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 .
Status of Claims
The amendments and remarks filed on 26FEB2026 have been entered and considered.
Claims 1-3, 6-13, & 16-20 are currently pending.
Claims 1 & 11 have been amended.
Claims 21-24 have been added.
New matter has been found in claims 1 & 11.
Claims 1-3, 6-13, & 16-24 are under examination.
Response to Arguments
Applicant's arguments filed 26FEB2026 regarding the rejections under 35 USC 103 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 9-12 of the Remarks):
The applicant argues that a blanking on/off period and pulse repetition rate/duty cycle are separate and distinct concepts that cannot be equated or used interchangeably.
However, the examiner is not persuaded because under the broadest reasonable interpretation one of ordinary skill in the art would understand that a blanking period for a laser involves a period of time where the laser is not active and no laser energy is reaching a target. This can be achieved by the use of a modulator as well as adjusting the pulse repetition rate such that the rate becomes zero. The examiner maintains that any prior art discussing a controlled period of laser energy delivery/deactivation would satisfy the limitation including a blanking on-off period regardless of if the controlling of the source is internal or from an external source. The embodiment of Figure 9B (Reproduced Below) fails to explicitly teach a plurality of blanking on-off periods, as it only shows 1 full on-off period and the start of an off period. However, regarding a different embodiment shown in Figures 7A-7B (Reproduced Below), Malek teaches “any number of triangles could be formed during the sweep” (¶0074), making it clear that the on-off periods can be repeated during a scan. Therefore, it would have been obvious to duplicate the blanking on-off periods of Figure 9B in the same way the blanking on-off periods of Figures 7A-7B are taught to be repeated, as this is merely use of known technique to improve similar devices, methods, or products in the same way. Alternatively, for the same reasons a person of ordinary skill in the art would desire to repeat the pattern in Figures 7A-7B, as explicitly taught by Malek, it would be obvious to repeat the pattern in Fig. 9B. Further, the examiner maintains that duty cycle and blanking (on/off periods) describe exactly the same physical mechanism: how long a laser fires compared to how long it rests. Blanking refers to the action of the laser switching on and off, while duty cycle is the mathematical ratio of that active state.
The applicant further argues that Malek operates in microseconds while the application requires milliseconds. They argue that since the scale is a magnitude of order different, Malek must represent a completely different technology and would require more than a simple adjustment to meet the claim limitations.
However, the examiner is not persuaded because Malek uses a pulse picker which is made with the express purpose of allowing the user to block as many laser pulses in a row as desired. The system of Malek is already designed for the flexibility of varying the pulse periods (Malek ¶0053 “As described herein acousto-optic module 15 of the laser 14 may optionally be used control one or more of the pulse energy, repetition rate and scan width of a scan line in accordance with many embodiments of the present invention.”) and therefore the adjustment of a period of milliseconds and microseconds is merely just a routine change in the settings for optimizing functional ranges. Further, there is no criticality associated with claimed ranges and that variable parameters are art-recognized result-effective variables. See MPEP 2144.05(II).
The applicant further argues that Malek’s high frequency settings (2-40MHz) creates a small pulse-pulse gap of 0.025-0.5 microseconds. It is argued that this is several magnitudes smaller than the claimed 1-50millisecond range claimed. Therefore, Malek cannot meet the claim limitations.
However, the examiner is not persuaded. Malek has shown that the system is intended to provide adjustable settings where Malek further explicitly teaches that you can program the system to block a group of pulses as desired. The claimed range of 1-50 milliseconds amounts to only a routine optimization to control heat buildup. The examiner therefore maintains that Malek having a user controllable system along with the cited portions of Malek would amount to a system that can be optimized for heat reduction such as in the claim limitations. Further, there is no criticality associated with claimed ranges and that variable parameters are art-recognized result-effective variables. See MPEP 2144.05(II).
The applicant further argues that Malek’s discontinuous region in Figure 9B only represents a couple missing pulses which is too short to reach the claimed 1-50millisecond blanking range.
