36. A method for establishing the validity of a display created by a non-secure printer, said method comprising the steps of:
     placing in said printer paper upon which information may be created, said paper containing preestablished data which is unique to said paper;
     communicating at least a portion of said preestablished data to a location independent from said printer, said independent location operable to send to said printer a security indicia, as part of a human readable display, said security indicia created in part by information contained in said preestablished media data and whereby said security indicia is validatable at a subsequent time partially under control of data contained in said preestablished paper data, said unique data being created on said paper defining one or more from the group consisting of:
     postage stamps, money orders, bank drafts, letters of credit, legal documents, legal certificates, diplomas, passports, birth certificates, visas, drivers licenses, social security cards, medical insurance cards, vacation packages, travel vouchers, car rental vouchers, hotel vouchers, meal vouchers, drink vouchers, food stamps, tickets, baggage tags, prescriptions (Rx), vehicle licenses, vehicle titles;
     wherein said paper is divided into sections each section adapted for printing thereon information pertaining to a different display, each such display having associated therewith a security indicia.

The district court read in a limitation to the independent claims requiring the security indicia to be created using a key.  The panel identified several sources of support for this construction from the district court’s construction order.  First, the district court found that “the history of secure systems design supports that this invention requires a key.”  Second, the district court found that the specification taught the use of a key.  On this second point, the panel noted that “[i]n the only detailed embodiments in the patent, the key is embedded in the preestablished data.”  Third, expert testimony indicated that certain words used in the claim were terms of art that indicated the use of a key.

The panel, however, found that “the plain language of the claims … does not require that the preprinted data contain a key … from which the security indicia would be generated.”  In addition to the plain language of the claim, the panel relied on claim differentiation:

Here, when the inventor wanted to restrict the claims to require the use of a key, he did so explicitly. None of the claims at issue on appeal recite the term “key.” By contrast, all of the other independent claims require either an “encryption key” or “key data.” ’179 patent claims 1, 14, 47, 54, 59, 66; ’575 patent claims 52, 60. In addition, dependent claim 2 of the ’575 patent explicitly adds the limitation to claim 1 of the ’575 patent that the security indicia “is validated by key information contained in at least a portion of said preestablished data.” This further indicates that the claims at issue on appeal do not require the use of a key in the preprinted paper.

As the panel found that the district court’s construction improperly limited the scope of the claims, it reversed on claim construction and remanded for further proceedings under the new construction.

- Using terms interchangeably in the specification can be interpreted as defining the terms as equivalents.  In the case at hand, the panel found that intraluminal graft and graft were used interchangeably and thus that graft in the claim meant intraluminal graft.

- Where all the described embodiments share a feature, the specification supports interpreting the claim language to include that feature.  Thus, where the specification described only intraluminal grafts, the specification supported interpreting the claims to require this feature. 

- Describing a particular embodiment or feature as “the present invention” supports a construction limiting the claim to include the indicated feature.

- Removing a limitation from a claim but then arguing that the removed limitation is a point of differentiation over the prior art doesn’t act to remove the limitation at claim construction time.

The appellant raised some interesting arguments that didn’t really get very far.  First, claim differentiation was raised in order to avoid a certain construction.  The panel gave little weight to the implications of the differentiation argument.  In essence, it was trumped by other analytical tools.  Second, the appellant sought to use certain language in the prosecution history to affect the panel’s construction.  In response, the PTO suggested that such language may not be probative if it was not relied upon by the Examiner.   Here, a statement by the then applicant regarding certain limitations of the claims were discounted becuase the purpose for which the comments were submitted, to solicit an interference, was not fulfilled. 

End result, affirming narrow claims and no infringement.

A method for playing a game of organized golf wherein the improvement is that each participating player or group of players is permitted under the official or sanctioned rules of said game for normal play to raise or tee the ball up above turf level at any time during play, except for designated hazard areas and greens, and further comprising the step of recording the number of strokes taken by each participating player of [sic] group of players throughout said game for the purpose of comparing said number of strokes with the number of strokes of each other participating player or group of players or to an average or expected number of strokes for golf play in accordance with said game.

The question of anticipation revolved around a manuscript for which the inventor had applied, and received, a copyright registration more than one year before the filing of the application at issue.  It was agreed that the manuscript fully disclosed the claimed matter.  However, the question remained as to whether the manuscript was “publicly accessible” so as to count as a printed publication under 102(b).  The Copyright Office’s catalog was searchable only by author and the first word of the title of the copyrighted work.  The parties and the panel apparently agreed that this level of searchability was not sufficient to make a work publicly accessible.  However, in rejecting the claims, the PTO alleged that two commercial services made the Copyright Office’s Catalog searchable by the entire title.  The PTO thus maintained that the manuscript qualified as a printed publication under 102(b). 

