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 .
Claim Objections
Claims 47 and 49 are objected to because of the following informalities:
Claim 47, line 3: “the length” should recite “a length”.
Claim 49, line 4: “a wavelength” should recite “the wavelength”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 57-63 and 70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 57 recites “wherein the therapeutic device is a balloon catheter”, claim 63 recites “further comprising passing a balloon catheter along the wire to a position distal the lesion” and claim 70 recites “further comprising passing a stent along the wire to a position distal the lesion”. The written description briefly describes the use of balloon catheters and stents in the background, stating “In successful procedures, the guidewires are then pushed across, or through, the obstruction and are kept in situ to act as a guide over which the diagnostic or therapeutic devices, such as balloon catheters and stents, are tracked to the site of the occlusion.” (see para. 0006 of the PGPUB US 2025/0009371 of the instant application). However, the written description only supports a method step for delivering therapeutic devices to treat the lesion (see para. 0068 of the PGPUB US 2025/0009371 of the instant application) and does not have support for passing a balloon catheter or a stent along the wire to a position distal the lesion as required in claims 57, 63, and 70.
Claim 58 recites the limitation “providing a single ultrasonic energy signal to a proximal section of the wire”. The written description discloses and supports the use of an ultrasonic signal generator (see para. 0073 of the PGPUB US 2025/0009371 of the instant application). However, the written description states that a cable connects to the ultrasonic signal generator to convey “power or signals” thereto (see para. 0074 of the PGPUB US 2025/0009371 of the instant application). Therefore, the written description does not have support for the specific method step of providing a single ultrasonic energy signal as claimed. For examination purposes, “a single ultrasonic energy signal” will be interpreted as “an ultrasonic energy signal”.
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) 44-46, 51-56, 58-69, 62, and 64-67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schafer et al. (US 20070066978) [hereinafter Schafer].
Regarding claim 44, Schafer discloses a method of treating a lesion within a patient's vasculature 6000 by ultrasonically exciting an endovascular wire 4000 (Figs. 3-6, para. 0056), the method comprising:
inserting the wire 4000 into the patient's vasculature 6000 (Fig. 3, para. 0056);
advancing a distal section 4040 of the wire 4000 (Figs. 2, 13A, para. 0049, 0074, 0079) to a position at which to engage the lesion (para. 0049-0050, 0056, 0078);
providing ultrasonic energy to a proximal section of the wire 4000 (interpreted as section positioned within acoustic coupler 3700, see Figs. 8, 9D, para. 0058, 0067) to generate longitudinal displacements of the wire (para. 0048, 0050, 0056);
generating lateral displacements of the wire 4000 by conveying the ultrasonic energy through a tapered intermediate section 4030, 4035 of the wire 4000 that extends between the proximal section and the distal section of the wire (Figs. 2, 13A, para. 0050, 0055-0056, 0076-0079); and
engaging the lesion 5000 via the longitudinal and lateral displacements of the wire 4000 (Figs. 3-6, para. 0055-0056).
Regarding claim 45, Schafer discloses wherein the longitudinal and lateral displacements of the wire 4000 excavate a lumen through the lesion 5000 (see Figs. 4-5, para. 0056), the lumen having a diameter greater than a diameter of the distal section of the wire 4000 (see Figs. 4-5, para. 0056).
Regarding claim 46 Schafer discloses further comprising amplifying the ultrasonic energy between the proximal section and the distal section 4040 of the wire 4000 by conveying the ultrasonic energy through the tapered intermediate section 4030, 4035 of the wire 4000 (Figs. 13A-B, para. 0074-0075, 0079).
Regarding claim 51, Schafer discloses wherein providing the ultrasonic energy to the proximal section of the wire further comprises coupling an ultrasonic transducer 3520 to the wire 4000 (Fig. 8, para. 0058) at a location selected from a plurality of locations along the wire that encourage the longitudinal and lateral displacements of the wire (para. 0060).
Regarding claim 52, Schafer discloses wherein the longitudinal and lateral displacements of the wire 4000 cause the lesion 5000 to be treated through cavitation, abrasion, or ablation of the lesion 5000 by a distal tip of the wire 4000 and by a portion of the distal section extending between the distal tip and the tapered intermediate section (Figs. 3-5, para. 0056, 0074, 0078).
Regarding claim 53, Schafer discloses wherein the distal section 4040 of the wire 4000 is bare (Figs. 2, 13A, para. 0074).
Regarding claim 54, Schafer discloses wherein the lesion 5000 forms a total occlusion (Fig. 3, para. 0056).
