DETAILED ACTION
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 the Claims and Response to Amendments
The amendments filed on August 5, 2026 have been acknowledged and entered. Claims 1, 21, 24, and 26-34 are pending. Claims 24 and 26 were previously but are now rejoined (see “Election/Restrictions” section below). Claims 2-20, 22, 23, and 25 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/US2022/023110, filed on April 1, 2022. This application also claims the benefits of priority to U.S. Provisional Application no. 63/170,561, filed on April 4, 2021.
Election/Restrictions
Note: Examiner previously restricted claims 1-16, 21, 22, 24, and 26 (“Requirement for Restriction/Election” dated February 5, 2026) into three invention groups:
Invention I (claims 1-16, 21, and 22), Invention II (claim 24), and Invention III (claim 26). Currently, claims 1, 21, and 27-34 correspond to Invention I; claim 24 still corresponds to Invention II; and claim 26 still corresponds to Invention III; claims 2-20, 22, 23, and 25 are cancelled.
According to MPEP section 804:
“(i) Application under examination has the earlier patent term filing date
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.”
Currently, a provisional nonstatutory double patenting rejection is the only rejection remaining amongst the elected claims (i.e., claims 1, 21, and 27-34). Note: the instantly elected claims have an earlier effective filing date compared to the co-pending application. As such, the provisional nonstatutory double patenting rejection is withdrawn such that claims 24 and 26 can be rejoined.
Claims 1, 21, and 27-34 are allowable. Claims 24 and 26, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among invention I through III (which is, as set forth in the Office action mailed on February 5, 2026, is hereby withdrawn and claims 24 and 26 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
In summary, claims 24 and 26 are rejoined; claims 1, 21, 24, and 26-34 are currently pending.
Specification - Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class.
Specification - Disclosure
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 errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112(a)
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.
Scope of Enablement
Claim 24 is 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 for treating hepatitis B, said method comprising administering to a subject in need thereof, an effective amount of at least one compound according to claim 1;
does not reasonably provide enablement for elements that are outside the scope of the enabling elements listed above. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01(a), “There are many factors 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.”
In evaluating the enablement question, several factors are to be considered. According to In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), these factors include:
1) The nature of the invention,
2) the state of the prior art,
3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present,
5) the presence or absence of working examples,
6) the breadth of the claims, and
7) the quantity of experimentation needed to make and use the invention based on the content of the disclosure, and
8) the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention
The nature of the invention claims hepatoselective inhibitors of PAPD 5 and 7 having a disease-modifying action in the treatment of diseases associated with PAPD 5 and 7 that include disease such as hepatitis B and liver cancer. Compositions comprising same; and methods of making and using same are also described in the instant specification.
State of the prior art and the predictability or lack thereof in the art
Prior art referenced:
Chang et al. (Chang) (Chang, M.-H. et al. Prevention of Hepatitis B. Cold Spring Harb Perspect Med 2015, 5, a021493.) and
Zhao et al. (Zhao) (Zhao, H. et al. Hepatitis B vaccine development and implementation. Hum Vaccin Immunother. 2020, 16, 1533-1544.)
Chang teaches:
“Either passive immunization by hepatitis B immuno globulin (HBIG) or active immunization by HBV vaccine is effective, and a combination of both yields the best efficacy in preventing HBV infection” (see abstract).
Zhao teaches that a newly licensed hepatitis B vaccine (licensed in 2018) contains recombinant HBsAg combined with an oligodeoxynucleotide (see pg. 1534, left col., “Newly licensed hepatitis B vaccine” section, 1st two sentences).
Summary:
Subject population: any individual in need of prophylaxis against HBV infection.
Prophylactic agent administered: an HBV vaccine which can comprise recombinant HBsAg and an oligodeoxynucleotide (note: neither component is a small-molecule compound).
Prior art referenced:
WHO (Prevention of mother-to-child transmission of hepatitis B virus: Guidelines on antiviral prophylaxis in pregnancy. World Health Organization 2020.)
WHO recommends that pregnant women testing positive for HBV infection (HBsAg positive) receive tenofovir prophylaxis from the 28th week of pregnancy until at least birth, to prevent mother-to-child transmission of HBV (see pg. xii, “Tenofovir prophylaxis to prevent mother-to-child transmission of HBV” section, see information in blue box). “Tenofovir prophylaxis” refers to the use of tenofovir disoproxil fumarate (TDF) to prevent mother-to-child transmission of HBV (see “Glossary of Terms” on pg. ix). TDF has the following structure:
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Summary:
Subject population: pregnant women who are at least 28 weeks pregnant to prevent mother-to-child transmission of HBV (i.e., ultimately preventing HBV in the child)
Prophylactic agent administered: tenofovir disoproxil fumarate.
