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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claims 1-20, the phrase "optionally" (used in multiple instances throughout the claims) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In particular, the phrase “based upon the optional auxiliary biometric information” is indefinite as it implies the information is not, in fact, optional.
Furthermore, limitations such as “scanning the eye of the patient in need of the intraocular lens implant surgery, using a noninvasive echo-locating instrument, optionally an optical coherence tomographic instrument including a whole eye optical coherence tomographic instrument, for obtaining nasal retina information about the eye, optionally the nasal retina information including, for all or part of a nasal retina, its dimensions, geometry, and/or positional location” are indefinite as it is unclear how much of the following language is considered optional and which features are considered requirements of the claim. Numerous instances of “optionally” are present, a thorough review and correction of the claims is required.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 12 recite the broad recitation recite the broad recitation “optionally obtaining auxiliary biometric information”, and the claim also recites “including one or any combination of photographic measurements . . . sectoral visual field information . . . and circumferential visual field information” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Numerous instances of broad/narrow ranges in the same claim are present, a thorough review and correction of the claims is required.
Claims 1 and 12 further state “using a noninvasive echo-locating instrument”, and the claim also recites “an optional coherence tomographic instrument,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-7, 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Erie et al. (Pub. No.: US 2021/0169639) in view of Giraudet et al. (Pub. No.: US 2024/0302677).
Erie et al. discloses a process for reducing a likelihood of dysphotopsia occurring as a result of intraocular lens implant surgery upon a patient in need of such intraocular lens implant surgery (abstract), the process comprising the steps of:
b) scanning the eye of the patient in need of the intraocular lens implant surgery, using a noninvasive echo-locating instrument (not disclosed), for obtaining nasal retina information about the eye (not disclosed),
c) based upon the
As provided in italicized text above, Erie lacks the step of scanning the eye using a non-invasive echo-locating instrument for obtaining nasal retina information about the eye. Giraudet et al. (hereinafter, Giraudet) teaches scanning the retina using Optical Coherence Tomography (OCT) in order to provide appropriate vision correction lenses (e.g., para. 183, 222). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provide Erie with the step of scanning the eye for obtaining nasal retina information as taught by Giraudet for the purpose of providing anatomical information in order to provide accurate dysphotopsia correction. This modification would have occurred using known methods and would have yielded predictable results.
For Claim 2, Giraudet teaches the process of claim 1, using OCT. It would have been obvious to have provided this optical coherence tomographic instrument as a handheld device, and the scanning is performed at a location of the intraocular lens implant surgery and during a same patient visit as the intraocular lens implant surgery as an obvious expedient.
For claim 3, Erie discloses the process of claim 2, wherein the intraocular lens implant surgery includes removal of a cataract (abstract).
For claim 4, Giraudet teaches the process of claim 3, wherein the nasal retina information includes an anatomic location of the nasal retina, relative to one or more anterior segment structures (e.g., para. 178-179)
For claim 5, Erie discloses the process of claim 4, wherein the at least one prophylactic measure for reducing the likelihood of dysphotopsia includes inserting into the eye an intraocular lens implant having an edge structure dimensioned and configured for blocking passage of light in a gap located between an anterior surface of the intraocular lens implant and either or both of a posterior surface of an iris of the eye or an internal surface of a contiguous ciliary body of the eye; and/or placing a mask within a capsular bag and/or a ciliary sulcus of the eye (e.g., fig. 10-11, para. 23).
For claim 6, Erie discloses the process of claim 4, wherein the at least one prophylactic measure for reducing the likelihood of dysphotopsia includes inserting into the eye an ophthalmic prosthetic dimensioned and configured for blocking passage of light in a gap located between an anterior surface of the intraocular lens implant and either or both of a posterior surface of an iris of the eye or an internal surface of a contiguous ciliary body of the eye (e.g., fig. 10-11, para. 23).