However, the examiner is not persuaded because Figure 9B of Malek should not be looked at solely rather than reviewing the entire reference. Figure 9B is provided to show the concept of a programmable system that blanks laser pulses on demand. The change of having blanking periods in the millisecond range versus the microsecond range does not require a new invention as Malek’s system would be used for its intended purpose of having a programmable system to address a range of treatments. Further, there is no criticality associated with claimed ranges and that variable parameters are art-recognized result-effective variables. See MPEP 2144.05(II).
Further, the applicant is suggesting that the specific 1-50 Millisecond blanking period range is a unique feature that Malek does not suggest.
However, the examiner is not persuaded because the act of selecting a period for laser blanking where the laser will be off is a design choice based on optimizing a laser’s performance based on managing heat buildup and would amount to an obvious design choice to include this range in a laser system. Malek would by nature encompass based on its pulse picker capabilities to create a customizable system. Further, there is no criticality associated with claimed ranges and that variable parameters are art-recognized result-effective variables. See MPEP 2144.05(II).
Further, the applicant argues that the office has failed to explain what the result effective variable is and why a skilled person would be motivated to change Malek’s fast pulse timing into something that is four orders or magnitude smaller.
The examiner notes that the result effective variable represents the duration of the lasers off period (blanking) and controls heat accumulation in the target area. The blanking periods in laser treatment is a well known issue such that considerations have to be made to account for tissue heating in the blanking process so there is not an accumulation of said heat. The result of the laser treatment is directly tied to this blanking system as this will control tissue damage as a result of the heating. A person of skill in the art would be very motivated to adjust Malek’s programmable pulse picker to create long off periods (such that you could shift from a microsecond range to millisecond range) to safely manage thermal build up, which is a routine method. Further, there is no criticality associated with claimed ranges and that variable parameters are art-recognized result-effective variables. See MPEP 2144.05(II).
Claim Rejections - 35 USC § 103
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 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.
Claims 1-3, 6-13, & 16- 24 are rejected under 35 U.S.C. 103 as being unpatentable under Malek et al. (US Publication No. 20190110926; Previously Cited).
Regarding claims 1 & 11, Malek discloses creating a lenticular incision using an ophthalmic surgical laser system (Malek ¶0018 “Other embodiments disclose an ophthalmic surgical laser system”; ¶0013; Abstract) comprising: a laser source configured to generate a pulsed laser beam comprising a plurality of laser pulses (Malek ¶0051 “In other embodiments, the laser 14 may comprise a laser source configured to deliver an ultraviolet laser beam comprising a plurality of ultraviolet laser pulses capable of photodecomposing one or more intraocular targets within the eye.”; ¶0068 “FIG. 6 illustrates a portion of an incision pattern characterized by overlapping cuts in which tissue is exposed multiple times to laser pulses having energy above the tissue modification thresholds.”; ¶0071; ¶0072); a laser delivery system configured to deliver the pulsed laser beam to a target tissue in a subject's eye (Malek ¶0013 “Hence, to obviate one or more problems due to limitations and disadvantages of the related art, this disclosure provides embodiments including an ophthalmic surgical laser system comprising a laser delivery system for delivering a pulsed laser beam to a target in a subject's eye”; ¶0018; ¶0051); a high frequency scanner configured to scan the pulsed laser beam back and forth at a predefined frequency (Malek Abstract “The controller controls the high frequency scanner to produce a scan line having a scan width; controls the XY-scan device and the Z-scan device to carry out of first sweep of the scan line in a first sweep direction and to carry out a second sweep of the scan line in a second sweep direction that is not parallel to the first sweep direction thereby defining an overlap region.”; ¶0082 “The shape and composition of the rod are selected to operate at a desired frequency to scan laser pulses.”); an XY-scanner configured to deflect the pulsed laser beam, the XY-scanner being separate from the high frequency scanner (Malek ¶0048 “and an XY-scanner 28 for deflecting or directing the pulsed laser beam 18 from the laser 14 on or within the material 12. The controller 22, such as a processor operating suitable control software, is operatively coupled with the Z-scanner 20, the XY-scanner 