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 .
Status of Claims
The claims filed December 10, 2021 are acknowledged and entered. Claims 1-15 are pending.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Priority
This application is a 371 of PCT/CA2020/050823, filed June 12, 2020, which claims benefit of 62/860,328, filed June 12, 2019.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/860,328, fails to provide adequate support in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application does not provide support for the full scope of compounds claimed. The prior-filed application does not provided support for the entire genus of Formula (I) or Formula (II) which is claimed, and fails to provide any support for Formula (III).
Application No. 62/860,328 only teaches compounds of instant Formula (I) wherein X is CH; R1 is methyl, and R2 is selected from a benzyl group, C6 cycloalkyl, methyl substituted with two phenyl groups, phenyl substituted with -OH, and -CH2CH2N(CH3)2 (see e.g. Formulae (II), (III), (IV) and (VI)). No compounds of instant Formula (II) are presented wherein R2 and R3 are H or alkyl, or wherein R2 and R3 form any ring other than a piperazinyl ring which is required by instant Formula (I). Moreover, no compounds of Formula (III) are disclosed. Accordingly the full scope of the claimed compounds are not supported by the prior application. The effective filing date of the claims is therefore June 12, 2020.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statement filed on June 7, 2023. All references have been considered except where marked with a strikethrough.
Election/Restriction
Applicant’s election without traverse of Group I (claims 1-7, drawn to a compound of Formula (I), Formula (II), or Formula (III)) and the species of Formula (I) corresponding to A4 (pictured below for convenience) in the reply filed on September 19, 2025 is acknowledged.
PNG
media_image1.png
242
510
media_image1.png
Greyscale
Claim 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 19, 2025.
The elected species corresponds to Formula (I) wherein
X is C; R1 is Me; and R2 is -CH2CH2N(CH3)2
The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species. Relevant portion of MPEP § 803.02 is provided here for convenience:
As an example, in the case of an application with a Markush-type claim drawn to the compound X-R, wherein R is a radical selected from the group consisting of A, B, C, D, and E, the examiner may require a provisional election of a single species, XA, XB, XC, XD, or XE. The Markush-type claim would then be examined fully with respect to the elected species and any species considered to be clearly unpatentable over the elected species. If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush-type claim and claims to the elected species shall be rejected, and claims to the nonelected species would be held withdrawn from further consideration. A second action on the rejected claims can be made final unless the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). See MPEP § 706.07(a).
If the elected species or group of patentably indistinct species is not anticipated by or obvious over the prior art, the examiner should extend the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The examiner need not extend the search beyond a proper Markush grouping. In other words, the examiner need not extend the search to any additional species that do not share a single structural similarity and a common use with the elected species (i.e., do not belong to the same recognized physical or chemical class or to the same art-recognized class and/or do not have a common use and/or do not share a substantial structural feature of a chemical compound and a use that flows from the substantial structural feature). The examiner should continue examination of the Markush claim to determine whether it meets all other requirements of patentability (e.g., 35 U.S.C. 101 and 112, nonstatutory double patenting, and proper Markush grouping).
The elected species was found in the prior art; however, the search was expanded to include the full scope of Formula (I). And art was found.
As noted above, the examiner need not extend the search beyond a proper Markush grouping. The search has thus been limited to Formula (I).
Claims 1-7 (all in part, other than the above indicated subgenus) are additionally withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Improper Markush Grouping Rejection
Claims 1 and 3-7 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of Formula (I), Formula (II) and Formula (III) is improper because the alternatives defined by each of the formulae do not share both a single structural similarity and a common use for the following reasons:
The compounds within the scope of Formula (I), Formula (II) and Formula (III) recited in the instant claims are not all members of the same recognized physical or chemical class or the same art-recognized class. The possible structures of the claimed compounds do not overlap and are comprised of different heterocyclic groups that have different classifications. Formula (I) requires a piperazinyl ring which is not required by either Formula (II) or Formula (III). Moreover, Formula (II) and Formula (III) do not require any additional heterocyclic ring as required by Formula (I). Formula (III) requires the additional group corresponding to NR4R5 which is not required by the claimed compounds of Formula (I) or Formula (II). The claims are thus drawn to an improper Markush group, that is, the claims lack unity of invention. Formula (I), Formula (II) and Formula (III) do not overlap and corresponds to several patentably distinct and independent compounds. In order to have unity of invention the compounds must have “a community of chemical or physical characteristics” which justify their inclusion in a common group, and that such inclusion is not repugnant to principles of scientific classification. In re JONES (CCPA) 74 USPQ 149 (see footnote 2). In this case, there is no substantial structural feature in common between the compounds of the instant claims.
Note, the rejection may be overcome by amending claims to recite a compound of Formula (I).
