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) 1-14 and 26-31 is/are pending. Claim(s) 13-14 and 31 is/are withdrawn. Claim(s) 15-25 and 32-39 is/are canceled.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/19/2025 is acknowledged.
Claims 13-14 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/2025.
Claim Objections
Claims 3 and 26 are objected to because of the following informalities:
Claim 3, line 2, recites “the anterior and posterior”, which should be “the anterior and the posterior”.
Claim 26, lines 6-7, recites “the peripheral portion, anterior side, and posterior side”, which should be “the peripheral portion, the anterior portion, and the posterior side”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6, line 3 recites the limitation "the assembly". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an assembly”.
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, 4-10, and 26-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Argento, et al (Argento) (US 2018/0177589 A1).
Regarding Claim 1, Agrento teaches an intraocular lens component (e.g. Figure 4A), comprising:
an anterior side (e.g. Figure 4A, [0223], annotated Figure 4A below) comprising an anterior optical surface disposed across an optical axis of the intraocular lens component (e.g. Figure 4A, #410);
a posterior side (e.g. Figure 4A, [0223], annotated Figure 4A below) comprising a posterior optical surface disposed across the optical axis (e.g. Figure 4A, #450);
a peripheral portion (e.g. annotated Figure 4A below) having an anterior portion coupled to the anterior side e.g. annotated Figure 4A below, a posterior portion coupled to the posterior side e.g. annotated Figure 4A below, and a joining channel disposed in one or both of the anterior portion and the posterior portion (e.g. annotated Figure 4A below); and
a joining substance disposed in the joining channel (e.g. [0084], adhesive in a groove; [0090], adhesive in a seam) to bond the posterior portion of the peripheral portion to the anterior portion of the peripheral portion (e.g. [0073]).
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Annotated Figure 4A, Argento
Regarding Claim 4, the joining substance forms a continuous feature in the peripheral portion that is configured to visually verify assembly of an intraocular lens when viewed from the anterior side (e.g. Figures 4B-C; the peripheral portions is annular and the groove follows the peripheral portion and thus is also annular).
Regarding Claim 5, the continuous feature is an annular structure that surrounds the optical axis of the intraocular lens component (e.g. Figures 4B-C, discussed supra for claim 4).
Regarding Claim 6, the continuous feature is configured to be visually disrupted under a retaining feature of the intraocular lens to visually verify the assembly of the intraocular lens when viewed from the anterior side (when the two sides of the peripheral portion are placed together at joint #401, at least a portion of the adhesive material in the groove that becomes covered is obscured by #401).
Regarding Claim 7, there is an inclined interface disposed in the peripheral portion between the posterior portion and the anterior portion (e.g. annotated Figure 4A above).
Regarding Claim 8, the inclined interface comprises an anterior inclined surface and a posterior inclined surface (e.g. annotated Figure 4A above), the inclined interface being disposed between the joining channel and a closed cavity (e.g. Figure 4A, the joining channel is at #401; the inclined surfaces are radially inward of #401).
Regarding Claim 9, the closed cavity is between the anterior optical surface and the posterior optical surface (e.g. Figure 4A, [0223], cavity #405).
Regarding Claim 10, the intraocular lens component comprises a material that is configured to adhere to a surface of a base member upon contact (e.g. [0130], the IOL is made of polymer(s) that are able to be bonded to a base member).
Regarding Claim 26, Argento teaches an intraocular lens component (discussed supra for claim 1), comprising:
an anterior side (discussed supra for claim 1) comprising an anterior optical surface disposed across an optical axis of the intraocular lens component (discussed supra for claim 1);
a posterior side (discussed supra for claim 1) comprising a posterior optical surface disposed across the optical axis (discussed supra for claim 1);
a peripheral portion coupled to the anterior side and the posterior side (discussed supra for claim 1), the peripheral portion, anterior side, and posterior side forming a closed cavity therebetween (discussed supra for claim 8 and e.g. Figure 4a, additional cavity space #403); and
a port having a first end disposed at a peripheral surface of the peripheral portion and a second end disposed within the peripheral portion between the first end and the closed cavity (e.g. [0536], [0561], [0580], the port is the channel formed by the needle; the noted thickened portion is shown in e.g. Figure 8, middle image and is in the peripheral portion; the first end is the radially outermost needle entry opening in the thickened portion and the second end is the hole in the thickened portion immediately adjacent the cavity).
