Written Description is Met by What the Disclosure Reasonably Conveys to Those Skilled in the Art

In Hologic, Inc. v. Smith & Nephew, Inc., [2017-1389] (March 14, 2018), the Federal Circuit affirmed the Board’s determination that S&N’s earlier-filed PCT application has sufficient written description to make it a priority document instead of an invalidating obviousness reference to U.S. Patent No. 8,061,359.

The claim in disputed is directed to an endoscope “having a light guide
permanently affixed therein.”  The PCT application from which the patent derived described a “fibre optics bundle.”  The Examiner found it did not, and rejected the claims as obvious over the prior PCT application.  However, the Board reversed, finding that the disclosure in the PCT provides sufficient written description support for the claimed “light guide,” entitling the patent to the priority date of the PCT.

The Federal Circuit said that to be entitled to the priority date of the earlier-filed PCT, S&N must show that the PCT discloses what the patent claims, according to the written description requirement of 35 U.S.C. §112.  Specifically, based on an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention
claimed.  The Federal Circuit found that it did.

The Federal Circuit noted that substantial evidence showed that the PCT
discloses a “light guide,” including the fact that the parties did not dispute that a “fibre optic bundle” is a type of light guide, and that various types of light guides were well-known in the art.  The Federal Circuit also rejected the argument that a light guide was not shown in the Figures, pointing out that “written description does not require that every claimed element be illustrated in the figures, particularly in predictable arts and where the element not depicted is conventional and not “necessary for the understanding of the subject matter sought to be patented.”

The Federal Circuit was satisfied that the Board applied the correct law and that substantial evidence supports the Board’s finding that the PCT provides sufficient written description disclosure of the claimed
“first channel having a light guide permanently affixed therein.”


Antigens Don’t Describe Antibodies, and the Value of Post-Priority Date Activity on Written Description and Enablement

In Amgen, Inc. v. Sanofi, [2017-1480](October 5, 2017), the Federal Circuit found that the district court erred by excluding Appellants’ evidence
regarding written description and enablement, and improperly instructed the jury on written description, so the Federal Circuit reversed-in-part the judgment below and remanded for a new trial on written description and enablement (concluding that defendants/appellants were not entitled to JMOL of no written description and no enablement.

The case relates to U.S. Patent Nos. 8,829,165 and 8,859,741 on  antibodies that help reduce low-density lipoprotein cholesterol (LDLC),
or “bad cholesterol.”  The district court  excluded Appellants’ evidence about antibodies, including Appellants’ infringing Praluent, developed after the patents’ priority date of January 9, 2008, reasoning that because the
evidence did not illuminate the state of the art at the time of filing,” it was not relevant “to determine whether there is sufficient disclosure of the claimed invention.”

However, the Federal Circuit found that Appellants were not offering
post-priority-date evidence to show that Appellees’ claimed genus is not enabled because of a change in the state of the art. Instead, Appellants offered Praluent and other post-priority-date antibodies to argue that the
claimed genus fails to disclose a representative number of species. As explained above, the use of post-priority-date evidence to show that a patent does not disclose a representative number of species of a claimed genus is proper. It was thus legal error for the district court to categorically
preclude all of Appellants’ post-priority-date evidence of Praluent and other antibodies. The Federal Circuit reversed the district court’s decision and remanded for a new trial on written description.

The Federal Circuit also found district court’s improper exclusion of post-priority-date evidence requires a new trial on enablement as well. Under the enablement requirement, the specification of a patent must teach
those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.  Appellants purportedly sought to introduce post-priority-date evidence showing that Appellees engaged in lengthy and potentially undue experimentation to enable the full scope of the claims. Such evidence could have been relevant to determining if the claims were enabled as of the priority date and should not have
been excluded simply because it post-dated the claims’ priority date.

The Federal Circuit turned to the jury instructions on written description.  The Federal Circuit said that the district court correctly instructed the jury that in order to satisfy the written description requirement, a patentee may disclose either a representative number of species falling within the scope of the genus or disclose structural features
common to the members of the genus so that one of skill in the art can visualize or recognize the members of the genus.  However the district court went on to instruct that “the correlation between structure and function may also be satisfied by the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties if you find that the level of skill and knowledge in the art of antibodies at the
time of filing was such that production of antibodies against such an antigen was conventional or routine.”  The Federal Circuit this instruction was not legally sound and is not based on any binding precedent.

The Federal Circuit said that this instruction improperly allowed a jury to find adequate written description merely from a finding of the ability to make and use the invention.  The Federal Circuit said that an adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.”
However, it is still contested whether the that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.  The Federal Circuit said that Section 112 requires a “written description of the invention,” not something that is not the invention.

The Federal Circuit affirmed the denial of JMOL of lack of written description and enablement, because with the exclusion of post-priority date evidence the record was incomplete to determine whether there is in fact a lack of written description and enablement.  The Federal Circuit also affirmed JMOL of non-obviousness, finding that the district court properly excluded the proffered prior art.  These references, two PCT applications were filed after the priority date, but claimed priority to provisional applications filed before the priority date.  The Federal Circuit noted that appellants did not proffer any evidence showing that the provisional applications contained representative species or common structural
elements sufficient to satisfy the written description requirement for the monoclonal antibodies claimed in the PCT applications.  Similarly, the Federal Circuit noted, Appellants provided no evidence that the claims of the PCT applications were enabled by the provisional application. Because the district court properly excluded the prior art relied upon by appellant, the court’s grant of JMOL of non-obviousness was proper.

