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
Reissue: Non-Final Office Action
Status of the Claims
On 12/20/2022 US Patent 11,530,277 issued to Babb et al. with claims 1-41. Claims 1-41 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims in reissue Application No. 18/418,409.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP § 1415.01.
Ongoing Duty To Disclose
Applicant(s) is/are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent 11,530,277 is or was involved. These proceedings would include any trial at the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Information Disclosure Statement
References lined-through on the information disclosure statement(s) were not considered because they were not provided.
Regarding the 10/30/2024 IDS, foreign patent documents 2 and 3 do not match the documents provided.
Regarding the 01/22/2024 IDS, MPEP § 1406 states that in reissue applications references that have been cited during original prosecution of the patent are considered. However, should applicants wish to ensure that all of the references which were cited in the original patent are considered and cited in the reissue application, an information disclosure statement (IDS) in compliance with 37 CFR 1.97 and 1.98 should be filed in the reissue application. Note that 37 CFR 1.98 requires copies of foreign patents and other (e.g., NPL) publications to be provided. No such copies were provided with the instant reissue application.
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was 02/27/2024.
Claim Objections
A. The claim set filed 01/22/2024 is objected to because it fails to point to support for the claim amendments. Pursuant to 37 CFR 1.173(c), each claim amendment must be accompanied by an explanation of the support in the disclosure of the patent for the amendment (i.e., support for all changes made in the claims, whether insertions or deletions). While the applicant states that no new matter has been added on p. 10 of the 01/22/2024 response, applicant has not pointed to where support can be found in the specification for the claim language as amended.
B. The amended claim set filed 01/22/2024 is improper because the amendment does not comply with 37 CFR 1.173 which sets forth the manner of making amendments in reissue applications. Specifically, the claim set uses strikethrough in amended claim 1 to show deletions, instead of single brackets as required by 37 C.F.R. 1.173(d).
While the improper amendment has been entered and considered, a supplemental paper correctly amending the reissue application is required. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
C. Claim 41 is objected to because the number "5" should not appear in the phrase "SEQ 5 ID NO: 2". The number "5" appears to be a typographical error, possibly due to copying and pasting text from the issued patent, and should be deleted.
D. Claims 10, 11, 16, and 17 are objected to because of the following informalities: the word "comprising" should be "comprises" in the phrases "the first vector comprising" and "the second vector comprising".
Appropriate correction is required.
Defective Declaration/Oath
The reissue oath/declaration filed with this application is defective because it fails to identify a claim the reissue application seeks to broaden. See 37 CFR 1.175 and MPEP § 1414.
Whether intentional or not, the amendment to claim 1 removes the limitation in original (patented) claim 1 that the HCFs and LCF are fragments of a bispecific antibody. Amended claim 1 is therefore broader than original (patented) claim 1 since the HCFs and LCF are only required to be fragments of a bispecific antigen-binding protein, not necessarily a bispecific antibody. See MPEP § 1414 II, which states, in relevant part:
What is needed for the oath/declaration statement as to error is the identification of “at least one error” relied upon. For an application filed on or after September 16, 2012 that seeks to enlarge the scope of the claims of the patent, the reissue oath or declaration must also identify a claim that the application seeks to broaden. A general statement, e.g., that all claims are broadened, is not sufficient to satisfy this requirement. In identifying the error, it is sufficient that the reissue oath/declaration identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid.
The examiner suggests expressly pointing to claim 1 as a claim intended to be broadened, and then specifically stating how the new claim is broader than original (patented) claim 1 by specifically detailing what the new claim lacks that the original claim had (i.e., since the new claim does not require the HCFs and LCF to be fragments of a bispecific antibody).
CLAIM REJECTIONS - 35 USC § 251
Claims 1-41 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office Action.
Broadening Reissue
The instant reissue application was filed on 01/22/2024, which is within two years of the issue date of US Patent 11,530,277 (issued on 12/20/2022); has a broadened claim (e.g., claim 1); and has clear intent to broaden the claim.
The broadening in this Reissue Application does not recapture claimed subject matter that was deliberately added, or argued to overcome a rejection in the original application or an application in the patent family.
Conclusion
Claims 1-41 are rejected. No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at (571) 272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-9900.
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.
Information regarding the status of applications may be obtained from Patent Center. Patent Center is available to registered users regarding unpublished application information. To file and manage patent submissions, visit: https://patentcenter.uspto.gov and for more information visit https://www.uspto.gov/patents/apply/patent-center and https://www.uspto.gov/patents/docx. The fax number for the organization where this application is assigned is (571) 273-8300. For additional questions, contact the Electronic Business Center (EBC) at (866) 217-9197. If you would like assistance from a USPTO Customer Service Representative, call (800) 786-9199 or (571) 272-1000.
All correspondence relating to this reissue proceeding may be submitted via:
Electronically: Registered users may submit via Patent Center:
https://patentcenter.uspto.gov/
By Fax to: (571) 273-9900
Central Reexam Unit
By mail to: Mail Stop Reexam/Reissue
Central Reexamination Unit
Commissioner for Patents
United States Patent & Trademark Office
P.O. Box 1450
Alexandria, VA 22313-1450
By hand: Customer Service Window
Knox Building
501 Dulany Street
Alexandria, VA 22314
For Patent Center transmissions, 37 CFR 1.8(a)(1)(i)(C) and (ii) states that correspondence (except for a request for reexamination and a corrected or replacement request for reexamination) will be considered timely filed if (a) it is transmitted via the Office’s electronic filing system in accordance with 37 CFR 1.6(a)(4), and (b) includes a certificate of transmission for each piece of correspondence stating the date of transmission, which is prior to the expiration of the set period of time in the Office Action.
/Kevin S Orwig/Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LEE E SANDERSON/ Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/ SPRS, Art Unit 3991
Prosecution Insights