DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/13/26 has been entered.
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Applicant's arguments filed 4/13/26 have been fully considered but they are not persuasive.
Applicant argues that Comer does not provide any motivation to have made the selection in its compound genus that the Examiner alleges would have been made by a person of ordinary skill in the art. Applicant argues that Comer’s Formula I permits variation across many variables and the examiner does not identify any lead compound in Comer, any lead subgenus or any reason why a POSA would have selected the claimed combination of variables rather than other permutations in Comer.
However, the examiner respectfully disagrees. In the modified rejections below, Comer does suggest a Table with 38 lead compounds (see Table 1, pp. 20-29). 2 of the 38 compounds (compound 1 and compound 38) exemplify almost all the variables of the compound of formula (I) recited in claim 1. Although Comer do not explicitly teach a compound with variables L2, L3, R2 and R3 in formula I of instant claim 1, Comer do generally suggest the following compound:
PNG
media_image1.png
246
404
media_image1.png
Greyscale
wherein R3 is hydrogen or -CH2-OR and R is C1-C12 alkyl; or a pharmaceutically acceptable salt thereof (see pg. 6, lines 14—pg. 7, line 16). Thus, according to KSR v. Telefex, 82 USPQ2d 1385, 1397 (U.S. 2007), there are a finite number of identified, predictable solutions and a skilled artisan would have good reason to pursue known options within his or her technical grasp. Contrary to Applicant’s arguments, Comer do suggest lead compounds and it would have been obvious for an artisan of ordinary skill to select from a finite set of variables (i.e., R3 in Comer).
Applicant further argues that the presently claimed compounds have unexpected properties such as increased efficacies as compared to exemplary compounds disclosed in Comer. Applicant submits that the compounds of the disclosure provide increased inhibitory properties against apicomplexan parasite FRS enzyme due to the dual inhibitor structure and more specifically, the cycloalkoxyl phenyl urea moiety claimed (R4 is cycloalkoxy). Applicant points to pg. 65, lines 2-6 of the specification which notes compound 1 (compound recited in claim 4) has three-fold better efficacy than Compound E1 of Comer. Applicant further points out teachings in its specification, which describe a structural basis for why the claimed architecture can exhibit different efficacy and selectivity.
However, even though Applicant argues there is unexpected results with the claimed compounds versus the compounds of Comer; no sufficient experimental data has been provided. The discussion in the specification regarding the efficacy of compound 1 versus compound E1 of Comer is merely a statement. See MPEP 716.01 (c) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) (“It is well settled that unexpected results must be established by factual evidence.” Until applicant provides actual data, applicant’s assertions constitute mere argument. See also In re Linder, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972; Ex parte George, 21 USPQ2d 1058 (Bd. Pat. Appl. & Inter. 1991).
Further, it should be noted that compound E1 of Comer and compound 1 (recited in claim 4) both have the claimed cycloalkoxyl phenyl urea moiety (R4 is cycloalkoxy), and thus a skilled artisan would expect similar increased inhibitory properties against the apicomplexan parasite FRS enzyme. The difference between compound E1 of Comer and the compound recited in claim 4 is the L2-R2 and L3-R3 variables. In this case, Applicant has not provided any data or evidence of why the recited compound of claim 4 would have higher efficacy due to the CH2-MeO variable versus compound E1 of Comer with the CH2-N(CH3)2 variable. Further, Applicant is reminded that any objective evidence presented must be commensurate in scope with the claims which the evidence is offered to support. Since properties of chemical compounds can be highly variant, it must be made clear that any results must be extended to the full range of compounds claimed. In this case, Applicant appears to be arguing that only the compound recited in claim 4 has unexpected efficacy and it should be noted that the compound scope of independent claim 1 is much broader.
With respect to claims 11 and 16, Applicant argues that Welsh provides no basis to contend that the activity of one chemical series in one species is extendible to another. Applicant submits that simply because some organisms may be in the same taxonomical phylum is insufficient to allege that a compound efficacy from one species is extendible to another. Applicant argues that analysis could only have been gleaned using knowledge from the present application that the rejection is premised on impermissible hindsight.
