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Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Arguments
It is noted that applicant has amended the claims but fails to specify where each of the amendments are supported, described within the original specification. For example, the examiner fails to locate any description of exposing the processing channel to a magnetic field for a period of time sufficient for a plurality of the complexes and a plurality of the cells of the second type to reach an equilibrium levitation value
It is hereby requested that that applicant specify, provide for the text of the original specification that supports each and all amendments.
As to the art rejection applicant states:
Paragraph 4.2.5 and figure 8 of D1 describe a non-equilibrium flow technique that relies upon shear stress to overcome a viscous drag force to drag the object into a new position and away from an object's equilibrium position. This is demonstrated only on polymeric particles. It is speculated that the technique could be used with cells.
Paragraph 4.6.3 and figure 13 of D1 describe a columnar assay to quantify binding reactions that could be physiologically relevant for medical conditions such as sepsis and myocardial infarction. The columnar-based assays, though potentially useful in the diagnostic assays as described, are not applicable to recovery and isolation of complexed and non- complexed cell populations from a mixture.
Paragraph 5.4.7 of D1 is a summary of hypothetical applications without any specific teaching relating to the hypothetical applications.
The current claimed inventions of claim 1 and new claim 21 are novel equilibrium-based magnetic levitation methods utilizing complex formation to remove and isolate complexed and non-complexed cells from a cellular mixture. Reference D1 does not disclose or suggest the elements of the claimed methods and furthermore teaches away from the claimed invention stating in paragraph 5.4.6 that "selective removal of small samples of liquids containing suspended particles from a MagLev system-particularly from sample of small quantities/volumes-is not an entirely solved problem."
The examiner respectfully disagrees. D1 discloses teaches that levitation of particles are achieved throughout the reference, including being applicable to cells “the same principle could be used to separate biological cells” (page 17838, left column). The method is performed such that particles in the stream “reach the stable levitation height in the direction orthogonal to the fluidic flow.” (page 17838, left column). See entire teachings of the reference.
Therefore, the rejection is hereby maintained.
Specification
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: There is no description of the invention as provided for in claim 1, more specifically steps d) and e). Furthermore, there is no description of . the glass microparticle is a glass microbead or a glass microbubble.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6, and 11-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The examiner fails to locate any description of steps d) and e in claim 1 as noted above.
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 1-4, 6, and 11-17 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.
As to claim 1, it is unclear what considered as “an equilibrium levitation value” because such is not defined in the claim nor specification.
It is noted that steps a) and b) are not required to be performed by nor any specific structures.
Claims 2-4, 6, and 11-17, are rejected via dependency upon a rejected claim.
Claims 12 recites the limitations "the first non-magnetic microparticle". There is insufficient antecedent basis for this limitation in the claim
Claims 14 recites the limitations "the first microparticle". There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the first microparticle" 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.
Claim 18 recites the limitations "the one or more cells of the first type and/or the one or more cells of the second type are live cells". 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) 1-4, 6, 11-13, 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, and withdrawing a first/second portion of the suspension from the channel.
(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) 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
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 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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. 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
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