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 .
Priority
This application is a 371 of PCT/KR2020/014074 (10/15/2020) and claims foreign priority to KOREA, REPUBLIC OF 10-2019-0129125 (10/17/2019)
KOREA, REPUBLIC OF 10-2020-0020639 (02/19/2020)
KOREA, REPUBLIC OF 10-2020-0101144 (08/12/2020).
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 9/12/25 is acknowledged. The traversal is on the ground(s) that Group I and II overlap. The traversal is partially persuasive and Groups I and II, directed to the method of claims 3 and 5, are joined and examined together.
The requirement is still deemed proper and is therefore made FINAL.
Applicant also elected the species of Formula 3 in claim 5 with the following structure:
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determined to read on claims 3 and 5.
As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nobuyuki et al. (JP2018090497, published 2018-06-14, citations to machine translation).
Nobuyuki teaches the following:
[0015] The present invention provides a prophylactic or therapeutic agent for internal ear diseases, the agent containing a necroptosis inhibitor as an active ingredient. In the present specification, the necroptosis inhibitor is specifically a selective inhibitor of RIP kinase 1 (RIPK1).
[0016] The inventors of the present invention have found that the above-described prophylactic or therapeutic agent suppresses falling and/or hair cell death of sensory hair in the inner ear.
[0017] The necroptosis inhibitor preferably used in the present invention is selected from Neclostatin -1, Neclostatin -2, Neclostatin -3, Neclostatin -4, Neclostatin -5, neclostatin -7, pothatinib, and pharmaceutically acceptable salts, solvates or prodrugs thereof.
[0018] These compounds can be synthesized, for example, based on descriptions such as Nature Chemical Biology 1, 112-119(2005); Cell Death and Differentiation 20, 185-187(2013); Cell Death and Differentiation 20, 366(2013) and the like, and commercially available products can also be obtained.
[0019] For example, Nerostatin -1, which is an example of a necroptosis inhibitor, is a compound represented by the following formula. 5-((1H-indol-3-yl) methyl)-3-methyl-2-thioximidazolidine-4-one is also referred to as methylhydantoin-(DL -) tryptophan. Neclostatin -1 can also be synthesized, and can also be obtained from Afcam, Inc. Abcam, or the like.
[0020] [Chem. 1]
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[0021] Neclostatin -1 has been reported as a specific inhibitor of necroptosis. For necroptosis, a model is proposed in which phosphorylation is induced continuously to RIPK (RIP kinase) 1 → RIPK 3 → MLKL (Mixed linage kinase domain-like, adapter molecules with a pseudokinase domain), and the phosphorylated MLKL forms pores in the cell membrane to perform necroptosis (Vanden Berghe et al. Nat. Rev. Mol. Cell Biol. 15(2), 135-147, 2014; Pasararkis and Vandenabe, Nature 517, 311-320, 2015). Necrosis is also inhibited by the selective inhibition mechanism of the RIP kinase 1 (RIPK 1: receptor interacting serine/threonine kinase 1) similar to neclostatin -1.
where Nobuyuki’s “Chem. 1” compound is the same as claim 5’s Formula 2 and is Nobuyuki teaches administration to prevent hair loss ([0016]).
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.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over by Nobuyuki et al. (JP2018090497, published 2018-06-14, citations to machine translation) in view of Yuan (US20140066466).
Nobuyuki teaches the following:
[0015] The present invention provides a prophylactic or therapeutic agent for internal ear diseases, the agent containing a necroptosis inhibitor as an active ingredient. In the present specification, the necroptosis inhibitor is specifically a selective inhibitor of RIP kinase 1 (RIPK1).
[0016] The inventors of the present invention have found that the above-described prophylactic or therapeutic agent suppresses falling and/or hair cell death of sensory hair in the inner ear.
[0017] The necroptosis inhibitor preferably used in the present invention is selected from Neclostatin -1, Neclostatin -2, Neclostatin -3, Neclostatin -4, Neclostatin -5, neclostatin -7, pothatinib, and pharmaceutically acceptable salts, solvates or prodrugs thereof.
[0018] These compounds can be synthesized, for example, based on descriptions such as Nature Chemical Biology 1, 112-119(2005); Cell Death and Differentiation 20, 185-187(2013); Cell Death and Differentiation 20, 366(2013) and the like, and commercially available products can also be obtained.
[0019] For example, Nerostatin -1, which is an example of a necroptosis inhibitor, is a compound represented by the following formula. 5-((1H-indol-3-yl) methyl)-3-methyl-2-thioximidazolidine-4-one is also referred to as methylhydantoin-(DL -) tryptophan. Neclostatin -1 can also be synthesized, and can also be obtained from Afcam, Inc. Abcam, or the like.
[0020] [Chem. 1]
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[0021] Neclostatin -1 has been reported as a specific inhibitor of necroptosis. For necroptosis, a model is proposed in which phosphorylation is induced continuously to RIPK (RIP kinase) 1 → RIPK 3 → MLKL (Mixed linage kinase domain-like, adapter molecules with a pseudokinase domain), and the phosphorylated MLKL forms pores in the cell membrane to perform necroptosis (Vanden Berghe et al. Nat. Rev. Mol. Cell Biol. 15(2), 135-147, 2014; Pasararkis and Vandenabe, Nature 517, 311-320, 2015). Necrosis is also inhibited by the selective inhibition mechanism of the RIP kinase 1 (RIPK 1: receptor interacting serine/threonine kinase 1) similar to neclostatin -1.
where Nobuyuki’s “Chem. 1” compound is the same as claim 5’s Formula 2 and is Nobuyuki teaches administration to prevent hair loss ([0016]). Nobuyuki teaches RIPK1 inhibitors are useful for preventing hair loss ([0015]).
Nobuyuki does not specifically teach the elected species of
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Yuan teaches treating diseases mediated by RIP1 kinase by administering inhibitor compounds ([0041]) including the following ([0291], claim 174):
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which is the same compound as the elected species. Yuan also teaches the same compound as Nobuyuki’s Chem. 1 ([0291], claim 174).
One of ordinary skill in the art following the teaching Nobuyuki would have considered other known RIP1 inhibitors for the same method of preventing hair loss because they share the same mechanism of action. In addition, both references teach the same compound of instant claim 5 Formula 2 which also shares a substantial structural similarity to instant claim 5 Formula 3 as taught by Yuan. As a result of the structural similarities and the common mechanism of action, one of ordinary skill in the art would have had an expectation that the compound of Yuan would have the same utility and arrive at the claimed invention with a reasonable expectation of success. The level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626