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 .
DETAILED ACTION
The office acknowledges Applicants filing of the claim amendments dated 2/6/2024. Claims 1-67 has been cancelled and claims 68-85 has been added new. Claims 68-85 are pending and are examined based on the merits herein.
Application Priority
This application filed on 12/21/2023 is a Continuation of 17807487, filed 06/17/2022, now U.S. 12064442, 17807487 is a Continuation of 17003584, filed 08/26/2020,now U.S. 11400101, 17003584 is a Continuation of 15903597, filed 02/23/2018, now U.S. 10758550, 15903597 is a Continuation in Part of 15842063, filed 12/14/2017, now U.S. 10653661, 15842063 is a Continuation in Part of 15716661, filed 09/27/2017, 15716661 is a Continuation in Part of 15691500, filed 08/30/2017, 15691500 is a Continuation in Part of 15636120, filed 06/28/2017, now U.S. 10016443, 15636120 is a Continuation in Part of 14682001, filed 04/08/2015, now U.S. Patent # 10548907, 14682001 is a Continuation in Part of 14506122, filed 10/03/2014, now U.S. 10646500.
It is noted that the claimed subject matter of the hydrocolloid and when shaken and stored (as in part c of claims 68, 76) and the composition of claim 84 has support in 15636120, filed 06/28/2017 and not in the parent applications, 14682001 and 14506122. Hence the priority date for claims 68-85 is 06/28/2017.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 12/21/2023 and 2/16/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 68-85 are rejected under 35 U.S.C. 103 as being unpatentable over Dhuppad et al. (US 20150079178 A1).
Dhuppad teachings relates to a method of treating rhinitis in a human in need thereof comprising administering by the nasal route a stable fixed dose, aqueous pharmaceutical composition which may be contained in a container comprises about 0.025 w/w to about 0.05% w/w mometasone or its salt and about 0.5% w/w to about 0.8% w/w olopatadine or its salt [0107]. The reference is explicit in teaching the following composition.
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The reference is explicit in teaching a stable fixed dose pharmaceutical aqueous suspension composition (e.g., contained in a container) for nasal administration to a human, where the composition comprises (1) about 0.025% w/w mometasone furoate monohydrate, (2) about 0.665% w/w olopatadine hydrochloride, (3) a hydrocolloid selected from about 0.3% w/w of xanthan gum and about 0.5 w/w carboxymethyl cellulose sodium, (4) about 1% w/w to about 1.2% w/w mixture of microcrystalline cellulose and carboxymethyl cellulose sodium, (5) about 0.02% w/w benzalkonium chloride, (6) about 0.4% w/w sodium chloride, (7) about 0.01% w/w di-sodium edetate, (8) about 0.94% w/w sodium phosphate heptahydrate, and (9) about 0.01% w/w polysorbate 80 [0038]. The term `stable` as used in connection with aqueous suspensions refers to a composition when shaken and then stored for at least 24 hours at ambient condition does not show phase separation on visual inspection [0059]. The sodium carboxymethyl cellulose may be present at a concentration of at least about 0.1% w/w, or preferably between about 0.1% w/w to about 3% w/w of the composition [0020]. In one embodiment, the composition is a suspension and includes a hydrocolloid in a sufficient amount to prevent phase separation (i.e., separation of the particles and solution) after 3 or 6 months of storage at 25.+-.2.degree. C. and 60%.+-.5% relative humidity (RH) or at 40.+-.2.degree. C. and 75%.+-.5% RH [0015].
The method includes spraying a stable fixed dose, aqueous pharmaceutical composition comprising mometasone furoate monohydrate, olopatadine hydrochloride and optionally a hydrocolloid such that each spray of the aqueous pharmaceutical composition provides (i) mometasone furoate monohydrate equivalent to about 25 mcg of mometasone furoate and (ii) olopatadine hydrochloride equivalent to about 600 mcg olopatadine [0035]. The composition comprising olopatadine and mometasone can be used to treat seasonal rhinitis [0110] . Further taught is that PATANASE.RTM. Nasal Spray, which contains 0.6% w/v olopatadine in a non-sterile aqueous solution. It is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older [0004].
