Patent Docs

USPTO Releases 2018-2022 Strategic Plan

By Kevin E. Noonan --

The U.S. Patent and Trademark Office has released its 2018-2022 Strategic Plan, the first under new Director Andrew Iancu.

Director Iancu provides an introductory Message in which he cites the grant of U.S. Patent No. 10,000,000 on June 19th of this year that "authenticates the brilliance of our Founding Fathers and serves as a testament to those who continue to bring forward their creative genius, imagination, and talent for the betterment of all."  While lauding the vitality of the Office's work in enabling inventors to contribute to the U.S. economy and the need for "predictable, reliable, and high-quality intellectual property (IP) rights," he notes that the USPTO needs to "continually challenge itself" to provide such patent rights.  He previews the Plan (which he calls "the roadmap for the future") by stating those goals: "(1) optimizing patent quality and timeliness, (2) optimizing trademark quality and timeliness, and (3) providing domestic and global leadership to improve IP policy, enforcement, and protection worldwide."

The Plan begins with the Office's Mission and Vision, a statement of Strategic Goals, and Guiding Principles.  The Mission:

Fostering innovation, competitiveness and job growth in the United States by conducting high quality and timely patent and trademark examination and review proceedings in order to produce reliable and predictable intellectual property rights; guiding intellectual property policy, and improving intellectual property rights protection; and delivering intellectual property information and education worldwide.

and the Vision:

Leading the nation and the world in intellectual property

The Plan has three specific Goals and a Mission Support Goal:

Goal I:    Optimize Patent Quality and Timeliness
Goal II:    Optimize Trademark Quality and Timeliness
Goal III:    Provide Domestic and Global Leadership to Improve Intellectual Property Policy, Enforcement, and Protection Worldwide

Mission Support Goal: Deliver Organizational Excellence

And finally in this Introductory Section, the Plan sets forth Guiding Principles:

• Through a culture of quality, we promote excellence throughout the organization by valuing accurate and consistent results, primarily in the examination processes.

• Through timeliness, we recognize the needs of our customers and stakeholders to have our products and services delivered at a time that meets their individual needs.

• Through efficiency, we are sound financial stewards of the user fees paid by our customers, and we use the lowest number of inputs to create the greatest number of outputs, maximizing results.

• Through effectiveness, we listen to our customers and stakeholders, and incorporate their feedback.

• Through accountability, we measure our activities, accept responsibility for them, and disclose the results in a transparent manner.

The Plan then sets forth the Office's intention in detail.  For Goal I, Optimize Patent Quality and Timeliness, the Plan sets forth the following Objectives, comprising Initiatives and Key Performance Indicators:

Objective 1: Optimize Patent Application Pendency

OBJECTIVE 1: OPTIMIZE PATENT APPLICATION PENDENCY

Initiatives

1. Optimize pendency and examination timeframes
2. Align production capacity with incoming workload
3. Leverage value obtained from international work products
4. Identify and offer additional prosecution options

Key Performance Indicators

1. Balance pendency targets within patent term adjustment examination timeframes
2. Define and implement a process for routing utility patent applications in light of the transition from U.S. classification to Cooperative Patent Classification
3. Provide examiners with information from an applicant's other applications filed in the United States and internationally
4. Achieve process efficiencies and quality improvements via available prosecution options

Objective 2: Issue Highly Reliable Patents

Initiatives

1. Increase examiners' ability to obtain the best prior art during examination
2. Improve content, delivery, and timeliness of technical and legal training to achieve more predictable outcomes
3. Use patent quality data to identify areas for improvement to achieve more consistent outcomes
4. Refine production standards to achieve patent quality expectations and goals
5. Enhance transparency and communication of quality metrics

Key Performance Indicators

1. Ensure that examiners consistently apply current policies and follow established procedures
2. Comprehensively study and adjust examination time goals to ensure optimal USPTO performance in patent pendency and quality
3. Increase the effectiveness, evaluation, and reporting of quality

Objective 3: Foster Innovation through Business Effectiveness

Initiatives

1. Enhance patent customer experience
2. Optimize development and delivery of information technology tools, including artificial intelligence and machine learning, for internal users of patent systems to ensure that they have the tools they need for a thorough search and examination
3. Enhance information technology interfaces available to external users of patent systems
4. Improve searchable access to domestic and international patent application files, including the prior art and Office actions contained therein
5. Retain and leverage nationwide talent
6. Document and standardize best practices to facilitate succession planning
7. Coordinate patent outreach efforts across the Patent organization and evaluate the impact of these efforts on the patent ecosystem

Key Performance Indicators

1. Complete initial implementation of Patents End-to-End
2. Enhance assistance to independent inventors and small businesses during the prosecution of their applications
3. Strengthen leadership values and behavior throughout

Objective 4: Enhance Operations of the Trial and Appeal Board

Initiatives

1. Resolve appeals and inter partes matters in a timely manner
2. Streamline procedures and standards where feasible and appropriate to ensure balance and predictability
3. Emphasize overall written quality, well-supported reasoning of orders and opinions, and decisional consistency
4. Increase internal and external engagement on Patent Trial and Appeal Board operations to promote understanding
5. Develop and enhance tools to promote transparency and enable increased use of operational data
6. Retain and leverage nationwide talent

Key Performance Indicators

1. Resolve all inter partes matters within statutory deadlines and improve appeal pendency
2. Ensure quality of Patent Trial and Appeal Board decisions
3. Pursue formal or informal collaborations and education opportunities with examiners and external stakeholders
4. Improve Patent Trial and Appeal Board processes and procedures through enhanced automation tools and data use

Goal II, Optimize Trademark Quality and Timeliness, also has four Objectives:

Objective 1: Optimize Trademark Application Pendency

Initiatives

1. Align production capacity with incoming workload and inventory
2. Work with customers to develop pendency goals that increase examination efficiency, maintain an optimal pendency level, and meet the expectations of the intellectual property community
3. Optimize pendencies for all types of actions throughout the trademark process

Key Performance Indicators

1. Maintain first action pendency between 2.5 and 3.5 months with 12 months or less for disposal pendency
2. Continue to evaluate timeliness
3. Use forecasting and analytics to align staffing to pendency goals

Objective 2: Issue High-Quality Trademarks

Initiatives

1. Continually improve quality measurements
2. Provide targeted training (including legal training and education) to address quality issues
3. Leverage analytics to drive training, process improvements, and consistency
4. Leverage state-of-the-art technologies that support high-quality examination and registration

Key Performance Indicators

1. Maintain high-quality targets of 95.5 percent for first actions, with 97.0 percent for final compliance and 45.0 percent for exceptional office action
2. Adopt data-driven analytics to enhance quality

Objective 3: Foster Business Effectiveness

Initiatives

1. Develop innovative recruitment strategies for staffing trademark positions
2. Develop leadership programs for succession planning, knowledge management, and employee engagement
3. Develop a workforce equipped to leverage information technology modernization
4. Focus information technology efforts on improving efficiencies in core business operations
5. Enhance the customer experience
6. Explore artificial and business intelligence to assist trademark customers
7. Partner with customers to define and address needs

Key Performance Indicators

1. Create a customer-focused organization
2. Strengthen workforce competencies (e.g., include education in diversity, talent, skills, empathy)
3. Align process and service to improve the customer experience and efficiency

Objective 4: Enhance Operations of the Trademark Trial and Appeal Board

Initiatives

1. Resolve appeals and inter partes matters in a timely manner
2. Streamline processes and procedures where feasible and appropriate and ensure procedural predictability
3. Emphasize overall written quality, well-supported reasoning of orders and opinions, and decisional consistency
4. Maintain increased internal and external engagement on Trademark Trial and Appeal Board operations to promote customer understanding of process and procedure
5. Document clear and comprehensive business requirements to facilitate enhancement of legacy information technology systems and prepare for next generation information technology systems
6. Retain and leverage nationwide talent

Key Performance Indicators

1. Maintain a customer-focused organization
2. Strengthen workforce competencies (e.g., include education in diversity, talent, skills, empathy)
3. Align process and service to improve customer experience and efficiency

Goal III, Provide Domestic and Global Leadership to Improve Intellectual Property Policy, Enforcement, and Protection Worldwide, has but two Objectives (being a more difficult goal insofar as it involves not only domestic issues but also interactions with foreign patent systems):

Objective 1: Provide Leadership and Education on Domestic Intellectual Property Policy and Awareness

Initiatives

1. Provide domestic policy formulation and guidance on key issues in all fields of intellectual property enforcement and protection
2. Engage other U.S. government agencies, stakeholders, and Congress on legislation that improves the intellectual property system
3. Provide domestic education on intellectual property at all levels, including to U.S. government agencies, stakeholders, the public, and state and local communities
4. Provide input to ongoing court considerations on key intellectual property issues
5. Advocate for the value of intellectual property as a critical driver of innovation and creativity