Finally, the Federal Circuit vacated the permanent injunction because it vacated the district court’s judgment as to written description and enablement, and was remanding the case for a new trial.

Written Description Must Support Claims; Not Exclude Alternatives

In The Board of Trustees of the Leland Stanford Junior University v. The Chinese University of Hong Kong, [2015-2011] (June 27, 2017), the Federal Circuit vacated the PTAB’s determination in an interference that Stanford’s claims were unpatentable for lack of written description, because the Board relied on improper evidence to support its key
findings and did not cite to other substantial evidence to support its findings.

Whether a patent claim satisfies the written description requirement of 35 U.S.C. § 112, paragraph 1, depends on whether the description clearly allows persons of ordinary skill in the art to recognize that the inventor
invented what is claimed.  Substantial evidence supports a finding that the specification satisfies the written description requirement when the essence of the original disclosure conveys the necessary information—regardless of how it conveys such information, and even when the disclosure’s words are open to different interpretations.

The Board determined that Stanford’s patent does not disclose the random massively parallel sequencing of nucleic acid sequences claimed in the later-added claims such that a person of skill in the art would have concluded that the Quake inventors were in possession of the method
claimed.  The Board concluded from the language of the specification that the specification referred to targeted, rather than the claimed random sequencing.  The specification specifically mentioned an Illumina sequencer, but in evaluating the specification, the Board relied upon information about a Roche sequencer.  Further the Board’s finding that the language did not exclude targeted sequencing ignores the fact the description might support both random and targeted sequencing.

The Federal Circuit said that the Board’s task was to determine whether the specification’s description discloses random sequencing, as recited
by the later-added claims, not whether the description does not preclude targeted MPS sequencing. The Federal Circuit said that the Board’s
error on this issue is compounded by its failure to explain the meaning of key sentences and phrases in the specification’s discussion of the sequencing process, and its failure to compare these statements to the claim limitations.

For these reasons the Federal Circuit vacated the interference decisions and remanded for the Board to reconsider whether Quake’s relevant patents and applications satisfy the written description requirement.  The Federal Circuit specifically instructed the Board to examine whether a person of ordinary skill in the art would have known, as of the priority date, that the specification’s reference to Illumina products meant random sequencing as recited in the claims, by examining the record evidence as
to pre-filing date art-related facts on Illumina products.  The Federal Circuit said that the Board may include an analysis of whether the record contains testimony or evidence, relevant to this written description analysis, showing that any post-filing date publications contain art-related facts on random sequencing or Illumina products existing on the filing date.


Drafting Broad Claims to Cover a Competitor is for Naught if the Specification Doesn’t Support Them

In Rivera v, ITC, [2016-1841] (May 23, 2017), the Federal Circuit affirmed the ITC’s decision that there was no violation of 19 U.S.C. §1337, because the claims of U.S. Patent No. 8,720,320 were invalid for lack of a written description.

The ‘320 patent relates to single brew coffee machines, which the patent divides into two categories: those configured to receive pods — small, flattened disk-shaped filter packages of beverage extract, and those configured to accommodate larger, cup-shaped beverage filter cartridges.  The ‘320 patent describes the invention as an adapter assembly configured to effect operative compatibility between a single serve beverage brewer and beverage pods.

The Federal Circuit noted that every embodiment in the ’320 patent shows a cup-shaped “receptacle,” adapted to receive a pod.  Although the claims originally filed referenced a pod adapter assembly, after seven years of prosecution none of the claims included any reference to a pod or a pod adapter assembly.  The accused products were adapted to receive loose coffee grounds.

The issue on appeal was whether the “pod adaptor assembly,” “pod,” and “receptacle” disclosures in the patent application as filed, the patent claim element “container . . . adapted to hold brewing material.”  The Commission concluded that the specification did not provide the necessary written description support for the full breadth of the asserted claims, because the specification was entirely focused on a “pod adaptor assembly” or “brewing chamber,” and did not disclose a container that was itself a pod or that contained an integrated filter.

The Federal Circuit noted that both parties analyze the written description issue under the assumption that the asserted claims read on the accused cup-shaped containers. While the parties further agreed that nothing in the ’320 patent explicitly described a pod adaptor assembly with a filter integrated into the cartridge, Rivera argued that the broad definition that pod:

is a broad term and shall have its ordinary meaning and shall include, but not be limited to, a package formed of a water permeable material and containing an amount of
ground coffee or other beverage therein.

in the specification provided adequate support. The Federal Circuit rejected Rivera’s argument, agreeing with the ITC and the intervenor.  The Federal Circuit noted the “underlying concern” of the ‘320 patent was compatibility between pods and cartridges. The Federal Circuit quoted extensively from the specification, noting the distinction between pods and cartridges “permeates the entire patent.”  The Federal Circuit said there was no hint or discussion of a cartridge or pod adaptor assembly or receptacle that also serves as the “pod.”  The Federal Circuit noted that the distinction carries through to every embodiment.  The Federal Circuit concluded that the “broad” definition of a pod
does not change the fact that however broad “pod” is, it must
still be distinct from pod adapter assembly.