From the teachings of Dhuppad, a person skilled in the art would have found it obvious to arrive at the claimed method with a reasonable amount of success in the treatment of seasonal allergic rhinitis because the reference is explicit in teaching the fixed dose aqueous composition comprising olopatadine hydrochloride, mometasone furoate and a hydrocolloid, carboxymethylcellulose sodium (at least about 0.5%) and xanthan gum (at least about 0.3%) and no phasing separation occurred upon shaking (stable composition) for at least 24 h and its use in a method of treating symptoms associated with seasonal allergic rhinitis. As to the limitation of ambient conditions, Dhuppad teach that the suspension composition includes a hydrocolloid in a sufficient amount to prevent phase separation after 3 or 6 months of storage at 25.+-.2.degree. C. and 60%.+-.5% relative humidity. As to the limitations of applying twice daily, two sprays per nostril of the fixed dose aqueous composition it is noted the dosage regimen and administration is within the skill of an artisan to routine adjust based on patient’s condition, age etc. Where 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). As to the limitation that administration provides a meaningful decrease in the allergic rhinitis symptoms of the human subject within 15 minutes of administration, it is noted that administration of the same fixed dose aqueous pharmaceutical composition comprising olopatadine hydrochloride, mometasone furoate to the same set of subjects, herein human subjects suffering from seasonal allergic rhinitis will results in the same pharmacological effects and within the time limit as claimed. It is noted that Applicants have not defined or stated in regards to meaningful. In general, meaningful is defined as significant. Thus claims 68, 76 are addressed. As to claim 69, it is noted that the reference teach that carboxymethyl cellulose sodium can be added in an amount of 0.1% w/w to about 3%. Claims 70-75, 77-83 are addressed by Dhuppad’s teaching of the composition for e.g. with chelating agent, EDTA (0.01%), isotonicity agent, NaCl (0.4% w/w), surfactant, e.g. about 0.01% w/w polysorbate 80, preservative, EDTA (0.01%), buffer, about 0.94% w/w sodium phosphate heptahydrate. As to claims 84-85 is addressed by Dhuppad’s teaching of the composition comprising the same agents, with the amounts that fall within the range as claimed (See [0038), examples) and its use in a method of treating seasonal rhinitis and its symptoms in a human subject. As to the limitation that administration provides a meaningful decrease in the allergic rhinitis symptoms of the human subject within 15 minutes of administration, it is noted that administration of the same fixed dose aqueous pharmaceutical composition comprising olopatadine hydrochloride, mometasone furoate to the same set of subjects, herein human subjects suffering from seasonal allergic rhinitis will results in the same pharmacological effects and within the time limit as claimed. Thus the claimed invention would have been obvious over the teachings of Dhuppad.
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 68, 76 and 84 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.
Claims 68, 76 and 84 recite a limitation of ‘a meaningful decrease in their allergic rhinitis symptoms of the human subject within 15 minutes of administration’.
The specification in page 26, lines 1-4 state,
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There is no definition provided in the specification to what amount of decrease is meaningful? In other words what is meaningful decrease? Is it 1% or 10% or 50% decrease? Clarification is required.
Note: For the sake of compact prosecution, the claims have been examined based on the generic definition of meaningful is ‘significant’.
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 §§ 706.07I 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 68-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. US 12303635 or claims 1-22 of co-pending application 19182237 (’237) in view of Dhuppad et al. (US 20150079178 A1).
The instant method claims are directed to a method of treating one or more symptoms of seasonal allergic rhinitis in a human subject in need thereof comprising nasally administering twice daily, two sprays per nostril of a fixed dose aqueous pharmaceutical composition, wherein (i) the composition comprises a) about 0.025% w/w mometasone furoate; b) about 0.665% w/w olopatadine hydrochloride; and c) a hydrocolloid selected from carboxymethylcellulose sodium in an amount of at least about 0.5% w/w and xanthan gum in an amount of at least about 0.3% w/w, (ii) when shaken and then stored for at least 24 hours at ambient conditions, the composition does not show phase separation, and (iii) the administration of the pharmaceutical composition provides a meaningful decrease in the allergic rhinitis symptoms of the human subject within 15 minutes of administration (claim 68); the dependent claims are limited to amount of carboxymethyl cellulose, further comprising agents. Claim 76 is the same method as claim 68 but the composition comprises at least 500 mcg of carboxymethyl cellulose sodium and at least about 300 mcg of xanthan gum. Claim 84 is to treating one or more symptoms of seasonal allergic rhinitis n a human subject in need thereof comprising nasally administering twice daily, two sprays per nostril of a fixed dose aqueous pharmaceutical composition, wherein the composition comprises a) about 0.025 % w/w mometasone furoate; b) about 0.665 % w/w olopatadine hydrochloride; c) about 0.5% w/w carboxymethylcellulose sodium; d) about 1.2% w/w of a mixture of microcrystalline cellulose and carboxymethylcellulose sodium with a carboxymethylcellulose sodium content in the mixture of about 8.3-13.8% w/w; e) about 0.94% w/w dibasic sodium phosphate; f) about 0.41% w/w sodium chloride; g) about 0.02% w/w benzalkonium chloride; h) about 0.01% w/w edetate disodium; and i) about 0.01% w/w polysorbate 80, wherein the administration of the pharmaceutical composition provides a meaningful decrease in the allergic rhinitis symptoms of the human subject within 15 minutes of administration.
