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
Applicant's election without traverse of Group III (claims 13-20) in the reply filed on 06/24/2026 is acknowledged. Claims 1-12 are withdrawn.
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 13-20 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 pre-AIA the applicant regards as the invention.
Claim 13 recites the limitations "the first vessel" in line 5. There is insufficient antecedent basis for these limitations in the claim. It is unclear the relationship between “a vessel” and ‘the first vessel’. The claim 13 is indefinite.
Claim 15 recites the limitations “the vessel bottom” in line 3-4. There is insufficient antecedent basis for these limitations in the claim. It is unclear where or how the item is pointed out. The claim 15 is indefinite.
Claims 14-20 depended on claim 13 are rejected as well.
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 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kondo et al. (JP6241252B, English translation provided), further in view of Schutt et al. (US 2011/0250264).
Regarding claims 13, 18, 20, Kondo discloses that, as illustrated in Figs. 1, 2, a process system for preparing microcarrier particles (page 1, lines 12-17), comprising:
1) an apparatus for preparing an emulsion (page 2, lines 96-97), comprising:
2) a vessel (i.e., as illustrated in Fig. 1, an acrylic resin member 2, a stainless-steel plate 3, a stainless-steel plate 4, and an acrylic resin member 1 are integrated to form the vessel (page 7, lines 378-383));
3) a multi-hole plate (i.e., the stainless-steel plat 4 having a plurality of minute holes 4a (page 7, lines 378-379)) arranged in the vessel and including a plurality of micro-wells (as shown in Fig. 1 (e.g., item 4b)); the multi-hole plate separating the interior of the first vessel into a first portion (e.g., an upper space) and a second portion (e.g., a lower space);
4) a dispersed phase inlet (item 7 in Fig. 1 (page 7, line 387)) connected with the first portion and used for feeding a dispersed phase liquid (page 7, lines 387-389);
5) a continuous phase inlet (item 5 in Fig. 1 (page 7, line 386)) connected with the second portion and used for feeding a continuous phase liquid (as shown in Fig. 1); and
6) a vessel outlet (item 6 in Fig. 1 (page 7, lines 385-387 and lines 389-390)) connected with the second portion.
7) wherein, the vessel outlet and the continuous phase inlet are arranged on opposite sides of the vessel (as shown in Fig. 1), such that the continuous phase liquid fed from the continuous phase inlet can flow through the second portion in a direction parallel (i.e., along a liquid flow path 3a (page 7, lines 382-383)) to the multi-hole plate and then flow out from the vessel outlet;
8) a first tank (item 14 in Fig. 2 (page 17, lines 998-1003)) connected with the dispersed phase inlet and used for containing the dispersed phase liquid, wherein the first tank is further connected with a pressurizing device or a gas cylinder so as to enable the dispersed phase liquid to enter the apparatus for preparing the emulsion under pressure (i.e., as illustrated in Fig. 4, the time-dependent change of the dispersion phase pressure gauge 12 is shown in Fig. 4. The pressure gradually began to rise and exceed 0.25 MPa (page 18, lines 1066-1067); it is noticed that, a pressurizing device such as a gear pump is applied to the emulsifying device 8 (page 17, lines 1001-1002));
9) a second tank (item 15 in Fig. 2 (page 17, lines 998-1003)) connected with the continuous phase inlet, used for containing the continuous phase liquid (i.e., it is noticed that, a pressurizing device such as a gear pump is applied to the emulsifying device 8 (Fig. 2; page 17, lines 1001-1002) (related to claim 18 (i.e., for the first tank 14 and the second tank 15, the gear pump(s) is disposed for each of them));
10) a third tank (item 9 in Fig. 2 (page 17, line 999)) connected with the vessel outlet.
Further, Kondo discloses that, it is preferably that the silica hydrogel when filtered (e.g., via a filer device for collecting) is sufficiently washed with water (page 10, lines 566-568).
However, Kondo does not disclose the continuous phase inlet is provided with a cooling device; and cooling the continuous phase liquid; the third tank is provided with a stirrer and a cooling device and used for carrying out emulsion reaction; and a fourth tank connected with the third tank, wherein the fourth tank is provided. Kondo does not disclose the fourth tank being connected to a fifth tank.
In the r field of endeavor, formulating synthetic membrane vesicles, Schutt discloses that, as illustrated in Figs. 1B, the tank 10 can feed a second fluid which can be a second liquid. In some embodiment, the second liquid can be an organic solvent (in an organic continuous phase) ([0192], lines 8-13 and line 19). In some embodiment, a majority of the first component can then be fed from the high shear mixer 25 into the heat exchanger 30, and the cooled first component can flow back to the high shear mixer 25 ([0192], lines 20-24). Thus, in the teachings of Schutt, at least one portion of the organic continuous phase (or the second liquid) has been cooled through the heat exchanger 30.
Further, as illustrated in Fig. 1C of the teachings of Schutt, in some embodiments, a portion of the large diameter synthetic membrane vesicles suspension can be pumped by a pump (Fig. 1A, component 125) through the feed line 120 into a mixing vessel 180 ([0204], lines 1-5). Thus, Schutt discloses that, in the mixing vessel 180, a stirrer may be applied.
Schutt discloses that, in some embodiments, the suspension/dextrose mixture can leave the holding coil tubing 156 (after exiting from the mixing device 180) to enter a retentate vessel 168 ([0205], lines 1-3). Here, the vessel 168 can be considered as the equivalence to the third tank. Schutt discloses that, in some embodiments, the retentate vessel 168 is temperature controlled or cooled ([0205], lines 1-2 from bottom).
