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 .
Response to Amendment
An amendment was filed on 06/02/2026. Claims 1-2 have been amended, and new claim 11 has been added. Currently, claims 1-11 are pending and are being examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 11 have been considered but are moot because the new ground of rejection does not rely on the same combination of teaching references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Notably, examiner points to a modification taught by Silvestrini in another embodiment therein, as described further below.
In response to the applicant’s arguments with respect to claim 1, wherein Silvestrini does not teach the implant comprising an upper and lower surface that are smooth between the anterior and the posterior edges when observed in a lateral view along an anterior-posterior axis, the examiner points to the embodiment of fig. 10A of an alternative expandable region, which demonstrates a smooth curve of the expandable region between the two edges.
In response to the applicant’s arguments with respect to claim 11 wherein Silvestrini does not teach the implant deprived from protuberance protruding from the upper and lower surfaces between the anterior and posterior edges, examiner points to the embodiment of fig. 10A wherein the surface appears smooth without protuberances.
It is further noted that the expanded region of Silvestrini is expandable (paragraph 0090), and thus appears to be able to be expanded after implementation and thus not cause tissue damage from having the region being inserted after inflation of the expandable region.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this instance, it appears that the implant being free from protuberance protruding from the upper and lower surfaces between the anterior and posterior edges suggests the same limitation as the implant being smooth between the anterior and posterior edges. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 1-3 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Silvestrini (US 20100274258).
Regarding claim 1, Silvestrini discloses a method for inserting an ophthalmological implant between a sclera and a uveal tissue in an eye of a patient (fig. 10D shows implant 505 between the sclera and the ciliary body, said ciliary body being uveal tissue), comprising:
- providing an ophthalmological implant having an anterior edge intended to face the anterior chamber and an posterior edge opposite the anterior edge (see annotated fig. 10D below),
- making at least one opening in a corneal tissue (paragraph 0011, “forming an incision in the cornea of the eye”),
- opening the iris root to form an insertion channel (paragraph 0063 describes an insertion of the device through the iris root. Paragraph 0069 describes an applier 515 that does not penetrate the inner wall of the sclera but does penetrate the iris root),
- inserting the ophthalmological implant through the insertion channel (paragraph 0032, “deliver an implant that can gently and bluntly dissect between tissue margins… for example, between the iris root and the scleral spur or this iris root part of the ciliary body”. Paragraph 0011, passing the implant along a pathway from the anterior chamber into the suprachoroidal space),
- positioning the ophthalmological implant between a sclera and a uveal tissue at a position wherein the anterior edge of the ophthalmological implant is located in or beyond the insertion channel (fig. 10D, implant 505 placed beyond the insertion channel), and
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Silvestrini is silent to the method of closing the insertion channel so that an iris tissue is disposed between the anterior edge and an anterior chamber of the eye of the patient, and does not teach the ophthalmological implant comprising an upper and a lower surfaces which are smooth between the anterior and the posterior edges when observed in a lateral view along an anterior-posterior axis.
However, the embodiment shown in Fig. 10D shows the anterior chamber outside of fluid communication to the implant (505), and describes such an embodiment as utilizing a solid bar that does not permit flow of aqueous humor around the implant and to just apply force to the ciliary body (fig. 10D, iris tissue between the anterior edge of implant 505 and anterior chamber 505, paragraph 0089 describes the implant 505 being a solid bar not permitting flow of aqueous humor around the implant and to just apply a force on the ciliary body, with the passage shown as closed).
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 Silvestrini to include closing the insertion channel so that an iris tissue is disposed between the anterior edge and an anterior chamber of the eye of the patient, for the purpose of providing a suitable method that further prevents aqueous humor to flow around or through the implant (paragraph 0089).
Silvestrini does not teach the ophthalmological implant comprising an upper and a lower surfaces which are smooth between the anterior and the posterior edges when observed in a lateral view along an anterior-posterior axis.
However, another embodiment of Silvestrini in fig. 10A teaches a smooth upper and lower surface between the two edges when observed in a lateral view along an anterior-posterior axis (fig. 10A, body of the implant 505 with expandable region 510 also has a smooth transition between the two edges)
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 device disclosed in Silvestrini such that the ophthalmological implant comprises an upper and a lower surfaces which are smooth between the anterior and the posterior edges when observed in a lateral view along an anterior-posterior axis, as taught by the embodiment of fig. 10A of Silvestrini, since both embodiments appear to perform the identical role or applying pressure to the ciliary body (paragraph 0088), and since it has been held that a change in shape would have been obvious absent persuasive evidence that the particular shape was significant. See MPEP 2144.04(IV)(B).
