Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
2. The 112(a) rejection of claim 1 and 3-6 is withdrawn in view of Applicant’s amendments.
3. The 112(b) rejection of claims 2 and 4 is withdrawn in view of Applicant’s amendment.
Double Patenting
4. 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.
5. Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,441,950. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘950 claims a method with essentially the same steps as the instant invention.
Patent ‘950 claims:
1. A method for transferring a target from a first fluid at a first location to a second location, the target being bound to a solid phase substrate to form a target bound solid phase substrate, comprising:
forming a non-concave meniscus with the first fluid;
providing a transfer device with a lower transfer surface and an upper surface;
positioning a transfer region of the lower transfer surface of the transfer device in axial alignment with and in spaced relation to the non-concave meniscus so as to provide a non-liquid air gap therebetween;
generating a force adjacent to the upper surface of the transfer device that is sufficient to attract the target bound solid phase substrate toward the transfer region;
drawing the target bound solid phase substrate from the first fluid, through the non-liquid air gap, and to the transfer region of the transfer device with the force;
maintaining the target bound solid phase substrate adjacent to the transfer region of the transfer device with the force;
aligning the transfer region with the second location, spaced from the first location;
reducing the force on the target bound solid phase substrate such that the force is insufficient to maintain the target bound solid phase substrate adjacent to the transfer region of the transfer device so as to release the target bound solid phase substrate from the transfer region of the transfer device and allow the target bound solid phase substrate to pass to the second location.
The method of patent ‘950 differs from the instant method in not having a reagent on the upper surface.
However, it would be obvious to one of ordinary skill in the art to place a reagent on the upper surface for further reaction with the targets.
6. Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,590,409. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘409 claims a method with steps and a device with essentially the same limitations as the instant method.
Patent ‘409 claims:
1. A method to facilitate the disaggregation of a plurality of solid phase substrates as the plurality of solid phase substrates are transferred from a first location to a second location, each solid phase substrate having a dimension and being configured to allow targets to bind to a corresponding one of the plurality of solid phase substrates, comprising the steps of:
providing the plurality of solid phase substrates coated with receptors and a plurality of particles in a first fluid, each of the plurality of particles has a dimension greater than the dimensions of each of the plurality of solid phase substrates;
selectively binding the targets in the first fluid to the receptors coated on the plurality of solid phase substrates;
depositing the first fluid on a first surface defining the first location, at least a first portion of the plurality of solid phase substrates forming an aggregation in the first fluid;
generating a force adjacent to a second surface defining the second location, the second surface being opposed to and generally parallel to the first surface; and
drawing the plurality of solid phase substrates from the first location to a second location with the force such that the plurality of solid phase substrates exit the first fluid; wherein:
the plurality of particles intersect the aggregation of the plurality of solid phase substrates and cause at least a second portion of the plurality of solid phase substrates to disaggregate from the aggregation of the plurality of solid phase substrates as the plurality of solid phase substrates is drawn from the first location to the second location.
2. The method of claim 1 wherein the plurality of particles are magnetic.
3. The method of claim 1 wherein the force generated is a magnetic force.
5. The method of claim 1 wherein the plurality of solid phase substrates are magnetic beads.
7. A method to facilitate the disaggregation of a plurality of solid phase substrates as the plurality of solid phase substrates are transferred from a first location to a second location, the plurality of solid phase substrates being configured to allow targets to bind to the plurality of solid phase substrates, the method comprising the steps of:
providing the plurality of solid phase substrates coated with receptors and a plurality of particles in a first fluid, each of the plurality of particles has a dimension and each of the plurality of solid phase substrates has a dimension, the dimensions of the plurality of particles being greater than the dimensions of the plurality of solid phase substrates;
selectively binding the targets in the first fluid to the receptors coated on the plurality of solid phase substrates;
depositing the first fluid on a first surface defining the first location, at least a first portion of the plurality of solid phase substrates forming an aggregation at the first location;
generating a force adjacent to a second surface defining the second location, the second surface being opposed to and generally parallel to the first surface; and
drawing the plurality of solid phase substrates from the first location to a second location with the force such that the plurality of solid phase substrates exit the first fluid; wherein:
the force causes the plurality of particles of the mixture to travel to the second location at a velocity greater than a velocity at which the plurality of solid phase substrates travels to the second location such that the plurality of particles intersect and disaggregate at least a second portion of the plurality of solid phase substrates from the aggregation of the plurality of solid phase substrates.
8. The method of claim 7 wherein the plurality of particles are magnetic.
9. The method of claim 7 wherein the force generated is a magnetic force.
10. The method of claim 7 wherein the plurality of solid phase substrates are magnetic beads.
The method of patent ‘409 differs from the instant method in the device used in the method does not recite an air gap between the first and second surfaces (i.e. plates as defined by the specification of patent ‘409) and provide a reagent on the second plate.
However, it would be obvious to one of ordinary skill in the art that the device in the method of patent ‘409 has an air gap between the first and second surfaces because particle are drawn out of the fluid between the first and second surfaces so there has to be an air gap for the particles to be drawn into from the liquid.
