DETAILED ACTION
Status of the Application
Claims 1, 3-19 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment of claims 1, 3-6, 8, cancellation of claim 1, addition of claims 9-19 and amendments to the specification as submitted in a communication filed on 10/24/2025 is acknowledged.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Specification
The title of the invention was objected as being non descriptive. In view of Applicant’s amendments, this objection is hereby withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/24/2025 IS acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to due to the recitation of “…(iii) performing an extraction…at a temperature comprised from 91 °C to 110 °C...”. To enhance clarity and to be consistent with commonly used claim language, the term should be amended to recite “…(iii) performing an extraction…at a temperature ranging from 91 °C to 110 °C...”. Appropriate correction is required.
Claim 1 is objected to due to the recitation of “…(iv) adding….(vii) processing…(viii) drying …”. The itemization labels should be consecutive. Therefore, the term should recite “…(iv) adding….(v) processing…(vi) drying …”. Appropriate correction is required.
Claim 1 is objected to due to the recitation of “(viii) drying ….molecular weight comprised from 10 kDA to 600 KDa”. To enhance clarity and to be consistent with commonly used claim language, the term should be amended to recite “….molecular weight ranging from 10 kDA to 600 KDa”. Appropriate correction is required.
Claim 4 is objected to due to the recitation of “…temperature comprised from 91 °C to 110 °C”. To enhance clarity and to be consistent with commonly used claim language, the term should be amended to recite “…temperature ranging from 91 °C to 110 °C”. Appropriate correction is required.
Claim 4 is objected to due to the recitation of “…for a period of time comprised from 0.5 hours to 8 hours”. To enhance clarity and to be consistent with commonly used claim language, the term should be amended to recite “…for a period of time ranging from 0.5 hours to 8 hours”. Appropriate correction is required.
Claim 11 is objected to due to the recitation of “wherein the extraction solvent is water”. To be consistent with the language used in claim 1 and avoid confusion, the term should be amended to recite “wherein the aqueous extraction solvent is water”. Appropriate correction is required.
Claim 12 is objected to due to the recitation of “room temperature comprised from 15 °C to 25 °C”. To be consistent with the language used in claim 1 and avoid confusion, the term should be amended to recite “room temperature ranging from 15 °C to 25 °C”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
Claims 1, 3-8 remain rejected and new claims 9-19 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 pre-AIA the applicant regards as the invention. New grounds of rejection are necessitated by amendment.
Claim 1 (claims 3-19 dependent thereon) is indefinite in the recitation of “dispersed in a volume of hydrolysis solvent.…optionally, following crushing or pulverization of the starting material to obtain a crushed or pulverized starting material” for the following reasons. It is unclear as to how the term “volume” further limits the claim. If the intended limitation is a solution comprising a starting material comprising a fungus of the species T. fuciformis and a hydrolysis solvent, the claim should be amended accordingly. In addition, the term “following” implies that the action of “crushing” or “pulverization” occurs after the prior step. In the instant case, step (i) requires providing a starting material from Tremella fuciformis dispersed in hydrolysis solvent prior to crushing or pulverization. Therefore, it is unclear as to how one could crush or pulverize the starting material if such material is already part of a liquid solution, namely the Tremella fuciformis starting material in a hydrolysis solvent. For examination purposes, it will be assumed that the starting material may or may not be crushed or pulverized pitot mixing it with the hydrolysis solvent. Correction is required.
Claim 1 (claims 3-19 dependent thereon) is indefinite in the recitation of “performing an enzymatic hydrolysis of said starting material by adding an enzyme to the volume of hydrolysis solvent …to obtain a mixture…” for the following reasons. As written, it is unclear if the enzyme is added to the volume of hydrolysis solvent prior to the addition of the Tremella fuciformis starting material to the hydrolysis solvent, or if the enzyme is added to the hydrolysis solvent having the Tremella fuciformis starting material already in it. For examination purposes, it will be assumed that the claim reads “performing an enzymatic hydrolysis of said starting material by adding an enzyme to the starting material dispersed in the volume of hydrolysis solvent …to obtain a mixture…”. Correction is required.
