DETAILED ACTION
Notice of 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 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.
Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 112(a) 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 9, the reflector being placed between a plaque and an ultrasound transducer is not supported by the Specification. The Applicant’s disclosure only describes a plaque deposit placed between a reflector and an ultrasound transducer.
Regarding claim 20, there is no description of how, “the reflector may reflect all of the ultrasound energy back toward the plaque deposit”, at least, due to the scattering nature of reflected ultrasound waves.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim(s) 9 is/are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 9, the language appears to imply that the reflector device is somehow integrated between a plaque deposit and the ultrasound transducer, instead of being configured for placement between a plaque and the transducer.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Emery (US 2015/0080926, of record).
Regarding claim 1, Emery discloses a system, comprising: an ultrasound transducer (Fig. 17, [0115]: “HIFU treatment device”); a catheter for insertion into a body lumen of a patient, the catheter including a distal end (Fig. 17, [0115]: “intravascular device”); and a reflector connected to the distal end of the catheter (Fig. 17, [0115]: “material 142”), the reflector formed from a material having an acoustic impedance mismatch with an adjacent material (Fig. 17, [0115]: “high-impedance metals” would have different impedance than surrounding human tissue).
Regarding claim 2, Emery discloses that the ultrasound transducer is separate from the catheter (Fig. 17).
Regarding claim 3, Emery discloses that the ultrasound transducer is configured to be operated outside of said body lumen (Fig. 17).
Claim Rejections - 35 USC § 103
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery (US 2015/0080926, of record).
Regarding claim 8, Emery does not explicitly disclose that the reflector is formed from a steel alloy. However, Emery does teach that the reflecting material may be “high-impedance medals (e.g. aluminum or nitinol)” ([0115]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply a steel alloy, as to provide a well-known type of high-impedance metal that offers robust biocompatibility.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery (US 2015/0080926, of record), as applied to claim 1 above, in view of Zhou (US 2006/0241572).
Regarding claim 4, Emery does not explicitly disclose an optical energy source connected to the catheter, an emission end of the optical energy source located at the distal end of the catheter. However, Zhou teaches an optical energy source located at the distal end of a catheter (Fig. 4A, [0051]: “fiber 41” transmits laser light for ablation). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the laser of Zhou to the catheter of Emery, as to provide additional means of breaking down plaque deposits.
Regarding claim 5, Emery does not explicitly disclose that the emission end is at least partially embedded in the reflector. However, Zhou teaches an optical energy source located at the distal end of a catheter (Fig. 4A, [0051]: “fiber 41” transmits laser light for ablation). The structure of Zhou’s distal end and the reflective material of Emery would be readily combined since the material covers the entirety of the distal end. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the laser of Zhou to the catheter of Emery, as to provide additional means of breaking down plaque deposits.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery (US 2015/0080926, of record), as applied to claim 1 above, in view of Acker (US 2002/0115990).
Regarding claim 6, Emery does not explicitly disclose an inflatable element proximate the reflector at the distal end of the catheter. However, Acker teaches an inflatable element integrated with a reflector at a distal end of a catheter (Fig. 2, [0021]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the inflatable element and reflector of Acker to the catheter of Emery, as to provide an integrated device at the distal end of a catheter.
Regarding claim 7, Emery does not explicitly disclose that the inflatable element includes the reflector. However, Acker teaches an inflatable element integrated with a reflector at a distal end of a catheter (Fig. 2, [0021]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the inflatable element and reflector of Acker to the catheter of Emery, as to provide an integrated device at the distal end of a catheter.
Claim(s) 10, 11, 15, 16, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery (US 2015/0080926, of record) in view of Duffy (US 2010/0010393).
Regarding claims 10 and 15, Emery discloses a method, comprising: transmitting ultrasound energy into a site within a body lumen; and reflecting at least a portion of the ultrasound energy back to said site in the body lumen with a reflector, the reflector connected to a distal end of a catheter located at said site in said body lumen (Fig. 7, [0115]). Emery does not explicitly disclose that the site comprises a plaque deposit. However, Duffy teaches using HIFU to soften an occlusion caused by plaque ([0032]…[0034]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the HIFU of Emery to a plaque occlusion, as taught by Duffy, as to provide a conventional use of HIFU to an intravascular procedure.
Regarding claims 11 and 16, while Emery does not explicitly disclose that transmitting the ultrasound energy includes transmitting the ultrasound energy at the reflector while the reflector is in contact, Emery teaches an intravascular device which would be at least in near-contact to a target within the vessel. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the contact between the reflector and the plaque deposit, as to provide robust concentration of reflected energy at the target site.
Regarding claim 19, Emery, in conjunction with Duffy, discloses that positioning the acoustic energy source includes positioning the acoustic energy source such that said plaque deposit is located between the reflector and the acoustic energy source (Fig. 17 of Emery in conjunction with Fig. 6 of Duffy). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the positioning of Emery to the treatment of a plaque as taught by Duffy, as to provide enhanced concentration of energy to a target.
Regarding claim 20, Emery does not explicitly disclose that the reflector reflects all of the ultrasound energy to the plaque deposit. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to reflect all of the ultrasound energy, as to provide maximum utilization of the energy.
Claim(s) 12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery (US 2015/0080926, of record) in view of Duffy (US 2010/0010393), as applied to claims 11 and 16 above, in view of Acker (US 2002/0115990).
Regarding claims 12 and 17, neither Emery nor Duffy explicitly disclose inflating an inflatable element to place the reflector in contact with said plaque deposit. However, Acker teaches an inflatable element integrated with a reflector at a distal end of a catheter (Fig. 2, [0021]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the inflatable element and reflector of Acker to the catheter of Emery, as to provide an integrated device at the distal end of a catheter that may encourage enhanced contact with the vessel wall.
Claim(s) 13, 14, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery (US 2015/0080926, of record) in view of Duffy (US 2010/0010393), as applied to claims 10 and 15 above, in view of Zhou (US 2006/0241572).
Regarding claims 13, 14, and 18, Emery does not explicitly disclose providing a sequence of laser pulses through an optical conduit to said plaque, simultaneous with the transmitting of ultrasound energy. However, Zhou teaches an optical energy source located at the distal end of a catheter (Fig. 4A, [0051]: “fiber 41” transmits laser light for ablation). Since the ultrasound and laser devices are separate devices, it would have been obvious that they may both be operated at the same time, to enhance the breakdown of the target structure. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the laser of Zhou to the catheter of Emery and Duffy, as to provide additional means of breaking down plaque deposits.
Conclusion
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/JASON M IP/Primary Examiner, Art Unit 3793
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