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 .
This action is in response to the application filed on June 20, 2023. Claims 1-20 are pending and examined below.
Information Disclosure Statement
The information disclosure statement filed on June 20, 2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because of incorrect patent numbers on the IDS, indicated by strikethrough. It has been placed in the application file, but the information as noted by strikethrough has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification fails to provide support for a wavelength that is different from the design wavelength by between 40 and 70 nm. Paragraphs [0005], [0050], and [0051] of the specification refer to the shift of said focal point, but different values are mentioned for the range from 40 to 70 nm for the difference in wavelength.
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, 3, 4, and 7 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2020/132703 (“Liu”).
Regarding claim 1, Liu discloses an intraocular lens (IOL) (multifocal diffractive IOL 10, see Fig. 1), comprising:
a lens body having an anterior surface and a posterior surface (IOL include a lens having an anterior surface and a posterior surface, see [41] and claim 1); and
a diffractive structure having a plurality of echelettes located on at least one of the
anterior surface or the posterior surface (at least one diffractive structure 12 disposed on either the anterior surface or posterior surface include a plurality of echelettes, see [41] and claim 1), wherein a surface profile of the diffractive structure comprises (diffractive zone 14 of the diffractive structure 12, see Fig. 1):
a base surface profile configured to diffract an incident light in one or more diffraction
orders (base optic 16 includes diffraction zone 14 with different radial widths that control for additional powers while the step structure within each diffraction zone 14 controls the amount of light diffracted into each of the focal points, see [42]); and
an achromatizing surface profile comprising increased step heights in the plurality
of echelettes in relation to the base surface profile (vertical step structure within each diffraction zone 14 of diffractive structure 12, which includes a plurality of echelettes in relation to base optic 16, see also step 2 and step 4 in Figs. 4 and 8); and
a plurality of phase offsets included in corresponding ones of the plurality of echelettes
(echelette micro-structure of diffractive structure 12 has four step structure that produces a phase relationship for different focal points, see [45] and Fig. 4).
Regarding claim 3, Liu further discloses that one or more diffraction orders provide distance vision, intermediate vision, and near vision (at least five focal points corresponding to diffractive orders (0th, 1st, 2nd, 3rd, 4th) allow for distance, near, and three stages of intermediate vision, see [41]).
Regarding claim 4, Liu further discloses that the achromatizing surface profile shifts the one or more diffraction orders by two (effective diffractive orders are shifted from 0, +1, +2, +3, and +4 to −2, −1, 0, +1, and +2 diffraction orders, showing diffraction orders are shifted +2 order numbers for the corresponding focal points, see [56] and Figs. 24 and 25) or four diffraction orders (energy producing diffraction orders are 0th, 1st, 2nd, 3rd, and 4th and the achromatizing versions use 4th, 5th, 6th, 7th, and 8th diffraction orders, which indicate each corresponding focal point shift upward by 4 diffraction orders in the achromatizing versions, see [52]).
Regarding claim 7, Liu further discloses one or more haptics coupled to the lens body (IOL 10 includes two haptics 18, see Fig. 1).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/132703 (“Liu”) in view of US 9,335,563 B2 (“Weeber”).
Regarding claim 2, Liu does not explicitly disclose that the increased step height is a non-integer multiple, however, Weeber discloses a similar ophthalmic lens, wherein at least one of the increased step heights is a non-integer multiple of a design wavelength (each echelette has varying step heights, at least one echelette having an optical path difference of 1.5 wavelengths, and the peripheral zone includes at least one echelette having an optical path difference of 1.366 wavelengths, which are non-integer multiples of wavelength, see col. 6, lines 23-28).
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 IOL in Liu to include a non-integer multiple of a design wavelength, as taught by Weeber, in order to tailor the phase delay and optimize distribution of light among diffraction orders.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/132703 (“Liu”).
Regarding claim 5, Liu does not disclose that the achromatizing surface profile shifts the one or more diffraction orders by five diffraction orders, however, Liu further discloses that the energy producing diffraction orders 0th, 1st, 2nd, 3rd, and 4th can be shifted to the achromatizing version with 4th, 5th, 6th, 7th, and 8th diffraction orders, which indicate each corresponding focal point shift upward by 4 diffraction orders in the achromatizing version (see [52]).
Liu teaches that the conversion is done to reduce the chromatic aberration of the pseudophakic eye by a change of the energy producing diffraction orders (see [52]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the shifting of the diffraction orders disclosed by Liu to have a shift by five diffraction orders, as the shifting of the diffraction order is recognized as a result-effective variable in order to reduce chromatic aberration for the best adapted IOL and vision needed by the patient. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum value involves only routine skill in the art (MPEP 2144.05).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/132703 (“Liu”) in view of US 2012/0143326 A1 (“Canovas Vidal”).
