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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, 12, 14 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakagawa (WO2011/102420).
As for claim 1, Nakagawa shows an apparatus for collecting a pharmaceutical product (abstract, powder a common form for a pharmaceutical product thus capable of manufacturing a pharmaceutical product) from a product reservoir of a dryer while the product reservoir of the dryer is under continuous vacuum pressure (p. 4, 6th paragraph), the apparatus comprising: a) a discharge chute (volume between 62 and 70, fig. 1) comprising (i) an internal chamber (63, fig. 1), (ii) a housing substantially surrounding the internal chamber (see sketch below), (iii) a product inlet that fluidly connects the internal chamber of the discharge chute to the product reservoir of the dryer (15, 9, fig. 1), (iv) a vacuum supply inlet that fluidly connects the internal chamber of the discharge chute to a vacuum source (62, 23, 11, 12, 3, fig. 1), (v) a gas inlet that fluidly connects the internal chamber of the discharge chute to a gas source (56, fig. 1), and (vi) a product outlet adapted to provide a fluid connection between the internal chamber of the discharge chute and a primary collection container (20a, 74, fig. 1); b) a vacuum supply control valve that is operable to open or close the vacuum supply inlet on the discharge chute to cause or prevent a suctioning of gas out of the internal chamber of the discharge chute through the vacuum supply inlet by operation of the vacuum source (66, fig. 1); c) a product inlet valve that is operable to open or close the product inlet on the discharge chute to cause or prevent a flow of at least a portion of the pharmaceutical product in the product reservoir of the dryer through the product inlet and into the internal chamber of the discharge chute (61, fig. 1); d) a gas control valve that is operable to open or close the gas inlet on the discharge chute to cause or prevent a flow of gas into the internal chamber of the discharge chute through the gas inlet by operation of the gas source (55a, 54a, fig. 1); and e) a collection control valve that is operable to open or close the product outlet on the internal chamber of the discharge chute to cause or prevent a flow of at least some of the pharmaceutical product inside of the internal chamber of the discharge chute through the product outlet and into the primary collection container (72, fig. 1).
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As for claim 6, Nakagawa shows the discharge chute further comprises a flow diverter assembly, the flow diverter assembly comprising: a) a common channel (20a, fig. 1); b) a primary exit channel adapted to provide a fluid connection between the common channel and the primary collection container, and configured so that the pharmaceutical product flowing into the primary exit channel from the common channel will flow only into the primary collection container (70, fig. 1, and conduit downstream of 72); c) an auxiliary exit channel, adapted to provide a fluid connection between the common channel and an auxiliary collection container (17, 19, fig. 1), and configured so that the pharmaceutical product flowing into the auxiliary exit channel from the common channel will flow only into the auxiliary collection container (70, fig. 1); a flow diverter, located at a nexus between the common channel, the primary exit channel and the auxiliary exit channel, the flow diverter being configured to direct the pharmaceutical product passing through the common channel into the primary exit channel, or into the auxiliary exit channel, or into both the primary exit channel and the auxiliary exit channel, depending on an orientation of the flow diverter (72, fig. 1); and e) a flow diverter controller, mechanically connected to the flow diverter, which is operable to control the orientation of the flow diverter (80, fig. 1, p. 8, fifth full paragraph).
As for claim 12, Nakagawa shows a discharge monitoring system, attached to the housing of the discharge chute, configured to provide a visual indication of a quantity or a physical state of the pharmaceutical product located inside the internal chamber of the discharge chute (8, 24, fig. 1, p. 4, second paragraph, control panel capable of providing a visual display).
As for claim 14, Nakagawa shows a thin- film evaporator, an agitated thin-film evaporator, a wiped film evaporator, a rotary dryer, a spray dryer, a conical dryer, a pressure filter, a fluid bed, or a combination of two or more thereof (2, fig. 1, conical dryer).
As for claim 18, Nakagawa shows an airlock assembly for collecting solids from a product reservoir of a drying device while the product reservoir remains under continuous vacuum pressure, the airlock assembly comprising: a) a discharge chute comprising an airtight internal chamber (volume between 62 and 70, fig. 1), a housing substantially surrounding the airtight internal chamber (see sketch above), a vacuum supply inlet that fluidly connects the airtight internal chamber of the discharge chute to a vacuum source (12, fig. 1), a solids inlet that fluidly connects the airtight internal chamber to the product reservoir (61, fig. 1), a gas inlet that fluidly connects the airtight internal chamber to a gas source (55a, fig. 1), and a solids outlet that fluidly connects the airtight internal chamber to a collection container (20a, 74, fig. 1); b) a vacuum supply control valve, attached to the vacuum supply inlet, that is operable to open and close the vacuum supply inlet (66, fig. 1), and thereby permit the vacuum source to suction a sufficient amount of gas from the airtight internal chamber to create inside the airtight internal chamber a pressure level that is less than or substantially equal to a second pressure level inside the product reservoir of the drying device (9, 66, 12, reservoir at ambient pressure, negative pressure applied via 12, fig. 1); c) a product inlet valve, attached to the solids inlet, that is operable to open and close the solids inlet while the pressure level inside the airtight internal chamber of the discharge chute is less than or substantially equal to the second pressure level inside the product reservoir, and thereby cause a gravity-induced flow of at least a portion of the solids from the product reservoir to the airtight internal chamber of the discharge chute through the solids inlet (61, fig. 1); d) a gas control valve, attached to the gas inlet, that is operable to open and close the gas inlet to permit the gas source to force gas into the airtight internal chamber of the discharge chute to bring the pressure level inside the airtight internal chamber to an ambient pressure level (55a, fig. 1); and e) a collection control valve, attached to the solids outlet, that is operable to open and close the solids outlet while the pressure level of the airtight internal chamber is at the ambient pressure level (vacuum applied to 63, ambient pressure returned via gas inlet 56), and thereby permit at least some of the solids inside of the airtight internal chamber of the discharge chute to flow out of the airtight internal chamber and into the collection container via the solids outlet (72, fig. 1).
