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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/10/2025 has been entered.
Claim Status
Claims 1-4, 8-19, 49, 52, 54, 57-58, 61-63, 67-68 and 71-72 are pending. Claims 71-72 have been added. Claims 50 and 69-70 have been canceled. Claims 1 and 3-4 have been amended. Claims 1-4, 11, 17-19, 49, 68 and 71-72 are being examined in this application. In the response to the restriction requirement, Applicants elected SEQ ID NO: 22 (FXN replacement therapeutic compound), SEQ ID NO: 3 (additional amino acid sequence), Charcot Marie Tooth disease, and muscle weakness. Claims 8-10, 12-16, 52, 54, 57-58, 61-63 and 67 are withdrawn as being drawn to a nonelected species.
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.
This rejection has been modified.
Claims 1-4, 11, 17-19, 68 and 71-72 are 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.
The claims are drawn to methods of treating a myelin associated disease, increasing the amount of myelin, and promoting oligodendrocyte maturation, comprising administering an effective amount of a frataxin (FXN) fusion protein, wherein said frataxin fusion protein has at least 99% identity to SEQ ID NO: 22.
When referring to the frataxin fusion protein, the specification does not provide any structural attribute.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
The specification fails to describe the amino acid sequence having at least about 99% sequence identity to SEQ ID NO: 22.
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
In the instant case, the specification fails to provide a representative number of examples for the claimed FXN fusion protein.
The specification teaches only two specific FXN fusion proteins (i.e. SEQ ID NOs: 1 and 22), both of which share the same sequence (i.e. SEQ ID NO: 1).
Considering that SEQ ID NO: 22 is 224 amino acids long, 11 amino acids could be changed to obtain a sequence 95% identical to SEQ ID NO: 22. Therefore, even just considering natural amino acids, one would end up with 999,040 (224x223x20) possible peptides.
The specification does not provide any teaching of what modifications can be made within the claimed sequence to allow for the claimed function (i.e. to treat a myelin associated disease, to increase myelin, and to promote oligodendrocyte maturation).
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
Response to Arguments
Applicant’s arguments filed on 9/10/2025 have been fully considered but they are not persuasive.
Applicant argues that “[T]able 4 of the specification lists the complete amino acid sequence of the FXN fusion protein corresponding to SEQ ID NO: 22. The specification teaches that the frataxin replacement therapeutic compound, e.g., an FXN fusion protein, may have "at least 99% or 100% sequence identity to SEQ ID NO: 22" (see, e.g., page 21, lines 5-9 of the specification). One of ordinary skill in the art would readily understand that an amino acid sequence having at least 99% sequence identity to SEQ ID NO: 22 can vary by one or two amino acids from SEQ ID NO: 22. Further, the specification teaches that "amino acid sequences (polypeptides), which differ from the polypeptides specifically defined in the present disclosure by insertions, deletions, substitutions and modifications of amino acid residues [ ] do not alter the activity of the original polypeptides" (emphasis added; see page 22, lines 24-27 of the specification). The specification also teaches that the variants contain conservative substitutions of amino acid sequences "with a chemically similar amino acid" (see page 22, lines 11-15 of the specification). The specification also teaches that variants "will have the same or substantially the same biological activity as its native form" (see page 23, lines 4-7 of the specification). Thus, one of ordinary skill in the art in view of the present specification would reasonably conclude that the specification sufficiently describes the genus of amino acid sequences having at least 99% sequence identity to SEQ ID NO: 22”.
Applicant’s arguments are not persuasive.
As discussed above, even just considering natural amino acids, one would end up with 999,040 (224x223x20) possible peptides having a sequence at least 99% identical to SEQ ID NO: 22. If one had to consider the more than thousands non-natural amino acids, one would end up with an even greater number.
Therefore, it is clear that the claimed invention lacks written description.
For the reasons stated above the rejection is maintained.
Allowable Subject Matter
Claim 49 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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