Matthew Barnet, Author at ElementIP Law

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.

U.S. examiners often combine two or more references in making an obviousness rejection. Sometimes, a possible argument against obviousness is that there would not have been a reasonable expectation of success in combining the references in the way proposed by the examiner. When making such an argument, however, applicants might inadvertently raise the issue of enablement. The recent case of Ex parte During (Appeal No. 2022-000776) illustrates this situation.

Independent claim 1 in During recited:

A method of treating narcolepsy comprising administering to a patient in need thereof a pharmaceutical composition comprising 4,5,6,7-tetrahydroisoxazolo [5,4-c] pyridine-3-ol (gaboxadol) or a pharmaceutically acceptable salt thereof.

The examiner rejected claim 1 as obvious based on a combination of two references: Walsh and Abad. Walsh taught that the drug gaboxadol enhances slow wave sleep (SWS). Abad taught that certain SWS-enhancers are effective to treat narcolepsy. Combining these references, the examiner found that it would have been obvious to treat narcolepsy with gaboxadol.[1]

The applicant argued that there would not have been a reasonable expectation of success in combining the cited references to obtain the claimed methods. For example, Abad indicated that it was unclear whether SWS enhancement was the appropriate mechanism for treating narcolepsy, and that the effectiveness of any one compound was uncertain until tested. The applicant further explained that the SWS-enhancers used in Abad bound to a different receptor than gaboxadol, and therefore acted by a different mechanism.

The PTAB agreed with the applicant. It found that the cited references “merely render[] gaboxadol obvious to try in a method to treat narcolepsy.” However, “Abad does not provide specific guidance as to how gaboxadol may be used to treat narcolepsy, concluding instead that ‘[m]ore research is needed to determine the usefulness of [other potential SWS enhancers] in consolidating nocturnal sleep in narcolepsy patients.’” The PTAB cited Abad’s conclusions that “[n]arcolepsy remains a complex disease whose cure remains elusive despite our expanding knowledge about its pathophysiology” and that “[d]isease-specific therapies need further development and testing before they can be clinically relevant.”

Finding that there would not have been a reasonable expectation of success in combining Walsh and Abad to obtain the claimed methods, the PTAB reversed the obviousness rejections.

However, the PTAB issued a new ground of rejection: lack of enablement.

The PTAB noted that independent claim 1 was narrow in terms of the drug (gaboxadol or pharmaceutically acceptable salts) and disease treated (narcolepsy). However, the PTAB explained that “the Specification not only lacks any working examples regarding treatment of narcolepsy using gaboxadol, but also provides only the most generic teachings regarding, e.g., the dosage, route, and/or timing or frequency of administration.” The PTAB cited Abad’s teaching that narcolepsy is “a complex disease whose cure remains elusive despite…expanding knowledge about its pathophysiology,” and found that “a significant quantity of experimentation would have been required to carry out the claimed method.”

Thus, the same teachings from the references used by the applicant to argue against obviousness were used by the PTAB to argue against enablement. Although the PTAB reversed the obviousness rejections, it found the claims not to be enabled.

Takeaway: Applicants should be careful when addressing obviousness rejections by arguing that there would not have been a reasonable expectation of success in combining references, since such an argument might open the door to an enablement rejection. That is, if the applicant argues that the references do not provide sufficient guidance for a skilled artisan to obtain the claimed invention, the applicant should be ready to explain how a skilled artisan could practice the claimed invention based on guidance from the specification.

Judges: Fredman, Jenks, Chang

[1] The examiner also made a second obviousness rejection, over Walsh in view of Mignot, where Mignot was cited for its teaching that SWS-enhancers are effective to treat narcolepsy, similar to the teaching in Abad.

In Ex parte Makarova (Appeal No. 2022-002730), the examiner rejected the claims as obvious based on a combination of references. The PTAB reversed, finding important differences between two references suggesting they should not be combined in the way proposed by the examiner.

