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 .
Status of the Claims
Claims 8, 18 – 21, 26, 43, 98 – 105, 107 – 109, and 111 were pending. Claims 8, 20, 43 have been amended; claim 117 has been newly added. Claims 8, 18 – 21, 26, 43, 98 – 105, 107 – 109, 111, and 117 are currently pending, with non-elected claim 19 is withdrawn from consideration. Claims 8, 18, 21, 26, 43, 98 – 105, 107 – 109, 111, and 117 are the subject of this Office Action.
REJECTIONS WITHDRAWN
Claim Rejections - 35 USC § 112
Claims 8, 18, 20 – 21, 26, 43, 98 – 105, 107 – 109, and 111 were 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.
In view of the claim amendments in the reply of 05/26/2026, this rejection is withdrawn.
REJECTIONS MAINTAINED IN MODIFIED FORM
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 20 – 21, and 26 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 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
On p. 19, second paragraph of the reply of 05/26/2026, Applicant states “that the optional amino acid substitutions in amended claim 8 correspond to substitutions in the framework region of the heavy chain and light chain variable regions”. Thus, because the CDRs that specifically bind tau are maintained and are not subject to the optional amino acid substitutions of claim 8, they provide sufficient structures for the antibody or antigen-binding antibody fragment that specifically binds to tau of claim 8, and the rejection of claim 8 under 112(a) as failing to comply with the written description requirement is withdrawn. Claims 18, 43, 98 – 105, 107 – 109, and 111 depend from claim 8 and require the CDRs of independent claim 8. Thus, the rejections of claims 18, 43, 98 – 105, 107 – 109, and 111 under 112(a) for failing to comply with written description requirement are also withdrawn.
However, claim 20 and its dependent claims 21 and 26 do not necessarily require the CDRs of the recited sequences and reads on possible variations in the CDR sequences. Claim 20 recites that “the humanized heavy chain variable region comprises a sequence that is at least 90% identical to the recited SEQ ID NOs and the humanized light chain variable region comprises a sequence that is at least 90% identical to the recited SEQ ID NOs. A 90% heavy or light chain identity may not necessarily cover the CDR portions of the recited sequences and thus, claim 20 reads on amino acid substitution in the CDRS. Therefore, claims 20, 21, and 26 fail to comply with the written description requirement for the reasons of record.
NEW REJECTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 20 indirectly depends from claim 8 and recites that the humanized heavy chain variable region comprises a sequence that is at least 90% identical to the recited SEQ ID NOs or that and the humanized light chain variable region comprises a sequence that is at least 90% identical to the recited SEQ ID NOs. Because 90% is broader than the full sequences recited in claim 8, claim 20 fails to further limit claim 8.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 8, 18 , 43, 98 – 105, 107 – 109, 111, and 117 are allowed.
An antibody or antigen-binding antibody fragment that specifically binds to tau, wherein the humanized heavy chain variable region comprises SEQ ID NO: 127 and the humanized light chain variable region comprises SEQ ID NO: 149 is free of the art. Also, an antibody or antigen-binding antibody fragment that specifically binds to tau with the CDRs of SEQ ID NO: 127 and 149 is free of the art.
Conclusion
Claims 20 – 21, and 26 are rejected, and claims 8, 18, 98 – 105, 107 – 109, 111, and 117 are allowed. Claim 43 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/PETER J REDDIG/Primary Examiner, Art Unit 1646
