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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 01/27/2026 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 27 January 2026.
Claims 1-4, 7-8, 13-15, 17, 20-21, 26-28, 31-33, 36, 39, and 43-45 are pending.
Claims 26-28, 36, 39, and 43-44 are withdrawn.
Claims 5-6, 9-12, 16, 18-19, 22-25, 29-30, 34-35, 37-38, and 40-42 are cancelled.
Claim 45 is newly added.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim recites “maintaining maintain” and should be amended to recite “maintain”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The claim recites “wherein the missing vessel including” and should be amended to recite “wherein the mixing vessel includes”. Appropriate correction is required.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“an agitator for mixing the solvent and the dry powder together” as in Claim 1.
“a discharge device for facilitating discharge of the dry powder mixture from the mixing chamber” as in Claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“protrusions/blades which reach down into the mixing chamber” as in Fig. 10 of Applicant’s instant drawings, and equivalents thereof.
“a pump, a positive pressure source, or a negative pressure source, such as a vacuum” as in para. [0010] of Applicant’s instant pre-grant publication US 2022/0250013 A1, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 7-8, 13, 15, 17, 20-21, 31, 33, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Tokita et al. (US 2008/0175936 A1), referred to hereinafter as “Tokita”, in view of Terentiev et al. (US 2002/0105856 A1), referred to hereinafter as “Terentiev”, and Barton (US PAT 8,740,187 B2), referred to hereinafter as “Bartin”.
Regarding Claim 1, Tokita teaches a containment system for mixing a solvent with a dry powder without exposing the dry powder to a surrounding atmosphere, wherein the dry powder is supplied to the containment system in a dry powder container having a sealed connection port ([0079]: “…preferably the powder of a material that has been previously prepared and packed in a sealed container externally to the system should be used.”), the containment system comprising:
a dual compartment isolator 1 for safely removing the dry powder from the dry powder container (Fig. 2), the dual compartment isolator including:
a staging compartment 20 (Fig. 1 and [0056]: “With reference to FIGS. 1 and 2, the sealed first housing 21 is constructed from such an outer wall (as reinforced with a frame, for example) that can shield the pre-process chamber 20 defined by the first housing 21 against the outside world completely, as pointed above…”),
a charging compartment 30 (Fig. 1 and [0055]: “…a sealed second housing 31 defining a sintering process chamber 30 in which a vacuum chamber of a pulse energization and pressure sintering machine is situated…”),
a raw material entry port 222 (Fig. 2), connected to the staging compartment 20, the raw material entry port 222 being configured to isolate the dry powder container from the surrounding atmosphere while transferring the dry powder container into the staging compartment 20 (See para. [0056], which discusses negative pressure in the system and discloses “This loading housing 22 also has a structure, such as a cylindrical structure, that is sufficiently robust not to be broken when the interior of a material loading chamber 220 is subject to a certain level of negative pressure (e.g., 10 Pa).” – As this chamber is subject to negative pressure, it is fully capable of isolating a dry powder container contained therein from the atmosphere.),
a partition 25 separating the staging compartment 20 from the charging compartment 30 (Figs. 1 and 2, and [0059]: “The first housing 21 and the second housing 31 are interconnected via a communication pipe 25…”),
a sealable opening 26 in the partition 25, the sealable opening configured for re-sealing after breaking the seal and permitting the dry powder container to be transferred out of the staging compartment 20 and into the charging compartment 20 without exposing the dry powder to the surrounding atmosphere (Figs. 1 and 2, and [0059]: “A gate valve 26 is disposed in the middle of the communication pipe 25, serving as an air tight shut-off system having a known structure. The gate valve 26 is adapted so that when placed in a closing position, the gate valve 26 blocks communication between the pre-process chamber 20 defined by the first housing 21 and the sintering process chamber 30 defined by the second housing 31 in an air tight condition, and when placed in an opening position, the gate valve 26 permits communication therebetween.”),
a negative cascading pressure controller configured to generate and continuously maintain negative pressure in both the staging compartment 20 and the charging compartment 30, such that a negative pressure gradient is present at all times during transfer of dry powder and mixing operations ([0029]: “…an automatic control unit for controlling automatically an operation of the systems and means.” – [0081]: “although the above description of the embodiment has been given with reference to the housing 21, 31 which are provided with the glove assembly, alternatively only the automated equipment as described above may be arranged in the housing 21, 31 but the glove assembly should be omitted, to thereby allow the sintering process to be carried out in a fully automated manner.” – Figs. 6 and 7 further detail the pressure regulation assembly of the chambers 220, 20, and 30. – see further paras. [0069-0070] discussing the vacuum systems for keeping the chambers at various vacuum. – See para. [0013]: “a vacuum chamber allowing for the sintering process to be carried out under a vacuum atmosphere OR an inert gas atmosphere”. – [0062]: “sintering chamber C is adapted to be controlled to have a vacuum atmosphere inside thereof by a system” – See also paras. [0069-0070] discussing various vacuum levels in the different chambers. – Examiner further notes that the controller recited as a ”controller for” merely requires a general controller. Applicant may wish to amend the claim to recite “a controller configured to” so as to positively require the process recited thereto. However, at present, the process of “generating and continuously maintaining” negative pressure is drawn to a process not afforded patentable weight in a device claim.); and
a mixing vessel 41 (Fig. 3) for mixing the dry powder with the solvent, the mixing vessel including:
a mixing chamber (the “bowl” of the bowl mill), a solids charging port fluidly connecting the mixing chamber (the upper opening of the bowl mill), an agitator for mixing the solvent and the dry powder together in the mixing chamber to produce a solvent and dry powder mixture (the grinding action of the bowl mill) ([0060]: “In the pre-process chamber 20 defined by the first housing 21, such units as a bowl mill 41 of a known structure are arranged for mixing and grinding at least one material (granular or powdered material) and thereby preparing it into a powder of a material having a desired nano-sized grain diameter…”) – A bowl mill is defined as a type of pulverizer that uses a rotating bowl and grinding rolls to reduce material size and mix materials together.),
as in Claim 1.
