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 1-20 are pending as originally filed, and are considered herein.
Formalities:
The drawings filed 2/8/28 are accepted.
The specification of 2/28/23 is accepted.
The IDS filings of 8/1/23 and 4/6/23 and their references cited have been considered are signed off upon by the Examiner, herewith.
Claim Objections
Claim 3 and 5 are objected to because of the following informalities:
Claim 3 recites “to returning the cell medium thereto”. This is not proper English. I would be appropriate to recite “to thereby return the cell medium thereto.”
Claim 5 recites “the passive mixing fluidic module”, but Claim 1 calls the same thing “passive mixing module”.
Appropriate correction is required.
Claim 3: Applicant is advised that should claim 2 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 2 requires the cell reactor, through an outlet to provide the medium back to the media stock reservoir, with an intent to recirculate the same. Claim 3 requires the cell reactor to be operatively linked to the media stock reservoir. In each case, they must be so-operatively linked, otherwise it would require a person to provide it back to the stock reservoir. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Claim 17: Applicant is advised that should claim 15 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 17 limits Claim 15, to a length of tubing required for a residency time of between 1 and 30 minutes before it reaches the cell reactor. However, Claim 15 requires the tubing to be there, and the residency time depends on the flow rate of fluid, but neither claim requires a specific flow rate, and thus, any residency time may be reached, depending on flow rate in the tubing. Therefore, despite a slight difference in wording, these claims have substantially the same scope.
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 15 and 18-20 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 15: Claim 15 is drawn to a system but recites “[NAS] containment” and “[TAS] containment”, twice each. Containment is an action, while the system is what is being claimed. It is not clear what is meant. For purposes of compact prosecution, the term, in each case, will be considered to be “container”.
Claims 18-20 each depend from claims that are currently not of record (I.e., Claims 23 or 30). As such the scope of such claims is not clear. As the scope is not known, no further prosecution on the records can be had.
Claim Rejections - 35 USC § 103
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 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) 1-3, 6, 9, 13, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 104974933 A to Qi, et al. and U.S. Patent No. 6,303,378 to Bridenbaugh, et al.
Claims 1-3 and 15-17:
Qi teaches a process of large-scale continuous suspensions of cells and expression of recombinant protein (e.g. TITLE). The ABSTRACT teaches continuous expression of recombinant protein, and utilizes perfusion technology to give the cells excellent growing conditions, and allow multiple transfections over time with no reduction in the transfection process, or affecting proliferation, to thereby increase the period of production and increase the yield of protein. In it, it taught to connect the various compartments by way of connections, which immediately suggests tubing (e.g, “Invention Contents”, paragraph 2-3). Thus, the structure of the system indicates that the cell culture container contains an inlet port for the perfusion media from the media tank, and an outlet port for the delivery of media from the culture container, to the media container (i.e., a perfusion setup). Next, the same disclosure makes clear the transfection compound mixing device is connected to pushing devise for the mixing components, and then to the cell reactor (e.g., “Invention Contents”, paragraphs 2-3). Lastly, Qi does mention the use of tubes to connect element, and it is noted as official notice, tubing is a well known method to connect the elements of such systems. It should be noted that Claim 17 included here for the same reason as found in the double patenting warning above: such depends on the speed of operation, and Applicant is claiming the device itself, not the device, but only the process of operating, otherwise, it would also be a double patenting objection warning over Claim 4.
However, Qi does not mention a static mixing mechanism that occurs during the process of adding the same to the culture, in a continuous process.
On the other hand, the Artisan would be aware of Bridenbaugh, for preparation of complexes for transfecting cells.
Bridenbaugh teaches methods for making transfection complexes, by the collision of two feed streams, and delivery under laminar flow. Such is taught to be easily scaleable and highly reproducible. (E.g. ABSTRACT.) Bridenbaugh teaches the complexes made by the continuous mixing and delivery provide for better particle size, which is larger due to reaching neutrality for static mixing (e.g., Example 3), and produces less precipitation (e.g., Example 4). Lastly, with regard to teachings of tubing (although office notice has been given), it is noted that Bridenbaugh also teaches the use of tubes to connect elements (e.g., Example 4).
