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 III in the reply filed on 5/20/2026 is acknowledged.
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 27 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.
Claim 27 recites the limitation " the nucleic acid sequence analysis". There is insufficient antecedent basis for this limitation 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.
Claim 13-17, 20-24, 28, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Carlo (WO 2020/037214 from IDS).
Regarding claim 13 Di Carlo discloses a method of screening B or T cells for one or more secretions of interest using a plurality of three-dimensional shaped particles comprising: loading single B or T cells into respective voids or cavities formed in the plurality of three-dimensional shaped particles; capturing the one or more secretions of interest with one or more capture agents disposed on or in the plurality of three-dimensional shaped particles; labeling the one or more captured secretions of interest with fluorescent reporters; sorting the three-dimensional shaped particles using a flow cytometer or fluorescence activated cell sorter based on a fluorescence signal from the fluorescent reporters to create a sorted population of three-dimensional shaped particles. (See De Carlo Abstract, Fig. 2 [0042]-[0043], [00122], and [00180]-[00182] wherein T-cell secretions of interest are screened by providing T-cells which are loaded into voids of a particles and secretions thereof are captured and fluorescently labeled prior to sorting with a flow cytometer.)
Regarding claim 14 Di Carlo discloses all the claim limitations as set forth above as well as the method further comprising performing nucleic acid sequence analysis on nucleic acids contained in at least some of the sorted population of three-dimensional shaped particles. (See Di Carlo [00208] wherein downstream nucleic acid sequencing is performed on cells in sorted populations of particles.)
Regarding claim 15 Di Carlo discloses all the claim limitations as set forth above as well as the method wherein the B or T cells are exposed to a lysing agent and subject to nucleic acid amplification prior to performing nucleic acid sequence analysis. (See Di Carlo [00144]-[00146] wherein cells are lysed using a lytic reagent and amplified and sequenced.)
Regarding claim 16 Di Carlo discloses all the claim limitations as set forth above as well as the method wherein the one or more capture agents comprise a plurality of capture agents that are disposed on or in the plurality of three-dimensional shaped particles, wherein each of the plurality of capture agents are specific to different secretions of interest. (See Di Carlo [00201] wherein multiple targets, i.e. secretions, are captured and labeled using specific capture agents disposed in or on the shaped particles.)
Regarding claim 17 Di Carlo discloses all the claim limitations as set forth above as well as the method, further comprising labeling one or more cell surface markers with fluorescent reporters. (See Di Carlo [00180] and [00201] wherein cell surfaces are marked with fluorescent reporters to perform detection and sorting thereof.)
Regarding claim 20 Di Carlo discloses all the claim limitations as set forth above as well as the method, wherein the capture agent comprises protein A, protein G, anti-IgG antibody, anti-Fc antibody, anti-H&L antibody or a fragment thereof. (See Di Carlo [0043] wherein the capture agent includes protein A.)
Regarding claim 21 Di Carlo discloses all the claim limitations as set forth above as well as the method wherein the fluorescent reporter comprises reporters comprise a fluorescently-labelled antigen. (See Di Carlo [0043] wherein the antigen is fluorescently labeled.)
Regarding claim 22 Di Carlo discloses all the claim limitations as set forth above as well as the method wherein the capture agent comprises an antigen. (See Di Carlo [0043] wherein the capture agent comprises antigens)
Regarding claim 23 Di Carlo discloses all the claim limitations as set forth above as well as the method wherein the fluorescent reporter comprises reporters comprise a fluorescently-labelled anti-IgG antibody, anti-Fc antibody, anti-H&L antibody or a fragment thereof. (See Di Carlo [0043] wherein ani-igG is used.)
Regarding claim 24 Di Carlo discloses all the claim limitations as set forth above as well as the method wherein the sorted population of three-dimensional shaped particles are sorted into respective vessels, wells, droplets, or containers each containing a single shaped particle. (See De Carlo [0012] and [0046] wherein sorted particles are sorted into droplets each containing a single particle.)
Regarding claims 28 and 35 Di Carlo discloses all the claim limitations as set forth above as well as the method wherein the fluorescence signal comprises a fluorescence intensity peak that is defined by a fluorescence height, fluorescence width, and fluorescence area. (See Di Carlo Figs. 18 wherein shows the fluorescence signal obtained during sorting 33which inherently has a peak defined by a height, width, and area as shown in the Fig. 18)
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.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Di Carlo (WO 2020/037214 from IDS) as applied to claims above, and further in view of Anderson et al. (US 2021/0263012).
Regarding claims 18 and 19 Di Carlo discloses the method of analysis may be used to sort and desired cell or secretion of interest but does not specify CAR-T cells and cytokines.
Anderson discloses studying cells by isolating CAR-T cells and that cytokines are secretions therefrom which are of interest to study.(See Anderson Abstract, [0035],[0148], [0277]
It would have been obvious to one of ordinary skill in the art to utilize CAR-T cells and cytokine secretions as described by Anderson in the methods of Di Carlo because such cells and secretions are known in the art to be advantageous for separation and study and desirably fulfills the need for such cells and secretions in the method of Di Carlo and one would have a reasonable expectation of success in carrying out the methods of Di Carlo utilizing such cells and secretions.
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Di Carlo (WO 2020/037214 from IDS) as applied to claims above, and further in view of Cappione et al. (US 2015/0135119)
Regarding claims 25-27 Di Carlo discloses all the claim limitations as set forth above as well as performing nucleic acid sequence analysis on sample particles but does not suggest sorting a single particle to a specific well in a multiwell plate and wherein the fluorescence signal and all analysis data associated with the single particles is linked in a data record that maps to the location of the specific well in the multiwell plate.
Cappione discloses flow cytometry methods whereby individual sorted particles are placed in individual wells of a multiwell plate and the fluorescence signal and other analysis data associated with the single particles is linked in a data record that maps to the location of the specific well in the multiwell plate. (See Cappione Abstract and [0047]-[0057])
It would have been obvious to one of ordinary skill in the art at the time of filing to sort particles into individual wells of a multiwell plate and link all analysis data associated with said particles in a data record that maps the location of a particle in the specific well as described by Cappione in the method of Di Carlo because such a sorting and mapping allows easier association of collected data with an individual sample and reduces complexity of operation as would be desirable in the method of Di Carlo.
Claims 29 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Di Carlo (WO 2020/037214 from IDS) as applied to claims above, and further in view of Hindson et al. (US 2013/0302792)
Regarding claims 29 and 36 Di Carlo discloses all the claim limitations as set forth above as well as sorting based on fluorescence thresholds but does not specifically disclose utilizing two or more of the fluorescence height, the fluorescence width, and the fluorescence area.
Hindson discloses a flow cytometry method whereby particles are sorted based at least in part on a threshold or gate on two or more of: the fluorescence peak area, the fluorescence peak height, and the fluorescence peak width. (See Hindson Abstract, Fig. 23, and [0160]-[0167] whereby particles, i.e. droplets, are sorted based on gates of height and width.)
It would have been obvious to one of ordinary skill in the art at the time of filing to sort particles based on at least peak area, peak height, and peak width as described by Hindson in the method of Di Carlo because sorting based on such parameters provides an accurate way to identify desired particles for sorting and one would have a reasonable expectation of success in utilizing such parameters in the methods of Di Carlo.
Allowable Subject Matter
Claim 37 is7 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
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