Regarding claim 2, Silvestrini discloses wherein the ophthalmological [implant] is positioned between a sclera and a uveal tissue so that the anterior edge is not in the anterior chamber (see annotated fig. 10D above).
Regarding claim 3, Silvestrini discloses the method further comprising a step of inserting instruments within the at least one opening in the corneal tissue to allow the ophthalmological implant to be inserted through the at least one opening (fig. 10A shows instruments such as the sheath 510 to aid the release of the implant, and figs. 6A-6D shows the sheath 510 along with the applier 515 utilizable with the embodiment shown in fig. 10D).
Regarding claim 6, Silvestrini discloses wherein the insertion channel comprises an anterior end facing the anterior chamber (see annotated fig. 10C below) and a posterior end facing a space between the sclera and the uveal tissues (see annotated fig. 10C below), the anterior end of the insertion channel being closed during the closing step (see annotated fig. 10d below)
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Regarding claim 7, Silvestrini discloses wherein the anterior edge of the ophthalmological implant is positioned between the anterior and posterior ends of the insertion channel (see annotated 10D above, noting the alternative posterior end of the insertion channel)
Regarding claim 8, Silvestrini discloses wherein the anterior edge of the ophthalmological implant is positioned out of the insertion channel (see annotated fig. 10D above, noting the first posterior end of the insertion channel)
Regarding claim 9, Silvestrini is silent to wherein both the anterior and the posterior ends of the insertion channel are closed during the closing step.
However, as previously mentioned in claim 1, and with annotated fig. 10D above, because the implant is not meant to have fluid from the anterior chamber go through or past the implant, it would have been obvious to one of ordinary skill in the art to modify the method disclosed in Silvestrini such that both the anterior chamber and the posterior ends of the insertion channel are closed during the closing step, for the purpose of providing a suitable method that further prevents aqueous humor to flow around or through the implant (paragraph 0089).
Regarding claim 10, Silvestrini, as described in the analysis of claim 1 above, discloses wherein the insertion channel comprises two parts which are separate from each other during the opening step (see annotated fig. 10D below), the step of closing the insertion channel comprises bringing said two parts of the insertion channel into contact with each other (see annotated fig. 10D below).
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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 Silvestrini such that the step of closing the insertion channel comprises bringing said two parts of the insertion channel into contact with each other, for the purpose of providing a suitable method that further prevents aqueous humor to flow around or through the implant (paragraph 0089).
Regarding claim 11, the embodiment of 10D of Silvestrini does not teach wherein the ophthalmological implant is deprived from protuberance protruding from the upper and lower surfaces between the anterior and the posterior edges when observed in a lateral view along an anterior-posterior axis.
However, the embodiment of 10A of Silvestrini teaches wherein the ophthalmological implant is deprived from protuberance protruding from the upper and lower surfaces between the anterior and the posterior edges when observed in a lateral view along an anterior-posterior axis (fig. 10A shows a smooth surface and is silent to any form of bumps along the smooth surface).
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 device disclosed n Silvestrini such that the ophthalmological implant is deprived from protuberance protruding from the upper and lower surfaces between the anterior and the posterior edges when observed in a lateral view along an anterior-posterior axis, as taught by the embodiment of fig. 10A of Silvestrini, since both embodiments appear to perform the identical role or applying pressure to the ciliary body (paragraph 0088), and since it has been held that a change in shape would have been obvious absent persuasive evidence that the particular shape was significant. See MPEP 2144.04(IV)(B).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Silvestrini in view of Anthone (US 20030093099).
Regarding claim 4, Silvestrini discloses wherein the device can be performed in conjunction with a cyclodialysis procedure (paragraph 0032) and utilizes an applier to penetrate the iris root (paragraph 0066), but is silent to wherein the iris root is opened using a cyclodialysis spatula.
However, Anthone teaches wherein the use of a cyclodialysis spatula sweep or retract strands of vitreous material is a known practice in the art (paragraph 0045)
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 Silvestrini such that the iris root is opened using a cyclodialysis spatula, as taught by Anthone, for the purpose of providing a suitable instrument that is capable of separating the iris root.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Silvestrini in view of Burns (US 20080228127).
Regarding claim 5, Silvestrini is silent to wherein the insertion step comprises the injection of a viscoelastic fluid in the anterior chamber and/or between the sclera and the uveal tissues.
However, Burns teaches a uveoscleral shunt (abstract) wherein a viscoelastic fluid can be injected between the sclera and the choroid (paragraph 0134). Notably, the choroid is also 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 Silvestrini such that the insertion step comprises the injection of a viscoelastic fluid in the anterior chamber and/or 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
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.
/Brandon W. Levy/Examiner, Art Unit 3781
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