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 .
Claim Status
Applicant’s amendments received 10MAR2026 are acknowledged.
Claims 1-26 and 28 have been canceled.
Claim 27 has been amended.
Claims 27 and 29-45 are pending in the instant application (i.e., Claim(s) 27, 36, and 40 is/are independent).
Claims 31 and 36-44 remain withdrawn.
Claims 27, 29-30, 32-35, and 45 are examined on the merits.
Priority
The present application is a 371 National Stage of PCT International Application No. PCT/EP2020/068052, filed 26JUN2020, which claims foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of EPO 19382537.9 filed on 26JUN2019 has been received and is acknowledged.
Specification
Applicant’s arguments, see p 10, Specification objection section, filed 10MAR2026, with respect to objections to the specification for minor informalities have been fully considered and said objections to the specification have been withdrawn in view of amendments to the specification filed as part of said response.
Claim Objections
Applicant’s arguments, see p 10, Claim status section, filed 10MAR2026, with respect to objections to claim(s) 27 for informalities have been fully considered and said objections to claim(s) 27 have been withdrawn in view of claim amendments filed as part of said response.
Withdrawn Rejections
Scope of Enablement
Applicant’s arguments, see p 13-16, Rejection under 35 USC §112 (Enablement) section, and the Declaration of Marta Corral under 37 CFR 1.132, filed 10MAR2026, with respect to the rejection(s) of claim(s) 27, 29, 32-35, and 45 under 35 USC §112(a) - enablement have been fully considered and said rejections of claims 27, 29, 32-35 and 45 have been withdrawn in view of the alanine screening of the second region of 9 amino acids filed as part of said response.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 27, 29-30, 32-35, and 45 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As presently written, the claims recite 11760 different 9 amino acid peptide structures for the second region and when combined with only three positions in the first region comprising any standard amino acid (i.e., 20 amino acids), results in over 9.4 x 107 peptide combinations (i.e., 20 x 20 x 20 x 6 x 2 x 7 x 7 x 1 x 2 x 10 x 1 x 1 = 94080000), which are derived from intermediate filaments. However, the specification and working examples discloses a list of potential peptides of the invention set forth in SEQ ID NOs: 19-39, core sequences of SEQ ID NOs: 43, 45, 51, 55-56, 61, 66, 77-79, and 81, and other sequences tested for inducing apoptosis as set forth in SEQ ID NOs: 80, and 82-86, which all fit into the breadth of claim 27 (i.e., nearly 40 sequences of the well-over 9.4 x 107 peptide combinations claimed). The working examples disclose effective apoptosis (i.e., greater than the control peptide of SEQ ID NO: 75) for SEQ ID NOs: 19-20, 24-31, 39, and 77-84 (Table 1 and Fig 3 and 23) or 19 peptides out of the nearly 40 supported in the specification, that three core peptides (i.e., 9 amino acid sequences of region 2) were ineffective (i.e., SEQ ID NOs: 51 and 55-56) without additional amino acid residues located at the N- or C-terminus, as displayed in SEQ ID NOs: 20 or 39, and that SEQ ID NOs: 85-86 performed similarly to the control peptide (Fig 23). Thus even if the remaining 35 of the 40 sequences disclosed in the specification were effective at either inducing apoptosis or as a vaccine adjuvant, the specification provides < 0.00004% functional examples of the possible combinations (i.e., 35 of the well-over 9.4 x 107 peptide combinations), which fails to indicate that the breadth of structures (i.e., peptides derived from SEQ ID NO: 14, with or without additional amino acid residues placed at the N- or C-terminus) encompassed by the language of the instant claims will have the same function. Therefore, as presently written, one of ordinary skill in the art would reasonably conclude that the applicant was not in possession of the full breadth of the claimed genus of peptides at the time the instant application was filed because there does not appear to be any correlation between the structures of the peptides and the ability to function.
Applicant argues that the specification provides evidence for activity of 18 different peptides and the Declaration under Rule 132 of Mara Corral, includes evidence of activity of additional peptides which fall under claim 27, thus providing evidence that Applicant was in possession of the entire invention at the time the application was filed. (p 10-13, Rejections under 35 USC §112 (Written description) section)].
RESPONSE
Applicant’s arguments have been fully considered but are found non-persuasive essentially for the reasons of record and as described further below.
As set forth in the rejection of record, the specification provides neither a representative number of the encompassed peptides consisting of, in order from N- to C-terminal end: i) a first region consisting of “n” amino acids, wherein “n” is 0-11 amino acids; ii) a second region consisting of 9 amino acids having 11760 combinations of SEQ ID NO: 14 (i.e., the number of combinations is calculated from the number of amino acid options provided for each of the 9 positions in the amino acid sequence: 6 x 2 x 7 x 7 x 1 x 2 x 10 x 1 x 1 = 11760), iii) a third region consisting of “m” amino acids, wherein “m” is 0-11 amino acids; wherein said peptide has a minimum length of 9 amino acids and a maximum length of 20 amino acids and is not SEQ ID NOs: 2-11, 13, 87, 96, or 98-101, nor does it provide a descriptive of structural features that are common to the encompassed peptides.
Furthermore, the declaration under 37 CFR 1.132 filed 10MAR2026 is insufficient to overcome the rejection of claims 27, 29-30, 32-35, and 45 based upon 35 USC §112a (written description) as set forth in the last Office action because: even with the cytotoxicity screening of 10 additional peptides which are based off of alanine screening and do not all fall into the breadth of claim 27 of Tables 1-3 of the Experimental Report, there are still < 0.00005% functional examples of the possible combinations (i.e., 45 of the well-over 9.4 x 107 peptide combinations).
Therefore, because the disclosure and the declaration fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the artisan cannot envision the detailed structure of the encompassed 11760 peptides derived from SEQ ID NO: 14, with additional amino acid residues placed at the N- or C-terminus (i.e., >>9.4 x 107 peptide combinations) and therefore Applicant was not in possession of the instant claimed invention.
Conclusion
No claims are allowed.
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.
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/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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