DETAILED ACTION
Status of Application
The response filed 12/01/2025 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1, 29 have been amended.
Claims 7, 11, 17 has been cancelled.
Claims 34-36 has been added.
Claims 1-2, 4-5, 9-10, 12-13, 15-16, 18, 21-23, 27-29, 34-36 are pending.
Claims 1-2, 4-5, 9-10, 12-13, 15-16, 18, 21-23, 27-29, 34-36 are present for examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn or moot as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-5, 9-10, 12-13, 15-16, 18, 21-23, 27-29, 34-36 are 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.
The independent claim and its dependent claims are directed to a method of treating corneal astigmatism, comprising administering a composition comprising from about 0.01 mg/mL to about 2.5 mg/mL of a copper-containing agent to an eye of a subject in need thereof, wherein the composition does not comprise an additional active ingredient. However the recitation that the “composition does not comprise an additional active ingredient” is indefinite as it is unclear what is the activity of the additional active ingredient that is being excluded. Preservatives are active ingredients but are recited in claim 10, buffers have activity and are active ingredients as they mitigate the pH of the composition but are recited in claim 10, and solubilizers improve the solubility of the composition. It does not allow one to ascertain the metes and bounds of the claims as written. For purposes of examination, the phrase is treated to be where the composition does not contain an additional therapeutic active agent.
Claim 34 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 34 recites the limitation "focal astigmatism" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
The claim is also indefinite as it recites “round astigmatism” which is unclear as astigmatism by definition is oval as addressed by Dr. H and by Ophthalmic Consultants of Vermont.
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When the cornea is round/spherical is normal and when oval it is has an astigmatism as established by Dr. H and by Ophthalmic Consultants of Vermont; wherein it is unclear what is “round astigmatism”. It is noted that all astigmatism results in multiple focal points (i.e. focal astigmatism, see Ophthalmic Consultants of Vermont) and would be oval wherein it does not allow one to ascertain the metes and bounds of the claims as written.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-5, 9-11, 13, 15-16, 18, 21-23, 27-28, 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Burr et al. (WO 2021/007578).
Rejection:
Burr et al. teaches treating eye conditions like astigmatism, keratoconus, myopia, and combinations thereof with the administration of a composition comprising a copper-containing agent like copper carbonate, copper chloride, copper fluoride, copper nitrate, copper perchlorate, copper iodide, and the exemplified cooper sulfate in a carrier (Example 2, crosslinker, Page 8 line 24-34, Page 14 line 18-26). The copper-containing agent can be administered alone or with a secondary therapeutic agent, and the copper containing agent is exemplified alone for administration (no additional active required, the Page 7 line 25-30, page 11 line 14-15, Page 14 line 16-17, Page 14 line 18-26, examples 1-4).
The composition forms comprising the crosslinking copper-containing agent include injections and sustained release forms and eyedrops with a drop volume from about 5µl to about 50µl (Page 4 line 26-30, Page 7 line 25-Page 8 line 6, Page 20 line 4-7, Page 15 line 8-16, Page 18 line 23-29). The copper-containing agent can be from about 0.00001%-about 15%wt. including from about 0.01--about 0.1% and the exemplified amount of 0.15mg/ml (falling within the claimed ranges, Page 10 lines 8-11 and 20-21, Page 20 line 26-Page 21 line 5, about 0.1mg/ml-about 1.0mg/ml=0.001-0.1%wt, Example 3).
The treatment can be administered once/day, 2x/day, 4x/day; for a duration for about 6 months to chronic treatment like 5 years until a desired outcome is achieved (Page 18 line 20-22, Page 20 line 26-32). The composition included a carrier comprising solubilizing agent, tonicity agent to have a tonicity such as about 270 to 330mOsm/L, pH adjuster to have a pH like about 5.-about 7.8, thickener, polymer or polymer matrix, preservative, water, and combinations thereof (Page 15 line 17-Page 13, see full document specifically areas cited).
