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Claims 11-16, 31, 41, and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/04/2026.
Applicant’s election without traverse of Group I (Claims 1-10 and 21) in the reply filed on 03/04/2026 is acknowledged.
*The Examiner notes that Applicant canceled claims 11-16, 31, 41, and 51 in the reply filed 03/04/2026. Applicant filed new claims 61-69 that depend from elected claim 21. Claims 1-10, 21, and 61-69 are currently pending and examined herein.
Information Disclosure Statement
The Information Disclosure Statements filed 10/04/2023 and 03/04/2026 have been considered by the Examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 62 objected to because of the following informalities:
Line 1: “The ophthalmic system of claim 22” should be changed. The Examiner believes the Applicant intended for this limitation to be “The ophthalmic system of claim 61”.
Appropriate correction is required.
Claim Interpretation
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.
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 are:
“an image analyzer configured to measure a volume change of the composite material by analyzing the one or more OCT images” in claim 21.
“a computing device configured to determine a change in a base power of the IOL based on the volume change of the composite material” in claim 21.
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.
The Examiner notes that for a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function (MPEP 2181(II)(B)). Evidence of such an algorithm for covering the corresponding structure, material, or acts are found in these locations of the specification:
Fig. 1, # 102, 130, 132; Fig. 3, # 304, 314, 330; Par. [0184]; Par. [0187] – As previously discussed, the image analyzer 330 can be configured to measure a change in at least one of the curvature of the anterior element 130, the curvature of the posterior element 132, and the axial thickness of the optic portion 102 of the IOL 100 based on OCT images (e.g., 2D cross-sectional OCT images and/or 3D composite OCT images) of the anterior element 130, the posterior element 132, and the optic portion 102 before and after an IOL structure made of the composite material 200 is exposed to the beam of laser light 125.; Par. [0188-0189]
Fig. 3, # 314; Par. [0185-0187] – the computing device 314 can determine the change in the base power of the IOL 100 by first estimating a volume of fluid (e.g., silicone oil) displaced from either the haptic fluid lumen 106 to the optic fluid chamber 108 or the optic fluid chamber 108 to the haptic fluid lumen 106 in response to the volume change of the composite material 200 measured. The computing device 314 can then determine the change in the base power of the IOL 100 by selecting a base power change value from a readout table associated with the volume of fluid displaced.
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 § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 62 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 62 is rejected under 35 U.S.C. 112(d) because it depends from a canceled claim (claim 22), and therefore fails to further limit the subject matter of the upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
*Note: the Examiner believes that Applicant intended for claim 62 to depend from claim 61.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 7, 10, 21, 61, 63-64, 66, and 69 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zickler, et al. (U.S. PGPub No. 2015/0057642 – cited on IDS).
Regarding claim 1, Zickler teaches a method of adjusting an intraocular lens (IOL) (Abstract – a method of modifying a refractive profile of an eye having an intraocular device implanted therein) with optical coherence tomography (OCT) guidance (Par. [0043] – optical coherence tomography scanners, pachymeters, and the like, can then be used to identify and locate optical aberrations of the cornea that require correction. Determination of the particular subsurface regions within the intraocular lens for alteration (e.g., mechanical or structural alteration via the pulsed laser beam 18) can be based on the refractive power map or other optical modeling of the patient's eye.), comprising:
(Fig. 1, # 10, 14 – laser, 18 – laser beam) directing a laser beam generated by a laser system (Par. [0027] – the system 10 includes, but is not necessarily limited to, a laser 14 capable of generating a pulsed laser beam 18, an energy control module 16 for varying the pulse energy of the pulsed laser beam 18, a scanner 20 (e.g., a micro-optics scanning system), a controller 22, a user interface 32, an imaging system 34, and focusing optics 28 for directing the pulsed laser beam 18 from the laser 14 into the eye 12.; Par. [0031]) at (Fig. 1, # 14, 30 – intraocular lens) a composite material making up part of the IOL (Par. [0036-0037] – the output of the laser 14 is preferably aligned with … the intraocular lens 30. After alignment or centration, the system 