Regarding claim 6, Liu does not disclose that the lens body comprises of hydrophobic acrylic polymeric material; however, Canovas Vidal discloses a multifocal ophthalmic lens including a lens body that comprises of hydrophobic acrylic polymeric material (lens 20 may be constructed of polymethylmethacrylate (PMMA), which is a hydrophobic acrylic polymeric material, see [0048]).
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 lens body in Liu to comprise of hydrophobic acrylic polymeric material, as taught by Canovas Vidal, as it is a commonly used material for optics due to its biocompatible nature and is capable of deforming to be rolled, folded or otherwise deformed and inserted into the eye through a small incision (see [0049]).
Claims 8, 9, 11-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/132703 (“Liu”) in view of US 5229797 A (“Futhey”) and US 2021/0173282 A1 (“Rosen”).
Regarding claim 8, Liu discloses an intraocular lens (IOL) (multifocal diffractive IOL 10, see Fig. 1), comprising:
a lens body having an anterior surface and a posterior surface (IOL include a lens having an anterior surface and a posterior surface, see [41]); and
a diffractive structure having a plurality of echelettes formed on at least one of the anterior surface and the posterior surface (at least one diffractive structure 12 includes a plurality of echelettes, and disposed on at least one of the anterior and posterior surface, see [41] and claims 1 and 4), wherein,
the diffractive structure is configured to provide a first focal point for distance vision (diffractive structure 12 includes a first focal point for distance vision, see [43] and Fig. 2), a second focal point for intermediate vision (at least one intermediate focal point is included for intermediate vision, see [43] and Fig. 2), and a third focal point for near vision for an incident light having a design wavelength (near focal point is included for near vision, where a design wavelength is used in defining the diffractive zone, see [43] and Fig. 2 for focal points and [45] for diffraction zone design).
Liu does not disclose a shift of the first focal point is less than 0.3 Diopter for an incident light having a wavelength that is different from the design wavelength, however Futhey discloses a similar multifocal diffractive ophthalmic lens, where the refractive and diffractive chromatic aberration at a selected focus can be minimized or essentially canceled out if equaled. Futhey teaches that the normal refractive chromatic aberration of the human eye is about 1 Diopter, while the diffractive chromatic aberration for a first order diffractive lens with 3 or 4 diopters of add power, is about -1 diopter, which results in a total chromatic aberration of essentially zero for the first order focus (see col. 2, lines 57-65). Futhey also connects the diffractive structure to a design wavelength, disclosing that the optical steps may have optical heights equal to 3λ/2 where λ is a design wavelength (see col. 3, lines 13-17).
Futhey teaches that the diffractive ophthalmic lenses may be designed so that the chromatic aberration focal shift at a selected focus is minimized or essentially canceled to be more stable, and the relevant diffractive step heights are chosen relative to a design wavelength.
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 IOL in Liu so that the first focal point for distance vision has a very small wavelength-dependent shift, or essentially canceled, as taught by Futhey, as applying that known design objective to reduce wavelength-dependent shift of the distance focus would have been obvious, with the exact residual shift value of less than 0.3 Diopter being a matter of routine optimization of known result-effective diffractive parameters.
Liu in view of Futhey does not disclose an incident light having a wavelength that is different from the design wavelength by between 40 and 70 nm, however, Rosen discloses an ophthalmic lens design with a design wavelength and further teaches additional visible wavelengths, including 455 nm, 505 nm, 575 nm and 665 nm (wavelength-dependent ophthalmic performance was evaluated at multiple visible wavelengths around a central design wavelength, including at least one wavelength offset falling within the 40-70 nm range from a 550 nm design wavelength), see [0052].
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 IOL of Liu in view of Futhey to include wavelength-based achromic optimization around a design wavelength as taught by Rosen. Doing so would improve focal stability for incident light near a design wavelength because minimizing chromatic aberration is a known goal in ophthalmic lens design. It would therefore have been obvious to modify Liu’s diffractive IOL using the known chromatic aberration minimization teachings of Futhey and the wavelength optimization framework of Rosen to achieve only a very small residual shift of the first focal point for nearby wavelengths, with the shift being less than 0.3 Diopter when the incident wavelength differs from the design wavelength by 40-70 nm, as a matter of routine optimization.
