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 .
Remarks
In response to communications sent June 18, 2026, claim(s) 1-7, 9, 14-17, 19-21, 23-24, and 95-97 is/are pending in this application; of these claim(s) 1 is/are in independent form. Claim(s) 8, 10-13, 18, 22, 25-94 is/are cancelled.
Information Disclosure Statement
The Information Disclosure Statement(s) is/are acknowledged and the references contained therein have been considered by the Examiner. This includes the Information Disclosure Statements(s) filed on: May 5, 2026.
Response to Arguments
Applicant’s arguments, see page 6 line 16 to page 8 line 23, filed June 18, 2026, with respect to the rejection(s) of claim(s) 1-10, 13-17, and 19-24 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. §103 and US 20130173618 A1 (“Banville”) in view of a second embodiment within the Banville reference at Para [0130] (hereinafter “Banville [0103]”.
Claim Interpretation
Applicant’s Specification at page 53 last paragraph (lines 16-22) attempts to redefine the meaning of 35 U.S.C. § 112(f). However, when the Applicant acts as their own lexicographer, the Applicant does not redefine the statutes promulgated by Congress. Likewise, the definition set forth by the Applicant does not overturn precedential court cases regarding interpretation of the claims under 35 U.S.C. § 112(f). Therefore, the Examiner will interpret the claims in accordance with the statutes and precedent in the usual way, without importing the Applicant’s definitions into the contemplation of law.
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.
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) 1-10, 13-17 and 19-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130173618 A1 (“Banville”) in view of a second embodiment of within the Banville reference at Para [0130] (hereinafter “Banville [0103]”.
As to claim 1, Banville teaches a method comprising:
receiving (Banville Para [0087]: receiving data from the flow cytometer for processing at the gate module):
a first gate comprising a set of vertices (Banville Para [0108]: initial gate boundary 350); and
flow cytometer data (Banville Para [0087]: flow cytometer data);
expanding the first gate to generate a second gate (Banville Para [0108]: expanding/perturbing the initial gate boundary by a specified distance from the centroid of the initial gate boundary);
generating a subset of classified flow cytometer data by (Banville Para [0030]: separating subpopulations of datapoints to separate subpopulations based on gate boundaries of a plurality of gates):
determining a set difference of the flow cytometer data, wherein the set difference is a set of flow cytometer data that is classified as being encompassed by the second gate but not the first gate (Banville Para [0095]: a region of difference between the initial gate boundary and the perturbed gate boundaries; the data that is stored as a “subset” of the data); and
obtaining a random sample to generate the subset of classified flow cytometer data, wherein the random sample comprises a percentage of the flow cytometer data within the set difference (Banville Para [0095]: a portion of the points are drawn from the region of difference between the initial gate boundary and the perturbed gate boundary); and
differentially sorting (the phrase “differentially sorting” in the independent claim by itself does not imply the existence of a plurality of different “collection vessels”) particles in a sample via a sorting flow cytometer based on the first and second gates (Banville Para [0087]: sorting cells using a flow cytometer using the data processing and gating module).
However, this embodiment of Banville does not teach that the portion is a random sample.
Nevertheless, Banville at Para [0130] teaches the element of random data points within a gated boundary. Para [0130] teaches it for the purpose of generating eigenvector calculations. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate the subset of data points for a different purpose: to reduce the portion set size because it reduces the amount of resources needed for sorting to the flow cytometry wells taught in Banville Para [0165].
Banville and the second embodiment of Banville in Para [0130] are in the same field of flow cytometry. There would be a reasonable expectation of success because sampling using routinely reduces set sizes.
As to claim 2, Banville as modified by Banville Para [0130] teaches the method according to Claim 1, wherein expanding the first gate to generate the second gate comprises calculating a centroid of the first gate (Banville Para [0108]: calculations involving a determination of the centroid of the initial gate boundary).
As to claim 3, Banville as modified by Banville Para [0130] teaches the method according to Claim 2, further comprising adjusting each vertex of the first gate such that horizontal and vertical differences of the vertices from the centroid is increased by a percentage (Banville Para [0109]: scaling vertices based on a scalar factor).
As to claim 4, Banville as modified by Banville Para [0130] teaches the method according to Claim 3, wherein the percentage ranges from 1% to 20% (Banville Para [0109] and Figure 3: the scaling of the vertices based on a scalar factor, as described in Para [0109], is a scaling that is visually between 1% and 20% in Figure 3).
As to claim 5, Banville as modified by Banville Para [0130] teaches the method according to Claim 1, wherein expanding the first gate to generate the second gate comprises Minkowski addition (Banville Para [0067]: scaling a gate boundary is a species of the genus of Minkowski addition, based on the definitional plain meaning of Minkowski addition, as understood by one of ordinary skill in the art).
