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 .
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 1-7 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. Claim 7 is drawn to a method, which falls within the statutory categories.
While claims 1-6 are drawn to a system, claim 1 recites a “signal acquisition unit” configured to drop exosomes acquired from a measurement target person onto a chip, and the only disclosed manner for dropping exosomes from a target person onto a chip is a human user (see paragraph 73 of the specification as originally filed). The system of claims 1-6 therefore does not fall within one of the four statutory categories because it is directed to subject matter encompassing a human per se. However, claims 1-6 will be further analyzed under the Alice/Mayo framework for purposes of prosecution efficiency.
Step 2A(1)
Independent claim 1 recites, in part, performing the steps of:
causing a mental illness diagnosis algorithm to be learned to classify exosome SERS signals included in input signal maps into 0 and 1 by inputting a first signal map acquired by using exosomes acquired from a normal person and a second signal map acquired by using exosomes acquired from a mental illness patient to the mental illness diagnosis algorithm;
acquiring a signal map including multiple exosome SERS signals;
inputting the acquired signal map to the mental illness diagnosis algorithm for which learning is completed,
acquiring a signal value of 0 or 1 for each of the exosome SERS signals included in the signal map, and
diagnosing the measurement target person as the normal person or the mental illness patient by using an average of acquired signal values.
These elements amount to a form of managing personal behavior or relationships or interactions between people as well as mathematical calculations, and therefore falls within the scope of an abstract idea in the form of a method of organizing human activity and mathematical concepts. Fundamentally the process is that of determining relationships between patient exosome data and mental illness, and using exosome data collected from a patient to diagnose the patient as having or not having a mental illness. These functions could be performed by a clinician as part of assessing a patient for mental illness.
Independent claim 7 recites similar limitations and also recites an abstract idea under the same analysis.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claim 1 recites the additional elements of a) the mental illness diagnosis system recited as “based on artificial intelligence,” b) a first learning unit used to cause the mental illness diagnosis algorithm to be learned, c) a signal acquisition unit and chip including multiple dot arrays, where the signal acquisition unit is used to drop the exosomes onto the chip and acquire the signal map, and d) a diagnosis unit used to perform data analysis including diagnosing the measurement target person as a mental illness patient or a normal person.
Claim 7 recites the additional element of a mental illness diagnosis system, where the method is recited as “using” the system.
Paragraph 28 of the specification as originally filed describe a mental illness diagnosis system as including a signal collection unit, a first learning unit, a second learning unit, a signal acquisition unit, a diagnosis unit, and a classification unit. Paragraph 33 further states that “[t]he first learning unit 120 constructs a mental illness diagnosis algorithm based on deep learning…”. No further disclosure is provided of the structure corresponding to the first learning unit or diagnosis unit, or any algorithms corresponding to the “deep learning” algorithm. As noted above, the only structure disclosed in connection with the functions corresponding to the signal acquisition unit is a human user (see paragraph 73).
Paragraph 36 states that “[t]he signal acquisition unit 140 drops exosomes collected from the plasma of a subject of a measurement target person onto a chip, and then performs Raman spectroscopy on the chip to acquire multiple exosome SERS signals.” As noted above, no structure is disclosed for the signal acquisition unit other than a human user. The chip is construed as encompassing any chip capable of providing a SERS signal map.
The above elements only amount to mere instructions to implement the abstract idea. The units are recited at a high level of generality as “configured to” perform corresponding functions, and no structure or specific devices are disclosed as corresponding to the respective units beyond a human disclosed as performing at least part of the functions of the signal acquisition unit. The chip is only recited at a high level of generality as a chip used to acquire the signal map. These elements are not sufficient to integrate the abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1 and 7 only recite the artificial intelligence, first learning unit, signal acquisition unit and chip including multiple dot arrays, and diagnosis unit as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f)
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claim 2 recites inputting multiple exosome SERS signals acquired from the measurement target person to multiple mental illness classification algorithms when the measurement target person is diagnosed as the mental illness patient, acquiring signal values of 0 or 1 for each of the multiple exosome SERS signals, and classifying types of mental illness by using an average of the signal values which are acquired. These limitations fall within the scope of the abstract idea as set out above.
