AUTM on the Air

• Inside the USPTO: Dr. Julie Burke on Culture, Quality, and Reform

  What does it take to safeguard innovation while making sure the patent system truly serves inventors and society? That’s the heart of today’s conversation, and few people are better positioned to answer than Dr. Julie Burke.Today, she brings a unique perspective to the world of intellectual property and patent prosecution. Dr. Burke spent more than two decades in the U.S. Patent and Trademark Office, eventually stepping into the role of Quality Assurance Specialist in Technology Center 1600. Her path there was built on a strong scientific foundation: a degree in molecular biology, a Ph.D. in biochemistry, and postdoctoral work at Johns Hopkins School of Medicine, where she earned a grant from the Cystic Fibrosis Foundation to study the CFTR protein.At the USPTO, she examined applications in areas that changed the course of modern medicine such as cancer immunology and recombinant antibody technologies. She also handled more than 900 petitions and received multiple awards for her contributions to patent quality and international guidelines. After leaving the Office, Dr. Burke brought her expertise to Knobbe Martens, later founded IP Quality Pro LLC, and has since become a recognized voice through her expert witness work and widely published articles. She also advises Petition.ai and serves on the board of the Association for American Innovation, where she advocates for policies that encourage inventors to keep creating.Dr. Burke candidly opens up about her career journey, the culture inside the USPTO, and the systemic challenges that affect patent quality. She also points us toward a future where reforms, transparency, and a renewed commitment to excellence can strengthen the system while unlocking more innovation for everyone.In This Episode:[02:52] Dr. Burke shares her academic journey through Biogen, Imperial Cancer Research Fund, and Johns Hopkins, and how she was pointed toward the USPTO.[05:20] She reflects on family ties to public service and her idealistic start at the USPTO.[05:51] Early years as a cancer immunology examiner and later transition to Quality Assurance Specialist in TC1600.[08:26] She describes USPTO culture, personalities of examiners, and the complaints she fielded as a QA specialist.[10:36] Dr. Burke recounts being told that allowing a patent on first action would earn her a derogatory label, and what that revealed about PTO culture.[12:22] Discussion of the “reject, reject, reject” mentality and how examiners were pressured into repeat RCEs.[14:55] Dr. Burke introduces the Sensitive Application Warning System (SAWS) program and explains how it secretly blocked pioneering cases.[17:42] How SAWS expanded into looking at inventors’ backgrounds, including finances and character.[18:32] Comparisons to IRS “BOLO” lists and the chilling effect of having allowances pulled at the last moment.[28:48] Dr. Burke explains new challenges with petition review work, including restrictions and procedures that create extra burdens. [32:41] What needs to change to address some of these quality issues. [37:12] Hazing culture in the Patent Training Academy and high attrition among new examiners.[41:00] Impact of PTAB changes: trials scaled back, discretionary denials increased, and appeals expedited.[42:11] Loss of examiner tools like ChemDraw and SciFinder forces some to use personal computers, creating security risks.[52:28] Dr. Burke contrasts production bonuses with quality bonuses, and the damage this does to examination integrity.[55:12] Reports show 40% of litigated patents invalidated which goes back to flawed performance incentives.[58:40] Current restraints and cuts are hard on patent examiners and students and inventors. [01:02:15] We discuss examiner morale, loss of union protections, and management culture shifts.[01:05:47] She shares closing reflections on reforms needed for transparency, consistency, and examiner support.[01:09:32] Dr. Burke connects the role of professional “guilds” in maintaining quality, and draws parallels to historical trade guilds.[01:12:54] Optimism about the Association for American Innovation (AAI) and its independent reform agenda.Resources: Dr. Julie Burke - IP WatchdogDr. Julie Burke - LinkedInPetition AI

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• The Landmark Cases That Shaped Biotech Patents with Jorge Goldstein