28, and the energy control unit 16 to direct a scan line 30 of the pulsed laser beam along a scan pattern on or in the material 12.”; ¶0065; Abstract “An ophthalmic surgical laser system includes: a laser that produces a pulsed laser beam having a pulse energy and pulse repetition rate; a high frequency fast scanner; an XY-scan device; a Z-scan device; and a controller.”); a Z-scanner configured to modify a depth of a focus of the pulsed laser beam (Malek ¶0013 “a Z-scan device to modify a depth of a focus of the pulsed laser beam”; ¶0018; ¶0048 Lines 3-4); and a controller configured to control the laser source, the high frequency scanner, the XY- scanner and the Z-scanner (Malek Abstract “The controller controls the high frequency scanner to produce a scan line having a scan width; controls the XY-scan device and the Z-scan device to carry out of first sweep of the scan line in a first sweep direction and to carry out a second sweep of the scan line in a second sweep direction that is not parallel to the first sweep direction thereby defining an overlap region.”; ¶0013; ¶0018; ¶0048; ¶0057; ¶0062)to successively form a plurality of sweeps which collectively form at least one lenticular incision of a lens in the subject's eye (Malek ¶0044 “FIG. 20 illustrates an exemplary plurality of sweep sequences performed by the surgical ophthalmic laser system according to the present invention adapted for use in connection performing lenticular incisions according to an embodiment of the present invention.; ¶0051; ¶0060) , the lens having a curved surface that defines an apex and a Z axis passing through the apex (Malek ¶0049 “Scanning along the third dimension, i.e., moving the focal plane along an optical axis (e.g., the z-axis), may be achieved by moving the focusing objective, or one or more lenses within the focusing objective, along the optical axis.”; ¶0065), wherein each sweep is formed by: controlling the high frequency scanner to deflect the pulsed laser beam to form a scan line (Malek ¶0065 “It is noted that in many embodiments, the XY-scanner 28 deflects the pulse laser beam 18 to form a scan line.”; ¶0013 “and a controller configured to control the high frequency scanner to produce a scan line,”; ¶0048), the scan line being a straight line having a predefined length and being tangential to a parallel of latitude of the lens, the parallel of latitude being a circle on the surface of the lens that is perpendicular to the Z axis and has a defined distance to the apex (Malek Figures 9A-9C as described by ¶0084), controlling the XY-scanner and the Z-scanner to move the scan line along a meridian of longitude of the lens, the meridian of longitude being a curve that passes through the apex and has a defined angular position around the Z axis, (Malek ¶0013 “control the XY-scan device and the Z-scan device to carry out a second sweep of the scan line in a second sweep direction that is not parallel to the first sweep direction, thereby defining an overlap region, wherein at least one of the pulse energy, repetition rate, XY-scan speed and the scan width are varied during at least one of the first sweep and second sweep so as to reduce the exposure of ophthalmic tissue in the overlap region to multiple exposures of laser pulses configured to modify ophthalmic tissue.”; ¶0017 “The scan line is typically tangential to the parallels of latitude of the cornea. The scan line is then typically moved along the meridians of longitude of the cornea. The top lenticular incision is moved over the top surface through the apex of the top surface, and the bottom lenticular incision is moved over the bottom surface through the apex of bottom surface.”), a duty cycle of 5-95% (Malek blank area 574 in Fig. 9B where the blank period is between 5-95% of the length of region 561 in Fig. 9B.) wherein the plurality of sweeps are successively formed one after another along the respective meridians of longitude which are different from one another. (Malek ¶0017 “The scan line is then typically moved along the meridians of longitude of the cornea. The top lenticular incision is moved over the top surface through the apex of the top surface, and the bottom lenticular incision is moved over the bottom surface through the apex of bottom surface.”; ¶0086; ¶0094).
Regarding the limitation “and a length of the blanking on-off period of 1.0-50.0 ms”, Malek is not found to disclose a length of the blanking on-off period of 1.0-50.0 ms. Malek ¶0076 states any frequency, number of pulses, etc. can be adjustable to selectively cut and not cut tissue but does not go int detail on periods of time over which this occurs. This time frame would be dependent on the frequencies used and the number of pulses delivered. According to MPEP 2144.05 “ the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process “.Therefore, it would have been obvious to have a length of the blanking on-off period of 1.0-50.0 ms since identifying the optimal time period is “a matter of routine optimization “ of a result effective variable.
