Tag Archives: Enablement

Canadian Supreme Court Confirms Plavix Patent Despite Evergreening Charges

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Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 (Canada Supreme Court 2008)

The Supreme Court of Canada has upheld Sanofi’s “selection patent” (the ‘875 patent) covering the blockbuster anti-clotting drug Plavix. A broader “genus” patent (the ‘777 patent) – also held by Sanofi – discloses over 250,000 different compounds. The narrower patent does have some additional patent scope. In particular, while ‘875 patent claims a particular dextro-rotatory isomer, the prior ‘777 patent only describes a racemate of that compound that includes two different isomers.

As an apparent “evergreening” strategy, Sanofi did not claim priority to its earlier patent filing. This allows for an additional decade of patent term. Looking at the case, the Supreme Court determined that it should simply follow the law of novelty and obviousness and not create any special ‘evergreening’ exception:

[97] Evergreening is a legitimate concern and, depending on the circumstances, strategies that attempt to extend the time limit of exclusivity of a patent may be contrary to the objectives of the Patent Act. The Act aims to promote inventiveness by conferring exclusivity for a limited period of time while providing for public disclosure of the invention to enable others to make or use it after expiry of the period of exclusivity.

[98] However, a generalized concern about evergreening is not a justification for an attack on the doctrine of selection patents for two reasons. First, a selection patent may be sought by a party other than the inventor or owner of the original genus patent. In such a case, anticipation or obviousness may be an issue, but evergreening does not arise.

On obviousness, the court found “a significant difference” between the claimed patent and the prior genus patent, and that the “difference was not obvious.”

Applying Bilski to Biotechnology and the Life Sciences

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By Professor Christopher M. Holman (University of Missouri at Kansas City School of Law and author of Holman’s Biotech IP Blog)

The Bilski majority characterizes its machine-transformation test as "the governing test for determining patent eligibility of a process under section 101." Under this test, a claim is patent-eligible if (and as applied in Bilski apparently only if): (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." As explained by the Court, the test serves as a proxy for assessing the more fundamental concern – ensuring that the claim does not seek to impermissibly "preempt the use of a fundamental principle." This might make sense in the context of so-called business method patents, where the fundamental principle implicated is typically characterized as an abstract idea or mental process. But it is unclear to what extent this test will prove applicable to patent claims arising out of the life sciences, where patentable subject matter challenges more often allege preemption of a natural phenomena or law of nature, rather than an abstract idea or mental process.

For example, although Bilski states that a process claim is "surely" patent-eligible under section 101 if it complies with the machine-transformation test, this cannot be literally correct with respect to a naturally occurring biological process. Photosynthesis transforms carbon dioxide and water into sugar, and in Bilski the Court specifically points to chemical reactions as the sort of physical transformation that will render a process patentable, but a claim directed to photosynthesis would clearly violate Supreme Court precedent which bars the patenting of natural phenomena.

Bilski acknowledge that the machine-transformation test might require refinement or augmentation in the future, and I think this refinement will likely be necessary when the court addresses patentable subject matter challenges based on allegations that a patent claim preempts a biological natural phenomenon. Three such cases are currently on appeal to the Federal Circuit – Ariad v. Lilly, Classen v. Biogen, and Prometheus v. Mayo. Nevertheless, since for the time being the machine-transformation test is apparently the governing test, it is worth considering how the claims at issue in these case, and some other controversial biotechnology patent claims, might fare under this approach.

Ariad’s claims essentially recite methods of altering the activity of a regulatory protein (NF-kB) in a cell, which would seem to satisfy the transformation prong of the test. This outcome would be consistent with the District Court’s determination that the claims comply with section 101, albeit for an entirely different reason. But Lilly argues (reasonably I think) that the claims wholly preempt the use of a natural biological phenomenon, and since Bilski acknowledges that the machine-transformation test is really just a proxy for weeding out patent claims that preempt "fundamental principles," this argument might prevail even though the claim does recite a physical transformation.

The claims at issue in Classen, on the other hand, are directed to methods for determining an optimal immunization schedule based on comparing the observed incidence of immune-mediated disorders in treatment groups subjected to different vaccination schedules. Determining an immunization schedule does not appear to satisfy either prong of the machine-transformation test. The claims do include an additional step of immunizing patients, but under Bilski this step would likely be classified as "insignificant extra-solution activity." For example, the majority particularly points to data collection steps as insufficient to render patentable a claim that is essentially directed to a process of analyzing the data. Notably, the majority strongly suggests that the inclusion of a data-gathering step in the claim at issue in LabCorp v. Metabolite is insufficient to confer patentability on that claim, the essence of which is directed to the non-tranformative step of observing a correlation between homocysteine and vitamin B levels in a body fluid. In this regard, Bilksi appears to be consistent with the approach suggested by Justice Breyer in his dissent from the Supreme Court’s decision not to decide LabCorp.

Similarly, the claims at issue in Prometheus essentially target observing the level of a drug metabolite in a patient, and based on that observation recognizing that an adjustment in dosage may be required. The claims recite the administration of the drug to a patient and determining the level of metabolite in the patient’s body, but under Bilski these might well be treated as an insignificant extra solution data-gathering steps, analogous to the assay step in the claim challenged in LabCorp. If we disregard these steps, the claims would appear to fail machine-transformation test.

Note that at the core, the reason the claims in Prometheus and Classen might fail the machine-transformation test has little to do with any underlying natural phenomenon, but rather because they preempt an abstract idea/mental process without tying that process to a specific machine or apparatus. In contrast, the challenge to Ariad’s claims is fundamentally different, being based on preemption of a natural phenomenon rather than preemption of an abstract idea that could be implemented mentally without the use of a machine. In my view, the machine-transformation test just does not work for claims such as Ariad’s.

Some of the most controversial biotechnology patents are so-called human gene patents, particularly those relating to genetic diagnostic testing. For example, Myriad has been widely criticized for its perceived aggressive enforcement of patents relating to the BRCA breast cancer genes. Some of these patents broadly claim methods of identifying mutations, with no apparent extra-solution step that transforms a particular article or is tied to a particular machine or apparatus. For example, U.S. Patent No. 5,753,441 claims a "method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene . . . with germline sequences of wild-type BRCA1 gene . . ., wherein a difference in the sequence of the BRCA1 gene . . . of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

Similarly, U.S. Patent No. 6,432,644 claims "a method for diagnosing the presence of a polymorphism in human KCNE1 . . . wherein said method is performed by means which identify the presence of said polymorphism . . .."

Arguably, these sorts of claims are merely directed to "comparing" naturally occurring genetic sequences, or "diagnosing" the presence of natural mutations, and lack the significant extra-solution step necessary for patent-eligibility under Bilski.

Finally, note that Bilski in effect treats the patentable subject matter doctrine as a mechanism for policing claim scope, a role more commonly associated with the enablement and written description requirements. For example, the majority points to its earlier decision in Abele as an example where a broad claim is invalid for encompassing patent-ineligible subject matter, but an appropriately narrowed dependent claim complies with Section 101. Similarly, genetic diagnostic testing claims might be fine if limited to a specific test or tests, but patent-ineligible if drafted so broadly as to effectively encompass any method for observing a genetic variation.

Written Description: Single Embodiment Insufficient

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This decision is nothing new. Broad claims must either be supported by multiple embodiments or some general principles describing how the single embodiment is applicable to other configurations. Failing that, a broad claim may fail the enablement prong. As seen here, even when enabled, a broad claim without sufficient support will be invalid under the written description requirement.

In re Alonso (Fed. Cir. 2008)

The PTO Board of Appeals (BPAI) rejected claim 92 of Kenneth Alonso’s for failing the written description requirement of Section 112. “To satisfy this requirement, the specification must describe the invention in sufficient detail so that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” (quoting case). In an opinion written by Judge Stearns (D.M.A.) sitting by designation, the Federal Circuit affirmed.

Claim 92 of the Alonso patent application claims a “method of treating neurofibrosarcoma in a human by administering an effective amount” of an idiotypic monoclonal antibody (mAb) secreted in a human-human cell hybridoma.

