*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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on October 17, 2025 has been entered.
Priority
This application is a 371 of PCT/US2020/041837 filed on 07/13/2020, and claims benefit
in provisional application 62/873,121 filed on 07/11/2019.
Claim Status
Claims 1-40 are pending. Claims 25-40 remain withdrawn. Claims 41-92 were canceled. Claims 1, 10, 25, and 33 were amended. Claims 1-24 are examined.
Withdrawn Claim Rejections — 35 USC § 103 and Double Patenting
All previous rejections are withdrawn because claim 1 was amended to require the secondary therapeutic agent to be selected from a list of drugs, which are not obvious over the cited references. Applicant’s arguments directed to these rejections are moot because rejections are withdrawn.
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 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.
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 1-21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ambati (WO 2017/155580 Al, published September 14, 2017) and Ostrow (CA 2 953 363 Published December 30, 2015).
The claims are drawn to a method of treating or preventing progression of myopia, comprising administering a therapeutically effective amount of an ophthalmic composition to an eye of a subject during a treatment period, said ophthalmic composition comprising: a corneal cross-linking agent and a secondary therapeutic agent present in amounts sufficient to treat myopic progression; wherein the secondary therapeutic agent is selected from the groups consisting of atropine, among others, and a pharmaceutically acceptable carrier.
The teachings of Ambati are related to an ophthalmic composition or dosage form that can include a therapeutically effective amount of a cross-linking agent and a pharmaceutically acceptable carrier. The composition or dosage form can be used to treat an ophthalmic condition by administering a therapeutically effective amount of the composition to an eye of a subject during a treatment period (Abstract). For example, keratoconus (KCN) is a progressive disorder associated with structural changes in corneal collagen organization that can lead to corneal thinning and ruptures in Bowman's layer and/or Descemet's membrane. Typically, the disease manifests in the second decade of life when the cornea assumes a more conical shape, which leads to irregular astigmatism, progressive myopia, corneal thinning and subsequently poor visual acuity (page 1 lines 14-19). Treating can be to reduce, ameliorate or eliminate symptoms associated with a condition present in a subject, or can be prophylactic, (i.e. to prevent or reduce the occurrence of the symptoms in a subject). Such prophylactic treatment can also be referred to as prevention of the condition (page 4 lines 27-30).
In one example, an ophthalmic composition or dosage form is described herein. The ophthalmic composition or dosage form can include an amount of a cross-linking agent, such as a copper-containing agent, that is sufficient to increase lysyl oxidase activity in an eye of a subject or otherwise increase cross-linking in the cornea of the subject. The composition or dosage form can further include a pharmaceutically acceptable carrier. In some examples, the dosage form can be an ophthalmic composition formulated as a topical eye drop and carried in a container adapted to dispense the composition in a drop-wise manner at a drop volume of from about 5 ul to about 50 ul. In another embodiment, a method is described for using such a composition or dosage form. The method can include administering a therapeutically effective amount of a composition or dosage form, as described herein, during a treatment period
(paragraph bridging pages 6-7). The compositions, dosage forms, and methods can be used to treat a variety of ophthalmic indications. For example, a variety of ophthalmic conditions can cause corneal thinning, biomechanical weakness of the cornea, and other corneal complications. Such conditions can include corneal ulcers, peripheral ulcerative keratitis, corneal melts, pellucid marginal degeneration, Terrien's marginal degeneration, neurotrophic disease of the cornea, corneal ectasia (such as after refractive surgery), keratoconus, the like, or combinations thereof (page 7 lines 14-25). The consequences of KCN are as variable as its epidemiology, ranging from mild astigmatism to severely distorted vision. However, treatment options are surprisingly limited. Most mild KCN can be corrected with glasses or soft contacts but very often patients will need toric or hard contacts as the disease progresses. Ultimately, 1 in 5 patients will require surgery, most commonly deep anterior