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 .
Status of the claims
The Preliminary Amendment filed 08/15/24 is acknowledged and has been entered. Claims 1, 4, 6-7, 9-11, 13-14, 23 and 27-28 have been amended. Claims 15-17, 20, 22, 24-26 and 29 have been canceled. Accordingly, claims 1-14, 18-19, 21, 23 and 27-28 are pending and under examination.
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 (e.g. page 13, lines 4 & 20). 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.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 28 is objected to because of the following informalities: Claim 28, line 9 the recitation “the subjects” should be --the subject--. Appropriate correction is required.
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 1-14, 18-19, 21, 23 and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claims are directed to a naturally occurring correlation between the levels of the recited biomarkers in a subject at risk of developing or suspected of having neurodegenerative disease, disorder, or condition compared to a reference. Also, claim 12 is directed to an abstract idea of calculating the proportion of cells.
Step 2A, Prong 2
The additional elements of measuring in a blood sample the recited biomarkers and making a comparison to a reference does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “wherein an increased level of at least one of CD38+ PBMCs, Th2, Th2/Th1 ratio, naïve T cells, and adenosine, as compared to a respective reference, and/or a decreased level of at least one trigonelline, GLUT1 expression in CD4+ T cells, allose, and HLA-DR T cells as compared to a respective reference, indicates that the subjects is likely developing, or is affected by, the neurodegenerative disease, disorder, or condition”. The “wherein” statement at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the recited biomarkers being correlated with neurodegenerative disease, disorder or condition. No active method steps are invoked or clearly required; the “wherein” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by both Sanchez-Melgar et al (Cells 2020, 9, pgs 1-15) it is well known, routine and conventional in the art to measure adenosine levels in a same and compare to that of a control (e.g. page 9). As shown, by Burns et al (Int. J. Mol. Sci., February 2021, 22, pages 1-19) it is well known, routine and conventional to measure CD38 PBMC and compare to that of a control (e.g. abstract).
With respect to the “administering an immune checkpoint modulator to the subject which is likely developing or is affected by, the neurodegenerative disease, disorder, or condition” as recited in claim 28. Although the claim invokes administering an immune checkpoint modulator to the subject the claim currently allows for a scenario wherein the subject is not diagnosed with a neurodegenerative disease, disorder, or condition when the levels are not as recited and thus allows for an embodiment wherein no treatment is administered. Therefore, this scenario does not recite something significantly more than the judicial exception.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Written Description
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The instant claims are directed to a method for treating or preventing a neurodegenerative disease, disorder or condition in a subject by measuring in a blood sample or fraction thereof the levels of at least one biomarker selected from the group consisting of CD38+ PBMCs, trigonelline, GLUT1 expression in CD4+ T cells, Th2, Th2/Th1 ratio, naïve T cells, adenosine, allose, and HLA-DR T cells, wherein an increased level of at least one of CD38+ PBMCs, trigonelline, GLUT1 expression in CD4+ T cells, Th2, Th2/Th1 ratio, naïve T cells, adenosine, as compared to a respective reference, and/or a decreased level of at least one trigonelline, GLUT1 expression in CD4+ T cells, allose, and HLA-DR T cells as compared to a respective reference, indicates that the subjects is likely developing, or is affected by, the neurodegenerative disease, disorder, or condition, and the method further comprising administering an immune checkpoint modulator to the subject which is likely developing, or is affected by, the neurodegenerative disease, disorder, or condition, thereby treating the subject.
The term “preventing” is interpreted as implying an absolute and complete prevention of a neurodegenerative disease, condition or disorder i.e. not any overt symptom or pre-symptomatic marker or damage may be present at any level. To overcome this rejection it is suggested that applicant use a term which does not imply an absolute and/or complete effect. Acceptable terms would be "inhibition," "retardation," etc. Applicant, however, must be able to point out specific support in the specification for any term used in lieu of "preventing". There is inadequate written description in the instant specification for a method of such method as claimed.
