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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 07/28/2022.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 05/08/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The applicant was called on 03/04/2026 so that they could make a proper species election. Jasmine Ange elected the species as D-psicose from species group A, rhododendrol from species group B, and water from species group C.
Claims 8-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/09/2025.
Claims 1-7 are being examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/09/2025 and 07/28/2022 are being considered by the examiner. The signed IDS form is attached with the instant office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 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.
Regarding claim 7, the phrase "preferably selected from" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are limiting the claimed invention limitation, since the phenolic compounds are already recited prior. The metes and bounds of the claim limitations are unclear. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed composition is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products raspberry ketone and one or more saccharides, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within plants. Plant extracts are made by partitioning the starting plant material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant extracts are purified by removing unwanted plant material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant is merely claiming components found within plants and nothing more.
The claims do not limit the composition to a physical manifestation of a specific practical application. Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
The claims as currently written are merely directed to extracted components from plant(s), which are the judicial exceptions which cannot be claimed. There has been nothing done to those judicial exceptions which would allow them any modified activities and they appear to be extractable from a single plant source which is Birch tree components such as the bark of the tree as can be appreciated from claim 2. Merely claiming these components without imparting some practical application or making any changes to those judicial exceptions is not permissible.
Claim Rejections - 35 USC § 102 / Claim Rejections - 35 USC § 103
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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Benoît Dumont et. al. (From IDS dated 07/28/2022, EP0707072A1).
Dumont teaches of compositions which comprise of raspberry ketones (see page 17, para. 4) and teaches of preparation methods for 4-(4'-hydroxyphenyl) butan-2-one (raspberry ketone; I), comprises contacting 4-(4'-hydroxyphenyl) butan-2-ol (rhododendrol; II) with an enzyme having alcohol dehydrogenase activity (see abstract). Dumont teaches wherein betuloside and rhododendrine are synonyms for the substrate-enzyme reaction from 4-(4'-hydroxyphenyl) butan-2-ol and 3- (4'-hydroxyphenyl) -1-methyl-propyl-β-D-glucopyranoside (see page 2, Description: para. 9).
According to this variant of the invention, the betuloside / rhododendrine is brought into contact with an enzymatic preparation having a 13-glucosidase activity, this preparation catalyzes the hydrolysis of the substrate” (see page 3, para. 15).
Dumont teaches that as an example source of betuloside it can be extracted from species of birch (Betulaceae) (see page 4, 1st para.). White birch (Betula alba) is particularly preferred, the fresh bark collected during the winter period being the richest in glucoside (between 1 and 30%, for example between 1 and 14%) (see page 4, 3rd para.).
Dumont further discloses wherein the extraction of 3- (4'-hydroxyphenyl) -1-methylpropyl-13-D-glucopyranoside from the vegetable source (ground to give pieces of size less than 1.5 cm) is normally carried out using water at 100 C., optionally followed by a partial purification step with magnesium oxide and hot alcohol (for example ethyl alcohol at 95 °) (see Sosa A., 1933, CRAcad. Sc. Paris, 196: 1827-1830; Sosa A. and Sosa-Bourdouil C., 1936, Bulletin de la Societe de Chimie Biologique, 18: 918-925). Normally, this extraction step has a duration of between 2 and 36 hours (for example 12 to 36 hours) and leads to the production of approximately 1 to 10 g of (pure) glucoside per kg of fresh plant material, depending on source. The purity of the glucoside is estimated between 10 and 20% (w / w), for example between 10 and 1 5% (w / w). It can reach 30 to 40% (w / w). Often the extract contains not only the glucoside, but also the corresponding aglucone, i.e. betuligenol or (+) rhododendrol. Among the impurities, one can note the presence of tannins, sugars, fats, waxes, resins, phytosterols, fatty acids and various condensed compounds.
"B-glucosidase activity" means, in the context of the invention, the capacity of the enzymatic preparation to hydrolyze betuloside (or rhododendrine) to 4- (4'hydroxyphenyl) butan-2-ol and glucose” (see page 4, 3rd para.).
“The enzyme/ substrate ratio is normally from 10 to 2000 mg / g depending on the nature and activity of the enzyme, advantageously from 10 to 1000 mg / g and, in
particular from 10 to 500 mg/ g and from interestingly from 10 to 30 mg/ g. For example in the case of Emulsin, the enzyme/ substrate ratio is approximately 19.5 mg/
g, when the activity of the enzyme is approximately 6.9 U /mg. When the enzyme is Rohapect, the enzyme/ substrate ratio may be around 600 mg I g. This step makes it
possible to obtain betuligenol / (+) rhododendrol with a molar yield of 60 to 100%, for example around 90%, the secondary alcohol then preferably being extracted from
the aqueous phase by an organic phase, by example diethyl ether, and dried to give rise to a dry residue (purity of betuligenol or (+) rhododendrol about 50 to 60%}.
The betuligenol and/ or (+) rhododendrol thus obtained is then brought into contact with an enzyme having alcohol dehydrogenase activity under conditions as
described above. If the source of the enzyme is a microorganism, the reaction medium must be adapted to the microorganism used.
The raspberry ketone obtained is finally extracted by carrying out a liquid / liquid extraction,” (see bottom of page 4, top of page 5).
Dumont does not specifically teach that the sugar is D-psicose as claimed.
However, Dumont teaches wherein the birch tree bark is extracted with water through decoction at 100 degrees Celsius (see example 1, page 6). This process would be expected to bring about the same sugars as claimed as the instant extraction appears to be done with water as can be appreciated from their recitation: “In one embodiment of the invention the aqueous solvent used for extracting the birch bark biomass is water or a mixture of water and an organic solvent selected from ethanol, ethyl acetate, methanol, tetrahydrofuran (THF), ace- tone and any mixture thereof. Preferably the aqueous solvent is water. Raspberry ketone is extracted from the bark of birch using only water as the extraction solvent” (see page 8-9).
Therefore it would have been obvious to persons having ordinary sill in the art before the effective filing date to recognize that purification steps are optional and that when the substrate and enzyme are in contact with each other rhododendrol is a byproduct formed in the process of making raspberry ketones along with glucose, as taught by Dumont. This intermediary step in the method of creating raspberry ketones would have created the instant product which is raspberry ketones with glucose as a byproduct, and which is also a monosaccharide coming from birch tree bark, along with rhododendrol, which is a phenolic compound.
Although Dumont does not specifically teach D-psicose as the monosaccharide, Dumont teaches the same aqueous water extract of the birch tree bark which would be expected to contain the monosaccharide as the extraction solvents are the same. The applicant recites “the monosaccharides of the composition can be naturally occurring monosaccharides that are extractable from the bark of birch tree, preferably the inner bark of birch tree” (see page 3). The applicant also recites “many of the naturally occurring monosaccharides, extractable from inner bark of birch tree together with raspberry ketone, such as psicose, rhamnose, fucose, mannose and arabinose, function as natural nutritive and non- nutritive sweeteners and together with raspberry ketone they function as a ready to use composition in foodstuff” (see page 4). Using the same extraction solvent on the same plant would extract out the same monosaccharides and so Dumont has disclosed the instant invention.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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