DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/15/2025 has been entered.
Response to Arguments
3. Applicant’s arguments with respect to claims 1, 2, 5-9 and 11, 12, and 14-20 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that Claims 3, 4, and 13 have been cancelled.
Claim Rejections - 35 USC § 112
4. Claims 1, 13, 15, and 16 were previously rejected under 35 U.S.C. 112(b) as being indefinite. Presently, Claims 1, 13, 15, and 16 been amended or cancelled to resolve the indefiniteness issues. Therefore, theses rejections have been withdrawn.
Claim Objections
5. Claim 1 is objected to because of the following informalities: in lines 9-10, the amended claim recites “the scattering layer is disposed on the outer surface of the corneal contact portion”. Assuming this language was meant to imitate the language previously present in Claim 3 (see Claim 3, filed on 01/22/2025), then it is assumed that “the outer surface” is meant to recite “an outer surface”). Appropriate correction is required.
Claim Rejections - 35 USC § 103
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claims 1, 2, 8-9, 12, 14, 15, and 17 rejected under 35 U.S.C. 103 as being unpatentable over Karakaya U.S. 2018/0235456 (herein referred to as “Karakaya”), and in view of Tai U.S. 2019/0232078 (herein referred to as “Tai”) and Lopath U.S. 2017/0367879 (herein referred to as “Lopath”).
8. Regarding Claim 1, Karakaya teaches a light source-integrated contact lens for electroretinography (see at least Figs. 10, 12, 14) comprising:
a. a light source as a single element or plural elements (Figs. 10, 12, and 14, ref num 30; para 0141, “illumination means 30 may consist of a LED or an array of LEDs”);
b. a scattering layer (Fig. 14, ref num 51);
c. a corneal contact portion (Figs. 10, 12, and 14, ref num 12) that is to be in contact with a corneal surface of an eyeball (Fig. 10, ref num 18 represents the eyelid, therefore, structures 12, 30, 32, and sometimes 20, are in contact with the cornea of the eyeball; para 0118, “the components of the device 10d that in direct contact with the eye”);
d. and a corneal contact electrode disposed on an inner surface of the corneal contact portion (Fig. 10, ref num 20 is on the inner surface of the device that contacts the cornea);
e. wherein the scattering layer is the corneal contact portion itself, or the scattering layer is disposed on an outer surface of the corneal contact portion (Fig. 14, ref num 51 is integrated into corneal contact portion; also see para 0163 and para 0039, “a filter may either be included in the transparent carrier or in the photosensor itself”; see Figs. 10-12, photosensor 20 may be located on an outer surface of the corneal contact portion, i.e., ref num 12),
f. wherein the scattering layer comprises a scattering material that scatters light from the light source (para 0163; also see para 0039, 0158),
g. wherein the light source is disposed at the scattering layer (Fig. 14, ref num 30 is disposed at ref num 51; see circumferential layers), and
i. wherein the light source as the single element is disposed at a position corresponding to a center point of the corneal contact portion in the case where the light source is the single element, and the light source as the plural elements has the plural elements arranged at the same distance and angle around the center point of the corneal contact portion (see Figs. 10, 12, and 14, ref num 30 is disposed at a center point on ref num 12).
Karakaya also teaches the light source (ref num 30) may be a LED (para 0047, 0141) that emits light at a single wavelength, or one particular color, in the visible spectrum (para 0048, “the illumination means is configured to emit light…at a wavelength in the visible spectrum…an illumination means may be suitable for emitting light at a single wavelength, i.e., light of one particular color”). It is well known in the art that LEDs emit light at wavelengths between 400 nm to 750 nm (see non-patent literature by D.H. Sliney, heading ‘What are the limits of the visible spectrum’, “The lower limit is generally taken between 360 and 400 nm and the upper limit between 760 and 830 nm”; also see heading ‘Background—Sources of Light’ for reference to LEDs). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the light source operate at a wavelength distribution between 400 nm to 750 nm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
While Karakaya teaches that the contact lens comprises a processor that determines certain changes within the eye during light stimulation (para 0050, 0164, and Fig. 16), they fail to explicitly teach (h) the corneal contact electrode is for measuring a change in electroretinogram due to stimulation from the light source, as well as fails to teach (j) the scattering layer comprises scattering particles as scattering material in an amount of 1 wt% to 10 wt%.
