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 Group I, claims 1-4, 11-13, 17-19, 22, 24-25, 27-29, 33 and 38 and species of tau phosphosite in CSF, one or more pT111, pT153, pT175 and semorinemab in the reply filed on 11/16/2025 is acknowledged. Upon further consideration, the species requirements are withdrawn.
Claims 7-9, 16, 41-43 and 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/6/2025.
Claims 1-4, 11-13, 17-19, 22, 24-25, 27-29, 33 and 38 are under consideration in the instant Office Action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see page 44. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1, 12, 19 and 33 are objected to because of the following informalities: the claim contains multiple periods within the claim. For example, "a.". Please change format to "a)". Applicant's attention is directed to MPEP 608.01(m) that deals with claim format. In particular, MPEP 608.01(m) discloses that each claim begins with a capital letter and ends with a period. In addition, it is disclosed that periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the claim recites an abbreviation and/or acronym of 18F GTP1 PET which should be [18F]GTP1 PET which should be spelled out at their first usage followed by the abbreviation/acronym in parenthesis as “Genentech tau probe 1”. Further, PET SUVR should also be spelled out in the first instance as “Positron Emission Tomography standardized uptake value ratios”. Appropriate correction is required.
Claims 3, 25, 27-28 are objected to because of the following informalities: the claim recites an abbreviation and/or acronym of “CN” subjects which is term that stands for cognitive normal subjects and needs to be spelled out at its first occurrence followed by the abbreviation/acronym in parenthesis in the instant claims under consideration. Appropriate correction is required.
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 3, 25 and 28 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.
Claims 3, 25 and 28 recite the limitation " ". Claims 3, 25 and 28 all depend from independent claim 1 which does not call for CN subjects There is insufficient antecedent basis for this limitation in the claim.
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 1-4, 11-13, 17-19, 22, 24-25, 27-29, 33 and 38 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. The claim(s) recite(s) a natural correlation and abstract ideas. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03
Regarding instant claims 1 and 12, Example 43 of “2019 PEG” is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims.
Regarding claim 1 of example 43 of the “2019 PEG” and per Step 1, the claim is directed to a process, which is one of the statutory categories of invention as the claim recites “A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype; (b) administering a treatment to the patient having a non-responder phenotype.” (Step 1: YES).
Similarly, instant claims 1 and 12 are directed to a statutory method that detects one or more phospho-tau species in a CSF sample from a subject, then using that measurement to discriminate an Alzheimer’s disease subject from a healthy state (Step 1: YES).
Step 2A, Prong 1: Does the claim recite a judicial exception?
This part of the eligibility analysis evaluates whether the claim recites a judicial
exception. As explained in MPEP 2106.04(II), 2019 Revised Patent Subject MatterEligibility Guidance, PEG and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Regarding instant claims 1-4, 11-13, 17-19, 22, 24-25, 27-29, 33 and 38, Example 43 of the “2019 PEG” shows a similar fact pattern.
Regarding claim 1 of Example 43, Limitation (a) in the claim recites several nature-based product limitations including C11, C13, and the blood sample, which raises the question of whether the markedly different characteristics analysis should be used to determine if the nature-based product limitations are product of nature exceptions. For a process claim, the general rule is that the claim is not subject to the markedly different analysis for nature-based products used in the process. MPEP 2106.04(c)(I)(C). While there is an exception to this general rule for process claims that are drafted in such a way that they are no different in substance than a product claim, claim 1 does not invoke this exception because review of this claim indicates that it is focused on a process of determining how much C11 and C13 is present in the blood sample and then treating a patient in accordance with that determination, and is not focused on the products per se. Thus, the general rule expressed in the MPEP applies, meaning that the markedly different characteristics analysis is not performed on the recited nature-based product limitations, and the claim is not considered to “recite” any products of nature for purposes of further eligibility analysis.
