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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in France on 03/23/2023. It is noted, however, that applicant has not filed a certified copy of the FR 2302607 application as required by 37 CFR 1.55. In fact, FR2302607 appears to lead to an application publication for a safety device for a lamp socket.
Drawings
The drawings are objected to because the reference numbers appear faded and not clearly identifiable and/or readable. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 5-6 objected to because of the following informalities:
Claim 5 recites “the posterior edges” without antecedent basis. While it is clear that this is the opposite of the anterior edge in the anteroposterior dimension, examiner recommends writing “between the anterior edge and a posterior edge”
Claim 6 recites “the injection of a viscoelastic fluid”. Examiner recommends the limitation to read “an injection of a viscoelastic fluid”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 7- 12 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Wong (WO 9402081). Measurement of the Limbus-Insertion Distance in Adult Strabismus Patients with Anterior Segment Optical Coherence Tomography (hereinafter Liu) will be utilized as extrinsic evidence.
Regarding claim 1, Wong discloses a method for inserting an ophthalmological implant between a sclera and a ciliary body in an eye of a patient (fig. 3, drain 40 between the sclera 12 and ciliary body 18), comprising:
- making at least one incision through the sclera in said eye of the patient forming at least one scleral edge (fig. 17, incision 220 forming an incision and a scleral edge. The incision may also be interpreted as the window made after scleral flap 202 or “trap door” 110 formed, with the edge of the scleral flap 202 being the scleral edge),
- inserting the ophthalmological implant between the sclera and the ciliary body through said at least one incision (fig. 19 shows the insert being inserted through both the incision 220 and the trap door as described);
- positioning the ophthalmological implant at a final position so that a distance between an anterior edge of the ophthalmological implant and a limbus of the eye of the patient is spaced away along an anteroposterior axis (see annotated fig. 3 below)
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but does not teach explicitly teach wherein the anterior edge is spaced away from the limbus of the eye at a distance equal to or greater than 2mm along an anteroposterior axis.
However, Wong teaches wherein the distal tip is positioned between 2-3 mm into the anterior chamber (pg. 11, lines 16-36). The instant specification describes the limbus as being directly between the sclera and the cornea (paragraph 00038, “the sclera 12 is connected to the periphery of the cornea 20 at the limbus 26”), and the anterior chamber being the space in between the corneal and the lens (paragraph 0038, “The anterior chamber 18 is disposed between the cornea 20 and the lens (no shown) bounded at its peripheral portion by the iris 22”). As Wong is shown to be between 2-3 mm into the anterior chamber, the anterior chamber being defined as being underneath the cornea, the limbus being defined as where the sclera ends and where the cornea begins, and the limbus being approximately 1.0 mm anterior to the anterior chamber angle in the horizontal meridian (see Liu, 2nd paragraph of Discussion) one of ordinary skill in the art would appreciate that being 2-3 mm into the anterior chamber is concurrent with being at least 2 mm away from the limbus.
Regarding claim 2, Wong is silent to wherein said distance between the anterior edge of the ophthalmological implant and the limbus of the eye of the patient is equal to or greater than 2.5mm along the anteroposterior axis.
However, similar to as recited above, the distal tip being positioned between 2-3 mm into the anterior chamber, with the limbus being 1.0 mm anterior to the anterior chamber, would let Wong anticipate having the anterior edge of the implant and the limbus being 2.5 mm apart or greater along the anteroposterior axis.
ophthalmological implant and a limbus of the eye of the patient is equal to or lower than 5mm along the anteroposterior axis.
However, similar to as recited above, the distal tip being positioned between 2-3 mm into the anterior chamber, with the limbus being 1.0 mm anterior to the anterior chamber, would let Wong anticipate having the anterior edge of the implant and the limbus being at most 5 mm apart along the anteroposterior axis.
Regarding claim 4, wherein said distance between the anterior edge of the ophthalmological implant and a limbus of the eye of the patient is equal to or lower than 4mm along the anteroposterior axis.
However, similar to as recited above, the distal tip being positioned between 2-3 mm into the anterior chamber, with the limbus being 1.0 mm anterior to the anterior chamber, would let Wong anticipate having the anterior edge of the implant and the limbus being at most 4 mm apart along the anteroposterior axis (the highest value being at 4.0 mm).
Regarding claim 5, Wong discloses wherein said ophthalmological implant has an anteroposterior dimension between the anterior and the posterior edges equal to or greater than 500 microns (pg. 8, lines 15-35, “the overall length of the drain in this example being between about 5 and 10 mm”).
Regarding claim 7, Wong discloses wherein said at least one incision extends along the anteroposterior axis (fig. 19, the incision interpreted as the scleral flap/window made extends along the anteroposterior axis).
Regarding claim 8, Wong discloses wherein said at least one incision comprises at least two incisions defining a first and a second incisions (fig. 17 shows an anterior incision 220 and a posterior incision 222).
Regarding claim 9, Wong discloses wherein said first and second incisions are provided so that said ophthalmological implant is positioned between the first and second incisions when in the final position (fig. 19 shows at least a section of the implant being between incision 220 and 222).
Regarding claim 10, Wong discloses wherein said first and second incisions are provided at an intermediate position (fig. 19, both incisions 220 and 222 are in an intermediate/middle position) of the ophthalmological implant so that said ophthalmological implant is inserted through said first or second incisions and then moved from said intermediate position wherein the ophthalmological implant is between the first and second incisions to said final position (figs. 18-19 demonstrate the drain 40 being initially placed at incisions 220 and 222, then being moved deeper into the patient away from both of the incisions)
Regarding claim 11, Wong discloses wherein said method includes providing an ophthalmological implant having an anterior edge intended to face the anterior chamber (fig. 3, distal tip facing the anterior chamber 32) and a posterior edge opposite the anterior edge (fig. 3, end section 44 opposite the distal tip)
Regarding claim 12, Wong discloses wherein said method includes lifting the at least one scleral edge prior to inserting the ophthalmological implant (Lifting the scleral edge may be interpreted as the flap 202 being lifted away as demonstrated in fig. 15).
Claim Rejections - 35 USC § 103
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wong in view of Burns (US 20080228127).
Regarding claim 6, Wong does not teach wherein the inserting step comprises the injection of a viscoelastic fluid between the sclera and the uveal tissues.
However, Burns teaches a uveoscleral shunt (abstract) wherein a viscoelastic fluid can be injected between the choroid and the sclera (paragraph 0134). Notably, the choroid is considered part of the uveal tissues.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Wong such that the inserting step comprises an injection of a viscoelastic fluid between the sclera and the uveal tissues, as taught by Burns, for the purpose of exposing more of the choroidal and scleral tissue area and increase uveoscleral outflow, causing a lower intraocular pressure (see Burns, paragraph 0134).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Clauson (US 20140081195) discloses a spacer that separates the sclera and the ciliary body
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781