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Claims 5-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/2025.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Itou (US 2011/0113643) in view of Livesey (US 6,194,136).
As for claim 1, Itou discloses a vacuum freeze-drying method that includes steps of injecting a raw material liquid from an injection nozzle (25, abstract, fig. 1) inside a vacuum chamber (10, a), generating frozen particles by self-freezing of the raw material liquid [0001], and drying the generated frozen particles to thereby produce a dry powder ([0039], [0048], powder dissolved into dispersing medium returns to powder when frozen particles are freeze dried), comprising: injecting the raw material liquid from the injection nozzle in a state in which the vacuum chamber is maintained at water vapor partial pressure corresponding to a self-freezing temperature of the raw material liquid ([0001], self-freezing indicates a vacuum chamber maintained at water vapor partial pressure corresponding to a self-freezing temperature of the raw material liquid); and adjusting an injection flow rate of the raw material liquid from the injection nozzle or properties of the injection nozzle such that frozen particles having a maximum diameter of 200 mu.m or less are generated ([0047], properties of the injection nozzle).
Itou discloses the claimed invention except for an injection initial velocity of the raw material liquid from the injection nozzle is 6 m/s or more and 33 m/s or less. However, it would have been obvious to try to inject the raw material liquid from the injection nozzle is 6 m/s or more and 33 m/s or less since the injection velocity of a raw material liquid to be sprayed into lyophilization chamber is a result effective variable which achieves the recognizable result. In this case feeding the raw material at a faster speed increases the product throughput while requiring adequate vacuum partial pressure to self-freeze the raw material liquid. It would be obvious to one of ordinary skill in the art at the time of filing to experiment with the feed rate of the raw material liquid to maximize the throughput of the vacuum chamber.
Itou discloses the claimed invention except for a condition where a cooling velocity from 20° C to -25°C in a case where the injection initial velocity is 13 m/s is 5900 degrees c/s or more. Livesey teaches a condition where a cooling velocity from 20° C to -25°C is 5900 degrees c/s or more (2:45-60) in order to prevent causing structural or functional damage to the dried product. Itou would benefit equally from preventing the structural or functional damage to the dried product. It would have been obvious for one of ordinary skill in the art at the time of filing to modify the dryer as disclosed by Itou with a condition where a cooling velocity from 20° C to -25°C is 5900 degrees c/s or more as taught by Livesey in order to prevent causing structural or functional damage to the dried product.
Examiner notes that the combination of Itou and Livesey fails to disclose or teach the injection initial velocity is 13 m/s. However, as discussed in paragraph 10 above, it would have been obvious to try to injecting the raw material with an initial velocity of 13 m/s or less since the injection velocity of a raw material liquid to be sprayed into lyophilization chamber is a result effective variable which achieves the recognizable result. In this case feeding the raw material at a faster speed increases the product throughput while requiring adequate vacuum partial pressure to self-freeze the raw material liquid. It would be obvious to one of ordinary skill in the art at the time of filing to experiment with the feed rate of the raw material liquid to maximize the throughput of the vacuum chamber.
As for claim 4, Itou discloses an injection pressure of the raw material liquid from the injection nozzle is adjusted in a range of 0.03 MPa or more and 0.7 MPa or less [0047].
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Itou in view of Livesey as to claim 1 above and further in view of Achanta (US 6,627,597).
As for claim 2, Itou discloses the raw material liquid includes a solvent or dispersion medium and a solute dissolved in the solvent or a dispersoid dispersed in the dispersion medium, viscosity of the solvent or dispersion medium or a composite medium of both is viscosity of pure water or more [0039]. Itou discloses the claimed invention except for expressly disclosing the viscosity of the raw material liquid is 5 mPa-s or less. Achanta teaches the viscosity of the raw material liquid is 5 mPa-s or less (4:14-17) which is a viscosity suitable atomization and formation of graded droplets. Itou would benefit equally from using viscosity suitable atomization and formation of graded droplets. It would have been obvious for one of ordinary skill in the art at the time of filing to modify the dryer as disclosed by Itou with the viscosity of the raw material liquid is 5 mPa-s or less as taught by Achanta because 5 mPa-s is a viscosity suitable atomization and formation of graded droplets.
As for claim 3, Itou discloses the water vapor partial pressure is maintained at 50 Pa or less [0047] and discloses the claimed invention except for the solute or dispersoid of the raw material liquid is frozen at a speed that inhibits cells from being damaged and protein and other constituent elements from being deteriorated in vacuum freeze-drying. Livesey teaches the solute or dispersoid of the raw material liquid is frozen at a speed that inhibits cells from being damaged and protein and other constituent elements from being deteriorated in vacuum freeze-drying (2:45-60) in order to prevent causing structural or functional damage to the dried product. Itou would benefit equally from preventing causing structural or functional damage to the dried product. It would have been obvious for one of ordinary skill in the art at the time of filing to modify the dryer as disclosed by Itou with the solute or dispersoid of the raw material liquid is frozen at a speed that inhibits cells from being damaged and protein and other constituent elements from being deteriorated in vacuum freeze-drying as taught by Livesey in order to prevent causing structural or functional damage to the dried product.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN PATRICK MCCORMACK whose telephone number is (571)270-7472. The examiner can normally be reached 9:00 - 1:30 PST.
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/JOHN P MCCORMACK/Primary Examiner, Art Unit 3762