U.S. patent practice is a “hybrid” structure centered on Title 35 (35 U.S.C.), with 37 C.F.R. (implementing regulations), the MPEP (Manual of Patent Examining Procedure), case law (Supreme Court and CAFC), and USPTO guidance collectively governing scope of protection, examination, and disputes.
Four Key Points to Understand in U.S. Patent Practice
The "primary law" of the U.S. patent system is 35 U.S.C. (Patent Act), with §101 (patentability), §102 (novelty and prior art), §103 (non-obviousness), and §112 (disclosure requirements) forming its core.Procedural operations are specified in 37 C.F.R. (Regulations) and the MPEP (Manual of Patent Examining Procedure), which examiners and practitioners refer to (e.g., forms and deadlines for claiming priority, IDS, abandonment, and reinstatement).
The USPTO is legally designated as the responsible entity for administrative functions such as patent grant and trademark registration, as well as the provision of information. In practice, it establishes the “rules of practice” for the system through the following three functions:
| Forum | Jurisdiction and Characteristics | Legal Basis |
|---|---|---|
| Federal District Courts | Exclusive jurisdiction over patent infringement lawsuits (state courts have no jurisdiction) | 28 U.S.C. §1338 |
| CAFC (U.S. Court of Appeals for the Federal Circuit) | Basic Principles of Judicial Review of PTAB Decisions | By design |
| ITC (U.S. International Trade Commission) | A separate forum specializing in injunctions (exclusion orders) in infringement cases involving imported goods | 19 U.S.C. §1337 |
The choice of application method is inextricably linked to the timing of publication, the maturity of R&D, funding plans, and data acquisition plans. We will organize this information around the central question: “How do we establish a priority date and proceed to U.S. examination?”
| Item | Provisional Application | Nonprovisional Application | Transition to the U.S. via PCT |
|---|---|---|---|
| Legal Status | May serve as the basis for domestic priority (under the framework of §119) | Main entry point for U.S. examination (directly linked to requirements under §112, etc.) | Initiates the national phase under §371 |
| Estimated Priority Period | Generally, transition to non-provisional status within 12 months | When involving foreign priority (Paris Convention), the treaty standard is 12 months | The deadline for filing in the U.S. is generally 30 months from the priority date |
| Volume of documentation | The quality of the “disclosure supporting future claims” is decisive (no new matters may be added) | Descriptions satisfying §112(a) + claim drafting are mandatory | Consistency between the original text (PCT) and U.S. requirements (English translation, declaration, and fees) |
| Government fees (Large) | $325 | Base $350 + Search, Examination, and Issuance Fees | Base National Phase fee of $350, etc., plus search and examination fees |
| Typical Use Cases | Early priority date, anticipated data additions, investor relations | Early examination and grant of rights; starting point for division and continuation | Parallel filing in multiple countries, buying time, redesign based on international search results |
Assuming a non-provisional application, the practical document set consists of the following:
| Documents | Practical Considerations |
|---|---|
| Specification | Meeting the disclosure requirements (§112(a)), including written description, enablement, and best mode, is the "most critical risk management point in U.S. practice" |
| Claims | Simultaneously design term definitions, examples, the depth of embodiments, and a “claim hierarchy” to anticipate interpretation and invalidity attacks in subsequent proceedings (Office Action, litigation, PTAB) |
| Oath/Declaration | Framework for inventor signature and oath (Section 115, 37 C.F.R.) |
| ADS (Application Data Sheet) | Submit standardized bibliographic data and priority claims (37 C.F.R. 1.76) |
| Fees | Multi-tiered structure comprising basic, search, examination, issuance, and excess claim fees |
Systematic “milestone events” are defined as: (i) 18-month publication (Section 122, with exceptions), (ii) Office Action response deadline (SSP + extension), (iii) Grant and issuance, and (iv) Maintenance annuities. Regarding Office Action responses, the regulations provide for an extension system (37 C.F.R. 1.136), and the practice is to pay an extension fee if a response cannot be filed early.
PTA (Patent Term Adjustment): If examination delays exceed a certain threshold—such as delays exceeding three years—the patent term may be adjusted (however, delays attributable to the applicant are deducted).
Assuming a typical utility (non-provisional) application and listing only basic items (excess claim fees, size fees, translations, IDS, RCE, etc. are separate).
| Category | Provisional Application Fee | Non-provisional: Basic filing fee | Search Fee | Examination fee | Publication Fee |
|---|---|---|---|---|---|
| Large | $325 | $350 | $770 | $880 | $1,290 |
| Small | $130 | $140 | $308 | $352 | $516 |
| Micro | $65 | $70 | $154 | $176 | $258 |
Small/Micro Entity Discount: Since there is a statutory basis (e.g., a 60% reduction for small entities), it is safest to treat the determination and maintenance of eligibility (including the impact of licenses, affiliates, and transfers) as a “continuing obligation.”
