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 .
DETAILED ACTION
This is a response to an amendment filed May 18th, 2026. By the amendment claims 1-12 and 14-20 are pending with claims 1-2 and 20 being amended and claim 13 being canceled. The 101 rejection of claim 20 has been withdrawn.
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 1-12 and 14-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
101 Analysis – Step 1
Independent claim 1 is directed to a system; therefore, claim 1 is within at least one of the four statutory categories.
Independent claim 2 is directed to a method; therefore, claim 2 is within at least one of the four statutory categories.
101 Analysis – Step 2A, Prong I
Regarding Prong I of Step 2A analysis in the 2019 PEG, the claims are to be analyzed to determine whether they recite subject matter that falls within one of the following groups of abstract ideas: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
Independent claim 1 includes limitations that recite an abstract idea (emphasized below), that is similar to independent method claim 2. and will be used as a representative claim for the remainder of the 101 rejection. Claim 1 recites:
A system comprising:
a cell sorting device, and
a computing device configured to perform the steps of:
collecting first cell sorter data associated with a first portion of a sample of one or more cells;
training a machine learning model based on one or more of the first cell sorter data and user input, wherein the machine learning model is trained without prior determination of a first representation of the first cell sorter data;
receiving one or more gating instructions from a user input based on the first cell sorter data, the machine learning model, or a combination thereof;
receiving second cell sorter data associated with a second portion of the sample of one or more cells;
determining, based on the trained machine learning model and the user-inputted gating instructions, a classification of the second cell sorter data, a representation of the second cell sorter data, or a combination thereof; and
sorting, based on the classification, a portion of the sample.
The examiner submits that the foregoing bolded limitations constitute “a mathematical concept” because under its broadest reasonable interpretation, the claim covers mathematical calculations. For example, “determining…” and “sorting…” in the context of this claim encompasses processing computations (math) of the machine learning model then using a field programmable gate array (computer) to make sorting decisions. Accordingly, the claim recites at least one abstract idea.
101 Analysis – Step 2A, Prong II
Regarding Prong II of the Step 2A analysis in the 2019 PEG, the claims are to be analyzed to determine whether the claim, as a whole, integrates the abstract into a practical application. As noted in the 2019 PEG, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement the abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
In the present case, the additional limitations beyond the above-noted abstract idea are as follows (where the underlined portions are the “additional limitations” while the bolded portions continue to represent the “abstract idea”):
A system comprising:
a cell sorting device, and
a computing device configured to perform the steps of:
collecting first cell sorter data associated with a first portion of a sample of one or more cells;
training a machine learning model based on one or more of the first cell sorter data and user input, wherein the machine learning model is trained without prior determination of a first representation of the first cell sorter data;
receiving one or more gating instructions from a user input based on the first cell sorter data, the machine learning model, or a combination thereof;
receiving second cell sorter data associated with a second portion of the sample of one or more cells;
determining, based on the trained machine learning model and the user-inputted gating instructions, a classification of the second cell sorter data, a representation of the second cell sorter data, or a combination thereof; and
sorting, based on the classification, a portion of the sample.
For the following reasons, the examiner submits that the above identified additional limitations do not integrate the above-noted abstract idea into a practical application.
Regarding the additional limitations of “collecting first cell sorter data…”, “receiving one or more gating instructions…” and “receiving second cell sorter data…”, the examiner submits that these limitations are insignificant extra-solution activities that are merely data gathering used to perform the process. In particular, the “collecting first cell sorter data” “receiving from a user input”, and “receiving second cell sorter data” are recited at a high level of generality (i.e. general means of gathering data using generic sensors and user input such as a generic GUI) and amounts to mere data gathering, which is a form of insignificant extra-solution activity.
