Source: https://www.patentdocs.org/2016/05/
Timestamp: 2019-04-25 10:37:56+00:00

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In December, the U.S. Patent and Trademark Office invited stakeholders to submit patent quality-related topics that could be used as case studies in a new Enhanced Patent Quality Initiative (EPQI) pilot program. At the time, the Office noted that it regularly performs case studies to investigate specific quality-related issues and analyze how those issues are being treated or addressed across hundreds or thousands of applications, and where appropriate, take action to remediate quality issues or to formulate best practices to further enhance quality.
Earlier this month, in a post by Deputy Commissioner for Patent Quality Valencia Martin Wallace on the USPTO's Director's Forum blog, the Office announced that six topics had been selected for the case study pilot program. The six topics were selected from more than 135 case study submissions from 110 submitters, which included intellectual property organizations, law firms, companies, and individuals. All of the case study submissions have been made available on the USPTO website.
The Deputy Commissioner noted that the six topics selected for the case study pilot program were picked from among the numerous submissions by determining whether a submitted topic was capable of being timely assessed via a case study, and then eliminating topics for which other programs or mechanisms within the USPTO were more appropriate for addressing the topic. Submissions that were deemed to be better addressed by other USPTO programs or mechanisms were forwarded to the appropriate offices for further evaluation.
1) Evaluation of the deviation of 35 U.S.C. §101 rejections from official guidance, correctness of rejections and completeness of the analysis. This study will evaluate whether examiners are properly making subject matter eligibility rejections under 35 U.S.C. §101 and clearly communicating their reasoning.
2) Review of consistency of the application of 35 U.S.C. §101 across art units/technology centers. This study will take a look at applications with related technologies located in different art units or technology centers and determine whether similar claims are being treated dissimilarly under 35 U.S.C. §101.
3) The practice of compact prosecution when 35 U.S.C. §101 rejections are made. This study will determine whether all appropriate rejections are being made in a first Office action when a subject matter eligibility issue is also identified.
4) Correctness and clarity of motivation statements in 35 U.S.C. §103 rejections. This study will evaluate whether reasons for combining references set forth in rejections under 35 U.S.C. §103 are being set forth clearly and with correct motivation to combine statements.
5) Enforcement of 35 U.S.C. §112(a) written description in continuing applications. This study will evaluate claims in continuing applications to determine if they contain subject matter unsupported by an original parent application and whether examiners are appropriately enforcing the requirements of 35 U.S.C. §112(a) written description.
6) Consistent treatment of claims after the May 2014 35 U.S.C. §112(f) training. This study will determine whether claims invoking 35 U.S.C. §112(f) are being properly interpreted and treated.
The Deputy Commissioner noted that the Office would provide updates on the selected case studies, and expected to publish results of the case studies by early 2017 (if not earlier). Results of the case studies will be posted to the Office's Case Studies Pilot Program website.
Infringement of U.S. Patent No. 8,664,215 ("Ocular Allergy Treatments with Alcaftadine," issued March 4, 2014), licensed to Allergan, following a Paragraph IV certification as part of Somerset's filing of an ANDA to manufacture a generic version of Allergan's Lastacaft® (alcaftadine ophthalmic solution 0.25%, used for the prevention of itching associated with allergic conjunctivitis). View the complaint here.
Forest Laboratories, LLC et al. v. Accord Healthcare, Inc. et al.
• Plaintiffs: Forest Laboratories, LLC; Forest Laboratories Holdings, Ltd.; Allergan USA, Inc.; Adamas Pharmaceuticals, Inc.
• Defendants: Accord Healthcare, Inc.; Intas Pharmaceuticals Ltd.
Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,058,291 ("Methods and Compositions For the Treatment of CNS-Related Conditions," issued November 15, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,293,794 (same title, issued October 23, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,338,485 ("Compositions for the Treatment of CNS-Related Conditions," issued December 25, 2012), 8,338,486 ("Methods for the Treatment of CNS-Related Conditions," issued December 25, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), 8,580,858 ("Compositions For the Treatment of CNS-Related Conditions," issued November 12, 2013), and 8,598,233 ("Method for Administering an NMDA Receptor Antagonist To A Subject," issued December 3, 2013) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Forest's Namzaric ® (memantine hydrochloride extended-release and donepezil hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer's type). View the complaint here.
