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 .
According to a preliminary amendment filed on Sep. 11, 2023, the applicants have canceled claims 7-9, 15, 17 and 24-25 and furthermore, have amended claims 2-6, 10-14, 16, 18-23 and 26-27.
Claims 1-6, 10-14, 16, 18-23 and 26-27 are pending in the application.
Claim Rejections - 35 USC § 112
4. 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 1-6, 10-14, 16, 18-23 and 26-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. For claims 1-5, 10-14, 16, 18-23 and 26-27, there is no written description for preparing and using instant compounds of formula (I) where variables X and Q represent every known 5- or 6-membered heteroaryl or heterocyclic ring in the art including 5- or 6-memberd rings containing 2-5 N atoms, 1-5 O atoms or 1-5 S atoms. The only written description is for preparing and using instant compounds of formula (I) where variable X represents 6-membered heteroaryl ring containing only one N atom and variable Q represents 6-membered heterocyclic ring containing only one N atom. Similarly, for claims 1-6, 10-14, 16 and 18-23, there is no written description for treating every known viral infection with the instant compounds of formula (I). There is no written description for any mechanism of action (such as enzyme inhibition, receptor agonism/antagonism etc.) of instant compounds of formula (I) for treating viral infection. The only written description is for treating humans infected with SARS-CoV virus with instant compounds of formula (I) as mentioned on page 10 (see lines 9-11) of specification.
7. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 10-14, 16 and 23 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The instant claims are directed to using compounds of formula (I) for treating viral infection. However, it is not clear who is being treated and furthermore, the steps of administration of compounds of formula (I) are also missing in the claims.
10. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-6, 10-14, 16 and 23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The instant claims are directed to use of the product but do not list further steps of administration and the subject being treated. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
(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.
Claims 1, 2, 4, 18, 19 and 26-27are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Hou (Chemico-Biol. Inter., cited on applicant’s form 1449).
Hou discloses compounds having inhibitory effect on SARS-CoV for treating corona virus infection. The inhibition of SARS-CoV by loratadine and desloratadine (see fig. 1) anticipates the instant claims when variable X represents 6-membered heteroaryl ring containing one N atom and variable Q represents 6-membered heterocyclic ring containing only one N atom in the instant compounds of formula (I).
Claims 1-6, 10-14, 16, 18 and 20-22 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Lithgow (WO 2006/017505 A2).
Lithgow discloses pharmaceutical formulations for treating virus infection. The pharmaceutical formulations using antiviral drugs alone or combination of two antiviral drugs disclosed in claims 15, 26 and 27 by Lithgow anticipate the instant claims when variable X represents 6-membered heteroaryl ring containing one N atom and variable Q represents 6-membered heterocyclic ring containing only one N atom (compounds azatadine, loratadine and desloratadine) in the instant compounds of formula (I).
(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, 2, 4, 10-14, 16, 18-23 and 26-27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Villoutreix (WO 2021/233899 A1, cited on applicant’s form 1449).
Villoutreix discloses compounds having inhibitory effect on SARS-CoV for treating corona virus infection. Th method of treating corona virus by loratadine and desloratadine either alone or in combination with other drugs (see claims 1 and 4-7) disclosed by Villoutreix anticipates the instant claims when variable X represents 6-membered heteroaryl ring containing one N atom and variable Q represents 6-membered heterocyclic ring containing only one N atom in the instant compounds of formula (I).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621