DETAILED ACTION
Claims 1-20 are pending.
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 .
Priority
The instant Application filed 06/21/2024, now U.S. Patent #12410330 is a Divisional of 17520410, filed 11/05/2021, now U.S. Patent # 12054620. 17520410 is a Continuation in Part of 17151949, filed 01/19/2021, now U.S. Patent # 11518895. 17151949 is a Divisional of 16018875, filed 06/26/2018, now U.S. Patent # 10927269. 16018875 Claims Priority from Provisional Application 62525507, filed 06/27/2017. 17520410 Claims Priority from Provisional Application 63110700, filed 11/06/2020.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 2/28/2025, 4/10/2025, and 8/22/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gosselin et al. US 2016/0206627 A1 published July 21, 2016; Philips US 2009/0149433 A1 published June 11, 2009; Perrett et al. US 2014/0303131 A1 published October 9, 2014; and Ham et al. European Journal of Nuclear Medicine 1984 (9) 362-365;
Claim 1 is generally directed towards a method of treating eosinophilic esophagitis (EoE) in a patient in need thereof, comprising administering an orally disintegrating tablet (ODT) comprising about 3 mg of fluticasone propionate, once daily at bedtime for at least 12 weeks.
Gosselin teaches orally administered compositions of topically acting corticosteroids for the treatment of inflammation of the gastrointestinal tracts such as eosinophilic esophagitis. The present invention also provides a method for treating conditions associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention as orally disintegrating tablets comprising a topically active corticosteroid adsorbed onto a pharmaceutically acceptable carrier such as silicified microcrystalline cellulose.
Gosselin in Example 12: Clinical Tests [0104] A proof of concept study is conducted for clinical batches Fluticasone ODT (ODT-FT) 1.5 mg and 3 mg dose strengths in patients with a diagnosis of EoE aged 12 years to 55 years. [0105] The doses utilized are 1.5 mg administered twice daily and 3.0 mg administered once daily. The study also included a placebo arm. Each arm enrolls 8 subjects. Findings of efficacy analyses demonstrate a positive signal for efficacy with the greatest response seen histologically in the decrease of peak eosinophil count per high power field (a hallmark of the disease and indicator of treatment response). Both 1.5 mg and 3 mg treatment groups are clearly more efficacious than placebo histologically. The percent of subjects with at least 30% decrease in the overall EoE symptom severity, as measured by patient questionnaire, also shows numerical superiority of the two FT-ODTs over placebo. Endoscopic improvements are also seen with changes in furrowing and vascularity showing the greatest differentiation of FT-ODTs from placebo, indicating a positive anti-inflammatory effect of the formulations. [0106] Overall, the FT-ODTs of the invention demonstrate improvements in histology, overall symptoms and overall endoscopic activity.
Gosselin in [0010] The composition of the invention which can be formulated as an orally disintegrating tablet (hereafter referred to as an ODT) that disintegrates within 30 seconds when tested using the USP <701> Disintegration Test, and/or disintegrates within 60 seconds when placed in the oral cavity of a human. This is required by instant claim 7.
The pharmacokinetic data, required by the instant claims are a positive recitation of inherent outcome of giving the ODT of 1.5 mg Fluticasone to a patient with EoE. Therefore claims requiring an AUC or other parameter are taught inherently.
The patient outcome data, efficacy, is a product of giving the patient 1.5 mg Fluticasone ODT. As such the outcome flows from the dose of the drug in the patient. This is simple recitation of the positive outcome. Therefore claims requiring an AUC or other parameter are taught inherently.
Gosselin teaches the microgranules comprise at least one disintegrant in combination with a sugar alcohol and/or a saccharide, [0029].
Gosselin doesn’t mention giving the treatment at night time/bedtime for the once daily dosing, and the duration of 12 weeks.
Philips teaches the topical treatment of EoE, [0002], [0014]. Philips teaches an oral corticosteroid, [0019], [0025]. Philips teaches the patient is in a substantially supine position for at least 30 minutes, [0060].