Key Performance Indicators

1. Provide intellectual property education to U.S. businesses, educators, and audiences at all levels, including through increased participation in USPTO domestic education and outreach partnerships with other U.S. government agencies
2. Facilitate U.S. government interagency efforts, lead stakeholder engagement on key intellectual property issues, and actively participate in U.S. government interagency efforts
3. Provide expert legal and technical advice on key intellectual property issues to internal and external decision-makers

Objective 2: Provide Leadership and Education on International  Intellectual Property Policy and Awareness

Initiatives

1. Provide international policy formulation and guidance on key issues in all fields of intellectual property enforcement and protection
2. Provide leadership, support, and advice to the administration in negotiating and monitoring compliance with intellectual property agreements and intellectual property provisions in trade agreements
3. Lead administration efforts at the World Intellectual Property Organization and other international organizations to improve intellectual property enforcement, protection, and cooperation worldwide
4. Engage other governments to improve their intellectual property enforcement and protection, including by providing education and capacity building
5. Work with Congress on matters pertaining to international agreements and their implementation
6. Work with the administration to improve intellectual property enforcement and protection in countries of interest, including through the intellectual property attaché program
7. Advocate for the value of intellectual property as a critical driver of innovation and creativity

Key Performance Indicators

1. Develop country-specific action plans to monitor priority economies' progress along the following dimensions:
    (a) institutional improvements of intellectual property office administration for advancing intellectual property rights,
    (b) improvements in intellectual property laws and regulations, (c) institutional improvements of intellectual property enforcement entities, (d) establishment of government-to-government cooperative mechanisms
2. Provide training and information on best practices to protect and enforce intellectual property
3. Further international work-sharing opportunities and cooperation with other intellectual property offices and relevant authorities, including through memoranda of understanding agreements
4. Provide substantive input and expert legal and technical advice on key IP issues and in agreement and treaty negotiations
5. Provide technical assistance and advice to members of Congress and key staff on key international intellectual property issues

These Goals are supported by a Mission Support Goal, to Deliver Organizational Excellence, itself comprising four Objectives:

Objective 1: Enhance Human Capital Management and Foster Employee Engagement

Initiatives

1. Optimize the performance culture
2. Leverage best practices to attract, recruit, and retain an engaged, diverse, mission-focused, and talented workforce
3. Optimize workspace to meet workforce needs
4. Continue to strengthen our telework environment
5. Enhance leadership capabilities to better develop, sustain, lead, and foster engagement and advocacy in the agency's diverse workforce
6. Identify and deploy an engagement strategy that ensures all employees understand how their work relates to the USPTO mission

Key Performance Indicators

1. Increase USPTO employee engagement, cultural, and environmental metrics
2. Develop and continue improvement in human capital management metrics and analytics
3. Improve space efficiency and quality metrics
4. Enhance quality and quantity of leadership programs and activities
5. Improve telework management and participation methods, controls, and practices

Objective 2: Optimize Speed, Quality, and Cost-effectiveness of Information Technology Delivery to Achieve Business Value

Initiatives

1. Involve the business unit experts in the information technology acquisition source selection process
2. Refine the agency-wide information technology prioritization process
3. Foster information technology innovation from our highly skilled workforce
4. Maintain effective legacy systems during transition to their retirement
5. Establish agency-wide data governance
6. Strengthen the information technology development and implementation lifecycle

Key Performance Indicators

1. Strengthen key stakeholder relationships
2. Develop and implement the USPTO Data Roadmap, including guidelines for data architecture and data management
3. Develop an information technology portfolio status dashboard

Objective 3: Enforce Financial Sustainability to Facilitate Effective USPTO Operations

Initiatives

1. Maintain the authority for fee-setting
2. Obtain authority to spend all fees collected
3. Ensure that the USPTO fee structure continuously meets the needs of the intellectual property environment of the future
4. Optimize the management of financial resources
5. Achieve optimal value from resources deployed to support USPTO operations

Key Performance Indicators

1. Demonstrate progress toward legislative solutions
2. Complete comprehensive assessment of USPTO fee structure
3. Ensure resources are continuously available to sustain operations

Objective 4: Enhance the USPTO's Interactions with Internal or External Stakeholders and the Public at Large

Initiatives

1. Strengthen relationships with the Department of Commerce, the Office of Management and Budget, other federal agencies, and Congress
2. Foster a culture across the USPTO for providing an outstanding customer experience
3. Foster relationships with internal and external stakeholders
4. Meet customer needs by timely delivery of intellectual property information and education to support and encourage growth of an innovation-based economy
5. Strengthen the public's understanding of intellectual property, including increasing the public's knowledge of how intellectual property, and the product and services that the USPTO offers, support our innovation-based economy

Key Performance Indicators

1. Improve quantity and quality of, and return on, internal and external stakeholder relationships
2. Enhance customer experience programs and metrics and improvement of the customer experience for internal and external USPTO customers

The Plan also contains Accompanying Information that explicates the Strategic Planning Process, supported by relevant External Factors (Appendix A) and Background of the Strategic Framework (Appendix B).

While the language of the Strategic Plan is replete with precatory and aspirational language of how the Office intends to achieve its Goals, it also advantageously contains sufficient specificity for the patent community and the public to be able to assess how well the Office satisfies the expectations raised in the Plan, and supplies the metrics to do so.  Director Iancu has raised expectations by his patent-supportive rhetoric since he assumed the position.  This Plan reflects those expectations and provides not only hope but also the basis for evaluating how well those hopes are realized.

Deer Genes Identified in Antler Production

By Kevin E. Noonan --

Growth is one of the defining properties of being biologically alive, and the biology of growth involves both cellular proliferation and differentiation from stem cells to one or a plurality of differentiated cells making up a bodily tissue.  Examples range from regeneration of an arm in starfish (and in the related sea cucumber, the ability to propel its gastrointestinal tract to distract a predator) through phylogeny to the capacity of human liver to regrow after resection.  Even normal development involves production of new tissues, and in some species both aspects of this biological phenomenon can be appreciated.  For example, deer grow and regrow antlers, which can account for 28% of the animal's body weight, and their regrowth rates are so rapid that deer can produce 10 kg or more over 2-3 months.  Deer antlers and human bone, while showing very different growth rates (2 cm/day for deer antler, 2 cm/yr for femoral growth during puberty) and other features have in common intramembranous and endochondrial modes of ossification, and this similarity prompted a research group* to undertake a study comparing the pattern of expressed genes in deer antlers and human bone.  The results of this study, entitled "Identifying deer antler uhrf1 proliferation and s100a10 mineralization genes using comparative RNA-seq," were published on October 31 in Stem Cell Research and Therapy.

Due to difficulties in elucidating the genes involved in antler production in the past, these researchers initiated their study by isolating reserve mesenchymal (RM) cells from fallow deer and human mesenchymal stem cells (hMSCs) and comparing RNA expression patterns in cultures of both cell types.  RM cells were chosen for the study because they expressed robust amounts of alkaline phosphatase (ALP) when contacted with bone morphogenic protein 2 (BMP-2) when assayed using immunofluorescence staining.  Cell growth for RM and hMSCs cultures were determined, and RM cells yielded 1.1-4.5 x 10⁵ cells after six day's growth in culture with a doubling time of 17.9-24.7 h and hMSCs yielded 1.2-3.9 x 10⁴ cells after six days in culture (10-fold fewer cells) and a doubling time of 37.8-60.1 h.  Differentiation studies showed RM cells differentiated into chondrocytes and osteocytes rather than adipocytes (the predominant differentiated cell type for hESCs).  In the presence of BMP-2, RM cells expressed ALP as well as osteocalcin, osteoblast-specific factor 1 and runt-related transcription factor, consistent with the results of the differentiation studies.  RM cells were also preferentially stained with Alizarin Red S in mineralization studies (1702.2.ug/mL) compared with hESCs (98.0 ug/mL).  These and other comparison of RM and hESCs supported the use of these two cell types for further studies of gene expression related to antler and bone growth in these two species.

Comparator RM and hMSCs cultures were assayed using RNA-seq methodology, which permits the complement of expressed RNA species in a cell to be determined and compared using a next-generation sequencing (NGS) approach:

The results of these studies showed similar patterns of activation of proliferation-associated genes in both cell types, including cdk1, rrm1, cdc7, aurka, and plk4.  Under conditions expected to promote mineralization both cells types showed "similar activation of osteogenic-associated pathways such as roles of osteoblasts, osteoclasts, and chondrocytes in rheumatoid arthritis as well as the expression of typical osteogenic genes such as dlx5, tsc22d3, alpl, klf4, ext1, and stc1."  Overall, these researchers identified 40 proliferation and 91 mineralization candidate genes from these two species:

These results were verified by immunofluorescence, gene over-expression and gene knockdown studies, using FD-derived proliferation candidate gene uhrf1 gene and mineralization candidate gene s100a10.  These results were consistent with the purported role in antler growth and regeneration suggested by gene expression patterns identified in in vitro cultured RM cells.

