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March 17, 2023by Matthew Barnet

Two recent cases – one at the PTAB and one at the Federal Circuit – illustrate key considerations in determining whether a nature-based product is patent eligible under 35 U.S.C. §101.

In ex Parte Ronchi, the PTAB reversed an examiner’s rejection of claims as patent ineligible under §101. Independent claim 13 recited:

A powder solid composition comprising at least one phospholipid and a hydroalcoholic extract of Bergamot fruit containing flavonoids, neoeriocitrin, naringin and neohesperidin as the only extract.

The examiner found that claim 13 was directed to a “product of nature, namely naturally occurring compounds found in Bergamot fruit.” The examiner acknowledged that the recited hydroalcoholic extract was not found in nature, but argued that isolation or purification by itself “does not result in a product which is ‘markedly different’ from the naturally-occurring component.”

The appellant acknowledged that the components in claim 13 were naturally occurring, but argued that the claimed powder solid composition “is a physical form distinct from any of the naturally-occurring sources of the claimed composition.” The appellant also argued that the combination of phospholipid with the hydroalcoholic extract provided a markedly different characteristic (improved bioavailability of at least naringin and neohesperidin) compared to the extract alone.

The PTAB agreed with the appellant. Citing the Supreme Court case of Myriad, the PTAB acknowledged that “claiming a natural product that is merely separated from elements found in its natural environment, where the structure of the natural product is not otherwise altered, does not support a conclusion that the isolated product is patent eligible.” However, the PTAB noted that “the mere fact that the components of the claimed composition are all nature-based does not end the inquiry as to whether the claimed composition recites a judicial exception.” Instead, according to Myriad (and Chakrabarty) it is necessary to evaluate the claimed composition for “markedly different characteristics from any found in nature.”

In analyzing the composition of claim 13 for markedly different characteristics, the PTAB explained that it “must compare the characteristics of the claimed nature-based composition to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed nature-based product are markedly different.” The PTAB thus looked for the appropriate naturally occurring counterpart.

The PTAB did not consider Bergamot fruit itself to be an appropriate naturally occurring counterpart.[1] Instead, it considered the appropriate counterpart to be a composition containing the components recited in the extract: flavonoids, neoeriocitrin, naringin and neohesperidin. The PTAB disagreed with the examiner’s finding that Bergamot fruit extract could contain the phospholipid lecithin. Accordingly, the PTAB “determine[d] that claim 13 recites two nature-based compositions: (1) the extract having flavonoids, neoeriocitrin, naringin, and neohesperidin, and (2) the phospholipid.”

The PTAB then looked at the appellant’s comparison of the claimed composition (combining the extract and phospholipid) to the extract alone. Data in the specification showed improved bioavailability of naringin and neohesperidin when provided in the claimed composition (extract + phospholipid) compared to when provided in the extract (without the phospholipid).

These data persuaded the PTAB that the claimed composition possessed markedly different characteristics from a naturally occurring counterpart composition, and thus that the claimed composition was patent eligible under §101. Accordingly, the PTAB reversed the examiner’s rejection.

In a different recent case, ChromaDex, Inc., Trustees of Dartmouth College v. Elysium Health, Inc., the Federal Circuit found claims to a nature-based product to be ineligible under §101.

Claim 1 in ChromaDex recited:

A composition comprising isolated nicotinamide riboside [NR] in combination with one or more of tryptophan, nicotinic acid, or nicotinamide, wherein said combination is in admixture with a carrier comprising a sugar, starch, cellulose, powdered tragacanth, malt, gelatin, talc, cocoa butter, suppository wax, oil, glycol, polyol, ester, agar, buffering agent, alginic acid, isotonic saline, Ringer’s solution, ethyl alcohol, polyester, polycarbonate, or polyanhydride, wherein said composition is formulated for oral administration and increased NAD+ biosynthesis upon oral administration.

The court found that claim 1 read on milk[2] as a naturally occurring product, with the only difference being that NR is not “isolated” in milk. As the PTAB did in Ronchi above, the court relied on the Supreme Court cases of Myriad and Chakrabarty in analyzing patent eligibility under §101.