Regarding Claim 27, a solid and continuous expanse of material extends between the second end of the port and the closed cavity (discussed supra for claim 26, the thickened portion is solid and continuous around the needle channel).
Regarding Claim 28, there is a channel formed between the second end of the port and the closed cavity for access to the closed cavity by a syringe (discussed supra for claim 26, the channel is for a needle and thus the channel is configured to be used with a syringe having a needle), the channel being self-sealing in an absence of the syringe (e.g. [0273]).
Regarding Claim 29, there is an optical fluid disposed in the closed cavity (e.g. abstract, [0509]).
Regarding Claim 30, a plug member disposed in the port (discussed supra for claims 26 and 28; the material of the thickened region that takes up the space of the needle channel when the needle is removed acts to plug the channel and thus is a plug member).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento, et al (Argento) (US 2018/0177589 A1) as discussed supra and further in view of Niwa, et al (Niwa) (US 2009/0043384 A1).
Regarding Claim 2, Argento discloses the invention substantially as claimed but fails to teach the joining substance includes a pigment or dye configured to facilitate visualization of an orientation of an intraocular lens.
Niwa teaches an outer peripheral coupling in an IOL is colored (e.g. abstract, [0020], [0155]).
Argento and Niwa are concerned with the same field of endeavor as the claimed invention, namely fluid-filled IOLs.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Argento such that the peripheral portion is colored (includes a pigment or dye) as taught by Niwa in order to prevent unwanted reflection or refraction (e.g. Niwa, [0020]).
The combination of Argento and Niwa teaches: the joining substance includes a pigment or dye (as the joining substance becomes part of the peripheral portion in the final IOL, in the combination it has the pigment or dye) configured to facilitate visualization of an orientation of an intraocular lens (as the peripheral portion forms an annular shape, the pigment or dye in the combination allows for determining if the annular ring is positioned as needed when implanted in the eye because the surgeon is able to see the outermost periphery of the lens and thus able to see its position, e.g. relative to the center of the capsular bag when implanted).
Regarding Claim 3, the pigment or dye is closer to the anterior side or posterior side (e.g. Argento, Figure 4A, when the adhesive is that on one of the anterior or posterior sides at joint #401’s contact location with the given side, the adhesive is closer to the given side).
Claims 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento, et al (Argento) (US 2018/0177589 A1) as discussed supra and further in view of Esch, et al (Esch) (US 2007/088433 A1)..
Regarding Claim 11, Argento discloses the invention substantially as claimed but fails to teach an anterior surface of the anterior portion, a posterior surface of the posterior portion, and a peripheral surface of the peripheral portion are rough to facilitate improved adhesion to a surface of a base member upon contact.
Esch teaches the use of barbs (e.g. Figure 7C, #63 and Figure 9A, #122, [0065]) to facilitate engagement to the capsular bag (e.g. [0067], equator; [0071], [0095]).
Esch and Argento are concerned with the same field of endeavor as the claimed invention, namely fluid-filled IOLs.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Argento to have an anterior surface of the anterior portion, a posterior surface of the posterior portion, and a peripheral surface of the peripheral portion are rough as taught by Esch in order to facilitate engagement to the capsular bag (e.g. Esch, [0067], equator; [0071], [0095]).
The combination of Argento and Esch teaches: the roughened texture facilitates improved adhesion to a surface of a base member upon contact (as these structures provide a gripping texture, when in contact with a base member, these textures facilitate improved adhesion with the base member).
Regarding Claim 12, the peripheral surface of the peripheral portion is rough to facilitate improved adhesion to the surface of the base member upon contact (discussed supra for claim 11).
Relevant Prior Art
US 2019/0269500 A1 to de Juan, et al teaches a multi-part fluid IOL having visualization markers (e.g. Figure 11A, #1100).
US 2018/0132997 A1 to Smiley, et al teaches a multi-part fluid IOL having an adhesive layer (e.g. abstract, [0046]).
US 2019/0159890 A1 to Salahieh, et al teaches a multi-part fluid IOL having components bonded together (e.g. abstract, [0035]).
US 2014/0135917 A1 to Glazier teaches a multi-part fluid IOL having components adhered together (e.g. abstract, [0031]).
Conclusion
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.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 12/22/2025