The authors of this study suggest that "[t]he approach developed here may be broadly applied towards studying another biological phenomenon, and the genes identified with this approach will not only advance our understanding of mammalian bone regeneration but also offer promising therapeutic strategies for bone tissue engineering."  In addition, they speculate that "a similar comparison strategy can be applied to almost any tissue for identifying the contributions of uniquely expressed genes to a phenomenon of interest."  These sentiments are supported by the results set forth in this paper, where a previously intractable biological problem (identification of genes associated with deer antler growth) was successfully addressed using the combination of in vitro biological and RNA-seq approaches set forth herein.

*Dai Fei Elmer Ker, Dan Wang, Rashmi Sharma, Bin Zhang, Ben Passarelli, Norma Nef, Chunyi Li, William Maloney,Stephen Quake and Yunzhi Peter Yang

Indivior Inc. v. Dr. Reddy's Laboratories, S.A. (Fed. Cir. 2018)

By Kevin E. Noonan --

Having a court grant a preliminary injunction is frequently an important strategic victory for a patent plaintiff in an infringement suit.  The injunction not only eliminates a revenue stream for the accused infringer but also imposes other requirements (such as burdensome efforts to remove the alleged infringing article from the stream of commerce) that can (and indeed, are intended to) pressure the defendant to consider settlement.  But in order for a plaintiff to obtain an injunction, she must show a likelihood of prevailing on the merits, and in Indivior Inc. v. Dr. Reddy's Laboratories, S.A., the Federal Circuit recently found the District Court erred in finding such a likelihood, based on the patentee having disclaimed embodiments that encompassed the accused infringing article.

The case arose in ANDA litigation over Indivior's suboxone film product Suboxone®, a rapidly dissolving film formulation of two active ingredients:  buprenorphine, which decreases a patient's need for opioids, and naloxone, which deters abuse; it is the leading treatment for opioid dependency according to the Federal Circuit opinion.  The challenge for such formulations is drug content uniformity, i.e., having the ingredients homogeneously distributed in the films, which are produced from larger sheets that are cut into individual dosage units based on a particular size and shape to provide the appropriate dose of each drug.  U.S. Patent Nos. 9,931,305 and 8,603,514 (which have identical specifications) cover Indivior's product (the '305 patent being the only patent at issue in the case), which disclose methods for mixing the drugs with a polymer, casting the mixture to produce a wet film, and then "controllably drying the film to produce a solid sheet having less than ten percent variance in active ingredient throughout any given area."  Relevant to the issues before the Court, prior art methods (involving drying the films by applying warm air to only the top surface) were inadequate to achieve content uniformity, with films produced in this manner having a "rippled" surface.  The invention overcame these limitations by "applying heat to the bottom of the film, introducing controlled microwaves, controlling the air flow above and beneath the film, and employing furnace filters."

The parties had engaged in ANDA litigation involving the '514 patent brought in the District of Delaware; claim 62 of this patent in informative:

62.  A drug delivery composition comprising:
    (i) a cast film comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more so substantially water soluble or water swellable polymers; and a desired amount of at least one active;
    wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix;
    (ii) a particulate active substantially uniformly stationed in the matrix; and
    (iii) a taste-masking agent selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste- masking of the active;
    wherein the particulate active has a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being dried without loss of substantial uniformity in the stationing of said particulate active therein; and
    wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active.

The District Court held that Indivior had disclaimed (indeed, disparaged) conventional air drying methods in these claims, and on this basis construed "dried" (and "drying") to exclude embodiments that only used "conventional convection air drying from the top."  The District Court found that Dr. Reddy's did not infringe the claims of the '514 patent (a decision on appeal to the Federal Circuit).

Reacting to this decision, Indivior amended claims in a pending application that matured into the '305 patent that replaced "dried" and "drying" with "continuously" and "continuously cast," as illustrated in claim 26 of the '305 patent:

26.  A drug delivery composition comprising:
    (i) a continuously cast film produced on a manufacturing line comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more substantially water soluble or water swellable polymers; and at least one active;
    wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self- aggregating uniformity of the active in the matrix;
    (ii) a particulate active substantially uniformly stationed in the matrix; and
    (iii) a taste-masking agent selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste- masking of the active;
    wherein the particulate active has a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being continuously cast on the manufacturing line without loss of substantial uniformity in the stationing of said particulate active therein; and
    wherein said uniformity of the continuously cast film is measured by substantially equally sized individual unit doses cut from the continuously cast film which do not vary by more than 10% of a desired amount of said at least one active.

Indivior brought this ANDA suit against Dr. Reddy's in New Jersey based on the '305 patent claims; nevertheless, Dr. Reddy's launched at risk after the FDA approved its ANDA.  Indivior petitioned the District Court for a temporary restraining order (TRO) and a preliminary injunction (PI), both of which were granted (the TRO after a telephone conference between the parties and the Court, and the PI after a hearing).  As part of the District Court's determinations in support of granting the PI, the Court held that Indivior was likely to succeed on the merits that Dr. Reddy's product infringed the '305 patent claims and that those claims were not invalid nor unenforceable.  In construing the scope of the asserted '305 patent claims, the New Jersey Court declined to apply the Delaware Court's reasoning that Indivior's specification disclaimed embodiments encompassing Dr. Reddy's product, based in part on the '305 patent claim not reciting a "drying" limitation.  This different construction also supported the New Jersey Court's decision that a PI (and Indivior's lawsuit) was not barred under the doctrine of claim preclusion.  This appeal followed.

The Federal Circuit reversed, in an opinion by Judge Stoll joined by Judge Lourie; Judge Newman filed a dissenting opinion.  The majority held that the District Court had abused its discretion in granting the PI, because in their view the '305 patent specification disclaimed conventional air-drying methods (such as those used by Dr. Reddy's) for producing such films.  This conclusion was supported by "remarks in the specification," specifically that such conventional methods did not solve the content uniformity problems in prior art drying methods.  Disclaimer (or, put another way, disavowal) requires that a specification be express ("make clear" that the inventor intends to disclaim part of the scope of a claim that would otherwise encompass certain embodiments based on the plain meaning of claim terms).  This must be more than merely expressing a patentee's preference with regard to certain features; characteristic of effective disclaimers are instances where "'the specification goes well beyond expressing the patentee's preference . . . [including, for example,] repeated derogatory statements about [a particular embodiment]," citing Openwave Sys., Inc. v. Apple Inc., 808 F.3d 509, 513 (Fed. Cir. 2015) (quoting Chicago Bd. Options Exch., Inc. v. Int'l Sec. Exch., LLC, 677 F.3d 1361, 1372 (Fed. Cir. 2012)).

In this case (and in direct analogy to the Openwave Systems case and SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1343–44 (Fed. Cir. 2001), "the '305 patent is 'rife with remarks that disparage, and therefore, disclaim' solely using conventional top air drying to form films," according to the majority opinion.  The opinion cited disclosure in the specification that "conventional drying methods themselves are unable to provide uniform films" and that such methods "produce a 'ripple effect' that results in 'an uneven, and therefore non-uniform film.'"  The opinion also cites two specific examples in the specification that illustrate the advantage of avoiding conventional top-only air drying in favor of the claimed methods that employed other drying geometries and methodologies; the opinion recites several portions of the specification to illustrate its points.

The majority rejected Indivior's argument that these statements in the specification were not relevant to construing the asserted '305 patent claims because these claims did not recite "drying" or "dried."  The majority held that the substitute language, "continuously cast film," implicated the disclaimer of conventional drying because drying was part of the disclosed methods for producing a continuously cast film.  And the opinion states that "[t]he specification makes clear that a film produced using only conventional top air drying cannot satisfy the claim limitations."

The majority also rejected Indivior's argument that "it is improper to import drying, a process limitation, into the '305 patent's composition claims because there is an absence of 'specific process language.'"  While acknowledging that "[a]s a general rule, product claims are not limited to the method of manufacture disclosed in the specification," citing Vanguard Prod. Corp. v. Parker Hannifin Corp., 234 F.3d 1370, 1372 (Fed. Cir. 2000), "process steps can be treated as part of a product claim if the patentee has made clear that the process steps are an essential part of the claimed invention," citing Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1375 (Fed. Cir. 2007).  That is the case here, in the majority's opinion, because a "continuously cast film" requires a process for achieving the end product.  The '305 patent discloses only an irrelevant extrusion method and a wet casting method, the product of which must be dried ("combining a polymer and a polar solvent, forming the combination into a film, and drying the film in a controlled manner").  Analogous to the Anderson case, the majority found that "Indivior's patent specification makes clear that the drying process is an essential part of the '305 claimed invention" in order to achieve content uniformity, which an expressly recited limitation in the '305 patent claims.