  Biotechnology law has evolved from a niche specialty into one of the most complex and debated areas of intellectual property, and Dr. Jorge Goldstein has been at the center of that journey. A founding partner of Stern, Kessler, Goldstein & Fox, Jorge has spent more than four decades helping define the legal boundaries of the life sciences while working alongside scientists, startups, and global institutions at the very front edge of discovery. His career path, shaped by mentors who saw the future in biology and patents, offers a rare window into how law and science grew together during the biotechnology revolution.His new book, Patenting Life: Tales from the Front Lines of Intellectual Property and the New Biology, captures that history through the people, cases, and controversies that shaped modern biotech. From the Chakrabarty decision that opened the door for patenting living inventions, to the Wands case that created the well-known enablement factors, Jorge brings to life the courtroom battles and policy debates that continue to influence how research becomes innovation. He also shares behind-the-scenes stories from his own practice, including the Myriad Genetics dispute over gene patents and the still-unfolding CRISPR battles that pit leading universities and scientists against each other.We also talk about artificial intelligence as the next great test for intellectual property law. With AI already designing new drugs and synthetic proteins, it raises the question of inventorship as more pressing than ever. The law still recognizes only human inventors. Change will have to come from Congress, and future generations of lawyers will be tasked with rewriting the rules for a world where human and machine creativity overlap. This conversation connects a past, present, and future that underscores how much the definition of “invention” shapes the pace of discovery.In This Episode:[01:21] Jorge describes how he came from Argentina to study chemistry at RPI, pursued a PhD at Harvard, and was encouraged by mentor Frank Westheimer to study biology.[02:15] Auditing James Watson’s molecular biology course opened his eyes to the future of genetics during the early days of recombinant DNA research.[03:45] He recalls being unaware of groundbreaking advances like monoclonal antibodies while focused on his thesis work.[04:48] Jorge explains why lab research didn’t suit him, realizing his temperament wasn’t suited for years of trial and error and delayed gratification.[06:32] A Harvard Law student introduced him to patent law, and he quickly saw its potential in the emerging field of biotechnology.[07:20] The Chakrabarty Supreme Court decision allowing patents on living organisms solidified his decision to enter biotech IP law.[08:21] Jorge recounts co-founding Stern Kessler Goldstein & Fox with Robert Stern, combining expertise in biology and electronics for a future-focused law firm.[10:15] Early interactions with young biotech companies like Genentech, Amgen, and Genetics Institute showed the demand for lawyers fluent in science.[11:48] He credits Marvin Guthrie of Massachusetts General Hospital with mentoring him on IP strategy and diplomacy in academic-industry partnerships.[13:31] Jorge explains how Guthrie, a founder of AUTM, gave him access to top scientists and Nobel Prize winners, shaping his approach to tech transfer.[14:51] He introduces his book Patenting Life and explains his motivation to document the history of biotech commercialization through human stories.[17:02] A writers’ circle helped him shed legal and scientific jargon, making the book approachable for a broader audience.[18:22] Jorge revisits the Myriad Genetics case over gene patents, explaining why eligibility battles over isolated DNA became so significant.[21:15] He describes the shock when a district court ruled that isolated genes were not patentable, contrary to decades of biotech practice.[23:48] The Federal Circuit reversed that ruling, with Judge Lourie emphasizing covalent bonds, before the Supreme Court ultimately sided against gene patents.[27:10] Jorge reflects on how the Supreme Court’s unanimous decision in Myriad reshaped eligibility standards under Section 101.[30:45] He notes how subsequent cases, including Prometheus and Alice, further unsettled patent law in diagnostics and other industries.[32:05] Jorge turns to In re Wands, explaining how it tested enablement of broad antibody claims and became a landmark case.[35:10] He recalls oral arguments before the Federal Circuit, including Judge Pauline Newman pressing the Patent Office on the impossibility of requiring unlimited deposits.[39:32] The resulting decision established the eight “Wands factors,” which remain central to enablement analysis today.[41:42] Jorge highlights how Wands has been cited thousands of times and even survived scrutiny in the recent Amgen v. Sanofi case.[44:15] He shares a personal story about Jack Wands, who the case was named after and dedicating a chapter of his book to him before his passing in 2023.[46:01] The conversation shifts to the CRISPR patent battle between UC Berkeley/Vienna and the Broad Institute, one of the most high-profile disputes in biotech law.[49:25] Jorge explains the interference process under the former first-to-invent system and why it made the CRISPR case especially complex.[52:10] Statements from Jennifer Doudna expressing scientific uncertainty were used against her in the legal proceedings.[54:40] He outlines how these admissions shaped arguments around conception versus reduction to practice.[57:16] Jorge recalls the year-long wait for the Federal Circuit’s ruling, which ultimately found that doubts expressed by inventors should not determine conception.[58:38] The appeals court sent the case back to the Patent Office with instructions to apply the correct legal test, leaving the battle unresolved.[1:00:08] He turns to emerging concerns about artificial intelligence in biotech innovation, from drug repurposing to protein design.[1:01:15] Jorge notes that current law does not recognize AI as an inventor, creating challenges for patenting AI-driven discoveries.[1:02:29] He argues that Congress should update patent law to allow AI to be recognized as a co-inventor, since control of patent rights is ultimately what matters.[1:03:15] Jorge closes by urging the next generation of lawyers to focus on AI’s impact on inventorship and the need for law to adapt to new models of innovation.Resources: Jorge A. GoldsteinJorge A. Goldstein - LinkedInJorge A. Goldstein, Ph.D. - Sterne, Kessler, Goldstein & FoxPatenting Life: Tales from the Front Lines of Intellectual Property and the New Biology