Lotus Pharmaceutical Co. Ltd v. GlaxoSmithKline LLC et al.
• Defendants: GlaxoSmithKline LLC; Glaxo Group Ltd.
Declaratory judgment of non-infringement of U.S. Patent Nos. 8,637,512 ("Formulations and Method of Treatment," issued January 28, 2014) and 9,144,547 ("Oral Dosage Form for Controlled Drug Release," issued September 29, 2015) based on Lotus' filing of an ANDA (and Paragraph IV certification) to manufacture a generic version of GSK's Lamictal XR® (lamotrigine, used as adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older and as conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED). View the complaint here.
The Question Worth Pondering: Innovation Provokers or Idea Thieves?
In the past five years Cisco and J.C. Penney have spent close to $350 million fending off demands from patent trolls, which are more politely known as 'patent assertion entities,' or PAEs. In February, a court in Texas ordered Apple to pay $532 million to a PAE. These are just two of the more high-profile reasons why both the US and the European Union have recognized that the laws and regulations around intellectual property are in profound need of an overhaul.
The question that remains is whether or not the necessary guidance would be most efficiently provided through competition law.
Exactly what approach is needed still needs careful consideration. Any guidance will need to take into account patent trends, actors, rights and obligations, and the nature of current regulatory concerns -- and it will need to do so despite the scant empirical analyses and modeling that has been done on patent trolls.
The US is a dominant force in this area, both by number of patents granted and the value of litigation associated with their assertion. By 2013 more than a quarter of the 9.45 million patents in force had been issued by the US Patent and Trademark Office. In that same year, two thirds of all US patent lawsuits were brought by PAEs -- doubling their share compared to 2010.
This recent growth in global patenting activity, and the emergence of specialized assertion entities, has been accompanied by a shift in the strategic and commercial use of intellectual property assets, and increasing concerns about its impact on competition, innovation, and economic welfare.
PAEs' activities vary significantly yet they are, by and large, usually met with general suspicion and outright hostility. At one point, the White House's position was that "on balance, PAEs have had a negative impact on innovation and growth". Yet after more recent evaluations of the same data on which that conclusion was based, the White House itself, seems to have backed up and are not endorsing this view. There are other analyses which suggest that PAEs can promote rather than obstruct innovation.
What can regulators do about this?
Regulators face a twofold challenge: First, they need to balance the legitimate interests of patent holders and licensees in order to determine which activities and contracts the law will enforce, or otherwise recognize as creating legal rights. Second, they need to establish rules that minimize both the costs of assessing a given case, and the costs of taking wrong decisions.
One traditional approach has been to use antitrust law. However, the ultimate position is that PAE assertion efforts are not, generally, easily caught by US competition rules that require harm to competition and competitive process in order to assign antitrust liability. This is not to suggest that they are pro-competitive, either; it simply means that attacks on this front are unlikely to be successful. New reforms in the US have begun to take account of this by targeting drivers of the PAEs' business model, for instance by preventing them from suing disparate entities in a single lawsuit.
In Europe, the EU's position on PAEs has most recently been outlined by Alexander Italianer, the European Commission's Director General for Competition. The EU expects PAEs to be less active in Europe because damages tend to be lower. PAEs are treated as any other company, including having the same right to defend their intellectual property and the need to honor fair, reasonable, and non-discriminatory (FRAND) commitments whenever standard essential licenses are sold.
It is generally considered legitimate to seek an injunction if a patent is infringed, although it can be considered abusive if the patent holder has given a commitment to license on FRAND terms, and the licensee has been willing to enter into a license under these terms.
What is missing, here, however, is that neither the Commission nor current case law helps to define what FRAND actually means. Instead, national courts are being called upon to determine whether or not an injunction is appropriate -- an approach known as regulatory delegation.
For instance, Germany's Court of Justice recently came back with a four-step negotiation process to sustain licensing in a FRAND manner. This is very much in line with the evolution of EU competition law, but has since been criticized because, in the absences of any benchmark to assess the "FRANDness" of licensing terms, a patent holder may follow the process and still be exposed to antitrust liability if his position is subsequently decided not to be FRAND.