In his application, Alonso only described the preparation of a single mAb, but claimed essentially all Mab’s that bind to neurofibrosarcoma, and the PTO found that a “skilled artisan would reasonably conclude that applicant was clearly not in possession of the claimed genus of compounds. Applicant should direct the claim language toward the only described embodiment (e.g., a mAb produced by hybridoma HB983).”

Standard of Review: The PTO’s factual determinations are reviewed for “substantial evidence.” Thus, the Federal Circuit will affirm when “a reasonable mind might accept [the evidence] as adequate to support a conclusion.” Even if the Federal Circuit might ultimately have seen the facts differently, it will affirm if the PTO’s position is reasonable.

Predictability: The Federal Circuit acknowledged that disclosure of a single embodiment can be sufficient for a broader genus claim. However, more disclosure is necessary when the composition and effectiveness of members of the genus is heterogeneous or unpredictable.

We have previously held in a similar context that “a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.” Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004).

Alonso argued that his single embodiment should be given more weight because he had actually reduced it to practice (unlike the Rochester COX-2 case). The Federal Circuit rejected that argument because Alonso had not provided the necessary predictive information – “nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method.”

Notes:

  • The court gives the following justification for the written description requirement: “The requirement ‘serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.'” quoting Univ. of Rochester, 358 F.3d 916 (Fed. Cir. 2004) (in turn quoting Enzo Biochem, 323 F.3d 956 (Fed. Cir. 2002)).
  • In his 2005 book on Electronic and Software Patents, Steve Lundberg, et al. include the understatement: “The purpose of the written description requirement has been in flux recently.”

In re Bilski: Patentable Process Must Either (1) be Tied to a particular machine or (2) Transform a Particular Article

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In re Bilski, __ F.3d __ (Fed. Cir. 2008)(en banc)

The Federal Circuit has affirmed the PTO’s Board of Patent Appeals (BPAI) finding that Bilski’s claimed invention (a method of hedging risks in commodities trading) does not satisfy the patentable subject matter requirements of 35 U.S.C. § 101. In doing so, the nine-member majority opinion (penned by Chief Judge Michel) spelled out the “machine-or-transformation” test as the sole test of subject matter eligibility for a claimed process.

The Supreme Court … has enunciated a definitive test to determine whether a process claim is tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to pre-empt the principle itself. A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.

….

Because the applicable test to determine whether a claim is drawn to a patent-eligible process under § 101 is the machine-or-transformation test set forth by the Supreme Court and clarified herein, and Applicants’ claim here plainly fails that test, the decision of the Board is AFFIRMED.

State Street Test Is Out: In State Street, the Federal Circuit used the “useful, concrete, and tangible result” of a process as a touchstone for patentability. In Bilski, the en banc panel found the State Street formulation “insufficient to determine whether a claim is patent-eligible under § 101.”

[W]e also conclude that the “useful, concrete and tangible result” inquiry is inadequate and reaffirm that the machine-or-transformation test outlined by the Supreme Court is the proper test to apply.

Some Business Methods and Software Are Still In: Still, the court made clear that business methods and Software will still be patentable – if they meet the machine-or-transformation test.

We rejected [a categorical] exclusion in State Street, noting that the so-called “business method exception” was unlawful and that business method claims (and indeed all process claims) are “subject to the same legal requirements for patentability as applied to any other process or method.” We reaffirm this conclusion.

…

[A]lthough invited to do so by several amici, we [also] decline to adopt a broad exclusion over software or any other such category of subject matter beyond the exclusion of claims drawn to fundamental principles set forth by the Supreme Court

To be clear, the machine-or-transformation test is not a physicality test – i.e., a claim can still be patentable even if it does not recite sufficient “physical steps.” On the flip-side, “a claim that recites ‘physical steps’ but neither recites a particular machine or apparatus, nor transforms any article into a different state or thing, is not drawn to patent-eligible subject matter.” Here, the court spelled out the specific issue in mind: a claimed process where every step may be performed entirely in the human mind. In that situation, the machine-or-transformation test would lead to unpatentability. “Of course, a claimed process wherein all of the process steps may be performed entirely in the human mind is obviously not tied to any machine and does not transform any article into a different state or thing. As a result, it would not be patent-eligible under § 101.”

Along this line, the court also dispelled two rising concerns, noting that that (1) neither novelty nor obviousness have any relevance to the section 101 inquiry, and (2) the fact that an individual claim element is – standing alone – patent ineligible does not render the claim unpatentable because patent eligibility is considered while examining the claim as a whole.

What is a Transformation?: The courts have already developed an understanding of transformation as it relates to the Section 101 inquiry. Here, the Federal Circuit referred to the distinction made in the 1982 Abele case. There, the court distinguished between two of Abele’s claims – finding only one patentable. The unpatentable claim recited “a process of graphically displaying variances of data from average values” without specifying “any particular type or nature of data … or from where the data was obtained or what the data represented.” The patentable dependent claim identified the “data [as] X-ray attenuation data produced in a two dimensional field by a computed tomography scanner.” In retrospect, the Federal Circuit sees the difference between these two claims to be that of transformation. The second claim included sufficiently specific transformation because it changed “raw data into a particular visual depiction of a physical object on a display.” Notably, the transformation did not require any underlying physical object. As the court noted later in the opinion, the transformed articles must be “physical objects or substances [or] representative of physical objects or substances.”

The Bilski claims themselves were not seen as transforming an article:

Purported transformations or manipulations simply of public or private legal obligations or relationships, business risks, or other such abstractions cannot meet the test because they are not physical objects or substances, and they are not representative of physical objects or substances. Applicants’ process at most incorporates only such ineligible transformations. . . . As discussed earlier, the process as claimed encompasses the exchange of only options, which are simply legal rights to purchase some commodity at a given price in a given time period. The claim only refers to “transactions” involving the exchange of these legal rights at a “fixed rate corresponding to a risk position.” Thus, claim 1 does not involve the transformation of any physical object or substance, or an electronic signal representative of any physical object or substance.

The principle behind the test is to prevent a patentee from obtaining claims that preempt the use of fundamental principles. That principle reaches back more than 150 years to the Morse case where the inventor was precluded from claiming all uses of electromagnetism to print characters at a distance.

We believe this is faithful to the concern the Supreme Court articulated as the basis for the machine-or-transformation test, namely the prevention of pre-emption of fundamental principles. So long as the claimed process is limited to a practical application of a fundamental principle to transform specific data, and the claim is limited to a visual depiction that represents specific physical objects or substances, there is no danger that the scope of the claim would wholly pre-empt all uses of the principle.

What is a “Particular Machine”?: For software and business methods, the question will remain as to whether a general purpose computer is sufficiently particular to qualify as a “particular machine.” “We leave to future cases the elaboration of the precise contours of machine implementation, as well as the answers to particular questions, such as whether or when recitation of a computer suffices to tie a process claim to a particular machine.” As Professor Duffy noted in an earlier Patently-O article, the PTO Board of Patent Appeals (BPAI) has already answered this question: “A general purpose computer is not a particular machine, and thus innovative software processes are unpatentable if they are tied only to a general purpose computer.” See Ex parte Langemyr (May 28, 2008) and Ex parte Wasynczuk (June 2, 2008). More commonly, the claim may tie the software to computer memory or a processor – is that sufficiently particular? I suspect this fact pattern will arise shortly.

Unpatentability Affirmed

Notes:

  • Although three dissenting opinions were filed, Judge Newman is the only judge who found patentable subject matter in Bilski’s claim.
  • In Dissent, Judge Mayer thought the decision did not go far enough: “Affording patent protection to business methods lacks constitutional and statutory support, serves to hinder rather than promote innovation and usurps that which rightfully belongs in the public domain.” Citing work by Professors Dreyfuss and Pollack, Mayer argues that business method patents have the overall effect of stifling innovation by restricting competition.
  • In his Dissent, Judge Rader asks the insightful question of why a new test is necessary when settled law already answers the question. Rader would have decided the opinion with one line: “Because Bilski claims merely an abstract idea, this court affirms the Board’s rejection.” I believe Rader’s position is quite defensible. In particular, the majority justifies its need for the test as a way to ensure that we avoid the “preemption of fundamental principles.” In the majority construct, the machine-or-transformation test serves as a fairly accurate proxy for preventing preemption. The court does not, however, answer why any proxy is necessary – if the purpose is to exclude overbroad abstract ideas why not simply rely on the current rule preventing patenting of abstract ideas (as well as the law requiring full enablement)?