As to claim 6, Banville as modified by Banville Para [0130] teaches the method according to Claim 5, wherein the Minkowski addition comprises the summation of the vertices of the first gate with an expansion circle (Banville Para [0067]: scaling a gate boundary by a constant factor; the Examiner argues that scaling by a constant factor is mathematically the same as Minkowski addition of a boundary using an expansion circle).
As to claim 7, Banville as modified by Banville Para [0130] teaches the method according to Claim 1, further comprising recording the subset of the classified flow cytometer data (Banville Para [0095]:a portion of the points are drawn from the region of difference between the initial gate boundary and the perturbed gate boundary; they are implicitly store in the computerized system that includes the database of Figure 21).
As to claim 9, Banville as modified by Banville Para [0130] teaches the method according to Claim 7, wherein the recorded subset of classified flow cytometer data consists of the random sample and the set of flow cytometer data encompassed by the first gate (Banville Para [0095]: the data of the random sample comprises a region of difference between the initial gate boundary and the perturbed gate boundaries; the data that is stored as a “subset” of the data comprises the “metrics”).
As to claim 14, Banville as modified by Banville Para [0130] teaches the method according to Claim 7, wherein the recorded subset of classified flow cytometer data comprises a random sample of the flow cytometer data within a given distance from the first gate (Banville Para [0130]: randomly recording and calculating random points within a scaled distance defined by an elliptical shape).
As to claim 15, Banville as modified by Banville Para [0130] teaches the method according to Claim 7, wherein the recorded subset of classified flow cytometer data comprises a random sample of the universal set of flow cytometer data (Banville Para [0165]: the boundary may encompass “all events” observed in a given well).
As to claim 16, Banville as modified by Banville Para [0130] teaches the method according to Claim 9, wherein the recorded subset of classified flow cytometer data comprises the set union of the random sample and the set of flow cytometer data encompassed by the first gate (Banville Para [0099]: analyzing data from the gated flow cytometer and a control dataset; both datasets taken together are the random sample and the data influenced by the gating).
As to claim 19, Banville as modified by Banville Para [0130] teaches the method according to Claim 7, further comprising associating the recorded subset of classified flow cytometer data with a phenotype (Banville Para [0165]: associating the data with various biological characteristics that are genetically defined, such as cell surface markers).
As to claim 20, Banville as modified by Banville Para [0130] teaches the method according to Claim 7, further comprising adjusting the vertices of the first gate based on the recorded subset of classified flow cytometer data (Banville Para [0175]: iterative adjustment of the gating process based on new data)
As to claim 21, Banville as modified by Banville Para [0130] teaches the method according to Claim 7, further comprising adjusting the vertices of the second gate based on the recorded subset of classified flow cytometer data (Banville Para [0167]: adjusting the boundaries based on characteristics of the cells).
As to claim 23, Banville as modified by Banville Para [0130] teaches the method according to Claim 1, further comprising sorting particles associated with the set of flow cytometer data encompassed by the first gate into a first collection vessel (Banville Para [0169]: flow cytometry wells).
As to claim 24, Banville as modified by Banville Para [0130] teaches the method according to Claim 23, further comprising sorting particles associated with flow cytometer data encompassed by the set difference of the set of flow cytometer data encompassed by the second gate and the set of flow cytometer data encompassed by the first gate into a second collection vessel (Banville Para [0087]: sorting cells using a flow cytometer using the data processing and gating module; sorting by the first gate into a first collection vessel does not necessarily occur at the same time with the same equipment as the sortation into the second vessel).
As to claim 95, Banville as modified by Banville Para [0130] teaches the method according to Claim 24, wherein the method further comprises re- sorting the particles within the second collection vessel (Banville Para [0169]: a plurality of flow cytometry wells).
As to claim 96, Banville as modified by Banville Para [0130] teaches the method according to Claim 1, wherein the percentage of the flow cytometer data within the set difference ranges from 30% to 70% (Banville Para [0099]: samples may be a “control” or “simulated” dataset; controls are generally split 50-50, hence the selection of a set difference of 50% for controlled experiments; 50% lies between 30% and 70%).
As to claim 97, Banville as modified by Banville Para [0130] teaches the method according to Claim 1, wherein the percentage of the flow cytometer data within the set difference is 50% (Banville Para [0099]: samples may be a “control” or “simulated” dataset; controls are generally split 50-50, hence the selection of a set difference of 50% for controlled experiments).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20120245889-A1: pertinent because of gating, thresholding, and modeling
US-20170061657 A1: Pertinent because of Figure 11
Price, Jeffrey H., Edward A. Hunter, and David A. Gough. "Accuracy of least squares designed spatial FIR filters for segmentation of images of fluorescence stained cell nuclei." Cytometry: The Journal of the International Society for Analytical Cytology 25.4 (1996): 303-316. (Year: 1996)
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 Jesse P Frumkin whose telephone number is (571)270-1849. The examiner can normally be reached Monday - Friday, 10-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 July 27, 2026
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