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<h2>Understanding Your Legal Needs</h2>
Choosing the right legal services is pivotal for achieving successful outcomes in any legal matter. Whether you're dealing with a personal issue, business matter, or any form of litigation, understanding your specific legal needs is the first step. Consider the complexity of your case, the stakes involved, and the area of law that pertains to your situation.

Different legal services specialize in various fields such as family law, corporate law, criminal defense, and more. Identifying the nature of your legal issue will guide you toward the right type of legal professional. Assessing your needs accurately helps in narrowing down your options effectively.

<figure id="figure-jhken9w9j6maarcam8"><img id="jhken9w9j6maarcam8" src="https://media.gettyimages.com/id/1847814092/photo/businessman-and-lawyer-discuss-and-advice-on-contract-documents-legal-treaty-agreement.jpg?b=1&s=2048x2048&w=0&k=20&c=CMuoILnJP6Sk_jTp0j_yrKrlfEzaVusq50j4yRaLyr0=" alt="legal documents" class="object-cover bg-gray-100" style="aspect-ratio: 16/9"></figure>

<h2>Researching Potential Legal Services</h2>
Once you have a clear understanding of your needs, it’s time to start researching potential legal services. Begin by seeking recommendations from friends, family, or colleagues who have dealt with similar issues. Online reviews and testimonials can also provide insight into the experiences of previous clients.

Look into the qualifications and experience of potential lawyers or law firms. A lawyer with a solid track record in cases similar to yours can often provide a strategic advantage. Check if they have any special certifications or memberships in professional associations that might lend credibility to their expertise.

<h3>Evaluating Reputation and Experience</h3>
The reputation of a legal service provider is crucial. Look for any accolades or recognition they may have received within the legal community. Experience also plays a significant role; a seasoned lawyer is often better equipped to handle unexpected challenges that may arise during your case.

<figure id="figure-iss9orwromaarcam8"><img id="iss9orwromaarcam8" src="https://media.gettyimages.com/id/2112766341/photo/lawyer-accepting-bribe-concept-for-signing-legal-contract-approval-rights-of-liberty-bribery.jpg?b=1&s=2048x2048&w=0&k=20&c=v5j8M7fj56KSiA2YWCqiDue3_vlptFSfp0ka7BpSkCM=" alt="lawyer meeting" class="object-cover bg-gray-100" style="aspect-ratio: 16/9"></figure>

<h2>Comparing Costs and Fee Structures</h2>
Legal services can vary significantly in cost, so it’s important to understand their fee structures. Some lawyers charge by the hour, while others may offer flat rates for certain services. Be sure to ask about any additional fees that may apply, such as court costs or expenses for expert witnesses.

During your initial consultations, discuss your budget openly and honestly. A transparent conversation about costs can help prevent misunderstandings later on and ensure that you select a service that fits within your financial constraints.

<h3>Understanding Communication and Availability</h3>
Effective communication is a key component of any client-lawyer relationship. During your initial meetings, pay attention to how promptly the lawyer responds to your inquiries and their willingness to explain complex legal terms in understandable language. This will give you a sense of their commitment to keeping you informed throughout the process.

<figure id="figure-f04tmq6pfcmaarcam8"><img id="f04tmq6pfcmaarcam8" src="https://media.gettyimages.com/id/2162362532/photo/lawyer-legal-counsel-presents-to-the-client-a-signed-contract-with-gavel-and-legal-law.jpg?b=1&s=2048x2048&w=0&k=20&c=caepw47BYJExpUqSfRzk2UAv4d_DgKwGME_4KAoyLUw=" alt="legal consultation" class="object-cover bg-gray-100" style="aspect-ratio: 16/9"></figure>

<h2>Making Your Decision</h2>
After evaluating all these factors, it's time to make your decision. Trust your instincts about which lawyer or firm feels like the best fit for you. Remember, the right legal service will not only have the expertise you need but will also be someone you feel comfortable working with.

Your choice should reflect both your personal comfort level and confidence in their ability to handle your case effectively. With careful consideration and thorough research, you can find a legal service that meets your needs and expectations.

Comparing Legal Services: How to Find the Best Fit for Your Needs

<h2>Understanding Your Legal Needs</h2>
Choosing the right lawyer in the Netherlands is crucial for successfully navigating the legal system. The first step is to clearly understand your specific legal needs. Are you dealing with a family matter, a business dispute, or a criminal case? Each of these areas requires a different kind of expertise. Knowing what you need will guide your search for the right professional.

<figure id="figure-fk7l8ntfnjma6h0mqn"><img id="fk7l8ntfnjma6h0mqn" src="https://media.gettyimages.com/id/1326458117/photo/shot-of-a-young-couple-sharing-a-handshake-with-a-consultant-theyre-meeting-to-discuss.jpg?b=1&s=2048x2048&w=0&k=20&c=99e0LN08322srn9ENIt8uq9o7lFaBzCKlu4uPFi_GRA=" alt="legal consultation" class="object-cover bg-gray-100" style="aspect-ratio: 16/9"></figure>

<h2>Research and Recommendations</h2>
Once you have identified your legal needs, start by gathering information. Seek recommendations from friends, family, or colleagues who have had similar legal issues. Additionally, online reviews and testimonials can provide insights into a lawyer's reputation and track record. Consider reaching out to professional organizations or legal directories in the Netherlands for verified lists of lawyers.

