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 04/14/2026, with respect to rejection under U.S.C. 112(b) have been fully considered and are persuasive. The rejection under U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed 4/14/2026 have been fully considered but they are not persuasive.
Applicant first argues that Chen does not teach the newly amended subject matter as Chen does not teach a probe axis being normal to the surface of the eye against which the distal end of the probe tip, as Chen defines an axis 358 that is not normal as required by Applicant’s claims. This argument is unpersuasive. While Chen defines axis 358 an axis to define probe output angle, this is not the probe axis to the surface of the eye against the distal end of the probe tip; it is a probe axis following beam 360. If we were to define this angle as the above probe angle, Applicant’s own device would not meet their claim language, As the beam/distal fiber tip of Applicant’s Fig. 3 is likewise not normal to the surface of the eye. Chen teaches that “In such embodiments, the sharp tip of the treatment fiber's angle cut distal end 350 may be approximately flush with the surface of distal end of the contact member 130/201” (Para. 0074), like Applicant’s device in Fig. 3, leaving the central axis of the probe, not the beam, perpendicular.
Applicant next argues that Chen does not teach the radiation exiting at an acute angle with the surface of the probe, as Chen states that the angle of the output is angled so that the beam exits “more perpendicularly” relative to the sclera. This is likewise unpersuasive. Chen states “more perpendicularly”, not perpendicularly, which is shown by the fact that the beam could exit at a range of acute angles (10-50 degrees, Para. 0073).
For these reasons, the claims remain rejected under U.S.C. 103.
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.
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, 5, 7, 10-17, 19, 22-24, 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 20200306080 awarded to Herekar et al, hereinafter Herekar, and further in view of U.S. Patent Publication 20200054488 awarded to Chen et al, hereinafter Chen.
Regarding Claim 1, Herekar teaches a paralimbal probe, comprising: a probe tip shaped to mate with an external surface of an eye at or near a corneal limbus of the eye (Para. 0108), the eye having a Schlemm' s canal and trabecular meshwork (Para. 0005); and a waveguide positioned within the probe tip to convey electromagnetic radiation from a source of electromagnetic radiation into the eye (Para. 0022), wherein the waveguide is oriented to direct the electromagnetic radiation along a treatment path intersecting the Schlemm' s canal and the trabecular meshwork (Para. 0093, “As illustrated in FIG. 3C, the angle θ increases from the pretreatment angle θpre to the posttreatment angle θpost thereby opening the outflow tract through the trabecular meshwork and Schlemm's canal”). Herekar does not teach wherein the probe comprises a probe axis that is normal to the surface of the eye against which the distal end of the probe tip rests, wherein the electromagnetic radiation exits the distal end of the probe tip at an acute angle with the surface of the distal end of the probe tip.
However, in the art of ophthalmic lasers, Chen teaches the usage of a probe for treating the limbus of the eye (Para. 0046) wherein radiation exits the tip at an acute angle to the distal end of the probe (Fig. 7, Para. 0073, “In some embodiments, the angle β may be between 10 and 50 degrees”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Herekar by Chen, i.e. by using the tip of Chen in the system of Herekar, for the predictable purpose of simply substituting one known tip element for another.
Regarding Claim 2, Herekar modified by Chen makes obvious the probe of claim 1, wherein the waveguide is further positioned within the probe tip such that the treatment path further intersects paralimbal tissue of the eye (abstract).
Regarding Claim 3, Herekar modified by Chen makes obvious the probe of claim 1, wherein the waveguide is further positioned within the probe tip such that the treatment path further intersects corneal tissue of the eye or scleral tissue of the eye (Para. 0108, “In other embodiments the distal face has a radius of curvature or radii of curvatures of between 8-12 mm to substantially conform to the shape of the cornea and sclera”).
Regarding Claim 5, Herekar modified by Chen makes obvious the probe of Claim 1, wherein the waveguide is an optical waveguide and the source of electromagnetic radiation is a light source or a laser (Para. 0108, “A system to treat glaucoma of an eye with the hand-held energy probe may comprise an energy source, such as one or more of the laser light sources as described herein”).
