Tag Archives: USPTO

SCHRÖDINGER’S POLYMORPH: WHEN A CRYSTALLINE FORM CLAIM IS OBVIOUS AND INVALID

Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., No. 22-2153 (Fed. Cir. 2024)

“Schrödinger’s cat,” is a paradoxical thought experiment devised by physicist Erwin Schrödinger, while debating quantum superposition in 1935. Oversimplified, in the thought experiment, there is a cat in a box, and you have no way of knowing what physical state the cat is in, like a quantum wave function, until you open the box and observe it.

While studying polymorphic forms, like Schrödinger’s hypothetical [albeit a long stretch], you do not know what form a solid compound is until you measure it with x-ray crystallography. However, unlike Schrödinger’s hypothetical, you may have a reasonable expectation of succeeding to figure out what form your compound is depending on the prior art and knowledge of a person of ordinary skill.

Shifting from quantum to organic chemistry patent law, if there is a reasonable expectation of success in characterizing a known crystalline product for potential polymorphism using routine, conventional methods and skill, then a claim to that crystalline product would be invalid for obviousness. Such was the decision in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., No. 22-2153 (Fed. Cir. 2024).

Salix claimed a specific crystalline form (form β) of rifaximin. The United States patent and Trademark Office (USPTO) granted Salix a patent on it.  However, when litigated, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed the District Court of Delaware’s finding that Salix’s claims to rifaximin form β were invalid for obviousness.*

“The difference between the prior art and the claims is thus effectively nothing more than the performance of routine characterization to identify the polymorphic forms that result from the known Cannata processes.”

Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., No. 22-2153 (Fed. Cir. 2024), at 15.

In other words, you cannot claim ownership of a compound just by making the expected crystalline form using someone else’s process and taking an x-ray crystal structure of it and giving a Greek letter name.

Background

  • Salix markets Xifaxan® (rifaximin), and Norwich wanted to sell a generic version.
  • Xifaxan® is a formulation of rifaximin crystalline form β.
    • Polymorph β is a commonly produced polymorph.
    • Polymorph β the most stable form of rifaximin.
  • Disputed patent claims: Claim 4 of U.S. Patent No. 7,612,199 and Claim 36 of U.S. Patent No. 7,902,206.
    • Claim 4. Rifaximin in polymorphic form β, wherein the rifaximin has x-ray powder diffraction pattern peaks at about 5.4°; 9.0°; and 20.9°2θ and wherein the rifaximin has a water content of greater than 5%.
  • Prior art: Cannata et al. U.S. Patent No. 4,557,866.
    • Although Cannata does not discuss rifaximin’s crystal structure in detail, it does disclose several preparation protocols for rifaximin that include solvents used for crystallization.
    • Experts testified that Cannata’s preparation of crystalline Rifaximin would have yielded its β form. But they could not say it would every time.
  • Rifaximin was a known compound with a known, useful activity (antibiotic).
    • While rifaximin was a known antibiotic, Salix owns rights to patents covering new method of use (hepatic encephalopathy). Salix won on appeal for such method-of-use claims.
  • Experts testified that Cannata’s preparation of crystalline rifaximin would have easily made and taken an X-Ray diffraction pattern to determine that rifaximin was in its β form.
    • The experts could not convince the judge that the prior art process would produce rifaximin form β “every time.” If they could, then Salix’s claims would have been anticipated (not novel) as inherently present in the prior art.‡
    • Although the experts could not convince the judge of the certainty of form β (novelty), they at least convinced the judge that form β was reasonably expected (obviousness).

    CAFC Opinion Discussion

    The CAFC decided that “the district court found a reasonable expectation of success in characterizing the crystalline product of Cannata for potential polymorphism using routine, conventional methods and skill [Salix Pharm., Ltd. v. Norwich Pharm., Inc., Civil Action No. 20-cv-430-RGA, (D. Del. Apr. 29, 2021), at *6–7].†  We see no clear error in that conclusion. Indeed, Salix has done no more than combine known elements of the prior art to verify readily accessible information concerning a compound already in the hands of those of ordinary skill in the art, and such routine efforts do not justify removing this polymorph from the public domain. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 427 (2007); see also Pfizer, 480 F.3d at 1367−68.”

