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 .
Status of Application
The Preliminary Amendment filed on 09/08/23 is acknowledged.
Claims 1-14 were cancelled.
New claims 15-38 were added and are included in the prosecution.
Priority
This Application is a 371 of PCT/IB2021/059110 filed on 10/05/21. This Application also claims foreign priority to it 10 2020000026236 filed on 11/04/20. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119 (a)-(d), which papers have been placed of record in the file.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) an English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 05/03/23 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Please see Page 6 (lines 32-33) of the instant specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 19, 30, and 33 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 pre-AIA the applicant regards as the invention.
Claim 19 recites the limitation "… wherein the polyoxyalkylene glycol moiety of said polyoxyalkylene glycol ester has a molecular weight …”, followed by “preferably between about 600 Da …” (emphasis added). The term “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 30 recites the limitation "… vitamins …”, followed by “preferably riboflavin-5-phosphate …” (emphasis added). The term “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 33 recites the limitation "the ocular diseases" in line 1. Claim 33 is dependent on claim 15, but claim 15 recites “ophthalmic diseases” and not “ocular diseases.” There is insufficient antecedent basis for this limitation in the claim.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
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.
Claims 15-38 are rejected under 35 U.S.C. 103 as being unpatentable over Pather et al. (US 2014/0056828 A1 – “Pather”) in view of Cannas et al. (J Infect Dev Ctries 2015; 9(6):650-654 – “Cannas”) and Mitra et al. (US 2009/0092665 A1 – “Mitra”).
Instant claim 15 is drawn to a method of treating ophthalmic diseases, comprising topically administering an effective amount of thymol or an extract of thymol in combination with about 0.001 - 0.400 μg per day of a tocopherol to the eyes of a patient in need thereof.
Pather teaches compositions in the form of suspensions, emulsions, tablets, pills, capsules, powders, sustained-release formulations and the administration can be topical, oral, or ocular ([0086]). The composition comprises a pharmaceutically acceptable oil ([0018], [0021], claims 1, 5, and 14) which includes thyme oil, Vitamin E TPGS (d-alpha tocopheryl polyethylene glycol 1000 succinate), or a mixture thereof ([0023], [0064], claims 6 and 18).
Pather does not expressly teach a method of treating ophthalmic diseases.
Cannas teaches essential oils (EOs) in ocular pathology (Title), including low cytotoxic effects at low concentrations and good antimicrobial activity of the essential oil (EO) of Thymus vulgaris (Abstract). The EO of Thymus vulgaris was used on three multidrug-resistant Pseudomonas aeruginosa strains isolated from eyes with very severe post-operative endophthalmitis (Page 651, Table 1 and Page 651, Col. 2, 5th ¶). EOs with cytotoxic properties can a high percentage of phenolic compounds such as thymol (Page 652, Col. 1, 3rd ¶). The antimicrobial activity of the EO of Thymus vulgaris L. and the associated MBC (minimum bactericidal concentration) values are disclosed (Page 653, Table 4 and 3rd ¶). Dilutions of EOs from 16% to 0.004% are disclosed (Page 651, 3rd ¶).
Mitra teaches ophthalmic compositions and methods for treating an ocular disease and/or condition using the disclosed compositions (Abstract and claims 1-51). The composition includes a calcineurin inhibitor; vitamin E TPGS; and octoxynol 40, wherein the composition is suitable for topical application to ocular tissue ([0006], [0067]-[0069], [0071]-[0073], Examples 1, 5, 12, 15, 16, claims 3, 9, 13, 18, 22, 30, 36, and 47). Vitamin E TPGS is present in the composition from about 0.01 wt% to about 20 wt%/volume ([0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising a mixture of thyme oil and Vitamin E TPGS for topical, oral, or ocular administration, as taught by Pather, in view of the use of the EO of Thymus vulgaris in ocular pathology, including as an antimicrobial in multidrug-resistant Pseudomonas aeruginosa strains, as taught by Cannas, and the method of treating an ocular disease and/or condition by topical application of a composition comprising Vitamin E TPGS, as taught by Mitra, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). Furthermore, the use of a known technique to improve similar methods in the same way is also obvious. Please see MPEP 2141(III)(C). One of ordinary skill in the art would have found it obvious to combine the thyme oil and vitamin E TPGS in an ocular administration based on the teaching of Pather and use this combination to treat ocular diseases and/or conditions based on the use of each of these components for treating the same diseases and/or conditions, i.e., ocular diseases and/or conditions, as taught by Cannas and Mitra, and have a reasonable expectation of success in efficaciously treating an ocular disease and/or condition.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 15 and 38, the limitations of a method of treating ophthalmic diseases would have been obvious over the ocular administration ([0086]) taught by Pather, in view of the use of EOs in ocular pathology (Abstract) including on three multidrug-resistant Pseudomonas aeruginosa strains isolated from eyes with very severe post-operative endophthalmitis (Page 651, Table 1 and Page 651, Col. 2, 5th ¶), as taught by Cannas, and by the methods for treating an ocular disease and/or condition (Abstract and claims 1-51), as taught by Mitra.
