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 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.
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 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2005/0278973 to Alstat in view of US Patent Publication 2010/0107436 to Velardi.
In Reference to Claim 1
Alstat discloses method of lyophilizing a target material, the method comprising: placing a container with a target material in a lyophilizer of a lyophilization system (Fig. 1, 101), the lyophilization system comprising the lyophilizer, a refrigeration system (Fig. 1, 104) coupled to the lyophilizer, a controller (Paragraph 6 discloses that the system is under controlled based on different product requirements, obviously, a controller is inherent) coupled to the refrigeration system, and a flow path (Fig. 1, 107) connecting the lyophilizer and the refrigeration system; activating the lyophilizer, wherein the lyophilizer includes a plurality of walls (AS showed in Fig. 1, the lyophilizer 101 has wall) defining an interior chamber and at least one shelf (Fig. 1, 105) disposed in the interior chamber; performing a freezing cycle (Paragraph 33, a pre-frozen process) by reducing a temperature of the at least one shelf; performing a primary drying cycle (Paragraph 33, a first “primary” step) by increasing the temperature of the at least one shelf; performing a secondary drying cycle; pumping a thermal fluid through the flow path during the freezing cycle, the primary drying cycle, and the secondary drying cycle (Paragraph 33, a second phase heat), wherein the flow path (Fig. 1, 107) is in fluid communication with the at least one shelf
Alstat discloses the flow path. Alstat does not teach the path having a valve.
Velardi teaches a valve (Fig. 1, 111) in selective fluid communication with at least one wall of the plurality of walls; and opening a valve disposed on the flow path (Fig. 1, 103) between the lyophilizer (Fig. 1, 101) and the fluid refrigeration system.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Velardi into the design of Alstat. Doing so, would result in control valve being added to the flow path between the lyophilizer and the refrigerator as being taught by Velardi. Both invention of Alstat and Velardi are in the same field of endeavor, Velardi teaches a method of actively control the temperature of the lyophilizer to improve the efficiency of the performance.
In Reference to Claim 3
Alstat discloses performing the secondary drying cycle includes removing a portion of a remaining adsorbed or bound moisture from the target material to complete dehydration. (Paragraph 33, moisture is extracted under increased vacuum)
Claims 2, 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Alstat in view of Velardi as applied to claim 1 above, and further in view of US Patent 7,640,756 to Brahmbhatt.
In Reference to Claim 2
The combination of Alstat and Velardi as applied to Claim 1 teaches a valve on flow path to supply fluid to the lyophilizer chamber.
The combination of Alstat and Velardi as applied to Claim 1 does not teach detail of the flow path in the chamber.
Brahmbhatt teaches pumping thermal fluid into the at least one wall of the plurality of walls (Fig. 3 show the fluid is delivered through the wall of cabinet and sent to a plurality of tube 33 of the shelves)
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Brahmbhatt into the combination of Alstat and Velardi as applied to Claim 1. Doing so, would result in the arrangement of the heat exchanging tube of Brahmbhatt being adopted as the shelf design of Alstat. Both inventions of Alstat and Brahmhbatt are in the same field of endeavor, Brahmhbatt teaches integrated design with high efficiency.
In Reference to Claims 7 and 8
The combination of Alstat, Velardi and Brahmhbatt as applied to Claim 2 teaches valves installed on the flow path.
The combination of Alstat, Velardi and Brahmhbatt as applied to Claim 2 does not teach the detail step of operation.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to determine the operation sequence of the valves since the object of the unit 102 of Alstat is to regulate temperature in the chamber supply heating or cooling fluid to the chamber, obviously, the valve would be open or close based on the temperature in the chamber.
In Reference to Claims 4-6
The combination of Alstat and Velardi as applied to Claim 1 teaches a valve on flow path to supply fluid to the lyophilizer chamber.
The combination of Alstat and Velardi as applied to Claim 1 does not teach detail of the flow path in the chamber.
Brahmbhatt teaches pumping thermal fluid into the at least one wall of the plurality of walls. (Fig. 3 show the fluid is delivered through the wall of cabinet and sent to a plurality of tube 33 of the shelves)
opening the first conduit includes connecting the refrigeration system with the plurality of walls. (As showed in Fig. 3, the cabinet (30) wall is connected the thermal fluid path. The thermal fluid path goes through the wall)
performing the freezing cycle includes pumping the thermal fluid through the at least one shelf. (Fig. 3, the fluid is delivered to shelf via tube 33)
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Brahmbhatt into the combination of Alstat and Velardi as applied to Claim 1. Doing so, would result in the arrangement of the heat exchanging tube of Brahmbhatt being adopted as the shelf design of Alstat. Both inventions of Alstat and Brahmhbatt are in the same field of endeavor, Brahmhbatt teaches integrated design with high efficiency.
Claim 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Alstat, Velardi and Brahmbhatt as applied to claim 2 above, and further in view of US Patent 3,484,946 to Sauer.
