DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
This Office Action is in response to applicant’s arguments filed on 9/4/25. Claims 1-213, 222-223, 230, 236-272 have been cancelled. Claim 274 has been added. Claims 214-221, 224-229, 231-235, 273-274 are pending. Claims 214, 224-225, 227-228 have been amended. Claims 224, 227-229 have been withdrawn. Claims 214-221, 225-226, 231-235, 273-274 are examined herein.
The terminal disclaimers filed on 9/4/25 disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of US Patents 10,028,928; 10,596,142; 11,395,811; and 11,612,579 have been reviewed and accepted. The terminal disclaimers have been recorded. The obviousness double patenting rejections are hereby withdrawn.
The claim amendments have rendered the 102 rejection of the last Office Action moot, therefore hereby withdrawn.
Applicant’s arguments with respect to the 103 rejection have been fully considered but found not persuasive, therefore maintained for reasons of record and modified below due to the claim amendments.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 214-221, 225-226, 231-235, 273-274 are rejected under 35 U.S.C. 103 as being unpatentable over Feuerstein et al. (US Patent Application 2007/0141138, of record) in view of Almarsson et al. (US Patent Application 2009/0030077, of record).
The instant claims are directed to a method of treating hypertriglyceridemia by administering EPA, DHA, and the surfactant, polysorbate 20.
Feuerstein et al. teach a method of treating hypertriglyceridemia (claims 17 and 18) by administering a pharmaceutical composition comprising EPA and DHA in a weight ratio from 3.5:1 to 6.99:1 (claim 1). The EPA and DHA fatty acids can be in the form of triglyceride or ethyl ester form (paragraph 0028). EPA and DHA are naturally found in fish and plants (paragraph 0003). The formulation is more than 90% omega-3 fatty acids by weight (claim 12). The omega-3 dosage forms may include oleic acid (paragraph 0040). Surfactants (paragraph 0030), alcohols, such as ethanol (paragraph 0043), and antioxidants (paragraph 0042) are also taught. The composition may be in the form of a gelatin capsule (paragraph 0021) and may be administered in an amount of 750-3000 mg daily (claim 23).
However, Feuerstein et al. fail to specifically teach the surfactant, polysorbate 20.
Almarsson et al. teach a novel fenofibrate formulation comprising an omega-3-oil, such as EPA and DHA (claims 1-5), an alcohol, and a surfactant (paragraph 0002), for example polysorbate 20 (Table 10), for methods of treating hypertriglyceridemia (claims 12-13).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have substituted the surfactant, polysorbate 20, as taught by Almarsson et al., for the surfactant in the composition comprising DHA and EPA, as taught by Feuerstein et al.
A person of ordinary skill in the art would have been motivated to substitute the particular surfactant, polysorbate 20, because both compositions taught by Feuerstein and Almarsson et al. contain surfactants and are used to treat the same disease, hypertriglyceridemia. Therefore, the skilled artisan would have had a reasonable expectation of success in treating hypertriglyceridemia by administering a composition comprising EPA, DHA, and the surfactant, polysorbate 20.
Response to Arguments
Applicant argues that Almarsson teaches away from using the surfactant, Polysorbate 20, in its formulations. A person skilled in the art would readily understand that a surfactant is not an essential component that contributes to maximizing the solubility of fenofibrate in a liquid formulation. Almarsson is completely silent to the nature or types of surfactants that can be present in the formulations. Moreover, Table 10 in Almarsson teaches that the solubility of fenofibrate is decreased when the surfactant, Cremophor EL, is replaced with Polysorbate 20 by at least 9 mg/mL and as much as 11 mg/mL. Therefore, Polysorbate 20 has a negative impact on the solubility of fenofibrate in Almarsson’s formulations.
This is not persuasive because the argument that a surfactant is not an essential component is moot since the primary reference, Feuerstein et al., already teaches a pharmaceutical composition comprising surfactants. With regard to Almarsson, the types of surfactants are clearly listed in Table 10. With regard to the decrease in solubility of fenofibrate in Table 10, this is not persuasive because Applicant has drawn a wrong conclusion. Just because Polysorbate 20 has a lower solubility on fenofibrate than a different surfactant (Cremophor EL) cannot be considered a teaching away or make fenofibrate completely insoluble for pharmaceutical use. There is simply no teaching or suggestion of this by Almarsson anywhere, let alone in Table 10. Conversely, one of ordinary skill in the art would know that a solubility value of 149 and 147 mg/mL is considered in the art to be easily soluble since it is over the solubility value of 100 mg/mL. Applicant is invited to show that evidence that the state of the art teaches otherwise.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623