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 .
Detailed Action
Filing Receipt and Priority
The filing receipt mailed 08/22/2024 states that the instant application is a 371 of PCT/CN2021/125660, filed 10/22/2021. The filing receipt also states that the instant application may have benefit of foreign application CHINA 20211145113.2, filed 10/23/2020.
The instant claims are supported by the foreign application. Therefore the effective filing date is 10/23/2020.
Information Disclosure Statement
The information disclosure statement submitted 04/21/2023 has been considered.
Species Election
Applicant’s election of the following species in the reply dated 02/27/2026 is acknowledged. The elected species are:
-GEN1-284 salt (form below),
-arthritis.
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Applicant has not submitted arguments against the species elections. Therefore, the election is treated as an election without traverse.
At examiner’s discretion, search and examination has been broaden to include the full scope of compound of formula II, shown below, and all STAT5-associated diseases.
Claims 10-12 are withdrawn.
Claim Objections
Claims 1, 4 state “however, the fused ring-containing compound represented by formula II is not the following…”. Examiner suggests amending to state “with the proviso that” instead.
Claims 5-7 use the following claim language: “when the R3 is C1-C3 alkyl….”. This claim language is not indefinite and does not have antecedent basis issues. However, language regarding substituents on a compound typically are worded to state that a variable substituent is a specific substituent. As an example, the claims should state “when R3 is…”.
Claims 5 states “ the ‘more’ means 2 or 3”. The instant specification on p. 17 states “The term ‘more’ or ‘multiple’ means 2, 3, 4, or 5.” Therefore, applicant may amend the claim to state “R3 is C1-C3 alkyl substituted with 1-3 halogens...”.
Claim 4 is objected to for the use of schemes 1-4. Within the chemical arts, “schemes” are understood to be steps of reactions in a synthetic route. Here applicant is using the term “scheme” to mean “structure”. See example below.
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Claim 5 is objected to. Claim 5 regarding R3 states “when R3 is C1-C3 alkyl, the C1-C3 alkyl is methyl, ethyl, n-propyl or isopropyl.” Methyl, ethyl, n-propyl, and isopropyl are the only C1-C3 alkyl groups. Including the specification that “C1-C3 alkyl is methyl, ethyl, n-propyl or isopropyl” is redundant. Applicant can state “R3 is C1-C3 alkyl” or “R3 is methyl, ethyl, n-propyl or isopropyl.”
Similar language is used regarding R4-2, R4-3, R4-1, R4-4, and R4-5.
Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Scope of Enablement
Claims 13-14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for arthritis, atherosclerosis, and psoriasis, does not reasonably provide enablement for all STAT5-associated diseases. Additionally, while the specification is enabling for treating, the specification does not reasonably provide for enablement for prevention. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The following Wands Factors have been considered if not explicitly discussed: (A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth of the Claims
Claim 13 states “A method for treating and/or preventing a STAT5-associated disease, arthritis, atherosclerosis, or psoriasis, comprising administering to a patient a therapeutically effective amount of a substance Y, wherein the substance Y is the fused ring-containing compound represented by formula II, the pharmaceutically acceptable salt thereof, the solvate thereof or the solvate of the pharmaceutically acceptable salt thereof according to claim 1.”
The term “STAT5-associated disease” is not explicitly defined in the instant disclosure. The instant specification contemplates arthritis, atherosclerosis, and psoriasis as STAT5-assoicated diseases. However, without an explicit definition, the broadest reasonable interpretation includes all STAT5-associated diseases.
The instant disclosure defines “preventing” as “reduction in risk of acquiring or developing a disease or disorder.”
Nature of the Invention
The invention is drawn to a clinical method to be practiced by one of ordinary skill in the art. The claimed method does not include any method to determine risk of developing arthritis, atherosclerosis, or psoriasis or any STAT5 associated disease.
State of the art
The use of the exact compound of claim 1 is not reported in any treatments for arthritis, atherosclerosis, or psoriasis.
Regarding STAT5-associated diseases, Rani (Journal of Interferon & Cytokine Research, Vol. 36, No. 4, 2016), in its abstract connects STAT5 to immune function and anti-tumor immunity. Rani states “…consistently activated STAT5 is associated with a suppression in antitumor immunity and an increase in proliferation, invasion and survival of tumor cells. Thus, therapeutic targeting of STAT5 is promising in cancer.”
Guidance provided and Working examples
The instant disclosure details a STAT5 Y694 phosphorylation assay (p. 93). The instant disclosure on p. 2-3 discusses the role of STAT5 in signaling pathways. The specification also states “Genetic experiments also show that knocking out the STAT5 gene can significantly reduce inflammation of the nervous system and arthritis in mice with multiple sclerosis…”.
The instant disclosure starting p. 104 discusses results of administering compounds of the instant claims to treat arthritis (p. 106), sclerosis (p. 119), and psoriasis (p. 128). There is no evidence or discussion of other diseases.
