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 .
Status of the Claims
The amendment filed 10/7/2025 has been entered. Claims 1-3 and 5-10 remain pending in the application and claims 4 and 11-19 are cancelled. Applicant’s amendments to the claims have overcome each 112(b) rejection previously set forth in the Non-Final Office Action mailed 5/9/2025.
Response to Arguments
Applicant's arguments filed 10/7/2025 have been fully considered but they are not persuasive.
Applicant argues on pp. 6-7 that Kido does not disclose recesses in the reactor housing that allow an engagement of magnets 62A and 62B in the reactor housing. This is not persuasive, as claim 1 of the instant application does not recite that the engagement of magnets occurs in the reactor housing, but rather in the recesses of the reactor housing (lines 17-18 of claim 1) which are disposed either on an upper side of the reactor housing or on a lower side of the reactor housing (lines 13-14 of claim 1). This limitation of the recesses engageable with the magnet system does not require the magnets to be disposed inside the reactor housing, but rather on the top or bottom of the reactor housing, which is shown in Figs. 9-10 of Kido. Therefore, claim 1 remains rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kido (US 2007/0125942 A1) (already of record).
Regarding claim 1, Kido teaches a preparation system for preparing a cell suspension (abstract), comprising a carrier (Fig. 10 60 motor mount) at which a reactor housing (Fig. 10 63 rotor assembly) and a magnet system (Fig. 10 62A, 62B magnets) are accommodated, wherein a reaction channel for receiving the cell suspension is formed in the reactor housing (Fig. 14 72 channel), said reaction channel extending between an inlet opening arranged centrally on an upper side of the reactor housing (Fig. 14B 65 chamber) and an outlet opening arranged on an outer perimeter of the reactor housing (Fig. 14B 66 chamber) and which reaction channel is bounded by at least one channel wall (Fig. 14B), and wherein the magnet system is disposed on the carrier so as to be movable between a first functional position (para. 0054 “magnets forming the magnetic field are periodically or continuously repositioned in proximity to the apparatus”), in which a pole face of the magnet system bears against the channel wall of the reaction channel (magnet 62B rests against chambers, seen in Fig. 13, which are connected to channels, seen in Fig. 14B) and a second functional position in which the pole face of the magnet system is located at a predetermined distance with respect to the channel wall (magnet 62A rests against rotor assembly 63 at a distance from the channels, seen in Fig. 9), and wherein the preparation system further comprises a reactor housing drive to initiate a rotational movement on the reactor housing about an axis of rotation (Fig. 10 10 motor), and
wherein the reactor housing comprises recesses disposed on an upper side of the reactor housing adjacent to the reactor channel and/or on a lower side of the reactor housing adjacent to the reaction channel, said recesses being engageable with the magnet system (Fig. 10 61A, 61B magnet holders have recesses holding magnets 62A, 62B), and
wherein the magnet system comprises, a surface profiling facing the reactor housing with depressions and elevation, the elevations enabling an engagement of the magnet system in the recesses of the reactor housing (magnet holders 61A, 61B hold magnets 62A, 62B in a recess, elevating magnets to engage with the rotor assembly seen in Figs. 9-10).
Regarding claim 5, Kido teaches a preparation system wherein a plurality of reaction channels are formed in the reactor housing and/or wherein the magnet system comprises one permanent magnet or a plurality of permanent magnets (para. 0053 “permanent magnetic elements”) and/or one solenoid coil or a plurality of solenoid coils.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kido (US 2007/0125942 A1) (already of record).
Regarding claim 2, Kido teaches a preparation system wherein the reaction channel comprises a first channel section (Fig. 5 40 channel) and a radially outer collecting basin (Fig. 5 44 collection chamber) and a second channel section (Fig. 5 42 siphon), the first channel section extending from the inlet opening (Fig. 5 46 inlet port) to the collecting basin (Fig. 5 40 channel) and has a rearwards directed orientation with respect to a predetermined first direction of rotation for the reactor housing (Fig. 5), the collecting basin being of concave design with respect to the first direction of rotation (Fig. 5), and the second channel section extending from the collecting basin to the outlet opening (Fig. 5 38 clarification chamber) and being aligned in a forwardly directed manner with respect to the first direction of rotation (Fig. 5). Kido teaches these features in the embodiment shown in Fig. 5, but does not teach these features in the embodiment shown in Figs. 10-14.
Kido teaches that this configuration of channels connecting chambers optimizes disruption, separation/purification, and analysis functions (para. 0046). It would have been obvious to a person of ordinary skill in the art to combine embodiments in Kido’s device with a reasonable expectation that it would optimizes disruption, separation/purification, and analysis functions of the device. Therefore, this method for modifying Kido’s device was within the ability of one of ordinary skill in the art before the effective filing date of the claimed invention based on the teachings of Kido.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kido (US 2007/0125942 A1) (already of record) in view of Gordon (US 2002/0151043 A1) (already of record).
Regarding claim 3, Kido teaches a preparation system comprising a first channel section, but does not teach wherein the first channel section extends spirally with respect to the axis of rotation.
However, Gordon teaches a channel in the shape of a spiral (Fig. 3A 24 separation chamber). Gordon teaches that the spiral shape creates a longer channel to increase resolution of the assay (para. 0054).