In Reference to Claims 9-11
Alstat discloses the fluid conduit delivery thermos fluid to the lyophilizer chamber.
The combination of Alstat, Velardi, and Brahmbhatt as applied to Claim 2 does not teach sensors attached to the fluid conduit.
Sauer teaches the at least one sensor (Fig. 1B, 11) associated with fluid conduit.
analyzing, by one or more processors of the temperature controller (Fig. 1B, 30), the sensor data associated with the temperature of the thermal fluid flowing through the at least one wall of the plurality of walls.
by one or more processors (Fig. 1B, 30), based on an analysis of the sensor data (As showed the regulator control the heat based the thermal couple info), a status or condition associated with the temperature of the thermal fluid flowing through the at least one wall of the plurality of walls.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Sauer into the combination of Alstat, Velardi and Brahmbhatt as applied to Claim 1. Doing so, would result in a thermal couple being attached to the fluid conduit to deliver the thermal status to the controller. Both inventions of Alstat and Sauer are for lyophilizer system with fluid delivery, Sauer teaches a method of accurately controlling the thermal fluid temperature to improve the operational efficiency.
In Reference to Claim 12
Alstat discloses the lyophilizer system comprising the flow path.
Alstat does not teach the control valve in the flow path.
Velardi teaches sending a signal (Fig. 1, controller 109 send signal) to the valve (Fig. 1, 111) to open or close based on the status or condition identified.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Velardi into the design of Alstat. Doing so, would result in control valve being added to the flow path between the lyophilizer and the refrigerator as being taught by Velardi. Both invention of Alstat and Velardi are in the same field of endeavor, Velardi teaches a method of actively control the temperature of the lyophilizer to improve the efficiency of the performance.
Claims 13 -15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Alstat in view of Velardi, Brahmbhatt, and further in view of Sauer.
In Reference to Claims 13 and 15
Alstat discloses a lyophilization system comprising: a plurality of walls defining a chamber (Fig. 1, 101, the cabinet has a plurality of wall);a shelf (Fig. 1, 105) disposed in the chamber; a first conduit (Fig. 1, 107) in fluid communication with at least one of the plurality of walls; a controller (Paragraph 6 discloses that the system is under controlled based on different product requirements, obviously, a controller is inherent) communicatively coupled to the lyophilizer to perform a freezing cycle (Paragraph 33, a pre-frozen process) , a primary drying cycle (Paragraph 33, a first “primary” step), and a secondary drying cycle (Paragraph 33, a second phase heat), the controller comprising: one or more processors (Fig. 1, 211); a memory communicatively coupled to the one or more processors and storing executable instructions that, when executed by the one or more processors, causes the one or more processors to: receive sensor data captured by the at least one sensor; analyze the sensor data to identify a status or condition associated with the temperature of the thermal fluid flowing through the first conduit during at least one of the freezing cycle, primary drying cycle, and secondary drying cycle; and send a signal (As showed in Fig. 1, the controller 211 is coupled to all heating element and flow control devices) to the valve to open or close based on the status or condition identified during the at least one of the freezing cycle, primary drying cycle, and secondary drying cycle.
Alstat does not teach a control valve coupled to the flow path.
Velardi teaches a valve (Fig. 1, 111) operatively coupled to the first conduit;
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Velardi into the design of Alstat. Doing so, would result in control valve being added to the flow path between the lyophilizer and the refrigerator as being taught by Velardi. Both invention of Alstat and Velardi are in the same field of endeavor, Velardi teaches a method of actively control the temperature of the lyophilizer to improve the efficiency of the performance.
The combination of Alstat and Velardi as applied to Claim 16 does not teach a second conduit.
Brahmbhatt teaches a second conduit in fluid communication with the shelf; (Fig. 3, 33)
a network of conduits including the first conduit and the second conduit. (As showed in Fig. 3)
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Brahmbhatt into the combination of Alstat and Velardi as applied to Claim 1. Doing so, would result in the arrangement of the heat exchanging tube of Brahmbhatt being adopted as the shelf design of Alstat. Both inventions of Alstat and Brahmhbatt are in the same field of endeavor, Brahmhbatt teaches integrated design with high efficiency.
The combination of Alstat, Velardi and Brahmhbatt as applied to Claim 16 does not teach a sensor.
Sauer teaches a sensor (Fig. 1B, 13) coupled to the first conduit to capture sensor data associated with a temperature of a thermal fluid flowing through the first conduit;
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Sauer into the combination of Alstat, Velardi and Brahmbhatt as applied to Claim 13. Doing so, would result in a thermal couple being attached to the fluid conduit to deliver the thermal status to the controller. Both inventions of Alstat and Sauer are for lyophilizer system with fluid delivery, Sauer teaches a method of accurately controlling the thermal fluid temperature to improve the operational efficiency.
