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 .
Status of the Claims
Claims 1-10 are pending and examined herein.
Priority
This application, filed 08/29/2023, claims foreign priority to CHINA 202310693299.2, filed 06/12/2023. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 06/12/2023. It is noted, however, that applicant has not filed a certified copy of the CHINA 202310693299.2 application as required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed 08/29/2023 is acknowledged and has been considered.
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.
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.
Claims 1, and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 7,425,455 B2, “BIOSENSOR, MAGNETIC MOLECULE MEASSUREMENT DEVICE” (patent dated 09/16/2008, referred to herein as Fukumoto) in view of WO 2017/207640 A1, “A MAGNETIC MEASUREMENT SYSTEM BASED ON AN ULTRASENSITIVE PHR BIOSENSOR AND A METHOD FOR MEASURING LOW SPECIFIC BIOP ARTICLES CONCENTRATIONS AND QUANTIFYING BIO-PARTICLES INTERACTIONS” (published 12/07/2017, referred to herein as Terki)
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In order words, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 II. Regarding claim 1, the recitation of “configured to detect breast cancer cells in blood samples” is considered an intended use of the claimed device which does not impart a structural significance to the claimed device. Further, the limitations of “that attracts magnetic particles combined with, linked to or bound to breast cancer cells” (lines 4-5), “configured to detect the magnetic particles combined with, linked to or bound to the breast cancer cells” (lines 8-9 and lines 12-13), “configured to linearize a relationship between the resistance of the magneto resistive sensor and the number of magnetic particles in the grid” (lines 15-17), and “configured to sense a position of each of the magnetic particles on the surface of the sensor” (lines 18-19), and “configured to sense the number of the magnetic particles in the grid” (lines 19-20) are all considered to be limitations directed to the intended use of the claimed device, but do not confer a structural difference between the claimed device and the device of the prior art.
Regarding claims 1 and 10, Fukumoto teaches a sensor comprising a metal which generates a magnetic field (col. 10, lines 33-39), a Hall magnetic sensor array (Figure 1, col. 9, lines 46-47), and baffles on walls, i.e. recesses, forming a grid (Figure 1, col. 9, lines 52-55) to accommodate the size of one magnetic particle (col. 9, lines 6-10).
Regarding claim 6, Fukumoto teaches wires on the surface of the sensor (col. 9, lines 21-24).
Regarding claim 7 and 9, Fukumoto teaches the metal comprises a coil or a permanent magnet (col. 10, lines 33-38).
However, Fukumoto does not teach a device comprising a magneto resistive sensor (claim 1) or a Helmholtz coil (claim 8).
Regarding claims 1, 5, and 8, Terki teaches a hybrid AMR/PHR sensor (p. 3, lines 23-26) which contains Hall sensor and magneto resistive sensor components (p. 2, lines 26-31) used with a Helmholtz coil. Terki teaches that the hybrid sensor improves the minimum detection level of bio-particles compared to existing systems (p. 3, lines 5-10).
It would have been obvious to one of skill in the art before the effective filing date of the claimed invention to substitute the AMR/PHR hybrid sensor and Helmholtz coil as taught by Terki for the individual Hall sensors and coil in the array taught by Fukumoto. An artisan would have been motivated to make this change in order to increase the sensitivity, as taught by Terki, of the array for bio-particles measured by Fukumoto. An artisan would have had a reasonable expectation of success in making this substitution because both the Hall sensors taught by Fukumoto and the hybrid sensors taught by Terki are magneto-based sensors used for the measurement of nanoparticles bound by biological targets. Further, Terki teaches that multiple hybrid sensors can be used together (p. 22, lines 17-18), which would suggest to an artisan that they could be used in an array, such as taught by Fukumoto.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Fukumoto in view of Terki as applied to claim 1 above, and further in view of US 2007/0042506 A1, “Apparatus For Carrying Out An Analysis Process, In Particular For Identification Of Biochemical Molecules, And Analysis Process Which Can Be Carried Out Using This Apparatus” (published 02/22/2007, referred to herein as Bangert).
Regarding claims 2-4, Fukumoto teaches that the PHR/AMR hybrid sensor has a rectangular shape (Figure 1).
However, the combined teaching of Fukumoto in view of Terki do not teach that the magneto resistive sensor comprises a TMR device.
Bangert teaches that, when detecting magnetic particles bound to target molecules, the use of AMR, GMR, and TMR sensors are interchangeable and functionally equivalent (para. 100, lines 4-8). Bangert teaches that these sensors are all “based on different magneto-resistance effects which occur in layer systems with very thin layers” (para. 100, lines 4-8).
It would have been obvious to one of skill in the art to substitute TMR components, as taught by Bangert, for the AMR components in the hybrid sensor taught by Fukumoto in view of Terki. One having ordinary skill in the art would have been motivated to make such a change as a mere alternative and functionally equivalent detection technique and since the same expected detection of particles would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired device orientation. An artisan would have had a reasonable expectation of success in making this change because, as taught by Bangert, the components, i.e. thin layers, are readily interchangeable for the use of nanoparticle detection in the field of biosensing.
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 May 22, 2026
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