Non-Final Rejection
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. This office action is in response to the papers filed on 06/02/2025.
3. The examiner for the prosecution of this application has been changed. Please address all future correspondence to Narayan K. Bhat, Primary examiner, AU1683
The examiner can be reached @ 5712725540.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 08/04/2021, 12/17/2024, 04/25/2022, 09/22/2022, 06/15/2023, 05/29/2024 and 12/17/2024 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
It is noted that the two IDS have been filed on 05/29/2024 (i.e. same date) one has listed references and the other one did not list any references. The examiner has not considered IDS filed on 05/29/2024 with no reference.
Response to Restriction Election
4. In response to restriction election applicant has elected Group I claims 1-12 drawn to a device preparing an exosome liquid sample.
5. Claims 13-23 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups II and III inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/02/2025.
Claim status
6. Claims 1-12 are under prosecution.
Claim interpretation
7. It is noted that eMPEP 2114 makes it clear that while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. Apparatus claims cover what a device is, not what a device does and the manner of operating the device does not differentiate apparatus claim from the prior art.
Non-Final Rejection
8. 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 (i.e., changing from AIA to pre-AIA ) 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.
(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.
9. Claims 1-6, 8-10, and 12 are rejected under 35 U.S.C. 102(a1) as being anticipated by US 2016,037,0265 (Cited in the IDS filed on 08/04/2021).
Claim interpretation
10. eMPEP 2114 makes it clear that while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. Apparatus claims cover what a device is, not what a device does and the manner of operating the device does not differentiate apparatus claim from the prior art.
11. The instant specification does not provide any guidance for a device components requiring solid state immobilization members, first capture materials, first target exosomes with separation markers specifically binding with first separation markers of first target exosomes associated with a predetermined disease and first reversible linkers.
The solid-state immobilization members have been interpreted to comprise bead or particle or any other form of solid (any type of solid support including glass bead or microsphere).
Abstract -accepted
12. The abstract filed on 08/04/2021 has been accepted by the examiner.
Specification -accepted
13. The specification filed on 08/04/2021 has been accepted by the examiner.
14. The drawings filed on 08/04/2021 has been accepted by the examiner.
Claim Rejections - 35 USC § 112 b
15. Claims 1-12 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.
16. 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.
17. The instant specification does not provide any guidance for solid state immobilization members, first separation markers, first target, first capture materials, first target exosomes associated with a predetermined disease in bulk population sample containing exosomes released from cells to capture the first target exosomes and first reversible linkers through which the first capture materials detachably bind to the immobilization members.
The review of the specification does not provide any guidance for any affinity reagent capable of binding to a specific target (i.e. specific solid-state member comprising a specific ligand or antibody, oligonucleotide or complementary nucleic acid, aptamer capable of binding capable of binding to a specific predetermined disease.
In other words the metes and bounds of claim 1 is unclear.
Claim Rejections - 35 USC § 102
18. 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 (i.e., changing from AIA to pre-AIA ) 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.
19. 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.
20. Claims 1-6, 8-10 and 12 are rejected under 35 U.S.C. 102(a1) as being anticipated by OTT et al (US 2016,0370265 published 12/22/2016).
Regarding claims 1-3 and 8, OTT teaches an exosome sub-subpopulation sample is obtained by: preparing an exosome sample through the use of a ligand attached to a solid substrate, obtaining an exosome subpopulation P by addition of a ligand specifically binding to the exosome subpopulation P, and obtaining an exosome
sub-subpopulation SP by addition of a ligand specifically binding to the exosome sub-subpopulation SP (paragraphs 0010-0016 and 0035 and claim 1).
Regarding claims 4-6, OTT teaches that polypeptides, proteins, antigens, receptors, enzymes, growth factors, polysaccharides, glycolipids, and the like may be used as ligands (paragraph 0035, and claim 1).
Regarding claim 9 and 10, OTT teaches that a magnetic bead or the like may be used as a solid substrate (paragraph 0015).
Claim Rejections - 35 USC § 103
21. 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 (i.e., changing from AIA to pre-AIA ) 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.
22. 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.
23. Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ott et al (US 2016,0370265 as cited above in view of CN 108802374, published 06, 25,2018).
24. Regarding claim 7, Ott does not teach the limitation of either antibodies, or protein receptors or cell receptors or aptamers or enzymes or nanoparticles or nanostructures, heavy metal chelators, which is taught by CN 108802374, who is in the same field teaches an exosome nucleic acid detection technology of magnetic enrichment electrochemical luminescence, step comprises: pre-treating the sample and exosome standard separation; the streptavidin activated magnetic bead and activated with biotin antibody, immune and exosome binding; exosome nucleic acid sample preparation, electrochemical luminescence detecting nucleic acid sequence of interest, advantages of this invention are as follows: the urine, serum, saliva and cell culture liquid of the exosome in a biological sample for separation and analysis, using biotin and streptavidin that specifically binds the antibody decorated on the bead surface. system is stable, which avoids the interference of non-specific, controllable system, by changing the antibody type separating exosome purification of different subtypes can be used for nucleic acid expression profile study and exosome parting research controllable; final concentration, magnetic concentration and then diluted or release to obtain the needed concentration, for subsequent detection, fast separating speed, simple requirement for instruments, which can simultaneously process a plurality of samples (CN 108802374 abstract).
Regarding claim 11, Ott in view of CN108802374 as discussed above also teaches a tube (CN108802374; Claim 1)
The artisan having ordinary skill in the art would recognize that the combined teachings of Ott in view of (CN108802374; Claim 1) teaches the limitation of claim 11.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the magnetic beads of CN108802374 publication with a reasonable expectation of success with the expected benefit of increasing the yield of exosomes as taught by CN108802374. An artisan having ordinary skill in the art would have reasonable expectation of success because it merely involves including magnetic beads which is routinely practiced in the art as exemplified by Ott in view of CN108802374.
Conclusion
25. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NARAYAN K. BHAT Ph. D. whose telephone number is (571)272-5540. The examiner can normally be reached MON-THURS 9am - 6.30 pm FRI 9 am -1 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NARAYAN K BHAT/Primary Examiner, Art Unit 1683