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 1/20/2026. Claims 1 and 4 are amended and claims 1-2, 4, 6-11, 13-16, and 18-21 are currently pending.
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 1-2, 4, 6-11, 13-16, and 18-21 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 1 has been amended to recite “the contact lens is providing visible light transmittance that is within at least 80% of the visible light transmittance provided by a conventional single vision contact lens that is free of the non-circular non-transparent aperture stop”. The disclosure is silent as to the methodology of determining the claimed transmittance and thus a person having ordinary skill in the art would not understand the metes and bounds of the invention. While the Specifications provides in haec verba support for this claim limitation, there is no description of the manner by which one determines transmittance of the contact lens. The primary point of confusion arises from there being no description of the extent to which transmittance corresponds to the contact lens. There are mutually exclusive interpretations of “providing visible light transmittance that is within at least 80%“, including at least the following: (1) transmittance across the entire contact lens surface is at least 80% of at least a portion of a conventional contact lens, (2) transmittance through the claimed non-transparent region is at least 80% of at least a portion of a conventional contact lens, (3) transmittance through the claimed transparent region is at least 80% of at least a portion of a conventional contact lens, (4) transmittance through an arbitrary portion of the contact lens (e.g. both transparent and non-transparent regions) is at least 80% of at least a portion of a conventional contact lens. A last possible embodiment relates to the inventive concept that the geometry of the non-transmitting region and the geometry of the transmitting region are essential to preventing the development of myopia. For dimensions of these regions on the order of the wearer’s pupil diameter, transmittance through the claimed contact lens may be relative to the light passing into the wearer’s pupil. In this case, the surface through which relative transmittance is measured is bound by an area, albeit varied by ocular muscles, defined by the wearer’s eye.
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Further, the mutually exclusive interpretations of the claimed transmittance are limited relative to an unknown and unknowable reference (i.e. “conventional single vision contact lens”). In the cited publication “Changes in UV-Visible Transmittance of Silicone-Hydrogel Contact Lenses Induced by Wear”, clear contact lens transmittance in the visible spectrum is approximately at least 80%. In US Pat. 5,905,561 an apodized mask transmittance varies from 100% to 0% continuously. There is no manner by which a person having ordinary skill in the art would understand “conventional single vision contact lens” to define a clear reference by which to measure the claimed transmittance and thus metes and bounds are indefinite and infringement would not be clear. For the purposes of examination, the claim will be interpreted as requiring at least a portion of the contact lens to exhibit transmittance of at least 80% of the transmittance through the same lens without a non-transparent region. In other words, the limitation does not further limit the apparatus as an arbitrary region in the transparent region may be selected for determining transmittance and is necessarily defined to be 100% relative to that region without a non-transparent region integrated within the same lens. Dependent claims fail to remedy the deficiencies of the base claim.
Claim Rejections - 35 USC § 103
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 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 1-2, 4-11, 13-16, 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over US PG Pub. 2018/0095296 to Lin et al. (hereinafter Lin; previously cited).
Regarding claim 1, Lin discloses a contact lens for a myopic eye, the contact lens comprising of an optical zone with an optical center (optical axis “O”, Fig. 7; [0069]-[0072]), and a non-optical peripheral zone (e.g. proximal to a light-blocking annular region 520, Fig. 7 and 8-10; [0069]-[0086]); the optical zone comprising: a transparent region with a single vision power profile (e.g. within an inner edge 520A of the light-blocking annular region 520, Fig. 7 and 8-10; [0069]-[0086]); a non-circular non-transparent region (e.g. a light-blocking annular region 520, Fig. 7 and 8-10; [0069]-[0086]) circumscribing the transparent region configured to form an aperture stop of the contact lens (Fig. 7); wherein the contact lens when characterized by testing on a model eye configured with a distance refractive error matching the single vision power profile provides a retinal image, for at least one pupil diameter between 3 mm and 6 mm inclusive, for at least one wavelength 420 nm to 760 nm inclusive, and for at least a wide field angle at the retina ([0006]-[0010],[0036],[0044]); wherein the retinal image when further characterized using a power spectrum Fourier transform analysis results in a spectral signature of the retinal image; wherein the aperture stop of the contact lens is capable of, at least in part, redistributing the incoming light energy entering the model eye into a plurality of oblique spatial frequencies of the spectral signature (polygons, Fig. 7-10; [0069]-[0086]); wherein the spectral signature is different to that obtained when a single vision contact lens with the single vision power profile configured free of the aperture stop is tested on the model eye under similar conditions; and wherein the spectral signature of the retinal image mimics a spectral signature obtained by a power spectrum Fourier transform analysis of a natural scene (polygons, Fig. 7-10; [0069]-[0086]); wherein the natural scene includes a forest scene, a mountain scene, a field scene, a beach scene, a coast scene, a river scene, or a waterfall scene, wherein the contact lens is providing visible light transmittance that is within at least 80% of the visible light transmittance provided by a conventional single vision contact lens that is free of the non-circular non-transparent aperture stop (CDmin = 9.00mm, CDmax = 12.50mm, D = 14.00mm in Table 9 and Tavg of region 520 = 15% in Table 10). The geometric relationship between the light-blocking annular region 520 and the light transmitting portions of the lens in Fig. 7 stems from the Table 9 values and is 63.6% by area. The Tavg value of 15% means that only 63.6% of the transmittance is reduced by 15% and the transmittance of the Fig. 7 lens with the light--blocking region 520 relative to a Fig. 7 lens without the light-blocking region 520.
