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
Claims 1-18 are pending.
Information Disclosure Statement
The information disclosure statements submitted on 29 April 2025 were filed before the mailing of an Office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being 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.
Claims 6-7 and 12-13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 6 and 12 state “a molecule resembling an IL-2 antigen:anti-IL-2 complex”. It is unclear what is meant by “resembling” an IL-2 antigen:anti-IL-2 complex, and the instant specification does not define what constitutes resembling an IL-2 antigen:anti-IL-2 complex. Therefore, the metes and bounds of the claim are not clearly defined.
The term “low viscosity” in claims 7 and 13 is a relative term which renders the claim indefinite. The term “low viscosity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what viscosity is considered within the scope of “low viscosity”. The instant specification and claims do not define what constitutes a low viscosity liquid.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7-11 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gu (US 2021/0100744 A1 or it’s parent WO 2019/217954 A1).
Gu teaches a bioresponsive hydrogel matrix comprising a polymer and a chemotherapeutic agent (Claims 1-3 and 9).
Regarding claim 1, Gu teaches that the bioresponsive hydrogel can comprise a biocompatible polymer ([0047]), the chemotherapeutic agent includes IL-2 ([0051], [0092]), and the bioresponsive hydrogel matrixes have a unique feature in that they form a stable gel at biocompatible temperatures and exhibited a suitable sol-to-gel transition temperature (around 22° C) ([0052], [0104]). Gu teaches that FIG. 3D shows photographs of the sol-to-gel transition with the increasing of temperature (a and b), and injectable gelation test in water at 37° C (d) ([0017]).
Gu does not explicitly disclose an example composition comprising an IL-2 polypeptide component or an anti-IL-2 antibody component as instantly claimed. However, Gu teaches that the bioresponsive hydrogel matrixes can further comprise one or more chemotherapeutic agents, such as IL-2 (Aldesleukin) ([0051], [0092]).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare a bioresponsive hydrogel according to Gu comprising a biologically compatible polymer and a chemotherapeutic agent, such as IL-2, wherein the hydrogel is a liquid at or below room temperature but forms a gel at about 37 °C. A person of ordinary skill in the art would have been motivated to select a suitable chemotherapeutic agent, such as IL-2 (Aldesleukin), for treating a non-immunogenic cancer in a subject and/or inducing PD-1/PD-L1 blockade inhibitor susceptibility in a tumor in a subject with a cancer, as suggested by Gu.
Regarding claim 8, Gu teaches a method of treating a cancer in a subject comprising administering to the subject a bioresponsive hydrogel matrix ([0008]; Claim 11).
Regarding claims 2 and 9, Gu teaches that exemplary polymers also include copolymers of polyethylene glycol (PEG) and the aforementioned polyesters, such as various forms of PLGA-PEG or PLA-PEG copolymers, collectively referred to herein as “PEGylated polymers” ([0048]).
Regarding claims 3 and 10, Gu teaches that as used herein biocompatible polymers include, but are not limited to… polyurethanes ([0047]).
Regarding claims 4 and 11, Gu teaches that chemotherapeutic agents that can be used in the disclosed hydrogel matrixes can comprise any chemotherapeutic known in the art, the including, but not limited to… Interleukin-2 (Aldesleukin) ([0051], [0092]).
Regarding claims 7 and 13, Gu teaches the bioresponsive hydrogel matrixes have a unique feature in that they form a stable gel at biocompatible temperatures and exhibited a suitable sol-to-gel transition temperature (around 22° C) ([0052], [0104]). Gu teaches that FIG. 3D shows photographs of the sol-to-gel transition with the increasing of temperature (a and b), and injectable gelation test in water at 37° C (d) ([0017]).
Regarding claim 14, Gu teaches that the compositions may be administered orally, parenterally (e.g., intravenously), by intramuscular injection, by intraperitoneal injection, transdermally, extracorporeally, topically or the like, including topical intranasal administration or administration by inhalant ([0046], [0074], [0082]; Fig. 1 and 3). Parenteral administration of the composition, if used, is generally characterized by injection. Injectables can be prepared in conventional forms, either as liquid solutions or suspensions, solid forms suitable for solution of suspension in liquid prior to injection, or as emulsions ([0075]).
Regarding claims 15-16, Gu teaches that “therapeutically effective amount” or “therapeutically effective dose” of a composition (e.g. a composition comprising an agent) refers to an amount that is effective to achieve a desired therapeutic result. In some embodiments, a desired therapeutic result is the control of type I diabetes ([0036]).
