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 .
Status of the Application
Claims 1-8, 11-24 and 31 are pending and under examination.
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.
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.
Dooley et al. and Basu et al.
Claim(s) 1, 2,4, 6 and 11-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dooley et al. (US20190060483; filed 24 August 2018; cited in IDS filed 02 November 2021) in view of Basu et al. (US20150307947).
Dooley et al. teach methods for preparing exosomes are known in the art. Furthermore, Dooley et al. teach exosomes are used as therapeutics(e.g. Entire Dooley reference and especially Abstract; exosomes are used for treatment of human disease as in para 0003-0006, pg. 1; para 022, pg. 2; para 0034-0035,pg. 3; para 0107,pg. 7; para 0110,pg. 8).
Dooley et al. teach methods comprising providing exosomes that express biomarkers on their surfaces, wherein the biomarkers include integrins, CD63 and PDGFR, i.e. cancer biomarkers. Furthermore, Dooley et al. teach isolation of exosomes comprising affinity purification from cell culture media or plasma using exosome proteins (e.g. Entire Dooley reference and especially para 0007-0009,para 0011, pg. 1; biomarkers such as CD9, CD63, CD81,PDGFR, GPI anchor proteins, LAMP2, LAMP2B, and a fragment thereof… as in para 0042,pg. 3; para 0129-0131, pg. 9; para 0143-0145, pg. 12; para 0151, pg. 13; collection from cell media as in para 0226,pg. 22).
Furthermore, Dooley et al. teach storage of exosomes is known in the art (e.g. Entire Dooley reference and especially para 0203, pg. 18).
Furthermore, Dooley et al. teach producing cell lines that are genetically engineered to generate surface-engineered exosomes, wherein the polynucleotide encoding the surface expressed protein is stably integrated into the cell genome. Dooley et al. teach cell lines grown in vitro, including stem cells (e.g. Entire Dooley reference and especially para 0012, pg. 1; cell lines including mesenchymal stem cells as in para 0014, pg. 2; inserted into cell genome as in para 0027,pg. 2; para 0036-0037, pg. 3; cell line as in para 0042, pg. 3; multiple cell lines of different origin providing exosomes that provide different surface proteins as in para 0078,pg. 5 and Fig 3;para 0097,pg. 6; producer cell as in para 0103, pg. 7; exosomes from diverse cell lines as in para 0226,pg. 22; producer cells as in Example 19 , para 0247-0249,pg. 26).
Furthermore, Dooley et al. teach methods are known in the art comprising generating stable cell lines comprising stably integrating exogenous polynucleotides in the cell genome, wherein the polynucleotides encode for surface proteins. Dooley et al. teach the genomic integration is done by gene editing mechanisms such as CRISPR/Cas9 and TALEN. Furthermore, Dooley et al. teach the exogenous sequence is a variant of the exosome surface protein (e.g. Entire Dooley reference and especially para 0135-0138, pg. 11; CRISPR/Cas9 and TALEN as in para 0137; variants as in para 0140,pg. 11; Cas9 mediated integration as in para 0216, pg. 20; modified proteins from polynucleotide variants, i.e. gene fusions as in para 0130,pg. 9; deletions as in Example 10, para 0227-0230, pg. 22-23, Example 18, para 0242-0246,pg. 25-26).
Furthermore, Dooley et al. teach methods are known in the art comprising detection of surface proteins( e.g. Entire Dooley reference and especially para 0013, pg. 1; para 0104, pg. 7; para 0185-0187, pg. 16; para 0198, pg. 18; Examples 1 and 2, pg. 18-20).
Furthermore, Dooley et al. teach methods are known in the art comprising generating exosomes that contain DNA RNA, lipids, peptides and proteins, wherein RNA analysis comprises assaying sample RNA that is reverse transcribed and purified based on size as well as providing RNA controls. Furthermore, Dooley et al. teach methods comprising detecting alterations on nucleic acid sequence, i.e. mutations, using well-known techniques, such as sequencing and RT-PCR (e.g. Entire Dooley reference and especially para 0186-0190, pg. 16).
