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 .
Duplicate Claim Warning
Applicant is advised that should claim 1 be found allowable, claims 9 and 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 1 recites a magnetic chip, claim 9 recites a detection card and claim 11 recites a detection device. The chip, card, and device claim identical structures.
Status of the Claims
Claims 1-11 were pending and are examined herein.
Claim Objections
Claim 11 is objected to because:
Claim 11 recites “detection card, which comprising a magnetic signal detection chip”, should be “detection card, which comprises a magnetic signal detection chip”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-11 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.
Claims 1, 9, and 11 recite sensing units. It is unclear from the claims language that the sensing units are magnetic sensing units. The preamble says magnetic signal detection chip but the claims fail to include elements that correlate with the magnetic signal detection.
Claim 1 recites a magnetic chip, claim 9 recites a detection card, and claim 11 recites a nucleic acid detection device, comprising a detection card. All claims recite chip/card/device of identical structure. It is unclear how the magnetic chip differs from the detection card and the device.
Claims 1 and 9 recite “a plurality of sensing units” and “a plurality of output pads”. The last sentence of each claim recites “each of the leads is connected to the sensing unit and the output pad”. It is unclear if all the leads are connected to the same sensing unit and the same output unit. Claims 2-8 and 10 are rejected because they depend from rejected claims 1 and 9.
Claim 5 recites “a symmetrical manner”. It is unclear what kind of symmetry is recited (rotational, translational, or mirror).
Claim 11 recites a nucleic acid detection device. It is unclear what specific structures make this device a nucleic acid detection device and what structures are responsible for capture of the nucleic acid.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rife et al. (Sensors and Actuators A: Physical, 107:3, 2003, 209-218) and as evidenced by Vo-Dinh et al. (Sensors and Actuators B 74 (2001) 2-11).
Regarding claim 1, Rife teaches design and performance of GMR sensors for the detection of magnetic microbeads in biosensors (Title). The reference teaches:
a magnetic signal detection chip – specifically, chip BARC-III containing an array with 64 individually addressable giant magnetoresistive (GMR) sensors (Fig. 2a-b and pg. 210, col. 2, last par.). The GMR sensors are the sensing units of instant disclosure;
a plurality of output pads, which are arranged outside the sensing region and are located on both sides of the sensing region, wherein taking a first centerline of the sensing region extending along a flow direction of chemical fluid inside the sensing region as a reference, each of the sensing units on one side is connected to a corresponding output pad on the one side via lead, while each of the sensing units on the other side is connected to a corresponding output pad on the other side via lead – specifically, Fig. 2a illustrates the output pads as spots at the ends of the wires leading from the sensor units to the periphery of the chip. Fig. 2a does not explicitly show flow inside the chip, however, Rife teaches that BARC chip is based on fluid flow – “In the current prototype BARC system (a tabletop apparatus), the assay is performed inside a flow cell mounted over the sensor chip” (pg. 210, col. 1, last par.) and
a plurality of the leads, each of the leads is connected to the sensing unit and the output pad – specifically, Fig. 2a illustrates wires (leads) leading from the sensor units to the output pads on the periphery of the chip.
Regarding claim 2, Rife teaches that on both sides of the sensing region, some output pads are arranged in one row respectively, which extends along the flow direction (Fig. 2a).
Rife does not specifically teach that all output pads on each side are arranged in one row. However, specific arrangement of the output pads on the sides of the sensing region would not have modified the function of the chip. Therefore, the particular placement of the output pads is an obvious matter of design choice. See MPEP 2144.04 - In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Regarding claim 3, Rife teaches the number of the output pads on the one side is equal with the number of the output pads on the other side (Fig. 2a).
Regarding claim 4, Rife does not specifically teach that in the flow direction the region where the output pads are arranged does not exceed the region where the sensing units are arranged. However, specific arrangement of the output pads to fit the length of the sensing region in the flow direction would not have modified the function of the chip (MPEP 2144.04). Therefore, the particular placement of the output pads is an obvious matter of design choice.
