomy and lithotripsy device (see abstract and figures 11-17), an elongated flexible drive shaft ("flexible drive shaft 13 6 includes a torque-transmitting coil of one or more helically wound filars," see col. 7 :23-40 and figures 1-19, and alternate/equivalent counterparts in other embodiments) comprising:
(i) a torque-transmitting coil of one or more filars ("flexible drive shaft 136 includes a torque-transmitting coil of one or more helically wound filars," see col. 7:23-40 and figures 1-19, and alternate/equivalent counterparts in other embodiments); and
(ii) abrasive burrs on a distal end portion of the torque-transmitting coil (one or more of first half of the "one or more abrasive elements 138," see col. 8: 1-51 and figures 1-3 for example, and alternate/equivalent counterparts in other embodiments, but no more than half of the burrs shown in the figures); and
activate one or more lithotripsy emitters emitter ( one or more of second half of the "one or more abrasive elements 13 8 ," see col. 8: 1-51 and figures 1-3 for example, and alternate/equivalent counterparts in other embodiments - that vibrates or reciprocates back and forth repeated, the reciprocation causing acoustic excitation, see col. 21:14-24 and claim 19) on the distal end portion of the torque transmitting coil to cause the one or more lithotripsy emitters to selectively emit acoustic energy.
Robinson et al. disclose pumping conductive fluid into the balloon to inflate the balloon before energizing the at least one lithotripsy emitter (see the inflatable balloon col. 20 :22-36) and disclose pumping the conductive fluid out of the balloon to deflate the balloon after energizing the at least one lithotripsy emitter (see the inflatable balloon - which is also deflatable, col. 20:22-36).
Although extremely well known in the art, Robinson et al. fail to explicitly recite the controller comprises:
A) a processor { claim 13 } ;
B) memory storing instructions that, when executed by the processor carry out the steps of using the aforementioned device/system { claim 13};
C) the elongated flexible drive shaft is coupled to a handle assembly and the
processor is physically separate from the handle assembly { claim 14 }; and
D) and the processor
I) activates a pump to convey conductive fluid into a balloon to inflate the balloon before activating the one or more lithotripsy emitters; and
II) activate the pump to convey the conductive fluid out of the balloon to deflate the balloon after activating the one or more lithotripsy emitters.
Like Robinson et al., Ellering et al. disclose an atherectomy device, system, method and teach providing the device/system with: A) a processor ("processor," see [0020], [0022]), and B) a memory having (storing) instructions (see [0020]-[0022], [0038], [0040] and claim 1) in order to provide carrying out the necessary steps in a known and workable manner of carrying out a method of treating blood vessels with atherectomy (and/or lithotripsy) to treat blood vessels.
It should be noted the prior art, Robinson et al., disclose a controller separate from the handle assembly ("controller 150" and "handle assembly 11 0," see col. 7:13-22).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Robinson et al., as taught by Ellering et al., to provide the device/system with: A) a processor, and B) a memory having (storing) instructions in order to provide carrying out the necessary steps in a known and workable manner of carrying out a method of treating blood vessels with atherectomy (and/or lithotripsy) to treat blood vessels.
Additionally, Robinson et al. fail to disclose causing the electrically energizing at least one lithotripsy emitter mounted to the torque-transmitting coil to apply acoustic energy to the stenotic lesion material within the artery.
Like Robinson et al., Anderson et al. disclose a rotational atherectomy and lithotripsy device and method and teach providing the system and method with an electrical power supply in order to electrically activate the lithotripsy emitter (“electrical energy supplied to the at least one electromagnetic coil 218 is transferred into vibrational energy of the plurality of bulbous elements 210,” see [0057], also see the AC source [0052] and [0056]) in order to provide an known and workable manner of electrically activating one or more lithotripsy emitter in order to treat a blood vessel of the patient.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Robinson et al. in view of Ellering et al., as taught by Anderson et al., to provide the system and method with an electrical power supply in order to electrically activate the lithotripsy emitter (“electrical energy supplied to the at least one electromagnetic coil 218 is transferred into vibrational energy of the plurality of bulbous elements 210,” see [0057]) in order to provide an known and workable manner of electrically activating one or more lithotripsy emitter in order to treat a blood vessel of the patient.
1) electrically energizing at least one lithotripsy emitter mounted to the torque-transmitting coil to apply acoustic energy to the stenotic lesion material within the artery, and/or
2) providing electrical power to a distal end portion of the torque-transmitting coil using one or more power sources to electrically energize the at least one lithotripsy emitter.
Like Robinson et al., Anderson et al. disclose a rotational atherectomy and lithotripsy device and method and teach providing the system and method with an electrical power supply in order to electrically activate the lithotripsy emitter (“electrical energy supplied to the at least one electromagnetic coil 218 is transferred into vibrational energy of the plurality of bulbous elements 210,” see [0057], also see the AC source [0052] and [0056]) in order to provide an known and workable manner of electrically activating one or more lithotripsy emitter in order to treat a blood vessel of the patient.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Robinson et al., as taught by Anderson et al., to provide the system and method with an electrical power supply in order to electrically activate the lithotripsy emitter (“electrical energy supplied to the at least one electromagnetic coil 218 is transferred into vibrational energy of the plurality of bulbous elements 210,” see [0057]) in order to provide an known and workable manner of electrically activating one or more lithotripsy emitter in order to treat a blood vessel of the patient.
Regarding claim 19, Robinson et al. disclose to execute the instructions in response to
input received from one or more buttons on a handle assembly of the rotational
atherectomy and lithotripsy device ("button that can be depressed to actuate .... ," see col.
12:38-60).
Regarding claim 20, Robinson et al. disclose the instructions in response to input
received from a user interface on a handle assembly of the rotational atherectomy and
lithotripsy device ("button that can be depressed to actuate .... ," see col. 12:38-60).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (U.S. Patent 10,463,390) in view of Ellering et al. (U.S. Patent Application Publication 2022/0265310) in further view of Anderson et al. (U.S. Patent Application Publication 2014/0100585) as applied to claim 13 above, and further in view of case law – Design Choice.
Regarding claim 15, Robinson et al. show the invention above including the elongated
flexible drive shaft is coupled to a handle assembly (see figure 1).
However, Robinson et al. fail to disclose the processor is provided within the handle assembly.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the processor in the handle, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (U.S. Patent 10,463,390) in view of Ellering et al. (U.S. Patent Application Publication 2022/0265310) in further view of Anderson et al. (U.S. Patent Application Publication 2014/0100585) as applied to claim 13 above, and further in view of Official Notice.
Regarding claim 18, Robinson et al. show the invention above,
but fail to disclose causing the processor to activate one or more light indicators associated with the rotational atherectomy and lithotripsy device.
However, the examiner takes Official Notice of the recited the processor activates one or more light indicators associated with the rotational atherectomy and lithotripsy device since it is extremely well known to provide controllers with LED's or lights that signify various activations of a surgical device. If applicant does not traverse the examiner's assertion of official notice or applicant's traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner's assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate," see MPEP 2144.03C.
Applicant did not traverse the Official Notice rejection, accordingly the Official Notice rejection is taken as admitted prior art.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Robinson et al., as taught by Official Notice, to provide the processor with activation of one or more light indicators associated with the rotational atherectomy and lithotripsy device since it is extremely well known to provide controllers with LED's or lights that signify various activations of a surgical device.
Conclusion
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.
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 AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON F ROANE/Primary Examiner, Art Unit 3792
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