Burr et al. does not expressly exemplify treating the astigmatism with the copper-containing agents, but does expressly teach treating these eye conditions like astigmatism with the administration of a therapeutic amount of copper-containing agent (crosslinker/therapeutic) wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the express teachings of the Burr et al. with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are centered on the assertion that Burr is concerned with multi agent ocular formulations that include a copper-containing agent and a secondary therapeutic agent wherein the instant method utilizes a composition where the copper-containing agent is the only active ingredient and the Examiner has not alleged that one would have been motivated to modify Burr to remove the secondary therapeutic agent.
This is fully considered but not persuasive.
Burr does teach treating eye conditions like astigmatism, keratoconus, myopia, and combinations thereof with the administration of a composition comprising a copper-containing agent and contrary to Applicant’s assertion - teaches that the copper-containing agent can be the active as one embodiment (alone) and also with a secondary therapeutic active as another embodiment (combination); and In fact, Burr exemplifies the copper-containing agent alone for administration where there is no additional therapeutic active required (Examples 2-4, Page 7 line 25-30, page 11 line 14-15), wherein it is prima facie obvious to utilize the taught embodiments such as where the copper containing active is the sole therapeutic active with a reasonable expectation of success.
Accordingly, the rejection stands.
Claims 29, 34 are rejected under 35 U.S.C. 103 as being unpatentable over Burr et al. (WO 2021/007578) as applied to claims 1-2, 4-5, 9-11, 13, 15-16, 18, 21-23, 27-28, 35-36 above, in view of Dr. H (astigmatism-A quick review of refractive errors).
Rejection:
The teachings of Burr et al. are addressed above.
Burr et al. does not expressly teach the type of astigmatism but does address treatment of astigmatism with copper-containing agents (crosslinker) in addition to keratoconus.
Dr. H teaches that astigmatism is an irregular curvature of the front part of the eye (cornea/lens) and the curvature is like a football (oval) with light at two different points (focal astigmatism), as when the corneal is normal it is spherical and has the same roundness all over like a basketball with one light point (normal). There are different types including regular astigmatism like bow-tie, and irregular astigmatism which can be from keratoconus (section - A quick review of refractive errors).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat regular bow tie astigmatism and irregular astigmatism (all astigmatism is structurally oval shaped with two light points (focal astigmatism)) as suggested by Dr. H and produce the claimed invention; as Burr et al. teaches treating astigmatism and it is prima facie obvious to treat the various types of astigmatism with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are to Burr which are addressed above. Applicant’s remaining argument are that Dr H is silent to copper compositions which is fully considered but not persuasive as it is against the reference individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Accordingly, the rejection stands.
Claims 1-2, 4-5, 9-10, 12-13, 15-16, 18, 21-23, 27-29, 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Coroneo (U.S. Pat. Pub. 2015/0164791) in view of Ambati et al. (U.S. Pat. Pub. 2019/0083529).
Rejection:
Coroneo teaches treating refractive errors like astigmatism and myopia by moulding corneal tissue by softening the cornea with a matrix metalloproteinase enzyme activator, shaping the cornea with a contact lens, applying a corneal hardening agent like crosslinker/oxidative hardener such as copper sulfate to retain the desired shape after lens removal (abstract, claims 1-2, 6, [14-22], does not recite the presence of keratoconus for the astigmatism). The corneal hardener like copper sulfate can be administered topically such as eyedrops, by contact lens, intraocularly, sustained release vehicles (claim 14-16, [30-32, 79, 82-83]). The corneal hardener such as copper sulfate is in a composition comprising one or more carriers/excipients including water, buffers, tonicity agents (i.e. isotonicity agents), polymers, solubilizing agents (claims 26-27, [42-43, 64, 77, 81], separate composition from initial corneal softener). The dose can be determined by one of skill in the art through routine experimentation and tested for its ability to produce corneal hardening [58]. A sufficient number of eye drops are applied topically to administer a desired concentration to the cornea ([79], see full document specifically areas cited).
