Patent Baristas » IP Litigation

You Can’t CIP Your Way Out of the Written Description Requirement

Stephen Jenei — Thu, 17 Mar 2011 18:55:52 +0000

After filing a series of five continuation-in-part (“CIP”) applications, which added new matter , a patent finally issued containing claims covering Abbott’s antibody. Centocor then relied on the added material as evidence of written description to support later asserted claims.

The Federal Circuit poo-poohed the idea saying that PTO guidelines prevent claiming a high affinity, neutralizing, A2 specific antibody with a human variable region if it was not possible at the time of filing using “conventional,” “routine,” “well developed and mature” technology. Centocor Ortho Biotech v. Abbott Labs, U.S. Court of Appeals for the Federal Circuit (10-1144).

Patent holders Centocor Ortho Biotech and New York University sued Abbott Labs alleging that Abbott’s Humira® antibody infringes claims 2, 3, 14, and 15 (“the asserted claims”) of U.S. Patent No. 7,070,775 (“’775 patent”). After a five-day trial, the jury found Abbott liable for willful infringement. The jury rejected Abbott’s argument that the asserted claims were invalid, and awarded Centocor over $1.67 billion in damages. Hence, Abbott appealed.

The patent involves antibodies to human tumor necrosis factor a (TNF-a). Overproduction of TNF-a can lead to various autoimmune conditions, including arthritis.

By 1985, many researchers had produced antibodies to human TNF-a. These antibodies were typically produced in mice and were not suitable for use in human patients. While such antibodies do bind to TNF-a, they do not bind to a place on TNF-a that reduces the harmful TNF-a activity. Since such antibodies do not reduce TNF-a activity, they cannot be used to produce the desired therapeutic effect. In other words, the activity of an antibody is related to both how tightly the antibody sticks as well as the specific location on TNF-a where the antibody binds.

In developing their therapeutic TNF-a antibodies, Centocor and Abbott pursued very different strategies. Centocor’s path began by identifying a mouse antibody to human TNF-a that had both high affinity and neutralizing activity (“the A2 mouse antibody”). Centocor then used known techniques to modify its mouse antibody to make it more human. By keeping the parts of the mouse antibody that are responsible for the affinity and the neutralizing activity and changing the less critical portions of the antibody to make these portions more human, scientists sought to preserve the activity of the antibody while reducing its immunogenicity.

By exchanging the A2 mouse antibody’s mouse constant region with a known human constant region, Centocor produced a “chimeric” antibody with a mouse variable region and a human constant region. The resulting chimeric antibody was less immunogenic than the A2 mouse antibody because it contained significantly less mouse protein.

Because the chimeric antibody contained a mouse variable region, it was not considered to be “fully human.” A chimeric antibody still contains foreign protein, so it is more likely to elicit an immune response than a fully-human antibody. Centocor filed a patent application disclosing both its A2 mouse antibody and the chimeric antibody in 1991. The application discussed the immunogenicity problem and the difficulties associated with making a fully-human antibody to a human protein like TNF-α.

Centocor subsequently filed a series of continuation-in-part (CIP) applications. In 1993, the U.S. Patent and Trademark Office rejected certain pending claims in a CIP application because they encompassed antibodies with “less than an entire mouse variable region[].” The PTO asserted that the specification only enabled antibodies with fully-mouse variable regions. Instead of responding to the rejections, Centocor filed a new CIP application and abandoned the pending application. So, the PTO issued the same rejection. Again, instead of responding, Centocor abandoned its application and filed three substantially identical CIP applications in 1994.

These 1994 CIP applications added new matter that Centocor relied on as evidence of written description to support the asserted claims. Although Centocor made these few additions, it did not present claims to human variable regions when it filed the 1994 CIP applications.

