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 .
Withdrawal of Rejections
The response and amendments filed on 01/07/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous 35 U.S.C. 112(b) rejections for indefiniteness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below. The previous 35 U.S.C. 102 rejections for anticipation have been withdrawn necessitated by Applicant’s amendments.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections – 35 USC § 112(b), Indefiniteness
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 1, 3, and 6-14 are rejected under 35 U.S.C. 112(b) 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 1, 6, and 9 recite the limitation “the content ratio”. There is insufficient antecedent basis for this limitation in the claim. No content ratio was previously recited.’
Claim 6 recites “the content ratio of fructose to glucuronic acid”; however, it is unclear if Applicant should instead be claiming “the content ratio of fucose to glucuronic acid” because “fructose” is not discussed in the instant Specification as part of the polysaccharide derived from T. fuciformis. Additionally, Liu (WO 2007/030975) teaches that the polysaccharide derived from T. fuciformis culture medium comprises “α-(1-3) mannose, mainly composed of 70-93% by weight of neutral total sugar, 6-28% of glucuronic acid, 0.1- 3% of the binding protein composition; the average molecular weight of the Tremella heteropolysaccharide is 85-1.6 million Daltons, wherein more than 90% by weight of the molecular weight is greater than 6000 Daltons. Wherein, the neutral total sugar mainly comprises the following content of glycosyl: 35-60% mannose, 10-25% fucose, 8-18% xylose and 5-15% glucose” (see, e.g., Liu, English Translation, “New use of Tremella fuciformis or its extracts”, pg. 2). Therefore, fructose is not taught as part of the polysaccharide derived from T. fuciformis. For the purposes of applying prior art, the Examiner has interpreted this as being fucose instead of fructose.
Claims 3, 7-8, and 10-14 are included in this rejection for depending on rejected independent claims 1 and 9 and failing to rectify the noted deficiencies.
Examiner’s Response to Arguments
Regarding Applicant’s arguments and amendments pertaining to the previous 35 U.S.C. 112(b) rejections for indefiniteness, as mentioned previously, these rejections have been withdrawn necessitated by Applicant’s amendments. However, new 35 U.S.C. 112(b) rejections have been set forth in light of Applicant’s amendments.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections – 35 USC § 112(a), New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 3, and 6-13 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 9 have been amended to recite “wherein the content ratio of fucose to glucuronic acid is 1:0.9 to 1:1.1”; however, there is no support in the instant specification for content ratios of fucose to glucuronic acid being 1:0.9 and 1:1.1. The instant specification only supports a content ratio of fucose to glucuronic acid that is 1:1, based on the results in table 2 of the instant specification (see, e.g., instant Specification, Table 2, pg. 13).
Claim 6 has been amended to recite “wherein the content ratio of fructose to glucuronic acid is 1:1”; however, there is no support in the instant specification for fructose as part of the polysaccharide, nor is there support for a content ratio comprising fructose. Moreover, “fructose” is not recited in the instant specification at all.
Claims 3, 7, 8, and 10-14 are included in this rejection for depending on rejected independent claims 1 and 9 and failing to rectify the noted deficiency.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 103, Obviousness
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kazuhisa (JP 2006/131558; Date of Publication: May 25, 2006 – previously cited) in view of Liu (WO 2007/030975; Date of Publication: March 22, 2007 – newly cited) and Marlowe (US 2013/0023492; Date of Publication: January 24, 2013 – newly cited).
Kazuhisa’s general disclosure relates to a collagen formation enhancer containing an
extract of a fungus of Tremellaceae wherein the collagen formation enhancer is effective in
“preventing the formation of wrinkles” (see, e.g., Kazuhisa , Technical Field, pg. 3).
Furthermore, Kazuhisa discloses that Tremella fuciformis is stable and exhibits an excellent
collagen production promoting effect (see, e.g., Kazuhisa, Technical Solution, pg. 3). Moreover,
Kazuhisa discloses the production of a Tremella fuciformis extract, wherein the extract promotes
anti-aging and collagen production and can be used in cosmetics, pharmaceuticals, or foods (see,
e.g., Kazuhisa, Technical Solution, pg. 3 & Industrial Applicability, pg. 5).
Regarding claims 1 and 9 pertaining to the Tremella fuciformis culture medium extract, Kazuhisa teaches a Tremella fuciformis culture extract (see, e.g., Kazuhisa, English
translation, “Technical Solution”, [2]) that can be used in cosmetic and food compositions to
prevent formation of wrinkles (see, e.g., Kazuhisa, English translation, “Technical Field” &“Technical Solution, [7]).
However, Kazuhisa does not teach: wherein the extract comprises a polysaccharide comprising fucose, xylose, mannose and glucuronic acid, wherein the content ratio of fucose to glucuronic acid is 1:0.9 to 1:1.1 (claims 1 and 9); or wherein the polysaccharide has a mannose content of 30% to 50% by weight (claims 3, 6, and 13-14); or wherein the content ratio of fructose to glucuronic acid is 1:1 (claims 6); or wherein the content ratio of fucose to glucuronic acid is 1:1 (claim 14).
Liu’s general disclosure relates to methods of producing and using Tremella fuciformis heteropolysaccharide extracts in medicaments and foods (see, e.g., Liu, English Translation, abstract). Moreover, Liu discloses that the T. fuciformis extract can be used for “promoting the growth and/or reproduction of probiotics, and the use thereof for improving constipation function and detoxifying beauty function” (see, e.g., Liu, English Translation, “New use of Tremella fuciformis or its extracts”, pg. 1). Furthermore, Liu teaches extracting Tremella fuciformis heteropolysaccharides in water from the fermentation broth (see, e.g., Liu, English Translation, “New use of Tremella fuciformis or its extracts”, pg. 3).
Regarding claims 1, 6, 9, and 14 pertaining to the polysaccharides and content ratio of fucose to glucuronic acid, Liu teaches “The structure of the Tremella heteropolysaccharide according to the present invention is mainly composed of α-(1-3) mannose, mainly composed of 70-93% by weight of neutral total sugar, 6-28% of glucuronic acid, 0.1-3% of the binding protein composition; the average molecular weight of the Tremella heteropolysaccharide is 85-1.6 million Daltons, wherein more than 90% by weight of the molecular weight is greater than 6000 Daltons. Wherein, the neutral total sugar mainly comprises the following content of glycosyl: 35-60% mannose, 10-25% fucose, 8-18% xylose and 5-15% glucose broth (see, e.g., Liu, English Translation, “New use of Tremella fuciformis or its extracts”, pg. 2). Therefore, based on the percentages set forth by Liu, glucuronic acid and fucose can be at a 1:1 ratio since the percentages of glucuronic acid and fucose can overlap (see, e.g., MPEP 2144.05(I)).
Regarding claims 3 and 13-14 pertaining to the mannose content, Liu teaches that the mannose content is 35-60% (see, e.g., Liu, English Translation, “New use of Tremella fuciformis or its extracts”, pg. 2) (see, e.g., MPEP 2144.05(I)).
Marlowe’s general disclosure relates to “A composition for providing relief to a discomfort of an eye comprises a pharmaceutically acceptable carrier and a polysaccharide extracted from a plant source. In certain embodiments, such a polysaccharide can be extracted from mushrooms, such as from the Tremella fuciformis species. The composition is administered to an affected eye to provide such relief or discomfort” (see, e.g., Marlowe, abstract). Moreover, Marlowe discloses that “the composition comprises a polysaccharide extracted from mushroom species (such as the Tremella species), which polysaccharide comprises a backbone chain of (1[Wingdings font/0xE0]3)α-linked mannose units and side chains comprising β-linked glucuronic acid and/or xylose units; wherein some of the carboxylic acid moieties of the glucuronic acid units may be acetylated. The side chains of these polysaccharides may also contain other saccharide units, such as glucose and fucose (see, e.g., Marlowe, [0040]). Furthermore, Marlowe teaches that Tremella polysaccharides exhibit viscoelasticity, shear thinning characteristics and that the viscosity of the polymer is maintained at high temperatures, making it good for pharmaceutical applications (see, e.g., Marlowe, [0044]).
Regarding claims 1, 6, 9, and 14 pertaining to the content ratio, Marlow teaches “The linear glucuronoxylomannan consists of a mannose (α,1-3 linkage) backbone with xylose and glucuronic acid along with fucose, glucose and other sugar residues attached to the backbone1. The high content of glucuronic acid of the polymer makes it similar to hyaluronic acid2, 3. The polymer has also been shown to have a high degree of water-binding capacity compared to hyaluronate” (see, e.g., Marlowe, [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kazuhisa’s Tremella fuciformis culture medium extract, wherein the ratio of fucose to glucuronic acid is 1:1, as taught by Liu and Marlowe. One would have been motivated to do so because Liu teaches a Tremella polysaccharide extract, wherein the fucose and glucuronic acid percentages are 10-25% and 6-28%, respectively, and wherein the extract is used “the functions of moisturizing and smoothing the skin and mucous membrane, enhancing the sense of lubrication, anti-oxidation aging, anti-allergy, thickening and stability” (see, e.g., Liu, English Translation, “New use of Tremella fuciformis or its extracts”, pg. 2). Additionally, Marlowe teaches that a high content of glucuronic acid in the polymer makes it similar to hyaluronic acid and allows the polymer to have a high degree of water-binding capacity (see, e.g., Marlow, [0043]), which is motivation for one of ordinary skill in the art to manipulate the amount of glucuronic acid. Moreover, Kazuhisa teaches that the polysaccharides extracted from Tremella fuciformis promotes collagen formation and can be used in cosmetic compositions (see, e.g., Kazuhisa, English Translation, “Technical Solution”, pg. 4). Therefore, based on the teachings of Kazuhisa, Liu, and Marlowe, it would have been obvious to produce a cosmetic composition comprising polysaccharides derived from Tremella fuciformis. One would have expected success because Kazuhisa, Liu, and Marlowe all teach polysaccharides derived from Tremella fuciformis for compositions.
Regarding claims 1, 6, 9, and 14’s content ratio limitations, those working in the biological and/or pharmaceutical arts would understand that adjustments of particular conventional working conditions (e.g., concentrations, percentages, amounts, etc.) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan (see, e.g., MPEP 2144.05). For example, the disclosure of Liu teaches “The structure of the Tremella heteropolysaccharide according to the present invention is mainly composed of α-(1-3) mannose, mainly composed of 70-93% by weight of neutral total sugar, 6-28% of glucuronic acid, 0.1- 3% of the binding protein composition; the average molecular weight of the Tremella heteropolysaccharide is 85-1.6 million Daltons, wherein more than 90% by weight of the molecular weight is greater than 6000 Daltons. Wherein, the neutral total sugar mainly comprises the following content of glycosyl: 35-60% mannose, 10-25% fucose, 8-18% xylose and 5-15% glucose broth (see, e.g., Liu, English Translation, “New use of Tremella fuciformis or its extracts”, pg. 2). Moreover, Marlowe teaches “The high content of glucuronic acid of the polymer makes it similar to hyaluronic acid2, 3. The polymer has also been shown to have a high degree of water-binding capacity compared to hyaluronate” (see, e.g., Marlowe, [0043]). Therefore, the percentages set forth by Liu and the teaches of Marlowe are motivation for one of ordinary skill in the art to manipulate the amount of glucuronic acid in order to achieve optimal water-binding capacity within a cosmetic composition. Moreover, Marlowe states “While specific embodiments of the present invention have been described in the foregoing, it will be appreciated by those skilled in the art that many equivalents, modifications, substitutions, and variations may be made thereto without departing from the spirit and scope of the invention as defined in the appended claims” (see, e.g., Marlowe, [0107]). Therefore, one of ordinary skill in the art would reasonably understand the amount of glucuronic acid influences the water-binding capacity of the polysaccharide and influences the cosmetic composition. This is motivation for someone of ordinary skill in the art to test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning concentration, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Regarding claims 7 and 11-12 pertaining to the extraction and culturing steps, these are considered product-by-process claims; therefore, patentability is based on the product itself and not on the method of production (see, e.g., MPEP 2113(I)). Therefore, for claims 7 and 11-12, patentability is based on the composition set forth in claim 1. Moreover, this composition is rendered obvious in view of Kazuhisa, Liu, and Marlowe, as discussed above.
Regarding claims 8 and 10 pertaining to the cosmetic composition exhibiting effects, these effects would be considered inherent. The combined prior art of Kazuhisa, Liu, and Marlowe teach the same cosmetic composition extracted from Tremella fuciformis, which would inherently lead to the same effect of skin moisturization, anti-wrinkle, and anti-oxidant functioning (see, e.g., MPEP 2112.01(I)-(II)).
Examiner’s Response to Arguments
Applicant's arguments filed 01/07/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Kazuhisa and Yang do not disclose an extract with a content ratio of fructose to glucuronic acid that is 1:0.9 to 1:1.1 (remarks, pages 5-6), as previously stated, the previous 35 U.S.C. 102 rejection have been withdrawn in light of Applicant’s amendments. Although Kazuhisa was relied upon in the 35 U.S.C 103 rejection above, this reference was not relied upon to teach the content ratio of fructose to glucuronic acid.
Regarding Applicant’s arguments pertaining to the results set forth in the Declaration under 37 CFR 1.132 (remarks, page 7), this Declaration is insufficient to overcome the rejection of claims 1, 3, and 6-14, as well as the prior art set forth above for multiple reasons:
First, the declaration refers only to the invention, not to the claims. Applicant is showing data that when fucose and glucuronic acid are at a 1:1 ratio, that the glucose content decreases and the mannose content increases in a T. fuciformis mycelium culture medium extract, compared to a T. fuciformis fruiting body extract. The instantly claimed invention does not claim that the content of glucose and mannose fluctuates based on the content of fucose and glucuronic acid. Furthermore, the instantly claimed invention is generally claiming “a Tremella fuciformis culture medium extract”; however, Applicant’s results set forth in the declaration focus on fluctuating glucose and mannose contents based on whether the polysaccharides are derived from a mycelium culture medium extract or a fruiting body culture medium extract. In the claims, Applicant is broadly claiming an extract derived from a T. fuciformis culture medium; however, in the results set forth in the declaration, Applicant is specifically comparing extracts derived from the mycelium and fruiting body of T. fuciformis.
Secondly, the results are not commensurate in scope with the claimed invention. For the results set forth in the declaration, Applicant is relying on culturing the T. fuciformis mycelium in 300 mL of Mushroom Complete Medium at 25oC at 180 rpm for 24 hours. Applicant is relying on mixing the cultured mycelium supernatant with ethanol at a 1:3 volume ratio and culture the supernatant overnight with stirring at 4oC, followed by centrifugation at 12,000 rpm to obtain a precipitate containing the polysaccharides. Applicant is relying on purification of the polysaccharides in purified water. Furthermore, Applicant is relying on analysis of the polysaccharide content of the extract via hydrolysis of neutral sugar, wherein 100 µg of a polysaccharide and 400 µl of 2 M TFA were added a tube and hydrolyzed at 100oC for 4 hours. Moreover, Applicant is relying on hydrolysis of glucuronic acid, wherein 100 µg of a polysaccharide and 400 µl of 2 M TFA were added a tube and hydrolyzed at 100oC for 6 hours. Furthermore, Applicant is relying on sugar analysis using HPAEC, wherein for neutral sugar, the solvent is 2 mM NaOH, the velocity flow (ml/min) is 0.5, the column is CarboPac PA20, and the temperature is 30oC and 8oC for the column oven and autosampler, respectively. For sugar analysis of glucuronic acid, Applicant is relying on 100 mM NaOH/150 mM sodium acetate for the solvent, 1.0 ml/min for the velocity of flow, and CarboPac PA1 for the column. Therefore, Applicant’s results are not commensurate in scope with the claimed invention because Applicant is relying on various parameters to isolate, identify, and compare ratios of the polysaccharides, all of which are not claimed.
Thirdly, Applicant states that “there is a synergistic effect and/or rather unexpected benefit derived from the claimed subject matter” (remarks, page 7); however, Applicant does not provide evidence of this and “arguments by applicant cannot take the place of evidence” (see, e.g., MPEP 716.01(c)(II)). There is no evidence set forth by the Applicant that the polysaccharides at these specific ratios exhibit synergistic effects or unexpected results, compared to either other polysaccharide ratios derived from the T. fuciformis mycelium and/or fruiting body, and/or the prior art.
As a whole, the data set forth by Applicant in the declaration and reiterated in the remarks on page 7 are not sufficient to cover come the prior arts of record, as set forth above.
Conclusion
Claims 1, 3, and 6-14 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653