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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 20, 2026 has been entered.
DETAILED ACTION
3. Claims 1, 8, 13, and 23 – 29 are pending in this application. Applicant’s Amendment and Remarks, filed January 20, 2026, is entered, wherein claims 1 and 8 are amended, claims 2 – 7, 9 – 12, and 14 – 22 are canceled, and claims 23 – 29 are new.
Claims 1, 8, 13, and 23 – 29 are currently examined.
Priority
4. This application is a national stage application of PCT/EP2021/057615, filed March 24, 2021, which claims benefit of foreign priority document EP20167493.4, filed April 1, 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections
5. The objection of claims 1 and 8 in the previous Office Action, mailed October 20, 2025, is withdrawn in view of the amended claims 1 and 8.
Withdrawn Rejections
6. The rejection of claims 2 – 6 and 10 – 12 in the previous Office Action, mailed October 20, 2025, 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for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention has been considered and is withdrawn in view of the canceled claims 2 – 6 and 10 – 12.
The rejection of claims 1 – 6, 8 – 15, and 18 – 19 in the previous Office Action, mailed October 20, 2025, under 35 U.S.C. 103 as being unpatentable over Bhosale et al. with evidence provided by Evonik in view of Kähkönen et al. and Wei et al. has been considered and is withdrawn in view of the amended claim 1.
The rejection of claims 16 – 17 and 20 – 21 in the previous Office Action, mailed October 20, 2025, under 35 U.S.C. 103 as being unpatentable over Bhosale et al. with evidence provided by Evonik in view of Kähkönen et al. and Wei et al., and further in view of Eidenberger has been considered and is withdrawn in view of the amended claim 1.
The rejection of claims 1 – 6, 8 – 10, and 13 in the previous Office Action, mailed October 20, 2025, on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 7 – 8, and 11 of copending Application No. 17/907,645 (reference application with claim set of August 27, 2025) with evidence provided by Kähkönen et al. has been considered and is withdrawn in view of the amended claim 1.
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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 13, 23, and 25 – 28 are rejected under 35 U.S.C. 103 as being unpatentable over NBR (Nutraceutical Business Review, 2018, Reference included with PTO-892) in view of Bell (Journal of Applied Physiology, 2006, Vol. 100, Issue 4, page 1164 – 1170, Reference included with PTO-892), with evidence provided by EMA (ema.europa.eu, 2015, Reference included with PTO-892), and Engler (Annals of Nursing and Practice, 2017, Vol. 4, Issue 1, page 1 – 9, Reference included with PTO-892).
a. Regarding claims 1, 13, 23, and 25 – 28, NBR teaches that omega-3 fatty acids confer a protective effect by reducing plasma triglycerides, blood pressure and inflammation, all of which are risk factors for atherosclerosis (page 2, para. 2). NBR teaches AvailOm is a highly purified omega-3 product containing high levels of EPA and DHA presented as a complex between the omega-3 free fatty acids and the natural amino acid lysine. This product is in the form of a powder that has superior stability compared with the ethyl ester and the free fatty acid forms and has a higher bioavailability compared with other commercial forms of omega-3 (page 3, para. 3 – 4 and 6).. NBR teaches that the minimum concentration of EPA and DHA in AvailOm is 45% (page 4, para. 5).
However, NBR does not disclose administering the composition comprising cyanidin-3-galactoside with a weight ratio of polyunsaturated fatty acid component to the anthocyanin component in a range of from 1:1 to 1:6 and NBR does not explicitly teach the composition will induce vasorelaxation.
Bell teaches that chokeberry contains four different anthocyanins with ~90% of its Ta content due to cyanidin-3-galactoside and cyanidin-3-arabinoside (page 1165, Left Col., para. 1). Chokeberry and Bilberry extracts produce dose-dependent vasorelaxation in isolated rings with endothelium. Response to chokeberry extract product the greatest degree of relaxation (page 1167, Right Col., para. 3). Bell teaches that chokeberry produce % maximal relaxation at 5 mg total anthocyanins per liter (Abstract). According to EMA, bilberry contains 15.3% delphinidin-3-arabinoside, which is the highest among all anthocyanins (page 5 – 6, Table 1).