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.
Claim 2, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Nakagawa as applied to claim 1 and 6 above, and further in view of Plitzko (US 2014/0237846).
As for claim 2, Nakagawa discloses the claimed invention except for a flexible isolator, attached to the discharge chute, configured to enclose the fluid connection between the product outlet on the discharge chute and the primary collection container, and thereby substantially isolate the fluid connection between the product outlet and the primary collection container from a surrounding environment. Plitzko teaches a flexible isolator, attached to the discharge chute, configured to enclose the fluid connection between the product outlet on the discharge chute and the primary collection container, and thereby substantially isolate the fluid connection between the product outlet and the primary collection container from a surrounding environment ([0035], tubing is known to be flexible) in order to provide hermetic closure to an enclosed volume. Nakagawa would benefit equally from providing hermetic closure to an enclosed volume. 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 Nakagawa with a flexible isolator, attached to the discharge chute, configured to enclose the fluid connection between the product outlet on the discharge chute and the primary collection container, and thereby substantially isolate the fluid connection between the product outlet and the primary collection container from a surrounding environment as taught by Plitzko in order to provide hermetic closure to an enclosed volume.
As for clam 7, Nakagawa discloses the claimed invention except for a flexible isolator, attached to the flow diverter assembly, configured to enclose the fluid connection between the primary exit channel and the primary collection container, and thereby substantially isolate the fluid connection between the primary exit channel and the primary collection container from a surrounding environment. Plitzko teaches a flexible isolator, attached to the flow diverter assembly, configured to enclose the fluid connection between the primary exit channel and the primary collection container, and thereby substantially isolate the fluid connection between the primary exit channel and the primary collection container from a surrounding environment ([0035], tubing is known to be flexible) in order to provide hermetic closure to an enclosed volume. Nakagawa would benefit equally from providing hermetic closure to an enclosed volume. 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 Nakagawa with a flexible isolator, attached to the flow diverter assembly, configured to enclose the fluid connection between the primary exit channel and the primary collection container, and thereby substantially isolate the fluid connection between the primary exit channel and the primary collection container from a surrounding environment as taught by Plitzko in order to provide hermetic closure to an enclosed volume.
As for claim 8, Nakagawa discloses the claimed invention except for the flexible isolator attached to the flow diverter assembly is further configured to enclose and surround the fluid connection between the auxiliary exit channel and the auxiliary collection container, and thereby substantially isolate from the surrounding environment both (i) the fluid connection between the primary exit channel of the flow diverter assembly and the primary collection container, and (ii) the fluid connection between the auxiliary exit channel of the flow diverter assembly and the auxiliary collection container. Plitzko teaches the flexible isolator attached to the flow diverter assembly is further configured to enclose and surround the fluid connection between the auxiliary exit channel and the auxiliary collection container, and thereby substantially isolate from the surrounding environment both (i) the fluid connection between the primary exit channel of the flow diverter assembly and the primary collection container, and (ii) the fluid connection between the auxiliary exit channel of the flow diverter assembly and the auxiliary collection container ([0035], tubing is known to be flexible) in order to provide hermetic closure to an enclosed volume. Nakagawa would benefit equally from providing hermetic closure to an enclosed volume. 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 Nakagawa with the flexible isolator attached to the flow diverter assembly is further configured to enclose and surround the fluid connection between the auxiliary exit channel and the auxiliary collection container, and thereby substantially isolate from the surrounding environment both (i) the fluid connection between the primary exit channel of the flow diverter assembly and the primary collection container, and (ii) the fluid connection between the auxiliary exit channel of the flow diverter assembly and the auxiliary collection container as taught by Plitzko in order to provide hermetic closure to an enclosed volume.
Examiner notes that Plitzko does not expressly teach use of the flexible isolator is further configured to enclose and surround the fluid connection between the auxiliary exit channel and the auxiliary collection container. However, a second isolator operating similarly to the first isolator is no more than an obvious duplication of parts necessitated by design choice. In this case, the teaching of Plitzko would work equally well for the exit channel or the auxiliary exit channel and is simply a matter of providing hermetic closure to an enclosed volume
Allowable Subject Matter
Claim 31 is allowed.
Reasons for Allowance
Claim 31 includes allowable subject matter because prior art could not be found to disclose a gas control module, stored in the memory and communicatively coupled to the discharge monitoring system and the gas inlet solenoid valve, the gas control module having program instructions that, when executed by the microprocessor, will cause the microprocessor to automatically open the gas inlet solenoid valve of the discharge chute in response to the product inlet module closing the product inlet solenoid valve, and thereby permit the gas source to admit gas into the internal chamber of the discharge chute through the gas inlet solenoid valve until the pressure gauge indicates that the pressure inside the internal chamber of the discharge chute has reached an ambient pressure level with all of the limitations of independent claim 33. The closest prior art is found in Nakagawa. However, modifying Nakagawa to include the above limitation would destroy the Nakagawa reference which requires that the gas inlet valve is opened at the same time the vacuum valve is open. The conditional limitation of permitting the gas source to admit gas until the pressure gauge indicates that the pressure has reached an ambient pressure level would not be achieved.
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