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 .
DETAILED ACTION
Claims 1-2 are pending in the application and are under examination.
With respect to the issue of priority Applicant submits that the Office should have been able to obtain PCT/EP2020/008796 through the Priority Document Exchange. In response, PCT/EP2020/008796, is to Applicant INTERNATIONAL BUSINESS MACHINES CORPORATION with no shared inventors, so the instant application is not a continuation of PCT/EP2020/008796 and does not benefit from PCT/EP2020/008796.
Grounds of Rejection Withdrawn
Applicant's amendment has obviated or rendered moot the grounds of rejection set forth in the previous Office action.
With respect to the issue of priority Applicant submits that the Office should have been able to obtain PCT/EP2020/008796 through the Priority Document Exchange. In response, PCT/EP2020/008796, is to Applicant INTERNATIONAL BUSINESS MACHINES CORPORATION with no shared inventors, so the instant application is not a continuation of PCT/EP2020/008796 and does not benefit from PCT/EP2020/008796.
New Grounds of Rejection
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 1-2 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 pre-AIA the applicant regards as the invention.
Claims 46-61 are indefinite in the recitation of “at least a Fab fragment of the therapeutic antibody in which all HVRs of the paratope” and later reciting “the therapeutic antibody is a bispecific antibody comprising two Fabs, or a bispecific Fab, wherein the first paratope is formed by the HVRs H-1, H-3 and L-2 and the second paratope is formed by the HVRs H-2, L-1 and L-3”.
Notably, each Fab of a bispecific antibody comprises two Fabs that comprise a single paratope so it is unclear what “the paratope” previously is referring to. Is each paratope and all HVRs in both paratopes replaced, or are HVRs in just one paratope altered? Then there is no antecedent basis for reciting the first paratope and the second paratope because the claim previously refers a therapeutic antibody specifically binding to a therapeutic target i.e, the antibody binds a single target (epitope). Accordingly, it is unclear how the first paratope and the second paratope fit into the claimed methods or how the therapeutic antibody is bispecific (i.e., binds two targets).
Additionally, the claim further recites step a) further comprises vi) the therapeutic antibody in which HVRs H-2, L-1 and L-3 have been replaced with non-binding HVRs, without reciting an actual step and skipping from part ii) to vi) so it is unclear how step a) further comprises vi) and it is unclear if other parts are missing from the methods. Then with respect to a bispecific antibody comprising two Fabs how does an antibody with separate Fabs with independent paratopes fit into step A and B.
Accordingly, the metes and bounds of the claims cannot be determined and the invention is not set forth with the clarity and particularity necessary to satisfy the requirement set forth 35 U.S.C. 112, second paragraph, so as permit the skilled artisan to know or determine infringing subject matter.
It is suggested that Applicant rewrite claim 1 into two independent method claims focusing one claim on a bispecific antibody comprising two Fabs with clear steps defining the method and one claim on a bispecific Fab with two paratopes with clear steps defining this different method.
Claim 2 is further 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 pre-AIA the applicant regards as the invention.
Claim 2 is indefinite because the claim recites “the … germline HVR” and claim 1 ahs been amended to not refer to “a germline HVR” such that there is no antecedent basis for reciting “the … germline HVR” in claim 2.
Accordingly, the metes and bounds of the claim cannot be determined and the invention is not set forth with the clarity and particularity necessary to satisfy the requirement set forth 35 U.S.C. 112, second paragraph, so as permit the skilled artisan to know or determine infringing subject matter.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The Examiner works a flexible schedule.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. 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.
Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
January 9, 2026
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