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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-6, 10-14, 16-20 and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,867,605 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the instant claims are anticipated by the noted U.S. Patent.
Claim 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-12 of U.S. Patent No. 11,867,605 B2 (‘605 hereinafter) in view of Muraki (U.S. PGPub No. 2011/0033339 A1).
U.S. Patent ‘605 does not explicitly disclose a particle sorter, wherein the feedback subsystem comprises a controller operably connected to the actuator and to a detector configured to detect a distance a droplet of the droplet stream is offset or a particle sorter, wherein the feedback subsystem is configured to iteratively adjust the offset between the first and second plates.
However, Muraki does disclose wherein the feedback subsystem comprises a controller (discharge confirming section 14/18) operably connected to the system and to a detector (12) configured to detect a distance a droplet of the droplet stream is offset (i.e. the distance to achieve the desired droplet reaching the acceptor 17 or cell 121) wherein the feedback subsystem is configured to iteratively adjust the offset between the first and second plates (this is implied by the use of “positions” plural, as in clearly in having movement in “all positions” the system of Muraki does not merely have absolute movement in all directions but only ever used one fixed position, instead the position is adjusted clearly based on the need to create a field to allow the droplet to get to a particular sorting position (17/121) ([0064]; [0073]; [0075]-[0076]; [0089]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify U.S. Patent ‘605 with a particle sorter, wherein the feedback subsystem comprises a controller operably connected to the actuator and to a detector configured to detect a distance a droplet of the droplet stream is offset or a particle sorter, wherein the feedback subsystem is configured to iteratively adjust the offset between the first and second plates in order to provide the advantage of increased accuracy as obviously making a common calibration/feedback analysis of the desired output (i.e. the location of the droplet) via detection with a camera and iterative movement of the first and second plates results in a confirmation/reduction of error and ensures all the particles/droplets reach their target location without loss ([0064]).
Claims 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12,379,302 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the instant claims are anticipated by the noted U.S. Patent in view of Petersen (U.S. PGPub No. 2018/0095022 A1).
‘302 does not explicitly disclose a particle sorter, wherein the known offset deflection force is sufficient to offset a drop deposition position by 2 mm or more.
However, Peterson does disclose in ([0005], ll. 7-9; [0055], ll. 7-15) that the deflection plates can apply a force to move the particle by 3 mm or more. Further Peterson disclose a plurality of collection container configurations, some with space as high as 50mm or more.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify ‘302 with a particle sorter, wherein the known offset deflection force is sufficient to offset a drop deposition position by 2 mm or more in order to provide the advantage of increased versatility in using a deflector field strong enough to deflect the particles 3mm or more one can accommodate a wider range of sample containers, potentially as high as 50mm or more between wells.
Claims 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12,379,302 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the instant claims are anticipated by the noted U.S. Patent in view of Mason et al. (U.S. PGPub No. 2017/0307502 A1).
As to claim 17, 302 does not explicitly disclose a particle sorter, wherein the diameter of each partition is 1.8 mm or less.
However, Mason does disclose in ([0311]) the it is well-known in a flow cytometry system to use a microwell for separation of the sample under test where the diameter of each well is 400 um.m or .4 mm. Further that such microwell plate is known to be in production by BD.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify ‘302 with a particle sorter, wherein the diameter of each partition is 1.8 mm or less in order to provide the advantage of reduction in cost in using a microwell plate from a company like BD one can easily acquire a known sorting system without having to spend time and money on developing a unique plate for sorting, while allowing multiple wells for sorting the sample under test.
Claim 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-12 of U.S. Patent No. 12,379,302 B2 (‘302 hereinafter) in view of Muraki (U.S. PGPub No. 2011/0033339 A1).
U.S. Patent ‘302 does not explicitly disclose a particle sorter, wherein the feedback subsystem comprises a controller operably connected to the actuator and to a detector configured to detect a distance a droplet of the droplet stream is offset or a particle sorter, wherein the feedback subsystem is configured to iteratively adjust the offset between the first and second plates.
