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) 20-22 and 24-36 is/are pending. Claim(s) 1-19 and 23 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 10/17/2025, with respect to the Double Patenting rejections have been fully considered and are persuasive. The Double Patenting rejections of claims 20 and 24-36 has/have been withdrawn due to the Applicant’s filing of a Terminal Disclaimer and its approval on 10/17/2025.
Applicant's arguments with respect to the prior art filed 10/17/2025 have been fully considered but they are not persuasive.
Applicant argues that Kahook is not intended to be used to displace the IOL in at least one of axial or angular directions (Applicant's Response on 10/17/2025, herein "Response", pages 8-9).
In response to applicant's argument that Kahook is not intended to be used to displace the IOL in at least one of axial or angular directions, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The Examiner notes the IOL is able to be moved relative to the lens support until it is locked in place. Applicant’s amendments do not restrict the functions claimed to occurring at any particular time point relative to implantation.
Applicant argues that the rejection including Galin is incorrect because Galin is directed to coating s that are optically clear rather than a fibrosis protector as claimed (Response, page 9).
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., the fibrosis protector device is a non-coating structure) 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).
Applicant’s amended language changing “fibrosis protector” to “fibrosis protector device” results in the new term for this element invoking 35 USC 112(f) (see below). The structure detailed in the specification is a ring shape, that may or may not have sharp edges (“preferably” does not indicate an element is required), and that is transparent.
Humayun teaches a fibrosis protector device that is a coating as cited in the prior art rejection section below and Galin teaches making coatings on IOLs is beneficial due to the need to not block light. The Humayun fibrosis protector device is further ring shaped (e.g. [0050]). Merriam Webster Online defines “ring” as “a circular line, figure, or object,” <https://www.merriam-webster.com/dictionary/ring>. Therefore, Applicant’s arguments are not persuasive.
Claim Interpretation - 35 USC § 112, 6th paragraph
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: see Table I below in claim see Table I below.
Table I: Language Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure in Applicant’s Specification
20
Device
Fibrosis protector
Ring shaped
#400 in e.g. Figures 4a-4b
Preferably having sharp edges
Transparent
Above at page 18, line 22 to page 19, line 2
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Functional language and intended use language is presented in italicized font.
Claims 20 and 24-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahook, et al (Kahook) (WO 2016/160456 A1) in view of Humayun, et al (Humayun) (US 2015/0272727 A1) as discussed supra and further in view of Galin (US 4,731,080).
Regarding Claim 20, Kahook teaches a lens support structure (e.g. abstract, Figure 1) for supporting an intraocular lens (IOL) (e.g. abstract), the lens support structure being configured and operable to be securely implanted in a lens capsule of a human eye (e.g. abstract), displace the IOL in at least one of axial or angular directions between a plurality of portions (e.g. page 2, lines 17-24; the IOL and the lens support move relative to one another during implantation; therefore, the IOL is able to be moved in either or both of the axial and angular positions), and hold the IOL in one position out of a plurality of positions (e.g. abstract), the lens support structure comprising:
a lens repositioning assembly (e.g. Figure 1) configured and operable to controllably and independently displace the IOL in at least one of axial or angular directions, respectively along or around an optical axis of the IOL (e.g. page 14, lines 4-13; the device is made of nitinol and is therefore able to be modified via temperature changes), the repositioning assembly comprises at least one actuator (#18) comprising a modifiable element (e.g. page 3, first and second arcuate arms are each modifiable elements) formed by a shape memory material (e.g. page 14, lines 4-13; the device is made of nitinol) configured and operable to be remotely activated by a remote energy source to thereby move the IOL between the plurality of positions (the device is made of nitinol and is therefore able to be modified via temperature changes, which would allow for the remote activation as claimed).
Kahook discloses the invention substantially as claimed but fails to teach
a fibrosis protector device configured to be attached to a part of the lens support structure and operable to seal the repositioning assembly and prevent fibrous tissue invasion to the repositioning assembly while enabling user inspection and the remote activation of the repositioning assembly.
