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/US2021/037037 (06/11/2021)
PCT/US2021/037037 has PRO 63/088,854 (10/07/2020)
PCT/US2021/037037 has PRO 63/038,000 (06/11/2020).
Status
Claims 1, 5-11 are pending. Claims 8-11 were newly presented.
Claim rejections not reiterated in this action are withdrawn.
Election/Restrictions
Applicant's election without traverse of Group II, claims 1, and 4-5, in the reply filed on 9/2/25 is acknowledged.
Applicant also elected the species of diroximel fumarate stated as reading on claims 1, and 4-5.
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the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn.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). Accordingly, claims 6-7 are withdrawn.
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.
New 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 1, 8, 10, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mirmehrabi et al. (US20090181953).
Mirmehrabi teaches fumarate compounds claim 1, useful in treating FMF ([0098]) and chronic fatigue syndrome ([0107]) which anticipates the claims.
New 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 1, 5, 8, 10, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Zeidan et al. (US9090558) in view of Duroz et al. (Rheumatology International, 2018, 38:75-81).
Zeidan teaches “The present invention relates to various prodrugs of monomethyl fumarate. In particular, the present invention relates to derivatives of monomethyl fumarate which offer improved properties relative to dimethylfumarate. The invention also relates to methods of treating various diseases.” “FAEs and other fumaric acid derivatives have been proposed for use in treating a wide-variety of diseases and conditions involving immunological, autoimmune, and/or inflammatory processes including psoriasis” (col 1).
Zeidan teaches treating disease including those characterized by inflammation including the autoimmune disease MS in a subject by administering a therapeutically effective amount of the following compound (claim 1):
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which as evidenced by PubChem (CID 73330464, create date 2014-03-31) is the elected species diroximel fumarate.
Zeidan does not teach treating FMF or CFC (chronic fatigue syndrome).
Duruoz teaches that FMF is the most common hereditary autoinflammatory disorder characterized by recurrent fever and inflammation attacks (p 75). Duruoz teaches in the chronic disease FMF fatigue is a common symptom (p. 75).
One of ordinary skill in the art following the teaching of Zeidan regarding treating autoinflammatory disease with fumarate such as MS would have considered the same therapeutic in other known autoinflammatory disease such as taught by Zadeh. One of ordinary skill in the art would have had a reasonable expectation of success because of the common mechanism of disease relating to inflammation as addressed by fumarate. The level of skill in the art is very high such that one of ordinary skill in the art would have readily considered such a combination due to the common mechanism. With each of the claims, 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. Thus, the claimed invention is prima facie obvious.
Claims 1, 5, 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zeidan et al. (US9090558) in view of Zarbato et al. (Neurotoxicity Research (2018) 34:418–430).
Zeidan teaches “The present invention relates to various prodrugs of monomethyl fumarate. In particular, the present invention relates to derivatives of monomethyl fumarate which offer improved properties relative to dimethylfumarate. The invention also relates to methods of treating various diseases.” “FAEs and other fumaric acid derivatives have been proposed for use in treating a wide-variety of diseases and conditions involving immunological, autoimmune, and/or inflammatory processes including psoriasis” (col 1).
Zeidan teaches treating disease including those characterized by inflammation including the autoimmune disease MS in a subject by administering a therapeutically effective amount of the following compound (claim 1):
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which as evidenced by PubChem (CID 73330464, create date 2014-03-31) is the elected species diroximel fumarate.
Zeidan does not teach treating sepsis.
Zarbato teaches treating sepsis with fumarate to reduce neuroinflammation in models (Abstract: “DMF reduces sepsis-induced neuroinflammation”).
One of ordinary skill in the art following the teaching of Zeidan regarding treating inflammatory disease with fumarate would have considered the same therapeutic in other known inflammatory disease such as taught by Zarbato. One of ordinary skill in the art would have had a reasonable expectation of success because of the common mechanism of disease relating to inflammation as addressed by fumarate. The level of skill in the art is very high such that one of ordinary skill in the art would have readily considered such a combination due to the common mechanism. With each of the claims, 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. Thus, the claimed invention is prima facie obvious.
Conclusion
No claims allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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