lamellar keratoplasty or a penetrating corneal transplant. Such procedures require considerable costs and entail significant risk of intraoperative and post-operative complications (bleeding, scarring, cataract formation, etc.). Thus, more effective pre-surgical treatment options are desperately needed. Intacs (clear crescent-shaped pieces of plastic polymer) have been used as a treatment option for mild to moderate keratoconus. These intrastomal corneal rings are inserted as a minimally invasive procedure and have a 74% success rate at restoring 20/20 best-corrected vision. However, cost and risk (neovascularization, channel deposits, secondary surgery etc.) are again limiting. Methods to strengthen collagen cross-links have also been attempted. Corneal Collagen Cross-link (CXL) therapy is a well-tolerated technique where riboflavin drops are applied over or under the corneal epithelium and ultraviolet-A light is then employed to release free oxygen radicals to strengthen collagen bonds. This procedure has been shown to significantly delay or halt progression of KCN. Although this technique carries minimal side-effects (the energy-rich UVA light and excessively high concentration of free oxygen radicals can cause toxicity), it is still cost- prohibitive to many subjects. The current disclosure describes an alternative composition, dosage form, and method for strengthening collagen cross-links using a cross-linking agent, such as a copper-containing agent, a calcium-containing agent, a magnesium-containing agent, a silver- containing agent, an aluminum-containing agent, a zinc-containing agent, iron-containing agent, or other suitable cross-linking agent. Some specific, but non-limiting, examples of cross- linking agents can include acai extract, decorin, copper (II) sulfate, or combinations thereof. In some examples, the cross-linking agent can be or include any divalent or multivalent ion or compound that is suitable to induce or facilitate cross- linking in the cornea (page 8 lines 1-30). The copper- containing agent can also be administered with a therapeutically effective amount of a second active or therapeutic agent. Such additional agents can include riboflavin, rose bengal, hydroxylysine, the like, or combinations thereof (page 11 lines 17-19).
Ambati does not teach a secondary therapeutic agent as required by applicant’s definition.
The teachings of Ostrow are related to ophthalmic compositions and methods of arresting or preventing myopia development by administering to an eye of an individual in need thereof an effective amount of an ophthalmic composition as described herein (Abstract). The ophthalmic composition comprises from about 0.001 wt. % to about 0.05 wt. % of a muscarinic antagonist and deuterated water, at a pD of from about 4.2 to about 7.9 (paragraph 0003). The muscarinic antagonist includes atropine (paragraph 0004). In one embodiment, the composition is in the form of an aqueous solution (paragraph 0014). The ophthalmic composition is formulated as an ophthalmic solution for the treatment of an ophthalmic disorder. In some embodiments, the ophthalmic disorder or condition is pre-myopia, myopia, or progression of myopia. In some embodiments, the ophthalmic composition is formulated as an ophthalmic solution for the treatment of pre-myopia, myopia, or progression of myopia (paragraph 0029). The composition is a solution (paragraph 0030). One embodiment teaches a method of arresting myopia development that comprises administering to an eye of an individual in need thereof an effective amount of the ophthalmic composition. One embodiment teaches a method of preventing myopia development that comprises administering to an eye of an individual in need thereof an effective amount of an ophthalmic composition described herein. In some embodiments, described herein is a method of arresting or preventing myopia development, comprising administering to an eye of an individual in need thereof an effective amount of an ophthalmic composition comprising from about 0.001 wt. % to about 0.05 wt. % of a muscarinic antagonist and deuterated water, at a pD of from about 4.2 to about 7.9 (paragraph 0031). Typical ophthalmic aqueous solutions are packaged in eye drop bottles and administered as drops. For example, a single administration (i.e. a single dose) of an ophthalmic aqueous solution includes a single drop, two drops, three drops or more into the eyes of the patient. In some embodiments, one dose of the ophthalmic aqueous solution described herein is one drop of the aqueous solution composition from the eye drop bottle (paragraph 00187). Table 1 teaches an ophthalmic aqueous solution
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(paragraph 00303).
