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 .
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.
Election/Restrictions
Examiner is maintaining claim objections and 102 rejection on file.
Examiner found prior art on species
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wherein X is O; V=Y=Z=C; R1 is
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; R2= R3 = R4 = R13=R12= H; R5= R6= -CH2CH3; m is 1. This search retrieved prior art. Therefore, Markush search will not be extended unnecessarily to additional species in this Office Action.
Claims 4-9, 12, 14-15,26, and 31-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 09/02/2025.
Current Status of 18/245,210
This Office Action is in response to the amended claims of 02/18/2026.
Claims 1, 43-44 and 46 are original; claims 2, 10-13, 16,18, 23, 24-25, 28,30, 34, and 39 are previously presented; claims 20-21, 29, 45 and 47 are currently amended.
Claims 4-9 12, 14-15,26, and 31-33 are withdrawn.
Claims 1-3, 10-11,13,16, 18, 20-25, 28-30, 34, 39 and 43-47 are examined in this office action.
Priority
The effective filing date is 09/23/2020 since the instant claims find support in provisional application no. 63/082,049.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks 02/18/2026. Examiner have reviewed these remarks and amendments.
Regarding claim objections, applicant amended claims 29, 30 and 47 by redrawing the structure, however the structures are pixilated and difficult to decipher. Therefore, objection to claims 29, 30 and 47 are maintained.
Regarding 112 rejections, applicant amended claims 20-21 by deleting C1-C6 alkylalkoxy from the claims, thus overcoming 112 rejection. Therefore 112 rejection is withdrawn.
Regarding 102/103 rejections,
Applicant argues:
Plasmepsin inhibitors have been used to achieve causal prophylaxis, which is when a drug blocks the initial stage of infection before disease. Favuzza et al described WM382 and demonstrated causal prophylaxis.
Pino et al., also describe causal prophylaxis. The step to demonstrate protective immunity was well short of either reference resulting from plasmepsin inhibitors.
Examiner Response:
Applicant argument of Plasmepsin inhibitors used for causal prophylaxis is interpreted as attorney opinion. Applicant have not shown any evidence showing the mechanism by which Plasmepsin inhibitors achieve chemovaccination is different or anything other than prophylaxis. Furthermore, Duffy et.al. (Clinical Infectious Diseases, Volume 71, Issue 6, 15 September 2020, Pages 1481-1490, https://doi.org/10.1093/cid/ciz1010 Published:17 October 2019) describes chemovaccination as prophylaxis(abstract). Therefore the 102/103 rejections are maintained.
Regarding Double patenting rejections, double patenting rejections is maintained for the reason stated in above paragraph [15].
Claim Rejections - 35 USC § 102 (maintained)
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.
Claims 1-3, 10-11, 13, 16, 20-21, 23-25,28-30, 39 and 46-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Favuzza et. al. (Cell Host & Microbe 27, 642–658, April 8, 2020).
Favuzza teaches a method of blocking multiple stages of the plasmodium life cycle against Plasmodium infections (examiner interpret this as chemovaccination) comprising administering, an effective amount of a dual inhibitor of plasmepsin IX(PMIX) and plasmepsin X(PMX),
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(claim 28-30) wherein X is O(claim 3); V=Y=Z= CH(claims 2 and 23-25); R1 is
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substituted with C1-C6 alkyl (claim 10-11); R2= R3 = R4 = R13=R12= H (claims 13 and claim 16, 20-21) ; R5= R6= -CH2CH3 (claim 18); m is 1(claim 3) (Pg. 642, Col. 1, Summary) thus anticipating claims 1-3, 10-11, 13, 16, 20-21, 23-25, and 28-30.
Compound
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is not depicted in the same way as compound of claims 28-30 and 47
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. The moiety
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is protruded out in
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((Pg. 642, Col. 1, Summary) in the prior art but is protruded inward in claims 28-30 and 47
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. Since structures in molecules are expected to rotate in nature, compound
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((Pg. 642, Col. 1, Summary) in the prior art is considered same as compound in claims 28-30 and 47
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.
Favuzza et.al. further teaches that administering compound
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cured mice of P. berghei and prevented blood infection from the liver (examiner is interpreting this as immune response to Plasmodium parasite infection) thus anticipating claim 46.
