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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-8 and 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath et al. (US 20120197175 A1, hereafter “Horvath”).
Regarding claim 1, Horvath discloses a system for treating glaucoma (para. [0026]), comprising: an intraocular shunt (26) made of a cross-linked gelatin (para. [0117]), the intraocular shunt (26) defining at least one interior flow path (hollow interior, para. [0119]) having a shunt inner diameter of between about 50 µm and about 70 µm (para. [0119]); and a needle (22) having a lumen to carry the intraocular shunt (para. [0104]).
Horvath does not explicitly disclose the intraocular shunt (26) having a shunt outer diameter of between about 170 µm to about 260 µm, and the lumen of the needle having a lumen inner diameter of between about 220 to about 280 µm. However, Horvath discloses ranges for the shunt outer diameter to be 80-300 microns (para. [0119]) and the needle inner diameter to be 200-400 microns (para. [0104]), where both ranges overlap the claimed ranges. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameters of Horvath from 80-300 microns (para. [0119]) for the shunt outer diameter to 170-260 microns and from 200-400 microns (para. [0104]) for the needle inner diameter to 220-280 microns 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.” See MPEP 2114.05. Further, applicant appears to have placed no criticality on the claimed range (see para. [0071, 0072] of specification indicating the diameters “can” be within their claimed range but also lists many other possible diameters).
Regarding claim 2, Horvath discloses the system of claim 1 and further discloses wherein an annular gap between an outer surface of the shunt and an inner surface of the lumen is between about 0 µm to about 20 µm.
Paragraphs [0104] and [0119] state the ranges of diameters the shunt and the needle may have. Although not explicitly stated, the ranges contemplate an annular gap between an outer surface of the shunt and an inner surface of the lumen of the needle. The inner diameter of the shunt is between 50-250 microns, the wall thickness of the shunt is between 30-70 microns, and the needle inner diameter is between 200-400 microns; therefore, a 0-micron annular gap can be achieved with a 140-micron inner diameter of the shunt and a 30-micron thick wall (making a 60-micron added diameter) for a needle inner diameter of 200 microns. A 20-micron annular gap can be achieved with a 100-micron shunt inner diameter, a 30-micron thick wall, and a needle inner diameter of 200 microns.
Regarding claim 3, Horvath discloses the system of claim 1 and further discloses wherein the shunt outer diameter is expandable (para. [0115]).
Regarding claim 4, Horvath discloses the system of claim 3 and further discloses wherein the shunt outer diameter expands to a maximum shunt outer diameter of about 260 µm (outer diameter is from 80-300 microns, para. [0115, 0119]).
Regarding claim 5, Horvath discloses the system of claim 1 and further discloses wherein the shunt inner diameter is about 63 µm (para. [0119]).
Regarding claim 6, Horvath discloses the system of claim 1 and further discloses wherein the intraocular shunt has a shunt wall thickness of between about 88 µm to about 99 µm (para. [0156]).
Regarding claim 7, Horvath discloses the system of claim 1 and further discloses wherein the intraocular shunt has a shunt length of about 6 millimeters (para. [0121]).
Regarding claim 8, Horvath discloses the system of claim 1 and further discloses wherein the lumen inner diameter is about 260 µm (para. [0104]).
Regarding claim 10, Horvath discloses the system of claim 1 and further discloses wherein the needle has a needle wall thickness of between about 70 µm to about 80 µm (para. [0119]).
Regarding claim 11, Horvath discloses the system of claim 1 and further discloses further comprising a movable plunger (32) disposed within the lumen (para. [0063]), wherein the plunger is configured to advance the shunt through the lumen (para. [0097]).
Regarding claim 12, Horvath discloses the system of claim 11 and further discloses further comprising a deployment mechanism (plunger arm 58 and guide block 66) configured to selectively move the plunger to advance the shunt (para. [0075]).
Regarding claim 13, Horvath discloses a method to treat glaucoma (para. [0026]), the method comprising: advancing a needle (22) through the sclera of the patient to create an opening (para. [0099]), wherein the needle (22) has a needle diameter of between about 400 µm to about 420 µm (para. [0104]); advancing an intraocular shunt (26) through a lumen of the needle and into the opening (para. [0087]), wherein the intraocular shunt has a shunt outer diameter of between about 240 to 260 µm (para. [0119]) and the lumen has a lumen inner diameter of between about 220 µm to about 280 µm (para. [0104]); and permitting flow through the intraocular shunt (para. [0022, 0119]), wherein the shunt has a shunt inner diameter of between about 50 µm to about 70 µm (para. [0119]).