Claim 1 (claims 3-19 dependent thereon) is indefinite in the recitation of “and optionally diluting said liquid product by adding water” for the following reasons. As written, it is unclear if the dilution occurs before or after removing the precipitation solvent. No patentable weight will be given to the term. Correction is required.
Claim 1 (claims 3-19 dependent thereon) is indefinite in the recitation of “drying ….to obtain a product PR1” for the following reasons. It is unclear as to what a product PR1 is. The term “PR1” does not convey a particular structure/function for the product such that one of skill in the art can determine what it encompasses. For examination purposes, no patentable weight will be given to the term “to obtain a PR1…600 KDa”. Correction is required.
Claims 1 and 4 (claims 3, 5-19 dependent thereon) are indefinite in the recitation of “…at a boiling temperature” for the following reasons. As known in the art, boiling temperature is variable and depends on the compound and other variables such as pressure. Therefore, in the absence of a statement indicating the compound and additional conditions, it is unclear as to which is the temperature associated with the term “boiling temperature” (boiling temperature of what?). For examination purposes, no patentable weight will be given to the term. Correction is required.
Claim 5 (claims 14-19 dependent thereon) is indefinite in the recitation of “…adding to the volume of hydrolysis solvent an amount of aqueous solvent ranging from…” for the following reasons. As written, it is unclear if the claim requires adding more liquid (aqueous solvent) to the mixture of hydrolysis solvent and starting material of step (i), or if the claim requires the volume of hydrolysis solvent to be a volume of an aqueous solvent wherein the volume of the solvent has a mass equivalent to 20-100 times of the weight of the starting material. For examination purposes, no patentable weight will be given to the term. Correction is required.
Claim 5 (claims 14-19 dependent thereon) is indefinite in the recitation of “…..the plant starting material…adding said enzyme at a % by volume ranging from…” for the following reasons. There is no antecedent basis for the plant starting material in claim 1, from which claim 5 depends. In addition, it is unclear as to which is the volume basis for the recited %. Is the % by volume related to the volume of hydrolysis solvent, the volume of the hydrolysis solvent plus the volume of aqueous solvent, or the volume of the hydrolysis solvent, plus the volume of the aqueous solvent and the volume of the starting material? For examination purposes, no patentable weight will be given to the term “adding said enzyme at a % by volume ranging from…”. Correction is required.
Claim 9 is indefinite in the recitation of “wherein the aqueous hydrolysis solvent is water” because there is no antecedent basis for the aqueous hydrolysis solvent in claim 1, from which claim 9 depends. Correction is required.
Claim 12 is indefinite in the recitation of “heating at a pressure lower than room temperature at a room temperature comprised from 15 °C to 25 °C” for the following reasons. Pressure is not temperature. Therefore, it is unclear as to how pressure could be lower than temperature. For examination purposes, claim 12 will be interpreted as a duplicate of claim 1. Correction is required.
Claim 15 is indefinite in the recitation of “the plant starting material” because there is no antecedent basis for the plant starting material in claim 1, from which claim 15 ultimately depends. For examination purposes, claim 15 will be interpreted as a duplicate of claim 5 as interpreted above. Correction is required.
Claim 16 is indefinite in the recitation of “wherein the enzyme is at a % by volume ranging from 0.005% to 0.01%” for the following reasons. It is unclear as to which is the volume basis for the recited %. Is the % by volume related to the volume of hydrolysis solvent, the volume of the hydrolysis solvent plus the volume of aqueous solvent, the volume of the hydrolysis solvent, plus the volume of the aqueous solvent and the volume of the starting material? For examination purposes, claim 16 will be considered a duplicate of claim 5 as interpreted above. Correction is required.
When amending the claims, applicant is advised to carefully review all examined claims and make the necessary changes to ensure proper antecedent basis and dependency.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
Claims 1-8 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description and enablement requirements.
