DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The instant application is a Divisional of abandoned Application No. 17/140,704, filed on January 04, 2021, which was filed as a Divisional of Application No. 15/984,956 on May 21, 2018, now US 10,881,669, which in turn was filed as a continuation of US Application No. 15/213,181 on July 18, 2016, now U.S. Patent 9,974,796, which in turn was filed as a continuation of Application No. 14/094,842 on December 03, 2013, now U.S. Patent 9,394,316, which in turn was filed as a continuation of Application No. 13/055,104 on February 25, 2011, now U.S. Patent 8,618,090, which was filed as the U.S. national phase of PCT/USO9/50637, filed July 15, 2009, claiming the benefit of United States Provisional Patent Application No. 6 1/083,000, filed July 23, 2008.
Status of Claims
Acknowledgement is made of cancelled (1-99) and new (100-108) claims filed on July 10, 2023. Claims 100-108 are pending in instant application.
Election/Restriction
The elected species are understood as follows: Formula IV CAS# 892225-65-9 and Formula V CAS# 933237-38-8.
Following extensive search and examination, the originally elected species have been deemed free of the prior art (excluding double patenting references).
Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to the genera of Formula IV and V.
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.
Claim 100-103, 105-108 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-12, of U.S. Patent No. 9,974,796 B21 in view of Remington2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 100-103, 105-106, US’796 claims administering combinations which read on the instantly claimed compositions comprising a compound of Formula IV and a compound of Formula V. For example, US’796 claims administering:
CAS# 901040-05-9 or CAS# 901040-65-1, and CAS# 881222-41-9
US’796 Claim 9
Formula V Species
CAS# 901040-05-9
Formula V Species
CAS# 901040-65-1
Formula IV Species
CAS# 881222-41-9
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101
227
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109
241
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92
296
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which reads on instant claims 100, 101, 102, 105, 106,
CAS# 901040-05-9 or CAS# 901040-65-1, and CAS# 403643-56-1
US’796 Claim 10
Formula V Species
CAS# 901040-05-9
Formula V Species
CAS# 901040-65-1
Formula IV Species
CAS# 403643-56-1
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101
227
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109
241
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97
294
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which reads on instant claims 100, 101, 102, 105, 106,
CAS# 901040-05-9 and CAS# 892225-65-9
US’796 Claim 11
Formula V Species
CAS# 901040-05-9
Instantly Elected Formula IV
CAS# 892225-65-9
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143
330
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152
443
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which reads on instant claims 100, 101, 102, 105, and 106,
CAS# 901040-05-9 and CAS# 884980-86-3
US’796 Claim 12
Formula V Species
CAS# 901040-05-9
Formula IV Species
CAS# 884980-86-3
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101
227
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131
250
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which reads on instant claims 100, 101, 103, 105, and 106.
Regarding instant claim 107, while US’796 does not specify instant CAS# 896355-03-6 or CAS# 933237-38-8 in combination with a compound of instant Formula IV, US’796 does teach CAS# 896355-03-6 and CAS# 933237-38-8 as species of Formula V (US’796 claim 7). Per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. It would have been obvious to one skilled in the art to substitute a compound species of Formula V (e.g. CAS# 901040-05-9, US’796 claim 11) for another compound species of Formula V (e.g. CAS# 896355-03-6, US’796 claim 7) in a known combination (e.g. CAS# 901040-05-9 and CAS# 892225-65-9, US’796 claim 11) with a reasonable expectation of success because the prior art teaches the compound species of Formula V (e.g. CAS# 901040-05-9 and CAS# 896355-03-6) are suitable alternatives for treating malaria (US’796 claims 1, 7, 9). Furthermore, it is well-within the skill of the art to substitute one known species of a genus for another.
US’796 Claim 7
US’796 Claim 11
Formula V Species
CAS# 896355-03-6
Formula V Species
CAS# 901040-05-9
Instantly Elected Formula IV
CAS# 892225-65-9
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102
361
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143
330
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152
443
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Regarding instant claims 100 and 108 and a composition comprising a carrier and formulated for oral administration, US’796 claims are drawn to methods rather than compositions. One skilled in the art would readily appreciate a method comprising administering two components suggests a composition comprising said components as a product used for such method. While US’796 does not specify a carrier in the combination or an oral administration route or formulation, these modifications would be obvious to one skilled in the art in light of Remington.
The instant specification states the pharmaceutically acceptable carrier may be a vehicle, adjuvant, excipient, or diluent (see instant spec. at p. 21 ¶[0053]). Remington teaches techniques for formulating drug substances for oral administration including tablets (see Remington at p. 889). Remington states large scale production methods require the presence of other materials in addition to the active ingredients to facilitate handling, enhance the physical appearance, improve stability, and aid in drug delivery (see Remington at p. 889 introduction left col.). Remington also teaches formulations for oral administration such as compressed tablets may be in combination with binders, disintegrants, controlled-release polymers, lubricants, diluents, or colorants (see Remington at p. 889 Tablets right col. ¶2), reading on instant “pharmaceutical carrier”.
Per MPEP § 2143(I)(D), a prima facie case of obviousness exists for applying a known technique to a known method or product ready for improvement to yield predictable results. It would have been obvious to one skilled in the art to formulate a known composition for administration taught by US’796 to further comprise a carrier and be suitable for oral administration with a reasonable expectation of success because Remington teaches solid dosages are suitable for oral administration, informs artisans how to formulate solid dosages for oral administration, and motivates artisans to incorporate carriers to improve stability, appearance, and handling. Furthermore it is well-within the ordinary skill in the art to formulate a known composition for oral administration.
Accordingly, one would arrive at the instant invention in light of the claims of US’796 and the teachings of Remington.
Allowable Subject Matter
Claim 104 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 100-103, 105-108 are rejected.
Claim 104 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KORTNEY KLINKEL can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.R./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
1 Patented May 22, 2018. Hereinafter US’796.
2 Remington's Pharmaceutical Sciences (21st Ed) New York, NY: Lippincott Williams and Wilkins 2005. Select Pages. Hereinafter Remington.