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 .
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 137-156 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 term “weak partitioning component” in claims 148 and 149 is a relative term which renders the claim indefinite. The term “weak partitioning component” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The components or concentrations of the recited load mixture to be used in the contacting step are thus unclear. This rejection affects all dependent claims.
Claim 143 recites a “second wash solution” in line 2, strongly implying a first wash solution. However, the claim (nor those it depends from) does not recite a “first wash solution”, rendering the claimed scope of methods unclear.
Claim 144 recites the limitation "the first wash solution" in line two. There is insufficient antecedent basis for this limitation in the claim.
Claims 137 and 148 are rejected as being indefinite for failing to recite a positive process step that refers back to the preamble of the claim. In order for the claimed method to be definite in terms of the metes and bounds of the invention, the claim must recite a method step that provides for the results of the method as claimed. Claims 137 and 148 recite methods for “separating intact adeno-associated (AAV) particles from empty AAV particles” but do not recite steps that result in said separation. All the claims require is addition of a wash solution/mobile phase to such particles that are apparently already bound to the AEX medium, without any further step of physically separating the two types AAV. Merely adding a wash solution, even one as claimed that results in “dissociation” of the empty AAV, does not separate the distinct types a AAV as they are both still present in the AEX medium/column/solution though the empty AAV is no longer bound to the solid phase. Using an AEX column with bound AAV as an example, merely adding a wash solution to such a column may dissociate empty AAV, but does not separate empty AAV from anything unless a minimum wash volume (column volume) is passed through the column and the empty AAV exits the AEX media into a distinct and separate fraction. This rejection affects all dependent claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 148 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qu et al (J. Virol. Met., 2007, of record).
Qu et al teach the separation of empty and intact AAV particles via AEX chromatography by loading AAV mixtures comprising empty (or “contaminant”) and intact AAV (using a 6:1 or 17:1 empty capsid:vector ratios) onto Q-Sepharose column in a buffer comprising 100mM NH4Ac, considered a weak partitioning component because stronger concentrations were used to elute the AAV. A first wash solution was then applied comprising, e.g., 130mM NH4Ac and a product mixture collected. See page 185, right column Fig. 5 and Table 1 in particular. The vector genomes collected were considered to have a 1.2 ratio of capsid to genome (Table 1), considered to be vector genome particles nearly free of empty capsid (page 187, top of the 2nd column; such a ratio of 0.9 is considered to be “empty capsid-free vector”). The product mixture thus produced by Qu et al is considered to be a majority of intact AAV particles having a ratio of empty capsid:vector that is less than the starting ratio. This is also considered to be a lower percentage of empty particles in the product mixture as compared to a process that does not include the NH4Ac in the load buffer because the empty particles are removed from the column in the first washes based on the concentration of NH4Ac (page 188, second column), which is included in the loading buffer. Further, this limitation is not a method step performed by the skilled artisan but is an inherent feature of the product mixture produced by including the “partitioning component” in the load mixture.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 137-156 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 10, 12, 16, 31, 61, 84 of copending Application No. 18/050,812 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘812 claims recite and anticipate the separation of empty and intact AAV capsids by contacting an AEX medium with a load mixture comprising magnesium chloride and an acetate followed by wash solutions that remove the empty AAV.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/MICHAEL D BURKHART/ Primary Examiner, Art Unit 1638