Regarding claim 55, Schafer discloses wherein the lesion 5000 includes a lumen (Figs. 4-5, para. 0056) and wherein engaging the lesion 5000 causes the lumen to be enlarged to a diameter greater than a diameter of the distal section of the wire 4000 (Figs. 3-5, para. 0056).
Regarding claim 56, Schafer discloses further comprising passing a therapeutic device (interpreted as fluid irrigating a region adjacent the lesion, para. 0057) along the wire 4000 to a position distal the lesion (para. 0057 discloses a catheter may be passed along the wire 4000 to deliver irrigation fluid adjacent the lesion which would flow distal to the lesion).
Regarding claim 58, Schafer discloses a method of treating a lesion 5000 within a patient's vasculature 6000 by ultrasonically exciting an endovascular wire 4000 (Figs. 3-6, para. 0056), the method comprising:
inserting the wire 4000 into the patient's vasculature 6000 (Fig. 3, para. 0056);
advancing a distal section 4040 of the wire 4000 (Figs. 2, 13A, para. 0049, 0074, 0079) to a position at which to engage the lesion (para. 0049-0050, 0056, 0078);
providing a single ultrasonic energy signal to a proximal section of the wire (interpreted as section positioned within acoustic coupler 3700, see Figs. 8, 9D, para. 0058, 0067, 0097-0098);
generating longitudinal and lateral displacements of the wire 4000 using the single ultrasonic energy signal (Figs. 2-6, para. 0055-0056, 0097-0098); and
engaging the lesion 5000 via the longitudinal and lateral displacements of the wire 4000 (Figs. 3-6, para. 0056).
Regarding claim 59, Schafer discloses further comprising generating the lateral displacements of the wire 4000 by conveying the single ultrasonic energy signal through a tapered intermediate section 4030, 4035 of the wire 4000 that extends between the proximal section and the distal section 4040 of the wire 4000 (Figs. 2, 13A, para. 0050, 0055-0056, 0076-0079).
Regarding claim 62, Schafer discloses wherein the longitudinal and lateral displacements of the wire 4000 excavate a lumen through the lesion 5000 (see Figs. 4-5, para. 0056), the lumen having a size greater than a diameter of the distal section of the wire 4000 (see Figs. 4-5, para. 0056).
Regarding claim 64, Schafer discloses a method of treating a lesion 5000 within a patient's vasculature 6000 by ultrasonically exciting an endovascular wire 4000 (Figs. 3-6, para. 0056), the method comprising:
inserting the wire 4000 into the patient's vasculature 6000 (Fig. 3, para. 0056);
advancing a distal section 4040 of the wire 4000 (Figs. 2, 13A, para. 0049, 0074, 0079) to a position at which to engage the lesion 5000 (para. 0049-0050, 0056, 0078);
providing ultrasonic energy to a proximal section of the wire (interpreted as section positioned within acoustic coupler 3700, see Figs. 8, 9D, para. 0058, 0067, 0097-0098) to generate axial displacements of the wire in the proximal section of the wire (Fig. 13A, para. 0050, 0076, 0097-0097);
conveying the axial displacements of the wire 4000 from the proximal section to the distal section 4040 of the wire 4000 to generate radial displacements of the wire in the distal section 4040 of the wire 4000 concurrent with the axial displacements in the distal section 4040 of the wire 4000 (Figs. 3-6, 13A, para. 0050, 0056, 0074, 0077, 0079); and
engaging the lesion 5000 via the axial and radial displacements in the distal section 4040 of the wire (Figs. 3-6, para. 0056).
Regarding claim 65, Schafer discloses further comprising generating undulating movements of the wire in the distal section of the wire (Fig. 2, para. 0050, 0056, 0074-0075).
Regarding claim 66, Schafer discloses further comprising generating the radial displacements of the wire 4000 in the distal section of the wire 4000 at or near a drive frequency of the ultrasonic energy and in secondary modes of differential harmonics (para. 0054-0056, 0074, 0098).
Regarding claim 67, Schafer discloses wherein waveforms of the radial displacements of the wire in the distal section of the wire interfere with each other (Figs. 2-6, para. 0050, 0056; The examiner notes that it is known in the art for waveforms of radial displacements to interfere with each other when contacting an object).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 47-48 and 60-61 are rejected under 35 U.S.C. 103 as being unpatentable over Schafer et al. (US 20070066978) [hereinafter Schafer], as applied to claims 44 and 59 above, and further in view of Levin et al. (US 6241703) [hereinafter Levin].