Independent claim 1 recited:

A microfilter comprising:

a single polymer layer formed from an epoxy-based negative photo-definable dry film, wherein the single polymer layer has a flexibility to be disposed on a roll and unrolled; and

a plurality of apertures formed by exposing the single polymer layer to a UV light via an optical mask to obtain a selected shape of said apertures based on said mask, each of said apertures extending through the single polymer layer having said flexibility,

said single polymer layer having said flexibility forming a freestanding unattached microfilter structure with uniform thickness and having said flexibility.

The examiner found that the primary reference (Wolfe) described most of the limitations of claim 1. For example, Wolfe described a particulate filter with regularly spaced micropores, which comprised a single flexible polymer layer formed from a photo-definable dry film (MYLAR). The single polymer layer in Wolfe had flexibility sufficient to be disposed on a roll and unrolled, and its apertures were formed by exposing the single polymer layer to radiation via an optical mask. The single polymer layer also formed a freestanding, unattached microfilter structure with a uniform thickness.

However, the film in Wolfe was not an epoxy-based film, as recited in claim 1. The examiner turned to a secondary reference (DuPont) for this limitation.

The examiner found that DuPont described a flexible epoxy-based negative photo-definable dry film that had excellent thickness uniformity after hot roll lamination. The examiner found that it would have been obvious to substitute the film from DuPont into Wolfe’s system because both references related to microfabricated polymer membrane structures.

The applicant argued that such a substitution would not have been obvious. In particular, the applicant noted that DuPont’s film was “best suited for permanent applications where it is imaged, cured and left on devices” rather than being a freestanding unattached structure as recited in claim 1. Additionally, the excellent thickness uniformity after hot roll lamination in DuPont was premised on the film being laminated to a substrate, rather than being freestanding.

The PTAB sided with the applicant. The PTAB found that “because DuPont specifically indicates that its film is best used while laminated to an underlying substrate, a person of skill in the art would not have thought that film to be a substitute for Wolfe’s freestanding polymeric sheet.” The PTAB concluded that “the Examiner’s rationale as to why a person of skill in the art would have substituted DuPont’s film for Wolfe’s polymeric sheet is not adequately supported by the evidence of record.” Accordingly, the PTAB reversed the obviousness rejection.

Takeaway: Obviousness rejections often involve a primary reference describing most of the claimed elements, with a secondary reference used to fill in gaps in the primary reference. When an examiner takes the position that it would have been obvious to substitute an element from the primary reference with an element from the secondary reference, it is worth challenging that position if there is a good reason not to make such a substitution.

Judges: Housel, Best, Wilson

In Ex parte Whiteman (Appeal No. 2021-003736), the examiner rejected the claims as obvious based on a hypothetical particle distribution consistent with the prior art. The PTAB reversed.

Independent claim 1 recited:

An inorganic particulate material comprising:

equal to or more than about 3 ppm of particles having a particle size equal to or greater than about 25 μm,

equal to or less than about 40 wt% of particles smaller than about 0.75 μm,

having a d98 less than about 11 μm, and

wherein the % of particles smaller than 0.5 μm is equal to or less than about 25 wt%.

Relevant to the appeal, the italicized limitations required that (i) particles smaller than about 0.75 μm made up no more than about 40 wt% of the particle distribution, and (ii) particles smaller than 0.5 μm made up no more than about 25 wt% of the particle distribution. In other words, there could not be a large fraction of very small particles. For example, a distribution in which 50 wt% of particles were smaller than 0.75 μm would be outside the scope of the claims, as would a distribution in which 30 wt% of particles were smaller than 0.5 μm.

