Merely Scaling Up of a Known Process is Not Patentable

Sometimes it is hard to know what the U.S. Patent Office will decide when allowing some patent claims over others. How much novelty is needed? The Manual of Patent Examining Procedure gives some guidance, and mere changes in size or dimension over a known solution is not enough. MPEP (MPEP) 2144.04(IV)(A) references two cases:

  • In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) — Claims directed to a lumber package “of appreciable size and weight requiring handling by a lift truck” where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.
  • In re Rinehart, 531 F.2d 1048, 1053, 189 USPQ 143, 148 (CCPA 1976) — “mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled.”

Some lessons from these cases are self-evident. Patent application drafters need to include enough detail in the technical description of the invention. While a lot of research money may be spent on scaling up a design, if there are no details as to how scaling up presented additional problems, and no details about how these problems were overcome, a set of patent claims will not be allowed just because there is claim to a large-scale facility. A patent will not be granted even though no one has previously developed a device or system on a massive scale. My recommendation is to include an item in your pre-filing checklist for this aspect of your patent application. If in doubt, have a patent professional look over your application before submitting it.

U.S. Supreme Court Requires Definiteness in Patent Claims

This post updates and supersedes my earlier post where the Federal Circuit ruled that it is allowable to have a certain amount of ambiguity in patent claims. The standard articulated was that a claim was indefinite “only when it is not amenable to construction . . . [or] insolubly ambiguous.” Slip Op. at *7. SPOILER ALERT: the Supreme Court of the United States (SCOTUS) corrects the Federal Circuit by vacating the decision and remands the case with new instructions to comply with the “reasonable certainty” standard. Slip Op. at *11. After some context, I present some highlights of the SCOTUS decision.

On 4 June 2014, SCOTUS decided, Nautilus, Inc. v. Biosig Instruments, Inc. (PDF). The Nautlius litigation involves U.S. Patent No. 5,337,753 protecting a heart rate monitoring device. The device operates by measuring electrocardiograph (“ECG”) signals related to a user’s heartbeat. The inventors observed that electromyogram (“EMG”) signals can cause inaccuracies in measuring ECG signals. EMG signals are generated by skeletal muscles and can interfere with detection at an exercise monitor grip. The patent claim called for a heart rate monitor having an “elongate member” (such as a cylindrical bar) and “a first live electrode and a first common electrode mounted on said first half in spaced relationship with each other [electrodes],” (emphasis added). See my earlier post for a complete copy of the claim in dispute.

At trial, the dispute centered on the term “spaced relationship”—how far apart the electrodes must be before they would be deemed to be in a “spaced relationship.” In the Markman hearing, the district court ruled that “there is a defined relationship between the live electrode and the common electrode on one side of the cylindrical bar and the same or a different defined relationship between the live electrode and the common electrode on the other side of the cylindrical bar.” Nautilus then moved for summary judgment, arguing that the term “spaced relationship” was indefinite. The district or trial court agreed and granted the motion reasoning that the claim language “did not tell . . . anyone what precisely the space should be.”

Before reaching the SCOTUS, the Federal Circuit reasoned that the disputed claim term “spaced relationship” did not suffer from indefiniteness and reversed the trial court’s interpretation. Because the term was amenable to construction, “indefiniteness . . . would require a showing that a person of ordinary skill would find ‘spaced relationship’ to be insolubly ambiguous—that it fails to provide sufficient clarity delineating the bounds of the claim to one skilled in the art,” and held that “a skilled artisan would find such boundaries provided in the intrinsic evidence,” that is, from an reading and understanding of the patent.

Note, the “insolubly ambiguous” standard is no longer the law because Nautilus appealed to the SCOTUS, which unanimously reverses the Federal Circuit’s decision.

In place of the “insolubly ambiguous” standard, SCOTUS states that “a patent is invalid for indefiniteness if its claims, read in light of the specification, delineating the patent, and the prosecution history, fail to inform with reasonable certainty, those skilled in the art about the scope of the invention.” Slip. Op. at *1. In supporting this conclusion, SCOTUS provides some guidance when it states, “[i]t cannot be sufficient that a court can ascribe some meaning to a patent’s claim” and the “definitiveness inquiry trains on the understanding of a skilled artisan at the time of the patent application, not that of a court viewing matters post-hoc.” SCOTUS further states, “[t]o tolerate imprecision that is just short of . . . ‘insolubly ambiguous’ would diminish the definiteness requirement’s public-notice function and foster the innovation-discouraging ‘zone of uncertainty.’” Slip. Op. at *12. The SCOTUS further states, the “Federal Circuit invoked a standard more amorphous than the statutory definiteness requirement [of 35 U.S.C. 112(2)] allows.” Slip Op. at *14.

