DETAILED ACTION
Applicant’s amendment and response received on 7/10/26 has been entered. Claims 21-31 are currently pending under examination. An action on the merits follows. The present application is being examined under the pre-AIA first to invent provisions.
Those sections of Title 35, US code, not included in this action can be found in a previous office action.
Claim Rejections - 35 USC § 103
The rejection of claims 21-31 under 35 U.S.C. 103(a) as being unpatentable over WO 2008/150477 (December 11, 2008), with an effective filing date of May 31, 2007, hereafter referred to as Huizing et al., in view of Noguchi et al. (2004) J. Biol. Chem., Vol. 279(12), 11402-11407, is withdrawn in view of applicant’s amendments to the claims which now recite that the sialic acid is “free sialic acid”, applicant’s arguments, and the evidence presented in the Huizing Presentation which has been made of record in the IDS filed on 12/14/23.
Double Patenting
The rejection of claims 21-31 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9,018,174, hereafter referred to as the ‘174 patent, in view of 2008/150477 (December 11, 2008), with an effective filing date of May 31, 2007, hereafter referred to as Huizing et al., is maintained. Applicant’s amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed below.
The applicant argues that Huizing et al. cannot be combined with the ‘174 patent because the ‘174 patent claims differ in scope from the instant claims by not specifically reciting that the subject with HIBM has a mutation in the GNE gene, specifically an M712T mutation, or further recite that the methods include identification of a mutation in the GNE gene prior to treatment, and Huizing teaches away from using free sialic to treat HIBM with a GNE mutation.
In response, the ‘174 patent claims recite a substantially similar method of orally administering free sialic acid to a treat HIBM or hyposialylation in a subject or skeletal muscle in a subject (claims 1 and 3), and further where the subject exhibits myopathic symptoms (claims 2 and 4). Applicant is correct that the ‘174 patent claims differ in scope from the instant claims by not specifically reciting that the subject with HIBM has a mutation in the GNE gene (instant claim 1), specifically an M712T mutation (instant claim 2), or further recite that the methods include identification of a mutation in the GNE gene prior to treatment (instant claims 26-31). However, the ‘174 patent claims clearly encompass the treatment of HIBM, including HIBM arising from specific genetic mutations. The specification of the ‘174 patent discloses the genetic basis of HIBM as a mutation in M721T, and further discloses identification of patients with this mutation. As, such, these nonclaimed embodiments encompassed by the ‘174 patent method claims represent obvious variants of the ‘174 patent method claims.
The MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for obvious-type double patenting rejections. In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. See In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In particular, those portions of the specification which provide support for the reference claims may 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 reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). 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 or application which provides support for the 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.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The MPEP gives the example that if the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim.
Furthermore, Huizing et al. was not relied upon for teaching to treat HIBM with the oral administration of free sialic acid. The ‘174 patent claims already claim such a method. Huizing et al. was cited for teaching the genetic basis of HIBM. As set forth in the rejection of record, Huizing et al. teaches that the underlying genetic defect in HIBM patients is related to mutations in the GNE gene which results in decreased production of sialic acid and hyposialylation of proteins (Huizing et al., pages 11-16). Huizing et al. teaches that HIBM is associated with myopathy and muscular atrophy (Huizing et al., pages 11-16). Huizing et al. teaches methods of treating HIBM, particularly in subjects with an M712T mutation commonly found in GNE gene of Iranian-Jewish HIBM patients, by increasing the amount of sialic acid (Huizing et al., pages 9-11, 32-34, and 47). Huizing et al. further teaches the identification of human patients with HIBM, where as part of the procedure, the patients DNA is tested for GNE gene mutations (Huizing et al., pages 34-35).
Therefore, in view of the known association of mutations in GNE with HIBM as taught by Huizing et al., and the further teachings of Huizing et al. to identify mutations in the GNE, including M712T, prior to treatment with a compound to increase sialic acid in patients with HIBM, it is maintained that it would have been prima facie obvious to the skilled artisan at the time of filing to practice the methods of treating a patient with HIBM as set forth in the ‘174 patent in patients with HIBM comprising a mutation in GNE, and more specifically a M721T mutation in GNE, and to further include in the methods of claims 1-4 of the ‘174 patent a step of identifying a mutation in GNE in a subject, and specifically the mutation M712T, prior to oral administration of free sialic acid to the subject in order to treat myopathy with a reasonable expectation of success.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
