DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 12364501. Although the claims at issue are not identical, they are not patentably distinct from each other because both application and patent claim a method of online testing of an efficiency or a treatment efficacy of an ultrasonic transducer.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 18-20 it is not clear how an impulse is applied to the transducer, and what the steps are for applying an impulse to the transducer, is it an electrical signal that's an impulse or some other means. Furthermore, the steps of measuring the response are also not clearly defined, appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-17 is/are rejected under pre-AIA 35 U.S.C. 102 b as being anticipated by U. S. Publication No. 2008/0221448 to Khuri-Yakub et al. (Khuri)
Regarding Claim 1, Khuri teaches a dual-use dual use ultrasonic transducer device for combined sensing and power transmission, the power transmission being for tissue ablation, comprising: a first piezoelectric transducer sized for placement in a body lumen (abstract and fig. 1 teaches a dual use ultrasound inside a blood vessel for imaging and hifu treatment); a power unit enabling an ultrasonic power beam for tissue ablation in a tissue ablation region (para 011 and 029 teaches a power for hifu treatment); and a sensing unit enabling an ultrasonic sensing beam for sensing at said tissue ablation region (abstract and para 0031 teaches imaging he treatment area after hifu treatment).
Regarding Claim 2, Khuri teaches that the ultrasonic power beam and the ultrasonic sensing beam are enabled through the first piezoelectric transducer (para 032 teaches the transducers are piezoelectric transducers).
Regarding Claim 3 and 4, Khuri teaches comprising: a catheter for supporting the first piezoelectric transducer (abstract and fig. 1 and claim 1 teaches a catheter to support the transducers, and all ultrasounic systems have a control processor for imaging/therapy).
Regarding Claim 5, Khuri teaches that the control system is configured to cause the power unit to output the ultrasonic power beam in bursts with a gap between each burst and cause the sensing unit to output the ultrasonic sensing beam during the gap (para 11 teaches high frequency output).
Regarding Claim 6, Khuri teaches that the control system is configured to determine a distance between the first piezoelectric transducer and a wall of a vessel based on reflected signals sensed by the sensing unit (fig. 1 and 5).
Regarding Claim 7, Khuri teaches that the control system continuously tests an efficiency of the first piezoelectric transducer during a treatment procedure in which one or both of the ultrasonic power beam and the ultrasonic sensing beam are emitted (abstract and fig. 1).
Regarding Claim 8, Khuri teaches that the control system is configured to monitor a treatment with the ultrasonic power beam during a treatment procedure by identifying changes in echo signals over time during the treatment procedure (para 025, 027 and claim 11).
Regarding Claim 9, Khuri teaches that the control system is configured to map tissue treated with the ultrasonic power beam (claims 1 and 11).
Regarding Claim 10, Khuri teaches that the first piezoelectric transducer is configured to provide the power transmission as a non-focused beam (abstract and claim 1 teaches imaging transducer which is is a non focused beam).
Regarding Claim 11, Khuri teaches that the first piezoelectric transducer comprises a first surface from which the ultrasonic sensing beam is emitted and a second surface from which the ultrasonic power beam is emitted (figs. 1 and 5 teaches multiple surfaces for emitting ultrasound).
Regarding Claim 12, Khuri teaches that the ultrasonic power beam is configured to provide a thermal effect to tissue and the ultrasonic sensing beam is configured to provide imaging of the thermal effect (abstract and claim 1 teaches HIFU ultrasonic therapy which cause tissue heating).
Regarding Claim 13, Khuri teaches that the sensing unit is configured to detect reflected signals from the ultrasonic sensing beam (abstract and claims 1 and 11 teaches sensing unit for detecting ultrasound signals to generate image).
Regarding Claim 14, Khuri teaches a method of using an ultrasonic transducer for simultaneous heating and monitoring of a target, the method comprising: providing a first ultrasonic transmission in bursts for heating a target site , with a gap between each burst (abstract and fig. 1 teaches a dual use ultrasound inside a blood vessel for imaging and hifu treatment); and providing a second ultrasonic transmission during each gap for monitoring the target, wherein the second ultrasonic transmission has a lower power level than a power level of the first ultrasonic transmission (abstract and para 0031 teaches imaging the treatment area after hifu treatment).
Regarding Claim 15, Khuri teaches comprising: using a surface of a piezoelectric transducer to produce the first ultrasonic transmission and the second ultrasonic transmission.
Regarding Claim 16, Khuri teaches that the surface comprises a first damping region having a first damping level and a second damping region having a second damping level that is less than the first damping level, the method comprising using the first damping region for monitoring the target and the second damping region for heating the target (abstract and claims 1 and 11 teaches imaging the treatment area after hifu treatment, where in the imaging transducer and the hifu transducers both have a damping region).
Regarding Claim 17, Khuri teaches comprising placing the ultrasonic transducer in a body lumen and carrying out the heating of the target and the measuring of the target while the ultrasonic transducer is in the body lumen (abstract and para 0031 teaches imaging the treatment area after hifu treatment; figs. 1 and 5 teaches the catheter is within the lumen for imaging and hifu therapy).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANJAY CATTUNGAL whose telephone number is (571)272-1306. The examiner can normally be reached M-F 9-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SANJAY CATTUNGAL/Primary Examiner, Art Unit 3798
Prosecution Insights