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 .
Product claims 1-17 were previously pending for which a Restriction was filed.
Now claims 1-33 are pending.
Election/Restrictions
Applicant elects without traverse atropine and F6H8 as the species; claims 1-17 and 19-29 read on this species election. This election is made.
Claims 1-17 and new claim 18-33 are pending.
Claims 1-15, 18-24, 26,, 27, 31 are drawn to product and new claims 16, 15, 25, 28, 29, 32, 33 are drawn to method claims.
Upon further consideration claims 1-33 are examined together.
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 1-15, 18-24, 26, 25, 30, 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11191751. Although the claims at issue are not identical, they are not patentably distinct from each other because the product claims containing overlapping subject matter as explained below with highlighted limitations of conflicting claims.
Relevant claims of 11191751:
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Instant base claim base claims 1, 26 and 30:
(Previously Presented) A topical ophthalmological composition comprising: a therapeutically effective amount of a muscarinic receptor antagonist as an active pharmaceutical ingredient; and a semifluorinated alkane, as a liquid vehicle.
26. (New) A topical ophthalmological composition comprising: a therapeutically effective amount of a muscarinic receptor antagonist as an active pharmaceutical ingredient, wherein the muscarinic receptor antagonist is atropine; and a semifluorinated alkane as a liquid vehicle, wherein the semifluorinated alkane is F6H8 (perfluorohexyloctane).
30. (New) A topical ophthalmological composition comprising: a therapeutically effective amount of a muscarinic receptor antagonist as an active pharmaceutical ingredient, wherein the muscarinic receptor antagonist is atropine; and a semifluorinated alkane as a liquid vehicle, wherein the semifluorinated alkane is F4H5 (perfluorobutylpentane).
For overlap of concentration ranges of claims of 11191751 see instant dependent claims 23, 24.
Claims 1-15, 18-24, 26, 25, 30, 31 and method claims 16, 17, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12485177. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter:
Base claim 1. of 12485177:
A topical ophthalmological composition comprising: about 0.001% to about 0.1% (w/w) of a muscarinic receptor antagonist as an active pharmaceutical ingredient (API) selected from the group consisting of atropine, pirenzepine, aclidinium bromide, benztropine, cyclopentolate, diphenhydramine, doxylamine, dimenhydrinate, dicyclomine, darifenacin, flavoxate, hydroxyzine, ipratropium, mebeverine, oxybutynin, procyclidine, scopolamine, solifenacin, tropicamide, tiotropium, trihexyphenidyl, and tolterodine; a medium chain triglyceride (MCT) liquid vehicle; and a semi-fluorinated alkane compound selected from the group consisting of perfluorobutylheptane (F4H5), perfluorobutylhexane (F4H6), perfluorohexylbutane (F6H4), perfluorohexylhexane (F6H6), perfluorohexyloctane (F6H8), and perfluorohexyl decane (F6H10), wherein the topical ophthalmological composition is non-aqueous. Base claim 10 of 12485177:
A topical ophthalmological composition comprising: about 0.001% to about 0.1% (w/w) of a muscarinic receptor antagonist as an active pharmaceutical ingredient (API) selected from the group consisting of atropine, pirenzepine, aclidinium bromide, benztropine, cyclopentolate, diphenhydramine, doxylamine, dimenhydrinate, dicyclomine, darifenacin, flavoxate, hydroxyzine, ipratropium, mebeverine, oxybutynin, procyclidine, scopolamine, solifenacin, tropicamide, tiotropium, trihexyphenidyl, and tolterodine; up to about 70% medium chain triglyceride (MCT) liquid vehicle; and a semi-fluorinated alkane compound selected from the group consisting of perfluorobutylheptane (F4H5), perfluorobutylhexane (F4H6), perfluorohexylbutane (F6H4), perfluorohexylhexane (F6H6), perfluorohexyloctane (F6H8), and perfluorohexyl decane (F6H10)
Method claims of 13 and 14 depend on the base claims 1 and 1-.
As such there is extensive overlap with the subject matter of instant claims.
Claims 1-15, 18-24, 26, 25, 30, 31 and method claims 16, 17, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12070501 further in view of US 20150141448.
