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
Applicant’s arguments, see page 6, filed 05/01/2026, with respect to the drawing objections have been fully considered and are persuasive. The drawing objections have been obviated by an amendment to the drawings. The drawing objections have been withdrawn.
Applicant’s arguments, see pages 6-7, filed 05/01/2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections have been obviated by amendments to the claims. The 35 U.S.C. 112(b) rejections have been withdrawn.
Applicant’s arguments, see pages 7-8, filed 05/01/2026, with respect to 35 U.S.C. 102 rejections have been fully considered but they are not persuasive. The Applicant argues that Wang fails to disclose all of the limitations of amended claim 11. The Applicant argues that Wang does not disclose “automatically plac[ing] a second focal point of the second laser with .01 μm of a first focal point of the first laser,” as recited in amended claim 11. The Applicant then points to Wang’s Par. [0038], where Wang discusses a calibration or registration procedure. The Applicant argues that because Wang requires a calibration and registration procedure to correct for misalignment and fundamental differences between the OCT beam 114 and UF beam 6, Wang fails to disclose at least “automatically plac[ing] a second focal point of the second laser with .01 μm of a first focal point of the first laser,” as recited in amended claim 11. The Applicant further argues that Wang is silent regarding the precise alignment of the OCT beam 114 relative to the UF beam 6 and therefore fails to disclose “plac[ing] a second focal point of the second laser with .01 μm of a first focal point of the first laser,” as recited in amended claim 11.
This is not found persuasive. The Examiner disagrees that Wang’s disclosure of a calibration or registration procedure in Par. [0038] precludes Wang from teaching the limitation “automatically plac[ing] a second focal point of the second laser with .01 μm of a first focal point of the first laser,” as recited in amended claim 11. The 35 U.S.C. 102 rejection has been updated to reflect the claim amendments of amended claim 11. The Examiner notes that Wang teaches that the aiming and treatment scan patterns can be automatically generated by the scanner 50 under the control of controller 300 (Par. [0031]). Further, the Examiner notes that Wang describes its calibration method as being “fast and efficient” (Par. [0022]) and as using calibration parameters that are stored in the controller (Par. [0052]). Therefore, regardless of Wang’s disclosure requiring the calibration step, Wang still meets the requirement of amended claim 11 to “automatically place a second focal point of the second laser with .01 μm of a first focal point of the first laser.” However, the Examiner wishes to propose that the Applicant could amend claim 11 to include a limitation involving “without calibration” in the limitation “automatically plac[ing] a second focal point of the second laser with .01 μm of a first focal point of the first laser.” Such a claim limitation is supported by Par. [0026] of the Applicant’s specification (i.e., “Accordingly, if an image of a floater is detected by the system 200 and possibly displayed on a screen of an operator, the treatment laser is automatically focused onto the floater. There is no need for co-calibration of the focus of the laser diode LD beam and the focus of the treatment laser TL beam.”) and would appear to differentiate over Wang’s disclosure, therefore obviating the current 35 U.S.C. 102 rejections. With regards to Applicant’s argument that Wang is silent regarding the precise alignment of the OCT beam 114 relative to the UF beam 6, the Examiner notes that Wang does teach that the OCT beam 114 is indicative of the location of UF beam 6 (Par. [0036]). The Examiner notes that this is interpreted as the focal points of the OCT beam 114 and UF beam 6 would be practically identical since the OCT beam 114 is indicative of the location of the UF beam 6. The Examiner also notes that this is therefore interpreted as reading on the limitation requiring the second focal point of the second laser being within .01 μm of the first focal point of the first laser. Therefore, the 35 U.S.C. 102 rejections over Wang are maintained. Please see 35 U.S.C. 102 rejections below.
Information Disclosure Statement
The information disclosure statement filed 10/24/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The Applicant has not filed a copy of NPL reference # 10 (“NIDEK, Scanning Laser Ophthalmoscope Mirante SLO/OCT Mirante SLO, …”) of the 10/24/2024 IDS. Please file the missing reference. All other references in the 10/24/2024 IDS have been considered.
