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 .
Status of the Claims
Claims 1-20 were originally filed October 19, 2023.
The amendment received November 17, 2023 canceled claims 1-20 and added new claims 21-40.
The amendment received September 9, 2026 amended claims 21, 25, 26, 37, 38, and 40 and canceled claims 22-24.
Claims 21-40 are currently pending.
Claims 21-26 and 37-40 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of preventing and/or treating a lung injury, annexin A5 at 0.2-5 mg/kg via intravenous injection, human, acute respiratory distress syndrome caused by an increase in neutrophils and a cytokine storm, glucocorticoid and a vitamin, and no additional method steps as the species in the reply filed on July 26, 2026 is acknowledged.
Please note: the election of “lung injury” is a genus, therefore, the genus was searched. The election of 0.2-5 mg/kg is a range, therefore, the range was searched. The election of the subgenus of “cytokine storm” resulted in the search of the subgenus. The election of the subgenuses of glucocorticoid and vitamin resulted in the subgenuses to be searched.
Claims 27-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 26, 2026.
Priority
The present application is a 371 (National Stage) of PCT/CN2021/131749 filed November 19, 2021 which claims foreign priority to China 202110448591.9 filed April 25, 2021.
A full priority analysis was not possible since all priority documents are in Chinese only.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome any rejection of record because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Withdrawn Objections
The objection to the disclosure regarding the first line should be updated to include PCT/CN2021/131749 filed November 19, 2021 is withdrawn in view of the amendment received September 9, 2026.
The objection to claim 38 regarding “aspray” should read “a spray” is withdrawn in view of the amendment received September 9, 2026.
The objection to claim 40 regarding “and” should read “or” (e.g. Markush group of alternatives; claim does not require all administration routes in a single human, etc.) is withdrawn in view of the amendment received September 9, 2026.
Withdrawn Rejections
The rejection of claim 40 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 is withdrawn in view of the amendment received September 9, 2026.
The rejection of claims 21, 22, and 38-40 under 35 U.S.C. 102(a)(1) as being anticipated by Blankenberg U.S. Patent Application Publication 2019/0008922 published January 10, 2019 is withdrawn in view of the amendment received September 9, 2026.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 102
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.
Claims 21, 25, 26, and 37-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feng et al. WO 2010/043045 published April 22, 2010.
For present claims 21-26 and 37-40, Feng et al. teach methods of treating an inflammatory disorder which are induced by proinflammatory cytokines including TNFa, IL-1b, and IL-6 via the cytokine cascade (i.e. cytokine storm) including cytokines released by neutrophils including adult respiratory distress syndrome (i.e. acute respiratory distress syndrome; ARDS) or acute lung injury via administering annexin A5 to a mammal including a human at a dose of about 0.1 mg/kg to 20 mg/kg intravenously (i.v.), intramuscularly, subcutaneously, intranasally, orally, etc. wherein annexin A5 composition can further comprise one or more pharmaceutical agents/in combination with other polypeptides, anti-inflammatory agents, etc. including glucocorticoids (please refer to the entire specification particularly the abstract; pages 1-9, 12-15, 17, 18, 23, 24).
Therefore, the teachings of Feng et al. anticipate the presently claimed method.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102(a)(1) as being anticipated by Feng et al. for claims 21, 25, 26, and 37-40 were considered but are not persuasive for the following reasons.
Applicants contend that Feng et al. does not teach glucocorticoid administration (i.e. present claim 37). Applicants contend that Feng et al. does not teach an increase in neutrophils and a cytokine storm.
Applicants’ arguments are not convincing since the teachings of Feng et al. anticipate the method of the instant claims. Feng et al. teach glucocorticoids and combination therapies (please refer to the entire specification particularly pages 2, 7, and 15). Feng et al. teach acute respiratory distress syndrome (i.e. same condition as presently claimed which would have the same symptoms, causes, etc.; please refer to the entire specification particularly pages 7-9, and 12). Feng et al. also teach neutrophils and cytokines which are part of the causes for the conditions disclosed (please refer to the entire specification particularly pages 2, 6-8, 14, and 15).
See the additional prior art section below regarding increased neutrophils and cytokine storm in acute respiratory distress syndrome (i.e. not a subset of the condition, but rather a known cause of the condition).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 25, 26, and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Feng et al. WO 2010/043045 published April 22, 2010 and Rocksen et al., 2004, Lung Effects During A Generalized Shwartzman Reaction And Therapeutic Intervention With Dexamethasone Or Vitamin E, Shock, 22(5): 482-490.
