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 .
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 46-59 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 claims require a specific antibody VLC and VHC of a specific vector that is contained in the deposit. Applicant's deposit statement on specification at PG Pub para 164 does not indicate the extent of public availability.
If a deposit is 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
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.
Claims 46-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 10689437. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to HC and LC of an antibody encoded by the RSV mAb 1G7 pOE YTE vector deposited at the ATCC under Patent Designation PTA-125141 capable of specifically binding the Respiratory Syncytial Virus (RSV) F protein.
Claim 46 has the heavy and light chains as patent claim 16.
Claims 47-48 have art known compositions for pharmaceutical use and would have been obvious to one of skill in the art.
For the method claims 49-59, the claim of 10689437 do not recite administering the antibody or to particular types of patients.
However, the instant methods claimed are not patentably distinct from using the composition of claim since the composition and the compositions used in the instant methods are identical and the methods of using the composition was disclosed, but not claimed, see column 1 lines 32-60column 21 section “III . Methods of Use” for the specific uses. Geneva Pharms. v. GlaxoSmithKline, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer v. Teva Pharms., 518 F.3d 1353 (Fed. Cir. 2008)
Thus, the claims are obvious.
Claims 60-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5, 9, and 12-18 of U.S. Patent No. 11661449. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to the same antibody heavy and light chains and methods of use.
For claim 60, the antibody is taught in claims 2, 5, and 9 of the patent.
For claims 61-66, the methods of use are in the corresponding claims 12-18 for the type of subject.
Thus, the claims are anticipated.
Claims 46-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5-8 of U.S. Patent No. 11186628. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to the same antibody heavy and light chains and methods of use.
Claim 46 has the heavy and light chains as patent claims 1 and 3 used in the method of claim 5.
For claims 47-48, the compositions for pharmaceutical use are in claims 25-26.
For the method claims 49-56, the types of subjects are listed in claims 6-8.
For claims 57-59, the patent has claims to nucleic acid, host cell, and method of making (claims 20-24).
For claim 60, the antibody is taught in claims 1, and 3 of the patent.
For claims 61-65, the methods of use are in the corresponding claims 5-8 for the type of subject. Under 6 weeks covers for both under six weeks and under two years old.
Thus, the claims are obvious over the patent.
Claims 46-56 and 60-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 14-18 of U.S. Patent No. 12173050. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to the same antibody heavy and light chains and methods of use.
Claim 46 has the heavy and light chains as patent claims 1-2.
Claims 47-48 have art known compositions for pharmaceutical use and would have been obvious to one of skill in the art.
For the method claims 49-56, the types of subjects are listed in claims 4-10.
For claim 60, the antibody is taught in claims 1, and 3 of the patent.
For claims 61-65, the methods of use are in the corresponding claims 5-8 for the type of subject.
Thus, the claims are obvious over the patent.
Conclusion
Citation of closest prior art:
Spits et al. (US 8562996) claim an antibody D25 that comprises SEQ ID# 8 (LCVR) but has different heavy chain CDR sequences. Eriksson et al. (US 8092804) teach the YTE mutations.
Neither reference makes obvious the specific CDR sequences of 1G7 or SEQ ID#s 8 and 23.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached on Mon, Tues, Thurs, Fri..
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, Michael Allen can be reached on 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1648
/Shanon A. Foley/Primary Examiner, Art Unit 1671
