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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/03/2025 has been entered.
Response to Arguments
Applicant’s arguments, filed 09/05/2025, directed to the Final Office Action mailed 06/06/2025 regarding the 102 rejection to Herekar were addressed in the Advisory Action mailed 09/18/2025, and are repeated below for ease of reference, as Applicant has simply relied upon the same arguments.
Applicant's first argument, that the device of Herekar is not a paralimbal probe, is unpersuasive. Herekar explicitly discloses "a handheld treatment probe" (Para. 0100) and that "These treatment locations that are located 2 mm or less from Schlemm's Canal are referred to herein as "juxtacanalicular" treatment locations. For purposes of distinction, treatment locations that are on the sclera more than 2 mm from Schlemm's Canal are referred to as "paralimbal" treatment locations." Any further limitations Applicant intends by the recitation of "paralimbal probe" should be recited in further claim amendments.
Applicant's second argument, that the device of Herekar does not contain a probe tip shaped to mate to make with an external surface at or near a corneal limbus of the eye, is likewise unpersuasive. As stated above, Para. 0081 states that the paralimbal area is treated, and Para. 0108 states "The distal face of the probe on which the light outputs are arranged can be a variety of shapes and sizes. The distal end may comprise a concave shape such as a spherical shape or a conical shape to engage the eye". Fig. 12 also shows the treatment path, showing two separate treatment path annuluses, on at and one near the corneal limbus area.
Applicant's third argument, that the device of Herekar does not teach treating an intersection of the Schlemm's Canal and trabecular meshwork, is likewise unpersuasive. As previously stated in the Final Office Action, Applicant's claims are directed to a device, and not a method. Applicant's invention is a handheld device, not controlled by either a processor or robotics. Therefore, the device of Herekar is not required to explicitly teach treating the Schlemm's canal and trabecular meshwork. The device needs only to be capable of being positioned in a manner that a treatment path intersecting the Schlemm's canal and the trabecular meshwork. Even if the claims were a method claim, the language does not require a singular treatment location wherein the one treatment is directed in a line intersecting the Schlemm's canal and the trabecular meshwork, but that a treatment path occurs wherein at any point the Schlemm's canal and the trabecular meshwork are intersected. As Fig. 12 shows two separate annular treatment paths the traverse 360 degrees around the eye of a subject, Para. 0187 discloses that "The juxtacanalicular or paralimbal annuli may be circular, or they may be oval, elliptical, egg-like, non-circular, non-elliptical, asymmetrical, or patterned to mimic (e.g. correspond to) the shape of Schlemm's canal or the limbus which may have a non-regular shape. The annuli may be shaped roughly the same as one another or may be differently shaped", and that Herekar teaches the other structural components required in Claim 1 of the probe, Herekar teaches a probe capable of intersecting the Schlemm's canal and the trabecular meshwork.
However, Applicant’s amendments entered with the RCE dated 10/03/2025 merit new ground(s) of rejection in view of Herekar and Chen. 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”).
Further, the amendments require a rejection under U.S.C. 112(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 7, 10-17, 19, 22-24, 26 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the claim recites the limitations "the distal end of the probe" and “the distal end”. There is insufficient antecedent basis for this limitation in the claim. The Examiner will be interpreting that the first instance is “a distal end of the probe” and the second is “the distal end of the probe”.
Regarding Claim 12, Claim 12 recites the limitations “the distal end”. The Examiner will be interpreting that the claim should read “the distal end of the probe”.
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 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 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
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/JLM/
Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792