Both US and EU regulators are struggling with the dilemma of devising standards that fit a variety of circumstances, yet can be easily applied. There is a need for more clear-cut regulatory direction on both sides of the Atlantic. As yet, however, it is not clear how that will be achieved.
* Ralf Boscheck is the Lundin Family Professor of Economics and Business Policy at IMD. He is program director of IMD's MBA program. With more than 20 years of teaching in a number of IMD's executive programs, Prof. Boscheck believes in using intensive and direct interaction to develop technical competencies, self-awareness and moral judgment.
For additional information regarding this topic, see Prof. Boscheck's paper "Patent Trolls: In Search of Efficient Regulatory Standards"
The Biotechnology Innovation Organization (BIO) will be holding its annual BIO International Convention June 6-9, 2016 in San Francisco, CA. Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. The BIO International Convention serves to educate the public and policymakers about biotechnology, while fostering partnering meetings and other business development activities to keep the biotech industry growing.
As part of the Convention, more than 1,800 biotech companies, organizations, and institutions will participate in the BIO Exhibition. A searchable list of exhibitors can be found here. Information regarding registration and pricing can be obtained here. Patent Docs authors Donald Zuhn, Kevin Noonan, and Andrew Williams, and Patent Docs contributors Sherri Oslick, James DeGiulio, Nate Chongsiriwatana, Josh Rich, and Grant Drutchas will be attending BIO as part of the MBHB contingent, and will be reporting on a few of the sessions listed above. Patent Docs readers who may be attending BIO are encouraged to stop by the MBHB booth (#504).
In addition, the Docs will be attending the MBHB reception at Kells Irish Pub (530 Jackson Street, San Francisco) on Tuesday, June 7 from 8:00 pm to 1:00 am. Additional information about the reception, including invitations for the event, can be picked up at the MBHB booth.
On the heels of the Federal Circuit handing down two subject matter eligibility decisions regarding software, the U.S. Patent and Trademark Office has published a memo to its examining corps regarding these cases. On May 12, in Enfish, LLC v. Microsoft Corp., the Court found software claims patent-eligible for the first time in almost 18 months. Five days later, in TLI Communications LLC v. AV Automotive, L.L.C., the Court once again invalidated claims directed to software for failing to meet the requirements of the two-part test set forth in Alice Corp. v. CLS Bank Int'l.
When applying the test to a claim, one must first determine whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then one must further determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception. Notably, generic computer implementation of an otherwise abstract process does not qualify as "significantly more."
First, the court noted that when determining whether a claim is directed to an abstract idea, it is appropriate to compare the claim to claims already found to be directed to an abstract idea in a previous court decision.
Second, the court emphasized that the "directed to" inquiry applies a filter to claims, when interpreted in view of the specification, based on whether their character as a whole is directed to a patent ineligible concept.
Third, the Federal Circuit cautioned against describing a claim at a high level of abstraction untethered from the language of the claim when determining the focus of the claimed invention.
Fourth, the court stated that an invention's ability to run on a general purpose computer does not automatically doom the claim.
The second and third points may be the most helpful for patentees. The second point permits "an examiner [to] determine that a claim directed to improvements in computer-related technology is not directed to an abstract idea" under the first prong of Alice, without having to analyze additional elements under the second prong. In making this determination, the examiner may look to the specification's teachings to decide whether the claimed invention achieves benefits over conventional approaches.
The third point may come in handy when a patentee argues that the examiner has not established a prima facie case of subject matter ineligibility. All too often, examiners characterize the claimed invention in a brief summary that, at best, describes the invention at a very high level and in simplistic terms. Here, the Office appears to be instructing the examining corps to honor the language of the claims when considering whether they are directed to an abstract idea. As a result, examiners may find it more difficult to conclude that some claims are abstract.
The USPTO discussed the TLI case mainly because it provides contrast to Enfish. The claims therein were found patent-ineligible because they "describe steps of recording, administration and archiving of digital images . . . directed to the abstract idea of classifying and storing digital images in an organized manner" and "the additional elements of performing these functions using a telephone unit and a server did not add significantly more to the abstract idea because they were well-understood, routine, conventional activities."
As the memo correctly points out, these decisions are consistent with the USPTO's subject matter eligibility guidance from July 2015. Nonetheless, applicants and patent holders may benefit from the substantive and procedural clarifications discussed above.
