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, as well as the applicant’s request for retrieval of the certified copy of foreign priority as previously requested. However, it appears that the incorrect form was used for the request and thus the priority document was not retrieved. Examiner recommends submitting a corrected ADS with the proper access code, as well as a request for a corrected filing receipt. For the purpose of examination however, examiner will still assume the priority date is proper.
Response to Amendment
An amendment was filed on 05/06/2026. Claims 1 and 5-6 have been amended. Currently, claims 1-12 are pending and are being examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, newly cited Peyman (US 20110125090) is recited to teach the newly amended claim 1.
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 1-6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 20110125090)
Regarding claim 1, Peyman discloses a method for inserting an ophthalmological implant between a sclera and a ciliary body in an eye of a patient (paragraph 0017, “The device is implanted under the sclera over the ciliary body”), comprising:
- making at least one incision through the sclera in said eye of the patient forming at least one scleral edge (paragraph 0017, “The device is implanted… through a small incision, preferably in the sclera at the plars plana area”),
- inserting the ophthalmological implant between the sclera and the ciliary body through said at least one incision (paragraph 0017);
But does not teach the method comprising 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 equal to or greater than 2mm along an anteroposterior axis.
However, Peyman teaches method comprising 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 between 1-4mm along an anteroposterior axis (paragraph 0017, “The device is implanted under the sclera over the ciliary body or the choroid of the eye through a small incision, preferably in the sclera at the plars plana area 1 mm to 4 mm behind the limbus of the cornea/sclera junction).
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 Peyman such that it comprises 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 equal to or greater than 2mm along an anteroposterior axis, since it has been held that “[i]n 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). Further, applicant appears to have placed no criticality on the claimed range (while [0015] of the instant specification describes the distance equal to or greater than 2mm from the limbus surprisingly allows significant reduction of the IOP, and is not near the iris root at less than 1mm from the limbus, this does not grant sufficient criticality against Peyman since Peyman teaches the implant being at most of the range, and even at 1 mm this is greater than “less than 1mm”)
Regarding claim 2, Peyman 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, Peyman teaches method comprising 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 between 1-4mm along an anteroposterior axis (paragraph 0017, “The device is implanted under the sclera over the ciliary body or the choroid of the eye through a small incision, preferably in the sclera at the plars plana area 1 mm to 4 mm behind the limbus of the cornea/sclera junction).
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 Peyman such that it comprises 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 equal to or greater than 2mm along an anteroposterior axis, since it has been held that “[i]n 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). Further, applicant appears to have placed no criticality on the claimed range (while [0015] of the instant specification describes the distance equal to or greater than 2mm from the limbus surprisingly allows significant reduction of the IOP, and is not near the iris root at less than 1mm from the limbus, this does not grant sufficient criticality against Peyman since Peyman teaches the implant being at most of the range, and even at 1 mm this is greater than “less than 1mm”)
Regarding claim 3, Peyman discloses 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 5mm along the anteroposterior axis (paragraph 0017, “The device is implanted under the sclera over the ciliary body or the choroid of the eye through a small incision, preferably in the sclera at the plars plana area 1 mm to 4 mm behind the limbus of the cornea/sclera junction).
Regarding claim 4, Peyman discloses 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 (paragraph 0017, “The device is implanted under the sclera over the ciliary body or the choroid of the eye through a small incision, preferably in the sclera at the plars plana area 1 mm to 4 mm behind the limbus of the cornea/sclera junction)
Regarding claim 5, Peyman discloses wherein said ophthalmological implant has an anteroposterior dimension between the anterior and the posterior edges equal to or greater than 500pm (paragraph 0017 describes the straight rod being threaded in the suprachoroidal space in any desired direction toward any meridian, wherein the length ranges from 1mm to 6mm as described in paragraph 0015).
Regarding claim 6, Peyman discloses wherein the inserting step comprises the injection of a viscoelastic fluid between the sclera and the uveal tissues (paragraph 0016, “for implanting, a viscoelastic substance is also implanted for lubrication and ease of implantation”. Since the implant is in between the sclera and the ciliary body, the fluid is injected between the sclera and uveal tissues).
Regarding claim 11, Peyman discloses wherein said method includes providing an ophthalmological implant having an anterior edge intended to face the anterior chamber and a posterior edge opposite the anterior edge (fig. 2B shows the implant with two edges, one facing the anterior chamber, and another facing away from the anterior chamber).
Claims 7-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Wong (US 4521210)
Regarding claim 7, Peyman is silent to wherein said at least one incision extends along the anteroposterior axis
However, Wong teaches an ocular implant wherein the incision extends along the anteroposterior axis (fig. 19, the incision interpreted as the scleral flap/window made extends along the anteroposterior axis)
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 Peyman such that said at least one incision extends along the anteroposterior axis, as taught by Wong, for the purpose of providing a suitable series of incisions that accommodate the passage of the implant lengthwise (pg. 11, lines 16-36)
Regarding claim 8, Peyman does not teach wherein said at least one incision comprises at least two incisions defining a first and a second incisions.
However, Wong teaches wherein said at least one incision comprises at least two incisions defining first and second incisions (fig. 17 shows an anterior incision 220 and a posterior incision 222)
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 Peyman such that said at least one incision comprises at least two incisions defining a first and a second incisions, as taught by Wong, for the purpose of providing a suitable series of incisions that accommodate the passage of the implant lengthwise (pg. 11, lines 16-36)
Regarding claim 9, Peyman does not teach 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.
However, Wong teaches 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 incisions 220 and 222).
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 Peyman such that the first and second incisions are provided so that said ophthalmological implant, as taught by Wong, for the purpose of providing a suitable series of incisions that accommodate the passage of the implant lengthwise (pg. 11, lines 16-36)
Regarding claim 10, Peyman does not teach wherein said first and second incisions are provided at an intermediate 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
However, Wong teaches wherein said first and second incisions are provided at an intermediate 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 incisions).
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 Peyman such that wherein said first and second incisions are provided at an intermediate 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, as taught by Wong, for the purpose of providing a suitable series of incisions that accommodate the passage of the implant lengthwise (pg. 11, lines 16-36)
Regarding claim 12, Peyman does not teach wherein said method includes lifting the at least one scleral edge prior to inserting the ophthalmological implant.
However, Wong teaches wherein the 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).
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 Peyman such that said method includes lifting the at least one scleral edge prior to inserting the ophthalmological implant, as taught by Wong, for the purpose of providing a suitable series of incisions that accommodate the passage of the implant lengthwise (pg. 11, lines 16-36)
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.
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
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