    The District Court supported its factual determinations of obviousness with expert testimony that:

    (1)  a skilled artisan would have had good reason to characterize the crystalline rifaximin obtained by following the Cannata protocols,

    (2)  such characterization was routine and could have been performed “in one day,” and

    (3)  doing so would have led the skilled artisan to have “detected rifaximin β.” 

    Salix argued that a person of ordinary skill in the art would not have “expect[ed] to succeed” because, as of the critical date, the polymorphic nature of rifaximin had not yet been reported and the identity of the β form remained undisclosed. They further argue that a skilled artisan would not have been able to predict which polymorphic form Cannata made. This argument was flawed. The CAFC states that Salix’s is incorrect in framing of the issue, as it suggests that no unknown entity could ever be obvious, as one cannot reasonably expect what was hitherto unknown.

    * In the same appeal, The CAFC did affirm the District Court’s finding that Salix’s other claims to methods of treating hepatic encephalopathy were valid and nonobvious.

    † Whether or not there would have been a reasonable expectation of success is a question of fact. “Whether or not there would have been a reasonable expectation of success is a question of fact, (IXI IP, LLC v. Samsung Elecs. Co., 903 F.3d 1257, 1262 (Fed. Cir. 2018)), which we review for clear error, Hospira, 946 F.3d at 1328. We review the ultimate conclusion of obviousness de novo.” Did the Justices themselves believe that the claims were obvious? Unknown. The CAFC perhaps equivocated or sidestepped the question. The justices did not say that they themselves believe that the polymorph claims were obvious. Rather, they merely said that they found no clear error in the District Court’s finding of obviousness. 

    ‡ The CAFC did not opine on whether or not the polymorph claims were invalid for being inherently anticipated (§102). The court said that they did not need to go that far since they already determined that the claims were invalid for obviousness (§103). The district court said that the polymorph claims were not anticipated as being inherent because Norwich did not prove with clear and convincing evidence that the prior art method would produce rifaximin form β “every time.” The inherency issue may deserve its own post. Question for discussion: Does the “every time” requirement go too high for “clear and “convincing evidence?” Perhaps requiring a specific result Every time may go up to the realm of “beyond a reasonable doubt,” which is not the level of burden of proof for patent law. Recall last year’s discussion of the Amgen case where there were arguments about how many examples enable the “full scope” of a claim. Stay tuned.

    Additional Information

    OrganicPatents.com page on Obviousness of Stereoisomers &Purified Compounds

    Obviousness of Stereoisomers & Purified Compounds

    See also PatentDocs’s post: https://www.jdsupra.com/legalnews/salix-pharmaceuticals-ltd-v-norwich-3362384/.


    May 8, 2024

    Inherency & Therapeutic Mechanisms: Reviewing In re Couvaras – (With No-Frills Diagrams)

    Q:  When can you patent a composition’s mechanism of action?

    A:  When the mechanism is not inherent in a known use of the composition.

    “Reciting the mechanism for known compounds to yield a known result cannot overcome a prima facie case of obviousness, even if the nature of that mechanism is unexpected.”

    In re Couvaras, 22-1489 (Fed. Cir., 2023)

    In re Couvaras, 22-1489, 2023 WL 3984753 (Fed. Cir., June 14, 2023)

    Precedential Opinion by Circuit Judge Lourie; joined by Circuit Judges Lourie, Dyk, and Stoll

    The United States Court of Appeals for the Federal Circuit (CAFC) agreed with the Patent Trial & Appeals Board (PTAB), and the USPTO examiner, that claims in U.S. Patent Application No. 15/131,442 (US2016/228,393), which recites methods of increasing prostacyclin release in the systemic blood vessels of a human with essential hypertension to improve vasodilation, were obvious because the claims relate to combatting hypertension with known antihypertensive agents and merely disclose their previously unappreciated mechanism of action.”

    High Level Summary

    The prior art taught that GABA-a agonists and ARBs reduce anti-hypertension. Dr. Couvaras discovered that GABA-a agonists and ARBs reduce anti-hypertension, in part, because they increase prostacyclin and promote vasodilation. Dr. Couvaras applied for a patent claiming a method of increasing prostacyclin in an individual with hypertension to improve vasodilation by providing an ARB and a GABA-a agonist.  However, the USPTO rejected the claims because the element of increasing prostacyclin was inherent in the well-known prior art method of independently treating hypertension with an ARB or a GABA-a agonist. 

    Visualizing the case with diagrams

    Now let’s skeletonize the elements of this case down to arrow diagrams. We don’t need too many facts getting in the way of this good story. 🙂 *

    Claim 11 (abridged): A method of increasing prostacyclin in an individual with hypertension to improve vasodilation by providing an ARB and a GABA-a agonist. 

    A = Providing an ARB and a GABA-a agonist 

    X = Increasing prostacyclin

    B = Vasodilation (treating hypertension)

    * But seriously, although I am scientist reluctant to loose any nuance, technical terms such as Angiotensin II Receptor Blocker (“ARB”) can be distracting in analyzing the the law in case.  Also, I believe that knowing the claims recite a combination therapy is superfluous and thereby distracting itself. (At least I found them distracting at first. Maybe that’s just me. Please work with me for now.) The CAFC’s rule of law works for both mono and combo therapies. See below for a discussion regarding combination therapies.

    The overall goal is to get from A to B. Doctors already know how to get from A to B. It is prior art. No argument there. Then an inventor discovers that X is the mechanism of action that leads to B.

    Doctors did not already know that going from A to B involves X. This is not taught in the prior art.  A→X is a genuine new discovery. No argument there either.

    Now you have  A→ X→ B.

    Although the discovery of A→ X is indeed new, inventors should not be able to patent a claim to the discovery. Even though doctors did not know it, doctors were inherently doing the process of A→ X→ B by simply prescribing A to treat B.  It makes sense that someone should not be able to patent a claim to  A→ X→ B, or even simply A→X, then suddenly prevent doctors from prescribing A→ B, which they have been doing all along.

    New methods and mechanisms of action may still be patented

    In re Couvaras, however, does not mean that all mechanisms and new uses are not patentable. New uses for old compounds May still be patentable. For example, an inventor may discover that A also renders the benefit of C, and that A affects B by going through mechanism Y.

    In this example, the inventor may be able to patent a claim to A→C.

    If an inventor simultaneously discovers that A→C goes through the mechanism “Y” then they may be able to patent a claim covering both A→C, A→Y,  and A→Y→C.  

    NOTE: The inventor should file both claims simultaneously so the inventor’s disclosure of A→C does not block the claim to A→Y. If not, then the inventor will have the same problem from In re Couvaras.

    In summary, patentability of mechanisms (X/Y) rest on the whether the overall benefit (B/C) is unexpected from the known composition (A).

    Secondary Considerations

    Of course, secondary considerations provide some leniency. But the secondary considerations surely need to be compelling.

    “To establish unexpected results, Couvaras would have needed to show that the co-administration of GABA-s agonist and an ARB provided an unexpected benefit,” such as, e.g., better control of hypertension or less toxicity.

    Failure of others: “The purported failure to achieve prostacyclin increase through pursuing an unrelated goal did not establish the non-obviousness of the claimed method.”

    No long felt need: The anti-hypertensive agents were admitted to be available already.

    “The pending claims of the ’422 application literally recite methods of increasing prostacyclin release in the systemic blood vessels of a human with essential hypertension to improve vasodilation. That increased prostacyclin release is achieved by co-administering two well-known types of antihypertensive agents: a GABA-a agonist and an Angiotensin II Receptor Blocker (“ARB”). In reality, the claims relate to combatting hypertension with known antihypertensive agents and claiming their previously unappreciated mechanism of action.”

    Novelty vs. Obviousness: Inherency

    Q: Why is inherency in a case about obviousness and not about novelty?

    A: Here is where the combo-therapy aspect comes in. A combination of two known compounds that render the same benefit is obvious. Dr. Couvaras argued that the discovery of the compounds’ mechanism of action overcame the obviousness rejection. Essentially the argument tried to convince the examiner that each mono therapy was novel. With two novel monotherapies in hand, reasoning follows that combination of two novel monotherapies would have been non-obvious.

    Post Script

    On bright side, The USPTO awarded Dr. Couvaras with U.S. Patent No. 9,339,542 in his earlier application. Composition claims to combinations were non-obvious.

    Granted Claim 1:  A composition effective to relax Smooth muscles in an individual in an altered state, the composition comprising: a dosage of GABA or GABA-a analogue; and a dosage of at least one of an ACE inhibitor and a ARB combined with the dosage of GABA or GABA-a analogue into a deliverable form.

    Small Molecule Lens for Viewing Amgen v. Sanofi

    The U.S. Supreme Court’s opinion in Amgen v. Sanofi (No. 21–757, Decided May 18, 2023) was indeed a big deal. From a small molecule chemistry perspective however, I do not believe that the Amgen decision will alter chemical patent prosecution practice regarding enablement law. True, applications may need even more examples to enable small molecule genus claims. But providing enough examples to enable claims has always been a challenge. And we have been already progressively honing our strategy likewise along with the USPTO’s progressively stringent requirements. Meanwhile, patent practitioners typically do not describe small molecules in functional terms anyway.

    Imagine Amgen’s claim 1 of U.S. 8,829,165 (the ’165 patent) being written for a small molecule.

    1.    A small molecule that binds to PCSK9, wherein the small molecule binds an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO: 3, and wherein the small molecule blocks binding of PCSK9 to LDLR.

    I am confident that most chemical patent agents and attorneys would expect such a claim to fail as not enabled.  No quantity of exemplary compounds can enable the full scope of covering any small molecule.

    Idenix v. Gilead

    Regarding enablement of small molecules, the law still stands from the Federal Circuit’s decision in Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. (Fed. Cir. 2019); 941 F.3d 1149 (2018 WL 922125). Prior to Amgen, the U.S. Supreme Court refused to hear Idenix’s appeal [cert. denied, 141 S. Ct. 1234 (2021) No. 20-380]. 

    Please see my earlier post: Idenix v. Gilead: Split CAFC Panel at Least Agrees – Valid or Not, Either Way it’s Idenix Loss – Claims Too Broad.

    Recall in Idenix, all three justices– including Justice Newman – agreed that Idenix did not enable the claims with regard to the claim’s infringed elements. Justice Newman disagreed, however, with the majority’s ruling that the claims were invalid. Instead, she argued that the claims should have been ruled to be unenforceable over the infringing product rather than be draconianly ruled as invalid as a whole.  I would tend to agree with Justice Newman. Idenix should be at least able to enforce their claims on some other competing product that would be covered by the enabled embodiments. However, I would tend agree with the majority if there were a broad claim to any small molecule defined by functionality alone, without a structure. I don’t believe such a claim should be valid, if not for enablement, perhaps for insufficient written description requirement.

    Idenix claimed a method for the treatment of a hepatitis C virus infection by administering an effective amount of a purine or pyrimidine β-D-2′-methyl-ribofuranosyl nucleoside or a phosphate thereof. However, none of their examples included a 2′-methyl “up” / 2’- fluoro “down” analog like Gilead’s sofosbuvir (Solvadi®). Rather, most examples showed 2′-methyl “up” / 2’- hydroxyl “down” analogs.

    As Justice Gorsuch opined, “in some cases, disclosing that general quality may reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset.” Channeling SCOTUS’s preference for seeing a common-quality within the claims, the common quality for Idenix would probably have been the 2’- fluoro “down” element, and not just the broad 2′-methyl element.

    Even prior to Amgen, chemical patent practitioners have been keen to include so-called common qualities in core aspects of generic structure formulas. Skilled patent practitioners draft intermediate and narrow sub-generic formulas for embodiments in case broad generic formulas are challenged. Such intermediate formulas often surround a preferred set of species.  The preferred set of species often have a common quality that may make them more active or stable than other series of compounds. Seek out your favorite medicinal chemist. They can explain it better than I can.

    Examples

    For example, a patent application may include a generic formula that recites the broad term “aromatic group.” Meanwhile, the patent application should also include backup provisions such as a sub-generic formula that narrows the term “aromatic” to “heteroaromatic.” Furthermore, the application should include an even narrower backup embodiment wherein the “heterocyclic group can be a specific heterocycle such as pyridine, pyrimidine or pyrazine. The scope of the generic formula would be guided by the compounds exemplified in the application.

    In one hypothetical scenario, a claim to any aromatic group may fail if only heteroaromatic groups are shown in examples. In a further scenario, a claim to a heteroaromatic group may fail if only pyridines are exemplified. Perhaps pyrimidines or pyrazines, with two nitrogens, may have significantly different functional properties than a pyridine having only one nitrogen.

    As before Amgen v. Sanofi, a greater variety of exemplary compounds provides a stronger argument for enablement.

    [ I intend to add more discussion soon. Check back. Thank you for reading! ]

    Said Goodbye to Ribbons – Now Say Goodbye to Paper: USPTO Officially Transitions to Issuing Electronic Patent Grants in 2023

    Get ready for Electronic Patent Grants!*   

    * And be ready to file continuations or divisionals earlier.

    USPTO-Ribbon small

    Recently in 2018 [okay perhaps ancient history to some] the USPTO stopped attaching actual ribbons to issued patents. Now the USPTO will stop automatically printing paper copies. This is of course good news for trees. This is also good news for applicants who want applications issued more efficiently. However, applicants need to be ready to file any continuing applications earlier than they have been accustomed because the USPTO will issue patents more quickly after providing applicants with a Notice of Issuance. Meanwhile, applicants still need to file continuing applications before issuance.

    Electronic Patent Grants – When:

    Effective April 18, 2023, the USPTO Officially Transitions from issuing patent grants on paper to Issuing electronic patent grants (Federal Register).

    Transition Period – USPTO will still provide free ceremonial copies

    • The USPTO will provide patentees a ceremonial paper copy of the issued patent during the transition period as a courtesy, free of charge.
    • The ceremonial paper copy resembles the paper patent that the USPTO traditionally provided to patent applicants as the issued patent.
    • The ceremonial paper copy will be bound with a cover sheet with both an embossed seal and the signature of the USPTO Director.
    • Length of Transition Period? TBD – Do not know.

    $$ After Transition Period

    • The ceremonial paper copy will be available for purchase for a nominal fee after the transition period, in addition to the presentation copy and certified copy.
    • How much is the “nominal fee” for a “ceremonial” copy? TBD –  Do not know. Though a “presentation copy” is presently $25.

    BE READY TO FILE CONTINUING APPLICATIONS!

    Patent Prosecution Best-Practice Note:  File Continuing applications (CON/DIV) as early as possible. Applicants will not have as much time between receiving an Issue Notification and seeing the patent office issue the granted patent.

    Warning from the USPTO:

    “The USPTO will issue the patent shortly after the payment of the issue fee. As a result, applicants will have less time, after the payment of the issue fee, to file continuing applications, Quick Path Information Disclosure Statements, or petitions under 37 CFR 1.313(c) to withdraw an application from issue. Therefore, the best practice would be for applicants to file these submissions as early as possible. Preferably, continuing applications should be filed before the payment of the issue fee. See Manual of Patent Examining Procedure (9th ed. Rev. 10.2019) (MPEP) sec. 211.01(b)(I).” (Federal Register/Vol. 88, No. 39/Tuesday, February 28, 2023/Rules and Regulations; Page 12561)

    Updated USPTO Form PTOL-85B (Issue Fee Transmittal) includes a reminder to file any continuing application prior to issue-fee payment so as not to jeopardize co-pendency. The newly modified form can be found here. The form no longer allows for advance orders of patent copies, because patents may be printed directly from Patent Center when issued. Advance orders for copies of patents issuing on or after April 18 will not be processed.

    More information from other insightful publications:

    Ready, Set, Go: Implications of USPTO’s Shift to Electronic Patent Grants (foxrothschild.com)

    eGrants and Quick Issuances | Patently-O (patentlyo.com)

    USPTO ushers in new era with introduction of electronic patent grants | USPTO

    USPTO Transitions to eGrants from Paper Patents | JDSupra

    USPTO To Transition To Electronically Granted Patents In April 2023 | Blogs | PharmaPatents | Foley & Lardner LLP

    Onglyza® and Kombiglyze® XR (saxagliptin) Patent Survives Challenge from Mylan

    September 12, 2017

    Mylan and other generic manufacturers petitioned the Patent Trial and Appeal Board (PTAB) to institute an inter partes review of AstraZeneca’s patent claiming compositions including saxagliptin. AstraZeneca markets saxagliptin as Onglyza® and Kombiglyze® XR for diabetes.

    Case IPR2015-01340 / Patent RE44,186 E

    The PTAB’s Administrative Patent Judges (APJ) decided that the petitioners did not show with preponderance of the evidence that the claims of Reissue RE44,186 of U.S. Patent No. 6,395,767 would have been obvious to a skilled artisan.  Particularly, saxagliptin was not obvious over “compound 25.”

    Saxagliptin:

    Saxagliptin Structure

    Saxagliptin Structure

    Prior art: “Compound 25”

    Structure of Prior Art "Compound-25"

    Structure of “Compound-25”

    State of the Art:

    Experienced medicinal chemists (Persons of Ordinary Skill in the Art [PHOSITA]) knew saxagliptin bound to DP 4.  But they did not have detailed knowledge of DP 4’s active site for guidance in designing inhibitors because DP 4’s crystalline structure was unknown. At the time of invention, knowledge of DP 4’s binding requirements came from structure-activity relationship (“SAR”) studies.

    Lead Compound Analysis:

    Petitioners cited a publication by Ashworth containing Compound-25, which they argued would have been selected as a lead compound. (Ashworth et al., 2-“Cyanopyrrolidides as Potent, Stable Inhibitors of Dipeptidyl Peptidase IV,” 6(10) Bioorganic &Med. Chem. Lett., 1163–66 (1996)).

    “Compound-25” would not have been selected as a lead compound

    The PTAB reasoned that a medicinal chemist would not have selected compound 25 as a lead compound because, among other reasons, (i) Compound 25 was only one of several other similar compounds (ii) Compound 25 only had in vitro data obtained using non-physiological conditions, (ii) there were two much more advanced compounds in clinical trials (i.e., NVP-DPP728 & P32/98) and (iii) Ashworth’s subsequent publication focused on different series of compounds.

    NVP-DPP728 & P32/98

    Clinical Compounds NVP-DPP728 & P32/98

    The PTAB’s analysis could have ended there. But even accepting Petitioners’ assertion that a skilled artisan would have chosen compound 25 as a lead compound, the PTAB determined that the Petitioners didn’t demonstrate that a skilled artisan would have had reason to modify compound 25 with a reasonable expectation of success to arrive at the claimed saxagliptin.

    Check out PatentDocs’s Post for further discussion:

    http://www.patentdocs.org/2017/09/mylan-pharm-v-astrazeneca-ab-ptab-2017.html

     

     

    The Fastest USPTO Technology Center is 1620 – Organic Chemistry!

    August 15, 2017

    USPTO Technology Center 1620 has the shortest delay before sending an Office Action.

    According to the Official Gazette, TC1620 has a <18-month delay.*

    * Numbers include RCE reworks that substantially reduce the delay of organic chemistry patent applications.

    The Average filing date for an organic chemistry patent application receiving an office action in the last 3-months is November 15, 2015.†

    † Report last updated on June 30, 2017.

    See also: PatentlyO Post

     

    Subject Matter Eligibility of a Chemical Process

    The USPTO, provides an example of a patent-eligible claim for a process of hydrolyzing fat molecules into free fatty acids and glycerol without using conventional methods (at the time of invention) of steam distillation with lye or sulfuric acid. [May, 2016]

    May 2016 Update: Subject Matter Eligibility Examples: Life Sciences (May 6, 2016)

    Example 33 “Hydrolysis of Fat” – From the USPTO’s Subject Matter Eligibility Examples: Life Sciences

    The USPTO based the following “patent eligible” claim on technology from US Patent 11,766, which was upheld by the Supreme Court in Tilghman v. Proctor, 102 U.S. 707 (1881).  Although the case is very old, the USPTO notes that Supreme Court has subsequently described the decision as upholding the eligibility of process claims containing a law of nature. See, e.g., Parker v. Flook, 437 U.S. 584, 590-91 and n.12 (1978); Gottschalk v. Benson, 409 U.S. 63, 70 (1972).

    Claim    1.   A process for obtaining free fatty acids and glycerol from fat comprising:

    (a) mixing substantially equal quantities of fat and water in a closed vessel; and

    (b) heating the mixture to an elevated temperature of at least 600 degrees Fahrenheit under sufficient pressure to prevent the formation of steam in the closed vessel; and maintaining the elevated temperature for at least 10 minutes.

    USPTO Analysis

    Although the claim is founded upon a chemical principle relating to neutral fats, the claim is eligible because, it is not attempting to tie up the chemical principal so that others cannot practice it.  Even if the claim were directed to a judicial exception, the claim amounts to something “significantly more” than any exception.  The claim would amount to something “significantly more” because the claim recites specific unconventional steps.