NON-FINAL 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 .
Response to Arguments
Applicant's arguments filed 23 March 2026 have been fully considered but they are not persuasive.
Applicant argues that “one skilled in the art, starting with Penkl and seeking to improve a sterile, single-use biotech separator, would have no reason to look at automotive engine components as taught in Sauter. The teaching of varying stacks of plates in Sauter is a solution to a high-volume manufacturing cost problem, not a solution to the biotech problem of process flexibility and sterile batch processing” (page 10, Remarks). This argument is unpersuasive. Prior art qualifies as analogous if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). See In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004). See MPEP 2141.01(a). Both Penkl and Sauter are centrifuges with inserted separating walls of conical shape, so they are in the same technical field. The field of endeavor is disc stack centrifugal separation, and it is not based on the downstream application.
Applicant argues that the previously cited combination of Penkl and Sauter does not teach or suggest first and second exchangeable separation inserts having different numbers of discs but a same height. The newly cited Merino and Nilsson references, together with Penkl and Sauter, teaches this limitation. Merino teaches same height interchangeable centrifuge inserts with different separating capacity for a common base unit, while Nilsson teaches frustoconical disc stacks with different disc counts can be accommodated within the same total stack height, as discussed in the rejections below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings were received on 30 March 2023. These drawings are acceptable.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As identified in the previous Office action, Claim 5 recites the limitation "the frustoconical separation discs" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 19 is rejected for the same reason due to its dependency upon said claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7, 9, 10, 12, 14-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Penkl et al. (U.S. Patent Application Pub. No. 2017/0203306, hereinafter Penkl) in view of Sauter et al. (U.S. Patent No. 6,973,925, hereinafter Sauter), further in view of Merino et al. (U.S. Patent Application Pub. No. 2003/0114289, hereinafter Merino), and further in view of Nilsson et al. (U.S. Patent Pub. No. 2014/0148327, hereinafter Nilsson).
Regarding claim 1, Penkl discloses a set of exchangeable inserts for a modular centrifugal separator system (a single use inner drum is exchanged for another single use inner drum, para [0005]) comprising a base unit (lower base part 3 or outer drum lower part 13 and outer drum upper part 14, Fig. 1a), the set comprising at least a first exchangeable separation insert (inner drum lower part 16, inner drum upper part 17, and covering ring body 37, Fig. 1a) and a second exchangeable separation insert (replacement “exchangeable preassembled unit”, para. [0005]), wherein each of the first and second exchangeable separation inserts comprises a rotor casing (inner drum lower part 16 and inner drum upper part 17, Fig. 1a) configured to rotate about an axis of rotation (D, Fig. 1a) and forming a separation space (centrifuging chamber 15, Fig. 1a), separation discs (disk assembly 25, Fig. 1a) arranged in the separation space, and fluid connections for a liquid feed mixture (attachment connector 38, Fig. 1e), a separated heavy phase (attachment connector 44, Fig. 1e), and a separated light phase (attachment connector 43, Fig. 1e), wherein the separation discs of the first exchangeable separation insert have a first area equivalent and the separation discs of the second exchangeable separation insert have a second area equivalent (“area equivalent” is considered a calculated property, it is considered that an area equivalent inherently results from the disclosed disc-stack geometry), wherein each of the rotor casings of the first and second separation inserts have a same external shape (replacement “exchangeable preassembled unit”, which is equivalent to the second separation insert, is mounted into the same space inside the outer drum lower part 13 and outer drum upper part 14 as the first separation insert, para. [0113], so it is considered that the first and second separation inserts have a same external shape) to an extent that they fit a rotatable member (outer drum lower part 13 and outer drum upper part 14, Fig. 1a) of a base unit of a modular centrifugal separator system, but does not expressly teach wherein the first area equivalent differs from the second area equivalent with each of the first and second area equivalents calculated for the same rotational speed; wherein the first and second exchangeable separation inserts have different number of discs by a same height.