Regarding claim 9, Liu in view of Futhey and Rosen further discloses a surface profile of the diffractive structure that comprises (see Liu for diffractive zone 14 of the diffractive structure 12):
a base surface profile configured to diffract an incident light in one or more diffraction orders (base optic 16 includes diffraction zone 14 with different radial widths that control for additional powers while the step structure within each diffraction zone 14 controls the amount of light diffracted into each of the focal points, see Liu [42]); and
an achromatizing surface profile comprising increased step heights in the plurality of echelettes in relation to the base surface profile (vertical step structure within each diffraction zone 14 of diffractive structure 12, which includes a plurality of echelettes in relation to base optic 16 of Liu, see also step 2 and step 4 in Figs. 4 and 8), and a plurality of phase offsets in corresponding ones of the plurality of echelettes (echelette micro-structure of diffractive structure 12 has four step structure that produces a phase relationship for different focal points, see Liu [45] and Fig. 4).
Regarding claim 11, Liu in view of Futhey and Rosen further discloses that one or more diffraction orders provide distance vision, intermediate vision, and near vision (at least five focal points corresponding to diffractive orders (0th, 1st, 2nd, 3rd, 4th) allow for distance, near, and three stages of intermediate vision, see Liu [41]).
Regarding claim 12, Liu in view of Futhey and Rosen further discloses that the achromatizing surface profile shifts the one or more diffraction orders by two (effective diffractive orders are shifted from 0, +1, +2, +3, and +4 to −2, −1, 0, +1, and +2 diffraction orders, showing diffraction orders are shifted +2 order numbers for the corresponding focal points, see Liu [56] and Figs. 24 and 25) or four diffraction orders (energy producing diffraction orders are 0th, 1st, 2nd, 3rd, and 4th and the achromatizing versions use 4th, 5th, 6th, 7th, and 8th diffraction orders, which indicate each corresponding focal point shift upward by 4 diffraction orders in the achromatizing versions, see Liu [52]).
Regarding claim 13, Liu in view of Futhey and Rosen does not disclose that the achromatizing surface profile shifts the one or more diffraction orders by five diffraction orders; however, Liu in view of Futhey and Rosen discloses that the energy producing diffraction orders 0th, 1st, 2nd, 3rd, and 4th can be shifted to the achromatizing version with 4th, 5th, 6th, 7th, and 8th diffraction orders, which indicate each corresponding focal point shift upward by 4 diffraction orders in the achromatizing version (see Liu [52]).
Liu in view of Futhey and Rosen teaches that the conversion is done to reduce the chromatic aberration of the pseudophakic eye by a change of the energy producing diffraction orders (see Liu [52]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the shifting of the diffraction orders disclosed by Liu in view of Futhey and Rosen to have a shift by five diffraction orders, as the shifting of the diffraction order is recognized as a result-effective variable in order to reduce chromatic aberration for the best adapted IOL and vision needed by the patient. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum value involves only routine skill in the art (MPEP 2144.05).
Regarding claim 15, Liu in view of Futhey and Rosen further discloses one or more haptics coupled to the lens body (IOL 10 includes two haptics 18, see Liu Fig. 1).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/132703 (“Liu”) in view of US 5229797 A (“Futhey”) and US 20210173282 A1 (“Rosen”), and further in view of US 9,335,563 B2 (“Weeber”).
Regarding claim 10, Liu in view of Futhey and Rosen does not explicitly disclose that the increased step height is a non-integer multiple, however, Weeber further discloses at least one of the increased step heights is a non-integer multiple of a design wavelength (each echelette has varying step heights, at least one echelette having an optical path difference of 1.5 wavelengths, and the peripheral zone includes at least one echelette having an optical path difference of 1.366 wavelengths, which are non-integer multiples of wavelength, see col. 6, lines 23-28).
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 IOL in Liu in view of Futhey and Rosen to include a non-integer multiple of a design wavelength, as taught by Weeber, in order to tailor the phase delay and optimize distribution of light among diffraction orders.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/132703 (“Liu”) in view of (“Futhey”) and US 20210173282 A1 (“Rosen”), and further in view of US 2012/0143326 A1 (“Canovas Vidal”).
Regarding claim 14, Liu in view of Futhey and Rosen does not disclose that the lens body comprises of hydrophobic acrylic polymeric material; however, Canovas Vidal discloses a multifocal ophthalmic lens including a lens body that comprises of hydrophobic acrylic polymeric material (lens 20 may be constructed of polymethylmethacrylate (PMMA), which is a hydrophobic acrylic polymeric material, see [0048]).
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 lens body disclosed by Liu in view of Futhey and Rosen to comprise of hydrophobic acrylic polymeric material, as taught by Canovas Vidal, as it is a commonly used material for optics due to its biocompatible nature and is capable of deforming to be rolled, folded or otherwise deformed and inserted into the eye through a small incision (see [0049]).