The specification on page 3, lines 28-29 discloses that the present invention provides a method for treating or preventing a neurodegenerative disease, disorder, or condition in a subject. The specification on page 33, lines 25-26 discloses the present invention provides a method for treating or preventing in a subject at risk for or diagnosed with a neurodegenerative disease, disorder, or condition. However, the specification fails to provide any data, results, tables, or experiments that such treatment prevents any and all neurodegenerative diseases, disorders or conditions. It is recommended to delete any reference to prevention from the claims. The applicant has not shown possession of methods of prevention of neurodegenerative diseases, disorders or conditions.
Written Description
Claims 1-14, 18-19, 21, 23, and 27-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a methods for early detection, diagnosis, treatment or assessment of treatment of any and all neurodegenerative diseases, disorders or conditions in any and all subjects at risk of developing or suspected of having the neurodegenerative disease, disorder or conditions by measuring in a blood sample obtained from the subject the levels of at least one of the recited biomarkers and comparing the to that of a reference. The limitation 'subject’ represents a genus and encompasses human and non-human including mouse, monkey, dog, rat, pig, insects, kangaroo, horse, canine and snake to name a few. The limitation ‘neurodegenerative disease, disorder or condition’ represents a genus and encompasses Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, Amyotrophic Lateral Sclerosis (ALS), Dementia with Lewy bodies, vascular dementia, Chronic traumatic encephalopathy (CTE), Frontotemporal dementia, Creutzfeldt-Jacob disease, Multiple sclerosis (MS), multiple system atrophy (MSA) to name a few. However, there is inadequate written description in the instant specification for a method of such broad scope as claimed currently.
In order to fulfill the written description requirements set forth under 35 U.S.C § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, each member correlated with the requisite function, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicants have possession the claimed invention. Applicants have not described and established structure-function correlation for a representative number of species within the broad genus of at least the recited ‘subject’, and ‘neurodegenerative disease, disorder or cndition’ such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the full scope of the claimed invention at the time the application was filed.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. When there is substantial structural variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
A review of the instant specification indicates the following. The specification on pages 1-2 discloses Alzheimer’s disease as a progressive neurodegenerative disorder with a strong genetic component. The specification on pages 4-5 discloses the tesing of Alzheimer’s disease patients and healthy subjects and the detection of biomarkers in these two groups of individuals The specification on page 5 discloses that in order to determine a molecular immune cell signature across Alzheimer’s disease progression, the inventions used in-depth immune profiling of human-derived blood samples. The specification on page 35 discloses doses of immune checkpoint modulator to be used for human use. The examples on pages 43-50 are limited to the measurement of the recited biomarkers in blood samples from human patients and Alzheimer’s disease. The specification does not provide data, testing or examples with a showing that any all and all subjects provide the recited biomarker at levels which can be specifically correlated with any and all neurodegenerative diseases, disorders and conditions. As shown by Lin et al (Frontiers in Aging Neuroscience, April 2018, Vol 10, Article 123, pages 1-9) a biomarker can have different levels in neurodegenerative diseases and disorders and can be at levels which allows for differentiation. Thus, showing that not all biomarkers appear at the same levels in all neurodegenerative diseases and disorders. Also, Torzewski et al, (Hindawl Publishing Corporation, Mediators of Inflammation, Vol 2014, Articles ID 683598, pages 1-7) teaches for example that CRP (biomarker) is an acute phase reactant in humans but not an acute phase reactant in a mouse (e.g. page 1). Van Der Vekens et al., (Cardiovascular Endocrinology, 2013, Vol 2, No. 4,pages 67-76) teaches that markers between human and equine show important species differences, which can be explained by variations in physiology or pathophysiology and also teaches pathological differences in the species (e.g. abstract).