While Coroneo does not exemplify treating astigmatism with copper sulfate, Coroneo does expressly teach treating refractive errors like astigmatism by moulding the cornea by softening the cornea, shaping the cornea with a lens and then hardening the cornea with a hardening agent like the claimed copper sulfate wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exemplify the teachings of Coroneo and produce the claimed invention with a reasonable expectation of success.
Coroneo does not expressly recite the amount of copper sulfate (corneal hardening agent/crosslinker/oxidative hardener) in the composition but does recite that the amount/dose can be determined by one of skill in the art through routine experimentation. Coroneo also does not recite the corneal hardening agent/crosslinker to be copper perchlorate but does teach the inclusion of corneal hardening agent/crosslinkers for the method.
Ambati et al. teaches that crosslinking agents (corneal hardener/crosslinker) such as copper sulfate and copper perchlorate, are known to be useful in ophthalmic compositions from about 0.000005 to about 5% including about 0.001 to about 0.1%wt., in forms like topical eyedrops with a drop volume from about 5µl to about 50µl and applied 1-4x/day for about 1 to chronic treatment like 36 months (abstract, [36, 43-45, 48, 69-71]) and useful for corneal conditions like keratoconus which presents with irregular astigmatism [3], and increases corneal tissue strength biomechanical weakness of the cornea (hardens the cornea [37-38]). Copper-containing compositions are known to be a pH from about 5.8 to about 7.8 and tonicity level of about 270 to about 330mOsm/L ([49, 54-55], claims 1-4, 6, 8-9, 12, 16-18, 20).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the copper sulfate from about 0.001-about 0.1% in an ophthalmic composition at the recited pH and tonicity level for the treatment duration as suggested by Ambati et al. and produce the claimed invention (falling within the instant claimed values i.e. about 0.01mg/ml-about 1.0mg/ml=0.001-0.1g/100ml=0.001-0.1%); as Coroneo teaches the use of copper sulfate in an ophthalmic composition with various carriers/excipients like buffers/pH adjuster and tonicity agents, and it is prima facie obvious to incorporate the copper sulfate at it’s known ophthlamically useful concentration, pH, and tonicity level with a reasonable expectation of success. While the prior art does not expressly teach the exact claimed values for the instant dependent claim (instant claim 9, about 0.1mg/ml-about 0.2mg/ml=about 0.01-about 0.02%wt.) it is embraced by the prior art range and Coroneo teaches that the amount/dose of the copper sulfate can be determined by one of skill in the art through routine experimentation wherein it would be prima facie obvious by one of ordinary skill in the art to optimize within the taught range and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality. It is also prima facie obvious use the copper sulfate at its known regimen (i.e. 1-4x/day like 2x/day) for as long as needed to attain the desired therapeutic profile absent evidence of criticality; and to treat the astigmatism wherever it presents itself such as the irregular astigmatism with keratoconus with a reasonable expectation of success. Simple substitution of one known crosslinker/corneal hardening agent for another such as copper perchlorate for copper sulfate is prima facie obvious with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are centered on the assertion that Coroneo recites copper sulfate in a laundry list of corneal hardening agents and only mentions astigmatism once and is focused on myopia, that the examples are prophetic and do not utilize copper, that Coroneo is silent on the amount of copper and Ambati is directed to the therapeutic effect of increasing the activity of lysyl oxidase and not astigmatism wherein one would appreciated that the concentration of copper to produce oxidative effects is higher than that to achieve activation of lysyl oxidase wherein one would not have been motivated to utilize the copper concentrations disclose by Ambati with a reasonable expectation of success, and the assertion of success in the clinical trail of Example 1 for treating corneal astigmatism with topical copper sulfate eye drops as 0.15mg/ml copper sulfate pentahydrate relative to placebo. This is fully considered but not persuasive. The assertion that copper sulfate is in a laundry list of corneal hardening agents is not persuasive as copper sulfate is in a limited and confined listing for the corneal hardener (see claim 6), not a numerous listing as asserted by Applicant - wherein it would be prima facie obvious to one of ordinary skill in the art to utilize the copper sulfate as a taught embodiment with a reasonable expectation of success.
