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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
Claims 1, 4-7, and 10 are pending and examined herein. Claims 2, 3, 8, 9, and 11-24 are cancelled.
Priority
This application, 18/570,460, filed 12/14/2023, is a 371 of PCT/EP2022/066057 filed on 06/13/2022, and claims benefit of GB2108449.6 filed on 06/14/2021. This priority is acknowledged and the claims examined herein are treated as having an effective filing date of 06/14/2021.
Information Disclosure Statement
The Information Disclosure Statement filed 12/14/2023 is acknowledged and has been considered.
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, 4-7, and 10 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification fails to provide an adequate written description of the invention and fails to provide an enabling disclosure, because the specification does not provide evidence
that the claimed biological materials are: (1) known and readily available to the public; (2)
reproducible from the written description; or, (3) deposited in compliance with the criteria
set forth in 37 CFR 1.801-1.809. The specification lacks complete deposit information for
the cell line deposited 07 May 2021 as ATCC Patent Deposit Number PTA-127062. Because it is not clear that the deposited cells possessing the properties of cell line expressing the 10D1F HER3-binding antibody is known and publicly available or can be reproducibly isolated without undue experimentation, and because the invention of claims 1, 4-7, and 10 claims or uses the cell line, a suitable deposit for patent purposes is required. Accordingly, filing of evidence of the reproducible production of the hybridoma is necessary to practice the instant invention or filing of evidence of deposit is required. Without a publicly available deposit of the above cell line, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the cell line is an unpredictable event. Applicants must comply with the criteria set forth in 37 CFR 1.801-1.809.
If the deposits are made under the terms of the Budapest Treaty, then an affidavit or
declaration by Applicant, or a statement by an attorney of record over his or her signature
and registration number, stating that the specific cell line expressing the 10D1F HER3-binding antibody has been deposited under the Budapest Treaty, that the cell line will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and that the specific cell line expressing the 10D1F antibody will be replaced should they ever become non-viable, would satisfy the deposit requirement made herein.
If the deposits have not been made under the Budapest Treaty, then in order to certify that the deposits meet the criteria set forth in 37 CFR 1.801-1.809, applicant may provide
assurance of compliance by an affidavit or declaration, or by a statement by an attorney of
record over his or her signature and registration number.
For each deposit made pursuant to these regulations, the specification shall contain:
(1) The accession number for the deposit;
(2) The date of the deposit;
(3) A description of the deposited biological material sufficient to specifically identify it
and to permit examination; and
(4) The name and address of the depository.
A viability statement for each deposit of a biological material not made under the Budapest Treaty on the International Recognition of the deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain:
(1) The name and address of the depository;
(2) The name and address of the depositor;
(3) The date of deposit;
(4) The identity of the deposit and the accession number given by the depository;
(5) The date of the viability test;
(5) The procedures used to obtain a sample if the test is not done by the depository; and Biological Deposits. MPEP 2401-2410 & 37 CFR 1.801-1.809
(6) A statement that the deposit is capable of reproduction.
Applicant must assure that:
(7) Access to the deposit will be available during pendency of the patent application
making reference to the deposit.
(8) All restrictions imposed by the depositor on the availability to the public of the
deposited material will be irrevocably removed upon the granting of the patent.
In this case, it is not clear that the deposit was made under the terms of the Budapest
Treaty, nor is there an available viability statement, i.e. one certifying that the deposit was
viable at the time of the deposit or a certificate verifying such from the depository. While the applicant provides a receipt of patent deposit material from the depository under Miscellaneous Incoming Letter received 12/14/2023, this document provides only unofficial deposit dates and patent deposit numbers, and forms BP/4 and BP/9 indicating that these deposit dates and patent deposit numbers became official are not provided. There is also no documentation providing information on the term of deposit. A deposit made before or during pendency of an application for patent shall be made for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposit was received by the depository.
If a deposit is made after the effective filing date of the application for patent in the
United States, a verified statement is required from a person in a position to corroborate
that the biological material described in the specification as filed is the same as that
deposited in the depository, stating that the deposited material is identical to the biological
material described in the specification and was in the Applicant’s possession at the time
the application was filed.
As a possible means for completing the record, applicant may submit a copy of the
contract with the depository for deposit and maintenance of each deposit along with the
necessary statements in order to meet the criteria set forth in 37 CFR 1.801-1.809.
Applicant’s attention is directed to In re Lundak, 773 F.2nd. 1216, 227 USPQ 90 (CAFC
1985) and 37 CRF 1.801-1.809 for further information concerning deposit practice.
Conclusion
For all the reasons discussed above, claims 1, 4-7, and 10 are rejected and therefore no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER JOSEPH HOFFMAN whose telephone number is (571)272-9080. The examiner can normally be reached 10:00-6:30 M-F.
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, Bao-Thuy Nguyen can be reached at (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER J. HOFFMAN/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 June 10, 2026
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