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 claims
Claims 1-13 as filed on 8/08/2024 are pending and under examination.
Claim Objections
Claim 10 is objected to because of the following informalities:
Term “cisplatin” repeated twice.
Appropriate clarification or correction is required.
Claim Rejections - 35 USC § 112
Indefinite
Claims 7 is 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.
Claim 7 is rendered indefinite by the phrase “comprised at a concentration of 70 to 500 mg/kg” because it is unclear whether this claim is intended to encompass a dose per 1 kg of a body of a subject under treatment. Concentration of extract being such 60-500 mg per 1 kg of a pharmaceutical composition appears to be questionable since pharmaceutical compositions are not normally measured in kg.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 8-13 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Lee et al (IDS reference; Frontiers in Immunology, 2020, Vol. 11, article 77, pages 1-17).
The cited reference by Lee discloses a method for preventing or treating a muscle diseases caused by cancer and anti-cancer drug side effect, wherein the method comprises step of administering to a subject in need thereof a pharmaceutical composition comprising a Magnolia officinalis extract or a magnolol from Magnolia officinalis as an active ingredient, wherein the subject is a cisplatin-induced sarcopenia mouse model (see entire document including abstract). Sarcopenia is a cancer cachexia defined as degenerative skeletal muscle loss and decline of muscle strength (see first line at introduction). Magnolol from Magnolia officinalis successfully prevented body weight loss and muscle mass in subjects under treatment (page 8, col.1).
Thus, the cited reference by Lee clearly anticipates claims 1-4 and 8-13.
Claim Rejections - 35 USC § 103
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (IDS reference; Frontiers in Immunology, 2020, Vol. 11, article 77, pages 1-17) in view of US 6,500,409 (Scherl et al), Park et al (Animal Cells and Systems, 2020, Vol. 24, No. 1, pages 60-68) and Wei et al (Frontiers in Cell and Developmental Biology, April 2021, Vol. 9, Article 634607, pages 1-20).
The cited reference by Lee is relied upon as explained above for the disclosure of a method for preventing or treating a muscle diseases caused by cancer and anti-cancer drug side effect, wherein the method comprises step of administering to a subject in need thereof a pharmaceutical composition comprising a Magnolia officinalis extract or a magnolol from Magnolia officinalis as an active ingredient, wherein the subject is a cisplatin-induced sarcopenia mouse model (see entire document including abstract)
The cited reference by Lee does not disclose how magnolol was extracted from Magnolia officinalis; and the reference is silent about the use of honokiol.
However, the prior art, for example: US 6,500,409 (Scherl et al), teaches that therapeutic extracts from Magnolia officinalis are made with various solvents including aqueous and organic solvents (col. 2, lines 55-65) and that the whole Magnolia officinalis extract contains about 15-25% by weigh of magnolol and about 5-10% by weigh of its isomer honokiol (col. 3, lines 9-10). Thus, both compounds are present in extracts from Magnolia officinalis in the same ratio or at least in overlapping ratios as recited in the claimed.
Further, it is known in the prior art that honokiol from Magnolia officinalis has multiple pharmacological activities against a variety of diseases and that honokiol was shown to provide against oxidative stress-induced DNA damage and apoptosis of myoblast cells (see abstract of Park). Honokiol is also found effective against doxorubicin-stimulated senescence (see Wei at page 13, col. 2, lines 6-8).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to use whole Magnolia officinalis extract or to add honokiol from Magnolia officinalis to magnolol from Magnolia officinalis in the therapeutic composition in the method of Lee for preventing cancer and/or cancer drug-caused muscle diseases with a reasonable expectation of success in preventing cancer and/or cancer drug-caused muscle diseases because both compounds are knonw to be effective against cancer drug induced cell and tissue damage including damage and loss of muscles cells and because both compounds are present in Magnolia officinalis extracts.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
With respect to claim 7 it is noted that a specific therapeutic dose for administration would be optimized by one of skill in the art depending on particular clinical situations including severity of subject conditions and protocols of treatment.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. 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.
Vera Afremova
July 8, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
Prosecution Insights