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 .
Election/Restrictions and Claim Status
Applicant’s election without traverse of Group 3 in the reply filed on 6/18/26 is acknowledged.
Claims 10-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/18/26.
Applicant’s election of the species of OPN, TIMP-1, IGFBP-4 and ARDS caused by aspiration in the reply filed on 6/18/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 1-9 are being examined.
Priority
The priority information is found in the filing receipt dated 3/9/26.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/18/26 and 11/11/25 have been considered by the examiner.
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.
Claim 9 is 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.
Claim 9 recites (3rd to last line on page 3 of the 6/18/26 claim set) ‘PCK1 (Phosphoenolpyruvate carboxykinase, cytosolic)’. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation PCK1 (which is not limited to cytosolic), and the claim also recites cytosolic which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites (3rd-4th line of the claim) ‘CD97 (G protein-coupled receptor)’. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation G-protein coupled receptor, and the claim also recites CD97 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites (1st line on page 4 of the 6/18/26 claim set) ‘Thrombomodulin (CD141, thrombin cofactor)’. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation thrombin cofactor, and the claim also recites thrombomodulin which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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 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) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sengupta et al. (NPL reference 219 of IDS of 11/11/25; ‘Sengupta’) as further evidenced by Sengupta et al. (NPL reference 080 of IDS of 6/18/26; ‘Senguptaresponse’).
Sengupta teach exosomes for treatment (title). Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption). Sengupta teach that this group of patients as often progressing to hypoxic respiratory failure (page 747 paragraph spanning columns 1-2). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879). Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879). Senguptaresponse is cited as a universal fact to provide additional facts about ExoFlo (MPEP 2124).
In relation to the subject as recited in claim 1, Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption).
In relation to the insult of claims 1-2 Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption) where severe COVID-19 is a pulmonary insult. Claim 2 recites optional but not required pulmonary insults. Sengupta teach patients with mechanical ventilation (Cohort C on page 748).
In relation to the administering and composition of claim 1, Sengupta teach exosomes for treatment (title). The instant specification recognizes that exosomes are extracellular vesicles (section 0044). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879).
In relation to claim 3, Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to claim 4, Sengupta teach all patients with a P/F ratio of less than or equal to 200 mm Hg (Table 1 caption).
In relation to claims 5 and 8, Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). The instant specification example teaches a 15 ml dose (page 168 last paragraph). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable.
In relation to claims 6-7 and 9, Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+ (section 2 on page 879) where CD63 antigen is recited in claim 9. Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879).
Claim Rejections - 35 USC § 103
The rejection below addressed additional embodiments of the claims.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sengupta et al. (NPL reference 219 of IDS of 11/11/25; ‘Sengupta’) in view of Sengupta et al. (NPL reference 080 of IDS of 6/18/26; ‘Senguptaresponse’) in view of Mitsailis et al. (US 2021/0128630 as cited with IDS of 11/11/25; ‘Mitsailis’) in view of Pettine et al. (WO 2021/216903 as cited with IDS of 11/11/25; ‘Pettine’).
Sengupta teach exosomes for treatment (title). Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption). Sengupta teach that this group of patients as often progressing to hypoxic respiratory failure (page 747 paragraph spanning columns 1-2). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
Sengupta does not recite ARDS caused by aspiration.
Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879). Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879).
Mitsailis teach exosomes for treating various diseases (abstract). Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066). Mitsailis teach that the exosomes are identified by protein markers (abstract) and specifically recites IGFBP4 (claim 1). Mitsailis also recites CD63 (claim 5). Mitsailis mentions that CD9 is not being expressed in the MSC (section 0041). Mitsailis teach that the proteins may be in the lipid membrane or encapsulated by the exosome (section 0048). Mitsailis teach that the extracellular vesicles are immunomodulatory (section 0120).
Pettine teach methods for treating acute respiratory distress syndrome (claim 14) and recognizes the use of exosomes and extracellular vesicles (page 1 lines 17-20). Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15). Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Sengupta because Sengupta specifically teach exosomes for treatment (title) specifically for patients with acute respiratory distress syndrome (ARDS) (abstract and Table 1 caption). Thus, one would have been motivated to incorporate the teachings of the other references which also suggest treating acute respiratory distress syndrome with endosomes. Since Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066) one would have been motivated to administer to such patients. Since Senguptaresponse teach extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) and Sengupta teach the effectiveness (abstract) one would have been motivated to use such particles. Since Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used. Since Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3) one would have been motivated to include such proteins. One would have had a reasonable expectation of success since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to the subject as recited in claim 1, Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption).