The examiner rejected claim 1 as obvious over a single reference (Calhoun). The examiner relied on a d₅₀ value (rather than wt%) in the range of 0.8 to 3 μm in Calhoun. A d₅₀ value of 0.8 μm, for example, would mean that 50% of the particles were smaller than 0.8 μm. The examiner took the position that the d₅₀ value in Calhoun “impl[ied] or at least suggest[ed] that the claimed wt% of <~0.75μm particles is met.” The examiner found that it would have been obvious “to adjust the particles’ size (either by removing undesirably-sized particles and/or agglomerates, grinding too large particles/agglomerates, and/or agglomerating too small particles)…to meet the claimed wt% of <~0.75μm particles.”

The applicant argued that although Calhoun described a d₅₀ value in the range of 0.8 to 3 μm, the reference said nothing about the fraction of particles smaller than 0.75 μm, or smaller than 0.5 μm, as recited in claim 1. The applicant argued that the examiner had created “a convoluted hypothetical” particle distribution from Calhoun, in which a d₅₀ value of 0.8 μm could be satisfied by 40 wt% of the particles being smaller than 0.75 μm (according to claim 1), and 10 wt% of the particles being between 0.75 and 0.80 μm. Although such a hypothetical particle distribution might have been consistent with the d₅₀ value in Calhoun, the applicant argued that this hypothetical particle distribution was in no way disclosed or suggested by Calhoun.

The PTAB sided with the applicant. The PTAB found that Calhoun’s d₅₀ value of 0.8 to 3 μm “neither discloses nor suggests anything about the particular percentage of particles smaller than about 0.75 μm or smaller than 0.5 μm.” The PTAB found that the “[e]xaminer assumes without providing sufficient evidence that Calhoun’s preferred particulate product having a d₅₀ of 0.8-3 μm contains ‘smaller portion[s] within’ the product, which meet the claimed particular product size distributions.” Accordingly, the PTAB reversed the obviousness rejection.

Takeaway: Obviousness cannot be based on speculation. If a U.S. examiner finds a claimed feature to be obvious over prior art describing a somewhat related, but different feature, the examiner must provide supporting evidence instead of mere speculation. If, as in Ex parte Whiteman, the examiner speculates about a “convoluted hypothetical” feature that is consistent with the prior art – but is not disclosed or suggested by the prior art – it is worth challenging the examiner’s position.

Judges: Colaianni, Dennett, McGee

In Ex parte Jung (Appeal No. 2021-003163), the examiner rejected the claims as obvious based on an inherency rationale. The PTAB reversed.

Independent claim 16 recited an inkjet set consisting of:

a black inkjet ink, a cyan inkjet ink, and two inkjet inks A and B… wherein

the inkjet ink A has a hue angle H* between 70 and 85 and a chroma C* between 30 and 80;

the inkjet ink B has a hue angle H* between 20 and 40 and a chroma C* between 30 and 80 …

The dispositive issue on appeal was whether the hue angle H* and chroma C* were inherent in the applied art.

The examiner cited a reference broadly disclosing mixtures of pigments, and including the specific pigments C.I. Pigment Orange 71, C.I. Pigment Yellow 139, C.I. Pigment Red 254, and C.I. Pigment Red 122 among a long list of suitable pigments. The examiner noted that these specific pigments were recited in the applicant’s dependent claims 19 and 21. Based on this, the examiner took the position that if these specific pigments were selected in the reference, the resulting inks “would intrinsically [i.e., inherently] have” the claimed H* and C* values.

The applicant argued that even if the specific pigments were selected in the reference, the claimed H* and C* values would not necessarily result. The applicant stated that these limitations “are not only achieved by selecting specific pigments, but also by the amounts of the pigments used and the weight ratio of the different pigments in the mixture.” Additionally, the applicant provided calculations of H* and C* values resulting from the examples of the reference, showing them to fall outside the claimed ranges. However, the examiner dismissed these calculations as “attorney argument and not evidence.”

The PTAB sided with the applicant. The PTAB found that “the use of the recited pigments alone is not adequate to guarantee that the H* and C* limitations are met” and that the ratio of different pigments mattered. Regarding the calculations provided by the applicant, the PTAB found that the examiner dismissed them in error (“There is no dispute that the calculations are based on examples disclosed by [the reference], and there is no dispute as to the accuracy of the calculations. Because [the reference] itself is evidence, the calculations made using the data from [its] examples should not have been disregarded as mere ‘attorney arguments.’”).

