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 .
Priority
The present application was filed on 04/23/2024. This application claims benefit of the application 16/684,532, which is a CIP of PCT/KR2018/005684 filed on 05/17/2018.
Claim status
Claims 2 and 7-9 are canceled. Claim 1 is amended. Claims 1, 3-6 are pending and examined herein.
Withdrawn Objections/Rejections
The rejection of claim 7 under 35 USC 112(d) is withdrawn in view of the cancelation of the claim.
The rejections of claims 1-9 under 35 USC 102 are withdrawn in view of the amendment of the claim 1 and the cancelation of claim 2.
The rejections of claims 1, 3-6 under 35 USC 102 are updated in view of the amendment of the claims.
Claim Objections
Claim 1 is objected to because of the following informalities:
The limitation “wherein the separating portion comprises a channel array” in the last line of the claim is newly added to the claim, so the last line should be underlined.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: The specification discloses the phrase “endocytosis of immune cells” in paragraphs 7,13, and 36, which literally means that the immune cells are taken up via endocytosis process. However, it appears that the applicant refers the “endocytosis of immune cells” to the process of taking up external substances into the immune cells (see pars.3, 13 and 20). Also, the process of interaction between the immune cells and the magnetic particles, disclosed in paragraph 13 of the specification, refers to a phenomenon in which “magnetic particles adhere to, enter, are invaginated by, or are trapped in the interior or exterior of immune cells”, which means that the particles are taken up by the immune cells via endocytosis process. The “endocytosis of the immune cells” in paragraphs 7,13, and 36 contradicts with the process of taking up the particles into the immune cells via endocytosis phenomenon and should be amended (e.g., --endocytosis of the particles--).
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The limitation “the magnetic particles have a diameter of 1 nm to 30 um” is newly added in the amended claim 1 but it has been recited in the original claim 8. Therefore, this limitation is not a new matter. However, this limitation is not disclosed in the specification and the drawings. The specification discloses that the magnetic particles have a diameter of 200 nm in paragraphs 91, 105, 113, and 123. The specification, in paragraph 27, discloses that the size of the particle is about 1nm to 30,000nm, but this measurement does not refer to the diameter of the particle. Therefore, the specification does not provide proper antecedent basis for the claim.
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.
Claim 1 is 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 limitation “wherein the immune cells… interact with the magnetic particles via endocytosis of the immune cells” in lines 11-12 means that the immune cells are taken up by the particles during the interaction. However, the process of interaction between the immune cells and the magnetic particles, which is disclosed in paragraph 13 of the specification, refers to a phenomenon in which “magnetic particles adhere to, enter, are invaginated by, or are trapped in the interior or exterior of immune cells”, which means that the particles are taken up by the immune cells. Thus, the “endocytosis of the immune cells” in line 12 of claim 1 contradicts with the process of up-taking the particles into the immune cells via endocytosis phenomenon. It is unclear what process the Applicant wants to claim, the immune cells are taken up by the particles or the particles are taken up by the immune cells.
Claim 5 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of a tube, a channel, a droplet, and a well is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: “a droplet” in line 2, which is defined as a very small drop of a liquid, does not share a single structural similarity and common use with the other members in the group (i.e., a tube, a channel, and a well) which are containers that can hold a liquid.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 and 3-6 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ward et al. (US20170248508).
