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 .
Response to Amendment
Receipt is acknowledged of the amendment filed 12/23/2025. Claims 47-48 and 51 are amended, claims 49-50, 55, 57, 60, 63, and 65-66 are canceled, and claims 47-48,51-54,56,58-59, 61-62, and 64 are currently pending.
Election/Restrictions
Claims 52-54, 56, 58-59, 61-62, and 64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. The election was improper as it did not address the requirement to elect between species. Upon further consideration, this requirement to elect between species has been withdrawn. Election was made without traverse in the reply filed on 12/23/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/11/23 and 12/19/23 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
Regarding claims 47-48 and 51, a claimed apparatus must be distinguished from the prior art apparatus on the basis of structure. Therefore, the patentability of an apparatus claim depends only on the claimed structure, not on the use or the purpose of that structure, Catalina Marketing Int’l., Inc. v. Coolsavings.com Inc., 289 F.3d 801, 809 (Fed. Cir. 2002), or the function or result of that structure. See In re Schrieber, 128 F.3d 1473, 1477 (Fed. Cir. 1997); In re Gardiner, 171.F2d 313, 315-16 (CCPA 1948).
Language in an apparatus claim directed to the function, operation, intent of use, and materials upon which these apparatus components work that does not structurally limit the apparatus components or patentably differentiate the claimed apparatus from an otherwise identical prior art apparatus will not support patentability. See, e.g. In re Rishoi, 107 F.2d 342, 344-45 (CCPA 1952); In re Otto, 312 F.2d 937, 940 (CCPA 1963); In re Ludtke, 441 F.2d 660,663-64 (CCPA 1971); In re Yanush, 477 F.2d 958, 959 (CCPA 1973).
Limitations regarding determination of a difference between first and second myopia controlling powers and lenses “capable to control anisometropia to bring the first and second eyes to the desired amount of anisometropia” are directed to intended use, function, and/or operation of the “lens system” in claim 47. Therefore, the limitation has been considered, but has not been given patentable weight.
Even if the limitation were given patentable weight, the limitation does not structurally limit the claim. Since the applied reference(s) teach all of the structural limitations of the claim, the reference(s) is presumed to be capable of the intended use, function, and/or operation.
The burden shifts to the Applicant to rebut the presumption that the structure of the applied reference(s) is not capable of the intended use, function, and/or operation.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “optical feature creating peripheral blur, optical feature affecting chromatic aberrations, optical feature creating visual cues or optical feature reducing retinal image contrast” must be shown or the feature(s) canceled from the claim(s). Examiner notes that ordinary lenses with different refractive powers in different regions are often depicted as Applicant’s Fig. 1 and thus that specie is considered to be shown in the drawing. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 48 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.
Claim 48 recites “the at least one myopia controlling parameter comprises at least one of a myopic peripheral defocus parameter with additional peripheral power, optical feature creating peripheral blur, optical feature affecting chromatic aberrations, optical feature creating visual cues or optical feature reducing retinal image contrast” in the context of the Claim 47 recitation “a difference between the first and second myopia controlling powers is determined in accordance with a desired amount of anisometropia to be obtained and to be lower than said existing amount of anisometropia defined by a difference between the first and second individual prescription powers of the first and second eyes, thereby providing that the optical property profiles of the first and second lenses in combination are capable to control anisometropia to bring the first and second eyes to the desired amount of anisometropia”. While Applicant has evidenced possession of a myopia controlling parameter embodied as “a myopic peripheral defocus parameter with additional peripheral power”, the disclosure does not provide in sufficient detail evidence of the remaining claimed embodiments of a myopia controlling parameter. For example, there is no description of an “optical feature creating peripheral blur” and thus no evidence that Applicant possessed the claimed genus at the time of invention.
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 47-48 and 51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 47 does not clearly limit the metes and bounds of the lens system between the various optional species implicitly and explicitly recited. At issue is whether the structure of the first and second lenses necessarily “control” myopia. Claim 47 recites “the first and second lenses are characterized by first and second given individual prescriptions for the first and second eyes” and “the first lens has an optical property profile defining a central optical zone first given individual prescription power of a corresponding the first eye and has a peripheral zone configured to provide a myopia controlling parameter with a first myopia controlling power” and “the second lens has an optical property profile defining one of the following (i) a central optical zone having second given individual prescription power and a peripheral zone being configured to provide a myopia controlling parameter with a second selected myopia controlling power lower than said first selected myopia controlling power; or (ii) a single vision optical property profile having the second given individual prescription and no myopia controlling parameter and no myopia controlling power”. In the Specifications, Applicant states “[e]ach myopia controlling parameter may be characterized by its myopia controlling power that may vary between 0 (no myopia controlling power, e.g., a regular single vision lens) to 1 (maximum possible myopia controlling power), depending on the specific implementation of the selected myopia controlling parameter” ([0018]). In light of the Specifications, a structure defined by a myopia controlling power may not exhibit myopia control as the “power” or “parameter” may be zero. Claim language defining the structure of the lenses as having a first myopia controlling power and a second myopia controlling power does not require a structure capable of myopia control. Therefore the metes and bounds of the claim include one or more lenses functioning to control myopia and one or more lenses that do not function to control myopia though are claimed to be defined for an individual with anisometropia. Dependent claims 48 and 51 are rejected as failing to cure the deficiencies of the base claim.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “power” in claim 47 is used by the claim to mean “parameter,” while the accepted meaning is “the degree to which a lens, mirror, or other optical system converges or diverges light.” The term is indefinite because the specification does not clearly redefine the term. Further, Claim 48 appears to use “power” in further defining the myopia controlling parameter when reciting “additional peripheral power”. Dependent claims 48 and 51 are rejected as failing to cure the deficiencies of the base claim.
