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 Amendment
Claims 21-32, 34, 35, and 37-40 are currently pending. Claims 37-40 remain withdrawn. Claim 1 has been amended.
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 (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.
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.
Claims 21-32, 34, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Rae et al. ‘183 (US Pub No. 2017/0232183 – previously cited) in view of Klass et al. ‘450 (US Pub No. 2011/0237450 – previously cited).
Regarding claim 21, Rae et al. ‘183 teaches a method (Title, Abstract) comprising:
obtaining whole blood from a subject ([0036]; “a method comprises obtaining a blood sample from a subject diagnosed with and/or at risk for development of VISE” It is noted that [0032] mentions that “whole blood” is obtained.);
separating the whole blood ([0097]; “blood separator”) into plasma ([0097]; “plasma”), and at least one cellular blood fraction (One of ordinary skill would understand that blood is made of red blood cells, plasma, white blood cells, and platelets. The red blood cells, white blood cells, and platelets are interpreted as “at least one cellular blood fraction.” [0097] also recites that plasma and other blood components make up blood. “Other blood components” is interpreted as “at least one cellular blood fraction.”);
contacting the plasma with a synthetic carbon particle (SCP) ([0053]; “adsorbent material comprises synthetic carbon particles (SCP)”), and forming treated plasma ([0091] teaches that adsorbent materials come in contact with plasma.);
forming reconstituted whole blood from the treated plasma and at least one cellular blood fraction ([0032]-[0033], [0102]); and
administering the reconstituted whole blood to the subject (Fig. 1 venous line/vein of the subject 392 and [0039]).
Rae et al. ‘183 teaches all of the elements of the current invention as mentioned above except for wherein the plasma comprises a first amount of unbound exosomes;
forming a complex, wherein the treated plasma comprises a second amount of unbound exosomes, and the complex comprises an amount of SCP-bound-exosomes, wherein a plurality of SCP-bound-exosomes are adsorbed onto the SCP; and
comparing the second amount of unbound exosomes with a first control and/or comparing the amount of SCP-bound-exosomes with a second control.
Klass et al. ‘450 teaches wherein the plasma comprises a first amount of unbound exosomes ([0112]; “…exosomes can also include any shed membrane bound particle that is derived from either the plasma membrane or an internal membrane.”);
forming a complex, wherein the treated plasma comprises a second amount of unbound exosomes (The exosomes that are not binded to the binding agents as mentioned in [0122]-[0123] are unbounded exosomes.), and the complex comprises an amount of SCP-bound-exosomes ([0122]-[0123] mention the use of binding agents, such as DNA, RNA, and synthetic or naturally occurring chemical compounds, to isolate exosomes.), wherein a plurality of SCP-bound-exosomes are adsorbed onto the SCP ([0122]-[0123]; The binding agent is interpreted as the SCP, which are used to isolate exosomes. The Examiner interprets the binding agent and exosomes to be SCP-bound-exosomes that are adsorbed onto the SCP. It is also noted that [0044] of the PGPUB of the current application mentions that “adsorb” and “bind” can be used interchangeably.); and
comparing the second amount of unbound exosomes with a first control and/or comparing the amount of SCP-bound-exosomes with a second control ([0260]; “The exosomes can be evaluated by comparing the level of exosomes with a reference level or value or exosomes.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Rae et al. ‘183 to include wherein the plasma comprises a first amount of unbound exosomes; forming a complex, wherein the treated plasma comprises a second amount of unbound exosomes, and the complex comprises an amount of SCP-bound-exosomes, wherein the SCP-bound-exosomes are adsorbed onto the SCP; and comparing the second amount of unbound exosomes with a first control and/or comparing the amount of SCP-bound-exosomes with a second control as Klass et al. ‘450 teaches that this will aid in detecting conditions and diseases, such as cancer ([0002]).
Regarding claim 22, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the first control comprises a known amount of unbounded exosomes, and the second control comprises a known amount of SCP-bound-exosomes.
