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 .
Application Status
The preliminary amendment filed on 7/31/2023 is acknowledged. Claims 1-12, 15-18, 21, 23 and 29-30 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statements filed on 10/16/2023 and 11/18/2024 have been considered except where lined through.
Specification
There are multiple uses of trade names or marks within the specification. For example, the use of the term SUNFIRE ®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Claim 23 recites the limitation “…or patient is later exposed to a wild-type Plasmodium parasite.” In the instant case, it is unclear how to interpret later exposed. Is this 2 days, 1 month or 1 year? Since this does not appear to be an active step that occurs immediately, the examiner is interpreting this limitation to be a patient whom is at risk of exposure or at risk of malaria.
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 1-12, 15-18, 21, 23 and 29-30 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.
The term “selective” in claim 1 is a relative term which renders the claim indefinite. The term “selective” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the instant case, neither the specification or claims teach what the selectivity is relative to. For example, is it selective to plasmepsin X relative to plasmepsin I or V or IX? Moreover, at what percent is it selective 51% or 85%? If the prior art teaches a plasmepsin X inhibitor, the examiner will interpret that as being selective towards plasmepsin X.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 depends from claim 20 which has been canceled. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 is/are rejected under 35 U.S.C. 102a(2) 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).
Claim(s) 1-12, 15-18, 21, 23 and 29-30 is/are 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).
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 is/are 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)
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 are 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.
Claims 1-12, 15-18, 21, 23 and 29-30 are 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.
Claim 1, 18 and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 19, 21-22, 24, 27-28 of 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 18, 21 and 29 are 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.
Claim 1, 18 and 29 are 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626