Tuesday Patent – A Future 101 Battle

The USPTO publishes the Official Gazette on Tuesdays, which is thus when all new patents issue.  Every Tuesday, I’ll highlight one or a few interesting patents with a focus on CPC A61K, the class where most pharmaceutical and cosmetic patents are found.

As promised, a patent for (yesterday), instead of last week.  This one belongs to Emory University and covers a method of treating a subset of bacterial infections.  Specifically, US Patent No. 9,572,864 uses galectin-4 (Gal-4) to treat blood group B positive E. coli infections.

Claim 1 is wonderfully simple, and notwithstanding issues that may arise if the law moves in certain directions, should be a model for claim drafting:

1. A method of treating blood group B positive (BGB+) Escherichia coli infections comprising

administering an effective amount of recombinant human Gal-4 or Gal-4 C-terminal domain peptide to a subject in need thereof.

The claim clearly tells the whole story.  The inventors discovered a utility for a class of compounds and used that discovery to invent an application of the compound: treating infections.  As a society, we should want scientists to make these kinds of discoveries and turn them into treatments we can buy at the pharmacy.

However, because Gal-4 is an innate, naturally occurring peptide, it is worth going through the Mayo-Alice test to see how a court could invalidate it.  Step 1: is the patent directed to a natural phenomenon?  It is important to remember that the claim must be evaluated as a whole in patent law.  Thus, the claim is directed to a method of treating E. coli infections = not a natural phenomenon.

Assuming for the sake of argument that the claim is directed to Gal-4, we move to step 2: is there an inventive something more beyond the natural phenomenon?  Again, the answer is clearly yes.  The product identified is being put to a use that was heretofore unknown.

Outside of the U.S., such method of treatment claims are not uniformly accepted as patentable subject matter.  There are those in the U.S. who advocate a similar result in the U.S., arguing that the compound (here, Gal-4) is naturally occurring, and thus using it to treat a patient is nothing more than “routine” activity (e.g., injecting).  That is, thankfully, not the current state of the law, and is not required by Ariosa v. Sequenom, but we should be concerned that the policy trend is towards less secure patents.  We must guard against these changes to protect a robust and well-functioning patent system.

 

Tuesday Patent – Smoking Is Good For You

The USPTO publishes the Official Gazette on Tuesdays, which is thus when all new patents issue.  Every Tuesday, I’ll highlight one or a few interesting patents with a focus on CPC A61K, the class where most pharmaceutical and cosmetic patents are found.

I’m making up for skipping last Tuesday and will add one from today once they are out.  Anyone who knows a smoker has heard some excuse trying to explain why smoking is actually good for them in some small, usually insignificant way.  Last Tuesday, Dignity Health received US Patent No. 9,566,273 that for at least some small group of people, suggests they may actually have a point.

Claim 1 illustrates the patent well:

1. A method of treating acute disseminated encephalomyelitis in a subject, comprising:

providing a composition comprising a nicotinic receptor agent, wherein the nicotinic receptor agent comprises one or more of nicotine, nicotine bitartrate, cytisine, nicotine polacrilex, nornicotine, nicotine 1-N-oxide, metanicotine, nicotine imine, nicotine N-glucuronide, N-methylnicotinium, N-n-decylnicotinium, 5′-cyanonicotine, 3,4-dihydrometanicotine, N’-methylnicotinium, N-octanoylnornicotine, 2,3,3a,4,5,9b-hexahydro-1-methyl-1H-pyrrolo(3,2-h)isoquinoline, 5-isothiocyanonicotine, 5-iodonicotine, 5′-hydroxycotinine-N-oxide, homoazanicotine, nicotine monomethiodide, N-4-azido-2-nitrophenylnornicotine, N-methylnornicotinium, nicotinium molybdophosphate resin, N-methyl-N’-oxonicotinium, N’-propylnornicotine, pseudooxynicotine, 4′-methylnicotine, 5-fluoronicotine, K(s-nic)5(Ga2(N,N’-bis-(2,3-dihydroxybenzoyl)-1,4-phenylenediamine)3), 5-methoxynicotine, 1-benzyl-4-phenylnicotinamidinium, 6-n-propylnicotine, SIB1663, 6-hydroxynicotine, N-methylnicotine, 6-(2-phenylethyl)nicotine, N’-formylnornicotine, N-n-octylnicotinium, N-(n-oct-3-enyl)nicotinium, N-(n-dec-9-enyl)nicotinium, 5′-acetoxy-N’-nitrosonornicotine, 4-hydroxynicotine, 4-(dimethylphenylsilyl)nicotine, N’-carbomethoxynornicotine, N-methylnicoton;

and administering a therapeutically effective dosage of the composition to enhance the activity of a compound that treats acute disseminated encephalomyelitis,

wherein the therapeutically effective dosage of the nicotinic receptor agent ranges from nicotine plasma levels of 1 ng/mL to 100 ng/mL.