Base claim 1 of 12070501
A topical ophthalmological composition comprising: about 0.001% to about 0.1% (w/w) atropine as an active pharmaceutical ingredient (API); a medium chain triglyceride (MCT) liquid vehicle; and a semi-fluorinated alkane compound selected from the group consisting of perfluorobutylheptane (F4H5), perfluorobutylhexane (F4H6), perfluorohexylbutane (F6H4), perfluorohexylhexane (F6H6), perfluorohexyloctane (F6H8), and perfluorohexyl decane (F6H10), wherein the topical ophthalmological composition is non-aqueous.
The difference is the active ingredient API of 12070501 and specific concentration of the API. For the latter see dependent claim 23. 20150141448 is invoked for the difference of MCT (see later below)
For reasons discussed below, the instant muscarinic receptor antagonist atropine is the species of the API of 12070501:
What is the meaning of API. The specification is consulted for the definition of API.
Note that reliance on specification of a potentially conflicting patent or application is generally prohibited. However limited exceptions do exist. Exceptions to the General Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application include Dictionary for claim terminology, Portions of the disclosure which provide support for the claims in the potentially conflicting patent or application.
The MPEP refers to two exceptions to the general prohibition of using the disclosure of a potentially conflicting patent or application in an ODP-Obviousness analysis. The two exceptions are:
1. The disclosure can be used as a dictionary for claim terminology; and
2. “[T]hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent” (MPEP § 804).
The MPEP further notes:
The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 since only the disclosure of the invention claimed in the patent may be examined.”)
As per disclosure 12070501 at column 2 line 18, the genus of AP! Includes atropine.
As to the MCT, see the disclosure 20150141448, at page 6 bottom of column A [0063] to column 6. at the minimum suggests that MCT and defluorinated hydrocarbon are equivalent and can be used interchangeably as non-aqueous pharmaceutically acceptable vehicles.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lallemand, Cyclosporine A delivery to the eye: A comprehensive review of academic and industrial efforts, European Journal of Pharmaceutics and Biopharmaceutics, Volume 117, August 2017, Pages 14-28.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
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.
Claim(s) 1-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leo WO2020074697 and Carlson WO2020160493 (2020-08-06) and Gunther US 20200268682.
Regarding claim 1, Leo teaches a topical ophthalmological composition (abstract, ophthalmic compositions dissolved in I-(perfluorobutyl)pentane for use in the topical treatment of dry eye disease) comprising: a therapeutically effective amount of a muscarinic receptor antagonist as an active pharmaceutical ingredient (pg 11, In 26-30, composition wherein patient suffers from keratoconjunctivitis sicca, treatment with atropine opiates. Atropine is a muscarinic receptor antagonist; see instant claim 3, wherein the muscarinic receptor antagonist is atropine); and a semifluorinated alkane, as a liquid vehicle (pg 8, In 17-19, ophthalmic composition employs, as a liquid vehicle, the compound I-(perfluorobutyl)pentane. I-(perfluorobutyl)pentane is a semifluorinated alkane), wherein the topical ophthalmological composition treats an ocular disease (abstract, ophthalmic compositions dissolved in I-(perfluorobutyl)pentane for use in the topical treatment of dry eye disease. Dry eye disease is an ocular disease), but does not specifically teach wherein the topical ophthalmological composition comprises all mentioned components in a single formulation. It would have been obvious to one of skill in the art to teach wherein the topical ophthalmological composition comprises a therapeutic amount of a muscarinic receptor antagonist as an active pharmaceutical ingredient and a semifluorinated alkane as a liquid vehicle in a single formulation by routine experimentation.