The teachings of Ambati and Ostrow are related to methods of treating myopia comprising topically administering an effective amount of a therapeutic agent to an eye of a subject, and it would have been obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claims 1 and 10, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have practiced a method of treating or preventing progression of myopia caused by KCN comprising administering a therapeutically effective amount of a composition to an eye of a subject wherein the composition comprises a copper-containing agent and a secondary therapeutic agent present in amounts sufficient to treat myopic progression caused by KCN and a pharmaceutically acceptable carrier, with a reasonable expectation of success because Ambati teaches a method of treating keratoconus (KCN), which is known to lead to progressive myopia, comprising administering a therapeutically effective amount of a composition to an eye of a subject during a treatment period, wherein the composition comprises a therapeutically effective amount of a copper-containing agent that is sufficient to increase lysyl oxidase activity in an eye of a subject or otherwise increase crosslinking in the cornea of the subject, a therapeutically effective amount of a second active or therapeutic agent, and a pharmaceutically acceptable carrier. Ambati does not teach a suitable second active or therapeutic agent. It would have been prima facie obvious to a person of ordinary skill in the art to have selected atropine as the second active agent in Ambati’s formulation, with a reasonable expectation of success because Ostrow teaches treating myopia by administering an ophthalmic formulation comprising atropine to an eye of a subject.
The selection of a known material suitable for its intended purpose supports obviousness and combining prior art elements according to known methods to obtain predictable results supports obviousness.
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Regarding claim 2, it would have been obvious to have formed the composition in the form of a gel, with a reasonable expectation of success because Ambati teaches gels as suitable pharmaceutically acceptable carriers (page 11 lines 25-30).
Regarding claim 3, it would have been obvious to have formed the composition as a sustained release composition configured to release the therapeutic agents over a predetermined period of time, with a reasonable expectation of success because Ambati teaches formulating the composition to biodegrade and provide controlled and sustained releases of the active agent over a predetermined period of time (page 14 lines 25-27). It would have been obvious to have
formulated the composition to release the therapeutic agents for a period of from about 1 month until the condition has been satisfactorily resolved with a reasonable expectation of success because Ambati teaches that the treatment period lasts from about 1 month until the condition has been satisfactorily resolved (page 16 lines 18-28). The claimed time period is obvious because it overlaps with the prior art time range.
Regarding claim 4, it would have been obvious to have administered the composition to the eye in dropwise manner or ocular instillation with a reasonable expectation of success because Ambati teaches administering the composition in the form of a drop to an eye (page 15 lines 22-24) and Ostrow teaches administering the composition to an eye wherein the composition is an eye drop composition. The drop would have spread to the cul-de-sac of the eye and the conjunctival fornix of the eye as a result of the administering.
Regarding claim 5, it would have been obvious to have administered the composition 1-4 times per day, where the dosage amount at teach time point is 5-50 uL, with a reasonable expectation of success because Ambati teaches said frequency and dosage amounts (page 16 lines 14-17). It would have been obvious to have formulated the composition to provide from about 0.0005 pg to about 0.5 ug of copper per administration event, with a reasonable expectation of success because Ambati teaches said amounts as suitable (page 14 lines 9-13). The claimed range is obvious because it overlaps with the prior art ranges, whether prior art composition is administered 1, 2, 3, or 4 times per day. Once a day administration would deliver about 0.0005 ug to about 0.5 ug of copper, twice per day administration would deliver 0.001-1 ug of copper, three times per day administration would deliver 0.0015-1.5 ug of copper, and four times per day administration would deliver 0.002-2 ug of copper.
Regarding claim 6, it would have been obvious to have formulated the composition to contain 0.001-0.05 wt. % atropine because Ostrow teaches said concentration range as a suitable concentration range of atropine in an ophthalmic composition (paragraph 00303). A composition having 0.001-0.05 wt. % of atropine is configured to deliver claimed amount of atropine to the eye of the subject, absent evidence to the contrary.
Regarding claims 7 and 8, it would have been obvious to have formulated the composition to comprise 0.001-0.05% of atropine, with a reasonable expectation of success because Ostrow teaches 0.001-0.05 wt. % of atropine as a suitable concentration range of atropine in an ophthalmic composition. The claimed ranges are obvious because they overlap with 0.001-0.05 wt. %.