10 directs the pulsed laser beam 18 at the support element (i.e., composite material) of the intraocular lens 30 implanted in the eye 12.; Par. [0083] – A support element (e.g., a haptic) is implanted within the eye, as indicated at 210), wherein (Figs. 1-2, # 10, 40) at least part of the composite material expands in volume in response to the laser beam directed at the composite material (Par. [0069] – the accommodating intraocular lens is implanted into the eye and includes a haptic of photosensitive polymer material that is partially polymerized. The partially polymerized haptic is more compliant for transport through the narrow conduit. Following implantation/insertion, the system 10, 40 can be used to direct the pulsed laser beam into the haptic to extend polymerization of the haptic until a pre-determined stiffness is achieved (e.g., a stiffness suited to the transfer of energy to the intraocular lens for accommodative motion and/or deformation of the optic));
measuring a volume change of the composite material (Par. [0039] – The scanning instruction can include pre-identified subsurface locations within the particular intraocular lens, or sets of locations, that correspond with increasing/decreasing flexibility of a support element (e.g., a hinge or a haptic), increasing/decreasing viscoelasticity of a portion of the intraocular lens, creating one or more slip zones at pre-determined subsurface regions, or altering a variety of other mechanical or structural properties of a desired portion of the intraocular lens) by analyzing one or more OCT images of the composite material produced by an OCT imaging apparatus (Par. [0036]; Par. [0040] – an image of the eye illustrating the locations of various anatomical structures of the eye as well the intraocular lens 30 location can be displayed on a touch-sensitive screen of the user interface 32. For a particular intraocular lens type and desired modification, the user interface 32 displays the locations of the subsurface regions to be scanned by the pulsed laser beam 18; Par. [0050]); and
(Figs. 1-2, # 10, 40) determining a change in a base power of the IOL (Par. [0073] – Using real-time wavefront analysis or other refractive analysis techniques of the eye for feedback input, the system 10, 40 can also indicate (e.g., via the user interface 32 shown in FIG. 1) the relative change to the refractive profile of the eye during re-orientation as well as subsequent to re-orientation of the intraocular lens 80) based on the (Fig. 3, # 69) volume change of the composite material measured (Par. [0055] – the capsular bag 65 contains the entire intraocular lens 30, in addition to a fluid (not shown) that occupies the remaining volume (e.g., unoccupied by the intraocular lens 30) and equalizes the pressure within the eye 60; Par. [0058] – the optic 69 may be configured to produce an effective change in the optical power of the optic by displacing the optic along the optical axis OA in response to an ocular force; Par. [0056] – The optic 69 is held in place by a positioning member 72 (e.g., a haptic), which couples the optic 69 to the capsular bag 65).
Therefore, claim 1 is unpatentable over Zickler, et al.
Regarding claim 2, Zickler teaches the method of claim 1, further comprising:
imaging the IOL comprising the composite material using the OCT imaging apparatus prior to directing the laser beam at the composite material (Par. [0039] – The scanning instruction can include pre-identified subsurface locations within the particular intraocular lens, or sets of locations, that correspond with increasing/decreasing flexibility of a support element (e.g., a hinge or a haptic), increasing/decreasing viscoelasticity of a portion of the intraocular lens, creating one or more slip zones at pre-determined subsurface regions, or altering a variety of other mechanical or structural properties of a desired portion of the intraocular lens. Each of the pre-programmed scanning instructions can be manually modified via the user interface 32; Par. [0043]); and
determining a location of the composite material based on the OCT imaging (Par. [0083] – One or more locations within the intraocular device are identified based on the corrected refractive profile, as indicated at 110. For example, the controller 22 determines which sub-surface regions of the intraocular lens 30 (e.g., within one or more haptics or support elements, within the optic, or within both) are to be irradiated with the pulsed laser beam 18 to produce the corresponding re-orientation of the intraocular lens 30).
Therefore, claim 2 is unpatentable over Zickler, et al.
Regarding claim 4, Zickler teaches the method of claim 1, further comprising (Fig. 1, # 14) adjusting a pulse repetition rate of the laser beam to between about 10 kHz to about 100 kHz (Par. [0033] – the laser 14 preferably has a pulse repetition rate of about 150 kHz, although the laser 14 may operate at other pulse repetition rates (e.g., 30 kHz, 60 kHz, 120 kHz, and the like)).