Moreover Favuzza et.al. teaches
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inhibit P. falicparum(wild type) examiner is interpreting this as simultaneously administering compound
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to wild-type P. falciparum sporozoites(this is interpreted as P.falciparum is forming spores, thus same as P. falciparum) (page 3, figure 1)thus anticipating claim 39.
Claims 1, and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pino et al. (Science 358, 522–528 (2017).
Pino et.al discloses compound
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(page 523, Figure1A. compound 49c) as target for PMIX and PMX (page 522 column 3, paragraph 3) in P. falicparum(wild type), therefore effective amount of compound
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can be used in a method for chemovaccination thus anticipating claim 1. Pino further discloses administering compound 49c to Mice infected with mCherry P. berghei parasites (a genetically modified Plasmdium parasite) and treated with 49c (figure 3, (M)) examiner is interpreting this as simultaneously administering chemovaccination with genetically modified Plasmdium parasite thus anticipating claim 44.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claim Rejections - 35 USC § 103 (maintained)
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.
Claims 1-3, 10-11,13,16, 18, 20-21, 23-25,28-30, 34, 39 and 43-47 are rejected under 35 U.S.C. 103 as being unpatentable over
Favuzza et. al. (Cell Host & Microbe 27, 642–658. April 8, 2020)
In view of
Pino et al. (Science 358, 522–528 (2017)
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Favuzza et.al. teaches claims 1-3, 10-11, 13, 16, 20-21, 23-25,28-30, 39 and 46-47 (see above 102 rejections)
Pino et al. teaches claims 1 and 44 (see above 102 rejection).
Anisel et. al. teaches dosage of pharmaceutical as routine optimization (page 50).
2. Ascertaining the differences between the prior art and the claims at issue.
Favuzza does not teach the injectable dosage of dual inhibitor of plasmepsin IX and X or combination therapy with one or more additional anti-malarial agent.
Pino et al. does not does not teach the injectable dosage of dual inhibitor of plasmepsin IX and X or combination therapy with one or more additional anti-malarial agent.
Anisel et. al. does not teach the injectable dosage of dual inhibitor of plasmepsin IX and X or combination therapy with one or more additional anti-malarial agent.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment for malaria and is looking to preemptively treat malaria in patient vulnerable to Plasmodium infection of P. falciparum (wild-type).
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A method of chemovaccination against Plasmodium infections comprising of plasmepsin IX and X dual inhibitor is known in prior art (Pino et.al. page 522 column 3, paragraph 3) and (Favuzza et.al. Pg. 642, Col. 1, Summary). Therefore, it would be obvious for a person skilled in the art to develop long-acting injectable formulation of plasmepsin IX and X dual inhibitor compounds
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(Favuzza et.al. Pg. 642, Col. 1, Summary). or
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(Pino et.al. page 523, Figure1A. compound 49c) for chemovaccination to prevent Plasmodium parasite(malaria causing parasite) infection in patient who may be exposed to Plasmodium parasite. A long-lasting injectable formula of plasmepsin IX and X dual inhibitor will be expected to prevent patient from getting infected by Plasmodium once exposed to plasmodium parasite, thus teaching claim 43-44, since presence of the dual inhibitor will prevent Plasmodium parasites from proliferating. Moreover, a person skilled in the art would be motivated to combine anti-malarial agent with plasmepsin IX and X dual inhibitor to develop a chemovaccination method against Plasmodium infections because combination of anti-malarial agent with plasmepsin IX and X dual inhibitor is expected to have same or better chemovaccination effect against Plasmodium infections therefore teaching claim 45. Therefore, it would obvious for a person skilled in the art to develop method of chemovaccination against with Plasmodium infections in patients with both
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(Favuzza et.al. Pg. 642, Col. 1, Summary). or
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(Pino et.al. page 523, Figure1A. compound 49c) thus teaching all the elements of Claims 1-3, 10-11,13,16, 18, 20-25,28-30, 39 and 43-47.
Claims 34 are directed to dosage of plasmepsin IX and X dual inhibitor administered to patients. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals are routinely optimized based on body weight and body surface area (Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, dosage of dual plasmepsin X and IX inhibitor is considered to be routine optimization (thus teaching claims 34) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 1-3, 10-11,13,16, 18, 20-21, 23-25,28-30, 34,39 and 43-47 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatenable over claims 1-31 and 43, 45-47 of U.S. Patent No. US, 12,350,270,
In view of
Favuzza et. al. (Cell Host & Microbe 27, 642–658. April 8, 2020)
And In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
Instant claims of 03/14/2023 is used to make this rejection.