Claim 51 recites “the myopia controlling parameter of the first lens is configured to fit a stronger additional peripheral power as compared to the second eye”. The metes and bounds of a parameter configured to fit an optical power to an eye is unclear and preempts examination on the merits. Examiner believes the intent may simply to be to limit the first myopia controlling power and the second myopia controlling power of the lens system of Claim 47 to be respective additional optical powers and for the additional optical power of the first myopia controlling power to be greater than the additional optical power of the second myopia controlling power. As it is worded, the claim introduces “fit” though it is unclear whether this is a fitting step associated with lens design or a fitting step associated with wearing the lens and the claimed “additional peripheral power” is compared to the second eye and not compared to another lens or lens region.
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.
Claims 47-48 and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US PG Pub. 2017/0336653 to Bakaraju (hereinafter Bakaraju), properly incorporating US Pat. 7,025,460 to Smith et al. (hereinafter Smith).
Regarding claim 47, Bakaraju discloses a lens system (Fig. 2A) for an individual with anisometropia, the lens system comprising first and second lenses (Fig. 2A; [0031]-[0035]),being spectacles or contact lenses, for first and second eyes of the individual, wherein the first and second lenses are characterized by first and second given individual prescriptions for the first and second eyes (“a pair of lenses of a given prescription is to be worn for a prescribed time period”), defining an existing amount of anisometropia (“where “1L” refers to the first prescription for the left eye, and “1R” refers to the first prescription for the right eye”); the first lens has an optical property profile defining a central optical zone first given individual prescription power of a corresponding the first eye and has a peripheral zone configured to provide a myopia controlling parameter with a first myopia controlling power (“the first lens for the right eye and the second lens for the left eye may be configured to provide peripheral image points that are not focused on the retinas of the right and the left eyes in peripheral region outside the foveas of the right and left eyes, such that image points are disposed predetermined distances away from the retina and suitable lenses of this type may be configured as disclosed, for example, in U.S. Pat. No. 7,025,460” in [0031]-[0035] and disclosed in Smith in col. 21, ln. 32-col. 22, ln. 2); the second lens has an optical property profile defining one of the following (i) a central optical zone having second given individual prescription power and a peripheral zone being configured to provide a myopia controlling parameter with a second selected myopia controlling power lower than said first selected myopia controlling power (“the individual may initially alternate between wearing a first pair of lenses and wearing a second pair of lenses of the first set such that in both pairs of lenses a left lens may be used in proximity to a left eye to achieve emmetropia in the left eye while the right lens used in proximity of the right eye may affect the right eye to change shape over time in a manner that may inhibit myopia progression of the right eye”; [0034]); or (ii) a single vision optical property profile having the second given individual prescription and no myopia controlling parameter and no myopia controlling power (“the individual may initially alternate between wearing a first pair of lenses and wearing a second pair of lenses of the first set such that in both pairs of lenses a left lens may be used in proximity to a left eye to achieve emmetropia in the left eye while the right lens used in proximity of the right eye may affect the right eye to change shape over time in a manner that may inhibit myopia progression of the right eye”); a difference between the first and second myopia controlling powers is determined in accordance with a desired amount of anisometropia to be obtained and to be lower than said existing amount of anisometropia defined by a difference between the first and second individual prescription powers of the first and second eyes, thereby providing that the optical property profiles of the first and second lenses in combination are capable to control anisometropia to bring the first and second eyes to the desired amount of anisometropia ([0032]-[0035] and Smith).
Regarding claim 48, Bakaraju discloses the at least one myopia controlling parameter comprises at least one of a myopic peripheral defocus parameter with additional peripheral power ([0031]-[0035] and Smith col. 21, ln. 32-col. 22, ln. 2), optical feature creating peripheral blur, optical feature affecting chromatic aberrations, optical feature creating visual cues or optical feature reducing retinal image contrast.
Regarding claim 51, Bakaraju discloses the myopia controlling parameter of the first lens is configured to fit a stronger additional peripheral power as compared to the second eye and the myopia controlling parameter of the second lens unit is configured to have a reduced additional peripheral power as compared to the first eye ([0031]-[0035] and Smith col. 21, ln. 32-col. 22, ln. 2).
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat. 8,899,746 to Back discloses a lens set to prevent or slow myopia progression using annular, peripheral defocus elements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J STANFORD whose telephone number is (571)270-3337. The examiner can normally be reached 8AM-4PM PST M-F.
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/CHRISTOPHER STANFORD/ Primary Examiner, Art Unit 2872