<h2>Qualifications and Experience</h2>
When choosing a lawyer, it is essential to check their qualifications and experience. Look for professionals who have specialized in the area of law relevant to your case. Inquire about their education, years of practice, and specific cases they have handled. An experienced lawyer will not only understand the intricacies of Dutch law but will also be familiar with the local court systems.

<figure id="figure-a73r8rrvrvma6h0mqn"><img id="a73r8rrvrvma6h0mqn" src="https://media.gettyimages.com/id/2102571053/photo/judge-or-legal-advisor-lawyer-examining-and-signing-legal-documents.jpg?b=1&s=2048x2048&w=0&k=20&c=--Il66lv11ynctY0Ks3o6QuBE3K98Rro0w3lJuv1GYM=" alt="lawyer office" class="object-cover bg-gray-100" style="aspect-ratio: 16/9"></figure>

<h2>Communication Skills</h2>
Effective communication is key in any legal matter. Your lawyer should be able to explain complex legal terms in a way that you can understand. During your initial consultation, assess their ability to listen and respond to your questions. A lawyer who communicates well will keep you informed throughout the process and will be more likely to represent your interests effectively.

<h2>Legal Fees and Costs</h2>
Understanding the cost structure is essential when hiring a lawyer. Inquire about their fee arrangements—whether they charge a flat fee, hourly rate, or contingency fee. Request a detailed fee agreement in writing to avoid any unexpected costs later. Remember that while fees are important, they should not be the sole deciding factor. The quality of service should be your priority.

<figure id="figure-xyu3k4ygmkma6h0mqn"><img id="xyu3k4ygmkma6h0mqn" src="https://media.gettyimages.com/id/2166667889/photo/senior-caucasian-multiracial-hispanic-woman-talks-with-colleagues-in-bright-modern-office.jpg?b=1&s=2048x2048&w=0&k=20&c=63bqYEaVpxrHnIqpUBl4iKTf_iu_L5yg4RlVaFwdSV4=" alt="financial planning" class="object-cover bg-gray-100" style="aspect-ratio: 16/9"></figure>

<h2>Initial Consultation</h2>
Most lawyers offer an initial consultation to discuss your case. Use this opportunity to evaluate if they are the right fit for you. Prepare a list of questions regarding your case and observe how attentive and knowledgeable they are during the meeting. This interaction will give you a sense of their dedication and how comfortable you feel working with them.

<h2>Trust and Comfort Level</h2>
Trust your instincts when choosing a lawyer. You need someone you feel comfortable with, as you will be sharing personal and sensitive information with them. A good lawyer-client relationship is built on trust, so ensure that you feel confident in their ability to represent you effectively.

<h2>The Decision-Making Process</h2>
After meeting with several lawyers, compare their qualifications, experience, communication style, and fees. Consider how each lawyer aligns with your requirements and comfort level. Making an informed decision involves balancing all these factors to select the lawyer who will best serve your needs in the Netherlands.

How to Choose the Right Lawyer for Your Needs in the Netherlands

EU Flags in front of European Commission European Union Flags

The first decision in a revocation action by the central division (Munich) has been published on July 16, 2024. Court also answers the questions in the Referral To The Enlarged Board Of Appeal – G 1/24. See the decision <a data-mce-href="https://www.unified-patent-court.org/sites/default/files/files/api_order/7BD3093D60CBD34C06940FCA0C598CEE_en.pdf" href="https://www.unified-patent-court.org/sites/default/files/files/api_order/7BD3093D60CBD34C06940FCA0C598CEE_en.pdf">here</a>.Here are the headnotes:&nbsp;<h3>Interpretation of Patent Claims:</h3>When interpreting a patent claim, a skilled person does not focus on the literal or philological meaning but instead determines the technical meaning of the terms with the help of the description and drawings. The technical function of the individual features, both separately and together, is deduced from their role in the context of the entire patent claim. The patent description can act as a unique dictionary for the patent. <h3>Same Invention under Article 87 EPC:</h3>An invention is considered the "same invention" as referred to in Article 87 EPC (priority right) if a skilled person can derive the subject matter of the claim directly and unambiguously from the prior application, using general knowledge.<h3>Assessment of Inventive Step:</h3>The assessment of the inventive step begins from a realistic starting point within the prior art, and there can be multiple valid starting points. Identifying the "most promising" starting point is not necessary. <h3>Obviousness of Claimed Solution:</h3>A claimed solution is obvious if a skilled person is motivated to consider and implement it as the next step in developing the prior art. It matters whether the skilled person would anticipate particular difficulties in taking these next steps. The mere fact that other solutions are suggested in the prior art or pursued by others does not automatically mean the claimed solution is non-obvious. The key question is whether the claimed solution is indeed non-obvious.<h3>Denial of Inventive Step:</h3>For denying an inventive step, it is sufficient if a skilled person, without making an inventive contribution, would arrive at a result that is covered by a claim. It is not about whether the skilled person would inevitably achieve the same result.<h3>Indication of Inventive Step:</h3>A technical effect or advantage of the claimed subject matter compared to prior art can indicate an inventive step. However, a feature chosen arbitrarily from several options generally does not contribute to an inventive step.