With respect to a reagent on the second plate, it would be obvious to provide a reagent on the second plate for further reaction with the targets.
7. Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,040,062 or 12,227,739. Although the claims at issue are not identical, they are not patentably distinct from each other because patents ‘062 and ‘739 claim devices with the same limitations as the device used in the instant method and when used make the instant method obvious.
Patent ‘062 claims:
1. A device for transferring a target received in a first fluid at a first location to a second location, the target being bound to a solid phase substrate to form a target bound solid phase substrate, comprising:
a transfer structure having a first surface and a second surface, the second surface defining a transfer surface including a first region for receiving the target bound solid phase substrate thereon for transfer and being movable between a first position wherein the transfer surface is axially aligned with an apex of the first fluid at the first location and spaced from the apex of the first fluid by a non-liquid air gap and a second position wherein the transfer surface is aligned with the second location which is spaced from the first location;
an alignment structure for aligning the transfer surface with respect to the second location, with the transfer surface in the second position; and
a force generator adjacent the first surface of the transfer structure and being configured to generate a force, the force generator being movable with respect to the transfer surface between a non-attraction position wherein the target bound solid phase substrate is free of the force and an attraction position; wherein, with the transfer surface in the first position and the force generator in the attraction position; wherein:
the transfer surface is spaced from the first location by a distance such that the force is sufficient to attract the target bound solid phase substrate; and
the target bound solid phase substrate received in the first fluid at the first location exits the first fluid and travels through the non-liquid air gap toward the first region of the transfer surface in response to the attraction of the target bound solid phase substrate to the force.
Patent ‘739 claims:
1. A device for facilitating the disaggregation of targets in a biological sample, comprising:
a mixture at least partially defined by:
a plurality of solid phase substrates coated with receptors, the plurality of solid phase substrates having dimensions, being magnetic and being moveable in response to a magnetic force, the targets in the biological sample selectively bindable to the receptors of the plurality of solid phase substrates and at least a portion of the plurality of solid phase substrates defining an aggregation in the mixture; and
a plurality of magnetic particles having dimensions greater that the dimensions of the plurality of solid phase substrate, the plurality of magnetic particles being free of receptors to which the targets selectively bind;
a first plate having a first side defining a first supporting surface for supporting the mixture and a second side; a second plate positioned alongside the first plate and spaced from the first plate such that the first side of the first plate and the first side of the second plate are out of contact and define a gap therebetween, the second plate having a first side defining a second supporting surface directed at the first supporting surface and a second side; and
a magnetic force generator generating a magnetic force, the magnetic force generator positionable adjacent the second side of the second plate such that the magnetic force acts on the plurality of magnetic particles and causes the plurality of magnetic particles in the mixture to travel through the gap between the first and second plates toward the second supporting surface, whereby the aggregation of the at least a portion of plurality of solid phase substrates in the mixture is disaggregated; wherein:
the mixture is receivable on the first supporting surface prior to the magnetic force acting on the plurality of magnetic particles;
the first and second plates are spaced such that at least a portion of the plurality of magnetic particles in the mixture are out of contact with both the first and second plates as the at least the portion of the plurality of magnetic particles in the mixture travels through the gap; and the aggregation of the at least a portion of plurality of solid phase substrates in the mixture is disaggregated by the plurality of magnetic particles travelling through the gap between the first and second plates.
Patents ‘062 and ‘739 differ from the instant invention in not claiming a method using the devices where a reagent is provided on the second/upper plate.
The instant method is obvious over the devices of patents ‘062 and ‘739 because the steps of the instant method are how the devices of patent ‘062 and ‘739 are to be used. A sample is applied on the first surface or lower plate of the devices of patent ‘062 and ‘739. A magnetic force is applied adjacent to the second surface or upper plate which draws target bound solid phase substrate in the sample from the first surface or lower plate through a non-liquid air gap between the surfaces or plates.
With respect to providing a reagent on the second surface or plate, it would be obvious to provide a reagent on the second surface or plate for further reaction with the targets.
8. The nonstatutory double patenting rejection of claim 1-4 over U.S. Patent No. 10,996,149 is withdrawn in view of Applicant’s arguments.
Response to Arguments
9. Applicant's arguments filed 1/2/26 have been fully considered but they are not persuasive.
a.) In response to the non-statutory double patenting rejections over US Patents 10,040,062; 10,441,950; 10,590,409; and 12,227,739, Applicants argue that the cited patents cannot serve as reference patents for non-statutory double patenting rejections based on the Ex Parte Baurin PTAB decision.
Applicant’s arguments have been considered but are not convincing because PTAB decision are non-precedential. The non-statutory double patenting rejections based on the aforementioned patents are proper and are maintained.
Allowable Subject Matter
10. Claims 1-6 are free of the prior art of record. The closest prior art is Ismagilov et al (US 2012/0028342) which disclose a device comprising a first plate and second plate but fails to disclose an air gap between the plates. While Ismagilov et al teach the use of magnetic particles, the magnet used to manipulate the magnetic particle does not draw magnetic particles from a sample from a first plate through an air gap to a second plate.
Conclusion
11. 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.
12. 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
9/30/2025