Tai teaches a contact lens of analogous art (Fig. 8) comprising a light source (Fig. 8, ref num 850) and an electrode (Fig. 8, ref num 880; para 0111, “the circuitry 880 can additional include…a set of electrodes”). The electrode measures a change in electroretinogram due to stimulation from the light source (para 0111, “the set of electrodes can be configured to measure ERG and/or EOG responses that are then usable to generate and/or maintain a transfer function of the light”; para 0026, 0046, 0061). By measuring the changes in electroretinogram, the treatment of the eye may be adjusted in order to treat the immediate problem and/or slow down the progression of the disease (para 0072, 0144). Therefore, it would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to have modified Karakaya to substitute the electrode with the one taught by Tai, as this electrode measures the change in electroretinogram, leading to an improved treatment plan for the patient.
Lopath teaches a contact lens of analogous art (Figs. 1 and 5, ref num 20; para 0026, “a device 20 (FIG. 1) generally in the form and shape of a contact lens”), wherein the contact lens comprise a light source (Figs. 1 and 5, ref num 39; para 0038, “bundle 39 of optical fibers 42… designed for transmitting UV”) and a scattering layer (Fig. 5, ref num 70). The scattering layer comprises scattering particles as scattering material (para 0036, “a mass of optically scattering material, also referred to as a diffuser 70… The diffuser is formed from a clear polymer such as a medical grade silicone or an epoxy having fine particles such as barium sulfate (BaSO.sub.4) dispersed therein”), such that the scattering material is in an amount of 1 wt% to 10 wt% (para 0036, “the diffuser may include about 1 to 10 weight percent barium sulfate”). The scattering material provides illumination that is uniform around the axis of the cornea (para 0045). 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 modified Karakaya and have the scattering material have an amount of 1 wt% to 10 wt% in order to uniformly disperse the light about the axis of the cornea.
9. Regarding Claim 2, Karakaya fails to teach the scattering layer has a thickness of 0.1 mm to 2 mm.
However, Lopath teaches the contact lens (Fig. 5, ref num 20) that houses the scattering layer within the shell structure (Fig. 5, ref num 70). The shell structure has a thickness dimension (see Fig. 5, “T” dimension), such that the overall thickness may be less than 1 mm thick (para 0046, “the structure, including the housing and the components disposed within the housing may be in the form of a shell having a thickness less than about 3 mm thick, and preferably less than about 1 mm thick”). While Lopath does not explicitly teach that the scattering layer has a thickness of 0.1 mm to 2 mm, it can be inferred that if the entirety of the shell structure is less than 1 mm, then the scattering layer would have to have a thickness of less than 1 mm. The small thickness provides the benefit of allowing one to wear the contact lens while still being able to blink. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the thickness of the scattering layer be between 0.1 to 2 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
10. Regarding Claim 8, Karakaya teaches a cable that connects the light source to an external power source (para 0045, 0123, 0150).
11. Regarding Claim 9, Karakaya teaches the light source is located on the scattering layer or at least a part of the light source is embedded in the scattering layer (Fig. 14, ref num 30 is disposed at ref num 51; see circumferential layers; para 0141, “a light source can be integrated with the device in various configurations”).
12. Regarding Claim 12, Karakaya teaches the light source is an LED element included singly or in plurality, wherein the plurality of the LED elements is the plural elements of the light source (para 0141, “an illumination means 30 may consist of a LED or an array of LEDs. Also, an illumination means may consist of an OLED unit (a single unit in various shapes and/or multiple units and/or an array of OLEDs)…”).
