Reply Under 37 C.F.R. § 1.116
`Prioritized Examination (Track 1)- Art Unit 1649
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`LUKASHEV et al.
`Appl. No.: 13/372,426
`Filed: February 13, 2012
`For: Treatment for Multiple Sclerosis
`
`Confirmation No.: 5998
`Art Unit: 1649
`Examiner: ULM, John D.
`Atty. Docket: 2159.3210002/JMC/MRG/U-S
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`l<.eply to Fhud Office Action Under 37 C~F.R. § Llt6
`
`MailStopAF
`
`Commissioner for Patents
`POBox 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`In reply to the Final Office Action dated October 12, 2012 ("the Final Office
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`Action"), Applicants submit the following Remarks.
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`The Claims are listed beginning on page 2 of this paper.
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`Remarks and Arguments begin on page 6 of this paper.
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`It is not believed that extensions of time or fees for net addition of claims are
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`required beyond those that may otherwise be provided for in documents accompanying
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`this paper. However, if additional extensions of time are necessary to prevent
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`abandonment of this application, then such extensions of time are hereby petitioned
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`under 37 C.F.R. § 1.136(a), and any fees required therefor (including fees for net
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`addition of claims) are hereby authorized to be charged to our Deposit Account
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`No. 19-0036.
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`Page 1 of 18
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`Biogen Exhibit 2012
`Coalition v. Biogen
`IPR2015-01136
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`-2-
`Reply to Final Office Action of October 12,2012
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`LUKASHEV et al.
`Appl. No. 13/372,426
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`Listing of the Claims
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`The claims are listed below for the Examiner's convenience.
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`1-17.
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`(Cancelled)
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`1 8.
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`(Previously Presented) A method of treating a subject in need of treatment for
`
`multiple sclerosis comprising orally administering to the subject in need thereof
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`a pharmaceutical composition consisting essentially of (a) a therapeutically
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`effective amount of dimethyl fumarate, monomethyl fumarate, or a combination
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`thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the
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`therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or
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`a combination thereof is about 480 mg per day.
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`19.
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`(Previously Presented) The method of claim 18, wherein the pharmaceutical
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`composition is administered in the form of a tablet, a suspension, or a capsule.
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`20.
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`(Previously Presented) The method of claim 18, wherein the therapeutically
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`effective amount is administered in separate administrations of 2, 3, 4, or 6 equal
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`doses.
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`21.
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`(Previously Presented) The method of claim 20, wherein the therapeutically
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`effective amount is administered in separate administrations of 2 equal doses.
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`22.
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`(Previously Presented) The method of claim 20, wherein the therapeutically
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`effective amount is administered in separate administrations of 3 equal doses.
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`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 2 of 18
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`- 3 -
`Reply to Final Office Action of October 12,2012
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`LUKASHEV et al.
`Appl. No. 13/372,426
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`23.
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`(Previously Presented) The method of claim 18, wherein the pharmaceutical
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`composition consists essentially of dimethyl fumarate and one or more
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`pharmaceutically acceptable excipients.
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`24.
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`(Previously Presented) The method of claim 18, wherein the pharmaceutical
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`composition consists essentially of monomethyl fumarate and one or more
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`pharmaceutically acceptable excipients.
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`25.
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`(Previously Presented) The method of claim 18, wherein the pharmaceutical
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`composition is administered to the subject for at least 12 weeks.
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`26.
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`(Previously Presented) The method of claim 23, wherein the therapeutically
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`effective amount is administered to the subject in 2 equal doses.
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`27.
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`(Previously Presented) The method of claim 26, wherein the therapeutically
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`effective amount is administered to the subject for at least 12 weeks.
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`28.
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`(Previously Presented) A method of treating a subject in need of treatment for
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`multiple sclerosis consisting essentially of orally administering to the subject
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`about 480 mg per day of dimethyl fumarate, monomethyl fumarate, or a
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`combination thereof.
