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 with respect to claims 1-16, and 21-24 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
New Grounds of rejection was necessitated by Applicant’s amendments to at least claims 1, 21, and 24.
Accordingly, this action is made FINAL.
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 1-10, 12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Berlin (U.S. Patent Application Publication 2020/0188173) in view of Raski (U.S. Patent Application Publication 2020/0078216).
Regarding claim 1, Berlin discloses a method of delivering laser energy to a surface of a trabecular meshwork of an eye comprising:
inserting a probe into the eye (see abstract, [0074], [0085] and figures 4-5, for example);
delivering, at multiple locations along the trabecular meshwork, shots of the laser energy via the probe to create a plurality of perforations in the trabecular meshwork (the plurality of target locations corresponding to the treatment reference markers, see [0008], [0032], [0060], [0074], [0100] and figures 6 to 9-3 for example).
Although Berlin appears to disclose a system and method for adjusting the x, y, and z coordinates of the treatment locations (see [0108] and figures 6 to 9-3), Berlin fails to explicitly recite the plurality of perforations form a line or curve that passes from a front portion of a Schlemm's canal in the eye to a rear portion of the Schlemm's canal, wherein the front portion of the Schlemm's canal is a first distance from a cornea of the eye and the rear portion of the Schlemm's canal is a second distance from the cornea, wherein the second distance is greater than the first distance.
Like Berlin, Raski discloses a system and method of making openings/channels in the trabecular meshwork to treat glaucoma and adjust fluid flow in the eye and teach providing the plurality of perforations form a line or curve that passes from a front portion of a Schlemm's canal in the eye to a rear portion of the Schlemm's canal, wherein the front portion of the Schlemm's canal is a first distance from a cornea of the eye and the rear portion of the Schlemm's canal is a second distance from the cornea, wherein the second distance is greater than the first distance (see 1) [0169] and figures 11a-11c, and/or 2) [0179]-[0183] and figures 15a-15c) in order to provide a known and workable manner of treating the trabecular meshwork in order to treat glaucoma and affect fluid flow and pressure in the eye.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Berlin, as taught by Raski, to provide the plurality of perforations form a line or curve that passes from a front portion of a Schlemm's canal in the eye to a rear portion of the Schlemm's canal, wherein the front portion of the Schlemm's canal is a first distance from a cornea of the eye and the rear portion of the Schlemm's canal is a second distance from the cornea, wherein the second distance is greater than the first distance in order to provide a known and workable manner of treating the trabecular meshwork in order to treat glaucoma and affect fluid flow and pressure in the eye.
Regarding claim 2, Berlin discloses the laser energy is delivered from an excimer laser source (see [0006], [0063], [0122]).
Regarding claim 3, Berlin discloses the treatment of glaucoma (see [0059], [0063]-[0064], [0069] for example).
Regarding claims 4-5, Berlin discloses suprachoroidal channels/pathways (see [0003], [0006], [0160], for example).
Regarding claims 6-7, Berlin in view of Raski disclose (or make obvious) the claimed invention, see Raski (see 1) [0169] and figures 11a-11c, and/or 2) [0179]-[0183] and figures 15a-15c).
Regarding claim 8, Berlin the claimed invention, see [0062]-[0063] and [0085].
Regarding claims 9-10, Berlin in view of Raski disclose (or make obvious), Raski discloses the claimed invention see for example 15a, wherein each shallow sub opening 923 is formed from at least one laser shot meaning there are at least 24 laser shots. Therefore the claimed subject matter of: 1) the shots comprises 10 shots per eye, and 2) the shots comprises greater than 10 shots per eye are both met by the prior art. The term “comprising” (the transitional phrase used in the claims) is open ended and is interpreted as “having at least” or “including” and since the treated volume of the eye in 15a has at least 24 laser shots it meets the claimed subject matter of claims 9 -10.
Regarding claims 12, and 14, Berlin the claimed invention, see [0071].
Regarding claim 16, Berlin the claimed invention, see [0013], [0018], [0022], and [0071]-[0072] for example.
Claims 11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Berlin (U.S. Patent Application Publication 2020/0188173) in view of Raski (U.S. Patent Application Publication 2020/0078216) as applied to claim 1 above, and further in view of Junger et al. (U.S. Patent Application Publication 2020/0330274).
Regarding claim 11, Berlin in view of Raski show the invention above but fail to explicitly recite each of the plurality of perforations has a diameter of 200 μm.