Sauter discloses analogous art related to a disk centrifuge, wherein the first area equivalent differs from the second area equivalent with each of the first and second area equivalents calculated for the same rotational speed; wherein the first and second exchangeable separation inserts have different numbers of discs (the stacks of plates 23, which are analogous to the first and second separation inserts, are pre-manufactured whereby versions with different numbers of plates can also be available, col. 5 lines 18-35). These structural variations inherently produce different area equivalents because the area equivalent is a function of disc number and geometry, producing different separation capacities. Sauter provides the teaching that the stacks of plates 23 can be made with different number of plates 9 depending on the volumetric flow to be cleaned (col. 2 lines 53-54), and Penkl teaches replaceable bowls that are compatible with a set housing and outer drum. A person of ordinary skill in the art would recognize that if Penkl’s system uses exchangeable modules, then providing a set of separation insert modules with different disc configurations as taught by Sauter is a predicable design choice in order to be able to achieve the desired degree of purity (col. 5 lines 18-24, Sauter). When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation. In re Aller, 220 F.20 454, 456, 105 USPO 233, 238 (CCPA 1955); In re Swain et al., 70 USPQ 412; Minnesota Mining and Mfg. Co. v. Coe, 38 USPQ 213; Allen et al. v. Coe, 57 USPQ 136; MPEP 2144.05(II)(A).
The combination of Penkl and Sauter does not explicitly disclose wherein the first and second exchangeable separation inserts have a same height.
Merino discloses analogous art related to a centrifuge apparatus in the pharmaceutical field, wherein the first and second exchangeable separation inserts with different area equivalents (first and second rotor assemblies, para. [0029]) and same axial height are positionable within the same rotor housing (“first rotor assembly having the first volume capacity” and “the second rotor assembly to define a second volume capacity”, para. [0029], “the rotor housing of the first and the second rotor assemblies is the same rotor housing”, claim 2; “the second core length is the same as the first core length”, claim 1). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the set of exchangeable separation inserts of the combination of Penkl and Sauter with two interchangeable inserts with different separation capacities or area equivalents having the same axial height for the same base unit as taught by Merino for the purpose of operating the centrifuge apparatus at certain predetermined parameters depending upon a product to be separated and is useable with a plurality of rotor assemblies compatible with a common base unit (Abstract, Merino).
Nilsson discloses analogous art related to disc stack centrifuges, wherein for a fixed disc stack axial height, the number of frustoconical separation discs within the stack is variable by adjusting the thickness of the spacing members (“the centrifugal rotor provides a separation space which is designed with a given total height for the stack of separation discs. In order to maximize the separating capacity of the centrifugal separator, there is a desire to fit as many separation discs as possible into the stack within that given height…An optimum height on each of the individual interspaces will however usually be given by (or depend on) the type of liquid mixture which is intended to be separated. Consequently, this leaves the option of making the separation discs as thin as possible to maximize the number of separation discs within said given total stack height”, para. [0005]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the set of exchangeable separation inserts of the combination of Penkl, Sauter, and Merino with fitting different numbers of frustoconical separation discs within a given total height by adjusting disc thickness as taught by Nilsson for the purpose of maximizing the separating capacity of the centrifugal separator (para. [0005], Nilsson).
Regarding claim 2, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein each of the rotor casings of the first and second separation inserts have a same external shape to an extent that they fit inside an inner space of a rotatable member of a base unit of a modular centrifugal separator system and abut against at least part of an inner surface of the rotatable member, the inner surface delimiting at least part of the inner space (a single use inner drum is exchanged for another single use inner drum, para [0005]; inner drum lower part 16 and inner drum upper part 17 is positioned inside outer drum lower part 13 and outer drum upper part 14, and abuts frustoconical walls of the outer lower and upper drum parts, Fig. 1a, Penkl).
Regarding claim 3, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the first area equivalent differing form the second area equivalent is provided by a difference in a number of separation discs between the first and second exchangeable separation insert (the stacks of plates 23 are pre-manufactured whereby versions with different numbers of plates can also be available, col. 5 lines 18-35, Sauter).
Regarding claim 4, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the separation discs are frustoconical separation discs (“conical partition disks”, para. [0029], Fig. 1a, Penkl).