Klass et al. ‘450 teaches that the exosomes can be evaluated by comparing the level of exosomes with a reference level or value of exosomes. The reference value can be particular to physical or temporal endpoint. For example, the reference value can be from the same subject from whom a sample is assessed for an exosome, or the reference value can be from a representative population of samples (e.g., samples from normal subjects not exhibiting a symptom of disease). Therefore, a reference value can provide a threshold measurement which is compared to a subject sample's readout for one or more exosome populations assayed in a given sample ([0260]). A reference value may be based on samples assessed from the same subject so to provide individualized tracking ([0261]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first control and the second control of Rae et al. ‘183 in view of Klass et al. ‘450 to include a known amount of unbound exosomes and a known amount of SCP-bound-exosomes, respectively, as Klass et al. ‘450 teaches that this will aid in allowing a physician to more accurately assess the patient’s disease stage or progression ([0261]).
Regarding claim 23, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the subject is diagnosed with or suspected of having a medical condition when the second amount of unbound exosomes is different from the first control and/or when the amount of SCP-bound-exosomes is different from the second control.
Klass et al. ‘450 teaches If a sample from a subject has a level or value that is similar to the reference, the subject can be identified to not have the disease, or of having a low likelihood of developing a disease ([0262]). A subject's value can be compared to the index and a diagnosis or prognosis of the disease can be determined, such as the disease stage or progression ([0263]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Rae et al. ‘183 in view of Klass et al. ‘450 to include wherein the subject is diagnosed with or suspected of having a medical condition when the second amount of unbound exosomes is different from the first control and/or when the amount of SCP-bound-exosomes is different from the second control as Klass et al. ‘450 teaches that this will aid in identifying if the subject has the disease or likelihood of developing the disease ([0262]) or determining the prognosis of the disease in a the subject, such as the disease stage or progression ([0263]).
Regarding claim 24, Rae et al. ‘183 teaches wherein the SCP comprises mesopores, micropores, macropores, or a combination thereof ([0053]).
Regarding claim 25, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the amount of SCP-bound-exosomes is from 10^2 exosomes/g SCP to greater than or equal to 10^9 exosomes/g SCP.
It is noted that the Applicant has failed to recite the criticality of the amount of SCP-bound-exosomes.
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to have the amount of SCP-bound-exosomes to be from about 102 exosomes/g SCP to equal to or greater than about 109 exosomes/g SCP since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is from about 102 exosomes/g SCP to equal to or greater than about 109 exosomes/g SCP which achieves the recognized result of diagnosing, prognosing, or theranosing a condition of a disease ([0003] of Klass et al. ‘450), therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Regarding claim 26, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the SCP-bound-exosomes comprises a first cargo.
It is noted that “first cargo” is interpreted broadly.” [0122]-[0123] of Klass et al. ‘450 mentions that the use of binding agents, such as DNA, RNA, and synthetic or naturally occurring chemical compounds, to isolate exosomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the SCP-bound-exosomes of Rae et al. ‘183 in view of Klass et al. ‘450 to include a first cargo as Klass et al. ‘450 teaches that this will aid in isolating exosomes using a biomarker ([0122]).
Regarding claim 27, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the first cargo is SCP-bound.
It is noted that “SCP-bound” is interpreted as an exosome being binded to an SCP. [0122]-[0123] of Klass et al. ‘450 mentions that the use of binding agents, such as DNA, RNA, and synthetic or naturally occurring chemical compounds, to isolate exosomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first cargo of Rae et al. ‘183 in view of Klass et al. ‘450 to include being SCP-bound as Klass et al. ‘450 teaches that this will aid in isolating exosomes using a biomarker ([0122]).
Regarding claim 28, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the first cargo comprises DNA, RNA, a protein, a lipid, or combinations thereof.
[0122]-[0123] of Klass et al. ‘450 mentions that the use of binding agents, such as DNA, RNA, and synthetic or naturally occurring chemical compounds, to isolate exosomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first cargo of Rae et al. ‘183 in view of Klass et al. ‘450 to comprise DNA, RNA, a protein, a lipid, or combinations thereof as Klass et al. ‘450 teaches that this will aid in isolating exosomes using a biomarker ([0122]).
Regarding claim 29, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the first cargo comprises mRNA, an antibody, or combinations thereof.