Already, some are contending that Enfish and TLI cannot be reconciled with one another. This is not true. Enfish stands for the notion that an improvement to computing technology, whether software or hardware, is not in and of itself abstract. TLI, on the other hand, reaffirms that merely using generic computer technology to carry out a procedure does not add patentable weight to a claimed invention. In one case, the claims recite the invention of new technology, and in the other case, the claims recite the use of old technology. A clear line has been drawn.
Still, many new and useful inventions are based on novel arrangements of old technology, and these inventions are at risk in a post-Alice world. We find ourselves in this state of affairs because the Alice test allows one to subjectively divide a claim into abstract and non-abstract parts when considering patent-eligibility, rather than view the claim as a whole. Nonetheless, if we accept that we have to live in the world of Alice at least for now, the distinction between Enfish and TLI is critical to understand, as it provides a roadmap to patent-eligibility for a great many software inventions.
Ventana Medical Systems, Inc. v. Hologic, Inc.
Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 7,718,369 ("Recurrent Gene Fusions in Prostate Cancer" issued on May 18, 2010) based on Ventana's manufacture and sale of its anti-ERG (EPR3864) monoclonal antibody product. View the complaint here.
ApoPharma Inc. et al. v. Taro Pharmaceutical Industries, Ltd. et al.
• Plaintiffs: ApoPharma Inc.; ApoPharma USA, Inc.; Apotex Technologies Inc.
• Defendants: Taro Pharmaceutical Industries, Ltd.; Taro Pharmaceuticals U.S.A., Inc.
Infringement of U.S. Patent No. 7,049,328 ("Use For Deferiprone," issued May 23, 2006) following a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of ApoPharma's Ferriprox® (deferiprone, used to treat patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate). View the complaint here.
Novartis AG et al. v. Mylan Pharmaceuticals, Inc. et al.
• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co., LTD.
• Defendants: Mylan Pharmaceuticals, Inc.; Mylan Inc.
Infringement of U.S. Patent No. 5,604,229 ("2-Amino-1,3-Propanediol Compound and Immunosuppressant," issued February 18, 1997) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis). View the complaint here.
Foundation Medicine, Inc. v. Guardant Health, Inc.
Infringement of U.S. Patent No. 9,340,830 ("Optimization of Multigene Analysis of Tumor Samples," issued May 17, 2016) based on Guardant's manufacture and sale of its Guardant360 genomic cancer testing product. View the complaint here.
Santen Pharmaceutical Co., Ltd. et al. v. Micro Labs Ltd. et al.
• Plaintiffs: Santen Pharmaceutical Co., Ltd.; Asahi Glass Co., Ltd.; Oak Pharmaceuticals, Inc.
• Defendants: Micro Labs Ltd.; Micro Labs USA Inc.
Santen Pharmaceutical Co., Ltd. et al. v. Sandoz Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 5,886,035 ("Difluoroprostaglandin Derivatives and Their Use," issued March 23, 1999) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Santen's Zioptan® (tafluprost ophthalmic solution, used for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension). View the Micro complaint here.
A few years ago, former PTO Solicitor General Nancy Linck arose from the audience at the BIO International Conference to provide her thoughts on how the Office had responded to the Supreme Court's decisions in Mayo v. Prometheus Labs and Association of Molecular Pathologists v. Myriad Genetics (see "USPTO Provides Update on Myriad-Mayo Guidance"). General Linck voiced her disappointment at the manner in which the Office had attempted to craft rules consistent with those decisions; in her view, the Office's responsibility was to provide the Court (and the patent community) with the benefit of their expertise and craft rules consistent with the Constitutional mandate that the patent system promote progress (even if the Supreme Court left open the possibility that this would not be the case). General Linck spoke forcefully and clearly from her heart, and she received (and deserved) a standing ovation that day.
On the podium and uncomfortably the recipient of General Linck's point of view was Drew Hirschfeld, at the time the head of the Office's legal department. Today he is Commissioner for Patents, and in the years since that day the Office's pronouncements on how the law of patent-eligible subject matter should be applied have been both more favorable to patent applicants and more consistent with patents promoting innovation than were those first set of guidances. Like Plato emerging from his famous cave, the Office opened the doors and drew back the shades of whatever closed room its officials inhabited in the first dark days of these Supreme Court precedents, and has since begun to craft guidances that permit (albeit still in only an attenuated fashion) applicants to receive patents more commensurate with their contributions to the Useful Arts.
