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 .
DETAILED ACTION
Priority
This Application is a national phase application filed under 35 U.S.C. § 371 claiming priority to International Application No. PCT/US2022/017083, filed on February 18, 2022, which claims priority to U.S Provisional Application No. 63/150,907, filed on February 18, 2021 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 08/14/2023 is acknowledged. Claims 1-23 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/14/2023 and 09/12/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 08/14/2023 are acknowledged and accepted by the Examiner.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
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. Claims 1, 2 and dependent claims 3-11 are directed to (1) a method of detecting a disease, condition, or disorder in a subject, the method comprising: (a) obtaining a set of ribonucleic acid (RNA) molecules from a population of exosomes in a biological sample obtained from the subject; (b) detecting a plurality of target RNA molecules corresponding to a selected set of cell-specific exosomal RNA molecules in the set of RNA molecules to generate a target RNA molecular profile for the sample; and, (c) determining that the target RNA molecular profile substantially matches a reference RNA molecular profile that correlates with the disease, condition, or disorder in a subject and/or using at least one algorithm that predicts a likelihood that the target RNA molecular profile correlates with the disease, condition, or disorder in a subject, thereby detecting the disease, condition, or disorder in the subject, and (2) a method of detecting severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in a biological sample, the method comprising: (a) obtaining a set of ribonucleic acid (RNA) molecules from a population of exosomes in the sample; (b) detecting a plurality of target RNA molecules corresponding to RNA molecules listed in Table 1 in the set of RNA molecules to generate a target RNA molecular profile for the sample; and, (c) determining that the target RNA molecular profile substantially matches a reference RNA molecular profile that correlates with a SARS-CoV-2 infection in a subject and/or using at least one algorithm that predicts a likelihood that the target RNA molecular profile correlates with a SARS-CoV-2 infection in a subject, thereby detecting the SARS-CoV-2 in the biological sample. Additionally, claim 7 comprises “prognosing a likely outcome for the test subject upon detecting the SARS-CoV-2” in a sample (i.e. a mental step).
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 claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims recite methods that are making use of a natural principle/correlation. Claims 1-2 and dependent claims 3-11 are a recital of a natural process/natural correlation accompanied by additional steps that must be taken to apply the natural process/natural correlation (e.g., the step of taking a sample to test for a naturally occurring correlation). Adding steps to a natural biological process/natural correlation that only recite well-understood, routine, conventional activity previously engaged in by researchers in the field are not sufficient to render the claims patentable. Further, claim 7 is a recital of a mental step/abstract idea in that the claim involves step of making a prognosis based upon detecting SARS-CoV-2 in the biological sample (a mental step/abstract idea). Thus, the mental step is at a high level of generality, and are necessary data gathering steps required in order to apply the natural correlation.
The claims read on methods comprising a product of a viral protein consisting of a naturally occurring virus (i.e. SARS-CoV-2) in a subject and obtaining RNA molecules specific to the viral protein. Further, the recitation of "detecting a plurality of target RNA molecules corresponding to a selected set of cell-specific exosomal RNA molecules" and “determining that the target RNA molecular profile substantially matches a reference RNA molecular profile correlates with the disease, condition, or disorder in a subject and/or using at least one algorithm that predicts a likelihood that the target RNA molecular profile correlates with the disease, condition, or disorder in a subject, thereby detecting the disease, condition, or disorder in the subject is a natural process/natural correlation accompanied by additional steps that must be taken to apply the natural process/natural correlation.
The method steps do not impose meaningful limits on the claim scope. The steps are drawn to obtaining a set of RNA molecules from a sample and corresponding said molecules to a selected set of exosomal RNA molecules are not considered meaningful limits because it does not narrow the claim so that others are not substantially foreclosed from using the judicial exception. The instant claims are reciting this natural process accompanied by no more than an instruction to apply the natural process using well known and routine techniques (e.g., generating a target RNA molecular profile and matching a reference RNA molecular profile) to carry out the natural process. While it takes a human action to trigger a manifestation of the natural process, the natural process exists in principle apart from any human action. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 10, 132 S.Ct. 1289, 101 USPQ2d 1961 (2012). Specifically, the steps of performing the detection of RNA molecules for a virus protein (i.e. SARS-CoV-2) to generate a profile that “correlates with the disease, condition, or disorder in a subject” does not add a feature that is more than well-understood, purely conventional or routine in the relevant field.
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.
Claims 1-4 and 12-23 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1-2, 12-13 and 23 recite “substantially”. The term “substantially” is not clear in that it is a relative term. Further, the specification does not define the term “substantially” and does not provide a standard for ascertaining the requisite degree, thus a skilled artisan would not be apprised to the metes and bounds of the recitations. Thus, the claims are rendered indefinite.
Claims 2-4 and 13-23 are rejected for containing a reference to tables (Dependent claims 15-23 are rejected as comprising the limitation of Table 1). MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim. See MPEP § 608.01(m) for information pertaining to the treatment of reference characters in a claim'.