Regarding claim 7, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the rotor casing (inner drum lower part 16 and inner drum upper part 17, Fig. 1a, Penkl) of each of the first and second exchangeable separation insert (replacement “exchangeable preassembled unit”, para. [0005], Penkl) has a first axial end portion and a second axial end portion (Fig. 1a, Penkl), and wherein each of the first and second exchangeable separation insert comprises at least a first fluid connection arranged at the first axial end portion (attachment connector 38, Fig. 1e, Penkl).
Regarding claim 9, the combination of Penkl, Sauter, Merino, and Nilsson discloses a modular centrifugal separator system configured for separating a liquid feed mixture into a heavy phase and light phase, the modular centrifugal separator system comprising a base unit (lower base part 3 or outer drum lower part 13 and outer drum upper part 14, Fig. 1a, Penkl) and a first exchangeable separation insert (inner drum lower part 16, inner drum upper part 17, and covering ring body 37, Fig. 1a, Penkl), wherein the base unit comprises a stationary frame (housing 1, Fig. 1a, Penkl), a rotatable member (outer drum lower part 13 and outer drum upper part 14, Fig. 1a, Penkl), and a drive unit (8, Fig. 1a, Penkl) for rotating the rotatable member about the axis of rotation, wherein the rotatable member delimits an inner space at least in a radial direction, the inner space being configured for receiving at least one part of the first exchangeable separation insert therein, wherein the modular separation system comprises a set of exchangeable separation inserts according to claim 1, and wherein the first exchangeable separation insert forms part of the set of exchangeable separation inserts (the first/second separation insert is mounted into the space inside the outer drum lower part 13 and outer drum upper part 14, para. [0113], Penkl).
Regarding claim 10, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the rotatable member (outer drum lower part 13 and outer drum upper part 14, Fig. 1a, Penkl) is configured to rotate about an axis of rotation (D, Fig. 1a, Penkl) arranged in the stationary frame and has a first axial end and a second axial end (top and bottom end as shown in Fig. 1a, Penkl), and the rotatable member is provided with a first opening (central opening 69, Fig. 5, Penkl) at the first axial end configured for at least a first fluid connection (attachment connector 38, Fig. 1e, Penkl) of the first or second exchangeable separation insert to extend through the first opening.
Regarding claim 12, the combination of Penkl, Sauter, Merino, and Nilsson discloses a method for operating the modular centrifugal separator system configured for separating a liquid feed mixture into a heavy phase and light phase according to claim 9, comprising steps of: providing the first exchangeable separation insert (entire inner drum together with the inflow and outflow system, para. [0086], Penkl); mounting the first exchangeable separation insert in the inner space of the rotatable member (para. [0019], Penkl); separating a first batch of liquid feed mixture in the modular centrifugal separator system into a first heavy phase and a first light phase utilizing the first exchangeable separation insert (para. [0085], Penkl); removing the first exchangeable separation insert from the inner space of the rotatable member (para. [0113], Penkl); providing the second exchangeable separation insert; mounting the second exchangeable separation insert in the inner space of the rotatable member (para. [0113], Penkl); and separating a second batch of liquid feed mixture in the modular centrifugal separator system into a second heavy phase and a second light phase utilizing the second exchangeable separation insert (Penkl teaches an exchange of those parts which make contact with the product during operation and which are designed as “singles-use” separator for one-off processing of a product batch, which suggests that there will be a processing of a second product batch using a new exchangeable, preassembled module, para. [0109], Penkl).
Regarding claim 14, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein each of the first and second batch of liquid feed mixture is a cell culture mixture (“fermentation broth or the like” is considered equivalent to cell culture mixture, para. [0033], Penkl).
Regarding claim 15, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the first area equivalent differing from the second area equivalent is provided by a difference in a number of separation discs between the first and second exchangeable separation insert (the stacks of plates 23 are pre-manufactured whereby versions with different numbers of plates can also be available, col. 5 lines 18-35, Sauter).
Regarding claim 16, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the separation discs are frustoconical separation discs (“conical partition disks”, para. [0029], Fig. 1a, Penkl).