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• Seismic Shifts: The Future of Tech Transfer Amidst Crisis and Uncertainty with Jodie Richardson

  Federal funding shakeups and new cost caps are hitting Tech Transfer offices from multiple angles. Jodie Richardson, Director of Customer Success at TechPipeline and Chair of AUTM’s Annual Meeting Planning Committee, has been right in the middle of these conversations. With a background in strategic planning, cross-functional leadership, and compliance, she’s been gathering insights from leaders across the country on how they’re coping along with what might come next.Her recent article, Weathering the Storm: How TTOs are Navigating Overhead Rate Caps and Federal Funding Challenges, dives into the real-world effects of these changes. In this conversation, Jodie talks about the hiring freezes and budget cuts many offices are facing, the drop in invention disclosures, and why those shifts could have lasting consequences for commercialization pipelines, startups, and research infrastructure. She also shares how teams are rethinking patent strategies, keeping industry relationships steady in a volatile climate, and preparing for an unprecedented level of federal compliance scrutiny.The discussion reaches into other stress points too including uncertainty around SBIR/STTR funding, the added hurdles in international collaborations, and the scramble to find alternative funding through alumni networks, foundations, and state programs. Jodie offers ideas for retaining talent, boosting staff morale, and making sure the public understands just how much academic research shapes everyday life. Even with all the challenges, she sees reason for optimism, pointing to the adaptability and problem-solving spirit that has always defined the tech transfer community.In This Episode:[01:12] Jodie explains what prompted her to write the article and how she brought together senior Tech Transfer leaders to talk through the fast-moving changes, challenges, and strategies.[03:22] She describes the anxiety and uncertainty created by daily breaking news affecting research and the innovation ecosystem.[05:19] The new 15% indirect cost cap from NIH, DOE, NSF, and now DOD is creating immediate concern, leading to hiring freezes, budget freezes, and reduced invention disclosures.[06:48] Staffing shortages are adding pressure to existing Tech Transfer staff who are trying to maintain operations and support faculty.[08:21] Researchers are spending more time securing alternative funding, adding to the workload for TTO staff who were already under stress.[09:40] Jodie outlines the potential long-term risks to commercialization pipelines, startup formation, and the wider innovation ecosystem if disclosure declines continue.[10:53] Patent strategies are shifting, with offices becoming more selective about filings, especially international patents, and focusing resources on cases with strong commercialization prospects.[12:17] Green energy, climate tech, biotech, and vaccine technologies are among the areas seeing greater selectivity.[13:04] Industry hesitation is impacting both sponsorships and licensing deals, with some master research agreements put on hold indefinitely.[14:57] Communication is key. Offices are proactively engaging with industry sponsors and licensees to understand concerns and salvage opportunities.[15:45] On August 8, the Trump administration announced a federal review of Harvard’s patents, threatening to exercise Bayh-Dole march-in rights.[17:35] Jodie talks about the unprecedented scale of this review and the short 30-day timeline to respond for thousands of inventions.[19:22] She stresses the importance of thorough documentation, compliance audits, and internal collaboration within the TTO.[22:41] The future of SBIR/STTR programs is uncertain, and startups are concerned about potential changes to qualification requirements and funding levels.[24:33] TTOs are partnering with venture support programs, industry engagement, and sponsored programs offices to help startups navigate possible funding gaps.[25:47] International collaborations face more red tape, with abrupt halts to some projects and tighter screening for partners in countries like China and Russia.[28:34] Ensuring licensees meet U.S. manufacturing requirements is becoming a greater priority in international deals.[29:21] Alumni foundations and state economic development programs are emerging as important sources of alternative funding.[31:28] Some states have increased funding to offset reductions in federal research dollars, though most cannot fully close the gap.[33:05] Jodie warns of the potential erosion of research infrastructure and loss of innovation leaders if talent leaves the U.S.[35:42] Institutions can help retain faculty and researchers by stepping in to support projects when funding is lost and easing the commercialization burden.[37:52] Shifts in research focus toward “safer” areas could reduce groundbreaking, high-risk innovations such as climate tech, vaccine development, and women’s health research.[39:35] Staff morale is being tested by uncertainty; transparent communication and safe spaces for discussion are critical.[42:21] National meetings like AUTM’s annual gathering provide opportunities for shared support, optimism, and advocacy.[43:40] Jodie sees a need for greater public education about how federally funded research works and the technologies it produces.[46:01] Even with the challenges, Jodie remains optimistic about the adaptability and resilience of the tech transfer community.Resources: Jodie Richardson - Tech PipelineJodie Richardson - LinkedInWeathering the Storm: How TTOs are Navigating Overhead Rate Caps and Federal Funding ChallengesSBIR/STTR Programs

