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 .
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 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.
Disposition of the Claims
Claims 21-40 are pending.
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.
Claims 21, 24, 25, 31-33, 35, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chow (US 10001660 B1, of record).
Regarding claim 21, Chow teaches a contact lens (Figs. 2, 3, 6) for shaping a cornea of an eye of a patient to treat high cylinder astigmatism, the contact lens comprising:
a first portion (C. 7, ll. 19-35, “the shape profile (comprised of a number of curve regions 50—see FIGS. 4 and 5—with example widths) of the contact lens 32 provides for areas of positive 37 and negative 38 forces to promote movement 40 of the epithelium tissue”) configured to cause migration (40) of epithelial cells from a periphery of the cornea of the eye of the patient towards a center of the cornea of the eye of the patient (see Figs. 2 and 3 and C. 7, ll. 36-45, “The push-pull balance of the different zones 50 provides for a pull-on of the tissues in the alignment zone D towards the reverse zone C as directed via the relief zone F, as well as push-off of the tissues in the treatment zone (zones A and B)”), the first portion extending from one or more outer edges of the contact lens (the portion providing the positive force 38);
a second portion (center of zones A+B indicated at 32 in Figs. 3 and 6, where Fig. 2 shows the positive pressure produced at that center) configured to cause migration of the epithelial cells from the center of the cornea towards the periphery of the cornea (into zone C that creates the space 36 and thus a negative pressure; see C. 7, ll. 36-45, “The push-pull balance of the different zones 50 provides for a pull-on of the tissues in the alignment zone D towards the reverse zone C as directed via the relief zone F, as well as push-off of the tissues in the treatment zone (zones A and B)”), the second portion being positioned at a center of the contact lens (Figs. 2 and 3); and
a staining feature (see Fig. 6, boundary between AC and FC where the lens surface itself contacts the corneal surface) configured to contact the cornea (34), thereby reshaping the cornea (C. 6, ll. 36-45, “the lens 32 is designed herein as a reverse geometry lens 32 (RGL) that reforms or molds epithelium tissue through applying both compression and tension forces at different sites across the corneal surface”) to treat high cylinder astigmatism (C. 11, ll. 18-25, “Further, the aspheric zone B (or zones A and B) can create even and smooth central applanation (otherwise known as flattening of the convex surface 34) at the center to provide clear vision and inhibit any mixed astigmatism during treatment (i.e. application of the designed lens 32 to the eyeball 30)”).
Regarding claim 24, Chow discloses the contact lens of claim 21, and further discloses wherein the first portion and the second portion are concave (Figs. 2 and 6), and wherein the staining feature is convex (id.) and the second portion has one or more base curves (sequitur that an ophthalmological lens exhibits base curves e.g. the profiles depicted in Figs. 2, 4-6).
Regarding claim 25, Chow discloses the contact lens of claim 21, wherein the staining feature is configured to apply a staining pattern to the cornea between the first portion and the second portion (sequitur since the lens contacts the corneal surface as in Fig. 6, which epithelial tissue inherently stains in response to mechanical force).
Regarding claim 31, Chow discloses a method of treating high cylinder astigmatism, the method comprising: providing a contact lens (32) for shaping a cornea of an eye of a patient (C. 7, ll. 19-35, “the shape profile (comprised of a number of curve regions 50—see FIGS. 4 and 5—with example widths) of the contact lens 32 provides for areas of positive 37 and negative 38 forces to promote movement 40 of the epithelium tissue”), the contact lens comprising:
a first portion configured to cause migration of epithelial cells from a periphery of the cornea of the eye of the patient towards a center of the cornea of the eye of the patient, the first portion extending from one or more outer edges of the contact lens (see Figs. 2 and 3, and C. 7, ll. 36-45, “The push-pull balance of the different zones 50 provides for a pull-on of the tissues in the alignment zone D towards the reverse zone C as directed via the relief zone F, as well as push-off of the tissues in the treatment zone (zones A and B)”); and
a second portion (center of zones A+B indicated at 32 in Figs. 3 and 6, where Fig. 2 shows the positive pressure produced at that center) configured to cause migration of the epithelial cells from the center of the cornea towards the periphery of the cornea (into zone C that creates the space 36 and thus a negative pressure; see C. 7, ll. 36-45, “The push-pull balance of the different zones 50 provides for a pull-on of the tissues in the alignment zone D towards the reverse zone C as directed via the relief zone F, as well as push-off of the tissues in the treatment zone (zones A and B)”), the second portion being positioned at a center of the contact lens (Figs. 2 and 3).
Regarding claim 32, Chow discloses the method of claim 31, and further discloses wherein the first portion and the second portion are concave (see Figs. 2 and 6; cf. Applicant’s Figure 3A).
Regarding claim 33, Chow discloses the method of claim 31, and further discloses further comprising: a staining feature (see Fig. 6, boundary between AC and FC where the lens surface itself contacts the corneal surface) configured to contact the cornea (34), thereby reshaping the cornea (C. 6, ll. 36-45, “the lens 32 is designed herein as a reverse geometry lens 32 (RGL) that reforms or molds epithelium tissue through applying both compression and tension forces at different sites across the corneal surface”) to treat high cylinder astigmatism (C. 11, ll. 18-25, “Further, the aspheric zone B (or zones A and B) can create even and smooth central applanation (otherwise known as flattening of the convex surface 34) at the center to provide clear vision and inhibit any mixed astigmatism during treatment (i.e. application of the designed lens 32 to the eyeball 30)”).
