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 “Applicant Arguments/Remarks”, filed 12/22/2025, with respect to the rejections under U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fu and Garcia.
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.
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.
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 1-3, 6-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20180008461 awarded to Fu et al, hereinafter Fu, as applied to the claims above, and further in view of U.S. Patent Publication 20200289320 awarded to Garcia et al, hereinafter Garcia.
Regarding Claims 1, 14, and 20, Fu teaches an ophthalmological device and method for surgical treatment of a cornea of an eye (abstract), the ophthalmological device comprising: a laser source (laser 14, Para. 0043) configured to generate a pulsed laser beam (pulsed laser beam 18); a focusing optical module configured to make the pulsed laser beam converge onto a focus in the cornea (Z-scanner 20) configured to move the focus to target locations in the cornea (Para. 0015, “a Z-scan device to modify a depth of a focus of the pulsed laser beam”); a scanner system (XY-scanner 28, Para. 0043, “an XY-scanner 28 for deflecting or directing the pulsed laser beam 18 from the laser 14 on or within the material 12”); and an electronic circuit configured to control the scanner system (controller 22, Para. 0043) and a computer program product comprising a non-transitory computer-readable medium having stored thereon computer program code (Para, 0180) to: move the focus to cut inside the cornea a lenticule (Para. 0079, lenticular incision 1300, Fig. 13), the lenticule having a posterior lenticule surface (top lens surface 1320) and an anterior lenticule surface (bottom lens surface 1310), and move the focus to cut in the cornea at least one opening incision in an exterior surface of the cornea (side cut 1350, Para. 0080, “A side cut 1350 is performed first to provide a path for gas to vent to prevent the formation of bubbles”), a first access channel and a second access channel (see annotation of Fig. 13 below), the first access channel connecting the at least one opening incision to the posterior lenticule surface to provide access for a surgical tool through the at least one opening incision to the posterior lenticule surface, and the second access channel connecting the at least one opening incision to the anterior lenticule surface to provide access for the surgical tool through the at least one opening incision to the anterior lenticule surface (Fig. 13, Para. 0082, “These exemplary lenticular incisions allow lenticular tissue to be extracted in a single unbroken piece through the side cut. The taper of the peripheral portions allows smooth extraction through the side cut as a gradual slope is provided”), wherein the first access channel running from the at least one opening incision to the lenticule, is separate from at least part of the second access channel, running from the at least one opening incision to the lenticule (Fig. 13 showing the access channel cuts separating into the posterior and anterior cuts, Paras. 0081-0082), and the first access channel and the second access channel overlap at least partially from a top view perspective onto the cornea (Fig. 13, showing top view 1304). Fu does not teach wherein the access channels separate prior to reaching the lenticule.
However, in the art of ophthalmologic laser treatments (abstract), Garcia teaches wherein the access channels (Tob and bottom tab surfaces of extraction tab shown in Fig. 2B) separate before reaching the lenticules (Fig. 2B) to improve extraction of the lenticule (Para. 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fu by Garcia, i.e. by using the tab structure of Garcia in the surgical cut plan of Fu, for the predictable improvement of increasing the ease of removing the lenticule in Fu as in Garcia.
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Annotation of Fig. 13 of Fu
Regarding Claims 2 and 15, Fu modified by Garcia makes obvious the ophthalmological device of claims 1 and 14. Fu further teaches wherein the electronic circuit is configured to control the scanner system to move the focus to cut one common opening incision in the exterior surface of the cornea for the first access channel and the second access channel (side cut 1350), to provide access for the surgical tool through the common opening incision and the first access channel to the posterior lenticule surface, and through the common opening incision and the second access channel to the anterior lenticule surface (Fig. 13 showing side cut 1350 meeting the tapered accesses channels identified in the annotation of Fig. 13 below).
Regarding Claims 3 and 16, Fu modified by Garcia makes obvious the ophthalmological device of claim 2 and 15. Fu further teaches wherein the electronic circuit is further configured to control the scanner system to move the focus to cut the first access channel and the second access channel with a partially common access channel to provide access for the surgical tool through the common opening incision (channel provided by side cut 1350), the common access channel and the first access channel to the posterior lenticule surface, and through the common opening incision, the common access channel and the second access channel to the anterior lenticule surface (Fig. 13 showing side cut 1350 meeting the tapered accesses channels identified in the annotation of Fig. 13 below).
Regarding Claims 6 and 19, Fu modified by Garcia makes obvious the ophthalmological device of claim 1. Fu does not teach wherein the electronic circuit is configured to control the scanner system to move the focus to cut the first access channel in the cornea with a first symmetry plane, and to cut the second access channel in the cornea with a second symmetry plane, whereby the first symmetry plane and the second symmetry plane run parallel to each other.
However, Fu does teach that the shaping of the access channels can be adjusted as needed based on the needs of the particular surgery (Paras. 0090-0091, Para. 0092, “The shape of the tapering zone 1330 need not be linear in shape. The tapering zone may be curved or any shape that minimizes light scattering at the cutting junctions and optimizes the matching of the two cut surfaces after lens extraction. The peripheral zone may be linear or a higher order polynomial”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fu, i.e. by adjusting the cutting of the access channels to have two parallel symmetry planes, as Fu teaches the need to adjust the shaping of the access channels based one the needs of the eye, and as Applicant’s Specification notes a lack of criticality to the usage of any of the particular methods to create planes of symmetry vs the end result of the access channels based on the needs of the eye (see Applicant’s Specification, Pg. 15, Line 15-Pg. 16, Line 5).