UPC: The First Revocation Decision

The Unified Patent Court (UPC) began its operations on June 1, 2023, and over the past year, the UPC has seen over 134 infringement actions, 39 revocation (invalidity) actions, and 26 requests for provisional measures (preliminary injunctions). Most of these cases have been concentrated in the German local divisions. The UPC distinguishes itself from traditional European and U.S. patent systems through its extensive geographical reach, short procedural timelines, and a higher propensity for issuing preliminary injunctions. We outline key decisions and considerations for those considering obtaining Unitary Patents.&nbsp;Geographical ReachThe UPC serves as a central court system with jurisdiction over both traditional European patents (EPs) not opted out of the UPC and Unitary Patents (UPs) issued by the European Patent Office (EPO) with unitary effect. Currently, the UPC includes <a data-mce-href="https://www.unified-patent-court.org/en/court/locations" href="https://www.unified-patent-court.org/en/court/locations">17 member states</a>, with Romania joining as the 18th member in September. This means a decision from a UPC patent dispute applies to major EU economies allowing patent owners to enforce their patents across these states with a single action.&nbsp;The UPC reach provides economic efficiencies for patent applicants, allowing them to secure protection across multiple UPC member states with a single request filed with the EPO, avoiding the costly and time-consuming process of validating a European patent in each state. This streamlines the administrative process and offers a more cost-effective solution for patent protection in the EU. See <a data-mce-href="https://www.epo.org/en/legal/guide-up/2022/uppg_a_v.html" href="https://www.epo.org/en/legal/guide-up/2022/uppg_a_v.html">EPO Unitary Patent Guide, the benefits of the Unitary Patent</a>.Enforcement at the UPCTraditionally, a European patent under dispute may require litigation in all validated countries, which is expensive and can lead to inconsistent results and legal uncertainty. In contrast, patents under the UPC’s jurisdiction allow patent owners to litigate in one of the UPC’s divisions and obtain a decision applicable in all member states. Additionally, patent challengers can bring revocation actions before the UPC, independent of EPO opposition proceedings, with successful revocations effective across all UPC member states.TimelineUnlike U.S. patent litigation, which can take several years, UPC cases require evidence identification in the complaint, with limited opportunities for additional evidence post-complaint. This front-loaded process enables the UPC to render decisions within a year. Defendants must provide a defense or counterclaim within two to three months, with deadlines generally non-extendable, placing substantial pressure on them.To address the limited opportunity for obtaining additional evidence post-complaint, the UPC authorizes orders to preserve evidence and inspect premises, potentially on an ex parte basis. If the relevant evidence is located in the US, one additional means of collecting evidence may be an action pursuant to 28 U.S.C. §1782 <a data-mce-href="https://www.ibanet.org/article/4E615B10-F115-461A-A6C9-91689F6A5B46" href="https://www.ibanet.org/article/4E615B10-F115-461A-A6C9-91689F6A5B46">(see International Bar Association, how to obtain section 1782 discovery)</a>. Additionally, defendants can request limited additional evidence from plaintiffs or third parties to substantiate their claims.Preliminary InjunctionsThe UPC is more inclined than U.S. courts to grant preliminary injunctions, with less stringent requirements for demonstrating irreparable harm. Applicants need to show a likelihood of patent validity and infringement and timely relief requests. The UPC’s first year indicates a high likelihood of issuing preliminary injunctions where validity and infringement are demonstrated by a preponderance of the evidence, even for non-practicing entities showing economic harm to its licensing program. see <a data-mce-href="chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.unified-patent-court.org/sites/default/files/upc_documents/2023-09-19-ld-munich-upc_cfi_2-2023-act_459746-2023-app_528389-2023-anonymized-english-translation.pdf" href="chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.unified-patent-court.org/sites/default/files/upc_documents/2023-09-19-ld-munich-upc_cfi_2-2023-act_459746-2023-app_528389-2023-anonymized-english-translation.pdf">10x Genomics, Inc. v. NanoString Techs. Inc.</a>. Moreover, the UPC has shown readiness to grant injunctions on an ex parte basis in urgent situations, as seen in the <a data-mce-href="https://www.unified-patent-court.org/sites/default/files/upc_documents/23-06-22-ld-dusseldorf-order-rop212-upc_cfi-177-2023-anonymized-1.pdf" href="https://www.unified-patent-court.org/sites/default/files/upc_documents/23-06-22-ld-dusseldorf-order-rop212-upc_cfi-177-2023-anonymized-1.pdf">myStromer AG v. Revolt Zycling AG</a> decision.Protective Letters&nbsp;Entities anticipating a request for provisional measures can file a protective letter, challenging the applicant’s expected assertions. While this does not eliminate the risk of preliminary injunctions, it may reduce the likelihood of ex parte issuance. However, the effectiveness of a protective letter depends on the strength of the arguments presented. Weak arguments, as seen in the myStromer case, may lead to the issuance of an ex parte injunction.LanguageEnglish is the preferred language of proceedings, making up around 50% of all proceedings. In <a data-mce-href="https://www.unified-patent-court.org/en/node/661" href="https://www.unified-patent-court.org/en/node/661">10x Genomics v. Curio Biosciencethe</a> UPC Court of Appeal clarified the circumstances relevant to switching to the language of the patent; the vast majority of European patents are in English. This may motivate parties to file UPC actions in the language of the patent.Access to PleadingsThird party access to pleadings varies among European national courts, however, in <a data-mce-href="https://www.unified-patent-court.org/en/node/657" href="https://www.unified-patent-court.org/en/node/657">Ocado v AutoStore</a>,&nbsp; the UPC Court of Appeal’s decision provided guidance as to the availability of written evidence and pleadings to the public upon “reasoned request”. The decision clarified that the chances of accessing documents during the course of proceedings are generally slim except when a member of the public has a specific interest instead of a general interest. The chances are increased after the proceedings have come to an end. One example of request to access to the pleadings&nbsp; is for the third party's intended use of the pleading documents in the parallel proceedings such as EPO oppositions.&nbsp;Security for costsThe UPC may grant security for costs where the financial position of one party may give rise to a legitimate and real concern that the costs may not be recoverable. This is more applicable if one party is located outside of the UPC’s jurisdiction, for example UK or US. In <a data-mce-href="https://www.unified-patent-court.org/en/node/459" href="https://www.unified-patent-court.org/en/node/459">NanoString v Harvard</a>, the Court ordered NanoString to provide security for legal costs and other expenses of EUR 300,000, because NanoString was UK-based and that was considered to create an additional burden and uncertainty on the party seeking to enforce the judgment in the UK.&nbsp;Considerations The UPC offers streamlined, cost-effective patent protection and enforcement across multiple EU states, with expedited timelines and a higher likelihood of preliminary injunctions. However, it also presents risks for patent owners. Patents within UPC jurisdiction are subject to single revocation actions, whereas those outside would need separate national challenges. Patent owners can opt out during the UPC’s seven-year transitional period, ending in June 2030. Initially, many patents were opted out, but confidence in the UPC has grown, with fewer opt-outs and some withdrawals of prior opt-outs. Opt-out strategies carry risks, such as precluding re-entry into UPC jurisdiction. Patent owners should ensure alignment among all owners on opt-out decisions to avoid rendering them ineffective. The opinions and recommendations expressed are those of the author and do not reflect the views of Leo Patent Law Office or its clients. This document is for general information purposes only and is not intended to be and should not be taken as legal advice.&nbsp; &nbsp;