Regarding Claim 7, Herekar modified by Chen makes obvious the probe of claim 1, wherein the probe tip includes a distal end shaped to mate with a curvature of the eye (Para. 0108), and wherein the distal end of the probe tip includes either: a corneal or sclearal portion having a curvature that mates with a curvature of a cornea or scleara of the eye (Para. 0108, “In other embodiments the distal face has a radius of curvature or radii of curvatures of between 8-12 mm to substantially conform to the shape of the cornea and sclera”).
Regarding Claim 10, Herekar modified by Chen makes obvious the probe of claim 1, further comprising one or more actuators coupled to the waveguide for adjusting the orientation of the treatment path with respect to the probe tip (Para. 0248).
Regarding Claim 11, Herekar modified by Chen makes obvious the probe of claim 1, wherein the source of electromagnetic radiation is housed within a probe body coupled to the probe tip (Para. 0012, “In a first aspect, a system for treating glaucoma of an eye is provided. The system comprises an energy source configured to generate energy to treat the eye, a processor, and an energy delivery system coupled to the energy source and the processor”).
Regarding Claim 12, Herekar modified by Chen makes obvious the probe of Claim 1, wherein the probe tip is shaped to mate with a second surface of the eye located anteriorly from the surface of the eye, and wherein the waveguide is oriented within the probe tip to direct additional electromagnetic radiation along an additional treatment path intersecting a pars plicata and an iris root site of the eye (Para. 0207, “Increased porosity of the perilimbal sclera and/or dilation or vacuoles may include treatment to relax or stretch the supra-ciliary and/or sub-conjunctival sclera alone or in combination with treatment at the pars plana and/or pars plicata. Treatment to increase porosity may provide reduced intraocular pressure as a stand-alone treatment or in combination with other treatment methods or patterns as described herein. Increased porosity in the mid-stromal near the pars plana and/or pars plicata may for example enhance hydraulic conductivity/transport of the supra-choroidal, ciliary, and/or lymphatic fluid outflow pathways. Treatment may be patterned to flatten the iris in order to open a closed angle. Treatment above the base of the iris root or the roof of the ciliary body may dilate Schlemm's canal and/or stretch the trabecular meshwork”).
Regarding Claim 13, Herekar modified by Chen makes obvious an assembly, comprising: a source of electromagnetic radiation (Para. 0012); a waveguide coupled to the source of electromagnetic radiation for conveying the electromagnetic radiation from a proximal end of the waveguide to a distal end of the waveguide (Para. 0100, “Energy is supplied to probe 250 though a fiber optic bundle 56 that communicates with a proximal end of handpiece 252”); and a probe having a probe body supporting a portion of the waveguide and a probe tip supporting the distal end of the waveguide (Para. 0038), wherein the probe tip is shaped to mate with an external surface of an eye at or near a corneal limbus of the eye, and wherein the distal end of the waveguide is oriented within the probe tip to direct the electromagnetic radiation along a treatment path intersecting a Schlemm's canal and trabecular meshwork of the eye (Para. 0093, “As illustrated in FIG. 3C, the angle θ increases from the pretreatment angle θpre to the posttreatment angle θpost thereby opening the outflow tract through the trabecular meshwork and Schlemm's canal”).
Regarding Claim 14, Herekar modified by Chen makes obvious the assembly of claim 13, wherein the waveguide is positioned within the probe tip such that the treatment path further intersects paralimbal tissue of the eye (abstract).
Regarding Claim 15, Herekar modified by Chen makes obvious the assembly of claim 13, wherein the waveguide is positioned within the probe tip such that the treatment path further intersects corneal tissue of the eye (Para. 0108).
Regarding Claim 16, Herekar modified by Chen makes obvious the assembly of claim 13, wherein the waveguide is positioned within the probe tip such that the treatment path further intersects scleral tissue of the eye (Para. 0108).