‘635 reference claims are directed to a dispensing device containing an aqueous suspension for nasal administration to a human subject, comprising: (a) about 0.025% w/w mometasone furoate in particulate form; and (b) about 0.665% w/w olopatadine hydrochloride in dissolved form; the suspension further comprises a hydrocolloid, xanthan gum and carboxymethyl cellulose sodium in an amount of at least 0.1%-3% w/w of the suspension; xanthan gum is present in an amount of at least 0.3%-3% w/w of the suspension. Claim 9 is to dispensing device of claim 1, wherein the suspension comprises 0.025% w/w mometasone furoate, 0.665% w/w olopatadine hydrochloride, 0.5% w/w carboxymethyl cellulose sodium, 1.2% w/w mixture of microcrystalline cellulose and carboxymethyl cellulose sodium, 0.02% w/w benzalkonium chloride, 0.4% w/w sodium chloride, 0.01% w/w di-sodium edetate, 0.94% w/w sodium phosphate heptahydrate, and 0.01% w/w polysorbate 80.
‘237 reference claims are directed to a dispensing device and pharmaceutical composition for nasal administration to a human, comprising a container, the container comprising an aqueous pharmaceutical composition in the container, the composition comprising: about 0.001% w/w to about 0.075% w/w mometasone, an ester thereof, or a salt thereof in particulate form; about 0.5% w/w to about 0.8% w/w olopatadine or its salt in dissolved form; and a hydrocolloid in an amount sufficient to inhibit phase separation for at least 24 hours when stored at 25 +20 C. and 60% + 5% relative humidity; wherein the composition comprises about 0.025% w/w mometasone furoate, about 0.665% w/w olopatadine hydrochloride, about 0.5%w/w carboxymethyl cellulose sodium, about 1 .2% w/w mixture of microcrystalline cellulose and carboxymethyl cellulose sodium, about 0.02% w/w benzalkonium chloride, about 0.4% w/w sodium chloride, about 0.01% w/w di-sodium edetate, about 0.94% w/w sodium phosphate heptahydrate, and about 0.01% w/w polysorbate 80.
The reference claims are not explicit in teaching the use of the mometasone, olopatadine suspension composition in a method of treating symptoms of seasonal allergic rhinitis.
Dhuppad et al. as discussed above.
From the teachings of Dhuppad, a person skilled in the art would have found it obvious to use the composition of the reference claims for treating seasonal allergic rhinitis. As to the limitations of when shaken and then stored for at least 24 hours at ambient conditions, the composition does not show phase separation, it is noted that the same composition as in the reference claim is taught by Dhuppad and further the reference teaches that the composition is stable, stable as defined, in connection with aqueous suspensions refers to a composition when shaken and then stored for at least 24 hours at ambient condition does not show phase separation on visual inspection. As to the limitation that administration provides a meaningful decrease in the allergic rhinitis symptoms of the human subject within 15 minutes of administration, it is noted that administration of the same fixed dose aqueous pharmaceutical composition comprising olopatadine hydrochloride, mometasone furoate to the same set of subjects, herein human subjects suffering from seasonal allergic rhinitis will results in the same pharmacological effects and within the time limit as claimed. Thus claims 68-85 would have been obvious over the teachings of the reference claims and Dhuppad.
Note: In regards to 19182237 (co-pending application), it is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 68-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8, 15-21 of co-pending application, 18/955,763 (‘763) and Dhuppad et al. (US 20150079178 A1)
The instant method claims as above.
