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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission of RCE on 6/10/25 and the amendment of claims has been entered.
Election/Restrictions
Applicant’s election without traverse of “method for assessing whether the subject is afflicted with a neurological disease or disorder”, “detecting the expression of the Fndc5 gene”, 14(b), 15(v) and 16(d) as the single species of Fndc5 polypeptide ad Parkinson’s disease as the neurological disease in the reply filed on 6/18/24 was previously acknowledged.
In the reply filed 10/28/24, Applicants canceled claims 12, 14-16 and 20. Claims 52-58 were newly added.
In the reply filed 6/10/25, Applicants amended claims 52, 53 and canceled claim 54.
Claims 52-53 and 55-58 are pending and under consideration.
Claim Objections-Withdrawn
The objection to claim 53 is withdrawn due to amendment of the claim.
Claim Rejections - 35 USC § 112-NEW
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.
Claim 57 is 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. This is a NEW rejection.
Claim 57 is indefinite because the limitation “the irisin polypeptide is pegylated” is unclear. The claim depends from claim 52 which drawn to the method of assessing whether a subject is afflicted with PD comprising the step of detecting the expression of BNDF and irisin. PEGylation is an artificial, non-naturally occurring modification that does not occur in vivo. Because the claimed method assess the amount of naturally occurring proteins (BDNF and irisin) in a subject and correlates that amount with disease status, the recited “pegylated irisin” cannot reasonably apply in this context. A skilled artisan would not understand how a diagnostic assessment of endogenous irisin could involve a pegylated species. One of ordinary skill in the art would be unable to determine what it means to detect pegylated irisin in the context of the diagnostic method. It is unclear if the method requires the presence of exogenously administered pegylated irisin that is not a recited step in claim 52 presently.
Claim Rejections - 35 USC § 101-NEW
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.
The rejection of claims 52-53 and 55-58 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter is maintained. Based upon an analysis with respect to the claim as a whole, claims 52-53 and 55-58 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s 2019 Revised Patent subject matter Eligibility Guidance (referred to as 2019 PEG) published January 2019 and the “PEG update” in October 2019.
Claim Interpretation
Claims 52 is drawn to a method for assessing whether a subject is afflicted with PD comprising the steps of detecting the expression of BDNF and irisin polypeptide having the sequence of residues 30-140 pf SEQ ID NO: 2 in a sample of a the subject comprising central nervous system fluid of cells, wherein each of BDNF and irisin polypeptides is detected using a reagent selected from the group consisting of an antibody, antibody derivative and an antibody fragment and wherein a decrease in the expression of BDNF and irisin polypeptide compared to a control indicates the subject is afflicted with PD.
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see, e.g., 79 FR 74621)?
Yes, the instant claims are directed to a process.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (see, e.g., 79 FR 74621)?
Yes, the claims are drawn to a law of nature and abstract idea. The claims are drawn to a natural correlation of BDNF and irisin expression in PD. The correlation is a law of nature because the claims recite a consequence of a natural process in the living body, e.g. the naturally occurring relationship between the expression of BDNF and irisin and manifestation of PD. The claims also recite an abstract idea-mental process; that is the step of comparing the expression or activity of irisin with controls. The judicial exception is not integrated into a practical application because the detecting step is performed to gather data for the mental process of comparing the law of nature correlation. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the detection step is generic: BDNF and irisin is detected using a reagent selected from an antibody, an antibody derivative or antibody fragment.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application?
No, the claim does not recite additional elements that integrate the judicial exception into a practical application because the techniques of detecting the expression/activity is routine and convention in the biotechnological art. With respect to claims 53 and 55-58, obtaining a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics. The steps are also recited at a high level of generality such that it amounts to insignificant pre-solution activity (i.e. a mere gathering step necessary to use the correlation). Importantly, as indicated previously detecting irisin in neural tissue was known before the effective filing date of the invention. Dun et al. (Neuroscience 2013, June 14, 240: 155-162) detected irisin in Purkinje cell of the cerebellum. Detecting of BDNF and irisin is present in the spinal fluid or cells merely instructs a scientist to use any detection technique with any generic antibody, derivative or fragment thereof.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see, e.g., 79 FR 74621)?
No, the claim does not recite additional elements that integrate the judicial exception into a practical application because the techniques of detecting the expression/activity is routine and convention in the biotechnological art.
Response to Arguments
Applicant's arguments filed 6/10/25 have been fully considered but they are not persuasive. Applicants argue that the claims have been amended to include detection of both BDNF and irisin using a reagent selected from an antibody, an antibody derivative and an antibody fragment. Applicants argue that the recited elements amount to significantly more than the judicial exception at least because the claim elements are not recited at a high level of generality and amount to more than insignificant extra-solution activity. In particular, the recited BDNF and irisin sequence amount to more because there is no art recognized associated of such polypeptide sequence either to each other or to the context of central nervous system fluid or cells and PD. Applicants argue the recitation of specific detection reagents are not generalized limitations and amount to significantly more.
This arguments are not persuasive because the claims are drawn to a natural correlation of BDNF and irisin in the CNS fluid or cells and PD. As indicated above, obtaining a sample such as CNS fluid or cells in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics. The steps and reagents are also recited at a high level of generality such that it amounts to insignificant pre-solution activity (i.e. a mere gathering step necessary to use the correlation and generic reagents). Detecting if BDNF and irisin is present in the spinal fluid or cells merely instructs a scientist to use any detection technique with any generic antibody, antibody derivative or antibody fragment. The claims do not recite a specific antibody or other reagent that is not routine or conventional for detection. Detecting if BDNF and irisin is present in the spinal fluid or cells merely instructs a scientist to use any detection technique with any generic antibody, derivative thereof or fragment thereof. Importantly, as indicated previously detecting irisin in neural tissue was known before the effective filing date of the invention. Dun et al. (Neuroscience 2013, June 14, 240: 155-162) detected irisin in Purkinje cell of the cerebellum.
Applicants are invited to review the Offices Subject Matter Eligibility Examples: Life Sciences (May 2013) Example 29. Example 29, claim 3 is drawn to a specific antibody for detection that was not routinely or conventionally used to detect human proteins such as JUL-1.
For the reasons presented above, the rejection is maintained.
Examiner’s comment
There was no teaching or suggestion to assess whether a subject is afflicted with PD by detecting the expression of BDNF and irisin having the sequence of residues 30-140 of SEQ ID NO: 2. The closest art is Novelle et al. (International Journal of Endocrinology, Vol. 2013, published after the filing date of the instant application). Novelle et al teach interest in irisin arose because of its therapeutic potential in diabetes (Abstract). Novelle et al. teach that irisin might be the link between exercise and healthy brain (p. 4, 1st col.). Novelle et al. teach irisin may be a therapeutic target for neurodegenerative diseases such as AD and PD (Fig. 2). Novelle et al. also teach that although it has been considered as a possible treatment for neurodegenerative diseases, new studies have questioned the initial expectations, so further studies are needed to elucidate the potential in this field (p. 6, top of 1st col.). However, Novelle et al. does not teach or suggest irisin as a marker for PD. Please note that reduced levels of BDNF have long been associated with PD. There was no art found that teaches or suggests irisin for the purposes of claim 52.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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, Lianko Garyu can be reached on (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TARA L MARTINEZ/Examiner, Art Unit 1654