DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 155-162 are pending in the instant invention. According to the Amendments to the Claims, filed April 9, 2024, claims 1-154 were cancelled and claims 155-162 were added.
Status of Priority
This invention is a Continuation-In-Part (CIP) of US Application No. 18/134,495, filed April 13, 2023, which is a Continuation (CON) of US Application No. 18/112,329, filed February 21, 2023 and now US 11,976,063, which is a Continuation (CON) of US Application No. 17/204,776, filed March 17, 2021 and now US 11,685,735, which is a Continuation (CON) of US Application No. 16/351,819, filed March 13, 2019 and now US 10,988,471, which is a Divisional (DIV) of US Application No. 15/303,468, filed October 11, 2016 and now US 10,301,303, which is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2015/085350, filed October 11, 2016, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application Nos.: a) 62/128,077, filed March 4, 2015; b) 62/030,147, filed July 29, 2014; and c) 62/030,140, filed July 29, 2014.
Restrictions / Election of Species
The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on May 16, 2026, is acknowledged: a) Group I - claims 155-160; and b) pharma-ceutical composition comprising: (a) berberine (BBR), or a pharmaceutically acceptable salt thereof; (b1) eicosapentaenoic acid (EPA), or an ester thereof; (b2) docosahexaenoic acid (DHA), or an ester thereof; and (c) a pharmaceutically acceptable excipient, carrier, or diluent - pharma-ceutical composition comprising: (a) berberine (BBR) hydrochloride; (b1) ethyl eicosa-pentaenoate; (b2) ethyl docosahexaenooate; (c) a pharmaceutically acceptable excipient, carrier, or diluent; and (d) vitamin D - p. 57, Example 1. Claims 155-160 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Likewise, the inventor or joint inventor should further note that the elected species was found to be free of the prior art.
Moreover, the inventor or joint inventor should further note that claims 161 and 162 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 155-160 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests identifying: a) the pharmaceutical composition comprising: (a) berberine (BBR), or a pharmaceutically acceptable salt thereof; (b1) eicosapentaenoic acid (EPA), or an ester thereof; (b2) docosahexaenoic acid (DHA), or an ester thereof; and (c) a pharmaceutically acceptable excipient, carrier, or diluent; and b) a particular utility for the pharmaceutical composition comprising: (a) berberine (BBR), or a pharmaceutically acceptable salt thereof; (b1) eicosapentaenoic acid (EPA), or an ester thereof; (b2) docosahexaenoic acid (DHA), or an ester thereof; and (c) a pharmaceutically acceptable excipient, carrier, or diluent.
The following title is suggested: PHARMACEUTICAL COMPOSITIONS COMPRISING BEREBERINE, OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, FOR THE TREATMENT OF VARIOUS DISEASES OR DISORDERS.
Appropriate correction is required.
Claim Objections
Claim 155 is objected to because of the following informalities: for clarity, precision and, to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising:
(a) berberine (BBR) of the following formula:
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or a pharmaceutically acceptable salt thereof;
(b1) eicosapentaenoic acid (EPA) of the following formula:
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or an ester thereof;
(b2) docosahexaenoic acid (DHA) of the following formula:
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or an ester thereof; and
(c) a pharmaceutically acceptable excipient, carrier, or diluent;
wherein the ratio of the weight of berberine (BBR) to the weight of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) is in the range of from 1:1 to 1:8; and
wherein the pharmaceutical composition does not contain any active agent that elicits a biological response, other than (a) berberine (BBR), (b1) eicosapentaenoic acid (EPA), and (b2) docosahexaenoic acid (DHA).
Appropriate correction is required. See MPEP § 2173.02.
Claim 156 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition according to claim 155, wherein the pharmaceutical composition further comprises a pharmaceutically acceptable salt of (a) berberine (BBR) selected from the group consisting of a chloride salt, a citrate salt, and a sulfate salt.
Appropriate correction is required. See MPEP § 2173.02.
Claim 157 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition according to claim 155, wherein the pharmaceutical composition further comprises (b1) ethyl eicosapentaenoate and (b2) ethyl docosahexaenooate.
Appropriate correction is required. See MPEP § 2173.02.
Claim 158 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition according to claim 155, wherein the pharmaceutical composition further comprises (d) at least one additional agent selected from the group consisting of benfotiamine, chrominum picolinate, vanadium, vitamin A, vitamin B12, vitamin C, vitamin D, and vitamin E.
Appropriate correction is required. See MPEP § 2173.02.
Claim 159 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A unit dosage form comprising the pharmaceutical composition according to claim 155.