Therefore, claim 4 is unpatentable over Zickler, et al.
Regarding claim 5, Zickler teaches the method of claim 1, further comprising (Fig. 1, # 18) adjusting a laser energy of the laser beam to between about 0.1 pJ to about 100 pJ of laser energy per pulse (Par. [0082] – The pulsed laser beam 18 may have a pre-determined pulse energy less than or equal to about 800 nanojoules/pulse, a pre-determined pulse width between about 300 picoseconds and about 10 femtoseconds, and/or a pre-determined wavelength between about 400 nm to about 3000 nm).
Therefore, claim 5 is unpatentable over Zickler, et al.
Regarding claim 7, Zickler teaches the method of claim 1, wherein (Fig. 1, # 18) the laser beam has a wavelength of between about 1030 nm to about 1064 nm (Par. [0032] – The wavelength of the pulsed laser beam 18 is generally in the range of about 3 μm to about 1.9 nm, preferably between about 400 nm to about 3000 nm, and is more preferably about 1053 nm).
Therefore, claim 7 is unpatentable over Zickler, et al.
Regarding claim 10, Zickler teaches the method of claim 1, wherein (Fig. 3, # 69) determining the change in the base power of the IOL further comprises estimating a volume of fluid displaced from either a haptic fluid lumen to an optic fluid chamber or the optic fluid chamber to the haptic fluid lumen in response to the volume change of the composite material measured, and determining the change in the base power by selecting a base power change value associated with the volume of fluid displaced from a readout table (Par. [0030] – look-up tables; Par. [0055] – the capsular bag 65 contains the entire intraocular lens 30, in addition to a fluid (not shown) that occupies the remaining volume (e.g., unoccupied by the intraocular lens 30) and equalizes the pressure within the eye 60; Par. [0058] – the optic 69 may be configured to produce an effective change in the optical power of the optic by displacing the optic along the optical axis OA in response to an ocular force; Par. [0056] – The optic 69 is held in place by a positioning member 72 (e.g., a haptic), which couples the optic 69 to the capsular bag 65).
Therefore, claim 10 is unpatentable over Zickler, et al.
Regarding claim 21, Zickler teaches (Fig. 1) an ophthalmic system (Par. [0006] – the present invention is generally directed to ophthalmic devices, systems, and methods for modification of an in-situ intraocular device (e.g., an intraocular lens) using a laser system), comprising:
a (Fig. 1, # 10, 14 – laser, 18 – laser beam) laser system configured to generate a laser beam (Par. [0027] – the system 10 includes, but is not necessarily limited to, a laser 14 capable of generating a pulsed laser beam 18, an energy control module 16 for varying the pulse energy of the pulsed laser beam 18, a scanner 20 (e.g., a micro-optics scanning system), a controller 22, a user interface 32, an imaging system 34, and focusing optics 28 for directing the pulsed laser beam 18 from the laser 14 into the eye 12.; Par. [0031]) directed (Fig. 1, # 14, 30 – intraocular lens) at a composite material making up part of an intraocular lens (IOL) (Par. [0036-0037] – the output of the laser 14 is preferably aligned with … the intraocular lens 30. After alignment or centration, the system 10 directs the pulsed laser beam 18 at the support element (i.e., composite material) of the intraocular lens 30 implanted in the eye 12.; Par. [0083] – A support element (e.g., a haptic) is implanted within the eye, as indicated at 210), wherein (Figs. 1-2, # 10, 40) at least part of the composite material expands in volume in response to the laser beam directed at the composite material (Par. [0069] – the accommodating intraocular lens is implanted into the eye and includes a haptic of photosensitive polymer material that is partially polymerized. The partially polymerized haptic is more compliant for transport through the narrow conduit. Following implantation/insertion, the system 10, 40 can be used to direct the pulsed laser beam into the haptic to extend polymerization of the haptic until a pre-determined stiffness is achieved (e.g., a stiffness suited to the transfer of energy to the intraocular lens for accommodative motion and/or deformation of the optic));