It would have been obvious to a person of ordinary skill in the art to use the Gordon configuration of a spiral-shaped channel in Kido’s device with a reasonable expectation that it would create a longer channel to increase resolution of the assay. This method for improving Kido’s device was within the ability of one of ordinary skill in the art based on the teachings of Gordon. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kido and Gordon to obtain the invention as specified in claim 3.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kido (US 2007/0125942 A1) (already of record) in view of Le et al. (US 2012/0171718 A1) (already of record).
Regarding claim 6, Kido teaches a preparation system wherein a distributor housing is arranged on the carrier (Fig. 11 68 insert), at least one inlet opening (Fig. 11 holes at 65-67 chambers on 68 insert) which is located adjacent to the outlet opening of the reactor housing (67 seen in Fig. 14B on 70 patterned layer), the inlet opening being arranged radially inwardly with respect to the axis of rotation (Fig. 11 holes at 65 chambers), and openings comprising receiving shafts to receive sample containers (Fig. 11; para. 0081 “Rotor 64 provides support to the array of vertically elongated chambers”).
Kido does not teach the distributor housing penetrated by a distributor channel extending from the at least one inlet opening to a plurality of outlet openings. However, Le et al. teaches a housing comprising an inlet opening arranged radially inwardly with respect to the axis of rotation (Fig. 2 23 inlet orifice), outlet openings arranged radially outwardly with respect to the axis of rotation (Fig. 1 9 recessed portions), and a channel which extends from the inlet opening to the plurality of outlet openings (Fig. 1 11 outlet channels). Le et al. teaches that this configuration for a distributor housing allows cells to continuously be provided with fresh liquid medium and sufficient supply of nutrients and oxygen (para. 0142).
It would have been obvious to a person of ordinary skill in the art to use the Le et al. configuration of a housing comprising an inlet opening arranged radially inwardly with respect to the axis of rotation, outlet openings arranged radially outwardly with respect to the axis of rotation, and a channel which extends from the inlet opening to the plurality of outlet openings in Kido’s device with a reasonable expectation that it would allow cells to continuously be provided with fresh liquid medium and sufficient supply of nutrients and oxygen. This method for improving Kido’s device was within the ability of one of ordinary skill in the art based on the teachings of Le et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kido and Le et al. to obtain the invention as specified in claim 6.
Regarding claim 7, Kido teaches a preparation system wherein the distributor housing is of annular design with respect to the axis of rotation (Fig. 11 68 insert), and wherein the carrier comprises a distributor housing drive to initiate a rotational movement on the distributor housing about the axis of rotation (Fig. 10 20 motor adapter).
Regarding claim 8, Kido teaches a preparation system wherein the receiving shafts are equipped with sample containers (Fig. 11; para. 0081 “Rotor 64 provides support to the array of vertically elongated chambers”) and wherein different sample containers are filled with analysis substances of different concentration and/or different composition (para. 0059; para. 0071; para. 0078).
Regarding claim 9, Kido teaches a preparation system wherein the reactor housing is circularly profiled along the axis of rotation (Fig. 10 63 rotor assembly) and the distributor housing is disposed within annular recesses of the reactor housing (Fig. 11 64 rotor) and is positioned on top of the distributor housing (Fig. 11 70 patterned layer). Kido does not teach wherein the reactor housing is received in an annular recess of the distributor housing, wherein the outlet opening is formed on an outer circumferential wall of the reactor housing and wherein the inlet opening of the distributor housing is arranged on an inner surface of the annular recess of the distributor housing.
However, Le et al. teaches a housing including an annular recess (Fig. 1 3 aperture) wherein an outlet opening is formed on an outer circumferential wall of the housing (Fig. 1 9 recessed portion) and wherein an inlet opening is arranged on an inner surface of the annular recess of the distributor housing (Fig. 2 23 inlet orifice). Le et al. teaches that this configuration for a distributor housing provides easy access for placing and removing cells, makes handling the device easier and quicker, and decreases the risk of contamination (para. 0062).
It would have been obvious to a person of ordinary skill in the art to use the Le et al. configuration of an annular recess wherein an outlet opening is formed on an outer circumferential wall of the housing and wherein an inlet opening is arranged on an inner surface of the annular recess of the distributor housing in Kido’s device with a reasonable expectation that it would provide easy access for placing and removing cells, make handling the device easier and quicker, and decreases the risk of contamination. This method for improving Kido’s device was within the ability of one of ordinary skill in the art based on the teachings of Le et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kido and Le et al. to obtain the invention as specified in claim 9.
Regarding claim 10, Kido teaches a preparation system comprising a magnet system (Fig. 10 62A, 62B magnets) and a reactor housing drive (Fig. 10 10 motor).
Kido does not teach a magnet system drive arranged on the carrier for introducing a linear movement along the axis of rotation onto the magnet system. However, Le et al. teaches a magnet system drive arranged on the carrier for introducing a linear movement along the axis of rotation onto the magnet system (para. 0090 “magnetic stirrer”). Le et al. teaches that the magnetic stirrer generates an intermittent flow wave that stimulates cells and activates pathways that lead to differentiation (para. 0092).
It would have been obvious to a person of ordinary skill in the art to use the Le et al. configuration of a magnet drive system (magnetic stirrer) in Kido’s device with a reasonable expectation that it would generate an intermittent flow wave that stimulates cells and activates pathways that lead to differentiation. This method for improving Kido’s device was within the ability of one of ordinary skill in the art based on the teachings of Le et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kido and Le et al. to obtain the invention as specified in claim 10.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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, Michael Marcheschi can be reached at 571-272-1374. 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.
/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799