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 .
Current Status of 17/800,516
This Office Action is responsive to the amended claims and Applicant remarks of 05/21/2026. Claims 1-34 and 36-51 are pending and have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/CA2021/050275, international filing date 03/02/2021, which claims priority to U.S. Provisional Patent Application No. 62/984,456, filed 03/03/2020.
Response to Arguments
Rejections under 35 U.S.C. §103:
Applicants contend that the artisan would not have been motivated to modify compound 3048 of reference Fader
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using the teachings of Sun to arrive at a compound within the scope of the instant claims. Applicants argue that the genus of Fader is broad, encompassing 77,760 species with only compound 3048 reading on the instant claims. Applicants further argue that Fader contains no express teachings to replace the amide group on the western ring of the bicyclic moiety with a 2-pyrrolidone group, as required by the instant claims. Applicants assert that R4 is H in compound 3048 and that the substitution of a 2-pyrrolidine moiety at this position is a non-preferred alternative with dissimilar properties to H.
Regarding the alleged deficiencies in the teachings of Sun. Applicants argue that Sun fails to teach or suggest an N-linked 2-pyrrolidone connectivity nor does the reference teach or suggest moving the group to an adjacent position on the bicyclic ring. To support their position, Applicants provided a diagram on pg. 25 of the Remarks of 07/07/2026 illustrating the steps required to modify compound 3048 to arrive at the 2-pyrrolidone structure of the instant claims. These arguments have been considered and are found persuasive. The previous rejections under 35 U.S.C. §103 are withdrawn.
Specification
The disclosure is objected to because of the following informalities: The study protocol table on pg. 167 is illegible. Table 4 (pg. 169) and Table 5 (pg. 170) are grainy and difficult to read. The indicated tables should be replaced with clear legible ones.
Appropriate correction is required.
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 39-40 and 43-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of inhibiting HCMV in a cell infected with HCMV comprising administering certain exemplary compounds of formula (I) and a method of treating HCMV comprising administering certain exemplary compounds of formula (I), does not reasonably provide enablement for a method of inhibiting other herpesviruses in cells infected with herpesviruses comprising contacting the cells with any compound of formula (I), nor does it reasonably provide enablement for a method of treating or preventing any other form of herpesvirus comprising administering an effective amount of any compound of formula (I). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
Claims 39 and 40 are drawn to a method of inhibiting herpesvirus in a cell infected with a herpesvirus comprising contacting the cell with a compound of formula (I). Claim 43 and 44 are drawn to a method of treating or preventing a herpesvirus infection in an individual comprising administering an effective amount of a compound of formula (I). Thus, claim 39 taken together with the specification implies that any compound of formula (I) is capable of inhibiting any form of herpes virus in a cell contacted by said compound. While claim 43 taken together with the specification implies that the administration of a therapeutically effective amount of any compound of formula (I) is capable of treating and preventing any form of herpesvirus in an individual. The scope of the claims is extremely broad.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the prior art is that activity against one herpesvirus polymerase does not predict activity against other types of herpesvirus polymerases. Thomsen et al. teaches that in vitro polymerase assays of PNU-183792 inhibited HSV-1, HSV-2, HCMV, VZV, and HHV-8 polymerase, but failed to inhibit HHV-6 polymerase (Abstract). Zarrouk et al. further highlight the uncertainty and unpredictability associated with inhibition of herpesvirus DNA polymerases. Section 5 of the reference teaches that although HSV and HCMV DNA polymerases belong to the same family of viral DNA polymerases and contain several conserved regions involved in polymerase activity, the enzymes are distinct and function with different viral factors. Section 7 of the reference further demonstrates that susceptibility to antiviral agents is dependent upon the particular structure of the viral polymerase inhibitors and confer antiviral drug resistance. These teachings indicate that conservation of polymerase function among herpesviruses does not necessarily result in uniform susceptibility to a particular inhibitor. Thus, activity against HCMV DNA polymerase would not reasonably establish corresponding activity against the distinct DNA polymerases encompassed by the full scope of the herpesviruses encompassed by the full scope of the instant claims. Further testing would be required to support such assertions.
(5) The relative skill of those in the art:
The artisan would have experience in organic chemistry, medicinal chemistry, pharmaceutical sciences, or a related field. The artisan would have experience in the design, synthesis, and evaluation of compound for use as antiviral agents, including compounds targeting herpesviruses.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided guidance for inhibiting HCMV replication in MRC5 cells infected with HCMV US3-6-EGFP-HCMV-AD169 using exemplary compound 1-7, 12-16, 19-22, 26-28, 36-37, and 40-46 (Example 4, pgs. 165-168). The specification also provides guidance regarding HCMV DNA polymerase through enzyme inhibition assays reporting whether the IC50 values were greater than or less than 1 mM for exemplary compound 1-4, 6, 10-19, 21-24, 26-28, and 36-46 (Example 3, pgs. 162-165).
However, the specification does not provide comparable data using cells infected with other herpesviruses. The specification does not provide working examples or disease models demonstrating that all compound encompassed by formula (I) are capable of treating infections caused by the full scope of claimed herpesviruses, nor does it provide models demonstrating that such compounds are capable of preventing infections caused by the full scope of claimed herpesviruses.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to the uncertainty associated with extrapolating the activity of an inhibitor demonstrated against HCMV to the inhibition of DNA polymerases across the full scope of herpesviruses, and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Conclusion
Claims 39-40 and 43-44 are rejected.
Claims 1-34, 36-38, and 50-51 are allowed.
Claims 41-42, and 45-49 are objected to for being dependent upon a rejected base claim.
The closest prior art is Fader which is discussed above in the Response to Arguments section. Fader’s compound 3048 is the closest compound to those encompassed by the instant claims. However, Fader, either alone or in combination with Sun, does not teach or suggest the structural modifications required to arrive at the instantly claimed compounds. Moreover, even assuming arguendo that the artisan would have made the required modifications, the prior art does not provide a reasonable expectation that the resulting compounds would retain the desired biological activity exhibited by the instant compound. Accordingly, the compound of formula (I) are considered novel and nonobvious over the prior art of record.
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/C.K.E./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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