Engler teaches that both EPA and DHA exert vasorelaxant effects in isolated arteries (page 5, Left Col., para. 4).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the AvailOm as taught by NBR with cyanidin-3-galactoside in view of Bell and Engler because both omega-3 fatty acids (EPA and DHA) and anthocyanins are known to induce vasorelaxation. It would have been obvious for one of ordinary skill in the art to do this because both AvailOm and chokeberry containing high amount of cyanidin-3-galactoside are known separately in the prior art for the purpose of vasorelaxation, and it would have been obvious to combine them for the same purpose. One would have been motivated to administer AvailOm rather than individual EPA and DHA because AvailOm offers superior bioavailability and stability. For the weight ratio of polyunsaturated fatty acid component to the anthocyanin component, NBR discloses the minimal concentration of EPA/DHA in AvailOm and Bell teaches the amount of total anthocyanins per liter for %maximal relaxation. Based on these disclosure, one would have performed routine experimentation to discover the best weight ratio for optimal treatment characteristics. Bell teaches that anthocyanin-rich berry extract exhibit vasorelaxation and further teaches that such vascular activity is associated with the anthocyanin content of the extract. EMA teaches that bilberry contains delphinidin-3-arabinoside as a known and major anthocyanin constituent. It would have been obvious to one of ordinary skill in the art to combine AvailOm and cyanidin-3-galactoside with delphinidin-3-arabinoside in the composition because delphinidin-3-arabinoside is a known anthocyanin from a berry source already taught in the art to provide vasorelaxation benefit. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to combine the AvailOm as taught by NBR with cyanidin-3-galactoside and delphinidin-3-arabinoside in view of Bell and Engler because it is well known to combine drugs for the same purpose to produce predictable effects.
Claims 8, 24, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over NBR (Nutraceutical Business Review, 2018, Reference included with PTO-892) in view of Thilavech et al. (Biomedicine & Pharmacotherapy, 2017, Vol. 95, Issue 2017, page 1251 – 1259, Reference included with PTO-892), and Engler (Annals of Nursing and Practice, 2017, Vol. 4, Issue 1, page 1 – 9, Reference included with PTO-892).
b. Regarding claims 8, 24, and 29, NBR teaches that omega-3 fatty acids confer a protective effect by reducing plasma triglycerides, blood pressure and inflammation, all of which are risk factors for atherosclerosis (page 2, para. 2). NBR teaches AvailOm is a highly purified omega-3 product containing high levels of EPA and DHA presented as a complex between the omega-3 free fatty acids and the natural amino acid lysine. This product is in the form of a powder that has superior stability compared with the ethyl ester and the free fatty acid forms and has a higher bioavailability compared with other commercial forms of omega-3 (page 3, para. 3 – 4 and 6).. NBR teaches that the minimum concentration of EPA and DHA in AvailOm is 45% (page 4, para. 5).
However, NBR does not disclose administering the composition comprising cyanidin-3-rutinoside with a weight ratio of the lysine salt of the EPA and DHA to the cyanidin-3-rutinoside in a range of from 1:1 to 1:6 and NBR does not explicitly teach the composition will induce vasorelaxation.
Thilavech et al. teach that cyanidin-3-rutinoside induce vasorelaxation in aortic rings with the EC50 of 2.43±0.57 for 92% maximum relaxation (Abstract).
Engler teaches that both EPA and DHA exert vasorelaxant effects in isolated arteries (page 5, Left Col., para. 4).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the AvailOm as taught by NBR with cyanidin-3-rutinoside in view of Thilavech et al. and Engler because both omega-3 fatty acids (EPA and DHA) and anthocyanins are known to induce vasorelaxation. It would have been obvious for one of ordinary skill in the art to do this because both AvailOm and cyanidin-3-rutinoside are known separately in the prior art for the purpose of vasorelaxation, and it would have been obvious to combine them for the same purpose. One would have been motivated to administer AvailOm rather than individual EPA and DHA because AvailOm offers superior bioavailability and stability. For the weight ratio of the lysine salt of the EPA and DHA to the cyanidin-3-rutinoside, NBR discloses the minimal concentration of EPA/DHA in AvailOm and Thilavech et al. teach the amount of EC50 for maximum relaxation. Based on these disclosure, one would have performed routine experimentation to discover the best weight ratio for optimal treatment characteristics. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to combine the AvailOm as taught by NBR with cyanidin-3-rutinoside in view of Thilavech et al. and Engler because it is well known to combine drugs for the same purpose to produce predictable effects.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed January 20, 2026, have been fully considered and are found to be not persuasive.
