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 .
Claims 18-37 are pending
Specification
2. The disclosure is objected to because of the following informalities:
a.) On page 1 of the specification, paragraph [001], the status of the cited applications should be updated.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
3. 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.
4. Claim 28 is 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.
Claim 28 is vague as it is not clear as to how a magnetic bead can comprise just recognition elements. The claim would read clearer by saying –“further comprising the magnetic beads functionalized with one or more recognition elements”.
Double Patenting
5. 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6. Claims 18-20, 22, and 25-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No.11,478,797. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘797 claims a system with essentially the same limitations as the instant invention.
Patent ‘797 claims:
1. A high-throughput, microfluidic system for detecting target entities in a fluid containing a quantity of magnetic beads and a quantity of target entities each bound to one or more of the magnetic beads, wherein the magnetic beads are smaller than the target entities and are functionalized for affinity-based binding to specific target entities, the system comprising:
a detector component having a first chamber separated from a second chamber by a plate having a surface facing the first chamber, wherein the plate defines a plurality of micro-openings therethrough, and wherein each micro-opening in the plate is sized to permit passage of the magnetic beads and further sized to prevent passage of the target entities; wherein the first chamber comprises a first inlet and a first outlet,
wherein
(i) the first inlet is arranged to be fluidly connectable to a pump that flows the fluid containing the magnetic beads and target entities into and through the first chamber at a controlled flow rate, and wherein the first outlet is arranged to be fluidly connectable to a collection vessel, or
(ii) the first outlet is arranged to be fluidly connectable to a pump that draws the fluid containing the magnetic beads and target entities into and through the first chamber at a controlled flow rate, and wherein a pump outlet is arranged to be fluidly connectable to a collection vessel; and
wherein the detector component is arranged within an adjustable magnetic field sufficient to attract at least some of the magnetic beads not bound to a target entity through the openings into the second chamber and sufficient to hold at least some of the target entities bound to one or more magnetic beads against the surface of the plate within the first chamber with a sufficient force to restrain the target entities from being washed away by the fluid flowing through the first chamber and across the plate.
2. The system of claim 1, wherein the detector component further includes a viewing panel forming part of the first chamber and arranged to view the surface of the plate in the first chamber.
3. The system of claim 1, further comprising a magnet adjustably arranged adjacent the detector component.
4. The system of claim 1, wherein each of the openings in the plate has an effective dimension of about 3.0 to about 5.0 microns.
5. The system of claim 1, wherein the surface of the plate is provided with a physiologically inert coating.
6. The system of claim 1, further comprising a pump connected to the first inlet or to the first outlet.
7. The system of claim 6, further comprising a control module and a flow protocol, wherein the control module executes the flow protocol to direct the pump to flow the fluid through the first chamber at a flow rate of at least about 1.0 mL/minute.
8. The system of claim 7, wherein the control module controls the magnet to modify the specific magnetic force to permit dislodgment of target entities held on the plate.
9. The system of claim 8, wherein the control module further directs the pump to flow a non-reactive liquid through the first chamber at a specific flow rate and linear flow velocity sufficient to dislodge target entities from the plate.
10. The system of claim 7, wherein the pump includes: a pump outlet connected to the first inlet of the first chamber; and a pump inlet connected to a source of the fluid containing the magnetic beads and the target entities.
11. The system of claim 6, wherein the second chamber includes a second inlet and a second outlet, wherein the second inlet is fluidly connectable to a source of non-reactive fluid different from the fluid containing the magnetic beads and target entities.
12. The system of claim 11, wherein the pump includes: a pump inlet connected to the first outlet of the first chamber and to the second outlet of the second chamber; and a pump outlet connected to a fluid line connectable to a first vessel for receiving fluid pumped through the first outlet and to a separate second vessel for receiving fluid pumped through the second outlet.
13. The system of claim 12, further comprising: a first controllable valve disposed between the first outlet and the second outlet and the pump inlet; and a separate second controllable valve disposed between the pump outlet and the first and second vessels.
14. The system of claim 12, further comprising: a bypass line connected to the second outlet and fluidly connectable to the source of the fluid containing the magnetic beads and target entities; and a controllable valve disposed between the bypass line for selectively directing fluid pumped through the second outlet to either the bypass line or the first vessel or the second vessel.
15. The system of claim 1, further comprising the magnetic beads, wherein each magnetic bead has a largest effective dimension of about 100 nm to about 5.0 microns.
16. The system of claim 1, further comprising: an outlet conduit connected to the first outlet and connectable to a fluid vessel for receiving fluid pumped through the first outlet; a bypass line disposed between the outlet conduit and the first inlet; and a controllable valve for directing fluid flowing through the first outlet to either the fluid vessel or the bypass line.
17. A method for detecting target entities in a fluid containing a quantity of magnetic beads and a quantity of target entities each bound to one or more of the magnetic beads, wherein the magnetic beads are smaller than the target entities and are functionalized for affinity-based binding to specific target entities, the method comprising:
flowing the fluid through a detector component having a first chamber separated from a second chamber by a plate having a surface facing the first chamber, wherein the plate defines a plurality of openings therethrough, and wherein each opening is sized to permit passage of the magnetic beads and to prevent passage of the target entities; and
applying a magnetic force beneath the plate sufficient to draw at least some of the magnetic beads not bound to a target entity through the openings into the second chamber and sufficient to hold at least some of the target entities bound to one or more magnetic beads against the surface of the plate within the first chamber with a sufficient force to restrain the target entities from being washed away by the fluid flowing through the first chamber and across the plate.
18. The method of claim 17, further comprising visualizing the plate surface to determine the presence and/or quantity of target cells.
19. The method of claim 17, further comprising: after the target entities have been held to the plate surface, modifying the magnetic force to a level sufficient to permit dislodgment of the target entities from the plate surface; and flowing a non-reactive liquid through the first chamber to dislodge the target entities.
20. The method of claim 19, wherein modifying the magnetic force includes applying a magnetic force above the plate surface to pull the target entities from the plate surface.
The system of patent ‘797 differs from the instant invention in not specifically positioning the plate and second chamber between the magnetic field and the first chamber.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to position the plate and second chamber between the magnetic field and the first chamber because such a position would draw the magnetic beads against the plate if bound to target entities or through the openings in the plate into the second chamber if not bound to target entities.
With respect to a control module to control the magnetic field and pump, claims 7-8 of patent ‘797 recite a control module that controls the flow rate of the pump and the strength of the magnetic field.
With respect to claim 22, claims 11-14 of patent ‘797 recite a one or more valves for flow of multiple fluid sources.
With respect to claim 26, patent ‘797 recites magnet with an adjustable variable magnetic field which suggests an electromagnet.
With respect to claims 29-34, patent ‘797 recites the magnetic beads being functionalized for affinity based binding to specific target entities wherein the target entities can be cells (claims 17 and 18). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to functionalize the magnetic beads with any of the specific recognition elements recited in instant claims 29-34 because one would use the appropriate binding reagent to detect the desired target entities in a given sample. Patent ‘797 specifically recites cells as target entities and thus one would use the appropriate recognition element that will specifically bind to the cells/target entities.
Allowable Subject Matter
7. Claims 21, 23, 24, and 35-37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 21, 23, and 24 are free of the prior art because the prior art does not teach a system of claim 18 for the detection of more than one target entity and more than one detector in the system of claim 18.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
12/27/2025