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 Amendment
In the amendment filed on 08/19/2026, Applicant amended claim1 and cancelled claims 2-5, 12 and 14. Claims 1, 6-11, 13 and 15-30 are pending; claims 20-30 remain withdrawn from prosecution for being drawn to non-elected subject matter. Claims 1, 6- 11, 13 and 15-19 are examined.
Maintained claim rejections
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, 6-11, 13 and 16-19 remain 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 for reasons of record.
On page 5-6 of the Remarks Applicant argues that: “Due to the typical level of skill in the art and the specific sequences and homologies in claim 1 as amended, Applicant respectfully submits the enablement requirement is satisfied.”
The arguments were carefully considered but not found persuasive because, first
of all, the rejection was a written description rejection (lack of possession of the broader
claim). As already indicated in the Non-final rejection of 06/16/2026:
“[T]he purpose of the written description requirement is to ‘ensure that the scope
of the right to exclude, as set forth in the claims, does not overreach the scope of the
inventor’s contribution to the field of art as described in the patent specification.’”
Examiner never argued about enablement, but the fact that DNA constructs may
comprise a vast number of arrangements of coding sequences for a set of four protein
encoding sequences, further comprising promoters and terminators, the skilled artisan
would not have been in possession of the vast repertoire of constructs encompassed by
the claimed invention; one of skill in the art would conclude that applicant was not in
possession of the structural attributes of a representative number of species possessed
by the members of the genera of possible DNA constructs as claimed. The amended
claim 1 provides 95% homology requirements for each of the four listed genes without
indication of the regions that need to be conserved or the specific arrangement of the
genes and promoters or terminators. One of skill in the art would conclude that the
specification fails to disclose a representative number of species to describe the claimed genera while describing only the construct of SEQ ID NO: 5 in claim 15. In the broadest reasonable interpretation, claim 13 might be considered as potentially allowable if the consideration of 95% identity is taken out of the independent claim 1.
Allowable Subject Matter
Claim 15 is allowed.
Conclusion
Claims 1, 6-11, 13 and 16-19 are not allowed. Claim 15 is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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