Similarly, instant claim 1 and 12 recites several nature-based product limitations including CSF, and one or more phospho-tau and Aβ species. While there is an exception to this general rule for process claims that are drafted in such a way that they are no different in substance than a product claim, instant claims 1 and 12 do not invoke an exception because review of this claims indicates that it is focused on a process of determining the presence/levels of phosphor-tau as present in a CSF and then using those values to discriminate an Alzheimer’s subject by comparing it to tau PET SUVT as a positive correlation and further compare it to a healthy state. Thus, the general rule expressed in the MPEP applies, meaning that the markedly different characteristics analysis is not performed on the recited nature-based product limitations, and the claim is not considered to “recite” any products of nature for purposes of further eligibility analysis. However, like claim 1 in Example 43, the instant claims 1 and 12 must then be further reviewed for any other type of judicial exception.
Example 43 of “2019 PEG” continues the analysis to determine whether it recites any other type of judicial exception, per Step 2A, prong 1, the claim recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” and according to broadest reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent phenotype.
Specifically, limitation (a) in claim 1 of Example 43 of the “2019 PEG” recites “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” which has a BRI that requires performing an arithmetic calculation in order to obtain the ratio of C11 to C13 levels, and then using this ratio to identify whether the patient has the non-responder phenotype (i.e., the patient has a calculated ratio of 3:1 or greater and thus is not responding, or will not respond, to glucocorticoids). This limitation therefore recites a mathematical calculation. The grouping of “mathematical concepts” in the 2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping
of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be
practically performed in the human mind, and is in fact performed in the human mind on a daily basis, for instance by school-aged children studying mathematics. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Thus, limitation (a) also falls into the “mental process” groupings of abstract ideas.
In addition, limitation (a) describes a naturally occurring relationship between the ratio of C11 to C13 and the non-responder phenotype, and thus may also be considered to recite a law of nature. Accordingly, limitation (a) recites a judicial exception (an abstract idea that falls within the mathematical concept and mental process groupings in the “2019 PEG”, and a law of nature), and the analysis must therefore proceed to Step 2A Prong Two.
Instant claims 1 and 12 recites “detecting the level of pT217in a cerebrospinal fluid (CSF) sample from the subject and correlating the level of pT217 in the sample with a tau PET SUVR for a subject and determining whether the subject is likely to have AD based on the level of the pT217compared to the tau PET SUVR, wherein the level of pT217 positively correlates with tau PET SUVR.” which describes a naturally occurring relationship between the one or more phosphor-tau and correlating it to AD, and thus is considered to recite a law of nature. Further, instant claims 1 and recite using the obtained phosphor-tau values from CSF and compare them to PET SUVR data to discriminate between an Alzheimer’s subject and a healthy state, which is directed towards an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion)). Comparing collected information to a predetermined threshold, which is an act of evaluating information that can be practically performed in the human mind. Consequently, like example 43, instant claims 1 and 12 recite the judicial exception of applying and using a law of nature and an abstract idea.
Dependent instant claims 2-4, 11,13, 17-19, 22, 24-25, 27-29, 33 and 38 contain limitations that fall under a judicial exception. The dependent claims recite measurements of biomarkers and/or natural correlations of the presence and levels of biomarkers with a disease. Further, instant claims 2-4, 11, 13, 17-19, 22, 24-25, 27-29, 33 and 38 have a BRI that requires a comparison between a subject’s biomarker levels to a healthy subject’s biomarker level, which is directed towards an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). Comparing collected information to a predetermined threshold, which is an act of evaluating information that can be practically performed in the human mind. Lastly, Instant claims recite “determining whether the subject is likely to have AD based on the level of the pT217 compared to the tau PET SUVR, wherein the level of pT217 positively correlates with tau PET SUVR.”, which has a BRI that requires performing an arithmetic calculation in order to obtain a value relative to a healthy control in order to indicate the subject as being at risk for AD or a non-AD subject. This limitation therefore recites a mathematical calculation. The grouping of “mathematical concepts” in the 2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be practically performed in the human mind, and is in fact performed in the human mind on a daily basis, for instance by school-aged children studying mathematics. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Thus, limitation (a) also falls into the “mental process” groupings of abstract ideas.
Accordingly, instant claims 1-4, 11-13, 17-19, 22, 24-25, 27-29, 33 and 38 recite a judicial exception (a law of nature, a natural correlation, and an abstract idea that falls within the mental process groupings) and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong 2: Does the claim recite additional elements that integrate the exception into a practical application?
