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 .
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed steps, the process steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claim 1, the Examiner notes that steps (1) and (2) are indistinguishable as it is unclear what Applicant regards as “treating” the sample. Step (1) recites “adding a chelating agent to a sample comprising extracellular vesicles, thereby obtaining a solution comprising the chelating agent and the extracellular vesicles.” Step (2) recites “treating the sample comprising extracellular vesicles with a chelating agent in the solution.” As such, adding a chelating agent to the sample is no different from treating the sample as nothing occurs in the treating step that distinguishes from the adding step. Essentially, based on the claim language, the sample is treated by adding a chelating agent, thus steps (1) and (2) of claim 1 appear to be identical.
For claim 1 step (5), the term “recovering” will be broadly interpreted as the claim does not recite any specific techniques that describe what “recovering” means. As such, the recovering step can be interpreted as removing the liquid portion recited in step (4).
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 1-11 and 21-29 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.
For claim 1, the Examiner is unable to determine the metes and bounds of the “adding” and “treating” steps as one cannot distinguish between the steps. Step (1) recites “adding a chelating agent to a sample comprising extracellular vesicles, thereby obtaining a solution comprising the chelating agent and the extracellular vesicles.” Step (2) recites “treating the sample comprising extracellular vesicles with a chelating agent in the solution.” As such, adding a chelating agent to the sample is no different from treating the sample as nothing occurs in the treating step that distinguishes from the adding step. For the purposes of examination, the Examiner will consider the treating step occurring once the chelating agent is added to the sample. Claims 2-11 and 21-29 depend directly or indirectly from claim 1, and are also indefinite.
For claims 3, 4, 6, 8, and 9, the phrase “the extracellular vesicle-comprising sample” is inconsistent with “a sample comprising extracellular vesicles” recited in claim 1. The Examiner requests Applicant amend the claims so that the limitations regarding the sample are consistent.
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), treating 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, and 29 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 and 4, 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 (paragraph 0112). 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 for CD9 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
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/DWAN A GERIDO/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797