Regarding claim 2, Lin discloses the model eye is a schematic, physical or a bench-top model eye (Figs. 7-10). This language does not further limit the structure of the apparatus as the testing methodology does not structurally distinguish an apparatus capable of being so-tested.
Regarding claim 4, Lin discloses wherein the non-circular non- transparent region is at least 1 square millimetre (e.g. CDmin = 9.00mm in Fig. 7, Table 9; CDmin = 7.50mm in Fig. 8, Table 11; CDmin = 4.50mm in Fig. 9, Table 13; CDmin = 5.50mm in Fig. 10, Table 15, Table 9; [0069]-[0086]). See discussion above regarding aperture scaling.
Regarding claim 5, Lin discloses the non-circular non- transparent region is shaped like a regular polygon with more than 3 sides and no greater than 12 sides (Figs. 7-10).
Regarding claim 6, Lin discloses the non-circular non- transparent region is not shaped like rectangle, square or a rhombus (Fig. 10).
Regarding claim 7, Lin discloses the transparent region includes spherical or astigmatic powers (“the optical region is a region corresponding to the range of the base curve of the contact lens, i.e., the region having refractive power”; [0104]).
Regarding claim 8, Lin discloses the transparent region includes positive or negative spherical aberration (“the optical region is a region corresponding to the range of the base curve of the contact lens, i.e., the region having refractive power”; [0104]).
Regarding claim 9, Lin discloses the non-circular non- transparent region is translucent, partially opaque, or opaque (“an average transmittance of visible light (400 nm-700 nm) of the light-blocking annular region 12 is Tavg, the following condition is satisfied: 0%<Tavg≦60%”).
Regarding claim 10, Lin discloses the non-circular non- transparent region is decentred with respect to the optical centre of the contact lens (“the light-blocking annular region 12 and the optical to region 11 can be concentric. Alternatively, the light-blocking annular region 12 and the optical region 11 can share different center.”).
Regarding claim 11, Lin discloses the non-circular non- transparent region is configured such that its diameter is larger than the physiological pupil of the myopic eye, measured in a scotopic or a dim light condition (Figs. 7-10 & Tables 9, 11, 13, 15).
Regarding claim 13, Lin discloses the spectral signature of the retinal image different from a spectral signature obtained by a power spectrum Fourier transform analysis of a man-made scene; wherein the man-made scene includes an indoor scene, a street scene, a high-building scene, a city-view scene, a highway scene, an office scene, or a portrait scene (Figs. 7-10; [0069]-[0086]).
Regarding claim 14, Lin discloses the spectral signature of the retinal image provides an optical stop signal to slow the progression of the myopic eye (Figs. 7-10; [0044], [0069]-[0086]).
Regarding claim 15, Lin discloses the contact lens is capable of providing the wearer with adequate visual field that is indistinguishable from a conventional single vision contact lens that is free of the non-circular non-transparent aperture stop (CDmin of Tables 9, 11, 13, 14; [0044], [0069]-[0086]).