As to claim 1, Ward teaches an apparatus for separating activated immune cells (Ward in Abstract discloses a device for processing cell purification). The apparatus comprises:
a chamber for storing a sample comprising immune cells and magnetic particles (see par(s).5 and 288: disclosing a microfluidic channel for separating particles where a particle can be a cell, see par(s).6 and 171: disclosing the particle with magnetically susceptible labels (e.g., magnetic or paramagnetic beads), see par.7: passing a sample comprising first particles through the system, i.e., microfluidic channel, see par.8: the sample comprises at least one white blood cell and at least one tumor cell; these teachings from Ward encompass a chamber for storing a sample comprising immune cells and magnetic particles),
wherein the immune cells comprise neutrophils, eosinophils, basophils, monocytes, lymphocytes, macrophages, mast cells, B cells, T cells, natural killer cells, or any combination thereof (see par(s).288 and 300: disclosing that the cells comprise neutrophil, eosinophil, basophil, lymphocyte, monocyte, NK cell, mast cell, B cells, T cells etc.), and
wherein the magnetic particles have a diameter of 1 nm to 30 µm (see par.316: Ward teaches that the magnetic beads can have various shapes and sizes, e.g., 10 nm to about 20 μm in diameter or width and height in the case of nonspherical particles, or about 3 to about 10 μm in diameter); and
a magnetic field-forming portion which is disposed to apply a magnetic field around the chamber, wherein activated immune cells, among the immune cells in the sample, interact with magnetic particles to form magnetic particle-immune cell complexes, and the magnetic particle- immune cell complexes are collected around a magnetic field formed by the magnetic field- forming portion (see par(s).5-6: teaching that magnets are disposed around the microfluidic channel to generate a magnetic field, see par.74: teaching that white blood cells can be labeled with magnetic beads (e.g., through antibodies binding to white blood cell markers), thus forming magnetic particle-immune cell complexes, see also par.74: teaching that the magnetic separator can retain the cells with magnetic beads, and allow the other cells flow through, then the retained cells can be released or flushed out of the magnetic separator to a collector for further analysis),
wherein the immune cells that interacted with the magnetic particles interact with the magnetic particles via endocytosis process (see par(s).288 and 310: teaching that the labels, e.g., magnetic beads, can comprise a primary antibody binding to a molecule on the surface or inside a particle (which is immune cell); par.313: teaching that labels can comprise genetically engineered labels for identifying certain cell types that might not employ affinity tags but create enrichment of magnetic particles, e.g., intentional endocytosis of magnetic particles); and
a plurality of inlets connected to an end part of the chamber (see par.47 and Fig.6: teaching that the system comprises two inlets (a sample inlet and a buffer inlet) or three inlets (two sample inlets and a buffer inlet), thus the teaching encompasses a plurality of inlets connected to the microfluidic system),
wherein the chamber further comprises a separating portion, wherein the magnetic field-forming portion is disposed on a surface of the chamber to apply a magnetic field, and wherein the separating portion comprises a channel array (see par(s).5-6, 159 and 163: magnets are arranged adjacent to a first side of a second microfluidic channel or cover the full-width of a microfluidic channel; see par(s).6 and 12: teaching that the magnetic separator is configured to retain particles with magnetically susceptible labels and allow particles without magnetically susceptible labels to pass through, and the magnetic separator is fluidically connected with the array of obstacles; see par.11: teaching that passing the sample through a first array of obstacles, wherein the first array of obstacles allows the first particles to move in a first direction and the second particles to move in a second direction different from the first direction; this teaching encompasses that the microfluidic comprises a separating portion comprising a channel array).
As to claim 3, Ward teaches the invention as discussed above. Ward teaches that the device further comprises an inlet which is connected to an end part of the chamber, and an outlet which is connected to another end part of the chamber (see par.17: teaching that a microfluidic channel comprises an inlet and outlet, see Fig.4 illustrating that the inlet and outlet are disposed on different ends of the microfluidic channel).
As to claim 4, Ward teaches the invention as discussed above. Ward teaches a detecting portion for detecting magnetic particle-immune cell complexes (see par.10: teaching that the system further comprises a particle sensor, see par.22: teaching that the sensor generates a signal when a particle of interest, e.g., particle-immune cell complex, arrives in the sensing zone).
As to claim 5, Ward teaches the invention as discussed above. Ward teaches that the chamber comprises one or more selected from the group consisting of a tube, a channel, and a well (see par.5: teaching that the apparatus for separating activated immune cells comprises microfluidic channel).
As to claim 6, Ward teaches the invention as discussed above. Ward teaches that the magnetic field-forming portion comprises one or more magnets (see par.5: teaching that a first and second magnets are disposed on the microfluidic channel).
Response to Arguments
For claims rejections under 35 USC 102:
Applicant's arguments filed 09/15/2025 have been fully considered but they are not persuasive.
Applicant argues that Ward does not teach the new limitations in the amended claim 1, which are “the immune cells comprise neutrophils, eosinophils, basophils, monocytes, lymphocytes, macrophages, mast cells, B cells, T cells, natural killer cells, or any combination thereof”, “wherein the immune cells that interacted with the magnetic particles interact with the magnetic particles via endocytosis of the immune cells”, and “wherein the separating portion comprises a channel array”.
However, these newly cited limitations are taught by Ward as discussed in the office action above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAU N.B. TRAN whose telephone number is (571)272-3663. The examiner can normally be reached Mon-Fri 8:30-6:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 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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/CHAU N.B. TRAN/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 January 29, 2026
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