Further regarding Claim 1, Tokita does not specifically teach a containment valve, located inside the charging compartment, the containment valve having a fitting suitably configured to mate with a sealed connection port on the dry powder material container, as in Claim 1.
However, Barton teaches a containment valve assembly 10 comprising a container 34 having a containment valve assembly 10 comprising a split butterfly valve ([col. 3, line 3] and Figs 2a and 2b) for the handling of solid-state powders and granular material between containers 34 via a pipe 36 (Fig. 1) so as to ensure sterile conditions on product contact parts ([col. 4, line 57]), thereby reducing errors related to contamination.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Tokita further comprising a containment valve, located inside the second compartment, the containment valve having a fitting suitably configured to mate with a sealed connection port on the dry powder material container, such as suggested by Barton, so as to ensure sterile conditions on product contact parts, thereby reducing errors related to contamination.
Further regarding Claim 1, Tokita does not specifically teach a solvent inlet formed in a wall of the mixing vessel and fluidly connected to the mixing chamber, the solvent inlet being configured to receive and introduce a liquid solvent into the mixing chamber; and an outlet valve for discharging the solvent and dry powder mixture from the mixing chamber, as in Claim 1.
However, Terentiev teaches an apparatus and method for mixing materials sealed in a container under sterile conditions, said apparatus comprising a container having an upper inlet 120A for receiving solvent for reconstituting a powder already contained therein, and a lower outlet 120B for outputting a mixture of reconstituted powder ( Fig. 2 and [0019]: “The tube 140 in this embodiment extends completely through the bag 120 through two seals 118 and 119 positioned respectively at the top and bottom ends of the bag 120. As before the seal 118 located at the neck 120A while seal 119 is located at the bottom neck 120B of the bag 120 and the static exit seal 164 is located at the opening in the foot of the container 120B.”), wherein said inlet/outlet are sealed, and wherein a stir rod penetrates the inlet/outlet but maintains said seal ([0009]). This arrangement allows for input, discharge, and mixing of sample within a sealed container such that the interior contents of the container remain sterile and uncontaminated ([0003]). It is further noted that Terentiev is similarly interested in mixing a contained powder with an added solvent ([0004]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the bowl mill of the apparatus of Tokita to include a solvent inlet formed in a wall of the mixing vessel and fluidly connected to the mixing chamber, the solvent inlet being configured to receive and introduce a liquid solvent into the mixing chamber; and an outlet valve for discharging the solvent and dry powder mixture from the mixing chamber, such as suggested by Terentiev, so as to allow for input, discharge, and mixing of sample within a sealed container such that the interior contents of the container remain sterile and uncontaminated; and would have a reasonable expectation of success therein.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Tokita/Terentiev/Barton does not specifically teach a second solvent inlet formed in a wall of the mixing vessel and fluidly connected to the mixing chamber, the second solvent inlet being configured to receive and introduce a second liquid solvent into the mixing chamber independently of the first solvent inlet, as in Claim 7.
However, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Herein, one of ordinary skill in the art would find it obvious to provide additional solvent inlets for providing additional solvent, as this would achieve a predictable result, and would have a reasonable expectation of success therein.
Regarding Claim 8, the prior art meets the limitations of Claim 7 as discussed above. Further, Tokita/Terentiev/Barton does not specifically teach the second solvent as an anti- solvent, as in Claim 8.
However, Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the apparatus of Tokita/Terentiev/Barton is fully capable of use with an anti-solvent.
Regarding Claim 13, Tokita teaches a containment system for mixing a solvent with a dry powder without exposing the dry powder to surrounding atmosphere, wherein the dry powder is supplied to the containment system in a dry powder container having a sealed connection port ([0079]: “…preferably the powder of a material that has been previously prepared and packed in a sealed container externally to the system should be used.”), the containment system comprising:
a dual compartment flexible isolator for safely removing the dry powder from the dry powder container (Fig. 2), the dual compartment flexible isolator including:
a top portion 21/31 and a bottom portion 511, the top portion 21/31 and the bottom portion 511 being linked together by one or more side walls (Fig. 2: The bottom walls of the top portion housings 21 and 31 meet with the surface of the table 511, the bottom portion.), forming an interior portion (Fig. 1: chambers 20 and 30), the interior portion comprising an internal wall 25 that is sealingly connected to the side walls 215 and 311 (Fig. 2) and that separates the interior portion into a first compartment 20 and a second compartment 30 ([0055]: “A nano-precision sintering system 1 of this embodiment comprises a sealed first housing 21 defining a pre-process chamber 20 serving for a series of operations in the pre-process covering from mixing and grinding of a powder of a material to filling a sintering mold with the prepared powder of a material and a sealed second housing 31 defining a sintering process chamber 30 in which a vacuum chamber of a pulse energization and pressure sintering machine is situated, both of which are arranged as illustrated.”);
at least one glove 24 formed in at least one of the side walls, said at least one glove 24 extending into the interior portion of the dual compartment flexible isolator (Fig. 2 and [0058]: “Each glove assembly 24, as shown in FIG. 4, comprises an annular attachment member 241 fixed to a loading port 215 in the front wall 212 of the housing 21, an annular holding member 242 adapted to be fixed to the attachment member 241 with a plurality of setscrews 243 (only one setscrew is illustrated in FIG. 4[A]), and a glove whose opening region is fixed by the attachment member 241 and the holding member 242.”); and
a first sealable opening 222 formed in one of the side walls 211 for permitting a dry powder material container to be placed inside the first compartment 20 (Fig. 1 and [0072]: “Then, the cover 222 disposed in the opening end of the loading chamber 22 is opened by using hands, and granules or powder of a material, for example, SiC or Al2O3, intended to use in the sintering should be previously loaded in the material loading chamber 220 as it is packed in a container. After the loading of the material into the material loading chamber 220 having been completed, the cover 222 is closed manually to seal the material loading chamber in the air tight condition.”);
a second sealable opening 26 formed in the internal wall 215/311 for permitting the dry powder container to be moved from the first compartment 20 into the second compartment 30 without exposing the dry powder to surrounding atmosphere (Figs. 1 and 2, and [0059]: “A gate valve 26 is disposed in the middle of the communication pipe 25, serving as an air tight shut-off system having a known structure. The gate valve 26 is adapted so that when placed in a closing position, the gate valve 26 blocks communication between the pre-process chamber 20 defined by the first housing 21 and the sintering process chamber 30 defined by the second housing 31 in an air tight condition, and when placed in an opening position, the gate valve 26 permits communication therebetween.”);
a negative cascading pressure controller configured to generate and continuously maintain negative pressure in both the staging compartment 20 and the charging compartment 30, such that a negative pressure gradient is present at all times during transfer of dry powder and mixing operations ([0029]: “…an automatic control unit for controlling automatically an operation of the systems and means.” – [0081]: “although the above description of the embodiment has been given with reference to the housing 21, 31 which are provided with the glove assembly, alternatively only the automated equipment as described above may be arranged in the housing 21, 31 but the glove assembly should be omitted, to thereby allow the sintering process to be carried out in a fully automated manner.” – Figs. 6 and 7 further detail the pressure regulation assembly of the chambers 220, 20, and 30. – See also para. [0013]: “a vacuum chamber allowing for the sintering process to be carried out under a vacuum atmosphere or an inert gas atmosphere”. – [0062]: “sintering chamber C is adapted to be controlled to have a vacuum atmosphere inside thereof by a system” – See also paras. [0069-0070] discussing various vacuum levels in the different chambers. – Examiner further notes that the controller recited as a ”controller for” merely requires a general controller. Applicant may wish to amend the claim to recite “a controller configured to” so as to positively require the process recited thereto. However, at present, the process of “generating and continuously maintaining” negative pressure is drawn to a process not afforded patentable weight in a device claim.); and
a mixing vessel 41 (Fig. 3) for mixing the dry powder with the solvent, the mixing vessel including:
a mixing chamber (the “bowl” of the bowl mill), a solids charging port fluidly connecting the mixing chamber (the upper opening of the bowl mill), an agitator for mixing the solvent and the dry powder together in the mixing chamber to produce a solvent and dry powder mixture (the grinding action of the bowl mill) ([0060]: “In the pre-process chamber 20 defined by the first housing 21, such units as a bowl mill 41 of a known structure are arranged for mixing and grinding at least one material (granular or powdered material) and thereby preparing it into a powder of a material having a desired nano-sized grain diameter…”) – A bowl mill is defined as a type of pulverizer that uses a rotating bowl and grinding rolls to reduce material size and mix materials together.),
as in Claim 13.
