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 18-20 have been cancelled. Claims 21-23 have been added. Claims 1-17 and 21-23 are pending and examined herein.
Priority
This application, filed 10/11/2022, claims benefit to 63/362,627, filed 04/07/2022, and 63/254,946, filed 10/12/2021. This priority is acknowledged and the claims examined herein are treated as having an effective filing date of 10/12/2021.
Information Disclosure Statement
The Information Disclosure Statement filed 02/02/2026 is acknowledged and have been considered.
Withdrawn Rejections/Objections
The rejection of claims 1-9 under 35 U.S.C. 102 has been withdrawn in response to Applicant’s amendment.
The rejection of claims 18-20 under 35 U.S.C. 103 has been withdrawn in response to Applicant’s cancellation of the claims.
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 1-9 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over by WO 2017/059353 A1, “SORTING BIOLOGICAL AND NON-BIOLOGICAL MOIETIES USING MAGNETIC LEVITATION” (published 04/06/2017, referred to herein as Baday).
Regarding claim 1-4, 7, and 23, Baday teaches a method of cell separation comprising combining a magnetic microparticle conjugated with a species-specific antibody and a population of cells comprising multiple cell types (para. 00155, lines 1-8). Baday teaches forming a suspension of the magnetic complexes and the heterogeneous population in paramagnetic fluid medium and introducing it into a flowcell cartridge (para. 0014, lines 1-8). Baday teaches that the moieties are cells (para. 0025, lines 1-2). Baday teaches exposing the channel to a magnetic field “to separate the heterogeneous population based on a difference in…magnetic susceptibility” (para. 0014, lines 4-8). Baday teaches that application of the magnetic field blocks at least some magnetic members from flowing, i.e. immobilizing these members (para. 0018, lines 9-11). Baday teaches separating the populations of cells by flowing out of separate outlets based on magnetic susceptibility, thereby forming a suspension depleted of the magnetic complex (para. 0014, lines 8-11). Baday teaches withdrawing the suspension depleted of the magnetic complex through one of two outlet channels (para. 0014, lines 8-11). Baday teaches a device with a single inlet to separate cells (para. 00134, lines 1-5).
However, Baday does not specifically teach each step of the claimed method with the device comprising a single inlet.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method steps taught by Baday with the single inlet device taught by Baday. Doing so is considered to be Combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)). Doing so would result in using the device in order to predictably separate cells, which is the intended use of the device as taught by Baday (para. 00134, lines 1-5).
Regarding claim 5, Baday teaches targeting bacterial cells (para. 00155, lines 1-3).
Regarding claim 6, Baday teaches targeting cells with anti-CD3 antibody beads (para. 00168, lines 1-4).
Regarding claim 8, Baday teaches the removal of magnetically separated cells in the absence of the magnetic field (para. 00144, lines 1-6).
Regarding claim 9, Baday teaches the removal of magnetically separated cells through a bottom outlet (para. 0014, lines 8-11).
Claims 10-17, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Baday, as applied to claim 1 above, in view of US 2002/0076825 A1, “INTEGRATED BIOCHIP SYSTEM FOR SAMPLE PREPARATION AND ANALYSIS” (published 06/20/2002, referred to herein as Cheng).
Regarding claims 10 and 11, Baday teaches the use of magnetic microparticles for the separation of cells using magnets (para. 00155, lines 1-3).
Regarding claim 12, 14, 15, 21, and 22, Baday teaches a method of cell separation by binding a first levitation-height altering agent, i.e. a cell-specific antibody-conjugated magnetic microparticle, to a cell in a population of mixed cell types (para. 00155, lines 1-8). Baday teaches a suspension comprising the captured cell with the magnetic particle (para. 00155, lines 1-8) in a paramagnetic fluid medium (para. 0014, lines 1-8) in a processing channel of a flowcell (para. 0014, lines 1-4). Baday teaches exposing the channel to a magnetic field “to separate the heterogeneous population based on a difference in…magnetic susceptibility” (para. 0014, lines 4-8). Baday teaches that the magnetic separation results in top and bottom portions enriched and depleted of the targeted cell type (para. 0014, lines 4-11). Baday teaches a device with a single inlet to separate cells (para. 00134, lines 1-5). Baday teaches withdrawing the suspension depleted of the magnetic complex through the one of two outlet channels (para. 0014, lines 8-11).
Regarding claim 13, Baday teaches that the magnetic complex of cells “sink toward to bottom of the microchannels” (para. 00155, lines 3-6).
Regarding claim 16, Baday teaches targeting bacterial cells (para. 00155, lines 1-3).
Regarding claim 17, Baday teaches targeting cells with anti-CD3 antibody beads (para. 00168, lines 1-4).
However, Baday does not teach the specific use of paramagnetic, superparamagnetic, ferromagnetic, or ferrimagnetic microparticles comprising metal, a metal salt, or a metal oxide.
Cheng teaches the use of paramagnetic microparticles conjugated to cell-specific antibodies for cell separation from a heterogeneous population (para. 0227, lines 1-5). Cheng teaches that the microparticles comprise metal (para. 0123, lines 7-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the specific magnetic microparticle taught by Cheng for the general magnetic microparticle taught by Baday. Doing so is considered to be Combining Prior Art Elements According to Known Methods to Yield Predictable Results (See MPEP 2143(I)(A)). An artisan would recognize that the microparticles of Baday and Cheng are used for the same purpose, i.e. the use of magnetic microparticles conjugated to cell-specific antibodies for cell separation from a heterogeneous population. An artisan would have a reasonable expectation of success since the use of these antibody-particles is well-known in the art of cell binding and separation.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the arguments are directed toward the rejection of claims 1-9 under 35 U.S.C. 102, which has been withdrawn in response to Applicant’s amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 May 27, 2026
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