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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group I, claims 1-10, without traverse, filed April 30, 2026 is acknowledged and has been entered. Claims 11-30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention. Accordingly, claims 1-30 are pending. Claims 1-10 are under examination.
Priority
2. Based on the filing receipt, the effective filing date of the instant application, therefore, is July 20, 2023.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 12-16, and 20-23 of copending Application No. 19/563,353 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a magnetic-field biosensor comprising: a substrate (common substrate); a plurality of magnetic-field sensing elements (one or more magnetoresistance (MR) elements) on the substrate, comprising: a first magnetic-field sensing element (first MR element); and a second magnetic-field sensing element (second MR element); an insulator (top insulating layer) on the substrate and the plurality of magnetic-field sensing elements, the insulator having a first plurality of portions and a second plurality of portions; wherein the second plurality of portions is thicker (200 nm thicker) than the first plurality of portions; and wherein the second plurality of portions has less sensitivity that the plurality of the first options. The first and second magnetic-field sensing elements are in a half bridge. The first and second magnetic-field sensing elements are in a full bridge.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Klein et al. (2021/0138462 A1) in view of Kasajima et al. (US 2024/0248156 A1).
Klein et al. disclose giant magnetoresistance element-based (GMR-based) magnetic-field biosensor (Figure 2E) comprising: a substrate; a plurality of magnetic-field sensing elements (GMR sensors 280) on the substrate, comprising: a first magnetic-field sensing element (first GMR) and a second magnetic-field sensing element (second GMR); and an insulator (non-magnetic conductive or insulator layers) on the substrate and the plurality of magnetic-field sensing elements that result in a highly sensitive magnetic sensor ([0057]; Figure 2E). Klein et al. specifically teach that each substrate may serve as a scaffold for each component above it (i.e. GMR sensors) [0057]. The insulator has a first plurality of portions and a second plurality of portions (layers: metallic multilayered structure with non-magnetic conductive interlayer sandwiched between two magnetic layers). According to Klein et al., the insulator may be constructed using a metallic structure with several nanometers of non-magnetic conductive film ([0057-0059]; Figure 2D; Figure 2E). The magnetic-field biosensor further comprises a first receptor (capture antibody) configured to attach to biological material (target, protein, biomarker) on a first portion of the first plurality of portions and directly above the magnetic-field sensing elements (i.e. first GMR); and a second receptor (capture antibody) configured to attach to the biological material on a first portion of the second plurality of portions and directly above the magnetic-field sensing elements (i.e. second GMR) ([0057, 0135]; Figure 2E). The first magnetic-field sensing element is configured to detect a magnetic field from a first magnetic nanoparticle (mNP1: nanomagnetic beads) attached to the biological material that is attached to the first receptor; and the second magnetic-field sensing element is configured to detect a magnetic field from a second magnetic nanoparticle (mNP2: nanomagnetic beads) attached to the biological material that is attached to the second receptor ([0057-0059]; Figure 2E).
Klein et al. teach that the first and second magnetic-field sensing elements are each a GMR element/sensor or a tunneling magnetoresistance (TMR) element [0135]. The magnetic-field biosensor comprises at least one magnetic coil in the substrate or magnetic field generator external to the substrate. The at least one coil generates the applied magnetic field. ([0061, 0163]; Figure 3). The biological material may be any one of a protein, a biomarker or a biological cell [0057, 0135]. The plurality of magnetic-field sensing elements further comprises: a third magnetic-field sensing element; and a fourth magnetic-field sensing element; a third receptor (capture antibody) configured to attach to the biological material (multiple biomarkers) on a second portion of the first plurality of portions and directly above the third magnetic-field sensing element; and a fourth receptor configured to attach to the biological material (multiple biomarkers) on a second portion of the second plurality of portions and directly above the fourth magnetic-field sensing element. The third magnetic-field sensing element is configured to detect a magnetic field from a third magnetic nanoparticle (mNP3) attached to the biological material that is attached to the third receptor (i.e. an array of GMR sensors) [0135]. The fourth magnetic-field sensing element is configured to detect a magnetic field from a fourth magnetic nanoparticle (mNP4) attached to the biological material that is attached to the fourth receptor. Klein et al. teach that the first and second magnetic-field sensing elements are each serpentine-shaped as fitted along a serpentine channel of the biosensor [0133].
