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 Objections
Claims 1-12 are objected to because of the following informalities: in step (6) there is space between “layer” and the semicolon, in step (7) there is no punctuation at the end of the line, step (10) erroneously ends in a period and “-layer” should be “layer”, and claims 1-8 all erroneously capitalize “Contact”. Additionally, “donut shape-layer” should be “donut shape layer” and “has thickness” should be “has a thickness” in the relevant claims.
Appropriate correction is required.
Applicant’s claims are replete with grammatical errors. Please review the claims for any additional errors not specifically mentioned by the examiner.
Specification
The disclosure is objected to because of the following informalities:
“donut shape-layer” should be “donut shape layer” in each case, and
please see the 112 section below with respect to “sandwich colored”.
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 1-16 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 claim 1, applicant claims a first female mold half and a second female mold half and then later in the claim only refers to surfaces of “the female mold half”. Since each of the first and second female mold halves may have a plurality of surfaces, it is not clear which female mold half is being claimed in (2), for example. Further, (3) includes language for the “first female mold half” and the broader “the female mold half”, which makes it unclear which female mold half is being discussed.
For the purposes of this action the office will interpret the claim based on the assumption that the female mold halves only have the surfaces claimed and are not interchangeable.
Regarding applicant’s claims 1-16, they refer to the contact lens as “sandwich colored”, which is not clear. Nowhere in applicant’s claims or specification have they defined a color, or colors, that one of ordinary skill in the art would understand as “sandwich colored”. Generally, one would expect a sandwich to be primarily the color of the bread used. Typical bread used in sandwiches is white, brown or yellow; however, bread may be dyed to be many other colors (see PGPUB 20060141100 where the sandwich bread has many colors, [0018]). Further, the contents of the sandwich may also provide additional color to sandwich (e.g. red marinara sauce or green lettuce). Therefore, the office cannot determine if a particular lens is “sandwich colored” or not.
It may also be that applicant means that the lens is layered, like a sandwich. In that case, the applicant should amend the claims to “sandwiched” colored, removing “sandwich” from the claims altogether or replacing “sandwich” with “layered”.
For the purposes of this action the office will interpret the claim such that the lens has a plurality of layers, like a sandwich, and any colors of the prior art that resemble a sandwich are irrelevant.
Allowable Subject Matter
Claims 1-8 would be allowable but for the 112(b) rejection of the claims and the assumptions/interpretations made by the examiner in that section.
Claim Rejections - 35 USC § 102
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.
Claim(s) 9-11 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (PGPUB 20200376787).
Regarding claim 9, Zhang discloses a sandwich colored hydrogel contact lens ([0070]), comprising:
a pupil section, a generally annular iris section surrounding the pupil section (Fig. 1, for example 101, which would surround the pupil section),
wherein the iris section having at least one colored, printed, opaque, intermittent pattern (102-104),
wherein the said pattern is embedded between a bulk lens-forming composition and a donut shape layer forming material (Fig. 1 where 101 and 105 surround layers 102-104 and all are donut-shaped),
wherein a bulk lens-forming composition and a donut shape layer forming material are the same or different ([0308] and [0311]),
wherein the donut shape layer has thickness larger than 10 µm ([0108] and [0308-[0311] where the donut shaped layer comprises at least 101-105 and are 5 microns thick, which is about 25 microns) .
Regarding claims 10-11, Zhang discloses wherein the donut shaped layer has thickness larger than 20 µm ([0108] and [0308-[0311] where the donut shaped layer comprises at least 101-105 and are 5 microns thick, which is about 25 microns).
Regarding claim 13, Zhang discloses wherein the donut shape layer-forming composition and the bulk lens-forming composition are the same and are silicone hydrogel material ([0309]-[0311]).
Regarding claim 14, Zhang discloses wherein the silicone hydrogel material is selected from a group consisting of lotrafilcon A, lotrafilcon B, balafilcon A,galyfilcon A, senofilcon A, narafilcon A, narafilcon B, comfilcon A, enfilcon A, and asmofilcon A ([0142]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang.
Regarding claim 12, Zhang does not disclose wherein the donut shape layer has a thickness larger than 25 µm.
However, due to the nature of optics/optical engineering the process of lens design includes manipulation of known result effective variables such as index or refraction, focal length, lens surface radii and other optical variables in order to make a lens meet its particular utility. This manipulation would normally be considered routine experimentation since the results are known optics/physics equations (unless the particular range of values meets secondary considerations). Further the court has determined 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.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to adjust the total layer thickness to be larger than 25 µm, 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 (C.C.P.A. 1955). In this case, one of ordinary skill in the art would have adjust the thickness of any of the layers to improve visibility of the colored pattern(s).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Chalberg et al. (PGPUB).
Regarding claim 15, Zhang does not disclose wherein the donut shape layer-forming composition and the bulk lens- forming composition are the same and are non-silicone hydrogel material.
However, Chalberg teaches a molded layered contact lens having annular sections wherein the material used for the layers is non-silicone hydrogel ([0065]-[0066]).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine Zhang and Chalberg such that the materials used for the lens were selected from other known alternatives to silicone hydrogel motivated by reducing the comfort for some lens wearers.
Regarding claim 16, modified Zhang discloses wherein the non-silicone hydrogel material is selected from a group consisting of alfafilcon A, acofilcon A, deltafilcon A, etafilcon A, focofilcon A, helfilcon A, helfilcon B, hilafilcon B, hioxifilcon A, hioxifilcon B, hioxifilcon D, methafilcon A, methafilcon B, nelfilcon A, nesofilcon A, ocufilcon A, ocufilcon B, ocufilcon C, ocufilcon D, omafilcon A, phemfilcon A, polymacon, samfilcon A, telfilcon A, tetrafilcon A, and vifilcon A ([0065]-[0066]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVIS S FISSEL whose telephone number is (313)446-6573. The examiner can normally be reached 9AM-5PM.
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/TRAVIS S FISSEL/Primary Examiner, Art Unit 2872