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 .
Election/Restrictions
Claims 3-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/25.
Applicant’s election without traverse of Species A, claims 1-2 and 12-20, in the reply filed on 12/23/25 is acknowledged.
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.
Claims 1-2 and 12-20 are 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 1 recites the limitation "the IOL folding guide having … a second end coupled to the housing or a user-actuatable handle, the user-actuatable handle having a first end accessible to a user and a second end coupled to the IOL folding guide or the IOL folding channel" in lines 11-13. It is unclear if the “user-actuatable handle” is part of the claimed invention if the second end is coupled to the housing. For examination purposes, the limitation will be interpreted as part of the claimed invention and the claim will be interpreted as reading “An intraocular lens (IOL) folding device, comprising: a housing; a user-actuatable handle; a pair of IOL storage shelves..”. Claims 2 and 12-20 are rejected for the same reasons as claim 1 by virtue of dependency on claim 1.
Claim 19 recites the limitation "the IOL housing location" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be read as “an IOL housing location”.
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 and 12-20 are rejected under 35 U.S.C. 102(b) as being anticipated by Kobayashi et al. (US 2003/0212406).
Regarding claim 1, an invention relating to IOL devices, Kobayashi discloses (Figs. 1A-3B) an intraocular lens (IOL) folding device (Abstract), comprising: a housing (10); a pair of IOL storage shelves (11b) disposed within opposite sides of the housing, each IOL storage shelf adapted to support a portion of an unfolded IOL (Par. 0048-0049); an IOL folding channel (39a, 39) formed between the IOL storage shelves, each of the IOL storage shelf coupled to the IOL folding channel by a lip (39b), the IOL folding channel having a longitudinal axis adapted to be aligned with a bore of an IOL injector (Par. 0044), and having a bottom surface forming a floor (39a); an IOL folding guide axially aligned and above the IOL folding channel, the IOL folding guide having a first end (13f) adapted to contact an upper surface of an IOL and a second end (13b) coupled to the housing or a user-actuatable handle (13a), the user-actuatable handle having a first end accessible to a user and a second end coupled to the IOL folding guide or the IOL folding channel (see annotated figure below & Par. 0055); and wherein, in response to actuation of a button (13a): the floor of the IOL folding channel and the IOL folding guide are adapted to be brought closer together, the IOL folding guide thereby configured to push an unfolded IOL into the IOL folding channel and adopt a folded conformation within the IOL folding channel (Figs. 3A-B; Abstract; Par. 0051, 0055, 0062).
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Regarding claim 12, Kobayashi discloses the IOL folding device of claim 1. Kobayashi further discloses wherein the lip of each shelf comprises an overhang extending from the IOL storage shelves partially over the IOL folding channel, wherein the overhang is configured to retain a folded IOL within the IOL folding channel (Par. 0055).
Regarding claim 13, Kobayashi discloses the IOL folding device of claim 1. Kobayashi further discloses wherein the IOL folding device is adapted to separately fold an IOL optic (Figs. 3A-B; Par. 0062).
Regarding claim 14, Kobayashi discloses the IOL folding device of claim 1. Kobayashi further discloses wherein the IOL folding device is adapted to concurrently fold an IOL base and an IOL optic (Figs. 3A-B; Par. 0062).
Regarding claim 15, Kobayashi discloses the IOL folding device of claim 1. Kobayashi further discloses wherein the floor is configured to be beneath a centroid of an unfolded IOL when the unfolded IOL is positioned on the IOL storage shelves (Figs. 2A-3A).
Regarding claim 16, Kobayashi discloses the IOL folding device of claim 1. Kobayashi further discloses (Fig. 1A) wherein the IOL folding device is fixedly disposed within or removably disposed within an IOL injector (30; Par. 0044).
Regarding claim 17, Kobayashi discloses the IOL folding device of claim 16. Kobayashi further discloses (Figs. 1A-2A) wherein the IOL injector comprises: an injector body (30) having: a main body (31) having a proximal end and a distal end (see annotated figure below); a nozzle ( 31b) having a proximal end and a distal end (see annotated figure below), the proximal end of the nozzle coupled to the distal end of the main body, the nozzle further having an IOL storage location [i.e. space within element 35] configured to house an unfolded IOL (Par. 0044), and an IOL dwell location distal to the IOL storage location [i.e. a location within element 32]; a bore having a longitudinal axis extending from the proximal end of the main body to the distal end of the nozzle, wherein a distal portion of the bore within the nozzle forms a delivery channel [i.e. lumen of element 32]; and a plunger (33) movably coupled within the injector body and aligned within the bore, the plunger having a plunger tip (33a) adapted to contact an IOL (Par. 0044-0046).
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Regarding claim 18, Kobayashi discloses the IOL folding device of claim 17. Kobayashi discloses wherein the IOL folding device is disposed within the nozzle (Par. 0044).
Regarding claim 19, Kobayashi discloses the IOL folding device of claim 18. Kobayashi further discloses (Fig. 1A) wherein the IOL folding device is disposed within an IOL housing location (35; Par. 0044).
Regarding claim 20, Kobayashi discloses the IOL folding device of claim 19. Kobayashi further discloses wherein the IOL folding device is configured such that the plunger is axially movable through the IOL folding channel (Par. 0044-0046).
Allowable Subject Matter
Claim 2 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Concerning claim 2, Kobayashi discloses the IOL folding device of claim 1. Kobayashi but fails to further disclose wherein: the IOL folding channel is disposed within a block, the block coupled to and slidably movable within the housing; the user-actuatable handle comprises a lever having a first end accessible to a user and a second end coupled to the block; the IOL folding device further comprising a spring having a first end coupled to the block and a second end coupled to the housing; and wherein in response to actuation of the lever: the block is adapted to move from a resting position wherein the IOL folding channel is aligned with the bore, such that the floor of the IOL folding channel moves towards the IOL folding guide, thereby pushing the IOL into the IOL folding channel; and the spring is adapted to return the block to the resting position.
Prior art reference Ichinohe et al. (US 2009/0043313) discloses (Fig. 2) wherein: a IOL folding channel (23) is disposed within a block (18), the block coupled to and slidably movable within a housing (3); a user-actuatable handle comprises a lever (20) having a first end accessible to a user and a second end coupled to the block (see annotated figure below); and wherein in response to actuation of the lever: the block is adapted to move from a resting position wherein the IOL folding channel is aligned with the bore, such that the floor of the IOL folding channel moves towards a IOL folding guide (15), thereby pushing the IOL into the IOL folding channel (Par. 0033-0035). However, Ichinohe fails to disclose the IOL folding device further comprising a spring having a first end coupled to the block and a second end coupled to the housing; and the spring is adapted to return the block to the resting position. Modifying the prior art to include the missing limitations wouldn’t have been obvious because modification would only be motivated by hindsight. Furthermore, a teaching reference with this missing structure could not be found.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 February 14, 2026