Regarding claim 17, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the separation discs are frustoconical separation discs (“conical partition disks”, para. [0029], Fig. 1a, Penkl).
Regarding claim 20, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the rotor casing (inner drum lower part 16 and inner drum upper part 17, Fig. 1a, Penkl) of each of the first and second exchangeable separation insert has a first axial end portion and a second axial end portion (Fig. 1a, Penkl), and wherein each of the first and second exchangeable separation insert comprises at least a first fluid connection (attachment connector 38, Fig. 1e, Penkl) arranged at the first axial end portion.
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Penkl in view of Sauter, further in view of Merino, and further in view of Nilsson, as applied in claim 1 above, and further in view of EP 0241128 (Krook).
Regarding claim 8, the combination of Penkl, Sauter, Merino, and Nilsson does not disclose wherein each of the first and second exchangeable separation insert comprises at least a second fluid connection arranged at the second axial end portion.
Krook discloses analogous art related to a centrifugal separator, wherein the separation insert (equivalent to rotor 1 and 2, Figure) comprises at least a second fluid connection (channels 32 and 33, Figure) arranged at the second axial end portion. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the set of exchangeable separation inserts of the combination of Penkl, Sauter, Merino, and Nilsson with the fluid connection at the second axial end portion as taught by Krook for the purpose of supplying a liquid mixture to the rotor and discharging separated sludge (col. 5 line 52 – col. 6 line 16, Krook).
Regarding claim 11, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein, the rotatable member comprises a second opening (leadthrough 6, Fig. 1a, Penkl) at the second axial end, but does not disclose at least a second fluid connection of the first or second exchangeable separation insert to extend through the second opening.
Krook discloses at least a second fluid connection (channels 32 and 33, Figure) of the first or second exchangeable separation insert (corresponding to rotor parts 1 and 2, Figure) arranged at the second axial end portion. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the modular centrifugal separator system of the combination of Penkl, Sauter, Merino, and Nilsson with the fluid connection at the second axial end portion as taught by Krook for the purpose of supplying a liquid mixture to the rotor and discharging separated sludge (col. 5 line 52 – col. 6 line 16, Krook).
Claims 5, 6, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Penkl in view of Sauter, further in view of Merino, and further in view of Nilsson, as applied in claim 1 above, and further in view of EP 2664385 (Hagqvist).
Regarding claim 5, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the frustoconical separation discs of the first exchangeable separation insert and the frustoconical separation discs of the second exchangeable separation insert have a same total height along the axis of rotation (“first rotor assembly having the first volume capacity” and “the second rotor assembly to define a second volume capacity”, para. [0029]; “the rotor housing of the first and the second rotor assemblies is the same rotor housing”, claim 2; “the second core length is the same as the first core length”, claim 1, Merino), but does not disclose wherein a distance between at least two of the frustoconical separation discs of the first exchangeable separation insert differs from a distance between at least two of the frustoconical separation discs of the second exchangeable separation insert.
Hagqvist discloses analogous art related to discs for a centrifugal separator, wherein the distance between a distance between at least two of the frustoconical separation discs of the first set of disc package (a separation of 0.4-0.75 mm, para. [0026]) differs from a distance between at least two of the frustoconical separation discs of the second set of disc package (a separation of 1.6-4.5 mm, para. [0026]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the known practice of providing disc stacks with different inter-disc spacing as taught by Hagqvist into the set of exchangeable separation inserts of the combination of Penkl, Sauter, Merino, and Nilsson for the purpose of having the fluid to be separate to flow radially inwardly in the passages between each two adjacent separation discs of any of the two sets (para. [0007]).
Regarding claim 6, the combination of Penkl, Sauter, Merino, and Nilsson does not disclose wherein the first area equivalent differing from the second area equivalent is provided by at least one of: a difference in an outer diameter of the frustoconical separation discs between the first and second exchangeable separation insert; a difference in an inner diameter of the frustoconical separation discs between the first and second exchangeable separation insert; and/or a difference in an angle α between an axis of rotation of the first and second exchangeable separation insert and an inner surface of one of the frustoconical separation discs between the first and second exchangeable separation insert.