‘763 reference claims are directed to a pharmaceutical composition suitable for a nasal spray device comprising an actuator and a dip tube through which the composition is to be delivered, wherein (a) the composition is in the form of an aqueous suspension suitable for nasal administration, and (b) the composition comprises mometasone furoate in an amount of about 0.025% w/w; olopatadine hydrochloride in an amount of about 0.665% w/w in dissolved form; the composition further comprises a hydrocolloid selected from carboxymethylcellulose sodium and xanthan gum in an amount of about 0.3% w/w to about 3% w/w; the composition further comprises a chelating agent in an amount of about 0.0002 to about 0.5% w/w; an isotonicity agent of about 0.001% to about 1% w/w; a surfactant in an amount of about 0.001% to about 1% w/w; preservative in an amount of about 0.005 to about 0.2% w/w; and a buffer in an amount of about 0.005% to about 1% w/w. Claim 17 is to a method of treating a patient suffering from allergic rhinitis comprising administering an effective amount of the pharmaceutical composition of claim 1 to the patient; the pharmaceutical composition comprising about mometasone furoate in an amount of about 0.025% w/w; olopatadine hydrochloride in an amount of about 0.665% w/w in dissolved form, 0.5% w/w carboxymethyl cellulose sodium, further comprises a hydrocolloid selected from carboxymethylcellulose sodium and xanthan gum in an amount of about 0.3% w/w to about 3% w/w; about 1.2% w/w of a mixture of microcrystalline cellulose and carboxymethyl cellulose sodium, about 0.02% w/w benzalkonium chloride, about 0.41% w/w sodium chloride, about 0.01% w/w di-sodium edetate, about 0.94% w/w dibasic sodium phosphate, and about 0.01% polysorbate 80.
Dhuppad teachings as discussed above.
From the teachings of the reference claims and Dhuppad, a person skilled in the art would have found it obvious to arrive at the claimed method because (i) the reference claims teach a method of treating allergic rhinitis using the same composition as in the instant methods (ii) Dhuppad teach a method of treating seasonal rhinitis using the same composition as in the instant methods. A skilled artisan would have found it obvious to arrive at the composition comprising the active agents and other components from the reference claims and Dhuppad with a reasonable amount of success and use it in treating allergic rhinitis. As to treating seasonal allergic rhinitis, it is a type of allergic rhinitis and hence a skilled artisan would have found it obvious to treat different types of allergic rhinitis conditions. As to the limitations of when shaken and then stored for at least 24 hours at ambient conditions, the composition does not show phase separation, it is noted that the same composition as in the reference claim is taught by Dhuppad and further the reference teaches that the composition is stable, stable as defined, in connection with aqueous suspensions refers to a composition when shaken and then stored for at least 24 hours at ambient condition does not show phase separation on visual inspection. As to the limitation that administration provides a meaningful decrease in the allergic rhinitis symptoms of the human subject within 15 minutes of administration, it is noted that administration of the same fixed dose aqueous pharmaceutical composition comprising olopatadine hydrochloride, mometasone furoate to the same set of subjects, herein human subjects suffering from seasonal allergic rhinitis will results in the same pharmacological effects and within the time limit as claimed. Thus claims 68-85 would have been obvious over the teachings of the reference claims and Dhuppad.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 68-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of US 9750754 (‘754) or claims of 1-14 of US 10765686 (‘686) or claims 1-22 of US 10561672 (‘672) or claims 1-25 of US 10517880 (‘880) or claims 1-32 of US 10376526 (‘526) or claims 1-8 of US 11679210 (‘210) or claims 1-36 of US 9937189 (‘189) or claims 1-21 of US 9370483 (‘483) in view of Dhuppad et al. (US 20150079178 A1).
The instant method claims as above.
‘754 reference claims are directed to a fixed dose pharmaceutical composition and to a method of treating allergic rhinitis comprising intranasal administration of a stable fixed dose aqueous pharmaceutical composition comprising 0.025% or 0.05% w/w mometasone furoate monohydrate; 0.665% w/w olopatadine hydrochloride; 0.5% w/w carboxymethyl cellulose sodium; 1.2% w/w of a mixture of microcrystalline cellulose and carboxymethyl cellulose sodium; 0.02% w/w benzalkonium chloride; 0.41% w/w sodium chloride; 0.01% w/w di-sodium edetate; and 0.01% w/w polysorbate 80.
‘686 reference claims are directed to a method of delivering a nasal spray comprising: nasally delivering an aqueous pharmaceutical composition in the form of a single phase suspension, comprising mometasone and olopatadine; claim 14 is directed to 0.025% w/w mometasone furoate monohydrate; 0.665% w/w olopatadine hydrochloride; 0.5% w/w carboxymethyl cellulose sodium; 1.2% w/w of a mixture of microcrystalline cellulose and carboxymethyl cellulose sodium; 0.02% w/w benzalkonium chloride; 0.41% w/w sodium chloride; 0.01% w/w di-sodium edetate; 0.94% w/w dibasic sodium phosphate heptahydrate; and 0.01% w/w polysorbate 80.