Galla et al. (Foods 14, 1362, pages 1-22, 2025; cited in the IDS) discloses the chemical characterization of a polysaccharide extract from Tremella fuciformis. Galla et al. discloses that non-animal hyaluronic acid from T. fuciformis has a hyaluronic acid content of approximately 87.76% and that this finding confirms the presence of hyaluronic acid in the T. fuciformis extract (page 15, second and third paragraphs). In view of Applicant’s amendment of claim 1, which now requires preparing a product that comprises hyaluronic acid from T. fuciformis, these rejections are hereby withdrawn.
Claim Rejections - 35 USC § 103 (AIA )
Claims 1, 3-8 remain rejected and new claims 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (U.S. Publication No. 2012/0009241, 1/12/2012) in view of Bin (Carbohydrate Polymers 81:420-424, 2010; cited in the IDS), Wu et al. (International Journal of Biological Macromolecules 121:1005-1010, 2019; cited in the IDS), Abdallah et al. (Carbohydrate Polymers 243, 116441, pages 1-11, available online 5/18/2020) and Homaei et al. (Amino Acids 38:937-942, 2010). This rejection as it relates to new claims 9-19 is necessitated by amendment.
This rejection has been discussed at length in the prior Office action. It is maintained and further applied to new claims 9-19 for the reasons of record and those set forth below.
Applicant argues that the claimed process includes steps absent from the method of Yang Applicant states that Yang teaches heating a composition comprising raw material from T. fuciformis and water to extract polysaccharides, followed by centrifugation to obtain a polysaccharide solution, while the claims require performing an enzymatic hydrolysis step of the starting material, an extraction step with an aqueous extraction solvent at a temperature of 91-110 °C, a precipitation step with an alcohol, a centrifugation step to obtain a liquid phase and a solids phase, and a drying step of the liquid phase obtained from the centrifugation step. Applicant states that Yang teaches a “heat and spin” process that can be repeated starting from the residue and not the extract as indicated in the instant claims. Applicant states that the products obtained from the process of Yang are different from those of the claimed method. Applicant refers to the references by Galla et al. (Foods 14, 1362, pages 1-22, 2025; cited in the IDS) and Galla et al. (International Journal of Molecular Sciences 23, 8114, pages 1-26, 2022; cited in the IDS) in support of the argument that the products obtained from the claimed method are not the same. Applicant cites the teachings of Shi et al. and Ma et al. who disclose the use of ethanol for precipitating polysaccharides. Applicant states that modifying the method of Yang to include an aqueous extraction to obtain an extract of the starting material and use alcohol to the extract to obtain a liquid product would be defeating Yang’s purpose of providing a skin wound dressing. Applicant states that even if one of skill in the art would have made the required changes to the method of Yang to arrive at the claimed process, it would have been unexpected to obtain a product comprising HA from fungi. Applicant requests the Examiner to show the passages of the cited prior art that would disclose, teach or suggest the claimed process. Applicant cites several passages of the MPEP in support of the argument that the claimed process is not obvious.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the rejection of claims 1, 3-8 or avoid the rejection of new claims 9-19. The Examiner acknowledges the amendments made to the claims, the sections of the MPEP cited with regard to obviousness, and the teachings of Galla et al., Shi et al. and Ma et al. However, the Examiner disagrees with Applicant’s assertion that the claimed invention is not obvious over the prior art.
Claims 1, 3-19 of the instant application as interpreted are directed in part to a process for preparing a product that comprises hyaluronic acid, wherein said method comprises (i) mixing material from Tremella fuciformis with water, hydrolyzing said material with an enzyme at a temperature between 10 °C to 90 °C wherein said enzyme can be a protease, performing two extractions of from the hydrolyzed material, wherein said extractions are carried out with water at a temperature between 91 °C-110 °C, wherein said extractions produce an aqueous extract, adding ethanol to the aqueous extract to obtain a liquid product, removing the ethanol from the liquid product, and drying the liquid product lacking ethanol to obtain a product that comprises a hyaluronic acid having a molecular weight between 10 kDa and 600 KDa. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ) for claim interpretation.