The latest guidance, distributed to the Examination Corps on May 4th and to the rest of us on May 5th is an example of this changed mindset (see memorandum entitled "Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection"). This new guidance has been discussed here (see "USPTO Issues Update to Subject Matter Eligibility Guidance") and elsewhere. While others properly ponder the minutiae and nuances of this guidance, it may be worthwhile to try to draw some more generalized lessons from them. The first bit of good news is that the guidance is focused on the claims (where of course it should be). Fortunately the Office seems content to abandon any attempt to accommodate outmoded concepts of "inventiveness" or "inventive concept" that are divorced from the statute, or to search for the "gist" or "heart" of the invention. Rather, Examiners are instructed that they must identify the abstract idea, the law of nature/natural phenomenon, or product of nature in first prong of Mayo/Alice test in the claim language itself. Moreover, the Memorandum draws a distinction between claim limitations that "set forth" a judicial exception (which are thus self-evident) and those that merely describe an exception (where the Examiner must "explain subject matter those limitations describe, and why the described subject matter is a judicial exception"). This portion of the memorandum also requires the Examiner set out a reasoned rationale for the arguments regarding the presence of an abstract idea, the law of nature/natural phenomenon, or product of nature in the claim and whether such claim elements recite or are directed to a judicial exception.
[M]ere knowledge of the particular laboratory technique or use of the particular laboratory technique by a few scientists is not sufficient to make the use of the particular laboratory technique routine or conventional in the relevant field.
The Memorandum has, it seems, also been influenced by the Office's current patent quality initiative, emphasizing that rejections grounded in Section 101 must set out the rejections' rationale with "clarity."
Taking the examples as a whole and considering both the express claim language and the Office's analysis of eligibility vel non of each of them, some trends and (current) PTO conclusions regarding eligibility are clear. For products that can be considered "products of nature," those comprising alterations in the compounds not found in nature (e.g., mutations, chemical reactions, changes in structure or physical form) are eligible. This is not a change in Office policies; earlier examples have made this eligibility determination. In these Examples changes other than structural ones are also considered patent eligible by the Office; these include formulations (particularly with components not found together in nature) that change properties or functional characteristics of product of nature, as well as changes in physical form (such as crystal structure) provided that these changes are related to changes in functional properties (in Example 30, for example, naturally occurring crystals of a natural sweetener are rendered eligible by converting them to more homogeneous in size and having better dissolution properties. The Office also exemplifies unconventionality of other aspects of the claimed invention (such as using microneedles for vaccination with otherwise patent-ineligible peptides; Example 28) to support eligibility.
For method claims, and particularly methods related to arriving at a diagnosis of disease (Example 29), illustrate an anomaly (albeit at the same time providing some comfort for claiming such methods going forward): detection methods per se (that do not recite a correlation that can be characterized as a law of nature) are eligible, if only because by not reciting anything that could be considered a law of nature the analysis is not implicated. Even for methods that do recite a correlation that could be considered a law of nature the Office interprets those that also recite novel reagents (porcine antibodies or monoclonal antibodies) or methods (hybridization detection methods such as SNOM or new amplification methods, such as "Cool Melt" PCR (all of which are hypothetical)) to be eligible. Method of treatment claims (which have not been held by courts to be patent ineligible (but see Bristol-Myers Squibb v. Merck) are considered eligible by the Office in these Examples when they comprise novel treatment methods of administration to patients diagnosed using the method, or specific treatment methods of administration to patients diagnosed using the method. Indeed, one lesson gleaned from the Examples is that claims reciting elements at a high level of generality are more likely to be considered ineligible (despite the Federal Circuit's treatment of Myriad's claims in Myriad Genetics v. Ambry).
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the law of nature, the claim recites additional steps of obtaining a plasma sample from a human patient (step a), and detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting resultant binding between JUL-1 and the antibody (step b). Obtaining a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics. Further, the step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., a mere data gathering step necessary to use the correlation. Detecting whether JUL-1 is present in the plasma sample merely instructs a scientist to use any detection technique with any generic anti-JUL-1 antibody. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant's invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting a protein using an antibody to that protein. Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
This assessment also extends the ineligibility concept for these claims to more expressly base it on the "information" content (consistent with Judge Dyk's analysis in Genetic Technologies v. Merial).