However, the examiner respectfully disagrees. It would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to administer the claimed compounds of Comer to treat subjects with a parasitic disease associated with Toxoplasma gondii. A skilled artisan would have been motivated to do so since the compounds of Comer are effective against apicomplexan protozoa like Plasmodium and Cryptosporidium and Welsh teach Toxoplasma gondii is also a species of apicomplexan protozoa. Thus, a skilled artisan would have a reasonable expectation that Comer’s compounds would be effective against Toxoplasma gondii since Welsh teach Toxoplasma gondii shares distinctive morphological features, cytoskeletal organization and modes of replication, motility and invasion with Plasmodium and Cryptosporidium. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
With respect to the double patenting rejections, Applicant argues that the presently claimed compounds represent a specific genus of compounds, different from those claims in the ‘441 patent, ‘260 patent and ‘997 application that includes compounds having unexpected properties such as increased efficacy. Applicant further notes that Comer and Welsh do not rectify these deficiencies.
In response to the arguments, Applicant is referred to the examiner’s response regarding the 103 rejections above, which is incorporated herein.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10, 12-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Comer et al (WO 2018/175385; cited in the IDS mailed 3/22/23).
Regarding claim 1; Comer et al exemplify compounds having the following structure:
PNG
media_image2.png
211
345
media_image2.png
Greyscale
PNG
media_image3.png
209
344
media_image3.png
Greyscale
.
See compounds E1 and E38 in Table 1 (pp. 20-29). According to claim 1, these compounds have structures wherein R1 is phenyl, L1 is
PNG
media_image4.png
26
40
media_image4.png
Greyscale
,R4 is cyclopropoxy, R5 and R6 are independently -OH, m is 1, n is 1, A is CH and R7 is hydrogen.
Comer et al do not explicitly teach a compound with variables L2, L3, R2 and R3 in formula I of instant claim 1, where said compound is not
PNG
media_image5.png
230
341
media_image5.png
Greyscale
.
However, Comer et al do generally suggest the following compound:
PNG
media_image1.png
246
404
media_image1.png
Greyscale
wherein R3 is hydrogen or -CH2-OR and R is C1-C12 alkyl; or a pharmaceutically acceptable salt thereof (see pg. 6, lines 14—pg. 7, line 16).
Thus, although the claimed compound of formula (I) wherein said compound is not
PNG
media_image6.png
214
378
media_image6.png
Greyscale
is not immediately envisaged within the teachings of Comer et al; it would have been obvious to an ordinary skilled artisan before the effective filing date to select from the variables of R3 within the scope of compounds in Comer et al and design a compound according to claim 1. In KSR v. Telefex, 82 USPQ2d 1385, 1397 (U.S. 2007), the Supreme Court has held that when there is market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person has good reason to pursue known options within his or her technical grasp. A skilled artisan would have been motivated to do so since the court has reasoned a reasonable expectation of success in the art by stating that reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle. Sinclair & Carroll Co., 325 U.S. at 335, 65 USPQ at 301.
Regarding claim 2; Comer et al teach a compound according to the claimed structure of formula II (see compounds E1 and E38 in Table 1, pp. 20-29), wherein R1 in Comer et al is phenyl.
Regarding claim 3; Comer et al teach a compound according to the claimed structure of formula III (see compounds E1 and E38 in Table 1, pp. 20-29), wherein R4 in Comer et al is cyclopropoxy.
Regarding claim 4; Comer et al teach a compound according to the claimed structure of claim 4 (see compounds E1 and E38 in Table 1, pp. 20-29), wherein R1 in Comer et al is phenyl, R4 in Comer et al is cyclopropoxy and L2-R2 and L3-R3 can be -CH2-OR where R is C1-C12 alkyl (see pg. 6, lines 14—pg. 7, line 16).
Regarding claim 5; Comer et al teach a pharmaceutical composition with a pharmaceutically acceptable excipient and the claimed compound of formula (I) (pg. 18, lines 11-13).
Regarding claim 6; Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that cause malaria (i.e., a disease associated with an apicomplexan parasite) via administration to a subject (claim 53; pg. 31, lines 21-25).
Regarding claim 7; Comer et al teach its compounds can treat humans (pg. 19, lines 30—pg. 20, lines 5-6).
Regarding claim 8; Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that cause malaria (i.e., Plasmodium and cryptosporidiosis) (pg. 31, lines 21-25).
Regarding claim 9; Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that cause malaria including P. falciparum, P. vivax, P. ovale and P. malariae (pg. 31, lines 21-25).
Regarding claim 10; Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that cause malaria including C. parvum and C. hominis (pg. 31, lines 21-25).