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`29.
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`(Previously Presented) The method of claim 28, wherein about 480 mg of
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`dimethyl fumarate per day is administered to the subject.
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`30.
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`(Previously Presented) The method of claim 29, wherein the dimethyl fumarate
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`is administered in separate administrations of 2 equal doses.
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`Page 3 of 18
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`Reply to Final Office Action of October 12, 2012
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`LUKASHEV et al.
`Appl. No. 13/372,426
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`31.
`
`(Previously Presented) The method of claim 29, wherein the dimethyl fumarate
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`is administered in separate administrations of 3 equal doses.
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`32.
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`(Previously Presented) A method of treating a subject in need of treatment for
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`multiple
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`sclerosis comprising orally administering
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`to
`
`the
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`subject a
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`pharmaceutical composition consisting essentially of (a) a therapeutically
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`effective amount of dimethyl fumarate and (b) one or more pharmaceutically
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`acceptable excipients, wherein the therapeutically effective amount of dimethyl
`
`fumarate is about 480 mg per day.
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`33.
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`(Previously Presented) The method of claim 32, wherein the dimethyl fumarate
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`is administered in separate administrations of 2 equal doses.
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`34.
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`(Previously Presented) The method of claim 18, wherein the expression level of
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`NQ01
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`in the subject is elevated after administering to the subject the
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`therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or
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`a combination thereof.
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`35.
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`(Previously Presented) The method of claim 28, wherein the expression level of
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`NQ01 in the subject is elevated after administering to the subject about 480 mg
`
`per day of dimethyl fumarate, monomethyl fumarate, or a combination thereof.
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`36.
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`(Previously Presented) The method of claim 32, wherein the expression level of
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`NQOl in the subject is elevated after administering to the subject the
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`therapeutically effective amount of dimethyl fumarate.
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`Page 4 of 18
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`Reply to Final Office Action of October 12, 2012
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`LUKASHEV et al.
`Appl. No. 13/372,426
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`37.
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`(Previously Pn.'St:nted) A method of treating a subject in need of treatment for
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`multiple S(~1erosis comprising treating the subject in need thereof with a therapeutically
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`effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof,
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`wherein the therapeutically effective amount of dimethyl fmnarate, monomethyl
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`:tumarate, or a combination thereof is about 480 mg per day.
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`Page 5 of 18
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`Reply to Final Office Action of October 12, 2012
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`LUKASHEV et al.
`Appl. No. 13/372,426
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`Remarks
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`Claims 18-37 are pending in the application, with claims 18, 28, 32, and 37 being
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`the independent claims. Based on the following remarks, Applicants respectfully
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`request that the Examiner reconsider all outstanding objections and rejections and that
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`they be withdravm.
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`I.
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`Summarr of the Claimed Subject Matter
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`The claimed invention is directed to methods of treating multiple sclerosis
`
`("MS") which involve the administration of, or treatment of a subject with, a specific
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`daily dose of about 480 rug/day of dimethyl fumarate ("DMF") and/or monomethyl
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`fumarate ("MMF") (a biologically active metabolite ofDMF).
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`As demonstrated in two phase 3 MS clinical studies, the claimed methods
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`produced unexpectedly high efficacy, i.e., 480 mg/day DMF showed very similar
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`efficacy in treating MS as 720 mg/day of DMF. The magnitude of the efficacy
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`demonstrated for the 480 mg/day dose was especially unexpected and quite surprising
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`given the results of an earlier Phase 2 clinical study in which 720 mg/day of DMF
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`showed statistically significant efficacy when compared to placebo while 120 rug/day
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`and 360 mg/day ofDMF did not exhibit statistically significant efficacy versus placebo.
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`See Applicants' prior responses in connection with U.S. Patent Application No.
`
`12/526,296, and the response to the first Office Action filed August 3, 2012 in the
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`instant application (collectively "the prior responses").