Klein et al. is silent in teaching that the second magnetic-field sensing element is configured to detect at least ten percent less of a magnetic field from a second magnetic nanoparticle (mNP2) attached to the biological material that is attached to the second receptor than the first magnetic-field sensing element detects from a first magnetic nanoparticle (mNP1) attached to the biological material that is attached to the first receptor, and wherein an output of the first magnetic-field sensing element and an output of the second magnetic-field sensing element are used to sense the magnetic field from the first magnetic nanoparticle (mNP1) by reducing an effect of an applied magnetic field. Klein et al. is also silent in teaching that the fourth magnetic-field sensing element is configured to detect at least ten percent less of a magnetic field from a fourth magnetic nanoparticle (mNP4) attached to the biological material that is attached to the fourth receptor than the third magnetic-field sensing element detects from a third magnetic nanoparticle (mNP3) attached to the biological material that is attached to the third receptor.
However, Klein et al. indeed, teach that the insulator may have a metallic multilayered structures with non-magnetic conductive interlayers sandwiched between two magnetic layers; and may be constructed as a structure with several nanometers height of non-magnetic conductive film which appear to encompass the first and the second plurality of portions recited in claim 1 ([0057-0059]; Figure 2D; Figure 2E). It is deemed that a device structure and its properties are inseparable. Therefore, if Klein et al. teach the structure of the device as claimed, the properties Applicant discloses and/or claims are necessarily present. When the USPTO shows a sound basis for believing that the product of the Applicant and the prior art are the same, the Applicant has the burden of showing that they are not. In re Best, 195 USPQ 430 (CCPA 1977), and In re Spada, 15 USPQ2d 1655 (Fed. Cir. 1990). See MPEP § 2112.01.
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)
The claim language “configured to detect at least 10 percent less of a magnetic field” is a statement of purpose and intended result and does result in a structural difference from the magnetic field biosensor taught by Klein et al. The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
Klein et al. further does not teach that the first and second magnetic-field sensing elements are in a half bridge; or that the first and second magnetic-field sensing elements are in a full bridge; or that the first, second, third, and fourth magnetic-field sensing elements are in a full bridge.
Kasajima et al. disclose a magnetic field measurement device that comprises magnetic-field sensing elements (i.e. first, second, third, fourth) which are each a Giant Magneto-Resistance element (GMR) or a Tunnel Magneto-Resistance element (TMR) having magnetosensitive elements with high sensitivity even in a low frequency region and capable of being magnetically saturated. The first and second magnetic-field sensing elements may be in a half bridge connecting two magnetic field sensing elements. The first and second magnetic-field sensing elements may also be in a full bridge connected to a third and a fourth magnetic-field sensing elements ([0027]; Figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to incorporate the teaching of Kasajima on configuring magnetic-field sensing elements of a GMR sensor into the biosensor of Klein to be either one of a half bridge connection or a full bridge connection because Kasajima taught that either configuration is an obvious design choice. One of ordinary skill would have had reasonable expectation of success in incorporating the teaching of Kasajima into the biosensor of Klein because both of Klein and Kasajima teach analogous art in producing a magnetic field-based biosensor device.
It is proper for purposes of the obviousness rejection to interpret the "insulator having a first plurality of portions and a second plurality of portions" recited in claim 1 as encompassing the “metallic multilayered structures with non-magnetic conductive interlayers sandwiched between two magnetic layers” and “constructed using a metallic structures with several nanometers of non-magnetic conductive film” as taught by Klein because unpatented claims are given the broadest reasonable interpretation consistent with the specification.
5. No claims are allowed.
Remarks
6. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Murakami et al. (US 2016/0158155) disclose magnetic-field biosensor comprising: a substrate; a plurality of magnetic-field sensing elements on the substrate, comprising: a first magnetic-field sensing element (a giant magnetoresistance element (GMR)) and a second magnetic-field sensing element (GMR); and an insulator (non-magnetic conductive or insulator layers) on the substrate and the plurality of magnetic-field sensing elements that result in a highly sensitive magnetic sensor: GMR ([0057]; Figure 9). The insulator has a first plurality of portions and a second plurality of portions ([0032, 0053]; Figure 9). The magnetic-field biosensor further comprises a first receptor (capture antibody) configured to attach to biological material on a first portion of the first plurality of portions and directly above the magnetic-field sensing elements (i.e. first) GMRs; and a second receptor (capture antibody) configured to attach to the biological material on a first a portion of the second plurality of portions and directly above the magnetic-field sensing elements (i.e. second) ([0057]; Figure 9). The first magnetic-field sensing element is configured to detect a magnetic field from a first magnetic nanoparticle (mNP1) attached to the biological material that is attached to the first receptor; and the second magnetic-field sensing element is configured to detect a magnetic field from a second magnetic nanoparticle (mNP2) attached to the biological material that is attached to the second receptor ([0057]; Figure 9). and
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
May 15, 2026
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