The court found that “the act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility. The claimed compositions remain indistinguishable from natural milk because, other than separation from some other components, the isolated NR is no different structurally or functionally from its natural counterpart in milk.”

The appellant argued that the claimed compositions were advantageous compared to milk because the isolation of NR allowed for significantly more NAD+ biosynthesis than provided by milk. However, the court found that the “claims do not require any minimum quantity of isolated NR. Nor do these claims attribute the claimed increase in NAD+ biosynthesis to the isolated NR, requiring only that the composition increase NAD+ production.” The court reasoned that “[b]ecause milk increases NAD+ biosynthesis, the claimed compositions do not possess characteristics markedly different from those found in nature.” The court concluded that “[t]he claimed compositions do not exhibit markedly different characteristics from natural milk and are, therefore, invalid for claiming a patent-ineligible product of nature.” Accordingly, the court found the claims invalid under §101.

Takeaway: Claims reciting nature-based products, i.e., products whose components are naturally occurring, face scrutiny under §101. Under the framework of Myriad and Chakrabarty, The USPTO and courts analyze these claims to determine if the claimed product possesses “markedly different characteristics” from a corresponding naturally occurring product. If such characteristics are shown (as in Ronchi) then the claims can be found patent eligible under §101. However, if such characteristics cannot be shown (as in ChromaDex) then the claims will be found patent ineligible.

[1] If it had done so, would it have found that cells in the fruit contained phospholipids in their membranes, and thus that the fruit itself contained each of the components recited in claim 13, even if not the specific phospholipids recited in dependent claim 21?

[2] Milk is a composition containing NR (but not “isolated” NR), tryptophan and nicotinamide, in admixture with a sugar (lactose). Milk is formulated for oral administration, and (through tryptophan) increases NAD+ biosynthesis upon consumption.

 


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December 22, 2021by Matthew Barnet

In Ex parte Ruvolo (Appeal No. 2021-001708), the examiner rejected nucleotide claims as anticipated under § 102. The PTAB reversed.

Independent claim 12 recited (in part):

A composition of matter comprising:

a first population of oligonucleotides comprising a top strand sequence having the following formula:

V1-B-3’; and

a second population of oligonucleotides comprising a bottom strand sequence having the following formula:

V2‘-B’-3’;…

Claim 12 further specified (in part) that (i) the nucleotide sequences of B and B’ are complementary and at least 15 nucleotides in length, (ii) the first and second population of oligonucleotides are capable of hybridizing to each other to produce a population of duplexes, and (iii) V1 and V2’ hybridize to different sites in a reference genome.

The examiner cited as anticipatory a reference (Koroulis) disclosing an oligonucleotide array. The reference included the general statement that the array could “contain all possible oligonucleotides of a given length n.” The examiner took the position that “[g]iven that the composition/array of Koroulis et al., encompasses all possible oligonucleotides of a length n, such must encompass the very oligonucleotides present in the claimed composition and kit, including that represented by the formulae of V1-B-3’; and V2‘-B’-3’.”

The appellant argued that the general statement in Koroulis was insufficient for anticipation, and that “[t]he Office Action makes no attempt to identify where Koroulis discloses the particular claim elements recited by the rejected claims.”

The PTAB sided with the appellant. It found that “[t]he bare statement that an array can include all possible nucleotides having an undefined length is not a disclosure of the two populations of oligonucleotides – having segments meeting specified structural requirements, arranged in a specified way – that are recited in Appellant’s claims.” Accordingly, the PTAB reversed the anticipation rejection.

The examiner also rejected the claims as patent ineligible under § 101, as allegedly directed to a natural phenomenon (“the claims are to oligonucleotides, the nucleotide sequence of which can occur in nature”). The PTAB also reversed this rejection, as a straightforward application of the U.S. Supreme Court’s Myriad decision.

In particular, the PTAB found the claimed oligonucleotides to be analogous to the cDNA found patent eligible in Myriad: “[t]he V1 and V2’ segments recited in Appellants’ claims might have the same sequence of nucleotides as found in a naturally occurring genome (since they hybridize to a reference genome) but the Examiner has not shown that a population of such segments – having variable sequences – are naturally found next to a common B or B’ sequence in their natural state.” Accordingly, the PTAB reversed the eligibility rejection.

