DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 13, 14, 19, 20, 27-31, and 33 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by US 2004/0193262 to Shadduck.
In the specification and figures, Shadduck discloses the method as claimed by Applicant. With regard to claims 13, 14, 19, 20, 28-31 and 33, Shadduck discloses a method for reducing intraocular pressure in a glaucoma patient using a porous shape memory support 140 and an introducer 175 comprising positioning a distal end of the introducer near Schlemm’s canal, wherein the support comprises a compressed arcuate member located in a lumen of the cannula, and pushing the support into the core of Schlemm’s canal, such that the support, when expanded is fully contained within a portion of Schlemm’s canal, propping the canal open and allowing transmural flow (see FIGS 8, 12, 16, ¶0007-0008, 0042, 0044, 0057).
With regard to claim 27, Shadduck discloses that in an embodiment, the support may extend entirely around the circumference of the anterior chamber, indicating that the support extends all the way around Schlemm’s canal (see ¶0068).
With regard to claim 31, Shadduck discloses that the support may comprise a non-tubular shape (see FIGS 5B, 9B).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-26 and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2004/0193262 to Shadduck.
In the specification and figures, Shadduck discloses the method substantially as claimed by Applicant (see rejections above). With regard to claims 21, 22, 25, 26, Shadduck does not disclose the fluid flow rate claimed by Applicant nor the partial percentage of Schlemm’s canal that is occupied by the support. However, Shadduck discloses that a plurality of stents of various dimensions may be deployed in order to achieve tissue expansion in Schlemm’s canal (see ¶0045). Shadduck further discloses that tissue retraction affects outflow pathways and routes, teaching that stent properties may be used to influence flow rate (see ¶0003). It is within the skill of a worker in the art to select a porosity, dimension, and density of an apparatus disclosed in the prior art to generate a desired tissue expansion, thereby affecting the flow rate through Schlemm’s canal to the collector channels.
With regard to claims 23 and 24, Shadduck does not disclose the claimed radii of curvature. However, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(B). In the instant case, there is no showing that the radii of curvature claimed by Applicant is critical to the claimed method.
With regard to claim 32, Shadduck discloses an embodiment wherein the implant is made of a shape memory alloy (see ¶0063). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a shape memory alloy as disclosed by Shadduck in the other embodiments disclosed by Shadduck, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP § 2144.07.
Claims 15 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2004/0193262 to Shadduck in view of US 2004/0127843 to Tu et al.
In the specification and figures, Shadduck discloses the method substantially as claimed by Applicant (see rejections above). Shadduck does not disclose the use of a guidewire. However, Tu discloses a method of placing an ocular implant comprising a cannula 246, support 229E, and a guidewire 245 disposed within a central bore of support 229E to guide the support into the desired position (see FIGS 52A-D and accompanying text).
Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.
In the instant case, it would have been obvious to a person having ordinary skill in the art at the time of invention to use a guidewire as disclosed by Tu as part of the support implantation process disclosed by Shadduck, since both methods were known at the time of invention.
Claims 17 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2004/0193262 to Shadduck in view of US 6,375,642 to Grieshaber.
In the specification and figures, Shadduck discloses the method substantially as claimed by Applicant (see rejections above). Shadduck does not disclose dilating Schlemm’s canal prior to support insertion. With regard to claims 17 and 18, Grieshaber discloses a method of dilating Schlemm’s canal by delivering high viscosity sodium hyaluronate solution to a patient comprising the steps of inserting a tubular cannula 29 at least partially within Schlemm's canal and using a probe/rod 24 to deliver the solution to Schlemm's canal, thereby expanding the lumen of the canal (see FIG 5, column 5, lines 1-34). Grieshaber further discloses that after the fluid injection, supports 30 may be placed within the lumen of the canal 19 (see column 6, lines 1-40). The support is flexible enough to conform to the curvature of the canal, yet firm enough to resist kinking (see column 6, lines 40-50).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 28 January 2026