However, Muraki does disclose wherein the feedback subsystem comprises a controller (discharge confirming section 14/18) operably connected to the system and to a detector (12) configured to detect a distance a droplet of the droplet stream is offset (i.e. the distance to achieve the desired droplet reaching the acceptor 17 or cell 121) wherein the feedback subsystem is configured to iteratively adjust the offset between the first and second plates (this is implied by the use of “positions” plural, as in clearly in having movement in “all positions” the system of Muraki does not merely have absolute movement in all directions but only ever used one fixed position, instead the position is adjusted clearly based on the need to create a field to allow the droplet to get to a particular sorting position (17/121) ([0064]; [0073]; [0075]-[0076]; [0089]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify U.S. Patent ‘302 with a particle sorter, wherein the feedback subsystem comprises a controller operably connected to the actuator and to a detector configured to detect a distance a droplet of the droplet stream is offset or a particle sorter, wherein the feedback subsystem is configured to iteratively adjust the offset between the first and second plates in order to provide the advantage of increased accuracy as obviously making a common calibration/feedback analysis of the desired output (i.e. the location of the droplet) via detection with a camera and iterative movement of the first and second plates results in a confirmation/reduction of error and ensures all the particles/droplets reach their target location without loss ([0064]).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mason et al. (U.S. PGPub No. 2017/0307502 A1).
As to claim 1, Mason discloses and shows in figure 2, a particle sorter comprising:
a flow cell (area 210) ([0167]; [0171]; as explicitly disclosed the system is a flow cell);
a light source (218) for irradiating an interrogation point (area 202c) of the flow cell ([0173], ll. 1-8);
a detector (222) for detecting light from the interrogation point ([0173], ll. 14-21);
a droplet generator (explicitly disclosed but not clearly shown as “the droplet drive generator, the examiner alternatively can merely interpret the nozzle with variable opening size also as a “droplet generator”) for producing a droplet stream from fluid exiting the flow cell ([0172]; [0176]; [0290]); and
a droplet deflector (228 and 236a-b) configured to apply a known offset deflection force (i.e. the precisely calibrated strength as disclosed) to the droplet stream ([0178]).
Claim(s) 1-6, 11-14, 16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muraki (U.S. PGPub No. 2011/0033339 A1).
As to claim 1, Muraki discloses and shows in figure 7, a particle sorter comprising:
a flow cell (11) ([0092], ll. 1-3);
a light source (19) for irradiating an interrogation point (focus point explicitly shown in figure 7) of the flow cell ([0094]);
a detector (20) for detecting light from the interrogation point ([0097]);
a droplet generator (15) for producing a droplet stream from fluid exiting the flow cell ([0092], ll. 3-11); and
a droplet deflector (13a-b) configured to apply a known offset deflection force (as the result of voltage applied to achieve the direction desired for sorting) to the droplet stream ([0071]; [0084]; [0133]; i.e. the force applied for proper sorting as disclosed).
As to claim 2, Muraki discloses and shows in figure 7, a particle sorter, wherein the droplet deflector comprises first (13a) and second plates (13b) configured to be offset from one another (explicitly shown in figure 7) ([0070], ll. 1-2).
As to claim 3, Muraki discloses a particle sorter, wherein the first and second plates are configured to be adjustably offset (e.g. they can be rotated as disclosed while being offset from one another) from one another ([0076], ll. 1-5).
As to claim 4, Muraki discloses a particle sorter, wherein the first and second plates are configured to be adjustably offset from one another with respect to a horizontal plane (i.e. rotated or up and down movement relative to the horizontal plane which applicant is defining as a plane perpendicular to the flow path of the droplets and parallel to the top surface cell holder 121) ([0076], ll. 1-5).
As to claim 5, Muraki discloses a particle sorter, wherein the horizontal plane is perpendicular to the axis of the droplet stream ([0076], ll. 1-5; where this interpretation was already address in claim 4).