In relation to the insult of claims 1-2 Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption) where severe COVID-19 is a pulmonary insult. Claim 2 recites optional but not required pulmonary insults. Sengupta teach patients with mechanical ventilation (Cohort C on page 748). Further, Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066).
In relation to the administering and composition of claim 1, Sengupta teach exosomes for treatment (title). The instant specification recognizes that exosomes are extracellular vesicles (section 0044). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879).
In relation to claim 3, Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to claim 4, Sengupta teach all patients with a P/F ratio of less than or equal to 200 mm Hg (Table 1 caption).
In relation to claims 5 and 8, Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). The instant specification example teaches a 15 ml dose (page 168 last paragraph). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used.
In relation to claims 6-7 and 9, Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+ (section 2 on page 879) where CD63 antigen is recited in claim 9. Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879). Further, Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3). Mitsailis teach that the proteins may be in the lipid membrane or encapsulated by the exosome (section 0048).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12570980 (as cited with IDS 6/18/26) in view of Sengupta et al. (NPL reference 219 of IDS of 11/11/25; ‘Sengupta’) in view of Sengupta et al. (NPL reference 080 of IDS of 6/18/26; ‘Senguptaresponse’) in view of Mitsailis et al. (US 2021/0128630 as cited with IDS of 11/11/25; ‘Mitsailis’) in view of Pettine et al. (WO 2021/216903 as cited with IDS of 11/11/25; ‘Pettine’).
12570980 recites treating ARDS comprising administering a composition comprising IGFBP-4 (claim 1).
12570980 does not recite aspiration.
Sengupta teach exosomes for treatment (title). Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption). Sengupta teach that this group of patients as often progressing to hypoxic respiratory failure (page 747 paragraph spanning columns 1-2). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879). Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879).
Mitsailis teach exosomes for treating various diseases (abstract). Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066). Mitsailis teach that the exosomes are identified by protein markers (abstract) and specifically recites IGFBP4 (claim 1). Mitsailis also recites CD63 (claim 5). Mitsailis mentions that CD9 is not being expressed in the MSC (section 0041). Mitsailis teach that the extracellular vesicles are immunomodulatory (section 0120).
Pettine teach methods for treating acute respiratory distress syndrome (claim 14) and recognizes the use of exosomes and extracellular vesicles (page 1 lines 17-20). Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15). Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 12570980 because 12570980 specifically teach compositions for treatment specifically for patients with acute respiratory distress syndrome (ARDS) (claim 1). Thus, one would have been motivated to incorporate the teachings of the other references which also suggest treating acute respiratory distress syndrome. Since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract) and Senguptaresponse teach that composition comprises extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) one would have been motivated to use such conditions. Since Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066) one would have been motivated to administer to such patients. Since Senguptaresponse teach extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) and Sengupta teach the effectiveness (abstract) one would have been motivated to use such particles. Since Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used. Since Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3) one would have been motivated to include such proteins. One would have had a reasonable expectation of success since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to the subject as recited in claim 1, 12570980 teach subjects with acute respiratory distress syndrome (claim 1). Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption).
In relation to the insult of claims 1-2 Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption) where severe COVID-19 is a pulmonary insult. Claim 2 recites optional but not required pulmonary insults. Sengupta teach patients with mechanical ventilation (Cohort C on page 748). Further, Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066).
In relation to the administering and composition of claim 1, 12570980 teach administration (claim 1). Sengupta teach exosomes for treatment (title). The instant specification recognizes that exosomes are extracellular vesicles (section 0044). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879).
In relation to claim 3, Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to claim 4, Sengupta teach all patients with a P/F ratio of less than or equal to 200 mm Hg (Table 1 caption).
In relation to claims 5 and 8, Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). The instant specification example teaches a 15 ml dose (page 168 last paragraph). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used.
In relation to claims 6-7 and 9, Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+ (section 2 on page 879) where CD63 antigen is recited in claim 9. Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879). Further, Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3). In addition, 12570980 recites IGFBP-4 (claim 1). Mitsailis teach that the proteins may be in the lipid membrane or encapsulated by the exosome (section 0048).
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12590310 (as cited with IDS 6/18/26) in view of Sengupta et al. (NPL reference 219 of IDS of 11/11/25; ‘Sengupta’) in view of Sengupta et al. (NPL reference 080 of IDS of 6/18/26; ‘Senguptaresponse’) in view of Mitsailis et al. (US 2021/0128630 as cited with IDS of 11/11/25; ‘Mitsailis’) in view of Pettine et al. (WO 2021/216903 as cited with IDS of 11/11/25; ‘Pettine’).