In addition, the majority found that Indivior was barred by the claim preclusion doctrine because the '305 patent claims were patentably indistinct from the '514 patent claims held before the Delaware District Court not to be infringed by Dr. Reddy's products (a decision that follows inexorably from the majority's holding that replacing "dried" and "drying" with "continuously cast" did not distinguish the claims of the '305 patent from the earlier-asserted claims of the '514 patent).  Finally, the majority held that Indivior's filing a terminal disclaimer provided a "strong clue" that these claims were not patentably distinct.

Judge Newman dissented.  In her opinion, the factors surrounding the District Court's grant of the PI (that "Dr. Reddy's Laboratories[] could readily be made whole by monetary payment if the injunction was imposed in error," that "Indivior could not recover its reputation and market share if the injunction was erroneously denied," and that Indivior had posted a $72 million bond protecting Dr. Reddy's from any adverse monetary consequences) were sufficient for the Court not to disturb the District Court's determination.  Judge Newman's opinion is based on the equitable nature of grant of a preliminary injunction, which requires appellate review on the propriety of a District Court's equitable discretion.  Here, Judge Newman chided her brethren for focusing on the substantive merits of Indivior's patent infringement allegations, supported by a decision of a different district court, "on a different patent with different claims" (and that is on appeal to the Federal Circuit), rather than on the equitable considerations in the case.

Judge Newman was also not persuaded on the question of whether there was specification disclaimer.  In her view, the majority improperly imported a process limitation into a claim for a formulation:

My colleagues select the drying method claimed in a different patent (the '514 parent patent) and place that limitation in the claims of the '305 patent, although the patentee expressly amended the '305 claims to remove the drying method.  My colleagues give the amended '305 claims identical scope to the claims of the '514 patent, the patent previously litigated in Delaware.  My colleagues then conclude that the '305 claims would have the same infringement position as the '514 claims were found to have in Delaware.  This is improper.  It is improper for a court to rewrite a product claim to contain a process limitation from the specification—here contained in a preferred but not sole embodiment—for it confounds the roles of the specification and the claims.  See Raytheon, 724 F.2d at 957.  "[I]f we once begin to include elements not mentioned in the claim, in order to limit such claim . . . , we should never know where to stop."  Phillips, 415 F.3d at 1312 (omission in original) (quoting McCarty v. Lehigh Valley R.R. Co., 160 U.S. 110, 116 (1895)) [citation to the record omitted].

Judge Newman saw nothing improper in the amendments to the claims that ultimately granted as the '305 patent, replacing "dried" and "drying" with "continuously" and "continuously cast."  To her, these amendments broadened the scope of the claim so as not to be limited to any particular film-casting (or drying) method.

Finally, Judge Newman disagreed with the majority on the issue of claim preclusion.  Citing precedent, she contended that it is improper to infer an admission from an applicant filing a terminal disclaimer; see, Ventana Medical Systems, Inc. v. Biogenex Laboratories, Inc., 473 F.3d 1173, 1184 n.4 (Fed. Cir. 2006).  Moreover, the status of the Delaware District Court's decision (being on appeal), raises the specter of the Court deciding Indivior's suit should be dismissed on issue preclusion grounds over a decision that might itself be overturned, citing Butler v. Eaton, 141 U.S. 240, 242–44 (1891), Levi Strauss & Co. v. Abercrombie & Fitch Trading Co., 719 F.3d 1367, 1372 (Fed. Cir. 2013), and 18A Charles A. Wright, et al., Federal Practice and Procedure § 4433 (2d ed. 2002).

Finally, Judge Newman objected to the majority's refusal to consider the District Court's reasoning on the other equitable factors involved in a preliminary injunction determination:

It is well settled that the granting of a temporary injunction, pending final hearing, is within the sound discretion of the trial court; and that, upon appeal, an order granting such an injunction will not be disturbed unless contrary to some rule of equity, or the result of improvident exercise of judicial discretion [citing Deckert v. Independence Shares Corp., 311 U.S. 282, 290 (1940)].

Indivior Inc. v. Dr. Reddy's Laboratories, S.A. (Fed. Cir. 2018)
Nonprecedential disposition
Panel: Circuit Judges Newman, Lourie, and Stoll
Opinion by Circuit Judge Stoll; dissenting opinion by Circuit Judge Newman

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2018)

By Kevin E. Noonan --

A certain amount of comment has recently been evinced from the patent bar by the voicing from several members of the Federal Circuit, including the Chief Judge, of their dismay over the number of patent cases coming to the Court.  In particular, this increase in the patent case census in Court is due in not some small degree to the number of cases arising from decisions by the Patent Trial and Appeal Board (PTAB) that the Court is tasked with reviewing regarding the validity vel non of patents from the various post-grant review proceedings (the largest number of which arise from inter partes reviews, IPRs).  Perhaps in reaction to its dismay, the Court in several cases has remanded PTAB decisions based on failure of the Board to properly support their decisions to be amenable to appellate review; see, for example, Securus Tech v. Global Tel*Link (Fed. Cir. 2017) (IPR2014-01278) (Pat. No. 7,860,222); Ultratec v. CaptionCall and Matal (Fed. Cir. 2017).  This basis for eschewing review has been much more rare in district court appeals but arose last week in the Court's decision in Tris Pharma Inc. v. Actavis Laboratories FL, Inc.

The case arose in ANDA litigation regarding Quillivant XR^®, an extended release methylphenidate (MPH) formulation for the treatment of Attention Deficit Hyperactive Disorder (ADHD).  The District Court found the asserted claims of U.S. Patent Nos. 8,465,765 ('765 patent), 8,563,033 ('033 patent), 8,778,390 ('390 patent), 8,956,649 ('649 patent), and 9,040,083 ('083 patent) were invalid as being obvious under 35 U.S.C. § 103.  As explained in the opinion, MPH is a widely used psychostimulant that has been used for treating ADHD since the 1950's.  Both immediate-release (IR) and extended-release (ER) formulations of the drug were also known in the art, and sustained-release (SR) formulations were developed more recently to overcome drawbacks of both IR and ER formulations.  Unfortunately, prior art SR formulations were disadvantageous for having slow onset action properties.  The claimed invention was a combination formulation comprising an IR component and an SR component that showed "a 45-minute therapeutic onset and 12 hours of therapeutic effect."

Asserted claim 6 (dependent on claim 1) was at issue in the litigation and is representative:

1.  A methylphenidate aqueous extended release oral suspension comprising (1) an immediate release methylphenidate component, (2) a sustained release methylphenidate component comprising a water-insoluble, water-permeable, pH-independent, barrier coated methylphenidate-ion exchange resin complex, and (3) water, wherein said suspension has a pH of about 3.5 to about 5 and said suspension provides a single mean average plasma concentration peak for methylphenidate and a therapeutically effective plasma profile for methylphenidate for about 12 hours.

6.  The suspension according to claim 1, wherein the suspension has a pharmacokinetic profile in which the single mean plasma concentration peak for d-methylphenidate has an area under the curve (AUC)_0-∞ of about 114 ng-hr/mL to about 180 ng-hr/mL, C_max of about 11 ng/mL to about 17 ng/mL, T_max of about 4 hours to about 5.25 hours and T_1/2 of about 5 hours to about 7 hours following a single oral administration of an aqueous suspension at a dose equivalent to 60 mg racemic methylphenidate HCl in adults.

The prior art considered by the District Court included several commercially available, extended-release MPH formulations (Concerta^®, Daytrana^®, Focalin XR^®, Metadate CD^®, and Ritalin LA^®), U.S. Patent Application Publication No. 2010/0260844, and certain scientific publications.  The commercial products all exhibited various pharmacokinetic and pharmacodynamics properties regarding a single or multiple PK peak profile, initial onset time and total duration.  The '844 patent publication disclosed "a formulation of MPH that provides a rapid onset of action within 1 to 1.5 hours, a single T_max of 5.5 to 7.5 hours, and a therapeutic duration of about 12 to 14 hours."  Actavis relied on the '844 application in combination with Concerta^®, Daytrana^®, and Metadate CD^® as teaching "a single mean peak PK profile, exhibiting an early onset of action, and exhibiting an extended duration of effect" that would have suggested to the skilled worker the early onset and extended duration formulation in the asserted claims.  Tris Pharma argued to the contrary that the prior at taught combinations of IR and ER MPH formulations that resulted in a bimodal PK profile.  This feature of combined IR and ER MPH formulations was designed to "mimic the peaks and valleys of multiple immediate release dosing regimens" which was not a feature of the claimed invention.  In addition, the commercially available formulations showed a later T_max that was important to achieve the longer duration.