Claim Rejections - 35 USC § 112b
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 1-7 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. [A] claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear (MPEP 2173.04). The following terms and/or phrases render the scope of the claims unclear because the specification does not provide a scope limiting definition of the phrase or term, or any direction for ascertaining the scope of the limitation indicated by the term or phrase. Accordingly, one skilled in the art could not ascertain the metes and bounds of the claimed invention.
Claim 1 recites the limitation “functional derivative” which is indefinite because the specification does not provide any direction for determining the scope of what Applicant regards as a “functional derivative” of the claimed compound. The specification teaches “functional derivative” refers to a molecule that retains a biological activity similar to that of the original compound ([00141]); however, the specification fails to provide any direction for ascertaining the chemical structure of what Applicant regards as a functional derivative of the claimed compounds. Based on the definition provided by Applicant, the claimed “derivative” could be any compound and would open to many different interpretations. A person skilled in the art could therefore not ascertain the metes and bound of the invention. The limitation “functional derivative” should be deleted.
In claim 1 the recitation “alky” immediately followed by “(Me, Et, iPr, nPr, nBu, iBu)” renders the claim indefinite because it is unclear whether the limitation(s) following “alkyl” are part of the claimed invention. See MPEP § 2173.05(d). Examiner suggests amending the claim to recite R1 is alkyl selected from the group consisting of Me, Et, iPr, nPr, nBu, iBu, or something similar.
The claims include the limitation “substituted” (e.g. claim 1 recites R1 is substituted phenyl, substituted benzyl; R2 is substituted phenyl, substituted benzyl…). The limitation “substituted” renders the claims unclear at each occurrence throughout the claims because no substituents are provided in the claim and the specification fails to provide a scope limiting definition of substituents. One skilled in the art could not say which substituents are included in the scope of the claim and therefore the metes and bounds of the invention. Examiner suggests amending the claim to recite specific substituents which are supported by the specification.
Claim 1 recites “heterocyclic ring” which is indefinite because the claim fails to recite any heteroatoms as well as if the ring is saturated or unsaturated. Additionally, the specification fails to provide any definition of what Applicant regards as a “heterocyclic ring”. The heterocyclic ring of the claims corresponds to many different structures, is open to different interpretations, and a person skilled in the art could not say which are intended to be included in the scope of the claim.
Claim 1 recites “X is C” which is indefinite because “C” requires and additional substituent. It is not clear if applicant intends CH or for C corresponding to X to be further substituted.
Claims 2-7 depend from claim 1, do not cure the above mentioned deficiencies, and are therefore indefinite for the same reasons.
The preamble of claims 2-7 recites “the composition of claim 1” and should instead recite “the compound of claim 1” for the reason that claim 1 is drawn to a compound.
Claims 3 and 4 recites the limitation "R2 is H ". There is insufficient antecedent basis for this limitation in the claim because the claim depends from claim 1 which does not permit R2 to be H.
Claims 4 and 5 recites the limitation “R1 is CH2CH2N(CH3)2 ". There is insufficient antecedent basis for this limitation in the claims because the claims depends from claim 1 which does not permit R1 to be CH2CH2N(CH3)2.
Claim 6 recites the limitation “R1 is CH2CH2N(CH(CH3)2)2”. There is insufficient antecedent basis for this limitation in the claim because the claim depends from claim 1 which does not permit R1 to be CH2CH2N(CH(CH3)2)2.
Claim 7 recite the limitation “CH2CH2N(CH3)2”; however, the claim does not associate this limitation with any variable (e.g. R1). The claim should be amended to clarify if Applicant intends R1 to be CH2CH2N(CH3)2.
Claim Rejections - 35 USC § 112d
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 3-6 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.
Claims 3 and 4 recites the limitation "R2 is H " which is not included in the scope of claim 1.
Claims 4 and 5 recites the limitation “R1 is CH2CH2N(CH3)2 ", and claim 6 recites the limitation “R1 is CH2CH2N(CH(CH3)2)”, which are limitations not included in the scope of claim 1.
Claims 3-6 are thus broader in scope than claim 1 and rejected for failing to further limit the subject matter of claim 1.
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
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elmenoufy et al. (J Med Chem 2019, 62, 7684-7696; which names a different inventive entity) (hereinafter “Elmenoufy”).
Elmenoufy teaches compound 4 (Abstract and Table 1; pictured below for convenience) which corresponds to the elected species of Formula (I) wherein X is C; R1 is Me; and R2 is -CH2CH2N(CH3)2
PNG
media_image2.png
266
457
media_image2.png
Greyscale
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dorjsuren et al. (Antiviral Research 69 2006 9-23) (hereinafter “Dorjsuren”).
Dorjsuren teaches a compound of instant Formula (I) wherein X is C; R1 is Me; and R2 is Me (Table 1, bottom of page 14; pictured below for convenience).
PNG
media_image3.png
103
285
media_image3.png
Greyscale
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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, Jeffrey Murray can be reached on (571) 272-9023. 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.
October 23, 2025
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624