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 .
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,925,138. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a solid oral dosage form comprising at least 0.5 mg of fingolimod lauryl! sulfate salt and one or more excipients including a sugar alcohol, binders, fillers and the like. The claims differ in that the 138 claims recite specific tablet disintegration times and other release kinetics. The instant claims are of broader scope than the 138 claims, however would encompass the tablets as they comprise the same components, arranged in the same way and as such should have the same release kinetics. These limitations are the result of optimization of result effective parameters and would have been obvious to an artisan of ordinary skill. For these reasons, the claims cannot be allowed together.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,925,829. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn toa solid oral dosage form comprising at least 0.5 mg of fingolimod lauryl sulfate salt and one or more excipients including a sugar alcohol, binders, fillers and the like. The claims differ in that the 829 claims recite specific tablet disintegration times and other release kinetics. The instant claims are of broader scope than the 829 claims, however would encompass the tablets as they comprise the same components, arranged in the
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al (US 2014/0199382 hereafter Kulkarni).
Kulkarni discloses a stable fingolimod formulation comprising about 0.56 mg of a fingolimod salt in a tablet form [abstract, 0004, 0027, Example 5, 6]. The formulation is made from blending fingolimod with a surfactant like sodium lauryl sulfate [0019]. The stable formulation has less than 1% degradation products and has over 80% potency [0023, 0028]. The dosage form include granules that can be formed in to tablets and capsules (0039, 0041]. The ingredients including binders, lubricants, and other excipients are dissolved in a solvents, dried and formed into the final dosage form [0032, Example 7, 8]. The formulation comprises a ratio of fingolimod to surfactant of 1:0.7 [Example 2].
Regarding the disintegration time and melting point of the fingolimod lauryl] sulfate, it is the position of the Examiner that these features do not distinguish the instant claims over the prior art as they are intrinsic to the formulation and cannot be separated. It is the position of the Examiner these physical features are dependent on the compositional components of the formulation, meaning that the same formulation with the same compositional components would have to have the same physical features. The claims recite that the solid table dosage form comprises a fingolimod lauryl sulfate complex or conjugates that is formed by reacting the compounds at a particular molar ratio. The prior art discloses these compounds reacted together at the same ratios. The instant claims recite a binder as an excipient and the prior art discloses the same excipients. The prior art discloses the same solid dosage form, same active agent, same excipients and the same concentrations as the instant claims and as such, since the disintegration time and other physical features are result dependent on these limitations, the prior art must have these features as well. “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding the lyophilization limitations drawn to the manner in which the formulation is formed, it is the position of the Examiner that such limitations do not distinguish the claims over the prior art. The claims are drawn to products and the prior art discloses the same product. The limitations are product-by-process limitations, that do not distinguish over the prior art. Even though product -by- process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). It would have been obvious to use the Kulkarni formulation as it comprises the same components, and product limitations specifically the same degradation properties as the instant claims. Barring evidence to the contrary, it remains the position of the Examiner that the formulations would perform the same.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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