The panel agreed that if the entire title of the manuscript were searchable, the manuscript itself would be publicly accessible for the purposes of 102(b).  However, the panel also accepted Appelant’s argument that the Office had failed to provide any evidence showing that the commercial services had indexed the full title of the manuscript prior to the critical date.  While the Office argued that the burden should be on the applicant to show the converse, the panel disagreed.  It reasoned that, in view of the complete lack of evidence on the point, the Office had not made a prima facie case of public availability and that it was therefore impermissible to shift the burden to the applicant to disprove the PTO’s allegation.  As a result, the panel remanded.  While a victory of sorts, the panel expressly recognized that other rejections might be raised on remand which were not presented on appeal.  Thus, the question of ultimate patentability will be finally decided at a later juncture.

At the district court, Biocare moved for summary judgment that its license from Harvard shielded it from liability for infringement of the patents. The district court agreed and granted summary judgment to that effect. On appeal the panel for the Federal Circuit avoided the dueling contract interpretation issues by focusing instead on an “antecedent question: whether AsymmetRx had the statutory right to bring an action for infringement without joining the patent owner, Harvard..” Interestingly, “[t]he issue of AsymmetRx’s standing to bring suit without Harvard joining as a plaintiff was not raised by either party or by the district court.”

It its analysis, the panel discussed two categories of cases which established the pattern for licenses which conferred standing to sue on the licensee and licenses which failed to do so. Abbott stood in as the poster-boy for lack of standing. Abbott Labs. v. Diamedix Corp., 47 F.3d 1128 (Fed. Cir. 1995). Vaupel and Speedplay filled the opposite role. Vaupel Textilmaschinen KG v. Meccanica Euro Italia S.P.A., 944 F.2d 870, 874 (Fed. Cir. 1991); Speedplay, Inc. v. Bebop, Inc., 211 F.3d 1245 (Fed. Cir. 2000).

In the end, the panel here found the license to AsymmetRx to be more like the license in Abbot than the licenses in Vaupel and Speedplay. In particular, the panel noted several provisions in the AsymmetRx that were inconsistent with the type of license which confers standing to sue without the patent owner:

Harvard retained substantial interests under the ’256 and ’227 patents, including the right to sue for infringement … Harvard also retained the right to make and use the p63 antibodies for its own academic research purposes, as well as the right to provide the p63 antibodies to non-profit or governmental institutions for academic research purposes. In addition, Harvard retained a great deal of control … such as requiring AsymmetRx to meet certain commercial use, availability, and FDA filing benchmarks; specifying that manufacture had to take place in the United States during the period of exclusivity; and maintaining input on sublicensing and receiving a share of those royalties. AsymmetRx was required to grant sublicenses suggested by Harvard, provided they were not contrary to sound and reasonable business practices and materially increased the availability to the public of the licensed products … AsymmetRx was to cooperate with Harvard to maintain the patent rights, so as to enable Harvard to apply for, to prosecute, and to maintain patent applications and patents in Harvard’s name … [I]f AsymmetRx elects not to exercise its right to sue, Harvard has the right to bring its own infringement action … In addition, even if AsymmetRx exercises its option to sue for infringement, it is obligated under the AsymmetRx License to consider Harvard’s views and the public interest, and Harvard’s approval is necessary for any settlement of suit … [I]f AsymmetRx does commence an infringement action, Harvard may elect to join as a party in that action and, if Harvard does join such an action, it jointly controls the suit with AsymmetRx.

In the panels view, “[w]hile any of these restrictions alone might not have been destructive of the transfer of all substantial rights, their totality is sufficient to do so.” Accordingly, the panel vacated the grant of summary judgment and remanded to the district court.

The Claim at issue:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The district court granted summary judgment that the claim at issue was directed to non-statutory subject matter under a pre-Bilski analysis.  The panel for the Federal Circuit reversed, finding that both steps a) and b) met the transformation prong of the machine or transformation test.  With respect to the transformation in steps a) and b), the panel held that:

 The transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined.

The panel also held that steps a) and b) were “not merely insignificant extra-solution activity.” The district court had discounted the administering and determining steps as solely related to data gathering.  The panel disagreed:

While it is true that the administering and determining steps gather useful data, it is also clear that the presence of those two steps in the claimed processes is not “merely” for the purpose of gathering data. Instead, the administering and determining steps are part of a treatment protocol, and they are transformative.

Under the panel’s analysis these steps constituted patentable subject matter regardless of the presence of additional limitations that were just mental steps.

Prosecutors rejoice, this opinion will give you plenty of ammunition for overcoming section 101 rejections.  Of course, the Supreme Court might render all this ammunition unuseable soon.

Inconsistent Claim Constructions

 The claim at issue relates to “[a] method of preventing the formation of an air pocket around rotating blades positioned in a pitcher of a blender” that involves positioning a plunger in a particular orientation within the blender.

 After a Markman hearing, the district court construed the asserted claim to exclude “a method of stirring to disperse, dislodge, or break-up an air pocket after it has begun to form” based on the prosecution history.   Based on this construction Basic argued that it did not infringe because its stir stick is used to stir the contents of the blender.  Vita-Mix argued that it was irrelevant to the infringement analysis whether Basic’s stir stick was used to stir the ingredients in the blender. Vita-Mix offered testimony and evidence that inserting the stir stick and allowing it to rest without actively stirring would meet the limitations of the claims even if the stick was capable of or alternatively used for stirring.  At summary judgment, the district court agreed with Basic finding that Vita-Mix had disclaimed “all stirring” and granted summary judgment of no direct infringement.

 The initial claim construction was not appealed.  However, Vita-Mix alleged that the district court applied a different construction for summary judgment than originally determined after the Markman hearing.  The panel for the Federal Circuit agreed. It found that the Court’s construction of “no stirring” on summary judgment was inconsistent with the original construction and that the original construction was correct.  Thus, the court reversed the order of summary judgment of no direct infringement.

Inducement and Contributory infringement

Vita-Max relied on inserting a stir stick into a blender without stirring as the conditions under which the accused product infringed.  The panel affirmed the grant of summary judgment on inducement and contributory infringement based on a lack of intent that users to operate the accused device in this manner and based on the existence of substantial non-infringing uses, i.e., stirring.  These rulings on indirect infringement lead to a dissent from Judge Bryson who would have let the issue go to the jury.

     One of the defenses asserted by Roche was invalidity of certain claims for obviousness-type double patenting.  A partial family tree of the patents at issue is shown below:

     The five patents at issue (in blue above) all claim priority back to application 06/675,298 (in yellow above) which issued as patent number 4,703,008.  The ‘298 application was subject to a restriction requirement during prosecution.  Amgen elected one set of claims in response to the restriction and pursued other sets in continuation applications as shown above.  35 U.S.C. § 121 provides a safe harbor against double patenting in certain circumstances.  At dispute here was the exact scope of that safe harbor. 

      The text of section 121 provides that:

 A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.

     Amgen persuaded the lower court to apply the safe harbor to its patents.  In defense of the lower court’s judgment on appeal, Amgen argued that its continuation applications fell within the safe harbor because they were “filed as a result of such a [restriction] requirement,” and because the continuation applications at issue conformed to the M.P.E.P.s description of divisional applications.  Roche argued that the statute only extended to true divisional applications.

     The court sided with Roche and held that: “because the ’178 and ’179 applications were filed as continuation—rather than divisional—applications, the ’933, ’422, and ’349 patents do not receive the benefit of § 121.”  The court largely relied upon the plain language of the statute and the lack of any legislative history concerning applicability to non-divisional applications.  The court also harmonized several cases on the topic by suggesting that had the ‘178 and ‘179 applications been filed as divisionals, the subsequent continuations in the family tree would not have removed the related patents from the safe harbor.

     The court dealt with several other significant issues in this lengthy opinion.

Between 2010 and 2013, more than half of Lilly’s current revenue will become exposed to generic competition due to U.S. patent expirations on four of its five top-selling drugs including the blockbuster antipsychotic Zyprexa. Sales of those drugs – nearly $11 billion last year – can be expected to decline by as much as 80%.

If accurate, the predictions indicate that expiration of its patents will cost Lilly 8.8 billion of annual sales and will cost several thousand people their jobs.  The losses to Lilly are offset, at least partially, by assumed gains in sales and jobs by the generic manufacturers and lower prices to the consumer.  However, as the benefits accrue primarily to third parties, one can see why Lilly might want strong patents (e.g., patents having a long duration).  While anecdotal at best, comparing the situation of Lilly to the recent fortunes of Microsoft in the patent arena (here and here) supports the narrative that patent reform is a battle between the interests of health related industries and hi-tech industries.