Philips teaches:
“[0060] In certain embodiments, a dose or composition described herein is administered with food. In some embodiments, a dose or composition described herein is administered without food. In certain embodiments, a dose or composition described herein is administered in a fed or fasted state. In some embodiments, a dose or composition described herein is administered in the morning, in the afternoon, in the evening, at night, or a combination thereof. In some embodiments, the dose is administered at night. In another aspect, the dose is administered about 30 minutes prior to bed, with no food or water given after administration of the compositions herein. In yet another embodiment of the instant invention, the dose is administered prior to bedtime, wherein after administration of the composition, the patient or individual is in a substantially supine position for at least 30 minutes, at least 1 hour, at least 2 hours, at least 4 hours or at least 8 hours.”
In regards to claims 7-10, and 15, Philips teaches:
[0081] In one embodiment, the present invention provides for a corticosteroid that has a low bioavailability. Due to the low bioavailability, the corticosteroid is used in certain embodiments of the invention, the corticosteroid remains in the gastrointestinal tract, for example, in the esophagus. In some embodiments, the low bioavailability results in decreased systemic side effects and complications, allowing patients with chronic conditions to receive treatment for longer periods of time.
Philips teaches the corticosteroid can be fluticasone, which is a poor bioavailable corticosteroid, as such the limited systemic exposure and AUC data is at once envisaged.
Perrett teaches oral corticosteroid formulations for the treatment of EoE, [0003], with non-systemic orally disintegrating tablets. Therefore, having the same disease and treatment as Philips. Perret describes a formulation at [0007] one embodiment, the present invention is directed to a solid pharmaceutical composition comprising less than or equal to 20 mg of a corticosteroid, wherein the composition has no significant systemic glucocorticoid or mineralcorticoid activity after oral administration, wherein the solid pharmaceutical composition disintegrates within 60 seconds in simulated saliva when tested using the USP <701> Disintegration Test, and/or which disintegrates within 60 seconds when placed in the oral cavity of a human. Perrett makes 4 mg tablets that have the disintegration profile, see Example 1. Perret also shows using known low bioavailability fluticasone propionate at 4 mg (Falcoz shows that 10mg twice daily the absolute oral bioavailability of the drug was <1%).
Ham is brought in to show why one might require a patient to be “substantially supine position for at least 30 minutes” after dosing, at bedtime. Given that the methods of both Philips and Perret are directed towards the topical treatment of the esophagus by oral ingestion of the corticosteroid, and the drugs used are show to be low bioavailable and therefore require contact with the tissue to be absorbed at the site, one would want to increase the time the esophagus is exposed to the topical medication before continuing swallowing of saliva washed the topical application from the surface. Ham shows that the esophageal transit time is increased when a person is in the supine position, see Figure 2A.
As such a person of ordinary skill in the art would have a reasonable expectation of success in treating EoE with topical low bioavailability fluticasone propionate at 3 mg with a rapidly disintegrating tablet by oral ingestion then lying in a supine position for a period of time to facilitate a longer transit time in tissue to be treated. The rationale for using Gosselin formulation in place of Philips is to lower systemic exposure, and the rationale of being supine as noted in Philips is made obvious in Ham, to increase exposure. As such the instant invention was prima facie obvious at the time of filing.
In regards to the duration of treatment, it is generally accepted that the treatment will continue as long as needed unless contradicted by side effects or intolerance. As such the duration of treatment is obvious unless Applicant can argue some significance.
In regards to the dependent claims, these are all properties of the result of taking a specific formulation and being supine/at bedtime. As such taking the formulation of Gosselin in a supine position would inherently meet the “outcome” noted in the dependent claims. In the MPEP 2111.04; the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,266,598. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to using the same ODT formulation in the same patients.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,260,061. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to using the same ODT formulation in the same patients.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,105,315. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to using the same ODT formulation in the same patients.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,026,887. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to using the same ODT formulation in the same patients.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,684,571. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to using the same ODT formulation in the same patients.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,896,710. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to using the same ODT formulation in the same patients.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 12,059,494. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to using the same ODT formulation in the same patients.
Conclusion
No claims allowed.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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