In short, the patent claims using nicotine to enhance the activity of a different compound that treats acute disseminated encephalomyelitis (ADEM).  ADEM often looks like multiple sclerosis, but is a single attack and often resolves without further incident.

The specification notes that human heavy smokers have a nicotine plasma level of 15-38 ng/mL, which is within the range of the claim.  As the claim does not limit the mode of delivering the nicotine, smoking is a claimed manner of providing nicotine.  Thus, the patent seemingly covers a method of treating ADEM by smoking and taking a drug that treats ADEM.

Although it is in a spirit of light-heartedness that I chose this patent, and I haven’t studied this patent well enough to comment on the significance of the particular advancement, patents of this kind represent an important part of our patent ecosystem.  Not every advancement in medicine is a new drug for a new disease.  Many advancements are based on taking old drugs and finding new and better ways of using them.  Incentivizing this work with patents assures that the research undertaken to make these advancements can be brought to clinical reality.

This patent illustrates the point.  The disclosed mouse research shows that nicotine can help treat encephalomyelitis.  But how to best bring the advancement to patients will require examining how nicotine interacts with specific drugs to treat ADEM, best doses and modes of delivery, and research directed at complying with regulatory requirements.  This patent that will allow the pursuit of this development program with reasonable assurances that a commercially viable product could come out the other side.

How To Define The Invention For 35 U.S.C. § 101

Although I discuss patent issues generally, I hope to give special attention to the broad policy and philosophical issues arising under § 101 patent eligibility.  Last Friday’s Federal Circuit decision relating to patent U.S. 7,702,682 provides a great example of how cases and the policy discussion generally often ignore the actual patents at issue.  Evolutionary Intelligence LLC v. Sprint Nextel Corp. (Fed. Cir., Feb. 17, 2017).

The first thing to remember is that the scope of the invention is defined by the claims.  Thus, the question to be asked  when determining patent eligibility in the Mayo-Alice test is”what are the claims directed to?”.  Unfortunately, we are often treated to a discussion of the invention or patent that makes no reference to the claims, and instead, relies principally on generic disclosure elsewhere in the patent.

The second thing to remember, although it is not important to this case, is that what “directed to” means is still an open question.  Hence, the need for proposals that reaffirm the importance of claims being treated as a whole.

In this case, the only description of the invention was that it is “directed to systems and methods for allowing computers to process data that are dynamically modified based upon external-to-the-device information, such as location and time. See, e.g., ’536 patent Abstract.”  As the quotation makes clear, only the abstract is used to characterize the invention.  A hypothetical claim based on that abstract, “a computer implemented method comprising processing dynamically modified data based upon external-to-the-device information, such as location and time” would quickly and justifiably be invalidated.

The claims in the ‘682 patent are more detailed and specific than the abstract.  For example, claim 1 reads:

1. A computer-implemented method comprising:

receiving a search query;

searching, using the computer, first container registers encapsulated and logically defined in a plurality of containers to identify identified containers responsive to the search query, the container registers having defined therein data comprising historical data associated with interactions of the identified containers with other containers from the plurality of containers, wherein searching the first container registers comprises searching the historical data; encapsulating the identified containers in a new container; updating second container registers of the identified containers with data associated with interactions of the identified containers with the new container; and

providing a list characterizing the identified containers.

I was a neuroscientist in my technical life, not a software engineer, so I won’t hazard an independent opinion of what was routine or conventional for the proper application of the Mayo-Alice test.  It suffices to recognize that the claim is directed particular steps of running a software program, and it is those steps, as a whole, that should have been analyzed for abstractness.  You may have a different opinion than what I have expressed about whether software should be patent eligible in the first place, but we should all be able to agree that it is the claims we should be analyzing, and not isolated statements in the abstract or specification.

PTAB Rejects End-Around Of § 311(b)

In a decision denying institution, the PTAB shot down a series of arguments that effectively tried to shoehorn into an IPR issues of indefiniteness.  Carefusion Corp. v. Baxter Int’l, Inc. (IPR 2016-01456, Feb. 6, 2017).

