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 Status
Claims 1-23 have been cancelled.
Claims 24-46 are rejected.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 30, 2026, has been entered.
Claim Rejections - 35 USC § 102
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) 24, 26-31, 33-41 and 43-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weggeman et al. (US 2009/0017523) [hereinafter Weggeman.
With respect to claim 24, Weggeman discloses a method for the purification of a replication competent group B adenovirus (see paragraphs 0008, 0034) from host cell proteins (see paragraphs 0015, 0101, 0106, 0107, 0111, 0132), comprising a purification step of: subjecting a composition comprising said group B adenovirus to diafiltration (see paragraphs 0056-0061) employing a diafiltration-buffer with a high salt concentration, wherein said salt concentration is in the range of 2.5 M to 5.5 M (see paragraph 0090 and abstract).
With respect to claim 26, Weggeman discloses wherein the buffer comprises a salt selected from a chloride salt, a sulfate salt, and any salt fully soluble and dissociated in water, and combinations thereof (see paragraphs 0090).
With respect to claim 27, Weggeman discloses wherein the salt in the diafiltration-buffer comprises one or more of the following: an alkaline earth metal salt, sodium acetate, Tris, Bis-Tris, NaH2PO4, NaCl and KCI (see paragraphs 0080-0082).
With respect to claim 28, Weggeman discloses wherein the diafiltration-buffer is selected from: meglumine buffer, Gly-NaCl buffer, and TRIS buffer (see paragraphs 0080-0082).
With respect to claim 29, Weggeman discloses wherein the diafiltration-buffer comprises HEPES (see paragraph 0109).
With respect to claim 30, Weggeman discloses wherein the diafiltration-buffer is at a pH in the range 7 to 9.8 (see paragraphs 0080-0082, 0109).
With respect to claim 31, Weggeman discloses wherein the diafiltration employs an ultrafiltration membrane at least 300KDa or greater (see paragraph 0057).
With respect to claim 33, Weggeman discloses wherein the diafiltration is carried out employing a hollow fiber cartridge or flat membrane cassette filter (see paragraphs 0109, 0057).
With respect to claim 34, Weggeman discloses wherein the diafiltration is performed using a tangential flow filtration (TFF), and the TFF is performed using a consistent volume method (see paragraphs 0058-0061).
With respect to claim 35, Weggeman discloses wherein the diafiltration is performed using at least 8 diavolumes of high salt diafiltration-buffer (see paragraph 0154).
With respect to claim 36, Weggeman discloses wherein the diafiltration comprises two steps (see paragraph 0109).
With respect to claim 37, Weggeman discloses wherein a first step of the diafiltration is diafiltration with the high salt diafiltration-buffer (see paragraph 0109).
With respect to claim 38, Weggeman discloses wherein a second step of the diafiltration is diafiltration with a final formulation buffer (see paragraph 0109).
With respect to claim 39, Weggeman discloses wherein only one diafiltration-buffer is employed (see paragraph 0060).
With respect to claim 40, Weggeman discloses a further purification step comprising subjecting the composition to a chromatography purification (see paragraph 0067).
With respect to claim 41, Weggeman discloses wherein the chromatography purification employs ion-exchange chromatography (see paragraph 0067).
With respect to claim 43, Weggeman discloses wherein the composition comprising the group B adenovirus is a clarified cell lysate obtained by: lysing host cells comprising the group B adenovirus to obtain a crude cell lysate (see paragraph 0041-0042); contacting the crude cell lysate with an endonuclease to obtain an endonuclease-treated cell lysate (see paragraph 0045-0051); and subjecting the endonuclease-treated cell lysate to filtration to obtain the clarified cell (see paragraphs 0052-0079).
With respect to claim 44, Weggeman discloses wherein a second filter is employed in the step of subjecting the endonuclease-treated cell lysate to filtration to obtain the clarified cell lysate (see paragraphs 0062-0079).
With respect to claim 45, Weggeman discloses a filtration step comprising passing the composition through a 0.2µm filter (see paragraph 0052).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 25, 32, 42 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Weggeman (US 2009/0017523).