The District Court disagreed (too cryptically, according to the Court's opinion) stating that "'[w]hile [it] believe[d] Tris'[s] evidence regarding the second generation products [wa]s persuasive, it [wa]s not dispositive on the obviousness inquiry.'"  The District Court also found that the '844 application taught "an oral form of MPH with a long duration of action, rapid onset, and a single mean peak PK profile" and thus the skilled worker would have been motivated to produce the claimed formulations despite these formulations in the application had not in fact been made.  The opinion also notes that the District Court relied on Actavis's expert's testimony regarding how a skilled worker would have interpreted the cited art and the meaning of specific terms and relationships between the features recited in the claims.  Finally, the District Court rejected Tris Pharma's assertion of unexpected results, long-felt need, commercial success, and copying.  The Court's opinion did not find that Tris Pharma had performed the requisite comparison experiments to show the results were unexpected, and that the existence of some of the commercially available formulations (specifically, Concerta^®, Metadate CD^®, and Ritalin LA^®) rebutted long-felt need based on Tris Pharma's own expert testimony.  The District Court also found only modest commercial success and that evidence of copying was "not compelling."  This appeal followed.

The Federal Circuit vacated the District Court's decision and remanded, in an opinion by Judge Chen, joined by Judges Newman and O'Malley.  The opinion is based on Fed. R. Civ. P. 52(a)(1), which stated that "[i]n an action tried on the facts without a jury or with an advisory jury, the court must find the facts specially and state its conclusions of law separately."  Citing Gechter v. Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997), the opinion notes that "[w]hen the opinion explaining the decision lacks adequate fact-findings, meaningful review is not possible, frustrating the very purpose of appellate review as well as this court's compliance with its statutory mandate."  And fact finding is adequate only when "they are sufficiently comprehensive and pertinent to the issue to form a basis for the decision," citing Medtronic, Inc. v. Daig Corp., 789 F.2d 903, 906 (Fed. Cir. 1986) (quoting Loctite Corp. v. Ultraseal Ltd., 781 F.2d 861, 873 (Fed. Cir. 1985)).  These considerations are important in this case because the paucity of the District Court's fact-finding made it impossible for the panel to properly assess the correctness of its legal conclusion of obviousness.  Specifically, the panel found it incapable of evaluating Tris Pharma's three arguments on appeal.  First, "that a skilled artisan would not have reasonably expected to successfully combine the claimed single mean peak PK profile with the claimed 45-minute onset of action and 12-hour duration of effect (PD characteristics) because the PK-PD relationship was unknown."  Second, "that the district court failed to address why the combination of an early T_max and a 12-hour duration of effect would have been obvious."  Third, that "the district court mistakenly disregarded Tris's evidence of unexpected results based on a belief that Tris's experts did not compare the claimed invention to the closest prior art."  The panel opinion summarizes these deficiencies as follows:

[T]he district court failed to make the necessary factual findings and provide sufficient analysis of the parties' arguments to permit effective appellate review.  Specifically, the district court's opinion merely recites the parties' arguments but fails to explain or identify which arguments it credits or rejects.  We thus cannot reach the merits of whether the Quillivant XR^® formulation would have been obvious over the prior art.  Rather, we identify gaps in the district court's opinion and remand for the district court to conduct further fact-findings and detailed analysis consistent with this opinion.

For example, regarding the obviousness of producing an MPH formulation having the characteristics of a single mean peak profile, 45-minute onset, and 12-hour duration, the Federal Circuit found that the District Court's opinion was devoid of adequate fact finding to support the conclusion that formulations having these properties would have been obvious.  For example, although the District Court found that the prior art would provide the skilled worker with an expectation that "a single mean peak PK profile could provide for rapid onset of action and extended duration of effect" it "never articulated which prior art references do so and how."  Even when asserting the factual bases for its opinion, the panel stated that "it is unclear if these statements amount to actual fact-findings as opposed to a mere recounting of Actavis's arguments."  The panel also found "holes" in the District Court's opinion, for example, "the district court never made explicit findings that Daytrana^®, Concerta^®, Metadate CD^®, and/or the '844 application] also teach a 45-minute onset of action or 12-hour duration of effect."  The panel opinion also characterized certain portions of the District Court's opinion as being "vague" and "imprecise[]" regarding "central, disputes issues on appeal."

The Court's opinion also criticized the District Court for not addressing "why a skilled artisan would have been motivated to use a single mean peak PK profile to achieve a formulation with a 45-minute onset of action and/or a 12- hour duration of effect with a reasonable expectation of success," particularly with regard to arguments both parties made on appeal.  And:

Without the requisite factual findings and adequate explanation for such findings, we cannot affirm the district court's conclusion that a formulation with (1) a single mean peak PK profile, (2) 45-minute onset of action, and (3) 12-hour duration of effect would have been obvious over the prior art.  We thus vacate those portions of the district court's opinion and remand those issues to the district court for specific factual findings [citations omitted].

The Federal Circuit found similar deficiencies in the District Court's opinion regarding issues related to the relationship between "early T_max and [the] 12-hour duration of effect."  The District Court's opinion on these elements was "very cursory," according to the Federal Circuit, and "[t]he entirety of the district court's discussion of T_max appears amounts to a mere recitation of Actavis's experts' testimony regarding how (1) T_max does not control the onset or duration of effect and (2) T_max ranges in the prior art formulations overlap with the claimed T_max range of 3.6 to 5.78 hours (factoring in the district court's construction of "about")."

Turning to the District Court's treatment of the objective indicia of non-obviousness, the Federal Circuit agreed with Tris Pharma that the District Court did not compare the properties of Tris Pharma's claimed invention with the prior art with regard to whether the invention showed unexpected results.  Regarding long-felt but unmet need the Federal Circuit criticized the District Court for finding prior art products each having properties of "(1) a liquid MPH product that does not require swallowing a tablet; (2) a 45-minute onset of action; and (3) 12-hour duration of effect" but did not find a product having all three of these properties.

Based on all these deficiencies the Federal Circuit remanded to the District Court for "further fact-finding."  Whether an increased frequency of these types of decisions based on Rule 52(a) in appeals from District Court opinions by a beleaguered Federal Circuit remains to be seen.

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2018)
Nonprecedential disposition
Panel: Circuit Judges Newman, O'Malley, and Chen
Opinion by Circuit Judge Chen

How to Draft Patent Claims for Machine Learning Inventions

By Michael Borella --

Introduction

It seems like everyone is talking about artificial intelligence, especially the subset thereof referred to as machine learning.  While some of the discussion is cast in terms of politically-stirred angst about human jobs being replaced by robots or algorithms, a more informed and rational dialog would also set forth machine learning as a platform for the next great breakthroughs in science, technology, medicine, and lifestyle.  Regardless of rhetorical positioning, machine learning represents a fundamental shift in how problems are solved across industries and lines of business.  In the near future, a machine learning library may become a standard part of all computers, just like networking and database technologies have in the past.

For the majority of the existence of computers, programmers wrote functions that were designed to take some input and produce a desired output.  Machine learning inverts this paradigm.  A data set (which in practice usually needs to be quite extensive) of mappings between inputs and their respective desired outputs is obtained.  This data set is fed into a machine learning algorithm (e.g., a neural network, decision tree, support vector machine, etc.) which trains a model to "learn" a function that produces the mappings with a reasonably high accuracy.  In other words, if you give the computer a large enough set of inputs and outputs, it finds the function for you.  And this function may even be able to produce the correct output for input that it has not seen during training.  The programmer (who has now earned the snazzy title of "data scientist") prepares the mappings, selects and tunes the machine learning algorithm, and evaluates the resulting model's performance.  Once the model is sufficiently accurate on test data, it can be deployed for production use.

Such models are already in use today -- they suggest what products you might want to purchase, and movies and music that you might find interesting.  They also silently improve the quality of photos taken from your digital camera, help security screeners at airports and sports stadiums, detect financial fraud, and improve your online search results.  And the real-world applicability of machine learning has yet to peak.

Naturally, innovators in machine learning, like innovators in any other industry sector, seek to protect their work with patents.  Indeed, the number of patent application filings related to artificial intelligence and machine learning has been growing dramatically in the past several years, especially in the U.S.  Nonetheless, inventors, applicants, and even patent attorneys have often struggled to adopt a claiming strategy for inventions incorporating machine learning.

Not surprisingly, the strategy to be taken when drafting such claims depends on the character of the invention and how machine learning is incorporated therein.  Thus, there is no one particular "silver bullet" approach.  Use of just a small number of guidelines, however, can help you focus your claim drafting approach in a direction that may bear the most fruit for your clients.

