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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18 in the reply filed on August 7, 2025 is acknowledged.
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claims 1-18 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.
Claim 1 recites the limitation "the first complexes" in line 2 of b). There is insufficient antecedent basis for this limitation in the claim. The claim previously only mentions “a first complex”.
As to claim 1, in the last 2 lines it is unclear what is meant required by the phrase “the second portion depleted in the first complex relative to the suspension” because the phrase appears to be grammatically incorrect. It appears as if the term “is” is missing before “depleted”. (see also the last 2 lines of claim 7).
Claim 1 recites the limitation "the first complexes" in b). There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the cells of the multiple cell types not bound by the first density modifying agent" in d). There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of any cells not being bound to the first density modifying agent.
The term “depleted” in claims 1 and 7 is a relative term which renders the claim indefinite. The term “depleted” 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. The term is not defined as being and specific value/amount of the first/fourth complex. What may be considered as “depleted” to one person may not be considered as such to another and vice versa.
As to claim 1, it is unclear which/what first complex is being referenced by “the first complex” in the last 3 lines because the claim previously recites “the first complexes”.
It appears as if the term “nonmagnetic” in claim 1 should be “non-magnetic”.
Dependent claims 2-18 are rejected via dependency upon a rejected claim.
As to claims 2-3, it is unclear which/what cell of the first type is being referenced by “the cell of the first type” because claim 1 previously recites “cells of the first type”.
As to claim 7, it is unclear which/what second complex is being referenced by “the second complex” because the claim previously recites “second complexes”.
Claim 7 recites the limitations "the density of the cell of the second type, the density of the first complex, and the density of the other types of cells of the multiple cell types" in the 3rd paragraph. There is insufficient antecedent basis for this limitation in the claim.
As to claim 7, it is unclear which/what first complex is being referenced by “the first complex” because the claim 1 previously recites “the first complexes”.
Furthermore, it is unclear what is considered as “the other types of cells” because there is no prior mention of such nor is there indication as what is required of any types of cells to be considered as “other” because such is not clearly provided for in the claim.
As to claim 7, in the 4th paragraph, it is unclear what is the nexus of “a plurality of second complexes” to the prior recited “second complexes”, if such are the same or different because the claim does not clearly provide for such.
In the last paragraph of claim 7, it is unclear which/what second complexes are being reference by “the second complexes” because the claim previously recites “second complexes” in the 2nd paragraph and “a plurality of second complexes” in the 4th paragraph.
Claim 7 recites the limitation "the cells of the multiple cell types not bound by the second density modifying agent" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of any such cells not being bound to the second density modifying agent.
As to claim 8, it is unclear which/what cell of the second type is being referenced by “the cell of the second type” because claim 7 previously recites “cells of the second type” in the first paragraph.
Claim 9 recites the limitations "the one or more non-covalent interactions of the first lining agent” and “the second linking agent". There is insufficient antecedent basis for these limitations in the claim. It is presumed that the term “lining” is intended to be “linking”. It is presumed that the claim is intended to refer to “the first one or more…”. However, it is noted that claim 4 provides for alternatives as indicated by “or”. There is no prior requirement for any non-covalent interactions to occur. Furthermore, there is no prior mention of an y second linking agent. Furthermore, it is unclear what is meant required by the term “independently”, what the term modifies. Furthermore, it is unclear what is the nexus of the substances listed in the claim (biotin, avidin-like molecule, antibody, antigen, binding protein, domain, etc.) to the linking agent and first non-magnetic microparticle (if linking agent and microparticle comprise the substances, etc.) because the claim does provide for such.
Regarding claim 9, the phrase "avidin-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Furthermore, it is unclear what “its” references and what is such “binding partner” because such is not provided for in the claim. More than one binding partner can exist.
As to claim 10, it is unclear what constitutes, has to be done to define “a stop-flow mode” and “a continuous flow mode” because such are not defined in the claim.
Claim 12 recites the limitation "the second microparticle". There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of any second microparticle that is involved in the method. It presumed that “first microparticle” is intended to be the first non-magnetic microparticle. Therefore, the claim should be amended to recite such. See also claims 14 and 16.
Claim 18 recites the limitations " the one or more cells of the first type” and “the one or more cells of the second type". There is insufficient antecedent basis for these limitations in the claim.
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) 1-6, 9-13, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GE SHENCHENG ET Al: "Magnetic Levitation in Chemistry, Materials Science, and Biochemistry", ANGEWANDTE CHEMIE INTERNATIONAL EDITION, vol. 59,110.41, 4 June 2019 (2019-06-04), pages 17810-17855. (D1).
D1 discloses a method and system of cell separation, comprising: a) binding anti-Siglec-8 antibody coated polystyrene beads to eosinophil granulocytes in a PBMC sample b) forming a suspension in a paramagnetic fluid medium c) introducing the suspension into a processing channel of a flowcell cartridge; and .d) exposing the processing channel to a magnetic field for a period of time sufficient for at least some of bound cells to separate from the unbound cells
(see 01: (paragraph [4.2.5.]; figure 8; paragraph [4,6.3.]; figure 13H; paragraph [5.4.7.]).
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.
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.
Claim(s) 7-8 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over GE SHENCHENG ET Al (D1) as applied, and further in view of US 2015/219636 A1 (RYCHAK JOSHUA et al.).
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
D1 does not specify the use of more than one binding agent nor the use of different microbeads.
However, the use of more than one binding agent to separate further cell types was known in the field of cell separation by e.g. flow cytometry and cell separation using micro/nanoparticles. The same applies to the use of a linking agent that is covalently bound to the non-magnetic microparticle.
Therefore, it would have been obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention employ multiple different binding agents to employ a linking agent to separate cells in a fluid in a method of D1.
As to claims 14-17, D2 discloses the use of microbubbles and beads.
Therefore, it would have been obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention employ microbubble and different beads in the method of D1 to separate cells in a fluid as such would yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kang; Joo Hun et al.; Min; Richard et al.; Demirci; Utkan et al.; Southgate; Peter David et al.; Hoet, Rene et al.; Southgate; Peter David et al.; and WHITESIDES; George M. et al. disclose devices and methods for magnetic separation of particles.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden can be reached at 571-272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798