Regarding the rejections, Applicant argues that no combination of the cited art describes the composition as claimed. However, the argument is moot because the rejections are now relied upon newly cited references. NBR teaches the AvailOm composition and Bell and Thilavech et al. teach the claimed anthocyanins. With the disclosure of Engler, it would have been obvious to combine the AvailOm with the claimed anthocyanins because they are known in the art for the effect of vasorelaxation.
Applicant further argues that the claimed ratio recited in claims 1, 8, and 23 – 24 not only improve dose-dependent vasorelaxation and nitric oxide production, but provide unexpected improvement. However, the argument is not persuasive because the results are limited. The data provided is not sufficient to establish unexpected results over the full scope of the claims. For example, the example provided only tests a limited number of embodiments, but does not test AvailOm in combination with delphinidin-3-arabinoside. Further, the example tests only a limited ratio. Applicant has not shown that the synergistic effect extends across the full claimed range. Therefore, the results are not commensurate in scope with the claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 13, 23, and 25 – 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 7 – 8, and 13 – 23 of copending Application No. 17/907,645 in view of Bell (Journal of Applied Physiology, 2006, Vol. 100, Issue 4, page 1164 – 1170, Reference included with PTO-892), with evidence provided by EMA (ema.europa.eu, 2015, Reference included with PTO-892), and Engler (Annals of Nursing and Practice, 2017, Vol. 4, Issue 1, page 1 – 9, Reference included with PTO-892).
a. Regarding claims 1, 13, 23, and 25 – 28, ‘645 teaches a composition comprises an amino acid salt of EPA and an amino acid salt of DHA; and cyanidin-3-glucoside, delphinidin-3-glucoside, malvidin-3-galactoside, peonidin-3-galactoside and/or malvidin-3-glucoside, wherein a weight ratio of the polyunsaturated fatty acid component to the anthocyanin component is in a range from 1:1 to 1:6 (claims 1, 7, 13 – 19, and 22 – 23). The amino acid salt comprises lysine (claims 2 and 8). (claim 11). The EPA and DHA are present in a range of from 40 to 65 wt.% relative to total amino acid salt weight (claims 20 – 21).
However, ‘645 does not teach a method of treating a disease, such as atherosclerosis, by inducing vasorelaxation, wherein the method comprises administering a lysine salt of EPA and DHA and cyanidin-3-galactoside and delphinidin-3-arabinoside.
Bell teaches that chokeberry contains four different anthocyanins with ~90% of its Ta content due to cyanidin-3-galactoside and cyanidin-3-arabinoside (page 1165, Left Col., para. 1). Chokeberry and Bilberry extracts produce dose-dependent vasorelaxation in isolated rings with endothelium. Response to chokeberry extract product the greatest degree of relaxation (page 1167, Right Col., para. 3). Bell teaches that chokeberry produce % maximal relaxation at 5 mg total anthocyanins per liter (Abstract). According to EMA, bilberry contains 15.3% delphinidin-3-arabinoside, which is the highest among all anthocyanins (page 5 – 6, Table 1).