Regarding Claim 7, Fu modified by Garcia makes obvious the ophthalmological device of claim 1. Fu further teaches wherein the electronic circuit is configured to control the scanner system to move the focus to cut the first access channel in the cornea with a first symmetry plane, and to cut the second access channel in the cornea with a second symmetry plane, whereby the first symmetry plane and the second symmetry plane run at an angle to each other (Fig. 13, showing the access channels intersecting at an angle).
Regarding Claim 8, Fu modified by Garcia makes obvious the ophthalmological device of claim 1. Fu further teaches wherein the electronic circuit is configured to control the scanner system to move the focus to cut the first access channel and the second access channel with a trapezoid shaped outline from the top view perspective onto the cornea (bottom of Fig. 13 showing the top down view).
Regarding Claim 9, Fu modified by Garcia makes obvious the ophthalmological device of claim 1. Fu further teaches wherein the electronic circuit is configured to control the scanner system to move the focus to cut at least one of the first access channel or the second access channel in the cornea from with an increasing width from the opening incision in the exterior surface of the cornea towards the posterior lenticule surface or the anterior lenticule surface, respectively (Fig. 13, Para. 0080, “A side cut 1350 is performed first to provide a path for gas to vent to prevent the formation of bubbles. A bottom surface cut 1310 is then performed prior to performing a top surface cut 1320 to prevent the cutting beam from being blocked by bubbles generated by previous cornea dissection. The top and bottom surface cuts each include a central portion and a peripheral portion. The central portions are concave while the peripheral portions of the top and bottom cuts tapers (diminishes) towards each other to meet in a circumferential ring or edge. The tapering peripheral portions minimize light scattering at the edges and further optimizes the matching of the cut surfaces and prevent folding after the lenticule has been removed”).
Regarding Claim 10, Fu modified by Garcia makes obvious the ophthalmological device of claim 1. Fu further teaches wherein the electronic circuit is configured to control the scanner system to move the focus to cut the first access channel along a first channel axis having at least one change of direction from the opening incision in the exterior surface of the cornea to the posterior lenticule surface, and to cut the second access channel along a second channel axis having at least one change of direction from the opening incision in the exterior surface of the cornea to the anterior lenticule surface (Fig. 13).
Regarding Claim 11, Fu modified by Garcia makes obvious the ophthalmological device of claim 1. Fu further teaches wherein the electronic circuit is configured to control the scanner system to move the focus to cut the first access channel to approach tangentially the posterior lenticule surface, and to cut the second access channel to approach tangentially the anterior lenticule surface (Fig. 13, Para. 0080, “A side cut 1350 is performed first to provide a path for gas to vent to prevent the formation of bubbles. A bottom surface cut 1310 is then performed prior to performing a top surface cut 1320 to prevent the cutting beam from being blocked by bubbles generated by previous cornea dissection. The top and bottom surface cuts each include a central portion and a peripheral portion. The central portions are concave while the peripheral portions of the top and bottom cuts tapers (diminishes) towards each other to meet in a circumferential ring or edge. The tapering peripheral portions minimize light scattering at the edges and further optimizes the matching of the cut surfaces and prevent folding after the lenticule has been removed”).
Regarding Claim 12, Fu modified by Garcia makes obvious the ophthalmological device of claim 1. Fu further teaches wherein the electronic circuit is configured to control the scanner system to move the focus to cut the first access channel with a first entry channel, from the at least one opening incision in the exterior surface of the cornea to a first turning area inside the cornea, and a first connecting channel from the first turning area to the posterior lenticule surface, and to cut the second access channel with a second entry channel from the at least one opening incision in the exterior surface of the cornea to a second turning area inside the cornea, and a second connecting channel from the second turning area to the anterior lenticule surface (Fig. 13).
Regarding Claim 13, Fu modified by Garcia makes obvious the ophthalmological device of claim 12. Fu further teaches wherein the electronic circuit is configured to control the scanner system to move the focus to cut the first entry channel and the second entry channel with a common channel portion from the at least one opening incision in the exterior surface of the cornea to a forking area inside the cornea (Fig. 13).
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20180008461 awarded to Fu et al, hereinafter Fu, in view of U.S. Patent Publication 20200289320 awarded to Garcia et al, hereinafter Garcia, further in view of U.S. Patent Publication 20130281992 awarded to Seiler et al, hereinafter Seiler.
Regarding Claims 5 and 18, Fu modified by Garcia makes obvious the ophthalmological device of claim 1. Fu does not teach wherein the electronic circuit is configured to control the scanner system to move the focus to cut the first access channel in the cornea with a first width, and to cut the second access channel in the cornea with a second width different from the first width.
However, in the art of ophthalmological surgery, Seiler teaches the usage of two access channels (118 and 120) wherein one access channel is wider than the other (Para. 0031) based on the needs of the particular eye/surgery (Para. 0031, “A channel may have any suitable size and shape. In certain embodiments, a channel with a center line .alpha..sub.i, where i identifies the channel, may have any suitable length l.sub.i, width w.sub.i, angle .phi..sub.i of center line .alpha..sub.i with respect to radius r, and angle .theta..sub.i of center line .alpha..sub.i with respect to the anterior surface of the eye. In FIG. 2, the anterior channel 118 has a narrower width w.sub.a towards the entrance of the channel and a wider width w.sub.a' towards the center of lenticule 110.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fu by Seiler, i.e. by creating the first access channel with a wider width than the second, as Seiler teaches that one of ordinary skill would modify the access channels as needed for the particular need of the eye as shown above.
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 Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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