Regarding claim 12; Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that cause malaria (i.e., a disease associated with an apicomplexan parasite) (pg. 31, lines 21-25).
Regarding claim 13; Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that cause malaria (i.e., Plasmodium and cryptosporidiosis) (pg. 31, lines 21-25).
Regarding claims 14 and 17-18; Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that cause malaria including P. falciparum, P. vivax, P. ovale and P. malariae (pg. 31, lines 21-25).
Regarding claim 15; Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that cause malaria including C. parvum and C. hominis (pg. 31, lines 21-25).
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Comer et al (WO 2018/175385; cited in the IDS mailed 3/22/23) as applied to claims 1-10, 12-15 and 17-18 above and in further view of Welsh et al (US Patent No. 8,486,987; cited in the PTO-892).
The disclosure of Comer et al is discussed above and incorporated herein.
Comer et al do not teach its compounds are used for treating a parasitic disease associated with Toxoplasma gondii in a subject or inhibiting the proliferation of a parasite that is Toxoplasma gondii that comprises administering to the subject or contacting the Toxoplasma gondii with its compounds, respectively.
Welsh et al teach apicomplexan protozoa are a phylum of diverse intracellular parasites that include species, such as Plasmodium, Cryptosporidium and Toxoplasma (column 1, lines 16--22). Such parasites produce disease of varying severity (column 1, lines 19-22) and share distinctive morphological features, cytoskeletal organization and modes of replication, motility and invasion (column 2, lines 39-41). According to Welsh et al, Toxoplasma gondii is a significant opportunistic pathogen in immunocompromised individuals, such as those infected by HIV-AIDS (column 1, lines 57-59).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to administer the claimed compounds of Comer et al to treat subjects with a parasitic disease associated with Toxoplasma gondii and contact the claimed compounds of Comer et al with an apicomplexan parasite that is Toxoplasma gondii. A skilled artisan would have been motivated to do so since the compounds of Comer et al are effective against apicomplexan protozoa like Plasmodium and Cryptosporidium and Welsh et al teach Toxoplasma gondii is also a species of apicomplexan protozoa. Thus, a skilled artisan would have a reasonable expectation that Comer’s compounds would be effective against Toxoplasma gondii since Welsh et al teach Toxoplasma gondii shares distinctive morphological features, cytoskeletal organization and modes of replication, motility and invasion with Plasmodium and Cryptosporidium.
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 1-6, 8 and 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 13-19 of U.S. Patent No. 11,866,441.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-4; all of the limitations therein are substantially recited and anticipated by claims 1-10 and 13 of US ‘441.
Regarding claim 5; all of the limitations therein are substantially recited and anticipated by claims 14-15 of US ‘441.
Regarding claims 6, 8, and 12-13; all of the limitations therein are substantially recited and anticipated by claims 16-19 of US ‘441.
Claims 7, 9-10, 14-15, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 13-19 of U.S. Patent No. 11,866,441 in view of Comer et al (WO 2018/175385; cited in the IDS mailed 3/22/23).
Regarding claim 7, the patented claims do not recite the administration of its compounds to a human.
Comer et al teach compounds having the claimed structure of formula (I) (see pg. 6, lines 14—pg. 7, line 16), wherein they are administered to humans (pg. 19, lines 30—pg. 20, lines 5-6) to inhibit the growth of or kill a parasitic protozoan that causes malaria (i.e., Plasmodium and cryptosporidiosis) (pg. 31, lines 21-25).
Therefore, it would have been obvious to an artisan of ordinary skill to administer the claimed compounds of the patented claims to humans as set forth in Comer et al. One would have been motivated to do so since Comer et al teach such compounds are effectively administered to humans to inhibit the growth of or kill a parasitic protozoan that causes malaria.
Regarding claims 9-10, 14-15, and 17-18; the patented claims do not recite its compounds are used for treating a parasitic disease associated with P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis in a subject or inhibiting the proliferation of a parasite that is P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis that comprises administering to the subject or contacting the P. falciparum, P. vivax, P. ovale, P. malariae , C. parvum and C. hominis with its compounds, respectively.