‘672 reference claims are directed to a aqueous pharmaceutical composition for nasal administration to a human in the form of a suspension, wherein the composition comprises: 0.025% w/w mometasone furoate monohydrate in the form of particles having a mean particle size of from 1 μm to 20 μm; 0.665% w/w olopatadine hydrochloride; 0.5% w/w carboxymethyl cellulose sodium; 1.2% w/w of a mixture of microcrystalline cellulose and carboxymethyl cellulose sodium; 0.02% w/w benzalkonium chloride; 0.41% w/w sodium chloride; 0.01% w/w di-sodium edetate; 0.94% w/w sodium phosphate heptahydrate; and 0.01% w/w polysorbate 80, wherein the composition has a pH of 3.3 to 4.1, and wherein the mometasone furoate and olopatadine hydrochloride are the sole active ingredients in the composition.
‘880 reference claims are directed to a sprayer containing an aqueous pharmaceutical composition in the form of a single phase suspension comprising mometasone or its salt and olopatadine or its salt, wherein the composition is a single phase aqueous suspension comprising: 0.025% w/w mometasone furoate monohydrate; 0.665% w/w olopatadine hydrochloride; 0.5% w/w carboxymethyl cellulose sodium; 1.2% w/w of a mixture of microcrystalline cellulose and carboxymethyl cellulose sodium; 0.02% w/w benzalkonium chloride; 0.41% w/w sodium chloride; 0.01% w/w di-sodium edetate; 0.94% w/w sodium phosphate heptahydrate; and 0.01% w/w polysorbate 80 and its use in a method of treating rhinitis.
526 reference claims are directed to aqueous pharmaceutical composition for nasal administration to a human in the form of a suspension comprising mometasone furoate, olopatadine hydrochloride, and a hydrocolloid in an amount sufficient for the suspension to remain in a single phase after 3 months of storage at 25±2° C. and 60%±5% relative humidity; claim 14 is to the aqueous pharmaceutical composition of claim 6, wherein the composition is a single phase aqueous suspension comprising: 0.025% w/w mometasone furoate monohydrate; 0.665% w/w olopatadine hydrochloride; 0.5% w/w carboxymethyl cellulose sodium; 1.2% w/w of a mixture of microcrystalline cellulose and carboxymethyl cellulose sodium; 0.02% w/w benzalkonium chloride; 0.41% w/w sodium chloride; 0.01% w/w di-sodium edetate; 0.94% w/w sodium phosphate heptahydrate; and 0.01% w/w polysorbate 8 the composition further comprises a buffer, dibasic sodium phosphate.
‘210 reference claims are directed to a dispensing device and pharmaceutical composition for nasal administration to a human wherein the pharmaceutical composition comprises about 0.025% w/w mometasone furoate, about 0.665% w/w olopatadine hydrochloride, about 0.5% w/w carboxymethyl cellulose sodium, about 1.2% w/w mixture of microcrystalline cellulose and carboxymethyl cellulose sodium, about 0.02% w/w benzalkonium chloride, about 0.4% w/w sodium chloride, about 0.01% w/w di-sodium edetate, about 0.94% w/w sodium phosphate heptahydrate, and about 0.01% w/w polysorbate 80 (claim 8).
‘189 reference claims are to a fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition being a suspension which comprises (a) mometasone furoate in particulate form; and (b) olopatadine hydrochloride in dissolved form; wherein the composition comprises 0.025% w/w of mometasone furoate and 0.665% w/w olopatadine hydrochloride; wherein the hydrocolloid comprises carboxymethyl cellulose sodium; wherein the composition when shaken and then stored for at least 24 hours at ambient conditions does not show phase separation on visual inspection; the composition further comprising dibasic sodium phosphate.
‘483 reference claims are to a stable fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition being a suspension which comprises (a) mometasone or its salt in particulate form; (b) olopatadine or its salt in dissolved form; wherein the composition comprises about 0.025% w/w to about 0.05% w/w of mometasone or its salt and about 0.6% w/w to about 0.7% w/w olopatadine or its salt; the composition further comprising a hydrocolloid, wherein the hydrocolloid comprises carboxymethylcellulose and is present in the amount of from about 0.1% w/w to about 2% w/w.
The reference claims are not explicit in teaching xanthan gum or the other components in the composition comprising mometasone and olopatadine.