The embodiment of Figure 9B (Reproduced Below) fails to explicitly teach a plurality of blanking on-off periods, as it only shows 1 full on-off period and the start of an off period. However, regarding a different embodiment shown in Figures 7A-7B (Reproduced Below), Malek teaches “any number of triangles could be formed during the sweep” (¶0074), making it clear that the on-off periods can be repeated during a scan. Therefore, it would have been obvious to duplicate the blanking on-off periods of Figure 9B in the same way the blanking on-off periods of Figures 7A-7B are taught to be repeated, as this is merely use of known technique to improve similar devices, methods, or products in the same way. Alternatively, for the same reasons a person of ordinary skill in the art would desire to repeat the pattern in Figures 7A-7B, as explicitly taught by Malek, it would be obvious to repeat the pattern in Fig. 9B.
PNG
media_image1.png
360
1128
media_image1.png
Greyscale
Figure 9B
PNG
media_image2.png
569
798
media_image2.png
Greyscale
Regarding claims 2 & 12, claims 1 & 11 are obvious over Malek. Malek further discloses periodically reducing a pulse energy of the laser pulses to a value below a photodisruption threshold of the target tissue. (Malek ¶0072 “During at least a portion the sweep, a higher energy portion 525 of the scan line is configured to modify ophthalmic tissue (which may be referred to herein as incising portion 525) and lower energy portions 527, 529 are not configured to modify ophthalmic tissues (which may be referred to herein as the non-incising portions 527, 529). In the embodiment of FIG. 7A, the size of the incising portion 525 decreases continuously as the scan line is swept along the scan trajectory and reaches a minimum at a predetermined location 521. After reaching predetermined location 521, the size of incising portion 525 continuously increases as scan line 501 is swept to end point 522.”; ¶0079; ¶0130).
Regarding claims 3 & 13, claims 1 & 11 are obvious over Malek. Malek further discloses periodically increasing a repetition rate of the laser pulses and reducing a pulse energy of the laser pulses to a value below a photodisruption threshold of the target tissue. (Malek ¶0053 “Energy control unit 16 may optionally comprise a second acousto-optic module 17 for controlling the energy and/or repetition rate of the laser pulses.”; ¶0079; ¶0130).
Regarding claims 6 & 16, claims 1 & 11 are obvious over Malek. Malek further discloses wherein the central area of the lens has a radius of 0.25-2.5 mm. (Malek ¶0111 “In order to minimize the amount of dissected cornea stroma material removed, the central thickness δc should be minimized. For example, the central thickness may be a few μm, which can be achieved by using a laser beam with a high numerical aperture (such as NA=0.3−0.8, preferably NA=0.6).”, Where the aperture relates to the size of the opening in which the light is produced and output from, which is directly related to the size of the patient’s eye (Shown in ¶0089 “The thickness of the lens may be determined, for example, by the total amount of correction (e.g., diopter) and the diameter of the lens”; ¶0066 “uses small field optics (e.g., a field diameter of 1.5 mm). The large surgical field (e.g., a field diameter of 10 mm or greater) is achieved with the XY-scanner, which may be unlimited.”; ¶0084 “scan width in an overlap region during a sweep of the scan line is not particularly limited.”).
Regarding claims 7 & 17, claims 1 & 11 are obvious over Malek. Malek further discloses wherein the controller is configured to move the scan line along the meridian of longitude of the lens at a speed of 10-100 mm/s in the central area. (Malek ¶0066 “FIG. 5 illustrates a scanning example of a laser system 10 using an 8 kHz resonant scanner 21 to produce a scan line 501 having a scafn width W.sub.sc of about 1 mm and a scan speed of about 25 m/sec, and X, Y, and Z scan mechanisms with the scan speed smaller than 0.1 m/sec.”).
