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 .
The following is a non-final, first office action on the merits, in response to application filed 6/23/2023. Claims 1-5, 7-14, 28, 30-32, 34, 62, 64 have been examined and are currently pending.
Priority
Acknowledgment is made of applicant's claim for a provisional application filed on 12/23/2020, and made of applicant's claim for foreign priority based on application filed in New Zealand (NZ) on 12/23/2021, and the instant application is a cont. of PCT/NZ2021/050230, filed 12/23/2021.
Response to Amendment
The amendment filed on 6/23/2023 cancelled claim 6, 15-27, 29, 33, 35-61, 63. No claim was previously cancelled. New claim 64 is added. Claims 1-5, 7-14, 28-32, 34, 62 have been amended. Claims 1-5, 7-14, 28, 30-32, 34, 62, 64 are considered and pending.
Specification
Modifications made to page 1 to the original specification are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/11/2025 follows the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is 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.
Claim 14 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 14 recites “ ….. the cells being transported in a laminar flow and classified as cells having a characteristic A or B”.
It is unclear what “characteristic A or B” refers to and render the claim to be indefinite. Clarification and correction are required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-14, 28, 30-32, 34, 62, 64 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Alice Corp. also establishes that the same analysis should be used for all categories of claims, regardless of a system/apparatus, a method, or a product claim.
The claimed invention (Claims 1-5, 7-14, 28, 30-32, 34, 62, 64) is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) abstract ideas including “Certain Methods of Organizing Human Activity”, “an idea “of itself”, which have been identified/found by the courts as abstract ideas in new 101 memos of the subject matter eligibility in here (https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility) including 2019 Revised Patent Subject Matter Eligibility Guidance. This judicial exception is not integrated into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because It/they is/are recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications:
Independent claim 1 (Step 2A, Prong I): is directed to multiple abstract ideas including “Certain Methods of Organizing Human Activity”, and “Mental process”.
Claim 1, Steps of,
receiving data comprising measurement datapoints for a plurality of cells;
selecting a subset of the measurement datapoints using a region-of-interest;
classifying the selected subset of measurement datapoints; and
sorting the plurality of cells based on the classifying.
fall within “Certain Methods of Organizing Human Activity” grouping of abstract idea because these steps mainly describe the concepts of itself. The instant claims recite “receiving data, selecting data, classifying data, sorting information”, which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer.
In addition, claim 1, steps mentioned above also falls within the abstract “Mental Processes” grouping of abstract ideas since these limitation covers performance of the limitations in the mind, or by paper and pen. For example, a human being can observe/receive/collect data, can observe/select/classify data, can observe/sort information.
Independent claim 1, Step 2A (Prong II): Accordingly, the claim recites an abstract idea(s) as pointed out above. This judicial exception(s) is/are not integrated into a practical application. In particular, the claim recites no additional element that are significant more than the abstract ideas. Other than reciting “a computer-implemented method in the preamble”, nothing in the claim element precludes the step from practically being performed in the mind, and is simply organized information through human activity or merely mental tasks, and is part of, or a related, judicial exception and does not meaningfully limit the application of the identified judicial exception, and as such does not constitute significantly more.
There is no specificity regarding any technology, just broadly, execute the programming instructions to collect data, select data, classify data, sort information. The steps are mainly receiving data, data, selecting data, classifying data, sorting data. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Accordingly, there is neither improvement to another technology or technical field nor an improvement to the functioning of the computer itself, and does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Independent claim 1, (step 2B):
There is no additional element and add nothing of substance to the underlying abstract idea; thus, they are not significantly more than the identified abstract idea. This component is merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic computer components recited as performing generic computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/send/display information over communication network/internet does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in claim 1).
Dependent claims 2-5, 7-14, 28, 30-32, 62, 64, are merely add further details of the abstract steps/elements recited in claim 1 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Therefore, dependent claims 2-5, 7-14, 28, 30-32, 62, 64, are also non-statutory subject matter.
Independent claim 28: Alice Corp. also establishes that the same analysis should be used for all categories of claims. Therefore, independent system/apparatus claim 28, is also rejected as ineligible subject matter under 35 U.S.C. 101 for substantially the same reasons as the method claim 1.
Further, the components (i.e., a cell sorting apparatus, a processor, a memory) described in independent claim 28, add nothing of substance to the underlying abstract idea. Similarly, as it relates to the computer system claims, the limitations appear to be performed by a generic computing system/device. These components are merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic computer components recited as performing generic computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/obtain/identify/update/transmit/display data/information over communication network/internet does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in method claim 1).
Dependent claims 30-32, 34, are merely add further details of the abstract steps/elements recited in claim 28, without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Therefore, dependent claims 30-32, 34 are also non-statutory subject matter.
Viewed as a whole, the claims (1-5, 7-14, 28, 30-32, 34, 62, 64) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
Thus, the claims do NOT recite limitations that are “significantly more” than the abstract idea because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment.
Thus, the claimed invention, as a whole, does not provide 'significantly more' than the abstract idea, and is non-statutory subject matter.
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.
Claims 1-5, 7-14, 28, 30-32, 34, 62, 64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trotter et al. (US 2019/0331586).
As per claim 1, 28, Trotter discloses, a computer-implemented method and a cell sorting apparatus, comprising
a processor ([0054]), and memory ([0054]),
for sorting cells, comprising:
receiving data comprising measurement datapoints for a plurality of cells (Abstract, receiving, from a particle analyzer, measurements for a first portion of particles associated with an experiment, 0014, 0016, 0037, 0098, 1038));
selecting a subset of the measurement datapoints using a region-of-interest ([0098, 0160, 0125, 0131, 0132, 0138, 0151]);
classifying the selected subset of measurement datapoints ([0017, 0018, 0037, 0038, 0077—0084, 0098, 0141, 0142]); and
sorting the plurality of cells based on the classifying ([0013, 0017, 0018, 0033, 0077-0079, 0084, 0089, 0090, 0160]).
