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 .
Claims 1-19 have been canceled. Claims 20-38 have been added and are under consideration.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 is vague and indefinite in the recitation of “a heavy chain variable region comprising SEQ ID NO:9” and “ a light chain variable region comprising SEQ ID NO:10” because SEQ ID NO:9 is identified in the specification as the entire anti-CD46 heavy chain and SEQ ID NO: 10 is identified in the specification as the entire anti-CD46 light chain. As such, the variable region of the heavy chain does not comprise SEQ ID NO:9 and the variable region of the light chain does not comprise SEQ ID NO: 10. It is unclear what applicant is intending to claim. For purpose of examination, instant claim 20 will be read as “heavy chain comprising SEQ ID NO: 9” and “light chain comprising SEQ ID NO: 10”.
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 20-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No.12,144,888. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patented claims.
Claims 1-19 teach all the limitations of the instant claims with the exception of the full sequence of the heavy and light chains of the anti-CD46 antibody.
Section 804 IIb of the M.P.E.P. states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).
In the instant case the ‘888 specification defines the heavy chain CDRs of the YS5FL anti-CD46 antibody as comprising SEQ ID NO:1-3 (Table 1) paired with the light chain CDRs of SEQ ID NO: 4-6 (Table 2). The ‘844 specification defines the heavy chain of the same YS5FL anti-CD46 antibody as SEQ ID NO: 9 (Table 5), paired with the light chai of SEQ ID NI: 10 (Table 6).
Thus, claims drawn to the full length YS5FL antibody are obvious over claims drawn to anti-CD46 antibodies comprising the heavy chain CDRs of SEQ ID NO: 1-3 and the light chain CDR of SEQ ID NO: 4-6 because SEQ ID NO: 1-3 and 4-6 are the CDRs of the YS5FL antibody which comprises SEQ ID NO: 9 paired with SEQ ID NO: 10 .
Claim 20-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No.11,484,604. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patented claims.
Claims 1-3 of the ‘601 patent teach the limitations of instant claims 20-28, wherein “about 1.2 mg “in claim 20, meet the limitation of “about 1.8” of the patent and “about” 2.1, 2.4 and 2.7 are doses obviously encompassed by the range of 1.8 mg.kg adjusted body weight to 3.0 mg/kg adjusted body weight”. The claims of the patent do not teach how to calculate the adjusted body weight.
Section 804 II(b) of the M.P.E.P. states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).
The ‘604 patent defines the adjusted body weight as:
As used herein, “adjusted body weight” (“AJBW”) is IBW+0.4×(Actual weight—IBW); and ideal body weight as:
“ideal body weight” (“IBW”) is 50 kg+2.3 kg×(Actual height—60 in) for males.
Thus, these limitations are encompassed with in 1.8 mg to about 3.0 mg of the immunoconjugate per adjusted body wight of claim 3 of the patent.
All other rejections and/or objections as set forth in the previous Office action are withdrawn.
All claims are rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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