The PTAB acknowledged that the claims still might have been obvious if the reference “teaches or suggests combining pigments in a way (e.g., optimizing the weight ratios of different pigments) that would have resulted in H* and C* values within the scope of claim 16.” However, the PTAB found no such teaching or suggestion. While the reference taught that the pigments or mixture of pigments be present “in an amount of 0.1 to 20% by weight based on the total weight of the non-aqueous inkjet ink,” the reference provided no teaching or suggestion for weight ratios among different pigments. Accordingly, the PTAB reversed the obviousness rejection.

Takeaway: Whenever an examiner takes the position that a claimed property is inherent in the applied art, it is important to carefully evaluate embodiments of the applied art that might result in the claimed property. Inherency requires necessity, not merely possibility. That is, just because it might be possible for the applied art to satisfy a claimed property, that does not mean that the applied art necessarily satisfies the property. If the prior art does not necessarily satisfy the claimed property, then inherency has not been established.

Judges: Abraham, Kennedy, Gupta

Composition claims sometimes recite a ratio of amounts of two different components in the composition. Similarly, claims relating to a polymeric compound sometimes recite a ratio between two different structural units of the compound. In evaluating obviousness, U.S. examiners search the prior art for ratios that overlap the claimed ratio. Ex parte Kraus (Appeal No. 2021-002347) is a recent decision of the Patent Trial and Appeal Board (“Board”) in which the examiner went a little too far in trying to find such a ratio in the prior art.

Independent claim 1 related to a polycondensate comprising at least four different structural units: (I), (IIa), (IIb) and (III). Among other limitations, the claim recited a molar ratio of structural unit (IIa) to (IIb) within the range of 0.2 to 1.5.

The examiner rejected claim 1 as obvious over one reference (Wieland), and separately over a different reference (Kraus). In the rejection based on Wieland, the examiner relied on a ratio that included structural units corresponding to (IIa) and (IIb). However, the examiner acknowledged that this was not exactly a ratio of (IIa) to (IIb) since the structural units of Wieland corresponding to (IIa) and (IIb) both were encompassed by the denominator of Wieland’s disclosed ratio. The examiner also relied on values derived from two specific examples in Wieland to construct a ratio of (IIa) to (IIb) overlapping the claimed range.

The Board reversed the rejection over Wieland. The Board found that “[t]he Examiner has not explained sufficiently why one of ordinary skill in the art would mix and match molar concentration values from two different examples to determine a ratio of (IIa) to (IIb) as claimed, particularly given that Wieland’s ratio is different.” The examiner’s calculation “involves picking and choosing convenient values from two unrelated examples to calculate a ratio not used by Wieland.”

In the rejection based on Kraus, the examiner combined a disclosed ratio of structural unit (I) to (IIa) with a disclosed ratio of the sum of structural units (I) and (IIa) to structural unit (IIb). The examiner found that this combination supported a range of molar ratios (IIa) to (IIb) that overlapped the claimed range of 0.2 to 1.5.

The Board also reversed this rejection. The Board found that the examiner had not adequately explained how the two disclosed ratios could be combined to obtain the claimed ratio. The Board noted that “[t]he calculation posited by the Examiner apparently requires substitution of a range within another range,” which it found not to be obvious.

Takeaway: A ratio between two components in a composition, or two structural units in a polymeric compound, can be a useful way to distinguish a claimed invention from prior art. If an examiner appears to be stretching the prior art to construct an overlapping ratio, it is worth challenging the examiner’s rationale.

Judges: Hastings, Kennedy, Cashion Jr.

U.S. patent claims typically use the terms “comprising” and “consisting of” when reciting components of a composition. “Comprising” indicates that the composition must include the recited components, but also can include unrecited components, while “consisting of” indicates that the composition excludes unrecited components.