Furthermore, Dooley et al. teach exosomes that are used as experimental controls(e.g. Entire Dooley reference and especially para 0225, pg. 22).
Dooley et al. do not expressly teach a single example of their method comprising the embodiments of the instant claims.
However, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the method of Dooley et al. comprising preparing exosomes to include producing cell lines that are genetically engineered to generate surface-engineered exosomes, wherein the exogenous polynucleotide encoding the surface expressed protein biomarker is stably integrated into the cell genome in one embodiment of Dooley and to include genomic integration done by gene editing mechanisms such as CRISPR/Cas9 and TALEN as taught in another embodiment of Dooley and to include exogenous sequence is a variant of the exosome surface protein as taught in another embodiment of Dooley and to include generating exosomes that contain DNA RNA, lipids, peptides and proteins, wherein the RNA can be reverse transcribed as taught by another embodiment of Dooley and to include generating multiple cell lines that can provide exosomes that provide different surface proteins as taught by another embodiment of Dooley and to include harvesting exosomes from cell culture media that is collected from different cell lines as taught by another embodiment of Dooley as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a method for producing exosomes, as recited by the claimed invention. Furthermore, a skilled artisan would appreciate that these are particular known techniques recognized as part of the ordinary capabilities of one skilled in the art that was recognized for achieving the predictable result of the claimed method.
Regarding the limitation: thereby generating a panel of exosomes comprising a panel of cancer specific mutations; wherein the cancer gene is selected from the group consisting of EGFR, KRAS, PIK3CA, and NRAS as recited in claim 1:
As previously discussed, Dooley et al. teach methods comprising providing exosomes that express biomarkers on their surfaces, wherein the biomarkers include integrins, CD63 and PDGFR, i.e. cancer biomarkers (e.g. Entire Dooley reference and especially para 0007-0009,para 0011, pg. 1; biomarkers such as CD9, CD63, CD81,PDGFR, GPI anchor proteins, LAMP2, LAMP2B, and a fragment thereof… as in para 0042,pg. 3; para 0129-0131, pg. 9; para 0143-0145, pg. 12; para 0151, pg. 13; para 0226,pg. 22).
Furthermore, prior to the effective filing date of the claimed invention, Basu et al. teach methods of molecular profiling are known comprising providing a biological sample and assaying the expression of a panel of genes, including EGFR, KRAS,PIK3CA AND NRAS, wherein the analysis comprise molecular profiling from DNA, RNA and/or protein, using routine and well-known lab techniques, including ISH,IHC,FISH, PCR and next gen sequencing. Furthermore, Basu et al. teach the method is used to profile a cancer. Furthermore, Basu et al. teach the sample comprises exosomes. Furthermore, Basu et al. teach mutation analysis of biomarkers including EGFR, KRAS, PIK3CA AND NRAS , wherein the EGFR mutations include T790M;L858R and E746_A750del (e.g. Entire Basu reference and especially para 007-0010,pg. 1-2; known techniques as in para 0011-0018,pg. 2-6;para 0133-0267, pg. 20-45; exosomes as in para 0112, pg. 16-17; para 0115-0117, pg. 18; para 0268-0270, pg. 45-46; ... In some embodiments, the genes used for the mutation profiling comprise one or more of PIK3CA, EGFR, cKIT, KRAS, NRAS and BRAF. Mutation profiling can be determined by sequencing, including Sanger sequencing, array sequencing, pyrosequencing, NextGen sequencing, etc. Sequence analysis may reveal that genes harbor activating mutations so that drugs that inhibit activity are indicated for treatment. Alternately, sequence analysis may reveal that genes harbor mutations that inhibit or eliminate activity, thereby indicating treatment for compensating therapies... as in para 0268,pg. 45; ...the invention provides a method of identifying a candidate treatment for a subject in need thereof by using molecular profiling of sets of known biomarkers. For example, the method can identify a chemotherapeutic agent for an individual with a cancer. The method comprises:... performing DNA sequencing on the sample to determine a sequencing mutation profile on at least one of KRAS, BRAF, c-KIT, PI3K (PIK3CA), NRAS and EGFR;... as in para 0270, pg. 46; EGFR mutations as in para 0411,pg. 97; Example 9, pg. 188-189).