Priority
The priority section from the previous Office Action is carried over herein.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 11-21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wang, et al. (U.S. PGPub No. 2020/0038241 – cited on IDS). The Article “Micro-optofluidic Lenses: A review” by Nguyen is relied upon as evidence for the rejection of claim 15 hereinbelow (see attached).
Regarding claim 11, Wang teaches (Fig. 1) a system (Title; Abstract; Par. [0001] – laser eye system for treating vitreous humor including ocular floaters) comprising:
(Fig. 1, # 40 – Z-adjust / Z scan device, 50 – scanning device) a three-dimensional scanner (Par. [0023] – using this system, a beam may be scanned in a patient’s eye in three dimensions: X, Y, Z.; Par. [0029-0030] – After passing through the z-adjust device 40, the beam 6 is directed to the x-y scan device by mirrors 46 & 48. X-Y scanning is achieved by scanning device 50);
(Fig. 1, # 102 – swept light source, i.e. first laser, 114 – OCT beam; Fig. 6) a first laser for imaging vitreous floaters (Par. [0034-0035] – OCT device includes a broadband or a swept light source 102; Par. [0078] – The OCT and/or the video camera system may be used to locate the vitreous floaters, and treatment plan is determined and executed to specifically target the floaters for treatment);
(Fig. 1, # 4 – UF light source, i.e. second laser) a second laser configured to emit pulses sufficient to disintegrate the vitreous floaters (Par. [0023] – ultrafast (UF) light source (e.g., femtosecond laser. The peak power of the focus spot is also sufficient to treat the vitreous humor, e.g. to treat floaters or liquify the vitreous humor; Par. [0078] – the laser focal spot may be scanned in a volume that includes the floaters to destroy or remove the floaters); and
(Fig. 1, # 34 – beamcombiner) one or more combining optics configured to direct a first light from the first laser and a second light from the second laser into the three-dimensional scanner (Par. [0028-0029] – Beamcombiner 34 reflects the UF beam 6 and transmits the OCT beam 114; Par. [0036] – once combined with the UF beam 6 subsequent to beamcombiner 34, OCT beam 114 follows the same path as UF beam 6 through the rest of the system. Both beams pass through the z-scan 40 and x-y scan 50 devices), the one or more combining optics configured to automatically place a second focal point of the second laser within .01 μm of a first focal point of the first laser (Par. [0031] – The aiming and treatment scan patterns can be automatically generated by the scanner 50 under the control of controller 300; Par. [0036] – In this way, OCT beam 114 is indicative of the location of UF beam 6. OCT beam 114 passes through the z-scan 40 and x-y scan 50 devices then the objective lens 58, contact lens 66 and on into the eye 68; The Examiner notes that this is interpreted as the focal points of the OCT beam 114 and UF beam 6 would be practically identical since the OCT beam 114 is indicative of the location of the UF beam 6. The Examiner also notes that this is therefore interpreted as reading on the limitation requiring the second focal point of the second laser being within .01 μm of the first focal point of the first laser).
Therefore, claim 11 is unpatentable over Wang, et al.
Regarding claim 12, Wang teaches the system of claim 11, wherein the three-dimensional scanner comprises a mirror driven by a resonant scanner (Par. [0047] – There are many possibilities for the configuration of the OCT interferometer, including time and frequency domain approaches, single and dual beam methods, swept source, etc., as described in U.S. Pat. Nos. 5,748,898; 5,748,352; 5,459,570; 6,111,645; and 6,053,613 (which are incorporated herein by reference.; In US5459570 (Swanson, et al.), it is explained that for very high speed scanning at high scan repetition rates that cannot be realized with servo-controlled constant velocity mechanical drives, resonantly (sinusoidal) driven mechanical actuators can be used to drive mirror 32. Swanson also explains that these actuators can be galvanometrically or electrodynamically driven at the resonant frequencies of the mechanical actuator system and are commercially available – Col. 8, lines 37-46).
