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 .
Election/Restrictions
In response to restriction requirement mailed on 5/08/2026 Applicants canceled previously presented claims 1-11 (Group I, drawn to a product) and claims 12-15 (Group II, drawn to a method of making a product) and presented new claims 16-19, drawn to a method of using a product.
Status of claims
New claims 16-19 as filed on 7/07/2026 are pending and under examination in the instant office action.
Information Disclosure Statement
IDS filed on 08/06/2024 has been partially considered. The cross-out signs indicate: 1) US patent which is either relevant or which citation is wrong; and 2) NPL document which has no publication date. These documents have been placed in the application file, but the information referred to therein has not been considered.
Specification
The disclosure is objected to because of the following informalities:
Section “Brief Description of Drawings” does not describe each drawing separately, some figure have subdrawings (1a, 1b, 1c, for example) but there is no description for each. Some abbreviations on drawings do not have explanation for their meaning or definitions in the text of specification, for example: CTL or P.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefinite
Claims 16-19 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.
Claim 16 is rendered indefinite by the phrase “concentrating the same” (see last line). It is unclear what is intended as “the same”. Is it a cell-free culture (supernatant) or cells that are removed from the culture?
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 16-19 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Lim et al (“Extracellular polysaccharides purified from Aureobasidium pullulans SM‑2001 (Polycan) inhibit dexamethasone‑induced muscle atrophy in mice”. International Journal of Molecular Medicine, 2018, 41, pages 1245-1264).
The reference by Lim teaches a method for improving muscle strength by administering to subjects with muscle atrophy a composition with a extracellular polysaccharide from Aureobasidium pullulans strain SM-2001 (EAP product). The cited reference acknowledges that ameliorating effects of EAP product associated with antioxidant and anti-inflammatory activities that modulate expression of genes involved in muscle protein synthesis (see abstract).
Thus, the cited reference teaches administration of a fermentation product (extracellular polysaccharide) produced by identical strain SM2001 belonging to the same species of Aureobasidium pullulans to the same subject which is in need of improving muscle strength as required by the claimed method.
Although the cited reference does not disclose a method of making EPA product, the product-by-process claims are not limited to the manipulations of the recited steps, but only to the structure implied by the steps. MPEP 2113. The product used for administration in the method is a fermentation product (extracellular polysaccharide) produced by identical strain SM2001 belonging to the same species of Aureobasidium pullulans as retyred by the claims.
Therefore, the cited reference by Lim is considered to anticipate the claimed invention.
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 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al (“Extracellular polysaccharides purified from Aureobasidium pullulans SM‑2001 (Polycan) inhibit dexamethasone‑induced muscle atrophy in mice”. International Journal of Molecular Medicine, 2018, 41, pages 1245-1264) in view of US 9,896,706 (Miura) and Liu et al (“Fermentation and complex enzyme hydrolysis enhance total phenolics and antioxidant activity of aqueous solution from rice bran pretreated by steaming with a-amylase”. Food Chemistry. 2017, 221, pages 636-643).
The reference by Lim teaches a method for improving muscle strength by administering to subjects with muscle atrophy a composition with a extracellular polysaccharide from Aureobasidium pullulans strain SM-2001 (EAP product). The cited reference acknowledges that ameliorating effects of EAP product associated with antioxidant and anti-inflammatory activities that modulate expression of genes involved in muscle protein synthesis (see abstract).
The cited reference by Lim teaches administration of a fermentation product (extracellular polysaccharide) produced by identical strain SM2001 belonging to the same species of Aureobasidium pullulans to the same subject which is in need of improving muscle strength as required by the claimed method.
But the cited reference does not disclose a method of making extracellular polysaccharide by culturing Aureobasidium pullulans on a medium comprising rice bran enzymatic lysate and vitamin C.
However, it is known in the prior art that rice bran and vitamin C are used in the medium for culturing representatives of species of Aureobasidium pullulans for production of polysaccharide beta-glucan. For example: see US 9,896,706 (Miura) at col. 9, lines 49-58, table 3 and col. 10, lines 14-16). The culturing step is practiced at temperature of about 25°C (col. 10, line 17).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to practice Lim’s method for improving muscle strength by administering to subjects with muscle atrophy a composition with a extracellular polysaccharide from Aureobasidium pullulans strain SM-2001, wherein the extracellular polysaccharide would be obtained upon culturing the strain on rice bran and vitamin C – containing medium with a reasonable expectation of success in improving muscle strength of subjects under treatment because glucan polysaccharide of Aureobasidium pullulans is produced on the rice bran and vitamin C-containing medium as evidenced by US 9,896,706 (Miura).
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.
Further, with respect to limitation drawn to enzymatic treatment of rice bran, it is known that enzymatic treatment of rice bran including amylase treatment increase amounts of phenolic and flavonoid antioxidants (see abstract of Liu); and the primary refence by Lim acknowledges that muscle improving effects are associated with antioxidant activities of the therapeutic agent (abstract).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to practice Lim’s method for improving muscle strength by administering to subjects with muscle atrophy a composition with a extracellular polysaccharide from Aureobasidium pullulans strain SM-2001, wherein the extracellular polysaccharide would be obtained upon culturing the strain on rice bran and vitamin C – containing medium and wherein rice bran substrate would be treated by enzymes including amylase with a reasonable expectation of success in improving muscle strength of subjects under treatment because glucan polysaccharide of Aureobasidium pullulans is produced on the rice bran and vitamin C-containing medium as evidenced by US 9,896,706 (Miura), because enzymatic treatment of rice bran increases amounts of phenolic and flavonoid antioxidants (as evidenced by Liu) and because muscle improving effects are associated with antioxidant activities of the therapeutic agents as taught by Lim.
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.
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Vera Afremova
August 5, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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