Further Gunther teaches a topical ophthalmological composition (para (0026)." topical administration of an ophthalmic composition) comprising: a therapeutically effective amount of a muscarinic receptor antagonist as an active pharmaceutical ingredient (para (0393), composition wherein patient suffers from keratoconjunctivitis sicca, treatment with atropine opiates. Atropine is a muscarinic receptor antagonist; see instant claim 3, wherein the muscarinic receptor antagonist is atropine. It is within reason that atropine is an active pharmaceutical ingredient since it is being used to treat keratoconjunctivitis sicca, or dry eye disease); and a semifluorinated alkane, as a liquid vehicle (para [0027), the ophthalmic composition consists of the semifluorinated alkane 1-perfluorohexyl-octane (F6H8); para (0664), Semifluorinated alkanes are able to dissolve well with non-polar and lipophilic substances), wherein the topical ophthalmological composition treats an ocular disease (para (0028), treatment of keratoconjunctivitis sicca (dry eye disease): Dry eye disease is an ocular disease). However, Gunther does not specifically teach wherein the topical ophthalmological composition comprises all mentioned components in a single formulation. It would have been obvious to one of skill in the art to teach wherein the topical ophthalmological composition comprises a therapeutic amount of a muscarinic receptor antagonist as an active pharmaceutical ingredient and a semifluorinated alkane as a liquid vehicle in a single formulation by routine experimentation.
Regarding claim 2, Leo teaches the topical ophthalmological composition of claim 1, wherein the muscarinic receptor antagonist is selected from the group consisting of atropine, pirenzepine, aclidinium bromide, benztropine, cyclopentolate, diphenhydramine, doxylamine, dimenhydrinate, dicyclomine, darifenacin, flavoxate, hydroxyzine, ipratropium, mebeverine, oxybutynin, procyclidine, scopolamine, solifenacin, tropicamide, tiotropium, trihexyphenidyl, and tolterodine (pg 11, In 26-30, composition wherein patient suffers from keratoconjunctivitis sicca, treatment with atropine opiates).
Regarding claim 3, Leo teaches the topical ophthalmological composition of claim 2, wherein the muscarinic receptor antagonist is atropine (pg 11, In 26-30, composition wherein patient suffers from keratoconjunctivitis sicca, treatment with atropine opiates).
Regarding claim 4, Leo teaches the topical ophthalmological composition of claim 3 but does not specifically teach wherein the atropine is in a free base form or a salt form. However, Leo teaches wherein the topical ophthalmological composition comprises atropine (pg 11, In 26-30, composition wherein patient suffers from keratoconjunctivitis sicca, treatment with atropine opiates). Based on the teachings of Novaliq-697, it would have been obvious to one of skill in the art to teach wherein the atropine is in a free base form or salt form by routine experimentation.
Regarding claim 5, Leo teaches the topical ophthalmological composition of claim 4 but does not specifically teach wherein the concentration of the atropine in a free base form is from about 0.0001% to about 1.0% (w/w), preferably, from about 0.001% to about 0.1% (w/w), more preferably, about 0.01% to about 0.1% (w/w). It would have been obvious to one of skill in the art to teach wherein the concentration of the atropine in a free base form is from about 0.0001% to about 1.0% (w/w), preferably, from about 0.001% to about 0.1% (w/w), more preferably, about 0.01% to about 0.1% (w/w) by routine experimentation.
Regarding claim 6, Leo teaches the topical ophthalmological composition of claim 1, wherein the semifluorinated alkane is a compound of formula RFRH or of formula RFRHRF (pg 8, In 17-19, ophthalmic composition employs, as a liquid vehicle, the compound 1-(perfluorobutyl)pentane. I-(perfluorobutyl)pentane is a semifluorinated alkane. I-(perfluorobutyl)pentane is F4H5, which is a compound of formula RFRH), wherein RF is a perfluorinated hydrocarbon with 15 or less carbon atoms (pg 8, In 21-22, F4H5, F denotes a linear perfluorinated alkane segment comprising 4 carbon atoms), and wherein RH is a non-fluorinated hydrocarbon with 15 or less carbon atoms (pg 8, In 22-24, H denotes a linear and non-fluorinated alkane hydrocarbon segment of 5 carbon atoms).
Regarding claim 7, Leo teaches the topical ophthalmological composition of claim 6, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F6H4, F6H6, F6H8 and F6H10 (pg 8, In 17-19, ophthalmic composition employs, as a liquid vehicle, the compound I-(perfluorobutyl)pentane. I-(perfluorobutyl)pentane is a semifluorinated alkane. I-(perfluorobutyl)pentane is F4H5).
