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 .
Election/Restrictions
Applicant’s election without traverse of invention II in the reply filed on 22 September 2026 is acknowledged.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 September 2026.
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:
Collection part, first recited in claim 6
Calculation part, first recited in claim 6
Judgment part, first recited in claim 6
Conversion part, first recited in claim 7
Processing part, first recited in claim 9
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 6-11 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.
Claim limitation “collection part” 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. The disclosure sets forth only the function (“ In the present disclosure, the collecting neural population activity signals from the cerebral cortex neurons may include converting a fluorescent signal of each neural cell into a time series signal from an image measured through a fluorescence microscope.”, p. 5, lines 16-19 as filed) and defining the collection part in terms of another disembodied “part” (“the collection part configured to collect neural population activity signals of cerebral cortex neurons may include a conversion part configured to convert a fluorescence signal of each neuron into a time series signal from an image measured through a fluorescence microscope”, p. 8 lines 7-12 as filed). At best the disclosure generally sets forth use of a computer (p. 4, lines 16-19) but there is no particular description of how a computer might be involved in “collecting”. 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.
Claim limitation “collection part” 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. The disclosure sets forth only the collection part as defined in terms of another disembodied “part” (“the calculation part configured to calculate a synchronization index may include a processing part”, p. 8 lines 13-15 as filed). At best the disclosure generally sets forth use of a computer (p. 4, lines 16-19) but there is no particular description of how a computer might be involved in the “calculation” or how it is particularly configured to perform any task. 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.
Claim limitation “judgement part” 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. The disclosure sets forth only that such a “part” can exist with no clear disclosure of structure. At best the disclosure generally sets forth use of a computer (p. 4, lines 16-19) but there is no particular description of how a computer might be involved in “judgement”. 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.
Claim limitation “conversion part” 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. The disclosure sets forth only that such a “part” can exist with no clear disclosure of structure. At best the disclosure generally sets forth use of a computer (p. 4, lines 16-19) but there is no particular description of how a computer might be involved in “judgement”. 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.
Claim limitation “processing part” 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. The disclosure sets forth only the function (“ a processing part that is configured to calculate a similarity (SR) index”, p. 8, lines 14-15) with no clear indication of how this is to be configured. At best the disclosure generally sets forth use of a computer (p. 4, lines 16-19) but there is no particular description of what particular part of the computer performs this “processing”. 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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 is directed only to a “device” comprising nothing more than the “system” of claim 6, failing to further limit that claimed invention. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 6-11 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 6 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 6 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “a calculation part configured to calculate a synchronization index” and “a judgement part configured to diagnose Alzheimer’s disease through the calculated index”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. At best, though not disclosed as such, these “parts” might be computing components but recited at a high level of generality and doing no more than providing a technological environment for execution of the abstract idea itself. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “parts” configured to perform the above tasks, and a “collection part” configured to collect neural activity signals. However, these “parts” elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Further, a non-specific “collection part” is recited at a high level of generality only for the insignificant extrasolution activity of data gathering - See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 6 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 7-11 fail to cure the deficiencies of independent claim 6 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Claim 7 is directed to data gathering, claim 8 is directed to an inherent natural phenomenon, claim 9 is directed to the abstract idea itself, claim 10 presents a mathematical calculation, which falls into another group of abstract ideas, and claim 11 does not further limit claim 6 and thus does not recite any additional eligible subject matter Thus, claim(s) 6-11 is/are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Busche (Busche, M., Kekuš, M., Adelsberger, H. et al. Rescue of long-range circuit dysfunction in Alzheimer's disease models. Nat Neurosci 18, 1623–1630 (2015).
Regarding claims 6 and 11, Busche discloses a system for diagnosing Alzheimer's disease based on neural population signal synchronization, comprising:
a “collection part” configured to collect neural population activity signals of cerebral cortex neurons (section 2 “Two-photon imaging in combination with fluorescent calcium indicators allows functional analyses of neuronal activity in the intact mouse brain with single-cell and single-action potential accuracy”, “By using this optical approach in the APP23 × PS45 model of AD, we revealed that neurons in layer 2/3 of the amyloid-depositing frontal cortex are functionally impaired in vivo”);
a “calculation part” configured to calculate a synchronization index from the collected signals (section 5, “Indeed, by employing large-scale calcium fluorescence imaging of the mouse cortical surface, we revealed that the long-range coherence of neuronal activity across neocortical areas was massively impaired in amyloid plaques-bearing APP23 and APP23 × PS45 mouse models when compared with wild-type littermates”); and
a “judgment part” configured to diagnose Alzheimer's disease through the calculated index (section 5, “the dysfunction of individual neurons observed in AD mouse models can impair the long-range communication between distant brain regions. Indeed, by employing large-scale calcium fluorescence imaging of the mouse cortical surface, we revealed that the long-range coherence of neuronal activity across neocortical areas was massively impaired in amyloid plaques-bearing APP23 and APP23 × PS45 mouse models when compared with wild-type littermates”).
Busche is not explicit as to these “parts” being part of a system or device, but the Examiner takes Official Notice that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have used a computing system or device to embody the tasks of gathering and processing data, thus having “parts” performing these tasks, as computing systems and devices were in widespread use at the time to improve the speed and accuracy of data gathering and processing.
Regarding claim 7, Busche further discloses that the “collection part” configured to collect neural population activity signals of cerebral cortex neurons comprises a “conversion part” that is configured to convert a fluorescence signal of each neuron into a time series signal from an image measured through a fluorescence microscope (section 2 “Two-photon imaging in combination with fluorescent calcium indicators allows functional analyses of neuronal activity in the intact mouse brain with single-cell and single-action potential accuracy”, “By using this optical approach in the APP23 × PS45 model of AD, we revealed that neurons in layer 2/3 of the amyloid-depositing frontal cortex are functionally impaired in vivo”; section 3 “two-photon microscopy”).
Regarding claim 8, Busche further discloses that the fluorescent signal of each neuron is generated through genetically encoded calcium indicators expressed in neurons (section 2 “Two-photon imaging in combination with fluorescent calcium indicators allows functional analyses of neuronal activity in the intact mouse brain with single-cell and single-action potential accuracy”, “By using this optical approach in the APP23 × PS45 model of AD, we revealed that neurons in layer 2/3 of the amyloid-depositing frontal cortex are functionally impaired in vivo”).
Regarding claim 9, Busche further discloses that the “calculation part” configured to calculate a synchronization index comprises a “processing part” that is configured to calculate a “similarity (SR) index” that indicates a degree of synchronization of the collected neural population activity signals (section 5, “Indeed, by employing large-scale calcium fluorescence imaging of the mouse cortical surface, we revealed that the long-range coherence of neuronal activity across neocortical areas was massively impaired in amyloid plaques-bearing APP23 and APP23 × PS45 mouse models when compared with wild-type littermates”).
Conclusion
No art has been applied against claim 10 at this time; however, as the claim is rejected under 112, 101, and depends from a claim rejected by art, the claim is not presently allowable and the question of prior art will be revisited, if applicable, upon resolution of these numerous other issues.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2011/0256565 to Schon
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/KAREN E TOTH/Examiner, Art Unit 3791
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