Annuities are legally designed based on the benchmarks of “3 years and 6 months / 7 years and 6 months / 11 years and 6 months,” and feature a three-tier structure consisting of a 6-month grace period, surcharges, and acceptance of late payments (unintentional) under certain conditions.
| Term | Annuities (Large / Small / Micro) | Grace Period Late Payment Surcharge | Estimated Time for Late Payment Acceptance (Petition) After Grace Period |
|---|---|---|---|
| 3.5 years | $2,150 / $860 / $430 | $540 / $216 / $108 | Example: Delay of 2 years or less: $2,260 (Large), etc. |
| 7.5 years | $4,040 / $1,616 / $808 | $540 / $216 / $108 | Same as above |
| 11.5 years | $8,280 / $3,312 / $1,656 | $540 / $216 / $108 | Same as above |
| Provisions | Requirements | Practical Points |
|---|---|---|
| §101 | Subject Matter of Patents: Must fall under the categories of process, machine, manufacture, composition of matter, etc. | Abstract concepts, laws of nature, and natural objects are excluded. The Alice/Mayo two-step test is central to examination practice |
| §102 | Novelty: No prior public knowledge, public use, sale, publication, or patenting prior to the effective filing date | Under the AIA, the first-inventor-to-file system applies. A grace period (1 year) is available |
| §103 | Non-obviousness: Differences from prior art must not be obvious to a person skilled in the art | Under KSR, “common sense, motivation, and predictability” are evaluated flexibly |
| §112 | Disclosure Requirements: written description / enablement / best mode / clarity | Since Amgen, the requirement for enablement of functional genera has become stricter |
Double risk: Since §101 and §112 “struggle to fill each other’s gaps,” it is important to note that over-abstracting under §101 may result in a lack of support under §112, and conversely, over-specifying under §112 may cause the claim to fall into the realm of abstract concepts under §101, creating a double risk.
| Case Law | Key Issues | Implications for Practice |
|---|---|---|
| Alice (2014) |
Abstract Concepts (Software/Business Methods) | Under Mayo’s two-step test, mere implementation of an abstract concept or general computer use is unlikely to constitute an “inventive concept.” The key is to structure claims around the framework of “technical problem → technical means → technical effect.” |
| Mayo (2012) |
Natural Laws and Diagnosis/Treatment Correlation | Merely stating a natural law plus “apply it” is insufficient; limitation to a specific inventive application is required. In biotechnology and diagnostics, it is crucial to design claims that link to specific procedures, processes, or measurement systems |
| Myriad (2013) |
Products of Nature and cDNA | The mere isolation of naturally occurring DNA tends to negate patent eligibility. cDNA may be treated as distinct from “the natural product itself.” It combines artificial construction (modification, sequence design, conferral of function, and limitation of use) with the requirement of non-obviousness under §112 |
| KSR (2007) |
Framework for determining obviousness | Rejects rigid adherence to the formal "TSM" framework; instead, flexibly evaluates a person of the art’s common sense, design motivation, and the predictability of combinations. Designs that demonstrate "unexpected results," "teaching away," and "inhibited combinations" through evidence are crucial |
| Amgen v. Sanofi (2023) |
Enablement (Functional Genus) | Requires disclosure sufficient for a person skilled in the art to practice the “entire scope of the claims,” taking a strict stance on genus claims broadly defined by function. Strategies involving thick data and claim division are increasing, with a focus on the number of representative examples, structural diversity, and reliance on screening. |
The core of infringement is unauthorized practice (manufacturing, use, offer for sale, sale, or import) (§271(a)), with derivative forms such as inducement to infringe (§271(b)). In litigation, the following three elements are constructed in parallel:
Phillips Standard for Claim Interpretation: The CAFC has established a framework for interpreting claims that starts with the claim language and places significant weight on extrinsic evidence such as the specification and examination history. Rather than creating a “favorable dictionary” for litigation, it is crucial to maintain consistent definitions and design of embodiments from the time of filing.
| Provisions | Content | Practical Points |
|---|---|---|
| §283 | Injunction | The court may grant an injunction in accordance with the principles of equity |
| §284 | Damages | The possibility of treble damages is provided for in the statute (the requirements for treble damages are specified in case law) |
| §285 | Attorney’s fees | In exceptional cases, reasonable attorney fees may be awarded to the prevailing party |
| §286 | Statute of Limitations | Limitation on recovery for infringements occurring more than six years prior |
| §287 | Marking and Notice | Inadequate product marking may limit recovery of damages |
Three design points: (1) Establish a marking system for product lines from the outset; (2) Align the design of infringement notices (when, to whom, under which claims, and regarding which embodiments) with litigation, ITC, and PTAB procedures; (3) Do not leave “weaknesses” in claims unaddressed, with an eye toward fee shifting (§285).
