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 .
Information Disclosure Statement
The information disclosure statements filed on 2/7/2025 and 4/10/2025 have been acknowledged and considered by the examiner. Initialed copies of supplied IDS(s) forms are included in this correspondence.
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 elliptical dots of the elliptical dot pattern of claims 1-7, 9-10, 12-13, 16, 19, 22-26, 29-30 must be shown or the feature(s) canceled from the claim(s). 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 Objections
Claim 16 is objected to because of the following informalities:
Claim 16 recites “ΔE” in parentheses. Examiner suggests deleting the parentheses.
Appropriate correction is required.
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 1-7, 9-10, 12-13, 16, 19, 22-26, 29-30 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 and 6, claims recite the limitation “elliptical dot pattern” in the first line of each claim. This limitation is unclear as it has multiple interpretations which would change the scope of the claims – the first being that the dot pattern as a whole is elliptical as positioned on the contact lens surface, and the second being the dots within the dot pattern being elliptical. Based on the instant specification paragraph 0043, the second interpretation of the claim language appears to be the intended meaning. Based on the current language of the claim, one of ordinary skill in the art would not be apprised as to the scope of the invention (MPEP §2173.05(b)). For purposes of compact prosecution, so long as the dots within a pattern may be ellipses, this limitation will be considered met.
Regarding claim 1, claim states the limitation “a negative space between 70 percent and 100 percent in an outermost annulus” in lines 2-3 of the claim. This limitation is unclear because what exactly is between 70 and 100 percent in the outermost annulus is not specified. Does this correspond to an amount of the elliptical dot pattern within the outermost annulus, the location of the negative space on the surface of the contact lens, the percentage of empty space on a specific region of the lens surface, or is there some other metric which corresponds to this percentage range? Due to this limitation, one of ordinary skill in the art would not be apprised as to the scope of the invention (MPEP §2173.05(b)). For purposes of compact prosecution, so long as there is a section on the contact lens with minimal dots shown in the figures or mentioned in the specification, this limitation will be considered met.
Regarding claim 7, claim recites the limitation “wherein the negative space is between 70 percent and 100 percent” in both lines of the claim. This limitation is unclear because which part of the negative space being between 70 percent and 100 percent is not specified. What is between 70 percent and 100 percent? Is this the size of the negative space on the contact lens surface, is this the percentage of the elliptical dot pattern within the negative space, is this the approximate location of the negative space on the contact lens surface, or some other metric? Due to the current limitation, one of ordinary skill in the art would not be apprised as to the scope of the invention (MPEP §2173.05(b)). For purposes of compact prosecution, examiner will assume this is a region of the elliptical dot pattern as stated in claim 1.
Regarding claim 12, claim recites the limitation “the diameter of the elliptical dot pattern is equal to an average iris diameter of a human population” in the last two lines of the claim. This limitation is unclear because “an average iris diameter of a human population” is not subjective. Based on the references used to determine what the average iris diameter is of a human population, the diameter of the elliptical dot pattern will change. For example, the average could be anywhere between 10 and 14 mm in diameter, or vary further from there. Due to this limitation, one of ordinary skill in the art would not be apprised as to the scope of the invention (MPEP §2173.05(b) IV). For purposes of compact prosecution, so long as the range stated in claim 1 is met for the diameter of the elliptical dot pattern, this limitation will be considered met.
Regarding claim 16, claim recites the limitation “wherein the elliptical dot pattern and the iris exhibit a color difference (ΔE) between 23 and 79” in the last line of the claim. This limitation is unclear as the color difference described is dependent on who is wearing the contact lens and the color of their eyes. Therefore, an identical device being worn by one person might give a ΔE of 50 while another could wear the same contact lens and give a ΔE of 20, which would simultaneously infringe and not infringe solely based on who is wearing the contact lens. This means that the only way to determine a ΔE is for someone to wear the contact lens. Further, most human irises have multiple colors within them – which color is the color ΔE is calculated from? Finally, how are these values calculated? Due to this limitation, one of ordinary skill in the art would not be apprised as to the scope of the invention (MPEP §2173.05(b) IV). For purposes of compact prosecution, so long as the limitations in claim 6 are met by the art, this limitation will necessarily be met.
Also, claims 2-5, 7, 9-10, 13, 16, 19, 22-26, 29-30 are rejected by virtue of their dependency.