Prior art referenced:
Lim et al. (Lim) (Lim, L. L. et al. Prophylactic lamivudine prevents hepatitis B reactivation in chemotherapy patients. Aliment Pharmacol Ther 2002, 16, 1939-1944.)
Lim teaches that prophylactic lamivudine appears to prevent hepatitis B virus reactivation and its associated mortality in patients treated with chemotherapy (see abstract, “Conclusions” subsection).
Summary:
Subject population: patients treated with chemotherapy.
Prophylactic agent administered: lamivudine which has the following structure:
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The level of the skill in the art
The level of ordinary skill in the art is relatively high. A person of ordinary skill would typically have formal training in medicinal chemistry and organic synthesis and would be familiar with standard methods for evaluating therapeutic efficacy of compounds.
The breadth of the claims
The method claims are broad insofar as they encompass:
A method for treating or preventing hepatitis B, said method comprising administering to a subject in need thereof an effective amount of at least one compound according to instant claim 1.
The presence or absence of working examples
Presence of working examples
The instant specification discloses the following experimental investigations:
The inhibitory activity of the instant compounds against PAPD5/7’s enzymatic function was evaluated (para. 0357 on pg. 99). The inhibitory potency of each of the instant compounds tested is recorded in Table 6 (para. 0361 on pg. 100).
The disclosed compounds were also evaluated in HBV-producing HepG2.2.15 cells for HBsAg inhibition and cellular toxicity (para. 0358 on pg. 99).
According to prior art, the “HBV-reporter cell line, HepG2.2.15 is one of the established systems for preliminary screening of anti-HBV drugs” and the anti-HBV potential of specific compounds can be assessed by the compounds’ inhibitory effects on HBsAg expressions in the HepG2.2.15 culture supernatants (see Parvez [citation below], pg. 398, left col., Discussion section, last two sentences, wherein the 2nd sentence continues to the right col.).
Parvez et al. (Parvez) (Parvez, M. K. et al. Plant-derived antiviral drugs as novel hepatitis B virus inhibitors: Cell culture and molecular docking study. Saudi Pharmaceutical Journal 2019, 27, 389-400.)
In other words, the instant specification provides data related to the instant compounds’ anti-HBV activity in vitro.
Compound 65042-E_OH was administered intravenously and orally to CD1 mice to obtain pharmacokinetic data and properties of the compound (para. 0363 on pg. 101; data provided in tables 7 through 11 of the instant specification).
Compound 65042-E-OH was also tested in OATP1B1- and OATP1B3-HEK293 cells and shown to be a substrate for both the OATP1B1 and OATP1B3 transporters (para. 0365 on pg. 105; data provided in tables 12 and 13 of the instant specification).
Absence of working examples
The instant specification provides no in vitro or in vivo working examples demonstrating that the disclosed compounds prevent hepatitis B.
Instead, the data provided by the instant specification is limited to data collected from in vitro assays relevant to cellular anti-HBV activity which provide insights into the treatment of hepatitis B in a subject rather than the complete prevention of the subject from acquiring hepatitis B in the first place.
The amount of direction or guidance present and the quantity of experimentation needed to make and use the invention based on the content of the disclosure
The instant specification does not provide sufficient guidance for carrying out the claimed method of preventing hepatitis B in a subject. Although the instant specification describes cellular assays showing that the disclosed compounds inhibit PAPD5/PAPD7 and exhibit cellular anti-HBV activity, it provides no in vitro or in vivo experiments showing that the compounds can actually prevent hepatitis B, prevent hepatitis B transmission, or prevent hepatitis B reactivation in a subject. The instant specification also does not identify which subjects should receive the compounds for prevention, when administration should begin in relation to HBV exposure, how long the compounds should be administered, or what dosing regimen should be used for prevention.
The prior art does not provide the missing guidance for the full scope of the claim. In the general population, hepatitis B was prevented primarily using an HBV vaccine, either alone or together with hepatitis B globulin. These preventative agents are materially different from the disclosed small-molecule PAPD5/PAPD7 inhibitors. Although small-molecule antiviral drugs had been used to prevent certain HBV-related outcomes, their use was limited to specific circumstances and patient populations. For example, tenofovir disoproxil fumarate was administered to HBV-positive pregnant women to reduce transmission of HBV to their infants, and lamivudine was used to prevent hepatitis B virus reactivation and its associated mortality in patients treated with chemotherapy. These specific uses would not have taught a POSITA how to use the disclosed PAPD5/PAPD7 inhibitors to prevent hepatitis B in any subject.