Comer et al teach compounds having the claimed structure of formula (I) (see pg. 6, lines 14—pg. 7, line 16), wherein they are administered to humans (pg. 19, lines 30—pg. 20, lines 5-6) to inhibit the growth of or kill a parasitic protozoan that causes malaria (i.e., Plasmodium and cryptosporidiosis) (pg. 31, lines 21-25). Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that causes malaria including P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis (pg. 31, lines 21-25).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to administer the claimed compounds of the patented claims to treat subjects with a parasitic disease associated with P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis and contact the claimed compounds of the patented claims with an apicomplexan parasite that is P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis. A skilled artisan would have been motivated to do so since Comer et al teach such compounds are useful to inhibit the growth of or kill a parasitic protozoan that causes malaria including P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis.
Claims 11 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 13-19 of U.S. Patent No. 11,866,441 in view of Welsh et al (US Patent No. 8,486,987; cited in the PTO-892).
Regarding claims 11 and 16, the patented claims do not recite its compounds are used for treating a parasitic disease associated with Toxoplasma gondii in a subject or inhibiting the proliferation of a parasite that is Toxoplasma gondii that comprises administering to the subject or contacting the Toxoplasma gondii with its compounds, respectively.
Welsh et al teach apicomplexan protozoa are a phylum of diverse intracellular parasites that include species, such as Plasmodium, Cryptosporidium and Toxoplasma (column 1, lines 16--22). Such parasites produce disease of varying severity (column 1, lines 19-22) and share distinctive morphological features, cytoskeletal organization and modes of replication, motility and invasion (column 2, lines 39-41). According to Welsh et al, Toxoplasma gondii is a significant opportunistic pathogen in immunocompromised individuals, such as those infected by HIV-AIDS (column 1, lines 57-59).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to administer the compounds of the patented claims to treat subjects with a parasitic disease associated with Toxoplasma gondii and contact the claimed compounds of the patented claims with an apicomplexan parasite that is Toxoplasma gondii. A skilled artisan would have been motivated to do so since the patented claims are effective against apicomplexan protozoa like Plasmodium and Welsh et al teach Toxoplasma gondii is also a species of apicomplexan protozoa. Thus, a skilled artisan would have a reasonable expectation that the compounds of the patented claims would be effective against Toxoplasma gondii since Welsh et al teach Toxoplasma gondii shares distinctive morphological features, cytoskeletal organization and modes of replication, motility and invasion with Plasmodium.
Claims 1-6 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15-21 of U.S. Patent No. 11,174, 260.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-4; all of the limitations therein are substantially recited and anticipated by claims 1-12 and 15-17 of US ‘260.
Regarding claim 5; all of the limitations therein are substantially recited and anticipated by claim 18 of US ‘260.
Regarding claims 6 and 12; all of the limitations therein are substantially recited and anticipated by claims 19-21 of US ‘260.
Claims 7-10, 13-15, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15-21 of U.S. Patent No. 11,174,260 in view of Comer et al (WO 2018/175385; cited in the IDS mailed 3/22/23).
Regarding claim 7, the patented claims do not recite the administration of its compounds to a human.
Comer et al teach compounds having the claimed structure of formula (I) (see pg. 6, lines 14—pg. 7, line 16), wherein they are administered to humans (pg. 19, lines 30—pg. 20, lines 5-6) to inhibit the growth of or kill a parasitic protozoan that causes malaria (i.e., Plasmodium and cryptosporidiosis) (pg. 31, lines 21-25).
Therefore, it would have been obvious to an artisan of ordinary skill to administer the claimed compounds of the patented claims to humans as set forth in Comer et al. One would have been motivated to do so since Comer et al teach such compounds are effectively administered to humans to inhibit the growth of or kill a parasitic protozoan that causes malaria.
Regarding claims 8-10, 13-15, and 17-18; the patented claims do not recite its compounds are used for treating a parasitic disease associated with P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis in a subject or inhibiting the proliferation of a parasite that is P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis that comprises administering to the subject or contacting the P. falciparum, P. vivax, P. ovale, P. malariae , C. parvum and C. hominis with its compounds, respectively.
Comer et al teach compounds having the claimed structure of formula (I) (see pg. 6, lines 14—pg. 7, line 16), wherein they are administered to humans (pg. 19, lines 30—pg. 20, lines 5-6) to inhibit the growth of or kill a parasitic protozoan that causes malaria (i.e., Plasmodium and cryptosporidiosis) (pg. 31, lines 21-25). Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that causes malaria including P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis (pg. 31, lines 21-25).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to administer the claimed compounds of the patented claims to treat subjects with a parasitic disease associated with P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis and contact the claimed compounds of the patented claims with an apicomplexan parasite that is P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis. A skilled artisan would have been motivated to do so since Comer et al teach such compounds are useful to inhibit the growth of or kill a parasitic protozoan that causes malaria including P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis.
Claims 11 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15-21 of U.S. Patent No. 11,174,260 in view of Comer et al (WO 2018/175385; cited in the IDS mailed 3/22/23) and Welsh et al (US Patent No. 8,486,987; cited in the PTO-892).
Regarding claims 11 and 16, the patented claims do not recite its compounds are used for treating a parasitic disease associated with Toxoplasma gondii in a subject or inhibiting the proliferation of a parasite that is Toxoplasma gondii that comprises administering to the subject or contacting the Toxoplasma gondii with its compounds, respectively.
Welsh et al teach apicomplexan protozoa are a phylum of diverse intracellular parasites that include species, such as Plasmodium, Cryptosporidium and Toxoplasma (column 1, lines 16--22). Such parasites produce disease of varying severity (column 1, lines 19-22) and share distinctive morphological features, cytoskeletal organization and modes of replication, motility and invasion (column 2, lines 39-41). According to Welsh et al, Toxoplasma gondii is a significant opportunistic pathogen in immunocompromised individuals, such as those infected by HIV-AIDS (column 1, lines 57-59).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to administer the compounds of the patented claims to treat subjects with a parasitic disease associated with Toxoplasma gondii and contact the claimed compounds of the patented claims with an apicomplexan parasite that is Toxoplasma gondii. A skilled artisan would have been motivated to do so since Comer et al teach the claimed compounds are effective against apicomplexan protozoa like Plasmodium and Cryptosporidium and Welsh et al teach Toxoplasma gondii is also a species of apicomplexan protozoa. Thus, a skilled artisan would have a reasonable expectation that the compounds of the patented claims would be effective against Toxoplasma gondii since Welsh et al teach Toxoplasma gondii shares distinctive morphological features, cytoskeletal organization and modes of replication, motility and invasion with Plasmodium and Cryptosporidium.
Claims 1-3, 5-8, 11-13, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 11-12, 16-17, 20, 22-24 and 27 of copending Application No. 17/276997 (reference application, now allowed).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-3; all of the limitations therein are substantially recited and anticipated by claims 1 and 11 of US ‘997.
Regarding claim 5; all of the limitations therein are substantially recited and anticipated by claims 22-24 of US ‘997.
Regarding claims 6-8, 11-13 and 16; all of the limitations therein are substantially recited and anticipated by claims 1, 12 and 16 of US ‘997.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9-10, 14-15 and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 11-12, 16-17, 20, 22-24 and 27 of copending Application No. 17/276997 (reference application, now allowed) in view of Comer et al (WO 2018/175385; cited in the IDS mailed 3/22/23).
Regarding claims 9-10, 14-15 and 17-18, the copending claims do not recite its compounds are used for treating a parasitic disease associated with P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis in a subject or inhibiting the proliferation of a parasite that is P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis that comprises administering to the subject or contacting the P. falciparum, P. vivax, P. ovale, P. malariae , C. parvum and C. hominis with its compounds, respectively.
Comer et al teach compounds having the claimed structure of formula (I) (see pg. 6, lines 14—pg. 7, line 16), wherein they are administered to humans (pg. 19, lines 30—pg. 20, lines 5-6) to inhibit the growth of or kill a parasitic protozoan that causes malaria (i.e., Plasmodium and cryptosporidiosis) (pg. 31, lines 21-25). Comer et al teach its compounds are useful to inhibit the growth of or kill a parasitic protozoan that causes malaria including P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis (pg. 31, lines 21-25).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to administer the claimed compounds of the copending claims to treat subjects with a parasitic disease associated with P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis and contact the claimed compounds of the copending claims with an apicomplexan parasite that is P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis. A skilled artisan would have been motivated to do so since Comer et al teach such compounds are useful to inhibit the growth of or kill a parasitic protozoan that causes malaria including P. falciparum, P. vivax, P. ovale and P. malariae as well as C. parvum and C. hominis.
Conclusion
Claims 1-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL E BREDEFELD whose telephone number is (571)270-5237. The examiner can normally be reached 8:00-5:00 Monday-Friday.
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, Alford Kindred can be reached at (571) 272-3606. 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.
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
Prosecution Insights