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`Page 6 of 18
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`Reply to Final Office Action of October 12, 2012
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`LUKASHEV eta/.
`Appl. No. 13/372,426
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`II.
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`APritna Facie Case of Obviousness Has Not Been Established
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`The Examiner maintains his obviousness rejections of claims 18-37 over U.S.
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`Patent Publication No. US 2003/0018072 to Joshi eta/. ("Joshi") and over Schimrigk et
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`al., European Journal of Neurology13:604-6l0 (2006) ("Schimrigk"). Applicants
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`respectfully traverse both rejections on the grounds that a prima facie case of
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`obviousness has not been adequately established. See Applicants' prior responses (see,
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`in particular, response dated August 3, 2012, page 7, line 10 to page 12, line 7).
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`As appreciated by the Examiner, neither Joshi nor Schimrigk teaches or suggests
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`using a 480 mg/day dose to treat MS. It is the Examiner's position that a skilled person
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`in the art, based on either Joshi or Schimrigk, would have engaged in routine
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`experimentation to arrive at the 480 mg/day dose as claimed, thus rendering it
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`prima facie obviousness. It is well established that obviousness cannot be based on
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`selectively picking and choosing from diverse teachings of references, but must be based
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`on the teachings of the prior art as a whole. See In re Dow Chemical Co., 837 F.2d 469,
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`473 (Fed. Cir. 1988) ("In determining whether such a suggestion can fairly be gleaned
`
`from the prior art, the full field of the invention must be considered; for the person of
`
`ordinary skill is charged with knowledge of the entire body of technological literature,
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`including that which might lead away from the claimed invention.") However,
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`considering the total knowledge available to the skilled person as of the filing date of the
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`present application, the results of the Phase 2 clinical study would not have motivated
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`the skilled person to use the 480 mg/day dose since the 720 mg/day was the dose a
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`skilled person would have expected to be most effective. In light of the lack of prior art
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`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 7 of 18
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`Reply to Final Office Action of October 12, 2012
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`LUKASHEV et al.
`Appl. No. 13/372,426
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`teachings directing a skilled person to the claimed dosage (and indeed directing to a
`
`higher dosage), a prima facie case of obviousness has not been established.
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`In addition, Applicants would like to address the Examiner's understanding of
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`Schimrigk.
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`In the Final Office Action (the paragraph bridging pages 7 and 8), the
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`Examiner justifies disregarding Applicants' remarks concerning Schimrigk's teaching of
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`using 1290 mg/day of fumaric acid esters (F AE) because the abstract recites a "target
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`dose of 720 mg/day" in connection with the main treatment phase and a "target dose of
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`360 mg/day" in connection with the second treatment phase. The abstract does not
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`reveal to what the term "target dose" refers. The Examiner seems to be under the
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`impression that the term "target dose" refers to the total daily amount of F AEs
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`administered to the MS patients. However, this conclusion is incorrect.
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`In the Schimrigk study, scientists used Fumaderm®, a medication that contains
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`DMF as well as three different monoethyl fumarate ("MEF") salts, also referred to as
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`ethylhydrogen fumarates in the study. This is clearly stated in the paragraph under
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`"Study Drug" on page 605 with Fumaderm forte® containing 120 mg of DMF and 95
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`mg of MEF. Schimrigk further states that patients were administered up to 6 tablets of
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`Fumaderm forte® in the main treatment phase and up to 3 tablets of Fumaderm forte®
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`in the second treatment phase. See page 605, left column, last sentence of the last full
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`paragraph. Simple additions of the F AE amounts in 6 tablets of Fumaderm forte® lead
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`to 720 mg/day of DMF and 570 mg/day of MEF - a total of 1290 mg!day of FAE.
