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 .
Applicants are informed that the rejections of the previous Office action not stated below have been withdrawn from consideration in view of the Applicant’s arguments and/or amendments.
Election/Restrictions
Applicant’s election without traverse of invention I and the required species in the replies filed on 11/18/24 and 5/13/25 are acknowledged.
Claims 52, 54 and 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/18/24.
Claims 37, 44-46 and 56-64 are examined on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Terminal Disclaimer
The terminal disclaimer filed on 12/29/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 10,905,678 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
(Prior Rejection Maintained) Claims 37, 44-46 and 56-64 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with (he written description requirement. The claim(s) contains subject matter which was not described in the specification in
such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint
inventor, or for pre-AIA the inventories), at the time the application was filed, had possession of the claimed invention.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. .112 written description requirements for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice.... reduction to drawings..,.or by disclosure of relevant, identifying characteristics, he., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See BU Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found -where the applicant has provided a number of examples sufficient so that one in the art would recognize front the specification the scope of what is being claimed.
Claims 37, 44-46 and 56-64 are rejected as lacking adequate descriptive support for the possession of a functionalized antibody or antibody conjugate or antibody-drug conjugate that possesses an N-linked oligosaccharide with a terminal sialoside covalently linked to a cytotoxic drug. Several options for a cytotoxic drug are provided, including doxorubicin and a linker (triazole) can be employed. However, the claimed property of “a functionalized antibody, antibody conjugate and antibody-drug conjugate” is at issue in this rejection. What structure does the antibody possess, the claims focus on the conjugation and drug that is attached to the antibody, but not what the antibody “looks like”. Antibodies by themselves inherently have at least two functions (binding epitopes and interacting between their Fc region and cells). In order to carry out these functions, antibodies possess 6 unique complementary determining regions (CDRs) in the variable region, which facility epitope binding and a Fc region which facilitates cell binding.
In support of the claimed genus of a composition comprising a a functionalized antibody, antibody conjugate and antibody-drug conjugate, wherein it comprises an N-linked oligosaccharide, comprising at least one terminal sialoside, said terminal sialoside covalently linked to a cytotoxic drug. The specification teaches linking Doxorubicin or detectable markers to what appears to be rituximab (the anti-CD22 antibody of Molina et al, see working example 1 at page 22, 2nd full paragraph). No other examples of specific antibodies linked to a drug are provided.
Furthermre, the decision arrived at in Amgen Inc. v. Sanofi, 598 US 594 (2023) supports expanded analysis of whether a claim drawn to an antibody, permits an applicant to pursue all possible antibodies that are capable of being produced without also claiming a structure that defines the antibody. Presently, the claimed functionalized antibody, antibody conjugate or antibody-drug conjugate are not defined by any particular structure.
In view of this uncertainty and the lack of a representative number of examples of the claimed genus, the claims are rejected for lack of adequate written description support.
Response to arguments:
Applicant presents the following arguments in traversal of the rejection:
The crux of the presently claimed invention is not the antibody itself, but how the cytotoxic drug is linked to the antibody. Thus, it does not matter what the structure of the antibody is; in essence, they all have a related structure made of amino acids, and it does not matter what the specific sequence is in order for the chemistry to link the cytotoxic drug, as presently claimed, to work. This contrasts with situations where claims are directed to an antibody itself, in which its therapeutic effect is the focus, thus requiring characterization of particular structural features of the antibody.
In response, applicants are reminded that each and every claim limitation is to be given a full review, see MPEP 2103, part “C. Review the Claims”. Therefore, the claim limitation of an “antibody” is also part of the invention and therefore will be examined on the merits. If applicants do not believe it is part of the invention, then it is suggested they cancel this claim limitation. As stated in the prior Office action and above, the issue being addressed in this rejection is what structure does the antibody possess? The claims focus on the conjugation of a drug that is attached to the antibody, but not what the antibody “looks like”. The claimed invention does contain a drug, but the presence of the antibody also imparts an additional function to the conjugate (i.e., the antibody binds to an epitope). Therefore, with the claimed invention not providing structure to the antibody and since the specification appears to provide one monoclonal antibody as an example, rituximab, it is the Examiner’s position that applicants are not in possession of the claimed invention as a whole.
Conclusion
THIS ACTION IS MADE FINAL. 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 BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached on M-F 8-5 EST.
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.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671