Abbott pursued an alternative path and sought to engineer a fully-human antibody. First, Abbott’s collaborators created an enormous phage display library containing a spectrum of human variable regions. They searched this library for variable regions that bind to human TNF-α. In the process, they developed a technique known as “guided selection” to help identify variable regions from the library that bind in a specific place so the variable regions have neutralizing activity. After identifying human variable regions that bind to human TNF-α, they used various techniques including “chain shuffling” and “affinity maturation” to improve the binding affinity of the variable regions. These human variable regions were combined with known human constant regions to create fully-human antibodies.

By 1995, Abbott had created the therapeutic antibody Humira®. Abbott filed a patent application disclosing this high affinity, neutralizing, fully-human antibody to human TNF-α in 1996. See U.S. Patent No. 6,090,382. The PTO granted the patent in 2000, and Abbott obtained regulatory approval to market Humira® in 2002.

After the grant of Abbott’s patent and after regulatory approval of Humira®, Centocor filed its claims to fully-human antibodies. Because the patent family disclosing Centocor’s own chimeric antibody was still pending in 2002, Centocor filed the claims as part of a thirteenth application in the family, explicitly claiming human variable regions and fully-human antibodies. Asserted claim 2 and the claim from which it depends are illustrative:

An isolated recombinant anti-TNF-α antibody or antigen-binding fragment thereof, said antibody or antigen-binding fragment comprising a human constant region, wherein said antibody or antigen binding fragment (i) competitively inhibits binding of A2 (ATCC Accession No. PTA-7045) to human TNF-α, and (ii) binds to a neutralizing epitope of human TNF-α in vivo with an affinity of at least 1×108 liter/mole, measured as an association constant (Ka), as determined by Scatchard analysis.
The antibody or antigen-binding fragment of claim1, wherein the antibody or antigen binding fragment comprises a human constant region and a human variable region.

Independent claim 1, which is not at issue in this appeal, covers antibodies with a human constant region and a variable region from any source. The scope of claim 1 includes, but is not limited to, chimeric antibodies. Asserted claim 2 is limited to antibodies with human constant regions and human variable regions. Asserted claim 3, which also depends from claim 1, likewise claims antibodies with human variable regions. All of the asserted claims cover human variable regions and fully-human antibodies like Abbott’s Humira®.

The district court jury found that the asserted claims were not invalid for anticipation, lack of enablement, or lack of written description.

The written description requirement of 35 U.S.C. § 112, ¶ 1 provides, in pertinent part, that:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

To satisfy the written description requirement, “the applicant must ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,’ and demonstrate that by disclosure in the specification of the patent.” Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991)). Assessing such “possession as shown in the disclosure” requires “an objective inquiry into the four corners of the specification.” Ariad, 598 F.3d at 1351. Ultimately, “the specification must describe an invention understandable to [a person of ordinary skill in the art] and show that the inventor actually invented the invention claimed.” Id. A “mere wish or plan” for obtaining the claimed invention is not adequate written description. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997).

The pivotal issue in this case concerns whether the ’775 patent provides adequate written description for the claimed human variable regions. The asserted claims cover fully-human antibodies that possess the same therapeutic properties as Centocor’s chimeric antibody, i.e., high affinity, neutralizing activity, and binding at a specific place on human TNF-α. Accordingly, the 1994 CIP applications must provide written description for an antibody to human TNF-α with (1) a human constant region, (2) a human variable region, (3) high affinity for human TNF-α, (4) neutralizing activity, and (5) the ability to bind to TNF-α in the same place as Centocor’s A2 mouse antibody (“A2 specificity”).

Abbott pointed out that the specification does not disclose any fully-human, high affinity, neutralizing, A2 specific antibody. Moreover, the specification does not disclose a single human variable region. Abbott argued that the only described antibody is the chimeric antibody, which has a mouse variable region. Abbott also argued that Centocor has merely disclosed tools that might be used in an attempt to make the claimed invention—essentially, that Centocor’s disclosure is no more than a mere wish or plan for how one might search for a fully-human antibody that satisfies the claims. Finally, Abbott pointed to testimony from Centocor’s inventor indicating that the disclosure did not include examples about making a human antibody because “it was never [Centocor’s] intention to make a human antibody.” J.A. 18312, 18:19-24.