One Year into the UPC

Female hand with smartwatch and health application icons nearby. 

We analyzed approximately 377 Patent Trial and Appeal Board (PTAB) appeal decisions from January 01 to June 25, 2024, specifically reviewing examiner’s rejection based on 35 U.S.C. § 112(a) enablement ground.&nbsp;Within this period, we identified one decision pertaining to a wearable device. We provide our analysis and offer recommendations to mitigate the risk of enablement rejection.Enablement Requirement under 35 U.S.C. § 112(a) &nbsp; In U.S. patent law, enablement is a requirement outlined in the Manual of Patent Examining Procedure (MPEP), specifically in MPEP § 2164. It means that a patent application must describe the invention clearly and in enough detail that someone skilled in the relevant field can make and use the invention without needing to do extensive extra work or guesswork, i.e., without undue experimentation.The Wands factors, derived from the case In re Wands, 858 F.2d 731 (Fed. Cir. 1988), are used to determine whether a patent application meets the enablement requirement. These factors include:· &nbsp; &nbsp; &nbsp; The Quantity of Experimentation Needed: How much work is required to practice the invention?· &nbsp; &nbsp; &nbsp; The Amount of Direction or Guidance Provided: Does the patent give clear instructions?· &nbsp; &nbsp; &nbsp; The Presence or Absence of Working Examples: Are there practical examples demonstrating the invention?· &nbsp; &nbsp; &nbsp; The Nature of the Invention: How complex is the invention?· &nbsp; &nbsp; &nbsp; The State of the Prior Art: What is the existing knowledge in the field?· &nbsp; &nbsp; &nbsp; The Relative Skill of Those in the Art: What is the skill level of someone in the relevant field?· &nbsp; &nbsp; &nbsp; The Predictability or Unpredictability of Art: How predictable is the technology area?· &nbsp; &nbsp; &nbsp; The Breadth of the Claims: How broad are the claims in the patent?These factors are considered together to determine if the disclosure in the patent application is sufficient for a person skilled in the art to make and use the invention without undue experimentation.Appeal Decision Appeal No. 2023003339: Wearable Device (March 20, 2024) &nbsp;Background:The case involves patent application No. 15/521,667. The patent application is related to a system designed to calculate the relative contribution of different biochemical energy systems (aerobic, alactic anaerobic, and lactic anaerobic) to an instantaneous physiological load estimate. The system consists of a wearable device that collects data from the user through motion capturing and heart rate sensors, and a server that processes this data to generate the physiological load estimate.While the document does not explicitly mention use of artificial intelligence (AI), the underlying technology could involve AI techniques. The patent application describes the use of models and equations, which in modern contexts often involve AI for improving accuracy and handling complex data patterns. For example, the dynamic heart rate model and the system's ability to estimate physiological load, the processing of motion and heart rate signals to accurately estimate physiological load, signal processing and data analysis algorithms, real-time analysis based on the data collected by the wearable device likely involve AI, particularly machine learning models.&nbsp;The application was rejected by the Examiner under 35 U.S.C. § 112, enablement. Applicants appealed these rejections to the PTAB. The PTAB upheld the rejection of the patent application.Representative Claim:Claim describes a system that combines wearable technology and server-based processing to estimate the contributions of different biochemical energy systems to a user's physiological load during physical activity. Representative claim 25:&nbsp;25. A system for calculating a relative contribution of different biochemical energy systems to an instantaneous physiological load estimate, the system comprising:(a) a wearable device for use by a user to collect data of the user, the wearable device comprising: i. a motion capturing sensor configured to generate a motion signal, wherein the motion capturing sensor comprises an accelerometer; ii. a heart rate sensor configured to generate a heart rate signal, wherein the heart rate sensor comprises an electrocardiogram (ECG) or a photoplethysmography (PPG) sensor; iii. a transmitter; and iv. a display; and(b) a server comprising: i. a transmitter; ii. memory; and iii. a processor,wherein the wearable device transmits the motion signal from the motion capturing sensor and the heart rate signal from the heart rate sensor to the server, wherein the processor is further configured to:· &nbsp; &nbsp; &nbsp; &nbsp;take a measurement of the motion signal from the motion capturing sensor and a measurement of the heart rate signal from the heart rate sensor,· &nbsp; &nbsp; &nbsp; &nbsp;apply a dynamic heart rate model to estimate the physiological load from the measurement of the motion signal and the heart rate signal, wherein the dynamic heart rate model is provided by the memory of the server,· &nbsp; &nbsp; &nbsp; &nbsp;calculate the relative contribution of each of the different biochemical energy systems to the physiological load estimate, and· &nbsp; &nbsp; &nbsp; &nbsp;transmit data regarding each of the relative