DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 11/12/2025 have been received and entered into the case. Claims 10-16 have been canceled. Claims 1-9 are pending, Claims 3, 5-6 and 8-9 have been withdrawn, and Claims 1-2, 4 and 7 have been considered on the merits, insofar as they read on the elected species of TP508, subcutaneous injection, and a subject is diagnosed with a respiratory virus infection. All arguments have been fully considered.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claims 1-2 and 4 under 35 U.S.C. 102(a)(1) / (a)(2) as being anticipated by Carney (US 2013/0101574 A1; 4/25/2013. Cited on IDS) under pre-AIA 35 U.S.C. 102 are withdrawn in view of applicant’s amendments.
Rejections of Claim 7 under 35 U.S.C. 103 as being unpatentable over Carney (US 2013/0101574 A1; 4/25/2013. Cited on IDS) in view of Lee et al (Evol Med Public Health. 2016;1:95–109.) are withdrawn in view of applicant’s amendments.
Claim Objections
Claim 4 is objected to because of the following informalities: the recitation of “the” on line 1 should be deleted. Appropriate correction is required.
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 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 of this title, 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 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Carney (US 2013/0101574 A1; 4/25/2013. Cited on IDS) in view of Bridges (Public Health England. 2009;1-108.).
The instant claims recite a method of treating a subject with respiratory distress comprising administering to the subject TP508 or a derivate thereof.
Carney teaches a method of reducing the risk of developing systemic bacterial, fungal or viral infection in a subject, comprising administering to the subject an effective amount of a thrombin peptide derivative, wherein the subject has been exposed to a bacterial, fungal or viral infection (para 0077, 0172), the subject has pneumonia or other pulmonary conditions that could lead to acute respiratory distress syndrome or systemic infections (para 0079), and the thrombin peptide derivative is TP508 (para 0153). Carney teaches the method wherein said administering includes subcutaneous injection (para 0180-0181).
Carney does not teach the method is for treating a subject with respiratory distress (claim 1).
However, Carney does teach the method wherein the thrombin peptide derivative including TP508 is used for reducing the risk of mortality in a subject exposed to a lethal dose of radiation, reducing the risk of developing bacterial, fungal or viral infection in a subject exposed to radiation, treating a subject with traumatic injury, dermal injury and/or burn injury who is also exposed to radiation, reducing radiation related injury in a subject undergoing radiation therapy, reducing the risk of developing a radiation induced illness in a subject undergoing radiation therapy (para 0025). Bridges teaches within a few hours of a very high dose of radiation, respiratory distress can occur (p.9 para 5, p.55 col right – para 4), and acute radiation pneumonitis develops 2-6 months after exposure and is manifested by cough, dyspnea, and respiratory difficulties (p.55 col right – para 3).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to treat a subject with respiratory distress using TP508, since Bridges discloses that respiratory distress can occur after radiation exposure, and Carney discloses that a thrombin peptide derivative including TP508 is useful for reducing the risk of mortality in a subject exposed to a lethal dose of radiation, reducing the risk of developing bacterial, fungal or viral infection in a subject exposed to radiation, treating a subject with traumatic injury, dermal injury and/or burn injury who is also exposed to radiation, reducing radiation related injury in a subject undergoing radiation therapy, reducing the risk of developing a radiation induced illness in a subject undergoing radiation therapy. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to treat a subject with respiratory distress using TP508, with a reasonable expectation of success.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carney (US 2013/0101574 A1; 4/25/2013. Cited on IDS) in view of Bridges (Public Health England. 2009;1-108.) as applied in claims 1-2 and 4 above, further in view of Lee et al (Evol Med Public Health. 2016;1:95–109.).
References cited above do not teach the method wherein the subject is diagnosed with a respiratory virus infection (claim 7).
However, Carney does teach the method reduces the risk of developing systemic bacterial, fungal or viral infection in a subject, wherein the subject has pneumonia or other pulmonary conditions that could lead to acute respiratory distress syndrome or systemic infections (para 0077, 0079. 0174). Before the effective filing date of the claimed invention, it was well-known in the art that a wide range of viral, bacterial and fungal agents can cause pneumonia, and viruses are the most common etiologic agent (Abstract of Lee).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to treat a subject diagnosed with a respiratory virus infection, since Lee discloses that viruses are the most common etiologic agent that can cause pneumonia, and Carney discloses a method of reducing the risk of developing systemic bacterial, fungal or viral infection in a subject, wherein the subject has pneumonia or other pulmonary conditions that could lead to acute respiratory distress syndrome or systemic infections. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to treat a subject diagnosed with a respiratory virus infection, with a reasonable expectation for successfully reducing the risk of developing systemic bacterial, fungal or viral infection in the subject.
Response to Arguments
Applicant argues that Carney provides no specific examples, data, or disclosure for ARDS treatment or prevention as the primary outcome. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims are allowed.
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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759