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 .
Drawings
The replacement drawings filed on May 4, 2026, are objected to under 37 CFR 1.83(a). The drawings are of lower resolution than the original drawings, and some of the reference characters in Figures 5A-5E are illegible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, Applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. No new matter should be entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Camras et al., US 2018/0311075 A1. Figure 5B illustrates a cannula 502B having an internal space and a second segment connected between a first segment defined by a beveled or tapered end and a third segment having an opening on its side (paragraphs 0080-0083) and geometrically capable of allowing a portion of an ocular implant to be inserted from an outside to an inside of the second segment such that the implant is separable from cannula 502B through the side opening (such as by further distally advancing cannula 502B and/or fixing or pulling a proximal portion of the implant) so as to remain in the eye while cannula 502B is withdrawn from the eye, whether or not such was an intended purpose of cannula 502B (MPEP § 2114). Regarding claims 4-7, the curved tapering (or sloping or inclination) at either end of said side opening defines continua of different heights and angles (MPEP § 2125). Regarding claims 8-9, a peak of the beveled wall thickness separating the side opening and the tapered open end of cannula 502B is viewed as a protrusion. Regarding claims 10, 12, and 14, implant or insert 700C (Figure 7C) has a body that is tubular in shape and comprises a core or matrix and microchannels 702C (paragraph 0090). Claim 11 may be interpreted as a product-by-process assembly (MPEP § 2113); moreover, inserting implant 700C through the side opening would have been inherent from the existence of the latter and in order to avoid interfering with the actuation mechanism (paragraph 0083).
Claim Rejections - 35 USC § 103
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Camras et al., US 2018/0311075. Regarding claim 2, a second segment length being equal to or larger than 1 mm would have been obvious to one of ordinary skill in the art at the effective filing date of the instant application in order to ensure sufficient durability and structural support at the wall separating the aforementioned openings, with cannula 502B being “made of a compressible and flexible material” at least in some embodiments (paragraph 0083). Regarding claim 3, the first and second segments collectively being equal to or smaller than 10 mm in length would likewise have been obvious in order to more readily install, access, or manipulate the insert (paragraphs 0080-0083), which may have relatively small dimensions (paragraphs 0087-0092).
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Camras et al., US 2018/0311075 A1, in view of Camras et al., US 2016/0058615 A1. Utilizing tool 500B and cannula 502B (Figure 5B of Camras et al. ‘075) to insert an entire ocular pressure reducing implant like those shown in the drawings of Camras et al. ‘615 [abstract; paragraphs 0001-0003, 0007, 0040-0041, 0078, 0084 (“minimal invasiveness”)], would have been obvious in order to facilitate deployment of the implant and withdrawal of tool 500B with a suitable actuation mechanism (Camras et al. ‘075: paragraph 0083), further motivation (to combine) provided by Camras et al. ‘075 similarly being directed to ocular pressure reducing implants and agents for treating an eye and facilitating implantation (Figures 1A-1C; abstract; paragraphs 0046+, 0073-0075, 0084).
Camras et al. ‘615 include various cores [such as filters and inner structures: Figures 3, 7-8, 11-12, 16, 19-20, 25, 28; paragraphs 0040, 0047 (“filter 40 functions to prevent bacterial migration and may be used to regulate intraocular pressure”), 0049, 0069], wings [Figures 1-2, 4, 6-7, 9-11, 13-15, 18-19, 22, 24-27, 29; paragraphs 0007 (“tabs are adapted to be disposed subconjunctivally for securing the drainage apparatus relative to the eyeball”), 0046 (“prevent extrusion or pultrusion”), 0064 (“suture wings 202”)], and matrix covers impregnated with a solution for eye disease [paragraphs 0073-0075 (“growth factors”; “heparin”; “drug eluting coating”)], and these features would have been obvious from the respective advantages, as explained in the cited passages.
Response to Arguments
Applicant’s remarks have been considered but are deemed moot in view of the new grounds of rejection. Claims 1-9 are drawn to a “subcombination” apparatus involving a cannula, and claims 10-15 are directed to a “combination” apparatus having a cannula and implant. None of the claims positively recite a particular stage or disposition or configuration of the implant relative to the cannula (as opposed to functional language), so the pertinent issues are adequately addressed in the grounds of rejection above.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL (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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Thomas Barrett can be reached at telephone number 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774
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