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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 RCE filed on November 28, 2025 and response submission filed on 11/07/2025 have been entered.
Response to Amendment
Applicant's amendment and argument filed 11/07/2025, in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 49, 81, 83-85 are pending and being examined on the merits.
Claim Rejections - 35 USC § 112
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.
Claims 84 and 85 are 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.
Claims 84 and 85 recite “a derivative or analog of berberine” and there appears to be no antecedent basis for this limitation in any of the preceding base claims. Claims 81 and 49 do not recite either limitation and therefore there is not antecedent basis.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 49, 81, 83-85 are rejected under 35 U.S.C. 103 as being unpatentable over Harris (Fish Oil supplementation: Evidence for health benefits, Cleveland Clinic Journal of Medicine, Vol 71, No 3, March 2004), Yan (Berberine promotes recovery of colitis and inhibits inflammatory responses in colonic macrophages and epithelial cells in DSS-treated mice, Am J Physiol Gastrointest Liver Physiol, Mar 1, 2012; 302(5): G504-G514) and Morris (WO2015034984A1). This is a new rejection based on the amendment and arguments filed on 11/07/2025.
Harris general disclosure is a report on the benefits of fish oil supplementation (see abstract).
Harris teaches that Omega-3 fatty acids have shown benefits in treating Crohn’s disease and ulcerative colitis (see page 218, Are Omega-3 Oils beneficial in noncardiac conditions). Both of these are inflammatory bowel diseases.
Harris also teaches that fish oil supplements are available as a triglyceride-based form or as a methyl or ethyl ester form and that there is little justification for choosing one formulation over the other but that Omega-3 products in the methyl ester or ethyl ester form are usually more concentrated than triglyceride forms: i.e., fewer capsules per day are required to achieve target intakes (see page 218, Is One Fish Oil Formulation Better Than Another?).
Harris also teaches generally 1 g of EPA and DHA per day would be an ideal amount for daily (see page 217, How Much Fish? How Many Capsules) is recommended (also see The AHA recommends 1 g of EPA/DHA per day, page 216, left side). Harris teaches the EPA/DHA to be in capsule form (see table 2).
Harris does not specifically teach wherein the composition comprises berberine pharmaceutical acceptable salt thereof.
Yan’s general disclosure is a scientific report on berberine promoting recovery of colitis and inhibiting inflammatory responses in the colon (see abstract).
Yan teaches “Berberine, an alkaloid derived from plants, is an alternative medicine for treating bacterial diarrhea and intestinal parasite infections. Recent studies suggest that berberine exerts several other beneficial effects, including inducing anti-inflammatory responses. Berberine ameliorated DSS-induced body weight loss, myeloperoxidase activity, shortening of the colon, injury, and inflammation scores. DSS-upregulated proinflammatory cytokine levels in the colon, including TNF, IFN-γ, KC, and IL-17 were reduced by berberine. Berberine decreased DSS-induced disruption of barrier function and apoptosis in the colon epithelium. Furthermore, berberine inhibited proinflammatory cytokine production in colonic macrophages and epithelial cells in DSS-treated mice and promoted apoptosis of colonic macrophages. In summary, berberine promotes recovery of DSS-induced colitis and exerts inhibitory effects on proinflammatory responses in colonic macrophages and epithelial cells. Thus, berberine may represent a new therapeutic approach for treating gastrointestinal inflammatory disorders” (see abstract).
Yan also teaches berberine chloride (Sigma-Aldrich, St. Louis, MO) was administered through gavage at 100 mg·kg body wt−1·day−1 for the 3-day recovery after 4-day DSS treatment or 2-, 4-, and 6-day recovery after 7-day DSS treatment.
Morris teaches dietary formulations which comprise berberine (see claim 14) and an omega-3 fatty acid, or esters thereof (see claim 1) and wherein the composition can be useful for treating small bowel inflammation (see claim 19), specifically Chron’s disease (see page 58, line 15). Morris additionally teaches using berberine salt forms such as chloride and sulfate (see page 19, lines 27-30).
Morris also teaches using soft gels (see page 45, line 15) and the use of vitamin E, A, D and K (see claim 1, part c) and claims 4-5) and teaches calcium (see page 20 lines 13-30), and berberine (see pages 18, line 23, 19, line 2, page 32 lines 14-32, etc.).