12590310 recites treating ARDS comprising administering a composition comprising IGFBP-4 (claim 1).
12590310 does not recite aspiration.
Sengupta teach exosomes for treatment (title). Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption). Sengupta teach that this group of patients as often progressing to hypoxic respiratory failure (page 747 paragraph spanning columns 1-2). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879). Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879).
Mitsailis teach exosomes for treating various diseases (abstract). Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066). Mitsailis teach that the exosomes are identified by protein markers (abstract) and specifically recites IGFBP4 (claim 1). Mitsailis also recites CD63 (claim 5). Mitsailis mentions that CD9 is not being expressed in the MSC (section 0041). Mitsailis teach that the extracellular vesicles are immunomodulatory (section 0120).
Pettine teach methods for treating acute respiratory distress syndrome (claim 14) and recognizes the use of exosomes and extracellular vesicles (page 1 lines 17-20). Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15). Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 12590310 because 12590310 specifically teach compositions for treatment specifically for patients with acute respiratory distress syndrome (ARDS) (claim 1). Thus, one would have been motivated to incorporate the teachings of the other references which also suggest treating acute respiratory distress syndrome. Since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract) and Senguptaresponse teach that composition comprises extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) one would have been motivated to use such conditions. Since Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066) one would have been motivated to administer to such patients. Since Senguptaresponse teach extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) and Sengupta teach the effectiveness (abstract) one would have been motivated to use such particles. Since Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used. Since Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3) one would have been motivated to include such proteins. One would have had a reasonable expectation of success since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to the subject as recited in claim 1, 12590310 teach subjects with acute respiratory distress syndrome (claim 1). Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption).
In relation to the insult of claims 1-2 Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption) where severe COVID-19 is a pulmonary insult. Claim 2 recites optional but not required pulmonary insults. Sengupta teach patients with mechanical ventilation (Cohort C on page 748). Further, Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066).
In relation to the administering and composition of claim 1, 12570980 teach administration (claim 1). Sengupta teach exosomes for treatment (title). The instant specification recognizes that exosomes are extracellular vesicles (section 0044). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879).
In relation to claim 3, Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to claim 4, Sengupta teach all patients with a P/F ratio of less than or equal to 200 mm Hg (Table 1 caption).
In relation to claims 5 and 8, Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). The instant specification example teaches a 15 ml dose (page 168 last paragraph). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used.
In relation to claims 6-7 and 9, Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+ (section 2 on page 879) where CD63 antigen is recited in claim 9. Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879). Further, Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3). In addition, 12590310 recites IGFBP-4 (claim 1). Mitsailis teach that the proteins may be in the lipid membrane or encapsulated by the exosome (section 0048).
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12213995 (as cited with IDS 11/11/25) in view of Sengupta et al. (NPL reference 219 of IDS of 11/11/25; ‘Sengupta’) in view of Sengupta et al. (NPL reference 080 of IDS of 6/18/26; ‘Senguptaresponse’) in view of Mitsailis et al. (US 2021/0128630 as cited with IDS of 11/11/25; ‘Mitsailis’) in view of Pettine et al. (WO 2021/216903 as cited with IDS of 11/11/25; ‘Pettine’).
12213995 recites treating an inflammatory condition comprising administering a composition comprising exosomes (claims 1 and 4).
12213995 does not recite aspiration.
Sengupta teach exosomes for treatment (title). Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption). Sengupta teach that this group of patients as often progressing to hypoxic respiratory failure (page 747 paragraph spanning columns 1-2). Sengupta teach ARDS as inflammatory (page 748 end complete paragraph). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879). Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879).
Mitsailis teach exosomes for treating various diseases (abstract). Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066). Mitsailis teach that the exosomes are identified by protein markers (abstract) and specifically recites IGFBP4 (claim 1). Mitsailis also recites CD63 (claim 5). Mitsailis mentions that CD9 is not being expressed in the MSC (section 0041). Mitsailis teach that the extracellular vesicles are immunomodulatory (section 0120).
