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 .
The rejections under section 112(a) are withdrawn in view of Applicant’s amendments limiting the instant constructs to those with support in the specification.
The rejection under section 103 is withdrawn in view of Applicant’s amendments.
The following are new grounds of rejection, necessitated by Applicant’s amendments:
Claim Rejections - 35 USC § 112
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 18, 20, 21, 23-30 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.
The groups defined for Z in claim 21 do not have antecedent basis in claim 18. Therefore, it is unclear what structures Applicant intends to cover.
In claim 18, it is unclear what antibody fragments Applicant intends to cover.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18, 20, 21, 23, 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., Chin Med J. 2000 Feb;113(2):151-3, Abstract, (Li) in view of WO 2014065661 (WO 661).
Li teaches anti-erb2 (i.e., anti-Her2) antibodies conjugated to IL-2 by a sulfosuccinimidyl 4-[N-maleimidomethyl] cyclohexane-1-carboxylate heterobifunctional linker.
The recited linkages were known, for example WO 661 teaches conjugates of antibodies and a molecule of interest (defined as “D”):
PNG
media_image1.png
228
798
media_image1.png
Greyscale
The molecule of interest is protein, peptide or amino acid (i.e., antibody fragment).
The molecule of interest can include biological molecules (page 36), which include the recited cytokines.
See page 35.
WO 661 teaches the structure of the instant conjugates:
PNG
media_image2.png
368
586
media_image2.png
Greyscale
Antibodies with the required specificities are taught, see page 17.
The molecule of interest can include biological molecules (page 36), which include the recited cytokines. Nonetheless, Li teaches anti-erb2 (i.e., anti-Her2) antibodies conjugateed to sulfosuccinimidyl 4-[N-maleimidomethyl] cyclohexane-1-carboxylate heterobifunctional linker.
Accordingly, WO 661 teaches that the recited linkers are applicable to antibody-IL conjugates. Specifically, WO 661 teaches that the particular known technique of using the recited linkers in antibody conjugates was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique to antibody conjugates, such as antibody-IL conjugates, would have yielded predictable results. Therefore, the difference between the recited references and the claimed inventions is that the references may not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, based on the above, the references teach the structural elements of the claimed constructs with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. 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).
/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646