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 .
Application Status
This action is written in response to applicant’s correspondence received 02/03/2026. Claims 1-16 and 19-22 are currently pending.
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
Withdrawn Claim Rejections - 35 USC § 103
The amendments to the claims, received 02/03/2026, have overcome the rejections of claims 1, 11, 14-16 and 19-21 under 35 USC 103. The amended claims recite specific concentrations required for the first and second assays. The prior art does not teach or suggest those specific concentrations. The closest prior art is WIPO Publication 2014/207140 A1 (priority filing date 06/27/2013, hereinafter ‘PGPUB140’). PGPUB140 teaches that the following reference ranges are typical in blood plasma (p. 8):
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However, the recited values are specific. The prior art does not provide any guidance which would have led the ordinary artisan to select the specifically recited values from all of the possible values within the known reference ranges for blood plasma to evolve conditionally active antibodies in blood plasma versus brain extracellular fluid.
Applicant's arguments filed 02/03/2026 have been fully considered but are moot in light of the amendments to the claims, which have overcome the previous rejections.
Claim Rejections - 35 USC § 112(b)
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 7 and 8 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.
Claim 7 recites the term “said one or more mutations”. There is insufficient antecedent basis for this limitation in the claim because claim 7, as amended, now depends from claim 1, which does not recite the term “one or more mutations”.
Amending the claim to depend from claim 13, which recites one or more mutations, or amending claim 1 to incorporate the relevant limitations of claim 13, would obviate this rejection.
Those claims identified in the statement of rejection but not explicitly referenced in the rejection are also rejected for depending from a rejected claim but failing to remedy the indefiniteness therein.
Conclusion
Claims 1-6, 9-16 and 19-22 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 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 AMANDA M ZAHORIK whose telephone number is (703)756-1433. The examiner can normally be reached M-F 8:00-16:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.M.Z./ Examiner, Art Unit 1636
/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636
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