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 .
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) 1-7, 9-15, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Le et al (US 20170072069 hereafter Le) in view of Blumberg et al (US 9580417 hereafter Blumberg) and Mateescu et al (WO 2015/164952 A1 hereafter Mateescu).
Le discloses a controlled release complex comprising a carboxylated polymer having carboxy] 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 antimalarial drug in an ionic complex [0070, 0172, 0240, Example 1-8]. The carboxylated polymers is a carboxymethyl starch with degree of substitution of about 0.3 [072]. The complex can be formed into solid tablets [0288]. The malaria drug is artemisinin [Example 1-8]. These dosages can be sued to treat malaria [0240-0243].
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 a 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.
While the reference discloses the formation of a complex with carboxyl groups and antimalaria drug. The reference is silent to the use of carboxymethyl cellulose in the complex. The use of methylcellulose in a drug complex is known in the art as seen in the Mateescu patent.
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 degree of substitution for the methylcellulose is about 0.7, while the degree of substitution can be about 0.3 for starches [0019-0044]. The carboxylated polymers form ionic complexes with various API and can be more cost effective than other means of encapsulation [00104, 00140, 00168]. The complexes can be formed into monolithic tablets [claims]. It would have been obvious to include these carboxylated polymers as they would have been a cost-effective means of forming a controlled release formulation.
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 Blumberg with the formulation of Le 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 combine the prior art with an expected result of a stable means of treating malaria.
Claim(s) 1 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Le et al (US 2017/0072069 hereafter Le) and Blumberg et al (US 9580417 hereafter Blumberg) in view of Frederich et al (Potential antimalarial of indole alkaloids; Transactions of the Royal of Tropical Medicine and Hygiene, 2008, 102, 11-19).
As discussed above, the combination of 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 combination is silent to the specific alkaloid is known in the art as seen in the Frederich study.
Frederich discloses the activity of various indole alkaloids with antimalarial activity including artemisinin and quinine (abstract). Several indole alkaloids of plants specific such as Strychnos usambarenis are investigated (Figure 2). These compounds have been found to have good activity and would have been an obvious substitution into the formulation of Le as they solve the same problem.
One of ordinary skill in the art would have been motivated to combine the alkaloids of Frederich into the formulation of Le and Blumberg as they solve the same problem. There would have been a reasonable expectation of success as Le provides a stable platform to complex antimalarial compounds and deliver them to the end user.
Claim(s) 1, 9, 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Le et al (US 2017/0072069 hereafter A1) and Blumberg et al (US 9580417 hereafter Blumberg) in view of Chan-Sew et al (CA 2779720 A1 hereafter Chan).
As discussed above, the combination of 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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