contribution of the different biochemical energy systems to the instantaneous physiological load estimate."Key Examiner's Arguments:The Examiner argues that the application lacks detailed guidance on how to calculate the relative contributions of different biochemical energy systems to the physiological load estimate.The Examiner finds that the specification uses undefined ordinary differential equations (ODEs), models, and equations. According to the examiner, the application does not provide the necessary mathematical or computational details required to implement the claimed system.The Examiner uses the Wands factors to argue that the patent application fails to meet the enablement requirement under 35 U.S.C. § 112(a):1. &nbsp; &nbsp; Quantity of Experimentation Necessary:The Examiner argues that the dynamic heart rate model and the method for calculating the relative contributions of different biochemical energy systems are not described in enough detail, requiring extensive experimentation to fill in the gaps. &nbsp;2. &nbsp; &nbsp; Amount of Direction or Guidance Presented:The specification lacks clear and detailed guidance on how to apply the dynamic heart rate model and the secondary model to calculate the physiological load and its components. The Examiner highlights that the heart rate models and equations needed to calculate the physiological load are not fully defined or explained. &nbsp;3. &nbsp; &nbsp; Presence or Absence of Working Examples:The Examiner notes Figures 7 and 8 of the application, which are cited by the applicant, show the outputs of the models but do not provide the detailed methodology or the models themselves. The absence of working examples increases the need for experimentation. &nbsp;4. &nbsp; &nbsp; Nature of the Invention:The invention involves a complex system integrating wearable technology, data collection, and advanced modeling to estimate physiological load. The nature of the invention, which relies on sophisticated algorithms and models, inherently requires precise and detailed descriptions to be reproducible. The Examiner finds the specification lacking in this regard. &nbsp;5. &nbsp; &nbsp; State of the Prior Art:The Examiner points out that the prior art does not provide sufficient methodologies for distinguishing between the three biochemical energy systems during exercise. This implies that the claimed invention goes beyond the current state of the art, requiring additional detailed guidance to be enabled. The specification fails to bridge this gap adequately. &nbsp;6. &nbsp; &nbsp; Relative Skill of Those in the Art:While those skilled in the art may have a high level of expertise, the Examiner argues that the complexity and novelty of the invention mean that even skilled practitioners would require more detailed instructions to implement the system. The declaration by Mr. van Niekerk, who has a higher level of expertise than a typical skilled artisan, further underscores this point. &nbsp;7. &nbsp; &nbsp; Predictability or Unpredictability of the Art:The field of physiological modeling and wearable technology is relatively unpredictable, especially when integrating multiple biochemical energy systems into a single model. This unpredictability necessitates detailed guidance to ensure that the invention can be practiced reliably and consistently.&nbsp; &nbsp;8. &nbsp; &nbsp; Breadth of the Claims:The breadth of Claim 25, which encompasses a comprehensive system for calculating physiological load contributions, requires a broad and detailed disclosure to be enabled. The Examiner finds that the specification does not provide enough information to support the full scope of the claim, requiring undue experimentation to achieve the claimed invention. &nbsp;The applicant submitted a declaration from Mr. van Niekerk under 37 C.F.R. § 1.132. The declaration attempted to support the argument that the specification enables the invention by referencing seven prior art documents and deriving equations and parameters needed to determine the relative contributions of biochemical energy systems. However, the Examiner argued that the declaration introduces additional equations, parameters, and variables that are not disclosed in the specification. These include factors such as blood lactate measurements, resting metabolic rate, and other biochemical constants. The need to incorporate these additional elements indicates that the original disclosure was insufficient.Key Appellant’s Argument: &nbsp;The appellant argued that the specification describes the use of a dynamic heart rate model to estimate physiological load and a secondary model to segment the physiological load into contributions from different biochemical energy systems. The appellant points to specific figures (e.g., Figure 7 and Figure 8) and descriptions in the specification that they believe provide sufficient detail on the dynamic heart rate model and the secondary model. They asserted that these figures and the accompanying text outline how the models work and how they can be implemented.The appellant further submitted a declaration from Mr. van Niekerk. The declaration explained how the models and equations described in the prior art can be combined to determine the relative contributions of different biochemical energy systems. The appellant argued that this declaration demonstrates that undue experimentation is not