DETAILED ACTION
The Office Action is in response to the Applicant's reply filed July 9, 2026 to the non-final rejection made on June 17, 2026.
Claims 1, 5, 9, 11, 13-15 are pending. Claims 1, 5, 9, 11, 13-15 herein acted on the merits.
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 .
Priority
This application filed 08/05/2022 is a 371 of PCT/KR2020/011962 filed on 09/04/2020 which claims foreign priority to KOREA, REPUBLIC OF 10-2019-0125775 filed on 10/11/2019.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 103 rejection of claims 1, 5, 9, and 13-15 over Wang et al. (KR 20070065996 A) is not persuasive. The rejection is herewith maintained. Applicant argues “in the claimed omega-3 fatty acid composition, the amphiphilic lipids containing a nonpolar tail group having 14 to 20 carbon atoms and a polar head group having a hydroxyl (-OH) or carboxyl group (-COOH), which are included in the liquid crystal former, function to form nanometer-scale liquid crystalline structures in an aqueous medium. As a result, they increase the solubility and dissolution of the omega-3 fatty acids under physiological conditions and thereby play a critical role in enhancing their in vivo absorption. However, neither Wang nor Rychen contains any teaching, suggestion, or motivation regarding such amphiphilic lipids or their function.”
In response, Wang et al. teaches glycerin fatty acid ester “plays a role of the secondary liquid crystal film forming agent together with the lecithin containing the phospholipid which is the primary liquid crystal film forming agent, and forms a powerful liquid crystal film to block the polyunsaturated fatty acid from the outside to maximize stability.” Furthermore, Wang et al. teaches “homomixed mixture passes through the microfluidizer and the particle size is reduced to a very small size. The lipophilic portion of the amphiphilic phospholipid contains liquid crystals at the interface between fats and oils containing polyunsaturated fatty acids and fats containing heavy chain fatty acids. It becomes easy to form a film.” Further, the fat or oil containing polyunsaturated fatty acid in the composition “is contained within the film stably formed by the liquid crystal film forming agent. Since the microliquid crystal film prevents direct contact with external stimuli, weak fats and oils are protected, and dispersibility is increased, and it is easy to mix when added to other foods. In addition, due to the relatively low intermolecular molecular mobility of the liquid crystal film, stability is improved.
Applicant argues “Furthermore, according to the present invention, the liquid crystal former comprising amphiphilic lipids and the liquid crystalline structure-forming aid spontaneously form thermodynamically stable self-assembled lyotropic liquid crystals in the gastrointestinal tract, irrespective of the digestive process. As a consequence, the omega-3 fatty acids are effectively solubilized, resulting in a remarkable improvement in dissolution. Accordingly, the present invention significantly improves the in vivo absorption of omega-3 fatty acids and enables equivalent or superior therapeutic efficacy to be achieved with a smaller amount of omega-3 fatty acids than conventional formulations. This, in turn, allows the capsule size to be reduced, thereby improving patient compliance.”
In response, absent any evidence to the contrary, it would be expected for the Wang et al. formulation to significantly improve in vivo absorption of omega-3 fatty acids and enable equivalent or superior therapeutic efficacy to be achieved, as the reference teaches prevention “of direct contact with external stimuli, weak fats and oils are protected, and dispersibility is increased.” The Examiner’s contention is that the claims are drawn to a formulation and not a method of use, as argued, however, Wang et al. describes the microliquid crystal film is easy to mix when added to other foods. Additionally, the claims do not relate to any specific amounts of omega-3 fatty acids, and no data is provided comparing the formulation with “conventional formulations.”
Lastly, Applicant argues the weight ratios were added to the claims to further distinguish from Wang et al.
The Examiner points out that in the absence of showing the criticality, the part by weight ratios of the liquid crystal former with respect to the liquid crystal structure forming aid are deemed to be manipulatable parameters practiced by an artisan to obtain the best possible pharmaceutical results.
Applicant’s arguments over the 35 U.S.C. 103 rejection of claim 11 over Wang et al. (KR 20070065996 A), as applied to claims 1, 5, 9, and 13-15, in view of Rychen et al. (Safety and efficacy of butylated hydroxyanisole (BHA) as a feed additive for all animal species. EFSA J. 2018;16:e05215) depends on the validity of the previous arguments which were not found persuasive.
The rejections are as below:
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 5, 9, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (KR 20070065996 A).
Wang et al. teaches a liquid crystal membrane emulsion composition comprises 10-80 parts by weight of fat and oil containing highly unsaturated fatty acid; 10-80 parts by weight of fat and oil containing a middle chain fatty acid; 1-10 parts by weight of the lecithin containing 25-85 wt% of phospholipid; and 1-15 parts by weight of a glycerin fatty acid ester. Preferably, the highly unsaturated fatty acid is DHA, EPA, gamma-linolenic acid or arachidonic acid (claim 9). The glycerin fatty acid ester is preferably selected from the group consisting of glycerin monolaurate, glycerin monooleate, polyglycerine-2-oleate, polyglycerine-2-stearate, and mixtures thereof. The composition of the present invention is a fat or oil containing polyunsaturated fatty acid is encapsulated in the micro-liquid crystal film, the oxidation stability is ensured, long-term storage is possible, and easy handling (reads on soft capsule). The fats and oils containing polyunsaturated fatty acids in the present invention are vegetable oils and animal fats.
While the reference teaches the composition of the claims, the reference fails to teach the weight ratios or omega-3-fatty acid amount, as claimed.
It would have been obvious to one of ordinary skill in the art at the time of filing to use liquid crystal formers or omega-3-fatty acid claimed amounts. The motivation to use liquid crystal formers or omega-3-fatty acid in the amounts claimed is because Wang teaches an amount of less than 1 part by weight is difficult to form a sufficient liquid crystal film and that the emulsion is added to foods. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results. Additionally, since the general conditions of the claim are taught in the prior art, discovering optimum or workable amounts of liquid crystal formers or omega-3-fatty acid and the part by weight ratios of the liquid crystal former with respect to the liquid crystal structure forming aid involves only routine skill in the art (In re Aller).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (KR 20070065996 A), as applied to claims 1, 5, 9, and 13-15, in view of Rychen et al. (Safety and efficacy of butylated hydroxyanisole (BHA) as a feed additive for all animal species. EFSA J. 2018;16:e05215.)
Wang et al. is as discussed above.
Wang et al. fails to teach the use of antioxidants in the formulation.
Rychen et al. teaches of butylated hydroxyanisole (BHA) as a feed additive for all animal species.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate butylated hydroxyanisole (BHA). The motivation to incorporate butylated hydroxyanisole (BHA) is because Rychen et al. teaches of butylated hydroxyanisole (BHA) as a feed additive for all animal species. Therefore, a skilled artisan would have reasonable expectation in success to encapsulated in soft gelatin capsules a lipid or lipophilic vehicle.
Conclusion
No claims allowed.
The arguments are not persuasive and the rejection is made FINAL.
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 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 LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
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:/Awww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, James Henry Alstrum-Acevedo, can be reached on (571)272-5548. 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.
/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
Prosecution Insights