CTNF 18/029,526 CTNF 92171 NON-FINAL ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Drawings 06-37 AIA The drawings were received on 30 March 2023 . These drawings are acceptable . Specification 06-31 AIA The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware of in the specification. The abstract of the disclosure is acceptable. The title of the invention is acceptable. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-20 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. Regarding claim 1, it is unclear if “a base unit” and “a modular centrifugal separator system” in lines 13 and 14 refer to the base unit and modular centrifugal separator system previously recited in line 1 and 2, or to a different base unit and modular centrifugal separator system. Claims 2-20 are rejected for the same reason due to their dependency upon said claim. Regarding claim 2, it is unclear if “a same external shape”, “a rotatable member”, “a base unit”, and “a modular centrifugal separator system” refer to the identically worded components previously recited in claim 1, upon which said claim depends, or to different components. 07-34-05 AIA Claim 5 recites the limitation " the frustoconical separation discs " in lines 1 and 2 . There is insufficient antecedent basis for this limitation in the claim. Regarding claim 7, it is unclear if “at least a first fluid connection” in line 4 refers to one of the fluid connections previously recited in claim 1, upon which said claim depends, or to a different fluid connection. Regarding claim 8, it is unclear if “at least a second fluid connection” in line 4 refers to one of the fluid connections previously recited in claim 1, upon which said claim depends, or to a different fluid connection. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 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) . 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 it 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 assumed 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. 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 (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). Regarding claim 2, the combination of Penkl and Sauter 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 (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 and Sauter 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 and Sauter discloses wherein the separation discs are frustoconical separation discs (“conical partition disks”, para. [0029], Fig. 1a, Penkl). Regarding claim 7, the combination of Penkl and Sauter 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 and Sauter 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 and Sauter discloses wherein the rotatable member 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 and Sauter 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]). Regarding claim 14, the combination of Penkl and Sauter 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 and Sauter 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 and Sauter discloses wherein the separation discs are frustoconical separation discs (“conical partition disks”, para. [0029], Fig. 1a, Penkl). Regarding claim 17, the combination of Penkl and Sauter discloses wherein the separation discs are frustoconical separation discs (“conical partition disks”, para. [0029], Fig. 1a, Penkl). Regarding claim 20, the combination of Penkl and Sauter 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 . 07-21-aia AIA Claim s 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Penkl in view of Sauter, as applied in claim 1 above, and further in view of EP 0241128 (Krook) . Regarding claim 8, the combination of Penkl and Sauter 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 and Sauter 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 and Sauter 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 and Sauter 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) . 07-21-aia AIA Claim s 5, 6, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Penkl in view of Sauter, as applied in claim 1 above, and further in view of EP 2664385 (Hagqvist) . Regarding claim 5, the combination of Penkl and Sauter 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 (Penkl teaches a 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]; Sauter teaches the stacks of plates 23 can be made with different number of plates 9, col. 2 lines 53-54), 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 and Sauter 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 and Sauter 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 and Sauter 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 and Sauter 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 (Penkl teaches a 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]; Sauter teaches the stacks of plates 23 can be made with different number of plates 9, col. 2 lines 53-54), 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 and Sauter 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 19, the combination of Penkl and Sauter 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 and Sauter 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) . 07-21-aia AIA Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Penkl in view of Sauter, 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 and Sauter 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 Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHUYI S LIU whose telephone number is (571)272-0496. The examiner can normally be reached MON - FRI 9:30AM - 2:30PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Shuyi S. Liu/ Examiner, Art Unit 1774 Application/Control Number: 18/029,526 Page 2 Art Unit: 1774 Application/Control Number: 18/029,526 Page 3 Art Unit: 1774 Application/Control Number: 18/029,526 Page 4 Art Unit: 1774 Application/Control Number: 18/029,526 Page 5 Art Unit: 1774 Application/Control Number: 18/029,526 Page 6 Art Unit: 1774 Application/Control Number: 18/029,526 Page 7 Art Unit: 1774 Application/Control Number: 18/029,526 Page 8 Art Unit: 1774 Application/Control Number: 18/029,526 Page 9 Art Unit: 1774 Application/Control Number: 18/029,526 Page 10 Art Unit: 1774 Application/Control Number: 18/029,526 Page 11 Art Unit: 1774 Application/Control Number: 18/029,526 Page 12 Art Unit: 1774 Application/Control Number: 18/029,526 Page 13 Art Unit: 1774 Application/Control Number: 18/029,526 Page 14 Art Unit: 1774 Application/Control Number: 18/029,526 Page 15 Art Unit: 1774 Application/Control Number: 18/029,526 Page 16 Art Unit: 1774