Thus, in light of Bridenbaugh, it would be obvious to modify the methods and device of Qi, to utilize the continuous mixing and delivery mechanisms of Bridenbaugh. The Artisan would do so to provide better quality product to the cells for transfection. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Claim 6:
Bridenbaugh teaches that flow rates may be adjusted as needed, to provide the properties desired, and the turbulent flow at the mixing point, and laminar flow after. Further, the concentrations of the elements may be such they do not require 1:1 mixing (one more concentrated than the other). (E.g., Description of the embodiments, paragraphs 22-27). Thus, depending on the concentrations of elements in the nucleic acid and the transfection agent solutions, one would find a 1:1 rate obvious. The artisan would do so to obtain the desired properties, and expect success, as it has been shown to work by Bridenbaugh.
Claim 9: the use of plasmid DNA is taught in Bridenbaugh (e.g. Example 5); and Claim 13: Cationic lipids are taught in Bridenbaugh (e.g., Example 3).
Thus, given the teachings of Bridenbaugh it would be obvious to utilize plasmid DNA and cationic lipids. The Artisan would do so, and expect success, as the elements are utilized for art-recognized purposes.
Claim Rejections - 35 USC § 103
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 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) 1-3, 5-6, 9, 13, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 104974933 A to Qi, et al. and U.S. Patent No. 6,303,378 to Bridenbaugh, et al., as applied to claims 1-3, 6, 9, 13, and 15-17, above, and further in view of U.S. Patent Application Publication No. 2010/0078086 A1 to Guidat, et al.
As shown above, the various claims are obvious over the art, however, the aspect of heart-shaped static mixer is not taught or obvious, the static mixers of Bridenbaugh only teaching the Kenics static mixers, which are not heart shaped.
On the other hand, the Artisan interested in static mixers would be aware of Guidat, which discloses such static mixers as heart-shaped (e.g., paragraphs 11 and 43-48, as well as Figures3-4).
It would be obvious to further modify the invention with that static mixers of Guidat. The Artisan would do and expect success, as these mixers are known in the art, and utilized for the same purpose of mixing.
Claim Rejections - 35 USC § 103
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 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) 1-3, 6, 9-13, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 104974933 A to Qi, et al. and U.S. Patent No. 6,303,378 to Bridenbaugh, et al., as applied to claims 1-3, 6, 9, 13, and 15-17, above, and further in view of Kimura, et al. (2019) “Production of adeno-associated virus vectors for in vitro and in vivo applications”, Scentific Reports, 9: article 13601, 13 pages as printed, e.g., ABSTRACT.
As shown above, the various claims are obvious over the art, however, the aspect of an AAV vector, for expressing a protein of interest, or a nucleic acid of interest, as found in Claims 10-12, is not taught of obvious from the base art.
However, the use of AAV plasmid for expression of a protein of interest, and/or nucleic acid of interest is not taught or obvious over the base art.
On the other it is well known to utilize a 3-plasmid system to produce adenovirus that is crippled, and expresses a transgene (e.g., Kimura, ABSTRACT).
Thus, in light of Kimura, it would be obvious to further modify the invention, to utilize the AAV plasmid method of Kimura to produce AAVs coding for proteins of the particle, as well therapeutic proteins. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Claims Free of the Art of Record
Claims 7-8 are free of the art of record, as it is noted in Bridenbaugh (US PAT NO 6,303,378) that ratios range from 1:6 to 1:12 (e.g., Brief description of the Drawings), as well as teaching that closer ratios tended to produce increased precipitation (e.g., Examples 2-3). Thus, the Artisan would not be motivated to utilize these closer charge ratios.
Claim 14 is similarly free of the Art of record. To wit, the prior art does not teach continuous perfusions of the mixed transfection composition for 30 minutes to 24 hours.
Claims 7-8 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638