As per claim 2, Trotter further discloses, wherein the region-of-interest is based on at least one of comprises predetermined thresholds which are predetermined and/or based on and pattern recognition ([0017, 0125, 0131, 0132, 0138, 0151]).
As per claim 3, 30, Trotter further discloses,
further comprising
clustering previously received measurement datapoints ([0134, 0135, 0141, 0142, 0160]); and
updating, based on the clustering, the region-of-interest by adjusting thresholds for the measurement datapoints ([0126, 0151], claim 8).
As per claim 4, 31, Trotter further discloses, wherein the clustering comprises one or more of the following selected from the group consisting of: K-means and K-medoids; mini- batch K-means and K-medoids; gaussian mixture modelling (GMM), balanced iterative reducing and clustering using hierarchies (BIRCH); density-based spatial clustering of applications with noise (DBSCAN); affinity propagation; agglomerative clustering; mean shift; spectral clustering; and ordering points to identify the clustering structure (OPTICS) ([0055, 0153, 0158]).
As per claim 5, 32, Trotter further discloses, wherein the classifying comprises using one or more selected from the group consisting of: a machine learning model; a non-linear function; a fuzzy classification; a gaussian mixture model (GMM); a statistical classifier; a convolutional and/or deep neural network; and a machine learning model trained using the previous measurement datapoints as labels ([0124, 0132, 0055]).
As per claim 7, 34, Trotter further discloses,
wherein the classifying comprises applying the machine learning model trained using the previous measurement datapoints as labels (Fig. 9, [0032, 0132, 0133, 0139, 0142]), and
wherein the previous measurement datapoints are initially classified using a non- linear function, the machine learning model being trained using the initially classified previous measurement datapoints (Fig. 9, [0032, 0078, 0132, 0133, 0139, 0142, 0150, 0155]).
As per claim 8, Trotter further discloses,
wherein the classifying comprises applying a machine learning model to the selected subset of measurement datapoints (Fig. 9, [0032, 0132, 0133, 0139, 0142]), and
wherein the machine learning model is selected from the group consisting of: Kernel Support Vector Machine (k-SVM); deep and/or convolutional neural network; a Gaussian process classifier (GPC); rules-based classifier; and decision tree base classifier (Abstract, [0014, 0033, 0046, 0090, 0160, 0097, 0150, 0155, 0156, 0016, 0017]).
As per claim 9, Trotter further discloses, further comprising
comparing a number of cells in a first population over a time period with a number of cells in a second population over the time period to calculate a sort efficiency parameter ([0088, 0141, 0156, 0178]).
As per claim 10, Trotter further discloses, wherein the first population is one or more of a number of cells classified as having a predetermined characteristic and a number of cells in the region-of-interest ([0017, 0018, 0123, 0125, 0132, 0138, 0151]), and wherein the second population is one or more the total number of cells and a number of cells in the region-of-interest ([0017, 0123, 0124, 0125, 0131, 0132, 0138, 10158, 0159]).
As per claim 11, Trotter further discloses, further comprising performing an action in response to when the sort efficiency parameter being is below a threshold ([0078, 0124, 0132, 0138, 0173]).
As per claim 12, Trotter further discloses, wherein the action is one or more of the following;
issuing a warning or alarm, stopping the method for sorting cells, and
performing an adjustment to an upstream cell delivery process ([0078, 0124, 0132, 0138, 0173]).
As per claim 13, Trotter further discloses,
wherein the plurality of cells are sperm cells ([0009]) and the measurement datapoints are derived from illumination pattern measurements from at least two different directions, at least some of the plurality of cells being classified according to a predetermined characteristic and wherein the sorting separates the classified cells from other cells ([0011, 0056, 0092, 0106, 0120, 0138]).
As per claim 14, Trotter further discloses, wherein the measurement datapoints are fluorescent measurements from detectors oriented at an angle to each other, the cells being transported in a laminar flow and classified as cells having a characteristic A or B Examiner Note, in light of the 112 2nd rejection above, limitation can be found in (Fig. 5, Fig. 8, [0005, 0008, 0009, 0011, 0019, 0047, 0078, 0127, 0131, 0138, 0177]).
As per claim 62, Trotter further discloses, a processor-readable storage medium storing instructions that when executed on a processor cause the processor to perform a method according to claim 1 ([0022]).
As per claim 64, Trotter further discloses,
wherein the classifying the selected measurement datapoints comprises:
applying a classifier to the selected measurement datapoints (Abstract. [0010, 0016, 0017, 0033, 0038, 0043, 0123]); and
updating the classifier based on previous measurement datapoints ([0097, 0123--0125, 0132, 0133, 0139, 0142, 0151]).
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Sharpe et al. (US 2012/0277902, teaches utilizing a sort monitoring system to monitor an operational characteristic for a particle sorting system),
Fox et al. (US 2011/0010144, teaches a self-tuning flow cytometer that uses a mathematical model to perform sort decisions that is based upon the biological response of the particular types of cells that are being sorted).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN M LI whose telephone number is (571)270-5489. The examiner can normally be reached on Mon-Thurs, 8:30am--5pm. Fax is 571-270-6489.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi, can be reached on 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUN M LI/Primary Examiner, Art Unit 3685
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