In short, these guidelines involve looking to several areas where innovation is most likely to occur in machine learning inventions:  (i) the structure of the model, (ii) the training process, (iii) input data preparation, (iv) input data mapping to the model, and (v) post-processing and interpretation of output data from the model.  Along with these five "positive" rules are two "negative" rules of what not to do:  (i) do not mix the training phase and the execution phase in the same claim, and (ii) be careful with inventions that are no more than just conventionally applying an existing model to existing data.

Each will be addressed in turn.  But throughout this discussion, it is important to remember that details matter.  Like claims to most inventions, claims to a machine learning process must specify enough detail for the reviewer (e.g., patent examiner or judge) to be able to determine that the invention as claimed is substantial enough for patenting.  High-level or vague claims are unlikely to meet the requirements of novelty and non-obviousness, much less subject-matter eligibility.

Claim the structure of the model

When the invention involves a new or unusual model structure, this aspect may be a candidate for claiming.  For example, is a neural network with a particular pattern of layers or number of neurons per layer key to providing a desirable result?  Or are multiple neural networks used in parallel or tandem?  Taking this point one step further, the best known solutions for some problems involve ensembles of two or more models.  If your problem is well-addressed by an ensemble, and the structure of the ensemble is new, that might be the starting point of a claim.

Claim the training process

Especially when an unconventional model is used, the training of this model may be unconventional as well.  This provides another avenue for claiming.  For instance, are parts of the model trained with specific subsets of the input data?  Or is the model trained in phases?  Does the training employ a clever form of parallel processing in order to reduce training time?  Regardless, if the execution of the trained model (i.e., its application to input data) is carried out in an orthodox manner, the training might be more easily protected and should be carefully considered.  On the other hand, detecting an infringing training phase might be difficult once the training is complete and the model is commercially deployed.

Claim the input data preparation

Data scientists spend a surprising amount of time preparing their data for introduction to a model.  Real-world data is messy and often needs to be normalized, transformed, have outliers removed, or otherwise processed so that its characteristics can help the model produce quality results.  Often, this is a trial-and-error procedure, with the data scientist attempting several approaches before finding one that is satisfactory.  For instance, some natural language processing models might be utilize word counts, but common words such as "and", "the", "it", and so on may be removed from these counts in order to force the model to focus of the words with a contextual meaning closer to that of the problem being addressed.

Claim the input mapping to the model

Once you have chosen your model and prepared your data, you have to map the input data to the model's input.  This is frequently an inherent process, as the model and input data preparation are selected to work together.  Nonetheless, this mapping can be of interest.  For example, a neural network that classifies sections of black and white images might have 64 inputs, one for each pixel in an 8x8 patch of an image.  The individual inputs may be numbers representing the intensity (brightness) of the respective pixels.  To the extent that such a mapping is innovative, it is fodder for a claim.

Claim the post-processing and interpretation of the output data

Just because a model provides a result, even a desirable result, that does not mean that the overall machine learning pipeline is over.  In some cases, the raw output of a model has to be transformed, normalized, or run through another algorithm to provide useful output data.  In other cases, and as hinted at above, the output of one model may be used (with or without intermediate processing) as input to another model.  For certain classes of models, part of the model itself is the output -- perhaps a particular layer of a neural network that encodes a semantic meaning of the input.

Do not mix the training phase and the execution phase in the same claim

A machine learning model is first trained and then deployed for production use.  Thus, it is likely that the entity performing the training and the entity executing the model are different.  Accordingly, combining steps or elements directed to both training and execution in a claim can result in divided infringement of the claim by these entities.  Instead, draft separate independent claims for the training and execution phases.  In cases where the execution phase does not seem to have enough substance to stand alone, the details of the training phase can be provided in passive clauses (e.g., "wherein the model was trained by comparing random pixel inputs to ground-truth image classifications . . .").

Don't claim conventionally applying an existing model to existing data

As with any type of technology, some solutions are less patentable than others.  If the invention at hand applies an off-the-shelf model to a known data set in a non-specific manner, and none of the above "positive" rules are pertinent, then the machine learning aspects might not be where to focus your claiming efforts.  While machine learning is new, the general concept of applying any generic model to a data set is likely to be considered obvious, at least.  Instead, look to other aspects of the invention for protectable innovation.

Conclusion

While machine learning will almost certainly remain an active area of patenting in the coming years, the path to obtaining meaningful protection for machine learning inventions is scattered with pitfalls.  While the above guidelines are not exhaustive, following them will avoid most of the elementary traps.

And finally, a note to patent agents and attorneys attempting to break into machine learning -- do your homework.  Do not treat machine learning as a black box technique that can be added to claims as an afterthought.  Instead, educate yourself in how and why machine learning works.  Read papers and books, watch videos, take a course, do some programming -- use whatever means are available.  Doing so will dramatically enhance your ability to draft meaningful claims (and other parts of patent applications) that employ these technologies.

Conference & CLE Calendar

November 27, 2018 - "Patent Claim and Specification Drafting and Prosecution -- Avoiding Traps That Lead to Royalty Free Licensing of Patented Technology" (Strafford) - 1:00 to 2:30 pm (EST)

November 28, 2018 - "Ch-Ch-Changes: Updates to the PTAB's Patent Trial Practice Guide for AIA Proceedings" (Federal Circuit Bar Association PTAB/TTAB Committee) - 3:00 pm to 4:00 pm (EST)

November 29, 2018 - "Privity at the PTAB since RPX" (Intellectual Property Owners Association) - 2:00 to 3:00 pm (ET)

December 3, 2018 - "Phillips Construction in PTAB Trials: Strategies for Petitioners and Patent Owners" (Federal Circuit Bar Association PTAB/TTAB Committee) - 3:00 pm to 4:00 pm (EST)

December 4, 2018 - "Conflicts in Patent Prosecution: Avoiding the Ethical Pitfalls -- Minimizing Risks of Malpractice Liability and Ethics Sanctions" (Strafford) - 1:00 to 2:30 pm (EST)

December 4, 2018 - Post-argument discussion on Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. (American University Washington College of Law Program on Information Justice & Intellectual Property) - 4:00 pm (Eastern), Washington, DC

December 6, 2018 - "Apportioning Patent Damages: Analysis, Calculations for Multi-Component Products, Impact of Claim Scope -- Implications of Apportionment for Patent Drafting, Licensing and Enforcement" (Strafford) - 1:00 to 2:30 pm (EST).

December 11, 2018 - "Patent Eligibility Post-Alice: Navigating the Nuances, Guidance From the Federal Circuit, the PTAB, and the USPTO" (Strafford) - 1:00 to 2:30 pm (EST)

IPO Webinar on Privity at the PTAB

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Privity at the PTAB since RPX" on November 29, 2018 from 2:00 to 3:00 pm (ET).  Gasper LaRosa of Jones Day, Brian Murphy of Haug Partners LLP, and Dorothy Whelan, Fish & Richardson, PC will analyze the case law, and the resulting changes in PTAB practice, since the Federal Circuit's decision in Applications in Internet Time (AIT) v. RPX, which found that the PTAB took an "impermissibly shallow" look at evidence presented by the patent owner about the relationship between the petitioner and another party.  The panel will analyze and discuss:

• The eventual boundaries of the "clear beneficiary" test for determining real-parties-in-interest, including whether joint defense groups will be impacted;
• The PTAB's new approach to granting discovery before institution, and how this offers patent owners a not-to-be-missed opportunity; and
• The PTAB's recent flexibility in sometimes allowing a petitioner to choose between naming additional RPIs to win institution or risking non-institution by contesting the need to do so.

The registration fee for the webinar is $135 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

Webinar on Conflicts in Patent Prosecution

Strafford will be offering a webinar entitled "Conflicts in Patent Prosecution: Avoiding the Ethical Pitfalls -- Minimizing Risks of Malpractice Liability and Ethics Sanctions" on December 4, 2018 from 1:00 to 2:30 pm (EST).  David C. Hricik of Taylor English Duma, Amy E. Richardson of Harris Wiltshire & Grannis, and Sandra P. Thompson of Finlayson Toffer Roosevelt & Lilly will guide IP counsel on the conflicts issues that often arise in patent prosecutions, and will outline best practices to identify and address the risks—and to minimize conflicts that can lead to malpractice liability and ethical violations.  The webinar will review the following issues:

• 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?

The registration fee for the webcast is $297.  Those interested in registering for the webinar, can do so here.

Washington College of Law Post-Argument Discussion of Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.

As part of its ongoing Supreme Court series, the American University Washington College of Law Program on Information Justice & Intellectual Property will be hosting a post-argument discussion on the Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. case beginning at 4:00 pm (Eastern) on December 4, 2018 at the American University Washington College of Law in Washington, DC.