As illustrated in Fig. 8 of the teachings of Schutt, multiple retentate vessels 8100, 8200, 8300 ([0289], [0291], [0292]) are applied in the diafiltration system 810 ([0289]). Filters 8170, 8190, 8172, 8192, 8174, and 8194 are sterilizing hydrophilic filters. Filters 8180, 8182, and 8184 are sterilizing hydrophobic gas vent filters used in the retentate vessels and fed by gas lines 8131, 8133, and 8135, respectively ([0293], lines 1-4).
Here, the retentate vessel 8100 is considered as the equivalence to the third tank, the retentate vessel 8200 is considered as the equivalence to the fourth tank, and the retentate vessel 8300 is considered as the equivalence to the fifth tank. Th gas lines 8131, 8133, and 8135 are considered as the evacuation devices for the third tank 8100, the fourth tank 8200, and the fifth tank 8300, respectively (related to claim 20).
Thus, Schutt discloses that, the fourth tank connected with the third tank, wherein the fourth tank is provided, and the fourth tank being connected to a fifth tank having the filtering device.
It would have been obvious to use the method of Kondo to have the process system for preparing microcarrier particles as Schutt teaches that it is known to have the continuous phase inlet is provided with a cooling device; and cooling the continuous phase liquid; the third tank is provided with a stirrer and a cooling device and used for carrying out emulsion reaction; and a fourth tank connected with the third tank, wherein the fourth tank is provided; and the fourth tank being connected to the fifth tank having their evacuation devices, respectively. It has been held that the combination of known technique to improve similar method is likely to be obvious when it does not more than yield predictable results to one of ordinary skill in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
Regarding claim 14, Kondo discloses that, the overall shape of the micropore portion is not particularly limited, and it may be, for example, a flat plate, a disk, a cylinder, a rectangular tube, or the like (page 5, lines 288-289). Thus, Kondo discloses that, if the overall shape of the plate 4 having the micropore portion is a rectangular plate, the vessel can be in a cuboid shape.
Regarding claim 15, Kondo discloses that, as illustrated in Fig. 1, at least the continuous phase inlet and the vessel outlet have the same height relative to the vessel bottom. Kondo discloses that, although one flow path may be defined by the partition wall, it is preferable to provide a plurality of flow paths in order to obtain high productivity (page 5, lines 276-277). Thus, Kondo discloses that, the number of continuous phase inlets is two or more, and the number of vessel outlets is also two or more.
Regarding claims 16, 17, Kondo discloses that, the alkali silicate aqueous solution extruded from the micropore portion 4a grows larger than the pore diameter at the outlet of the micropore portion 4a due to the interfacial tension (page 7, lines 392-393). Kondo discloses that, the average particle diameter (D50) of the spherical silica is preferably 10 micron or more (page 11, line 622) (overlapping the claimed range of 0.1 μm to 500 μm or 30 μm to 50 μm).
Thus, it is reasonable to say that, in the teachings of Kondo, the micro-wells have a diameter between 0.1 μm and 500 μm or the micro-wells have a diameter between 30 μm and 50 μm.
For one of ordinary skill in the art at the time the invention was filed would have considered the invention to have been obvious because the range taught by Kondo overlap the instantly claimed ranges and therefore are considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, MPEP 2144.05.
Regarding claim 19, Kondo discloses that, it is preferably that the silica hydrogel when filtered (e.g., via a filer device) is sufficiently washed with water. In some cases, water may be added again to the wet cake after washing, and the filtration and water washing may be repeated again as a slurry (page 10, lines 566-568).
However, Kondo does not explicitly disclose a fifth tank being connected with the fourth tank.
Schutt discloses that, in some embodiments, the suspension/dextrose mixture can leave the holding coil tubing 156 (after exiting from the mixing device 180) to enter a retentate vessel 168 ([0205], lines 1-3). Here, the vessel 168 can be considered as the equivalence to the third tank. Schutt discloses that, in some embodiments, the retentate vessel 168 is temperature controlled or cooled ([0205], lines 1-2 from bottom).
As illustrated in Fig. 8 of the teachings of Schutt, multiple retentate vessels 8100, 8200, 8300 ([0289], [0291], [0292]) are applied in the diafiltration system 810 ([0289]). Filters 8170, 8190, 8172, 8192, 8174, and 8194 are sterilizing hydrophilic filters. Filters 8180, 8182, and 8184 are sterilizing hydrophobic gas vent filters used in the retentate vessels ([0293], lines 1-4).
Here, the retentate vessel 8100 is considered as the equivalence to the third tank, the retentate vessel 8200 is considered as the equivalence to the fourth tank, and the retentate vessel 8300 is considered as the equivalence to the fifth tank.
Thus, Schutt discloses that, the fourth tank connected with the third tank, wherein the fourth tank is provided, and the fourth tank being connected to a fifth tank having the filtering device.
It would have been obvious to use the method of Kondo to have the process system for preparing microcarrier particles as Schutt teaches that it is known to have the fourth tank is provided; and the fourth tank being connected to the fifth tank with a filtering device for washing the particles. It has been held that the combination of known technique to improve similar method is likely to be obvious when it does not more than yield predictable results to one of ordinary skill in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIBIN LIANG whose telephone number is (571)272-8811. The examiner can normally be reached on M-F 8:30 - 4:30.
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/SHIBIN LIANG/Examiner, Art Unit 1741
/ALISON L HINDENLANG/Supervisory Patent Examiner, Art Unit 1741
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