Furthermore, Basu et al. teach mutation analysis of biomarker variants comprising deletion, insertions, spliced variants and gene fusions(e.g. Entire Basu reference and especially para 0193-0203, pg. 28-29; fusions as in para 0274, pg. 47).
Therefore, as both Dooley et al. and Basu et al. teach methods comprising analysis of exosomes, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the method of Dooley et al. comprising profiling mutations in cancer biomarker profiling , including biomarkers EGFR, KRAS, PIK3CA AND NRAS and including EGFR mutations T790M;L858R and E746_A750del and using routine and well-known lab techniques, including ISH,IHC,FISH, PCR and next gen sequencing, as taught by Basu et al. as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a method for producing exosomes, as recited by the claimed invention. Furthermore, a skilled artisan would appreciate that these are particular known techniques recognized as part of the ordinary capabilities of one skilled in the art that was recognized for achieving the predictable result of the claimed method.
Therefore, the combined teachings of Dooley et al. and Basu et al. render obvious the limitations: A method for producing a panel of exosomes, the method comprising: generating a plurality of cells, each comprising a mutation of a respective cancer gene by using a genome editing enzyme; culturing the plurality of cells in a medium that allows each of the plurality of cells to secrete to the medium an exosome containing an RNA transcribed from the respective cancer gene and comprising the mutation; and collecting the medium that contains the exosomes, thereby generating a panel of exosomes comprising a panel of cancer specific mutations; wherein the cancer gene is selected from the group consisting of EGFR, KRAS, PIK3CA, and NRAS as recited in claim 1.
Furthermore, as Dooley et al. teach diverse cell lines, the combined teachings of Dooley et al. and Basu et al. render obvious claim 2.
Furthermore, as Dooley et al. teach mesenchymal stem cells, the combined teachings of Dooley et al. and Basu et al. render obvious claim 4.
Furthermore, as Dooley et al. teach genomic integration done by gene editing mechanisms such as CRISPR/Cas9 and TALEN, the combined teachings of Dooley et al. and Basu et al. render obvious claim 6.
Furthermore, as Dooley et al. and Basu et al. both teach biomarker deletions and gene fusions, the combined teachings of Dooley et al. and Basu et al. render obvious claim 11.
Furthermore, as Basu et al. teach mutation analysis of biomarkers including EGFR, KRAS, PIK3CA AND NRAS , wherein the EGFR mutations include T790M;L858R and E746_A750del (e.g. Entire Basu reference and especially para 0411,pg. 97; Example 9, pg. 188-189), the combined teachings of Dooley et al. and Basu et al. render obvious claim 12.
Furthermore, as Dooley et al. teach isolating and analyzing exosomes (e.g. Entire Dooley reference and especially para 0009,pg. 1; Example 10, para 0227-0230, pg. 22-23), the combined teachings of Dooley et al. and Basu et al. render obvious claims 13 and 14.
Furthermore, as Dooley et al. teach exosomes that are used as experimental controls(e.g. para 0225, pg. 22), the combined teachings of Dooley et al. and Basu et al. render obvious claim 15.
Furthermore, as Dooley et al. teach methods are known in the art comprising generating exosomes that contain DNA RNA, lipids, peptides and proteins, wherein RNA analysis comprises assaying sample RNA that is reverse transcribed and purified based on size as well as providing RNA controls (e.g. Entire Dooley reference and especially para 0186-0190, pg. 16), the combined teachings of Dooley et al. and Basu et al. render obvious claims 16-18.
Furthermore, as Dooley et al. teach detection of cancer biomarkers such as CD63 and PDGFR, the combined teachings of Dooley et al. and Basu et al. render obvious claims 19 and 20.