The Federal Circuit made of point of stating that the Patent Owner agreed that the claim covered the accused product.  Setting the scope set the question of adequate written description. Otherwise, construing a claim in view of the specification would result in a narrower scope, rather than invalidity. Perhaps the claim could have been saved, but it wouldn’t cover what the patent owner wanted it to.

While the focus of patent scope is rightly on crafting the claims, to get the full scope of the carefully crafted claims, the specification needs to provide a written description and an enable disclosure.




Written Description Lacking Where Nothing in the Specification Suggests Inventor Contemplated Claimed Invention

In Cisco Systems, Inc. v. Cirrex Systems, LLC, [2016-1143, 2016-1144](May 10, 2017), the Federal Circuit affirmed in part, and reversed in part the Board’s decision in inter partes reexamination of U.S. Patent No. 6,415,082.  Cisco appealed the patentability finding of five of the claims, and Cirrex appealed the rejection of the remainder of the claims.  The Federal Circuit found that all of the claims on appeal were unpatentable for lack of written description support.

The ‘082 patent is directed to the field of fiber optic communication signals.  At issue was the claim requirement of discrete attenuation of the various wavelengths of light, which the parties agreed must occur in the planar lightguide circuit (PLC).  However, there was not written description of how discrete attenuation could occur within the PLC, rather that attenuation of all of the wavelengths (i.e. collective attenuation).  The Federal Circuit agreed twith Cisco that the claims are directed to subject matter that is indisputably missing from the ’082 specification.

The Federal Circuit said that the ’082 specification does not meet the quid pro quo required by the written description requirement for the disputed claims because demultiplexing light to manipulate separately the intensities of individual wavelengths of light while the light is still inside the PLC is a technically difficult solution that the ’082 specification does not solve, let alone contemplate or suggest as a goal or desired result. The Federal Circuit added:

Nothing in the ’082 specification explains how individual wavelengths of light are separately manipulated while those wavelengths are still inside the PLC. Nor is there anything in the specification that suggests that the inventor contemplated that approach. To the contrary, the ’082 specification expressly describes using the PLC to separate wavelengths of light to allow the manipulation of each individual wavelength—outside the PLC—before it is rerouted back into the PLC for remultiplexing.

The Board also rejected Cirrex’s arguments that the claims requiring a diverting element were supported by adequate written description.   The Board concluded that the totality of of the disclosure did not establish that the inventors possessed an embodiment with a diverting element inside the PLC, and the Federal Circuit agreed.





Broad Original Claims Prevent Invalidity for Lack of Adequate Written Description

In Scriptpro LLC, v. Innovation Associates, Inc., [2015-1565] (August 15, 2016), the Federal Circuit reversed Summary Judgment that claims 1, 2, 4, and 8 of U.S. Patent
No. 6,910,601 were invalid for lack of written description.  The patent was directed to a “collating unit” used with a control center and an automatic dispensing system (“ADS”) to store prescription containers after a medication has been dispensed into the containers.

At issue was whether the patent’s specification limits the invention to a collating unit that sorts and stores prescription containers by patient-identifying information and slot availability. In the decision appealed from, the district court determined that the specification was limiting and that the asserted claims, which are not so limited,
are invalid for lack of written description.

The Federal Circuit agreed with the Patent Owner that the specification does not limit the claimed invention to sorting and storing prescription containers by patient-identifying information.  The patent expressly states that containers can be sorted and stored “by
patient, prescription, or other predetermined storage scheme without input or handling by the operator.”  Consistent with this express disclosure, the original claims filed as part of the application from which the patent issued were not limited to sorting and storing prescription containers by patient-identifying information.  Rather, these original claims, like the asserted claims, recite a collating unit that automatically stores prescription containers dispensed by an ADS. As we have explained, “[o]riginal claims are part of the specification and in many cases will satisfy the written description requirement.”

A specification’s focus on one particular embodiment or purpose cannot limit the described invention where that specification expressly contemplates other embodiments or purposes.  This is especially true in cases such as this, where the
originally filed claims are not limited to the embodiment or purpose that is the focus of the specification.  Similarly, mere recognition in the specification that an aspect of a
prior art system is “inconvenient” does not constitute “disparagement” sufficient to limit the described invention — especially where the same specification expressly
contemplates that some embodiments of the described invention incorporate the “inconvenient” aspect.

The Federal Circuit said that it is certainly reasonable that different claims could be directed to covering different aspects of the invention. Not every claim must contain every limitation or achieve every disclosed purpose. The original claims did not include
a requirement that sorting and storing be done by use of patient-identifying.  The Federal Circuit said that the district court erred when it determined that the specification limited the invention to storing prescription containers based on patient name and slot availability.

The Federal Circuit concluded that because the specification does not limit the scope of the invention in the manner the district court described, the asserted claims are
not invalid for lacking such a limitation.