Regarding claims 17-18, Gu teaches that the bioresponsive hydrogel matrixes of the present disclosure have a unique feature in that they form a stable gel at biocompatible temperatures. In one aspect, a composition comprising the bioresponsive hydrogel matrixes disclosed herein (including hydrogels comprising chemotherapeutic agents and immune blockade inhibitors) can be formulated as a solution and upon administration to the subject transition to a gel ([0052]).
Gu does not explicitly disclose a kit comprising the bioresponsive hydrogel matrix, as instantly claimed.
Gu teaches that parenteral administration of the composition, if used, is generally characterized by injection. Injectables can be prepared in conventional forms, either as liquid solutions or suspensions, solid forms suitable for solution of suspension in liquid prior to injection, or as emulsions ([0075]). Gu also teaches that in one aspect, a composition comprising the bioresponsive hydrogel matrixes disclosed herein (including hydrogels comprising chemotherapeutic agents and immune blockade inhibitors) can be formulated as a solution and upon administration to the subject transition to a gel ([0052]).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare a kit comprising the bioresponsive hydrogel matrix according to Gu, wherein the kit is stored at or below room temperature (i.e., stored as a solution) and upon administration to the subject transition to a gel.
Claims 1, 4, 7-8, 11, 13-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US 2021/0163691 A1).
Song et al. teach a thermosensitive hydrogel composition, in which a reversible sol-gel transition property is altered, comprising a polyphosphazene-based polymer (Claim 1).
Regarding claims 1, 4, 7-8, 11, 13-14 and 16, Song et al. teach that by adjusting the proportion of the polyethylene glycol moiety substituted to the polyphosphazene backbone to an appropriate range according to the length of the polyethylene glycol moiety, the solution containing the polyethylene glycol moiety can remain in a liquid state from low temperature to room temperature and can be gelled near the body temperature of 37° C ([0005]). Song et al. teach that the drug delivery system of the present invention may include drugs, cells, nanoparticles, microparticles, physiologically active materials, or a combination thereof, as a functional material, wherein the functional materials include IL-2 ([0086]-[0087]). Song et al. teach injecting a composition comprising a polyphosphazene-based polymer to a damaged tissue site in need thereof (Claim 11).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions for the treatment of damaged tissue, wherein the compositions comprising a thermosensitive hydrogel composition comprising a biocompatible polymer and a functional material, such as IL-2, wherein the composition is injected into a damaged tissue site.
Regarding claims 17-18, Song et al. teach a drug delivery system (i.e., kit) comprising the polyphosphazene-based polymer and a functional material ([0022]). Song et al. teach the solution containing the polyethylene glycol moiety can remain in a liquid state from low temperature to room temperature ([0005]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare a kit comprising the drug delivery system according to Song et al., wherein the kit is formulated for storage at or below room temperature to maintain the composition as a liquid.
Claims 5-6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gu (US 2021/0100744 A1) as applied to claims 1-4, 7-11 and 13-18, further in view of Rondon et al. (US 2021/0061902 A1).
The teachings of Gu are discussed above.
Regarding claims 5-6 and 12, Gu does not explicitly disclose an IL-2 antigen:anti-IL-2 complex, as instantly claimed.
Rondon et al. teach antibodies, e.g., full length antibodies and antigen-binding portions thereof that specifically bind interleukin-2 (IL-2). The disclosure further relates to compositions comprising antibodies to IL-2, and methods of using the antibodies as a medicament. The anti-IL-2 antibodies are useful for treating and preventing autoimmune diseases, disorders and conditions and for immunosuppression ([0004]).
Rondon et al. teach a method for treating an inflammatory condition such as an autoimmune disease or inducing immunosuppression in a human subject in need thereof, comprising administering to the subject an effective amount of an antibody or antigen-binding portion of the disclosure or a pharmaceutical composition of the disclosure. In some embodiments, the antibody is administered in complex with IL-2. In related aspects, the disclosure provides an antibody or antigen-binding portion of the disclosure or a pharmaceutical composition of the disclosure for use in treating a human subject having an inflammatory condition such as an autoimmune disease or in need of immunosuppression, wherein the antibody or portion is optionally administered in complex with IL-2; and the use of an antibody or antigen-binding portion of the disclosure in the manufacture of a medicament for treating an inflammatory condition such as an autoimmune disease or inducing immunosuppression, wherein the antibody or portion is optionally administered in complex with IL-2 ([0113]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to modify the thermosensitive hydrogel composition of Gu by administering a complex of an IL-2 and anti-IL-2 antibody, as taught by Rondon et al. A person of ordinary skill in the art would have been motivated to administer a complex of IL-2 and anti-IL-2 antibody suitable for use in treating a subject having an autoimmune disease.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571) 272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.W.S/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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