The court agreed:

Contrary to Centocor’s assertions, very little in the ’775 patent supports that Centocor possessed a high affinity, neutralizing, A2 specific antibody that also contained a human variable region. The overwhelming majority of the ’775 patent describes the A2 mouse anti-body and the single chimeric antibody that Centocor made based on A2’s mouse variable region.

At bottom, the asserted claims constitute a wish list of properties that a fully-human, therapeutic TNF-α antibody should have: high affinity, neutralizing activity, and the ability to bind in the same place as the mouse A2 antibody. The specification at best describes a plan for making fully-human antibodies and then identifying those that satisfy the claim limitations. But a “mere wish or plan” for obtaining the claimed invention is not sufficient. See id. at 1566. At the time the 1994 CIP applications were filed, it was entirely possible that that no fully-human antibody existed that satisfied the claims. Because Centocor had not invented a fully-human, high affinity, neutralizing, A2 specific antibody in 1994, a reasonable jury could not conclude that it possessed one.

While our precedent suggests that written description for certain antibody claims can be satisfied by disclosing a well-characterized antigen, that reasoning applies to disclosure of newly characterized antigens where creation of the claimed antibodies is routine.

Claiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described.

Indeed, we have repeatedly indicated that the written description requirement does not demand either examples or an actual reduction to practice. Ariad, 598 F.3d at 1352. What it does demand is that one of skill in the art can “visualize or recognize” the claimed antibodies based on the specification’s disclosure. Eli Lilly, 119 F.3d at 1568.

Practicing an Industry Standard May Be Basis For Infringement

Stephen Jenei — Fri, 24 Sep 2010 18:31:08 +0000

The Federal Circuit recently affirmed that an admission that an accused infringing device practices an industry standard may, without more, be the basis for a finding of infringement. Fujitsu, LG and Philips v. Netgear, US Court of Appeals for the Federal Circuit (10-1045).

Philips asserted claims of U.S. patent no. 4,974,952, Fujitsu asserted claims from U.S. patent no. 6,018,642, and LG asserted claims of U.S. patent no. 6,469,993 all against Netgear. Each patent describes and claims a different aspect of wireless communications technologies. They accused Netgear of infringing by implementing wireless networking protocols for sending and receiving messages between a base station, such as a wireless router, and a mobile station, such as a laptop.

The three plaintiffs, part of a licensing pool (Via Licensing) that purports to include patents that any manufacturer of 802.11 and WMM compliant products must license. The plaintiffs never identified particular claims or accused products prior to filing. The plaintiffs argued that by simply complying with the standard, Netgear necessarily infringed the asserted claims. The court said that the plaintiffs must show evidence of infringement for each accused product. Fujitsu, LG, and Philips appealed the district court’s denial of summary judgment of infringement and grant of summary judgment of noninfringement.

Netgear argued that the court should establish a rule precluding the use of industry standards in assessing infringement. Instead, Netgear wants any plaintiff to separately accuse and prove infringement for all accused products, even if those products all comply with a standard that is relevant to the patent-in-suit. It argued that it is legally incorrect to compare claims to a standard rather than directly to accused products. Netgear also argued that a holding that practicing a standard infringes a patent would amount to an automatic conclusion of infringement against all future accused infringers. It argues that these later litigants would be deprived of a fair opportunity to prove that their products do not infringe.

An amicus brief by Association of Corporate Counsel, supporting Netgear, argued that it is dangerous to assess infringement based on a standard because the text of a standard may not be specific enough to ensure that all possible implementations infringe a patent claim. Further, it argues that many standard sections are optional and that users may never activate a potentially infringing feature. Finally, to allow this type of analysis would have a “chilling effect” on industries that rely on standards. It argues that companies would be less likely to comply with industry standards if a patent owner can argue that all compliant products infringe.