The only examples utilized in the specification appears to be limited to patients that are human and the measurement of the recited biomarkers in blood samples from the human subjects for diagnosing Alzheimer’s disease and for the treatment and assessment of treatment of Alzheimer’s in human subjects. The specification does not disclose that the recited biomarkers which appear at levels in blood samples of Alzheimer’s disease also appear at these levels in any and all neurodegenerative diseases, conditions and disorders and would be expected to appear in all neurodegenerative diseases, conditions or disorders at levels which specifically allows for the correlation of these diseases, conditions and disorders. As stated supra the specification appears to be limited to patients that are human and the measurement of the recited biomarkers in blood samples from the human subjects for diagnosing Alzheimer’s disease and for the treatment and assessment of treatment of Alzheimer’s in human subjects.
The specification also fails to provide for a correlation of the recited biomarkers in all subjects such as dogs, cats, cows, monkey, horse, rabbit squirrel and mice (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease) Further, it is not well known in the art that a biomarker which appears in one neurodegenerative disease, disorder or condition provides for a correlation with all neurodegenerative diseases, disorders or conditions. The examples in the specification appear to be limited to patients that are human and the measurement of the recited biomarkers in blood samples from the human subjects for diagnosing Alzheimer’s disease and for the treatment and assessment of treatment of Alzheimer’s in human subjects. The purpose of the ‘written description; requirement is broader than to merely explain how to ‘make and use’, Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
It must be noted that "[t]he applicant must . . . convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir.1991). The invention, is for purposes of the ‘written description’ inquiry, whatever is now claimed.” See page 1117. The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the full scope of the claimed invention at the time of filing. The Written Description Guidelines state: There is an inverse correlation between the level of predictability in the art and the amount of disclosure necessary to satisfy the written description requirement. For example, if there is a well-established correlation between the structure and function in the art, one skilled in the art will be able to reasonably predict the complete structure of the claimed invention from its function. Furthermore, the written description provision of 35 U.S.C § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ‘Written Description’ Requirement (66 FIR 1099-1111, January 5,2001) state, ‘[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention’ (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. Factual evidence of an actual reduction to practice has not been disclosed in the instant specification, nor has Applicant shown the invention was ‘ready for patenting’. The Guidelines further state, ‘[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus' (Id. at 1106). For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. Instant claims are viewed as not meeting the written description provision of 35 U.S.C § 112, first paragraph. The specification fails to disclose the measurement of the recited biomarkers in any and all subjects wherein the level of the recited biomarkers is specifically correlated with any and all neurodegenerative diseases, disorders or conditions.
Scope of Enablement
Claims 1-14, 18-19, 21, 23, and 27-28 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method for the diagnosis of Alzheimer’s disease in a human subject suspected of having the Alzheimer’s disease comprising measuring in a blood sample obtained from the subject or a fraction thereof the levels of at least one biomarker selected from the group consisting of CD38+ peripheral blood mononuclear cells (PBMCs), trigonelline, GLUT1 expression in CD4+ T cells, Th2, Th2/Th1 ratio, naïve T cells, adenosine, allose, and HLA-DR T cells, wherein an increased level of at least one of CD38+ PBMCs, Th2, Th2/Th1 ratio, naïve T cells, and adenosine, as compared to a respective reference, and/or a decreased level of at least one of trigonelline, GLUT1 expression in CD4+ T cells, allose, and HLA-DR T cells as compared to a respective reference, indicates that the subject has Alzheimer’s disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Enablement requires that the specification teach those in the art to make and use the invention without undue experimentation. The factors that must be considered in determining undue experimentation are set forth in In re Wands USPTQ2d 14000. Factors to be considered in determining whether a disclosure would require undue experimentation include (1) the nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the quantity of experimentation necessary, (7) the relative skill of those in the art, and (8) the breadth of the claims.
The instant claims are directed to a methods for early detection, diagnosis, treatment or assessment of treatment of any and all neurodegenerative diseases, disorders or conditions in any and all subjects at risk of developing or suspected of having the neurodegenerative disease, disorder or conditions by measuring in a blood sample obtained from the subject the levels of at least one of the recited biomarkers and comparing the to that of a reference.
One cannot extrapolate the teaching of the specification to the enablement of the claims because other than detecting B2MG in a human serum or plasma sample and comparing to a control survivor patient suffering from cardiogenic shock and determining an increased level as compared to the control as indicating mortality risk in the patient.
