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 .
Status of Application
Receipt of Preliminary Amendment filed on September 6, 2024 is acknowledged.
Claims 1-16 are pending this application.
Claims 3-16 have been amended.
No claims have been cancelled.
All claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on September 6, 2024; August 11, 2025; September 4, 2025; September 8, 2025; September 19, 2025; November 17, 2026; January 9, 2026; April 5, 2026; May 27, 2026; September 3, 2026; and October 5, 2026 is acknowledged. Signed copies are attached to this office action.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 3-6, 8, and 14-16 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.
Regarding claims 3-6 and 8, the claims recite “in particular”, the phrase renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding claim 4, the claim has been amended to depend from claim 1, however, the claim also recites “according to any of the preceding claims”, therefore, it is unclear what the metes and bounds of the claim are.
Regarding claims 14-16, the claims recite the “Use of an animal feed, drinking water, or animal feed additive”, however, the claims merely recites a use without any active, positive steps delimiting how this use is actually practiced.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9-13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims are drawn to an animal feed, drinking water, or animal feed additive (a composition of matter). Claims 9-13 do not further limit the structural elements of claim 1, from which claims 9-13 depend. The claims recite future intended use of the composition. Applicant is reminded that future intended use does not hold patentable weight in a composition claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the instantly rejected claims are drawn to the “use” of a composition. It appears to be an attempt to claim a process without setting forth any steps involved in the process.
Allowable Subject Matter
The claims are free of the art. The closest prior art is that of:
Maroko (US 4,761,417) which discloses a therapeutic method for increasing contractility of the mammalian heart as shown by a positive inotropic effect which comprises administering to a mammal in need thereof in an amount effective to cause a positive inotropic effect, a composition which comprises a biologically acceptable carrier and a compound selected from the group consisting of berberrubine and the pharmaceutically acceptable salts thereof, causing a positive inotropic effect and discontinuing administration (abstract).
Park et al. (KR 20050082448) which relates to a composition for the prevention and treatment of arteriosclerosis, hyperlipidemia and liver disease, which contains tetrahydroberberine as an active ingredient, and more specifically, activity of lowering the concentration of lipids in the blood and strongly inhibiting liver cell damage and fatty liver formation. It relates to a composition for the prevention and treatment of atherosclerosis, hyperlipidemia and liver disease containing tetrahydroberberine (abstract).
There is no disclosure within the prior art of berberrubine and canadine in the same composition, nor is there motivation to combine the compounds into a single composition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615