Concurring opinion by Judge DYK (joined by Judge LINN) attempt to reconcile the history of the patent system with the new rule of patentability.

The Trade Secret Value of Early Patent Filing

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Patent.Law168The patent laws promote an early filing doctrine.  Most directly, by filing patent application documents early, an applicant can avoid problems created by pre-filing disclosures that can negate patentability.[1]  Inter alia, early filing also provides a presumptive date of invention and reduction to practice that may have important evidentiary benefits for the applicant.[2]  Some doctrines push against early filing. Notably, earlier filed applications may be more likely to have inadequate disclosure.  A rushed disclosure could result in the patent application being rejected under the utility, written description, or enablement requirements of the Patent Act.[3] Alternatively, if the application is filed prior to gaining an understanding of the eventual market, an applicant may have insufficient disclosure to support the most valuable claims potential. 

Going unrecognized is another benefit of early filing – the ability to keep secret later developed innovations and parameters.  That secret information can then be protected and exploited as trade secret information.

At the time of filing, the applicant must provide a complete description including the best mode contemplated by the inventor. However, many if not most patent applications are filed well before the associated product or method is ready for public consumption – before the inventor knows the best commercially viable mode.  Post-application developments could take any number of forms, such as particularly operative formulations; ideal antibiotic manufacturing parameters; software code that implements a novel algorithm; a more durable circuit arrangement; etc. Commonly, these tweaks and advances may take the form of a specific species of a disclosed and claimed genus.  Of course, this later-stage developments could be incredibly important to anyone wanting to practice the invention or develop some follow-on technology.

Even though product development typically continues after the patent application is filed, the law allows the patent applicant to legitimately keep any later developed information as trade secret.  Patent applications are not allowed to add ‘new matter’ to a patent application during prosecution. Likewise, the applicant has no duty to otherwise inform the patent office or the public of ongoing development. Rather, the application is set at filing and ex post developments are generally irrelevant to patentability.[4]

In a later post, I’ll explore whether this potential overlap of patent and trade secret rights is good from a policy perspective.



[1] 35 U.S.C. §102(b).  This is especially critical if filing foreign applications.

[2] See, for example, 35 U.S.C. §102(g) and §102(a).

[3] See 35 U.S.C. §101 and §112¶1.

[4] There may be some exception here when arguing secondary factors of nonobviousness.

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Anticipation Requires More Than Disclosing All the Elements

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Net MoneyIn v. Verisign (Fed. Cir. 2008)

NMI sued Verisign and others for infringing its credit card processing patent. One of NMI’s claims was found anticipated by a single prior art reference. That reference taught each element in the invalidated claim. However, there was no single example that taught all the elements together.

On appeal, the Federal Circuit reversed – holding that anticipation takes more than simply locating each element within the four corners of a single document.

In its rebuttal, the appellate panel focused on the concept anticipating the invention. To anticipate, the prior art must teach all the claim elements and the claimed arrangement.

Section 102 embodies the concept of novelty—if a device or process has been previously invented (and disclosed to the public), then it is not new, and therefore the claimed invention is “anticipated” by the prior invention. . . . Because the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements “arranged as in the claim.”

Focusing for a moment on arrangement – to anticipate, the reference must teach “all of the limitations arranged or combined in the same way as recited in the claim.”

Applying the rule to this case, the appellate panel found that the prior art reference was not anticipating. The reference disclosed two transaction protocols, but neither protocol contained all of the elements combined in the manner claimed. “Thus, although the iKP reference might anticipate a claim directed to either of the two protocols disclosed, it cannot anticipate the system of claim 23. The district court was wrong to conclude otherwise.”

Means Plus Function: After claim construction, the district court also found NMI’s means-plus-function claims invalid because they lacked any corresponding structure in the specification. On appeal, the Federal Circuit affirmed.

The patent statute allows patentees to draft claims in more generic ‘means plus function’ language. That language allows a patentee claim various elements based on their function. However, means plus function claims are only valid if the specification describes some structure to carry out the proposed function. According to the courts, this structure requirement is separate from any enablement requirement. Thus, some structure must be provided in the specification even if one skilled in the art would not need that disclosure to make the invention.

Here, NMI claimed a “[a bank computer including] means for generating an authorization indicia” but did not provide any corresponding structure in the specification to perform that structure.

On appeal, NMI incredibly argued that the claim was not a means-plus-function claim. The Federal Circuit disagreed – finding that the claim lacks structure.

Searching for structure in the specification, NMI pointed to its recitation of a “bank computer.” Of course that recitation is insufficient.

‘To avoid purely functional claiming in cases involving computer-implemented inventions, we have “consistently required that the structure disclosed in the specification be more than simply a general purpose computer or microprocessor.” Quoting Aristocrat

…

Consequently, a means-plus-function claim element for which the only disclosed structure is a general purpose computer is invalid if the specification fails to disclose an algorithm for performing the claimed function.

Holding of MPF claim invalidity affirmed.

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Shifting Burden of Production Does Not Shift Burden of Proof; PTO Deference

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Technology Licensing Corp v. Videotek (Fed. Cir. 2008)

The independent inventor J. Carl Cooper invented and patented technology separating a sync signal from a video signal to better ensure vertical and horizontal hold on a video screen. Cooper assigned his rights to TLC which sued Videotek for infringement. Videotek pulled-in its supplier Gennum for indemnification. Gennum now remains as the only defendant.

Priority Date: Cooper’s asserted patent claims priority to an earlier application filed in 1992. The district court found specifically that claim 33 could not claim priority all the way back because the claim included a limitation to an “other circuit” which was only disclosed in the subsequent continuation.

Burdens of Proof and Production: Although a defendant ultimately bears the burden of proving invalidity, the burden of producing evidence may shift back and forth during litigation. For instance, once a defendant provides evidence of anticipation, the patentee then has the “burden of going forward with evidence either that the prior art does not actually anticipate, or … that it is not prior art because the asserted claim is entitled to the benefit of a filing date prior to the alleged prior art.” Proving priority requires evidence of the priority claim and also evidence showing that “the written description in the earlier application supports the claim.” Here, the court required cooper to produce “sufficient evidence and argument to show that [the priority document] contains a written description that supports all the limitations of claim 33, the claim being asserted.” Once the evidence is on the table, the claim will only be invalid if the defendant’s proof remains is clear and convincing.

[B]ecause an issued patent is by statute presumed valid, a challenger has the burden of persuasion to show by clear and convincing evidence that the contrary is true. That ultimate burden never shifts, however much the burden of going forward may jump from one party to another as the issues in the case are raised and developed.

Here, the Federal Circuit agreed that the defendants had clearly proven that the original written description was insufficient – and thus that the patentee could not claim priority all the way back.

Deference To and Waiting For the PTO: The PTO issued Cooper’s patent and then, through a reissue, again allowed the challenged claim to issue even after considering the same prior art (the reissue issued while the appeal was pending). On appeal, the Federal Circuit distinguished Ralston v. Far-Mar-Co (Fed. Cir. 1985). In Ralston, the court deferred to the PTO’s determination of priority date. Here, however, there was no evidence that the PTO specifically considered the priority dates. However, the Federal Circuit refused to “add an additional deference-thumb to the scale, or, even more disruptive, our asking the trial court to reopen the entire invalidity question to reweigh the intangible worth of additional deference.”

This is not to say that the determinations made by the corps of examiners are not important, or should not be worthy of appropriate deference to their expertise in these technical matters, especially when we have the benefit of well-reasoned explications. It is to say that when dealing with the intangible worth to be accorded an administrative agency’s decision making, the judicial process cannot be held hostage to the timing of either the agency or the litigants who have invoked the agency’s further review. In some circumstances a party may be able to obtain a stay from the trial court while awaiting the sought-for agency action; absent that, and absent extenuating circumstances not here present, the case must be decided on the record the litigants present for appeal.

