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 .
Election/Restrictions
Claims 13-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected apparatus, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/23/2026.
Claim Objections
Regarding claim 12, it is suggested that the second lumen in the first line of the claim be deleted in order to enhance the clarity of the claim.
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.
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.
Claims 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, and 12, are rejected under 35 U.S.C. 103 as being unpatentable over Lopresti (U.S. Patent 1,096,0367) in view of Larwick (U.S. Patent 5,344,619) in further view of Zambaux (U.S. Publication 2005/0078552).
Regarding claim 1, Lopresti teaches a method of inducing powder for production (Fig. 1 shows a method of inducing powder for production including powder eductor item 30), the method comprising: inducing the powder in a powder container (see container feeding into item 74, proximate item 70 which is shown as a container) into a powder flow pathway (the powder flow pathway includes item 74, 72, 76, and 31) towards a branch lumen (item 30 is considered reading on a branched lumen since there is a top inlet, a left side inlet, and an outlet on the right side), closed container (container shown proximate item 70 in figure 1 would inherently have to be closed while transporting in order to contain the desired amount of powder), and inducing the powder from the branched lumen into a recirculation flow pathway toward a mix tank (the recirculation flow path extends from the exit of item 30, up in item 62, through tank 50, pump 48 and back towards item 30), wherein a pump assembly is located in the recirculation flow pathway (pump item 20); and recirculating the powder in the recirculation flow pathway toward the mix tank (powder goes through item 62, through tank 50 and back into item 30) wherein the powder flow pathway and the recirculation flow pathway are collectively an enclosed pathway (valve item 45 is used to close the pathway if a recycle is desired, see column 5 lines 9-12). Regarding claim 1, Lopresti is silent to the powder specifically being for pharmaceutical production, wherein the powder container is a single use, wherein an air inlet is coupled to the powder flow pathway downstream of the powder container and upstream of the branched lumen, and the specific air flow rate and the specific recirculation flow rate. Regarding claim 1, Larwick teaches delivering powder (item 2) to a branched lumen (item 14 which has inlets and an outlet, forming a t-shape), wherein an air inlet is coupled to the flow path downstream of the powder container and upstream of the branched lumen (item 9 feeds air at a nozzle 11 which is both downstream of item 4 and upstream of item 14). Regarding claim 1, Zambaux teaches a pharmaceutical application (paragraph 2) including a closed (paragraph 33 describes the container as sealed) single use container (paragraph 19 teaches the container being disposable) for storing and delivering (paragraph 19 teaches using the disposable bag to store and dispense material) powder (paragraph 77 teaches the solid components may be powders). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the mixing operation of Lopresti with the air inlet configuration of Larwick in order to better mix the dry powder. It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the mixer of Lopresti in view of Larwick with the pharmaceutical single use bag of Zambaux in order to prevent contamination (see Zambaux paragraph 32). Regarding claim 1, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date to modify the flow rates in order to obtain the desired amount of product since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Lopresti is silent to the language of claim 2. Regarding claim 2, Zambaux teaches the use of a powder container is a bag (paragraph 19 taches a bag for storing and dispensing material, paragraph 77 teaches the solid components may be powders). It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the mixer of Lopresti in view of Larwick with the pharmaceutical single use bag of Zambaux in order to prevent contamination (see Zambaux paragraph 32).
Lopresti is silent to the language of claim 3. Regarding claim 3, Larwick teaches the powder container has a vent through which the air from the air inlet exits (item 6 is considered part of the powder container, and air vents downward through the bottom of item 7). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the mixing operation of Lopresti with the air inlet configuration of Larwick in order to better mix the dry powder. It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the mixer of Lopresti in view of Larwick with the pharmaceutical single use bag of Zambaux in order to prevent contamination (see Zambaux paragraph 32).
Lopresti is silent to the ranges of claim 4. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the mixing operation of Lopresti with the air inlet configuration of Larwick in order to better mix the dry powder. It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the mixer of Lopresti in view of Larwick with the pharmaceutical single use bag of Zambaux in order to prevent contamination (see Zambaux paragraph 32). Regarding claim 4, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date to modify the flow rates in order to obtain the desired amount of product since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 5, Lopresti teaches wherein the branched lumen is a manifold (eductor 30 is a static mixer with inlets, and outlet wherein material is mixed inside item 30 and therefore considered reading on a manifold).
Regarding claim 6, Lopresti the pump assembly is located downstream of the manifold relative to an entryway into the recirculation flow pathway and the pump assembly is located upstream of the mix tank relative to the entryway into the recirculation flow pathway (twin screw pump 20 is both downstream of item 30 and upstream of item 50).
Regarding claim 7, Lopresti teaches wherein the powder is initially induced into the recirculation flow pathway via the manifold (item 30 is considered reading on a manifold), then into the pump assembly (material exits item 30 into item 20), and then into the mix tank along the recirculation flow pathway (item 20 sends material from line 62 into item 50).
Regarding claim 8, Lopresti is silent to the height of the powder container relative to the height of liquid in the container. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the mixing operation of Lopresti with the air inlet configuration of Larwick in order to better mix the dry powder. It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the mixer of Lopresti in view of Larwick with the pharmaceutical single use bag of Zambaux in order to prevent contamination (see Zambaux paragraph 32). Regarding claim 8, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to rearrange the location of the system in order to allow for more convenient operation by a user since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 9, Lopresti teaches wherein the branched lumen is an eductor (item 30 powder eductor).
Regarding claim 10, Lopresti teaches wherein the pump assembly is located downstream of the mix tank relative to an entryway into the recirculation flow pathway and upstream of the eductor relative to the entryway into the recirculation flow pathway (Lopresti teaches a pump assembly, item 48, downstream of the tank 50 and upstream of eductor 30).
Regarding claim 11, Lopresti teaches wherein the powder is initially induced into the recirculation flow pathway via the eductor, then into the mix tank, and then into the pump assembly along the recirculation flow pathway (powder flows through item 30, then through item 50, then pump assembly item 48).
Regarding claim 12, Lopresti teaches wherein the eductor has an internal lumen sized and shaped to achieve the venturi effect as fluid flows through the internal lumen (flow paths in item 30 are considered branched lumen, the eductor inherently utilizes the venturi effect in order to mix material).
Conclusion
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/ANSHU BHATIA/Primary Examiner, Art Unit 1774