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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/27/2026 has been entered.
Claims 1-12, 15-18, 21, 23 and 29-30 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 8/27/2026 is acknowledged and has been considered except where lined through.
Specification
The substitute specification filed on 5/29/2026 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: a marked up copy of the specification has not been supplied (in addition to the clean copy).
In response, Applicants contend that the specification was amended in accordance with MPEP Section 714, which, provides that replacement paragraphs must include markings to show the changes, and that a separate clean version is not required.
In the instant case, the Examiner acknowledges MPEP section 714. However, the Examiner recognizes that the issue occurs when there have been prior amendments to the specification. For example, the specification filed on 7/31/2023 was amended in a similar fashion via a preliminary amendment adding a cross reference to related applications section. No, clean copy or marked up copy were provided during this preliminary amendment. Thus, it is unclear whether the “current” specification contains both amendments or just the most recent. Accordingly, the amendment filed on 5/29/2026 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: a marked up copy of the specification has not been supplied (in addition to the clean copy) containing all of the changes that have occurred including the most recent.
Rejections Maintained, but amended upon reconsideration:
Claim Interpretation
Upon reconsideration of the claims/specification and Applicants arguments on page 4, regarding claim 23, the Examiner would like to provide their interpretation of what the patient population and/or active steps of claim 23 appear to encompass. Claim 23 limits the patient population of claim 1 by reciting “… wherein the patient does not have a Plasmodium parasitic infection, and wherein the patient is simultaneously or sequentially administered a wild-type Plasmodium parasite, or patient is exposed to a wild-type Plasmodium parasite”. In view of this, it would appear that the patient population is one that does not have a Plasmodium parasitic infection at the time of administration of the compound. Accordingly, for the sequential administration, the compound is administered first and the parasite occurs at some point after wards. Moreover, administration of the compound during an infection which would protect the patient from subsequent exposure to the parasite such as that taught in specification (Chemovaccination of Mice with Example 2) would be excluded from this patient population. Note: The Example provided in the specification for chemovaccination appears to utilize the general experimental procedure which first inoculates with the parasite followed by administration of the compound 36 to 48 hours after inoculation. Moreover, the mice challenged with bites from mosquitoes infected for PbmCherry Luci sporozoites utilized a sample of mice previously chemovaccinated (e.g., mice where first inoculated followed by administration of the compound) and the “boost” immunization utilized “cured” mice from the previous challenge that were immunized again with sporozoites and treated with the compound.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 18 remain rejected under 35 U.S.C. 102a(1) as being anticipated by Meyers et al. (ACS Med. Chem. Lett. 2014, 5, 89-93) as evidenced by Nasamu et al. (Science 2017;358:518-522).
Meyers et al. discloses an evaluation of aminohydantoins as a novel class of antimalarial agents (Title). In particular, Meyers et al. teach an in vivo evaluation of compounds, in particular compound 8p at 100 mg/kg, in mice infected with Plasmodium chabaudi (page 92, Table 3). In addition to the in vivo efficacy against Plasmodium chabaudi, Meyers et al. teach that compound 8p is orally bioavailable in rats with a half-life of 2.9 h (page 93, 1st column, 3rd full paragraph). While Meyers et al. does not specifically teach that compound 8 is a plasmepsin X inhibitor, as evidenced by Nasamu et al. compound CWHM-117, which is compound 8 of Meyers et al., acts as an inhibitor of plasmepsin X (PMX) (Figure 4). Regarding the amounts, 100 mg/kg in mice equates to a dose of 2.5 mg to 4 mg considering the average weight of laboratory mice typically ranges from 25 to 40 grams. Note: Patient is defined in the specification to include mice or rats (see page 73).
In response to this rejection, Applicants contend that this rejection fails because none of the references, alone or in combination, teach or suggest the claimed chemovaccination method or provides any motivation to use Plasmepsin inhibitors to induce protective immunity. Regarding Meyers specifically, Applicants contends that Meyers et al. discloses aminohydantion compounds as potential antimalarial agents and focuses entirely on killing or inhibiting the malaria parasite to treat the active infections. However, Applicants assert that Meyers provides no teaching whatsoever regarding induction of immunity, chemovaccination, or the unexpected late-liver-stage-arrest mechanism that enables the CALM strategy. Moreover, Applicants contend that the Examiner has not identified any motivation in the prior art to combine a Plasmepsin inhibitor with deliberate exposure to wild-type Plasmodium parasites to generate protective immunity. Lastly, Applicants contend that the cited reference teach away from the claimed invention because they are directed to parasite eradication, which is antithetical to the controlled parasite exposure required for chemovaccination.