an (Fig. 1, # 20, 34; Fig. 2, # 57-58) optical coherence tomography (OCT) imaging apparatus configured to produce one or more OCT images of the composite material making up part of the IOL (Par. [0040] – an image of the eye illustrating the locations of various anatomical structures of the eye as well the intraocular lens 30 location can be displayed on a touch-sensitive screen of the user interface 32. For a particular intraocular lens type and desired modification, the user interface 32 displays the locations of the subsurface regions to be scanned by the pulsed laser beam 18; Par. [0043] – optical coherence tomography scanners, pachymeters, and the like, can then be used to identify and locate optical aberrations of the cornea that require correction. Determination of the particular subsurface regions within the intraocular lens for alteration (e.g., mechanical or structural alteration via the pulsed laser beam 18) can be based on the refractive power map or other optical modeling of the patient's eye.; Par. [0050]);
an (Fig. 1, # 34; Fig. 2, # 58) image analyzer configured to measure a volume change of the composite material (Par. [0039] – The scanning instruction can include pre-identified subsurface locations within the particular intraocular lens, or sets of locations, that correspond with increasing/decreasing flexibility of a support element (e.g., a hinge or a haptic), increasing/decreasing viscoelasticity of a portion of the intraocular lens, creating one or more slip zones at pre-determined subsurface regions, or altering a variety of other mechanical or structural properties of a desired portion of the intraocular lens; Par. [0050]) by analyzing the one or more OCT images (Par. [0036]; Par. [0040] – an image of the eye illustrating the locations of various anatomical structures of the eye as well the intraocular lens 30 location can be displayed on a touch-sensitive screen of the user interface 32. For a particular intraocular lens type and desired modification, the user interface 32 displays the locations of the subsurface regions to be scanned by the pulsed laser beam 18; Par. [0050]);
a (Figs. 1-2, # 10, 40) computing device configured to determine a change in a base power of the IOL (Par. [0073] – Using real-time wavefront analysis or other refractive analysis techniques of the eye for feedback input, the system 10, 40 can also indicate (e.g., via the user interface 32 shown in FIG. 1) the relative change to the refractive profile of the eye during re-orientation as well as subsequent to re-orientation of the intraocular lens 80) based on the (Fig. 3, # 69) volume change of the composite material (Par. [0055] – the capsular bag 65 contains the entire intraocular lens 30, in addition to a fluid (not shown) that occupies the remaining volume (e.g., unoccupied by the intraocular lens 30) and equalizes the pressure within the eye 60; Par. [0058] – the optic 69 may be configured to produce an effective change in the optical power of the optic by displacing the optic along the optical axis OA in response to an ocular force; Par. [0056] – The optic 69 is held in place by a positioning member 72 (e.g., a haptic), which couples the optic 69 to the capsular bag 65).
Therefore, claim 21 is unpatentable over Zickler, et al.
Regarding claim 61, Zickler teaches the ophthalmic system of claim 21, wherein the OCT imaging apparatus is configured to image the IOL prior to the laser beam being directed at the composite material (Par. [0039] – The scanning instruction can include pre-identified subsurface locations within the particular intraocular lens, or sets of locations, that correspond with increasing/decreasing flexibility of a support element (e.g., a hinge or a haptic), increasing/decreasing viscoelasticity of a portion of the intraocular lens, creating one or more slip zones at pre-determined subsurface regions, or altering a variety of other mechanical or structural properties of a desired portion of the intraocular lens. Each of the pre-programmed scanning instructions can be manually modified via the user interface 32; Par. [0043]), and wherein the computing device is configured to determine a location of the composite material based on the one or more OCT images of the IOL (Par. [0083] – One or more locations within the intraocular device are identified based on the corrected refractive profile, as indicated at 110. For example, the controller 22 determines which sub-surface regions of the intraocular lens 30 (e.g., within one or more haptics or support elements, within the optic, or within both) are to be irradiated with the pulsed laser beam 18 to produce the corresponding re-orientation of the intraocular lens 30).
Therefore, claim 61 is unpatentable over Zickler, et al.
Regarding claim 63, Zickler teaches the ophthalmic system of claim 21, wherein (Fig. 1, # 14) the laser beam directed at the composite material has a pulse repetition rate of between 10 kHz to 100 kHz (Par. [0033] – the laser 14 preferably has a pulse repetition rate of about 150 kHz, although the laser 14 may operate at other pulse repetition rates (e.g., 30 kHz, 60 kHz, 120 kHz, and the like)).
