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 .
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2, “the ophthalmological” should read -the ophthalmological implant-. Moreover, “a sclera and a uveal tissue” should read -the sclera and the uveal tissue” as the sclera and the uveal tissue were already cited in claim 1.
Appropriate correction is required.
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 6-10 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.
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).
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).
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
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