Further regarding Claim 13, Tokita does not specifically teach a containment valve, located inside the second compartment, the containment valve having a fitting suitably configured to mate with the sealed connection on the dry powder container, as in Claim 13.
However, Barton teaches a containment valve assembly 10 comprising a container 34 having a containment valve assembly 10 comprising a split butterfly valve ([col. 3, line 3] and Figs 2a and 2b) for the handling of solid-state powders and granular material between containers 34 via a pipe 36 (Fig. 1) so as to ensure sterile conditions on product contact parts ([col. 4, line 57]), thereby reducing errors related to contamination.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Tokita further comprising a containment valve, located inside the second compartment, the containment valve having a fitting suitably configured to mate with the sealed connection on the dry powder container, such as suggested by Barton, so as to ensure sterile conditions on product contact parts, thereby reducing errors related to contamination.
Further regarding Claim 13, Tokita does not specifically teach a solvent inlet formed in a wall of the mixing vessel and fluidly connected to the mixing chamber, the solvent inlet being configured to receive and introduce a liquid solvent into the mixing chamber, as in Claim 13.
However, Terentiev teaches an apparatus and method for mixing materials sealed in a container under sterile conditions, said apparatus comprising a container having an upper inlet 120A for receiving solvent for reconstituting a powder already contained therein, and a lower outlet 120B for outputting a mixture of reconstituted powder ( Fig. 2 and [0019]: “The tube 140 in this embodiment extends completely through the bag 120 through two seals 118 and 119 positioned respectively at the top and bottom ends of the bag 120. As before the seal 118 located at the neck 120A while seal 119 is located at the bottom neck 120B of the bag 120 and the static exit seal 164 is located at the opening in the foot of the container 120B.”), wherein said inlet/outlet are sealed, and wherein a stir rod penetrates the inlet/outlet but maintains said seal ([0009]). This arrangement allows for input, discharge, and mixing of sample within a sealed container such that the interior contents of the container remain sterile and uncontaminated ([0003]). It is further noted that Terentiev is similarly interested in mixing a contained powder with an added solvent ([0004]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the bowl mill of the apparatus of Tokita to include a solvent inlet for admitting the solvent into the mixing chamber; and an outlet valve for discharging the solvent and dry powder mixture from the mixing chamber, such as suggested by Terentiev, so as to allow for input, discharge, and mixing of sample within a sealed container such that the interior contents of the container remain sterile and uncontaminated; and would have a reasonable expectation of success therein.
Regarding Claim 15, the prior art meets the limitations of Claim 13 as discussed above. Further, Tokita teaches the containment system discussed above wherein the dual compartment flexible isolator 1 comprises four side walls (Fig. 1: sidewalls 211, 311, 215, and 315, for example.), as in Claim 15.
Regarding Claim 17, the prior art meets the limitations of Claim 13 as discussed above. Further, Tokita does not specifically discuss the containment system wherein the negative cascading pressure controller continuously maintains a first negative pressure differential between the outside of the dual compartment flexible isolator and the first compartment of about 0.01 to about 0.5 inches of water (first negative pressure differential as referenced from the outside of the dual compartment flexible isolator), and a second negative pressure differential between the first compartment and the second compartment of about 0.01 to about 0.5 inches of water (second negative pressure differential referenced from the inside of the first compartment of the dual compartment flexible isolator), as in Claim 17.
However, this recitation is drawn to a process recitation (“the negative cascading pressure controller provides…”). As the claims are drawn to a device, such process recitation is not afforded patentable weight. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).
Herein, given that Tokita discusses maintaining the compartments of the taught containment system at specific pressure (para. [0056]), the containment system of Tokita is fully capable of providing a first negative pressure differential between the outside of the dual compartment flexible isolator and the first compartment of about 0.01 to about 0.5 inches of water, and a second negative pressure differential between the first compartment and the second compartment of about 0.01 to about 0.5 inches of water, as in Claim 17.
See also para. [0013]: “a vacuum chamber allowing for the sintering process to be carried out under a vacuum atmosphere or an inert gas atmosphere”. – [0062]: “sintering chamber C is adapted to be controlled to have a vacuum atmosphere inside thereof by a system” – See also paras. [0069-0070] discussing various vacuum levels in the different chambers.