Inequitable Conduct:

There has never been an exception [requiring submission of] anticipatory cumulative references, and we are not inclined to create one now.

Definiteness of Means Plus Function Claim: A MPF claim must be supported by structural disclosure found in the patent specification – this requirement is akin to the written description requirement and focuses on actual disclosure rather than enablement.

The question is not whether one of skill in the art would be capable of implementing a structure to perform the function, but whether that person would understand the written description itself to disclose such a structure.

In electronic circuit cases the actual circuit disclosures are not necessarily required. Rather, generic “core logic” may be sufficient. Here, the defendants were unable to provide clear and convincing evidence of a lack of structure.

Sample Responses to Office Actions

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Attorneys have always learned by following the example of their elders and peers. With that in-mind, I would like to post several exemplary responses to patent office rejections and objections. Please forward to dcrouch@patentlyo.com with a very brief explanation of the topic/technology. If you like, you may scrub the response for anonymity. Likewise, feel free to submit good ones you have found that were written by others. Potential topics:

  • Arguing that combination is nonobvious (under KSR);
  • Arguing secondary factors of nonobviousness;
  • Swearing behind prior art;
  • Arguing that prior art is not enabled;
  • Disputing date of prior art;
  • Arguing that prior art is not inherently anticipatory;
  • Responding to obviousness type double patenting;
  • Arguing utility;
  • Responding to restriction;
  • Arguing against indefiniteness;
  • Arguing amendment is not new matter;
  • Etc.

Prior Art Must Enable a Skilled Artisan to Make the Invention without Undue Experimentation

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Impax Labs v. Aventis Pharmaceuticals (Fed. Cir. 2008)

This appeal focuses on the question of when a prior art disclosure is sufficiently enabled.

An Aventis patent covers the use of RILUTEK (riluzole) to treat ALS. Impax filed an ANDA with the FDA (seeking to market a generic version of the drug). In subsequent litigation, Impax also alleged, inter alia, that the listed patent should be held invalid. In particular, Impax argued that an earlier Aventis patent (the ‘940 patent) anticipates the asserted Aventis patent (the ‘814 patent) by suggesting a class of compounds may be used to treat ALS. The district court, however found that the ‘940 patent “does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the ‘814 patent.”

Burden particularly heavy: A defendant who hopes to use previously considered art to invalidate a patent has a “particularly heavy” burden.

Thus, a party challenging patent validity has the burden to prove its case with clear and convincing evidence. When the examiner considered the asserted prior art and basis for the validity challenge during patent prosecution, that burden becomes particularly heavy. See Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1467 (Fed. Cir. 1990).

In this case, the ‘940 patent had been considered by the examiner during prosecution of the asserted patent.

Enabled Prior Art: To anticipate, the prior art must be enabling – i.e., it must “enable one of ordinary skill in the art to make the invention without undue experimentation.”  This enablement standard is different from the applicant’s 112 enablement requirement which requires enablement of both making and using the invention.  That distinction becomes lost in cases like this, however, where the patent covers a method of treatment.  Here, the Federal Circuit appears to require anticipatory prior art to enable practicing the claimed method.

Enablement of prior art is a question of law, but is based on underlying factual findings. In close cases, the important factual finding is the amount of experimentation that would have been necessary. Applying Wands factors, the Federal Circuit agreed that the prior reference was not enabling.

As shown by the trial court, the [prior art] ‘940 patent’s dosage guidelines are broad and general without sufficient direction or guidance to prescribe a treatment regimen. The alleged prior art also contains no working examples. Finally, nothing in the ‘940 patent would have led one of skill in the art to identify riluzole as a treatment for ALS. In sum, each component of the claimed invention—identifying riluzole as a treatment for ALS and devising dosage parameters—would require undue experimentation based on the teachings of the ‘940 patent.

Burden of Proving Enabled Prior Art: In judging anticipation, courts generally presume that prior art is enabled. That presumption may be overcome by a patentee by providing “persuasive evidence” of nonenablement. At that point, the ultimate burden of proof (with clear and convincing evidence) lies with the accused infringer. In this case, the district court did not explicitly follow this burden shifting framework. On appeal, the Federal Circuit held that articulation of the rule was not necessary. The burden was properly shifted because Aventis presented “sufficient evidence to overcome the presumption of enablement.”

Holding: Affirmed. Validity challenge defeated because prior art was not enabled.

Notes:

  • The opinion did not focus on timing: As technology develops more and more prior art references become enabled. Thus, it is important to consider at what point in time the reference must be enabling.

Disclosure: My former colleagues at MBHB represent Aventis in this case. The district court case was ongoing while I was there.

CAFC Applies Lilly to Invalidate Carnegie Mellon’s Plasmid Claims

Enablement, Patent, Patent Cases 2008,

Carnegie Mellon University v. Hoffman-La Roche (Fed. Cir. 2008)

Carnegie Mellon’s patents cover recombinant plasmids used to enhance expression of an DNA polymerase. On appeal, the CAFC affirmed the lower court holding that the patent claims fail to meet the written description requirement under Lilly.

35 U.S.C. §112 requires that the patent document “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.

The written description requirement is used to make sure that the patentee only claims what has been invented. The public gets a “meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.” Quoting Enzo Biochem (Fed. Cir. 2002).

A common written description argument is that the claims have not been disclosed to their full scope. In the Lilly case, for instance, the CAFC found that a generic claim directed to “any vertebrate and mammalian cDNA” were not supported by a specification that only discussed one species – rat cDNA.

To be clear, written description is not about enablement. Patent claims may well be enabled based on PHOSITA’s knowledge of the art, but still fail the written description requirement because the patentee did not disclose the entire scope of its invention.

A representative claim from Carnegie’s patents reads as follows:

1. A recombinant plasmid containing a cloned complete structural gene coding region isolated from a bacterial source for the expression of DNA polymerase I, under operable control of a conditionally controllable foreign promoter functionally linked to said structural gene coding region, said foreign promoter being functional to express said DNA polymerase I in a suitable bacterial or yeast host system.

In reviewing the claim, the CAFC noted that the DNA coding sequence is “broadly defined … only by its function of encoding DNA polymerase I” and that the claims are not limited to any particular bacterial or yeast species.

The specification only discloses one operative gene – the E. coli polA gene. And at the time of the patent, only three polA genes had been cloned (out of thousands of bacteria strains). “[W]ith regard to the promoter, the patents fail to disclose the nucleotide sequence or other descriptive features for a polA gene (including the promoter sequence) from any bacterial source other than E. coli.”

“To satisfy the written description requirement in the case of a chemical or biotechnological genus, more than a statement of the genus is normally required. One must show that one has possession, as described in the application, of sufficient species to show that he or she invented and disclosed the totality of the genus. . . . [W]e conclude that that requirement was not met here.

Gentry Gallery: The district court also applied Gentry Gallery to invalidate other claims. In Gentry, the CAFC found a patent claim invalid because the claim failed to recite an “essential element” of the invention. Here, Roche argued that the patents were directed to avoiding the problem of lethality to host cells, but that the claims did not include that limitation. As it has done repeatedly, the CAFC rejected the idea that Gentry Gallery created an essential element test. (The claims remain invalid under the Lilly analysis.).

Public & Experimental Use: Reduction to Practice Requires Knowledge that Invention Works for Intended Purpose

Patent, Patent Cases 2007, Public Use,

In re Omeprazole Patent Litigation (Fed. Cir. 2008)

The CAFC has affirmed a lower court trial finding that AstraZeneca’s Prilosec (omeprazole with an enteric coating and a subcoating) patents are infringed by the ANDA filings of Apotex, Torpharm, and Impax. (See U.S. Patent Nos. 4,786,505 and 4,853,230). This complex consolidated case has been handled by Judge Jones of the Southern District of New York. The case includes several important procedural issues, but here I focus on public use.

Public Use of a Pharmaceutical Formulation: Under 35 U.S.C. § 102(b), a patent will be considered invalid if the invention was “in public use” more than one year before the filing date. (i.e., before the “critical date”). The use in question was Astra’s large clinical trials used to test its omeprazole formulation. The district court ruled for Astra on two separate grounds: First that the clinical trials were an “experimental use” and therefore cannot qualify as public uses and second that the formulation was not yet ready for patenting until after the trials were completed.