Humayun teaches an intraocular implant having a fibrous protector device (e.g. [0050]).
Humayun and Kahook are concerned with the same field of endeavor as the claimed invention, namely intraocular implants placed in the capsular bag.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Kahook such that there is a fibrous protector device as taught by Humayun in order to prevent capsular fibrosis (e.g. Humayun, [0050]).
The combination of Kahook and Humayun teaches:
the protector is configured and operable to seal the repositioning assembly and prevent fibrous tissue invasion to the repositioning assembly (the assembly is sealed where it is coated; e.g. Humayun, [0050]) thereby enabling user inspection of the repositioning assembly and activation of the repositioning assembly (a user is able to view the device and also able to activate the change in the assembly).
The combination of Kahook and Humayun discloses the invention substantially as claimed but fails to teach said fibrosis protector device is made from a transparent material to allow said user visual inspection.
Galin teaches coatings for intraocular lenses being optically clear (e.g. column 3, lines 33-52).
Galin and the combination of Kahook and Humayun are concerned with the same field of endeavor as the claimed invention, namely intraocular lenses having coatings.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Kahook and Humayun such that the fibrosis protector device is made of a transparent material as taught by Galin as it is a simple substitution of one known element (here, IOL coating material) for another to obtain predictable results (MPEP 2143(I)) of a material that does not interfere with the patient’s vision. This reasoning is important in peripheral components as well as the lens in the event that any part of the peripheral element(s) comes into the visual field.
Regarding Claim 24, said repositioning assembly is configured to provide incremental transitions of said IOL between at least part of said plurality of positions (an IOL is able to be rotated angularly around the optical axis until it is locked into its final position).
Regarding Claim 25, said repositioning assembly comprises at least one teeth arrangement (e.g. Kahook, Figures 14, 16-17; the threads form teeth) facing said at least one actuator (e.g. Kahook, page 16, lines 1-8), wherein one of the at least one actuator and the at least one teeth arrangement has a fixed spatial relationship with the IOL such that when the at least one actuator or the at least one teeth arrangement moves the IOL moves with it (the teeth are fixed at the radial outer diameter of the lens and that diameter does not change and is thereby fixed), the at least one actuator being configured and operable by said remote energy source to selectively engage and disengage with the at least one teeth arrangement (the actuator is fully capable of being actuated via temperature changes due to its material composition), such that when engaging the actuator pushes against one tooth of a plurality of teeth of the at least one teeth arrangement and causes a relative axial or angular incremental movement between the at least one actuator and the at least one teeth arrangement (when the actuator is pushed against the tooth it is able to move in each axial and angular directions relative to the actuator, e.g. Kahook, Figures 1-2), thereby resulting in displacement of the IOL between two adjacent positions of said plurality of positions (movement of the actuator is fully capable of causing an IOL within the actuator to also move).
Regarding Claim 26, said at least one actuator is reversibly shiftable between a first three-dimensional shape when activated by the remote source energy to engage with the at least one teeth arrangement and a second three-dimensional shape when at rest to be disengaged from the at least one teeth arrangement (the device is made of nitinol and is therefore able to be modified via temperature changes, which would allow for the remote activation as claimed).
Regarding Claim 27, said at least one actuator and said at least one teeth arrangement define(s) a ratchet mechanism (teeth) such that said relative incremental movement occurs in only one direction in each of said at least one of the axial or angular directions, being respectively along or around the optical axis of the IOL (the movement is fully capable of being in only one direction).
Regarding Claim 28, said at least one actuator comprises a spring element (the element acts “like” a spring as it can be changed from one state to another via heat) coupled to said modifiable element (e.g. Kahook, Figures 1-2) and being configured and operable to force the actuator to return to said second three-dimensional shape when said actuator is not activated by said remote energy source (set/remembered state of the material).
