DETAILED ACTION
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 .
Status of the Application
Applicant's election of Group I, drawn to a method of treating or preventing amyotrophic lateral sclerosis by administering a VSP inhibitor, and the species (ML240), in the reply filed on 4/24/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Upon further consideration, the species requirement for the VSP inhibitor is hereby withdrawn.
Claims 1-5, 10, 14, 17-18, 27, 32, 35-36 are pending. Claims 27, 32, 35-36 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-5, 10, 14, 17-18 are examined herein insofar as they read on the elected invention and species.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112(b):
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.
Claim 18 is rejected under 35 U.S.C. 112(b), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claim 18 recites the broad recitation 12 VCP inhibitors, and the claim also recites optionally the same 9 VCP inhibitors which is the narrower statement of the range/limitation, which then optionally followed by a single VCP inhibitor.
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.
Claims 1-5, 14, 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Caroni et al. (WO 2013/068431, of record).
Caroni et al. teach a method for treating a neurodegenerative disease in a subject by administering a VCP inhibitor (claims 2-3), wherein the VCP inhibitor is Eeyarestatin-I (claim 4) and the neurodegenerative disease is Amyotrophic Lateral Sclerosis (ALS) (claim 5).
It is noted that the limitation regarding “wherein the VCP inhibitor inhibits the D2 ATPase domain of VCP” will necessarily occur since this is drawn to a mechanism of action in vivo.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Caroni et al. (WO 2013/068431, of record) in view of Mitra et al. (“Motor neuron disease-associated loss of nuclear TDP-43 is linked to DNA double-strand break repair defects,” PNAS, 2019, 116, 10, 4696-4705).
The instant claims are directed to a method of treating or preventing amyotrophic lateral sclerosis by administering a VCP inhibitor.
However, Caroni et al. fail to disclose the nexus between ALS and reduction in the nuclear-to-cytoplasmic ratio of TDP-43.
Mitra et al. teach Amyotrophic lateral sclerosis (ALS) is a devastating, motor neuron degenerative disease without any cure to date. About 95% of ALS patients feature abnormalities in the RNA/DNA binding protein TDP-43, involving its nucleus-cytoplasmic mislocalization in spinal motor neurons (page 4696, right column, last paragraph). Mitra et al. also teach the loss of nuclear TDP-43 in ALS patients (page 4701, left column, last paragraph). Data suggests the correlation of loss of monomeric TDP-43 to genomic instability in ALS patients (page 4704, right column, first paragraph).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have administered the VCP inhibitor, Eeyarestatin-I, as taught by Caroni et al., to a subject with ALS characterized by a reduction in the nuclear-to-cytoplasmic ratio of TDP-43, as taught by Mitra et al.
A person of ordinary skill in the art would have been motivated to administer Eeyarestatin-I to treat ALS characterized by a reduction in the nuclear-to-cytoplasmic ratio of TDP-43 because Caroni et al. teach that Eeyarestatin-I is useful in the treatment of ALS, in general. Furthermore, since ALS characterized by a reduction in the nuclear-to-cytoplasmic ratio of TDP-43 is a subset or species to the genus ALS, it is obvious absent a showing of unexpected results or criticality. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating ALS characterized by a reduction in the nuclear-to-cytoplasmic ratio of TDP-43 by administering the VCP inhibitor, Eeyarestatin-I.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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