The experiments described in the instant specification are directed toward determining whether the disclosed compounds may be useful for treating an existing HBV infection rather than preventing HBV infection. Specifically, the disclosed compounds were evaluated in HBV-producing HepG2.2.15 cells for HBsAg inhibition and cellular toxicity (para. 0358 on pg. 99), wherein HepG2.2.15 is one of the established systems for preliminary screening of anti-HBV drugs (see Parvez, pg. 398, left col., Discussion section, last two sentences, wherein the 2nd sentence continues to the right col.). The prior art does not establish that the results from this type of cellular assay demonstrate that a compound can prevent HBV infection in a subject. Thus, a POSITA would still need to determine:
whether the compounds can prevent initial hepatitis B infection, transmission, or reactivation (and, therefore, prevent hepatitis B disease);
which subjects should the instant compounds be administered to; and
the appropriate prophylactic dose, route, timing, and duration of prophylactic administration.
Since both the instant specification and prior art provides no guidance or working examples addressing these matters, practicing the full scope of the claimed prevention method would require undue, rather than routine, experimentation.
Written Description
Claim 26 is 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.
Currently, the method claim is broad insofar as it not only encompasses diseases, disorders, and conditions for which the therapeutic benefit of inhibiting a DHQ sensitive function is presently established, but also diseases, disorders, and conditions for which such a benefit has not yet been demonstrated and may be identified only through future scientific investigation.
Although the instant claims are broad, the instant specification provides very limited working examples. Specifically, the instant specification discloses the following experimental investigations:
The inhibitory activity of the instant compounds against PAPD5/7’s enzymatic function was evaluated using an enzymatic assay (para. 0357 on pg. 99). The inhibitory potency of each of the instant compounds tested is recorded in Table 6 (para. 0361 on pg. 100).
Compound 65042-E_OH was administered intravenously and orally to CD1 mice to obtain pharmacokinetic data and properties of the compound (para. 0363 on pg. 101; data provided in tables 7 through 11 of the instant specification).
Compound 65042-E-OH was also tested in OATP1B1- and OATP1B3-HEK293 cells and shown to be a substrate for both the OATP1B1 and OATP1B3 transporters (para. 0365 on pg. 105; data provided in tables 12 and 13 of the instant specification).
In particular, showing that a compound inhibits PAPD5 or PAPD7 in an enzymatic assay does not establish that the compound can treat any disease, disorder, or condition in a subject wherein inhibiting a DHQ sensitive function is beneficial. Additional disease-specific evidence is needed to show that PAPD5 or PAPD7 inhibition results in a therapeutic benefit. Furthermore, the instant specification does not establish that inhibition of the PAPD5 or PAPD7 enzyme in an assay necessarily translates into the treatment of any disease, disorder, or condition for which such inhibition may be beneficial.
Additionally, the recitation of “a disease, disorder or condition wherein inhibiting a DHQ sensitive function such as PAPD5 or PAPD7 is beneficial” creates a “reach-through” aspect to the claim. Specifically, the scope of the claim is not confined to diseases, disorders, or conditions presently recognized as being treated via beneficial inhibition of a DHQ sensitive function, but, instead, potentially reaches through to diseases, disorders, or conditions that may later be discovered to be treated via beneficial inhibition of a DHQ sensitive function. However, the instant specification does not reasonably convey possession of such a broad genus. Furthermore, the relevance of the instant compounds in treating hepatitis B does not provide a representative disclosure or identify structural features common to the claimed compound genus sufficient to demonstrate possession of the full scope of “a disease, disorder or condition wherein inhibiting a DHQ sensitive function such as PAPD5 or PAPD7 is beneficial.” Accordingly, the “reach-through” scope of the claim further demonstrates that the instant specification does not reasonably convey possession of the full scope of “a disease, disorder or condition wherein inhibiting a DHQ sensitive function such as PAPD5 or PAPD7 is beneficial” as presently claimed.
Claim Rejections - 35 USC § 112(b)
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.
Claim 26 is 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.
Regarding claim 26, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 21, 24, and 26-34 are provisionally rejected on the ground of nonstatutory double patenting as explained below:
Note: As discussed above, a provisional nonstatutory double patenting rejection was the only rejection remaining amongst the elected claims (i.e., claims 1, 21, and 27-34). Since the instantly elected claims have an earlier effective filing date compared to the co-pending application, the provisional nonstatutory double patenting rejection was withdrawn such that claims 24 and 26 can be rejoined. However, because the claims are not all otherwise in condition for allowance following rejoinder, the provisional nonstatutory double patenting rejection is reinstated against claims 1, 21, and 27-34 and is also applied to rejoined claims 24 and 26.
Part 1:
Claims 1, 21, and 27-34 are provisionally rejected on the ground of nonstatutory double patenting as explained below: being unpatentable over:
claims 1, 7, 8, 21, and 22 of U.S. Patent Application No. 18/869,126 (‘126).