Engler teaches that both EPA and DHA exert vasorelaxant effects in isolated arteries (page 5, Left Col., para. 4).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the lysine salt of EPA and DHA as taught by ‘645 with cyanidin-3-galactoside in view of Bell and Engler because both omega-3 fatty acids (EPA and DHA) and anthocyanins are known to induce vasorelaxation. It would have been obvious for one of ordinary skill in the art to do this because both the lysine salt of EPA and DHA and chokeberry containing high amount of cyanidin-3-galactoside are known separately in the prior art for the purpose of vasorelaxation, and it would have been obvious to combine them for the same purpose. For the weight ratio of polyunsaturated fatty acid component to the anthocyanin component, ‘645 discloses the weight ratio of the polyunsaturated fatty acid component to the anthocyanin component and Bell teaches the amount of total anthocyanins per liter for %maximal relaxation. Based on these disclosure, one would have performed routine experimentation to discover the best weight ratio for optimal treatment characteristics. Bell teaches that anthocyanin-rich berry extract exhibit vasorelaxation and further teaches that such vascular activity is associated with the anthocyanin content of the extract. EMA teaches that bilberry contains delphinidin-3-arabinoside as a known and major anthocyanin constituent. It would have been obvious to one of ordinary skill in the art to combine the lysine salt of EPA and DHA as taught by ‘645 with cyanidin-3-galactoside and delphinidin-3-arabinoside in the composition because delphinidin-3-arabinoside is a known anthocyanin from a berry source already taught in the art to provide vasorelaxation benefit. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to combine the lysine salt of EPA and DHA as taught by ‘645 with cyanidin-3-galactoside and delphinidin-3-arabinoside in view of Bell and Engler because it is well known to combine drugs for the same purpose to produce predictable effects.
This is a provisional nonstatutory double patenting rejection.
Claims 8, 24, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 7 – 8, and 13 – 23 of copending Application No. 17/907,645 in view of Thilavech et al. (Biomedicine & Pharmacotherapy, 2017, Vol. 95, Issue 2017, page 1251 – 1259, Reference included with PTO-892), and Engler (Annals of Nursing and Practice, 2017, Vol. 4, Issue 1, page 1 – 9, Reference included with PTO-892).
b. Regarding claims 8, 24, and 29, ‘645 teaches a composition comprises an amino acid salt of EPA and an amino acid salt of DHA; and cyanidin-3-glucoside, delphinidin-3-glucoside, malvidin-3-galactoside, peonidin-3-galactoside and/or malvidin-3-glucoside, wherein a weight ratio of the polyunsaturated fatty acid component to the anthocyanin component is in a range from 1:1 to 1:6 (claims 1, 7, 13 – 19, and 22 – 23). The amino acid salt comprises lysine (claims 2 and 8). (claim 11). The EPA and DHA are present in a range of from 40 to 65 wt.% relative to total amino acid salt weight (claims 20 – 21).
However, ‘645 does not disclose administering the composition comprising cyanidin-3-rutinoside and ‘645 does not explicitly teach the composition will induce vasorelaxation.
Thilavech et al. teach that cyanidin-3-rutinoside induce vasorelaxation in aortic rings with the EC50 of 2.43±0.57 for 92% maximum relaxation (Abstract).
Engler teaches that both EPA and DHA exert vasorelaxant effects in isolated arteries (page 5, Left Col., para. 4).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the lysine salt of EPA and DHA as taught by ‘645 with cyanidin-3-rutinoside in view of Thilavech et al. and Engler because both omega-3 fatty acids (EPA and DHA) and anthocyanins are known to induce vasorelaxation. It would have been obvious for one of ordinary skill in the art to do this because both the lysine salt of EPA and DHA and cyanidin-3-rutinoside are known separately in the prior art for the purpose of vasorelaxation, and it would have been obvious to combine them for the same purpose. For the weight ratio of the lysine salt of the EPA and DHA to the cyanidin-3-rutinoside, ‘645 discloses the weight ratio of the polyunsaturated fatty acid component to the anthocyanin component and Thilavech et al. teach the amount of EC50 for maximum relaxation. Based on these disclosure, one would have performed routine experimentation to discover the best weight ratio for optimal treatment characteristics. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to combine the lysine salt of EPA and DHA as taught by ‘645 with cyanidin-3-rutinoside in view of Thilavech et al. and Engler because it is well known to combine drugs for the same purpose to produce predictable effects.
This is a provisional nonstatutory double patenting rejection.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed January 20, 2026, have been fully considered and are found to be not persuasive.
Applicant does not provide additional arguments for the double patenting rejection in particular. The arguments are all addressed as discussed above.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOI YAN LEE whose telephone number is 571-270-0265. The examiner can normally be reached Monday - Thursday 7:30 - 17:30.
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, SCARLETT GOON can be reached at 571-270-5241. 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.
/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693