Additional information about the post-argument discussion, including registration/CLE information, can be found here.

Webinar on Apportioning Patent Damages

Strafford will be offering a webinar entitled "Apportioning Patent Damages: Analysis, Calculations for Multi-Component Products, Impact of Claim Scope -- Implications of Apportionment for Patent Drafting, Licensing and Enforcement" on December 6, 2018 from 1:00 to 2:30 pm (EST).  Timothy P. McAnulty and Jeffrey C. Totten of Finnegan Henderson Farabow Garrett & Dunner will guide patent counsel on apportionment of patent damages, review how the courts have treated the issue of damages apportionment, discuss the damages analysis as well as calculating damages for multi-component products, and also consider how apportionment is affected by claim scope and the impact on patent drafting, licensing and enforcement.  The webinar will review the following issues:

• How does the claim scope impact apportionment?
• How can counsel draft patent claims to maximize the value of the invention?
• What litigation strategies can companies and their counsel employ to improve their damages analysis?

The registration fee for the webcast is $297.  Those interested in registering for the webinar, can do so here.

Webinar on Patent Eligibility Post-Alice

Strafford will be offering a webinar entitled "Patent Eligibility Post-Alice: Navigating the Nuances, Guidance From the Federal Circuit, the PTAB, and the USPTO" on December 11, 2018 from 1:00 to 2:30 pm (EST).  Michael L. Kiklis of Bass Berry & Sims and Stephen G. Kunin of Maier & Maier will examine recent decisions applying the Supreme Court's decision in Alice Corp. v. CLS Bank on patent eligibility, and discuss the guidance from these opinions and offer best practices for addressing patent eligibility issues.  The webinar will review the following issues:

• How are the courts applying the framework for patent eligibility created in Alice Corp.?
• How can patent litigation defendants take advantage of the guidance for §101 challenges?
• What are best practices for patent counsel to demonstrate patent eligibility?
• How can patent counsel address subject eligibility rejections made by patent examiners?

The registration fee for the webcast is $297.  Those interested in registering for the webinar, can do so here.

Happy Thanksgiving from Patent Docs

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 23rd.

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 23rd.

Acceleration Bay, LLC v. Activision Blizzard Inc. (Fed. Cir. 2018)

What is a Printed Publication for Prior Art Purposes?

By Joseph Herndon --

Patent owner Acceleration Bay, LLC ("Acceleration") appealed the final written decisions of the Patent Trial and Appeal Board holding unpatentable claims of U.S. Patent Nos. 6,829,634; 6,701,344; and 6,714,966.  Activision Blizzard, Inc., Electronic Arts Inc., Take-Two Interactive Software, Inc., 2k Sports, Inc., and Rockstar Games, Inc. (collectively, "Blizzard") cross-appealed portions of the Board's decisions holding that the Lin article is not a printed publication under 35 U.S.C. § 102(a), among other issues.

Here, we look at the determination of features in a "preamble" as being limitations of the claim, as well as, requirements of an article being considered a printed publication for prior art purposes.

The patents at issue are directed to a broadcast technique in which a broadcast channel overlays a point-to-point communications network.  The communications network consists of a graph of point-to-point connections between host computers or "nodes," through which the broadcast channel is implemented.

Blizzard filed six inter partes review ("IPR") petitions—two for each of the '344, '966, and '634 patents—based principally on two different prior art references:  one set of IPRs challenged claims based on the Shoubridge article alone or combined with a prior art book Direct-Play ("Shoubridge IPRs"), and another set of IPRs challenged claims based on the Lin article alone or combined with DirectPlay ("Lin IPRs").

The Board instituted an IPR on each petition, on many of the grounds and claims raised, and rendered six final decisions.  In the Shoubridge IPRs, the Board determined many claims to be unpatentable, and in the Lin IPRs, the Board concluded that Lin is not a printed publication under 35 U.S.C. § 102(a) and thus determined Blizzard failed to show the challenged claims are unpatentable over Lin.

Shoubridge IPRs

Acceleration appealed portions of the Board's decisions in the Shoubridge IPRs.  Claim 1 of the '966 patent is representative of the claim construction disputes in Acceleration's appeal (emphases added):

1.  A computer network for providing an information delivery service for a plurality of participants, each participant having connections to at least three neighbor participants, wherein an originating participant sends data to the other participants by sending the data through each of its connections to its neighbor participants and wherein each participant sends data that it receives from a neighbor participant to its other neighbor participants, further wherein the network is m-regular, where m is the exact number of neighbor participants of each participant and further wherein the number of participants is at least two greater than m thus resulting in a non-complete graph.

Claim 1 of the '344 patent is very similar and begins "1. A computer network for providing a game environment for a plurality of participants, ...".

Acceleration argued that the terms "game environment" and "information delivery service," appearing in the '344 and '966 patents, respectively, should have been given patentable weight despite appearing in the preambles because they provide structure for the remainder of the claims.  Acceleration alternatively argues that these terms appear in the body of the claims because there is no transition phrase denoting a preamble.

Regarding the latter argument, the Federal Circuit responded that Acceleration's poor claim drafting will not be an excuse for it to infuse confusion into its claim scope, and simply concluded that "game environment" and "information delivery service" are part of the preamble of the claims.

The Federal Circuit noted that there is no beneficial purpose to be served by failing to include a transition word in a claim to clearly delineate the claim's preamble from the body, and it "caution[ed] patentees against doing so."

Then, because the terms at issue appear in preambles, it must be determined whether the terms are limitations.  General case law indicates that a preamble limits the invention if it recites essential structure or steps, or is necessary to give life, meaning, and vitality to the claim.

The Federal Circuit agreed with the Board that the claim terms "game environment" and "information delivery service" are non-limiting because they merely describe intended uses for what is otherwise a structurally complete invention.  They do not impart any structure into or serve as antecedents for the claims at issue.  Instead, they simply provide an intended use for what is otherwise a claim for a network.

Lin IPRs

Blizzard cross-appealed many portions of the Board's decisions in the Lin IPRs, and here we only discuss the issue of whether Lin is a printed publication under § 102(a).

Whether a reference qualifies as a printed publication under § 102 is a legal conclusion based on underlying fact findings.  One such fact question is public accessibility.  Because there are many ways in which a reference may be disseminated to the interested public, public accessibility has been called the touchstone in determining whether a reference constitutes a printed publication.

Case law has indicated that a reference is considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.

The Board found that Lin was not publicly accessible before the critical date.

Based on the testimony of Glenn Little, a Systems Administrator at the Computer Science and Engineering ("CSE") department of the University of California, San Diego ("UCSD"), the Board found that Lin had been uploaded to the CSE Technical Reports Library's website as of November 23, 1999, which is not challenged on appeal.  As the Board explained, according to Mr. Little, "the CSE department regularly maintains electronic technical reports and records concerning those reports, and a staff member assigns a unique identifier to each report based on the year it was uploaded and the relative order it was uploaded in comparison to other papers."

The Board then noted that public accessibility requires more than technical accessibility.  Because there was no evidence that Lin was disseminated to the public, the Board focused on whether an interested skilled artisan, using reasonable diligence, would have found Lin on the CSE Technical Reports Library website.  The Board found that despite some indexing and search functionality on the website, Lin was not publicly accessible.  It found the website allowed a user to view a list of technical reports indexed only by author or year and that there was no evidence as to how many reports were in the Library's database in 1999.  The Board determined that at best, Blizzard's evidence suggests that an artisan might have located Lin by skimming through potentially hundreds of titles in the same year, with most containing unrelated subject matter, or by viewing all titles in the database listed by author, when the authors were not particularly well known.  The Board also found the website's advanced search form to be deficient.  It found that while the advanced search form appeared to allow a user to search keywords for author, title, and abstract fields, evidence demonstrated that functionality was not reliable.  In sum, the Board determined that Blizzard had not shown sufficiently that the UCSD CSE Technical Reports Library was searchable or indexed in a meaningful way so that a person of ordinary skill in the art would have located Lin.  The Board, therefore, concluded Lin is not a printed publication under § 102(a).

The Federal Circuit found no error in the Board's reasoning.  Namely, the Federal Circuit found that substantial evidence supports the Board's findings that Lin was not publicly accessible, including that Lin was not indexed in a meaningful way and that the website's advanced search form was deficient.  Mr. Little testified he does not know how the search works or how keywords are generated, that he never searched for Lin using the advanced search form, and that it was not the CSE department's practice to verify the advanced search capability for title and abstract when a new article was uploaded.  Mr. Little also admitted it was possible the search function did not work.

Acceleration also presented evidence that a recent advanced search for keywords in the title and abstract of Lin failed to produce any results.

