DETAILED ACTION
Claims 1-13 and 15 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 06/11/2024, 10/14/2024, and 03/18/2025 have been considered by the examiner.
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.
1.Claims 1-13 and 15 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.
The term “functional proximity” in claims 1, 4, 6, and 13 is a relative term which renders the claim indefinite. The term “functional proximity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A skilled artisan would lack a clear and specific understanding of what distances between the magnetic label and the magnetic tunnel unction would make this device and method inoperable.
Claims 2-3, 5, 7-12, and 15 are included in this rejection because they depend on rejected independent claims 1 and 13.
Instant claim 11 recites “wherein said sample is contacted with at least 100 sensor elements, at least 300 sensor elements, at least 500 sensor element, at least 1,000 sensor element, at least 5,000 sensor elements, at least 10,000 sensor element, at least 50,000 sensor elements or at least 100,000 sensor elements”. The specification does not provide any examples or further clarification on what elements are being referred to. It is unclear if the element is the bioreceptors, the transducers, the signal amplifier, the signal processors, the electrodes, the insulator, the storage or free layers, and/or the magnetic field. It is unclear what element of the sensor the applicant is referring to.
Claim 12 is also rejected under 35 USC 112(b) as it depends on rejected claim 11.
Claim 6 recites “wherein said at least one magnetic label is located in functional proximity to the magnetic tunnel junction with a first occurrence rate if the second binding agent is in an unbound state and becomes in functional proximity to the magnetic tunnel junction with a second occurrence rate if the second binding agent is part of the complex, wherein said second occurrence rate is higher than the first occurrence rate”. The specification does not provide any examples or further clarification on a “first occurrence rate” and a “second occurrence rate” are. It is unclear if the “occurrence rate” is referring to a fluctuation rate, switch rate, generation rate, sampling rate, failure rate, or defect occurrence, for example. It is unclear what rate the applicant is referring to.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
2.Claims 1-5, 7-10, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Aghvanyan et al., (WO 2015175856 A1) (IDS filed on 06/11/2024), in view of Koo et al., (US20070154881A1) (IDS filed on 06/11/2024), and in view of Shi et al., (WO 2009091589 A1).
Aghvanyan teaches a method and device for determining an analyte suspected to be present in a sample (see claim 1 of Aghvanyan) comprising:
(a) contacting said sample with a sensor element (see page 96 lines 1-5, see page 100 lines 9-15) comprising:
(i) an anchor layer which is present on a solid support (see page 95 “reagents may be present in free form or supported on solid phases”, see claim 1 of Aghvanyan, see page 39 lines 3-4 “The surface can also comprise a slide, assay chips, or assay array; a pin, probe, bead, or filtration media; lateral flow media, e.g., a filtration membrane”);
(ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer (see claim 1 of Aghvanyan);
(iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support (see claim 1 of Aghvanyan) (instant claims 1, 13, and 15).
Aghvanyan teaches the sample being under conditions sufficient for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent (see page 50 lines 4-25) , and (b) detecting the formation the complex of first binding agent, analyte and second binding agent based on an altered signal whereby the analyte is determined (see page 96 lines 20-30) (instant claim 1). Aghvanyan teaches wherein said signal can be detected for a predetermined characteristic time period (see page 100 lines 9-18) (instant claim 3). Aghvanyan teaches the anchor layer is a lipid layer (see page 83 lines 20-23 “In order to probe internal target molecules, (cargo proteins, lipids or RNA molecules) the exosomes can be fixed and permeablized either prior to or after capture but before adding detection reagents.”) (instant claim 7). Aghvanyan teaches the first and second binding agents being selected from the group consisting of: an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claims 3-4 of Aghvanyan) (instant claims 8-9). Aghvanyan teaches wherein said determining an analyte comprises determining the amount of said analyte (see page 5 lines 10-13 “The measuring step of embodiment (1) can further comprise binding the extended sequence to a detection probe having a detectable label, measuring the detectable label and correlating the measurement to the amount of analyte in the sample”) (instant claim 10). Aghvanyan teaches a kit for determining an analyte suspected to be present in a sample (see claim 31 of Aghvanyan) (instant claim 15).
Aghvanyan does not teach the second binding agent comprising at least one magnetic label nor the use of a magnetic tunnel junction.