Experimental Use and Reduction to Practice: In a series of cases over the past decade, the Federal Circuit has made clear that the experimental use defense “cannot negate a public use” that occurs after the invention is reduced to practice. At the same time, public use now requires proof that an invention is “ready for patenting” which generally requires reduction to practice (or at least being enabled to practice). For the most part, this rather new interpretation of public use subsumes the experimental use defense.

Here, the pills had been manufactured and were being used by clinical subjects. However, there were not “reduced to practice” because RTP requires knowledge “that the invention would work for its intended purpose.” On appeal, the Federal Circuit refused to overturn the lower court’s factual findings – instead agreeing the formulation was not reduced to practice because the company lacked experience of how it would perform clinically:

[Astra’s expert witness] testified that as of May 1983 the Astra scientists did not have enough information to satisfy themselves that the Phase III formulation would work for its intended purpose. Instead, he testified that the Astra scientists thought the Phase III formulation “had a good possibility to be used as a marketing drug” but that the team did not have long-term stability data and had “no experience of how it performed in clinical studies.”

….

The Astra scientists had long understood that omeprazole could provide a safe and effective treatment for certain gastrointestinal diseases. The challenge they faced was developing a formulation to deliver omeprazole to the small intestine, a challenge that was made difficult by omeprazole’s sensitivity to acidic environments, such as the stomach. Impax has not demonstrated that, without conducting the Phase III clinical tests, the inventors knew that the Phase III formulation would achieve the goals of long-term stability and in vivo stability such that it would be effective as a treatment for gastrointestinal disease.

Because the efficacy of the formulation was not reduced to practice, its use could not be a public use.

Notes:

  • Of interest here is the idea that reduction to practice requires knowledge that the invention will work for its “intended purposes.” The specification of these patents detail the need for stability, so that purpose is clear. Because “purposes of the invention” have been used to limit claim scope, many modern patent applications don’t include such information. In those cases, will the purpose be found in extrinsic evidence?
  • The court here focused on reduction to practice to fulfill the “ready for patenting” prong of the public use analysis. Seemingly, the defendants may have had a better shot trying to show ready for patenting based on evidence that “prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.”

What’s Wrong with Software Patents?

Academic Studies, Book Review, Patent, , ,

by James Bessen and Michael J. Meurer

[This post is the third in a series of posts based on empirical research in a new book, Patent Failure, by James Bessen and Michael Meurer. Read Part I and Part II]

Patents on computer programs, financial processes and business methods have been controversial at least since the 1960s. Surveys regularly find that computer programmers are opposed to patents on software by a wide margin. In what other field is the class of inventors so opposed to patents?

Is there a problem?

Some people contend that there is nothing particularly wrong with patents on software, arguing that "patent thickets" are not preventing innovators from entering software markets. But the latest evidence [LINK] suggests that patent thickets do, in fact, inhibit startups in software. More important, patent thickets might not be the only or even the most important problem with software patents.

Indeed, our evidence suggests an important problem of another sort: software patents are four times more likely to be litigated than are chemical patents; business methods patents are twelve times more likely to be litigated; finance patents are 49 times more likely. Moreover, the evidence also suggests that these patents have lower values than chemical patents, so these patents are not being litigated more because they are more valuable.

Other people admit that there are problems with software patents, but they suggest that this is only temporary: once judges and patent examiners understand this technology better, once they have become familiar with the prior art, etc., then the uncertainty about these patents will abate and litigation rates will go down. But the evidence shows that after a decade of issuing software patents in large numbers (over 200,000), the probability that a newly-issued software patent will be litigated is continuing to rise.

So it does seem that patents on software and related technologies at least have a particular problem with litigiousness. And this problem is central to the poor performance of the patent system generally. In the previous post we highlighted how litigation costs have substantially outgrown the profits that public firms receive from patents outside of the pharmaceutical and chemical industries. In 1999, 38% of the cost of litigation among public firms arose from lawsuits involving software patents; preliminary data suggest that this share has increased since then. Litigation over software patents is clearly a major factor in the poor performance of the patent system. So in a very real way, the overall performance of the patent system cannot be fixed unless the particular problems of software patents are also fixed.

Why are there so many lawsuits over software patents?

A variety of evidence leads us to conclude that software patents are involved in relatively more litigation because they are more likely to have "fuzzy boundaries." Statistical evidence shows, for example, that software and business method patents are much more likely than other patents to have their claim construction appealed to the Federal Circuit. Part of this tendency arises because of the nature of the technology and part arises because of the way the courts have treated this technology.

Our reading of the case law convinces us that patent law tolerates too many software claims untethered to any real invention or structure; in such a world clear boundaries are unattainable. When patent claims relate to actual devices or chemical structures, then their meanings can be interpreted by reference to those physical or chemical entities. However, when the words refer to abstract ideas, they are often subject to multiple interpretations and are therefore more ambiguous. For example, many people thought that "point of sale location" (in the famous E-Data patent) was computer industry jargon for that place in a retail store where transactions take place, formerly occupied by a cash register. When the Federal Circuit interpreted this claim, they decided that it referred to any location where an e-commerce transaction might take place, although it is highly unlikely that this is what the inventor had contemplated 17 years earlier. Thus a broadly worded invention for a kiosk in a retail store was read to cover a broad swath of e-commerce. Not surprisingly, this patent generated quite a few lawsuits.

Patent doctrines that might serve to prevent such fuzzy claims have been undermined. For example, the enablement doctrine has historically been used to keep patents from claiming much more than what was actually invented. Unfortunately, as a result of Federal Circuit decisions on software patents during the 1990s, these patents no longer need to provide computer code, a flowchart, nor any detailed description of specific operation in order to be enabled.

Fixing the problem

A lot of people have very strong opinions about how patent policy should or should not change regarding software patents. We wish we had such clarity, but we do not. We are convinced that the current treatment of software patents creates significant problems and that these are getting worse. But the problem is complex and fixing it will likely involve multiple changes in law and institutions.

Certainly, KSR should help and so would a stronger indefiniteness requirement. Additionally, it might help to restore a substantial enablement requirement for software patents so that these patents are restricted to claiming more or less what was actually invented and disclosed.

Possibly, a subject matter test might help. We confess we do not have a rule that cleanly distinguishes inventions using software that should be patentable from abstract processes that should not be patentable. Some people argue that any attempt to proscribe subject matter will only increase uncertainty and encourage avoidance through clever claim drafting. But the evidence suggests that the subject matter tests used following Benson and Flook did not, in fact, encourage excessive litigation during the 1980s, even though there was some evasive claim drafting. Litigation rates for software patents then were about the same as those for all patents. On the other hand, we doubt that a subject matter test by itself would be sufficient to fix the problems of software patents.

Patently-O Bits and Bytes No. 44: Deferred Examination

Accelerated Examination, Bits and Bytes, Patent, ,
  • Deferred Examination I: For the current state of PTO backlog, I am a strong believer in providing a mechanism to either (i) allowing the inventor pay to move to the front of the examination line if the patent needs to be obtained quickly or (ii) allowing the inventor to delay prosecution if it is unclear whether the invented technology will have any market value. There are some potential negative issues of allowing deferred prosecution — particularly the potential for submarining and shifting claim scope to encompass market changes. These problems would largely be limited through early publication of deferred applications as well as continued enforcement of the written description and enablement requirements.  In addition, the patent term should continue to run during deferment.
  • Deferred Examination II: In its response to congressional queries, PTO Director Jon Dudas has come-out in favor of a system that allows for deferred examination. The PTO’s tentatively proposed implementation scheme would move along a three-step process:
    • Allow a 14–month extendible period for responding to a notice to file missing parts.
    • Use a tiered payment structure that allows for delayed payment of the examination fee.
    • Empower Provisional Applications: Allow applicant to claim priority to a provisional application for up to five years.
  • Deferred Examination III: For many, including the PTO, the hope with deferred examination is that “many inventions … would be recognized as obsolete [or otherwise worthless] before expiration of the five year period and therefore would not require examination resources.”
  • Rocket Docket Examination: In the past, the AIPLA and others have argued against having a rocket-docket examination based simply on the payment of a fee. Their argument is that it is somehow inequitable and un-American to line-jump based on the availability of funds. That argument is largely hog-wash.  Many of the richest companies in the US maintain tight controls over patent prosecution costs. I suspect those companies would only rarely pay an additional $5,000 in PTO fees for rapid examination. (If a rocket docket for patent prosecution is created, the fee should be high enough to ensure that it does not simply create an additional bottleneck.)
  • Clear Channel Communications now owes $90 million to Grantley Patent Holdings. The Eastern District of Texas jury found the patent willfully infringed with damages of $66 million. Last week, the Judge awarded an additional $16 million in enhanced damages in addition to prejudgment interest and interim royalties due.

