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 .
Status of the Claims
Claim 10 has been canceled.
Claims 1-9 and 11-20 are currently pending.
Election/Restrictions
Applicant’s election with traverse of Group I, Claims 1-9 and 16-18, and of species a double mutant W235R and R275S tPA, in the reply filed on 9/11/2025 is acknowledged. The traversal is on the ground(s) that the claimed invention has a special technical feature different from Zhang. This is not found persuasive because as indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8, 11-15 and 19-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 1-7, 9 and 16-18 are being examined in this application, insofar as they read on the elected species of a double mutant W235R and R275S tPA.
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.
Claims 7, 16 and 17 are 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 pre-AIA the applicant regards as the invention.
Claims 7 (line 2), 16 (line 2), and 17 (line 2) recite “(w/v)”. It is unclear what the parenthetical information is conveying. Further, parenthesis is reserved for reference characters and information within parenthesis has no effect on the scope of the claims. See MPEP 608.01(m). Applicant is advised to amend claims to recite “w/v”.
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 1-7, 9 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vivien et al (WO 2013/034710 A1; 3/14/2013.) in view of Giuliano et al (Medicines. 2019;6(7):1-20.).
The instant claims recite a composition comprising a thermoreversible polymer and a nanoparticle comprising a plasminogen activator.
Vivien teaches a composition comprising a protein comprises a double mutation W253R and R275S (a plasminogen activator) (p.11 line 4-5, line 15 line 22-23). Note: Sequence is listed in Search results filed on 10/6/2025, 20251006_100604_us-17-998-432-1.rag file, Result 1, see below.
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Vivien does not teach the composition comprises a thermoreversible polymer including poloxamer 188 and 407 having the claimed amount (claims 1-7 and 16-17).
Giuliano teaches poloxamer 407 has been widely studied as a potential biomaterial for obtaining thermos-sensitive hydrogels thanks to its solubilizing capacity, low toxicity, drug release characteristics, and compatibility with numerous biomolecules and excipients (p.2 para 2). Solutions of poloxamer 407 at copolymer concentrations of 15-30% w/w have a low critical solution temperature similar to that of normal body temperature so they can easily be injected with a needle and syringe due to the initial low viscosity and will then promote the controlled release of an encapsulated drug by means of the gelation process (p.3 para 3). Poloxamer 407 is often used in association with other poloxamers, especially with poloxamer 188, in order to modulate the sol-gel transition temperature (p.3 para 6). Poloxamer 407-based hydrogels are attractive pharmaceutical formulations for medical application, the peculiar thermos-reversible behavior they exhibit makes poloxamer 407-based hydrogels suitable and versatile pharmaceutical formulations (p.12 para 4), and poloxamer 407-based hydrogels have been used as delivery systems for a wide range of compounds including proteins (p.4 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 incorporate poloxamer 188 and 407, since Vivien discloses a protein comprises a double mutation W253R and R275S useful for treating diseases, and Giuliano discloses that poloxamer 407-based hydrogels are suitable and versatile pharmaceutical formulations, that poloxamer 407-based hydrogels have been used as delivery systems for a wide range of compounds including proteins, and that poloxamer 407 is often used in association with poloxamer 188. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the concentration as a matter of routine experimentation. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) 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 and routine practice to incorporate an optimized amount of poloxamer 407 and 188 with a reasonable expectation for successfully obtaining a composition.
Conclusion
No claims are allowed.
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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/Lynn Y Fan/
Primary Examiner, Art Unit 1759