Regarding Claim 20, the prior art meets the limitations of Claim 13 as discussed above. Further, Tokita teaches the containment system discussed above further comprising an additional port attached to the first compartment or the second compartment of the dual compartment isolator, the additional port being configure for fluidly connecting the dual compartment flexible isolator to another device (Fig. 6 shows the gas circulating and refining system of the isolator, wherein the piping system 66 is shown as connecting to the first chamber 20 and the second chamber 30 via ports, wherein this connects the chambers to various other devices such as the pump 63 and the refining unit 61. – Further note that this gaseous system of Tokita comprises a “fluid connection” as gas is a fluid (takes the shape of its container).), as in Claim 20.
Regarding Claim 21, the prior art meets the limitations of Claim 20 as discussed above. Further, Tokita teaches the containment system discussed above wherein said additional port may be selectively connected to:
a vacuum source 63 (Fig. 6 and para. [0068]), and
a source of inert gas 61, whereby air within said dual compartment flexible isolator may be replaced by inert gas (Fig. 6 and [0068]: “The gas circulating and refining system selectively feeds an inert gas, for example, argon gas…”),
as in Claim 21.
Regarding Claim 31, Tokita teaches a containment system for mixing a solvent with a dry powder without exposing the dry powder to a surrounding atmosphere, comprising:
A primary containment subsystem comprising a mixing vessel 41 ([0060]: “In the pre-process chamber 20 defined by the first housing 21, such units as a bowl mill 41 of a known structure are arranged for mixing and grinding at least one material (granular or powdered material) and thereby preparing it into a powder of a material having a desired nano-sized grain diameter…”),
a dual compartment flexible isolator 1 (Fig. 1 shows the two compartments 20 and 30 of the isolator.), and
a negative cascading pressure controller configured to continuously maintain a negative pressure gradient in both the primary containment subsystem and the secondary containment subsystem, such that a negative pressure gradient is present at all times during a mixing operation in the mixing vessel ([0029]: “…an automatic control unit for controlling automatically an operation of the systems and means.” – [0081]: “although the above description of the embodiment has been given with reference to the housing 21, 31 which are provided with the glove assembly, alternatively only the automated equipment as described above may be arranged in the housing 21, 31 but the glove assembly should be omitted, to thereby allow the sintering process to be carried out in a fully automated manner.” – Figs. 6 and 7 further detail the pressure regulation assembly of the chambers 220, 20, and 30. -- See also para. [0013]: “a vacuum chamber allowing for the sintering process to be carried out under a vacuum atmosphere or an inert gas atmosphere”. – [0062]: “sintering chamber C is adapted to be controlled to have a vacuum atmosphere inside thereof by a system” – See also paras. [0069-0070] discussing various vacuum levels in the different chambers.),
as in Claim 31.
Further regarding Claim 31, Tokita does not specifically teach the containment system discussed above comprising a secondary containment subsystem, coupled to the primary containment subsystem, the secondary containment subsystem comprising a containment valve with a fitting configured to accept a sealed connection port on a dry powder container, and a connection to solids charging port of a mixing vessel, as in Claim 31.
However, Barton teaches a containment valve assembly 10 comprising a container 34 having a containment valve assembly 10 comprising a split butterfly valve ([col. 3, line 3] and Figs 2a and 2b) for the handling of solid-state powders and granular material between containers 34 via a pipe 36 (Fig. 1) so as to ensure sterile conditions on product contact parts ([col. 4, line 57]), thereby reducing errors related to contamination.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Tokita further comprising a secondary containment subsystem, coupled to the primary containment subsystem, the secondary containment subsystem comprising a containment valve with a fitting configured to accept a sealed connection port on a dry powder container, and a connection to solids charging port of a mixing vessel, such as suggested by Barton, so as to ensure sterile conditions on product contact parts, thereby reducing errors related to contamination.
Additionally, as discussed above, Terentiev teaches a powder container comprising an opening for interfacing with a receiving container, wherein this arrangement allows for sterile transfer of reagents and minimizes risk of contamination.