Therefore, claim 63 is unpatentable over Zickler, et al.
Regarding claim 64, Zickler teaches the ophthalmic system of claim 21, wherein (Fig. 1, # 18) the laser beam directed at the composite material has a laser energy per pulse of between about 0.1 pJ to about 100 pJ (Par. [0082] – The pulsed laser beam 18 may have a pre-determined pulse energy less than or equal to about 800 nanojoules/pulse, a pre-determined pulse width between about 300 picoseconds and about 10 femtoseconds, and/or a pre-determined wavelength between about 400 nm to about 3000 nm).
Therefore, claim 64 is unpatentable over Zickler, et al.
Regarding claim 66, Zickler teaches the ophthalmic system of claim 21, wherein (Fig. 1, # 18) the laser beam has a wavelength of between about 1030 nm to about 1064 nm (Par. [0032] – The wavelength of the pulsed laser beam 18 is generally in the range of about 3 μm to about 1.9 nm, preferably between about 400 nm to about 3000 nm, and is more preferably about 1053 nm).
Therefore, claim 66 is unpatentable over Zickler, et al.
Regarding claim 69, Zickler teaches the ophthalmic system of claim 21, wherein the computing device is further configured to:
(Fig. 3, # 69) estimate a volume of fluid displaced from either a haptic fluid lumen to an optic fluid chamber or the optic fluid chamber to the haptic fluid lumen in response to the volume change of the composite material measured; and
determine the change in the base power of the IOL by selecting a base power change value associated with the volume of fluid displaced from a readout table (Par. [0030] – look-up tables; Par. [0055] – the capsular bag 65 contains the entire intraocular lens 30, in addition to a fluid (not shown) that occupies the remaining volume (e.g., unoccupied by the intraocular lens 30) and equalizes the pressure within the eye 60; Par. [0058] – the optic 69 may be configured to produce an effective change in the optical power of the optic by displacing the optic along the optical axis OA in response to an ocular force; Par. [0056] – The optic 69 is held in place by a positioning member 72 (e.g., a haptic), which couples the optic 69 to the capsular bag 65).
Therefore, claim 69 is unpatentable over Zickler, et al.
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 3 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Zickler, et al. (U.S. PGPub No. 2015/0057642 – cited on IDS) and Smiley, et al. (U.S. PGPub No. 2020/0000577 – cited on IDS).
Regarding claims 3 and 62, Zickler teaches the method of claim 2 and the ophthalmic system of claim 61,
wherein (Fig. 1, # 10, 12, 18, 30; Fig. 10, # 210) the composite material is configured as a lumen filler making up part of the radially-inner haptic lumen wall (Par. [0083] – A support element (e.g., a haptic) is implanted within the eye, as indicated at 210; Par. [0037] – the system 10 directs the pulsed laser beam 18 at the support element of the intraocular lens 30 implanted in the eye 12) and wherein (Figs. 1-2, # 10, 40) the lumen filler is configured to expand into at least part of the haptic fluid lumen to reduce a volume of the haptic fluid lumen in response to the laser beam directed at the lumen filler (Par. [0069] – intraocular lens is implanted into the eye and includes a haptic of photosensitive polymer material that is partially polymerized. The partially polymerized haptic is more compliant for transport through the narrow conduit. Following implantation/insertion, the system 10, 40 can be used to direct the pulsed laser beam into the haptic to extend polymerization of the haptic until a pre-determined stiffness is achieved (e.g., a stiffness suited to the transfer of energy to the intraocular lens for accommodative motion and/or deformation of the optic).), and
wherein (Fig. 3, # 30, 60, 65, 69, 72) the composite material is also configured as a lumen expander making up another part of the radially-inner haptic lumen wall and wherein the lumen expander is configured to expand to increase the volume of the haptic fluid lumen in response to the laser beam directed at the lumen expander (Par. [0055] – the capsular bag 65 contains the entire intraocular lens 30, in addition to a fluid (not shown) that occupies the remaining volume (e.g., unoccupied by the intraocular lens 30) and equalizes the pressure within the eye 60; Par. [0058] – the optic 69 may be configured to produce an effective change in the optical power of the optic by displacing the optic along the optical axis OA in response to an ocular force. The positioning member 72 is generally flexible and configured for changing the shape of the optic 69 in response to the ocular force; Par. [0056] – The optic 69 is held in place by a positioning member 72 (e.g., a haptic), which couples the optic 69 to the capsular bag 65); and
wherein the method further comprises (Figs. 1-2, # 12, 34, 57, 58, 59) differentiating between the lumen filler and the lumen expander by analyzing the one or more OCT images (Par. [0050] – The imaging system 34 preferably provides a real-time, magnified, high resolution digital image of the eye 12 and includes, but is not necessarily limited to, an image sensor 57, an imaging interface 59, and an image processor 58 coupled to the sensor 57 and the interface 59).