required, and that the invention can be practiced based on the information in the specification and common knowledge in the field.Additionally, the appellant argued that the state of knowledge in the field should be considered. They claim that the methods for determining the contributions of different biochemical energy systems are well known to those skilled in the art. Thus, the lack of detailed equations in the specification should not be seen as a deficiency, as those skilled in the art would know how to derive and apply these equations. PTAB Decision &nbsp;The Board found that the specification does not adequately teach how to calculate the relative contribution of different biochemical energy systems to the instantaneous physiological load estimate. They agreed with the Examiner's conclusions on several Wand factors.The Board also agreed with the Examiner that the figures cited by the appellant (Figures 7 and 8) do not depict the models themselves but rather the outputs. This does not provide sufficient guidance for implementing the invention.The Board considered the declaration from Mr. van Niekerk but concurred with the Examiner that the need to reference additional documents and derive new equations indicates that the specification is not self-enabling.&nbsp;While the appellant argued that the methods for determining contributions from biochemical energy systems are known, the Board found that this does not compensate for the lack of detailed guidance in the specification.&nbsp; Conclusion: &nbsp;The Board finds that the Examiner correctly applied the Wands factors and that the appellant's arguments and supporting declaration do not overcome the deficiencies in the specification. As a result, the rejection of the patent application under 35 U.S.C. § 112(a) is affirmed. &nbsp;Strategies to Overcome Enablement Challenges &nbsp;To mitigate risks of enablement rejection when drafting a patent application, it is crucial to provide a detailed and comprehensive disclosure. Based on the analysis of the document provided, here are recommended strategies:1. Detailed Description of Invention Clearly define all models and equations used in the invention. Provide detailed mathematical formulations, including any differential equations, algorithms, and computational methods. Describe step-by-step procedures for implementing the invention. This includes data collection methods, data processing steps, and how to apply models to derive the desired outputs. Ensure all technical terms, variables, and parameters are well-defined. Include any necessary background information to help understand these terms. &nbsp;2. Provide Working Examples Include multiple working examples that demonstrate how the invention can be implemented. These should cover different scenarios and variations of the invention to show its applicability. Provide experimental data or simulation results that illustrate the performance and accuracy of the invention. This helps validate the models and methods described. &nbsp;3. Figures and Diagrams Use detailed figures and diagrams to illustrate key components, processes, and results of the invention. Ensure that these figures are accompanied by thorough explanations. Include flowcharts that outline the steps involved in the methods described, making it easier to understand the sequence of operations. &nbsp;4. Incorporate Known Techniques Reference and incorporate known techniques and methods from prior art where relevant. Clearly distinguish how the invention improves upon or differs from these prior methods. Include citations to relevant scientific literature, patents, and other resources that support the methodologies used in the invention. &nbsp;5. Address the Wands Factors Minimize the amount of experimentation needed by providing comprehensive details and examples. Offer clear guidance and instructions for each aspect of the invention, ensuring that a person skilled in the art can follow them without ambiguity. Include sufficient working examples to demonstrate the practical application of the invention. Clearly describe the invention's nature, focusing on the innovative aspects and their implementation. Explain the state of the prior art and how the invention advances or differs from it. Assume a reasonable level of skill in the art but avoid expecting expertise beyond that level. Address any unpredictability in the field by providing additional details and examples. Ensure that the breadth of the claims is supported by the detailed description and examples provided. &nbsp;6. Use Declarations Wisely If including expert declarations, ensure they directly address the points of enablement and provide concrete evidence that the invention can be practiced based on the specification. Ensure that any additional information provided in declarations is consistent with and directly supported by the original specification. These strategies will help ensure that application meets the enablement requirement and reduces the risk of rejection under 35 U.S.C. § 112(a). &nbsp; &nbsp; &nbsp; &nbsp; Ronny Amirsehhi is a managing partner at Leo Patent Law Office.&nbsp; The opinions and recommendations expressed are those of the author and do not reflect the views of Leo Patent Law Office or its clients. This document is for general information purposes only and is not intended to be and should not be taken as legal advice.&nbsp;

