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 .
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 1-23 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.
Claim 1 recited the phrase “the ophthalmic preparation carrier or auxiliary material comprises the following ingredients: a surfactant, an ionic polymer and a solvent; or, the ophthalmic preparation carrier or auxiliary material contains the following ingredients: povidone with low polymerization degree, povidone with medium polymerization degree and a solvent.” This limitation appears to be a range within a range, where the second limitation following the first limitation is a narrower limit than the first limitation.
Regarding claims that recited the phrase “preferable” or “preferably”, the phrase renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 5, 10, and 17 recited the limitation “selected from the group”. If Markush language is intended, the proper phrasing should read: selected from the group consisting of.
Claim 16 recited a method that comprises steps 1 through 3, following by an “or” steps a through c. Steps a through c appear to be a range within a range, where the second limitation following the first limitation is a narrower limit than the first limitation.
Claim 18 recited the phrase “preparation according to claim 1 for use in the preparation of medicaments for treating fundus disease”. The phrase “for use in” is a future intended use. Was this intended to be a method of treating? If so then what is the different between claim 18 and 20?
Claim 23 recites the limitation “the way used is” in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 20 did not recite any way of use.
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 1, 4, 5, 7-9 and 12-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitra et al. US 2010/0310642 A1.
Mitra teaches an eye drop formulation includes a corticosteroid at a concentration ranging from about 0.01% w/v to about 1.00% w/v; vitamin E TPGS at a concentration ranging from about 3.0% w/v to about 5.0% w/v; and octoxynol-40 at a concentration ranging from about 1.0% w/v to about 3.0% w/v, wherein the corticosteroid is solubilized through entrapment in a mixed micellar hydrophobic core of the vitamin E TPGS and the octoxynol-40. See abstract and paragraph 0072. A method of preparing nanomicelles of the present disclosure includes mixing a corticosteroid with a first surfactant having an HLB index greater than about 10 and a second surfactant having an HLB index of greater than about 13 in a solvent to form a solvent solution; evaporating the solvent solution to form a near-solid matter; hydrating the near-solid matter with an aqueous solution; and dissolving the near-solid matter to produce the nanomicelles, wherein the nanomicelles are optically clear. In an embodiment, the corticosteroid is selected from one of a prednisolone, methylprednisolone, prednisone, triamcinolone, hydrocortisone, betamethasone, dexamethasone, analog thereof or a combination thereof. In an embodiment, the corticosteroid is dexamethasone. See paragraph 0074. A method for treating, reducing, ameliorating, or alleviating an ocular condition in a subject includes providing an aqueous ophthalmic solution that includes nanomicelles in a physiologically acceptable buffer, having a pH of 5.0 to 8.0, wherein a corticosteroid at a concentration from about 0.01% w/v to about 1.00% w/v is solubilized through entrapment in a mixed micellar hydrophobic core with a corona composed of hydrophilic chains extending from the hydrophobic core, wherein the nanomicelles comprise vitamin E TPGS at a concentration ranging from about 3.0% w/v to about 5.0% w/v stabilized with octoxynol-40 at a concentration ranging from about 1.0% w/v to about 3.0% w/v; and administering to the subject an amount of the aqueous ophthalmic solution at a frequency sufficient to treat, reduce, ameliorate, or alleviate the ocular condition. In an embodiment, the ocular condition is a back-of-the-eye condition or disorder. In an embodiment, the corticosteroid is selected from one of a prednisolone, methylprednisolone, prednisone, triamcinolone, hydrocortisone, betamethasone, dexamethasone, analog thereof or a combination thereof. In an embodiment, the corticosteroid is dexamethasone. See paragraph 0075. In an embodiment, a mixed nanomicellar formulation of the present disclosure includes two non-ionic surfactants. In an embodiment, a mixed nanomicellar formulation of the present disclosure includes a first non-ionic surfactant with an HLB index greater than about 10, and a second non-ionic surfactant with an HLB index of greater than about 13. In an embodiment, the first non-ionic surfactant having a HLB greater than about 10 is selected from various chemical derivatives of vitamin E with ester and ether linkages of various chemical moieties to polyethylene glycol of various lengths. Particularly preferred are vitamin E tocopherol polyethylene glycol succinate (TPGS) derivatives with PEG molecular weights between about 500 and 6000 Da. In an embodiment, the vitamin E polymeric derivative with an HLB index greater than about 10 is vitamin E tocopherol polyethylene glycol 1000 succinate (Vitamin E TPGS, tocophersolan). In an embodiment, the Vitamin E TPGS contributes to the solubilization of the water-insoluble drug and may reduce ocular discomfort in aqueous conditions. In an embodiment, the vitamin E TPGS is present in from about 0.01% w/v to about 20% w/v of the composition. In an embodiment, the vitamin E TPGS is present in from about 1.0% w/v to about 7.0% w/v of the composition. It will be understood that throughout the specification the term weight percent (wt %) refers to mass per unit volume, unless otherwise specified. See paragraph 0055. Nanomicelles with a size ranging from about 10 nm to about 20 nm is found in paragraph 0017 and Examples. Fundus disease such as macular edema is found in paragraph 0070.
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 2, 3, 6, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mitra et al. US 20100310642 A1.
Mitra is relied upon for the reason stated above. Mitra does not expressly tech the claimed ratio between ionic polymer to surfactant to solvent. However, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.) Therefore, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation select a range of ratio that would fall within the claimed ranges with the expectation of at least similar result. This is because Mitra teaches a preparation similar to that of the present invention, namely, an eye drop formulation useful for the delivery of glucocorticoid active agents for the treatment of fundus diseases.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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