The co-pending application (‘126) claims a method for treating disease due to infection with Hepatitis A Virus (HAV); or preventing HAV-related disease in a subject known or suspected to have been exposed to the virus; said method comprising administering to a subject in need thereof, an effective amount of a compound having formula (I):
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Including hydrates, solvates, pharmaceutically acceptable salts, prodrugs and complexes thereof. It is noted here that formula (I) of ‘126 encompasses formula (XXIV) of the instant application. The claimed method of ‘126 necessarily requires the use of a compound of instant formula (XXIV) as an active agent. Thus, the compound of instant formula (XXIV) is fully encompassed within the subject matter of the co-pending claims.
Accordingly, a POSITA would have found it obvious that the compound of instant formula (XXIV) is not patentably distinct from the method of using that same compound (as disclosed in ‘126), since the method claims of ‘126 necessarily require possession and use of the identical compound. In other words, because the claims of the co-pending application are directed to a method of using a compound of Formula I for a particular purpose, it would have been obvious to claim compounds encompassed by Formula I of ‘126 itself in the instant application because the compound was known to have a specific utility.
Thus, the instant claims represent an obvious variation of the claims of the co-pending application as they are directed to overlapping compounds that are already required to practice the claimed method of the co-pending application.
Part 2:
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1, 7, 8, 21, and 22 of U.S. Patent Application No. 18/869,126 (‘126) in view of
Kulsuptrakul et al. (Kulsuptrakul) (Kulsuptrakul, J. et al. A genome-wide CRISPR screen identifies UFMylation and TRAMP-like complexes as host factors required for hepatitis A virus infection. Cell Reports 2021, 34, 108859.; published March 16, 2021.)
Claim 1 of the co-pending application recites:
A method for:
treating disease due to infection with Hepatitis A Virus (HAV); or preventing HAV-related disease in a subject known or suspected to have been exposed to the virus; said method comprising administering to a subject in need thereof, an effective amount of a compound having formula (I), wherein formula (I) of the co-pending application overlaps with the compounds encompassed by instant claim 1.
Although the co-pending claim does not recite treating or preventing hepatitis B, Kulsuptrakul teaches that RG7834 is a small-molecule compound that was first identified as a potent inhibitor of hepatitis B virus surface antigen secretion, and PAPD5 and PAPD7 were subsequently shown to be its cellular targets (pg. 7, left col., “Pharmacological inhibition of PAPD5 and PAPD7 exhibits an antiviral effect against HAV infection” section, 1st paragraph, last two sentences). Kulsuptrakul also teaches that inhibition of PAPD5 and PAPD7 by RG7834 reduces HAV infection in human hepatocyte cells and human liver organoids (see Fig. 5 and caption). RG7834 has the following structure:
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(see pg. 8, Fig. 5A) which is similar to the structures of the compounds represented by instant Formula (XXIV) or Formula (I) of the co-pending application. Thus, Kulsuptrakul establishes that compounds possessing the core structure of RG7834 act through PAPD5/PAPD7 inhibition and possess activity against both HAV and HBV. Accordingly, it would have been obvious to try and use the formula I compounds recited in claim 1 of the co-pending application (which encompasses the instant compounds) to treat HBV, as recited by instant claim 24, because RG7834 (i.e., a compound with the same core structure as the instant compounds) were known to produce anti-HBV activity. Therefore, instant claim 24 is not patentably distinct from claim 1, 7, 8, 21, and 22 of the co-pending application.
Part 3:
Claim 26 is provisionally rejected on the ground of nonstatutory double patenting as explained below: being unpatentable over:
claims 1, 7, 8, 21, and 22 of U.S. Patent Application No. 18/869,126 (‘126).
Claim 1 of the co-pending application, for example, recites:
A method for:
treating disease due to infection with Hepatitis A Virus (HAV); or preventing HAV-related disease in a subject known or suspected to have been exposed to the virus; said method comprising administering to a subject in need thereof, an effective amount of a compound having formula (I), wherein formula (I) of the co-pending application overlaps with the compounds encompassed by instant claim 1.
Instant claim 26 more broadly recites administering a compound according to instant claim 1 to treat any disease, disorder, or condition for which inhibition of a DHQ-sensitive function, such as PAPD5 or PAPD7, is beneficial. Because the instant compounds are PAPD5/PAPD7-inhibiting compounds (as disclosed in the instant specification), treatment of a disease due to infection with HAV using the instant compounds (as encompassed in the co-pending claim 1) is also encompassed by the broader method of instant claim 26. The broader recitation of treating any disease, disorder, or condition for which inhibition of a DHQ-sensitive function is beneficial does not patentably distinguish instant claim 26 from the specifically claimed treatment of a disease due to infection with HAV using the instant compounds which are also encompassed by Formula (I) of the co-pending application. Accordingly, instant claim 26 is not patentably distinct from claim 1, 7, 8, 21, and 22 of the co-pending application as it encompasses those claims from the co-pending application.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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