Pettine teach methods for treating acute respiratory distress syndrome (claim 14) and recognizes the use of exosomes and extracellular vesicles (page 1 lines 17-20). Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15). Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 12213995 because 12213995 specifically teach compositions for treatment inflammatory conditions (claim 3) and Sengupta teach ARDS as inflammatory (page 748 2nd complete paragraph). Thus, one would have been motivated to incorporate the teachings of the other references which also suggest treating acute respiratory distress syndrome. Since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract) and Senguptaresponse teach that composition comprises extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) one would have been motivated to use such conditions. Since Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066) one would have been motivated to administer to such patients. Since Senguptaresponse teach extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) and Sengupta teach the effectiveness (abstract) one would have been motivated to use such particles. Since Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used. Since Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3) one would have been motivated to include such proteins. One would have had a reasonable expectation of success since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to the subject as recited in claim 1, Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption).
In relation to the insult of claims 1-2 Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption) where severe COVID-19 is a pulmonary insult. Claim 2 recites optional but not required pulmonary insults. Sengupta teach patients with mechanical ventilation (Cohort C on page 748). Further, Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066).
In relation to the administering and composition of claim 1, 12213995 teach administration (claim 3). Sengupta teach exosomes for treatment (title). The instant specification recognizes that exosomes are extracellular vesicles (section 0044). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879).
In relation to claim 3, Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to claim 4, Sengupta teach all patients with a P/F ratio of less than or equal to 200 mm Hg (Table 1 caption).
In relation to claims 5 and 8, Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). The instant specification example teaches a 15 ml dose (page 168 last paragraph). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used.
In relation to claims 6-7 and 9, Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+ (section 2 on page 879) where CD63 antigen is recited in claim 9. Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879). Further, Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3). Mitsailis teach that the proteins may be in the lipid membrane or encapsulated by the exosome (section 0048).
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12453743 (as cited with IDS 6/18/26) in view of Sengupta et al. (NPL reference 219 of IDS of 11/11/25; ‘Sengupta’) in view of Sengupta et al. (NPL reference 080 of IDS of 6/18/26; ‘Senguptaresponse’) in view of Mitsailis et al. (US 2021/0128630 as cited with IDS of 11/11/25; ‘Mitsailis’) in view of Pettine et al. (WO 2021/216903 as cited with IDS of 11/11/25; ‘Pettine’).
12453743 recites an anti-inflammatory composition comprising a secretome (claim 2).
12453743 does not recite aspiration.
Sengupta teach exosomes for treatment (title). Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption). Sengupta teach that this group of patients as often progressing to hypoxic respiratory failure (page 747 paragraph spanning columns 1-2). Sengupta teach ARDS as inflammatory (page 748 end complete paragraph). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879). Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879).
Mitsailis teach exosomes for treating various diseases (abstract). Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066). Mitsailis teach that the exosomes are identified by protein markers (abstract) and specifically recites IGFBP4 (claim 1). Mitsailis also recites CD63 (claim 5). Mitsailis mentions that CD9 is not being expressed in the MSC (section 0041). Mitsailis teach that the extracellular vesicles are immunomodulatory (section 0120).
Pettine teach methods for treating acute respiratory distress syndrome (claim 14) and recognizes the use of exosomes and extracellular vesicles (page 1 lines 17-20). Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15). Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 12453743 because 12453743 specifically teach compositions that are anti-inflammatory (claim 1) and Sengupta teach ARDS as inflammatory (page 748 2nd complete paragraph). Thus, one would have been motivated to incorporate the teachings of the other references which also suggest treating acute respiratory distress syndrome. Since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract) and Senguptaresponse teach that composition comprises extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) one would have been motivated to use such conditions. Since Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066) one would have been motivated to administer to such patients. Since Senguptaresponse teach extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) and Sengupta teach the effectiveness (abstract) one would have been motivated to use such particles. Since Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used. Since Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3) one would have been motivated to include such proteins. One would have had a reasonable expectation of success since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to the subject as recited in claim 1, Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption).
In relation to the insult of claims 1-2 Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption) where severe COVID-19 is a pulmonary insult. Claim 2 recites optional but not required pulmonary insults. Sengupta teach patients with mechanical ventilation (Cohort C on page 748). Further, Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066).
In relation to the administering and composition of claim 1, Sengupta teach exosomes for treatment (title). The instant specification recognizes that exosomes are extracellular vesicles (section 0044). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879).
In relation to claim 3, Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to claim 4, Sengupta teach all patients with a P/F ratio of less than or equal to 200 mm Hg (Table 1 caption).
In relation to claims 5 and 8, Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). The instant specification example teaches a 15 ml dose (page 168 last paragraph). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used.