Dhuppad teachings as discussed above. The reference further teach that the "hydrocolloid" refers to a colloid system wherein hydrophilic colloid particles, they can exist in gel state, and are dispersed in water. The hydrocolloid includes xanthan gum or carboxymethylcellulose sodium [0054].
From the teachings of Dhuppad, a person skilled in the art would have found it obvious to add xanthan gum to the composition comprising 0.025% w/w mometasone furoate, about 0.665% w/w olopatadine hydrochloride, about 0.5% w/w carboxymethyl cellulose sodium because Dhuppad teach both xanthan gum and carboxymethyl cellulose sodium are hydrocolloids, teach their equivalence. A skilled artisan would have found it obvious to add xanthan gum as a hydrocolloid in the composition with a reasonable amount of success and add both of them to make stronger gels or solutions or suspensions and enhance the stability of the pharmaceutical composition.
A skilled artisan would have found it obvious to arrive at the composition comprising the active agents and other components from Dhuppad with a reasonable amount of success and use it in treating allergic rhinitis. A person skilled in the art would have found it obvious to arrive at the claimed method because both the reference claims and Dhuppad teach a composition comprising mometasone, olopatadine and specific ingredients (with the amounts about the same or overlapping). Dhuppad is explicit in teaching the composition comprising mometasone and olopatadine for treating seasonal rhinitis. As to seasonal allergic rhinitis, it is a type of allergic rhinitis and hence a skilled artisan would have found it obvious to treat different types of allergic rhinitis conditions with the mometasone, olopatadine composition. As to the limitations of when shaken and then stored for at least 24 hours at ambient conditions, the composition does not show phase separation, it is noted that the same composition as in the reference claim is taught by Dhuppad and further the reference teaches that the composition is stable, stable as defined, in connection with aqueous suspensions refers to a composition when shaken and then stored for at least 24 hours at ambient condition does not show phase separation on visual inspection. As to the limitation that administration provides a meaningful decrease in the allergic rhinitis symptoms of the human subject within 15 minutes of administration, it is noted that administration of the same fixed dose aqueous pharmaceutical composition comprising olopatadine hydrochloride, mometasone furoate to the same set of subjects, herein human subjects suffering from seasonal allergic rhinitis will results in the same pharmacological effects and within the time limit as claimed. Thus claims 68-85 would have been obvious over the teachings of the reference claims and Dhuppad.
Claims 68-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US 9078923 (‘923) in view of Dhuppad et al. (US 20150079178 A1).
The instant method claims as above.
‘923 reference claims are directed to a stable fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition being a single phase suspension which comprises (a) about 0.001% w/w to about 0.075% w/w mometasone or its salt in particulate form; (b) about 0.5% w/w to about 0.8% w/w olopatadine or its salt in dissolved form; and (c) a hydrocolloid system in an amount sufficient to inhibit phase separation for at least 24 hours when stored at 25.+-.2.degree. C. and 60% .+-.5% relative humidity and to the use of the composition in a method of treating rhinitis in a human in need thereof. Claim 19 is to a stable fixed dose pharmaceutical composition for nasal administration to a human, the composition being a single phase aqueous suspension comprising: 0.025% or 0.05% w/w mometasone furoate monohydrate; 0.665% w/w olopatadine hydrochloride; 0.5% w/w carboxymethyl cellulose sodium; 1.2% w/w of a mixture of microcrystalline cellulose and carboxymethyl cellulose sodium; 0.02% w/w benzalkonium chloride; 0.41% w/w sodium chloride; 0.01% w/w di-sodium edetate; 0.94% w/w sodium phosphate heptahydrate; and 0.01% w/w polysorbate 80; wherein the composition has a pH of about 3.3 to about 4.1 and to the use of the composition in a method of treating rhinitis in a human in need thereof.
The reference claims do not teach xanthan gum in the composition.
Dhuppad teachings as discussed above. The reference further teach that the "hydrocolloid" refers to a colloid system wherein hydrophilic colloid particles, they can exist in gel state, and are dispersed in water. The hydrocolloid includes xanthan gum or carboxymethylcellulose sodium [0054].
From the teachings of Dhuppad, a person skilled in the art would have found it obvious to add xanthan gum to the composition comprising 0.025% w/w mometasone furoate, about 0.665% w/w olopatadine hydrochloride, about 0.5% w/w carboxymethyl cellulose sodium because Dhuppad teach both xanthan gum and carboxymethyl cellulose sodium are hydrocolloids, teach their equivalence. A skilled artisan would have found it obvious to add xanthan gum as a hydrocolloid in the composition with a reasonable amount of success and add both of them to make stronger gels or solutions or suspensions and enhance the stability of the pharmaceutical composition. A skilled artisan would have found it obvious to arrive at the composition comprising the active agents and other components from Dhuppad with a reasonable amount of success and use it in treating allergic rhinitis.