As for the assertion that Coroneo only mentions astigmatism once and is focused on myopia, this is not persuasive. Contrary to Applicant’s argument, Coroneo is not solely focused on myopia as Coroneo states:
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wherein Coroneo is clear and explicit in the teaching for treating astigmatism and not solely on myopia as asserted.
With regards to the assertion that the examples are prophetic and do not utilize copper, this is not persuasive as the teachings of Coroneo are not held solely to the examples when the general teaching is for a specific finite grouping of three well-known refractive eye errors which include astigmatism. As for the assertion that Coroneo is silent on the amount of copper and that Ambati is not to astigmatism, this is an argument against the references individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As for the assertion that the concentration of copper to produce oxidative effects is higher than the concentration to achieve activation of lysyl oxidase citing Proudfoot, wherein one would not have been motivated to utilize the copper concentrations disclose by Ambati with a reasonable expectation of success is fully considered but not persuasive. Coroneo is directed to the use of corneal hardeners like crosslinkers/oxidative hardeners like copper sulfate not oxidation of low-density lipoprotein as in the reference Proudfoot, wherein Ambati is presented merely to demonstrate that copper-containing agents like copper sulfate are known to be ophthlamically used at about 0.000005 to about 5% including about 0.001 to about 0.1%wt., as seen by the limited section cited wherein using the copper-containing agent in its known ophthlamically useful concentration is prima facie obvious with a reasonable expectation of success.
As for the assertion of success in the clinical trial of Example 1 for treating corneal astigmatism with topical copper sulfate eye drops as 0.15mg/ml copper sulfate pentahydrate relative to placebo, this is fully considered but not persuasive. The example does not demonstrate evidence of criticality over the prior art and also is not commensurate in scope with the claims as written which is significantly broader as it allows for additional steps other than the topical administration of 0.15% of copper sulfate eyedrops BID for 16 weeks for the treatment of astigmatism.
Accordingly, the rejection stands.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Coroneo (U.S. Pat. Pub. 2015/0164791) in view of Ambati et al. (U.S. Pat. Pub. 2019/0083529) as applied to claims 1-2, 4-5, 9-10, 12-13, 15-16, 18, 21-23, 27-29, 35-36 above, further in view of Ophthalmic Consultants of Vermont (Astigmatism).
The teachings of Coroneo in view of Ambati et al. are addressed above.
Coroneo in view of Ambati et al. does not expressly recite that the astigmatism is oval but does teach treating astigmatism.
Ophthalmic Consultants of Vermont establishes that astigmatism occurs when the cornea is more oval than spherical and results in multiple focal points (astigmatisms is from an oval cornea and has multiple focal points/focal astigmatism).
Wherein it is implicit if not prima facie obvious that any astigmatism present for treatment would be oval (as it is from an oval corneal with multiple focal points/focal astigmatism) as that it the structural presentation for astigmatism.
Claims 1-2, 4-5, 9-10, 12-13, 15-16, 18, 21-23, 27-28, 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Coroneo (U.S. Pat. Pub. 2015/0164791) in view of Burr et al. (WO 2019/136358).
Rejection:
Coroneo teaches treating refractive errors like astigmatism and myopia by moulding corneal tissue by softening the cornea with a matrix metalloproteinase enzyme activator, shaping the cornea with a contact lens, applying a corneal hardening agent like crosslinker/oxidative hardener such as copper sulfate to retain the desired shape after lens removal (abstract, claims 1-2, 6, [14-22], does not recite the presence of keratoconus for the astigmatism). The corneal hardener like copper sulfate can be administered topically such as eyedrops, by contact lens, intraocularly, sustained release vehicles (claim 14-16, [30-32, 79, 82-83]). The corneal hardener such as copper sulfate is in a composition comprising one or more carriers/excipients including water, buffers, tonicity agents (i.e. isotonicity agents), polymers, solubilizing agents (claims 26-27, [42-43, 64, 77, 81], separate composition from initial corneal softener). The dose can be determined by one of skill in the art through routine experimentation and tested for its ability to produce corneal hardening [58]. A sufficient number of eye drops are applied topically to administer a desired concentration to the cornea ([79], see full document specifically areas cited).
