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.
This rejection has been withdrawn in view of the Amendment filed 07/20/2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The 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, 3, 5, 9-18 and 21-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18/262625 (‘625). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘625 application discloses an ophthalmic preparation for eye drop administration, characterized in that it is a preparation composed of the carrier or auxiliary material of an ophthalmic preparation as well as an active pharmaceutical ingredient for treating eye diseases. See claim 19.
A carrier or auxiliary material of an ophthalmic preparation, characterized in that it contains the following components: a surfactant and an ionic polymer, and it also contains a solvent, wherein the mass ratio of the surfactant to the ionic polymer is (1-100):(0.1-50); the ratio of the surfactant to the solvent is: every 100 mL of the solvent contains 5-3000 mg of the surfactant; preferably, the mass ratio of the surfactant to the ionic polymer is (1-31):(1-7.5); the ratio of the surfactant to the solvent is: every 100 mL of the solvent contains 50-3000 mg of the surfactant. See claims 1-2. Non-ionic surfactant is found in claims 3-4. Active pharmaceutical ingredient including glucocorticoid is found in claim 23.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘625 application. This is because the ‘625 application discloses an invention similar to that of the present invention, namely, an ophthalmic formulation comprising the claimed active agent and the claimed auxiliary carrier in the form of an eye drop.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 9-18 and 21-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 18/262628 (‘628). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘628 application discloses an ophthalmic preparation comprising an active pharmaceutical ingredient and an ophthalmic preparation carrier or adjuvant;wherein the active pharmaceutical ingredient comprises at least one selected from the group consisting of lipoic acid or a stereoisomer thereof, lipoate or a stereoisomer salt thereof, metformin or a salt thereof, resveratrol or a salt thereof, doxycycline or a salt thereof, and tetracycline or a salt thereof; wherein the ophthalmic preparation carrier or adjuvant comprises a surfactant, an ionic macromolecule, and a solvent;wherein the mass ratio of the surfactant to the ionic macromolecule in the ophthalmic preparation carrier or adjuvant is: (1-100):(0.1-50); andwherein the ratio of the surfactant to the solvent in the ophthalmic preparation carrier or adjuvant is: every 100 mL of the solvent contains 5-3000 mg of the surfactant.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘625 application. This is because the ‘625 application discloses an invention similar to that of the present invention, namely, an ophthalmic formulation comprising the claimed active agent and the claimed auxiliary carrier in the form of an eye drop.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
This rejection has been withdrawn in view of the Amendment filed 07/20/2026.
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, 3, 5, 9-18 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Mitra et al. US 20100310642 A1, in view of Liu et al. WO 2021017475 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.
Mitra does not expressly teach 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. This is further in view of the teaching in Liu et al.
Liu discloses an ophthalmic pharmaceutical comprises 0.01%-0.5% of a cyclosporine, 0.2%-0.9% of an oil phase, and 0.1%-5.0% of a surfactant. The ophthalmic solution of the present invention can be stored stably for 24 months with low impurities. In some embodiments of the present invention, the content of the first surfactant is 0.05%-3%, such as 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9% Or 3.0%. Preferably, the content of the first surfactant is 0.5%-2%, 0.5%-1%, 1%-2%, 0.5%-1.5%, 0.8%-1.2%, 0.5%, 1.0% or 2.0 %. In some embodiments of the present invention, the ratio of the weight percentage content of the medium-chain triglyceride to the first surfactant is (0.8-1.2): 4, for example (0.85-1.15): 4, (0.95-1.05) : 4; preferably (0.9-1.1): 4, more preferably 1:4. In some embodiments of the present invention, the ophthalmic pharmaceutical composition further includes a second surfactant. In some embodiments of the present invention, the second surfactant is one or more selected from polyethylene glycol 400 , fatty alcohol polyoxyethylene ether, and propylene glycol, preferably polyethylene glycol 400. In some embodiments of the present invention, the content of the second surfactant is 0.05%-2.0%, such as 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9% or 2.0%. Preferably, the content of the second surfactant is 0.1%-1.0%. In some embodiments of the present invention, the first surfactant is polyoxyethylene hydrogenated castor oil, and the second surfactant is polyethylene glycol. In some embodiments of the present invention, the thickener is one or more selected from glycerin, sodium hyaluronate, carbomer and sodium carboxymethyl cellulose, preferably glycerin.
Thus, one of ordinary skill in the art would have been motivated to optimize the teaching in Mitra to obtain an ophthalmic solution comprising an auxiliary solution having the ratio that falls within the claimed range in view of the teaching in Liu. This is because Liu teaches an ophthalmic solution comprising surfactant, solvent and cosolvent in the claimed ratio is known in the art.
Response to Arguments
Applicant’s arguments filed 07/20/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
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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