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
This Office action is in response to the communication filed 12/22/2025.
The Amendments to Claims 1, 2, and 9, filed 12/22/2025, are acknowledged and accepted.
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive. Applicant argues that Dorin fails to disclose that his contact lens 106 and speculum 132 are formed as a single piece, as recited by Claim 1. The Examiner respectfully disagrees. By applicant’s own submission, paragraph 0019 discloses integrated contact lens apparatus may also have a first portion and a second portion that are merged, coupled, connected, or otherwise bonded into a single apparatus using known joining techniques in the art, such as through use of an adhesive, welding, or fastening. Paragraph 0138 discloses Speculum 132 is also configured to conform to and secure collar 104 between blades 138, 140 and Examiner notes that to conform is to bring one thing into correspondence or agreement with another. Therefore the claim limitation has been met.
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.
Claim 2 is 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 2 is dependent from apparatus claims and disclose a method for joining the contact lens portion, the upper speculum portion, and the lower speculum portion. The method of using an apparatus cannot be included in the apparatus claims and is therefore indefinite. The MPEP 2173.05 (II. Product by Process In The Same Claim) states that a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2 and 12-15 is/are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Dorin et al. (2022/0031503), hereinafter Dorin. Regarding claim 1, Dorin discloses, in figures 6A-6C, an integrated contact lens apparatus (100, interface for a laser treatment device) (paragraph 0134), comprising: a contact lens portion (104, lens holder and 106, contact lens) having a circumferential edge, an anterior surface, and a posterior surface (figure 6B and paragraph 0134), wherein the contact lens portion (104, lens holder and 106, contact lens) has a center traversed by a true horizontal axis that defines an upper portion and a lower portion of the circumferential edge (figure 6B); an upper speculum portion (138, speculum blade) coupled to the contact lens portion (104, lens holder and 106, contact lens) along the upper portion of the circumferential edge for an upper inner minor arc circumference, the upper speculum portion comprising a posterior tine that at least partially defines an upper speculum cup (paragraph 0137) (figures 6B, 6C, and figure 7A); and a lower speculum portion (140, speculum blade) coupled to the contact lens portion (104, lens holder and 106, contact lens) along the lower portion of the circumferential edge for a lower inner minor arc circumference, the lower speculum portion comprising a posterior tine that that at least partially defines a lower speculum cup (paragraph 0137 and figures 6B, 6C, and 7A), wherein the contact lens portion, the upper speculum portion, and the lower speculum portion are formed as a single piece (By applicant’s own submission, paragraph 0019 discloses integrated contact lens apparatus may also have a first portion and a second portion that are merged, coupled, connected, or otherwise bonded into a single apparatus using known joining techniques in the art, such as through use of an adhesive, welding, or fastening and paragraph 0138 discloses Speculum 132 is also configured to conform to and secure collar 104 between blades 138, 140; Examiner notes that to conform tis to bring one thing into correspondence or agreement with another), wherein the upper speculum cup is configured to receive and retain an upper eyelid in a retracted manner when the posterior tine of the upper speculum portion is positioned between portions of an upper conjunctiva (figures 7A and 7B and paragraph 0140), and wherein the lower speculum cup is configured to receive and retain a lower eyelid in a retracted manner when the posterior tine of the lower speculum portion is positioned between portions of a lower conjunctiva (figures 7A and 7B and paragraph 0140).
Also regarding claim 1, It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the invention to wherein the contact lens portion, the upper speculum portion, and the lower speculum portion are formed as a single piece, since it has been that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (Howard v. Detroit Stove Works, 150 U.S. 164 (1893), this being reasonably based upon designing a more compact and lightweight piece that is also easier to handle.
Regarding claim 2, Dorin discloses wherein the contact lens portion, the upper speculum portion, and the lower speculum portion are joined (104, is connected to the speculum) (paragraph 0139 and figures 6B and 6D).
Dorin does not specifically disclose the contact lens portion, the upper speculum portion, and the lower speculum portion are joined by adhesive or welds into the single piece.