Regarding instant claims 1 and 12, Example 43 of “2019 PEG” shows a similar fact pattern.
In claim 1 of example 43 of the “2019 PEG” and per Step 2A, prong 2, the claim as a whole does not integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the abstract idea, the claim 1 of example 43 of the “2019 PEG” recites the additional element of “(b) administering a treatment to the patient having a non-responder phenotype”. Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Thus, limitation (b) of example 43 of the “2019 PEG” fails to meaningfully limit the claim because it does not require any particular application of the recited calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, limitation (b) of example 43 of the “2019 PEG” does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception.
Similarly, instant claims 1 and 12 do not have additional elements that would integrate the judicial exception cited above into a practical application. In comparison, claim 1 of Example 43 did not pass step 2A prong 2 with step of general treatment, instant claims 1 and 12 do not even recite any steps of treatment. Example 43 failed with the step of general treatment, instant claims 1 and 12 do not even recite a further active step, let alone a step for treatment.
Therefore, instant claims1 and 12 does not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
Regarding claim 1 of example 43 of the “2019 PEG” and per Step 2B, this part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, the claim recites a single additional element in limitation (b), which does not require any particular application of the recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.
Similarly, instant claims 1 and 12 recite the additional limitation of (a) providing a processed CSF obtained from a subject that is enriched for one or more phosphor-tau and Aβ species which recites measuring naturally occurring biomarkers in a sample from a subject which are mere instructions of obtaining a judicial exception and cannot be considered an inventive concept. Accordingly, instant claims 1 and 12 not eligible (STEP 2B: NO).
Instant claims 1-4, 11-13, 17-19, 22, 24-25, 27-29, 33 and 38 are rejected as ineligible under 35 USC 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 19, 24-25, 28-29 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wildsmith et al., 2018 (Abstract; instant PTO-892).
The instant claims are towards methods of determining whether a human subject is likely to have Alzheimer’s disease (AD) by detecting the level of phosphorylated tau including pT217, in a cerebrospinal fluid (CSF) sample from a subject, and correlating the level of pT217 in the sample with a tau PET SUVR obtained with 18F GTP1 and determining whether the subject has AD based on the level of the pT217 compared to the tau PET SUVR, wherein the level of pT217 positively correlates with tau PET SUVR.
Wildsmith teaches determining the levels of phosphorylated tau in CSF samples to determine the diagnosis of subject to determine if they have AD and reads on in instant claims 1-4. Wildsmith teaches using CSF samples analyzed by nano-LC-MS/MS and paired phosphorylated and unphosphorylated peptides at sites T181, S202, T205 and T217 were quantified and reads on instant claims 1-4, 11, 18 -19, 24-25, 28-29, 33 and 38. Wildsmith teaches CSF tau levels, in particular the T181 phospho-variant, can support a diagnosis of AD when combined with CSF Ab42 levels and reads on instant claim 19. Wildsmith teaches using the tau PET tracer [18F]GTP1, and CSF measurements of different phosphorylated tau sites using a highly specific LC-MS/MS assay wherein the matched CSF samples, [18F]GTP1 and florbetapir images collected from cognitively normal (amyloid positive or negative), and amyloid positive cognitively impaired subjects (aged 50-85) who were sub-classified as prodromal, mild or moderate AD and reads on instant claims 1, 4, 19, 24-25 and 28. Wildsmith teaches that this study provides insight into the relationship between tau PET imaging and CSF phospho-tau, and helps guide the usage and interpretation of biomarker data in the clinic and that CSF species containing phosphosites T217 and T205 are more closely reflective of tauopathy such as AD, as detected by tau PET.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 11-13, 17-19, 22, 24-25, 27-29, 33 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Wildsmith et al., 2018 (instant PTO-892) as applied to claims 1-4, 19, 24-25, 28-29 and 38 above, and further in view of Barthelemy et al., WO 2019213612A1 (IDS filed on 9/27/2022).