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 1-7, 9-10, 12-13, 16, 22-26, 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nicholl et. al WO 2022208205 (hereinafter “Nicholl”).
Regarding claim 1, Nicholl teaches a cosmetic contact lens comprising an elliptical dot pattern (Nicholl fig. 4-5 – 410, 504, 510, see also pg. 15 lines 20-29 – dots are circles, though any geometric shape may be utilized), wherein the elliptical dot pattern (410, 504, 510) has a diameter equal to or greater than 8 millimeters (Nicholl fig. 5, see also pg. 16 lines 20-25 teaches a range about 8mm to about 12mm) and has a negative space between 70 percent and 100 percent in an outermost annulus (Nicholl fig. 5 – 408, 508, see also pg. 16 lines 7-9 – no dots in 508), said outermost annulus (Nichol fig. 5 - 508) having a thickness between 0.2 millimeters and 2.0 millimeters (Nicholl pg. 16 lines 23-25 – teaches a range of about 0.5 to about 2.5 mm, more preferably 0.75 to about 1.25 mm which lies within the claimed range – which is an overlapping range of sufficient specificity (MPEP §2131.03)).
Regarding claim 2, Nicholl teaches the cosmetic contact lens of claim 1, and Nichol further teaches wherein the outermost annulus (508) has a thickness between 0.5 millimeters and 1.5 millimeters (Nicholl pg. 16 lines 23-25 – teaches a range about 0.75 to about 1.25 mm which lies within the claimed range – which is an overlapping range of sufficient specificity (MPEP §2131.03)).
Regarding claim 3, Nicholl teaches the cosmetic contact lens of claim 1, and Nicholl further teaches wherein the diameter of the elliptical dot pattern (410, 504, 510) is between 9 millimeters and 14 millimeters (Nicholl fig. 5, see also pg. 16 lines 20-25 teaches a range about 8mm to about 12mm).
Regarding claim 4, Nicholl teaches the cosmetic contact lens of claim 3, and Nicholl further teaches wherein the diameter of the elliptical dot pattern (401, 504, 510) is between 11 millimeters and 13 millimeters (Nicholl fig. 5, see also pg. 16 lines 20-25 teaches a range about 8mm to about 12mm).
Regarding claim 5, Nicholl teaches the cosmetic contact lens of claim 1, and Nicholl further teaches wherein the negative space in the outermost annulus is between 80 percent and 100 percent (Nicholl fig. 5 - 508, see also pg. 16 lines 7-9 – no dots in 508).
Regarding claim 6, Nicholl teaches a cosmetic contact lens comprising an elliptical dot pattern (Nicholl fig. 4-5 – 410, 504, 510, see also pg. 15 lines 20-29 – dots are circles, though any geometric shape may be utilized), the elliptical dot pattern (410, 504, 510) including a negative space (Nicholl fig. 4-5 – negative space between dots in each figure), wherein the negative space creates an apparent limbal ring when the elliptical dot pattern (410, 504, 510) overlays an iris (Nicholl fig. 4-5).
Regarding claim 7, Nicholl teaches the cosmetic contact lens of claim 6, and Nicholl further teaches wherein the negative space is between 70 percent and 100 percent (Nicholl fig. 5 – 408, 508, see also pg. 16 lines 7-9 – no dots in 508).
Regarding claim 9, Nicholl teaches the cosmetic contact lens of claim 6, and Nicholl further teaches wherein the negative space increases radially from the center of the lens (Nicholl fig. 4-5).
Regarding claim 10, Nicholl teaches the cosmetic contact lens of claim 6, and Nicholl further teaches wherein the apparent limbal ring has a thickness between 0.2 millimeters and 2.0 millimeters (Nicholl pg. 16 lines 23-25 – teaches a range of about 0.5 to about 2.5 mm, more preferably 0.75 to about 1.25 mm which lies within the claimed range – which is an overlapping range of sufficient specificity (MPEP §2131.03)).
Regarding claim 12, Nicholl teaches the cosmetic contact lens of claim 6, and Nicholl further teaches wherein the diameter of the elliptical dot pattern (410, 504, 510) is equal to an average iris diameter of a human population (Nicholl fig. 5, see also pg. 16 lines 20-25 teaches a range about 8mm to about 12mm).