Therefore, claim 12 is unpatentable over Wang, et al.
Regarding claim 13, Wang teaches the system of claim 12, wherein (Fig. 1, # 42 and 44) the three-dimensional scanner comprises one or more adjustable lenses (Par. [0029] – The x-adjust or Z scan device includes a Galilean telescope with two lens groups 42 and 44. Lens group 42 moves along the z-axis about the collimation position of the telescope. In this way, the focus position of the spot in the patient’s eye 68 moves along the z-axis as indicated. Alternatively, lens group 44 could be moved along the z-axis to actuate the z-adjust, and scan).
Therefore, claim 13 is unpatentable over Wang, et al.
Regarding claim 14, Wang teaches the system of claim 13, wherein (Fig. 1, # 52 and 54) the one or more adjustable lenses comprise one or more lenses mounted to an actuator (Par. [0030] – X-Y scanning is achieved by the scanning device 50 preferably using two mirrors 52 and 54 under the control of control electronics 300, which rotate in orthogonal directions using motors, galvanometers, or any other well known optic moving device).
Therefore, claim 14 is unpatentable over Wang, et al.
Regarding claim 15, Wang teaches the system of claim 13, wherein the one or more adjustable lenses comprises an electrically tunable optofluidic lens (Par. [0030] – X-Y scanning is achieved by the scanning device 50 preferably using two mirrors 52 and 54 under the control electronics 300 which rotate in orthogonal directions using motors, galvanometers, or any other well known optic moving device.; As evidenced by Nguyen in “Micro-optofluidic Lenses: A review”, optofluidic lenses are shown to be a well-known optic moving device, and are often used over solid lens systems for their advantage of not having to require the use of large actuators such as servo motors (Abstract). Nguyen also explains that microfluidic lenses are attractive as a candidate for miniaturization of imaging optics (Introduction)).
Therefore, claim 15 is unpatentable over Wang, et al.
Regarding claim 16, Wang teaches the system of claim 12, wherein (Fig. 1, # 34) the one or more combining optics comprise one or more beam splitters positioned to receive the first light from the first laser and the second light from the second laser (Par. [0006] – optical components including at least one beam splitter, configured to direct the laser beam and the imaging beam output by the scanning assembly and the illumination light to the objective lens assembly; Par. [0028] – Beamcombiner 34 reflects the UF beam 6 (and transmits both the OCT 114 and aim 202 beam).
Therefore, claim 16 is unpatentable over Wang, et al.
Regarding claim 17, Wang teaches the system of claim 16, wherein the one or more beam splitters comprise:
(Fig. 1, # 34) a first beam splitter configured to pass a first portion of the first light and direct a second portion of the second light to be parallel to the first portion (Par. [0006]; Par. [0028-0029] – Beamcombiner 34 reflects the UF beam 6 (and transmits the OCT beam 114); Par. [0036] – Once combined with the UF beam 6 subsequent to beamcombiner 34, OCT beam 114 follows the same path as UF beam 6 through the rest of the system).
Therefore, claim 17 is unpatentable over Wang, et al.
Regarding claim 18, Wang teaches the system of claim 17, wherein the one or more beam splitters comprise:
(Fig. 1, # 34 – beamcombiner, i.e. first beam splitter, 102 – swept light source, i.e. first laser, 126 – beamcombiner, i.e. second beam splitter, 128 – detection device, i.e. photodiode) a second beam splitter positioned between the first beam splitter and the first laser, the second beam splitter configured to direct a third portion of the first light reflected from the vitreous floaters onto a photodiode (Par. [0034]; Par. [0035] – beam combiner 126; Par. [0036] – Reflections and scatter off of structures within the eye (e.g., floaters) provide return beams that retrace back through the optical system (i.e., including second beam splitter 126), into connector 112, through coupler 104, and to OCT detector 128. These return back reflections provide OCT signals that are in turn interpreted by the system as to the location in X, Y, Z of UF beam 6 focal location).
