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 .
Election/Restrictions
Amended claim 3 and dependent claims 4-8 and 11-13 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The originally presented claims are directed to a method for evaluating the viral clearance capabilities of a virus removal medium comprising, inter alia, quantifying the number of total viral capsid particles in the solution to be purified and the total number of viral capsid particles in the purified solution. Claim 3 has been amended to be an independent claim directed to a method for evaluating the viral clearance capabilities of a virus removal medium comprising, inter alia, quantifying a nucleic acid of a virus in the solution to be purified and a nucleic acid of a virus in the purified solution. Each method differs in the method steps, in the reagents used, and have different final outcomes. Consequently, the search burden is at least doubled and deemed unduly burdensome.
Since applicant has received an action on the merits for the originally presented invention (quantifying the number of viral capsid particles), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 3-8 and 11-13 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Status of the Claims
Claims 3-8 and 11-13 have been withdrawn as being directed to a non-elected invention. Claims 5 and 6 have been withdrawn as being directed to a non-elected species. Claims 1-2 and 9-18 are under examination at this time.
Withdrawn Rejections
The rejection of claims 3, 7-8 and 11-13 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, has been withdrawn in view of applicant’s amendments to the claims.
The rejection of claims 1, 2, 4, 9, 10 and 14-15 under 35 U.S.C. 102(a)(1) as being anticipated by Cetlin et al. (U.S. Patent Application No. 2015/0072339; published March 12, 2015) has been withdrawn in view of applicant’s amendments to the claims to recite “infectious virus”.
The rejection of claim 16 under 35 U.S.C. 103 as being unpatentable over Cetlin et al. has been withdrawn in view of applicant’s amendments to the claims to recite “infectious virus”.
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 17 and 18 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 17 states that wherein the infectivity of virus in the solution before and after purification and the number of total viral particles in the solution before and after purification are calculated from ratio T. Ratio T is defined as the value obtained by dividing the number of total viral capsid particles by the infectivity in the viral capsid-containing liquid to be added to the solution to be purified before purification.
It is not clear if the “total capsid particles” refers to the total capsid particles in the solution before purification or the total capsid particles in the solution after purification. Further, it is not clear how dividing the “total capsid particles” by infectivity in the viral capsid-containing liquid results in “the infectivity of virus in the solution before and after purification and the number of total viral particles in the solution before and after purification”. Lastly, it is not clear how “infectivity in the viral capsid-containing liquid” is determined. Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Claim 18 recites the limitation "biological material-containing solution" in part (c). There is insufficient antecedent basis for this limitation in the claim.
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 16 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 1, from which claim 16 depends, requires that the viral capsid-containing liquid comprise an infectious virus. However, claim 16 states that the viral capsid-containing liquid comprises a virus having a nucleic acid and empty viral particles. A virus having a nucleic acid can be non-infectious (e.g., attenuated viral particles) and empty viral particles are non-infectious. Thus, claim 16 changes the scope of claim 1 and does not further limit claim 1.
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.
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.
Claims 1, 2, 9, 10 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burnham et al. (BioProcess International, March 2018, 16(3):52-57).
The instant claims are directed to a method for evaluating the viral clearance capability of a virus removal medium, comprising:
(a) adding a viral capsid-containing liquid comprising an infectious virus to a solution to be purified;
(b) contacting the virus removal medium with the solution to be purified that has been supplemented with the viral capsid-containing liquid to harvest a purified solution; and
(c) quantifying the number of total viral capsid particles in the solution to be purified before the purification and the number of total viral capsid particles in the purified solution.
Burnham et al. teaches a method of quantifying the amount of infectious retrovirus or parvovirus removed from a solution wherein the method comprises:
a) adding infectious xenotropic murine leukemia virus (X-MuLV) or infectious minute virus of mice (MVM) to a feed solution comprising human IgG [claim 1, step (a)];
b) processing the spiked solution through a filter 0.2 µm filter (MVM-spiked solution) or a 0.45 µm filter (X-MuLV-spiked solution) [claim 1, step (b) and claim 2]; and
c) quantifying the amount of MVM and X-MuLV particles removed from the solution via virus titration assays (see page 54). The log reduction value was calculated by taking the ratio of the starting material virus load (before purification) over the filtrate virus load (after purification) (see page 56 and Equation 1) [claim 1, step (c)].
For claims 9 and 10, Burnham et al. teaches that the spiked solution is filtered through a filter 0.2 µm filter (MVM-spiked solution) or a 0.45 µm filter (X-MuLV-spiked solution), each comprising a membrane.
For claims 14-15, Burnham et al. teaches that the MVM is a member of the Parvoviridae family (see Table 1).
Conclusion
No claim is 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.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672