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 .
Claims 56-75 are pending as amended 4/23/24 and are considered herein.
Formalities:
The specification as amended 4/23/24 is accepted.
The drawings of 2/29/24 are accepted.
The IDS of 4/23/24 and references therein have been considered and a signed copy of the IDS is provided herewith.
Applicant’s priority is noted to be:
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Claim Rejections - 35 USC § 112
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.
Claims 72, 73, and 75 are 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. The claims are to compositions made by the method from the claim from which they depend. However, they not limited to the same, and are anticipated by the composition made by other methods. 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.
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 56-57 and 59-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,013,774 in view of Clark (2002) “Recent advances in recombinant adeno-associated virus vector production”, Kidney International, 61(symposium 1): s9-S15.
Claim 56: Patent Claim 1 teaches inactivating adenovirus in a sample containing AdV and AAV particles, and a buffer comprising at least 10mM di-/tri-valent cations or at least 10mM kosmotropic salt, comprising heating the sample to a temperature of at least 45 deg C, thereby inactivating the adenovirus.
Claim 57: Claim 2 teaches 46-65 deg C.
Claim 59: Claim 5 teaches more than 4.7 kb of DNA.
Claim 60: Claim 7 teaches a chaotropic salt. Claim 9 teaches each member of the Markush of element b.
Claim 61: Claim 10 teaches pH between 3 and 10 at a temperature between 4 and 70 deg C.
Claim 62: Claim 12 teaches tris, phosphate and trazolamine buffers.
Claim 63: Claim 11 teaches each of the Markush including 40mM bis-tris propane.
Claims 64-65: Claim 13 teaches the helper may be adenovirus serotype 5.
Claim 66: Claim 14 teaches 10 to 500 mM di- or tri- valent cations.
Claims 67-68: Claims 15-16 teach the same Markush, including Mg/Mg+2.
Claim 69: Claim 15 teaches Sc+3.
Claim 70: Claim 17 teaches the same kosmostropic salt of 10mM or greater, including, e.g., ammonium sulfate.
Claim 71: Claim 19 provides for 1M kosmotropic salt.
Claim 74: Claim 2 teaches 1 minute to 6 hours, Claim 14 teaches 500mM di/tri valent cations, and Claim 19 teaches 1M kosmotropic salt.
However, the patent does not claim (although it is the whole purpose throughout it’s disclosure) the growth of AAV with helper virus (e.g., ABSTRACT). It is maintained that it is the essential written description for this method which is provided by the patent’s specification. Nor is the purification of the obtained rAAV taught, though it is a result of the methods as taught throughout the specification (e.g., ABSTRACT).However, in the interest of further providing the knowledge in the Art, the following is provided.
In the Art it is well known to culture cells with rAAV and helper plasmids in, e.g., a mammalian cell, to produce the rAAV particles (e.g., Clark (2002) “Recent advances in recombinant adeno-associated virus vector production”, Kidney International, 61(symposium 1): s9-S15, Figure 1). Further purification of the AAV is taught (e.g., ABSTRACT).
Thus, in light of the essential written description, as well as the disclosure of Clark, the invention as claimed is obvious. The Artisan would do so and expect success, as the purpose of the methods of the patent, as well as known in the art by Clark, because such is well known for that purpose.
*Examiner’s position on Claims 58:
The examiner has not rejected Claim 58 here against the patent above. This is because it is the office’s position that a range or number within a claimed range is not obvious over that claimed larger range. Here Claim 50 requires heating for 10-180 minutes, but the patent teaches the wider range 1 minute to 6 hours. The office takes the position that unless there is more art to anticipate the smaller range, even though found within the larger range, there is motivation to the utilize range disclosed.
Claims 56-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,944,658 in view of Clark (2002) “Recent advances in recombinant adeno-associated virus vector production”, Kidney International, 61(symposium 1): s9-S15.
Claim 56: Claim 1 teaches inactivating helper virus in a sample further containing AAV particles, comprising, in a buffer containing 25-500mM di/tri valent cations, or 0.5-0.6 M Kosmotropic salt, and heating it to 45-55 deg C, for 1minute to 6 hours.
Claim 57: Claim 1 teaches 45-55 deg C.
Claim 58: Claim 2 teaches 10 to 180 mins.
Claim 59: Claim 4 teaches genomes of about 4.7kb or more DNA.
Claim 60: Claim 5 teaches a chaotropic salt, and Claim 6 teaches a Markush of polyols that anticipate element (b).
Claim 61: Claim 7 teaches a buffer for pH 3-10 at a temperature of 4-70 deg C.
Claim 62: Claim 9 teaches the same Markush of buffers.
Claim 63: Claim 8 teaches the same Markush of buffers, including bis-tris propane at 40nM.
Claim 64: Claim 10 teaches adenovirus as the helper.
Claim 65: Claim 11 teaches adenovirus serotype 5.
Claim 66: Claim 12 teaches 25-400mM di/tri valent cations.
Claim 67: Claim 13 teaches the same Markush of metal di/tri valent cations.
Claim 68: Claim 14 teaches the same Markush of cations, including Mg+2.
Claim 69: Claim 17 teaches Sc+3.
Claim 70: Claim 18 teaches the same kosmotropic salt Markush, including ammonium sulfate.
Claim 71: Claim 20 teaches 0.5 M kosmotropic salt.
Claim 74: As shown above, the various elements are taught.
However, the patent does not claim (although it is the whole purpose throughout it’s disclosure) the growth of AAV with helper virus (e.g., ABSTRACT). It is maintained that it is the essential written description for this method which is provided by the patent’s specification. Nor is the purification of the obtained rAAV taught, though it is a result of the methods as taught throughout the specification (e.g., ABSTRACT).However, in the interest of further providing the knowledge in the Art, the following is provided.
In the Art it is well known to culture cells with rAAV and helper plasmids in, e.g., a mammalian cell, to produce the rAAV particles (e.g., Clark (2002) “Recent advances in recombinant adeno-associated virus vector production”, Kidney International, 61(symposium 1): s9-S15, Figure 1). Further purification of the AAV is taught (e.g., ABSTRACT).
Thus, in light of the essential written description, as well as the disclosure of Clark, the invention as claimed is obvious. The Artisan would do so and expect success, as the purpose of the methods of the patent, as well as known in the art by Clark, because such is well known for that purpose.
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) 72, 73, and 75 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clark (2002) “Recent advances in recombinant adeno-associated virus vector production”, Kidney International, 61(symposium 1): s9-S15.
Claims 72 and 75: Clark teaches the purification of rAAV particles. As such, regardless of the method of how it is made, it anticipates the composition.
Claim 73: Clark teaches the purification of rAAV, and the presence of helper virus/proteins (e.g., p. s13). As such, although not made by the same method, it is still anticipatory to the claim.
Claim(s) 72, 73 and 75 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiao, et al. (1998) “Production of High-Titer Recombinant Adeno-Associated Virus Vectors in the Absence of Helper Adenovirus”, Journal of Virology, 72(3): 2224-32.
Claims 72, 73 and 75: Xiao teaches it is well known in the Art to heat inactivate Adenovirus (helper AdV) in compositions for the purification of AAV. As such, the compositions are anticipated.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638
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