The term “comprising” advantageously provides the applicant with broader scope of protection than “consisting of.” However, such breadth sometimes opens claims to additional prior art. In such cases, “consisting of” can be helpful to distinguish the claims from the prior art.

When claims use both “comprising” and “consisting of,” the scope of the claims must be analyzed carefully. This issue is illustrated in the recent case of Ex parte Rankin (Appeal No. 2021-001726).

Independent claim 40 recited (in part) a composition comprising:

(i) a gel base consisting of:

a wax or oil and;

a salt; and

(ii) titanium dioxide, zinc oxide, barium sulfate, or a combination thereof dispersed in the gel base.

The examiner rejected claim 40 as anticipated by two different references disclosing gels containing titanium dioxide. The gels also included polymeric gelling agents. In each case, the examiner took the position that the gelling agent was within the scope of the claim based on the open “comprising” term in the preamble. For example, in one anticipation rejection, the examiner stated that claim 40 “is interpreted to mean that the gel base consists of a wax or oil, and a salt, but it does not exclude addition of other components, such as the block polymers taught by [the cited reference] to make the final…product.”

In contrast, the applicant argued that the closed “consisting of” term excluded the polymeric gelling agents of the prior art. For example, the applicant alleged that the gels of the cited reference “differ structurally from the gel of claims 40-55 due to the latter being composed exclusively of a wax or oil and salt and therefore excluding the polymers…as constituent structural components.”

The PTAB agreed with the applicant. The PTAB acknowledged that “the ‘comprising’ language in the claim allows the mixture of the gel base and titanium dioxide, zinc oxide, barium sulfate or combination to include additional components dispersed in the gel base.” However, due to the “consisting of” language, “the gel base may contain only the recited wax or oil and salt…[W]e do not agree [with the examiner] that the claim language allows for the addition of ingredients to the gel base.” Accordingly, the PTAB reversed the anticipation rejections.

Takeaway: Whenever a claim uses both “comprising” and “consisting of,” the scope of the claim must be analyzed carefully. The closed, “consisting of” term might be intended to exclude a component disclosed in the prior art, but the examiner might take the position that the component is within the claim scope due to the “comprising” term. In such cases, it is important to clearly identify how the components of the prior art correspond to the claim. In Rankin, the applicant successfully argued that the polymeric gelling agent of the prior art was a component of the gel base (thus excluded by the “consisting of” term) rather than a component dispersed in the gel base (which would have been included by the “comprising” term).

Judges: Adams, Grimes, Jenks

In Ex parte Abbott (Appeal No. 2021-000770), the examiner rejected the claims as obvious based on an optimization rationale. The PTAB reversed.

Independent claim 1 recited a lighting device for an additive manufacturing machine (i.e., a 3D printer). The device included an array of light sources configured to emit monochromatic light within a band of wavelengths. The band of wavelengths included a peak light absorption of a liquid coalescing agent, so that when the liquid coalescing agent absorbed the light, heat would be generated to melt or sinter a patterned building material.

Claim 1 recited a spectral intensity of at least 1 x 10¹² W m^-3 sr^-1 for each of the monochromatic light sources. The dispositive issue on appeal was whether this limitation was suggested by the applied references.

The examiner acknowledged that the primary reference (Miller) did not disclose this limitation. However, the examiner cited Miller’s teaching that the “amount of radiation provided to each location on the built model should be the amount that ensures sufficient curing in that location,” and that “[t]he radiation may be of any type, or in any wavelength that causes curing of the build material.” The examiner found that a skilled artisan “would have recognized that the light sources taught by Miller could be operated to emit a desired spectral intensity.” The examiner concluded that the claimed spectral intensity could be obtained through “routine optimization of this result-effective variable to provide the intended result of curing of build material during an additive manufacturing process.”