A person skilled in the art would have found it obvious to arrive at the claimed method because both the reference claims and Dhuppad teach a composition comprising mometasone, olopatadine and specific ingredients (with the amounts about the same or overlapping) and its use in treating allergic rhinitis or seasonal rhinitis. As to treating seasonal allergic rhinitis, it is a type of allergic rhinitis and hence a skilled artisan would have found it obvious to treat different types of allergic rhinitis conditions with the mometasone, olopatadine composition. As to the limitations of when shaken and then stored for at least 24 hours at ambient conditions, the composition does not show phase separation, it is noted that it is addressed by the reference claims. As to the limitation that administration provides a meaningful decrease in the allergic rhinitis symptoms of the human subject within 15 minutes of administration, it is noted that administration of the same fixed dose aqueous pharmaceutical composition comprising olopatadine hydrochloride, mometasone furoate to the same set of subjects, herein human subjects suffering from seasonal allergic rhinitis will results in the same pharmacological effects and within the time limit as claimed. Thus claims 68-85 would have been obvious over the teachings of the reference claims and Dhuppad.
Claims 68-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of US 10758550 (‘550) or claims 1-26 of US 11400101 (‘101) or claims 1-18 of US 12064442 or claims 1-5 of US 10653661 (‘661) or claims US 10016443 (‘443) or claims 1-32 of US 10548907 (‘907) or claims 1-15 of US 10646500 (‘500) in view of Dhuppad et al. (US 20150079178 A1).
The instant method claims as above.
‘550 claims are directed to method of providing a faster onset of action for relief of allergic rhinitis in a pediatric human subject in need thereof, the method comprising nasally administering to a subject twice daily, one spray per nostril of a fixed-dose pharmaceutical composition comprising mometasone furoate and olopatadine hydrochloride, wherein (i) each spray comprises about 25 mcg of mometasone furoate and about 665 mcg olopatadine hydrochloride, and (ii) the administration provides relief from one or more symptoms of allergic rhinitis faster than nasal administration of 25 mcg mometasone furoate or 665 mcg olopatadine hydrochloride per nostril alone; pharmaceutical composition provides relief from one or more symptoms of allergic rhinitis within 15 minutes of administration.
‘101 claims are directed to method of treating one or more symptoms associated with allergic rhinitis in a human subject in need thereof comprising nasally administering twice daily, two sprays per nostril of a fixed-dose pharmaceutical composition comprising mometasone furoate and olopatadine hydrochloride, wherein (i) each spray comprises about 25 mcg of mometasone furoate and about 665 mcg olopatadine hydrochloride, and (ii) the administration provides relief from one or more symptoms associated with allergic rhinitis faster than nasal administration of the 50 mcg mometasone furoate or 1330 mcg olopatadine hydrochloride alone; further (a) onset of action for relief of one or more symptoms of allergic rhinitis within 15 minutes of administration, and (b) a diagnosis of the human subject as suffering from allergic rhinitis.
‘442 claims are directed to a method of treating allergic rhinitis and/or symptoms associated therewith in a human in need thereof comprising nasally administering to the human an effective amount of a fixed-dose pharmaceutical composition comprising mometasone furoate and olopatadine or its salt, in a weight ratio of from about 1:12 to about 1:53, wherein (i) the composition is nasally administered as 1 or 2 sprays per nostril, at least once daily, (ii) the pharmaceutical composition has a pH between about 3.3 and about 4.1, and (iii) each spray comprises olopatadine hydrochloride equivalent to about 600 mcg of olopatadine and about 25 mcg to about 50 mcg of mometasone furoate; the method provides reduction in at least one treatment-related adverse effect relative to the use of olopatadine alone. Claim 14 includes a limitation of (iii) the composition has a total impurity content of no more than 1.0% after storage at about 25° C. and 60% relative humidity for a period of at least 6 months; claim 15 includes a limitation of after 3 months of storage at 25° C.±2° C. and 60%±5% relative humidity; claim 17 includes a limitation of based on the 100% total weight of olopatadine hydrochloride in the composition, after 3 months of storage at 40° C.±2° C. and 75%±5% relative humidity.