35 U.S.C. § 311(b) limits IPRs to only grounds “that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.”  This excludes instituting an IPR based on an assertion that the patent claims are indefinite.  However, the PTO requires that petitioners include a construction of any challenged claim.  37 C.F.R. § 42.104(b)(3).

The pairing of the statute and the rule seemed to allow a way to slip a challenge to the definiteness of the claims into an IPR.  Certainly during the run up to America Invents Act implementation, I had my fair share of discussions with fellow law students about the holes in the statute.  The strategy employed by Carefusion is one that came up often: when proposing a claim construction, argue that the claims cannot be construed and are therefore indefinite.  If needed, simultaneously, the petitioner would propose a backup claim construction for use in assessing § 102 or § 103 issues.

Specifically, Carefusion asserted that the means-plus-function limitations in US 5,782,805 lacked a corresponding structure in the specification.  The claims would therefore be indefinite.  In the alternative, Carefusion agreed to use Baxter’s proposed constructions from parallel litigation for the purposes of the IPR only.

The PTAB here did not bite.  Although there are a few methods it could have used to discard the argument (e.g., denying for failure to comply with procedural requirements), it chose to reach the merits of the patentability argument.  But having rejected the petitioner’s claim constructions, it took little effort to conclude that the petition had failed to demonstrate unpatentability because it’s arguments were based on faulty premises.

The statute prohibits consideration of indefiniteness, so this seems to be the right result.  But it does raise the possibility that indefinite patent claims are insulated from attacks in IPR proceedings; a thoroughly bizarre result.

On a final note, the PTAB rejected Carefusion’s alternative claim constructions because “for IPR purposes only” was not sufficient acceptance of the construction.  Nonetheless, for some claim constructions, the PTAB went on to discuss why the corresponding structure was not sufficient.  Whether these factual conclusions end up mattering in the parallel court proceedings will be interesting to watch.

Does The Skilled Artisan Care About Commas?

In an otherwise unremarkable opinion, the Federal Circuit took an extra deep dive into the precise structure of sentences in the specification in order to reach an otherwise straightforward claim construction.  3form, Inc. v. Lumicor, Inc. (Fed. Cir., Feb. 2, 2017)

3form’s utility patent covers a method of making a decorative laminate panel without deforming objects placed in the laminate.  The claim terms requiring construction recite that the method does not lead to “an unnatural appearing conformation” and that the final product has a “substantially natural appearing conformation.”

Although the parties had largely agreed on a construction, the district court followed its own path, which eliminated “splitting” and “cracking” from the construction of “unnatural appearing conformation” and imposed a rigid 75% compression level.

The relevant portion of the specification reads:

For the purposes of this specification and claims, “critical pressure” refers to the pressure at which the structural integrity of the object collapses, such that the object splits, cracks, or otherwise compresses into an unnatural conformation. There are, of course, varying grades of collapse, or compression, for any given compressible object, such that an “unnatural conformation” may mean that an object has compressed to 90% of its thickness in one direction, 75% of its thickness in one direction, and so on.

The opinion would eventually find error in the reliance solely on the 75% clause by the district court.  But before getting there, it parsed the comma usage of the first sentence.  Despite comma usage in law being the subject of no small amount of controversy, the Federal Circuit quickly concluded that the lack of a comma between “otherwise” and “compresses” decided the issue.  Of course, it that comma had been there, the word “otherwise” would become a verb (as part of a list with “splits” and “cracks”), and the sentence would make no sense.

Even though the Federal Circuit understood the sentence correctly, it still seems bizarre that it went through such a detailed and formalistic reading of the specification.  Patents are legal instruments.  That is why claim construction after Teva v. Sandoz is still reviewed de novo when only intrinsic evidence is used.

However, specifications are read and understood from the prospective of the skilled artisan.  In most technical fields, it is hard to imagine a skilled artisan scrutinizing comma usage to determine whether a modifier applies to an entire list or only a portion.  If the sentence is truly ambiguous, skilled artisans are more likely to rely on experience or other portions of the patent to sort out the ambiguity than look to the presence or absence of a comma in a single sentence.

In this case, the sentence is clear enough that the comma analysis  seems superfluous.  It may not be in a future case.  Thus, it is worth thinking about not just what a patent teaches to the skilled artisan, but how the skilled artisan actually goes about reading a patent document.

Welcome To The Next Patent Blog

As a budding patent scholar, I consider it important to provide my thoughts and commentary on the patent issues of the day, even when the topic requires less than a 30,000 word law review article.  This blog is the repository of those thoughts.  I hope that you all enjoy reading it as much as I enjoy writing it.