Blizzard argued these results are unauthenticated hearsay and are based on searches conducted years after the critical date, but Mr. Little testified that as to the website, "[i]t's pretty much the same, actually, between [1999] and now.  We're running the same software."  The Federal Circuit found no reason to discount the Board's weighing of the evidence.  Substantial evidence was thus found to support the Board's finding that there was insufficient evidence of record to support a finding that a person of ordinary skill in the art in 1999 could have located Lin using the CSE Library website's search function.

The Federal Circuit thus distinguished a similar case:  In re Lister, 583 F.3d 1307 (Fed. Cir. 2009).  In Lister, a reasonably diligent researcher with access to a database that permits the searching of titles by keyword would be able to attempt several searches using a variety of keyword combinations, and thus, the manuscript at issue was publicly accessible as of the date it was included in databases that permitted keyword searching of titles.

The Federal Circuit noted that unlike in Lister, here the record supports the Board's finding that the CSE Library website's advanced search function did not successfully permit keyword searching of titles, a key feature in Lister.  The Board's fact finding that, with available reports indexed only by author or year, Lin was not meaningfully indexed, was found to be supported by substantial evidence.

Blizzard argued that because Lin was indexed by title for a given year, author name, and unique sequence number, that was sufficient for public accessibility.  But, the Federal Circuit stated that the test for public accessibility is not "has the reference been indexed?"  Where indexing is concerned, whether online or in tangible media, the ultimate question has been whether the reference was available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.

Here, the Board found that although Lin was indexed by author and year, it was not meaningfully indexed such that an interested artisan exercising reasonable diligence would have found it, which is a proper consideration under the Federal Circuit precedent.  As such, the Federal Circuit found that Lin was not a printed publication under § 102.

Acceleration Bay, LLC v. Activision Blizzard Inc. (Fed. Cir. 2018)
Panel: Chief Judge Prost and Circuit Judges Moore and Reyna
Opinion by Circuit Judge Moore

FWP IP ApS v. Biogen MA, Inc. (Fed. Cir. 2018)

By Donald Zuhn –-

Last month, in FWP IP ApS v. Biogen MA, Inc., the Federal Circuit affirmed a decision by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board granting Biogen's motion that FWP's U.S. Application No. 11/576,871 did not provide an adequate written description under 35 U.S.C. § 112 for claims directed to a method for treating multiple sclerosis.  The MS treatment at dispute involves administering a specific daily dosage (480 mg) of fumarates, specifically dimethyl fumarate (DMF) and/or monomethyl fumarate (MMF), to a subject.

The appeal arose from an interference proceeding involving the above method for treating multiple sclerosis.  U.S. Patent No. 8,399,514, owned by Biogen, describes and claims such a method.  The '871 application, which was assigned to FWP by original Appellant Forward Pharma A/S after the appeal was docketed, discloses controlled release compositions of fumarates.  In the interference proceeding, Forward argued that the '871 application describes the treatment method in dispute.  Although the Board determined that the '871 application had an earlier priority date than the '514 patent, it granted Biogen's motion that the MS treatment method Forward sought to claim was not supported by an adequate written description.

The '871 application is a U.S. national phase filing of a PCT application that was filed on October 7, 2005, and which claims priority to a Danish patent application filed on October 8, 2004.  The '514 patent claims priority to a U.S. provisional patent application filed on February 8, 2007.  During prosecution of the '871 application, Forward cancelled all pending claims and added claims that closely tracked the claims that issued in the '514 patent.  The Board declared an interference between the '871 application and '514 patent, designating Forward as the senior party with a constructive reduction to practice date of October 8, 2004.

Finding that the focus of the '871 application was on "controlled release fumarate compositions" and that "general teaching of applicability of the fumarates to [the] treatment of a variety of possible disease or conditions and the teaching of a broad range of possible dosages would not have conveyed possession or description of the specific treatment of MS that [Forward] now claims," the Board granted Biogen's motion that the claims of the '871 application were not supported by an adequate written description.  The Board pointed to claim 69 of the '871 application as representative:

69.  A method of treating a subject in need of treatment for multiple sclerosis comprising
    (a) a therapeutically effective amount of dimethyl fumarate and
    (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate is about 480 mg per day.

Looking to claim 69, the Board distilled the claimed treatment method at issue into three limitations: (1) an MS treatment, (2) by oral administration of a therapeutically effective amount of DMF and/or MMF, at (3) a dosage of 480 mg per day.  With respect to the first limitation, the Board determined that the '871 application lists over twenty diseases and conditions, that MS is not identified as a disease or condition of particular interest, and that the application instead focuses on psoriasis and conditions associated with psoriasis.  Regarding the third limitation, the Board determined that while the 480 mg/day dosage is expressly mentioned in the specification, there "is no discussion that would guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day, or any other therapeutically effective dose within the ranges disclosed."

The Board also rejected Forward's arguments based on Snitzer v. Etzel, 465 F.2d 899 (CCPA 1972); Falkner v. Inglis, 448 F.3d 1357 (Fed. Cir. 2006); and Streck, Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269 (Fed. Cir. 2012).  The Board determined that unlike the invention in Snitzer, Forward's case required the selection and combination of claim elements from more than a single limited list, and that unlike Falkner and Streck, the '871 application did not provide the blaze marks necessary to guide a skilled artisan to the claimed invention.  The Board concluded that even though each required claim element is mentioned separately in the '871 application, the specification did not disclose the claimed invention in a manner that adequately describes the claimed MS treatment to a skilled artisan, and therefore, that the claims of the '871 application failed to meet the written description requirement.

On appeal, Forward argued that the interference count was disclosed in an up-scale table in the '871 application, which Forward argued (1) discloses a 480 mg/day dosage, (2) is reasonably directed at using DMF to treat the listed conditions, and (3) is linked to the treatment of MS.  The up-scale table describes scaling up the daily dosage level of fumerates over a nine-week period, with the 480 mg/day dosage occurring during week seven, and is designed to minimize the side-effects of ingesting fumarates by increasing the dose gradually over time to allow the patient to acclimate.  The Federal Circuit, however, stated that it was not persuaded by Forward's argument, and agreed with the Board that "the '871 application does not disclose the now-claimed MS treatment as a unified whole."

With respect to the 480 mg/day dosage, the Federal Circuit noted that this dosage is an interim dosage, and that Forward failed to present persuasive evidence as to why a skilled artisan would have understood the week seven interim dosage to be therapeutically effective.  The Court also noted that Biogen's expert testified that because MS is a chronic disease, a skilled artisan would not have viewed a one week, interim dosage in the middle of a nine week up-scale schedule as an adequate treatment dosage, let alone one for a particular disease such as MS.

In affirming the Board's decision, the Federal Circuit stated that "[g]iven the brief references to MS and the lack of recognition of 480 mg/day as a therapeutically effective daily dosage, we agree with the Board’s finding that there 'is no discussion [in the '871 application] that would guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day. . . .'"  The Court was also unpersuaded by Forward's attempt to use the prior art to supply the link between the therapeutically effective dose of 480 mg/day and MS, noting that "even if we allow Forward to rely on the prior art for establishing a prior, known link between MS and fumarates, the prior art does not teach the key limitation of the count: the 480 mg daily dosage."

The Federal Circuit also rejected Forward's argument that the original claims of the '871 application adequately describe the MS treatment that it was seeking to claim.  According to the Court, "Forward's argument is premised on piecing together elements of several of the claims."  In rejecting this argument, the Court explained that:

Th[e original] claims are mainly directed to controlled release compositions of numerous fumarates and pharmaceutically acceptable salts.  Some claims recited numerous possible dosing schedules (claims 30–32) and dosages (claims 33–38).  And others replicate the laundry list of diseases and conditions enumerated in the specification (claims 44 and 45).  This large number of disease conditions, dosages, dosing schedules, active ingredients, pharmaceutical formulations for controlled release, and combinations thereof covered by the original claims detracts from Forward's argument that it possessed and invented the now-claimed, specific MS treatment.  . . .  Rather, what the scale of the claims demonstrate is that Forward possessed, as of the 2004 critical date, a mere wish for obtaining some type of fumarate formulation to treat any one of a number of diseases and conditions, one of which was MS, using almost any possible daily dosage.

Finding that "the '871 application does not disclose 480 mg of fumarates per day as a therapeutically effective dose for treating MS," the Federal Circuit determined that substantial evidence supported the Board's finding that the MS treatment Forward sought to claim was not supported by an adequate written description under 35 U.S.C. § 112.  The Federal Circuit therefore affirmed the Board's decision.

FWP IP ApS v. Biogen MA, Inc. (Fed. Cir. 2018)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Wallach and Chen
Opinion by Circuit Judge Chen