NON-FINAL REJECTION
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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the United Kingdom of Great Britain and Northern Ireland on 12/17/2020 (GB2020065.5; hereinafter “the UK application”). It is noted, however, that applicant has not filed a certified copy of the UK application as required by 37 CFR 1.55.
Response to Amendment
The preliminary amendment dated 11/3/2025 has been entered and considered for this Office Action. The preliminary amendment cancels claims 2-56. Only a single claim (i.e., claim 1) remains presented for examination on the merits.
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 1 is rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Reisen, WO 2019/152898 A1 and/or US 2021/0007760 A1 (already of record; see IDS dated 7/14/2025).
Note: The subject matter disclosed in the WIPO and US documents appears to be identical. In this rejection, references will be made to the US document’s paragraph numbers. However, the WIPO document discloses the same subject matter and therefore independently forms a basis for rejection too.
Reisen discloses an endovascular apparatus for determining the condition of a vessel in a body, the apparatus comprising:
an elongate waveguide element (550, Figs. 5A and 5B);
an activation unit comprising a source of ultrasonic energy (transducer 520) and a coupling (hub 120 and horn 510) for coupling the source to the waveguide element to activate the waveguide element, thereby transmitting ultrasonic energy from the source along the waveguide element to an active distal section (inner core end 530 and needle tip 534) of the waveguide element (see ¶ [0068]-[0070]); and
a signal acquisition system that is configured to acquire feedback signals from the apparatus for interpretation of vessel condition (¶ [0077]-[0085]; Fig. 11A, 11B, 12, and 13); wherein the signal acquisition system comprises
at least one acoustic sensor for acquiring acoustic feedback signals generated by the apparatus when the waveguide element is activated (“Machine parameter sensing can be performed directly and/or indirectly by measuring one or more changes in, but not limited to, ultrasound characteristics (such as frequency, amplitude, phase, and/or stroke length), voltage, current, impedance, vacuum pump speed, pressure levels, suction level, irrigation flow, temperature, and/or optical reflectivity/transmissivity/absorbance/scattering, using internal system built-in controllers and/or by incorporation of one or more sensors to the system, such as, but not limited to: pressure sensors, flow sensors, optical sensors, accelerometers, displacement sensors and/or others.” ¶ [0078]; the ordinarily skilled artisan would understand that a pressure sensor that can directly measure ultrasound characteristics such as frequency, etc. reads on an acoustic sensor).
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.
Claim 1 of the Instant Application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,376,826 (hereinafter “Reference Patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the Reference Patent includes or recites every limitation of the claim of the Instant Application.
Instant Application (19/267,798)
Reference Patent (US 12,376,826 B2)
1. Endovascular apparatus for determining the condition of a vessel in a body, the apparatus comprising:
1. Endovascular apparatus for determining the condition of a vessel in a body, the apparatus comprising:
an elongate waveguide element;
an elongate waveguide element, being a wire;
an activation unit comprising a source of ultrasonic energy and a coupling for coupling the source to the waveguide element to activate the waveguide element, thereby transmitting ultrasonic energy from the source along the waveguide element to an active distal section of the waveguide element; and
an activation unit comprising a source of ultrasonic energy and a coupling for coupling the source to the wire to activate the wire, thereby transmitting ultrasonic energy from the source along the wire to an active distal section of the wire; and
a signal acquisition system that is configured to acquire feedback signals from the apparatus for interpretation of vessel condition;
a signal acquisition system that is configured to acquire feedback signals from the apparatus for interpretation of vessel condition;
wherein the signal acquisition system comprises at least one acoustic sensor for acquiring acoustic feedback signals generated by the apparatus when the waveguide element is activated.
wherein the signal acquisition system comprises at least one acoustic sensor for acquiring acoustic feedback signals generated by interaction of the active distal section of the wire with neighbouring tissues or obstructions when the wire is activated,
the at least one acoustic sensor being outside a housing of the activation unit, the at least one acoustic sensor further being:
an extra-corporeal sensor arranged to lie against a part of the body, or
an intra-corporeal sensor arranged to be inserted into the body, or
mounted on a catheter surrounding the wire.
Claim 1 of the instant application is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/420,048 (hereinafter “Reference Application”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the Reference Application includes or recites every limitation of the claim of the Instant Application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant Application (19/267,798)
Reference Application (19/420,048)
1. Endovascular apparatus for determining the condition of a vessel in a body, the apparatus comprising:
1. Endovascular apparatus for determining the condition of a vessel, cavity or structure in a body, the apparatus comprising:
an elongate waveguide element;
an elongate waveguide element;
an activation unit comprising a source of ultrasonic energy and a coupling for coupling the source to the waveguide element to activate the waveguide element, thereby transmitting ultrasonic energy from the source along the waveguide element to an active distal section of the waveguide element; and
an activation unit comprising a source of ultrasonic energy and a coupling for coupling the source to the waveguide element to activate the waveguide element, thereby transmitting ultrasonic energy from the source along the waveguide element to an active distal section of the waveguide element; and
a signal acquisition system that is configured to acquire feedback signals from the apparatus for interpretation of vessel condition;
a signal acquisition system that is configured to acquire feedback signals from the apparatus for interpreting the condition of the vessel, cavity or structure;
wherein the signal acquisition system comprises
at least one acoustic sensor for acquiring acoustic feedback signals generated by the apparatus when the waveguide element is activated.
wherein the signal acquisition system comprises:
at least one acoustic sensor for acquiring acoustic feedback signals generated by the apparatus when the waveguide element is activated; and/or
at least one inertial sensor for acquiring information representing orientation and/or acceleration of the activation unit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M. 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.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
22 August 2026
