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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/15/2025, 05/08/2025, 06/26/2025, 08/05/2025, and 09/24/2025 has been considered by the examiner.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 2-21 have been renumbered to claims 3-22, respectively.
Claims 5, 18, and 20 are also objected to because of the following informalities:
In claim 5, “an FRR value” should be “a fractional flow reserve (FFR) value” for clarity (see claim 17).
In claim 18, “wherein the method is performed to image a lesion comprising a diameter of less than 0.080"” should be “further comprising imaging a lesion comprising a diameter of less than 0.080"” for clarity.
In claim 20, “OCT data” should be “optical coherence tomography (OCT) data” for clarity.
Appropriate correction is required.
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 2-6, 8-12, 18, and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10-11, 20-22, and 25 of U.S. Patent No. 12,239,412 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are an obvious variant of the claim set from the patent only including minor differences in structure.
Claim 2 of the instant invention and claim 1 (see col. 58, lines 20-30) of US patent ‘412 similarly recites an imaging probe, comprising: an elongate shaft comprising a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion; an optical core comprising a proximal end and a distal end, wherein at least a portion of the rotatable optical core is positioned within the lumen of the elongate shaft; and an optical assembly positioned proximate the distal end of the optical core. The instant invention specifies inserting the imaging probe into a blood vessel to acquire intravascular imaging data.
Claim 2 of the instant invention and claim 1 (see col. 58, lines 30-35) of US patent ‘412 similarly recites directing light from a light source having a coherence length greater than 10mm to the optical assembly, and receiving reflected light from tissue at the optical assembly.
Claim 2 of the instant invention and claim 1 (see col. 58, lines 43-45) of US patent ‘412 similarly recites a distal portion of the elongate shaft comprising an outer diameter no greater than 2.6Fr (0.034").
Claim 2 of the instant invention and claim 1 (see col. 58, lines 41-44) of US patent ‘412 similarly recites rotating the optical core to scan tissue over a scan range of no less than 6mm.
Claims 3-4 of the instant invention and claims 2-5 (see col. 58, lines 46-57) of US patent ‘412 similarly recites outer diameter values of the distal portion of the elongate shaft.
Claim 5 of the instant invention and claim 6 (see col. 58, lines 58-60) of US patent ‘412 similarly recites calculating an FFR value based on the intravascular imaging data.
Claim 6 of the instant invention and claim 10 (see col. 59, lines 1-3) of US patent ‘412 similarly recites acquiring intravascular imaging data is performed during a pullback procedure, wherein the optical core is retracted at a rate of at least 25 mm/sec.
Claim 8 of the instant invention and claims 10-11 (see col. 59, lines 1-6) of US patent ‘412 similarly recites wherein a pullback distance of the pullback procedure is at least 10 cm and the pullback procedure is performed in a time period of no more than 4 seconds.
Claims 9-11 of the instant invention and claims 21-22 (see col. 60, lines 11-17) of US patent ‘412 similarly recites a second imaging device configured to gather angiography data. The instant invention specifies the angiography data is co-registered with intravascular imaging data.
Claim 12 of the instant invention and claim 20 (see col. 60, lines 8-10) of US patent ‘412 similarly recites providing treatment information based on the intravascular imaging data.
Claim 18 of the instant invention and claim 6 (see col. 58, lines 58-60) of US patent ‘412 similarly recites imaging a lesion comprising a diameter of less than 0.080".
Claim 20 of the instant invention and claim 20 (see col. 60, lines 8-10) of US patent ‘412 similarly recites wherein the intravascular imaging data is OCT data
Claim 21 of the instant invention and claim 25 (see col. 60, lines 23-26) of US patent ‘412 similarly recites imaging a clot of 5 μm or more.
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with (see Claim objections and Double patenting rejections above). See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter:
For claim 2, no non-double patenting prior art was found that teaches the combination of limitations, as disclosed in the applicant’s specification (see para. 0125, 0148, and 0226) and Fig. 1, without hindsight reasoning. Any combination of the prior art of record does not explicitly teach this limitation as the limitation in combination with all of the other elements of the claim is not obvious or similar.
The closest prior art found to teach the combination of limitations is Kemp (US 20120022360 A1, published January 26, 2012), which teaches a laser (coherence) light source with a coherence length of over 10 mm (see para. 0026 — “The OCT light source may be a swept laser source such as a High Speed Scanning Laser HSL-2000 (Santec) with an instantaneous coherence length of over 10 mm.”), and a fiber diameter of no more than 0.034 inches (see para. 0061 — “The fiber may include a core diameter of 39 um, a hexagonal inner cladding diameter of 420 um and an outer cladding diameter of 520 um [within range of less than 0.034 inches or 863.6 um].”), but does not explicitly teach rotating the optical core to scan tissue over a scan range of no less than 6mm, and where at least the distal portion of the elongate shaft of the imaging probe comprises an outer diameter of no more than 0.034 inches without hindsight reasoning.
Kemp only teaches the diameter of an optical fiber, not the diameter of an imaging probe, where the imaging probe includes a rotatable optical core and an optical assembly positioned within the lumen of the elongate shaft.
Adler et al. (US 20160313507 A1, published October 27, 2016) teaches an elongate shaft comprising a proximal end, a distal portion comprising an outer diameter no greater than 2.6Fr (0.034") (Fig. 1; see para. 0083 – “The beam can expand up to a maximum diameter equal to the outer diameter of the cap [29, distal end], which can range from about 160 μm [0.006’’] to about 500 μm [0.020’’].” where the outer diameter of the distal portion of the shaft (cap 29) is between 0.006’’ and 0.020’’, which is no greater than 0.034’’), but does not explicitly teach directing light from a light source having a coherence length greater than 10mm to the optical assembly, and rotating the optical core to scan tissue over a scan range of no less than 6mm without hindsight reasoning.
Claims 3-22 are dependent of claim 2, and therefore considered allowable subject matter as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/Nyrobi Celestine/Examiner, Art Unit 3798