Regarding claim 8, Leo teaches the topical ophthalmological composition of claim 7 but does not specifically teach wherein the semifluorinated alkane is F6H8 (perfluorohexyloctane). However, in a similar invention, Gunther teaches wherein the semifluorinated alkane is F6H8 (perfluorohexyloctane) (para [0027), the ophthalmic composition consists of the semifluorinated alkane 1-perfluorohexyl-octane (F6H8)). Hence, it would have been obvious to one of skill in the art to combine both references to teach wherein the semifluorinaled alkane is F6H8 to be used as an efficient liquid vehicle that adequately dissolves the atropine in the topical ophthalmological composition.
Regarding claim 9, Leo teaches the topical ophthalmological composition of claim 1, further comprising an organic cosolvent selected from the group consisting of phenylethyl alcohol, ethanol, isopropanol, glycerol, propylene glycol, and polyethylene glycol (pg 10, In 8-9, the ophthalmic composition comprises up to about 1.0 % (w/w) ethanol).
Regarding claim 10, Leo teaches the topical ophthalmological composition of claim 9, wherein the organic cosolvent is ethanol or phenylethyl alcohol (pg 10, In 8-9, the ophthalmic composition comprises up to about 1.0 % (w/w) ethanol).
Regarding claim 11, Leo teaches the topical ophthalmological composition of claim 10, wherein the concentration of ethanol is about 1% (w/w) or less (pg 10, In 8-9, the ophthalmic composition comprises up to about 1.0 % (w/w) ethanol).
Regarding claim 12, Gunther teaches the topical ophthalmological composition of claim 1, wherein the topical ophthalmological composition is a non-aqueous solution, a suspension, or an emulsion (para (0677), formulating non-aqueous ophthalmic compositions which are microbiologically stable; para (0017), used as oily solutions or oil-in-water emulsions. Oily solutions do not contain water).
Regarding claim 13, Gunther teaches the topical ophthalmological composition of claim 12 but doesn't specifically teach wherein the atropine in the topical ophthalmological composition is chemically stable for at least 0.5 years, for at least 1 year, or for at least 2 years. It would have been obvious to one of skill in the art to teach wherein the atropine in the topical ophthalmological composition chemical stable for at least 0.5 years, for at least 1 year, or for at least 2 years by routine experimentation.
Regarding claim 14, Leo teaches the topical ophthalmological composition of claim 1, wherein the topical ophthalmological composition is adapted for topically administering as eye drops to an eye of a patient (pg 10, In 19-20, the composition is administered in a dose of a single drop per eye).
Regarding claim 15, Leo teaches the topical ophthalmological composition of claim 14, wherein the topical ophthalmological composition causes minimal irritation in the eye (abstract, ophthalmic compositions dissolved in I-(perfluorobutyl)pentane for use in the topical treatment of dry eye disease. Composition is used to treat dry eye disease, which includes eye irritation, so it is within reason to interpret that the composition does not cause irritation to the eye since it is used to treat eye irritation; see pg 6, In 5-6, subjects suffering dry eye disease may experience symptoms such as irritation).
Regarding claim 16, Leo teaches the topical ophthalmological composition of claims 1 but does not specifically teach wherein the ocular disease is myopia. In a similar invention, however, Carlson teaches wherein the ocular disease is myopia (para (0004), compositions to prevent or delay onset of myopia). Hence, it would have been obvious to one of skill in the art to combine both references to teach wherein the ocular disease is myopia to adequately reduce nearsightedness/shortsightedness, prevent myopic progression, and improve overall eyesight.
Regarding claim 17, Carlson teaches the topical ophthalmological composition of claim 16, wherein the topical ophthalmological the composition slows a myopia progression (para [0004), compositions to prevent or delay onset of myopia, or preventing or reducing progression of myopia, these compounds work by antagonizing one or more of the family of muscarinic receptors; para [0048), embodiments include carriers for topical administration).
Claims 18, 30 (F4H5), claims 19-22 non-aqueous solution, claims 23, 24 (W/W concentration), claim 26-27, 31 ((organic (co)solvent)) in topical ophthalmological compositions for the claim(-25, 28, 29, 32, 33)-ed methods are explicitly taught as discussed above.
Taken together all the claimed critical elements of active, inactive ingredients and the use of their in topical ophthalmological composition combinations and are taught in the cited prior art. Since all the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition. Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625