Two Hong Kong companies have been fighting over a coffee maker design patent.  Simatelex (who manufacturers for Sunbeam) has signed a consent decree admitting contributory infringement. The patentee’s case against Sunbeam is still pending in the Southern District of New York. Wing Shing v. Simatelex.

Theory of Dependent Claims: Survey Results

Academic Studies, Articles and Publications, Claim Drafting Tips, Patent, , , ,

Patent claims define the scope of an invention much like metes and bounds define real property boundaries or a statute delineates the difference between criminal and non-criminal activity.  Often, patent applicants submit a series of claims all directed toward the same invention. Various independent claims allow an applicant to focus on various aspects of the invention. These broad aspects may be directed to various nodes of a larger system or regions of a compound, processes for creating or using various elements, etc.  Dependent claims by definition add additional limitations. Thus, for instance disputed claim 1 and 2 from the recent Lovanex dispute reads as follows:

1. A heterogeneous intimate admixture of sulfated heparinic polysaccharides … consisting essentially of

from 9% to 20% of polysaccharide chains having a molecular weight less than 2,000 daltons
from 5% to 20% of polysaccharide chains having a molecular weight greater than 8,000 daltons, and
from 60-86% of polysaccharide chains having a molecular weight of between 2,000 and 8,000 daltons ….

2. The heterogeneous polysaccharide admixture as defined by claim 1, comprising less than 2% of dermatan sulfate.

Claim 2 is interpreted to include all the limitations of claim 1 with the additional limitation of “less than 2% of dermatan sulfate.” See 37 CFR 1.71(c).

Earlier this week, I polled Patently-O readers on why they file dependent claims and received just over 1000 responses. (Listed below).

Theory of Dependent Claims            
Why do you file dependent claims?             
  Percent of Responses  
Answer Options Strongly Agree Mostly Agree Neither Agree nor Disagree Mostly Disagree Strongly Disagree Rating Average
Dependent claims are backup in case the independent claim is rejected in prosecution. 59% 34% 4% 2% 0%        1.51
Dependent claims are backup in case the independent claim is found invalid in litigation. 59% 31% 6% 3% 1%        1.56
Claim Differentiation: The dependent claims expand or alter scope of other claims. 47% 37% 8% 6% 3%        1.82
Dependent claims focus on particular commercial embodiments to make infringement easier to explain to a jury. 29% 44% 21% 4% 2%        2.07
I primarily include dependent claims with nonobvious additional limitations.  19% 45% 25% 9% 1%        2.29
I was taught to draft dependent claims. 26% 34% 26% 8% 7%        2.35
USPTO fees: Patent office does not charge extra for first twenty-claims. 26% 34% 24% 9% 7%        2.36
Dependent structure better supports foreign filing. 7% 19% 58% 11% 3%        2.84
Dependent claims are easier to draft and manage than independent claims. 6% 23% 37% 23% 11%        3.08
Client demands a certain number of claims. 6% 16% 29% 25% 23%        3.42
Dependent claims help avoid restriction requirements. 2% 13% 39% 31% 15%        3.44
A longer application is more valuable. 2% 13% 29% 34% 22%        3.60
          answered question 1029
          skipped question 0

Responses were also allowed to add additional reasons in the comment section. I have compiled a few of those individual responses below.

  • Drafting Process: A few responses commented on the iterative process of drafting a patent. For some, drafting the dependent claims helps refocus and redefine potentially problematic terms from the independent claims. For many, the dependent claims also serve as a guide for fully drafting the specification.
  • Prosecution Process: Some responses proposed that the dependent claims are helpful during prosecution for several reasons. First, there is a perception amongst patent practitioners that examiners read and consider the claim-set before looking at the actual specification. For that reason, the claims should be considered as a way to teach the examiner about the features and purpose of the invention.  For some, obvious limitations in a dependent claim are useful in that regard to show the examiner an intended use (practical embodiment) of the invention.  For those who see patent prosecution as a negotiation, a series of narrowing dependent claims speed up the the process — the applicant and examiner need only agree upon how narrow the claims need be.  Some propose at least some dependent claims being “super narrow” to serve as a “foot in the door” to increase the likelihood that there is at least some patentable subject matter.  Once you have agreed that a patent will issue, it may be easier to debate the scope of the eventual claims. On a practical note, the existence of dependent claims means that an applicant can get to a post-final rejection allowance without filing a request for continued examination. These practical concerns are important considering that the vast majority of patent applicants amend their claims during prosecution.
  • Claim Differentiation: Most practitioners agreed that the claim differentiation benefit of dependent claims is important. The doctrine encourages courts to consider that each claimed element covers something different than the others. Pushing that line, a typical reasoning is that two or more dependent claims providing alternative implementations of a term from an independent claim will help ensure that the independent claim element is not limited to a single embodiment. Some folks quibbled with my statements regarding dependent claims “expanding scope” of other claims and instead used a more PC version of “aiding construction.”  It is important to realize that the originally filed dependent claims also form part of the specification and can thus help overcome enablement and written description hurdles.
  • Appeasing Clients: Many inventors see their invention narrowly — as their particular embodiment. Dependent claims provide an easy way to satisfy the inventor’s desire to claim their invention without limiting legal rights. On this “politics” side — dependent claims also give reason to add joint inventors, which may be good for office politics. “An invention may only warrant one independent claim embodiment, but many clients like to see many claims. They believe the more claims they have the stronger the patent and that they are getting value for there money.So you add them, e.g., a blue widget, a red widget. It is like chicken soup for a cold, it can’t hurt.”
  • Ease of Analysis: “Filing dependent claims rather than only independent claims makes it much easier for several parties (attorneys prosecuting the application, examiners and the BPAI examining the patent, attorneys analyzing the issued patent, courts analyzing the issued patent) to more readily evaluate the differences and similarities of claims.”  Others noted that it is also useful as a way for potential licensees to know that the proposed product is literally and explicitly covered. For some patent owners, this “ease of analysis” is actually a negative. (Try to read NTP’s $600,000,000 claims). A long claim-set makes it more likely that a potential defendant will easily cave rather than pursue an expensive invalidity / noninfringement study.
  • Capture “minor inventions”: Dependent claims allow an applicant “to capture improvements to the invention that are not important enough to justify a separate application, but that one would want to avoid having a competitor step in and patent something similar.”
  • Tradition: There is nothing wrong with tradition and custom. It helps ensure that we’re all on the same page.  For many the 3/17 rule of independent/dependent claims serves as a default rule that can be adapted for unique circumstances.
  • International: Internationally, patents use fewer independent claims than in the US. One European attorney made the following comment: “Multiple independent claims in the US style cause major headaches and costs in Europe, so one good independent, with well gradated dependents, is the best solution for me.”
  • I will attach the full comments once reformatted.

New Counsel On Appeal Does Not Overcome Waiver of Novelty Argument

Patent,

PatentLawPic303Golden Bridge Tech. v. Nokia and Lucent Tech. (Fed. Cir. 2008)

Golden Bridge’s patent covers a CDMA mobile communication scheme that gradually ramps-up the communication power signal in order to avoid interference with other mobile phones.  On summary Judgment, the E.D.Texas court held that Golden Bridge’s patent CDMA mobile communication scheme asserted claims were anticipated by the prior art.

