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PCT Entry into the U.S.Ā for In-House Counsel

Entering the U.S. national stage is a critical step in managing an international patent portfolio. For in-house legal teams, particularly at established technology, biotech, and medical device companies, the priority is not simply filing—it is predictability, alignment with global strategy, and controlled execution.

Biotech Beach Law provides U.S. national stage representation for PCT applications with a focus on biotechnology, life sciences, and medical devices, supporting in-house counsel who require clear communication, reliable prosecution, and disciplined cost management.

U.S. National Stage Representation Aligned with Your Global Portfolio Strategy

U.S. patent prosecution differs in important ways from other jurisdictions

Differences in claim interpretation, disclosure requirements, and examination practice can materially affect portfolio value if not handled carefully.

Our approach emphasizes:

  • Continuity with the international phase

  • Alignment with existing global patent strategy

  • Early identification of U.S.-specific risks

  • Avoidance of unnecessary procedural complexity

The objective is a U.S. national stage application that integrates cleanly into a well-managed, long-term international portfolio.

Supporting In-House Legal Teams

In-house counsel are responsible for balancing legal risk, business priorities, and cost predictability—often across multiple jurisdictions and internal stakeholders.

We support in-house teams by providing:

  • Clear ownership of U.S. national stage execution

  • Practical explanations of U.S. prosecution requirements

  • Early visibility into cost drivers and timing

  • Strategic input grounded in USPTO experience

Our role is to make U.S. national stage prosecution manageable and predictable, not a source of ongoing uncertainty.

Biotech & Medical Device Experience

Life science, biotechnology and medical device patent applications frequently encounter heightened scrutiny during U.S. prosecution, particularly with respect to:

  • Written description and enablement

  • Functional and result-oriented claiming

  • Diagnostics and method-of-treatment claims

  • Software-enabled and connected medical technologies

Our practice is focused on these technologies, allowing us to anticipate common issues and address them efficiently at the national stage and beyond.

Claim Review and Adaptation for U.S. PracticeĀ 

Claims that proceed smoothly in other jurisdictions may require adjustment for U.S. examination practice. We approach claim adaptation carefully and selectively.

Our process includes:

  • Reviewing claim scope against U.S. enablement and support standards

  • Identifying provisions likely to attract §112 or subject-matter issues

  • Proposing targeted adjustments only where necessary

  • Preserving fallback positions consistent with global strategy

The goal is to achieve defensible U.S. claim scope without unnecessary rewriting or over-fragmentation.

Examiner Interaction and Prosecution Management

Effective U.S. prosecution often benefits from direct interaction with examiners. Where appropriate, we conduct examiner interviews to clarify issues and streamline prosecution.

For in-house counsel, we provide:

  • Clear summaries of examiner positions

  • Practical assessment of prosecution options

  • Reasoned recommendations tied to business and portfolio goals

This allows in-house teams to make informed decisions without being drawn into procedural detail.

Communication and Reporting

We recognize that in-house counsel value structure, clarity, and reliability.

Our workflow emphasizes:

  • Experienced attorney oversight

  • Clear written reporting

  • Timely communication aligned with agreed deadlines

  • Straightforward explanations without unnecessary jargon

We adapt our communication style to fit established internal review and approval processes.

Cost Predictability and Planning

For established companies, cost control is not about minimizing spend at all costs—it is about predictability and justification.

Our approach focuses on:

  • Defined scope at U.S. entry

  • Transparent fee structures

  • Early identification of potential cost drivers

  • Avoidance of unnecessary procedural steps

Our Basic U.S. Entry Fee is $1,425 plus costs and includes:

  • Information Disclosure Statement (IDS) from International Search Report (you provide foreign patents and nonpatent literature)
  • Preliminary Amendment to remove multiple dependencies from claims and adding USPTO headings to specification
  • Assignment if needed
  • All subsequent reporting

Our Patent Attorney Rate is $475 per hour.

Why In-House Teams Work with Biotech Beach LawĀ 

In-house counsel work with us because we offer:

  • Focused experience in biotech and medical device technologies

  • Strong familiarity with USPTO prosecution practice

  • A disciplined, non-opportunistic approach to U.S. national stage work

  • Clear communication and predictable execution

  • Respect for established global patent strategies

Our aim is to be a reliable U.S. prosecution partner, not an additional management burden.

If your organization is preparing to enter the U.S. national stage for PCT applications in biotechnology or medical devices, we welcome the opportunity to discuss timing, scope, and expectations.

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