Regarding Claim 33, the prior art meets the limitations of Claim 31 as discussed above. Further, Tokita teaches the containment system discussed above wherein the dual compartment flexible isolator comprises:
a staging compartment 20 (Fig. 1 and [0056]: “With reference to FIGS. 1 and 2, the sealed first housing 21 is constructed from such an outer wall (as reinforced with a frame, for example) that can shield the pre-process chamber 20 defined by the first housing 21 against the outside world completely, as pointed above…”),
a charging compartment 30 (Fig. 1 and [0055]: “…a sealed second housing 31 defining a sintering process chamber 30 in which a vacuum chamber of a pulse energization and pressure sintering machine is situated…”),
a raw material entry port 222 (Fig. 2), connected to the staging compartment 20, the raw material entry port 222 being configured to isolate the dry powder container from the surrounding atmosphere while transferring the dry powder container into the staging compartment 20 (See para. [0056], which discusses negative pressure in the system and discloses “This loading housing 22 also has a structure, such as a cylindrical structure, that is sufficiently robust not to be broken when the interior of a material loading chamber 220 is subject to a certain level of negative pressure (e.g., 10 Pa).” – As this chamber is subject to negative pressure, it is fully capable of isolating a dry powder container contained therein from the atmosphere.),
a partition 25 separating the staging compartment 20 from the charging compartment 30 (Figs. 1 and 2, and [0059]: “The first housing 21 and the second housing 31 are interconnected via a communication pipe 25…”),
a sealable opening 26 in the partition 25, the sealable opening configured for re-sealing after breaking the seal and permitting the dry powder container to be transferred out of the staging compartment 20 and into the charging compartment 20 without exposing the dry powder to the surrounding atmosphere (Figs. 1 and 2, and [0059]: “A gate valve 26 is disposed in the middle of the communication pipe 25, serving as an air tight shut-off system having a known structure. The gate valve 26 is adapted so that when placed in a closing position, the gate valve 26 blocks communication between the pre-process chamber 20 defined by the first housing 21 and the sintering process chamber 30 defined by the second housing 31 in an air tight condition, and when placed in an opening position, the gate valve 26 permits communication therebetween.”),
as in Claim 33.
Regarding Claim 45, the prior art meets the limitations of Claim 1 as discussed above. Further, Tokita does not specifically teach the containment system discussed above wherein the mixing vessel is located external to the dual compartment isolator, as in Claim 45.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C).
Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of the mixing vessel with respect to the dual compartment isolator would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the mixing vessel.
The mixing vessel of Tokita is commensurately loaded and emptied through sterile valve ports and is thereby is not required to be entirely within the isolator to maintain sterility. One of ordinary skill in the art would find it an obvious matter of design choice to merely move the mixing vessel at least partially external to the isolator while the valves remain within/in valved fluid communication the isolator, thereby remaining to serve the identical function of receiving sterile material.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Tokita in view of Terentiev and Barton, as applied to Claims 1, 7-8, 13, 15, 17, 20-21, 31, 33, and 45 above, and in further view of Benitez et al. (US 2017/0283792 A1), referred to hereinafter as “Benitez”.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Tokita/Terentiev/Barton does not specifically teach the containment system discussed above further comprising a discharge device for facilitating discharge of the dry powder mixture from the mixing chamber via the outlet valve, as in Claim 2.
However, Benitez teaches a respective container wherein a sample is removed from the container via a negative pressure provided by a pump (Benitez Claims 1 and 27 – See also para. [0008]), wherein this arrangement provides for active, controllable sample flow, thereby accelerating content removal and ensuring full extraction of the contents.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Tokita/Terentiev/Barton to include a discharge device for facilitating discharge of the dry powder mixture from the mixing chamber via the outlet valve, such as suggested by Benitez, so as to provide for active, controllable sample flow, thereby accelerating content removal and ensuring full extraction of the contents; and would have a reasonable expectation of success therein.
Regarding Claim 3, the prior art meets the limitations of Claim 2 as discussed above. Further, as the “discharge device” of Claim 2 is taught by Benitez as a pump, one of ordinary skill in the art would find it obvious that when modifying the device of Tokita/Terentiev/Barton with the discharge device of Benitez, that the discharge device be embodied as a pump as in Benitez para. [0008]. Thus, the obvious combination of Tokita/Terentiev/Barton with Benitez meets the Claim 3 limitation of “wherein the discharge device comprises a pump, a positive pressure source, or a negative pressure source”, as in Claim 3.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tokita in view of Terentiev and Barton, as applied to Claims 1, 7-8, 13, 15, 17, 20-21, 31, 33, and 45 above, and in further view of Nara et al. (US 2003/0106951 A1), referred to hereinafter as “Nara”.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Tokita/Terentiev/Barton does not specifically teach the containment system discussed above wherein the containment valve in the charging compartment comprises a split butterfly valve, as in Claim 4.
However, Nara teaches a respective powder processing apparatus comprising a split butterfly valve provided to provide continuous negative pressure so that pulverized materials can be collected and sealed without contact with outside air ([0040]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Tokita/Terentiev/Barton wherein the containment valve in the charging compartment comprises a split butterfly valve, such as suggested by Nara, so as to provide continuous negative pressure so that pulverized materials can be collected and sealed without contact with outside air; and would have a reasonable expectation of success therein.