Anticipation is a question of fact normally decided by a jury. However, it may be amenable to summary judgment “if the record reveals no genuine dispute of material fact.”

Waiver of Novelty Argument: On appeal, Golden Bridge argued that the prior art does not disclose a claimed synchronization element. That factual contention, however, was only first presented on appeal. Finding that Golden Bridge had ample opportunity to raise the contention at the district court level, the CAFC found that any appeal on the synchronization issue had been waived.

“There is no reason why Golden Bridge could not have raised the issue of whether the synchronization limitation was disclosed in the Häkkinen [prior art] reference during the summary judgment proceedings either before the magistrate judge or before the district court judge. . . Golden Bridge cannot simply choose to make its arguments in iterative fashion, raising a new one on appeal after losing on its other at the district court. This is an appellate court and as such we abide by the general rule that new arguments will not be decided in the first instance on appeal.

New Counsel: Golden Bridge argued that it should be given another opportunity to raise the issue because it had hired new counsel on appeal. The appellate panel quickly rejected that argument — holding that “[n]ew appellate counsel does not present an exceptional case or circumstance in which our declining review will result in injustice. To hold otherwise would open the door to every litigant who is unsuccessful at the district court to simply hire new counsel and then argue he should get to raise new issues on appeal.”

Not Fact Finders: Although not directed at any particular colleagues, Judge Moore’s opinion here strongly re-states the the limited role of the Federal Circuit as an appellate panel: “Appellate courts review district court judgments; we do not find facts. Middleton v. Dep’t of Def., 185 F.3d 1374, 1383 (Fed. Cir. 1999) (‘[A]s an appellate court, we may not find facts . . . .’).”

Notes:

  • Based on a request by Nokia, the patent is concurrently under reexamination at the USPTO.

CAFC Rejects Patent on Invention to Overcome the Second Law of Thermodynamics

Patent,

In re Speas (Fed. Cir. 2008)

In a short non-precedential opinion, the CAFC affirmed the PTO’s rejection of Speas patent application as both non-enabled and lacking utility. The application claims:

“all devices and systems which operate in such a manner as to violate the second law of thermodynamics as it is currently understood.”

The CAFC briefly described operation of an embodiment:

‘According to the specification, the invention raises a ferrofluid out of a reservoir by a magnetic column into a mass. The ferrofluid then escapes a “gradually decreasing magnetic field which holds it up against gravitational force” and is drawn away via tubular element by a capillary force aided by Brownian motion. At the end of the tubular element, drops of this ferrofluid accumulate and drop back into the reservoir below, spinning a wheel along their downward paths. Thus, the movement of the ferrofluid imparts mechanical energy upon the wheel. Speas claims that because this ferrofluid is moved and adds energy to the paddle wheel “without input into the system other than ambient thermal energy,” it is proof that the second law of thermodynamics is not inviolate – an object of the invention.’

Notes:

  • Although this type of case is fun to read, it also provides an interesting lesson — that the patent office has tools to reject inadequate patent applications on their merits without resorting to broad exclusions of particular subject matter. 
  • Speas is the inventor of several issued patents covering more practical applications such as an internal combustion engine and an adjustable bicycle drive mechanism. His home of record is in the town of Haiku on the island of Maui.

Pharma Prosecution: CIP Breaks Priority for Restricted Claims

Patent,

Pfizer v. Teva (Fed. Cir. 2008)

A family of three Pfizer patents covers aspects of the bestselling drug Celebrex. Seeing some possible holes* in the patents, Teva field an Abbreviated New Drug Application (ANDA) with the FDA with a Paragraph IV certification challenging the patents as invalid and unenforceable.

Continuation-in-Part After Restriction: 35 USC 121 blocks the use of a parent application “as a reference … against a divisional application” if the divisional was the result of a restriction requirement. 

One of the Pfizer patents (the ‘068) is a continuation-in-part (CIP) filed after a restriction requirement. On appeal, the CAFC confirmed that Section 121 does not apply to CIPs: “a divisional application contains an identical disclosure to its parent application, but a CIP introduces new matter. . . . [T]he protection afforded by section 121 . . . is limited to divisional applications.”

Thus, the parent application of a CIP will potentially be used for an obviousness-type double patenting rejection. Here, the CAFC held that the CIP claims were indeed obvious when compared to the parent application.

Pfizer’s Strategy: From Dan Feigelson’s comment below:

Pfizer could have cured the problem with the ‘068 patent – even during the trial or the appeal – by filing a terminal disclaimer in that patent. I’m guessing they chose not to b/c they had nothing to lose and everything to gain by having the court adjudicate the question of 35 USC 121 to CIPs.

Best Mode: A patent is invalid when the applicant fails to satisfy the best mode requirement of Section 112. The requirement can be broken down into two elements:

  1. Whether the applicant subjectively “possessed” a best mode for practicing the invention at the time the application was filed; and, if so,
  2. Whether the disclosure would objectively enable a PHOSITA to practise the best mode.

Like other invalidity issues, best mode is determined on a claim-by-claim basis.  There was no real question here that the COX-specific claims did satisfy the best mode requirement. The appellate panel refused to speculate further on the moot issue of how the best mode requirement is met for claims covering a larger class of compounds.

Note:

  • * The post was updated to ensure that Patently-O remains non-controversial (See comments below).

CAFC Continues to Expand Doctrine of Full Scope Enablement

Enablement, Patent, ,

ScreenShot028Sitrick v. Dreamworks (Fed. Cir. 2008)

Sitrick’s patented invention involves a method for a integrating user-generated audio and visual effects into a video game or movie. The solo-inventor sued Dreamworks and other defendants who use the “ReVoice Studio” software to allow users to add their own voice to the imagery.  The issue on appeal is whether the asserted claims are enabled under 35 U.S.C. 112 ¶ 1.

Full Scope Enablement: Although loosely tied to the patent statute — the enablement requirement continues to grow and develop through Federal Circuit panel opinions.  Generally, the “requirement is satisfied when one skilled in the art, after reading the specification, could practice the claimed invention without undue experimentation.”

When analyzing enablement, the court looks to ensure that the “full scope of the invention” is enabled — and thus looking beyond whether the particular accused design is enabled. The “full scope” doctrine has recently been applied by the Federal Circuit to invalidate several patents. (See below)

Broad Claim Narrow Disclosure: It is easy to criticize patentees who attempt to enforce broad claims supported only by a narrow disclosure. This is especially true in cases such as Liebel’s where the claim scope had been expanded well after filing the original application. (i.e., “late claiming”).

However, the “full scope” doctrine has serious deficiencies. The most notable are the potentially chaotic results from applying the doctrine to claims that include the comprising transition language.  The problem arises because the comprising transition allows a claim to implicitly encompass a wide variety of add on limitations that might be found in an infringing device. See, for example Automotive Technologies Int’l v. BMW (Fed. Cir. 2007) (claim scope that implicitly covered both mechanical and electrical sensor was not enabled by description of mechanical sensor); Liebel-Flarsheim v. Medrad (Fed. Cir. 2007) (claim scope that implicitly covered both jacketed and jacket-free needle holders was not enabled by description of jacketed needle holders).

Here, the asserted claims were construed as covering both movies and video games. Thus, the patent must enable both types of applications. Here, the CAFC confirmed that Sitrick had failed to enable its use in movies — and thus that the claims are not fully enabled.

  • Buyer Beware: As with other recent enablement cases, this one may be best seen through the lens of the claim construction process. In each case, the patentee requested (or at least did not challenge) broad claim construction.  Consequently, the court was not sympathetic to enablement arguments that could have been avoided by a narrower construction of the claims. This line of thinking was spelled out by Judge Laurie in the Liebel case: “The irony of this situation is that Liebel successfully pressed to have its claims include a jacketless system, but, having won that battle, it then had to show that such a claim was fully enabled, a challenge it could not meet. The motto, “beware of what one asks for,” might be applicable here.”  This buyer beware theory is also useful to break the potential analytical morass of full scope enablement of claims drafted with comprising transitions. 
  • Don’t Begin with the Specification: One aspect of enablement that is continually bothersome. In the opinion, the court noted that “enablement analysis begins with the disclosure in the specification.”  That approach unduly confuses enablement with written description. Rather, I would contend that enablement should begin with the knowledge of one skilled in the art and move forward from there.
  • Johnson v. M’Intosh: In my property law class, we recently discussed Johnson v. M’Intosh and the doctrine of of sovereign authorized discovery of land. In those empire building years, we also saw over-zealous claiming.
  • David Sitrick: The inventor, David Sitrick, is a Skokie based patent attorney registered with the firm of Sitrick & Sitrick. (Reg. No. 29349).  Mr. Sitrick prosecuted the patent himself. His son, Greg Sitrick, is an associate at the Bell Boyd firm in Chicago. (Reg. No. 57195).

Patently-O Bits and Bytes No. 5

Patent,
  • PatentLawPic158Majority Leader Harry Reid Plans to Move Quickly on Patent Reform: In the first work period of the Senate, Reid intends to move on patent reform (after handling the defense appropriations bill and economic stimulus). “Once we work these issues out, time permitting, we will also turn to two other priorities in this first work period: patent reform and an energy package.”  Perhaps appropriately, Reid’s concept of invention is tied-up with entrepreneurs: “On patent reform, we must carefully strike the right balance with a bill that promotes rather than blocks innovation from enterprising entrepreneurs.”  In Reid’s view, the bills should have become law in 2007: “If not for the obstruction of just a few Senators, we would have passed these bills last year. I am hopeful that the overwhelming majority of Senators – Democrats and Republicans alike – will have their voices heard this year.” [Zura]
  • ScreenShot024Comments for Japanese Patent Office: The JPO recently established a Policy Committee and have a schedule to recommend JPO policy changes in a report in April/May 2008. The Committee has generated broad goals of (1) a global system; (2) a predictable system; and (3) a system that promotes both creation and utilization. Comments on the goals and potential solutions are requested by Feb 25 (Japan time). [More Info] [Committee Broad Goals and Plan]
  • PatentLawPic157Patent Bar Exam: Patent Agent Alex Nix has created an excellent wiki to help those studying for the Patent Registration Exam: www.PatentBarQuestions.com. Learn and Contribute!

To the Congress of the United States: I am transmitting to the Congress today a legislative proposal entitled, the “National Productivity and Innovation Act of 1983.” The bill would modify the Federal antitrust and intellectual property laws in ways that will enhance this country’s productivity and the competitiveness of U.S. industries in international markets. As you know, one of the most important goals of my Administration has been to revitalize the competitiveness and productivity of American industry. Tax cuts proposed by my Administration and enacted during the 97th Congress have greatly stimulated economic activity. In addition, our efforts to rationalize Federal rules and regulations have significantly enhanced the efficiency of our economy. For the first time in over a decade, there exists the foundation for a period of strong and sustained economic growth. The ability of the United States to improve productivity and industrial competitiveness will also depend largely on our ability to create and develop new technologies. Advances in technology provide our economy with the means to produce new or improved goods and services and to produce at lower cost those goods and services already on the market. It is difficult to overstate the importance of technological development to a strong and healthy United States economy. It has been estimated that advances in scientific and technological knowledge have been responsible for almost half of the increase in this country’s labor productivity over the last 50 years. New technology also creates new jobs and gives us an advantage in world markets. For example, the U.S. computer industry, which was in its infancy just a short time ago, directly provides jobs for about 830,000 Americans and is a leader in world markets. The private and public sectors must spend a great deal of time, money, and effort to discover and develop new technologies. My Administration has moved to bolster research and development (R&D) in the public sector by proposing in our 1984 budget to increase Federal funding of R&D by 17 percent, to $47 billion. However, it is vital that our laws affecting the creation and development of new technologies properly encourage private sector R&D as well. The Economic Recovery Tax Act of 1981 provides a 25 percent tax credit to encourage firms to invest in additional R&D. Our economic program has helped reduce inflation and interest rates and thus has lowered substantially the cost of conducting research. The antitrust and intellectual property laws also have a very significant effect on private investment in R&D. The antitrust laws are designed to protect consumers from anti-competitive conduct. While the economy generally benefits most from vigorous competition among independent businesses, the antitrust laws recognize that in some areas, like the creation and development of technology, cooperation among producers, even competitors, can actually serve to maximize the well-being of consumers. The intellectual property laws, for example, those dealing with patents and copyrights, also serve to promote the interests of consumers. The promise of the financial reward provided by exclusive rights to intellectual property induces individuals to compete to create and develop new and useful technologies. After reviewing the effect of the antitrust and intellectual property laws on the creation and development of new technologies and after consultations with key members of Congress, I have concluded that the antitrust laws can be clarified in some respects and modified in other respects to stimulate significantly private sector R&D. This can be done while maintaining strong safeguards to protect the economy against collusive actions that would improperly restrict competition. The National Productivity and Innovation Act of 1983, which embodies those changes, is a package of four substantive proposals that deals with all phases of the innovation process. Title II of the bill would ensure that the antitrust laws do not unnecessarily inhibit United States firms from pooling their resources to engage jointly in procompetitive R&D projects. Joint ventures often may be necessary to reduce the risk and cost associated with R&D. So long as the venture does not threaten to facilitate price fixing or to reduce innovation, such ventures do not violate the antitrust laws. Nevertheless, the risk remains that some courts may not fully appreciate the beneficial aspects of joint R&D. This risk is unnecessarily magnified by the fact that a successful antitrust claimant is automatically entitled to three times the damages actually suffered. Title II would alleviate the adverse deterrent effect that this risk may have on procompetitive joint R&D ventures. This title provides that the courts may not find that a joint R&D venture violates the antitrust laws without first considering its procompetitive benefits. In addition, Title II provides that a joint R&D venture that has been fully disclosed to the Department of Justice and the Federal Trade Commission may be sued only for the actual damage caused by its conduct plus prejudgment interest. This combination of changes will encourage the formation of procompetitive joint R&D ventures. And unlike some other proposals currently before Congress, it will do so with the minimal amount of bureaucratic interference in the functioning of those ventures. If we are to assure that our laws stimulate investment in new technologies, however, it is not enough merely to correct the adverse deterrent effect the antitrust laws may have on procompetitive joint R&D. Rather, we must also assure that the antitrust and intellectual property laws allow — indeed encourage — those who create new technologies to bring their technology to market in the most efficient manner. Only in this way can those who invest their time, money, and effort in R&D be assured of earning the maximum legitimate reward. Titles III and IV recognize that very frequently the most efficient way to develop new technology is to license that technology to others. Licensing can enable intellectual property owners to employ the superior ability of other enterprises to market technology more quickly at lower cost. This can be particularly important for small businesses that do not have the ability to develop all possible applications of new technologies by themselves. However, the courts have not always been sympathetic to these procompetitive benefits of licensing. Title III would prohibit courts from finding that an intellectual property licensing arrangement violates the antitrust laws without first considering its procompetitive benefits. In addition, the title would eliminate the potential of treble damage liability under the antitrust laws for intellectual property licensing. Although those who suffer antitrust injury as a result of licensing would still be able to sue for their actual damages plus prejudgment interest, Title III would minimize the deterrence that the antitrust laws currently may have on potentially beneficial licensing of technology. Title IV would also encourage the procompetitive licensing of intellectual property. Pursuant to this title, the courts may refuse to enforce a valid patent or copyright on the ground of misuse only after considering meaningful economic analysis. Finally, Title V will close a loophole in the patent laws that has discouraged investment in efficiency-enhancing technologies. Creation of and improvements in the process of making products can be just as important as creating and improving the product itself. Currently, if someone uses a United States process patent outside this country without the owner’s consent and then imports the resulting product into the United States, the importer is not guilty of infringement. Title V of the bill would close this loophole so that owners of process patents can earn their rightful reward by preventing the unauthorized use of their technology. We must not delay making the necessary changes in the law to encourage the creation and development of new technology, to increase this country’s productivity, and to enable our industries to compete more effectively in international markets. We must act now. I therefore urge prompt consideration and passage of this legislative proposal. Ronald Reagan The White House, September 12, 1983. —–