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 .
Response to Arguments
In the response, dated 6/24/2026, the Applicant has provided amendments to the claims, and arguments drawn to the previous rejections. Additionally, the Applicant has provided an Information Disclosure Statement, and amended the specification. The IDS has been considered, and the amendments to the specification have provided for a withdrawal of the objection.
On pages 10 and 11 of the Applicant’s Arguments, the Applicant indicates that an additional functional limitation has been provided to the independent claim, and that the skilled artisan would be capable of a “high throughput screen” in order to make and use the claimed sequences. However, based upon all of the guidance provided by the Office, regarding the recitation of functional limitations in sequence claims, the instant limitation continues to provide for written description issues. Furthermore, adding an additional functional limitation provides for even greater written descripting issues, since the skilled artisan must now test all possible sequences for three highly specific functions.
Based upon the broadest reasonable interpretation of the rejected claims, the skilled artisan can delete, add, or mutate as many as 51 amino acids of SEQ ID NO 1. If we just consider mutation, alone, and only consider natural amino acids, the claim requires the skilled artisan to test (51!)21 possible variants; now, if we include deletions or additions, which would continue to be within the claimed scope, the possible variants becomes an exponentially larger number. Considering the fact that there are less than 30 disclosed sequences in the instantly claimed invention, it seems clear that the Applicant was not in possession of a number of sequences that reasonably represents the number of possible iterations that the claimed scope can provide. Ironically, if the Applicant removes all of the functional limitations, the claim will not have written description issues. This interpretation is consistent with all of the Office guidance regarding 35 USC 112(a) Written Description rejections of sequences with functional limitations, this guidance can be found on the USPTO website.
On pages 11 and 12 of the Applicant’s Arguments, the Applicant indicates that claims 69 and 80 have been canceled. The cancelation of these claims has rendered their rejections moot, and as such, these rejections are withdrawn.
Claims 1, 13, 34, 66, 70, 71, 74-79, 83, and 84 continue to be rejected under 35 USC 112(a) Written Description, for the reasons provided previously and those discussed above; the Applicant is urged to go to the USPTO website and find the 35 USC 112(a) Written Description examples for sequence claims. Claims 4, 11, 28, 30, 32 and 64 continue to be allowable, but are objected to because they are dependent on a rejected base claim.
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.
Claims 1, 13, 34, 66, 70, 71, 74-79, 83, and 84 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. Claim 1 provides for a polypeptide having esterase activity, wherein the polypeptide has at least 80% homology to SEQ ID No 1. Based upon the most recent guidance, regarding 35 USC 112(a) Written Description rejections and interpretation, since the claim explicitly lists a functional limitation, with respect to a variable sequence, the specification must be analyzed to determine if the Applicant provides for a reasonable number of embodiments that fulfill the 80% homology claim that also include esterase activity.
First, it must be noted that the instant specification appears to provide reasonable support that all of the sequences listed with a SEQ ID have esterase activity. Additionally, claims 11, 28, 30, and 32 all provide for smaller possible mutations that would not require an unreasonable amount of testing for the skilled artisan; as such, these claims, and claim 64 are not rejected under 35 USC 112(a). However, when considering the base claim, the number of possible mutations accounts for approximately 51 possible substitutions, mutations, or deletions, that would provide more possible sequences than there are atoms in the universe. As such, the base claim provides such an immense number of possibilities that the skilled artisan would be under a tremendous burden to test all of these possible sequences to determine which sequences possess esterase activity. If the “esterase activity” limitation is removed from the independent claim, the rejection of claims 13, 34, 66, and 69 would likely be withdrawn. Since claims 70, 71, 74-79, and 83 are drawn to sequences that must have esterase activity, they would provide for the written description issues, even if the limitation was removed from claim 1; therefore, these claims must have limitations drawn to specific sequences, or specific mutations, wherein there is reasonable evidence of esterase activity, for the rejection to be withdrawn.
Allowable Subject Matter
Claims 4, 11, 28, 30, 32 and 64 are 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
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 DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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