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 .
Acknowledgement of Receipt
Applicant's response filed on 08/26/2025 to the Office Action mailed on 05/29/2025 is acknowledged.
Claim Status
Claims 1 and 27-41 are pending.
Claims 19-24 were previously cancelled and claims 2-18, 25 and 26 are cacnelled.
Claim 1 is currently amended.
Claims 27-41 are newly added.
Claims 1 and 27-41 have been examined.
Claims 1 and 27-41 are rejected.
Priority
Priority to 371 PCT/JP2021/019622 filed on 05/24/2021, which claims priority to Japanese patent application 2020-090194 filed on 05/25/2020 is acknowledged.
Drawings
The drawings filed on 11/17/2022 are accepted.
Withdrawn and New Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Response to Applicant’s Arguments
The rejection of claim(s) 2-10 and 13-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benavides et al. (US Patent 5543421, Published 08/06/1996) as evidenced by Tesar et al. (International Application Published Under the PCT WO 2018/022904 A2, Published 02/01/2018) is moot since the claims are cancelled.
The rejection of claim 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benavides et al. (US Patent 5543421, Published 08/06/1996) as evidenced by Tesar et al. (International Application Published Under the PCT WO 2018/022904 A2, Published 02/01/2018) is withdrawn in view of the amendment to the claim.
This is a new ground of rejection necessitated by the amendment to the claims.
Claim(s) 1, 27, 28, and 31-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cole et al. (Ziprasidone for Agitation or Psychosis in Dementia: Four Cases, Published 03/01/2005) as evidenced by Korey et al. (International Application Published Under the PCT WO 0192238 A1, Published 12/06/2001), Tesar et al. (International Application Published Under the PCT WO 2018/022904 A2, Published 02/01/2018), and Gatticchi et al. (Selected cholesterol biosynthesis inhibitors produce accumulation of the intermediate FF-MAS that targets nucleus and activates LXRα in HepG2 cells, Published 05/09/2017).
With regard to claims 1, 28, 36, and 39, Cole et al. teach a 86-year old female with a history of Alzheimer’s disease (page 95, paragraph 5) was treated with 20mg/day and then 20mg bid, and finally 20mg tid of ziprasidone resulting in dramatic gait and attention improvement; Her facial expression returned more to her previous state; Her mood, affect, spontaneous sense of humor and interpersonal interactions were better than they had been in years (page 96, paragraph 2).
With regard to claims 1, 27, 28, 38, and 39, Korey et al. teach that Alzheimer’s disease a neuromuscular junction disease (abstract).
With regard to claims 31-35, Tesar et al. teach ziprasidone l is a sterol 14-reductase (TM7SF2/LBR) inhibitor (paragraph 00146).
With regard to the limitation “FF-MAS metabolism inhibitor”, Gattichi et al. teach “In this study, we used AY9944 and 17-hydroxyprogesterone (17OHP) to inhibit C14-sterol reductases and the downstream C4-demethylase complex to accumulate MAS in HepG2 cells and to investigate their effects on cholesterol metabolism, LXRα signaling, and cellular proliferation. The pharmacological approach allows to overcome the redundancy of TM7SF2 and LBR as C14-sterol reductases, favouring the accumulation of FF-MAS and other Δ14-unsaturated sterols” (page 843, column 1, paragraph 2). In other words, inhibition of TM7SF2 and LBR results in inhibition of FF-MAS metabolism.
With regard to the limitations that composition/compound results in “protection and/or regeneration of neuromuscular junction” is an inherent property of ziprasidone and/or the method of Cole et al. The prior art method steps, composition, and patient population are identical to the instantly claimed method steps, composition, and patient population. Therefore, the method of Cole et al. will necessarily result in protection and/or regeneration of a neuromuscular junction. Furthermore, "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Therefore, the effect of administering ziprasidone to an Alzheimer’s patient would necessarily result in “protection and/or regeneration of neuromuscular junction”. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). When, the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use. The court went on to reverse the obviousness rejection of claims 2-5 and 7-10 which recited a process of using a new compound. The court relied on evidence showing that the nonaddictive property of the new compound was unexpected.) Here the limitation “protection and/or regeneration of neuromuscular junction” is nothing more than an explanation of how ziprasidone treats patients with Alzheimer’s disease. The prior art already teaches treating Alzheimer’s disease with ziprasidone, therefore the discovery of the new property of the compound and method steps is merely a scientific explanation of the function thereof. For the foregoing reasons, the instant claims are anticipated by the prior art.