Claims 12-13 and 17 recite “partially”. The term “partially” is not clear in that it is a relative term. Further, the specification does not define the term “partially” and does not provide a standard for ascertaining the requisite degree, thus a skilled artisan would not be apprised to the metes and bounds of the recitations. Thus, the claims are rendered indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-2 and 5-12 are rejected under 35 U.S.C. 103(a) as being unpatentable over Zhang et al. “Zhang” (MedRxiv, 2020:1-14, IDS of record dated 08/14/2023), in view of Newman et al. “Newman” (U.S. Patent no. US9487837).
The claims are directed to a method of detecting a disease, condition, or disorder in a subject, the method comprising: (a) obtaining a set of ribonucleic acid (RNA) molecules from a population of exosomes in a biological sample obtained from the subject; (b) detecting a plurality of target RNA molecules corresponding to a selected set of cell-specific exosomal RNA molecules in the set of RNA molecules to generate a target RNA molecular profile for the sample; and, (c) determining that the target RNA molecular profile substantially matches a reference RNA molecular profile that correlates with the disease, condition, or disorder in a subject and/or using at least one algorithm that predicts a likelihood that the target RNA molecular profile correlates with the disease, condition, or disorder in a subject, thereby detecting the disease, condition, or disorder in the subject.
Regarding claims 1-2 and 5-12, Zhang discloses a method of detecting a disease, including severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in a biological sample (respiratory specimens (swabs)), comprising: detecting a plurality of target RNA molecules; and determining that the target RNA molecular profile substantially matches a reference RNA molecular profile that correlates with a SARS-CoV-2 infection in a subject and using an algorithm that predicts a likelihood that the target RNA molecular profile correlates with a SARS-CoV-2 infection in a subject, thereby detecting the SARS-CoV-2 in the biological sample; and a system, comprising a device, comprising; a controller operably connected, or connectable, to the biosensor device, which controller comprises computer readable media comprising non-transitory computer executable instructions, a separation module having a body structure, which separation module is configured to substantially separate ribonucleic acid (RNA) molecules from other components in a biological sample when the biological sample is introduces into the fluidic channels (pages 2-6, fig. 2 and table 2).
Zhang does not explicitly teach exosomal RNA molecules in the set of RNA molecules.
Newman, however, discloses a method for diagnosing virus infection in a subject based on biomarkers present on exosomes in a bodily fluid sample as well as a kit for diagnosing infection and/or condition based on said biomarkers on exosomes in bodily fluid samples from the subject (Abstract). Newman discloses that because of their cellular origin, exosomes bear specific protein markers of the endosomal pathway, such as tetraspanins (CD63, CD9 and CD81) and that exosome profiling using cellular exosome markers can provide information correlating the presence of infectious agent biomarkers or infectious agent associated cellular biomarkers with particular cell types in the context of diagnosing a disease (column 13 lines 41-55) as well as prognosis (column 14 lines 12-15). Newman discloses that cell-derived exosomes, hepatic-derived exosomes (cell-specific) include typical exosomal markers, which may be utilized; and hepatic cell-type specific proteins and nucleic acids, including mRNAs, microRNAs (miRNAs) and other non-coding RNAs (column 14 lines 17-26) in various detection arrays (columns 17-19, e.g. affinity-binding, fluorescence and colorimetric). Newman also discloses in embodiments that the diagnosis step is further coupled with the step of administering to the subject a therapeutic drug that (column 4 lines 45-47 and claims 7 and 9 of Newman). Newman also discloses that the infectious agent in the methods described may be viral in nature that include severe acute respiratory syndrome (SARS) coronavirus (column 9 liens 26-46).
Accordingly, it would have been obvious to one of ordinary skill in the art to generate a method of detecting a disease, condition, or disorder in a subject comprising obtaining a set of RNA molecules from a subject in a biological sample, detecting a plurality of target RNA molecules to generate a target RNA molecular profile for the sample; and determining the target RNA molecular profile matches a reference RNA molecular profile that correlates with the disease, condition, or disorder in a subject and/or using at least one algorithm that predicts a likelihood that the target RNA molecular profile correlates with the disease as disclosed by Zhang, whereby the method comprises obtaining RNA molecules from a population of exosomes to a selected set of cell-specific exosomal RNA molecules in the set of RNA molecules to generate a target RNA molecular profile as disclosed by Newman. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the fact that Zhang discloses and successfully demonstrates the method of detecting SARS-CoV-2 in a biological sample utilizing target RNA molecules; and given the knowledge that Newman discloses a method for diagnosing virus infection in a subject based on biomarkers present on exosomes in a bodily fluid sample as well as a kit for diagnosing infection and/or condition based on said biomarkers on exosomes in bodily fluid samples from the subject; exosome profiling using cellular exosome markers can provide information correlating the presence of infectious agent biomarkers or infectious agent associated cellular biomarkers with particular cell types in the context of diagnosing a disease (column 13 lines 41-55) that can be done in a cell-specific manner as Newman discloses that cell-derived exosomes such as hepatic cell-type specific proteins and nucleic acids, including mRNAs, microRNAs (miRNAs) and other non-coding RNAs (column 14 lines 17-26) are utilized in the methods that can be translated to other infectious diseases that “include severe acute respiratory syndrome (SARS) coronavirus” (column 9 liens 26-46). Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure and is listed below.
Kuslich et al. (WO2011/066589).
Klass et al. (U.S. Patent 7,888,035B2).
Klass et al. (U.S. Patent 7,897,356B2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672