With regard to the argument that the claimed process includes steps absent from the method of Yang, it is noted that the instant rejection is not an anticipation rejection but rather an obviousness rejection based on the combination of references. As such, the teachings of Yang alone are not intended to provide all the limitations recited in the claims.
As previously indicated, Yang teaches a method for the isolation of polysaccharides from Tremella fuciformis, wherein said method comprises obtaining raw material of the fruiting bodies of Tremella fuciformis, followed by extraction of the polysaccharides with water at a temperature between 80-175 °C. Wu et al. teach the production of polysaccharides from Tremella fuciformis by pulverizing fruiting bodies followed by extraction in hot water for several hours, filtration or centrifugation of the product obtained after extraction in hot water to obtain a supernatant with polysaccharides and a solid fraction (residue). Wu et al. teach that the extraction in hot water of the residue is repeated three times. Wu et al. teach concentration of the supernatant comprising the polysaccharides to a quarter of the original volume, followed by precipitation with ethanol, collection of the precipitate by centrifugation (removal of ethanol), and freeze drying of the precipitate to obtain polysaccharides (page 1006, left column, Extraction and Purification). Wu et al. teach polysaccharides obtained with their method having a molecular weight that is in the range of 1.19 kDa to 550 kDa (page 1007, Table 2). Therefore, the teachings of Yang and Wu et al. clearly teach a method to produce polysaccharides from Tremella fuciformis by pulverizing fruiting bodies followed by extraction of polysaccharides from T. fuciformis material by using hot water. As previously indicated, it was well known in the art, as evidenced by Abdallah et al. (page 5, right column, first full paragraph, Digestion using enzymes), that enzymatic hydrolysis is a common technique for isolation of polysaccharides from biological material using enzymes such as papain, trypsin, pepsin and pronase to degrade tissue and breakdown of the protein fractions to isolate hyaluronic acid and chondroitin sulfate. Therefore, one of skill in the art would have been highly motivated to add enzymatic hydrolysis to the method of Yang or Wu to further degrade the starting material thus allowing more hyaluronic acid and other polysaccharides to be released. With regard to the precipitation step with ethanol, it is reiterated herein that Wu et al. teach precipitation with ethanol, removal of ethanol by centrifugation, and freeze drying of the precipitate to obtain polysaccharides. Adding ethanol to the hydrolyzed material would result in a liquid product by virtue of the fact that ethanol is a liquid and the hydrolyzed material is in an aqueous environment. Removal of ethanol would result in a processed product (e.g., precipitate).
With regard to the argument that the products obtained by the method of Yang are different from the products obtained from the claimed method, it is noted that the prior art as evidenced by Qiu et al. (CN 105950688 published 9/21/2016; cited in the IDS) discloses that white fungus (Tremella fuciformis) produces a polysaccharide which is a plant-base hyaluronic acid. This is also corroborated by the post filing references by Calla et al. provided by Applicant. The extraction step of the method of Yang is an extraction that uses water at a temperature between 80-175 °C, which is the same extraction step of the claimed method. Therefore, while one could agree that the polysaccharide mixture produced by the method of Yang is not identical to that of the method of the instant claims, one of skill in the art would reasonably conclude that the polysaccharide mixture produced by the method of Yang has hyaluronic acid. One of skill in the art would reasonably conclude that the method of Yang, Wu et al., Bin et al., Abdallah et al. and Homaei et al. would generate a product comprising hyaluronic acid by virtue of the fact that (i) Tremella fuciformis produces a polysaccharide which is a plant-base hyaluronic acid, (ii) the extraction steps consists essentially of extraction with water at a temperature between 80-175 °C, which is the same extraction step of the claimed method, (iii) the enzymatic hydrolysis step is one that has been shown to aid in the release of hyaluronic acid and other polysaccharides from tissues, and (iv) the precipitation step with ethanol has been shown to produce polysaccharides as evidenced by Wu et al. and also by Applicant’s own references by Ma et al. and Shi et al.
