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 .
Claims 1, 5-6, and 10 remain pending an examined on the merits.
Prosecution on the merits has been reopened after the decision on appeal, providing
further rationale as to why it is prima facie obvious to PHOSITA to attach nucleic acids
generally to cell penetrating peptide constructs to carrier such as cargo into cells, absent
something more (e.g. secondary considerations of unexpected results).
Claim Rejections - 35 USC § 103 – Obviousness, Modified
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-6, and 10 - as drawn to the carrier peptide TLKERCLQVVRSLVKKKRTLRKNDRKKR (SEQ ID NO: 1; comprising the N-terminal 15mer peptide TLKERCLQVVRSLVK and C-terminal 13mer carrier peptide KKRTLRKNDRKKR (SEQ ID NO: 2)); wherein peptide SEQ ID NO: 1 is bound at either the N- or C-terminus to ‘any’ nucleic acid (no nucleic acid species being claimed, recited, and/or tested in the instant description; only an unclaimed dye (FAM) was tested as bound to only the N-terminus (not the C-terminus) of the aforementioned peptide SEQ ID NO: 1 or peptide SEQ ID NO: 2) - are rejected under 35 U.S.C. 103 as being unpatentable over the applied two (2) earlier references by applicant published in 2010 and 2012, respectively (note: the original prior art combination included four (4) references, of which the rejection has been simplified, as only applicant’s two (2) references are sufficient to maintain the prima facie case obviousness here) as well as new reference to McCarthy et al. (WO 2014/087023, published 06/12/2014):
1. Kobayashi et al. (Applicant’s 2010 Reference) “Nucleolar Localization Signals of LIMKinase2 Function as a Cell-Penetrating Peptide.” Protein & Peptide Letters, vol.17, no. 12 (2010), pp.1480-1488. (cited in IDS; see Table 1 page 1482, 1st Peptide).
As noted at the outset of the last Office action, applicant acknowledges and does not dispute that the instantly claimed peptide SEQ ID NO: 1 is a known peptide taught within applicant’s 2010 Kobayashi NPL reference (see Table 1, page 1482):
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Kobayashi does not teach binding of the above to a nucleic acid molecule.
IN VIEW OF (OR VICE-VERSA)
2. Yoshida et al. (Applicant’s 2012 Reference):U.S. Patent Publication No. 20120122210.
Applicant’s 2012 Yoshida patent application publication teach a peptide ‘comprising’ (see abstract: “a construct . . . that contains . . .”) the 13mer carrier peptide KKRTLRKNDRKKR (SEQ ID NO: 1 in applicant’s earlier Yoshida reference and corresponding to peptide SEQ ID NO: 2 in applicant’s instant description/sequence listing) - the C-terminal segment of instant peptide TLKERCLQVVRSLVKKKRTLRKNDRKKR (SEQ ID NO: 1 recited in applicant’s other earlier noted 2010 Kobayashi reference above and equally corresponding to peptide SEQ ID NO: 1 in the instant application description/sequence listing/claims) - bound at the N- or C-terminus to a nucleic acid; for introduction into eukaryotic cell cytoplasm (see applicant’s earlier Yoshida at e.g. abstract, para’s [0021-22]; [0047]):
Abstract A method for transferring a foreign substance includes the steps of: preparing a construct for transferring a foreign substance that contains a carrier peptide fragment including either the amino acid sequence KKRTLRKNDRKKR (SEQ ID NO. 1) or an amino acid sequence formed by the substitution, deletion, and/or addition (insertion) of 1, 2, or 3 amino acid residues in the amino acid sequence, and a foreign substance of interest that is bonded to the N-terminus and/or C-terminus of the carrier peptide fragment; supplying the construct for transferring a foreign substance to a test sample that contains a target eukaryotic cell; [
[0021] More specifically, the method for transferring a foreign substance of the present invention with the abovementioned configuration enables a foreign substance of interest to pass through the cell membrane from outside a eukaryotic cell (outside the cell membrane) and be transferred into the cytoplasm (more preferably, pass through the nuclear membrane and into the nucleus) with high efficiency by preparing a construct for transferring a foreign substance by bonding a foreign substance of interest (typically, an organic chemical such as a polypeptide, nucleic acid, dye, drug, etc.) either directly or indirectly via a suitable linker to the N-terminus and/or C-terminus of the abovementioned peptide fragment and supplying that construct to a test sample containing a target eukaryotic cell (typically a culture containing the cells) (in other words, by adding the construct to living eukaryotic cells).
[0022] In one preferred mode of the method for transferring a foreign substance disclosed herein, the abovementioned foreign substance is characterized in that it is any organic compound selected from a group consisting of polypeptides, nucleic acids, dyes, and drugs. A construct prepared so that it contains this type of organic compound enables the efficient transfer thereof into a target cell.
While applicant’s earlier Yoshida reference does teach binding nucleic acids (para [0022]) to the 13mer carrier peptide KKRTLRKNDRKKR (SEQ ID NO: 1 in applicant’s earlier Yoshida reference) comprised within the instantly claimed peptide SEQ ID NO: 1 (and corresponding to peptide SEQ ID NO: 2 in applicant’s instant description/sequence listing), Yoshida does not teach the addition of peptide TLKERCLQVVRSLVK thereto - the other segment of instantly claimed peptide SEQ ID NO: 1 and fully taught by applicant’s earlier Kobayashi above (the latter of which did not teach attaching nucleic acids thereto – the missing element which Yoshida teaches binding to part of the peptide but not the complete peptide of Kobayashi).
BOTH FURTHER IN VIEW OF:
3. WO 2014087023 (hereafter McCarthy et al., published 06/12/2014)
McCarthy et al., merely as representative of the field of cell penetrating peptide carriers for nucleic acids, teach amphipathic cell penetrating peptides having specified amino acid residues, useful as delivery system for delivering nucleic acids to cells (see abstract, claims):
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Thus, it would have been prima facie obvious to a PHOSITA to take applicant’s earlier 2010 Kobayashi reference carrier peptide TLKERCLQVVRSLVKKKRTLRKNDRKKR (instant SEQ ID NO: 1), which ‘comprises’ at the C-terminal end the same carrier peptide KKRTLRKNDRKKR (instant SEQ ID NO: 2; peptide SEQ ID NO: 2 in Yoshida) ‘comprised’ within any larger ‘construct’ (e.g. larger peptide) taught in applicant’s 2012 Yoshida reference (abstract; para’s [0021-22]), and then simply follow that latter 2012 Yoshida reference of applicant’s and – at a minimum - attach any nucleic acid at that same C-terminus Arginine, for introduction into any eukaryotic cell cytoplasm, further in view of that representative within the field of such constructs for nucleic acid cell delivery via cell penetrating peptides such as that set forth in McCarthy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
Prosecution Insights