That language seems pretty serious. The SCOTUS was concerned with “lower court confusion.” Slip Op. at *11. The function of the claims is to give certainty to what is protected and what is not protected by a patent. The SCOTUS reminded the Federal Circuit that “the definiteness inquiry trains on the understanding of a skilled artisan at the time of the patent application, not that of a court viewing matters post hoc.” Slip Op. at *12. Further, the SCOTUS reminds us that, “patents are not addressed to lawyers, or even to the public generally, but rather to those skilled in the relevant art.” Slip Op. at *9 (internal quotes omitted).

I do not look forward to the opinion from the Federal Circuit on remand. Given its history, I suspect we will see a very short discussion of the new standard in the second opinion from the Federal Circuit in this case. Also, the SCOTUS “leaves for another day,” two issues: (1) whether the ultimate issue of definiteness triggers the clear-and-convincing-evidence standard, and (2) whether deference is due to the USPTO’s resolution of disputed issues of fact. See. footnote 5, Slip Op. at *13.

There are several lessons from this opinion. Inventors need to clearly articulate and record what is their invention. Inventors need to communicate the necessary details to whomever drafts the patent application. Further, patent attorneys need to take the time and effort to clearly draft patent applications so that there is no ambiguity. Patent attorneys need to carefully draft claims and not make fuzzy claims to try to ensnare all possible future infringements.

Another lesson from this SCOTUS opinion is that patent applications should be written with future possible litigation in mind. I imagine that the U.S. patent judges in post-issuance proceedings will be aware of this decision and will not hesitate to strike claims that are indefinite.

Supreme Court Ends de novo Review of Claim Construction

On October 15, 2014, the Supreme Court of the United States (SCOTUS) heard oral arguments in Teva Pharmaceuticals v. Sandoz. On 20 January 2015, SCOTUS issued its 7-2 decision as Teva Pharmaceuticals USA, Inc., et al. v. Sandoz, Inc., et al., 574 U.S. ___ (2015). The opinion was written by Justice Breyer and remanded the judgment with instructions that the appellate court must apply a “clear error” standard to review questions of fact. This opinion ends de novo review by the Federal Circuit when reviewing the meaning of claim terms. Here are some details about why this decision is important and returns some certainty to claim construction decisions by trial court judges.

Teva owned a patent that covers a manufacturing method for producing Copaxone®, a drug to treat the symptoms of multiple sclerosis. Sandoz attempted to market a generic version and was sued by Teva for patent infringement to prevent the generic from hitting the market earlier than the law allowed.During trial, Sandoz argued that the active ingredient that was described as an ingredient with a “molecular weight of 5 to 9 kilodaltons.” Sandoz asserted that the language in the patent was fatally flawed on the ground of indefiniteness under 35 U.S.C. 112 because the patent did not describe which of three methods was used to determine that weight. The three methods were provided but yield different results. At trial, the district court judge determined that the patent claim was sufficiently definite and that the patent was valid and infringed. The judge determined that only the first method made sense to a person having ordinary skill in the relevant art (a PHOSITA), and ruled that the patent claims were valid and infringed by Sandoz. Slip op. at *2-3.

On appeal, the Federal circuit reviewed de novo all aspects of the district court’s claim construction, including the district court’s determination of subsidiary facts.

On appeal to SCOTUS, Teva argued that claim construction is intertwined with fact finding, that Federal Rule of Civil Procedure (FRCP) 52(a) should apply to claim construction, and that a district court’s claim construction should only be set aside for clear error. In short, the Federal Circuit’s long-standing practice of de novo review of claim construction should be overruled even though de novo review was validated by the Supreme Court’s 1996 decision in  Markman v. Westview Instruments and confirmed by the Federal Circuit (6-4)  en banc decision in February 2014 in  Lighting Ballast Control v. Philips Electronics. Sandoz and other generic drug makers countered that:

  • Markman is good law, that Rule 52(a) applies to fact finding outside the context of claim construction,
  • claim construction is a purely legal matter best left in the hands of a judge rather than a jury,
  • the current law promotes uniformity and predictability because the Federal Circuit can uniformly review trial court decisions, and
  • the Federal Circuit can and should review claim construction without deference to the lower court, or de novo.

FRCP 52(a)(6) states that a court of appeals “must not . . . set aside” a district court’s “[f]indings of fact” unless they are “clearly eroneous,” and “does not make exceptions or . . . exclude certain categories of factual findings” from the court of appeals.