The method of forming a device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. The MPEP 2113 (I.) states that [E]ven 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 a product does not depend on its method of production and 2113 (III.) states that [T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established.
Regarding claim 12, Dorin discloses wherein the upper speculum portion has symmetry with respect to a true vertical axis of the lens portion, wherein the true vertical axis traverses the center (figures 6B-7A).
Regarding claim 13, Dorin discloses wherein the lower speculum portion has symmetry with respect to a true vertical axis of the lens portion, wherein the true vertical axis traverses the center (figures 6B-7A).
Regarding claim 14, wherein the upper speculum portion and the lower speculum portion have symmetry with one another in relation to the true horizontal axis (figures 6B and 7A).
Regarding claim 15, where the integrated contact lens apparatus comprises a polymer material formed from a polymerization reaction of one or more monomers selected from the group consisting of methacrylic acid (MAA), methyl methacrylate (MMA), vinyl alcohol (VA), diacetone acrylamide (DA), N-carboxyl vinyl ester (NCVE), phosphorylcholine (PC), ethylene glycol (EG), N,N-dimethyl acrylamide (DMAA), 2-hydroxyethyl methacrylate (HEMA), N-vinyl pyrrolidone (NVP), ethylene glycol dimethacrylate (EGDMA), triethylene glycol dimethacrylate (TEGDMA), tetraethyleneglycol dimethacrylat (TTEGMDA) dimethyl siloxane (DMS), tris(hydroxymethyl)aminomethane, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate (TRIS), 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate (TRIS-VC), and dimethyl siloxyl di(silylbutanol) bis(vinyl carbamate) (BVC) (paragraph 0150 discloses lns material of PMMA).
Claim(s) 3-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dorin et al. (2022/0031503), hereinafter Dorin as applied to claim 1 above, and further in view of Pomerantzeff (4265519), hereinafter ‘519.
Regarding claim 3, Dorin discloses all the limitations in common with claim 1, and such is hereby incorporated.
Dorin does not disclose wherein a diameter of the contact lens portion as measured through the center is in a range of from about 8.00 mm (millimeters) to about 15.00 mm.
‘519 discloses wherein a diameter of the contact lens portion as measured through the center is in a range of from about 8.00 mm (millimeters) to about 15.00 mm (col. 9, lines 5-8).
Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Dorin with the diameter of the contact lens of ‘519 for the purpose of the lens providing about 2.5 power magnification.
Regarding claim 4, ‘519 discloses wherein an upper speculum arc angle as measured from the center is in a range of from about 10° (angle degrees) to about 65° (300; col. 7, lines 1-10).
Regarding claim 5, ‘519 discloses wherein a lower speculum arc angle as measured from the center is in a range of from about 10° to about 65° (col. 7, lines 1-10).
Regarding claim 6, ‘519 discloses wherein the upper speculum portion includes an upper speculum inner minor arc circumference having an arc length in a range of from about 3.00 mm to about 10.00 mm (4mm; col. 6, lines 65-66).
Regarding claim 7, ‘519 discloses wherein the lower speculum portion includes a lower speculum inner minor arc circumference having an arc length in a range of from about 3.00 mm to about 10.00 mm (4mm; col. 6, lines 65-66).
Regarding claims 8 and 9, ‘519 discloses wherein the upper speculum portion has an anterior tine height (3.6mm; col. 17, lines 17-19).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to in a range of from about 1.00 mm to about 3.00 mm since the claimed ranges and the prior art ranges are close enough that one skilled in the art would have expected them to have the same properties, Titanium Metals Corp. of America v. Nabber, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) and further being motivated to illuminate the posterior pole.
Regarding claims 10 and 11, ‘519 does not specifically disclose wherein the upper speculum cup has a cup depth in a range of from about 0.5 mm to about 2.5 mm.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to wherein the upper speculum cup has a cup depth in a range of from about 0.5 mm to about 2.5 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 (C.C.P.A. 1955).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRANDI N THOMAS whose telephone number is (571)272-2341. The examiner can normally be reached Monday - Friday 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephone Allen can be reached at 571-272-2434. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDI N THOMAS/Primary Examiner, Art Unit 2872
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