Like Berlin and Raski, Junger et al. disclose a method and system for treating glaucoma having a probe with a fiber optic for propagating laser treatment light for perforating the trabecular meshwork and teach providing “perforations, each having a diameter of about 200 μm” in order to “achieve easier drainage of the aqueous humor in order to reduce IOP,” (see [0010]).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Berlin in view of Raski, as taught by Junger et al., to provide “perforations, each having a diameter of about 200 μm” in order to “achieve easier drainage of the aqueous humor in order to reduce IOP.”
Regarding claim 13, Berlin in view of Raski show the invention above but fail to explicitly recite analyzing effectiveness of the shots by visualizing drainage of aqueous humor and bloody reflux.
Like Berlin and Raski, Junger et al. disclose a method and system for treating glaucoma having a probe with a fiber optic for propagating laser treatment light for perforating the trabecular meshwork and teach “observing the bloody reflux and drainage of aqueous humor, the physician is able to immediately verify the effectiveness of the laser treatment,” (see [0029]).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Berlin in view of Raski, as taught by Junger et al., “observing the bloody reflux and drainage of aqueous humor, the physician is able to immediately verify the effectiveness of the laser treatment.”
Regarding claim 15, Berlin in view of Raski show the invention above but fail to explicitly recite “the excimer laser source comprising a xenon chloride laser.”
Like Berlin and Raski, Junger et al. disclose a method and system for treating glaucoma having a probe with a fiber optic for propagating laser treatment light for perforating the trabecular meshwork and teach “embodiments of the invention use a 308-nm xenon-chloride ultraviolet excimer laser, which causes minimal thermal damage compared with visible or infrared lasers,” (see [0009]).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Berlin in view of Raski, as taught by Junger et al., providing “a 308-nm xenon-chloride ultraviolet excimer laser, which causes minimal thermal damage compared with visible or infrared lasers.”
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Berlin (U.S. Patent Application Publication 2020/0188173) in view of Raski (U.S. Patent Application Publication 2020/0078216).
Regarding claims 21-22, and 24, Berlin discloses a method of delivering laser energy to a surface of a trabecular meshwork of an eye comprising:
inserting a probe into the eye (see abstract, [0074], [0085] and figures 4-5, for example);
delivering, at multiple locations along the trabecular meshwork, shots of the laser energy via the probe to create a plurality of perforations in the trabecular meshwork (the plurality of target locations corresponding to the treatment reference markers, see [0008], [0032], [0060], [0074], [0100] and figures 6 to 9-3 for example),
the shots create a plurality of perforations in the trabecular meshwork (see [0072]),
the plurality of perforations comprises at least one first perforation that does not fluidly connect with the Schlemm's canal (suprachoroidal channels/pathways (see [0003], [0006], [0160], for example)), and
the plurality of perforations comprises a plurality of second perforations that fluidly connect with the Schlemm's canal (see [0072]).
Although Berlin appears to disclose a system and method for adjusting the x, y, and z coordinates of the treatment locations (see [0108] and figures 6 to 9-3), Berlin fails to explicitly recite the plurality of perforations form a line or curve that passes from a front portion of a Schlemm's canal in the eye to a rear portion of the Schlemm's canal, wherein the front portion of the Schlemm's canal is a first distance from a cornea of the eye and the rear portion of the Schlemm's canal is a second distance from the cornea, wherein the second distance is greater than the first distance.
Like Berlin, Raski discloses a system and method of making openings/channels in the trabecular meshwork to treat glaucoma and adjust fluid flow in the eye and teach providing the plurality of perforations form a line or curve that passes from a front portion of a Schlemm's canal in the eye to a rear portion of the Schlemm's canal, wherein the front portion of the Schlemm's canal is a first distance from a cornea of the eye and the rear portion of the Schlemm's canal is a second distance from the cornea, wherein the second distance is greater than the first distance (see 1) [0169] and figures 11a-11c, and/or 2) [0179]-[0183] and figures 15a-15c) in order to provide a known and workable manner of treating the trabecular meshwork in order to treat glaucoma and affect fluid flow and pressure in the eye.
Regarding claim 23, Berlin in view of Raski disclose (or make obvious), Raski discloses the claimed invention see for example 15a, wherein distal portion of the distal shallow sub openings 923 in figures 15a-15c is distal to the proximal/posterior surface of a portion of the iris (the proximal portion of the iris directly connecting to the ciliary body 6, see figure 6).
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.
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 AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792