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 .
Priority
This application claims priority from foreign application EP22195652.7 filed 09/14/2022.
Status of Claims
Claims 1-4 and 6-12 are pending.
Claim 5 has been cancelled.
Election/Restrictions
Applicant’s election without traverse of Species 1 (Figures 1-3), Species B (Both Haptics are colored), and Species II (Both Tabs are colored) in the reply filed on 04/02/2026 is acknowledged.
Specification
The previous objection to the abstract has been withdrawn in view of the applicant’s amendments.
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) 1, 3, and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poler USPN 4,434,515.
1. Poler discloses an intraocular lens (Figure 9) capable of posterior chamber sutureless scleral fixation (this is considered an intended use limitation and given limited weight, accordingly the IOL of Poler is fully capable of being inserted in the same manner as the applicant’s invention because it has a similar size and shape), comprising an optic plate (41) and two haptics (45-48), each haptic of said two haptics having, at its extremity, a respective plug (45f/46f/47f/48f) for anchoring to the sclera (2:20-25), each plug bearing a hole (45d/46d/47d/48d);
wherein the intraocular lens , further comprises a tab (54/54’) realized as an extension of a corresponding plug (the tabs extend inward from the plugs), each tab bearing a respective hole (52/52’/53/53’).
3. Poler discloses said plugs are flexible (5:60-6:3).
4. Poler discloses two tabs (54/54’).
.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over A Novel Intraocular Lens Designed for Sutureless Scleral Fixation: Surgical Series (Carlevale, Published 06/11/2020, Cited in the applicant’s IDS) in view of Poler.
1. Carlevale discloses the invention substantially as claimed being an intraocular lens (Figures A/B) capable of posterior chamber sutureless scleral fixation (Lens design p. 258), comprising an optic plate (Figures A/B) and two haptics (thin struts top and bottom of Figures A/B), each haptic of said two haptics having, at its extremity, a respective plug (upper most and lower most T-shaped portions Figures A/B) for anchoring to the sclera (Lens design p. 258),
wherein the intraocular lens, further comprises a tab (skinny middle two struts extending up/down from the curved strut at the base of the T shaped plug) realized as an extension of a corresponding plug (Figures A/B).
However, Carlevale does not disclose each plug bearing a hole and each tab bearing a respective hole
Poler teaches the use of an intraocular lens (Figure9) comprising a plate with two haptics 47a-c/48a-e each including a plug 47c with a bearing hole 47d and a tab 54/54’ with a hole 52/53 in the same field of endeavor for the purpose of lightening the frame, increasing flexibility, tool engagement, and allowing for attachment through ingrowth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the holes taught by Poler with the plugs and tabs of Carlevale in order to lightening the frame, increase flexibility, provide locations for tool engagement, and allowing for attachment through ingrowth.
2. Carlevale discloses said plugs are T-shaped (Figure A).
3. Carlevale discloses said plugs are flexible (Lens design discloses they are foldable which means they must be flexible p. 258).
4. Carlevale discloses two tabs (there are two tabs at each end extending down and up from the curved strut at the base of the plugs).
6. Carlevale discloses having a 5 to 8 mm optic diameter and an overall diameter between 11 and 15 mm (Lens design discloses 6.5mm and 13.2mm p. 258).
7. Carlevale discloses the haptics have a 0-13° anterior angulation with respect to the optic plate (Lens design discloses 5° p. 258).
8. Carlevale discloses a hydrophilic material (p. 261 last paragraph).
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlevale and Poler (Combination 1) as applied to claims 1-8 above, and further in view of Chu US 2011/0251685 A1.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the use of hydrophobic material or colored portions.
Chu teaches the use of an IOL comprising a plate with two haptics Figures 7A/B. Chu discloses its old and well known in the art of IOLs to interchangeably use hydrophobic or hydrophilic materials based on the patients’ needs [0075]. The applicant admits that the benefits and detriments of these materials are known in art as document by the scientific literature [0040].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the IOL of Combination 1 to comprise a hydrophobic material in order to be more compatible with lubricants such as silicone.