13. Regarding Claim 14, Karakaya teaches the LED element is a single white LED element (para 0141, 0158).
14. Regarding Claim 15, Karakaya teaches the LED element is the plural elements of the light source and the plural elements of the light source is a plurality of white LED elements (para 0141, 0158).
15. Regarding Claim 17, Karakaya as modified by Tai teaches the light source-integrated contact lens for electroretinography according to claim 1 (see claim 1 rejection), such that the light source-integrated contact lens is used to measure an electroretinogram of humans (Tai, ref num 150; para 0111, “the set of electrodes can be configured to measure ERG and/or EOG responses that are then usable to generate and/or maintain a transfer function of the light”; para 0026, 0046, 0061). By measuring the changes in electroretinogram, the treatment of the eye may be adjusted in order to treat the immediate problem and/or slow down the progression of the disease (para 0072, 0144). Therefore, it would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to have modified Karakaya to measure electroretinograms of humans, since measuring the change in electroretinograms improves treatment plan for the patient.
16. Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Karakaya, Tai, and Lopath, and further in view of Hetling U.S. 2015/0029463 (herein referred to as “Hetling 2015”).
17. Regarding Claims 5 and 6, Karakaya teaches the scattering layer (ref num 51), but fails to teach the scattering layer is an elastomer layer in which the scattering particles are dispersed, further that the elastomer layer is made of a polydimethylsiloxane (PDMS).
Hetling 2015 teaches a device of analogous art, wherein the device comprises of a contact lens (para 0039), comprising a scattering layer (Fig. 17, ref num 60). The scattering layer is an elastomer layer, made of PDMS, in which the scattering particles are dispersed (para 0057, 0059). The elastomer is biocompatible and translucent, which is desirable for a contact lens (para 0039). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the scattering layer made of an elastomer, such as PDMS, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
18. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Karakaya, Tai, and Lopath, and further in view of Hetling U.S. 2018/0242834 (herein referred to as “Hetling 2018”).
19. Regarding Claim 7, Karakaya teaches the scattering layer (ref num 51), but fails to teach the scattering particles of the elastomer layer are SiO2 or TiO2 nanoparticles.
Hetling 2018 teaches a device of analogous art (Figs. 1, 3, and 4) wherein the device comprises a scattering layer (Fig. 7, ref num 235). The scattering layer is an elastomer layer, and the layer includes titanium dioxide nanoparticles (para 0100). This material allows the reflection of the light source to be tuned to the desired wavelengths (para 0100)). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the scattering layer include titanium dioxide nanoparticles, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
20. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Karakaya, Tai, and Lopath, and further in view of Gupta U.S. 2021/0263336 (herein referred to as “Gupta”).
21. Regarding Claim 11, Karakaya fails to teach the light source has a form in which the light source is mounted on a flexible printed circuit board.
Gupta teaches a contact lens of analogous art (Fig. 4A), wherein the contact lens comprises a light source (Fig. 4A, ref num 320). The light source has a form in which the light source is mounted on a flexible printed circuit board (FPCB = ref num 420; para 0033). The circuit board is provided in order to power the light source (para 0030). 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 modified Glynn and mounted the light source to a FPCB in order to power the light source.
22. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Karakaya Tai, and Lopath, and further in view of Wyss U.S. 2021/0311326 (herein referred to as “Wyss”.
23. Regarding Claim 16, Karakaya teaches the LED element is the plural elements of the light source (para 0141), such that they have a plurality of colors (para 0048).
Karakaya fails to teach that the plural elements are three LED elements of red, blue, and green.
Wyss teaches a contact lens of analogous art (Fig. 1), wherein there is a light source (Fig. 1, ref num 12), such that the light source is an LED element that includes three elements of red, blue, and green (Fig. 1, ref num 12, three are present; para 0013, 0049). These colors provide the peak wavelength of stimulation to the eye (para 0013, 0049), in order to produce a therapeutic benefit (para 0050). 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 modified Karakaya to include three LED elements of red, blue, and green, since Karakaya already teaches of a plurality of LEDs with different colors, and the red, blue, and green colors would produce the same expected result of stimulation to the eye via light.
24. Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Karakaya, Tai, and Lopath, and further in view of Hones U.S. 12,111,518 (herein referred to as “Hones”).
25. Regarding Claim 18, Karakaya as modified by Tai teaches a method of manufacturing the light source-integrated contact lens for electroretinography according to Claim 1 (see Claim 1 rejection).
But Karakaya as modified fails to teach the method comprising: providing a solution comprising a scattering material; and, providing the light source to the solution and curing the solution.
Hones teaches a method of manufacturing an optical lens device (Col. 3, lines 5-7; Fig. 1A), wherein the lens comprises a light source (Col. 10, lines 34-44; Fig. 4B, ref num 434) and a solution comprising a scattering material (Fig. 1B, ref num 124; Col. 5, lines 62-67 – Col. 6, lines 1-11). The light is applied to the solution and cures the solution (Col. 5, lines 62-67 – Col. 6, lines 1-11, “layer 124 is composed of an electro-optic material such as a polymer dispersed liquid crystal…which is then solidified or cured to form a dispersion of liquid crystal droplets in a polymer matrix”). The curing of the solution causes the dispersion of the particles in order to scatter the light in the lens (Col. 5, lines 62-67 – Col. 6, lines 1-11). 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 modified Karakaya to include a solution of scattering material that is cured in order to scatter the light within the lens.
26. Regarding Claim 19, Karakaya as modified teaches the method of Claim 18 (see rejection above), which is according to the light source-integrated contact lens of Claim 1 (see Claim 1 rejection above), such that the method further comprises:
i. providing a corneal contact portion (Figs. 10, 12, and 14, ref num 12) that is to be in contact with a corneal surface of an eyeball (Fig. 10, ref num 18 represents the eyelid, therefore, structures 12, 30, 32, and sometimes 20, are in contact with the cornea of the eyeball; para 0118, “the components of the device 10d that in direct contact with the eye”); and,
ii. wherein the scattering material and light source are provided on an outer surface of the corneal contact portion (Fig. 14, ref num 51; para 0163; para 0039, “a filter may either be included in the transparent carrier or in the photosensor itself”; see Figs. 10-12, photosensor 20 may be located on an outer surface of the corneal contact portion, i.e., ref num 12; also see Figs. 10-12 for light source, ref num 30, being on an outer surface of the corneal contact portion, ref num 12).
While Karakaya fails to teach that the solution is cured, according to the rejection of claim 18 above, Karakaya as modified by Hones teaches the solution with scattering material being cured (see claim 18 rejection above and rationale).
27. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Karakaya, Tai, and Lopath, and further in view of Hones and Gupta.
28. Regarding Claim 20, Karakaya as modified teaches the method of Claim 18 (see rejection above), but fails to teach the solution comprising the scattering material and the light source are provided to a mold capable of manufacturing a lens shape and cured.
Hones teaches a method of manufacturing an optical lens device (Col. 3, lines 5-7; Fig. 1A), wherein the lens comprises a light source (Col. 10, lines 34-44; Fig. 4B, ref num 434) and a solution comprising a scattering material (Fig. 1B, ref num 124; Col. 5, lines 62-67 – Col. 6, lines 1-11). The light source and scattering material are found at an outer surface of the lens (see Fig. 1B). The light is applied to the solution and cures the solution (Col. 5, lines 62-67 – Col. 6, lines 1-11, “layer 124 is composed of an electro-optic material such as a polymer dispersed liquid crystal…which is then solidified or cured to form a dispersion of liquid crystal droplets in a polymer matrix”). The curing of the solution causes the dispersion of the particles in order to scatter the light in the lens (Col. 5, lines 62-67 – Col. 6, lines 1-11). 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 modified Glynn to include a solution of scattering material that is cured in order to scatter the light within the lens.
Gupta teaches the contact lens being fabricated by a mold capable of manufacturing a lens shape (para 0044). Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985).
Conclusion
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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