DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application, Amendments and/or Claims
1. Claims 1-6 and 8-56 have been canceled as requested in the amendment filed October 8, 2021. Following the amendment, claim 7 is pending in the present application.
2. Claim 7 is under examination in the current office action.
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.
3. Claim 7 is 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.
Claim 7 is directed to a hybridoma. In order to use the claimed hybridoma and make an antibody that is produced by the hybridoma, a skilled artisan would need to have access to the deposited biological material recited in the claims, that is, the hybridoma having ATCC number PTA-7238. The examiner acknowledges that the specification discloses that hybridomas have been deposited under the terms of the Budapest Treaty, for example at p. 48, paragraph 0166, which indicates that the hybridoma ML5-8F5.1F2.2A2, which produces the monoclonal antibody 8F5, has been deposited. As a deposit has been made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
4. Claim 7 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 16 of prior U.S. Patent No. 10,208,109. This is a statutory double patenting rejection.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
5. Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-14 and 17-20 of U.S. Patent No. 10,208,109. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented ‘109 claims encompass the murine monoclonal antibody (mAb) designated 8F5 that is produced by the hybridoma having the designation number ATCC PTA-7238. The patented claims also are drawn to an antibody comprising the CDR, VH and/or VL sequences of the 8F5 mAb, as well as a hybridoma that produces a monoclonal antibody having these VH and VL sequences. Because the presently claimed hybridoma (PTA-7238) is the source of the 8F5 mAb, the hybridoma and mAb are inexorably linked and therefore anticipate each other or else render each other obvious.
6. Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 6 of U.S. Patent No. 10,323,084. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented ‘084 claims are drawn to a therapeutic method that comprises administering an antibody having the CDR sequences of the 8F5 mAb. The 8F5 mAb is produced by the hybridoma having ATCC designation number PTA-7238, as in the instant claim. Therefore, it would have been obvious to have used the presently claimed hybridoma to make the 8F5 mAb for subsequent therapeutic administration according to the methods encompassed by the claims of the ‘084 patent.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
7. Claim(s) 7 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Barghorn et al. (J. Neurochem. 2005, 95:834-847).
Barghorn et al. disclose the preparation and use of the monoclonal antibody 8F5 (see “Preparation of amyloid b-peptide1-42 globulomer antibodies” on p. 835). The instant specification indicates that the 8F5 antibody is produced by the hybridoma having ATCC designation number PTA-7238, as in the instant claim. Because Barghorn describes the preparation of the 8F5 monoclonal antibody (mAb), and because mAbs can only be initially obtained and prepared from a hybridoma that produces that specific mAb, Barghorn would have inherently been in possession of the hybridoma in order to make and use the 8F5 mAb. Therefore, Barghorn implicitly teaches the hybridoma of present claim 7.
Conclusion
8. Claim 7 is rejected.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly A. Ballard whose telephone number is (571)272-2150. The examiner can normally be reached Mon-Fri 8AM - 5PM EST.
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/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675