Koo teaches a second binding agent comprising at least one magnetic label (see claims 1 and 9 of Koo). Koo teaches label detection by magnetic tunnel junction (see [0094], see [0099]) (instant claims 1, 13, and 15). Koo teaches wherein said formation of the complex of first binding agent, analyte and second binding agent is detected by measuring the strength and/or duration of a signal elicited by the at least one magnetic label (see claims 1 and 9 of Koo, see [0085]) (instant claim 2).
Aghvanyan and Koo do not teach the binding agent being in proximity to the second binding agent and the binding agent generating a signal when its in proximity to a magnetic label.
Shi teaches that the binding agent is in proximity to the magnetic tunnel junction (see page 7) and the binding agent generates a signal when it is in proximity to a magnetic label (see page 10). Shi teaches that the altered signal is generated by the magnetic tunnel junction and the signal indicates the analyte is present (see page 10) (instant claims 1, 13, and 15). Shi teaches the magnetic label is located outside of the functional proximity and/or outside the anchor layer if the second binding agent is in an unbound state and comes located in a functional proximity if the second binding agent is a part of the complex (see claims 20-21 of Shi, see page 1-2 “The magnetic beads are made to attach to the molecules by coating the beads with a chemical or biological species that binds (e.g. by covalent bonding) to the molecules in the mixture. Then, a surface (i.e., a solid substrate) is provided on which there has been affixed receptor sites (specific molecules) to which only the target molecules will bond…”, see pages 5-6 “The magnetizable particles are preferably superparamagnetic iron-oxide impregnated polymer beads and the sensor is a magnetoresistive material. The detector can indicate the presence or absence of a target molecule while molecules that do not bind to the recognition agents (non-target molecules) are removed from the system by the application of a magnetic field.”) (instant claims 4-5).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant application to combine the methods and device for determining an analyte suspected to be present in the sample taught by Aghvanyan with the magnetic labels of Koo, with the magnetic tunnel junction sensor of Shi. Aghvanyan teaches the use of magnetized particles and the use of magnetic fields (see pages 68-69, see page 101). Koo provides motivation by teaching that magnetic labels allows for detection through optical readout (see [0007], see claim 1 of Koo). Shi provides motivation by teaching that magnetic tunnel junction sensors are effective for detecting the presence of target molecules (see page 1). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
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.
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.
3.Claims 1-3, 7-10, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12, and 15 of copending Application No. 18541476 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1 and 13, ‘476 teaches a method and device for determining an analyte suspected to be present in a sample comprising:(a) contacting said sample with a sensor element comprising: (i) an anchor layer which is present on a solid support; (ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer; (iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support, said second binding agent comprising at least one magnetic label; for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent; and (b) detecting the formation of the complex of first binding agent, analyte and second binding agent whereby the analyte is determined (see claims 1, 10, and 12 of ‘476).
While the claims do not explicitly state the use of magnetic tunnel junctions, the specification of 18541476 teaches separate detection by using magnetic tunnel junctions (see page 12).
Regarding instant claim 2, ‘476 teaches wherein said formation of the complex of first binding agent, analyte and second binding agent is detected by measuring the strength and/or duration of a signal elicited by the at least one magnetic label (see claims 2 and 10 of ‘476).
Regarding instant claim 3, ‘476 teaches wherein said signal can be detected for a predetermined characteristic time period (see claim 3 of ‘476).
Regarding instant claim 7, ‘476 teaches wherein said anchor layer is a lipid layer or lipid bi-layer (see claim 4 of ‘476).
Regarding instant claim 8, ‘476 teaches wherein said first binding agent is selected from the group consisting of: an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claim 7 of ‘476).
Regarding instant claim 9, ‘476 teaches wherein said second binding agent is selected from the group consisting of: an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claim 8 of ‘476).
Regarding instant claim 10, ‘476 teaches wherein said determining an analyte comprises determining the amount of said analyte (see claim 9 of ‘476).
Regarding instant claim 15, ‘476 teaches a kit for determining an analyte suspected to be present in a sample (see claim 15 of ‘476).
This is a provisional nonstatutory double patenting rejection.
4. Claims 1-3, 10-13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 14, 19, 21, and 35 of copending Application No. 17350822 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, ‘882 teaches a method for determining an analyte suspected to be present in a sample comprising:(a) contacting said sample with a sensor element comprising: (i) an anchor layer which is present on a solid support; (ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer; (iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support, said second binding agent comprising at least one magnetic label; and (iv) a magnetic tunnel junction in functional proximity to the second binding agent which generates a signal elicited in proximity to the at least one magnetic label of the second binding agent; for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent; and (b) detecting the formation the complex of first binding agent, analyte and second binding agent based on an altered signal which is generated by the magnetic tunnel junction whereby the analyte is determined (see claim 1 of ‘882).
