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 .
Acknowledgement of Papers Received: Amendment/Response dated 5/19/26.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/26/26 was filed after the mailing date of the previous Office Action on 11/07/24. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 4, 6, 9-15 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mateescu et al (WO 2015/164950 A1 hereafter Mateescu) in view of Le et al (US 2017/0072069 hereafter Le) and Blumberg et al (US 9,580,417 hereafter Blumberg).
Mateescu discloses a controlled release ionic complex comprising carboxylated polymers in ionic complex with API [0061]. The carboxylated polymers include starches and methylcellulose [0021-0023]. The carboxylated polymers form ionic complexes with various API and can be more cost effective than other means of encapsulation [00104, 00140, 00168]. The formulation comprises both carboxymethylcellulose and carboxymethylstarch, where the degree of substitution of the carboxymethylcellulose is from 0.2 to 2, preferably 0.3-0.9 and the degree of separation of the carboxymethylstarch is from 0.2 to 2, preferably 0.2 to 1 [0033-0040]. The complexes can be formed into monolithic tablets [claims]. The formulation further comprises excipients such as [0074]. The tablet is a monolithic tablet [claims].
While the reference discloses a controlled release complex comprising a carboxylated polymer forming an ionic complex between an active agent compound and the carboxylated polymer. The reference is however silent to the inclusion of antimalaria drugs with carboxymethyl compounds. These compounds are found in the Le patent.
Le discloses a controlled release complex comprising a carboxylated polymer having carboxyl groups having a degree of substitution of at least 0.25, preferably between 0.4-1.0 [0067]. The carboxylated polymer forms a complex with antimalaria drug in an ionic complex [0070, 0172, 0240, Example 1-8]. The carboxylated polymer is a carboxymethyl starch with degree of substitution of about 0.3 [0072]. The complex can be formed into solid tableted [0288]. The malaria drug is artemisinin [Example 1-8]. These dosages can be used to treat malaria [0240-0243]. It would have been obvious to include the compound of Le into the formulation of Mateescu as they solve the same problem of using carboxymethyl compounds as carriers for APIs.
The reference discloses a controlled release complex comprising carboxylated polymers with low degrees of substitution combined with antimalaria alkaloids like artemisinin. The reference is however silent to the specific components or the combination of an additional antimalaria drug. Further the use of the tablets but these components are known in the art as seen in the Blumberg.
Blumberg discloses a tablet formulation comprising voacamine which is an alkaloid extract of Peschiera fuchsiaefolia (abstract, col. 5, lin. 35-50; col. 6, lin. 30-40). The tablet comprises excipients such as carboxymethylcellulose, starch and lactose (col. 71, lin. 20-40). Further lubricants include magnesium stearate and talc (col. 72, lin. 50-60). It would have been obvious to combine the formulation with that of Le as they solve the same problem, and it is obvious to combine like formulations for an additive effect.
Regarding the ratios of the instant claims, it is the position of the Examiner that such limitations do not distinguish over the prior art as they would have been determined through routine experimentation. The prior art discloses the general conditions of the claims, namely an ionic complex comprising carboxylated polymer in combination with an antimalaria drug where the drug is the same and the carboxylated polymer has the same degree of substitution. Where 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. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind, it would have been obvious to combine the disclosures of the prior art in order to produce a stable controlled release formulation useful in treating malaria. It would have been obvious to combine the components of Le and Blumberg with the formulation of Mateescu as they solve the same problem. It would have been obvious to combine the carboxylated polymers of Mateescu into the similarly formed tablets of Le as they solve the same problem. There would have been reasonable expectation of success as they use the same components for the same purpose. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable means of treating malaria.
Claim(s) 1, 9, 13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Mateescu et al (WO 2015/164950 A1 hereafter Mateescu) in view of Le et al (US 2017/0072069 hereafter Le) and Blumberg et al (US 9,580,417 hereafter Blumberg) as applied above in further view of Chan-Sew et al (CA 2779720 A1 hereafter Chan).
As discussed above, the combination of Mateescu, Le and Blumberg discloses a controlled release complex comprising a carboxylated polymer and a combination of antimalarial drug, where one is an alkaloid extract from Peschiera fuchsiaefolia. The formation of bilayered tablets is known in the art, especially with malaria formulation to include further agents for maximum potency. This is seen in the Chan-Sew patent.
Chan-Sew discloses a tablet formulation for treating malaria (abstract). The tablet comprises carboxyl methylcellulose along with common excipients like starches (Examples). The formulation comprises multiple agents including artesunate, arranged in bilayers with a second drug in the other layer (claims). It would have been obvious to include this structure into the Le tablet in order to optimize treatment of malaria. One of ordinary skill in the art would have been motivated to combine the prior art in order to optimize a treatment for malaria. It would have been obvious to form a bilayer tablet with multiple agents as seen Chan-sew with the formulation of Le/Blumberg as they solve the same problem of treating malaria with similar structures.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, 4, 6 and 9-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Mateescu, Le and Blumberg are reapplied in a different order with Mateescu as the primary reference to establishes the level of skill in the art regarding carboxymethyl compound in ionic complexes with active agents. Le is applied to show that the specific malaria drugs of the claims can be combined with carboxymethyl compounds with similar degrees of substitution and Blumberg provides the specific alkaloid extract of the instant claims. The claims remain rejected as the prior art continues to render the claims obvious.
Conclusion
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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