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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 11/14/2025 is acknowledged. The traversal is on the grounds that both the device and method claims have been amended to require medical laser systems being used during a medical procedure. This is not found persuasive because intended use/functional language recited in a device claim does not actually require such a use/function. MPEP 2114 states: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, while the laser device is intended to be used, i.e. needs to be capable of use, during a medical procedure, the prior art does not need to teach a medical laser being used in a medical procedure to read on the recited/required structure. Therefore, the examiner’s previous position of a device being used in a materially different method, e.g. industrial or communication applications, still holds true, as the device can still be used in these methods and still read on the current claim language. Stated differently, amending the intended use into the device claim does not change the fact that the device can still be used in different light-delivery applications, as other applications/intended uses are not precluded by this amendment.
The requirement is still deemed proper and is therefore made FINAL.
It is emphasized that applicant only traversed the restriction between Inventions I and II and did NOT traverse the species restriction. Therefore, applicant’s election without traverse of species A3, B2 and C2 in the reply filed on 11/14/2025 is acknowledged. Claims 3-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement. See explanation above, as to why this traversal is not persuasive.
Therefore claims 3-4 and 13-20 are withdrawn from consideration, leaving claims 1, 2 and 5-12 pending examination.
Claim Objections
Claims 3-4 and 13-20 are objected to because of the following informalities: the correct status identifier for these claims should be “withdrawn”. 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 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.
[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; 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 and controllably adjusts an output setting of the laser source based on this determination (distance determining logic 520 and controller 180; 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.
[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
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 for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2 and 5-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0184020 to Kowalewski in view US 6,087,182 to Jeng et al.
[Claims 1 and 2] Kowalewski discloses a medical laser system (Figs. 1 and 5), comprising:
a laser source (laser device 130) configured to generate laser energy (Pars 0055-56), and an optical fiber (at least one source fiber 300, Fig. 3 or fiber bundle 504) for directing the laser energy to a target during a medical procedure (Pars 0063 and 0066);
an optical detector (optical property sensing logic 515, including “at least one of a spectrometer, filtered light sensor(s), charge-coupled device (CCD) array”) configured to receive a signal reflected from the target (Abstract; Par 0070-71) and transmitted through the optical fiber, in response to electromagnetic radiation from a light source (The majority of Kowalewski focuses on an embodiment with separate source fibers 300 and return fibers 302, but Par 0110 makes it clear that the same/single fiber can be used for both transmitting light to the target and reflected/return light to the detector. See also Par 0053 which discusses a diagnostic light source); and
control circuitry (controller 180) configured to:
receive a signal reflected from the target in response to electromagnetic radiation (Abstract; Pars 0071-73);
generate a reflect signal parameter associated with the received reflected signal (Pars 0071-75; A spectrometer/CCD array inherently generate a spectroscopic/image parameter associated with a spectroscopic/image signal of the target. “The at least one property of the region 506 may include at least one of a transmittance of the region 506, a reflectance of the region 506, an absorbance of the region 506, a scattering coefficient of the region 506, and an intensity of the reflected light within a spectrum” Par 0075);
generate a calibration curve indicating a relationship between values of the reflect signal parameter and corresponding fiber-to-target distances from a distal end of the optical fiber to an outer surface of the target (Fig. 8, Pars 0080 and 0086-88. While Kowalewski does not specifically use the term “calibration curve”, it’s clear that what is described/shown in Fig. 8 is, by definition, a calibration curve);
determine a change in values of the reflect signal parameter over a plurality of fiber-to-target distances (“the optical property sensing logic 515 and the optical property determining logic 516 may use changes in intensity of reflected light to determine the reflectance of the region 506”; Par 0075);
determine whether the target is within a specific laser firing range (“shorter than desired” or “dangerously close contact” in Par 0078 are interpreted as a specific laser firing range) based on a comparison between the determined rate of change and the generated calibration curve (“The information from the optical property determining logic 516 regarding the determined at least one property of the region 506 may, for example, be compared against information in the library to determine the type of the material in the region 506 and/or the distance to the material” Par 0080); 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 (Pars 0078-79. Par 0079 discloses an “automatic” adjustment of the laser intensity based on the determination of whether or not the target is within the specific laser firing range). See also Fig. 10 and Pars 0094-100.