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`Schimrigk may have referred to the DMF dose in the abstract as "the target dose" as a
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`short hand notation since there was more DMF (120 mg) than MEF (95 mg) in a
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`Page 8 of 18
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`Reply to Final Office Action of October 12,2012
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`Appl. No. 13/372,426
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`Fumadenn® tablet. But a skilled person in the art reading the entire Schimrigk
`
`reference would have realized that the reference taught administration of 1290 mg/day
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`F AE.
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`Indeed, a skilled person in the art would have been aware that Fumadenn®
`
`contains four active ingredients, i.e., DMF + 3 MEF salts. See, e.g. "Summary of
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`Product Characteristics" for Fumadenn® (also referred to herein as Fumadenn forte®,
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`"Fumadenn") and Fumaderm® Initial, which is submitted herewith as Exhibit A. The
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`Examiner clearly acknowledges that Schimrigk teaches the use of a mixture of fumaric
`
`acid esters. See, e.g., Final Office Action, page 7, lines 1-4.1 Importantly, Schimrigk
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`does not teach that the MEF salts were inert in this study. The Examiner's conclusion
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`that the predominant active ingredient in Fumaderm is DMF appears to be unsupported
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`based on the teaching of Schimrigk alone.2 See Final Office Action, page 8, lines 3-5.
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`No evidence was presented as to why a skilled person in the art would have ignored the
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`presence ofMEF in the Fumadenn tablets and used only DMF.
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`In summary, the Examiner has provided no rationale as to why a person of
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`ordinary skill in the art, based on Schimrigk in its entirety, would have made the
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`changes necessary to arrive at the instant invention, i.e., (1) DMF+MEF to DMF only
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`and (2) 1290 mg/day fumarates to 480 mg/day ofDMF or MMF.
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`1 Applicants would like to point out that Fumaderm (as used in the study described in Schimrigk)
`contains DMF and 3 different MEF (monoethylfumarate) salts, and not "methyl ethyl fll1l1arate and diethyl
`fumarate" as stated in the Final Office Action, page 7, lines 3-4.
`2The two most abundant active ingredients in Fumaderm are DMF and MEF, Ca salt. The ratio
`of the amount ofDMF vs. MEF, Ca salt is 58% (120 mg) vs. 40% (87 mg). Applicants disagree that DMF
`can be considered the predominant active ingredient in a Fumaderm tablet.
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`Page 9 of 18
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`Reply to Final Office Action of October 12,2012
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`LUKASHEV eta/.
`Appl. No. 13/372,426
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`Contrary to the Examiner's position and for at least the reasons stated here, as
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`well as those set forth in the prior responses, the claimed method is not prima facie
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`obvious in view of either Joshi or Schimrigk.
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`lli.
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`Even if A Prima Facie Case Of Obviousness Had Been Established,
`Applicants' Evidence of Unexpected Results Would Overcome it
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`The Examiner acknowledges "[t]he unexpected and advantageous results
`
`demonstrated for the claimed method relative to the other embodiments that are
`
`disclosed in the instant specification are not in dispute." See Final Office Action, page
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`3, lines 3-5. However, the Examiner continues to maintain that because "neither those
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`unexpected and allegedly advantageous results nor the particular combination now
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`claimed are described in the specification as filed" (see Final Office Action, page 3,
`
`lines 5-7; emphasis original), the unexpected results cannot be used to overcome the
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`obviousness rejection. Thus, it appears that the following two issues must be addressed
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`in determining whether the unexpected results must be considered for overcoming the
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`prima facie obviousness rejections (assuming they have been established, which
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`Applicants disagree): (1) does the specification describe or reasonably convey the
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`claimed invention to a skilled person in the art? and (2) do the unexpected results have
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`to be described in the specification as filed for them to be considered?
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`A.
