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 .
Applicant’s filing of claims 1-20 on 8/11/23 is acknowledged. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/11/23 were acknowledged. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-9 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 is rejected because the claim does not appear to particularly point out and distinctly claim the subject matter of segregating cellular particles. Claim 1 recites “sorting” the cellular particles by a size alone, but does not particularly point out and distinctly claim how the sorting is performed.
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 are rejected under 35 U.S.C. 103 as being unpatentable over Sells et al. (“Sells,” WO 2016/122552 A1) in view of Collins (US Pub. No. 2014/0248621, cited in IDS).
As to claim 1, Sells teaches a method of segregating cellular particles, comprising: sorting the cellular particles in a sample by size into at least a first cellular particle population and a second cellular particle population, wherein the first cellular particle population is enriched in cellular particles having an average diameter ranging from about 4 μm to about 12 μm (see 6 micrometers in [0075]), and wherein the second cellular particle population is enriched in cellular particles having an average diameter ranging from about 50-300 nanometers or on the order of 130μm ([0079]), wherein the cellular particles are not tagged or labeled prior to or during the sorting (see fig. 16 and [0039] et seq.).
Regarding claim 1, while Sells teaches sorting the cellular particles by zones having a particular diameter, Sells does not specifically teach the average diameter ranging from about 12 μm to about 50 μm of the second cellular particle population. Collins teaches in [0100] and fig. 11 a 3-D mesh design of a chip that sorts CTCs from whole blood by diameter, which include CTCs (RBCs .about.5 um; leukocytes about 8-14 um; CTCs about 16-20 um diameter). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to sort cells based on the average diameter ranging from about 12 μm to about 50 μm (“second cellular particle population”) because it would be desirable to sort cells for cancer diagnosis from whole blood ([0101] of Collins).
As to claim 2, the sample is a fixed sample (see microfluidic devices may be employed in cytology in [0020] et seq. of Sells).
As to claims 3 and 6, the combination of Sells and Collins teaches the sample is a tumor sample (see [0101] of Collins). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to sort cells from a tumor sample because it would be desirable to sort cells for cancer diagnosis ([0101] of Collins).
As to claims 4 and 5, see [0020] et seq. of Sells.
As to claims 7-9, see fig. 11 and [0068] et seq. of Sells, which discloses a microfluidic device which utilizes inertial focusing in straight channels.
Claims 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Collins (US Pub. No. 2014/0248621, cited in IDS) in view of Ravkin et al. (“Ravkin,” US Pub. No. 2003/0059764, cited in IDS).
See Collins above.
As to claim 10, Collins teaches a method of sorting cells, comprising: (i) obtaining a homogenized sample, wherein the homogenized sample is derived from one or more tissue specimens (e.g., [0053] et seq.), and where any aliquot of the homogenized sample substantially uniformly expresses the heterogeneity of the one or more tissue specimens (e.g., [0053] et seq.); (ii) sorting untagged or unlabeled cells in the obtained homogenized tissue sample by size into at least a first cellular population and a second cellular population ([0100] et seq.).
Regarding claim 10, Collins does not specifically teach (iii) sequencing at least one of the first or second cellular populations. Ravkin teaches in e.g., [0321] et seq., sequencing cellular populations. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to sequence cellular populations because it would be beneficial to determine expression patterns of the receptors or other molecules of interest (e.g., [0321] of Ravkin).
As to claim 11, see chip in [0100] et seq. of Collins.
As to claim 12, the combination of Collins and Ravkin teach fixed samples in [0182] et seq. of Ravkin. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include fixed samples because it would be beneficial to vary the mode of analysis.
As to claims 13, 15 and 16, see [0101] et seq. of Collins.
As to claim 14, see [0017] et seq. of Collins.
As to claim 17, Collins teaches a method of segregating cells from a sample comprising: homogenizing a sample to provide a homogenized sample; sorting the cells in the homogenized sample by size, wherein the cells are sorted into first and second cell populations, the first cell population is enriched in cells having an average diameter ranging from about 6 μm to 12 μm, and wherein the second cell population is enriched in cells having an average diameter of greater than 12 μm. See [0101] et seq. of Collins.
As to claim 18, see [0024] et seq. of Collins.
As to claim 19, see abstract et seq. of Collins.
As to claim 20, see [0015] et seq. of Collins.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
12/27/2025