As to claim 6, Muraki disclose a particle sorter, wherein the first plate comprises an elongated section (i.e. the rectangular section of the electrode shown can explicitly be interpreted as an elongated section in being rectangular, further applicant has not defined any other sections of the plate, thus the plate as a whole can be the only section present) configured to allow the first plate to be adjustably offset from the second plate with respect to the horizontal plane (i.e. rotated or moved up and down, the examiner notes that implicitly something is attached to and holding/moving the plates 13a-b as they clearly do not float in the air by themselves as shown as this was just for the simplicity of the prior art figure) ([0076], ll. 1-5).
As to claim 11, Muraki discloses and shows in figure 1a particle sorter, wherein the known offset deflection force is sufficient to offset a drop deposition position by one droplet diameter or less ([0088]; clearly if the droplets are moved to different cells, they are moved by a force that moves them at least the droplet diameter or less, this more clearly shown in figure 1a).
As to claim 12, Muraki discloses and shows in figure 7, a particle sorter, further comprising a plurality of partitions (explicitly shown in figure 7) configured to receive droplets deflected by the droplet deflector ([0065], ll. 6-11).
As to claim 13, Muraki discloses and shows in figure 7, a particle sorter, wherein the partitions comprise a collection container (i.e. cells) ([0065], ll. 6-11).
As to claim 14, Muraki discloses and show sin figure 7, a particle sorter, wherein the collection container is a multi-well plate (where the examiner is interpreting the multiple cell/well of Muraki as a multi-well plate as it explicitly shown in a plate-like form) ([0065], ll. 6-11).
As to claim 16, Muraki discloses and shows in figure 7, a particle sorter, wherein the partitions comprise collection tubes ([0086]; where the examiner is interpreting the cells 121 as tubes, further Muraki implies they can be “collection tubes”).
As to claim 19, Muraki discloses a particle sorter, wherein the first and second plates are configured to be adjustably rotated to face one another ([0076], ll. 1-5).
As to claim 20, Muraki discloses a particle sorter, wherein the second plate comprises an elongated section configured to allow the second plate to be adjustably offset from the first plate with respect to the horizontal plane ([0076], ll. 1-5, where the same interpretation as applied about relative to the first plate likewise applies to the second plate).
Claim Rejections - 35 USC § 103
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(s) 7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Muraki in view of Durack et al. (U.S. PGPub No. 2011/0269175 A1).
As to claims 7 and 21, Muraki does not explicitly disclose a particle sorter, wherein the elongated section of the first plate comprises a set screw configured to allow the first/second plate to be adjustably offset from the first/second plate with respect to the horizontal plane.
However, Durack does disclose in figure 84 and in ([0404]) the basic concept of using set screws (2231 of 2235) to adjust the position of a structure within a flow cytometry system. Obviously, the same basic fastening structure can be used predictably in conjunction with the movable deflection plates of Muraki to allow movement adjust in a similar manner as taught by Durack.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muraki with a particle sorter, wherein the elongated section of the first plate comprises a set screw configured to allow the first/second plate to be adjustably offset from the first/second plate with respect to the horizontal plane in order to provide the advantage of expected results and reduction in cost in using one of the most basic and well-known movement techniques known throughout multiple arts, specifically set screws designed to allow movement adjustment of structures, which in this case could obviously and predictably be used for the horizontal or vertical movement as already disclosed in Muraki.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Muraki in view of Petersen (U.S. PGPub No. 2018/0095022 A1).
As to claim 10, Muraki does not explicitly disclose a particle sorter, wherein the known offset deflection force is sufficient to offset a drop deposition position by 2 mm or more.
However, Peterson does disclose in ([0005], ll. 7-9; [0055], ll. 7-15) that the deflection plates can apply a force to move the particle by 3 mm or more. Further Peterson disclose a plurality of collection container configurations, some with space as high as 50mm or more.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muraki with a particle sorter, wherein the known offset deflection force is sufficient to offset a drop deposition position by 2 mm or more in order to provide the advantage of increased versatility in using a deflector field strong enough to deflect the particles 3mm or more one can accommodate a wider range of sample containers, potentially as high as 50mm or more between wells.