Philips argueds that it is more efficient for courts to assess infringement based on industry standards when applicable. It can alleviate the need for highly technical fact-finding such as the review of complicated source code and save judicial resources by not requiring the courts to separately consider products that all function in accordance with that standard.

The Federal Circuit affirmed that this can certainly be the case:

We hold that a district court may rely on an industry standard in analyzing infringement. If a district court construes the claims and finds that the reach of the claims includes any device that practices a standard, then this can be sufficient for a finding of infringement. We agree that claims should be compared to the accused product to determine infringement. However, if an accused product operates in accordance with a standard, then comparing the claims to that standard is the same as comparing the claims to the accused product. We accepted this approach in Dynacore where the court held a claim not infringed by comparing it to an industry standard rather than an accused product. An accused infringer is free to either prove that the claims do not cover all implementations of the standard or to prove that it does not practice the standard.

Public policy weighs in favor of this approach. If a court determines that all implementations of a standard infringe the claims of a patent, then it would be a waste of judicial resources to separately analyze every accused product that undisputedly practices the standard. This is not prejudicial to present or future litigants. If two products undisputedly operate in the same manner, a finding of infringement against one will create a persuasive case against the other. In such a case, there will be no prejudice.

We acknowledge, however, that in many instances, an industry standard does not provide the level of specificity required to establish that practicing that standard would always result in infringement. Or, as with the ’952 patent, the relevant section of the standard is optional, and standards compliance alone would not establish that the accused infringer chooses to implement the optional section. In these instances, it is not sufficient for the patent owner to establish infringement by arguing that the product admittedly practices the standard, therefore it infringes. In these cases, the patent owner must compare the claims to the accused products or, if appropriate, prove that the accused products implement any relevant optional sections of the standard. This should alleviate any concern about the use of standard compliance in assessing patent infringement. Only in the situation where a patent covers every possible implementation of a standard will it be enough to prove infringement by showing standard compliance.

Biopolymer Engineering and MIT Fail to Get Vacation (of Summary Judgment)

Stephen Jenei — Fri, 13 Aug 2010 15:27:41 +0000

In a nonprecidential opionion, the U.S. Court of Appeals for the Federal Circuit dismissed an appeal by Biopolymer Engineering (Biothera) as moot after it appealed a District Court order granting summary judgment of noninfringement by Immunocorp and Biotec Pharmacon ASA (Biotec). Biopolymer Engineering and MIT v. Immunocorp and Biotec Pharmacon ASA (2010-1096).

Biothera sued Biotec alleging that Biotec for infringement of 14 of Biothera’s patents. Both parties filed summary judgment motions concerning one of the patents in suit, United States Patent No. 5,702,719, a patent related to the use of purified beta (1,3) yeast extract glucan particles, in particular finely ground, as nutritional supplements and as dermatological agents. The district court granted Biotec’s motion for summary judgment that the ’719 patent was not infringed.

While the case was pending in the district court, the parties entered into a settlement agreement. Pursuant to the terms of the settlement agreement, the district court entered judgment of noninfringement, and Biothera appealed.

Biotec showed a letter indicating that, pursuant to the settlement agreement, it had agreed not to participate in this appeal. The court then directed Biothera to show cause why this case should not be dismissed as moot due to lack of a case or controversy.

Biothera said that this appeal is not moot because:

“[a] very real and current controversy exists as to whether defendants’ products infringe the ’719 patent.” Biothera states that this appeal “will directly decide the legal rights between Biothera and the defendants. If Biothera fails to prevail in its appeal, the judgment of non-infringement of all of Defendant’s accused products will become final. However, if Biothera prevails in its appeal, the judgment of non-infringement will be reversed or vacated.”

A settlement agreement does not necessarily result in mootness of an appeal. However, if by reason of settlement or other circumstance a court can no longer grant effectual relief, a case becomes moot and must be dismissed:

Based on Biothera’s response and the court’s review of the settlement agreement, that this court cannot grant any effectual relief to Biothera. Biothera has not shown that any claim for monetary or other relief is contingent on this court’s determination. Under these circumstances, this case does not present a “definite and concrete [case or controversy], touching the legal relations of parties having adverse legal interests.” Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 240-41 (1937). In this case, because the court cannot grant Biothera any effectual relief, there is no case or controversy and the appeal must be dismissed.

In addition, when a case becomes moot due to settlement, vacatur is not justified in the absence of exceptional circumstances. In this case, Biothera did not show that exceptional circumstances warrant vacatur.

Request denied.

Eli Lilly Loses Method Patent After the Use Was Disclosed in an Earlier Patent

Stephen Jenei — Thu, 05 Aug 2010 21:03:58 +0000

Eli Lilly lost an appeal from a final judgment of the U.S. District Court for the Eastern District of Michigan, finding claims 2, 6, and 7 of U.S. Patent No. 5,464,826 invalid for obviousness-type double patenting over its earlier U.S. Patent No. 4,808,614. See, Sun Pharmaceutical Industries v. Eli Lilly and Co., United States Court of Appeals for the Federal Circuit (2010-1105).

Lilly markets the drug Gemzar® (gemcitabine) for the treatment of various forms of cancer. Both the ’614 patent and the ’826 patent cover gemcitabine and are therefore listed in the Food and Drug Administration’s (FDA’s) Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) with respect to Gemzar®. The ’614 patent claims gemcitabine, as well as a method of using gemcitabine for treating viral infections. The ’826 patent, however, claims a method of using gemcitabine for treating cancer.

Specifically, the specification of the ’614 patent explains:

In addition to the antiviral utility of the present compounds, certain of the compounds of the present invention have also demonstrated excellent oncolytic activity in standard cancer screens. A particularly preferred compound with this utility is [gemcitabine].

The ’614 patent does not claim a method of using any of the claimed nucleosides for treating cancer.

On December 4, 1984, the same day that Lilly filed the continuation-in-part that resulted in the ’614 patent, Lilly filed another patent application that ultimately issued as the ’826 patent. Lilly did not file a terminal disclaimer with respect to the ’826 patent.

Each claim of the ’826 patent is directed to a method of treating cancer with an effective amount of a class of nucleosides, which includes gemcitabine. Specifically, claim 1 of the ’826 patent recites:

“[a] method of treating susceptible neoplasms[, i.e., cancer,] in mammals comprising administering to a mammal in need of such treatment a therapeutically effective amount” of the class of nucleosides.

Claim 2 of the ’826 patent is specifically directed to a method of using gemcitabine.

After Sun Pharma filed an Abbreviated New Drug Application (ANDA) with the FDA for approval to market a generic version of Gemzar® and certified that both the ’614 patent and the ’826 patent were invalid or not infringed, Sun filed a declaratory judgment action against Lilly, seeking judgment that the ’826 patent is invalid and not infringed.

The district court granted Sun’s motion for partial summary judgment that the claims, namely claims are invalid for obviousness-type double patenting over the earlier ’614 patent after it concluded that, given the ’614 patent’s disclosure of gemcitabine’s anticancer use, claim 12 of the earlier ’614 patent, which claims gemcitabine, and claims 2, 6, and 7 of the later ’826 patent, which claim a method of using gemcitabine for cancer treatment, are not patentably distinct as a matter of law.

The doctrine of double patenting is intended to prevent a patentee from obtaining an extension of a patent for the same invention or an obvious modification. The proscription against double patenting takes two forms: (1) statutory double patenting, which stems from 35 U.S.C. § 101 and prohibits a later patent from covering the same invention, i.e., identical subject matter, as an earlier patent, and (2) obviousness-type double patenting, which is a judicially created doctrine that prevents a later patent from covering a slight variation of an earlier patented invention.

Obviousness-type double patenting prohibits “claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent. An obviousness-type double patenting analysis consists of two steps. First, the court “construes the claim[s] in the earlier patent and the claim[s] in the later patent and determines the differences.” Second, the court “determines whether those differences render the claims patentably distinct.”

Lilly argued that the double-patenting analysis of earlier cases did not apply to the later ’826 patent claims because, though the specification of the earlier ’614 patent disclosed gemcitabine’s use in treating both viral infections and cancer, the antiviral use provided the essential utility necessary to the patentability of the ’614 patent’s claim to gemcitabine. Lilly objected to what it said was the district court’s extension of the obviousness-type double patenting analysis to any utility disclosed in the specification of an earlier patent.

The Federal Circuit summarily rejected Lilly’s argument.

Moreover, the analysis in the Pfizer decision shows that obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound. Pfizer never implies that its reasoning depends in any way on the number of uses disclosed in the specification of the earlier patent.

Thus, the holding of Geneva and Pfizer, that a “claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,” extends to any and all such uses disclosed in the specification of the earlier patent. Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. Indeed, as both cases recognized, [i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.

Affirmed

Jackson Labs Doesn’t Infringe After Patent Discloses But Does Not Claim Mouse

Stephen Jenei — Mon, 07 Jun 2010 16:36:10 +0000

The Jackson Laboratory, a biomedical research institution and repository for laboratory mice, won a summary judgment of no patent infringement against The Central Institute for Experimental Animals (CIEA). CIEA, a non-profit Japanese corporation that develops animal models used for scientific research, alleged that Jackson had infringed U.S. Pat. No. No. 7,145,055 directed to the creation of transgenic immunodeficient mice by breeding particular progenitor mice, called the NSG mouse. Central Institute for Experimental Animals v. Jackson Labs, No. C-08-05568.

The ’055 Patent claims a method of producing an immunodeficient mouse by backcrossing two strains of mice as well as the mouse produced by this method and the use of the mouse. The method claimed in the ’055 Patent involves backcrossing a NOD/Shi mouse with a C.B.-17-scid mouse to create a NOD/Shi-scid mouse and then backcrossing the NOD/Shi-scid mouse with an interleukin 2 receptor γ chain gene knockout mouse (“IL-2Rγ KO mouse”). Backcrossing is a process of mating two animals so that the offspring have a genetic identity that is closer to the genetic identity of a selected parent.

Claim 1:

1. A mouse produced by a method comprising backcrossing a mouse B with a mouse A, wherein said mouse A is a mouse obtained by backcrossing a C.B-17-scid mouse with an NOD/Shi mouse, and wherein said mouse B is an interleukin 2 receptor .gamma. chain gene knockout mouse, wherein said mouse produced by the method does not express the interleukin 2 receptor .gamma. chain, has an enhanced engraftment capacity of heterologous cells relative to a NOD/shi-scid mouse, has neither functional T-cells nor functional B-cells, exhibits reduced macrophage function relative to a NOD/shi-scid mouse, exhibits no NK cells or NK cell activity, and exhibits reduced dendritic function relative to a NOD/Shi-scid mouse.

Following a claim construction hearing, the court construed the term “NOD/Shi mouse” to mean a non-obese diabetic mouse that:

has not been reproductively separated from the NOD mouse colony created by Dr. Susumu Makino at Shionogi Research Laboratories or
has been reproductively separated from that colony by 20 or fewer generations.

The court construed “NOD/Shi-scid mouse” to mean a mouse strain produced by multiple backcross generations of a C.B.-17 scid mouse with a NOD/Shi mouse.

Jackson’s NSG mouse is created by backcrossing a NOD/LtSz-scid mouse. Because NOD/LtSz-scid mice are produced from NOD/LtSz mice, which have been reproductively separated from Dr. Makino’s NOD mouse colony for over 20 generations, a NOD/LtSz-scid mouse is not a NOD/Shi-scid mouse. Accordingly, CIEA concedes that under the court’s claim construction Jackson’s NSG mouse does not literally infringe the ’055 Patent. The parties dispute whether Jackson’s NSG mouse infringes the ’055 Patent under the doctrine of equivalents.

CIEA tried to claim infringement under the doctrine of equivalents based on its contention that use of the NOD/LtSz-scid mouse is equivalent to use of the NOD/Shi-scid mouse in the context of the invention. Jackson argued that CIEA is barred from asserting infringement under this theory because:

the ’055 Patent discloses but fails to claim use of NOD/LtSz-scid mice, and
adopting CIEA’s position that any substrain of NOD mice are equivalent to the NOD/Shi mice would vitiate the NOD/Shi and NOD/Shi-scid claim limitation in its entirety.

The court found no claim infringement under the doctrine of equivalents based on the disclosure-dedication rule. That is, when a patent discloses but does not claim subject matter, the unclaimed subject matter is dedicated to the public and cannot be recaptured under the doctrine of equivalents. See Johnson & Johnston Assocs., Inc. v. R.E. Serv. Co., Inc., 285 F.3d 1046, 1054 (Fed. Cir. 2002). What is claimed is protected, and “what is not claimed is public property.”

The Federal Circuit considered how specific a disclosure in a written description must be to dedicate matter to the public and held that:

[I]f one of ordinary skill in the art can understand the unclaimed disclosed teaching upon reading the written description, the alternative matter disclosed has been dedicated to the public. This ‘disclosure-dedication’ rule does not mean that any generic reference in a written description necessarily dedicates all members of that particular genus to the public. The disclosure must be of such specificity that one of ordinary skill in the art could identify the subject matter that had been disclosed and not claimed. PSC Computer Prods., Inc. v. Foxconn Int’l, Inc., 335 F.3d 1353, 1360 (Fed. Cir. 2004).

In other words, the relevant test is whether one of ordinary skill in the art reading the patent could identify a specific, unclaimed alternative and understand that it could be used as a substitute for the claimed matter. This test is met when the patent mentions the alternative in a way that would be understood by one of ordinary skill in the art. The disclosure of unclaimed subject matter need not satisfy the written description requirement of 35 U.S.C. § 112.

The court said that the disclosure-dedication rule would preclude CIEA from asserting infringement under the doctrine of equivalents if the ’055 Patent disclosed use of the NOD/LtSz-scid mouse as an alternative since it did not claim such use of the NOD/LtSz-scid mouse.

Indeed, CIEA contended in its claim construction brief and at the Markman hearing that a person of ordinary skill in the art reading the patent would understand that any NOD-scid mouse, including a NOD/LtSz-scid mouse, could be used to achieve the patent’s stated objective of creating an immunodeficient mouse with engraftment capacity.

As discussed above, the ’055 Patent clearly disclosed use of the NOD/LtSz-scid mouse in the prior art. Indeed, the ’055 Patent’s discussion of how the NOD/LtSz-scid mouse had been used in the prior art is far more extensive than the brief mention of plastic parts in the PSC patent. Accordingly, the ’055 Patent placed the public on notice that NOD/LtSz-scid mice had been used as an alternative to NOD/Shi-scid mice in the prior art, and future use of NOD/LtSz-scid mice would therefore not infringe.

Because the ’055 Patent discloses but does not claim use of the NOD/LtSz-scid mouse, this unclaimed subject matter is dedicated to the public and cannot be recaptured under the doctrine of equivalents. See Johnson & Johnston, 285 F.3d at 1054. Even if the patentee did not intend to dedicate this subject matter to the public, “[t]he patentee, rather than the public, must bear the burden of inadvertent errors in the patent – including inadvertent dedications.” PSC, 355 F.3d at 1361. Since the disclosure-dedication rule bars CIEA from asserting infringement under the doctrine of equivalents, the court need not reach Jackson’s alternative argument that CIEA’s doctrine of equivalents position would vitiate the NOD/Shi and NOD/Shi-scid claim limitation in its entirety.