While Coroneo does not exemplify treating astigmatism with copper sulfate, Coroneo does expressly teach treating refractive errors like astigmatism by moulding the cornea by softening the cornea, shaping the cornea with a lens and then hardening the cornea with a hardening agent like the claimed copper sulfate wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exemplify the teachings of Coroneo and produce the claimed invention with a reasonable expectation of success.
Coroneo does not expressly recite the amount of copper sulfate (corneal hardening agent/crosslinker/oxidative hardener) in the composition but does recite that the amount/dose can be determined by one of skill in the art through routine experimentation. Coroneo also does not recite the corneal hardening agent/crosslinker to be copper perchlorate but does teach the inclusion of corneal hardening agent/crosslinkers like copper sulfate for the method.
Burr et al. teaches that copper-containing agents (crosslinkers/hardening agents) like copper sulfate and copper perchlorate (Page 8 line 1-8) are known to be useful in ophthalmic compositions from about 0.00001-about 15% including about 0.001-about 0.01%wt. and about 0.01-about 0.1%wt. (claim 26 and 28, Page 10 line 25 and 30-33), with tonicity from about 350mOsm/L-about 450mOsm/L(Page 13 line 23-24) and a pH of about 5.8-about 7.8 (Page 13 line 32-Page 14 line 2). The copper compositions are useful for the eye (i.e. a refractive error like myopia, claims 22 and 28). The composition can be in forms like topical eyedrops with a drop volume from about 5µl to about 100µl (claim 35, Page 8 line 8-11) and applied 1x-4x/day inducing 2x/day for about 6 months to chronic treatment like 5 year or other suitable periods until a desired outcome is achieved (claims 54 and 58, Page 15 line 26-31, Page 18 line 1-8).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the copper sulfate from about 0.001-about 0.1% in an ophthalmic composition at the recited pH and tonicity level for the treatment duration as suggested by Burr et al. and produce the claimed invention; as Coroneo teaches the use of copper sulfate in an ophthalmic composition with various carriers/excipients like buffers/pH adjuster and tonicity agents – and that the amount/dose of the corneal hardener like copper sulfate can be determined by one of skill in the art through routine experimentation; wherein it is prima facie obvious to incorporate the corneal hardener like copper sulfate in its known ophthlamically useful pH, tonicity level, and concentration such as about 0.001-about 0.01% or about 0.01-about 0.1%wt. (falling within the instant claimed values, about 0.01mg/ml-about 2.5mg/ml=0.001-0.25g/100ml=0.001-0.25%) with a reasonable expectation of success absent evidence of criticality. It is also obvious to incorporate copper perchlorate as simple substitution of one known crosslinker/corneal hardener for another is prima facie obvious with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are centered on the assertion that Coroneo recites copper sulfate in a laundry list of corneal hardening agents and only mentions astigmatism once and is focused on myopia, that the examples are prophetic and do not utilize copper, that Coroneo is silent on the amount of copper and Burr (2019) is directed to the therapeutic effect of increasing the activity of lysyl oxidase and not astigmatism wherein one would appreciated that the concentration of copper to produce oxidative effects is higher than that to achieve activation of lysyl oxidase wherein one would not have been motivated to utilize the copper concentrations disclose by Burr (2019) with a reasonable expectation of success, and the assertion of success in the clinical trial of Example 1 for treating corneal astigmatism with topical copper sulfate eye drops as 0.15mg/ml copper sulfate pentahydrate relative to placebo. This is fully considered but not persuasive. The assertion that copper sulfate is in a laundry list of corneal hardening agents is not persuasive as copper sulfate is in a limited and confined listing for the corneal hardener (see claim 6), not a numerous listing as asserted by Applicant - wherein it would be prima facie obvious to one of ordinary skill in the art to utilize the copper sulfate as a taught embodiment with a reasonable expectation of success.