Claim(s) 17 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Muraki in view of Mason et al. (U.S. PGPub No. 2017/0307502 A1).
As to claim 17, Muraki does not explicitly disclose a particle sorter, wherein the diameter of each partition is 1.8 mm or less.
However, Mason does disclose in ([0311]) the it is well-known in a flow cytometry system to use a microwell for separation of the sample under test where the diameter of each well is 400 um.m or .4 mm. Further that such microwell plate is known to be in production by BD.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muraki with a particle sorter, wherein the diameter of each partition is 1.8 mm or less in order to provide the advantage of reduction in cost in using a microwell plate from a company like BD one can easily acquire a known sorting system without having to spend time and money on developing a unique plate for sorting, while allowing multiple wells for sorting the sample under test.
As to claims 22-25, Muraki does disclose wherein the feedback subsystem comprises a controller (discharge confirming section 14/18) operably connected to the system and to a detector (12) configured to detect a distance a droplet of the droplet stream is offset (i.e. the distance to achieve the desired droplet reaching the acceptor 17 or cell 121) wherein the feedback subsystem is configured to iteratively adjust the offset between the first and second plates (this is implied by the use of “positions” plural, as in clearly in having movement in “all positions” the system of Muraki does not merely have absolute movement in all directions but only ever used one fixed position, instead the position is adjusted clearly based on the need to create a field to allow the droplet to get to a particular sorting position (17/121) ([0064]; [0073]; [0075]-[0076]; [0089]).
Muraki does not explicitly disclose a particle sorter, wherein the droplet deflector further comprises an actuator configured to adjust the offset between the first and second plates or wherein the actuator is operably linked to a feedback subsystem or where the controller is explicitly attached to an actuator and detector when detecting a distance the droplet stream is offset.
However, Muraki does disclose in ([0076], ll. 1-5) the use of multiple forms of adjustment of the noted plates. Further since Muraki is attempting to precisely position plates to move droplets into very precise locations, obviously feedback regarding the position they are in and have moved to is obvious to confirm the disclosed movement has been efficiently and correctly be executed. Further as evidenced by Mason ([0325]) stepper motors (i.e. actuators) to provide a required offset of structures within a flow cell are known. Mason also explicitly discloses in ([0187]) “Any displacement protocol may be employed to move the support structures, such as moving the support stages with a motor actuated translation stage, leadscrew translation assembly, geared translation device, such as those employing a stepper motor, servo motor, brushless electric motor, brushed DC motor, micro-step drive motor, high resolution stepper motor, among other types of motor” as such obviously the disclosed movement of Muraki can use said motors to achieve the disclosed result in a well-known in predictable manner.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muraki as modified by Mason with a particle sorter, wherein the droplet deflector further comprises an actuator configured to adjust the offset between the first and second plates or wherein the actuator is operably linked to a feedback subsystem in order to provide the advantage of expected results as obviously in using a basic actuator linked to a feedback system one can precisely and repeatably move the deflection plates to the desired orientation and confirm said orientation has been realized in a well-known and predictable manner.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Muraki in view of Van den Engh et al. (U.S. Patent No. 5,483,469).
As to claim 18, Muraki does not explicitly disclose a particle sorter, wherein the first and second plates are configured to be parallel to one another.
However, Van den Engh does disclose and show in figures 1, 2 and 4 and in (col. 3, ll. 56-62) the use of deflection plates that are both parallel or at an angle closer in design to Muraki.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muraki wherein the first and second plates are configured to be parallel to one another in order to provide the advantage of expected results in using either parallel or angled plates one can make changes to how the magnetic field is precisely controlled relative to the particles being sorted and such a choice of either is well-known to one having ordinary skill as exemplified by both being present in Van den Engh.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P LAPAGE whose telephone number is (571)270-3833. The examiner can normally be reached Monday-Friday 8-5:30.
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/Michael P LaPage/Primary Examiner, Art Unit 2877
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