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/132703 (“Liu”) in view of US 9,335,563 B2 (“Weeber”).
Regarding claim 16, Liu discloses an intraocular lens (IOL) (multifocal diffractive IOL 10, see Fig. 1), comprising:
a lens body having an anterior surface and a posterior surface (IOL include a lens having an anterior surface and a posterior surface, see [41] and claim 1); and
a diffractive structure having a plurality of echelettes located on at least one of the anterior surface or the posterior surface (at least one diffractive structure 12 disposed on either the anterior surface or posterior surface include a plurality of echelettes, see [41] and claim 1), wherein a surface profile of the diffractive structure comprises (diffractive zone 14 of the diffractive structure 12, see Fig. 1):
a base surface profile configured to diffract an incident light in one or more diffraction orders (base optic 16 includes diffraction zone 14 with different radial widths that control for additional powers while the step structure within each diffraction zone 14 controls the amount of light diffracted into each of the focal points, see [42]); and
an achromatizing surface profile comprising the plurality of echelettes with increased step heights in relation to the base surface profile (vertical step structure within each diffraction zone 14 of diffractive structure 12, which includes a plurality of echelettes in relation to base optic 16, see also step 2 and step 4 in Figs. 4 and 8).
Liu does not disclose that the increased step height is a non-integer multiple, however, Weeber further discloses at least one of the increased step heights is a non-integer multiple of a design wavelength (each echelette has varying step heights, at least one echelette having an optical path difference of 1.5 wavelengths, and the peripheral zone includes at least one echelette having an optical path difference of 1.366 wavelengths, which are non-integer multiples of wavelength, see col. 6, lines 23-28).
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 IOL in Liu to include a non-integer multiple of a design wavelength, as taught by Weeber, in order to tailor the phase delay and optimize the distribution of light among diffraction orders.
Regarding claim 17, Liu in view of Weeber further discloses that one or more diffraction orders provide distance vision, intermediate vision, and near vision (at least five focal points corresponding to diffractive orders (0th, 1st, 2nd, 3rd, 4th) allow for distance, near, and three stages of intermediate vision, see Liu [41]).
Regarding claim 18, Liu in view of Weeber further discloses that the achromatizing surface profile shifts the one or more diffraction orders by four diffraction orders (energy producing diffraction orders are 0th, 1st, 2nd, 3rd, and 4th and the achromatizing version use 4th, 5th, 6th, 7th, and 8th diffraction orders, where each corresponding focal point shift upward by 4 diffraction orders in the achromatizing version, see Liu [52]).
Regarding claim 19, Liu in view of Weeber does not disclose that the achromatizing surface profile shifts the one or more diffraction orders by five diffraction orders, however, Liu in view of Weeber discloses that the energy producing diffraction orders 0th, 1st, 2nd, 3rd, and 4th can be shifted to the achromatizing version with 4th, 5th, 6th, 7th, and 8th diffraction orders, where each corresponding focal point shift upward by 4 diffraction orders in the achromatizing version (see Liu [52]).
Liu in view of Weeber teaches that the conversion is done to reduce the chromatic aberration of the pseudophakic eye by a change of the energy producing diffraction orders (see Liu [52]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the shifting of the diffraction orders disclosed by Liu in view of Weeber to have a shift by five diffraction orders, as the shifting of the diffraction order is recognized as a result-effective variable in order to reduce chromatic aberration for the best adapted IOL and vision needed by the patient. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum value involves only routine skill in the art (MPEP 2144.05).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/132703 (“Liu”) in view of US 9,335,563 B2 (“Weeber”), and further in view of US 2012/0143326 A1 (“Canovas Vidal”).
Regarding claim 20, Liu in view of Weeber does not disclose that the lens body comprises of hydrophobic acrylic polymeric material; however, Canovas Vidal discloses a multifocal ophthalmic lens including a lens body that comprises of hydrophobic acrylic polymeric material (lens 20 may be constructed of polymethylmethacrylate (PMMA), which is a hydrophobic acrylic polymeric material, see [0048]).
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 lens body in Liu in view of Weeber to comprise of hydrophobic acrylic polymeric material, as taught by Canovas Vidal, as it is a commonly used material for optics due to its biocompatible nature and is capable of deforming to be rolled, folded or otherwise deformed and inserted into the eye through a small incision (see [0049]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHA UYEN C NGUYEN whose telephone number is (571)272-3399. The examiner can normally be reached Monday-Friday 8:30-5:30pm.
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/N.C.N./Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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