Furthermore, as Dooley et al. and Basu et al. both teach methods comprising detecting alterations on nucleic acid sequence, i.e. mutations, using well-known techniques, including IHC, FISH, sequencing and RT-PCR, the combined teachings of Dooley et al. and Basu et al. render obvious claims 21-23.
Furthermore, as Dooley et al. teach exosomes are used as therapeutics(e.g. Entire Dooley reference and especially Abstract; exosomes are used for treatment of human disease as in para 0003-0006, pg. 1; para 022, pg. 2; para 0034-0035,pg. 3; para 0107,pg. 7; para 0110,pg. 8), the combined teachings of Dooley et al. and Basu et al. render obvious claim 24.
Dooley et al., Basu et al. and Kuslich et al.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Dooley et al. and Basu et al., as applied to claims 1, 2,4, 6 and 11-24 above, and further in view of Kuslich et al. (US20140162888; cited in IDS filed 02 November 2021).
The combined teachings of Dooley et al. and Basu et al. as applied in the rejection above are incorporated in this rejection.
The combined teachings of Dooley et al. and Basu et al. render obvious a method of producing exosomes as recited by claim 1. Furthermore, Dooley et al. teach cell lines grown in vitro, including stem cells (e.g. Entire Dooley reference and especially cell lines including mesenchymal stem cells as in para 0014, pg. 2; cell line as in para 0042, pg. 3; multiple cell lines of different origin providing exosomes that provide different surface proteins as in para 0078,pg. 5 and Fig 3;para 0097,pg. 6; producer cell as in para 0103, pg. 7; exosomes from diverse cell lines as in para 0226,pg. 22; producer cells as in Example 19 , para 0247-0249,pg. 26).
However, Dooley et al. and Basu et al. do not expressly teach claim 3.
Prior to the effective filing date of the claimed invention, Kuslich et al. teach exosomes, i.e. vesicles, that are derived from HCT116 and RKO cells are known in the art( e.g. Entire Kuslich reference and especially exosomes as in para 0191,pg. 18; para 0501, pg. 53; HCT116 and RKO cells as in para 1668,pg. 181).
Therefore, as Dooley et al., Basu et al. and Kuslich et al. all teach methods comprising analysis of exosomes, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the method of Dooley et al. and Basu et al. comprising preparing exosomes to include HCT116 and RKO cells as taught by Kuslich et al. as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a method for producing exosomes, as recited by the claimed invention. Furthermore, a skilled artisan would appreciate that these are particular known techniques recognized as part of the ordinary capabilities of one skilled in the art that was recognized for achieving the predictable result of the claimed method.
Therefore, the combined teachings Dooley et al., Basu et al. and Kuslich et al. render obvious claim 3.
Dooley et al., Basu et al. and Kraig et al.
Claim(s) 5 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Dooley et al. and Basu et al., as applied to claims 1, 2,4, 6 and 11-24 above, and further in view of Kraig et al. (WO2018029656 filed 11 August 2017; cited in IDS filed 02 November 2021).
The combined teachings of Dooley et al. and Basu et al. as applied in the previous rejection above are incorporated in this rejection.
The combined teachings of Dooley et al. and Basu et al. render obvious a method of producing exosomes as recited by claim 1. Furthermore, Dooley et al. teach cell lines grown in vitro, including stem cells (e.g. Entire Dooley reference and especially cell lines including mesenchymal stem cells as in para 0014, pg. 2; cell line as in para 0042, pg. 3; multiple cell lines of different origin providing exosomes that provide different surface proteins as in para 0078,pg. 5 and Fig 3;para 0097,pg. 6; producer cell as in para 0103, pg. 7; exosomes from diverse cell lines as in para 0226,pg. 22; producer cells as in Example 19 , para 0247-0249,pg. 26).
Furthermore, Dooley et al. teach exosomes are used as therapeutics(e.g. Entire Dooley reference and especially Abstract; exosomes are used for treatment of human disease as in para 0003-0006, pg. 1; para 022, pg. 2; para 0034-0035,pg. 3; para 0107,pg. 7; para 0110,pg. 8).
