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
Priority and Status of the Claims
1. This application is a CON of 17/569,804 01/06/2022 PAT 11980630,
which is a DIV of 16/629,057 01/07/2020 PAT 11253529, which is a 371 of PCT/US2018/015352 with a filing date 01/26/2018, which claims benefit of 62/539,034 with a filing date 07/312017.
2. Amendment of claims 1-15 are pending in the application.
Claim Rejections - 35 USC § 112
3. 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.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first
paragraph (pre-AIA ), because the specification does not reasonably provide
enablement of the instant “McGulgan”, “Ac”, “MP”, “DP” and “TP” without limitation (i.e.,
no named moiety). The specification does not enable any person skilled in the art to
which it pertains, or with which it is most nearly connected, to make the invention
commensurate in scope with these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is a method of use using “McGulgan”, “Ac”, “MP”, “DP” and “TP” without limitation (i.e., no named moiety), see claims 1 and 13.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Radtake’s US 11,253,529, it discloses a compound of
formula (MR064), see column 15.
The amount of direction or guidance present and the presence or absence
of working examples
The only direction or guidance present in the instant specification is the description of a number of “McGulgan”, “Ac”, “MP”, “DP” and “TP” of the instant glycine on page 6-10 of the specification. There is no data present in the instant specification for the “McGulgan”, “Ac”, “MP”, “DP” and “TP” without limitation (i.e., no named moiety).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “McGulgan”, “Ac”, “MP”, “DP” and “TP” is without limitation (i.e., no named moiety).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “McGulgan” , “Ac”, “MP”, “DP” and “TP” without limitation. There is no guidance or working examples present for constitutional any “McGulgan”, “Ac”, “MP”, “DP” and “TP” without limitation for the instant invention. Incorporation of the limitation of “McGulgan, “Ac”, “MP”, “DP” and “TP” (i.e., claims 1 and 9) supported by specification into claims 1 and 13 respectively would overcome this rejection.
Double Patenting
4. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 9 and 13 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable independently over claims 1-4 of Radtke et al. US 10,058,516, and over claims 2 and 8 of Radtke et al. US 10,226,434, over claim1 of Radtk’s US 11,253,529, and over claim 1 of Radtk’s US 11,980,630 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a fleximer nucleoside analogue based on the acyclic nucleoside acyclovir (ACV) selected from:
PNG
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304
418
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Greyscale
or a pharmaceutically acceptable salt, isomer, hydrate, prodrug or solvate thereof, wherein Ac is CH3-C(=0), MP is monophosphate, DP is diphosphate, and TP is triphosphate, and McGulgan is
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200
318
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, see claims 1 and 9.
Applicants claim a method of treating and/or reducing the effects of a filovirus, flavivirus or coronavirus in a subject in need of such treatment, the method comprising administering to the subject a therapeutically effective amount of an acyclic fleximer nucleoside analogue selected from:
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304
418
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Greyscale
or a pharmaceutically acceptable salt, isomer, hydrate, prodrug or solvate thereof, see claim 13.
Radtke et al. ‘516 claims a compound
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152
286
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Greyscale
, which is an acyclic fleximer nucleoside analogue and for treating and/or reducing the effects of a coronavirus in a subject, see columns 24-25.
Radtke et al. ‘434 claims a compound
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174
400
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Greyscale
, which is an acyclic fleximer nucleoside analogue and for treating and/or reducing the effects of a coronavirus in a subject, see columns 23-24.
Radtke et al. ‘529 claims a method of method of preventing, treating and/or
reducing the effects of a filovirus, flavivirus or coronavirus in a subject in need of such
treatment, the method comprising administering to the subject a therapeutically effective
amount of an acyclic fleximer nucleoside analogue selected from the group consisting of
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230
232
media_image5.png
Greyscale
, see columns 14-15.
Radtke et al. ‘630 claims a fleximer nucleoside analogue selected from the group
consisting of:
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142
244
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Greyscale
and
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104
234
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Greyscale
, see columns 15-16.
The difference between instant claims and Radtke’s ‘516, ‘434, ‘529 and ‘630 is that Radtke’s ‘516, ‘434, ‘529 and ‘630 are silent on the instant compounds MR064 and 2MR04.
One having ordinary skill in the art would find the claims 1, 9 and 13 prima facie obvious because one would be motivated to employ the compounds and methods of use of Radtke’s ‘516, ‘434, ‘529 and ‘630 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known compound and methods of use of Radtke’s ‘516, ‘434, ‘529 and ‘630 would possess similar activity to that which is claimed in the reference.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
June 29, 2026
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