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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 filed on 8/27/2025 has been entered.
Applicant’s election of the species of SEQ ID No. 1, 3, 5-10, 13 and 14 in the reply filed on 5/21/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-5,8, 22, 27, 32-34 are pending. Claim 27 is withdrawn as being drawn to a nonelected species. Claims 6-7,9-21,23-26,28-31 have been cancelled.
The rejections for claims 1-5,8, 22,32-34 are newly applied or modified as necessitated by amendment with response to arguments following.
This action is NONFINAL.
Withdrawn Rejections
The 35 USC 112 Scope of Enablement made in the previous office action is withdrawn based upon amendments to the claims.
Newly Applied 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.
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.
Claims 1-5,8, 22,32-34 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Upon review of the specification, the specification does not appear to provide support for the recitation of “a decreased level of expression of the small non-coding RNAs compared to the reference level”. The amendments to the claims raise issues of new matter because the amendments include specific expression level of each of the SEQ ID Numbers which is not supported in the instant specification.
The reply points to page 5, paragraph 1, page 21 paragraph 2, page 22 paragraph 2 and former claim 31 (p. 6). Formal claim 31 does not provide a specific expression level (decreased level) and SEQ ID Nos. 1, 3, 5-10, 13-14. Page 5 provides the statement of the SEQ ID numbers compared to a reference, but does not provide support that each are decreased. Paget 21 -22 provides differing samples but does not provide support that each of the recited SEQ ID Numbers are decreased.
Table 2 of the instant specification provides differentially expressed serum exosomal miRNA with PD (p. 55). This table appears to be the only recitation of fold change and miRNA in serum. SEQ No. 5 is not listed in the listing of miRNA. As such there is no indication that SEQ ID No. 5 is decreased. Furthermore, this table is based upon serum, wherein the sample type can be blood, serum or plasma. There is no written support that blood and plasma provide the same decreased fold change.
These amendments to the claims, therefore, constitute new matter.
Newly applied Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5,8, 22,32-34 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 1-5,8, 22,32-34 are indefinite over the phrase “treating the Parkinson’s disease or the predisposition to Parkinson’s disease by administering to the subject a therapeutically effective amount”. The specification does not provide a definition or examples of therapy that would be “therapeutically effective amount”. The term is indefinite as it is not clear which treatments/dosages would be considered “therapeutically effective”. For example it is not clear which treatments would be considered “therapeutically effective”. PD does not have a known treatment to cure the disease, but rather, the treatments are used to reduce symptoms of PD. It is not clear if the claim is attempting to include any treatment that could reduce these symptoms or if the claims are attempting to include other types of therapies. The specification states assessing exosomal miRNA from samples of patients treated with effective therapies or non-effective therapies for selection of therapy (p 46) however the claims appear to know which treatments would be effective without this selection.
Modified 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 1-5,8, 22,32, and 34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a law of nature / natural phenomenon (correlation disease condition and expression level of miRNA) and an abstract idea of “comparing the expression level” without significantly more. The 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 for the reasons that follow.
Note that the unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, No. 08-964, 2010 WL 2555192 (June 28, 2010) and in Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014).
Applicant’s attention is directed to the USPTO January 7, 2019 Revised Patent Subject Matter Eligibility Guidance (i.e., “PEG”) available at URL:
<https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf>.
Regarding Step 1 of the PEG, the claims are directed to the statutory category of a process.
Regarding Step 2A, prong one, the claims recite the judicial exception of a law of nature / natural phenomenon. The claims recite the correlation miRNA expression and determining disease state. As in Mayo Collaborative Services v. Prometheus, the recited relationship is a natural phenomenon that exists apart from any human action.
Further, the claims recite an abstract idea (comparing the expression) which can be interpreted as a mental step.
Thus, the claims recite and are directed to the patent-ineligible concepts of a law of nature / natural phenomenon and an abstract idea.
Regarding Step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
Herein, the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). The recitation of measuring the expression levels is considered routine and conventional as this would encompass any assays that determine expression. The steps of comparing and determining does not practically apply the judicial exception. Rather, these steps are part of the data gathering process necessary to apply the judicial exception and an abstract idea. As noted below these steps are considered routine steps. The claims are further drawn to “treating the Parkinson’s disease or the predisposition to Parkinson’s disease by administering to the subject a therapeutically effective amount of an anti-Parkinson’s disease therapy”. This step appears to include general treatments such as rehabilitation or exercise. As such this does not appear to be an integration of the judicial exception as it is routine and conventional.
Regarding Step 2B, the next question is whether the remaining elements/steps – i.e., the non-patent-ineligible elements/steps - either in isolation or combination, amount to significantly more than the judicial exception.
Herein, the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than routine and conventional activity and do not add something “significantly more” so as to render the claims patent-eligible. The additionally recited steps of obtaining a sample, and determining expression level is routine. This fact is evidenced by the teachings in the specification. See, for example, p 22-25 where is shown that the applicant uses naturally occurring samples and detects using known and conventional assays. Further the dependent claims further limit the judicial exception and the controls, but these are routine conventional samples in the prior art and routine to measure expression levels in such populations. Klass et al. (US Patent Application Publication 2015/0024961 January 22, 2015)teaches measuring miRNAs that encompass the recited sequences (has-mirR-222-3p, has-mirR-122-5p, has-mirR-133a-3p, has-mirR-146b-5p, has-mirR-181a-5p, has-mirR-181a-5p, has-mirR-183-5p, has-mirR-192-5p, has-mirR-193a-5p, has-mirR-31-5p, has-mirR-34a-5p) in exosomes (para 4, 59, 338-339). The claim limitation of a step of treating Parkinson’s disease or a predisposition to Parkinson’s disease is a generic step of administering general treatments to any patient that has Parkinson’s disease.
The present claims do not require performing any steps that are not routine and conventional. For example, the claims do not require using novel oligonucleotide probes to detect the level of expression. See Ariosa Diagnostics, Inc. v. Sequenom, Inc., F. Supp. 2d, 2013 WL 5863022, at *10 (N.D. Cal. Oct. 30, 2013) noting that "had the inventors of the [patent-in-suit] created an innovative method of performing DNA detection while searching for paternally inherited cffDNA, such as a new method of amplification or fractionation, those claims would be patentable.” Note that this decision was affirmed by the Federal Circuit (No. 2014-1139, -1144. June 2015) wherein it is stated that “Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.”
For the reasons set forth above, when the claims are considered as a whole, the claims are not considered to recite something significantly more than a judicial exception and thereby are not directed to patent eligible subject matter.
Response to Arguments
The reply traverses the rejection. A summary of the arguments are provided below with response to arguments following.
The reply points to MPEP 2106.04(d) and assets that the claims have been amended to a practical application.
These arguetmsn have been reviewed but have not been found persuasive.
It is noted the MPEP states that the treatment should be “a particular treatment”, however, the claims are not limited to a particular treatments. Rather the claims are drawn to “treating the Parkinson’s disease or the predisposition to Parkinson’s disease by administering to the subject a therapeutically effective amount of an anti-Parkinson’s disease therapy”. This step appears to include general treatments such as rehabilitation or exercise. As such this does not appear to be an integration of the judicial exception as it is routine and conventional. It is noted that the specific species of COMT inhibitors, dopamine agonists, MAO-B inhibitors in claims 32 would be considered specific treatments.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682