The instant specification on p. 109 discusses administration of the claimed compounds to prevent arthritis. However, the specification states “The positive control tofacitinib treatment group began to significantly inhibit the score of arthritis on day 34. The compound GEN1-284s at doses of 50 mg/kg and 150 mg/kg began to consistently and significantly inhibit the score of arthritis on day 32 and day 34 respectively.” This evidence does not support prevention of arthritis.
Amount of Experimentation
Considering the above, one of ordinary skill in the art would have an undue burden of experimentation should they attempt to practice the claimed method in efforts to prevent arthritis, sclerosis, or psoriasis and in efforts to treat any other STAT5-associated disease.
As claim 14 is dependent on claim 13, it is also rejected.
Written Description – Impossible compound structures
Claims 1-3, 5-7, 9, and 13-14 are is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 claims a compound of the following structure with the variable substituents shown below.
Claim 1 compound
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The limitation “m is 0, 1, 2, 3, or 4” is not possible within the full scope of the claim. The bicyclic ring system containing an m amount of R4-4 groups cannot support 4 R4-4 groups. The ring system only has space for 3 R4-4 groups. Similarly, the A-ring system is a 5-6 membered heteroaryl ring. Claim 1 claims a t amount of R4-5 groups on this heteroaryl system. “t” ranges from 0-4 total. However, “t” can be only, at most, 3.
The compounds are therefore not possible and one of ordinary skill would recognize that applicant does not have possession of an impossible compound.
Claim Rejections - 35 USC § 112(b)
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.
Indefinite Term
Claim 13 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 13 states “A method for treating and/or preventing a STAT5-associated disease…”. The term “STAT5-associated disease is not explicitly defined within the instant specification. The instant disclosure contemplates arthritis, atherosclerosis or psoriasis as STAT5-associated diseases, but there is not a clear listing or method of determining which diseases are STAT5-associated or not.
The instant disclosure also discloses a STAT5 Y694 phosphorylation assay (p. 93) but does not disclose any diseases which may benefit from the use of this assay. Therefore, one of ordinary skill in the art would not know the metes of bounds of the claims from the use of “STAT5-associated disease”.
Contradictory Limitations
Claim 2 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 2 states
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in l. 4 of said claim. Claim 2 in the last line of the claim also states “and/or when R1 is hydrogen…”. Applicant’s use of “and/or” includes situations where R1 is the phosphate moiety above and where R1 is hydrogen. In the scenario that R1 is the phosphate moiety, the claim cannot also claim “and when R1 is hydrogen.”
Claim 2 states “…and/or n is 0, and/or R4 is [moiety omitted]…”. “n” is not included within the claimed R4 moiety. The claim cannot have both R4 as the following moiety and “n”, even if “n” is denoted as zero.
Redundant Limitation
Claim 8 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 8 states “The fused ring-containing compound represented by formula II, the pharmaceutically acceptable salt thereof, the solvate thereof or the solvate of the pharmaceutically acceptable salt thereof according to claim 1, wherein the fused ring-containing compound represented by formula II is any one of the following compounds:”. A table of compounds within the claim includes the following compound GEN1-284 salt.
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The claim then states “and/or the pharmaceutically acceptable salt of the fused ring-containing compound represented by formula II is
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”
The second iteration of the pharmaceutically acceptable salt is redundant. Additionally, the use of “and/or” within the claim language implies an impossible scenario where “the pharmaceutically acceptable salt” is one of the compounds listed and where the same pharmaceutically acceptable salt is the salt above. Therefore, one of ordinary skill in the art would not know the metes and bounds of the claim because of this contradiction.
Indefinite Claim Language
Claim 14 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 14 states “The method according to claim 13, wherein the method satisfies one or more of the following conditions: (1) the STAT5-associated disease is arthritis or psoriasis; (2) the arthritis is rheumatoid arthritis, adjuvant arthritis, or collagen-induced arthritis; and (3) the psoriasis is imiquimod-induced psoriasis.”
The conditions 1-3, as currently claim, cannot be separated as implied by the use of “one of more”. If the only condition “selected” is condition (2) or (3), then condition (1) is already satisfied. The claim should be amended to state “The method according to claim 13, wherein the STAT5-associated disease is arthritis, atherosclerosis or psoriasis; wherein the arthritis is rheumatoid arthritis, adjuvant arthritis or collagen-induced arthritis; and wherein the psoriasis is imiquimod-induced psoriasis.”
Further, claim 14 depends from claim 13 which states “A method for treating and/or preventing a STAT5-associated disease, arthritis, atherosclerosis or psoriasis….”. The claim language of claim 13 implies that the “arthritis, atherosclerosis or psoriasis” are distinct conditions from “a STAT5-associated disease”. This is contradicted by the claim language of claim 14 which states that the STAT5-associated disease is arthritis, atherosclerosis or psoriasis. One of ordinary skill in the art would not know the metes and bounds of the claims from this contradiction.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624