For claim 7, Erie discloses the process of claim 4, wherein the at least one prophylactic measure for reducing the likelihood of dysphotopsia includes inserting into the eye an ophthalmic prosthetic dimensioned and configured for blocking passage of light in a gap located between an anterior surface of the intraocular implant lens, and either or both of a posterior surface of an iris of the eye or an internal surface of a contiguous ciliary body of the eye, and the ophthalmic prosthetic is characterized by one or any combination of the following: (a) it is opaque, partially opaque, translucent, polarized, frosted, or any combination thereof; (b) a thickness of the ophthalmic prosthetic is from about 0.01 mm to about 1.2 mm; (c) the ophthalmic prosthetic has an annular sector, which optionally is configured to locate in a nasal hemisphere of the eye, a temporal hemisphere of the eye, or both; (d) the ophthalmic prosthetic is annular and includes a centrally positioned though-hole opening; (e) the ophthalmic prosthetic has a centrally positioned though- hole opening with a diameter of about 1.5 mm to 6 mm; (f) at least a portion of the ophthalmic prosthetic has been treated to modify a surface property of the ophthalmic prosthetic (g) over at least a portion of the ophthalmic prosthetic it is flexible, foldable, compressible, dehydratable, rehydratable, or any combination thereof; (h) the ophthalmic prosthetic includes one or more haptics, which are configured to prevent the ophthalmic prosthetic from moving or rotating within the eye, and the one or more haptics are elongate projections that extend radially from an outer perimeter of the ophthalmic prosthetic (e.g., fig. 4-5).
For claim 12, Erie discloses a process for correcting dysphotopsia occurring as a result of intraocular lens implant surgery upon a patient in need of such intraocular lens implant surgery (abstract), the process comprising the steps of:
b) scanning the eye of the patient in need of the intraocular lens implant surgery, using a noninvasive echo-locating instrument (not disclosed), ), for obtaining nasal retina information about the eye (not disclosed),
c) based upon the
As provided in italicized text above, Erie lacks the step of scanning the eye using a non-invasive echo-locating instrument for obtaining nasal retina information about the eye. Giraudet et al. (hereinafter, Giraudet) teaches scanning the retina using Optical Coherence Tomography (OCT) in order to provide appropriate vision correction lenses (e.g., para. 183, 222). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provide Erie with the step of scanning the eye for obtaining nasal retina information as taught by Giraudet for the purpose of providing anatomical information in order to provide accurate dysphotopsia correction. This modification would have occurred using known methods and would have yielded predictable results.
For claim 13, Giraudet teaches he process of claim 12, using OCT. It would have been obvious to have provided this optical coherence tomographic instrument as a handheld device, and the scanning is performed at a location of the intraocular lens implant surgery and during a same patient visit as the intraocular lens implant surgery as an obvious expedient.
For claim 14, Erie discloses the process of claim 13, wherein the intraocular lens implant surgery includes removal of a cataract (abstract).
For claim 15, Giraudet teaches the process of claim 14, wherein the nasal retina information includes an anatomic location of the nasal retina, relative to one or more anterior segment structures (e.g., para. 178-179).
For claim 16, Erie discloses the process of claim 15, wherein the at least one corrective measure for reducing the likelihood of dysphotopsia includes inserting into the eye an intraocular lens implant having an edge structure dimensioned and configured for blocking passage of light in a gap located between an anterior surface of the intraocular lens implant and either or both of a posterior surface of an iris of the eye or an internal surface of a contiguous ciliary body of the eye; and/or placing a mask within a capsular bag and/or a ciliary sulcus of the eye (e.g., fig. 10-11, para. 23).
For claim 17, Erie discloses the process of claim 15, wherein the at least one corrective measure for reducing the likelihood of dysphotopsia includes inserting into the eye an ophthalmic prosthetic dimensioned and configured for blocking passage of light in a gap located between an anterior surface of the intraocular lens implant and either or both of a posterior surface of an iris of the eye or an internal surface of a contiguous ciliary body of the eye (e.g., fig. 10-11, para. 23).