In contrast, the applicant noted that the Miller reference taught no specific values or ranges for spectral intensity. Because of this, the applicant argued that an optimization rationale was unsupported. The applicant cautioned that if the examiner’s position were correct, then the general disclosure of Miller would be sufficient to “render obvious the use of radiation to solidify anything under any conditions for every 3D printing process no matter how specific and how novel the radiation and no matter how different the process.”

The PTAB agreed with the applicant. The PTAB found the lack of any disclosed range of spectral intensity in Miller to be “akin to a very broad range (as there is not a set limit since no limit is provided in Miller).” The PTAB found such a broad range to be “so broad that there is no invitation for routine optimization.” Accordingly, the PTAB reversed the obviousness rejection.

Takeaway: Whenever an examiner takes the position that a claimed variable is a result-effective variable that would have been obvious to optimize, it is important to carefully evaluate the teaching of the prior art relating to the claimed variable. If, as in Ex parte Abbott, there are no specific values or ranges of the claimed variable in the prior art, then the optimization rationale might lack adequate support.

Judges: Franklin, Praiss, Inglese

In Ex parte Scheich (Appeal No. 2021-003495), the examiner rejected the claims as obvious over a combination of two references. The PTAB reversed.

Independent claim 1 recited:

A diffuser material of pore-containing quartz glass with

a chemical purity of at least 99.9% SiO₂,

a cristobalite content of not more than 1%, and

a density in the range of 2.0 to 2.18 g/cm³,

whereby at least 80% of the pores have a maximum pore dimension of less than 20 μm,

wherein the quartz glass is produced synthetically,

has a hydroxyl group content in the range of more than 200 wt. ppm, and

contains hydrogen in a concentration in the range of 10¹⁷ molecules/cm³ to 10¹⁹ molecules/cm³.

The examiner found that the primary reference (Moritz) satisfied each limitation of claim 1, except for being silent about a hydrogen concentration. The examiner cited a secondary reference (Ohama) describing a similar quartz glass. The quartz glass in Ohama was made from a silica powder having a hydrogen concentration overlapping the range recited in claim 1.

The examiner took the position that it would have been obvious to use Ohama’s silica starting material to prepare the quartz glass of Moritz. The examiner found that the hydrogen concentration of the finished product would be expected to be the same as that of the starting material because “[n]o evidence is given” to the contrary, and “Ohama provides no teaching or suggestion that the hydrogen is removed from the powder prior to or during formation of the inventive quartz material.”

In contrast, the applicant argued that the finished product in Ohama would not be expected to have the same hydrogen content as the starting material. In particular, the applicant argued that the sintering process in Ohama would be expected to reduce or remove molecular hydrogen from the starting material in forming Ohama’s finished product. As evidence, the applicant cited a portion of Ohama describing that the hydrogen in the starting material “react[s] with free oxygen to form OH groups, and the OH groups are fixed in the glass to suppress pore expansion from occurring.”

The PTAB agreed with the applicant. The PTAB found that “Ohama discloses that the hydrogen in Ohama’s starting material reacts with oxygen in a way that would consume Ohama’s hydrogen, such that Ohama’s final quartz glass product would not have the same hydrogen concentration as its silica powder starting material.” In a footnote, the PTAB acknowledged that the broad range of hydrogen concentration in Ohama’s starting material might allow for significant removal of hydrogen while still satisfying the claimed range for the finished product. However, since the examiner made no findings as to an expected magnitude of the decrease of hydrogen, the PTAB reversed the obviousness rejection.

Takeaway: U.S. examiners often make inferences beyond the explicit teachings of prior art references. These inferences usually are phrased in terms of what would have been expected based on the technical knowledge of a person of ordinary skill in the art. Sometimes applicants can rebut such inferences with evidence of their own. This evidence can be provided in the form of a Rule 132 Declaration, or, as in Ex parte Scheich, by reference to portions of the applied art.

Judges: Best, Kennedy, Cashion Jr.

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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