In its decision, the SCOTUS states, “[P]ractical considerations favor clear error review. We have previously pointed out that clear error review is “particularly” important where patent law is at issue because patent law is “a field where so much depends upon familiarity with specific scientific problems and principles not usually contained in the general storehouse of knowledge and experience,” citing to Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U. S. 605, 610 (1950). Slip op. at *4. “We have made clear that the Rule sets forth a clear command . . . [and] applies to both subsidiary and ultimate facts.”  Id. SCOTUS also states that, “Even if exceptions to the Rule (FRCP) were permissible, we cannot find any convincing ground for creating an exception to that Rule here.”

The Court also states, “[Parties] have already been forced to concentrate their energies and resources on persuading the trial judge that their account of the facts is the correct one; requiring them to persuade three more judges at the appellate level is requiring too much.” Slip op. at *9.

There are several immediate lessons from this decision:

  • There should be more finality to claim interpretation at trial as long as the trial judge provides enough factual basis in the decision related to the meaning of patent claim terms.
  • There is no more “do-over” in front of the Fed. Cir; appeals on the meaning of claim terms should drop off significantly.
  • Patent application writers should take extra time to draft claims and applications that avoid ambiguity in claim construction. Writers should consider including a detailed glossary of terms in every patent application.
  • New legislation could amend the FRCP to give back to the Federal Circuit de novo review of claim interpretation.

Hindsight and Patentability

tube of cream

In order to get patent claims allowed and issued at the U.S. Patent Office (USPTO), a patent examiner has to be persuaded that an invention is non-obvious. Each issued patent is supposed to protect something significantly better than what has been invented before. But how much better? That’s the controversial question!

In practice, about 50% of applications are rejected and end without any patent being issued. Many rejections are on the basis of this fuzzy notion and law of non-obviousness found at 35 U.S.C. 103. Everyone seems to have his own deeply-felt opinion on the topic.

Examiners are not allowed to use a patent application as a road map to reject really great technical break-throughs. A finding of non-obviousness (a rejection) cannot be found on the basis of hindsight. In 2013, the Federal Circuit, provided guidance on avoiding the use of hindsight in Leo Pharmaceutical Products, Ltd v. Rea, 726 F.3d 1346 (Fed. Cir. 2013).

First, a little background. U.S. Patent No. 6,753,013 was assigned to Leo Pharmaceuticals. This ‘013 patent claimed a “storage-stable” pharmaceutical composition comprising a vitamin D analog, a corticosteroid and at least one solvent component for topical treatment of skin conditions such as psoriasis.

Galderma R&D, as a third-party, challenged the patent in a re-examination proceeding. During re-examination, the examiner rejected the claims as being obvious over 3 prior art references. The rejection was upheld on appeal to the Patent Board of Appeals and Interferences (BPAI).

The following is guidance taken from the Federal Circuit opinion.

  • The Board erred by collapsing the obviousness analysis into a hindsight-guided combination of elements. The record, disclosed several reasons that a person of ordinary skill in the art would not have been motivated to try, let alone make, the claimed invention of the ’013 patent because no scientist investigated the issue of how shelf-stable the mixture was.
  • The record showed that Turi, Serup, and Dikstein (the 3 references) described compositions for the same therapeutic purpose, but did not include a motivation to combine them.
  • In the face of strong objective indicia of nonobviousness, the Board erred by using hindsight to determine that the addition of Serup’s or Dikstein’s vitamin D analog to Turi’s formulation would have been obvious.
  • Even though the patented formulation was one of the available alternatives, the numerous known combinations indicated that these disclosures would not have rendered the claimed invention obvious to try.
  • There was a considerable time lapse between the references and the submission of the patent application.
    • It took over a decade—after Dikstein’s disclosure of the benefits of combining vitamin D and corticosteroid treatments into one formulation—for Dikstein’s formulations to be tested for storage stability.
    • It was twenty-two years after Turi and fourteen years after Dikstein that the solution was created to meet the long felt and unsolved need for a combined treatment of vitamin D and corticosteroid.
  • The record showed “extensive experimental evidence” of unexpected results that contradicted the Board’s obviousness finding.
  • Objective indicia “can be the most probative evidence of nonobviousness in the record, and enables the court to avert the trap of hindsight.” Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294, 1310 (Fed. Cir. 2010).
  • In this case, the objective indicia of nonobviousness were crucial in avoiding the trap of hindsight when reviewing a combination of known elements.

If you have a patent-related question, find me and let’s talk.