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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-14, in the reply filed on 1/21/2026 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/21/2026.
Information Disclosure Statement
The information disclosure statement dated 12/03/2025 has been considered and made of record. Note: Foreign Patent Documents 1-4 and Non-Patent Literature Documents 4-6 have been lined through because a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed has not been provided. Note: When filing a continuing application that claims benefit under 35 U.S.C. 120 to an international application that designated the U.S. (see MPEP § 1895), it will be necessary for the applicant to submit an information disclosure statement complying with 37 CFR 1.97 and 1.98 in the continuing application listing the documents cited in the international search report and/or the international preliminary examination report of the international application if applicant wishes to ensure that the information is considered by the examiner in the continuing application.
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 5 and 9 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.
In claim 5, “the device” lacks antecedent basis. It appears that the “device” should be “cartridge”. Clarification and/or correction is requested.
In claim 9, it is not clear if the recited “a shell” is different or the same as the “a tube shell” recited in claim. Clarification and/or correction is requested.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (US 2005/0118701).
With respect to claim 1, the reference of Zhou et al. discloses:
A method for mechanically lysing cells (¶[0056], [0063] (Examples 2-3)(¶[0066]-[0077]), comprising flowing a suspension, the suspension comprising a plurality of cells (¶[0056], [0063] (Examples 2-3)(¶[0066]-[0077]), through a cartridge, the cartridge comprising a plurality of hollow fibers (a hollow fiber ultrafiltration system)(¶[0056], [0063] (Examples 2-3)(¶[0066]-[0077]), wherein the plurality of cells is exposed to a pressure differential, thereby lysing a portion of the plurality of cells in the suspension.
While the reference of Zhou et al. specifically discloses the use of differential pressures of 7 and 7.5 psi in the examples, claim 1 differs by reciting using a pressure of about 20 to 50 psi.
However, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine optimal pressures to be used through routine experimentation and based on considerations such as, the specific cells to be lysed in the system, the size/dimensions of the hollow fiber device employed to provide the lysing conditions, the properties of the media flowing in the hollow fiber device and the desired number of cycles or passes of the culture liquid through the hollow fiber device. Note: “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation” (MPEP 2144.05, II).
With respect to claim 2, the reference of Zhou et al. discloses that the method includes recirculating the plurality of cells through the cartridge for one or more cycles, thereby increasing a proportion of the plurality of cells that are lysed (recirculation)(¶[0056]).
With respect to claim 3, the reference of Zhou et al. discloses the use of producer cells (PER.C6)(Ex. 2-3) that express viral particles.
With respect to claim 4, the reference of Zhou et al. discloses introducing the cells to the cartridge by following a flow path (¶[0056]).
With respect to claim 5, the reference of Zhou et al. discloses that the cells are sheared inside the cartridge (¶[0056]).
With respect to claims 6 and 7, the reference of Zhou et al. discloses applying mechanical shear to the cells from turbulence or friction from the cells flowing through the hollow fibers (¶[0056]).
With respect to claims 8 and 9, the reference of Zhou et al. discloses the use of hollow fiber cartridges (¶[0053], [0056], Ex. 2-3) which would meet the structure required of claims 8 and 9.
With respect to claim 10, the reference of Zhou et al. discloses:
A method for isolating viral particles and nucleic acid molecules from a suspension of cells, the method comprising steps of:
(i) flowing the suspension of cells, the suspension of cells comprising particles, the particles comprising viral particles and nucleic acid molecules (cell suspension)(¶[0056], [0063] (Examples 2-3)(¶[0066]-[0077]), through a cartridge, the cartridge comprising a plurality of hollow fibers (a hollow fiber ultrafiltration system)(¶[0056], [0063] (Examples 2-3)(¶[0066]-[0077]), and wherein the cells are exposed to an average pressure differential, thereby lysing a portion of the cells in the suspension to produce a mixed suspension comprising lysed cells and unlysed cells;
(ii) recirculating (recirculation)(¶[0056]) the mixed suspension formed in step (i) through the cartridge for one or more additional cycles, wherein additional proportions of the cells are lysed at each successive cycle to produce a target suspension, the target suspension comprising lysed cells and cellular debris; and
(iii) separating the particles from the target suspension, thereby isolating the particles (¶[0057]).
With respect to claim 10, while the reference of Zhou et al. does not disclose the specific inter diameters of the hollow fibers in the examples, the reference discusses the use of hollow fibers with diameters in a range from .5-3mm (¶[0053]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine optimal hollow fiber diameters to be used through routine experimentation and based on considerations such as, the specific cells to be lysed in the system, the size/dimensions of the hollow fiber device employed to provide the lysing conditions, the properties of the media flowing in the hollow fiber device and the desired number of cycles or passes of the culture liquid through the hollow fiber device. Note: “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation” (MPEP 2144.05, II).
While the reference of Zhou et al. specifically discloses the use of differential pressures of 7 and 7.5 psi in the examples, claim 10 differs by reciting using a pressure of about 20 to 50 psi.
However, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine optimal pressures to be used through routine experimentation and based on considerations such as, the specific cells to be lysed in the system, the size/dimensions of the hollow fiber device employed to provide the lysing conditions, the properties of the media flowing in the hollow fiber device and the desired number of cycles or passes of the culture liquid through the hollow fiber device. Note: “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation” (MPEP 2144.05, II).
With respect to claim 12, the reference of Zhou et al. discloses the use of producer cells (PER.C6)(Ex. 2-3) that express viral particles.
Claims 11, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (US 2005/0118701) in view of Maranga et al. (WO 2019/241486).
The reference of Zhou et al. has been discussed above with respect to claim 10.
While the reference of Zhou et al. is drawn to the production of AV particles, claims 11, 13 and 14 differ by reciting the production of AAV particles, lentiviral particles and particles of a recombinant baculovirus expression vector.
The reference of Maranga et al. discloses that it is known in the art to employ the production steps as the reference of Zhou et al. when producing AAV particles (¶[0214]).
In view of this disclosure and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to modify the method of the reference of Zhou et al. for the production of AAV particles for the known and expected result of providing an art recognized means for producing viral particles while providing the advantages associated with the production method of the reference of Zhou et al.
With respect to claims 13 and 14, the reference of Maranga et al. additionally suggests the production of lentiviral particles (¶[0084]) and particles of a recombinant baculovirus expression vector (¶[0123], [0200]-[0201], [0221], [0340] and [0352]-[0364]) which would have been well within the purview of one having ordinary skill in the art while providing the advantages associated with the production method of the reference of Zhou et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The references of Konz, JR et al. (US 2005/0196854) and Subramanian et al. (Biotech. Prog.) are cited as prior art which pertains to the recovery of adenovirus using hollow fiber membrane devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB