Thu. Jun 20th, 2024

On July 10, 2023, the Patent Trial and Enchantment Board (PTAB) reversed an examiner’s discovering of apparent on the premise of a failure to point out a motivation to switch the prior artwork and a scarcity of an affordable expectation of success. The enchantment (No. 2023-002080, USSN 15/558,153, Know-how Middle 1700) of Ex parte MARK HETHERINGTON started with the submitting of a Discover of Enchantment on Might 13, 2022, after submitting the nationwide stage utility on September 13, 2017. The primary appealed declare recited:

[a] course of for producing a meal fraction of Brassica carinataoilseed having decreased sinigrin content material, the tactic comprising: a. urgent seeds of Brassica carinataoilseed to provide oilseed flakes; b. cooking the oilseed flakes at a temperature within the vary of 105°C to 180°C; c. urgent the cooked oilseed flakes to take away oil from the oilseed flakes, thereby producing an oil fraction and a meal fraction; d. treating the meal fraction with hexane to extract residual oil; e. desolventizing-toasting the hexane-extracted meal fraction to take away residual hexane for a interval of higher than 1 hour however lower than 5 hours; and f. drying the meal fraction to a moisture content material of 12% or much less, and g. recovering a meal fraction of Brassica carinatahaving a sinigrin content material of lower than 20 μmol per gram of meal.

The claims had been rejected by Examiner Stefanie Cox, supervised for the primary three years of prosecution by Major Examiner Michele Jacobson, underneath Supervisory Patent Examiner Amber Orlando, all of whom had been conferees within the final choice to drive an enchantment upon the applicant. That’s, the applicant obtained 9 workplace actions from Examiner Cox, of which 5 had been signed by Examiner Jacobson, and the Examiner’s Reply (to ship the enchantment temporary to the PTAB) was signed by Examiners Cox, Jacobson, and Orlando.

Given the breadth of the reversal of the examiner’s place, the prosecution historical past of the Hetherington utility warrants dialogue. The unique unbiased claims of the Hetherington utility, i.e., claims 1, 25, and 29, are offered under.

Declare 1: A course of for eradicating no less than one glucosinolate from a meal fraction of oilseed comprising: (a) treating the meal fraction of oilseed with exogenous myrosinase to transform the no less than one glucosinolate to a risky isothiocyanate; and (b) eradicating the risky isothiocyanate from the handled meal fraction of oilseed underneath situations of delicate warmth and unfavourable stress. Declare 25: A course of for eradicating no less than one glucosinolate from a meal fraction of a Brassica carinataoilseed comprising: (a) heating and making use of stress to the oilseed earlier than, throughout, or after the extraction of oil; (b) treating the meal fraction of oilseed with exogenous myrosinase to transform the no less than one glucosinolate to a risky isothiocyanate; and (c) eradicating the risky isothiocyanate from the handled meal fraction of oilseed underneath situations of delicate warmth and unfavourable stress. Declare 29: A course of for eradicating no less than one glucosinolate from a meal fraction of a Brassica carinataoilseed comprising heating and making use of stress to the oilseed earlier than, throughout, or after the extraction of oil.

As detailed within the background of the Hetherington utility and within the PTAB choice, the pressed fibrous the rest from Brassica carinata oilseed crops (also called “Ethiopian mustard” or “carinata”) incorporates excessive ranges of glucoinolates, i.e.,

which restrict its utility as a livestock feed. Carinata varieties are helpful in making “biofuels,” and it might be helpful to make use of the pressed fibrous the rest as feed, as is finished for different oilseed plant supplies. Glucosinolates and their metabolites may be dangerous to livestock. Sure glucosinolates are identified to be degraded by enzymes akin to myrosinase, which is of course current in mustard seeds, in a water hydrolysis breaking down, e.g., sinigrin (2-propenyl glucosinolate or allyl glucosinolate) into glucose, allyl isothiocyanate (liable for the “chunk” of horseradish and wasabi), and a sulfate anion, seen under.

Sure glucoinolates adversely have an effect on animal well being, and their hydrolysis can intervene with animal thyroid perform.

The claims had been initially rejected as missing novelty over US 2005/0031768 A1 (Sakai), which describes acquiring or making ready a mustard seed inventory, whereby

[t]he mustard seed inventory is cracked, both by grinding or crushing or urgent or different actions. Alternatively, a mustard cake materials produced by the prior crushing of mustard seed may be used and that cake may very well be damaged up or blended with every other uncooked mustard seed materials to create the preliminary beginning batch of mustard seed inventory for use within the course of. As soon as the mustard seed inventory has been cracked, the method may be continued. [0027] Whatever the beginning materials, the following stage within the course of includes inserting the cracked mustard seed inventory together with water in a response chamber by which hydrolysis and distillation can happen underneath situations of decreased stress. Combining the cracked mustard seed inventory with water to activate the enzyme myrosinase contained therein successfully creates an activated mustard slurry. The myrosinase hydrolysis will happen in a response chamber or the like within the activated mustard slurry and, on this foundation, the hydrolysis will convert or degrade sinigrin within the activated mustard slurry into the fractioned allyl isothiocyanate. That is also called allyl oil. The hydrolysis will probably be performed over a time frame that’s acceptable to create the requisite or desired quantity of allyl oil, at a predetermined efficient temperature and at a predetermined efficient atmospheric stress. … [0029] By way of temperature of stress, it’s contemplated that the hydrolysis would possible happen within the vary of 30 to 90 minutes in a preferable temperature vary of 40° C. to 50° C. and at a stress of 45 mM Hg. Beneath these situations, hydrolysis of the sinigrin current in any such mustard seed inventory would produce risky allyl oil, which is concurrently distilled off of the response chamber and the activated mustard slurry. The removing of allyl oil from the activated mustard slurry by distillation will considerably enhance the self-life of the ready mustard merchandise yielded from the rest or spent mustard slurry, as the traditional breakdown of allyl oil contributes considerably to product spoilage. [0030] Thus, the method yields a spent mustard slurry by which hydrolysis has taken place and from which allyl oil is generated by myrosinase exercise. The allyl oil is evaporated by situations of elevated temperature and decreased stress and is distilled away from the rest or remaining spent mustard slurry. Thus, Sakai described an identical course of with desire for a temperature vary of 40 to 50°C and at a stress of 45 mM Hg (underpressure).

The applicant amended the treating step to recite “including treating the meal fraction of oilseed with exogenous myrosinase to the meal fraction of oilseed to transform the no less than one glucosinolate to a risky isothiocyanate” within the preliminary response, after which the primary claims had been rejected over Sakai and US 6,824,796 (Pusateri) on the premise that though Sakai failed to explain including exogenous myrosinase to the meal fraction, Pusateri described including exogenous myrosinase. After cancelling unbiased claims 1 and 29, the applicant amended declare 25 to additional recite that “the temperature throughout heating is bigger than 85°C however lower than l80°C,” and “the stress is utilized utilizing an expeller or screw press.” The applicant argued that Sakai teaches a temperature vary of 40-50°C for myrosinase-catalyzed hydrolysis of sinigrin, which the applicant famous, pointing to Sakai’s ¶ [0004] was taught to protect exercise of the myrosinase enzyme (“any methodology of manufacturing that includes heating the combination to temperatures above 45° C. will make inconceivable to keep up the exercise of myrosinase”).

The claims had been then rejected as apparent over a grasp’s thesis entitled “Evaluation of Oilseed Glucosinolate and Their Destiny Throughout Urgent or Dehulling” by Deyun Yuan of the College of Saskatchewan (Yuan). The examiner argued that Yuan’s introduction on pp. 10 to 14, which embrace the textual content offered instantly under on Yuan’s p. 14.

Many revealed strategies described extraction at temperatures between 70 and 100°C with the intention to inactivate the endogenous myrosinase (Cools and Terry, 2012; ISO, 1992; Kiddle et al., 2001; Szmigielska and Schoenau, 2000; Wathelet et al., 1999). However warmth remedy is controversial. Tsao et al. (2002) identified that heating earlier than extraction might not inactivate myrosinase fully, particularly when the moisture content material is lower than 8%. In different circumstances, heating might result in degradation of glycosides like glucosinolates.

In response, the applicant cancelled all pending claims and launched a brand new unbiased declare as indicated under.

Declare 38: A course of for producing a meal fraction of Brassica carinataoilseed having decreased sinigrin content material, the tactic comprising: a. urgent seeds of Brassica carinataoilseed to provide oilseed flakes; b. cooking the oilseed flakes at a temperature within the vary of 105°C to 180°C; c. urgent the cooked oilseed flakes to take away oil from the oilseed flakes, thereby producing an oil fraction and a meal fraction; d. treating the meal fraction with hexane to extract residual oil; e. desolventizing-toasting the hexane-extracted meal fraction to take away residual hexane; and f. drying the meal fraction to a moisture content material of 12% or much less, and g. recovering a meal fraction of Brassica carinatahaving a sinigrin content material of lower than 20 μmol per gram of meal.

The applicant argued that Examples 9 to 12 of the appliance present that its presently claimed course of leads to substantial decreases in sinigrin content material within the meal fraction of B. carinata oilseed. Referencing the experimental proof within the utility, the applicant indicated that Pattern 1 is a management pattern comprising defatted B. carinata selection A110 meal produced by grinding B. carinata oilseed in a blender to kind a uniform meal, with out the appliance of stress, heating the meal at 80°C for 20 minutes, permitting the meal to chill, then extracting the meal with hexane 4 occasions to provide a defatted meal pattern to acquire a defatted meal pattern with a sinigrin focus of 68.72 μmol/g. In distinction, the applicant pointed to its Samples 2 and three with the identical selection oil seed, this time ready with stress utilized by an expeller or extruder, and heating at a temperature higher than 105°C, resulting in respective sinigrin contents in defatted meal samples of 13.13 μmol/g (decreased 81% from management) or 18.75 μmol/g (decreased 73% from management). The applicant identified that Yuan disclosed nothing about stress or the tolerability of processing to heating above the boiling level of hexane, and illustrated that Yuan’s course of results in sinigrin contents in defatted meal samples of 117.55 μmol/g.

The examiner responded by rejecting the claims over Verkoeijen (US 2013/0101723 A1) and Yuan, arguing that Verkoeijen describes heating oilseed flakes after grinding to 120 to 160°C, which may very well be Brassica carinata oilseed. In actual fact, Verkoeijen described “a course of for acquiring a polyunsaturated fatty acid having no less than 20 carbon atoms (LC-PUFA) or an oil comprising a LC-PUFA from seeds,” in response to Verkoeijen’s ¶¶ [0001] and [0005], and though solely regarding the oil and never the press cake / pressed fibrous mass, Verkoeijen’s ¶ [0028] described a desire for seeds of a (transgenic) plant of the household Brassicaceae, together with Brassica carinata. The examiner thought-about Verkoeijen to principally disclose all claimed parts, however relied on Yuan to treatment Verkoeijen’s failure to particularly disclose desolventizing-toasting to evaporate hexane from the meal fraction.

Though Verkoeijen was admitted to not disclose utilizing the press cake or the sinigrin content material characteristic, the examiner cited kind language from the MPEP that “[w]right here the claimed and prior artwork merchandise are equivalent or considerably equivalent in construction or composition, or are produced by equivalent or considerably equivalent processes, a prima facie case of both anticipation or obviousness has been established,” citing to In re Greatest, 562 F.2nd 1252, 1255 (CCPA 1977). Though such inherency rejections, mentioned in MPEP § 2112, historically utilized to conditions involving in any other case anticipatory rejections, however for the lacking inherent ingredient / property, the rejection right here (authorised by a supervisory examiner) reassembled unconnected parts of Verkoeijen’s disclosure, then concluded that the reconstruction of the claims inherently possessed lacking options as a consequence of tracing the claims. Many prosecutors could also be conversant in any such improper inherency rejection, because it seems to be in accord with current USPTO analyzing corps coverage.

The applicant responded with 12 pages of detailed remarks on the deficiencies of Verkoeijen and Yuan, in addition to proof of data within the artwork previous to submitting, citing Molecules 2015, 20, 15827-15841 (Bhandari1), entitled “Comparability of Glucosinolate Profiles in Totally different Tissues of 9 Brassica Crops,” and Phytochem. 1991, 30(8), 2623-2638 (Daxenbichler2), entitled “Glucosinolate composition of seeds from 297 species of untamed vegetation.”

The examiner responded by rejecting the claims once more, supplementing Verkoeijen and Yuan with US 2010/0234569 A1 (Helling), supplementing the in any other case equivalent rejection with the assertion that Helling3 describes that press muffins or meal fractions ensuing from standard seed oil extraction processes are recovered after the oil extraction step to make use of as a feed composition for quite a lot of courses of animals, citing to Helling’s FIG. 1 and ¶¶ [0003] and [0023]. The examiner concluded that it might have been apparent to get well the press cake of Verkoeijen as a result of Helling discloses that the press cake is helpful as a novel feed composition for animals.

The applicant responded twice extra, within the penultimate response submitting a 12-page declaration from an skilled with over 35 years within the oilseed processing trade, detailing the outcomes achieved by the claimed innovations and the deficiencies of the cited artwork, and amending step (e) to recite “desolventizing-toasting the hexane-extracted meal fraction to take away residual hexane for a interval of higher than 1 hour however lower than 5 hours.” The examiner maintained her place on the inherency of recovering a meal fraction having the claimed sinigrin content material, dismissing the prior artwork’s failure to acknowledge the issue of excessive sinigrin content material primarily based on the commonly-cited non-precedential opinion4 of the previous Board of Patent Appeals and Interferences, Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985), present in MPEP § 2145(II) underneath “Arguing Further Benefits or Latent Properties.” Not like the claimed invention and most claims towards which it’s cited, In re Obiaya opines on an equipment claim5 which was argued to supply shorter response occasions primarily based upon using a widely known element, however the well-known element (labyrinth heater) was motivated for use for sustaining uniform temperatures. In a way declare reciting the shortening of the response time, it’s possible that the opinion in Obiaya would have been completely different.

The PTAB made comparatively brief shrift of the positions taken by the analyzing corps, with out addressing the secondary proof to which the appealed claims had been no less than partially tailor-made. The PTAB famous that Helling pertains to canola or rapeseed press cake, to not carinata, that Yuan is the one reference discussing the potential use of carinata press cake, however states that carinata seed meal has the very best sinigrin content material of any of the carinata-derived supplies examined in Yuan, and observes on p. 64 that this “would possibly recommend that this materials will not be the most effective candidate as feed for livestock.” On this foundation, the PTAB concluded that no motivation to mix Verkoeijen, Yuan, and Helling to reach on the claimed invention was supported by the proof of file.

Along with this, citing to Yuan’s disclosure that, on the time of the invention, it was identified that carinata press cake had little utility as an animal feed element due to its excessive sinigrin content material, the PTAB discovered that the examiner didn’t cite any prior artwork description that there would have been an affordable perception that the meal fraction produced by Verkoeijen’s course of, as modified in view of Yuan and Helling, would have a decreased sinigrin content material. On this second foundation, the PTAB opined that the examiner had not established a prima facie case of obviousness.

The end result within the Hetherington utility leaves questions on which scope of the claims might have been obtained earlier in prosecution. For instance, it’s not clear that using stress and excessive temperature was apparent as submitted within the first declare modification. However, the Hetherington utility is a reminder to candidates that there’s a sturdy case of non-obviousness when the reference relied upon by the examiner itself signifies that the claims are non-obvious, as was the case in each Sakai and Yuan. As well as, though the USPTO analyzing corps applies more and more outlandish inherency-obviousness rejections, primarily based on Frankensteinesque reconstructions of lively claims.

Not like the strategy taken the Hetherington utility, the Federal Circuit has held that “[a] get together should … meet a excessive customary with the intention to depend on inherency to ascertain the existence of a declare limitation within the prior artwork in an obviousness evaluation—the limitation at challenge essentially should be current, or the pure results of the mixture of parts explicitly disclosed by the prior artwork.” Par Pharmaceutical v. TWi Prescribed drugs, Inc., 773 F.3d 1186, 1195-1196 (Fed. Cir. 2014). The Federal Circuit has additionally said that

[w]e have beforehand said that using inherency within the context of obviousness should be fastidiously circumscribed as a result of “[t]hat which can be inherent will not be essentially identified” and that which is unknown can’t be apparent.” Honeywell Int’l v. Mexichem Amanco Holding, 865 F.3d 1348 1354 (Fed. Cir. 2017) citing In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993) (quoting In re Spormann, 363 F.2nd 444, 448 (1966)); see additionally PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014). … What’s vital relating to properties which may be inherent, however unknown, is whether or not they’re sudden. All properties of a composition are inherent in that composition, however sudden properties might trigger what might look like an apparent composition to be nonobvious.

Honeywell Int’l v. Mexichem Amanco Holding, 865 F.3d 1348, 1354-1355 (Fed. Cir. 2017) citing In re Papesch, 315 F.2nd 381, 391 (CCPA 1963). In additional patent-friendly eras of the USPTO, inherency is historically utilized in conditions by which “the allegedly inherent attribute essentially flows from the teachings of the utilized prior artwork,” as indicated in MPEP § 2112(IV), and was typically confined to conditions by which a single referenced disclosed all parts of the declare apart from the lacking property or attribute, no less than in unpredictable arts. Nevertheless, the PTAB (just like the Federal Circuit) will not be constrained to developments in making use of inherency by the USPTO analyzing corps, sure to observe MPEP steerage. Accordingly, to achieve a distinct evaluation of the claims, it might be obligatory on the USPTO to take your arguments past even pre-appeal conferences, to the PTAB.

Past this, as a procedural consideration, many examiners in coaching are coached into rejecting claims by their signatories, i.e., main examiners (on this case Examiner Jacobson), somewhat than contemplating the patentability of claims. Normally, the USPTO work depend system makes examiners extra afraid of being reversed by high quality management (typically together with the identical SPEs who signal Examiner’s Solutions) than by the PTAB, since a reversal by QC can obligate examiners to do work with out accreditation of the work, whereas a reversal by the PTAB can guarantee examiners of secure allowance of claims with out concern of QC reversal.

Footnotes

1. Bhandari was alleged to explain “that cauliflower seeds comprise 49.52 μmol/g glucosinolate of hich 34.09 μmol/g is sinigrin whereas seeds of Pakchoi comprise 107.75 μmol/g glucosinolate of which solely 0.07 μmol/g is sinigrin.”

2. Daxenbichler was alleged to listing “the glucosinolate content material and composition for seeds of just about 300 of brassicaceae and allied species. As proven in Desk 2 [of Daxenbichler], complete glucosinolate content material varies extensively.”

3. The examiner’s complement to the rejection was merely basic information on widespread seed oil extraction, relevant to completely different plant sorts and already defined in substantial element to be inapplicable to the actual selection claimed, Brassica carinata.

4. The Obiaya kind language within the MPEP, additionally cited by the examiner right here, was “[t]he proven fact that applicant has acknowledged one other benefit which might circulate naturally from following the suggestion of the prior artwork can’t be the premise for patentability when the variations would in any other case be apparent.” For precedential opinions, please see https://www.uspto.gov/patents/ptab/decisions-and-opinions/precedential.

5. 1. A flamable fluid and oxygen focus sensor comprising: a. a flamable focus analyzer; b. an oxygen focus analyzer; c. conduit means for routing a fluid pattern previous mentioned flamable focus analyzer and oxygen focus analyzer; d. an inlet port to mentioned conduit means for receiving a pattern fluid; e. an outlet port from mentioned conduit means for ejecting mentioned pattern after evaluation; f. means for producing fluid circulate in mentioned conduit means from mentioned inlet port to mentioned outlet port; g. means to attach the flamable focus analyzer to an indicator; and h. means to attach the oxygen analyzer to a second indicator; i. mentioned conduit means comprising: i. first and second parts organized to divide the circulate into separate paths downstream from mentioned inlet and upstream from mentioned circulate producing means; ii. mentioned first portion supplying the oxygen analyzer however not the flamable analyzer [sic, analyzer] with pattern fluid; iii. mentioned second portion supplying the flamable analyzer however not the oxygen analyzer with pattern fluid; iv. a heater related to mentioned second portion upstream of mentioned flamable analyzer; and v. an inlet for offering air to mentioned second portion upstream of mentioned heater, to insure full flamable evaluation inside mentioned flamable analyzer.

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