Regarding the “determining a rate of change in values of the reflect signal parameter”, Kowalewski only teaches a change in value, not a rate of change (which is the derivative). It is emphasized that applicant’s own specification makes no distinction between using only a variation/change (as taught by Kowalewski) compared to a rate of change (as currently claimed) to analyze the data (see Par 0084 of applicant’s specification), i.e. there is no criticality, unexpected result or functional significance/advantage to using rate of change vs just change to analyze the data. Therefore, the examiner takes the position that it would be obvious to use either the change/variation in these values or the rate of change (first derivative of change) of these values, as both options are commonly known and used in data analysis. To further support this position, as it specifically relates to spectroscopic data, Jeng discusses “derivative spectroscopy” which “refers to the rate of change of the spectrum with respect to the rate of change of wavelength” (Col 9, line 57 to Col 10, line 5) and how this is a known “technique that can be used to bring about noise reduction” (Col 21, line 66 to Col 22, line 13). Therefore, it would have been obvious to one of ordinary skill in the art to use/try derivative spectroscopy, i.e. determining a rate of change in values of the reflect signal parameter, as a known technique that reduces noise and provides more accurate results during spectroscopic analysis.
[Claim 5] Kowalewski discloses “at least one source fiber 300” (Par 0063; Fig. 3) which clearly shows/encompasses an additional/second/separate fiber to transmit light from the light source to target. Alternatively or additionally, additional fiber (304) could also be considered the claimed second fiber. See also Par 0053 which discusses a diagnostic light source.
[Claim 6] Kowalewski discloses using the protrusion angle to generate the reflect signal parameter (Par 0081)
Additionally, this is seemingly an inherent feature of all spectroscopic feedback that involves optical fibers, as the outer diameter and angle of protrusion of the optical fiber inherently effects the intensity of the reflectance signal. Applicant seemingly admits the inherent relationship/correlation themselves “for example, an outer diameter of the laser fiber 512 or an outer diameter of a separate optical pathway for transmitting the spectroscopic signal reflected from the target to the spectrometer 611, or an angle of protrusion of said fiber or pathway from the endoscope 510, may affect the intensity of reflected signal.” Therefore, the information regarding the optical fiber’s diameter and angle of protrusion are inherently used when generating the spectroscopic properties as these structural characteristics inherently affect the intensity of the signal and therefore affect the spectroscopic reading.
[Claim 7] Regarding the combination of Kowalewski and Jeng, Kowalewski discloses generating a calibration curve by determining a change in the intensity of the reflection signal over a known amount of change in fiber-to-target distances, i.e. as the device is moved (See Fig. 8, Pars 0080 and 0086-88). The proposed combination of Kowalski and Jeng, makes it clear that using the “rate of change” of the reflect signal parameter instead of just the change is an obvious modification. Neither Kowalewski or Jeng explicitly disclose normalizing this data. However, the examiner takes official notice that normalizing data is a well-known and common tactic/tool in data/statistical analysis, e.g. as a known way to reduce redundancy and improve integrity. Therefore, it would have been obvious to one of ordinary skill in the art to modify the calibration curve and data analysis techniques taught by Kowalewski or Jeng to include normalizing the data, as a common and well-know way to effectively analyze data, as discussed above.
[Claim 8] Kowalewski teaches/suggest powering off the laser when the laser is “in dangerously close contact” with the target (Pars 0079-80; see also Par 0099). It’s clear/common sense that the laser is disabled when the target is out of, i.e. not in, the specific/proper laser firing range.
[Claim 9] Kowalewski disclose generating an alert for the user to adjust the distal end of the optical fiber relative to the target based on the determination of whether the target is within the specific laser firing range (Par 0099. Par 0087 discloses other alerts, including moving the catheter up, down, left or right)
[Claims 10 and 11] Kowalewski discloses identifying the target as one of a plurality of structure types based on the reflect signal parameter (material type determining logic 518; Pars 0076-77) and adjust the output setting based on this identification (Par 0079)
[Claim 12] It is noted that the recited language of at least one of a first operating mode, a second operating mode OR a third operating mode, only requires one of these modes in order to read on the claim language. The examiner takes the position that Kowalewski teaches the third operating mode, where the target is identified as neither an anatomical structure not a calculus; Pars 0076-77 detail all of the different types of materials and Pars 0079-80 make it clear that this identification determines a specific laser output mode, e.g. a change in intensity.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2008/0125634 to Ryan disclose a similar laser catheter device that determines the fiber to target distance by comparing a change in spectroscopic information to a calibration curve (Pars 0017 and 0100-101).
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