AI in Healthcare & Life Sciences: Mid-Year PTAB-Appeal Decisions on Enablement

View of Cyborg hand holding Quantum computing concept with qubit icon 3d rendering

We analyzed approximately 377 Patent Trial and Appeal Board (PTAB) appeal decisions from January 01 to June 25, 2024, specifically reviewing examiner’s rejection based on 35 U.S.C. § 112(a) enablement ground. Within this period, we identified only one decision pertaining to quantum computing technology and enablement. We provide our analysis and offer recommendations to mitigate the risk of enablement rejection.Enablement Requirement under 35 U.S.C. § 112(a) &nbsp; In U.S. patent law, enablement is a requirement outlined in the Manual of Patent Examining Procedure (MPEP), specifically in MPEP § 2164. It means that a patent application must describe the invention clearly and in enough detail that someone skilled in the relevant field can make and use the invention without needing to do extensive extra work or guesswork, i.e., without undue experimentation.The Wands factors, derived from the case In re Wands, 858 F.2d 731 (Fed. Cir. 1988), are used to determine whether a patent application meets the enablement requirement. These factors include:· &nbsp; &nbsp; &nbsp; The Quantity of Experimentation Needed: How much work is required to practice the invention?· &nbsp; &nbsp; &nbsp; The Amount of Direction or Guidance Provided: Does the patent give clear instructions?· &nbsp; &nbsp; &nbsp; The Presence or Absence of Working Examples: Are there practical examples demonstrating the invention?· &nbsp; &nbsp; &nbsp; The Nature of the Invention: How complex is the invention?· &nbsp; &nbsp; &nbsp; The State of the Prior Art: What is the existing knowledge in the field?· &nbsp; &nbsp; &nbsp; The Relative Skill of Those in the Art: What is the skill level of someone in the relevant field?· &nbsp; &nbsp; &nbsp; The Predictability or Unpredictability of Art: How predictable is the technology area?· &nbsp; &nbsp; &nbsp; The Breadth of the Claims: How broad are the claims in the patent?These factors are considered together to determine if the disclosure in the patent application is sufficient for a person skilled in the art to make and use the invention without undue experimentation.<h3>Appeal Decision</h3><h3>Appeal No. 2023002850: Quantum Entanglement and external deep learning (January 23, 2024) &nbsp;</h3><h3>Background:</h3>The case involves a patent application (No. 16/204,784) filed by IBM. The invention pertains to a method where a computing device selects layers from a plurality of external deep learning models, concatenates these layers to form a core deep learning model, trains this core model, and synchronizes its layers with the external models using quantum entanglement.The application was rejected by the Examiner on several grounds under 35 U.S.C. § 112, relating to issues of indefiniteness, written description, and enablement. IBM appealed these rejections to the PTAB.Representative Claim:A method comprising:· &nbsp; &nbsp; &nbsp; Selecting by a computing device layers from a plurality of external deep learning models;· &nbsp; &nbsp; &nbsp; Concatenating by the computing device the selected layers from the plurality of external deep learning models to form a core deep learning model;· &nbsp; &nbsp; &nbsp; Training by the computing device the core deep learning model; and· &nbsp; &nbsp; &nbsp; Synchronizing by the computing device layers in the core deep learning model with the layers from the plurality of external deep learning models using quantum entanglement.This claim outlines a method involving the selection, concatenation, training, and synchronization of deep learning model layers, with a step of using quantum entanglement for synchronization. This specific step of using quantum entanglement became a significant point of contention in the enablement rejection, as the Examiner found the specification lacked sufficient detail on how quantum entanglement was to be practically applied in this context.<h3>Key Examiner's Arguments:</h3>Regarding the enablement requirement under 35 U.S.C. § 112(a), the examiner argued that the specification lacked a detailed description of how quantum entanglement is used to synchronize the layers of deep learning models. While the claims included this step, the specification did not provide enough technical detail or guidance on how to implement this process. According to the Examiner, quantum entanglement is a complex physical phenomenon, and applying it to synchronize deep learning models requires a thorough understanding of both quantum physics and deep learning technologies. The Examiner noted that the specification did not describe any specific starting materials, conditions, or methods for achieving quantum entanglement in the context of deep learning models.The Examiner conducted an analysis based on the Wands factors which included:· &nbsp; &nbsp; &nbsp; Quantity of Experimentation Necessary: The Examiner concluded that significant experimentation would be needed to implement the claimed invention.· &nbsp; &nbsp; &nbsp; Amount of Direction or Guidance Presented: The specification provided minimal guidance on how to achieve synchronization using quantum entanglement.· &nbsp; &nbsp; &nbsp; Presence or Absence of Working Examples: The specification lacked concrete examples or experimental results demonstrating the use of quantum entanglement in this context.· &nbsp; &nbsp; &nbsp; Nature of the Invention: The invention's nature involves complex and cutting-edge technology requiring detailed and specific disclosure.· &nbsp; &nbsp; &nbsp; State of the Prior Art: The Examiner cited references to show that the use of quantum entanglement in such applications is not straightforward or well-understood in the art. The references included:o &nbsp; Wikipedia Articles: These provided general information on quantum entanglement and qubits, illustrating the complexity and challenges of the technology.&nbsp;o &nbsp; Cheng et al. Model Compression and Acceleration for Deep Neural Networks (2018): Highlighted the intricacies of deep learning models.&nbsp;o &nbsp; Phys.org Articles: Discussed advancements and challenges in quantum entanglement, indicating that the technology is still in the experimental stage and not easily applicable to deep learning.· &nbsp; &nbsp; &nbsp; Relative Skill of Those in the Art: Given the high level of skill required in both quantum mechanics and deep learning, the specification did not provide sufficient details for a person skilled in these areas to implement the invention.