With respect to claim 25, Weggeman lacks wherein the diafiltration-buffer has a conductivity of at least 180 mScm-1. However, the conductivity of a buffer solution depends on its concentration and therefore, it is inherent and/or obvious that the diafiltration buffer disclosed by Weggeman has the claimed conductivity since it has the claimed concentration.
With respect to claim 32, Weggeman lacks wherein the diafiltration has a flow rate of 1 to 3m2/s. However, this would have been obvious to one of ordinary skill in the art in order to achieve a desired filtration.
With respect to claim 42, Weggeman lacks wherein the method does not employ chromatography. However, Weggeman teaches a further purifying adenovirus step, preferably with at least one chromatography step (see paragraph 0008). It would have been obvious to one of ordinary skill in the art to not employ chromatography in the process disclosed by Weggeman, as claimed by applicant, since Weggeman teaches the chromatography as a preferred step (see paragraph 0008) and one of ordinary skill would recognize that the chromatography step is not necessary and can be either skipped in the desired filtration is achieved, or a different purification step may be employed.
With respect to claim 46, Weggeman lacks the specific formula for the group B adenovirus. However, Weggeman teaches that any species, strain, subtype, or mixture of species, strains or subtypes of adenovirus may be used including adenovirus of group B, for instance Ad11, Ad35, Ad51, (see paragraph 0034). Therefore, it would have been obvious to one of ordinary skill in the art to use the specific type of group B adenovirus claimed by applicant, since one of ordinary skill would recognize to choose a desired type of group B adenovirus and since Weggeman teaches that any species, strain, subtype, or mixture of species, strains or subtypes of adenovirus may be used including adenovirus of group B, for instance Ad11, Ad35, Ad51, (see paragraph 0034).
Response to Arguments
Applicant's arguments filed on January 30, 2026, have been fully considered but they are not persuasive.
In response to applicant’s argument that Weggeman does not provide an enabling disclosure because the only example in Weggeman including a group B adenovirus is carried out with a clarification buffer containing 1M NaCl followed by a diafiltration with a solution comprising only 0.1M NaCl: This argument is not persuasive. Weggeman teaches the claimed method steps, including the claimed range of 2.5M to 5.5M (see paragraph 0090). Weggeman teaches that “Buffers containing other salts and having a similar or higher conductivity can, for instance, now easily be tested for suitability in removing DNA binding proteins from partially purified virus, according to the invention. It is expected that this embodiment will work up to saturation of the NaCl concentration (this is about 6 M NaCl), but for practical reasons, it is preferred to use buffers that are not saturated, e.g., 5 M NaCl. Preferably, the solution comprises at least 1.5 M NaCl or another salt providing an equivalent ionic strength. More preferably, the solution comprises at least 2 M NaCl or another salt providing an equivalent ionic strength. Even more preferably, the solution comprises at least 3 M NaCl or another salt providing an equivalent ionic strength. Even yet more preferably, the solution comprises at least 4 M NaCl or another salt providing an equivalent ionic strength. Most preferably, the solution comprises around 5 M Na Cl or another salt providing an equivalent ionic strength. The high salt solution comprising the virus may be incubated for a certain time, preferably at least one hour, more preferably at least two hours. In general, the examples show an increased purification of the DNA binding protein from the virus when incubation is longer, at least up to overnight. Further, a higher ionic strength appears to improve the purification”. Weggeman teaches the claimed limitations, as stated above.
In response to applicant’s argument that Weggeman lacks the limitations of new claim 46: Weggeman teaches that any species, strain, subtype, or mixture of species, strains or subtypes of adenovirus may be used including adenovirus of group B, for instance Ad11, Ad35, Ad51, (see paragraph 0034). Therefore, it would have been obvious to one of ordinary skill in the art to use the specific type of group B adenovirus claimed by applicant, since one of ordinary skill would recognize to choose a desired type of group B adenovirus and since Weggeman teaches that any species, strain, subtype, or mixture of species, strains or subtypes of adenovirus may be used including adenovirus of group B, for instance Ad11, Ad35, Ad51, (see paragraph 0034).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE GONZALEZ whose telephone number is (571)272-5502. The examiner can normally be reached M-F 9-5:30.
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/MADELINE GONZALEZ/Primary Examiner, Art Unit 1773