For present claims 21, 25, 26, and 37-40, Feng et al. teach methods of treating an inflammatory disorder which are induced by proinflammatory cytokines including TNFa, IL-1b, and IL-6 via the cytokine cascade (i.e. cytokine storm) including cytokines released by neutrophils including adult respiratory distress syndrome (i.e. acute respiratory distress syndrome; ARDS) or acute lung injury via administering annexin A5 to a mammal including a human at a dose of about 0.1 mg/kg to 20 mg/kg intravenously (i.v.), intramuscularly, subcutaneously, intranasally, orally, etc. wherein annexin A5 composition can further comprise one or more pharmaceutical agents/in combination with other polypeptides, anti-inflammatory agents, etc. including glucocorticoids (please refer to the entire specification particularly the abstract; pages 1-9, 12-15, 17, 18, 23, 24).
However, Feng et al. does not teach vitamins.
For present claims 21, 25, 26, and 37-40, Rocksen et al. teach methods of producing an acute respiratory distress syndrome mouse model with increased expression of proinflammatory cytokines including TNF-a, IL-1b and IL-6 and an increase in lung neutrophilia and administering vitamin E or dexamethasone (i.e. glucocorticoid) improved respiratory function and down-modulated proinflammatory cytokines (please refer to the entire reference particularly the abstract; Introduction; Materials and Methods; “Early treatment with dexamethasone and vitamin E improve respiratory capacity”; Figure 4; “Effect of dexamethasone and vitamin E on lung edema”; “Treatment with dexamethasone and vitamin E down-modulates cytokines in serum”, Figure 6).
All the claimed elements (methods of coadministration of annexin A5 with other therapeutic to treat lung injury including acute respiratory distress syndrome; glucocorticoids and vitamins for treating acute respiratory distress syndrome) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. treat lung injury including acute respiratory distress syndrome) and the combination would have yielded predictable results (i.e. treat lung injury including acute respiratory distress syndrome) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of other therapeutic agents for lung injury) for another (i.e. glucocorticoid and vitamins for treatment of acute respiratory distress syndrome) would have yielded predictable results (i.e. treatment of acute respiratory distress syndrome) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. cotherapies for treatment of acute respiratory distress syndrome) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Feng et al. and Rocksen et al. for claims 21, 25, 26, and 37-40 were considered but are not persuasive for the following reasons.
Applicants contend that Feng et al. does not single out a particular type of acute respiratory distress syndrome caused by increased neutrophils and a cytokine storm. Applicants contend that Rocksen et al. do not teach annexin 5 administration.
Applicants’ arguments are not convincing since the teachings of Feng et al. and Rocksen et al. render the method of the instant claims prima facie obvious.
Feng et al. teach acute respiratory distress syndrome (i.e. same condition as presently claimed which would have the same symptoms, causes, etc.; please refer to the entire specification particularly pages 7-9, and 12). Feng et al. also teach neutrophils and cytokines which are part of the causes for the conditions disclosed (please refer to the entire specification particularly pages 2, 6-8, 14, and 15).
Feng et al. teach glucocorticoids and combination therapies with annexin 5 (please refer to the entire specification particularly pages 2, 7, and 15).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
See the additional prior art section below regarding increased neutrophils and cytokine storm in acute respiratory distress syndrome (i.e. not a subset of the condition, but rather a known cause of the condition).
Claims 21, 25, 26, and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Blankenberg U.S. Patent Application Publication 2019/0008922 published January 10, 2019; Feng et al. WO 2010/043045 published April 22, 2010; and Rocksen et al., 2004, Lung Effects During A Generalized Shwartzman Reaction And Therapeutic Intervention With Dexamethasone Or Vitamin E, Shock, 22(5): 482-490.
For present claims 21, 25, 26, and 38-7-40, Blankenberg teaches methods of administering annexin V (i.e. annexin A5) to a mammal including a human with sepsis at a dose of up to about 1 mg/kg, up to about 1.5 mg/kg, up to about 2 mg/kg, up to about 5 mg/kg intravenously, parenterally, intramuscularly, subcutaneously, bronchial, intranasal, oral, etc. (e.g. reducing a quantity of neutrophils, no specific patient population required) (please refer to the entire specification particularly the abstract; Figures 1A, 3, 4; paragraphs 7-15, 21-24, 33-43, 48, 48, 51, 55, 57, 60, 63-66, 68, 73, 75). Blankenberg also teaches combination therapy (please refer to the entire specification particularly paragraphs 50, 55, 61).