[0122]-[0123] of Klass et al. ‘450 mentions that the use of binding agents, such as DNA, RNA, synthetic or naturally occurring chemical compounds, monoclonal antibodies, or single chain antibodies, to isolate exosomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first cargo of Rae et al. ‘183 in view of Klass et al. ‘450 to comprise mRNA, an antibody, or combinations thereof as Klass et al. ‘450 teaches that this will aid in isolating exosomes using a biomarker ([0122]).
Regarding claim 30, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the complex further comprises an SCP-bound-extracellular membrane-derived vesicle.
Klass et al. ‘450 teaches that exosomes are vesicles ([0111]), which may be referred to as icrovesicles, nanovesicles, vesicles, dexosomes, bleb, blebby, prostasomes, microparticles, intralumenal vesicles, endosomal-like vesicles or exocytosed vehicles ([0112]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the complex of Rae et al. ‘183 in view of Klass et al. ‘450 to include an SCP-bound-extracellular membrane-derived vesicle as Klass et al. ‘450 teaches that vesicles and exosomes are the same ([0111]-[0112]).
Regarding claim 31, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the SCP-bound-extravesicle comprises a second cargo.
It is noted that “second cargo” is interpreted broadly.” [0122]-[0123] of Klass et al. ‘450 mentions that the use of binding agents, such as DNA, RNA, and synthetic or naturally occurring chemical compounds, to isolate exosomes. It is noted that the terms “exosome” and “vesicle” can be used interchangeably, as mentioned in the 35 U.S.C. 103 rejection of claim 30.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the SCP-bound-extravesicle of Rae et al. ‘183 in view of Klass et al. ‘450 to include a second cargo as Klass et al. ‘450 teaches that this will aid in isolating exosomes using a biomarker ([0122]).
Regarding claim 32, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the second cargo is extravesicle-bound.
It is noted that “extravesicle-bound” is interpreted as an exosome being binded to a binding agent. [0122]-[0123] of Klass et al. ‘450 mentions that the use of binding agents, such as DNA, RNA, and synthetic or naturally occurring chemical compounds, to isolate exosomes. It is noted that the terms “exosome” and “vesicle” can be used interchangeably, as mentioned in the 35 U.S.C. 103 rejection of claim 30.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second cargo of Rae et al. ‘183 in view of Klass et al. ‘450 to include being extravesicle-bound as Klass et al. ‘450 teaches that this will aid in isolating exosomes using a biomarker ([0122]).
Regarding claim 34, Rae et al. ‘183 in view of Klass et al. ‘450 teaches all of the elements of the current invention as mentioned above except for wherein the second cargo comprises RNA, a lipid, a protein, or combinations thereof.
[0122]-[0123] of Klass et al. ‘450 mentions that the use of binding agents, such as DNA, RNA, and synthetic or naturally occurring chemical compounds, to isolate exosomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second cargo of Rae et al. ‘183 in view of Klass et al. ‘450 to comprise comprises RNA, a lipid, a protein, or combinations thereof as Klass et al. ‘450 teaches that this will aid in isolating exosomes using a biomarker ([0122]).
Regarding claim 35, Rae et al. ‘183 teaches wherein the SCP comprises a surface area of 300-3000 m2/g ([0055]; “The mesoporous carbon may have a BET surface area of 250-800 m2/g without activation…up to 2000 m2/g and even higher e.g. 1000-2000 m2/g.”)
Response to Arguments
Applicant argues that Klass et al. ‘450 does not teach the limitation “wherein a plurality of SCP-bound-exosomes are adsorbed onto the SCP” and that the Non-Final Office Action mailed on 04 September 2025 does not establish a prima facie case of obviousness. Examiner respectfully disagrees, as Klass et al. ‘450 was used to teach this limitation. A screenshot of page 4 of the Non-Final Office Action has been provided below. The highlighted portion shows how Klass et al. ‘450 teaches the limitation. Furthermore, [0122]-[0123] mentions that exosomes (plural) are isolated from the biological signal, indicating that “a plurality of SCP-bound-exosomes are adsorbed onto the SCP.” As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 103 rejection has been maintained.
PNG
media_image1.png
336
670
media_image1.png
Greyscale
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 AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AURELIE H TU/ Primary Examiner, Art Unit 3791
Prosecution Insights