`
`The Claimed Invention Is Described In The Specification As Filed -
`The Specification Directs a Person Of Ordinary Skill To The
`Claimed Invention
`
`As summarized below, the specification contains ample teachings directing a
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`person of ordinary skill in the art to the claimed invention (treating MS ""ith DMF/MMF
`
`using a 480 mg/day dose). It is well settled that when considering whether a claimed
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`Appl. No. 13/372,426
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`invention is described in the specification, the totality of the teaching of the application
`
`must be considered (see, e.g., In re Dow Chemical Co., supra).
`
`1.
`
`The Specification Focuses On Trettfing 11fS with DMF and/or
`MMF
`
`The Examiner indicates that MS is disclosed in the description only in the
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`context of a long list of neurological diseases and that the description does not disclose
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`"a particular advantage to applying tlie method described therein to MS." See Final
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`Office Action, the paragraph bridging pages 3-4. Contrary to the Examiner's assertion,
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`MS is singled out throughout the specification and is clearly not just one of many
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`diseases in a long laundry list of diseases.
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`In fact, paragraphs [0001] to [0004] of the background section are explicitly
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`directed toMS, as well as treatments ofMS available as of the filing date. Additionally,
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`the abstract lists MS as the sole exemplary disease to be treated. The application also
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`specifically discloses that the neurological disease can be MS. See, e.g., page 4,
`
`paragraph [0010] and page 25, paragraph [0104]. Furthermore, paragraph [0032]
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`explains DMF's neuroprotective nature and activation of Nrf2 pathway help form the
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`rationale for its effective treatment of neurological disorders such as MS. Additionally,
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`the one animal disease model disclosed in the specification to test the effect ofDMF and
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`~iF is a generally accepted mouse model ofMS, known as Experimental Autoimmune
`
`Encephalomyelitis (EAE). See, e.g., pages 26-27, paragraphs [108]-[0110] and Example
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`3.
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`There is well-established case law holding that guidance or so-called "blaze
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`marks" contained in the originally filed disclosure, which direct the skilled artisan to the
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`Appl. No. 13/372,426
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`claimed invention, are sufficient to describe the claimed invention and to reasonably
`
`convey to a person of skill in the art that Applicants had possession of the invention.
`
`See, e.g., In re Ruschig, 379 F.2d 990, 154 U.S.P.Q. 118 (C.C.P.A. 1967) and Purdue
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`Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 56 U.S.P.Q. 2d 1481 (Fed. Cir. 2000).
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`The Court in Purdue notes that "[t]he blaze marks directing the skilled artisan to [the
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`claimed invention] must be in the originally filed disclosure." Purdue, 230 F.3d at
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`1326-1327.
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`There are a number of blaze marks in the instant specification which clearly
`
`direct a person of ordinary skill in the art to use DMF and/or MMF in treating MS. For
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`example, Applicants disclose (i) a method (method 4) comprising administering to a
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`mammal a therapeutically effective amount of at least one neuroprotective compound,
`
`e.g., DMF or MMF (see, page 13, paragraph [0063]) and (ii) a specific embodiment of
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`neurological disease being MS (see, page 4, paragraph [0010]).
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`Therefore, Applicants respectfully submit that, contrary to the Examiner's
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`contention, treatment of MS with DMF and/or MMF is specifically singled out and
`
`described in the present application.
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`2.
`
`The Specification Teaches The Claimed Dose of 480 mgldav
`DMF and/or MMF
`
`The Examiner asserts that "the specification, as filed, fails to demonstrate, or
`
`even predict, any particular advantage to be realized from the administration of a dosage
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`of 480 mg/day of DMF ... to an indhridual suffering from MS." See Final Office
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`Action, page 4, lines 18-21. The Examiner further states that "the instant specification,
`
`as filed, fails to suggest any specific daily dosage of DMF or MMF that had been shown
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`or could reasonably be predicted to be effective in the treatment of MS in particular. Id.
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`at page 5, lines 12-14. Applicants respectfully disagree with the Examiner and submit
`
`that the specific dose of 480 mg/day is clearly conveyed in the specification to a skilled
`
`person in the art.
