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
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, is acknowledged.
Status of Claims
Claims 1-20 are currently pending in the application.
Receipt is acknowledged of amendment / response filed on April 13, 2026 and that has been entered.
Response to Election/Restriction
In response to the restriction requirement Applicants have elected Group II, which includes claims 1-20 drawn to a method of treating a viral disease or viral infection in a subject in need thereof and the method comprising administering to a subject a therapeutically effective amount of a compound of formula (I) and the elected species as set forth and identified as a compound of formula (II), such as,
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, with traverse, is acknowledged. Applicant’s arguments (to withdraw the restriction requirements) have been fully considered and found persuasive and therefore, Examiner agreed to withdraw the restriction requirements to include and examine Group I, together with the elected invention of Group II, because they commensurate within the scope of the elected invention.
Applicants preserve their right to file a divisional on the non-elected subject matter (if any).
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 1-7 and 16-18 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Kwon et al (2014). Applicant claims a method of treating a viral disease or viral infection in a subject in need thereof and the method comprising administering to a subject a compound of formula (I) or formula (II) thereof. Kwon et al also disclose an identical compound for preventing and treating viral diseases, which anticipates the instantly claimed inventions, wherein A, X, R1 to R3, are all hydrogen [
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, STN International, CAPLUS database, Accession Number 2014 : 2104796, a copy is provided with this Office action].
Claims 1-7 and 16-18 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Chen et al (2000, IDS). Applicant claims a method of treating a viral disease or viral infection in a subject in need thereof and the method comprising administering to a subject a compound of formula (I) or formula (II) thereof. Chen et al also disclose an identical compound for preventing and treating viral disease (HIV-I) , which anticipates the instantly claimed inventions, wherein A, R1 to R3, are all hydrogen and X is CH3 [
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, Compound 2, right-hand column, page 2388].
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The expression a method of treating “or preventing a viral disease” (claim 1, line 1, page 2, and all other occurrences of claims 1-20, if any), which broadens the enabling disclosure because it is unclear what kind of “viral disease”, the Applicant is intending to encompass with this broad expression, since any “viral disease” may fall within the broad definition of compound class. The above expression, which is not described in such a way as to satisfy the statutory requirements within the purview of 35 U.S.C. 112 first paragraph and therefore, the specification fails to provide sufficient support to treat all the wide range of ‘viral disease’ or viral infection, by administering to a subject, comprising a compound of formula (I) or formula (II) thereof. The type or mode of action and functionality (structure / function relationship) of preventable or treatable ‘viral disease’ is not defined in the claims or anywhere in the specification so as to ascertain the scope and breadth of the claimed subject matter.
The recitation a method of treating “or preventing a viral disease”, which is not described in such a way as to satisfy the statutory requirements within the purview of 35 U.S.C. § 112 first paragraph because the specification does not provide essential description to carry out the invention and thus lacks enablement as well. As stated in the MPEP 2164.01 (a), there are many factors [1) The nature of the invention, 2) The state of the prior art, 3) The level of ordinary skill in the art, 4) The level of predictability in the art, 5) The amount of direction and guidance provided by the inventor, 6) The existence of working examples, 7) The breadth of the claims, and 8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure (In re Wands, 8 USPQ 2d 1400, 1404 (CAFC, 1988)] to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” Therefore, it is not likely that a single compound would be predicted to be able to prevent, delay or treat the progression of diverse “viral disease”, as claimed in the instant application. Based on the unpredictable nature of the invention and state of the prior art (Chen et al and WO 2005/082860, IDS) and the extreme breadth of the claims, one skilled in the art could not perform the claimed methods of use without undue experimentation, see In re Armbruster 185 USPQ 152 CCPA 1975. Thus, the specification fails to provide sufficient support of the broad use of the method claims 1-20 to treat all kinds of viral diseases, wherein the method comprising administering to a subject a compound of formula (I) or formula (II) thereof. Therefore, it is suggested to amend the claims within the context and scope of the claims [such as, deleting the word “or preventing” and limiting with very specific type of “viral disease” that actually contemplated in the specification (e.g., incorporating the limitations of claims 8-9 into claim 1) and that have enough support] in order to overcome the rejection.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Golam Shameem, Ph.D. whose telephone number is (571) 272-0706. The examiner can normally be reached on Monday-Thursday from 7:30 AM - 6:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks, Ph.D. can be reached at (571) 270-7682.
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://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist, whose telephone number is (571) 272-1600.
/GOLAM M SHAMEEM/Primary Examiner, Art Unit 1621
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