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
Status of Application/Amendment/Claims
Applicant's response filed 11/28/2025 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 07/29/2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
With entry of the amendment filed on 11/28/2025, claims 20, 22-25, 29-32, 36-39 and 42-47 are pending and currently under examination.
Claim 20, 22-25, 29-32, 36-39 and 42-44 are allowed.
The previous objection and indication of allowability of claims 46 and 47 is withdrawn in view of the new rejection herein.
The 103 rejection is withdrawn in view of the new rejection herein.
Claims 45-47 are rejected.
New Claim Rejections
Claim Rejections - 35 USC § 103
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 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Ge et al. ("MicroRNAs regulated by adiponectin as novel targets for controlling adipose tissue inflammation." Endocrinology 153.11 (2012): 5285-5296), Blondal, Thorarinn, et al. ("Assessing sample and miRNA profile quality in serum and plasma or other biofluids." Methods 59.1 (2013): S1-S6 of record 892 04/01/2025) and Li et al. ("Method for microRNA isolation from clinical serum samples." Analytical biochemistry 431.1 (2012): 69-75 of record 892 07/29/2025).
Ge et al. teach that a growing body of evidence indicates that deregulation of miRNAs is closely associated with obesity-related metabolic disorders including type 2 diabetes and atherosclerosis (see page 5286 second para). Ge et al. teach measuring miR-1983 in adipose cells and comparing this to a control sample and teach the samples were from obese subjects with a body mass index of 42 and from 2 samples of subjects not diagnosed with diabetes (see page 5286 Subjects). Ge et al. teach the measurement of mir1983 was performed using specific primers in a RT-PCR assay (see page 5286 last 3 para.)
Ge et al. do not specifically teach detection from blood, plasma or serum samples.
Blondal, Thorarinn, et al. ("Assessing sample and miRNA profile quality in serum and plasma or other biofluids." Methods 59.1 (2013): S1-S6) teach well known methods of detecting miRNA in serum samples using PCR reactions (see page S2, section 2) Blondal et al. teach miRNAs present in biofluids such as plasma and serum show great promise as minimally invasive biomarkers for pathological conditions and describe using PCR methods for detection of specific miRNA biomarkers.
Likewise, Li et al. teach very efficient miRNA isolation from serum samples and teach methods of measure using PCR (see page 70 and last para page 74 ).
Because Ge et al. teach it was known in the art that deregulation of miRNAs is closely associated with obesity-related metabolic disorders including type 2 diabetes and it was known there were improved methods of collecting miRNA samples for testing, one of skill in the art would have been capable of using the methods of Blondal et al. or Li et al. to measure miRNAs such as miR-1983 taught by Ge et al. given the improved methods are a minimally invasive method for analysis compared to cells.
Further the Court in KSR (International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)) states that applying a known technique to a known device (method, or product) ready for improvement to yield predictable results is a rational that would support an obviousness rejection (MPEP 2143(D). Using blood, plasma or serum samples was known as a great improvement in measuring miRNA in a sample as compared to cells or tissue, the results of which would yield predictable results to one of skill in the art.
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Applicant’s Arguments
A response to Applicant’s arguement against the prior art reference of Edinger et al. in the 103 rejection is moot as this reference and rejection has been withdrawn.
Closest Prior Art for allowable claims
Blondal, Thorarinn, et al. ("Assessing sample and miRNA profile quality in serum and plasma or other biofluids." Methods 59.1 (2013): S1-S6) teach well known methods of detecting miRNA in serum samples using PCR reactions (see page S2, section 2.) but does not teach detecting levels of miR-1983 in neuronal cells and correlating the levels with insulin resistance.
Wang-Xia, et al. ("Focus on RNA isolation: obtaining RNA for microRNA (miRNA) expression profiling analyses of neural tissue." Biochimica et Biophysica Acta (BBA)-Gene Regulatory Mechanisms 1779.11 (2008): 749-757). teach isolating RNA from neural tissue for miRNA expression profiling. Wang et al. do not teach detecting levels of miR-1983 in neuronal cells and correlating the levels with insulin resistance.
Conclusion
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636