Reply to Office Action of December 15, 2017
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`SAZANI et a].
`Application No. 15/789,862
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`Remarks
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`I.
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`Statement of substance of Interview in accordance with 37 C.F.R. § 1.133(b) and
`MPEP § 713. 04
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`On February 23, 2018, Applicant’s patent counsel, Eric Steffe and David Holman, along
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`with Applicant’s representative, Marc Evans, held an Applicant-initiated telephonic interview with
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`Examiner McDonald to discuss the outstanding 35 U.S.C. §§ 102 and 103 rejections over
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`Popplewell, U.S. Patent No. 8,084,601. Applicant again thanks Examiner McDonald for agreeing to
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`the interview. Counsel for Applicant discussed the pending claims in View of the disclosures in
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`Popplewell, and Examiner McDonald agreed to consider the discussion when reviewing the present
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`Response to Office Action. See, e. g, Interview Summary mailed March 1, 2018 (“[i]t was agreed
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`that the rejection of claim 66 over Popplewell would likely be easily rebutted.”)
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`II.
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`Status of the claims
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`Upon entry of the foregoing amendment, claims 66-67 are pending in the application, with
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`both claims 66 and 67 being independent claims. Claims 68—69 are sought to be canceled without
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`prejudice to or disclaimer of the subject matter therein. These changes are believed to introduce no
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`new matter, and their entry is respectfully requested.
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`Based on the above amendment and the following remarks, Applicant respectfully requests
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`that the Examiner reconsider all outstanding objections and rejections and that they be Withdrawn.
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`III.
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`Rejections under 35 U.S. C. § 102
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`On page 3 of the Office Action, claims 66-69 are rejected under pre—AIA 35 U.S.C. § 102(e)
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`as allegedly anticipated by U.S. Patent No. 8,084,601 to Popplewell, et a]. (“Popplewell”).
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`Applicant respectfully traverses the rejection.
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`Atty. Dkt. No. 4140.001000B
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`Reply to Office Action of December 15, 2017
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`SAZANI er al.
`Application No. 15/789,862
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`The Office Action states that SEQ ID NO: 22 of Popplewell—which is 30 nucleotides
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`long—overlaps with 29 consecutive nucleotides in SEQ ID NO: 631 of the present application. See
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`Office Action, p. 3. However, claim 66 is directed to “an antisense oligonucleotide of formula (1)”
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`wherein “Z is 19.” Claim 67 is directed to a pharmaceutical composition comprising the same
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`antisense oligonucleotide recited in claim 66. Thus, given the structure of formula (I) and the
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`requirement that “Z is 19,” claims 66 and 67 require antisense oligonucleotides that are 2]
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`nucleotides long (a “21—mer”). Popplewell’s SEQ ID NO: 22, however, is 30 nucleotides long (a
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`“30-mer”). Popplewell does not disclose 21-mer oligonucleotides. To be anticipatory, “the reference
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`must disclose each and every element of the claimed invention, whether it does so explicitly or
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`inherently.” In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). Popplewell does not disclose “each
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`and every element of the claimed invention” because Popplewell does not disclose the claimed 21-
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`mer of claim 67 or the composition of claim 68. Popplewell thus does not anticipate claims 66 and
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`67.
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`Accordingly, Applicant respectfully requests that the rejection under 35 U.S.C. §102 be
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`reconsidered and withdrawn. Discussed above, claims 68-69 are canceled without prejudice to or
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`disclaimer of the claimed subject matter. Thus, Applicant respectfully submits that the rejection of
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`claims 6869 under 35 U.S.C. § 102 is moot and should be withdrawn.
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`IV.
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`Rejections under 35 US. C. § 103
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`On page 4 of the Office Action, claims 66-69 are rejected under pre-AIA 35 U.S.C. § 103(a)
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`as allegedly obvious over Popplewell. Applicant respectfully traverses the rejection.
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`Atty. Dkt. No. 4140.001000B
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`Reply to Office Action of December 15, 2017
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`SAZANI et a].
`Application No. 15/789,862
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`Applicant respectfully submits that the Examiner has not established a case of prima facie
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`obviousness. Discussed above, Popplewell does not disclose all the elements of claims 66 and 67
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`because, inter alia, Popplewell does not disclose or even suggest 21-mers. In fact, Popplewell
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`expressly discloses that the antisense oligonucleotides must comprise “at least a 25 base length”
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`and that, “[i]f the molecule is less than 25 bases in length, the exon Skipping efficiency is reduced.”
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`See Popplewell, col. 2:30 and col. 7:1-2 (emphasis added).
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`As the Supreme Court noted in KSR, “rejections on obviousness grounds cannot be
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`sustained by mere conclusory statements; instead, there must be some articulated reasoning with
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`some rational underpinning to support the legal conclusion of obviousness.” KSR Int ’1 Co. v.
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`Teleflex Inc, 550 US 398, 418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
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`Here, the Office failed to articulate any basis or reason a person of ordinary skill in the art would
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`have purportedly modified Popplewell’s 30-mer oligonucleotide of SEQ ID NO: 22 to arrive at the
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`claimed 2l-mer and composition of claims 66—67. Nor has the Office established that a skilled
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`artisan would have had a reasonable expectation of success in so doing. Accordingly, Applicant
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`respectfully requests that the rejection be reconsidered and withdrawn.
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`Discussed above, claims 68-69 are canceled without prejudice to or disclaimer of the
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`claimed subject matter. Thus, Applicant respectfully submits that the rejection of claims 68—69
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`under 35 U.S.C. § 103 is moot and should be withdrawn.
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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. Applicant therefore respectfully requests that the Examiner
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`reconsider all presently outstanding objections and rejections and that they be withdrawn. Applicant
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`Atty. Dkt. No. 4140.001000B
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`Reply to Office Action of December 15, 2017
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`Application No. 15/789,862
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`SAZANI et al.
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`believes that a full and complete reply has been made to the outstanding Office Action and, as such,
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`the present application is in condition for allowance. If the Examiner believes, for any reason, that
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`personal communication will expedite prosecution of this application, the Examiner is invited to
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`telephone the undersigned at the number provided.
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`Prompt and favorable consideration of this Amendment and Reply is respectfully requested.
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`Respectfully submitted,
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`STERNE, KESSLER, GOLDSTEIN & Fox P.L.L.C.
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`w/fl/
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`Eric K. Steffe
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`Attorney for Applicant
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`RegistrationNo. 36,688
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`M57012 9 33M
`Date: _y‘y%;
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`1 100 New York Avenue, NW.
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`Washington, DC. 20005—3934
`(202) 371—2600
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`9o99237_1
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`Atty. Dkt. No. 4140.001000B
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