Regarding claim 16, Lin discloses the contact lens is capable of providing the wearer with adequate visual performance that is indistinguishable from a conventional single vision contact lens that is free of the non- circular non-transparent aperture stop (Table 9-10 shows a construction meeting the requirements on account that Applicant’s lower transmittance would provide the claimed visual performance).
Regarding claim 18, Lin discloses the retinal image resulting in the spectral signature includes at least two pupil diameters between 3 mm to 6 mm, inclusive ([0069]-[0086]). This language does not further limit the structure of the apparatus as the testing methodology does not structurally distinguish an apparatus capable of being so-tested.
Regarding claim 19, Lin discloses the retinal image resulting in the spectral signature includes at least two visible light wavelengths between 460 rnm to 760 am, inclusive ([0069]-[0086]). This language does not further limit the structure of the apparatus as the testing methodology does not structurally distinguish an apparatus capable of being so-tested.
Regarding claim 20, Lin discloses the wide-field angle for deriving the retinal image resulting in the spectral signature includes at least 15 degrees field angle ([0069]-[0086]). This language does not further limit the structure of the apparatus as the testing methodology does not structurally distinguish an apparatus capable of being so-tested.
Regarding claim 21, Lin discloses the spectral signature represents at least 60% of the energy captured within the power spectrum Fourier transform analysis (Figs. 7-10; Tables 9, 11, 13, 15; [0069]-[0086]). This language does not further limit the structure of the apparatus as the testing methodology does not structurally distinguish an apparatus capable of being so-tested.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive.
On page 1 of the Remarks, Applicant argues “Lin does not mention the pupil diameter” and “Lin fails to disclose the limitation “wherein the contact lens when characterised by testing on a model eye configured with a distance refractive error matching the single vision power profile provides a retinal image, for at least one pupil diameter between 3 mm and 6 mm inclusive, for at least one wavelength 420 nm to 760 nm inclusive, and for at least a wide field angle at the retina”. Examiner respectfully disagrees as the claimed apparatus does not incorporate the pupil as a structural element, but rather limits the apparatus as functionally related to the pupil. 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). In this instance, the manner by which a lens is tested does not limit the lens structure distinctly from a lens that is not tested as claimed. The physical parameters of the lens disclosed by Lin (e.g. shapes, opacity, etc.) anticipate the claimed structure in light of the functional language limiting the testing with a particular pupil.
On page 13 of the Remarks, Applicant argues “Lin’s disclosure describes a contact lens with an annular(ring-like shaped) region … that blocks of reduces the transmission of visible light” and “[t]his is different from the limitation ‘redistributing the incoming light energy entering the model eye into a plurality of oblique spatial frequencies of the spectral signature’”. Examiner agrees with these statements. Applicant further agues that Lin fails to disclose the limitations related to the retinal image and spectral signature. Examiner respectfully disagrees with this argument. As stated above in response to the arguments concerning the testing on a pupil, the limitations related to the retinal image and spectral signature are functional limitations on the apparatus. The Lin Fig. 7 lens with the decagonal aperture is inherently capable of performing the claimed function despite Lin’s aim to provide the lens to wearers for different reasons. Further, Lin discloses that an additional benefit to the lens having an aperture would be “slowing down the development of myopia” ([0044]). The claims are not directed to a method of preventing myopia or other vision correction therapy. A structurally identical contact lens anticipates the claimed structure and is presumed capable of performing the same functions. There is no rebuttal that the structure of the Lin Fig. 7 contact lens is capable of performing the claimed functions.
On page 14, Applicant argues that the Lin teaching of Tavg is “different from visible light transmittance of the contact lens of claim 1”. Examiner respectfully disagrees. This is primarily addressed in the 35 U.S.C. 112(b) rejection above and also in the 35 U.S.C. 102 rejection with reworded grounds for rejection. In summary, the claim does not specifically limit transmittance through the whole of the contact lens as there is no clear boundary on the correspondence between transmittance and a contact lens surface. As the contact lenses at issue have regions of more or less transparency, it is important to limit the scope of the measure to a particular region of the lens. The rejection in view of Lin above demonstrates that transmittance through the entire lens also meets the claim requirement of “at least 80%” as the light-blocking region 520 is only about 64% of the surface area and exhibits a transmittance of 15%.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached at (571)272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER STANFORD/Primary Examiner, Art Unit 2872