See Wildsmith, as discussed above. Wildsmith teaches the limitations of instant claims 12-13, 17-18 as set forth above since it teaches using CSF tau samples and comparing to tau PET SUVR. While Wildsmith teaches some of the target phosphorylated tau species, Wildsmith does not teach all of the claimed tau species.
Barthelemy teaches a method of discriminating a tauopathy, the method comprising providing a processed CSF or blood sample obtained from a subject with an isolated tau sample purified from cerebrospinal fluid (CSF) obtained from a subject, wherein the CSF is enriched for one or more phospho-tau (see [0060], [0139]). Barthelemy teaches a method to diagnose a subject's stage of AD comprising providing an isolated tau sample obtained from a subject and measuring, in the isolated tau sample, tau phosphorylation at one or more amino acid residue chosen from chosen from T111, S113, T181, S199, S202, S208, T153, T175, T205, S214, T217, and T231, and measuring total tau; and diagnosing the stage of the subject's AD when the measured phosphorylation level(s) significantly deviate from the mean in a control population without brain amyloid plaques as measured by PET imaging (see figure 13, see figure 15, see [0064], [0072]) and meets the tau species limitations of instant claims 1-3, 11, 18, 22, 24-25, 27-29, 33 and 38. Barthelemy teaches measuring, in the isolated tau sample, tau phosphorylation at one or more amino acid residue chosen from T181 , T205 and T217 and measuring total tau; and diagnosing the subject as being a certain number of years after onset of MCI due to AD when the measured phosphorylation levels significantly deviate from the mean in a control population without brain amyloid plaques as measured by PET imaging (see [0010], [0271]) or a ratio calculated from the measured phosphorylation levels and total tau. Barthelemy teaches wherein the subject is diagnosed as having or at an increased risk of having AD when the detected pT153/T153 value is increased relative to a healthy control population and/or a non-AD tauopathy population (see [0072]); wherein the subject is diagnosed as having or at an increased risk of having AD when the detected pT111/T111 value is increased relative to a healthy control population and/or a non-AD tauopathy population (see figure 11, see [ 0025], [0071]) teaching measuring T111 in order to diagnose AD staging and where the pT111 levels are significantly deviated from the mean of the control population; wherein the subject is diagnosed as having or at an increased risk of having a tauopathy when the detected pT205/T205 value is increased relative to a healthy control population (see [0032] [0282]) teaching an increase in pT205 levels: wherein the subject is diagnosed as having or at an increased risk of having AD when the detected pS208/S208 value is increased relative to a healthy control population (see [0023] [0072]). Barthelemy teaches determining a composite pT217/T217 value wherein an increased composite value relative to a healthy control population indicates the subject as having or at an increased risk for AD or a non-AD tauopathy (see [0008] – [0009], [0070]).
While Barthelemy doesn’t explicitly teach the specific combination of phosphorylated tau combinations or increasing or decreasing ratios for all the species of tau it would have been prima facia obvious to one of ordinary skill in the art at the time of the instant application to consider measuring all of the disclosed species taught by Wildsmith and Barthelemy. One of ordinary skill in the art would be motivated to use the teachings of Wildsmith and Barthelemy to determine if someone has or is at risk for having AD since both Wildsmith and Barthelemy teach all of the required species and the methods taught by Wildsmith are capable of determining the ratios of tau species in the CSF and PET SUVR that predict the likely hood of diagnosing AD. One of ordinary skill in the art would have considered comparing the levels of the biomarkers from the subject to a healthy control to determine if the levels have increased, decreased, or stayed the same. Using a healthy control sample when measuring biomarkers to compare values is a commonly used technique in the art.
One of ordinary skill in the art would have considered comparing the biomarker levels from the subject to a control (AD population) in order to discriminate AD and non-AD. It is a common technique in the diagnostic art to compare biomarker levels to a control population in order to differentiate/discriminate between diseases. It would have been prima facia obvious to one of ordinary skill in the art to exclude a subject from an AD diagnosis when they do not have the biomarker levels that are associated with AD disease.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vemuri et al., 2017 (instant PTO-892) disclosed methods of measuring amyloid deposit using PET SUVT and it use a tau PET.
Saint-Aubert et al., 2017 (instant PTO-892) disclosed used and tau tracers for tau PET imaging.
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675