DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s amendment filed on June 8, 2026 is acknowledged.
Claims 2, 3, 6-9, 11-16, and 19-21 have been canceled.
Claims 1, 4, 5, 10, 17, and 18 are pending and currently under consideration.
3. In view of applicant’s amendment, following objections and rejection are set forth.
4. The specification is once again objected to for following sequence compliance issues:
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures.
The following amino acid sequences and polynucleotide sequences disclosed in the instant specification do not have SEQ ID NOs.
Table 4 in pages 33-34 of the specification as-filed discloses SEQ ID NOs: 22a, 22b, 22c, 22d, 22e, 22f, and 22g. These sequences correspond to the newly submitted SEQ ID NOs: 372-378 (see page 8 of the Remarks filed by applicant on February 5, 2026). Applicant is required to replace the SEQ ID NOs to the corresponding SEQ ID NOs as listed in the sequence listing. For example, SEQ ID NO:22a must be replaced with SEQ ID NO:372 as shown in the newly submitted sequence listing.
Once again, each sequence must be assigned a separate numerical sequence identifier (not 22a) and where a sequence is presented in a drawing or claims, reference must be made to the sequence by use of the sequence identifier (§ 1.823(a)(5)).
5. Claims 1, 5, 10, 17, and 18 are objected to for following reasons:
A) Claims 1, 5, 10, 17, and 18 are objected to for following informality:
Independent claim 1 and dependent claims 17, and 18 recites “SEQ ID NO.”. The correct reference to a sequence should be “SEQ ID NO:”. Appropriate correction is required.
B) Claim 18 is objected to for the reasons stated above regarding the sequence issues in the instant specification. Specifically, claim 18 recites SEQ ID NOs: 22a-g. In the Letter Requiring Sequence Listing in Computer Readable Format mailed on April 8, 2026, the Examiner requested applicant to amend claim 18 to recite the SEQ ID NOs as shown in the newly submitted sequence listing. However, no such amendment was made. Therefore, claim 18 is objected to for being noncompliant with requirements for amino acid sequence disclosures. Once again, each sequence must be assigned a separate numerical sequence identifier (not 22a) and where a sequence is presented in a drawing or claims, reference must be made to the sequence by use of the sequence identifier (§ 1.823(a)(5)).
6. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
7. Claims 17 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 17 is depended upon claim 1, and recites ‘wherein SEQ ID NO:22 has substitutions consisting of T307N, V308P, L309Y, H433R, and N434W. SEQ ID NO:22 recited in claim 1 already consists of amino acid substitutions T307N, V308P, L309Y, H433R, and N434W.
When the phrase "consists of" appears in a clause of the body of a claim, rather than immediately following the preamble, it limits only the element set forth in that clause; other elements are not excluded from the claim as a whole. Mannesmann Demag Corp. v. Engineered Metal Products Co., 793 F.2d 1279, 230 USPQ 45 (Fed. Cir. 1986). >See also In re Crish, 393 F.3d 1253, 73 USPQ2d 1364 (Fed. Cir. 2004) (The claims at issue "related to purified DNA molecules having promoter activity for the human involucrin gene (hINV)." Id., 73 USPQ2d at 1365. In determining the scope of applicant's claims directed to "a purified oligonucleotide comprising at least a portion of the nucleotide sequence of SEQ ID NO:1 wherein said portion consists of the nucleotide sequence from . to 2473 of SEQ ID NO:1, and wherein said portion of the nucleotide sequence of SEQ ID NO:1 has promoter activity," the court stated that the use of "consists" in the body of the claims did not limit the open-ended "comprising" language in the claims (emphases added). Id. at 1257, 73 USPQ2d at 1367.
Here, the recitation of “wherein SEQ ID NO:22 has amino acid substitution consisting of T307N, V308P, L309Y, H433R, and N434W” in claim 17 does not limit the open-ended “having” language in the claims with respect to the amino acid substitutions. As such, the recitation of “having” in claim 17 would allow additional unspecified substitutions in SEQ ID NO:22, and therefore does not further limit the subject matter of SEQ ID NO:22 in claim 1, wherein SEQ ID NO:22 already consists of the amino acid substitutions recited in claim 17.
Further, claim 18 does not further limit the subject matter of claims 1 and 17 in that following sequences are shorter than SEQ ID NO:22 as recited in claim 1:
SEQ ID NO:22c corresponding to SEQ ID NO:374,
SEQ ID NO:22e corresponding to SEQ ID NO:376,
SEQ ID NO:22f corresponding to SEQ ID NO:377, and
SEQ ID NO:22g corresponding to SEQ ID NO:378
Furthermore, following sequences appear to be identical to SEQ ID NO:22 as recited in claim 1:
SEQ ID NO:22b corresponding to SEQ ID NO:373, and
SEQ ID NO:22d corresponding to SEQ ID NO:375
As such, claim 18 fails to further limit the subject matter of claim 1 (SEQ ID NO:22).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
8. SEQ ID NO:22 is free of the prior art.
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641
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