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 .
Status of claims
Claims 1-13 as amended on 5/26/2026 are pending and under examination in the instant office action.
Claim Objections
Claims 2 and 9 remain objected to because of the following informalities:
In the claims 2 and 9 all Latin names of plants should be italicized .
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefinite
Claims 2, 4, 6, 7 amd 13 as result of amendment to preceding claim 1 are now 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 2 is rendered indefinite by the phrase "preferably" since the claim recites both a broad recitation (pistil extract) and the narrower recitation (aqueous extract of pistil cytoplasm). Thus, it is unclear if the scope is limited to the broad or narrow embodiment.
Claim 4 is rendered indefinite by the phrase "preferentially" since the claim recites both a broad recitation (one generic vitamin) and the narrower recitation (vitaminD3, B6 or E alone or as a mixture). Thus, it is unclear if the scope is limited to the broad or narrow embodiment.
Claim 6, line 4, is rendered indefinite by the phrase "preferably". A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation 60-90% (line 3)) and the claim also recites 60-86.5% (line 4), which is the narrower statement of the range. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 6 is indefinite because it is inconsistent and unclear about percentages of various pollen extracts (lines 4, 6, 8, 10 and 12) in some “final” preparations of several entities such as “final pollen extract” (line 4), “final pollen cytoplasm extract” (lines 6, 8 and 10), “pistil cytoplasm… of the final pollen cytoplasm” (lines 11-12). It is unclear whether percentages refer to concertation of individual pollen in its individual aqueous final preparation, or whether percentages refer to concentration of each plant pollen in the whole mixture of all 4 plant pollens.
Claim 7 is rendered indefinite by the repeated phrases "preferably" for the same reasons as explained above.
Claim 7 is rendered indefinite because it depends on claim 1 which requires pollen of all 4 plants but claim 7 recites plants as members of a Markush group, thereby, allows for one only plant and/or excluding other 3 plants.
Claim 13 recites the limitation "pistil cytoplasm" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 9 remains rejected under 35 U.S.C. 102 (a) (1) as being anticipated by CN 104187611 (Hu).
The cited document CN 104187611 (Hu) discloses an oral composition for treating gastrointestinal comprising spirulina, pine pollen, vitamins D, E and B6 and selenium (see English abstract and description).
Thus, the cited disclosure anticipates claim 9 as drawn to alternative incorporation of pollen extract from one plant Pinus by virtue of language “and/or”.
Thus, the cited disclosure anticipates the claimed composition.
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.
Claims 1-13 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0216877 (Morra), WO 2020/178720 (Barratt), Gaia Garden (published on line Sep 14, 2020; https://www.gaiagarden.com/products/pine-pollen-powder-pinus-massoniana-dried-herb; page 1, retrieved on 2/23/2026) and CN 104187611 (Hu) discloses an oral composition for treating gastrointestinal comprising spirulina, pine pollen, vitamins D, E and B6 and selenium (see English abstract and description).
The cited document US 2019/0216877 (Morra) discloses an oral composition for immune boost and treating infections (abstract and par. 0005, 0176), wherein the composition comprises: aqueous extracts of pollen cytoplasm from Secale cereale, Zea mays Pinus sylvestris and Dactylis glomerata, an aqueous extract of pistil cytoplasm from Zea mays (par. 097-0101) in the same amounts as recited in the pending claims (par. 0074-0080). The composition further comprises generic vitamins (par. 0144) and coating agent (par. 0185). The cited document US 2019/0216877 (Morra) also discloses a method of making compositions by aqueous extraction of plant pollen and pistil, by spray-drying and by mixing components (par. 0107-0111; par. 0131-0136).
The cited US 20190/0216877 is silent about incorporation of spirulina and particular vitamins D3, B6 and E and selenium into an oral composition for boosting immune system.
However, WO 2020/178720 (Barratt) discloses an oral composition for boosting immune system comprising spirulina and micronutrients (abstract), wherein micronutrients are vitamins D3, B6, E and selenium (page 3, lines 26-31; page 19, lines 18-30). The composition also comprises components of rye Secale cereale and maize Zea mays (page 19, line 23). The cited document discloses effective amounts of active ingredients that fall within the claimed ranges such up to 50% of spirulina and 0.02-0.05 % of micronutrients (page 12, lines 11-14). The cited WO 2020/178720 (Barratt) also recognized antiviral HIV effects of spirulina (page 2, lines 7-8).
Further, the reference Gaia Garden suggests a combination of composition with pine pollen and spirulina as intended for improving immune system. The reference Gaia Garden recognizes that pine pollen is rich in vitamins D3, B6, E and selenium.
Moreover, CN 104187611 (Hu) discloses an oral composition for treating gastrointestinal comprising spirulina, pine pollen, vitamins D, E and B6 and selenium (see English abstract and description).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was made to combine plant pollen extracts-containing composition of US 2019/0216877 (Morra) with spirulina and micronutrients-containing composition of WO 2020/178720 (Barratt) with a reasonable expectation of success in providing a combined composition for boosting immune system as suggested by Gaia Garden because both compositions including plant pollen extracts-containing composition and spirulina and micronutrients-containing composition have been knonw in the prier art as suitable for oral administration for boosting immune system and because a combination of both active ingredients spirulina and pine plant pollen have been suggested (Gaia Garden) and knonw (CN 104187611) as effective for improving nutrition and immune system.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 5/26/2026 have been fully considered but they are not persuasive.
With regard to claim rejection under 35 U.S.C. 102 (a) (1) as being anticipated by CN 104187611 (Hu) Applicants argued that the claimed invention is now limited to the use of pollen of 4 plants. But claim 9 is still drawn to alternative incorporation of pollen extract from one plant Pinus by virtue of language “and/or”.
With regard to claim rejection under 35 U.S.C. 103 Applicant’s main argument is directed to unexpected immunomodulating effects of the claim-recited composition comprising spirulina extract and aqueous pollen extract from pollen cytoplasm of 4 particular plants.
This argument is not found persuasive with respect to the present claim-recited limitations. It is well knonw that the scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). Moreover, synergism is a highly unpredictable result that is very dependent on the ingredients used and the amounts of each. Thus, any combination for which synergism is not clearly established would be properly rejected because non-obviousness would not have been established.
In the instant case, the synergistic effects is shown for one only specific composition (Composition A in the example 5), wherein Composition A comprises specific amounts of spirulina extract (par. 0276) and specific amount of aqueous pollen extract from pollen cytoplasm (par. 0277) made from 4 plants, wherein final pollen cytoplasm extract comprises specific amounts of each 4 individual plant pollen cytoplasm extracts (table 1). None of the pending claims is so limited. For example: claim 6 does not recited amount of spirulina in the total weigh of the composition. Claim 7 does not require all 4-plant aqueous pollen extract as Applicant’s Composition A and the amounts for each of 4 plant pollen cytoplasm extracts are recited. Moreover, due to the use of language “preferably” and “preferentially” claims are indefinite with regard specific amounts and concentrations of each as shown for synergistic or unexpected immunomodulating effects as argued.
Thus, any combination for which synergism is not clearly established would be properly rejected because non-obviousness would not have been established.
No claims are allowed in the instant office action.
Conclusion
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.
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Vera Afremova
August 6, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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