Regarding claim 9, it would have been obvious to have selected Ostrow’s composition from Example 1 in Ambati’s composition because Ostrow teaches that the composition in Example 1 is suitable for ophthalmic administration and teaches that the composition suitable for treating myopia. The composition contains 0.01-0.5 mg/g of atropine and the composition is mostly deuterated water. It would have been reasonable to conclude that the density of the solution as about 1.11 g/mL because deuterated water is the main component of the composition, and it was known that the density of deuterated water is 1.11 g/mL. Therefore, the concentration of atropine in the solution in mg/mL would have been from about 0.009 mg/mL to about 0.45 mg/mL. the claimed concentration range is obvious because it overlaps with from about 0.009 mg/mL to about 0.45 mg/mL.
Regarding claims 11-13, Ambati teaches a container of about 0.5 ml to about 50 ml where the container can hold a plurality of dosage forms or a single dosage form. In some examples, about 0.005 mg to about 1 mg of the copper-containing agent can be included in the container (page 15 lines 8-18). A 0.5 ml container would have a concentration of copper from 0.01 mg/ml to 2 mg/ml. A 50 ml container would have a concentration of copper from 0.0001 mg/ml to 0.02 mg/ml. The claimed concentration ranges are obvious because they overlap with prior art concentration ranges.
Regarding claim 14, it would have been obvious to have selected copper sulfate as the copper-containing compound, with a reasonable expectation of success because Ambati teaches copper sulfate (page 9 lines 15-20).
Regarding claim 15, it would have been obvious to have formulated the carrier with solubilizing agent, a tonicity agent, a pH adjuster, a thickener or gelling agent, a polymer or polymeric matrix, a preservative, water, and combinations thereof, with a reasonable expectation of success because Ambati teaches said components as suitable for making a pharmaceutically acceptable carrier (paragraph bridging pages 11-12).
Regarding claim 16, it would have been obvious to have formed the composition having a tonicity of from about 250 to about 350 mOsm/L, with a reasonable expectation of success because Ambati teaches said range as suitable (page 12 lines 13-19).
Regarding claim 17, it would have been obvious to have formed the pH of the composition in the range of about 5.5 to about 8.5, with a reasonable expectation of success because Ambati teaches from about 5.5 to about 8.5 as a suitable pH range of the composition (page 12 lines 25-30).
Regarding claim 18, it would have been obvious to have administered the composition in a dropwise manner at a drop volume of from about 5 ul to about 50 wl, with a reasonable expectation of success because Ambati teaches said range as suitable (page 15 lines 22-24). The claimed range is obvious because it overlaps with the prior art range.
Regarding claim 19, Ambati teaches a container of about 0.5 ml to about 50 ml where the container can hold a plurality of dosage forms or a single dosage form. In some examples, about
0.005 mg to about 1 mg of the copper-containing agent can be included in the container (page 15 lines 8-18). A 0.5 ml container would have a concentration of copper from 0.01 mg/ml to 2 mg/ml. A 50 ml container would have a concentration of copper from 0.0001 mg/ml to 0.02 mg/ml. It would have been obvious to have administered the composition in a dropwise manner at a drop volume of from about 5 ul to about 50 ul, with a reasonable expectation of success because Ambati teaches said range as suitable (page 15 lines 22-24).
A 5 ul (equivalent to 0.005 ml) drop having a copper concentration of from 0.0001 mg/ml to 2 mg/ml would deliver 0.0000005 mg to 0.01 mg of copper.
A 50 ul (equivalent to 0.05 ml) drop having a copper concentration of from 0.0001 mg/ml to 2 mg/ml would deliver 0.000005 mg to 0.1 mg of copper.
The claimed range is obvious because it overlaps with the prior art range.
Regarding claim 20, it would have been obvious to have administered the composition from 1 to 4 time points per day per eye in need thereof, with a reasonable expectation of success because Ambati teaches 1-4 times per day as a suitable administration frequency. A person skilled in the art would have recognized that the administration schedule is per eye in need of treatment.
