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
Elections/Restrictions
Applicant's election with traverse of Group I, claims 1-9 and 12 and species: SEQ ID NO: 16, SEQ ID NO: 3, SEQ ID NO: 9, PE38, leukemia, non-Hodgkin’s lymphoma, hairy cell leukemia, and humans in the reply filed 12/12/2025 is acknowledged. The traversal is on the ground(s) that the antibody of Group I is also used in the other, restricted group. This is not found persuasive because the restriction requirement splits up the invention into statutory categories of invention. Group I is drawn to a product, while Group II is drawn to a method of use. As is, these groups are considered patentably distinct until Group I is found allowable, at which point Group II would be rejoined and examined.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11, 13-21 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 12/12/2025.
Claims 1, 3-9, 12, and new claims 22-23 are now under consideration in the instant Office Action.
Withdrawn Objections
Objections to the drawings are hereby withdrawn in view of arguments presented by Applicant, which show that drawings were filed on 03/23/2023 as part of the instant application.
Objections to the specification in view of embedded hyperlinks and trademark symbols are hereby withdrawn in view of the substitute specification filed which address these issues.
Objections to claim 4 due to minor informalities are hereby withdrawn in view of amendments to the claims.
Withdrawn Rejections
Rejections of claims 1-5 and 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter are hereby withdrawn in view of amendments to the claims to obviate the existing issues.
Rejections of claims 1-9 and 12 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to satisfy the written description requirement are hereby withdrawn in view of amendments to the claims that obviate the existing issues.
Rejections of claims 1-9 and 12 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a humanized anti-CD22 recombinant immunotoxin comprising complete VH/VL sequences, does not reasonably provide enablement for any anti-CD22 recombinant immunotoxins without fully defined sequences are hereby withdrawn in view of amendments to the claims that obviate the existing issues.
Rejections of claims 1-9 and 12 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hunter et al. are hereby withdrawn in view of amendments to the claims which amend the scope of the claims in a manner that obviates the prior art.
Rejections of claims 1-9 and 12 that are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 6-10 of copending Application No. 18/246,838, hereinafter ‘838 are hereby withdrawn in view of the filing dates of the applications. The instant application has a filing date of 03/23/2023, while ‘838 has a filing date of 03/27/2023. As such, the earlier-filed application may continue without a terminal disclaimer. See MPEP § 804.
New Objections
Claims 1, 5, and 12 are objected to because of the following informalities: when using the abbreviation for a sequence identity number, the correct symbol used to denote it is a colon and not a period. For example, the instant claims should read “SEQ ID NO: [X]”. Appropriate correction is required.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-9, 12, and new claims 22-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Instant claims 1, 5, and 12 recite the terminology “as shown in” to describe the contents of the sequence identity number which follows. It is unclear what is meant by “as shown in” as the use of the terminology broadens the scope of the claim as it does not explicitly define all embodiments of the sequence. The dependent claims 3-4, 6-9, 12, and new claims 22-23 are also rejected because they fail to remedy the issue. Applicant is encouraged to amend the claim language to read as “…comprising SEQ ID NO:…” or “…comprising the amino acid sequence of SEQ ID NO:…” at every iteration to obviate this rejection.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
Prosecution Insights