In relation to claims 6-7 and 9, Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+ (section 2 on page 879) where CD63 antigen is recited in claim 9. Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879). Further, Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3). Mitsailis teach that the proteins may be in the lipid membrane or encapsulated by the exosome (section 0048).
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 50-69 of copending Application No. 19584296 in view of Sengupta et al. (NPL reference 219 of IDS of 11/11/25; ‘Sengupta’) in view of Sengupta et al. (NPL reference 080 of IDS of 6/18/26; ‘Senguptaresponse’) in view of Mitsailis et al. (US 2021/0128630 as cited with IDS of 11/11/25; ‘Mitsailis’) in view of Pettine et al. (WO 2021/216903 as cited with IDS of 11/11/25; ‘Pettine’).
This is a provisional nonstatutory double patenting rejection.
19584296 recites treating a subject with covid (claim 50).
19584296 does not recite aspiration.
Sengupta teach exosomes for treatment (title). Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption). Sengupta teach that this group of patients as often progressing to hypoxic respiratory failure (page 747 paragraph spanning columns 1-2). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879). Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879).
Mitsailis teach exosomes for treating various diseases (abstract). Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066). Mitsailis teach that the exosomes are identified by protein markers (abstract) and specifically recites IGFBP4 (claim 1). Mitsailis also recites CD63 (claim 5). Mitsailis mentions that CD9 is not being expressed in the MSC (section 0041). Mitsailis teach that the extracellular vesicles are immunomodulatory (section 0120).
Pettine teach methods for treating acute respiratory distress syndrome (claim 14) and recognizes the use of exosomes and extracellular vesicles (page 1 lines 17-20). Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15). Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 19584296 because 19584296 specifically teach subjects with covid and Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption). Thus, one would have been motivated to incorporate the teachings of the other references which also suggest treating acute respiratory distress syndrome. Since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract) and Senguptaresponse teach that composition comprises extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) one would have been motivated to use such conditions. Since Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066) one would have been motivated to administer to such patients. Since Senguptaresponse teach extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879) and Sengupta teach the effectiveness (abstract) one would have been motivated to use such particles. Since Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used. Since Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3) one would have been motivated to include such proteins. One would have had a reasonable expectation of success since Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to the subject as recited in claim 1, Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption).
In relation to the insult of claims 1-2 Sengupta teach patients with acute respiratory distress syndrome (ARDS) and severe COVID-19 (abstract and Table 1 caption) where severe COVID-19 is a pulmonary insult. Claim 2 recites optional but not required pulmonary insults. Sengupta teach patients with mechanical ventilation (Cohort C on page 748). Further, Mitsailis specifically teach treating acute respiratory distress syndrome that may be a result of aspiration (section 0066).
In relation to the administering and composition of claim 1, Sengupta teach exosomes for treatment (title). The instant specification recognizes that exosomes are extracellular vesicles (section 0044). Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+, CD9- and CD81- (section 2 on page 879).
In relation to claim 3, Sengupta teach oxygenation improved after treatment with an average pressure of arterial oxygen to fraction of inspired oxygen ratio increase of 192% (abstract).
In relation to claim 4, Sengupta teach all patients with a P/F ratio of less than or equal to 200 mm Hg (Table 1 caption).
In relation to claims 5 and 8, Sengupta teach that a 15 mL dose of ExoFlo was administered to the patients (abstract). The instant specification example teaches a 15 ml dose (page 168 last paragraph). It is noted that the results presented in figure 3 of Sengupta are identical to those reported in instant figure 1 and MPEP 2112.01 recognizes that a chemical composition and its properties are inseparable. Further, Pettine teach that the number of vesicles may be about 1 million to about 100 billion vesicles per ml (page 21 lines 13-15) and since the references suggest for a specific use (treating ARDS) one would have been motivated to optimize the amount used.
In relation to claims 6-7 and 9, Senguptaresponse is a follow up response to Sengupta. Senguptaresponse teach that ExoFlo are extracellular vesicles where 95% of the particles are CD63+ (section 2 on page 879) where CD63 antigen is recited in claim 9. Senguptaresponse states that ExoFlo includes proteins (section 3 on page 879). Further, Pettine recognizes the inclusion of proteins including OPN and TIMP-1 (page 14 lines 23-29) and IGFBP-4 (page 15 line 3). Mitsailis teach that the proteins may be in the lipid membrane or encapsulated by the exosome (section 0048).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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, Melissa Fisher can be reached at 571-270-7430. 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.
RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights