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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/17/2026 has been entered.
Withdrawal of Rejections
The response and amendments filed on 06/17/2026 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minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments.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Briefly, the previous claim rejections under 35 U.S.C. 112(b) for indefiniteness have been withdrawn necessitated by Applicant’s amendments. The previous claim rejections under 35 U.S.C. 112(a) for new matter have been withdrawn necessitated by Applicant’s amendments. The previous claim rejections under 35 U.S.C. 103 for obviousness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 101
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 7-13 rejected under 35 U.S.C. 101 because they are drawn to ineligible subject matter (based on the 2019 Revised Patent Subject Matter Eligibility Guidance).
Broadest Reasonable Interpretation (BRI) of independent claim 1: the broadest scope of claim 1 is drawn to a composition comprising polysaccharides derived from a Tremella fuciformis mycelium.
STEP 1: Is the claim directed to a process, machine, manufacture, or a composition of matter?
YES, the claims are directed to a composition of matter.
STEP 2A: PRONG ONE: Does the claim recite an abstract idea, law of nature, or a natural phenomenon?
YES, the claims are considered to be a “product of nature” exception. The courts have held that “products of nature” fall under the law of nature and/or natural phenomenon exceptions. The claims are directed to a natural product, wherein the natural product is the mycelium culture medium extract comprising glucose, fucose, xylose, mannose, and glucuronic acid.
Kuo teaches “Sometimes called the "snow fungus," Tremella fuciformis is a tropical and subtropical jelly fungus found on hardwood logs after heavy rains” (see, e.g., Kuo, Tremella fuciformis; 2008). Additionally, Zhu (Comparing the sugar profiles and primary structures of alkali-extracted water-soluble polysaccharides in cell wall between the yeast and mycelial phases from Tremella fuciformis; 2016) teaches extraction of cell wall materials from Tremella fuciformis in order to obtain polysaccharides (see, e.g., Zhu, Materials and Methods, pg. 382). Additionally, Zhu teaches “PTF-M38 was mainly composed of xylose, mannose, glucose, and galactose in a ratio of 1:1.47:0.48:0.34, while PTF-Y3 and PTF-Y8 were mainly composed of xylose, mannose and glucose in a ratio of 1:1.65:4.06 and 1:1.21:0.44, respectively. Wang (Nanostructures assembly and the property of polysaccharide extracted from Tremella fuciformis fruiting body; 2019) discloses “the acidic polysaccharide of Tremella fuciformis was extracted by boiling and precipitated by ethanol. The total sugar content obtained by freeze-drying after ion exchange chromatography purification was 93.6%. It is mainly composed of mannose, glucuronic acid, xylose and fucose. According to the peak area, the mass ratio of the substance is about 6.8:1:1.5:0.6, which indicates that TFP is a polysaccharide with mannose as its main chain and glucuronic acid, fucose and xylose as well as a small amount of glucose as the branch chain” (see, e.g., Wang, abstract). Moreover, the instant specification teaches that the Tremella fuciformis mycelium culture medium extract comprises fucose, glucose, xylose, annose, glucuronic acid, and mannose (see, e.g., instant specification, Table 2 & [62]), which further proves that these polysaccharides are inherent to the Tremella fuciformis culture medium extract. Therefore, based on these teachings, these polysaccharides are inherent to the naturally occurring in Tremella fuciformis.
Recitation of a specific percentage of glucose (i.e., 1.3% by weight of glucose, as recited in claims 1 and 9) and specific concentration of mannose (i.e., 30 to 50% by weight, as recited in claims 3 and 13) does not change the product itself. The composition still contains naturally occurring polysaccharides, such as glucose and mannose, since Zhu teaches that these polysaccharides are inherent to the Tremella fuciformis mycelium, as discussed above. Therefore, recitation of a specific percentage of glucose and mannose does not change the composition itself because these polysaccharides are inherent and naturally occurring in the T. fuciformis mycelium and the composition still contains naturally occurring polysaccharides regardless of their percentage or concentration. Furthermore, Applicant does not provide evidence that glucose at 1.3% and/or mannose at 30 to 50% interacts with the other polysaccharides inherent to the Tremella fuciformis mycelium to form a markedly different product. All the polysaccharides obtained from Tremella fuciformis are naturally occurring and there is no evidence that these polysaccharides interact to form a markedly different product, regardless of their concentration.
Therefore, there is no indication that the claimed composition has any markedly different characteristic (e.g., structure, function, phenotype, etc.) that is different than what is found in nature. Applicant does not provide evidence showing that a Tremella fuciformis mycelium culture medium polysaccharide extract has a markedly different structure or characteristic than what is found in nature, or that the polysaccharides interact to form a composition that is markedly different from what is found in nature. Therefore, it appears that the Applicant is merely claiming a naturally occurring product. Moreover, note that MPEP 2106.04(b) also states: “Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess a markedly different characteristic from any naturally occurring counterpart.”
PRONG TWO: Does the claim recite additional elements that integrate the judicial exception into a practical application?
NO, the additional elements or combination or elements in the claims does not impose a meaningful limit on the judicial exception. Note that the markedly different characteristics analysis is used to determine if a nature-based product is a “product of nature” exception. Thus, the markedly different characteristic analysis is part of step 2A, i.e., it helps answer the question of whether a claim is directed to an exception, which is further explained below.
Regarding claim 1 and 9’s recitation of “for improving procollagen synthetic ability and moisturizing ability of skin” and “wherein the composition improves the moisturizing ability of skin by inducing production of endogenous hyaluronic acid and aquaporin 3 in skin cells”, as well as claim 8 and 10’s recitation of “for use in skin moisturization, anti-wrinkle, or antioxidant”, these are considered intended use limitations and do not impart a structure for the claimed product (i.e., the cosmetic composition). MPEP 2106.04(d)(2) states “If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “treatment or prophylaxis” consideration”; therefore, the therapeutic affects imparted by the composition are considered intended use limitations and do not integrate the judicial exception into practical application. Moreover, the treatment limitation is not particular, in that it encompasses many applications of the judicial exception; therefore, the treatment step is not particular and is instead merely instructions to “apply” the exception in a generic way (see, e.g., MPEP 2106.04(d)(2) & MPEP 2106.05(f)).
STEP 2B: Does the claim recite additional elements that amount to significantly more than the
judicial exception?
NO, the claimed invention is directed to a law of nature and/or a natural phenomenon (i.e., product of nature) without significantly more. Note that the claimed must be interpreted under the BRI standard when evaluating for a marked difference. Under BRI, the claims broadly read on a Tremella fuciformis mycelium culture medium extract. The claims do not recite any additional elements that amount to significantly more than merely a Tremella fuciformis mycelium culture medium extract comprising glucose, fucose, xylose, mannose, and glucuronic acid.
Recitation of “for improving procollagen synthetic ability and moisturization ability of skin”, “wherein the composition improves the moisturization ability of skin by inducing production of endogenous hyaluronic acid and aquaporin 3 in skin cells”, and “wherein the cosmetic composition is for use in skin, moisturization, anti-wrinkle, and anti-oxidant” are merely instructions to apply the judicial exception at a high level of generality and is not found to be enough to quality as “significantly more” than the judicial exception (see, e.g., MPEP 2106.05). Therefore, these additional elements do not amount to significantly more than the judicial exception because these are merely instruction to generically apply the judicial exception in a generic way (see, e.g., MPEP 2106.05(f)).
Therefore, the claims are interpreted under the BRI standard, wherein the claims do not include additional elements that are sufficient to amount to anything more than the judicial exception because the claims do not recite any additional elements that amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 112(a), New Matter
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 7-13 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 recite “wherein the polysaccharide comprises about 1.3% by weight or less of the glucose”; however, there is no support in the instant specification for “about 1.3%” because this would encompass glucose percentages above and below 1.3% and the instant specification does not provide support for glucose percentages above and below 1.3%.
Claims 3, 7-8, and 10-13 are included in this rejection for depending on independent claims 1 and 9 and failing to rectify the noted deficiency.
Claim Rejections - 35 USC § 103, Obviousness
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 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (Comparing the sugar profiles and primary structures of alkali-extracted water-soluble polysaccharides in cell wall between the yeast and mycelial phases from Tremella fuciformis; 2016 – previously cited) in view of Wang (Nanostructures assembly and the property of polysaccharide extracted from Tremella fuciformis fruiting body; 2019 – newly cited).
Zhu’s general disclosure relates to “cell wall polysaccharides from Tremella fuciformis strains were obtained from alkali- extracted water-soluble fractions PTF-M38 (from the mycelial form), PTF-Y3 and PTF-Y8 (from the yeast form) of T. fuciformis strains were used to gain some insights into dimorphism study” (see, e.g., Zhu, abstract). Moreover, Zhu discloses “PTF-M38 was mainly composed of xylose, mannose, glucose, and galactose in a ratio of 1:1.47:0.48:0.34, while PTF-Y3 and PTF-Y8 were mainly composed of xylose, mannose and glucose in a ratio of 1:1.65:4.06 and 1:1.21:0.44, respectively. The sugar pro files of PTF-M38, PTF-Y3 and PTF-Y8 were also established for further comparison. These profiles showed that all three polysaccharides contained the same sugars but in different ratios, and the carbon sources (xylose, mannose, glucose, and galactose) affected the sugar ratios within the polysaccharides” (see, e.g., Zhu, abstract).
Regarding claims 1 and 9 pertaining to a Tremella fuciformis mycelium culture medium extract, Zhu teaches culturing T. fuciformis M38 (mycelial form) followed by extraction and purification of cell wall polysaccharides from T. fuciformis M38 (see, e.g., Zhu, Materials and Methods, pgs. 382). Moreover, Zhu teaches that the T. fuciformis M38 strain contains xylose, mannose, glucose, and galactose (see, e.g., Zhu, Figure 1B).
Regarding claims 1 and 9 pertaining to the percentage of glucose, Zhu teaches “From the peak areas obtained by GC analysis (Fig. 1), the polysaccharides from M38 were composed mainly of xylose, mannose, glucose, and galactose in the ratio of 1:1.47:0.48:0.34” (see, e.g., Zhu, “Monosaccharide composition of PTF-M38, PTF-Y3, and PTF-Y8”, pg. 383). One of ordinary skill in the art would readily understand that, based on these ratios, the percentage of glucose is approximately 14.5%. Furthermore, Zhu teaches “The sugar profiles indicated that their relationship with the strains is not static and depends on the environment to which the organisms are exposed. It appears that the sugar profiles of polysaccharides probably represents an averaging of the different types of polymers produced in these systems and the relationship between strains and environmental factors” (see, e.g., Zhu, Discussion, pg. 385).
Regarding claims 3 and 13 pertaining to the mannose content, Zhu teaches that the mannose content in T. fuciformis M38 is ~30% (see, e.g., Zhu, Figure 4A) (see, e.g., MPEP 2144.05(I)).
However, Zhu does not teach: wherein the extract comprises fucose and glucuronic acid (claims 1 and 9).
Wang’s general disclosure relates to studying the preparation methods of fungal polysaccharides in order to improve utilization of said polysaccharides (see, e.g., Wang, abstract). Moreover, Wang discloses “the acidic polysaccharide of Tremella fuciformis was extracted by boiling and precipitated by ethanol. The total sugar content obtained by freeze-drying after ion exchange chromatography purification was 93.6%. It is mainly composed of mannose, glucuronic acid, xylose and fucose. According to the peak area, the mass ratio of the substance is about 6.8:1:1.5:0.6, which indicates that TFP is a polysaccharide with mannose as its main chain and glucuronic acid, fucose and xylose as well as a small amount of glucose as the branch chain” (see, e.g., Wang, abstract). Furthermore, Wang teaches “the mass ratio of mannose, glucuronic acid, glucose, xylose and fucose is 6.8:1:0.15:1.5:0.6” (see, e.g., Wang, Figure 1), which would result in a glucose percentage of 1.49% in the fruiting body extract.
Regarding claims 1 and 9 pertaining to fucose and glucuronic acid, Wang teaches that the isolated Tremella fuciformis polysaccharide comprises glucuronic acid and fucose (see, e.g., Wang, Section 3.1, pg. 753).
It would have been obvious to one of ordinary skill in the art to measure fucose and glucuronic acid, as taught by Wang, in the Tremella fuciformis mycelium culture medium extract, as taught by Zhu. One would have been motivated to do so because Wang teaches “The molecule of polysaccharide extracted by hydrothermal method from Tremella fuciformis fruiting body ordinarily has a main chain with a-(1–3)-D-mannose. The monosaccharide is composed of glucose, mannose, fructose, fucose, arabinose, xylose and glucuronic acid” (see, e.g., Wang, Introduction, pgs. 751-752). Furthermore, Zhu teaches that the cell wall polysaccharides of the Tremella fuciformis mycelial form contains xylose, mannose, glucose, and galactose (see, e.g., Zhu, Figure 1B). Therefore, based on the teachings of Zhu and Wang, it would have been obvious to determine if the polysaccharides identified in the Tremella fuciformis fruiting body are also present in the mycelial form since both Wang and Zhu teach that glucose, mannose, and xylose are present in both the mycelial and fruiting body forms. One would have expected success because Zhu and Wang both teach identification of cell wall polysaccharides in Tremella fuciformis.
Regarding claims 1 and 9’s percentage of glucose limitation, those working in the biological and/or pharmaceutical arts would understand that adjustments of particular conventional working conditions 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, Zhu teaches cell wall monosaccharide compositions for mycelial (PRT-M38) and yeast (PTF-Y3 and PTF-Y8) forms of Tremella fuciformis, and further teaches “the poly saccharides from M38 were composed mainly of xylose, man nose, glucose, and galactose in the ratio of 1:1.47:0.48:0.34 while PTF-Y3 and PTF-Y8 were composed mainly of xylose, mannose and glucose in the ratio of 1:1.65:4.06 and 1:1.21:0.44, respectively. Galactose was hardly examined in PTF-Y3 and PTF-Y8” (see, e.g., Zhu, “Monosaccharide composition of PTF-M38, PTF-Y3, and PTF-Y8”, pg. 383). Furthermore, Zhu teaches “Xylose, mannose, glucose, and galactose were adopted as the carbon sources. The results (Fig. 4) showed that the mono saccharide composition of PTF-M38, PTF-Y3, and PTF-Y8 were similar but exhibited different ratios. The sugar ratio of PTF-M38, PTF-Y3, and PTF-Y8 also varied with the strains and with the carbon sources” (see, e.g., “Establishment of sugar profile”, pg. 384). Furthermore, Zhu teaches “The sugar profiles indicated that their relationship with the strains is not static and depends on the environment to which the organisms are exposed. It appears that the sugar profiles of polysaccharides probably represents an averaging of the different types of polymers produced in these systems and the relationship between strains and environmental factors” (see, e.g., Zhu, Discussion, pg. 385). Therefore, the environment from which the Tremella fuciformis is obtained will influence the sugar profiles of the polysaccharides in the mycelial and yeast strains. 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 the glucose percentage, it would be prima facie obvious that one of ordinary skill in the art would recognize that these limitations are result effective variables which can be met as a matter of routine optimization.
Regarding claims 1 and 9 pertaining to “improving procollagen synthetic ability and moisturizing ability of the skin” and “wherein the composition improves the moisturizing ability of skin by inducing production of endogenous hyaluronic acid and aquaporin 3 in skin cells”, these have been interpreted as intended use limitations and do not carry patentable weight. The intended use does not impart structural limitation(s) for the claimed product (i.e., the Tremella fuciformis mycelium culture extract) and the combined prior art of Zhu and Wang teaches the instantly claimed composition; therefore, the structure is capable of performing the intended use of improving procollagen synthetic ability, skin moisturization, and production of endogenous hyaluronic acid and aquaporin 3 in skin cells.
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 the method of production (see, e.g., MPEP 2113(I)). Moreover, the product-by-process limitations recited in claims 7 and 11-12 do not impart structural characteristics to the final product. Therefore, for claims 7 and 11-12, patentability is based on the composition set forth in claim 1. Moreover, the composition is rendered obvious in view of Zhu and Wang.
Regarding claims 8 and 10 pertaining to the composition exhibiting effects, these effects have been interpreted as intended use limitations and do not carry patentable weight. The intended use does not impart structural limitation(s) for the claimed product (i.e., the Tremella fuciformis mycelium culture extract) and the combined prior art of Zhu and Wang teaches the instantly claimed composition; therefore, the structure is capable of performing the intended use of skin moisturization, anti-wrinkle, and antioxidant.
Examiner’s Response to Arguments
Applicant's arguments filed 06/17/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments pertaining to a declaration submitted on May 21, 2026 (“Yoem Declaration”) (remarks, pages 4-5), this argument is not persuasive because there is no declaration submitted on May 21, 2026. The only declarations submitted for this application were received on January 7, 2026 and June 6, 2025. Therefore, Applicant’s arguments are moot.
Regarding Applicant’s arguments pertaining to Liu and Marlowe (remarks, pages 5-7), as discussed above, all previous 35 U.S.C. 103 rejection have been withdrawn and new grounds of rejection were set forth above. Liu and Marlowe were not relied upon in the 35 U.S.C. 103 rejection presented above; therefore, Applicant’s arguments are moot.
Conclusion
Claims 1, 3, and 7-13 are rejected.
No claims are allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights