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 .
Response to Arguments
Applicant's arguments filed May 26, 2026 have been fully considered but they are not persuasive. Applicant has argued that reference to Kang et al., do not anticipate independent claim 1 for various reasons. The Examiner respectfully disagrees.
Applicant has argued that reference to Kang et al., do not anticipate independent claim 1 because Kang et al., utilizes a chelating agent for a purpose different from the instant claims. The Examiner notes that at issue is whether the claimed process steps are taught by the prior art, and not whether the prior art includes all the rationale and/or purposes Applicant has for performing the claimed process steps. The Examiner also notes that Applicants arguments regarding the concentration of the chelating agent, source of the sample, and centrifugation are not commensurate with the scope of claim 1 as the claim does not recite any specific concentrations for a chelating agent, does not indicate the source of the sample, and does not recite any specifics with respect to centrifugation. As such, Applicant’s arguments regarding the chelating agent concentration, source of the sample, and centrifugation are not persuasive.
Applicant has also argued that reference to Kang et al., teach utilizing EDTA, and does not assess other chelating agents. The Examiner first notes that independent claim 1 does not recite any specific chelating agents, thus Applicant’s arguments are not commensurate with the scope of claim 1. Additionally, the Examiner notes that claim 2 recites various chelating agents, but specifically states that “the chelating agent is at least one selected from the group” of various chelating agents. Claim 2 only requires one chelating agent of which EDTA is listed as a suitable chelating agent. As such, utilizing EDTA as a chelating agent taught by Kang et al., meets the limitations of claims 1 and 2.
Applicant has also argued that reference to Newman et al., do not cure the alleged deficiencies of Kang et al., thus the combination of Kang et al., in view of Newman et al., do not render the claims obvious under 35 U.S.C. 103. The Examiner notes that reference to Newman et al., is cited for teaching specific concentration ranges of chelating agents as detailed below. The Examiner notes that Newman et al., teach chelating agents at concentrations ranging from 0.1 mM to 100 mM and 0.5 mM to 50 mM are typical concentration ranges for chelating agents, thus one of ordinary skill in the art would have found it obvious to combine the teachings of Kang et al., in view of Newman et al., as typical concentration ranges are within the skill of one of ordinary skill in the art. As such, the Examiner contends that the combination of Kang et al., in view of Newman et al., is proper, and meets the claim limitations. Therefore, in light of the teachings of the prior art, and the arguments provider here, the Examiner contends that the limitations of the instant claims are taught by the references cited below, thus the claims are not in condition for allowance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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(s) 1, 2, 5-11, and 21-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang et al., (US 2015/0125864).
For claim 1, Kang et al., teach a method of stabilizing a vesicle (paragraphs 0023) in a sample comprising adding a chelating agent to a sample comprising vesicles (paragraphs 0025, 0026, 0028), mixing the sample with the chelating agent (paragraphs 0025, 0026, 0028), separating the vesicles from the sample by removing the reaction mixture (paragraph 0032), and recovering the precipitated vesicles (paragraphs 0032, 0034).
For claim 2, 23, and 24, Kang et al., teach EDTA and EGTA as suitable chelating agents (paragraph 0025).
For claim 5, Kang et al., teach the vesicles being exosomes (paragraph 0023).
For claims 6 and 7, Kang et al., teach immunoprecipitation with CD9 antibodies (paragraph 0039).
For claims 8 and 9, Kang et al., teach blood, urine, and breast fluids as suitable samples (paragraph 0024).
For claims 10 and 11, Kang et al., teach analyzing proteins in the vesicles by immunoassay, or with an electron microscope (paragraph 0032).
For claim 21, Kang et al., teach treating the sample with a chelating agent up to 48 hours (paragraph 0029).
For claim 22, Kang et al., teach treating the sample in a temperature range of 0 to 30°C (paragraph 0028).
For claim 25, Kang et al., teach preparing a blood plasma sample comprising vesicles (paragraph 0035).
For claim 26, Kang et al., teach samples other than urine (paragraph 0024).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3, 4, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al., (US 2015/0125864) in view of Newman et al., (US 2010/0086956).
Regarding claims 3, 4, and 30, Kang et al., do not teach treating a sample with 1 to 200 mM chelating agent.
Newman et al., teach detection of proteins in urine wherein exosomes in a urine sample are isolated, and treated with a chelating agent in a concentration ranging from 0.1 mM to 100 mM and 0.5 mM to 50 mM (paragraph 0054). Newman et al., teach the concentration ranges as "typical" concentration ranges for chelating agents (paragraph 0054). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. References to Kang et al., and Newman et al., both teach separating vesicles from a sample and treating the separated vesicles with a chelating agent. As such, one having ordinary skill in the art would have been motivated by the teachings of Newman et al., to utilize a typical concentration of chelating agents so as to prevent degradation and improve preservation of biomolecules as taught by Newman et al. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kang et al., wherein the chelating agent is utilized at a concentration ranging from 0.1 mM to 100 mM, or 0.5 mM to 50 mM as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 29, Kang et al., do not teach resuspending vesicles in a solution that does not comprise a chelating agent.
Newman et al., teach detecting proteins in urine samples wherein exosomes are isolated and resuspended in PBS (paragraph 0079). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Newman et al., clearly teach that isolated exosomes can be stored at 4°C in PBS, thus one of ordinary skill in the art would have recognized that isolated exosomes can be resuspended and stored in PBS. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kang et al., wherein isolated vesicles are resuspended in PBS as taught by Newman et al., as combining prior art references according to known methods to yield predictable results requires only routine skill in the art.
Claim(s) 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al., (US 2015/0125864) in view of Cooper et al., (US 2019/0192576).
Regarding claims 27 and 28, Kang et al., do not teach CD9 bound to a solid phase wherein the solid phase is magnetic beads.
Cooper et al., teach adipose derived stem cell exosomes wherein magnetic beads comprising CD9 are utilized to isolate exosomes (paragraph0112). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Cooper et al., clearly teach that magnetic beads for CD9 are utilized to isolate exosomes, thus one having ordinary skill in the art would have recognized that magnetic beads for CD9 can be utilized to isolate exosomes. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kang et al., wherein magnetic beads forCD9 are utilized to isolate exosomes as taught by Cooper et al., as combining prior art methods according to known methods to yield predictable results requires only routine skill in the art.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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