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 April 17, 2026 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 Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.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 2-5, 16-22, 27, 38, 40, 43, 45, 50, 51, 75-79 are pending.
Election/Restrictions
4. In the reply filed on September 8, 2025, applicant elected Group III, now claims 38, 40 43, and 75-79 and Chlorella for species without traverse.
5. Claims 1-5, 16-22, 27, 45, 50, and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
6. Claims 38, 40, 43, and 75-79 are examined on the merits in regards to the elected species.
Claim Rejections - 35 USC § 112
7. Claim 77 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a synergistic combination of an ethanolic extract of chaga and a chlorophyll-free extract from Tetraselmis chuii where the T. chuii extract and the chaga extract are in a 1:2 and 1:4 ratio, does not reasonably provide enablement for synergistic combinations of all alcohol extracts of chaga and chlorophyll-free extracts from all phytoplankton green algae for the reasons set forth in the previous Office action for claims 39 and 40.
Applicant argues that the cancelling of claim 39 renders the rejection moot and that new claim 77 is supported by Example 5 in the specification. However, as discussed in the previous Office action, Example 5 shows a synergistic effect is present with an ethanolic extract of chaga and a chlorophyll-free extract from Tetraselmis chuii where the T. chuii extract and the chaga extract are in a 1:2 and 1:4 ratio. Example 5 does not disclose any results or evidence related to Chlorella. Chlorella is a distinct type of green algae from T. chuii and applicant has not provided any evidence to show that an artisan would expect the results from T. chuii to also be seen in Chlorella. Thus, the specification is still not considered to be enabling for a synergistic combination as claimed in claim 77.
Claim Rejections - 35 USC § 101
8. Claims 38, 40, 43, 75, 76, 78, and 79 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more for the reasons set forth in the previous Office action for claims 38 and 43.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues “Claim 38 is directed to a human-made composition comprising two separately processed extracts, each of which has been structurally and chemically altered by solvent extraction and, in the case of the algae extract, by selective removal of chlorophyll.” However, as discussed in the previous Office action, the extraction of the algae to remove chlorophyll is not considered to create a composition with a marked distinction. The removal of chlorophyll only partitions a portion of the naturally occurring compounds in the algae away from the chlorophyll. There is no evidence or reason to expect that any new compounds are formed.
Applicant also argues “Claim 43 further recites a formulated composition including a pharmaceutically acceptable carrier…”. However, pharmaceutically acceptable carriers can also be naturally occurring substances such as water. Thus, claim 43 is considered to read on a combination of natural products without any markedly distinct characteristics.
In addition, applicant argues:
Under the markedly different analysis, the inquiry ends properly at Step 2A:Prong One. The claimed compositions are markedly different at least because the claimed combinations exhibit biological properties not present in the natural source materials, such as preferential cytotoxicity to cancer cells and, in certain defined embodiments, synergistic anticancer effects. These characteristics arise only after human intervention and combination of the extracts and are not properties of chaga or phytoplankton green algae as they exist in nature.
However, as discussed in the previous Office action, applicant’s specification only shows a markedly distinct effect (i.e. synergism) is present with an ethanolic extract of chaga and a chlorophyll-free extract from Tetraselmis chuii where the T. chuii extract and the chaga extract are in a 1:2 and 1:4 ratio (see Example 5). The specification specifically states that not all concentrations show a synergistic effect, specifically pages 22 and 23 state that a 1:1 ratio of these ingredients shows only an additive effect which would not be considered markedly distinct. Furthermore, these results are not of the same scope as the broadly claimed invention. The specification tests one type of chaga extract and one type of phytoplankton green algae extract while the claims are drawn to any alcoholic extract from chaga and any type of phytoplankton green algae. A combination of chaga with a different type of green algae would be expected to show different results which might or might not be markedly distinct. Thus, applicant has not shown evidence to support a claim for a markedly distinct product over the breadth of the claimed invention.
In addition, applicant argues “claim 43 would integrate any alleged judicial exception into a practical application, namely compositions formulated for therapeutic use.” However, MPEP § 2106.05(I)(A) states “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements of a pharmaceutically acceptable carrier in claim 43 and “formulation for administration to a mammalian subject” is not considered to amount to significantly more because they are directed to intended uses a pharmaceutical. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
9. Claim(s) 38, 40, 43, and 75-79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (International Journal of Food Science and Technology (2015), vol. 50, pp. 465-471) in view of Ruen-ngam (Chem. Eng. Technol. (2012), vol. 35, no. 2, pp. 255-260) for the reasons set forth in the previous Office action for claims 38-40 and 43.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues:
Zhang is directed to characterizing antioxidant activity of mushroom extracts in
isolation, while Ruen-ngam is directed to a process for selectively removing chlorophyll to improve lutein recovery from Chlorella, and not to therapeutic compositions or combination products. There is no evidence that simply because the compositions might contain antioxidants that the skilled person would have selected and combined those in the normal course of research and development. Neither reference suggests combining fungal extracts with algal extracts, nor do they address any problem that would lead the skilled person to look to the other reference for a solution. The Office Action's rationale relies on impermissible hindsight reconstruction based on a sweeping theory concerning antioxidants rather than the required showing that the person would have in the normal course selected and combined the particular teachings.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In addition, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Both references demonstrate that applicant’s claimed ingredients were known to be useful for the same purpose. It is well established that is considered prima facie obvious to combine together two or more ingredients that were known in the art to be useful for the same purpose. Thus, applicant’s arguments are not persuasive.
In regards to claims 43 and 78, an artisan would be motivated to formulate the pharmaceutical suggested by the references for administration to a subject using carriers as known in the art.
In regards to new claim 75, Zhang teaches that the extract from chaga (Inonotus obliquus) is an ethanolic extract (see Summary).
In regards to new claim 77, as discussed above, applicant’s specification does not demonstrate that the combination is synergistic. Thus, the addition of this term to the claim is not considered to render the claim allowable over the combination of the references because the term is not supported with evidence. In regards to new claim 79, product-by-process claims, note that MPEP § 2113 states “The patentability of a product does not depend on its method of production…”. The Chlorella extract taught by the reference reasonably appears to be the same product despite a different production manner since the resulting product is also a Chlorella extract that is chlorophyll free.
10. 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 Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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