Regarding claim 5, Rife teaches the plurality of sensing units are divided into multiple groups, and multiple groups of the sensing units are disposed in a symmetrical manner with respect to a second centerline of the sensing region, wherein the second centerline extends along a direction orthogonal to the flow direction - Fig. 2a illustrates that the sensing units are divided into four symmetrical groups according to claim 5 limitation.
Regarding claim 6, Rife teaches the plurality of sensing units are arranged in multiple rows, which extend along the flow direction – Fig. 2a-b illustrate three rows of sensing units arranged symmetrically along the length of the sensor chip.
Rife does not specifically teach the sensing units in one row are staggered from the sensing units in an adjacent row. However, specific arrangement of the sensing units in a staggered configuration would not have modified the function of the sensing units and the chip (MPEP 2144.04). The chemical fluid flow would have reached all the sensing units regardless of their arrangement in the staggered or non-staggered configuration. Therefore, the particular placement of the sensing units is an obvious matter of design choice.
Regarding claim 7, Rife teaches that each sensor unit has two leads, one lead is on the left-hand side going up and the other is on the right-hand side of the sensor going down (Fig. 2c). The function of the ground lead inherently does not require a separate ground pad for each individual ground lead. All ground leads from individual sensor units are connected together and have four output leads connected to four ground pads on the periphery of the sensor chip – ground leads coincide with “Ref. sensor” and “Ref.” markings in Fig. 2b.
Regarding claim 8, the four ground pads are arranged in the rows of the output pads along the flow direction (Fig. 2b).
Regarding claims 9-10, Rife teaches a detection card, comprising a magnetic signal detection chip comprising the sensing units according to claim 9 - “The chip itself is wire-bonded to a printed circuit board housed in a disposable plastic cartridge that contains all the required reagents. The cartridge plugs into an automated electronic controller and connects to a miniature pumping system” (pg. 210, col. 1, last par.). The disposable plastic cartridge of Rife is the detection card of instant invention.
Rife does not explicitly teach the limitation of claim 10 reciting “a plurality of bond pads and a plurality of wires, wherein the output pad on one side of the magnetic signal detection chip is connected to the bond pad on the one side via the wire, while the output pad on the other side of the magnetic signal detection chip is connected to the bond pad on the other side.” However, it is a standard practice to mount a sensor chip on a board which provides mechanical support for the chip and means for connecting the chip outputs to inputs of device’s electronic circuit to further process chip’s signals and generate an output for a performed measurement.
Vo-Dinh provides evidence for a biochip sensor element (an array of sensing units) mounted on a biochip platform which provides a number of electrical connections (pins) for interaction with the device electronic circuit (Fig. 6a).
Regarding claim 11, Rife teaches a nucleic acid detection device, comprising a detection card, which comprising a magnetic signal detection chip of claim 1. Specifically, the reference teaches that the approach used in the Bead ARray Counter biosensor system (BARC) has been applied to the detection of DNA (pg. 210, col. 1, par. 2). Additionally, Rife teaches “The chip itself is wire-bonded to a printed circuit board housed in a disposable plastic cartridge that contains all the required reagents. The cartridge plugs into an automated electronic controller and connects to a miniature pumping system” (pg. 210, col. 1, last par.). The combination of the disposable plastic cartridge with the reagents, the automated electronic controller, and the miniature pumping system is the detection device of instant invention.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 14-18 of copending Application No. 17/914,396 (reference application). Although the claims recite a method, the method comprises a device to which the instant claims are directed.
Instant claims 1 and 11 are anticipated by claims 12 and 14-18 of ‘396 reciting a method of detecting composition containing target DNA fragment in chemical fluid, comprising the following steps: chemical fluid flowing step and detecting step, in which the composition containing the target DNA fragment is detected by the magnetic signal detection chip.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (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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/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677