‘661 reference claims are directed to a method of treating one or more symptoms associated with perennial allergic rhinitis in a human subject in need thereof comprising nasally administering, twice daily, to the human subject about 1330 mcg per nostril of olopatadine hydrochloride and about 50 mcg per nostril of mometasone furoate, wherein (i) the mometasone furoate and olopatadine hydrochloride are administered in a fixed-dose pharmaceutical composition, and (ii) the twice daily administration of the pharmaceutical composition provides a faster onset of action than twice daily administration of 1330 mcg per nostril of olopatadine hydrochloride alone.
‘443 claims are to a method of treating one or more symptoms associated with allergic rhinitis in a human subject in need thereof comprising nasally administering twice daily, two sprays per nostril of a fixed-dose pharmaceutical composition comprising mometasone furoate and olopatadine hydrochloride, wherein (i) each spray comprises about 25 mcg of mometasone furoate and about 665 mcg olopatadine hydrochloride, and (ii) the administration of the pharmaceutical composition provides relief from one or more symptoms of allergic rhinitis within 15 minutes of administration.
‘907 reference claims are to a method of treating one or more symptoms associated with allergic rhinitis in a human subject in need thereof comprising twice daily nasal administration to the human subject of about 1330 mcg per nostril of olopatadine hydrochloride and about 50 mcg per nostril of mometasone furoate, wherein (i) the olopatadine hydrochloride and mometasone furoate are administered in a single pharmaceutical composition as a nasal spray, and (ii) the twice daily administration of the pharmaceutical composition provides a faster onset of action than twice daily administration of 1330 mcg per nostril of olopatadine hydrochloride alone.
‘500 reference claims are directed to a method of treating one or more symptoms associated with allergic rhinitis in a human subject in need thereof comprising nasally administering to the human subject a fixed-dose pharmaceutical composition comprising mometasone furoate and olopatadine hydrochloride, wherein (i) the composition is nasally administered as 2 sprays per nostril of the human subject twice daily, (ii) each spray of the composition comprises about 25 mcg mometasone furoate and olopatadine hydrochloride equivalent to about 600 mcg olopatadine, and (iii) the twice daily administration of the pharmaceutical composition provides a faster onset of action than twice daily administration of olopatadine hydrochloride equivalent to about 1200 mcg olopatadine per nostril alone.
The reference claims do not teach carboxymethyl cellulose, xanthan gum and/or the other agents in the composition comprising mometasone and olopatadine for treating rhinitis.
Dhuppad teachings as discussed above. The reference further teach that the "hydrocolloid" refers to a colloid system wherein hydrophilic colloid particles, they can exist in gel state, and are dispersed in water. The hydrocolloid includes xanthan gum or carboxymethylcellulose sodium [0054].
From the teachings of Dhuppad, a person skilled in the art would have found it obvious to add xanthan gum to the composition comprising 0.025% w/w mometasone furoate, about 0.665% w/w olopatadine hydrochloride, about 0.5% w/w carboxymethyl cellulose sodium because Dhuppad teach both xanthan gum and carboxymethyl cellulose sodium are hydrocolloids, teach their equivalence. A skilled artisan would have found it obvious to add xanthan gum as a hydrocolloid in the composition with a reasonable amount of success and add both of them to make stronger gels or solutions or suspensions and enhance the stability of the pharmaceutical composition. A skilled artisan would have found it obvious to arrive at the composition comprising the active agents and other components from Dhuppad with a reasonable amount of success and use it in treating allergic rhinitis.
A person skilled in the art would have found it obvious to arrive at the claimed method because both the reference claims and Dhuppad teach a composition comprising mometasone, olopatadine and specific ingredients (with the amounts about the same or overlapping) and its use in treating allergic rhinitis or seasonal rhinitis. As to treating seasonal allergic rhinitis, it is a type of allergic rhinitis and hence a skilled artisan would have found it obvious to treat different types of allergic rhinitis conditions with the mometasone, olopatadine composition. As to the limitations of when shaken and then stored for at least 24 hours at ambient conditions, the composition does not show phase separation, it is noted that it is addressed by the reference claims. As to the limitation that administration provides a meaningful decrease in the allergic rhinitis symptoms of the human subject within 15 minutes of administration, it is noted that administration of the same fixed dose aqueous pharmaceutical composition comprising olopatadine hydrochloride, mometasone furoate to the same set of subjects, herein human subjects suffering from seasonal allergic rhinitis will results in the same pharmacological effects and within the time limit as claimed. Thus claims 68-85 would have been obvious over the teachings of the reference claims and Dhuppad.
Conclusion
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627