Regarding claim 35, Chow discloses the method of claim 33, and further discloses wherein the staining feature includes at least one of: a first staining feature positioned at the one or more outer edges of the contact lens, or a second staining feature positioned at an end of the second portion (Figs. 2, 4-6, showing high height staining features between the portions and at the edge).
Regarding claim 38, Chow discloses the method of claim 36, and further discloses wherein the first portion, the second portion, and the third portion are integrally formed (integrated into a contact lens as in Figs. 2-6).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 29, 30, 39, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Chow as applied to claim 21 above.
Regarding claim 29, Chow discloses the contact lens of claim 21, but does not explicitly show wherein a width of the first portion is approximately 0.1 mm to 0.5 mm, a radius of curvature of the first portion is approximately 10.0 mm to 13.5 mm, and a Diopter reading of the first portion is approximately 33.75 Diopter to 25 Diopter. Nevertheless, since the contact lens of Chow is functional for epithelial remodeling of myopic and astigmatic eyes as detailed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the claimed dimensions according to patient ophthalmological needs for the purpose of epithelial remodeling toward vision correction, 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).
Regarding claim 30, Chow discloses the contact lens of claim 21, but does not explicitly show wherein a width of the second portion is approximately 5.00 mm to 7.50 mm, a radius of curvature of the second portion is approximately 6.5 mm to 9.5 mm, and a Diopter reading of the second portion is approximately 52.00 Diopter to 35.50 Diopter. Nevertheless, since the contact lens of Chow is functional for epithelial remodeling of myopic and astigmatic eyes as detailed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the claimed dimensions according to patient ophthalmological needs for the purpose of epithelial remodeling toward vision correction, 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).
Regarding claim 39, Chow discloses the method of claim 31, but does not explicitly show wherein a width of the first portion is approximately 0.1 mm to 0.5 mm, a radius of curvature of the first portion is approximately 10.0 mm to 13.5 mm, and a Diopter reading of the first portion is approximately 33.75 Diopter to 25 Diopter. Nevertheless, since the contact lens of Chow is functional for epithelial remodeling of myopic and astigmatic eyes as detailed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the claimed dimensions according to patient ophthalmological needs for the purpose of epithelial remodeling toward vision correction, 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).
Regarding claim 40, Chow discloses the method of claim 31, but does not explicitly show wherein a width of the second portion is approximately 5.00 mm to 7.50 mm, a radius of curvature of the second portion is approximately 6.5 mm to 9.5 mm, and a Diopter reading of the second portion is approximately 52.00 Diopter to 35.50 Diopter. Nevertheless, since the contact lens of Chow is functional for epithelial remodeling of myopic and astigmatic eyes as detailed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the claimed dimensions according to patient ophthalmological needs for the purpose of epithelial remodeling toward vision correction, 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).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-40 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10725321. Although the claims at issue are not identical, they are not patentably distinct from each other because the narrower scope of the ‘321 patent’s claims reads on the broader scope of the instant claims 21-40.
Allowable Subject Matter
Claims 22, 23, 26-28, 34, 36, and 37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 22, Chow discloses the contact lens of claim 21, wherein the staining feature is positioned at the one or more outer edges of the contact lens.
Regarding claim 23, Chow discloses the contact lens of claim 21, wherein the staining feature is positioned at an end of the second portion.
Regarding claim 26, Chow discloses the contact lens of claim 21, further comprising: a third portion having the staining feature, and the third portion having one or more reverse curves.
Regarding claims 27 and 28, the dependent claims depend from a claim that recites allowable subject matter and thus recite allowable subject matter.
Regarding claim 34, Chow discloses the method of claim 33, but does not explicitly show wherein the staining feature is configured to apply a ribbon-shaped staining pattern to the cornea between the first portion and the second portion.
Regarding claim 36, Chow discloses the method of claim 33, but does not explicitly show further comprising: a third portion having the staining feature, and the third portion having one or more reverse curves.
Regarding claim 37, the dependent claim depends from a claim that recites allowable subject matter and thus recites allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20220221736 A1 discloses orthokeratology lenses for growth rate control
US 20180024381 A1 discloses orthokeratology lenses for stromal remodeling
KR 101435777 B1 discloses orthokeratology lenses for treating myopia and astigmatism
US 8500273 B2 discloses orthokeratology lenses for treating ametropia
JP 2008112120 A discloses orthokeratology lenses having multiple surface fittings
US 20020186344 A1 discloses orthokeratology lenses for treating hyperopia and presbyopia
US 5428412 A discloses orthokeratology lenses for corneal remodeling
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLLIN X BEATTY whose telephone number is (571)270-1255. The examiner can normally be reached M - F, 10am - 6pm.
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/COLLIN X BEATTY/Primary Examiner, Art Unit 2872
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