Regarding Claim 29, said modifiable element comprises nitinol (e.g. Kahook, page 14, lines 4-13; the device is made of nitinol).
Regarding Claim 30, said remote energy source is configured and operable to heat said modifiable element of the at least one actuator (e.g. Kahook, page 14, lines 4-13; the device is made of nitinol and is therefore able to be modified via temperature changes).
Regarding Claim 31, said remote energy source comprises a radiating element (radiating elements create heat and thus are usable with the nitinol device for temperature based adjustments).
Regarding Claim 32, said remote energy source comprises a laser source (lasers create heat and thus are usable with the nitinol device for temperature based adjustments).
Regarding Claim 33, said remote energy source comprises an electromagnetic radiation transmitter (radiation create heat and thus are usable with the nitinol device for temperature based adjustments) and said repositioning assembly comprises an electromagnetic radiation receiver (as broadly claimed, the materials of the device can receive the electromagnetic signal; there is no requirement this “receiver” do anything with the signal).
Regarding Claim 34, said repositioning assembly comprises:
- at least two actuators of said at least one actuator (e.g. Kahook, Figure 1, each actuator is consider half of #18), each actuator of said at least two actuators being configured and operable to controllably displace the IOL in one of opposite directions either around or along the optical axis of the IOL (e.g. page 14, lines 4-13; the device is made of nitinol and is therefore able to be modified via temperature changes), and
- at least two teeth arrangements of said at least one teeth arrangement (e.g. Kahook, Figures 1-2), each of said at least two teeth arrangements interacts with one of said at least two actuators (the radially adjacent actuator) to thereby enable displacement of the IOL in opposite angular directions around the optical axis of the IOL (movement of the actuator is fully capable of causing an IOL within the actuator to also move).
Regarding Claim 35, said repositioning assembly comprises:
- at least two actuators of said at least one actuator (e.g. Kahook, Figure 1, each actuator is consider half of #18), each actuator of said at least two actuators being configured and operable to controllably displace the IOL in one of opposite directions either around or along the optical axis of the IOL (e.g. page 14, lines 4-13; the device is made of nitinol and is therefore able to be modified via temperature changes), and
- a single teeth arrangement (e.g. Kahook, Figures 1-2) that interacts with said at least two actuators to thereby enable displacement of the IOL in opposite axial directions along the optical axis of the IOL (movement of the actuator is fully capable of causing an IOL within the actuator to also move).
Regarding Claim 36, Kahook and Humayun teach an intraocular lens system comprising the lens support structure of claim 20 (discussed supra for claim 20) and the IOL integrally mounted in the lens support structure (e.g. Kahook, abstract).
Claims 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahook, et al (Kahook) (WO 2016/160456 A1) in view of Humayun, et al (Humayun) (US 2015/0272727 A1) in view of Galin (US 4,731,080) as discussed supra and further in view of Bretton, et al (Bretton) (US 6,454,802 B1).
Regarding Claim 21, the combination of Kahook, Humayun, and Galin discloses the invention substantially as claimed but fails to teach said fibrosis protector has a ring shape configured to match the lens support structure such that it covers the repositioning assembly.
Bretton teaches a coating for an intraocular implant to prevent fibrosis (PCO) (e.g. column 6, lines 24-39).
Bretton and the combination of Kahook, Humayun, and Galin are concerned with the same field of endeavor as the claimed invention, namely intraocular implants.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Kahook, Humayun, and Galin by incorporating the specific fibrosis protector as taught by Bretton as it is a simple substitution of one known element (here, fibrosis protector) for another to obtain predictable results (MPEP 2143(I)) of reducing PCO for an intraocular implant placed in a capsular bag.
Regarding Claim 22, said fibrosis protector is configured with sharp edges that provide discontinuity for fibrous tissue cells to inhibit or at least minimize the fibrous tissue cells progress (the fibrosis protector is coated over the device and thus takes on the shape of the base device, which has square (sharp) edges, e.g. Kahook, Figures 102).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (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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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 1/15/2026
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