Appropriate correction is required. See MPEP § 2173.02.
Claim 160 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The unit dosage form according to claim 159, wherein the unit dosage form is formulated as a softgel capsule.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 155-160 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Likewise, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising: (a) berberine (BBR), or a pharmaceutically acceptable salt thereof; (b1) eicosa-pentaenoic acid (EPA), or an ester thereof; (b2) docosahexaenoic acid (DHA), or an ester thereof; and (c) a pharmaceutically acceptable excipient, carrier, or diluent, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 155, 156 and 158-160 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 155 recites the broad limitation, docosahexaenoic acid (DHA) or an ester thereof, with respect to (b2), and the claim also recites ethyl ester of docosahexaenoic acid (DHA), with respect to (b2), which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Next, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 160 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 160 recites the limitation, The unit dosage form of claim 155, being a softgel capsule, in line 1 of the claim.
Similarly, the inventor or joint inventor should further note that there is insufficient antecedent basis, in claim 155, for this limitation, particularly with respect to the unit dosage form comprising a pharmaceutical composition comprising: (a) berberine (BBR), or a pharmaceutically acceptable salt thereof; (b1) eicosapentaenoic acid (EPA), or an ester thereof; (b2) docosa-hexaenoic acid (DHA), or an ester thereof; and (c) a pharmaceutically acceptable excipient, carrier, or diluent, respectively.
Moreover, the inventor or joint inventor should further note that claim 155 recites a pharmaceutical composition comprising: (a) berberine (BBR), or a pharmaceutically acceptable salt thereof; (b1) eicosapentaenoic acid (EPA), or an ester thereof; (b2) docosahexaenoic acid (DHA), or an ester thereof; and (c) a pharmaceutically acceptable excipient, carrier, or diluent, respectively.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - Obviousness-type 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 obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined invention claim is not patentably distinct from the reference claims because the examined invention claim is either anticipated by, or would have been obvious over, the reference claims. {See 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969)}.
US Patent No. 11,369,573
Consequently, at least claims 155-157 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of US Patent No. 11,369,573. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in the instant invention recites a pharmaceutical composition comprising: (a) berberine (BBR), or a pharmaceutically acceptable salt thereof; (b1) eicosa-pentaenoic acid (EPA), or an ester thereof; (b2) docosahexaenoic acid (DHA), or an ester thereof; and (c) a pharmaceutically acceptable excipient, carrier, or diluent, respectively, which is administered within the method for reducing one or more of total cholesterol (TC), triglyceride (TG) and low-density lipoprotein cholesterol (LDL-c) levels, comprising administering… a pharmaceutical composition comprising: (a) berberine (BBR), or a chloride, sulfate, or citrate salt thereof; (b1) ethyl ester of eicosapentaenoic acid (EPA); (b2) ethyl ester of docosahexaenoic acid (DHA); and (c) a pharmaceutically acceptable excipient, carrier, or diluent, respectively, as recited in claim 1 of US 11,369,573.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Moreover, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
US Patent No. 11,883,539
At least claims 159 and 160 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 of US Patent No. 11,883,539. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 159 in US 11,883,539 recites a softgel capsule having a unit dose of a pharmaceutical composition, wherein the pharmaceutical composition consists of: (a) berberine (BBR), or a chloride, sulfate, or citrate salt thereof; (b1) eicosapentaenoic acid (EPA), or an ethyl ester thereof; (b2) docosahexaenoic acid (DHA), or an ethyl ester thereof; and (c) a pharmaceutically acceptable excipient, carrier, or diluent, respectively, which provides overlapping subject matter with respect to the instantly recited unit dosage form comprising a pharmaceutical composition comprising: (a) berberine (BBR), or a pharmaceutically acceptable salt thereof; (b1) eicosapentaenoic acid (EPA), or an ester thereof; (b2) docosahexaenoic acid (DHA), or an ester thereof; and (c) a pharmaceutically acceptable excipient, carrier, or diluent, respectively.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Then, the inventor or joint inventor should further note that a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 37 CFR 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground, provided the conflicting invention or patent either is shown to be commonly owned with this invention, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Moreover, the inventor or joint inventor should further note that the USPTO internet Web site contains terminal disclaimer forms which may be used, and the inventor or joint inventor is encouraged to visit http://www.uspto.gov/forms/, where (i) the filing date of the invention will determine what form should be used, and (ii) a web-based eTerminal Disclaimer may be filled out completely online using web-screens, respectively.
Also, the inventor or joint inventor should further note that an eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
Finally, for more information about eTerminal Disclaimers, the inventor or joint inventor should refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
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