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 statement (IDS) submitted on 11/19/2024 and 12/30/2025 have been considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,171,692. Although the claims at issue are not identical, they are not patentably distinct from each other because the removal of the limitations “the etching utility is configured to be responsive to the operational instructions to etch the selected two-dimensional pattern as the surface relief on a surface of the cornea of the user substantially without modifying a corneal shape; and eye drops including an aqueous solution having a plurality of nanoparticles made of biocompatible protein chains, said plurality of nanoparticles, being configured to be dispersed within incision regions of the surface relief of the cornea defined by said selected two-dimensional pattern on the surface of the cornea” renders claims 1-19 of the instant application as broadened and obvious variants of claims 1-19 of U.S. Patent No. 12,171,692.
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, 6-7, 16-18 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berry (US 2008/0027418; already of record).
Regarding claim 1, Berry discloses, a kit for use in correction of visual impediments of an individual, the kit comprising:
a patterning utility configured and operable to utilize prescribed data indicative of a selected vision correction pattern corresponding to an optical effect of targeted correction of vision impediments of the individual, and create said pattern in the form of a surface relief on individual's cornea while substantially maintaining a corneal shape; and
an ophthalmological formulation made of biocompatible material and being configured to be dispersed within incision regions of the surface relief of the cornea defined by said selected vision correction pattern, such that said ophthalmological formulation, when dispersed within the incision regions of said surface relief, functionalize and activate said optical effect and increase stability of the optical effect of the selected vision correction pattern.
Regarding claim 6, Berry discloses, the targeted correction of vision impediments comprises at least one of the following: correction of at least one of myopia, hyperopia, presbyopia, astigmatism, and myopia control (Para. 0008-0010 and 0031).
Regarding claim 7, Berry discloses, the optical effect provided by said surface relief with the ophthalmological formulation dispersed in the incision regions thereof comprises at least one of a prescribed optical power addition and a prescribed increase of depth of focus (Para. 0031).
Regarding claim 16, Berry discloses, the patterning utility is configured for carrying out one of the following: (i) transmitting selected ultra-sound waves for creating said surface relief on the cornea; (ii) performing mechanical etching of said surface relief on the cornea; (iii) providing optical energy for creating said surface relief on the cornea (Para. 0031 and see 102).
Regarding claim 17, Berry discloses, the patterning utility is configured for providing optical energy for creating said surface relief on the cornea, the optical energy providing the incision regions at a selected ablation depth in the cornea (Para. 0031 and see 102).
Regarding claim 18, Berry discloses, the selected vision correction pattern is configured as a diffractive pattern (Para. 0085).
Regarding claim 21, Berry discloses, the patterning utility is configured for communication with a correction pattern module for receiving therefrom said prescribed data indicative of the selected vision correction pattern, wherein said correction pattern module is configured for determining, or retrieving from a storage utility, said prescribed data based on input data indicative of required vision correction for an individual's eye (Para. 0040 and see 120).
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 2-5 and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 2008/0027418; already of record) as applied to claim 1 above, in view of Hai et al. (Maghemite nanoparticles coated with human serum albumin: combining targeting by the iron-acquisition pathway and potential in photothermal therapies; already of record).
Berry remains as applied to claim 1 above.
Berry does not explicitly disclose the ophthalmological formulation contains a plurality of nanoparticles.
Hai teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the ophthalmological formulation contains a plurality of nanoparticles (Abstract and Pages 4-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the ophthalmological formulation contains a plurality of nanoparticles as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 3, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the plurality of nanoparticles comprises protein-containing nanoparticles (Abstract and Pages 4-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 4, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the plurality of nanoparticles comprises metal-containing nanoparticles (Abstract and Pages 4-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 5, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the plurality of nanoparticles comprises metal-containing nanoparticles (Abstract and Pages 4-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 8, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the protein-containing nanoparticles comprise albumin type proteins (Abstract and Page 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 9, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the protein-containing nanoparticles comprise human serum albumin proteins (Abstract and Page 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 10, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the protein-containing nanoparticles comprise metallic nanoparticles wrapped by biocompatible protein chains (Abstract and Page 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 11, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the biocompatible protein chains comprise human serum albumin (HSA) protein chains (Abstract and Page 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 12, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the protein-containing nanoparticles comprise metallic nanoparticles carried by albumin shell (Abstract and Page 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 13, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the ophthalmological formulation is configured as a drug carrier for carrying one or more selected drugs (Page 2, Col. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 14, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the ophthalmological formulation is in the form of eye drops including an aqueous solution containing said plurality of nanoparticles (Abstract and Pages 4-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Regarding claim 15, Berry in view of Hai discloses and teaches as set forth above, and Hai further teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the aqueous solution includes at least one of water, bacteriostatic water, sodium chloride solutions, glucose solutions, liquid surfactant, or pH-buffered solution (Page 8, lines 17-21).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the kit for use in correction of visual impediments of an individual of Hai in the kit for use in correction of visual impediments of an individual of Berry since Hai teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a high-performance kit for use in correction of visual impediments of an individual.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 2008/0027418; already of record) as applied to claim 1 above, in view of Zalevsky (US 7,859,769; already of record).
Berry remains as applied to claim 1 above.
Berry does not disclose the selected vision correction pattern is configured as a phase effecting interference pattern.
Zalevsky teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the selected vision correction pattern is configured as a phase effecting interference pattern (Col. 7, lines 38-45).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the selected vision correction pattern is configured as a phase effecting interference pattern as taught by the kit for use in correction of visual impediments of an individual of Zalevsky in the kit for use in correction of visual impediments of an individual of Berry since Zalevsky teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a kit for use in correction of visual impediments of an individual with reduced imaging errors.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 2008/0027418; already of record) as applied to claim 1 above, in view of The Applicant’s Admitted Prior Art (herein referred to as the “AAPA”).
Berry remains as applied to claim 1 above.
Berry does not disclose the selected vision correction pattern comprises a Fresnel rings pattern.
The AAPA teaches, from the same field of endeavor that in a kit for use in correction of visual impediments of an individual that it would have been desirable to make the selected vision correction pattern comprises a Fresnel rings pattern (Para. 0003).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the selected vision correction pattern comprises a Fresnel rings pattern as taught by the kit for use in correction of visual impediments of an individual of the AAPA in the kit for use in correction of visual impediments of an individual of Berry since the AAPA teaches it is known to include this feature in a kit for use in correction of visual impediments of an individual for the purpose of providing a kit for use in correction of visual impediments of an individual with increased depth of focus and suitable optical power.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Peyman (US 2017/0007395) discloses a kit for use in correction of visual impediments of an individual that includes a patterning utility and an ophthalmological formulation made of biocompatible material.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWAYNE A PINKNEY whose telephone number is (571)270-1305. The examiner can normally be reached M-F 9-5.
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/DAWAYNE PINKNEY/Primary Examiner, Art Unit 2872 08/05/2026
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