Zickler does not explicitly teach the limitation of instant claims 3 and 62, that is wherein the IOL comprises at least one haptic comprising a haptic fluid lumen and a radially-inner haptic lumen wall surrounding at least part of the haptic fluid lumen.
However, Smiley is directed to analogous art and teaches accommodating intraocular lenses and methods of use (Title, Abstract). Smiley also teaches the limitation of instant claims 3 and 62, that is wherein (Fig. 1A, # 10 – intraocular lens, 14 – haptics) the IOL comprises at least one haptic (Par. [0047] – Fig. 1A is a top view illustrating accommodating intraocular lens 10 that includes optic portion 12 and a peripheral portion that in this embodiment includes first and second haptics 14) comprising (Fig. 1C, # 22 – fluid chamber, i.e. haptic fluid lumen) a haptic fluid lumen (Par. [0049] – Each haptic 14 includes a fluid chamber 22 that is in fluid communication with optic fluid chamber 24 in optic portion 12. The haptic fluid chamber 22 to the left in the figure is shown in fluid communication with optic fluid chamber 24 via two apertures 26, which are formed in posterior element 20.) and a (Fig. 2D, # 43 – radially inner wall) radially-inner haptic lumen wall surrounding at least part of the haptic fluid lumen (Par. [0068] – The fluid chamber 22 has a general D-shaped configuration, in which the radially inner wall 43 is less curved (but not perfectly linear) than radial outer wall 45).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zickler’s method/system so that the IOL comprises at least one haptic comprising a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least part of the haptic fluid lumen based on the teachings of Smiley. One of ordinary skill in the art would have been motivated to accommodate intraocular lenses that are stiffer in an anterior-to-posterior direction than in a radial direction (see Smiley’s abstract).
Therefore, claims 3 and 62 are unpatentable over Zickler, et al. and Smiley, et al.
Claims 6, 8-9, 65, and 67-68 are rejected under 35 U.S.C. 103 as being unpatentable over Zickler, et al. (U.S. PGPub No. 2015/0057642 – cited on IDS) and Raksi (U.S. PGPub No. 2020/0405541 – cited on IDS). “Numerical Aperture Calculators” by GoPhotonics is relied upon as evidence (please see attached).
Regarding claims 6 and 65, Zickler teaches the method of claim 1 and the ophthalmic system of claim 21, as indicated hereinabove. Zickler fails to teach the limitation of instant claims 6 and 65, that is wherein the method/system is further comprising controlling the volume change of the composite material by controlling a laser spot diameter created by the laser beam on the composite material, wherein the laser spot diameter is dictated by the relationship:
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Raksi is directed to analogous art, and teaches non-invasive and minimally invasive laser surgery for the reduction of intraocular pressure in the eye (Title, Abstract). Raksi teaches the limitation of instant claims 6 and 65, that is wherein the method/system is further comprising controlling the volume change of the composite material by controlling a laser spot diameter created by the laser beam on the composite material, wherein the laser spot diameter is dictated by the relationship: laser spot diameter = focal point depth * (2*tan(sin(cone angle of laser beam/2))) (Par. [0101] – to minimize the threshold energy of the laser for photo-disruptive interaction, the size of the laser spot should be no more than approximately 5 μm).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zickler’s method/system in order to control the volume change of the composite material by controlling a laser spot diameter created by the laser beam on the composite material based on the teachings of Raski. One of ordinary skill in the art would have been motivated to modify Zickler with the teachings of Raksi in order to deliver the laser source to targeted locations with several micrometer accuracy (see Par. [0101] of Raksi). It is noted that the equation for laser spot diameter recited in the claim is simply a rearrangement of the equation for numerical aperture in order to solve for laser spot diameter, as evidenced by GoPhotonics in “Numerical Aperture Calculators” (please see attached).