As for the assertion that Coroneo only mentions astigmatism once and is focused on myopia, this is not persuasive. Contrary to Applicant’s argument, Coroneo is not solely focused on myopia as Coroneo states:
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wherein Coroneo is clear and explicit in the teaching for treating astigmatism and not solely on myopia as asserted.
With regards to the assertion that the examples are prophetic and do not utilize copper, this is not persuasive as the teachings of Coroneo are not held solely to the examples when the general teaching is for a specific finite grouping of three well-known refractive eye errors which include astigmatism. As for the assertion that Coroneo is silent on the amount of copper and that Burr (2019) is not to astigmatism, this is an argument against the references individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As for the assertion that the concentration of copper to produce oxidative effects is higher than the concentration to achieve activation of lysyl oxidase citing Proudfoot, wherein one would not have been motivated to utilize the copper concentrations disclose by Burr (2019) with a reasonable expectation of success is fully considered but not persuasive. Coroneo is directed to the use of corneal hardeners like crosslinkers/oxidative hardeners like copper sulfate not oxidation of low-density lipoprotein as in the reference Proudfoot, wherein Burr (2019) is presented merely to demonstrate that copper-containing agents like copper sulfate are known to be ophthlamically used at about 0.00001-about 15% including about 0.001-about 0.01%wt. and about 0.01-about 0.1%wt., as seen by the limited section cited wherein using the copper-containing agent in its known ophthlamically useful concentration is prima facie obvious with a reasonable expectation of success.
As for the assertion of success in the clinical trial of Example 1 for treating corneal astigmatism with topical copper sulfate eye drops as 0.15mg/ml copper sulfate pentahydrate relative to placebo, this is fully considered but not persuasive. The example does not demonstrate evidence of criticality over the prior art and also is not commensurate in scope with the claims as written which is significantly broader as it allows for additional steps other than the topical administration of 0.15% of copper sulfate eyedrops BID for 16 weeks for the treatment of astigmatism.
Accordingly, the rejection stands.
Claims 29, 34 are rejected under 35 U.S.C. 103 as being unpatentable over Coroneo (U.S. Pat. Pub. 2015/0164791) in view of Burr et al. (WO 2019/136358) as applied to claims 1-2, 4-5, 9-10, 12-13, 15-16, 18, 21-23, 27-28, 35-36 above, further in view of Dr. H (astigmatism-A quick review of refractive errors).
Rejection:
The teachings of Coroneo in view of Burr et al. are addressed above.
Coroneo in view of Burr et al. does not expressly teach the type of astigmatism but does address treatment of astigmatism with corneal hardeners like copper sulfate (crosslinker/corneal hardener/oxidative hardener).
Dr. H teaches that astigmatism is an irregular curvature of the front part of the eye (cornea/lens) and the curvature is like a football (oval) with light at two different points (focal astigmatism), as when the corneal is normal it is spherical and has the same roundness all over like a basketball with one light point (normal). There are different types including regular astigmatism like bow-tie, and irregular astigmatism which can be from keratoconus (section - A quick review of refractive errors).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat regular bow tie astigmatism and irregular astigmatism (all astigmatism is structurally oval shaped with two light points (focal astigmatism)) as suggested by Dr. H and produce the claimed invention; as Burr et al. teaches treating astigmatism and it is prima facie obvious to treat the various types of astigmatism with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are directed to Coroneo in view of Burr (2019) which are addressed above.
Accordingly, the rejection stands.
Conclusion
Claims 1-2, 4-5, 9-10, 12-13, 15-16, 18, 21-23, 27-29, 34-36 are rejected.
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 GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613