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`The specification discloses a
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`limited number of progressively narrowing
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`effective dose ranges of DMF or MMF and discloses the 480 to 720 mg/day dosage
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`range as the narrowest range for the treatment of a patient with a neurodegenerative
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`disease (see page 30, paragraph [0116]). As set forth above, MS is a neurodegenerative
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`disease that is specifically singled out in the specification. Therefore, for at least these
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`reasons and those discussed above, it is clear that the specification describes and directs
`
`a skilled person in the art to the claimed combination (i.e., using 480 mg!day DMF
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`and/or MMF to treat MS). See, e.g., In re Wertheim, 541 F.2d 257, 191 U.S.P.Q. 90
`
`(C.C.P.A. 1976).
`
`B. Unexpected Results or Advantages That Inherently Flow From A
`Claimed Invention Must Be Given Significant Weight
`
`As mentioned above, even though the Examiner acknowledges the unexpected
`
`and advantageous results demonstrated for the claimed method, he nevertheless
`
`maintains the obviousness rejections on the basis that such unexpected results are not
`
`described in the specification as filed (see Final Office Action, page 3, lines 3-5).
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`Contrary to the Examiner's position, the law is clear that unexpected results or
`
`advantages need not be disclosed in the specification as filed. So long as the advantages
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`or unexpected results inherently flow from the claimed invention described in the
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`specification, substantial weight must be given to
`
`them
`
`in
`
`the obviousness
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`determination.
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`In support of his position, the Examiner relied on two cases, In re Lundberg, 253
`
`F.2d 244, 117 U.S.P.Q. 190 (C. C.P.A. 1958) and In re Chu, 66 F.3d 292, 36 U.S.P.Q.2d
`
`1089 (Fed. Cir. 1995). However, neither case supports the Examiner's position that
`
`unexpected results or advantages of a claimed invention must be found in the
`
`specification to be considered.
`
`In the Lundberg case, while it is true that the asserted advantages or unexpected
`
`results were not disclosed in the specification and they were not given weight, the reason
`
`they were not given weight was that they did not flow from the claimed invention as
`
`disclosed in the specification. Rather, they flowed from a feature of an invention that
`
`was not described in the specification. In re Lundberg, 253 F.2d at 247. In marked
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`contrast, the unexpected results or advantages of the instant invention inherently flow
`
`from an invention that was disclosed in the specification as filed, i.e., 480 mg/day DMF
`
`to treat MS. As such, the unexpected results or advantages presented in the instant case
`
`must be considered. The Lundberg case is clearly distinguishable from the present case.
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`The Examiner's reliance on the Chu case is equally misplaced.
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`In Chu, to
`
`overcome an obviousness rejection, the applicant presented advantages that had not been
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`disclosed in the specit1cation that were based on the location of the catalyst. The Board
`
`in Chu, like the Examiner in the present case, justified its rejection by stating Chu's
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`"specification is virtually silent on the matter of any purported advantage to locating the
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`catalyst within the bag retainer" and "does not state that the claimed location of the
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`catalyst 'inside the bag retainer' solves any particular problem or produces any
`
`unexpected result." While the location of the catalyst in In re Chu was disclosed, its
`
`"criticality" was not disclosed. Both the examiner and Board in that case found the
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`location to be a "design choice." The Board concluded that the specification was
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`"virtually silent on the matter of any pwported advantage" of the location. In re Chu, 66
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`F.3d 292, 298 (Fed. Cir. 1995). The Federal Circuit, however, rejected the Board's
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`holding that advantages must be contained within the specification in order for them to
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`be considered.