Regarding instant claim 2, ‘882 teaches wherein said formation of the complex of first binding agent, analyte and second binding agent is detected by measuring the strength and/or duration of a signal elicited by the at least one magnetic label (see claim 2 of ‘882).
Regarding instant claim 3, ‘882 teaches wherein said signal can be detected for a predetermined characteristic time period (see claim 3 of ‘882).
Regarding instant claim 10, ‘882 teaches wherein said determining an analyte comprises determining the amount of said analyte (see claim 8 of ‘882).
Regarding instant claim 11, ‘882 teaches wherein said sample is contacted with at least 100 sensor elements (see claim 19 of ‘882).
Regarding instant claim 12, ‘882 teaches wherein said determining the amount of said analyte comprises counting the individual measured signals generated by the magnetic tunnel junctions (see claim 21 of ‘882).
Regarding instant claim 13, ‘882 teaches a device for determining an analyte suspected to be present in a sample comprising a sensor element comprising:(i) an anchor layer which is present on a solid support; (ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer; (iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support, said second binding agent comprising at least one magnetic label; and (iv) a magnetic tunnel junction in functional proximity to the second binding agent which generates a signal elicited in proximity to the at least one magnetic label of the second binding agent (see claim 14 of ‘882).
Regarding instant claim 15, ‘882 teaches a kit for determining an analyte suspected to be present in a sample comprising the device of claim 13 (see claim 35 of ‘882).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
5.Claims 1-3, 7-13, and 15 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-4, 7-8, 10-13, and 15 of copending Application No. 18541875 (reference application).
Regarding instant claim 1, ‘875 teaches a method for determining an analyte suspected to be present in a sample comprising:(a) contacting said sample with a sensor element comprising: (i) an anchor layer which is present on a solid support; (ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer; (iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support, said second binding agent comprising at least one magnetic label; and (iv) a magnetic tunnel junction in functional proximity to the second binding agent which generates a signal elicited in proximity to the at least one magnetic label of the second binding agent; for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent; and (b) detecting the formation the complex of first binding agent, analyte and second binding agent based on an altered signal which is generated by the magnetic tunnel junction whereby the analyte is determined (see claim 1 of ‘875).
Regarding instant claim 2, ‘875 teaches wherein said formation of the complex of first binding agent, analyte and second binding agent is detected by measuring the strength and/or duration of a signal elicited by the at least one magnetic label (see claim 2 of ‘875).
Regarding instant claim 3, ‘875 teaches wherein said signal can be detected for a predetermined characteristic time period (see claim 3 of ‘875).
Regarding instant claim 7, ‘875 teaches wherein said anchor layer is a lipid layer or lipid bi-layer (see claim 4 of ‘875).
Regarding instant claim 8, ‘875 teaches wherein said first binding agent is selected from the group consisting of: an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claim 7 of ‘875).
Regarding instant claim 9, ‘875 teaches wherein said second binding agent is selected from the group consisting of: an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claim 8 of ‘875).
Regarding instant claim 10, ‘875 teaches wherein said determining an analyte comprises determining the amount of said analyte (see claim 10 of ‘875).
Regarding instant claim 11, ‘875 teaches wherein said sample is contacted with at least 100 sensor elements, at least 300 sensor elements, at least 500 sensor element, at least 1,000 sensor element, at least 5,000 sensor elements, at least 10,000 sensor element, at least 50,000 sensor elements or at least 100,000 sensor elements (see claim 11 of ‘875).
Regarding instant claim 12, ‘875 teaches wherein said determining the amount of said analyte comprises counting the individual measured signals generated by the magnetic tunnel junctions (see claim 12 of ‘875).
Regarding instant claim 13, ‘875 teaches a device for determining an analyte suspected to be present in a sample comprising a sensor element comprising:(i) an anchor layer which is present on a solid support; (ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer; (iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support, said second binding agent comprising at least one magnetic label; and (iv) a magnetic tunnel junction in functional proximity to the second binding agent which generates a signal elicited in proximity to the at least one magnetic label of the second binding agent (see claim 13 of ‘875).
Regarding instant claim 15, ‘875 teaches a kit for determining an analyte suspected to be present in a sample comprising the device of claim 13 (see claim 15 of ‘875).
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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