Takeaway: Anticipation requires that a reference discloses “all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Ex parte Ruvolo shows that an overly general disclosure is insufficient to establish anticipation if the disclosure does not address specific limitations in the claims. By emphasizing the specific limitations in the claims, the Appellant in Ex parte Ruvolo overcame the anticipation rejection, as well as the § 101 rejection.

Judges: Grimes, Hulse, Townsend


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December 11, 2020by Matthew Barnet

Section 101 broadly recognizes patent eligibility for “any new and useful process, machine, manufacture, or composition of matter.” However, the U.S. Supreme Court has identified exceptions to patent eligibility, including laws of nature, natural phenomena, and abstract ideas.

The Supreme Court has articulated a two-step framework for evaluating patent eligibility, based on the Alice (573 U.S. 208) and Mayo (566 U.S. 66) cases. Step 1 asks whether the claim relates to at least one of the statutory categories (process, machine, manufacture, or composition of matter). If the answer is yes, then step 2A asks whether the claim is directed to a judicial exception (law of nature, natural phenomenon, or abstract idea). If the claim is directed to a judicial exception, then step 2B asks whether the claim recites additional elements that amount to significantly more than the judicial exception.

The judicial exception of natural phenomena includes products of nature. For claims relating to products of nature, a key issue is whether the claimed product has markedly different characteristics from the naturally occurring product. If so, then the claimed product is patent eligible. If not, then the claimed product is not patent eligible.

This issue is illustrated in the recent Patent Trial and Appeal Board (“Board”) case of Ex parte Asolkar.

Independent claim 3 recited:

A composition comprising:

(a) a whole cell broth collected from Flavobacterium sp. H492 (NRRL Accession No. B-50584) agitated fermentation, and

(b) a carrier, diluent, surfactant or adjuvant;

wherein said composition has pesticidal or plant growth modulating activity.

The examiner rejected claim 3 under section 101. Since this claim related to a composition of matter, it satisfied step 1 of the Alice/Mayo framework. At step 2A, however, the examiner took the position that claim 3 was “directed to a natural product (i.e., a law of nature/a natural phenomenon).” At step 2B, the examiner took the position that the claim did “not include additional elements that are sufficient to amount to significantly more than the judicial exception.”

In particular, the examiner found that the claimed composition was “not markedly different from its naturally-occurring counterpart because there is no indication that the extract composition has any characteristics or properties that are different from the naturally-occurring counterpart.”

The applicant explained that the whole cell broth in claim 3 was produced by agitated fermentation. The applicant explained that this agitated fermentation led to the claimed property of “pesticidal or plant growth modulating activity,” and that this property was not exhibited under natural conditions.

To support this position, the applicant submitted a Rule 132 declaration. The declaration included data showing a difference in pesticidal properties depending on the culturing conditions of Flavobacterium. In particular, the data showed that bacteria grown under agitated fermentation conditions exhibited pesticidal activity, whereas bacteria grown under non-agitated fermentation conditions did not exhibit such activity. Based on this, the applicant argued that the claimed composition exhibited markedly different characteristics from the bacteria found in nature.

The Board agreed with the applicant. The Board found that the applicant “demonstrate[d] that the claimed composition exhibits phenotypic differences compared to what would be exhibited by a similar, natural composition, which are due to processing by agitated fermentation, as claimed.” The Board concluded that “the claimed composition possesses markedly different characteristics from any found in nature, in the form of phenotypic differences that have come about by the effort of the inventors, not independently as a natural phenomenon.” Accordingly, the Board reversed the rejection under section 101.

Takeaway: If an examiner takes the position that a claimed product does not have markedly different characteristics from a product of nature, and rejects the claim under section 101, it is critical for the applicant to provide evidence that the claimed product does have markedly different characteristics. Such evidence can be in the form of a technical explanation, preferably supported by experimental data.

Judges: Schneider, Flax, Townsend