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`In the instant case, the Examiner distinguishes the present case and justifies not
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`giving weight to the unexpected results submitted by the Applicants post-filing by
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`stating that "the instant specification does not disclose the criticality of the
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`limitations ... nor does it identify the claimed combination as being particularly
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`advantageous ... " (see Final Office Action, page 6, lines 9-13). First, nowhere in Chu
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`did the Court state that criticality of a claimed feature must be contained in the
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`specification. In fact, the Court in Chu simply stated that evidence and/or arguments to
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`rebut an obviousness rejection do not need to be disclosed in the specification. Id at
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`299. Further, the Court explicitly rejected the Board's requirement that the specification
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`must disclose an advantage of the claimed feature to be considered. Thus, the
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`Examiner's justification for requiring the specification to disclose criticality or to
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`identify advantageous features of the claimed invention is unsupported.
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`In fact,
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`Applicants emphasize the guidance outlined in the MPEP 716.02(f): "[t]he specification
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`need not disclose proportions or values as critical for applicants to present evidence
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`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 15 of 18
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`Reply to Final Office Action of October 12, 2012
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`LUKASHEV et al.
`Appl. No. 13/372,426
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`showing the proportions or values to be critical. In re Saunders, 444 F.2d 599, 607, 170
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`USPQ 213, 220 (CCPA 1971)" (emphasis added).
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`Based on the relevant section in the MPEP and the case law discussed above, it is
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`clear that unexpected results or advantages or criticaliiy of a claimed feature do not need
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`to be disclosed in the specification to be considered. The Examiner must therefore give
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`substantial weight to the unexpected results, which flow inherently from the claimed
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`invention of using the 480 mg!day ofDMF to treat MS.
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`IV.
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`Addressing the Examiner's Remaining Reasons For Maintaining The
`Obviousness Rejection
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`In the Final Office Action, the Examiner states that in his VIew the true
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`unexpectedness of the instant rejection resides in the inoperability of a majorit-y of
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`embodiments disclosed in the specification. See Final Office Action, page 3, lines 3-10.
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`As discussed in the Applicants' response to the Office Action filed August 3, 2012, the
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`Examiner's position is unsupported and no evidence or argument was presented in the
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`Final Office Action to address Applicants' rebuttal. As pointed out in Applicants
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`previous response, the unexpectedness of the instant invention is the magnitude of the
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`effect of the 480 mg/day dose and not simply that the dose is efficacious as expressed by
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`the Examiner (see Final Office Action, page 3, lines 7-8). Further, no reason was given
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`as to why the operability of an unclaimed species would be relevant to the patentability
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`of the claimed invention.
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`In the instant case, the unexpected results flow inherently
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`from the claimed invention, and that should be the focal point in determining whether
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`the obviousness rejection has been overcome.
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`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 16 of 18
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`Reply to Final Office Action of October 12, 2012
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`LUKASHEV et al.
`Appl. No. 13/372,426
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`V.
`
`Summary
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`Based on the reasons set forth above and those presented in Applicants' prior
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`responses, Applicants submit that the present claims are patentable over the art of
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`record. Applicants respectfully request the Examiner reconsider the rejections in the
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`Final Office Action.
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`Conclusion
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`All of the stated grounds of objection and rejection have been properly traversed,
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`accommodated, or rendered moot. Applicants therefore respectfully request that the
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`Examiner reconsider all presently outstanding objections and rejections and that they be
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`withdrawn. Applicants believe that a full and complete reply has been made to the
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`outstanding Office Action and, as such, the present application is in condition for
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`allowance. If the Examiner believes, for any reason, that personal communication will
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`expedite prosecution of this application, the Examiner is invited to telephone the
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`undersigned at the number provided.
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`Prompt and favorable consideration of this Amendment and Reply is respectfully
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`requested.
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`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 17 of 18
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`Reply to Final Office Action of October 12, 2012
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`LUKASHEV et al.
`Appl. No. 13/372,426
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`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`. Covert
`Jo
`A omey for Applicants
`Registration No. 38,759
`
`Date: December 12, 2012
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`1621047_LDOCX
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`Atty. Dkt. No. 2159.3210002/JMC/MRG!U-S
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`Page 18 of 18