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 .
DETAILED ACTION
Claim Status
Claims 101, 103-104, 106-109 and 113-118 are pending. Claims 110-111 have been cancelled. Claims 101 and 114 have been amended. In the response to the restriction requirement, Applicants elected Group II and the cyclic peptide CPP1-20 (cyclo(AspDecyRRRRQ).
Applicants elected species was deemed to be free of the prior art. In accordance with Markush Practice, the search was extended to the Markush group/independent claim, and a reference was discovered that anticipated it. As a result, claims 101, 108-109 and 113 have been examined and claims 103-104, 106-107, 110-111 and 114-118 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time. This is proper, as MPEP 803.02 states that, in these circumstances, the prior art search, however, will not be extended unnecessarily to cover all nonelected species (MPEP 803.02).
Response to arguments
Applicant argues that the withdrawn claims should have been examined. This is not persuasive.
As discussed above, when the elected species is found be free of the prior art, the Examiner picks a new species to be examined. All the claims that do not read on the species searched are properly withdrawn. In the event that a claim reads ONLY on the elected species, it would be indicated as allowable. Claims that read on the elected species as well as other species, as in the instant case, are properly withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
This rejection has been modified.
Claims 101, 108-109 and 113 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kemper et al. (US 2016/0271216).
With respect to claims 101 and 113, Kemper et al. teach the cell penetrating peptide (CPP) RKKRRQRRR (SEQ ID NO: 5), wherein the CPP is cyclic (Table 2; para [0129]), which corresponds to instant formula III-B, wherein m is 4, and n is 1 (i.e. c[AAu1-AAu2-AAu3- AAu4-AAx-AAH1-R-R-AAz]), wherein AAu1 is Arg, AAu2 is Lys, AAu3 is Lys, AAu4 is Arg, AAx is Arg, AAH1 is Gln, and AAz is Arg.
Please note that glutamine is an asparagine further comprising an alkyl.
With respect to claims 108-109, Kemper et al. teach pharmaceutical compositions comprising pharmaceutically acceptable carriers for parenteral administration (paras [0180]-[0182], [0185]).
Examiner’s Note
It is noted that the rejection based on the species RKKRRARRR (SEQ ID NO: 8) of Kemper et al. has been withdrawn in view of the amendments to the claims. However, as discussed in the rejection above, Kemper et al. teach the cell penetrating peptide (CPP) RKKRRQRRR (SEQ ID NO: 5), which corresponds to instant formula III-B.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658