However, Dooley et al. and Basu et al. do not expressly teach claim 5.
Prior to the effective filing date of the claimed invention, Kraig et al. teach methods are known wherein exosomes are administered as therapeutic(e.g. Entire Kraig reference and especially Further aspects relate to a method for treating a patient at risk for or having a demyelinating disorder comprising administering to the patient an effective amount of the pharmaceutical compositions or exosomes of the disclosure … as in para 0009, pg. 2; para 0030-0031,pg. 7; para 0042, pg. 9-10; para 0166, pg. 42).
Furthermore, Kraig et al. teach exosomes that are derived from human induced pluripotent stem cells are known in the art (e.g. Entire Kraig reference and especially para 0292, Example 13, pg. 78).
Therefore, as Dooley et al., Basu et al. and Kraig et al. all teach methods comprising analysis of exosomes, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the method of Dooley et al. and Basu et al. comprising preparing exosomes to include human induced pluripotent stem cells , wherein the exosomes are used as therapeutics that are administered to a subject as taught by Kraig et al. as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a method for producing exosomes, as recited by the claimed invention. Furthermore, a skilled artisan would appreciate that these are particular known techniques recognized as part of the ordinary capabilities of one skilled in the art that was recognized for achieving the predictable result of the claimed method.
Therefore, the combined teachings Dooley et al., Basu et al. and Kraig et al. render obvious claims 5 and 24.
Dooley et al., Basu et al. and Garraway et al.
Claim(s) 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Dooley et al. and Basu et al., as applied to claims 1, 2, 4, 6 and 11-24 above, and further in view of Garraway et al. (WO2019018553; filed 18 July 2018; cited in IDS filed 02 November 2021).
The combined teachings of Dooley et al. and Basu et al. as applied in the previous rejection above are incorporated in this rejection.
The combined teachings of Dooley et al. and Basu et al. render obvious a method of producing exosomes as recited by claim 1. Furthermore, Dooley et al. teach the genomic integration is done by gene editing mechanisms such as CRISPR/Cas9 and TALEN. Furthermore, Dooley et al. teach the exogenous sequence is a variant of the exosome surface protein (e.g. Entire Dooley reference and especially para 0135-0138, pg. 11; CRISPR/Cas9 and TALEN as in para 0137; variants as in para 0140,pg. 11; Cas9 mediated integration as in para 0216, pg. 20; modified proteins from polynucleotide variants, i.e. gene fusions as in para 0130,pg. 9; deletions as in Example 10, para 0227-0230, pg. 22-23, Example 18, para 0242-0246,pg. 25-26).
However, Dooley et al. and Basu et al. do not expressly teach claims 7 and 8.
Prior to the effective filing date of the claimed invention, Garraway et al. teach methods are known wherein cancer genes comprising heterozygous or homozygous mutations are edited using CRISPR or TALEN (e.g. Entire Garraway reference and especially para 0017, pg. 6-7; para 0024-0027, pg. 8-9; the present invention provides for a non-naturally occurring or engineered composition comprising a CRISPR system, the system comprising: a CRISPR enzyme; and one or more guide RNAs, each capable of targeting the enzyme to a locus as in para 0026, pg. 8-9; para 0092-0097, pg. 24-68).
Therefore, as both Dooley et al. and Garraway et al. teach methods comprising analysis using gene editing mechanisms, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the method of Dooley et al. and Basu et al. comprising using a CRISPR or TALEN system to include editing cancer genes using CRISPR or TALEN as taught by Garraway et al. as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a method for producing exosomes, as recited by the claimed invention. Furthermore, a skilled artisan would appreciate that these are particular known techniques recognized as part of the ordinary capabilities of one skilled in the art that was recognized for achieving the predictable result of the claimed method.
Therefore, the combined teachings Dooley et al., Basu et al. and Garraway et al. render obvious claims 7 and 8.
Dooley et al., Basu et al. and Lim et al.