1. Determining the scope and contents of the prior art.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-31 teaches compound of instant claims 1-3, 10-11, 13, 16, 20-21, 23-25,28-30 and 46-47 including the species
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( reference claims 23 and 31) corresponding to genus formula (‘I) of instant claim 2, wherein X is O; V=Y=Z=C; R1 is
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; R2= R3 = R4 = R13=R12= H; R5= R6= -CH2CH3; m is 1 . Reference claims 43, 45-47 teaches a method of treating Plamodium infection (examiner is interpreting this as chemovaccination and inducing immune response (same as instant claim 46) with compound of reference claims 1 partially teaching claims 1-3, 10-11, 13, 16, 20-21, 23-25,28-30 and 46-47.
Favuzza et.al. teaches claims 1-3, 10-11, 13, 16, 20-21, 23-25,28-30, 39 and 46-47 (see above 102 rejections)
Anisel et. al. teaches dosage of pharmaceutical as routine optimization (page 50).
2. Ascertaining the differences between the prior art and the claims at issue.
Reference claims do not teach dual inhibitor of plasmepsin IX and X.
Favuzza et.al. does not teach dosage of dual inhibitor of plasmepsin IX and X.
Anisel et. al. does not teach method of chemovaccition with dual inhibitor of plasmepsin IX and X.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing dosage for chemovaccination for Plasmodium infection of P. falciparum (wild-type).
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A method of chemovaccination against Plasmodium infections comprising of plasmepsin IX and X dual inhibitor is known in prior art
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(Favuzza et.al. Pg. 642, Col. 1, Summary). Therefore, it would be obvious for a person skilled in the art to combine the teaching of reference claims 1-31 and 43, 45-47 with the same compounds
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(Favuzza et.al. Pg. 642, Col. 1, Summary) propose instant claims 1-3, 10-11, 13, 16, 20-21, 23-25,28-30, 39 and 46-47.
A person skilled in the art would be motivated to develop a long-lasting injectable formula of plasmepsin IX and X dual inhibitor, since long lasting injectable formula will be expected to prevent patient from getting infected by Plasmodium once exposed to plasmodium parasite, thus teaching claim 43-44. Moreover, a person skilled in the art would be motivated to combine anti-malarial agent with plasmepsin IX and X dual inhibitor to develop a chemovaccination method against Plasmodium infections because combination of anti-malarial agent with plasmepsin IX and X dual inhibitor is expected to have same or better chemovaccination effect against Plasmodium infections thus teaching claim 45.
Claim 1 provisionally rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 19-24 of copending Application No. 17/795,349 (reference application). Instant claims of 03/14/2023 is used to make this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 17 teaches method of treating Plamodium infection (examiner is interpreting this as chemovaccination) (reference claim 17) with inhibitor for, inhibiting plasmepsin X (reference claim 19,21-22 and 24) and plasmepsin IX(reference claims 20-21 and 23) therefore dual inhibitor of plasmepsin IX and X, same as instant claim 1.
Claim 1 provisionally rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 18-24 and 26-27 of copending Application No. 17/776,040 (reference application). Instant claims of 03/14/2023 is used to make this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 18-24 and 26-27 teaches method of treating Plamodium infection (examiner is interpreting this as chemovaccination) (reference claim 17) with inhibitor for, inhibiting plasmepsin X (reference claim 19,21 and 27) and plasmepsin IX(reference claims 19,21 and 27) therefore dual inhibitor of plasmepsin IX and X, same as instant claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Response to Amendment
Claim Objections
Claims 29, 30 and 47 are objected to because bonds in the structure are NOT clearly depicted as shown by the circled area below
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(claim 29),
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(claim 30) and
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(claim 47). Corrections are required for advancing prosecution.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Conclusion
No claims are allowed as written
Please note Favuzza et.al. teaches species of formula (I’) therefore 102 and 103 rejections can be made with other species formula (I’) when the Markush search is eventually extended.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571)272-913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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