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 This application is a CON of 18/152,449 01/10/2023 ABN
18/152,449 is a CON of 16/814,669 03/10/2020 ABN, which claims benefit of the foreign application: PCT/IB2019/052012 03/12/2019.
2. Claims 31-57 are pending in the application.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION-The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 31-57 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 31 and 49 independently recite a limitation “the human subject has an influenza B virus infection…and the complication risk factor is not caused by the influenza B virus infection” is indefinite and ambiguous, i.e., see lines 7-15 in claim 31. It is unclear if the subject has been infected by influenza B virus. Clarification is required.
4. 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 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.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103(a) 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 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(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 31 and 49 are rejected under 35 U.S.C. 103(a) as being obvious over
Kawai et al. US 2018/0118760 A1. It is noted that Kawai et al. ‘760 is a 102(a)(2) reference.
Applicants claim a method for reducing time to improvement of at least one symptom of an influenza virus infection in a human subject in need thereof, comprising: administering an effective amount of a compound having one of following formula (I) or formula (II) to the human subject in need thereof:
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, or a pharmaceutically acceptable salt thereof, wherein: the human subject has an influenza B virus infection; the human subject is at a high risk of an influenza complication due to having at least one complication risk factor selected from the group consisting of chronic lung disease, an endocrine disorder, heart disease, morbid obesity, being 65 years of age or older, being a current resident of a long-term care facility, a compromised immune system, a neurological disorder, a neurodevelopmental disorder, a blood disorder, being a female who is within two weeks postpartum and is not breastfeeding, and having American Indian or Alaskan native heritage; and the complication risk factor is not caused by the influenza B virus infection, see claim 31.
Applicants claim a method for reducing time to improvement of at least one symptom of an influenza virus infection in a human subject in need thereof, comprising: administering an effective amount of a compound of formula (1) to the human subject in need thereof:
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, wherein the human subject has an influenza B virus infection; the human subject is at high risk of an influenza complication due to having at least one complication risk factor selected from the group consisting of chronic lung disease, an endocrine disorder, heart disease, morbid obesity, being 65 years of age or older, being a current resident of a long-term care facility, a compromised immune system, a neurological disorder, a neurodevelopmental disorder, a blood disorder, being a female who is within two weeks postpartum and is not breastfeeding, and having American Indian or Alaskan native heritage; and the complication risk factor is not caused by the influenza B virus infection; and wherein: the human subject weighs in a range from 40 kg to less than 80 kg and the effective amount administered is about 40 mg of the compound of formula (I); or the human subject weighs at least 80 kg and the effective amount administered is about 80 mg of the compound of formula (I), see claim 49.
Determination of the scope and content of the prior art (MPEP §2141.01)
Kawai et al. ‘760 discloses methods of use for treating influenza infection using a compound of the formula:
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or
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, see claim 14 in column 104, and section [0033] in column 4.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Kawai et al. ‘760 is that the instant claims are embraced within the scope of Kawai et al. ‘760. Kawai et al. ‘760 broadly read on the instant claims 31 and 49.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 31 and 49 prima facie obvious because one would be motivated to employ the compound/ composition and methods of use of Kawai et al. ‘760 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known compound/composition and methods of use of Kawai et al. ‘760 would possess similar activity to that which is claimed in the reference.
Double Patenting
6. 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 31 and 49 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Kawai’s US 10,392,406, over claim 2 of Kawai’s US 10,633,397 and over claim 9 of Kawai’s US 10,759,814 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a method for reducing time to improvement of at least one symptom of an influenza virus infection in a human subject in need thereof, comprising: administering an effective amount of a compound having one of following formula (I) or formula (II) to the human subject in need thereof:
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, or a pharmaceutically acceptable salt thereof, wherein: the human subject has an influenza B virus infection; the human subject is at a high risk of an influenza complication due to having at least one complication risk factor selected from the group consisting of chronic lung disease, an endocrine disorder, heart disease, morbid obesity, being 65 years of age or older, being a current resident of a long-term care facility, a compromised immune system, a neurological disorder, a neurodevelopmental disorder, a blood disorder, being a female who is within two weeks postpartum and is not breastfeeding, and having American Indian or Alaskan native heritage; and the complication risk factor is not caused by the influenza B virus infection, see claim 31.
Applicants claim a method for reducing time to improvement of at least one symptom of an influenza virus infection in a human subject in need thereof, comprising: administering an effective amount of a compound of formula (1) to the human subject in need thereof:
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378
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, wherein the human subject has an influenza B virus infection; the human subject is at high risk of an influenza complication due to having at least one complication risk factor selected from the group consisting of chronic lung disease, an endocrine disorder, heart disease, morbid obesity, being 65 years of age or older, being a current resident of a long-term care facility, a compromised immune system, a neurological disorder, a neurodevelopmental disorder, a blood disorder, being a female who is within two weeks postpartum and is not breastfeeding, and having American Indian or Alaskan native heritage; and the complication risk factor is not caused by the influenza B virus infection; and wherein: the human subject weighs in a range from 40 kg to less than 80 kg and the effective amount administered is about 40 mg of the compound of formula (I); or the human subject weighs at least 80 kg and the effective amount administered is about 80 mg of the compound of formula (I), see claim 49.
Kawai et al. ‘406 claims a compound of the formula:
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, see column 186. Kawai et al. ‘406 compound is used for treating influenza infection, see columns 4-10.
Kawai et al. ‘397 claims a method for treating influenza comprising administering a compound represented by the following formula:
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or its pharmaceutically acceptable salt, to a patient in need thereof, see claim 2 in column 190.
Kawai et al. ‘814 claims a pharmaceutical composition comprising a crystal compound of the formula:
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and a pharmaceutical acceptable carrier or diluent, see column 212. Kawai et al. ‘814 composition is used for treating influenza infection.
The difference between instant claims and Kawai et al. ‘406, ‘397 and ‘814 is that the instant claims are embraced within the scope of Kawai et al. ‘406, ‘397 and ‘814. Kawai et al. ‘406, ‘397 and ‘814 compound/composition and methods of use
Broadly read on the instant claims 31 and 49.
One having ordinary skill in the art would find the claims 31 and 49 prima facie obvious because one would be motivated to employ the methods of use of Kawai et al.
‘406, ‘397 and ‘814 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known compound/composition and methods of use of Kawai et al. ‘406, ‘397 and ‘814 would possess similar activity to that which is claimed in the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to REI TSANG SHIAO whose telephone number is
(571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
January 26, 2026