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 .
Withdrawn Objections/Rejections
The objections to claims 1, 3, and 5 are withdrawn. The suggested corrections made to the claims by amended.
The rejection of claims 1-10, as presented in the last office action, 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn. The amendments to the claims do not actually clarify the preparing of a primary solution as previously discussed and further add issues of indefiniteness. As such, the rejection is being withdrawn and a new rejection that addresses the new indefiniteness issues introduced by amendment will put in place.
The following new rejection is necessitated by the amendments to the claims:
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 1-10 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.
The claims, as amended or originally presented, still are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 1, as amended, recites, “preparing a primary solution through 0.1 to 5 kDA ultrafiltration of the concentrate obtained through the separation”. By amending the claim to specify “through 0.1 to 5 kDA ultrafiltration of the concentrate”, the amendments now require the filtering step to be two ultrafiltration steps and not just one that produced the concentrate and the filtrate as was the indefiniteness issues discussed in the last office action. However, this amendment also adds a new issue of indefiniteness. The “concentrate” produced by ultrafiltration is a solid component separated from the liquid filtrate. As such, the relationship of the 0.1 to 5 kDA ultrafiltration to the making of the primary solution is not apparent because it is not apparent how the concentrate prepared for filtration and it is not apparent how the primary solution is being prepared (i.e. is the primary solution the filtrate of the 2nd ultracentrifugation or a solubilized form of the concentrate that results from the second 0.1 to 5kDA filtration). As such, the metes and bound of the “preparing a primary solution” are not apparent.
Claims 2-10 depend upon claim 1 and thus also comprise the indefinite subject matter of claim 1.
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 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 MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632