DETAILED ACTION
The office action is responsive to a continuation filed on 10/13/23 and is being examined under the first inventor to file provisions of the AIA . Claims 1-20 are pending.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Under the broadest reasonable interpretation, the claims covers performance of the limitation in the mind or by pencil and paper.
Claims 1 and 11
Regarding step 1, claims 1 and 11 are directed towards a system and a method, which has the claims fall within the eligible statutory categories of processes, machines, manufactures and composition of matter under 35 U.S.C. 101.
Claim 11
Regarding step 2A, prong 1, claim 11 recites “determining at least one known pre quantitation attribute and creates a data pair with the at least one post quantitation attribute and at least one pre quantitation attribute via a computing device”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Regarding step 2A, prong 2, the limitation of “processing at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample via an instrument” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how the processing is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “processing at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample via an instrument” amounts to mere instructions to apply an exception, where the instrument is functioning as a tool, see MPEP 2106.05(f) (2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
Also, the limitation of “developing a model based on the at least one pre quantitation attribute and the at least one post quantitatively attribute via the computing device” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how developing of a model is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “determining an unknown attribute related to at least one second biological sample based on the model via the computing device” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how the unknown attribute is being determined. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the claim language includes the additional element of a computing device. The computing device is recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using a computer and/or a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Regarding Step 2B, the limitation of “processing at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample via an instrument” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how the processing is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “processing at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample via an instrument” amounts to mere instructions to apply an exception, where the instrument is functioning as a tool, see MPEP 2106.05(f) (2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
Also, the limitation of “developing a model based on the at least one pre quantitation attribute and the at least one post quantitatively attribute via the computing device” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how developing of a model is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “determining an unknown attribute related to at least one second biological sample based on the model via the computing device” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how the unknown attribute is being determined. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Further, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of the computing device amounts no more than mere instructions to apply the exception using a generic computer component that does not impose any meaningful limits on practicing the abstract idea and therefore cannot provide an inventive concept (See MPEP 2106.05(b).
Claim 1
Regarding step 2A, prong 1, claim 1 recites “a computing device that determines at least one known pre quantitation attribute and creates a data pair with the at least one post quantitation attribute and at least one pre quantitation attribute”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Regarding step 2A, prong 2, the limitation of “an instrument that processes at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how the processing is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “an instrument that processes at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample” amounts to mere instructions to apply an exception, where the instrument is functioning as a tool, see MPEP 2106.05(f) (2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
Also, the limitation of “wherein, the computing device develops a model based on the at least one pre quantitation attribute and the at least one post quantitatively attribute” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how developing of a model is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “the computing device determines an unknown attribute related to at least one second biological sample based on the model” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how the unknown attribute is being determined. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the claim language includes the additional element of a computing device. The computing device is recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using a computer and/or a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Regarding Step 2B, the limitation of“an instrument that processes at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how the processing is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “an instrument that processes at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample” amounts to mere instructions to apply an exception, where the instrument is functioning as a tool, see MPEP 2106.05(f) (2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
Also, the limitation of “wherein, the computing device develops a model based on the at least one pre quantitation attribute and the at least one post quantitatively attribute” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how developing of a model is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “the computing device determines an unknown attribute related to at least one second biological sample based on the model” amounts to mere instructions to apply an exception, where it recites an idea of a solution. This limitation doesn’t indicate how the unknown attribute is being determined. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Further, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of the computing device amounts no more than mere instructions to apply the exception using a generic computer component that does not impose any meaningful limits on practicing the abstract idea and therefore cannot provide an inventive concept (See MPEP 2106.05(b).
Claims 2 and 12
Dependent claims 2 and 12 recites “wherein the model is processed by the instrument.”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Also, the limitation of wherein the model is processed by the instrument amounts to mere instructions to apply an exception, where the instrument is functioning as a tool, see MPEP 2106.05(f) (2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
Claims 3 and 13
Dependent claims 3 and 13 recites “wherein the first at least one biological sample is altered prior to processing and the alterations are incorporated into the model.”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claims 4 and 14
Dependent claims 4 and 14 recites “wherein each data pair is unique.”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claims 5 and 15
Dependent claims 5 and 15 recites “the second biological sample is processed by the same instrument as the first biological sample.”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claims 6 and 16
Dependent claims 6 and 16 recites “wherein the model includes information transmitted from the instrument”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claims 7 and 17
Dependent claims 7 and 17 recites “wherein the at least one second biological sample is altered in the same manner as the at least one first biological sample.”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claims 8 and 18
Dependent claims 8 and 18 recites “wherein the computing device is communicatively coupled to the instrument.”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Also, the claim language includes the additional element of a computing device. The computing device is recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using a computer and/or a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Claims 9 and 19
Dependent claims 9 and 19 recites “wherein the at least one first biological sample and at least one second biological sample are subjected to a degradation scheme.”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claims 10 and 20
Dependent claims 9 and 19 recites “wherein the degradation scheme includes modifications to the environmental conditions the samples are subject to.”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claims 1-20 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
While Leong et al. (U.S. PGPub 2010/0228496) teaches a method of determining a copy number of a target genomic sequence; either a target gene or genomic sequence of interest, in a biological sample, Altschuler et al. (U.S. PGPub 2008/0195322) teaches a multivariate, automated and scalable method for extracting profiles from images to quantify the effects of perturbations on biological samples, Tsypin (U.S. PGPub 2005/0267689) teaches a method for identifying peaks in mass spectral data, Risby et al. (U.S. Patent 4,075,475) teaches a method facilitating the rapid and objective classification and/or identification of an unknown biological specimen, none of these reference taken either alone or in combination with the prior art of record disclose, an instrument that processes at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample; a computing device that determines at least one known pre quantitation attribute and creates a data pair with the at least one post quantitation attribute and at least one pre quantitation attribute, the computing device determines an unknown attribute related to at least one second biological sample based on the model.
Claim 1 “an instrument that processes at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample;
a computing device that determines at least one known pre quantitation attribute and creates a data pair with the at least one post quantitation attribute and at least one pre quantitation attribute, wherein,
the computing device determines an unknown attribute related to at least one second biological sample based on the model.”
Claim 11 “processing at least one first biological sample to determine at least one post quantitation attributes of the at least one biological sample via an instrument;
determining at least one known pre quantitation attribute and creates a data pair with the at least one post quantitation attribute and at least one pre quantitation attribute via a computing device,
determining an unknown attribute related to at least one second biological sample based on the model via the computing device.”, in combination with the remaining elements and features of the claimed invention.
It is for these reasons that the applicant’s invention defines over the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the
payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BERNARD E COTHRAN whose telephone number is (571)270-5594. The examiner can normally be reached 9AM -5:30PM EST M-F.
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/BERNARD E COTHRAN/Examiner, Art Unit 2188
/RYAN F PITARO/Supervisory Patent Examiner, Art Unit 2188