Regarding claims 47-48 and 60, Schafer discloses all of the limitations set forth above in claims 44 and 59 above. Schafer further comprises providing the ultrasonic energy to the proximal section of the wire at a driving frequency having a wavelength (Figs. 8, 13A, para. 0058-0059, 0067, 0074). However, Schafer fails to disclose the length of the tapered intermediate section of the wire is substantially equal to a multiple of a fraction of the wavelength of the driving frequency (claim 47), wherein the fraction of the wavelength of the driving frequency has a numerator of one and an even denominator (claim 48).
Levin in the same field of endeavor of ultrasonic devices 200 teaches that it is known in the art to have a length of a tapered intermediate section A of an ultrasonic element substantially equal to a multiple of a fraction of the wavelength of the driving frequency (Fig. 1, col. 8 lines4-8), wherein the fraction of the wavelength of the driving frequency has a numerator of one and an even denominator (Fig. 1, col. 8 lines 4-8).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Levin to have the length of the tapered intermediate section of the ultrasonic element be substantially equal to the multiple of the fraction of the wavelength of the driving frequency, wherein the fraction of the wavelength of the driving frequency has the numerator of one and the even denominator to the tapered intermediate section of the wire of Schafer would have yielded predicable results, namely to provide a structure that would amplify or increase the amplitude of ultrasonic vibrations (col. 2 lines 32-43 of Levin).
Regarding claim 61, modified Schafer discloses wherein the longitudinal and lateral displacements of the wire 4000 cause the lesion 5000 to be treated through cavitation, abrasion, or ablation of the lesion by a distal tip 4020 of the wire 4000 and by a portion of the distal section 4040 extending between the distal tip 4020 and the tapered intermediate section 4030, 4035 (Figs. 3-6, 13A, para. 0050, 0055-0056, 0076-0079 of Schafer).
Claim(s) 49 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Schafer et al. (US 20070066978) [hereinafter Schafer], as applied to claim 44 above, and further in view of Akagane (US 20140358043).
Regarding claims 49 and 50, Schafer discloses all the limitations set forth above in claim 44. Schafer further comprises providing the ultrasonic energy to the proximal section of the wire at a driving frequency having a wavelength (Figs. 8, 13A, para. 0058-0059, 0067, 0074). However, Schafer fails to disclose that a length of the distal section of the wire is substantially equal to a multiple of a fraction of a wavelength of the driving frequency, the fraction of the wavelength of the driving frequency having a numerator of one and an even denominator (claim 49), wherein the length of the distal section of the wire is substantially equal to the wavelength of the driving frequency (claim 50).
Akagane in the same field of endeavor of ultrasonic devices (Fig. 3A, para. 0048) teaches that it is known in the art to have a length of a distal section (interpreted as the section comprising a second area 74 and a treatment area 64) of an ultrasonic probe 52 is substantially equal to a multiple of a fraction of a wavelength of the driving frequency (Fig. 3A, para. 0049-0050), the fraction of the wavelength of the driving frequency having a numerator of one and an even denominator (para. 0049), wherein the length of the distal section of the wire is substantially equal to the wavelength of the driving frequency (para. 0049-0050).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Akagane to have the length of the distal section of an ultrasonic probe is substantially equal to the multiple of the fraction of the wavelength of the driving frequency, the fraction of the wavelength of the driving frequency having the numerator of one and the even denominator, wherein the length of the distal section of the wire is substantially equal to the wavelength of the driving frequency to the distal section of the wire of Schafer would have yielded predicable results, namely a way to construct a body of the wire for effective ultrasonic vibration (para. 0049-0050 of Akagane).
Claim(s) 68 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Schafer et al. (US 20070066978) [hereinafter Schafer], as applied to claim 44 above, and further in view of Hare et al. (US 20040176686) [hereinafter Hare].
Regarding claim 68, Schafer discloses all of the limitations set forth above in claim 64. However, Schafer fails to disclose wherein a sleeve, coating or jacket around the wire terminates before the distal section of the wire, the distal section of the wire being bare.
Hare in the same field of endeavor of ultrasonic wire devices (Figs. 1-2A, para. 0045) teaches that it is known in the art to have a coating around a wire 15 terminates before a distal section 24 of the wire 14 (Fig. 3, para. 0067, 0077), the distal section 24 of the wire 15 being bare (para. 0067).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Hare to include the coating around the wire terminating before the distal section of the wire to the wire of Schafer would have yielded predicable results, namely a way to manufacture the ultrasonic wire of Schafer with a coating located proximal the distal section of the wire (para. 0067, 0077 of Hare).
Regarding claim 69, Schafer discloses wherein a distal edge of the coating substantially coincides with a resonant or harmonic length of the bare distal section 24 of the wire 15 (Figs. 1, 2A, 3, para. 0048, 0052, 0067 of Hare).
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771