Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of the Claims
1. Claims 1-20 are the original the claims filed on 8/16/2023. In the Preliminary Response of 11/19/2023, claims 1-20 are canceled and new claims 21-33 are added. Claims 21-33 are the pending claims.
Priority
2. USAN 18/450,995, filed 08/16/2023, is a Continuation of 17/071,121, filed 10/15/2020, now abandoned and having 1 RCE-type filing therein,
17071121 is a Continuation of 15/866,139, filed 01/09/2018, now U.S. Patent # 10844133, 15/86,6139 is a Continuation of 15/206,039, filed 07/08/2016, now U.S. Patent # 9902778 and having 1 RCE-type filing therein, 15/206,039 is a Divisional of 13/808,423, filed 03/18/2013, now U.S. Patent # 9718886 and having 1 RCE-type filing therein, 13/808,423 is a National Stage entry of PCT/EP2011/003312, International Filing Date: 07/04/2011, PCT/EP2011/003312 Claims Priority from Provisional Application 61/361,632, filed 07/06/2010, claims foreign priority to EP 10006957.4, filed 07/06/2010.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the EPO on 07/06/2010. It is noted, however, that applicant has not filed a certified copy of the EP application as required by 37 CFR 1.55.
Information Disclosure Statement
3. As of 2/17/2026, a total of two (2) IDS are filed: 8/16/2023; and 3/27/2024. The corresponding initialed and dated 1449 form is considered and of record unless specific references are otherwise lined through for inadequate information.
Objections
Specification
4. The abstract of the disclosure is objected to because it contains implied language, i.e., “such as”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
5. The disclosure is objected to because of the following informalities:
a) The use of the term, i.e., Triton, Lipofectin, Lipofectamine, FASTA, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
b) The specification contains a misspelling for lipofectin.
c) The specification contains sequences > 10 nucleic acids in length that are required to be identified by a sequence identifier pursuant to 37 CFR 1.821-1.825. See
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Appropriate correction is required.
Claim Objections
6. Claims 21-33 are objected to because of the following informalities:
a) Claims 21-33 are not drawn to the species of CLDN6 protein to which the antibodies are directed whilst Example 2 shows the species to be that for human CLDN6.
b) Amend claim 29 to recite “a radiolabel, a cytotoxin or a cytotoxic enzyme.”
Appropriate correction is required.
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.
Enablement
7. Claims 21-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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 claimed invention requires the following hybridomas:
a. a hybridoma deposited under accession no. DSM ACC3059 (GT512muMAB 36A),
b. a hybridoma deposited under accession no. DSM ACC3058 (GT512muMAB 27A), and
c. a hybridoma deposited under accession no. DSM ACC3057 (GT512muMAB 5F2D2).
Applicants have identified the depository by name and address and the date of deposit, i.e., the specification at p.10, lines 10-14. However, Applicants specification does not have a statement of assurances, i.e., that the depositors assure that all restrictions imposed on the availability to the public of the deposited materials will be irrevocably removed upon granting a patent.
Further, a search of the DSMZ website did not identify any accession numbers for the deposit numbers for each clone: DSM ACC3059; DSM ACC3058; and DSM ACC3057.
Therefore, a suitable deposit (or copy of a deposit certificate and a declaration of deposit assurances) for patent purposes is suggested. Without a publicly available deposit of the above hybridoma 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: (1) the claimed cell line; (2) a cell line which produces the chemically and functionally distinct CLBN6 antibody claimed; and/or (3) the claimed antibody's amino acid or nucleic acid sequence is an unpredictable event.
If the deposit is made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposited material will be irrevocably removed upon the grant of a patent on this application. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposit is not made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR 1.801-1.809 regarding availability and permanency of deposits, assurance of compliance is required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request:
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application: and
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest.
As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit. 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. Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
8. Claims 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9718886. The reference patent is not afforded safe harbor protection under 35 USC 121 because the instant application did not arise from a restriction or speciation of a method of production as between itself and the reference patent. In other words, a method of production invention was not present in the restricted claim set for the ‘886 patent. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the identical antibody species of the following hybridomas:
a. a hybridoma deposited under accession no. DSM ACC3059 (GT512muMAB 36A),
b. a hybridoma deposited under accession no. DSM ACC3058 (GT512muMAB 27A), and
c. a hybridoma deposited under accession no. DSM ACC3057 (GT512muMAB 5F2D2).
9. Claims 21-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9902778. The reference patent is not afforded safe harbor protection under 35 USC 121 because the instant application did not arise from a restriction or speciation of a method of production as between itself and the reference patent. In other words, a method of production invention was not present in the restricted claim set for the ‘778 patent. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the identical antibody species of the following hybridomas:
a. a hybridoma deposited under accession no. DSM ACC3059 (GT512muMAB 36A),
b. a hybridoma deposited under accession no. DSM ACC3058 (GT512muMAB 27A), and
c. a hybridoma deposited under accession no. DSM ACC3057 (GT512muMAB 5F2D2).
10. Claims 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10844133. The reference patent is not afforded safe harbor protection under 35 USC 121 because the instant application did not arise from a restriction or speciation of a method of production as between itself and the reference patent. In other words, a method of production invention was not present in the restricted claim set for the ‘133 patent. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the identical antibody species of the following hybridomas:
a. a hybridoma deposited under accession no. DSM ACC3059 (GT512muMAB 36A),
b. a hybridoma deposited under accession no. DSM ACC3058 (GT512muMAB 27A), and
c. a hybridoma deposited under accession no. DSM ACC3057 (GT512muMAB 5F2D2).
Conclusion
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643