Chu further discloses its old and well known in the art of IOLs to form the haptics with a colored or opaque [0058] in order to create a strong high contrast color difference between the haptics and lens to provide the surgeon with better visualization of the haptics during the surgery.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the entire haptics of Combination 1 to be opaque and colored in order to provide the surgeon with better visualization of the haptics during the surgery.
Examiner’s Comment
It is noted that the 103 rejection of claims 9-12 in view of Chu, is also applicable to being made over just Poler and Chu. The modifications and motivations would remain the same but Poler would be the base reference. In order to promote compact prosecution only one rejection was made using the references closest to that of the current application.
Response to Arguments
Applicant's arguments filed 07/22/2026 have been fully considered but they are not persuasive.
The applicant argues that Poler does not disclose a plug disposed at the extremity of a haptic having a tab extending therefrom. This is not persuasive because as explained above all of the claimed features are present within Poler’s Figure 9. The applicant focuses this argument on the fact that because Poler describes a process where the arms 54 / 54’ may be removed, they are not part of the implanted lens. This is not persuasive because Figure 9 clearly shows the final implantable lens. Whether portions are initially removed, removed at a later time, or even worn away after surgery, the device disclosed in Figure 9 is fully capable of being implanted. Since the claims are not directed at a method of inserting the implant, the applicant’s and Poler’s desired steps for insertion, place of insertion, and other aspects of the steps are not given patentable weight. The claims are directed at the structure of the implant, which Figure 9 if Poler discloses as including the tabs. Whether than can be removed or not is moot because they are disclosed as part of the implant.
With respect to the 103 rejection the applicant argues that the prior art of record fails to teach the proposed combination. The applicant proposes that Carlevale already provides complete fixation arrangement as does not identify a need to further modify. If this logic was to stand then basically every 103 rejection ever made would be invalidated. There is not a requirement or expectation for prior art or base references within a 103 rejection to suggest all weaknesses or desired improvements. As explained above, the modification is simply adding holes to multiple places within the lens of Carlevale. Poler clearly discloses multiple openings including those within the claimed portions. A person of ordinary skill would recognize that by providing additional openings there are a plethora of benefits. The benefits include: increased flexibility, reduction in weight of the lens, reduced material costs, providing locations for tool engagement during implantation/removal/adjustment, providing additional anchoring points, and allowing for attachment through ingrowth. Therefore, there is clear motivation for a person of ordinary skill in the art to make the modification of Carlevale in view of the teachings of Poler.
The applicant then goes on to argue that the teachings of Poler do not support the rationale. As an initial note the motivations do not need to be specifically recited within either reference. However, as pointed out by the applicant Poler “explains the various apertures are used in connection with assembly procedures and with passage of filament or future material”. This is a clear disclosure by Poler that additional openings provide areas for tools to aid the operator during the process of inserting the implant.
The applicant then argues that the structures relied upon in Poler are incompatible with the fixation concept of Carlevale. This argument is misplaced because the structures of Poler are merely openings. There is no factual evidence as to how addition of openings are incompatible with the implant of Carlevale. The openings provide a plethora of benefits and would have no negative effect on the implant. The implant would still function in the same exact manner but provide numerous minor improvements including increased workability and adaptability during insertion.
The applicant then argues that the features relied upon by the combination are not part of the lens implanted by Poler. This argument is not persuasive because no pieces are being taken from Poler. Only the concept of providing openings is taken from Poler and they are being applied to places already present in the device of Carlevale. There is no removed part of Carlevale that isn’t implanted. Even if that was the case, that argument is still moot because the claims are directed at the initial implant structure not the method of inserting it.
The applicant then argues that Chu fails to cure the deficiencies of Poler and Carlevale. This is not persuasive because as explained above, Poler alone as well as combined with Carlevale disclose all the claimed elements.
Finally, the applicant argues that Chu does not teach the use of the non-transparent or colored portions on the plugs. This is not persuasive because the prior art combination is applying the color/non-transparent teachings to the portion defined by the entire haptic including all subcomponents such as the plugs.
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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