Therefore, it would have been obvious at the effective filing date to combine one or more omega-3 fatty acids and berberine for the treatment of inflammatory bowel disease or related disease or condition, because Harris teaches that EPA and DHA have an increasing benefit in doing so and Yan teaches that berberine has many benefits for treating IBD, specifically inhibiting inflammation, ameliorated body weight loss, shortening of the colon etc. It is further obvious to include vitamins in the formulation as Morris teaches including these in soft gel formulations along with berberine and/or different salts thereof for treating Chron’s disease. Selecting these components would have been prima facie obvious given the prior art and with the knowledge of those having ordinary skill in the art.
It would also been obvious to use the ethyl ester formulations of EPA and DHA because they are more concentrated than the free form and would cost less to utilize in the composition and/or require fewer doses and when compared to the other formulations there appears to be no difference in formulations.
It would further have been obvious to comprise these components into a unit dosage from, a soft gel capsule with a pharmaceutically acceptable carrier or a kit, and in the ratios of the instant invention because Harris teaches the EPA/DHA recommendations should be at 1 g and Yan teaches the berberine being administered at 100 mg, thus this would equal a ratio of 1: 10 which is within the amount being claimed. Providing instructions in a kit does not make the kit, product or composition patentably distinct from the prior art and would have been obvious before the effective filing date.
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 49, 81, 83-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18-20 and 76 of U.S. Patent No. US11865106. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a composition comprising of the same active components berberine, EPA and DHA ethyl esters which when considered can be the same as the instantly claimed omega-3 fatty acids or esters thereof, within the same ratios and for the same purpose (same patient population). Selecting EPA and DHA as the omega-3 fatty acids or ethyl esters thereof would have been prima facie obvious as these are some of the most commonly studied omega-3 fatty acids.
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive. The applicant argues that Belluzzi, which is a reference cited by Harris teaches a fish oil preparation with an unspecified composition, particularly that while it is known that fish oils are rich in omega-3 fatty acids, Belluzzi is silent with regard to what the actual omega-3 fatty acids are and which ones are responsible for the observed outcome. Belluzzi does not have to teach which particular omega-3 fatty acids exert what particular mechanism of action because Harris is the art being relied upon. Additionally, if it is the intent of the applicant to rely on additional references, the applicant should provide them in an IDS and submit the reference, not merely make statements in their argument directing the Office’s attention to those teachings. Those arguments pertaining to art not relied upon are not being taken into consideration at this point.
The applicant argues that their claim 1 recites a pharmaceutical composition “consisting of”: (a) berberine, or a chloride, sulfate or citrate salt thereof, (bl) ethyl ester of eicosapentaenoic acid, and (b2) ethyl ester of docosahexaenoic acid, with no other active ingredients. The applicant’s last set of amended claims do not recite such limitations. The most currently amended claims set recites “comprising of” language and indeed recites more active ingredients than the components just recited (see claim set dated 11/07/2025).
The applicant argues that Yan’s teachings did not focus on berberine in combination with EPA/DHA. The Office did not make an anticipatory rejection with Yan and instead made an obviousness type rejection which relies on multiple pieces of art to show why it would have been obvious to combine the information obtained through those pieces in creating the instant invention.
The applicant argues that Morris does not provide working examples that provides evidence as to which exemplary formulation would be suited for which disease. Morris does not need to supply an exemplary formulation to require their teachings to be enabling or to give support for their teachings. The applicant argues that Morris does not teach the proper ratio of berberine to omega-3 fatty acids. Morris does not teach this component however Yan and Harris do because Harris teaches the EPA/DHA recommendations should be at 1 g and Yan teaches the berberine being administered at 100 mg, thus this would equal a ratio of 1: 10 which is within the amount being claimed. The applicant argues that due to technical evidence that there would be undue experimentation needed to combine the art references together to arrive at the instant invention, but this statement is conclusory at best. Given the prior art it would have been obvious to combine these components into a single formulation such as a unit dosage soft gel capsule for treating symptoms of IBD as this is exactly what the art teaches each component to be useful for.
Conclusion
Currently no claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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, Anand Desai can be reached at 571-272-0947.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.
JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655