Claim(s) 31 is rejected under 35 U.S.C. 103 as being unpatentable over Dooley et al. and Basu et al., as applied to claims 1, 2,4, 6 and 11-24 above, and further in view of Lim et al. (WO2018070939).
The combined teachings of Dooley et al. and Basu et al. as applied in the rejection above are incorporated in this rejection.
The combined teachings of Dooley et al. and Basu et al. render obvious a method of producing exosomes as recited by claim 1. Furthermore, Dooley et al. teach cell lines grown in vitro, including stem cells (e.g. Entire Dooley reference and especially cell lines including mesenchymal stem cells as in para 0014, pg. 2; cell line as in para 0042, pg. 3; multiple cell lines of different origin providing exosomes that provide different surface proteins as in para 0078,pg. 5 and Fig 3;para 0097,pg. 6; producer cell as in para 0103, pg. 7; exosomes from diverse cell lines as in para 0226,pg. 22; producer cells as in Example 19 , para 0247-0249,pg. 26).
Furthermore, Dooley et al. teach exosomes are used as therapeutics(e.g. Entire Dooley reference and especially Abstract; exosomes are used for treatment of human disease as in para 0003-0006, pg. 1; para 022, pg. 2; para 0034-0035,pg. 3; para 0107,pg. 7; para 0110,pg. 8).
Furthermore, Dooley et al. teach storage of exosomes is known in the art (e.g. para 0203, pg. 18).
However, Dooley et al. and Basu et al. do not expressly teach claim 31.
Prior to the effective filing date of the claimed invention, Lim et al. teach lyophilizing exosomes for long term storage is known in the art. Furthermore, the lyophilizing buffer comprises about 10% sugar, such as trehalose, i.e. 10% or less , 9% or less (e.g. Entire Lim reference and especially lines 15-30, pg. 2- lines 1-15, pg. 3; We describe a method for lyophilising an exosome. The method comprises providing an exosome suspension in a lyophilisation buffer comprising a sugar at less than 10% w/v; freezing the exosome suspension; and removing water from the frozen suspension by freeze drying. The lyophilisation buffer may comprise a sugar at a concentration of 9% or less... as in lines 17-21, pg. 4; Examples of sugars for use in the method described here include trehalose, sucrose... as in line 5, pg. 5; ... The concentration of the sugar may be 10% w/v or less, such as 9% w/v or less... (i.e. about 10%) as in line 13, pg. 14; lines 17-29, pg. 15- lines 1-11, pg. 16).
Therefore, as Dooley et al., Basu et al. and Lim et al. all teach methods comprising analysis of exosomes, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the method of Dooley et al. and Basu et al. comprising preparing exosomes to include lyophilizing exosomes for long term storage is known in the art, wherein the lyophilizing buffer comprises about 10% sugar, such as trehalose as taught by Lim et al. as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a method for producing exosomes, as recited by the claimed invention. Furthermore, a skilled artisan would appreciate that these are particular known techniques recognized as part of the ordinary capabilities of one skilled in the art that was recognized for achieving the predictable result of the claimed method.
Therefore, the combined teachings Dooley et al., Basu et al. and Lim et al. render obvious claim 31.
Response to the Arguments
Any rejection not reiterated or specifically addressed has been overcome by amendment. New rejections are set forth to address the amended claims.
However, previously cited references teach art relevant to the amended claims and therefore are included in the new rejections.
Regarding Applicants’ arguments that the previously cited art does not meet the requirements of the amended claims: these arguments are not persuasive.
As discussed in the current rejections, Basu et al. teach using exosomes for profiling of cancer biomarkers including EGFR, KRAS, PIK3CA and NRAS is known in the art. Furthermore, Lim et al. teach lyophilizing exosomes for long term storage using a buffer comprising about 10% trehalose is known in the art.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SAHANA S KAUP whose telephone number is (571)272-6897. The examiner can normally be reached on M-F 7-10 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, HEATHER CALAMITA can be reached on 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHANA S KAUP/ Primary Examiner, Art Unit 1684
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