While Blankenberg et al. teach sepsis, Blankenberg et al. does not teach lung injury.
For present claims 21, 25, 26, and 37-40, Rocksen et al. teach that sepsis can lead to acute respiratory distress syndrome and methods of producing an acute respiratory distress syndrome mouse model with increased expression of proinflammatory cytokines including TNF-a, IL-1b and IL-6 and an increase in lung neutrophilia and administering vitamin E or dexamethasone (i.e. glucocorticoid) improved respiratory function and down-modulated proinflammatory cytokines (please refer to the entire reference particularly the abstract; Introduction; Materials and Methods; “Early treatment with dexamethasone and vitamin E improve respiratory capacity”; Figure 4; “Effect of dexamethasone and vitamin E on lung edema”; “Treatment with dexamethasone and vitamin E down-modulates cytokines in serum”, Figure 6).
For present claims 21, 25, 26, and 37-40, Feng et al. teach methods of treating an inflammatory disorder which are induced by proinflammatory cytokines including TNFa, IL-1b, and IL-6 via the cytokine cascade (i.e. cytokine storm) including cytokines released by neutrophils including adult respiratory distress syndrome (i.e. acute respiratory distress syndrome; ARDS) or acute lung injury via administering annexin A5 to a mammal including a human at a dose of about 0.1 mg/kg to 20 mg/kg intravenously (i.v.), intramuscularly, subcutaneously, intranasally, orally, etc. wherein annexin A5 composition can further comprise one or more pharmaceutical agents/in combination with other polypeptides, anti-inflammatory agents, etc. including glucocorticoids (please refer to the entire specification particularly the abstract; pages 1-9, 12-15, 17, 18, 23, 24).
All the claimed elements (methods of coadministration of annexin A5 with other therapeutic to treat lung injury including acute respiratory distress syndrome; glucocorticoids and vitamins for treating acute respiratory distress syndrome) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. treat lung injury including acute respiratory distress syndrome) and the combination would have yielded predictable results (i.e. treat lung injury including acute respiratory distress syndrome) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of other therapeutic agents for lung injury) for another (i.e. glucocorticoid and vitamins for treatment of acute respiratory distress syndrome) would have yielded predictable results (i.e. treatment of acute respiratory distress syndrome) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. cotherapies for treatment of acute respiratory distress syndrome) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Blankenberg; Feng et al.; and Rocksen et al. for claims 21, 25, 26, and 37-40 were considered but are not persuasive for the following reasons.
Applicants contend that Feng et al. does not single out a particular type of acute respiratory distress syndrome causes by increased neutrophils and a cytokine storm. Applicants contend that Rocksen et al. do not teach annexin 5 administration. Applicants contend that Blankenberg does not teach acute respiratory distress syndrome.
Applicants’ arguments are not convincing since the teachings of Blankenberg; Feng et al.; and Rocksen et al. render the method of the instant claims prima facie obvious.
Feng et al. teach acute respiratory distress syndrome (i.e. same condition as presently claimed which would have the same symptoms, causes, etc.; please refer to the entire specification particularly pages 7-9, and 12). Feng et al. also teach neutrophils and cytokines which are part of the causes for the conditions disclosed (please refer to the entire specification particularly pages 2, 6-8, 14, and 15).
Feng et al. teach glucocorticoids and combination therapies with annexin 5 (please refer to the entire specification particularly pages 2, 7, and 15).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
See the additional prior art section below regarding increased neutrophils and cytokine storm in acute respiratory distress syndrome (i.e. not a subset of the condition, but rather a known cause of the condition).
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 21, 25, 26, and 37-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19/160,178 (reference application) in view of Feng et al. WO 2010/043045 published April 22, 2010 and Rocksen et al., 2004, Lung Effects During A Generalized Shwartzman Reaction And Therapeutic Intervention With Dexamethasone Or Vitamin E, Shock, 22(5): 482-490.
The claims of copending Application No. 19/160,178 (reference application) are drawn to methods of administering annexin A5 via injection.