These arguments have been carefully considered, but are not found persuasive.
In response to Applicants arguments, the Examiner would first like to point out that claim 1, for example, recites “A method of chemovaccination against Plasmodium infection comprising administering to a patient an effective amount of an inhibitor of Plasmepsin X.” The specification (as originally filed) defines the following:
-“Chemovaccination” means induction of adaptive immune responses to Plasmodium infection during anti-viral drug administration (see page 72, lines 32-33);
-As used herein “patient” means any patient with a liver stage Plasmodium infection, e.g. of Plasmodium falciparum or Plasmodium vivax. Alternatively, a “patient” could mean a patient without Plasmodium parasite infection, that is administered a Plasmodium parasite inoculum, such as a wild-type Plasmodium parasite or a genetically modified Plasmodium parasite and a selective inhibitor of plasmepsin X. (see page 73, lines 11-15).
Accordingly, Meyers et al. teaching of an in vivo evaluation of compounds, in particular compound 8p at 100 mg/kg, in mice infected with Plasmodium chabaudi anticipates the instant claims in view of a “patient” encompassing one which has a Plasmodium infection at the time of administration of an inhibitor of plasmepsin X. In other words, the prior art teaches administering the same compound to the same patient population. As noted in the Final rejection, the Examiner recognizes that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In the instant case, the examiner recognizes that the prior art teaches administration of the same compound to the same patient population. As such, such chemoprevention seems to flow logically from the teachings of the prior art. Applicants are reminded that the Patent Office does not have the facilities and resources to determine whether said property is necessarily present. The burden is on Applicants to determine whether such property does not occur from practicing the teachings of the prior art. See MPEP 2112. Moreover, it should be noted that the rejected claims do not specifically recite first administration of the compound to the patient followed by “deliberate” exposure to the parasite or alternatively, simultaneous exposure of the compound and parasite. Lastly, it should be noted that the instant rejection is an anticipation rejection, not an obvious rejection and therefore, arguments pertaining to no motivation to combine or a teaching away are not pertinent.
Claim(s) 1-12, 15-18, 21, 23 and 29-30 remain rejected under 35 U.S.C. 102(a)(2) as being anticipated by McCauley et al. (US 12,338,219, 2025-06-24).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
McCauley et al. teach a method of treating a Plasmodium infection or treating malaria comprising administering to said subject a therapeutically effective amount of a compound of formula 1
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alone or in combination with another anti-malarial agent (claims 15-16 of the Patent). With regards to the compounds of Formula 1, McCauley provides numerous examples including, but not limited to, compounds having the structures
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,
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,
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and
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which read on the instant compound of formula I, as well as, compounds claimed in claim 16 of the instant application (claim 13 of the US Patent). With regards to the therapeutically effective amount, the US Patent teaches that dosages range from about 1 mg to about 25 mg (column 64, lines 38-40). Moreover, the US Patent teaches that the present invention is useful in treating malaria in that the compounds inhibit the onset, growth or progression of the disease in a subject afflicted with or at risk of contracting the condition (column 63, lines 32-44).
In response to this rejection, Applicants contend that the rejection fails to account for a fundamental distinction between two entirely different therapeutic paradigms: (1) treating or preventing an existing malaria infection (the goal of McCauley), and (2) inducing protective immunity through chemovaccination (the goal of the instant claims). In particular, Applicants contend that Chemovaccination, as claimed, involves deliberate exposure to the Plasmodium parasite in conjunction with administration of a Plasmepsin X inhibitor to induce protective immunity which is evidenced by dependent claim 23, which expressly requires that “the patient does not have a Plasmodium parasite infection” and “the patient is simultaneously or sequentially administered a wild-type Plasmodium parasite, or patient is exposed to a wild-type Plasmodium parasite”.
In response to Applicants arguments pertaining to the fundamental distinction between the goal of McCauley and the goal of the instant claims, the Examiner would like to first incorporate herein the examiners comments above regarding the recitation of at least claim 1 and the definition provided in the specification for at least “chemovaccination” and “the patient population”. It appears that Applicants acknowledge that McCauley is directed to “methods of treating malaria” and “methods of treatment of Plasmodium infection”. As such, it appears that McCauley administers the compounds encompassed by at least claim 2 to the same patient population. Moreover, Applicants appear to be arguing that the “goals” are different. However, Applicants have not provided any evidence to show that chemovaccination, while not recognized by McCauley, does not also occur by the methods taught by McCauley. Regarding Applicants arguments pertaining to chemovaccination, the Examiner recognizes that this does not appear to be consistent with the definition within the specification. In particular, there is no definition in the specification that chemovaccination involves a deliberate exposure to the Plasmodium parasite in conjunction with administration of a Plasmespsin X inhibitor. Moreover, the specification and claims do not specifically indicate any particular timing of when this deliberate exposure should occur. Regarding Applicants argument pertaining to claim 23, the Examiner acknowledges and has provided their interpretation of Claim 23. Since there is no definition of “sequential”, McCauley’s teaching that the present invention is useful in treating malaria in that the compounds inhibit the onset, growth or progression of the disease in a subject afflicted with or at risk of contracting the condition would read on the claimed limitation since administration of the compound encompasses any time prior to exposure to a wild type Plasmodium parasite, for example a mosquito bite.