Regarding instant claims 15 and 38, the limitations of topically (claim 15) or orally (claim 38) administering an effective amount of thymol or an extract of thymol in combination with about 0.001 - 0.400 μg per day of a tocopherol to the eyes of a patient in need thereof would have been obvious over the topical or oral administration ([0086]) of a composition comprising a pharmaceutically acceptable oil ([0018], [0021], claims 1, 5, and 14) which includes thyme oil, Vitamin E TPGS, or a mixture thereof ([0023], [0064], claims 6 and 18), as taught by Pather, in view of the administration of the EO of Thymus vulgaris (Abstract) on three multidrug-resistant Pseudomonas aeruginosa strains isolated from eyes with very severe post-operative endophthalmitis (Page 651, Table 1 and Page 651, Col. 2, 5th ¶), wherein the EO of T. vulgaris contains thymol (Page 652, Col. 1, 3rd ¶), as taught by Cannas, and the administration of vitamin E TPGS by topical application to ocular tissue ([0006], [0067]-[0069], [0071]-[0073], Examples 1, 5, 12, 15, 16, claims 3, 9, 13, 18, 22, 30, 36, and 47), wherein the vitamin E TPGS is present in the composition from about 0.01 wt% to about 20 wt%/volume ([0067]), as taught by Mitra. One of ordinary skill in the art would have found it obvious to modify the concentration of vitamin E TPGS administered to a patient per day based on the ocular disease/condition and the efficacious and safe dosage to treat the patient’s disease/condition given the guidance of the concentration range taught by Mitra absent evidence of criticality or unexpected results.
Regarding instant claims 16-20, the limitations of the tocopherol would have been obvious over the Vitamin E TPGS ([0023], [0064], claims 6 and 18) as taught by Pather, and the vitamin E TPGS ([0006], [0067]-[0069], [0071]-[0073], Examples 1, 5, 12, 15, 16, claims 3, 9, 13, 18, 22, 30, 36, and 47), as taught by Mitra.
Regarding instant claims 21-22, the limitations of thymol extract would have been obvious over the thyme oil ([0023], [0064], claims 6 and 18), as taught by Pather, in view of the EO of Thymus vulgaris (Abstract) which contains thymol (Page 652, Col. 1, 3rd ¶), as taught by Cannas.
Regarding instant claims 23-29, the limitations of the weight ratio of the thymol extract or thymol and the tocopherol and the concentrations of thymol extract or thymol and tocopherol would have been obvious over the dilutions of EOs, which include the EO of Thymus vulgaris, of from 16% to 0.004% (Page 651, 3rd ¶), as taught by Cannas, and the Vitamin E TPGS present in the composition from about 0.01 wt% to about 20 wt%/volume ([0067]), as taught by Mitra. One of ordinary skill in the art would have found it obvious to use various ratios of thymol extract and tocopherol based on the guidance of the concentrations taught by Cannas and Mitra and based on the desired ocular disease/condition being treated, the optimal dosage, bioavailability, and stability, absent evidence of criticality or unexpected results. Also, according to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 30, the limitation of further administering vitamins would have been obvious over the antioxidants and vitamins which may be added to the basic formulation ([0330]), as taught by Pather, as well as mixtures of a calcineurin or an mTOR inhibitor with one or more drugs or vitamins ([0071]), as taught by Mitra.
Regarding instant claims 31-32 and 38, the limitations of an isotonic solution would have been obvious over the solutions ([0011]) and pharmaceutical carriers including isotonic agents ([0084]), as taught by Pather, and the aqueous solutions ([0005], claims 17, 22), including an artificial tear composition comprising an aqueous solution (claims 47 and 49-51), tonicity agents and buffers used to adjust the osmolality of the compositions ([0083]-[0084], [0097]-[0099], and claim 49), and the pH of the aqueous solution ranging from about 6.6 to about 7.0 (claim 51), as taught by Mitra.
Regarding instant claims 33-35, the limitations of the ocular infections would have been obvious over the administration of the EO of Thymus vulgaris (Abstract) on three multidrug-resistant Pseudomonas aeruginosa strains isolated from eyes with very severe post-operative endophthalmitis (Page 651, Table 1 and Page 651, Col. 2, 5th ¶), as taught by Cannas, and the treatment of ocular infections ([0023]), uveitis, conjunctivitis (pink eye), keratitis, blepharitis ([0022] and claim 34), as taught by Mitra.
Regarding instant claim 36, the limitations of the ocular disease would have been obvious over the treatment of glaucoma ([0023] and [0183]), dry eye syndrome ([0022], claims 23, 25, and 34), as taught by Mitra.
Regarding instant claims 37 and 38, the limitations of the thymol or thymol extract administered separately from the tocopherol or simultaneously would have been obvious over the topical or ocular administration ([0086]) of a composition comprising a pharmaceutically acceptable oil ([0018], [0021], claims 1, 5, and 14) which includes thyme oil, Vitamin E TPGS, or a mixture thereof ([0023], [0064], claims 6 and 18), as taught by Pather. One of ordinary skill in the art would have found it obvious to administer the thyme oil and vitamin E TPGS either together or separately/sequentially based on the optimal delivery of these components for the efficacious treatment of the particular ocular disease/condition being treated. According to MPEP 2144.04(IV)(C), the selection of any order of performing steps is prima facie obvious in the absence of new or unexpected results.
Regarding instant claim 38, the limitations of capsules, tablets, pills, lozenges, solutions, suspensions, and syrups would have been obvious over the compositions in the form of tablets, troches, capsules, elixirs, beverages, suspensions, and syrups ([0087]), as taught by Pather.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615