While on balance this Guidance and the Examples illustrating the Guidance are an improvement on earlier iterations, the analysis continues to be frustrated by resistance to fully embracing consideration of the claims as a whole. It is unclear why this analysis should not arrive at patent eligibility for using a conventional method with a novel biomarker to produce a novel result (even if it is based on an underlying law of nature). Mayo is not to the contrary: recall that every step in the recited method had been performed in the prior art, so that the only inventive aspect was in the correlation. By definition, using a conventional method with a novel biomarker to produce a novel result is not the same, and certainly "promotes progress" pursuant to the Constitutional mandate. Also absent (but here representing a sin of omission) is an express recognition that differences in purity with functional effects (the difference between chewing a pound of yew bark and taking a pill, for example), or producing a product having a specific activity different from what is found in nature, should be patent eligible. Even in the vaccine example (#28) the Office did not include instances of, inter alia, immunological assays like sandwich assays to distinguish what occurs in nature and what is invented by man. The Office also seems to have conflated (or, more kindly, synthesized) the "routine, well-understood and conventional" standard from Mayo into the Myriad product of nature analysis; while it may be likely that the Supreme Court will one day perform that synthesis, prudence suggests that we let the Court do it any not have the Office try to help.
It should also be recognized that the Office expressly did not consider in drafting the Guidance or the Examples recent case law (including Sequenom and Merial) and that at least one of the claims (Claim 1 of Example 28) that the Office considers patent eligible would not be considered patent eligible under the Federal Circuit's Sequenom decision. In view of the fact that Sequenom filed a petition for certiorari that the Supreme Court has not granted or denied the eligibility of such claims must be at best considered provisional.
At a high level of generality, it can be understood that what the Office is unwilling to acknowledge (and perhaps doesn't think it can, another instance of hands being tied by inelegant expressions of the law by the Supreme Court case law) is the distinctions attendant on qualitative and quantitative differences between what is in nature (and thus perhaps should be "avallable to all men"): when differences in use (taxol) or novel properties related to concentration, specific activity, etc. evince "the hand of man" then eligibility should be acknowledged. This Guidance and the Examples suggest that we may be getting there, but not yet.
On May 4, 2016, the USPTO Patent Trial and Appeal Board (PTAB) issued a decision denying institution of a Covered Business Method (CBM) patent review in a proceeding between AT&T Mobility and Intellectual Ventures, based on U.S. Patent No. 5,339,352. This is another useful decision by the PTAB placing boundaries on patents that are eligible for CBM review requiring more than a mere example in the specification mentioning a financial activity.
AT&T filed a petition to institute a CBM patent review of claims 1, 2, 5, and 9 of the '352 patent. Ultimately, the PTAB found that the information presented in the petition did not establish that the '352 patent qualifies as a CBM patent for purposes of section 18(d)(1) of the Leahy-Smith America Invents Act ("AIA").
The '352 patent discloses systems and methods for providing Directory Assistance Call Completion ("DACC") services to cellular telephone users. One embodiment of the '352 patent provides a system that implements a DACC service for cellular subscribers in which a mobile telephone switching office or "MTSO" is owned and operated by the cellular carrier and provides a switched connection point between the network operated by the cellular carrier and the landline telephone network. The MTSO connects to an operator service system (OSS) that functions as a directory assistance service system. According to the '352 patent, any existing interconnection between MTSO and OSS is replaced with dedicated trunk, and use of a dedicated trunk serves as a means for OSS to identify the carrier and to determine whether the caller can use directory assistance. The dedicated trunk has an area code and exchange number (referred to as the NPA-NXX). The NPA-NXX of the dedicated trunk is also the NPA-NXX of the wireless switch, e.g., MTSO, and because the trunk has a fixed location, the NPA-NXX of the dedicated trunk provides present location information for the calling wireless customer. Therefore, OSS can use the NPA-NXX of the dedicated trunk, rather than the received calling number (ANI), to check eligibility for directory assistance and calculate charges for call completion based on the location.
recording the identity of the wireless communication terminal in the operator service system.