Therefore, claim 18 is unpatentable over Wang, et al.
Regarding claim 19, Wang teaches the system of claim 18, further comprising (Fig. 1, # 118 – aperture, i.e. confocal pinhole filter) a confocal pinhole filter positioned between the second beam splitter and the photodiode (Par. [0035] – Following collimating lens 116 is aperture 118 which further modifies the resultant NA of the OCT beam. The diameter of aperture 118 is chosen to optimize OCT light incident on the target tissue and the strength of the return signal).
Therefore, claim 19 is unpatentable over Wang, et al.
Regarding claim 20, Wang teaches the system of claim 19, further comprising (Fig. 1, # 120 – polarization control element) a lens positioned between the second beam splitter and the confocal pinhole filter such that a focal point of the third portion of the first light is positioned at the confocal pinhole filter (Par. [0035] – Polarization control element 120 (i.e., lens), which may be active or dynamic, is used to compensate for polarization state changes which may be induced by individual differences in corneal birefringence, for example).
Therefore, claim 20 is unpatentable over Wang, et al.
Regarding claim 21, Wang teaches the system of claim 11, wherein (Fig. 1, # 40) the second laser is transmitted at a deepest Z layer of a treatment box and moved in an anterior direction to disintegrate the vitreous floaters (Par. [0070] – move the focal zone of the OCT beam in the anterior direction by a predetermined distance from the relevant structure identified in step 1 (the predetermined distance corresponds to a safety zone, e.g. 2 mm from the retina); Par. [0073] – The parameters of the Z scan device that correspond to these various depths are determined, which can then be used by the controller to scan the focal zone of the treatment laser beam for treating the vitreous humor, e.g. to treat floaters or liquify the vitreous humor as described herein. The scan of the treatment beam is performed within the volume bound by the safety limitation positions described above.; Par. [0076]; Par. [0078]).
Therefore, claim 21 is unpatentable over Wang, et al.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Wang, et al. (U.S. PGPub No. 2020/0038241 – cited on IDS) in view of Raksi (U.S. PGPub No. 2013/0237971).
Regarding claim 22, Wang teaches the system of claim 11, as indicated hereinabove. Wang does not explicitly teach the limitation of instant claim 22, that is wherein the pulses of the second laser generate transient cavitation bubbles having a diameter of at least 370 pm.
Raksi, directed to analogous art, teaches ophthalmic surgical laser systems (Title; Abstract; Par. [0001]). Raksi also teaches the limitation of instant claim 22, that is wherein the pulses of the second laser generate transient cavitation bubbles having a diameter of at least 370 pm (Par. [0073] - When cutting with a femtosecond laser, this plasma-tissue interaction length is typically the diameter of the laser-induced cavitation bubbles in the tissue, often in the 1-20 micrometer range; Examiner notes that 1-20 micrometers is equivalent to 1,000,000 pm to 20,000,000 pm (i.e., at least 370 pm)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Raksi’s teaching of a femtosecond laser creating cavitation bubbles greater than 370 pm in diameter into Wang’s disclosed system in order to arrive at the claimed invention. Like Raksi, Wang teaches using a femtosecond laser source for laser eye surgery (see Fig. 1, # 4 and Par. [0023] of Wang). One of ordinary skill in the art would have recognized that Wang’s femtosecond laser source would likely create cavitation bubbles when in contact with the eye tissue, as shown in Raksi’s teaching. One of ordinary skill in the art would find it obvious that such cavitation bubbles would have a diameter greater than 370 pm, as Rakis explains that such a value is typical (see Par. [0073] of Raksi).
Therefore, claim 22 is unpatentable over Wang, et al. and Raksi.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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