A review of the instant specification indicates the following. The specification on pages 1-2 discloses Alzheimer’s disease as a progressive neurodegenerative disorder with a strong genetic component. The specification on pages 4-5 discloses the tesing of Alzheimer’s disease patients and healthy subjects and the detection of biomarkers in these two groups of individuals The specification on page 5 discloses that in order to determine a molecular immune cell signature across Alzheimer’s disease progression, the inventions used in-depth immune profiling of human-derived blood samples. The specification on page 35 discloses doses of immune checkpoint modulator to be used for human use. The examples on pages 43-50 are limited to the measurement of the recited biomarkers in blood samples from human patients and Alzheimer’s disease. The specification does not provide data, testing or examples with a showing that any all and all subjects provide the recited biomarker at levels which can be specifically correlated with any and all neurodegenerative diseases, disorders and conditions. As shown by Lin et al (Frontiers in Aging Neuroscience, April 2018, Vol 10, Article 123, pages 1-9) a biomarker can have different levels in neurodegenerative diseases and disorders and can be at levels which allows for differentiation. Thus, showing that not all biomarkers appear at the same levels in all neurodegenerative diseases and disorders. Also, Torzewski et al, (Hindawl Publishing Corporation, Mediators of Inflammation, Vol 2014, Articles ID 683598, pages 1-7) teaches for example that CRP (biomarker) is an acute phase reactant in humans but not an acute phase reactant in a mouse (e.g. page 1). Van Der Vekens et al., (Cardiovascular Endocrinology, 2013, Vol 2, No. 4,pages 67-76) teaches that markers between human and equine show important species differences, which can be explained by variations in physiology or pathophysiology and also teaches pathological differences in the species (e.g. abstract).
The only examples utilized in the specification appears to be limited to patients that are human and the measurement of the recited biomarkers in blood samples from the human subjects for diagnosing Alzheimer’s disease and for the treatment and assessment of treatment of Alzheimer’s in human subjects. The specification does not disclose that the recited biomarkers which appear at levels in blood samples of Alzheimer’s disease also appear at these levels in any and all neurodegenerative diseases, conditions and disorders and would be expected to appear in all neurodegenerative diseases, conditions or disorders at levels which specifically allows for the correlation of these diseases, conditions and disorders. As stated supra the specification appears to be limited to patients that are human and the measurement of the recited biomarkers in blood samples from the human subjects for diagnosing Alzheimer’s disease and for the treatment and assessment of treatment of Alzheimer’s in human subjects.
The specification also fails to provide for a correlation of the recited biomarkers in all subjects such as dogs, cats, cows, monkey, horse, rabbit squirrel and mice (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease) Further, it is not well known in the art that a biomarker which appears in one neurodegenerative disease, disorder or condition provides for a correlation with all neurodegenerative diseases, disorders or conditions. The examples in the specification appear to be limited to patients that are human and the measurement of the recited biomarkers in blood samples from the human subjects for diagnosing Alzheimer’s disease and for the treatment and assessment of treatment of Alzheimer’s in human subjects. Thus, one cannot practice the claimed invention without undue experimentation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(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.
Claim 1 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated Commissiong et al (WO 2014/205406).
Commissiong et al discloses a method of diagnosing chronic traumatic encephalopathy (CTE) (neurodegenerative disease, disorder or condition) (e.g. abstract, pgs 2-3, 17). Commissiong et al discloses the method comprising obtaining a blood sample from a subject and quantifying the expression of surface markers such as CD38 on peripheral blood mononuclear cells (PMBC) and comparing to that of a reference wherein a higher level as compared to the control indicates the CTE (e.g. para’s 0011, 0018-0025, 0090, 0099-0100).
Allowable Subject Matter
Claims 2-14, 18-19, 21, 23 and 27-28 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, 35 U.S.C. 112(a), and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. The prior art of record does not teach nor fairly suggest measuring the recited biomarkers and diagnosing neurodegenerative disease and assessing efficacy of treatment as currently recited.
Conclusion
No claims are allowed.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678