In Reference to Claim 14
Alstat discloses a refrigeration system (Fig. 1, 104) communicatively coupled to the controller (Fig. 1, 211), wherein the executable instructions cause the one or more processors to send a signal to the refrigeration system to pump a thermal fluid based on a status or condition associated with the temperature of the thermal fluid flowing through the first conduit.
In Reference to Claim 17
Alstat discloses the plurality of walls includes a first sidewall, a second sidewall, a ceiling, and a floor. (As showed in Fig. 1, the chamber is a closed space, therefore, it has a first sidewall, a second sidewall, a ceiling, and a floor)
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Alstat in view of Velardi and further in view of Brahmbhatt and Sauer.
In Reference to Claim 18
Alstat discloses a method of lyophilizing a target material, the method comprising: placing a container with a target material in a lyophilizer of a lyophilization system (Fig. 1, 101, the product shelf), the lyophilization system comprising the lyophilizer (Fig. 1, 101), a refrigeration system (Fig. 1,104) coupled to the lyophilizer, a temperature controller coupled to the refrigeration system (Paragraph 6, Freeze-dry systems are typically operated from a control panel that provides program control over, temperature), and a flow path (Fig. 1, 107) connecting the lyophilizer and the refrigeration system; activating the lyophilizer, wherein the lyophilizer includes a plurality of walls (As showed in Fig. 1, the camber is a closes space, therefore, walls are inherent) defining an interior chamber and at least one shelf (Fig. 1, 105) disposed in the interior chamber; performing a freezing cycle (Paragraph 33, a pre-frozen); performing a primary drying cycle (Paragraph 33, a first “primary” phase); and performing a secondary drying cycle (Paragraph 33, a second phase); capturing,; analyzing, by one or more processors of the temperature controller, the sensor data associated with the temperature of the thermal fluid flowing through the at least one wall of the plurality of walls; identifying, by one or more processors, (Fig. 1, 211) based on an analysis of the sensor data, a status or condition associated with the temperature of the thermal fluid flowing through the at least one wall of the plurality of walls; sending, during at least one of the freezing cycle, the primary drying cycle, and the secondary drying cycle
Alstat does not teach a valve in flow path.
Velardi teaches a signal to a valve (Fig. 1, 111) to open or close based on the status or condition identified, wherein the valve is disposed in a first conduit (Fig. 1, 103) of the flow path, the flow path including the first conduit connected to the at least one wall of the plurality of walls
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Velardi into the design of Alstat. Doing so, would result in control valve being added to the flow path between the lyophilizer and the refrigerator as being taught by Velardi. Both invention of Alstat and Velardi are in the same field of endeavor, Velardi teaches a method of actively control the temperature of the lyophilizer to improve the efficiency of the performance.
The combination of Alstat and Velardi as applied to Claim 18 does not teach a second conduit.
Brahmbhatt teaches a second conduit (Fig. 3, 33) connected to the at least one shelf.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Brahmbhatt into the combination of Alstat and Velardi as applied to Claim 18. Doing so, would result in the arrangement of the heat exchanging tube of Brahmbhatt being adopted as the shelf design of Alstat. Both inventions of Alstat and Brahmhbatt are in the same field of endeavor, Brahmhbatt teaches integrated design with high efficiency.
The combination of Alstat, Velardi and Brahmhbatt as applied to Claim 18 does not teach a sensor.
Sauer teaches by at least one sensor (Fig. 1B, 11/13) associated with a conduit of the flow path,
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings from Sauer into the combination of Alstat, Velardi and Brahmbhatt as applied to Claim 18. Doing so, would result in a thermal couple being attached to the fluid conduit to deliver the thermal status to the controller. Both inventions of Alstat and Sauer are for lyophilizer system with fluid delivery, Sauer teaches a method of accurately controlling the thermal fluid temperature to improve the operational efficiency.
In Reference to Claim 19
Alstat discloses pumping (Fig. 1, 103) a thermal fluid through the flow path during at least one of the freezing cycle, the primary drying cycle, and the secondary drying cycle.
In Reference to Claim 20
The combination of Alstat, Velardi, Brahmhbatt and Sauer as applied to Claim 20 teaches valves installed on the flow path.
The combination of Alstat, Velardi, Brahmhbatt and Sauer as applied to Claim 20 does not teach the detail step of operation.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to determine the operation sequence of the valves since the object of the unit 102 of Alstat is to regulate temperature in the chamber supply heating or cooling fluid to the chamber, obviously, the valve would be open or close based on the temperature in the chamber.
Allowable Subject Matter
Claim 16 is 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.
The following is a statement of reasons for the indication of allowable subject matter: Claim 16 recites fluid conduit is fluidly connected into the wall of the chamber.
Conclusion
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DEMING . WAN
Examiner
Art Unit 3762
/DEMING WAN/Primary Examiner, Art Unit 3762 7/15/26
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