Therefore, claims 6 and 65 are unpatentable over Zickler, et al. and Raksi.
Regarding claims 8 and 67, Zickler teaches the method of claim 1 and the ophthalmic system of claim 21, as indicated hereinabove. Zickler does not explicitly teach the limitation of instant claims 8 and 67, that is wherein the laser beam is focused by a focusing objective having a numerical aperture of between 0.2 and 0.6, and wherein the laser beam is focused by the focusing objective onto the composite material.
Raksi is directed to analogous art, and teaches non-invasive and minimally invasive laser surgery for the reduction of intraocular pressure in the eye (Title, Abstract). Raksi teaches the limitation of instant claims 8 and 67, that is wherein (Fig. 9A, # 740 – mirror, i.e. focusing objective) the laser beam is focused by a focusing objective having a numerical aperture of between 0.2 and 0.6, and wherein the laser beam is focused by the focusing objective onto the composite material (Par. [0132]; Par. [0134] – This design produces diffraction limited focusing of 1030 nm wavelength laser beams and 850 nm wavelength OCT beams with numerical aperture (NA) up to 0.2. In one design, the optical aberrations of the first optical subsystem are compensated to a degree that the Strehl ratio of the first optical subsystem for a beam with numerical aperture larger than 0.15 at the irido-corneal angle is larger than 0.9. In another design, the optical aberrations of the first optical subsystem are partially compensated, the remaining uncompensated aberrations of the first optical system are compensated by the second optical subsystem to a degree that the Strehl ratio of the combined first and second optical subsystem for a beam with numerical aperture larger than 0.15 at the irido-corneal angle is larger than 0.9).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zickler’s method/system so that the laser beam is focused by a focusing objective having a numerical aperture of between 0.2 and 0.6, and wherein the laser beam is focused by the focusing objective onto the composite material lumen based on the teachings of Raksi. One of ordinary skill in the art would have been motivated to modify Zickler’s method/system with Raksi’s method/system in order to provide OCT imaging for surgery planning and monitoring (see Abstract of Raksi).
Therefore, claims 8 and 67 are unpatentable over Zickler, et al. and Raksi.
Regarding claims 9 and 68, Zickler teaches the method of claim 1 and the ophthalmic system of claim 21, as indicated hereinabove. Zickler does not explicitly teach the limitation of instant claim 9 and 68, that is wherein the method/system is further comprising redirecting the laser beam at the composite material using a gonio lens (in a patient interface) such that the laser beam reaches a part of the IOL obscured by an anatomical structure of the eye.
Raksi is directed to analogous art, and teaches non-invasive and minimally invasive laser surgery for the reduction of intraocular pressure in the eye (Title, Abstract). Raksi teaches the limitation of instant claim 9 and 68, that is wherein the method is further comprising redirecting the laser beam at the composite material using a gonio lens such that the laser beam reaches a part of the IOL obscured by an anatomical structure of the eye (Par. [0015] – Imaging methods include slit lamp examination (i.e., patient interface), observation of the irido-corneal angle with a gonioscopic lens and optical coherence tomography (OCT) imaging of the anterior chamber and the retina).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zickler’s method/system for redirecting the laser beam at the composite material using a gonio lens such that the laser beam reaches a part of the IOL obscured by an anatomical structure of the eye based on the teachings of Raksi. One of ordinary skill in the art would have been motivated to include a gonio lens in Zickler’s method/system in order to be able to diagnose the condition of the eye of a patient with glaucoma (see Par. [0015] of Raksi).
Therefore, claims 9 and 68 are unpatentable over Zickler, et al. and Raksi.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Neal, et al. (U.S. PGPub No. 2020/0113433)
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796