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 .
Applicant’s reply on 5/19/2026, is acknowledged. Claims 8-10, 14-15 and 17-24 are pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 8-10, 14-15 and 17-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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) 8-10, 14-15, 17-18 and 20-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coughlan et al., Current Protocols in Cell Biology e110, Volume 88 (2020) in view of Gingeras et al. (US 2017/0051282).
Regarding claim 8, Coughlan et al. studied “exosome isolation by ultracentrifugation and precipitation and techniques for downstream analyses.” Title. As to ultracentrifugation, Coughlan et al. teaches that “it produces highly enriched EV fractions while also allowing for the collection of additional vesicle factions (e.g., larger vesicles, which are pelleted first in a lower-speed spin at 10,000 x g) and then an EV-free supernatant, which is generated after a high-speed spin.” Page 5. In line with this general procedure Coughlan et al. teaches to “collect 4 ml human whole blood in lavender-top Vacutainer® EDTA tubes.” Page 4. Centrifuging it for 15 mins at 1500 x g at room temperature. See id. Removing plasma from the EDTA tube and centrifuging plasma in a microcentrifuge plasma for 10 min. at 2200 x g, 4 °C. See id., Later collecting supernatant, ultracentrifuging for 2 hours at 100,000 x g, 4 °C, and discarding supernatant. See page 6. This procedure is substantially similar to the procedure of claim 8 but for a 100 RC discrepancy in step A2 and performing step A4 at room temperature. Coughlan et al. considers the ultracentrifugation “the gold-standard method for exosome isolation” (current claim 23). Page 23.
Coughlan et al. does not teach that the sample of blood plasma is from an oncological patient.
Gingeras et al. relates to “methods and compositions for treating cancers.” Abstract. In this regard, Gingeras et al. teaches “isolating EVs from a biological sample from a subject.” Para. [0034]. Gingeras et al. further teaches that the best suited sample would be “biological fluids and organs that would be predicted to contain cancer-derived EVs.” Para. [0176]. This implies isolating a sample from a subject with cancer. Furthermore, “the biological sample is blood or a component thereof. In some embodiments, the biological sample comprises milk, blood, serum, plasma, ascites, cyst fluid, pleural fluid, peritoneal fluid, cerebral spinal fluid, tears, urine, saliva, sputum, or combinations thereof.” Id.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention in view of the combination of Coughlan et al. and Gingeras et al. to arrive at the claimed invention. Simply, one of ordinary skill in the art would have been motivated to utilize the gold-standard method of isolating exosomes taught by Coughlan et al. to practice the teaching of Gingeras et al.
Regarding claims 9 and 10, Coughlan et al. teaches the exosome pellet is resuspended and applied to a purification column. See page 7.
Regarding claims 14 and 17, Coughlan et al. teaches incubating with a labeling dye. See page 10.
Regarding claims 15 and 24, Coughlan et al. teaches “the ultracentrifugation samples had an average of concentration of 16 x 109 particles per 250 µl.” Page 23.
Regarding claims 18 and 21, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 20, Gingeras et al. teaches paclitaxel. See para. [0194].
Regarding claim 22, Coughlan et al. teaches exosome-sized particles having mean diameters of 160.97 nm for ultracentrifugation. See page 23.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coughlan et al., Current Protocols in Cell Biology e110, Volume 88 (2020) in view of Gingeras et al. (US 2017/0051282) as applied to claims 8-10, 14-15, 17-18 and 20-24 above, and further in view of Zheng et al. (US 2021/0212955).
Teachings of Coughlan et al. and Gingeras et al. are discussed above.
Regarding claim 19, neither reference teaches indocyanine green.
Zheng et al. teaches extracellular vesicle – MOF- protein (EMP) nanoparticles loaded with indocyanine green. See para. [0236].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to arrive at the claimed invention in view of the combination of Coughlan et al., Gingeras et al. and Zheng et al. In this regard, it is prima facie obviousness to select a known material based on its suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See, e.g., In re Linder, 457 F.2d 506, 507 (CCPA 1972); see also In re Dial, 326 F.2d 430,432 (CCPA 1964). It would have been obvious to employ indocyanine green as a fluorescent label as taught by Zheng et al. for Coughlan et al.’s exosome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S CABRAL/ Primary Examiner, Art Unit 1614
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