Withdrawn and New 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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Response to Applicant’s Arguments
The rejection of claims 2-18 and 25 under 35 U.S.C. 103 as being unpatentable over Benavides et al. (Japanese Patent application publication H0840902 A, Published 02/13/1996) as evidenced by Tesar et al. (International Application Published Under the PCT WO 2018/022904 A2, Published 02/01/2018) is rendered moot since the claims are cancelled.
The rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Benavides et al. (Japanese Patent application publication H0840902 A, Published 02/13/1996) as evidenced by Tesar et al. (International Application Published Under the PCT WO 2018/022904 A2, Published 02/01/2018) is withdrawn in view of the amendment to the claim.
The rejection of claim 26 under 35 U.S.C. 103 as being unpatentable over Benavides et al. (Japanese Patent application publication H0840902 A, Published 02/13/1996) as evidenced by Tesar et al. (International Application Published Under the PCT WO 2018/022904 A2, Published 02/01/2018) as applied to claim1-18 above, and further in view of Parys et al. (US Patent Application Publication 2004/0067934 A1, Published 04/08/2004) is moot since the claim is cancelled.
This is a new ground of rejection necessitated by the amendment to the claims.
Claim(s) 29, 30 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benavides et al. (Japanese Patent application publication H0840902 A, Published 02/13/1996) as evidenced by Tesar et al. (International Application Published Under the PCT WO 2018/022904 A2, Published 02/01/2018) and Gatticchi et al. (Selected cholesterol biosynthesis inhibitors produce accumulation of the intermediate FF-MAS that targets nucleus and activates LXRα in HepG2 cells, Published 05/09/2017).
Benavides et al. teach a method of treating peripheral neuropathies in a patient in need thereof which comprises administering to said patient a therapeutically effective amount of ifenprodil; wherein the peripheral neuropathies are amyotrophic lateral sclerosis and muscular dystrophy and chronic neurodegenerative diseases are Alzheimer’s disease and Parkinson’s disease (abstract). Ifenprodil can be combined with other therapeutic agents, which can reduce the side effects of the drugs (paragraph 0015).
Tesar et al. teach ifenprodil is a sterol 14-reductase (TM7SF2/LBR) inhibitor (paragraph 00146).
Benavides et al. lacks a preferred embodiment wherein ifenprodil is administered to treat a myogenic disease such as muscular dystrophy. However, Benavides et al. does suggest treating muscular dystrophy.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to treat muscular dystrophy by administering ifenprodil and have a reasonable expectation of success. One would have been motivated to do so since muscular dystrophy is one of the neuropathies that can be treated with ifenprodil.
With regard to the limitation “FF-MAS metabolism inhibitor”, Gattichi et al. teach “In this study, we used AY9944 and 17-hydroxyprogesterone (17OHP) to inhibit C14-sterol reductases and the downstream C4-demethylase complex to accumulate MAS in HepG2 cells and to investigate their effects on cholesterol metabolism, LXRα signaling, and cellular proliferation. The pharmacological approach allows to overcome the redundancy of TM7SF2 and LBR as C14-sterol reductases, favouring the accumulation of FF-MAS and other Δ14-unsaturated sterols” (page 843, column 1, paragraph 2). In other words, inhibition of TM7SF2 and LBR results in inhibition of FF-MAS metabolism.
With regard to the limitations that composition/compound results in “protection and/or regeneration of neuromuscular junction” is an inherent property of ziprasidone and/or the method of Cole et al. The prior art method steps, composition, and patient population are identical to the instantly claimed method steps, composition, and patient population. Therefore, the method of Benavides et al. will necessarily result in protection and/or regeneration of a neuromuscular junction. Furthermore, "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Therefore, the effect of administering ziprasidone to an Alzheimer’s patient would necessarily result in “protection and/or regeneration of neuromuscular junction”. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). When, the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use. The court went on to reverse the obviousness rejection of claims 2-5 and 7-10 which recited a process of using a new compound. The court relied on evidence showing that the nonaddictive property of the new compound was unexpected.) Here the limitation “protection and/or regeneration of neuromuscular junction” is nothing more than an explanation of how ifenoprodil treats patients with muscular dystrophy. The prior art already suggests treating muscular dystrophy with ifenoprodil, therefore the discovery of the new property of the compound and method steps is merely a scientific explanation of the function thereof.
For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614