Claim 2 further recites the additional element of a classification unit as used to perform the subsequent input, acquisition, and classification functions.
Paragraphs 38 and 39 describe a classification unit in terms of its functions of inputting exosome signals to the mental illness classification algorithms and comparing the average of the output signals to a classification criterion. No actual structure corresponding to the classification unit is disclosed.
The classification unit only amounts to mere instructions to implement the abstract idea. The classification unit is recited at a high level of generality as used to perform the subsequent data analysis functions, and no structure or devices are disclosed as corresponding to the classification unit. This element is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 3 recites acquiring the first signal map from the exosomes acquired from the normal person, acquiring the second signal map from the exosomes acquired from the mental illness patient, labeling all of n*m (here, n and m are natural numbers that are equal to or different from each other) exosome SERS signals included in the first signal map as 0, and labeling all of n*m exosome SERS signals included in the second signal map as 1. These limitations fall within the scope of the abstract idea as set out above.
Claim 3 further recites the additional element of a SERS signal collection unit as used to perform the subsequent acquisition and labeling functions.
Paragraphs 28, 29, and 32 describe a SERS signal collection unit as part of the system and in terms of its functions of performing Raman spectroscopy and acquiring exosome signals. No actual structure corresponding to the SERS signal collection unit is disclosed.
The SERS signal collection unit only amounts to mere instructions to implement the abstract idea. The SERS signal collection unit is recited at a high level of generality as used to perform the subsequent data analysis functions, and no structure or devices are disclosed as corresponding to the SERS signal collection unit. This element is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 4 recites inputting the second signal map acquired from a mental illness patient corresponding to a specific type of mental illness among the mental illness patients, and the second signal map acquired from other mental illness patients excluding the specific type of mental illness to multiple mental illness classification algorithms, and causing the mental illness classification algorithms to be learned to determine whether a signal map which is input corresponds to the specific type of mental illness. These limitations fall within the scope of the abstract idea as set out above.
Claim 4 further recites the additional element of a second learning unit as used to perform the subsequent functions.
Paragraphs 28, 34, 35, and 66 describe a second learning unit as part of the system and in terms of its functions of acquiring exosome signals and causing the algorithms “to be learned.” No actual structure corresponding to the second learning unit is disclosed.
The second learning unit only amounts to mere instructions to implement the abstract idea. The second learning unit is recited at a high level of generality as used to perform the subsequent data analysis functions, and no structure or devices are disclosed as corresponding to the second learning unit. This element is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 5 recites inputting the n*m exosome SERS signals included in the acquired signal map to the mental illness diagnosis algorithm and outputs a signal value of 0 or 1 corresponding to each of the n*m exosome SERS signals, and classifying as a normal person when an average of output signal values is close to 0, and diagnosing as a mental illness patient when the average of the output signal values is close to 1. These limitations fall within the scope of the abstract idea as set out above.
Claim 5 further recites the additional element of the diagnostic unit as used to perform the subsequent input, classification, and diagnosis functions.
Paragraphs 36, 37, and 75 describe a diagnostic unit in terms of its functions of inputting exosome signals to the mental illness classification algorithm and diagnosing the patient. No actual structure corresponding to the diagnostic unit is disclosed.
The diagnostic unit only amounts to mere instructions to implement the abstract idea. The diagnostic unit is recited at a high level of generality as used to perform the subsequent data analysis functions, and no structure or devices are disclosed as corresponding to the diagnostic unit. This element is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 6 recites inputting the n*m exosome SERS signals to the multiple mental illness classification algorithms, and the multiple mental illness classification algorithms output signal values of 0 or 1 for each of the n*m exosome SERS signals that are input, and comparing an average of the signal values with a classification reference value for a specific type of mental illness to determine whether to correspond to the specific type of mental illness. These limitations fall within the scope of the abstract idea as set out above.
Claim 6 further recites the additional element of the classification unit as used to perform the subsequent input and comparing functions.