Regarding Claim 17, Herekar modified by Chen makes obvious the assembly of claim 13, wherein the waveguide is an optical waveguide and the source of electromagnetic radiation is a light source or a laser (Para. 0101).
Regarding Claim 19, Herekar modified by Chen makes obvious the wherein the probe tip includes a distal end shaped to mate with a curvature of the eye (Para. 0108), and wherein the distal end of the probe tip includes either: a corneal or sclearal portion having a curvature that mates with a curvature of a cornea or scleara of the eye (Para. 0108, “In other embodiments the distal face has a radius of curvature or radii of curvatures of between 8-12 mm to substantially conform to the shape of the cornea and sclera”).
Regarding Claim 22, Herekar modified by Chen makes obvious the assembly of claim 13, wherein the probe further comprises one or more actuators coupled to the waveguide for adjusting the orientation of the treatment path with respect to the probe tip (Para. 0248).
Regarding Claim 23, Herekar teaches a scleral limbal probe, comprising: a probe tip shaped to mate with a surface of an eye at or near a scleral limbal area of the eye (Para. 0108), the eye having a pars plicata and an iris root site (Para. 0207); and a waveguide positioned within the probe tip to convey electromagnetic radiation from a source of electromagnetic radiation into the eye, wherein the waveguide is oriented to direct the electromagnetic radiation along a treatment path (Para. 0100, “Energy is supplied to probe 250 though a fiber optic bundle 56 that communicates with a proximal end of handpiece 252”) intersecting the pars plicata and the iris root site (Para. 0207, “Increased porosity of the perilimbal sclera and/or dilation or vacuoles may include treatment to relax or stretch the supra-ciliary and/or sub-conjunctival sclera alone or in combination with treatment at the pars plana and/or pars plicata. Treatment to increase porosity may provide reduced intraocular pressure as a stand-alone treatment or in combination with other treatment methods or patterns as described herein. Increased porosity in the mid-stromal near the pars plana and/or pars plicata may for example enhance hydraulic conductivity/transport of the supra-choroidal, ciliary, and/or lymphatic fluid outflow pathways. Treatment may be patterned to flatten the iris in order to open a closed angle. Treatment above the base of the iris root or the roof of the ciliary body may dilate Schlemm's canal and/or stretch the trabecular meshwork”). Herekar does not teach wherein the probe comprises a probe axis that is normal to the surface of the eye against which the distal end of the probe tip rests, wherein the electromagnetic radiation exits the distal end of the probe tip at an acute angle with the surface of the distal end of the probe tip.
However, in the art of ophthalmic lasers, Chen teaches the usage of a probe for treating the limbus of the eye (Para. 0046) wherein radiation exits the tip at an acute angle to a probe axis/the distal end of the probe (Fig. 7, Para. 0073, “In some embodiments, the angle β may be between 10 and 50 degrees”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Herekar by Chen, i.e. by using the tip of Chen in the system of Herekar, for the predictable purpose of simply substituting one known tip element for another.
Regarding Claim 24, Herekar modified by Chen makes obvious the probe of claim 23, wherein the waveguide is an optical waveguide (Para. 0100, “Energy is supplied to probe 250 though a fiber optic bundle 56 that communicates with a proximal end of handpiece 252”) and the source of electromagnetic radiation is a light source or a laser (Para. 0101).
Regarding Claim 26, Herekar modified by Chen makes obvious the herein the probe tip includes a distal end shaped to mate with a curvature of the eye (Para. 0108), and wherein the distal end of the probe tip includes either: a corneal or sclearal portion having a curvature that mates with a curvature of a cornea or scleara of the eye (Para. 0108, “In other embodiments the distal face has a radius of curvature or radii of curvatures of between 8-12 mm to substantially conform to the shape of the cornea and sclera”).
Regarding Claim 29, Herekar modified by Chen makes obvious the probe of claim 23, further comprising one or more actuators coupled to the waveguide for adjusting the orientation of the treatment path with respect to the probe tip (Para. 0248).
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
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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