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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 21-41 is/are pending. Claim(s) 36-41 is/are withdrawn. Claim(s) 1-20 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 7/19/2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of claims 21 and 24 has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments filed 7/19/2026 have been fully considered but they are not persuasive.
Applicant argues Mandell fails to teach "a first anterior panel with a first fixation loop extending posteriorly therefrom" (Applicant's Response on 7/19/2026, herein "Response", page 6).
As shown in the 5/19/2026 Office action (herein "Office action", annotated Figure 2E, page 5, shows where the anterior panel (panel 1) is located in the drug delivery device. The Office action indicates the posts and posterior panel (panel 2) are the claimed fixation loop, which is consistent with claim 23. The aperture of the loop is the central aperture of #100. The entirety of the loop is posterior to the anterior panel as required. All of these citations are to structural elements and none have been considered functional by the Examiner. Therefore, this argument is not persuasive.
Applicant argues Mandell fails to teach the anterior panel and fixation loop are physically separate elements (Response, page 6). The Examiner notes there is no requirement of separation between these elements or requirement that these elements be non-continuous or non-integral with each other.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., separation between the anterior panel and the fixation loop or requirement that these elements be non-continuous or non-integral with each other) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
Claim(s) 21-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mandell (US 2020/0405538 A1).
Regarding Claim 21, Mandell teaches an ocular implant for implantation into an eye of a subject (e.g. abstract, [0012]), the ocular implant comprising:
a compressible frame (e.g. Figure 3, portions other than the optic #301 and the drug delivery device #100; see also Figures 5A, 7B-7D) and
a first drug delivery device couplable to the compressible frame (e.g. Figures 2A-H, #100, [0310]), the compressible frame circumscribing a central aperture (e.g. Figure 3A, edge surrounding recessed #301; see also Figures 5A, 7B-7D) and including first and second outward extension portions (e.g. Figure 3A, #s 302, 304; see also Figures 5A, 7B-7D), the first drug delivery device including a first anterior panel (e.g. Figure 2E embodiment; annotated Figure 2E below, Panel 1 or Figure 2A embodiment; annotated Figure 2A below) and a first fixation loop extending posteriorly from the first anterior panel (e.g. Figure 2E or Figure 2A, remainder of device #100), the first fixation loop defining a first aperture therethrough (e.g. Figure 2E or Figure 2A; opening at label #110), the first drug delivery device couplable to the compressible frame via the first outward extension portion being disposed through the first aperture (e.g. Figures 3, 5A, 7B-7D) such that the first anterior panel is positioned anteriorly of the first outward extension portion (e.g. Figure 3B shows the panels extend toward their respective sides of the IOL).
PNG
media_image1.png
668
536
media_image1.png
Greyscale
Annotated Figure 2E, Mandell
PNG
media_image2.png
660
495
media_image2.png
Greyscale
Annotated Figure 2A, Mandell
Regarding Claim 22, the first outward extension portion includes a pair of concave surfaces (e.g. annotated Figure 3 below), wherein, when the first drug delivery device is coupled to the compressive compressible frame, the fixation loop wraps around the pair of concave surfaces of the first outward extension portion (e.g. Figures 3, 5A, 7B-7D; the loop when positioned in the smaller concave recess is around both the overall concave shape of the haptic and the concave shape of the recess).
PNG
media_image3.png
298
370
media_image3.png
Greyscale
Annotated Figure 3, Mandell
Regarding Claim 23, the first fixation loop includes a first posterior panel and a pair of first posts interconnecting the first posterior panel and the first anterior panel (e.g. annotated Figure 2E or Figure 2A above), the first anterior panel being larger than the first posterior panel (e.g. annotated Figure 2E or Figure 2A above).
Regarding Claim 24, each of the first and the second outward extension portions includes an inner portion having a first width (e.g. annotated Figure 3 above, the smaller recess) and an outer portion having a second width (e.g. annotated Figure 3 above, the haptic arm extending from the recess to the free end), the inner portion positioned closer to the central aperture than the outer portion (e.g. annotated Figure 3 above), the first width being narrower than the second width (e.g. annotated Figure 3 above).
Regarding Claim 25, the fixation loop wraps around the inner portion of the first outward extension portion when the first drug delivery device is coupled to the compressible frame (e.g. Figure 5A, 7B-7D).
Regarding Claim 26, the anterior panel includes an arcuate inner edge facing the central aperture when the drug delivery device is coupled to the compressible frame (e.g. annotated Figure 2A above).
Regarding Claim 27, wherein the first anterior panel further includes a first planar anterior surface (e.g. Figure 2B).
Regarding Claim 28, the first outward extension portion includes a waist (e.g. Figure 3, recessed section) and a pair of shoulders extending laterally outward from the waist (e.g. Figure 3, either side of the recess along the remainder of the haptic), wherein, when the first drug delivery device is coupled to the compressive frame, the fixation loop wraps around the waist of the first outward extension portion (e.g. Figures 5A, 7B-7D).
Regarding Claim 29, wherein the pair of shoulders retain a position of the first drug delivery device at the waist (e.g. Figures 5A, 7B-7D; as the device is within the recess, the shoulders retain the device because it is smaller in diameter than the shoulders; further the device is stretched into place, e.g. Figures 9A-C, [0331]).
Regarding Claim 30, wherein the ocular implant is devoid of a lens (as defined in claim 21, the ocular implant does not include the lens; i.e. the lens is a separate element from the ocular implant and thus not part of the implant; the Examiner notes Applicant has not claimed that the ocular implant has a central opening that is an empty through hole; rather as worded the claim requires the ocular implant not have a lens, which is met when the lens is considered a separate from the ocular implant structure and its sub-components; alternatively, see e.g. [0333], where there is a central hole present).
Regarding Claim 31, the compressible frame is an unbroken ring (e.g. Figure 3, [0333]).
Regarding Claim 32, there is second drug delivery device couplable to the second outward extension portion (e.g. [0015], each haptic has its own drug delivery device).
Regarding Claim 33, the first drug delivery device comprises at least one therapeutic agent (e.g. [0310]).
Regarding Claim 34, the drug delivery component device further comprises a polymer matrix in which the at least one therapeutic agent is dispersed therein (e.g. abstract, [0013], [0358]).
Regarding Claim 35, an entirety of the compressible frame lies in a plane (e.g. Figure 3B, 7C).
Conclusion
THIS ACTION IS MADE FINAL. 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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 9/11/2026
Prosecution Insights