Qualifying as a CBM Patent for CBM Review?
The AIA defines "covered business method patent" as "a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions." AIA § 18(d)(1); see 37 C.F.R. § 42.301(a).
To determine whether a patent is eligible for a covered business method patent review, the focus is on the claims, and a patent need have only one claim directed to a covered business method to be eligible for review.
AT&T contends the '352 patent is a covered business method patent because the '352 patent specification and claims "are directed to collecting and recording data (e.g., the identity of a wireless caller) for billing for call completion services from an OSS." AT&T relies on the last limitation of claim 1 to support its position, arguing that the step is performed for the purpose of "recording the identity of the wireless communication terminal in the operator service system" for use as billing information by the operator services.
The PTAB stated that the claims are devoid of any terms that reasonably could be argued as rooted in the financial sector or directed to a financial transaction. Additionally, although statements in the specification that a claimed invention has particular utility in financial applications may weigh in favor of determining that a patent is eligible for CBM patent review, here, the PTAB did not find CBM review available for claims directed to generally useful technologies that also happen to be useful to financial applications.
The PTAB acknowledged that the specification includes at least one illustrative embodiment directed to an application of the claimed method for billing purposes, but found that such an example is insufficient to make the challenged claims of the '352 patent eligible for CBM patent review. The PTAB explained that mere ability to use the claimed invention in a financial context, standing alone, does not require a finding that the financial prong has been met, especially when the specification as a whole suggests a broader application.
The PTAB concluded that the challenged claims recite a method of general utility for providing a directory assistance call completion service to a wireless communication service subscriber, and the cited example from the '352 patent makes clear that any financial aspect of the invention as discussed in the specification is, at most, a non-limiting example.
In a strategic move, IV had filed a statutory disclaimer under 37 C.F.R. § 1.321(a) of claims 2, 3, 7, and 17, which recited to form a "billing record" and "accounting data". The PTAB noted that it is treated as though the disclaimed claims never existed, and thus, this removed any possible financial language in nature from the claim set. As a result, the claims were better positioned to survive the CBM challenge.
Have you ever mixed up the obviousness determinations of "motivation to combine" and "reasonable expectation of success"? If so, you are apparently not alone -- the Federal Circuit recently faulted the Patent Trial and Appeal Board of doing just that. In Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., the Court reviewed the Board's determination that Intelligent Bio-Systems, Inc. ("IBS") failed to establish the obviousness of one of Illumina's patents, the 7,566,537 patent, in view of prior art cited in an IPR petition. Importantly, the Court determined that the Board incorrectly found there was no "reasonable expectation of success" because the "success" on which the Board focused was identified only in prior art references. Instead, the correct analysis required a showing of an "expectation of success" in obtaining the claims at issue when combining the cited references. In this case, the claims at issue did not contain a limitation that would have put the "expectation of success" in question. Nevertheless, the Federal Circuit clarified that what the Board had meant to say was that there would have been no motivation to combine the cited references. This was true, however, because one skilled in the art would not have expected the particular combination of references to have worked for the purposes as found within those references. In other words, the Federal Circuit clarified that if the references cited in an allegation of obviousness provide reasons why a skilled artisan would not have combined them, it negates a "motivation to combine" and not a "reasonable expectation of success" of ultimately combining the references.
A method of labeling a nucleic acid molecule, the method comprising incorporating into the nucleic acid molecule a nucleotide or nucleoside molecule, wherein the nucleotide or nucleoside molecule has a base that is linked to a detectable label via a cleavable linker and the nucleotide or nucleoside molecule has a ribose or deoxyribose sugar moiety, wherein the ribose or deoxyribose sugar moiety comprises a protecting group attached via the 2' or 3' oxygen atom, and said protecting group can be modified or removed to expose a 3' OH group and the protecting group comprises an azido group.
The Federal Circuit emphasized the claim language underlined above. Importantly, the Board had found that claim 1 did not require that the protecting group be removed, and neither party challenged this finding.
