DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed September 2, 2025 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1 and 4 are pending.
Claim Rejections - 35 USC § 112
4. Claim 4 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 4 is indefinite because it states that the Ganoderma lucidum extract is present in the composition at a concentration of 2.5 to 5 mg/ml but also states that the composition is in the form of a powder, granule, tablet, or capsule. “Mg/ml” indicates the concentration of a substance in a liquid. It is confusing to state the concentration using a liquid notation but then to also state that the composition can be in the form of a solid. Therefore, it is unclear what concentrations of the G. lucidum extract must be present if the composition is formulated into a solid formulation.
Claim Rejections - 35 USC § 101
5. Claims 1 and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues:
First, amended claim 1 (also amended claim 4) recites a specific ethanol extract of Ganoderma lucidum fruiting body, made from a powdered fruiting body using 95% ethanol, and present in the composition at a concentration of 2.5—5 mg/ml. This is not a mere “general extraction” of a natural product. Rather, it is a carefully controlled, high- purity ethanol extraction that yields a composition enriched in certain ethanol-soluble compounds and lacking many constituents of the natural mushroom (e.g. insoluble polysaccharides, proteins, and fibrous matter that remain in the solid residue). The resultant extract’s structure and composition differ markedly from the raw Ganoderma in its natural state, as the extract is a concentrated mixture of specific molecules not found together in isolation in nature.
However, as discussed in the previous Office action, general extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds in the Ganoderma lucidum. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the Ganoderma lucidum and soluble in ethanol are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the Ganoderma lucidum. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in 95% ethanol and present at the claimed concentration of 2.5 to 5 mg/ml. Thus, while extraction of the compounds with 95% ethanol would separate a portion of the mushroom matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the Ganoderma lucidum; i.e., the composition is not inventive or “man-made.”
Applicant also argues:
Importantly, the claimed extract exhibits markedly different functional characteristics compared to the natural product. Experimental evidence in the specification shows that the ethanol extract at 5 mg/ml displays very strong thrombin, prothrombin, and blood coagulation factor inhibition, with anticoagulant activity better than that of aspirin at 1.5 mg/ml. Additionally, the extract was found to have no hemolytic activity (i.e., it is non-toxic to human red blood cells) and to possess excellent thermal and acid stability, allowing it to be used in various forms. Such enhanced efficacy and stability are not present in the naturally occurring Ganoderma lucidum fruiting body itself or in a “general” extract thereof. These markedly different properties (significantly increased potency, stability, and safety profile) demonstrate that the claimed extracted composition is not simply a natural product but rather a human-made formulation with its own distinct characteristics.
However, the closest natural product is not the G. lucidum mushroom itself, rather it is the naturally occurring compounds that are soluble in the selected concentration of ethanol. There is no evidence that extracting the G. lucidum with 95% ethanol produces a composition with a markedly distinct characteristic. In addition, applicant has not provided any specific evidence to show that the claimed extract show “significantly increased potency, stability, and safety profile…” in comparison with the naturally occurring counterpart.
In addition, applicant argues:
Furthermore, while the goal of the claimed process is to isolate and concentrate the active components, it is entirely possible that the specific extraction conditions (95% ethanol on a powdered dried fruiting body) result in chemical changes to certain constituents — for example, removing water and using a high concentration ethanol could induce formation of particular solvates or derivatives that are not present in the mushroom in its natural state. Even if no entirely “new” molecule were formed, the combination and proportions of compounds in the claimed extract are novel and produced by human intervention.
However, applicant has not provided any evidence to support the assertion that new compounds are formed. Thus, the argument is not persuasive.
Applicant also argues “Nature does not provide a 95% ethanol extract of Ganoderma lucidum at 5 mg/ml concentration; this composition exists only because of the inventor’s specific extraction process and formulation…”. However, the patent eligibility analysis it not whether or not a composition exists in nature. The analysis is based on whether or not the nature based product, i.e. the extract, shows markedly distinct characteristics in comparison with the closest occurring natural counterpart. In this case, the natural counterpart is the naturally occurring compounds in G. lucidum that are soluble in ethanol.
In addition, applicant argues “The evidence of the extract’s dramatically improved function (e.g. outperforming a known pharmaceutical like aspirin) is indicative that the extract as a whole has characteristics far beyond a mere sum of naturally occurring parts…”. However, the comparison with the claimed extract to aspirin is not considered to show a markedly distinct characteristic because aspirin is not the closest naturally occurring counterpart. Rather, as discussed above, this counterpart is the ethanol soluble components found in G. lucidum. Therefore, applicant’s argument are not persuasive because the there is no evidence to show that a 95% ethanolic extract from G. lucidum produces a product with markedly distinct characteristics in comparison with the naturally occurring ethanol soluble compounds of G. lucidum.
In regards to claim 4, powder, granule, and beverage formulations are not considered to lend a markedly distinct structure to the natural product because these formulations can be achieved by either drying the natural product or mixing the products with water. However, tablets and capsules as recited in this claim are considered to have a markedly distinct structure.
Claim Rejections - 35 USC § 102
6. Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nie (CN 105294874 A – English translation).
This reference teaches making a 95% ethanolic extract from powdered fruiting body of Ganoderma lucidum. The extract is mixed with water to form a solution with a concentration of 3-5 mg/ml (see (1) and (3) on page 2 of the translation).
The reference does not teach that the composition has the same effects on the body as claimed by applicant. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
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.
7. Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nie (CN 10529874 A – English translation).
The teachings of this reference are discussed above. The reference does not teach formulating the extract into a tablet or capsule. However, these are well known pharmaceutical formulation that an artisan would reasonably expect to be appropriate for the formulation of the extract taught by the reference. Thus, the use of these formulations would be obvious for the artisan to employ.
8. Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 9,238,049).
This reference teaches a pharmaceutical composition made by extracting small particles of Ganoderma lucidum fruiting body with 95% ethanol. The extract is formulated into a capsule, powder, or solution (see column 3, line 20-column 4, line 6).
The reference does not specifically teach using the extract in the claimed concentration of 2.5 to 5 mg/ml. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The reference teaches the use of the extract in a pharmaceutical composition. Varying the concentration of an active ingredient within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the extract produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
The reference does not teach that the composition has the same effects on the body as claimed by applicant. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
9. No claims are allowed.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655