Moreover, Applicants present evidence of unexpected results supporting nonobviousness in the form of a peer-reviewed publication by Boddey et al. (Science, August 13, 2026) which provides compelling evidence that the use of dual Plasmepsin IX/X inhibitors for chemovaccination produces unexpected results that are neither predicted nor suggested by the prior art. Applicants contend that Boddey et al. describes the “CALM” (Chemo-Attenuated Liver Merozoites) chemovaccination strategy, which exploits a unique property of dual Plasmepsin IX/X inhibitors: their precise targeting of the very late liver stage of parasite development. In particular, Applicants note that the study demonstrated that when hosts infected with Plasmodium sporozoites (either by injection or natural mosquito bites) and then administered a Plasmepsin IX/X inhibitor such as WM382 or the clinical candidate MK7602, the parasites were permitted to complete nearly the entire liver stage development cycle, resulting in massive amplification of antigenic material.
In response to Applicants arguments pertaining to unexpected results supporting nonobviousness, the Examiner would like to first point out that the instant rejection is an anticipation rejection and not an obviousness rejection. As such, unexpected results are not a proper response to anticipation rejection. As noted above, it appears that Applicants acknowledge that McCauley is directed to “methods of treating malaria” and “methods of treatment of Plasmodium infection”. As such, it appears that McCauley administers the compounds encompassed by at least claim 2 to the same patient population. Thus, while Applicants argue that that Boddey et al. describes the “CALM” (Chemo-Attenuated Liver Merozoites) chemovaccination strategy, which exploits a unique property of dual Plasmepsin IX/X inhibitors: their precise targeting of the very late liver stage of parasite development, Applicants have not provided any evidence that such “property” would not be present by the methods of the prior art. (emphasis added). The Examiner recognizes that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In the instant case, the examiner recognizes that the prior art teaches administration of the same compound to the same patient population. As such, such chemoprevention seems to flow logically from the teachings of the prior art. Applicants are reminded that the Patent Office does not have the facilities and resources to determine whether said property is necessarily present. The burden is on Applicants to determine whether such property does not occur from practicing the teachings of the prior art. See MPEP 2112. Moreover, neither the specification, claims or Boddey et al. set forth any timing between the inoculation of the patient and administration of the compound that is critical to achieve chemovaccination versus no chemovaccination.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 29 remains rejected under 35 U.S.C. 103 as being unpatentable over Meyers et al. (ACS Med. Chem. Lett. 2014, 5, 89-93) as evidenced by Nasamu et al. (Science 2017;358:518-522), as applied to claims 1 and 18 above, in view of N.J. White (Drug Resistance Updates 1998; 1: 3-9) referred to herein as White.
Meyers et al. discloses an evaluation of aminohydantoins as a novel class of antimalarial agents (Title). In particular, Meyers et al. teach an in vivo evaluation of compounds, in particular compound 8p at 100 mg/kg, in mice infected with Plasmodium chabaudi (page 92, Table 3). In addition to the in vivo efficacy against Plasmodium chabaudi, Meyers et al. teach that compound 8p is orally bioavailable in rats with a half-life of 2.9 h (page 93, 1st column, 3rd full paragraph).
Meyers et al. does not teach compound 8p in combination with another anti-malaria agent.
White teaches that the development of resistance to antimalarial drugs can be delayed or prevented by using drug combinations, wherein there are good arguments for combining, de novo, an artemisinin derivative with all newly introduced antimalarial drugs (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to combine compound 8p as taught by Meyers et al. with another antimalarial drug in view of the teachings of White. One of ordinary skill in the art would have been motivated to make such a combination, with a reasonable expectation of success, because:
- White teaches that the development of resistance to antimalarial drugs can be delayed or prevented by using drug combinations, wherein there are good arguments for combining, de novo, an artemisinin derivative with all newly introduced antimalarial drugs.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
Applicants arguments mirror those set forth above and have been considered. The arguments have not been found persuasive for the reasons set forth above and incorporated herein.