Although Horvath does not expressly disclose wherein the inner diameter is within that range for reducing any gap between the shunt and the opening to minimize peritubular flow therebetween, the device of Horvath is capable of performing such a function because the exact claimed dimensions are anticipated. While features of an apparatus may be recited either structurally or functionally, claims directed to a device must be distinguished from the prior art in terms of structure rather than function, because device claims cover what a device is, not what a device does (MPEP 2114).
Regarding claim 14, Horvath discloses the method of claim 13 and further discloses comprising permitting expansion of the intraocular shunt (para. [0115]).
Regarding claim 15, Horvath discloses the method of claim 14 and further discloses wherein the shunt outer diameter is limited to approximately the lumen inner diameter during expansion.
The outer diameter of the shunt is approximately 80-300 microns with a minimum wall thickness of 30-70 microns, so the total diameter of the shunt is between 110-370 microns. The lumen of the needle is between 200-400 microns, so the wide range of potential diameters of the shunt fits well within the potential range of the lumen when the outer diameter swells (para. [0104, 0119, 0115]).
Regarding claim 16, Horvath discloses the method of claim 13 and further discloses comprising expanding the shunt outer diameter to approximately an inner diameter of the opening when the shunt is outside of the lumen of the needle.
The outer diameter of the shunt is approximately 80-300 microns with a minimum wall thickness of 30-70 microns, so the total diameter of the shunt is between 110-370 microns. The lumen of the needle is between 200-400 microns, so the wide range of potential diameters of the shunt fits well within the potential range of the lumen when the outer diameter swells and is capable of swelling after the shunt is implanted and outside of the needle (para. [0104, 0119, 0115]).
Claim(s) 9 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath (US 20120197175 A1) in view of Trogden et al. (US 20080033351 A1, hereafter “Trogden”).
Regarding claim 9, Horvath discloses the system of claim 1, but fails to disclose wherein the needle has a needle outer diameter of between about 400 µm to about 420 µm.
Trogden teaches an ocular implant delivery system wherein the needle has a needle outer diameter of between about 400 µm to about 420 µm (para. [0011, 0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle of Horvath to have the outer diameter of Trogden. Horvath is silent to the outer diameter of the needle, but anticipates the inner diameter of the needle and the plunger mechanism, but no specific dimension of the outer diameter is mentioned. It would have been obvious because a thin-walled needle would need to still deploy the ocular implant through the needle in the micro-scale environment and considering the needle of Horvath necessarily has some outer diameter, a diameter within the claimed range as shown by Trogden would have been obvious.
Regarding claim 18, Horvath discloses a system for treating glaucoma (para. [0026]), comprising: an intraocular shunt (26) made of a cross-linked gelatin (para. [0117]), the intraocular shunt (26) having a shunt outer diameter of between about 170 µm to about 260 µm (para. [0119]), and the intraocular shunt (26) defining at least one interior flow path (hollow interior, para. [0119]) having a shunt inner diameter of about 63 µm (para. [0119]); and a needle (22) having a lumen to carry the intraocular shunt (26, para. [0104]).
However, Horvath fails to disclose wherein the needle having a needle outer diameter of between about 400 µm to about 420 µm.
Trogden teaches an ocular implant delivery system wherein the needle has a needle outer diameter of between about 400 µm to about 420 µm (para. [0011, 0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle of Horvath to have the outer diameter of Trogden. Horvath is silent to the outer diameter of the needle, but anticipates the inner diameter of the needle and the plunger mechanism, but no specific dimension of the outer diameter is mentioned. It would have been obvious because a thin-walled needle would need to still deploy the ocular implant through the needle in the micro-scale environment and considering the needle of Horvath necessarily has some outer diameter, a diameter within the claimed range as shown by Trogden would have been obvious.
Regarding claim 19, the combination of Horvath and Trogden discloses the system of claim 18. Horvath further discloses wherein the intraocular shunt has a shunt wall thickness of between about 88 µm to about 99 µm (para. [0156]).
Regarding claim 20, the combination of Horvath and Trogden discloses the system of claim 18. Horvath further discloses wherein the needle has a needle wall thickness of between about 70 µm to about 80 µm (para. [0119]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath (US 20120197175 A1) in view of Pinchuk (US 20130184631 A1).
Horvath discloses the method of claim 13, but fails to disclose further comprising cutting the sclera via a tip of the needle to form the opening.
Pinchuk teaches a similar method of implanting a device for treating glaucoma further comprising cutting the sclera via a tip of the needle to form the opening (para. [0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Horvath and incorporate the cutting step of Pinchuk with a predictable result—an opening for the needle to go through for implantation. Hovarth discloses wherein an incision is made before the needle is inserted or the needle is pierced directly without first making an incision. Pinchuk discloses using the needle to cut an entrance of the sclera and it would have been obvious to incorporate that step to enlarge an incision sight to better fit the needle (para. [0076]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 7 January 2026