Regarding claim 13, Nicholl teaches the cosmetic contact lens of claim 6, and Nicholl further teaches wherein the diameter of the elliptical dot pattern (410, 504, 510) is equal to or greater than 8 millimeters (Nicholl fig. 5, see also pg. 16 lines 20-25 teaches a range about 8mm to about 12mm).
Regarding claim 16, Nicholl teaches the cosmetic contact lens of claim 6, and Nicholl further teaches wherein the elliptical dot pattern (410, 504, 510) and the iris exhibit a color difference (ΔE) between 23 and 79 (Nicholl teaches the structure of claim 6, therefore necessarily meets this limitation).
Regarding claim 22, Nicholl teaches the cosmetic contact lens of claim 1, and Nicholl further teaches wherein the elliptical dots are circles (Nicholl pg. 15 lines 20-29 – dots are circles).
Regarding claim 23, Nicholl teaches the cosmetic contact lens of claim 1, and Nicholl further teaches wherein the elliptical dot pattern (410, 504, 510) further comprises dots of non-elliptical shapes (Nicholl pg. 15 lines 20-29 – any geometric shape may be utilized for the dot shape).
Regarding claim 24, Nicholl teaches the cosmetic contact lens of claim 1, and Nicholl further teaches wherein the elliptical dot pattern (410, 504, 510) is formed by pad printing using an ink comprising a colorant (Nicholl fig. 19, see also pg. 52 lines 1-15).
Regarding claim 25, Nicholl teaches the cosmetic contact lens of claim 24, and Nicholl further teaches wherein the colorant is selected from the group consisting of iron oxides, titanium dioxide, mica pigments, phthalocyanines, carbazole violet, and combinations thereof (Nicholl pg. 64 lines 18-30).
Regarding claim 26, Nicholl teaches the cosmetic contact lens of claim 24, and Nicholl further teaches wherein the elliptical dot pattern (510, 504, 510) is formed by pad printing using one or more print layers individually composed of elliptical dot patterns (Nicholl fig. 19-20, see also pg. 52 lines 1-30 and pg. 53 lines 1-7).
Regarding claim 29, Nicholl teaches the cosmetic contact lens of claim 1, and Nicholl further teaches wherein the cosmetic contact lens is made from a hydrogel (Nicholl pg. 65 lines 8-9 – silicone hydrogel).
Regarding claim 30, Nicholl teaches the cosmetic contact lens of claim 1, and Nicholl further teaches wherein the cosmetic contact lens is made from a silicone hydrogel (Nicholl pg. 65 lines 8-9 – silicone hydrogel).
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Nicholl as applied to claim 1 above, and further in view of Ota et. al JP 2016189034 (hereinafter “Ota”).
Regarding claim 19, Nicholl teaches the cosmetic contact lens of claim 1.
Nicholl does not specify wherein the elliptical dot pattern comprises elliptical dots having major axes between 10 micrometers and 200 micrometers.
In the same field of endeavor, Ota teaches wherein the elliptical dot pattern comprises elliptical dots having major axes between 10 micrometers and 200 micrometers (Ota para. 0054 – “40 to 300 μm in the circumferential direction, preferably 70 to 250 μm, and 70 to 600 μm in the radial direction, preferably 100 to 400 μm”). Ota para. 0054 – teaches the ranges “40 to 300 μm in the circumferential direction, preferably 70 to 250 μm, and 70 to 600 μm in the radial direction, preferably 100 to 400 μm” which overlap the claimed range – which is an overlapping range made prima facie obvious (MPEP §2144.05)) for the purpose of achieving a colored state that is consistent across the entire colored region (Ota para. 0054). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the claimed range of major axes between 10 micrometers and 200 micrometers in order to achieve a colored state that is consistent across the entire colored region (Ota para. 0054).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Francis et. al US 20030035083, teaches a similar contact lens to the instant application;
Dukes et. al US 20050254002, teaches a similar cosmetic contact lens to the instant application;
Jahnke et. al US Patent 5,414,477, teaches a similar cosmetic contact lens with elliptical dot patterns shown in the figures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH M HALL whose telephone number is (703)756-5795. The examiner can normally be reached Mon-Fri 9-5:30 pm PST.
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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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/ELIZABETH M HALL/Examiner, Art Unit 2872
/RICKY L MACK/Supervisory Patent Examiner, Art Unit 2872
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