Regarding claims 8 & 18, claims 1 & 11 are obvious over Malek. Malek further discloses wherein the high frequency scanner is a resonant scanner with a scanning frequency between 0.5 kHz and 20 kHz, and the predetermined length of the scan lines is between 0.2 mm and 1.2 mm. (Malek ¶0056 “A fast-Z scanner 20 and a resonant scanner 21 direct the laser beam 18 to the prism 23.”; ¶0066 “In other embodiments, the beam scanning can be realized with a “fast-scan-slow-sweep” scanning scheme. The scheme consists of two scanning mechanisms: first, a high frequency fast scanner is used to produce a short, fast scan line (e.g., a resonant scanner 21 of FIG. 3); second, the fast scan line is slowly swept by much slower X, Y, and Z scan mechanisms. FIG. 5 illustrates a scanning example of a laser system 10 using an 8 kHz resonant scanner 21 to produce a scan line 501 having a scan width W.sub.sc of about 1 mm and a scan speed of about 25 m/sec, and X, Y, and Z scan mechanisms with the scan speed smaller than 0.1 m/sec.”; ¶0082).
Regarding claims 9 & 19, claims 1 & 11 are obvious over Malek. Malek further discloses a prism disposed to receive scanned pulsed laser beam from the high frequency scanner, and wherein the controller is configured to rotate the prism to rotate an orientation of the scan line between successive sweeps. (Malek ¶0048 “a prism 23”; ¶0056 “The prism 23 rotates the resonant scan line in any direction on the XY plane. The fast-Z scanner 20 sets the incision depth and produces a side cut. The system 10 may also include an auto-Z module 32 to provide depth reference.”; ¶0086).
Regarding claims 10 & 20, claims 1 & 11 are obvious over Malek. Malek further discloses wherein the at least one lenticular incision includes a top lenticular incision and a bottom lenticular incision, wherein the curved surface is a top surface of the lens corresponding to the top lenticular incision, the lens further including a bottom surface corresponding to the bottom lenticular incision and defining another apex, and wherein the scan line for each of the sweeps forming the top lenticular incision is moved over the top surface of the lens through the apex of the top surface of the lens, and the scan line for each of the sweeps forming the bottom lenticular incision is moved over the bottom surface of the lens through the other apex of the bottom surface of the lens. (Malek ¶0089 “In an embodiment, FIG. 12 shows an exemplary lenticular incision 900 for extraction using the laser system 10. FIG. 12 shows an exemplary cross-sectional view 910 illustrating a patient interface 905 (or patient interface 31 as shown in FIG. 3), cornea 906, and lenticular incision volume 915, which will be referred herein as lens to be extracted. Rt and Rb are the radii of curvature for the top surface and bottom surface of a lenticular incision, respectively. ZFt (Zt) is the depth of the top surface of the lenticular incision. ZFb (Zb) is the depth of the bottom surface of the lenticular incision.”; ¶0094; ¶0095).
Regarding claims 21 & 23, claims 1 & 11 are obvious over Malek. Malek further discloses wherein each blanking on-off period contains multiple laser pulses. (Malek ¶0065 “¶0065; Abstract “An ophthalmic surgical laser system includes: a laser that produces a pulsed laser beam having a pulse energy and pulse repetition rate” Figure 9; Figure 7).
Regarding claims 22 & 24, claims 1 & 11 are obvious over Malek. Malek further discloses wherein the pulsed laser beam has a pulse repetition rate of 2-40 MHz. (Malek ¶0076 “In an exemplary embodiment, when the AOM 15 is adjusted to pick one pulse for every 6 pulses, a pulse repetition rate of 10 MHz is achieved, which is sufficient to modify ophthalmic tissue. However, when the AOM 15 is adjusted to pick 2, 3, 4, 5, or 6 pulses for every 6 pulses, a pulse repetition rate of 20 MHz, 30 MHz, 40 MHz, 50 MHz or 60 MHz, respectively is achieved.”).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Megan Fedorky whose telephone number is 571-272-2117. The examiner can normally be reached Mon-Fri 3PM-11PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on Mon-Fri 9am-5pm ET. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
