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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 7-15 in the reply filed on 5/4/2026 is acknowledged.
Claims 16-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/4/2026.
As directed by the amendment, the status of the claim(s) are:
Claim(s) 1-6 is/are cancelled;
Claim(s) 7-26 is/are presently pending;
Claim(s) 16-26 is/are withdrawn;
Claim(s) 7-15 is/are examined on the merits.
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.
Claim(s) 7-9, 11, 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raksi (US 20200016002 A1; 1/16/2020) in view of Berlin (US 4846172 A; 7/11/1989).
Regarding claim 7, Raksi teaches an apparatus for forming a laser-cut channel from the trabecular meshwork into scleral tissue (Abstract; Fig. 6-7), comprising:
a pulsed laser unit configured to emit a pulsed laser beam in a photodisruptive regime for ablation of ocular tissue in the anterior angle (Fig. 6-8; [0024]; [0064]; [0066]);
a delivery head adapted to be placed in optical communication with a cornea of the eye, the delivery head focusing the pulsed laser beam for traversing Schlemm's canal and disrupting a portion of scleral tissue (Fig. 8-9b; [0117]);
a scanning controller configured to vary the laser beam's lateral position and depth for creating a channel (Fig. 7-8; [0024]; [0026]; [0119]; [0121]).
Raksi does not explicitly teach channel that bridges the anterior chamber and the scleral tissue. Note that Raksi does teach treating a variety of ocular tissues and creating channel opening ([0117]; [0120]-[0121]). However, Berlin teaches in the same field of endeavor (Abstract; Fig. 2) creating channel that bridges the anterior chamber and the scleral tissue (Col. 3 lines 30-37; Col. 4 lines 28-44 “through the Canal of Schlemm”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Raksi to include this feature as taught by Berlin because this is suitable for treating glaucoma (Col. 4 lines 28-44).
In the combination of Raksi and Berlin, Raksi teaches a housing that supports both the pulsed laser unit and the delivery head in a fixed alignment, enabling an ab interno approach for channel creation (Fig. 8-9b).
Regarding claim 8, in the combination of Raksi and Berlin, Raksi teaches wherein the pulsed laser unit is configured to generate ultrashort pulse durations comprising femtosecond pulses or nanosecond pulses, and wherein the scanning controller is configured to select between these pulse durations ([0024]; [0064]; [0074]-[0075]).
Regarding claim 9, in the combination of Raksi and Berlin, Raksi teaches wherein the delivery head comprises a lens assembly configured to minimize spherical aberration when focusing through the cornea and aqueous humor (Fig. 7-10c; [0068]; [0092]).
Regarding claim 11, in the combination of Raksi and Berlin, Raksi teaches further comprising a debris-management feature in which the scanning controller moves the focal spot from a distal portion of the scleral tissue toward a proximal portion near the trabecular meshwork, pushing ablated tissue debris anteriorly ([0123] “In general, the incision progresses should proceed from a location further form the laser and progress towards a location closer to the laser”; Fig. 6; Fig. 11A; compare to instant specification [0057] “d) The laser scanning pattern may include sections where the laser spot is scanned from deeper inside the tissue (posterior, further down in the direction of the laser beam) to be opened to more shallow layers (anterior, further up the laser beam) such that the debris caused by the photo disruptive shockwaves is being pushed towards the anterior chamber and therefore minimizing occlusions inside Schlemms Canal and inside the collector channel that could be caused by this debris”.)
For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 13, in the combination of Raksi and Berlin, Raksi teaches further comprising a memory device storing operational parameters, including pulse energy, spot size, and scanning trajectory for each patient's treatment session ([0074] “pre-programmed…surgical plans…setting of surgical parameters”; [0124]; [0118]-[0123]).
Regarding claim 14, in the combination of Raksi and Berlin, Raksi teaches wherein the delivery head includes a disposable contact lens that seats on the cornea, ensuring sterility and preventing fluid ingress into the housing (Fig.9a-10b; [0093]; [0095]-[0096]).
Regarding claim 15, the combination of Raksi and Berlin teaches wherein the scanning controller is configured to create multiple channels circumferentially spaced around Schlemm's canal (Raksi [0019]; [0117]; [0131]; [0134]; claim 36), each channel extending into scleral tissue (Berlin Col. 3 lines 30-37; Col. 4 lines 28-44 “through the Canal of Schlemm”). Further, this would be an obvious duplication of parts to create multiple channels; MPEP 2144.04. As an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raksi and Berlin as applied to claim 7 above, in view of Berlin (US 20080082078 A1; 4/3/2008); hereinafter Berlin ‘078.
Regarding claim 12, in the combination of Raksi and Berlin, Raski does not teach wherein the pulsed laser unit has a selectable repetition rate between about 10 Hz and about 1000 Hz to accommodate different channel sizes. Note that Berlin teaches 20 Hz (Col. 7 lines 30-31). However, Berlin ‘078 teaches in the same field of endeavor (Abstract) wherein the pulsed laser unit has a selectable repetition rate between about 10 Hz and about 1000 Hz to accommodate different channel sizes ([0078] “5 to about 75 Hertz. The corresponding repetition rate can be varied to compensate for the thermal time constant of the tissues in relation to the fluence of the laser energy radiating the target tissues.”; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Raksi and Berlin to include this feature as taught by Berlin ‘078 because this is a suitable parameter to use for photoablate the eye tissue ([0078]).
For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Allowable Subject Matter
Claim(s) 10 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 10 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the scanning controller is configured to create a tapered channel profile by adjusting the beam spot size during the cutting sequence.
Raksi (US 20200016002 A1; 1/16/2020) teaches that channels can be created with different cross sections with size of channel opening and/or cross-sectional area determining conductivity or outflow ([0119]-[0121]). Raksi does not teach creating a tapered channel profile as recited.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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