For claim 18, Erie discloses the process of claim 15, wherein the at least one corrective measure for reducing the likelihood of dysphotopsia includes inserting into the eye an ophthalmic prosthetic dimensioned and configured for blocking passage of light in a gap located between an anterior surface of the intraocular implant lens, and either or both of a posterior surface of an iris of the eye or an internal surface of a contiguous ciliary body of the eye, and the ophthalmic prosthetic is characterized by one or any combination of the following: (a) it is opaque, partially opaque, translucent, polarized, frosted, or any combination thereof; (b) a thickness of the ophthalmic prosthetic is from about 0.01 mm to about 1.2 mm; (c) the ophthalmic prosthetic has an annular sector, which optionally is configured to locate in a nasal hemisphere of the eye, a temporal hemisphere of the eye, or both; (d) the ophthalmic prosthetic is annular and includes a centrally positioned though-hole opening; (e) the ophthalmic prosthetic has a centrally positioned though- hole opening with a diameter of about 1.5 mm to 6 mm; (f) at least a portion of the ophthalmic prosthetichas been treated to modify a surface property of the ophthalmic prosthetic (g) over at least a portion of the ophthalmic prosthetic it is flexible, foldable, compressible, dehydratable, rehydratable, or any combination thereof; (h) the ophthalmic prosthetic includes one or more haptics, which are configured to prevent the ophthalmic prosthetic from moving or rotating within the eye, and the one or more haptics are elongate projections that extend radially from an outer perimeter of the ophthalmic prosthetic (e.g., fig. 4-5).
Claims 1-7, 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Erie et al. (Pub. No.: US 2021/0169639) in view of Giraudet et al. (Pub. No.: US 2024/0302677) in view of Masket (U.S. Pat. No.: 8,652,206).
For claims 8 and 19, Erie discloses forming an incision in a cornea of the eye, inserting the ophthalmic prosthetic into the eye through the incision, however, Erie does not disclose locating the ophthalmic prosthetic between the iris and an intraocular lens implant. Masket teaches the “piggyback method” includes a previously implanted IOL and a second later-positioned IOL for correcting negative dysphotopsia (col. 2 lines 31-41). Therefore it would have been obvious to place the Erie IOL between the iris an a previously implanted IOL for the purpose of proving a piggyback style correction for negative dysphotopsia.
Claims 9-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Erie et al. (Pub. No.: US 2021/0169639) in view of Giraudet et al. (Pub. No.: US 2024/0302677), further in view of Patton (U.S. Pat. No.: 12,465,436).
Erie and Giraudet lack computer generated recommendations. Patton teaches use of a computerized treatment database and algorithm system to provide interactive models of the eye and provide an optimized treatment plan, including the dimensions of the eye and an implant (col. 11, lines 21-42). It would have been obvious to have provided computer generated recommendation and the structure of the eye together with the nasal retina information of Erie and Giraudet as an efficient mechanism of providing standardized treatment. This modification would have occurred using known methods and would have yielded predictable results.
For claim 10, Patton teaches the process of claim 9, wherein the computer-generated recommendation is derived by a processor executing computer executable instructions programmed on a non-transitory storage medium to perform training of a computational model with a machine learning algorithm (e.g., col. 19 lines 4-25).
For claim 11, Patton teaches The process of claim 10, wherein the machine learning algorithm includes an artificial neural network (e.g., col. 16, lines 3-12),
For claim 20, Patton teaches the process of claim 1, wherein the step of employing the at least one corrective measure is based upon a computer generated recommendation that is based upon a combination of the nasal retina information about the eye and one or more of (a) a structure (optionally a peripheral edge structure), material, location in eye, and/or dimensions, of any implant including an intraocular lens or an ophthalmic prosthetic to be inserted into the eye; (b) demographic information about the patient; (c) a personality profile of the patient; and (d) data from past or ongoing studies about similar procedures performed upon different patients in need than the patient in need (Erie and Giraudet lack computer generated recommendations. Patton teaches use of a computerized treatment database and algorithm system to provide interactive models of the eye and provide an optimized treatment plan, including the dimensions of the eye and an implant (col. 11, lines 21-42). It would have been obvious to have provided computer generated recommendation and the structure of the eye together with the nasal retina information of Erie and Giraudet as an efficient mechanism of providing standardized treatment. This modification would have occurred using known methods and would have yielded predictable results);
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774