Regarding Claim 14, the prior art meets the limitations of Claim 1 as discussed above. Further, Tokita/Terentiev/Barton does not specifically teach the containment system discussed above wherein the containment valve in the second compartment comprises a split butterfly valve, as in Claim 14.
However, Nara teaches a respective powder processing apparatus comprising a split butterfly valve provided to provide continuous negative pressure so that pulverized materials can be collected and sealed without contact with outside air ([0040]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Tokita/Terentiev/Barton wherein the containment valve in the second compartment comprises a split butterfly valve, such as suggested by Nara, so as to provide continuous negative pressure so that pulverized materials can be collected and sealed without contact with outside air; and would have a reasonable expectation of success therein.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Tokita in view of Terentiev and Barton, as applied to Claims 1, 7-8, 13, 15, 17, 20-21, 31, 33, and 45 above, and in further view of Henry et al. (US PAT 7,985,382 B1), hereinafter “Henry”.
Regarding Claim 32, the prior art meets the limitations of Claim 31 as discussed above. Further, Tokita does not specifically teach the containment system discussed above further comprising a tertiary containment subsystem comprising at least one of:
a negatively-pressurized room surrounding the primary and secondary containment subsystems;
a down-flow booth positioned to direct filtered air over and around the containment system;
a gas exhaust system configured to remove airborne contaminants from the area surrounding the containment system;
a solvent exhaust system configured to capture and remove solvent vapors from the area surrounding the containment system;
protective flooring disposed beneath the containment system to capture spills or leaks;
a single-use protective curtain positioned to isolate the containment system from the surrounding environment; or
a combination of two or more of the foregoing elements;
as in Claim 32.
However, Henry teaches a containment system having a negatively pressurized room ([col. 3, line 50]) and air handling system providing continuously filtered air (abstract) containing laboratory equipment such as biosafety cabinet or isolation glovebox (abstract), thereby reducing contamination from the outside environment, as well as preventing hazardous materials from escaping and causing harm.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the containment system of Tokita/Terentiev/Barton further comprising a gas exhaust system configured to remove airborne contaminants from the area surrounding the containment system, such as suggested by Henry, so as to reduce contamination from the outside environment, as well as prevent hazardous materials from escaping and causing harm.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Tokita in view of Terentiev and Barton, as applied to Claims 1, 7-8, 13, 15, 17, 20-21, 31, 33, and 45 above, and in further view of Chen et al. (CN 103805835 B; as seen through the machine translation available on Google Patents and attached herein), hereinafter “Chen”.
Regarding Claim 45, the prior art meets the limitations of Claim 1 as discussed above. Further, even if the mixing bowl being external to the dual compartment isolator in Tokita is not taken as a mere rearrangement of parts as discussed above regarding Claim 45, Chen teaches a respective glovebox isolator 39 connected via a valve door 40 to respective downstream mixing (agglomerating) chambers exterior to the glovebox (See Fig. 1 and abstract). Therein, this arrangement in Chen represents a mere alternative arrangement to that of Tokita and would be obvious to one skilled in the art as an alternative with a reasonable expectation of success given its commensurate maintenance of sterility within the device satisfied by isolation chambers and valves.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the isolator of Tokita wherein the mixing chamber is located external to the dual compartment isolator, such as suggested by Chen, as a mere inspired alternative to the arrangement of Tokita achieving the identical function of maintaining a sterile environment for reagent transfer operations.
Response to Arguments
35 USC 112(f)
Applicant argues on the alleged grounds that the terms “agitator” and “discharge device” are improperly interpreted under 35 USC 112f because the terms are allegedly understood to describe structural components known to those of ordinary skill in the art.
Applicant’s arguments are not persuasive because the terms “agitator” and “discharge device” do not imply any sort of particular structure and, as these terms are generic placeholders appended with function, they are properly interpreted under 35 USC 112f in view of the corresponding structures within the disclosure and equivalents thereof.
Thus, Examiner maintains the interpretation of the terms “agitator” and “discharge device” of Claim 1 under 35 USC 112f as discussed in the Claim Interpretation section above.
A. Negative cascading pressure controller
Applicant’s arguments are on the grounds that the primary prior art reference of Tokita (as well as the secondary references of Terentiev and Barton) does not teach the controller configured to hold the chambers of the device at negative pressure at all times, as in the amendments to Claim 1, but rather create a transient negative pressure environment for replacement with an inert gas.
Applicant’s arguments are not persuasive because Tokita teaches operations performed under inert gas and under vacuum as alternatives. Tokita does not limit the use of the device to only be used with inert gas at ambient atmosphere. – See para. [0013]: “the sintering process to be carried out under a vacuum atmosphere OR an inert gas atmosphere” and paras. [0069-0070] discussing chambers of the device held at various vacuum. While Tokita does additionally teach the use of vacuum for preparing the apparatus to be filled with inert gas, this does not preclude Tokita’s positive provision that the processes therein may also be performed under continuous vacuum.