With regard to the argument that modifying the method of Yang to include an aqueous extraction to obtain an extract of the starting material and use alcohol to the extract to obtain a liquid product would be defeating Yang’s purpose of providing a skin wound dressing, it is noted that Yang teaches that their extracted polysaccharide is further used to form a skin wound dressing by mixing the extracted polysaccharide with other compounds and materials to make the dressing. The additional steps suggested by the teachings of Wu et al., Bin et al., Abdallah et al. and Homaei et al. would simply provide an improved polysaccharide composition that has a higher concentration of polysaccharides and can have a longer shelf life by virtue of being in a dry state prior to further processing it to create the skin wound dressing. The additional steps do not interfere in any way with the step of further processing the extracted polysaccharides with compounds or materials to make the dressing. Therefore, contrary to Applicant’s assertions, modifying the method of Yang to include an aqueous extraction and alcohol precipitation does not defeat Yang’s purpose of providing a skin would dressing.
With regard to the argument that it would have been unexpected to obtain a product comprising HA from fungi by modifying the method of Yang to arrive at the claimed invention, it is reiterated herein that (i) it was well known in the art at the time of the invention that Tremella fuciformis produces a polysaccharide which is a plant-base hyaluronic acid, (ii) the extraction steps consists essentially of extraction with water at a temperature between 80-175 °C, which is the same extraction step of the claimed method, (iii) the enzymatic hydrolysis step is one that has been shown to aid in the release of hyaluronic acid and other polysaccharides from tissues, and (iv) the precipitation step with ethanol has been shown to produce polysaccharides as evidenced by Wu et al. and also by Applicant’s own references by Ma et al. and Shi et al. Therefore, while it is agreed that there was no absolute certainty that adding the additional steps to the method of Yang would result in a product that comprises hyaluronic acid (HA), there was a reasonable expectation of success in obtaining a polysaccharide mixture that contains hyaluronic acid.
As previously indicated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Yang by (a) pulverizing the fruiting bodies of Tremella fuciformis, prior to the extraction step with water, (b) hydrolyze the pulverized fruiting bodies of Tremella fuciformis, with an enzyme prior to the extraction step with water, (c) precipitating the polysaccharide containing fraction obtained from the extraction step with ethanol, and removing the ethanol to obtain a product comprising a polysaccharide having a molecular weight between 10 kDa and 600 KDa. A person of ordinary skill in the art is motivated to add these additional steps to the method of Yang et al. because (a) pulverizing fruiting bodies of Tremella fuciformis, prior to the extraction step with water is a well-known step as evidenced by Wu et al., (b) enzymatic hydrolysis is a well-known step for the extraction of polysaccharides including hyaluronic acid from biological material because it allows degradation of tissue and breakdown of the protein fractions to isolate the desired polysaccharide, (c) precipitation with ethanol is a well-known step for isolation of polysaccharides from Tremella fuciformis, and (d) removal of ethanol after precipitation is desirable to obtain a product with a higher concentration of therapeutic polysaccharides that can be further dried to preserve it for future use. One of ordinary skill in the art has a reasonable expectation of success at adding these steps to the method of Yang because all these steps have been previously used with material containing Tremella fuciformis to obtain polysaccharides having a molecular weight within the range recited.
Therefore, for the reasons of record and those set forth above, one cannot reasonably conclude that the claimed invention is not obvious over the teachings of the prior art.
Double Patenting
Claims 1-8 were provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7, 9, 17-20 of copending Application No. 17/616,960. In view of Applicant’s timely submission of a terminal disclaimer, this rejection is hereby withdrawn.
Conclusion
No claim is in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Applicant is advised that any Internet email communication by the Examiner has to be authorized by Applicant in written form. See MPEP § 502.03 (II). Without a written authorization by Applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Sample written authorization language can be found in MPEP § 502.03 (II). An Authorization for Internet Communications in a Patent Application or Request to Withdraw Authorization for Internet Communications form (SB/439) can be found at https://www.uspto.gov/patent/forms/ forms-patent-applications-filed-or-after-september-16-2012, which can be electronically filed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
February 3, 2026