This case began when IBS filed a revised petition requesting inter partes review of claims 1-6 and 8 of the '537 patent. IBS identified three references that it alleged rendered the claims at issue obvious: (1) WO 91/06678 ("Tsien"), (2) U.S. Patent No. 6,664,079 ("Ju"), and (3) Zavgorodny et al., 32 Tetrahedron Letters 7593 (1991) ("Zavgorodny"). Ju and Tsien were cited as teaching SBS using a labeled nucleotide and using a protecting group at the 3'-OH position. The Board found that Zavgorodny taught an azidomethyl moiety as a suitable protecting group for the 3'-OH position of nucleosides, and that the group was cleavable under specific and mild conditions. Nevertheless, Ju taught that for SBS to be successful, the protecting group must be removed with high yield (in order to allow the incorporation and detection of subsequent nucleotides), and Tsien taught that for quantitative deblocking, efficiency needs to be close to 100%. Moreover, as Illumina pointed out, the prior art reference Loubinoux et al., 44 Tetrahedron 6055 (1988) ("Loubinoux"), reported that azidomethyl group removal from phenols using the same conditions as Zavgorodny resulted in no more than 60-80% removal efficiency.
When looking at the "predictable result" aspect of obviousness as articulated in KSR, a reasonable expectation of success requires that the combination of references work for its intended purpose. The Board found that, because of the low level of removal efficiency as taught by Loubinoux, IBS's "[p]etition did not provide a specific or credible explanation why an ordinary artisan would have expected Zavgorodny's azidomethyl protecting group to meet Tsien's quantitative deblocking requirement under conditions suitable for use in Tsien's sequencing methods." Beyond this, however, the Federal Circuit could not figure out if the Board was relying on "reasonable expectation of success," "motivation to combine," or "both." Therefore, to the extent the decision was based on "reasonable expectation of success," the Federal Circuit found it to be flawed. The problem was that the Board should have identified a reasonable expectation of making the claimed invention, not of combining the references for the purposes found in the prior art. As mentioned above, the Board interpreted the claims as not requiring that the azido group be removed. As such, Loubinoux's teaching of low deblocking efficiency was irrelevant. And, therefore, as far as the obviousness determination turned on that factor, it was in error.
Nevertheless, as the Court put it, the Federal Circuit "sit[s] to review judgments, not opinions," citing Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1540 (Fed. Cir. 1983). While the language cited above from the Final Written Decision of the Board (about there being no specific or credible explanation why a skilled artisan would have expected the azido group to meet the deblocking requirement of Tsien) was not relevant to an expectation of success analysis, it was relevant to the motivation to combine. The Federal Circuit held that, based on the findings of the Board, there was no suggestion or reason to combine Tsien or Ju with Zavgorodny to achieve the claimed invention. In other words, the low deblocking efficiency did not impact the expectation of success, but it did provide a disincentive for combining these references that was not otherwise overcome by IBS. Thus, the finding that Illumina's patent was not obvious was correct.
The Federal Circuit also considered IBS's contention that the Board should have considered its reply brief. IBS attempted to explain why a skilled artisan would have modified the cleavage conditions such that the alleged high-percentage cleavage requirement would have been satisfied. The Board did not consider this argument because it was raised for the first time in the reply brief. On appeal, the Federal Circuit noted the expedited nature of the IPRs, and that it is incumbent on petitioners to identify "with particularity" all evidence in the petition that supports the identified grounds. The reply brief should only address issues raised in the Patent Owner's response. "While the Board's requirements are strict ones, they are requirements of which petitioners are aware when they seek to institute an IPR." As such, the Federal Circuit found that the Board did not abuse its discretion in excluding this evidence. The Board's decision in this case was therefore affirmed.
The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Life Science and Section 101: USPTO New Examiner Guidelines" on May 25, 2016 from 2:00 to 3:00 pm (ET). Raul Tamayo of the U.S. Patent and Trademark Office, Courtenay Brinckerhoff of Foley & Lardner, and Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP will probe deeply into the new examples published by the USPTO this month that show how claims for life science inventions should be examined by the agency for subject-matter patent eligibility. The panel will also crystallize the examples into "dos and don'ts" for patent prosecutors in life science matters relating to Subject 101, and discuss pending litigation and how the guidelines will have to change if the U.S. Supreme Court denies certiorari in the Sequenom case.
• What policies and practices should counsel have in place to identify potential conflicts in patent prosecutions?
• What steps can patent prosecutors take to minimize the risk of subject matter conflicts?
• How should patent counsel respond after identifying conflicts?

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