Feng et al. teach methods of treating an inflammatory disorder which are induced by proinflammatory cytokines including TNFa, IL-1b, and IL-6 via the cytokine cascade (i.e. cytokine storm) including cytokines released by neutrophils including adult respiratory distress syndrome (i.e. acute respiratory distress syndrome; ARDS) or acute lung injury via administering annexin A5 to a mammal including a human at a dose of about 0.1 mg/kg to 20 mg/kg intravenously (i.v.), intramuscularly, subcutaneously, intranasally, orally, etc. wherein annexin A5 composition can further comprise one or more pharmaceutical agents/in combination with other polypeptides, anti-inflammatory agents, etc. including glucocorticoids (please refer to the entire specification particularly the abstract; pages 1-9, 12-15, 17, 18, 23, 24).
Rocksen et al. teach methods of producing an acute respiratory distress syndrome mouse model with increased expression of proinflammatory cytokines including TNF-a, IL-1b and IL-6 and an increase in lung neutrophilia and administering vitamin E or dexamethasone (i.e. glucocorticoid) improved respiratory function and down-modulated proinflammatory cytokines (please refer to the entire reference particularly the abstract; Introduction; Materials and Methods; “Early treatment with dexamethasone and vitamin E improve respiratory capacity”; Figure 4; “Effect of dexamethasone and vitamin E on lung edema”; “Treatment with dexamethasone and vitamin E down-modulates cytokines in serum”, Figure 6).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
See the additional prior art section below regarding increased neutrophils and cytokine storm in acute respiratory distress syndrome (i.e. not a subset of the condition, but rather a known cause of the condition).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Guido et al., 2013, Annexin-A1 peptide down-regulates the leukocyte recruitment and up-regulates interleukin-10 release into lung after intestinal ischemia-reperfusion in mice, Journal of Inflammation, 10: 10 pages.
Koike et al., 2008, Pretreatment with olprinone hydrochloride, a phosphodiesterase III inhibitor, attenuates lipopolysaccharide-induced lung injury via an anti-inflammatory effect, Pulmonary Pharmacology & Therapeutics, 21: 166-171.
Sayah et al., 2021, Interleukin-6, procalcitonin and neutrophil-to-lymphocyte ration: Potential immune-inflammatory parameters to identify severe and fatal forms of COVID-19, Cytokine, 141: 155428 (8 pages).
Wonderlich et al., 2017, Widespread virus replication in alveoli drives acute repiratory distress syndrome in aerosolized H5N1 influenza infection of macaques, J Immunol, 198(4): 1616-1626.
Hanan et al., 2021, The Many Faces of Innate Immunity in SARS-CoV-2 Infection, Vaccines, 9: 596 (17 pages).
Borges et al., 2020, COVID-19 and Neutrophils: The Relationship between Hyperinflammation and Neutrophil Extracellular Traps, Mediators of Inflammation, 8829674 (7 pages).
Wang et al., 2016, Regulatory effect of cytokine-induced neutrophil chemoattractant, epithelial neutrophil-activating peptide 78 and pyrrolidine dithiocarbamate on pulmonary neutrophil aggregation mediated by nuclear factor-kB in lipopolysaccharide-induced acute respiratory distress syndrome mice, Experimental and Therapeutic Medicine, 12: 1785-1794.
Shi et al., 2020, Neutrophil-targeted engineered prodrug nanoparticles for anti-inflammation, The FASEB Journal, 34: 9828-9831.
Tanaka et al., 2009, Vitamin K3 attenuates lipopolysaccharide-induced acute lung injury through inhibition of nuclear factor-kB activation, Clinical and Experimental Immunology, 160: 283-292.
Hybertson et al., 2006, Phagocytes and Acute Lung Injury: Dual Roles For Interleukin-1, Annuals New York Academy of Sciences, 266-273.
Uchiyama et al., 2004, A Novel Water-Soluble Vitamin E Derivative Prevents Acute Lung Injury By Bacterial Endotoxin, Clinical and Experimental Pharmacology and Physiology, 31: 226-230.
Jonas et al., 1993, In Vitro Effect of Ascorbic Acid on Neutrophil-Endothelial Cell Interaction, J Biolumin Chemilumin, 8: 15-20.
Dwenger et al., 1994, Ascorbic acid reduces the endotoxin-induced lung injury in awake sheep, European Journal of Clinical Investigation, 24: 229-235.
Meduri et al., 2007, Methylprednisolone Infusion in Early Severe ARDS, Chest, 131: 954-963.
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.
Future Communications
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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