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 and 4-7 are now under consideration in the instant Office Action.
Withdrawn Rejections
Rejections of claims 1-7 under 35 U.S.C. 112(b)/35 U.S.C. 101 as being “use” claims that set forth processes of using a monoclonal antibody to treat chemotherapy-induced neuropathy are hereby withdrawn in view of amendments to the claims which now recite a method.
Rejections of claims 3 and 7 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paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter are hereby withdrawn in view of amendments to the claims and the cancellation of claim 3.
Rejections of claims 1-2 and 4-11 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or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement are hereby withdrawn in view of amendments to the claims to recite sequences for the instantly claimed antibody.
Rejections of claims 1-2 and 4-11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for using monoclonal antibodies comprising SEQ ID NOs: 3-4 targeting nerve growth factor to treat chemotherapy-induced peripheral neuropathy, does not reasonably provide enablement for the use of any monoclonal antibody targeting nerve growth factor to treat and prevent chemotherapy-induced peripheral neuropathy are hereby withdrawn in view of amendments to the claims to recite sequences for the instantly claimed antibody.
Rejections of claims 1-2, 4-6, 8, and 10-11 under 35 U.S.C. 102(a)(1) as being anticipated by Velasco et al. are hereby withdrawn in view of amendments to the claims which now recite the novel antibody sequences which obviate the prior art.
Rejections of claims 1-2 and 4-11 under 35 U.S.C. 103 as being unpatentable over Velasco et al., in view of Gropp et al. are hereby withdrawn in view of amendments to the claims which now recite the novel antibody sequences which obviate the prior art.
New Rejections
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 and 4-7 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.
Instant claims 1 and 4-7 recite the heavy and light chain sequences of the claimed antibody as “… wherein an amino acid sequence … set forth in SEQ ID NO: [X]…” It is unclear what is meant by “an amino acid sequence set forth in” as the use of “an amino acid” broadens the scope of the claim as it does not explicitly define all embodiments of the sequence. For example, this terminology of “an amino acid” can be interpreted as a subset of amino acids contained within the listed sequence identity number. Applicant is encouraged to amend the claim language to read as “…comprising SEQ ID NO:…” or “…comprising the amino acid sequence of SEQ ID NO:…” at every iteration to obviate this rejection.
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 SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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