As set out above, paragraphs 38 and 39 describe a classification unit in terms of its functions of inputting exosome signals to the mental illness classification algorithms and comparing the average of the output signals to a classification criterion. No actual structure corresponding to the classification unit is disclosed.
The classification unit only amounts to mere instructions to implement the abstract idea. The classification unit is recited at a high level of generality as used to perform the subsequent data analysis functions, and no structure or devices are disclosed as corresponding to the classification unit. This element is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claims 1-7 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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:
a first learning unit in claim 1;
a signal acquisition unit in claim 1;
a diagnosis unit in claims 1 and 5;
a classification unit in claims 2 and 6;
a SERS signal collection unit in claim 3;
a second learning unit in claim 4; and
a mental illness diagnosis system in claim 7.
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 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.
Claims 1-7 are 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.
The claim limitations reciting “a first learning unit” and “a signal acquisition unit” in claim 1, “a diagnosis unit” in claims 1 and 5, “a classification unit” in claims 2 and 6, “a SERS signal collection unit” in claim 3, “a second learning unit” in claim 4, and “a mental illness diagnosis system” in claim 7 invoke 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 of each element above, and to clearly link the structure, material, or acts to the respective functions.
Paragraph 28 of the specification as originally filed describe a mental illness diagnosis system as including a SERS signal collection unit, a first learning unit, a second learning unit, a signal acquisition unit, a diagnosis unit, and a classification unit. While the specification further describes the SERS signal collection unit, first learning unit, second learning unit, diagnosis unit, and classification unit in terms of their respective data processing functions (see e.g. paragraphs 29 and 32-39) the disclosure fails to provide the corresponding structure, material, or acts capable of performing the entire claimed function of each element above, and fails to clearly link any such structure, material, or acts to the respective functions.
With respect to the signal acquisition unit, the only other disclosed manner of performing the function of dropping exosomes from a target person onto a chip is via a human user (see paragraph 73).
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.
Claim 4 recites the limitation "the mental illness patients" in line 4. There is insufficient antecedent basis for this limitation in the claim. While the claim previously recites a mental illness patient, it does not recite a plurality of mental illness patients.
Claim 6 inherits the deficiencies of claim 4 through dependency and is likewise rejected.
Claim 5 is indefinite because the terms “close to 0” and “close to 1” are each relative terms which render the claim indefinite. The above terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While paragraphs 13 and 77 of the specification use each term in the same context as recited in the claim, the disclosure does not provide sufficient information to determine what would constitute “close to 0” or “close to 1.”
Claim 6 is indefinite because Examiner is unable to determine the metes and bounds of the claim based on the recitation of “to determine whether to correspond to the specific type of mental illness.” This limitation contains grammatical errors which make the intended meaning and scope of the unclear. Examiner requests that Applicant amend the claim to clarify the intended scope and meaning.
Claim 7 is further indefinite because Examiner is unable to determine the metes and bounds of the claim based on the recitation of the claimed mental illness diagnosis method as “using a mental illness diagnosis system.” The claim does not contain any further limitations specifying structure for the mental illness diagnosis system, or specifying which functions of the method the mental illness diagnosis system is used to perform. It is therefore not clear what the scope of the mental illness diagnosis system, or the scope of its “use” in performing the method, actually is.
Claims Not Presently Rejected Under 35 USC 102/103
Claims 1-7 are not presently rejected under 35 USC 102/103 in view of the closest prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shin et al, Extracellular Vesicle Identification Using Label-Free Surface-Enhanced Raman Spectroscopy: Detection and Signal Analysis Strategies;
Shin et al, Correlation between Cancerous Exosomes and Protein Markers Based on Surface-Enhanced Raman Spectroscopy (SERS) and Principal Component Analysis (PCA);
Hassantabar et al (US Patent Application Publication 2025/0078998);
Choi et al (US Patent Application Publication 2021/0247382);
Lee et al (US Patent Application Publication 2020/0080151).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM G LULTSCHIK whose telephone number is (571)272-3780. The examiner can normally be reached 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Gregory Lultschik/Examiner, Art Unit 3682
Prosecution Insights