B. Combination of Tokita, Terentiev, and Barton
1. Applicant argues on the alleged grounds that Tokita and Terentiev have different technical problems and incompatible objectives. Applicant alleges that, as tokita is drawn to high-energy, high-pressure mixing, one of ordinary skill in the art would not look to the low-energy, low-pressure biological solution mixing system of Terentiev.
Applicant’s arguments are not persuasive because the flexible nature of the mixing bag of Terentiev is not applied to the high-pressure system of Tokita, but rather Terentiev is relied upon for its inlets and outlets of the flexible mixing bag (mixing chamber) for making sterile transfers of reagent into and out of the mixing bag. As one of ordinary skill in the art would recognize the need for sterility in the reagent transfer steps of the sintering process so as to uphold product safety and integrity, said skilled artisan would look to the device of Terentiev teaching sterile reagent transfer and mixing operations through sealed inlets and outlets avoiding reagent contact with atmosphere. As such, the devices of Tokita and Terentiev solve the same technical problem of maintaining sterile reagent transfer and have the same objective of maintaining sterility during reagent transfer processes.
2. Applicant argues on the alleged grounds that the combination of Tokita and Terentiev would render the Tokita system inoperable for its intended purpose. Applicant alleges that the low-pressure valves attached to the neck of a bag in Terentiev would not translate to the mixing chamber of Tokita as said mixing chamber operates under high pressure and such low-pressure valves of Terentiev are not designed to be appended to a rigid sintering mill and would not withstand the high pressures therein.
Applicant’s arguments are not persuasive because the rejection does not require that the bag-embedded valve of Terentiev be copied unchanged and installed directly onto the rigid sintering bowl without any engineering adaptation. Rather, Terentiev is relied upon for the broader teaching of using a valve/port arrangement to permit sterile transfer material into or out of a receiving container while maintaining a closed, contamination-free environment. It would have been obvious to one of ordinary skill in the art to provide such sterile transfer means to the high-pressure sintering bowl to incorporate the sterile transfer functionality taught by Terentiev, while making the routine engineering modifications necessary for the different operating environment.
A known component does not need to be used in precisely the same physical context in which it was originally disclosed. The relevant question is whether the prior art would have suggested the claimed functionality and whether one of ordinary skill in the art would have a reasonable expectation of success in adapting it. Here, the combination is proper because both references address controlled transfer of material while preserving sterility. Substituting or adapting a sterile transfer valve/port for use with a rigid bowl would have predictably provided the benefit of sterile reagent transfer in the sintering apparatus of Tokita and require no more than routine engineering choices to be adapted for use in Tokita.
3. Applicant argues on the alleged grounds that the combination of Tokita and Barton provides redundant advantages. Applicant alleges that the Tokita system already includes gate valves for maintaining isolation between compartments, so there would be no motivation to modify said gate valves using the split butterfly valves of Barton.
Applicant’s arguments are not persuasive because the fact that Tokita already provides containment using multiple chambers and valves does not mean there would have been no reason to improve the specific valve interfaces between chambers. Barton’s split butterfly valve provides the distinct benefits of ensuring sterile conditions on product contact parts (“The valves of the present invention are able to operate in a complete sterile manner, with, in one embodiment, an in situ sterilisation step before and after each docking, regardless of how many times the valve is split open and re-docked, ensuring sterile conditions on product contact parts.”) and would thereby be attractive to the skilled artisan for use in Tokita where sterility is important for maintaining product integrity and safety by being free from contaminants.
Thus, in view of the discussion above, Examiner maintains the rejection of Claims 1, 7-8, 13, 15, 17, 20-21, 31, and 33 (and further dependents thereof) under 35 U.S.C. 103 as being unpatentable over at least Tokita in view of Terentiev and Barton. As such, Applicant’s arguments that claims depending from Claim 1 are allowable by virtue of their dependence are moot as Claim 1 is maintained rejected under 35 USC 103.
New Claim 45
New Claim 45 is rejected under 35 USC 103 as unpatentable over Tokita in view of Terentiev and Barton, as discussed above in the body of the action as a mere matter of design choice.
Applicant argues that the entire sintering process of Tokita occurs within the isolator to maintain sterility, so there would be no motivation to move the mixing vessel outside the isolator. However, as discussed above in the body of the action, the mixing vessel of Tokita may be moved external to the isolator and still be capable of its intended purpose of sterile transfer within the isolator when the ports/valves remain within the isolator.
Additionally, New Claim 45 is further rejected under 35 USC 103 as unpatentable over Tokita in view of Terentiev, Barton, and Chen (newly-added herein), as discussed above in the body of the action.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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