Regarding claim 21, it would have been obvious to have administered the composition in a dropwise manner at a drop volume of from about 5 ul to about 50 wl, with a reasonable expectation of success because Ambati teaches said range as suitable (page 15 lines 22-24). Each administration time point would have required at least one drop, which would have provided 5- 50 ul of the composition. The claimed range is obvious because it overlaps with the prior art range.
Regarding claim 23, it would have been obvious to have treated a patient of 10-30 years old, with a reasonable expectation of success because Ambati teaches treating children and teenagers of ages 10-18, and adults of age 18-30 (page 16 lines 18-25).
Regarding claim 24, it would have been obvious to have treated a patient for a period form about 6 months to about 12 months or until the conditions has been satisfactorily resolved (page 16 lines 25-28).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ambati and Ostrow as applied to claims 1-21, 23, and 24 above, and further in view of Wesley (WO 98/52090 Published November 19, 1998).
The claim further defines the method of claim 1.
The teachings of Ambati and Ostrow are relied upon as described above. They do not teach an ocular-shaping device configured to re-shape an elongated myopic eye.
The teachings of Wesley are related to a device for creating an imprint on the eye comprising a first zone for facilitating tear exchange, a second zone defining a pressure curve, a third zone defining a relief area for receiving the cornea displaced from the second zone, and a fourth zone defining a base curve for imparting outward pressure on the eye (Abstract). In one embodiment, a contact lens that can be used for orthokeratology is provided (page 5 lines 20-21). One embodiment provides a lens that can be used to reshape the cornea of a myopic patient (paragraph bridging pages 12-13).
The teachings of Wesley and Ambati modified by Ostrow are related to methods of treating myopia, and it would have been obvious to have combined them because they are in the same field of endeavor. It would have been obvious to have administered Ambati’s composition
modified by Ostrow using a lens, with a reasonable expectation of success because Ambati teaches that a contact lens may be used to administer the composition (page 11 lines 25-32). It would have been obvious to have selected a lens for reshaping the cornea of a myopic eye, with a reasonable expectation of success because a lens for reshaping cornea of a myopic patient was known from Wesley. The selection of a known material based on its suitability for its intended purpose supports obviousness and combining prior art elements according to known methods to obtain predictable results supports obviousness.
Double Patenting Rejections
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 18/546,258 in view of Wesley, Ambati, and Ostrow. The teachings of copending claims and prior art references are related to methods of treating myopia. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method in copending claims with the teachings of Ambati and Ostrow to arrive at the invention of present claims 1-21, 23, and 24, with a reasonable expectation of success for the same reasons described in detail above. It would have been further obvious to have modified the method of copending claims as modified by Ambati and Ostrow by Wesley in order to arrive at the invention of present claim 22, with a reasonable expectation of success for the same reasons as described above in the rejection.
This is a provisional nonstatutory double patenting rejection.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/080,466 in view of Wesley, Ambati, and Ostrow. The teachings of copending claims are related to compositions for treating myopia and prior art references are related to methods of treating myopia. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the composition of copending claims in a method of treating myopia, with a reasonable expectation of success because the intended use of the claimed composition is treatment of myopia. It would have been obvious to have treated the
myopia using the method steps of Ambati and Ostrow because these references are concerned with methods of treating myopia. It would have been obvious modified the copending claims with the teachings of Ambati and Ostrow to arrive at the invention of present claims 1-21, 23, and 24, with a reasonable expectation of success for the same reasons described in detail above. It would have been further obvious to have modified the method of copending claims as modified by Ambati and Ostrow by Wesley in order to arrive at the invention of present claim 22, with a reasonable expectation of success for the same reasons as described above in the rejection.
This is a provisional nonstatutory double patenting rejection.
Claims 1-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,524,032 (of record in IDS dated 02/15/2023) in view of Wesley, Ambati, and Ostrow. The teachings of patented claims and prior art references are related to methods of treating myopia. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method in patented claims with the teachings of Ambati and Ostrow to arrive at the invention of present claims 1-21, 23, and 24, with a reasonable expectation of success for the same reasons described in detail above. It would have been further obvious to have modified the method of patented claims as modified by Ambati and Ostrow by Wesley in order to arrive at the invention of present claim 22, with a reasonable expectation of success for the same reasons as described above in the rejection.