Thus, taken alone, the additional elements do not integrate the abstract idea into a practical application. Further, looking at the additional limitation(s) as an ordered combination or as a whole, the limitation(s) add nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception in some other meaningful way. Accordingly, the additional limitation(s) do/does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
101 Analysis – Step 2B
Regarding Step 2B of the 2019 PEG, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application. As discussed above with respect to integration of the abstract idea into a practical application, the additional element “collecting first cell sorter data…”, “receiving one or more gating instructions…” and “receiving second cell sorter data…”, amounts to nothing more than applying the exception using a generic computer component. Generally applying an exception using a generic computer component cannot provide an inventive concept. And as discussed above, the additional limitations of
“collecting first cell sorter data…”, “receiving one or more gating instructions…” and “receiving second cell sorter data…”, the examiner submits that these limitations are insignificant extra-solution activities.
Further, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if they are more than what is well-understood, routine, conventional activity in the field. The additional limitations of “collecting first cell sorter data…”, “receiving one or more gating instructions…” and “receiving second cell sorter data…”, are well-understood, routine, and conventional activities because the background recites that current strategies for cell sorting based rely on algorithms that construct sequences of exclusionary gates MPEP 2106.05(d)(II), and the cases cited therein, including Intellectual Ventures I, LLC v. Symantec Corp., 838 F.3d 1307, 1321 (Fed. Cir. 2016), TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610 (Fed. Cir. 2016), and OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015), indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner. The additional limitation of “displaying…,” is a well-understood, routine, and conventional activity because the Federal Circuit in Trading Techs. Int’l v. IBG LLC, 921 F.3d 1084, 1093 (Fed. Cir. 2019), and Intellectual Ventures I LLC v. Erie Indemnity Co., 850 F.3d 1315, 1331 (Fed. Cir. 2017), for example, indicated that the mere displaying of data is a well understood, routine, and conventional function. Hence, the claim is not patent eligible.
Dependent claim(s) 3-12 and 14-19 do not recite any further limitations that cause the claim(s) to be patent eligible. Rather, the limitations of dependent claims are directed toward additional aspects of the judicial exception and/or well-understood, routine and conventional additional elements that do not integrate the judicial exception into a practical application [provide concise explanation]. Therefore, dependent claims 3-12 and 14-19 are not patent eligible under the same rationale as provided for in the rejection of independent claim 2.
Therefore, claim(s) 1-12 and 14-19 is/are ineligible under 35 USC §101.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "cell sorting device" in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.+
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.
Claim 1 is 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 term “cell sorting device” is interpreted under 35 U.S.C. 112(f) but there is no indication in the specification of what the cell sorting device actually is.
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 1 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 limitation “cell sorting device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no indication of what this cell sorter device actually is. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Allowable Subject Matter
Claim 20 is allowable.
Independent claim 20 is allowable for disclosing “wherein the machine learning model is trained without prior determination of a first representation of the first cell sorter data.”
The closest prior art of Lin et al (US 20200072727)discloses, a method of sorting a sample of particles (Abstract), the method comprising: collecting first cell sorter data associated with a first portion of a sample of one or more particles comprising cells(P0116-117); training, based on one or more of the first cell sorter data, user input, a first representation of the first cell sorter data or a combination thereof, a machine learning model (P0116,P0122); receiving one or more gating instructions from a user input based on the first cell sorter data, the machine learning model, or a combination thereof (P0127); receiving second cell sorter data associated with a second portion of the sample of one or more cells(P0138); determining, based on the trained machine learning model and the user-inputted gating instructions, a classification of the second cell sorter data(P0138), a representation of the second cell sorter data, or a combination thereof; and sorting, based on the classification, a portion of the sample(P0138).
There is no teaching or suggestion in the prior art that would render it obvious to a person with ordinary skill in the art before the effective filing date of the invention to train the machine learning model without transforming the cell sorter data.
Response to Arguments
The applicant’s arguments regarding Lin and when the machine learning training is done according to the amended claims are persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA LYNN BURKMAN whose telephone number is (571)272-5824. The examiner can normally be reached M-Th 7:30am to 6:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael McCullough can be reached at (571)272-7805. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.L.B./Examiner, Art Unit 3653
/MICHAEL MCCULLOUGH/Supervisory Patent Examiner, Art Unit 3653
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