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 Objections
Claim 19 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim may depend from a previous claim in the alternative only. See MPEP § 608.01(n). (Furthermore, one of those recited claims, claim 5, is no longer even a pending claim.) Accordingly, the claim 19 has not been further treated on the merits.
Appropriate correction is required.
Claim 25 is objected to because of the following informalities: for grammatical reasons, the examiner respectfully suggests that the claim text should properly read: …calculated by conducting a correction by subtracting the plasma ω3 polyunsaturated fatty acid concentration….
Appropriate correction is required.
Claim 34 is objected to because of the following informalities: for grammatical reasons, the examiner respectfully suggests that the claim text should properly read: …as calculated by conducting a correction by subtracting the ω3 PUFA concentration….
Appropriate correction is required.
Inventor’s assistance is respectfully requested in correcting any other minor spelling and/or grammatical errors which may be present in the claim set.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15, 18-29 and 32-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a self-emulsifying composition comprising 70-90% by weight of the ethyl ester of eicosapentaenoic acid as the ω3 polyunsaturated fatty acid, does not reasonably provide enablement for a preparation containing a self-emulsifying composition comprising 70-90% by weight of the universe of ω3 polyunsaturated fatty acids and the universe of their pharmaceutically acceptable salts and esters. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
With regard to rejections under 35 USC 112(a) or 35 USC 112, first paragraph, the following factors are considered (In re Wands 8 USPQ 2d 1400, 1404 (CAFC 1988)): a) Breadth of claims; b) Nature of invention; c) State of the prior art; d) Level of ordinary skill in the art; e) Level of predictability in the art; f) Amount of direction and guidance provided by the inventor; g) Working examples and; h) Level of experimentation needed to make or use the invention based on the content of the disclosure.
a) The claims are extraordinarily broad:
A self-emulsifying composition comprising, when the total amount of the composition is 100% by weight:
70 to 90% by weight of an ω3 polyunsaturated fatty acid (ω3 PUFA) or a pharmaceutically acceptable salt or ester thereof,… (independent claim 15).
Dependent claims 18-25 (from claim 15) further define the composition and its properties. Independent claim 26, and its dependent claims 27-29 and 32-34, teach a method of utilizing this self-emulsifying composition in treating, preventing or suppressing the progression of a cardiovascular event.
b,c) The nature of the invention is determined in part by the state of the prior art.
The prior art, in general, teaches specific polyunsaturated fatty acid compositions, having specific concentrations of components, for specific therapeutic uses (e.g. European Journal of Pharmaceutical Sciences (2008), 33, pp. 351-360, cited in the IDS).
d) The level of skill in the art is considered to be relatively high.
e) The level of predictability in the art is considered to be relatively low.
The basis of all modern medicine and biology is, of course, chemistry. Yet even under the best of circumstances, and more than two hundred years after Lavoisier laid the foundations of its modern practice, chemistry remains an experimental science. Neither the medicinal/biological arts nor the chemical arts upon which they are based have advanced to the point where certainty has replaced the need for clinical and/or laboratory experimentation.
Note that the enabled scope varies inversely with the degree of unpredictability in the art. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d, 833, 839, 166 USPQ 18, 24 (1970).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples.
All of inventor’s working examples (specification page 106, Table 1, Examples 1-11) utilize a single ω3 polyunsaturated fatty acid ester: ethyl eicosapentaenoate (i.e. the ethyl ester of eicosapentaenoic acid). (All of inventor’s working examples utilize polyoxyethylene (20) sorbitan oleate and/or polyoxyethylene sorbitan trioleate, and/or polyoxyl 35 castor oil and/or polyoxyethylene (60) hydrogenated castor oil as the emulsifiers.)
h) Inventor’s extrapolation from a single working example of a ω3 polyunsaturated fatty acid ester to the universe of ω3 polyunsaturated fatty acids and the universe of their pharmaceutically acceptable salts and esters, is unreasonable. It would clearly require an extraordinary - and thus undue - amount of experimentation, in an unpredictable art, in order to discover firstly, (a) which combinations of 70-90% by weight of the universe of ω3 polyunsaturated fatty acids and the universe of their pharmaceutically acceptable salts and esters, 0.5-6% by weight of water, 1-29% by weight of a polyoxyethylene sorbitan fatty acid ester and a polyoxyethylene castor oil as emulsifiers, and 2.1-36% by weight of lecithin, would yield a self-emulsifying composition, and then secondly, (b) which subset of these self-emulsifying compositions so discovered would prove efficacious in treating, preventing or suppressing the progression of a cardiovascular event (clinical trials, etc.).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The dependency of the claim is unclear because the claim depends from a canceled claim (claim 5). (Note also the related objection to the claim outlined above.)
Allowable Subject Matter
Claims 16, 17, 30 and 31 are 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. The following is a statement of reasons for the indication of allowable subject matter:
US 8,618,168 B2, cited in the IDS and applicant’s own work, may be taken as a representative example of the closest prior art. The reference teaches similar self-emulsifying compositions (column 3, SUMMARY OF INVENTION), but, significantly, explicitly teaches away from the inclusion of water (column 15, line 31).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 3/11/2026
Prosecution Insights