Claims 1-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,065,275 in view of Wesley, Ambati, and Ostrow. The teachings of patented claims are drawn to methods of treating keratoconus and prior art references are related to methods of treating myopia. As evidenced by Ambati, keratoconus leads to progressive myopia. Thus, it would have been obvious to treat myopia using the method of patented claims. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method in patented claims with the teachings of Ambati and Ostrow to arrive at the invention of present claims 1-21, 23, and 24, with a reasonable expectation of success for the same reasons described in detail above. It would have been further obvious to have modified the method of patented claims as modified by Ambati and Ostrow by Wesley in order to arrive at the invention of present claim 22, with a reasonable expectation of success for the same reasons as described above in the rejection.
Response to Arguments
Applicant’s arguments, that are relevant to Ambati, submitted in the remarks dated October 17, 2025 were fully considered, but are not persuasive for the following reasons.
Applicant’s argument that Ambati does not teach treating or preventing progression of myopia at all, is not persuasive because based on the phrase "the disease manifests itself in the second decade of life when the cornea assumes a more conical shape, which leads to irregular astigmatism, progressive myopia,...", a person skilled in the art would have understood that KCN manifests in the second decade of life when the cornea assumes a more conical shape, which leads to progressive myopia. In other words, KCN becomes apparent or obvious when the cornea assumes a conical shape which leads to progressive myopia. The conical shape of the cornea is a result of KCN disease. To further show that examiner's interpretation of Ambati's background section is correct, the following references are provided as evidence:
"Keratoconus" (https:/Awww.cedars-sinai.org/health-library/diseases-and-conditions/k/keratoconus.html, accessed May 23, 2025, pages 1-6 – of record in PTO-892 dated May 29, 2025) and
"Why Keratoconus Causes Nearsightedness" (https://keratoconustreatments.com/ why-keratoconus-causes-nearsightedness/, Accessed May 23, 2025, pages 1-4 – of record in PTO-892 dated May 29, 2025).
"Keratoconus” teaches that keratoconus is an eye disorder in which the cornea thins over time. The cornea also bulges out to form a conelike shape. These changes in the cornea can cause vision problems such as myopia and astigmatism (page 1). Keratoconus causes myopia (page 2).
"Why Keratoconus Causes Nearsightedness" teaches that the normally round-shaped cornea is elongated into a cone-shape in keratoconus. Not only does the abnormally shaped cornea cause myopia in a person with keratoconus, but it can cause other vision impacting symptoms such as sensitivity to sunlight (page 2).
Applicant argued that it would not have been obvious to use a secondary active agent to treat progressive myopia.
The argument is not persuasive because Ambati teaches that a secondary active agent may be used in the treatment method, thus Ambati intended to treat progressive myopia with a combination of active agents. Since Ambati does not limit the secondary active agent, it would have been obvious to select another active agent intended for treating progressive myopia and used in Ambati’s method. There is no evidence on the record showing that a secondary active agent would not have been suitable for use with Ambati’s copper active agent. The skilled artisan would have been capable of a selecting a secondary active agent and its concentration based on the teachings of the prior art. Since there is no reference on record teaching away from combining the copper active agent with a secondary active agent, the examiner maintains that it would have been obvious to select another active agent suitable for treating progressive myopia and combined with Ambati’s copper active agent.
Arguments against Takruri are moot because current rejections do not rely on the reference.
Arguments against the rejection of claim 22 are moot because the rejection is based on the argument that the cited references do not teach the secondary active agent as claimed, and the examiner agrees. The rejection over Ambati, Takruri, and Wesley is withdrawn.
Double patenting rejections were withdrawn and new rejections are made over references that teach newly added limitations.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alma - Pipic whose telephone number is (571)270-7459. The examiner can normally be reached M-F 9:00am-5:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/ALMA PIPIC/
Primary Examiner, Art Unit 1617