· &nbsp; &nbsp; &nbsp; Predictability or Unpredictability of the Art: Quantum entanglement is highly unpredictable, further complicating the implementation.· &nbsp; &nbsp; &nbsp; Breadth of the Claims: The claims are broad and cover a wide scope, increasing the need for detailed guidance in the specification.The Examiner concluded that the specification did not enable the full scope of the claimed invention as it did not provide sufficient details on how to practically apply quantum entanglement to synchronize layers in deep learning models.&nbsp;<h3>Key Arguments Presented by the Appellant:</h3>The appellant argued that the specification includes detailed technical disclosures explaining how the layers in the core deep learning model are synchronized with layers from external deep learning models using quantum entanglement. Specific paragraphs of the specification were cited to support this argument.Additionally, the appellant referenced the article "Deep Learning and Quantum Entanglement: Fundamental Connections with Implications to Network Design" by Levine, arguing that it provides evidence that quantum entanglement measures are well understood by those skilled in the art.The appellant asserted that quantum entanglement measurements are employed in the analysis of correlations modeled by deep convolutional networks. The specification’s use of quantum entanglement to synchronize layers in deep learning models aligns with well-established principles in the field.In response to the Wands Factors Analysis, the appellant contended that the Examiner's application of the Wands factors was flawed. They argued that:· &nbsp; &nbsp; &nbsp; The amount of experimentation required was not undue given the state of the art and the skill level of practitioners in the relevant fields.· &nbsp; &nbsp; &nbsp; The specification offered sufficient guidance and direction.· &nbsp; &nbsp; &nbsp; The absence of working examples did not necessarily imply non-enablement, as the detailed descriptions in the specification should suffice.The appellant further provided examples and analogies to illustrate how quantum entanglement can be practically applied in synchronizing deep learning model layers. They argued that similar techniques are already being researched and developed in the field, supporting the feasibility of their approach.<h3>PTAB Response &nbsp;</h3>The Board concurred with the Examiner’s assessment that the specification did not enable the full scope of the claimed invention without undue experimentation. They found the Examiner’s analysis of the Wands factors thorough and convincing.Insufficient Technical Details:The Board emphasized that the specification lacked sufficient technical details on how to practically implement quantum entanglement for synchronizing deep learning model layers. The references to paragraphs in the specification made by the appellant were not found to provide the necessary guidance.&nbsp;Quantum Entanglement Complexity:Quantum entanglement is a complex and advanced concept, especially when applied to synchronizing deep learning model layers. The Board agreed with the Examiner that the specification did not describe any specific starting materials, conditions, or methods for achieving quantum entanglement in this context. The Board pointed out that achieving quantum entanglement typically involves sophisticated hardware and precise conditions, which were not addressed in the specification.Reliance on External Knowledge:The Board noted that while the appellant referenced external sources (such as the Levine article) to support their argument, these sources did not compensate for the lack of detailed implementation guidance within the patent application itself. The specification must independently enable the invention without requiring excessive reliance on external sources or additional experimentation.The Board examined the appellant’s reliance on the Levine article, which discusses the theoretical connections between deep learning and quantum entanglement. The Board found that while the article provided some theoretical background, it did not offer practical implementation details relevant to the claimed invention. The Board emphasized that the specification must show possession of the invention by explaining how the claimed function (synchronizing using quantum entanglement) is achieved, which the Levine article did not do.<h3>Conclusion:</h3>In summary, the PTAB affirmed the Examiner's rejection of the claims under the enablement requirement. The Board found that the specification did not provide sufficient technical details or guidance to enable a person skilled in the art to make and use the claimed invention without undue experimentation. The appellant’s arguments and references to external sources were not adequate to overcome the deficiencies identified by the Examiner.&nbsp;<h2>&nbsp; Strategies to Overcome Enablement Challenges &nbsp;</h2>· &nbsp; &nbsp; &nbsp; Detailed Technical Descriptions: Ensure the specification includes comprehensive descriptions of the invention, specifying starting materials, methods, and conditions. Clear and detailed technical explanations help demonstrate practical implementation.· &nbsp; &nbsp; &nbsp; Multiple Working Examples: Provide multiple examples illustrating the full scope of the claimed invention. These examples should cover diverse scenarios to demonstrate feasibility across different applications.· &nbsp; &nbsp; &nbsp; Expert Testimony and Declarations: Include expert testimony, declarations, and post-filing evidence together to support the enablement of complex technologies requiring specialized knowledge.· &nbsp; &nbsp; &nbsp; Communication with Inventors: Engage with inventors to understand the level of ordinary skill in the art and ensure the specification reflects this level, including necessary technical details and context.By following these strategies, patent practitioners can better navigate the complexities of quantum computing patents and address enablement issues.The opinions and recommendations expressed are those of the author and do not reflect the views of Leo Patent Law Office or its clients. This document is for general information purposes only and is not intended to be and should not be taken as legal advice.&nbsp;

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