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 .
Response to Arguments
Regarding the claim objections, applicant’s amendments have overcome this rejection and it is hereby withdrawn.
Regarding the double patenting rejections, applicant’s amendments and related arguments have been fully considered, but are not persuasive; see updated double patenting rejection that addresses applicant’s amendments.
Regarding the 103 rejections, applicant’s arguments, specifically regarding the limitation “rate of change over a plurality of fiber-to-target distances” on pages 9-10 of applicant’s response, have been fully considered and are persuasive. Therefore, the 103 rejection of claims 1-2 and 5-12 has been withdrawn, and no new prior art rejection is proper.
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 1-2 and 5-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 12,023,097 in view of US 2016/0184020 to Kowalewski et al. and further in view of US 2019/0201100 to Brown et al.
[Claim 1] Patented claim 11 anticipates the majority of the limitations of current claim 1 including a laser source (claim 1), an optical fiber (claim 11), an optical detector (claim 1; see explanation below) and control circuitry to generate a reflect signal parameter, generate a calibration curve and determine rate of change (claim 1). While an optical detector is not explicitly recited in the patented claims, the examiner contends that because the patented claims refer to “spectroscopic properties” that are generated from a signal reflected from the target in response to electromagnetic radiation, a spectrometer is implicitly/inherently required in order to generate such spectroscopic properties, and therefore the scope of the patented claims inherently/implicitly includes an optical detector, as claimed in current claim 1. If applicant disagrees with the examiner’s position of inherency, then such an inclusion of an optical detector, i.e. spectrometer, that produces such spectroscopic properties is obvious, as this is merely how spectroscopic properties of a reflected signal are generated, as is common knowledge within the art. The rest of the claimed limitations of current claim 1 are clearly anticipated by the limitations in patented claim 1. While the patented claims are narrower than the current claims, specifically providing more details on how the calibration curve is generated and how the fiber-to-target to distance is determined, they nonetheless anticipate the majority of the current claim language.
The patented claims fails to explicitly teach the last two limitations of current claim 1, i.e. “control circuitry configured to… determine whether the target is within a specific laser firing range based on a comparison between the determined rate of change and the generated calibration curve, wherein the target is within the specific laser firing range when the fiber-to-target distance from the distal end of the optical fiber to the outer surface of the target is at or below a threshold distance; and controllably adjust at least one of an output setting of the laser source or a position of the distal end of the optical fiber relative to the target based at least in part on the determination of whether the target is within the specific laser firing range”. However, in the same field of endeavor, Kowalewski discloses the claimed control circuitry that determines whether the target is within a specific firing range, i.e. optimal and controllably adjusts an output setting of the laser source based on this determination (distance determining logic 520 and controller 180; at least Pars 0078-79). These paragraphs make it clear that the distance determining logic can determine if the distance to the target is “shorter than desired”, i.e. within a specific laser firing range, and the controller can then automatically adjust the laser intensity, i.e. output setting, of the laser source based on this determination. Therefore, it would have been obvious to one of ordinary skill in the art to modify the patented claims to include the control circuitry that determines if the target is within a specific firing range and control the laser output based on this determination, as taught by Kowalewski, as a known safety measure to ensure the device is properly positioned in relation to the target in order to safely and effectively apply light to the target for treatment.
AS discussed above, Kowalski discloses a determining a firing range that is too close to the target tissue, which is the opposite of applicant’s claim language requiring the determination of a firing range to indicate that the fiber is close enough to, i.e. not too far away from, the target. However, in the same field of endeavor, Brown discloses “copending U.S. patent application Ser. No. 15/992,609 discloses a method of detecting contact between a stone and a fiber tip, for the purpose of limiting such contact, but which can also be used to detect proximity between the fiber tip and the stone. In one embodiment, a detection method is disclosed that involves analyzing a spectrum for the presence of vaporized material indicative of stone distance from the fiber tip, and which can be used to reducing surgery time by causing the laser to pulse only when the fiber tip is in an optimal position for target vaporization, thus reducing extraneous pulses that cause target retro-repulsion and wear on equipment” (Par 0008; see also Pars 0013 and 0026). It’s clear from Brown that proximity detection can not only be used to determine when a target is too close (similar to what is taught in Kowalski), but can also be used to determine the opposite, i.e. determine that the fiber is close enough to the target to fire/actuate the laser. Therefore, it would have been obvious to modify the patented invention and Kowalski with the proximity detection taught by Brown, specifically determining a laser firing range when the fiber-to-target distance from the distal end of the optical fiber to the outer surface of the target is at or below a threshold distance, as taught by Brown, as a known safety feature to ensure that the laser is at the proper/optimal position when firing at target tissue.
[Claim 2] As discussed above, the patented claims explicitly teach a spectroscopic parameter/property.
[Claim 5] See claim 15
[Claim 6] See claims 16 and 17
[Claim 7] See claim 1
[Claim 8] See claim 1. Also, Pars 0079 and 0099 of Kowalewski disclose powering off the laser, i.e. disabling the laser, in response to the determination.
[Claim 9] Par 0078 of Kowalewski discloses a controller that generates an alert to the user to adjust the position of the distal end of the optical fiber relative to the target (at least Par 0099)
[Claims 10-12] See claims 1 and 10
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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