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, 18 and 29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-52 of U.S. Patent No. 12,350,270B2 to McCauley et al. (2025-07-08). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US Patent and instant application substantially overlap in scope wherein each claim a method of treating a Plasmodium infection and/or malaria comprising administering an inhibitor of plasmepsin IX and/or plasmepsin X to a patient in need thereof. Please note: Since the present application has not defined what the selectivity for plasmepsin X is, a dual inhibitor that inhibits plasmepsin IX and/or plasmepsin X would read on the instantly claimed invention.
Applicants arguments mirror those set forth above and have been considered. The arguments have not been found persuasive for the reasons set forth above and incorporated herein.
Claims 1-12, 15-18, 21, 23 and 29-30 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,338,219. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US Patent and instant application substantially overlap in scope wherein each claim a method of treating a Plasmodium infection and/or malaria comprising administering compound of formula 1
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, wherein specific species of formula are claimed in each of the applications.
Applicants arguments mirror those set forth above and have been considered. The arguments have not been found persuasive for the reasons set forth above and incorporated herein.
Claims 1, 18 and 29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-18 and 21-22 of US Patent No. 12629374 (issued 5/19/2026, formally copending Application No. 17/795,349 (reference application)). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application and instant application substantially overlap in scope wherein each claim a method of treating a Plasmodium infection and/or malaria comprising administering an inhibitor of plasmepsin IX and/or plasmepsin X to a patient in need thereof. Please note: Since the present application has not defined what the selectivity for plasmepsin X is, a dual inhibitor that inhibits plasmepsin IX and/or plasmepsin X would read on the instantly claimed invention.
Applicants arguments mirror those set forth above and have been considered. The arguments have not been found persuasive for the reasons set forth above and incorporated herein.
Claim 1, 18, 21 and 29 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 34, 39 and 45 of copending Application No. 18/245,210 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application and instant application substantially overlap in scope wherein each claim a method of treating a Plasmodium infection and/or malaria comprising administering an inhibitor of plasmepsin IX and/or plasmepsin X to a patient in need thereof. Please note: Since the present application has not defined what the selectivity for plasmepsin X is, a dual inhibitor that inhibits plasmepsin IX and/or plasmepsin X would read on the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants have not provided any arguments for the above rejection. As such, the rejection is maintained.
Claim 1, 18 and 29 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-26, 28, 35-36 of copending Application No. 18/716,280 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application and instant application substantially overlap in scope wherein each claim a method of treating a Plasmodium infection and/or malaria comprising administering an inhibitor of plasmepsin IX and/or plasmepsin X to a patient in need thereof. Please note: Since the present application has not defined what the selectivity for plasmepsin X is, a dual inhibitor that inhibits plasmepsin IX and/or plasmepsin X would read on the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants have not provided any arguments for the above rejection. As such, the rejection is maintained.
New Rejection upon the Request for Reconsideration:
Claim Rejections - 35 USC § 112
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 2-12, 15-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites recites the limitation “the selective inhibitor of ”. There is insufficient antecedent basis for this limitation in the claim since claim 1 does not recite that the inhibitor of Plasmepsin X is a selective inhibitor.
Claim Rejections - 35 USC § 102
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.
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, 18, 21, 23 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheng et al. (US9353089B2, 2016-05-31).
Cheng et al. teach aminohydantoin compounds which are useful for the treatment of malaria and other diseases caused by Plasmodium parasites, wherein the compounds inhibit PM-I-PM-X (column 10, lines 30-37). With regards to the malaria, Cheng et al. teach that the most serious forms of diseases caused by the plasmodium parasite that can affect humans is Plasmodium falciparum and that malaria caused by plasmodium vivax is typically milder and generally not fatal in humans (column 10, lines 61-65). In addition to the treatment of malaria, Cheng et al. teach that the compounds can be administered to a patient as a prophylactic treatment which includes inhibiting the onset of a disease in a subject or patient which may be at risk and/or predisposed to the disease but does not yet experience or display any or all of the pathology or symptomatology of the disease (see column 10, 43-45 and column 29, lines 3-7). Moreover, Cheng et al. teach that the aminohydrantoin can be used either as a monotherapy or in combination with a second agent such as an anti-malarial (see Column 41, lines 16-19). Lastly, Cheng et al. provides the in vivo antimalarial effect of several aminohydrantoins, wherein compounds such as compound 117 were administered at 100 mg/kg to mice inoculated with rodent Plasmodium (column 134, starting at line 21 and Table 14). Regarding the amounts, 100 mg/kg in mice equates to a dose of 2.5 mg to 4 mg considering the average weight of laboratory mice typically ranges from 25 to 40 grams.
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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