DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments, filed 2 June 2026, with respect to the rejections of the pending claims over Shadduck have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Stegmann, as presented below.
This action is non-final.
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 13-15, 17-20, and 25-31 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by US 2006/0195187 to Stegmann et al.
In the specification and figures, Stegmann discloses the method as claimed by Applicant. With regard to claims 13-15, Stegmann discloses a method of reducing intraocular pressure in a glaucoma patient using a support and an introducer comprising the steps of placing a distal end of a cannula at Schlemm’s canal, wherein the support comprises an arcuate shape and pushing the implant out of the cannula with a guidewire to place the support within Schlemm’s canal—Stegmann discloses that the ends of the implant connect to one another inside Schlemm’s canal, teaching that the implant is entirely within Schlemm’s canal (see FIGS 4a, 4b, 5b, ¶0008-0009, 0010, 0018-0020, 0039, 0048, 0049).
With regard to claims 17 and 18, Stegmann discloses that the instrument is provided with means for injecting a dilating fluid into the Schlemm’s canal prior to support insertion, teaching the limitations claimed by Applicant (see ¶0037, 0049).
With regard to claims 19 and 20, the support is configured to prop open, or dilate Schlemm’s canal while allowing transmural flow (see ¶0041-0042).
With regard to claims 25-28, Stegmann discloses that the implant may traverse the entire canal or sections thereof, teaching the limitations of the claims (see ¶0043).
With regard to claims 29 and 30, Stegmann discloses an embodiment in which the support comprises fenestrations 34 (see FIG 13 and accompanying text).
With regard to claim 31, Stegmann discloses a support with non-tubular embodiments (see FIGS 6a, 6b).
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 13-17 and 19-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2003/0069637 to Lynch et al in view of US 2004/0127843 to Tu et al.
In the specification and figures, Lynch teaches the method substantially as claimed by Applicant. With regard to claims 13-17, 19, 20, 28-30, Lynch teaches a method for reducing intraocular pressure in a glaucoma patient by maintaining patency within Schlemm’s canal comprising the steps of placing an introducer at Schlemm’s canal dilating the canal, and introducing an arcuate, fenestrated 15 support 10 into the canal, wherein the support is entirely contained (or fully received) within Schlemm’s canal and maintains fluid flow therethrough and through the fenestrations (see FIGS 1, 5, ¶0020, 0030, 0035-0036).
Lynch insinuates, but does not disclose pushing a support out of a cannula using a guidewire through a central bore of the support. 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 Lynch, since both methods were known at the time of invention.
With regard to claims 21 and 22, Lynch does not disclose the flow rate. However, Lynch teaches the method of implantation substantially as claimed by Applicant. It flows naturally that when a person of ordinary skill in the art performs the method as claimed by Applicant, the results claimed by Applicant will be achieved by the prior art method.
With regard to claims 23 and 24, Lynch discloses that the radius of curvature of the support is chosen to approximate the radius of curvature of Schlemm’s canal, around 6mm (see ¶0032).
With regard to claims 25-27, Lynch discloses that multiple stents may be used to result in a near-circumferential traverse of Schlemm’s canal (see ¶0035).
With regard to claim 31, Lynch discloses a non-tubular embodiment (see FIG 3).
With regard to claim 32, Lynch discloses that the support may be made of nitinol, a shape memory material (see ¶0033).
With regard to claim 33, Lynch discloses that the support may move between a d first insertion position and a second expanded position after implantation (see ¶0027).
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2003/0069637 to Lynch et al in view of US 2006/0195187 to Stegmann et al l.
In the specification and figures, Lynch discloses the method substantially as claimed by Applicant (see rejections above). Lynch discloses dilation of Schlemm’s canal before implantation, but does not disclose it is performed with a dilating fluid. However, Stegmann discloses a method for implanting a stent in Schlemm’s canal in which the canal may be pre-dilated with a viscoelastic fluid in order to facilitate placement of the implant (see ¶0037, 0049). It would have been obvious to a person of ordinary skill in the art at the time of invention to use a known technique, such as a fluid injection as taught by Stegmann to dilate Schlemm’s canal in the method disclosed by Lynch, in order to facilitate insertion of the implant, as taught by Stegmann.
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 18 June 2026
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