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 .
Applicant’s response (non-substantive amendments, arguments, affidavit) is acknowledgd.
Claims 1, 5-6, and 10 remain pending an examined on the merits.
See also Interview Summary attached.
The examiner remains open to interview to advance prosecution on the merits.
Claim Rejections - 35 USC § 103 – Obviousness, Maintained
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):
PNG
media_image1.png
214
693
media_image1.png
Greyscale
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):
PNG
media_image2.png
222
536
media_image2.png
Greyscale
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.
Response to Arguments and Affidavit
Applicant’s arguments and affidavit have been fully considered but are not found persuasive. The attachment of any active cargo (here any nucleic acid) to a known carrier/penetration peptide remains prima facie obvious over applicant’s own early guiding references in combination with the secondary references thereto, remains prima facie obvious for the reasons of record. Additionally (see also Interview Summary attached), as for the evidentiary test data supplied by affidavit, the test data is not commensurate in scope with that claimed. The claimed invention is drawn to the claimed carrier/penetration peptide bound to any nucleic acid. The data was to testing the known carrier/penetration peptide alone against another control (that such worked better alone does not alter that such was still open for simple selection from a known class of molecules known to aid passage of any unnamed nucleic acid as claimed here). Further, there is no teaching away for selection thereof. As such, applicant's two prior art references combined in the obviousness rejection remain rendering the instantly claimed invention prima facie obvious without more.
Conclusion
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 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
Prosecution Insights