The ITC can serve as a strategic forum for obtaining remedies such as exclusion orders against imported goods. The legal basis for this is found in 19 U.S.C. §1337 (Section 337).
Strengths of the ITC
The AIA introduced a framework for challenging post-grant claim validity through administrative proceedings from multiple angles, with the PTAB serving as the primary adjudicating body. PTAB decisions (such as IPR/PGR findings of fact and law) are, by design, subject to appeal to the CAFC.
| Procedure | Petitioner | Government Fees (Major) | Main Purpose |
|---|---|---|---|
| IPR (Inter Partes Review) |
Generally a third party (typically the alleged infringer) | Petition (≤20 claims) $23,750 + $28,125 after initiation |
Parallel invalidity challenge in district court, obtaining a stay, bargaining chip |
| PGR (Post-Grant Review) |
Generally initiated by a third party | Petition (≤20 claims) $25,000 + $34,375 after grant |
Early comprehensive invalidity challenge (eligibility requirements and time period differ from IPR) |
| CBM (Historical System) |
Limited scope | Same fee bracket as PGR on the fee schedule | Post-grant challenges in the financial sector, etc. (refer to past cases) |
Budgeting pitfalls: Note that AIA review costs include not only the petition fee but also a separate “post-institution fee.”
Maintenance fees are primarily required for utility patents (and reissued utility patents); the statutory due dates (3 years and 6 months, 7 years and 6 months, 11 years and 6 months), a 6-month grace period, and acceptance of late payments due to unintentional delay are codified.
Regarding abandonment and reinstatement of applications, reinstatement petitions based on 37 C.F.R. § 1.137 (unintentional delay) are central, and the USPTO clearly specifies the required documents (required reply, fee, unintentional delay statement, etc.).Regarding patent terms, §154 establishes the standard term structure and provisions for PTA (patent term adjustment). For pharmaceuticals and similar fields, extensions due to regulatory compliance (PTE) are provided for under §156.
Deadlines for Claiming Priority (Pitfalls): Regarding foreign priority claims, the MPEP generally outlines a deadline framework such as the “4-month/16-month rule” (the later of 4 months from the U.S. filing or 16 months from the foreign filing) and clarifies that these deadlines are non-extendable. Since relying on post-filing remedies (petitions) significantly increases costs and uncertainty, the practice of obtaining and submitting ADS and priority documents at the time of filing should be implemented.
Transitioning from the PCT to the U.S. is generally designed to enter the national phase 30 months from the priority date, and the framework for U.S. procedures is set forth in §371. When asserting rights based on an international application, certified copies and English translations may be required as necessary (§365).
| Field | Trends |
|---|---|
| §101 (Software/AI) | Publication of the 2019 PEG in the Official Gazette and subsequent updates. Supplementary guidance on eligibility assessments, including AI, was issued in 2024 |
| AI Inventors | Revised and replacement guidance in 2025 following the 2024 guidance publication. AI is a tool, and inventors are natural persons |
| Biotechnology (§112 Enablement) | Following Amgen v. Sanofi, the standard for determining enablement of functional genus has been tightened. The USPTO has also published an explanatory memorandum on examination practice |
| PTAB Practices | The final MTA rule (2024) and proposed rules regarding IPR system operations (2025) were published in the Federal Register, and system design (discovery, coordination of parallel litigation, and amendment practices) continues to be updated |
| FY25 Statistics | Institution rates and outcome distributions have been published, allowing the "probability of reaching the end of proceedings" to be factored into case evaluations |
In U.S. patent practice, claim drafting that accounts for the §101–§103–§112 triangle and a specification depth that anticipates the Phillips standard determine success or failure in examination, litigation, and PTAB proceedings.From the interplay between federal district courts, the ITC, and the PTAB, to the requirements for injunctive relief, damages, and marking (Sections 283–287), and even to the management of annuities and priority-based filing deadlines, there are a wide range of issues that Japanese companies must master from both an offensive and defensive perspective.Strategic responses based on the latest developments in the Alice/Mayo/Myriad/KSR/Amgen case law and USPTO guidance are directly linked to maximizing intellectual property value in the U.S. market.
EVORIX International Patent Office provides comprehensive support for patent applications and enforcement in major countries, including the United States. From strategic planning for provisional applications and PCT filings to responses to Office Actions, PTAB proceedings, and infringement litigation, our experienced patent attorneys—working in collaboration with local agents—are here to assist you.
*This article is intended to provide general information based on Title 35 U.S.C., 37 C.F.R., the MPEP, USPTO publications, CAFC case law, and other materials as of April 2026. We recommend consulting with experts, including U.S. patent attorneys, for specific decisions regarding individual cases.