Hagqvist discloses a difference in an outer diameter of the frustoconical separation discs between the first and second exchangeable separation insert (diameter A of separation discs of the first set is smaller than the diameter B of separation discs of the second set, para. [0011]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the set of exchangeable separation inserts of the combination of Penkl, Sauter, Merino, and Nilsson with different separation discs diameters as taught by Hagqvist for the purpose of minimizing the risk of separated particles being recirculated into the separating passages and maintaining an open space for separation radially outside the disc package (para. [0011], Hagqvist).
Regarding claim 18, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein the frustoconical separation discs of the first exchangeable separation insert and the frustoconical separation discs of the second exchangeable separation insert have a same total height along the axis of rotation (“first rotor assembly having the first volume capacity” and “the second rotor assembly to define a second volume capacity”, para. [0029]; “the rotor housing of the first and the second rotor assemblies is the same rotor housing”, claim 2; “the second core length is the same as the first core length”, claim 1, Merino), but does not disclose wherein a distance between at least two of the frustoconical separation discs of the first exchangeable separation insert differs from a distance between at least two of the frustoconical separation discs of the second exchangeable separation insert.
Hagqvist discloses analogous art related to discs for a centrifugal separator, wherein the distance between a distance between at least two of the frustoconical separation discs of the first set of disc package (a separation of 0.4-0.75 mm, para. [0026]) differs from a distance between at least two of the frustoconical separation discs of the second set of disc package (a separation of 1.6-4.5 mm, para. [0026]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the known practice of providing disc stacks with different inter-disc spacing as taught by Hagqvist into the set of exchangeable separation inserts of the combination of Penkl, Sauter, Merino, and Nilsson for the purpose of having the fluid to be separated to flow radially inwardly in the passages between each two adjacent separation discs of any of the two sets (para. [0007], Hagqvist).
Regarding claim 19, the combination of Penkl, Sauter, Merino, and Nilsson does not disclose wherein the first area equivalent differing from the second area equivalent is provided by at least one of: a difference in an outer diameter of the frustoconical separation discs between the first and second exchangeable separation insert; a difference in an inner diameter of the frustoconical separation discs between the first and second exchangeable separation insert; and/or a difference in an angle α between an axis of rotation of the first and second exchangeable separation insert and an inner surface of one of the frustoconical separation discs between the first and second exchangeable separation insert.
Hagqvist discloses a difference in an outer diameter of the frustoconical separation discs between the first and second exchangeable separation insert (diameter A of separation discs of the first set is smaller than the diameter B of separation discs of the second set, para. [0011]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the set of exchangeable separation inserts of the combination of Penkl, Sauter, Merino, and Nilsson with different separation discs diameters as taught by Hagqvist for the purpose of minimizing the risk of separated particles being recirculated into the separating passages and maintaining an open space for separation radially outside the disc package (para. [0011], Hagqvist).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Penkl in view of Sauter, further in view of Merino, and further in view of Nilsson, as applied in claim 12 above, and further in view of EP 3199511 (Warren et al., hereinafter Warren).
Regarding claim 13, the combination of Penkl, Sauter, Merino, and Nilsson discloses wherein each of the first and second batch of liquid feed mixture comprises solid matter (Penkl teaches three-phase separators for separation into three phases which would typically include solids, para. [0085]), but does not explicitly teach wherein the first batch of liquid feed mixture differs from the second batch of liquid feed mixture by at least one of: type of solid matter; concentration of solid matter; and/or content of the separated first light phase and content of the separated second light phase.
Warren teaches analogous art related to separating a liquid fraction from a solid fraction comprising cells, wherein the first batch of liquid feed mixture differs from the second batch of liquid feed mixture by at least one of: type of solid matter (para. [0021]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Penkl and Sauter with the processing of batches of liquid feed mixture differing in the type of solid matter for the purpose of isolating other water miscible compounds of interest using the same procedures (para. [0021], Warren).
Conclusion
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/Shuyi S. Liu/ Examiner, Art Unit 1774
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