DETAILED ACTION
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 .
Status of the Claims
Claims 1-11 are pending and examined.
Claim of Foreign Priority
Applicant’s claim of foreign priority and Certified Copy of Foreign Priority Documents are acknowledged. To perfect foreign priority, Applicant must file an English translation of the foreign priority document.
Objection to the Drawings
The drawings are objected to for being illegible. The examiner cannot decipher the lines that correspond to the keys shown at the bottom of the Figures for each of Figures 1-3. The lines are not clearly depicted. Corrected drawings are requested.
Claim Objections
Claim 11 is objected to because of the following informalities: The Phrase Figure 1 is in brackets below claim 11. This appears to be inadvertent and Figure 1 does not appear to be involved in the substance of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 8-11 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. In particular, the claims recite “for use in” treating or preventing a condition. However, the claims are interpreted as product claims as they are directed to a pharmaceutical composition and the claims do not recite any step to be properly considered a method claim. According to M.P.E.P. 2173.05(q): Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
While the language discussed renders the claims indefinite, the claims are interpreted for the purposes of examination below as product claims that are not particularly limited by their potential use.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Paek et al., (US2015/0376173) (cited in ISR), in view of Liu (US2016/0206557), and in view of Kulkarni et al., (US2014/0199382), and in view of Ruegger et al., (US2010/0267675).
Paek teaches sphingosine-1-phosphate (S1P) receptor agonists which can be used to treat autoimmune diseases, including multiple sclerosis and to treat and prevent immunoregulation. See Abstract. The compounds can including pharmaceutically acceptable salts including hydrochloric acid, sulfuric, nitric, and others salts. See par. 32. Pharmaceutical carriers including diluents can be used. See par. 284. Diluents including lactose can be used, lubricants including magnesium stearate can be use, disintegrants and binders are also contemplated. See par. 289. Compound 153 was synthesized as an example and is shown below.
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253
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This is the claimed compound. Compounds can be obtained, separate, and purified by methods including recrystallization. See par. 276.
Paek does not teach particle size.
Liu teaches a sphingosine-1-phosphate (S1P) receptor agonist that can has a range of particle sizes to include one with a mean particle size of less than 50 microns and most preferably less than 20 microns. Particle size can be determined by any method employed in the art. The hydrochloride salt is contemplated. See par. 44. A preferred lubricant is sodium stearyl fumarate. See par. 132. Hydroxypropyl cellulose is used as a moisture facilitating excipient. See par. 40. Croscarmellose sodium is used as a disintegrant. See par. 61.
Kulkarni also teaches stable S1P receptor agonists with excipients for treating multiple sclerosis. See Abstract. Excipients that can be used include diluents, lubricants, binders, and others. See par. 20. Salts forms include a hydrochloride salt, among many others. See par. 27. Further, croscarmellose sodium is a suitable disintegrant, HPC is a suitable binder, sodium stearyl fumarate is an acceptable lubricant. See par.’s 31, 32, 33, and 34. The S1P receptor agonist is micronized and has a D90 that is less than 50 microns and a D50 that is less than 25 microns. See prior art claim 4.
Ruegger teaches compositions comprising S1P receptor modulators, including agonists. See par. 6. A final formulation typically includes binders, fillers, lubricants, and disintegrants. See par. 67. A filler includes lactose monohydrate as preferred. See par. 72. Magnesium stearate is a preferred lubricant. See par. 73. Croscarmellose sodium is also contemplated for use. See par. 75. Hydroxypropyl cellulose is also contemplated. See Example 6, Table 7. The examiner notes that prior art claim 1 includes: lactose monohydrate, sodium stearyl fumarate, hydroxypropyl cellulose, and croscarmellose sodium as one of a few optional fillers, binders, disintegrants, lubricants, and matrix formers.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to combine the teachings of Paek, Liu, and Ruegger to arrive at the claimed products. One would be motivated to do so because Paek teaches the claimed API as a S1P receptor agonist for use with claimed excipients to treat a number of conditions including MS. Similarly, Liu teaches S1P receptor agonists with a preferable particle size of less than 20 microns for treating similar conditions with similar excipients. Kulkarni independently teaches an API with the same excipients claimed and a particle size that is Finally, Ruegger also teaches compositions comprising S1P receptor agonists including the claimed excipients each of which are taught for use in prior art claim 1. Thus, the claimed excipients are usable together and they appear to be commonly employed excipients for use in compositions comprising S1P receptor agonists. Thus, there is a reasonable and predictable expectation of success in arriving at the claimed products in view of the cited prior art as the use of the claimed excipients and particle sizes for S1P receptor agonists are known and employed in the art.
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,540,362, in view of Liu (US2016/0206557), in view of Kulkarni et al., (US2014/0199382), and in view of Ruegger et al., (US2010/0267675).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed API is claimed in claim 3 of the ‘362 patent. See col. 186, line 47. Further, the patent application publication of the ‘362 patent corresponds to the teaches of Paek et al. as set forth above. It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to combine the teachings of Liu, Kulkarni, and Ruegger to arrive at the claimed products. One would be motivated to do so because Paek teaches the claimed API as a S1P receptor agonist for use with claimed excipients to treat a number of conditions including MS. Similarly, Liu teaches S1P receptor agonists with a preferable particle size of less than 20 microns for treating similar conditions with similar excipients. Kulkarni independently teaches an API with the same excipients claimed and a particle size that is Finally, Ruegger also teaches compositions comprising S1P receptor agonists including the claimed excipients each of which are taught for use in prior art claim 1. Thus, the claimed excipients are usable together and they appear to be commonly employed excipients for use in compositions comprising S1P receptor agonists. Thus, there is a reasonable and predictable expectation of success in arriving at the claimed products in view of the cited prior art.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-13 of U.S. Patent No. 12,479,836, in view of Liu (US2016/0206557), and in view of Kulkarni et al., (US2014/0199382), and in view of Ruegger et al., (US2010/0267675).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed API is claimed within the scope of Formula (I) of the ‘836 patent. Further, claims 12 and 13 of the ‘836 patent are directed to treating conditions that fall within the “use” claims of the instant application and are taught by Paek et al. These conditions include MS, among others. It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to combine the teachings of Liu, and Ruegger to arrive at the claimed products. One would be motivated to do so because Paek teaches the claimed API as a S1P receptor agonist for use with claimed excipients to treat a number of conditions including MS. Similarly, Liu teaches S1P receptor agonists with a preferable particle size of less than 20 microns for treating similar conditions with similar excipients. Kulkarni independently teaches an API with the same excipients claimed and a particle size that is Finally, Ruegger also teaches compositions comprising S1P receptor agonists including the claimed excipients each of which are taught for use in prior art claim 1. Thus, the claimed excipients are usable together and they appear to be commonly employed excipients for use in compositions comprising S1P receptor agonists. Thus, there is a reasonable and predictable expectation of success in arriving at the claimed products in view of the cited prior art.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628