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• Patents, Peer Review, and Policy: What Congress Needs to Understand Now with Kate Zernike

  America's leadership in global innovation depends on the critical link between federal policy and scientific funding. Cuts to research budgets, restrictions on international visas, and the rollback of diversity programs are converging to create uncertainty that threaten labs, universities, and communities that depend on them. What happens in the next budget cycle will determine whether the U.S. continues to set the pace for global discovery or risks ceding that ground to competitors eager to recruit American-trained talent.I’m thrilled to welcome back Kate Zernike, Pulitzer Prize–winning national correspondent for The New York Times. Kate brings both personal understanding and journalistic rigor to covering science policy. Her grandfather was Nobel Prize–winning physicist Frits Zernike, and she has spent decades reporting on the politics of research and innovation. She is perhaps best known for breaking the 1999 story of MIT’s admission that it had discriminated against women on its faculty. This reporting laid the foundation for her acclaimed 2023 book The Exceptions: Nancy Hopkins, MIT, and the Fight for Women in Science. Her distinguished career also includes a Pulitzer for explanatory reporting on Al Qaeda in 2002, underscoring her ability to connect complex issues to the human stories behind them. In this episode, we discuss her recent reporting on two pivotal articles: U.S. Scientists Warn That Trump’s Cuts Will Set Off a Brain Drain and The Surprising Scientists Hit by Trump’s DEI Cuts. She explains how uncertainty is pushing young researchers to reconsider careers in science, forcing labs to halt promising projects such as mRNA cancer research, and eroding public trust in the scientific enterprise after COVID. She also reveals a surprising twist where many of the scientists most affected by DEI rollbacks are rural, first-generation, and conservative-leaning students who depended on those programs to access research careers. We also take on the breaking news of the federal government’s unprecedented investigation into Harvard’s patents under the Bayh-Dole Act, a move that raises profound questions about intellectual property, peer review, and the future of university–industry partnerships.In This Episode:[02:10] We’ll discuss Kate’s June 3rd article on Trump’s proposed funding cuts and the potential “brain drain” in U.S. science.[04:45] The American Dream story of Nobel laureate Ardem Patapoutian and concerns from scientists at Harvard and Johns Hopkins.[06:00] Why U.S. science relies heavily on international talent and the risks of disrupting this pipeline.[07:23] Cultural differences and how countries like India prioritize science as a top career path compared to the U.S.[08:23] Evidence of China, France, Germany, and others actively recruiting American-trained scientists.[10:03] Historical perspective and the migration of rocket scientists after WWII and how talent shaped U.S. supremacy in science.[12:22] NIH and NSF budget cuts, with biotechnology and computer science research seen as most vulnerable.[15:30] How federal research funding connects to U.S. competitiveness and public misconceptions of science.[18:45] Making the case for better science communication and opening up opportunities in science. [20:35] We talk about DEI grant cuts and the impact on rural and socioeconomically diverse scientists.[21:35] Stories of researchers like Lucas Dillard, Gabrielle Merchant, Ashley Albright, and Nicole Gross losing critical grants.[23:50] The lingering resentment toward science post-COVID and challenges in rebuilding public trust.[24:48] Simultaneous threats including funding cuts, talent loss, DEI program eliminations, and IP risks are compounding uncertainty.[27:00] The taxpayer debate and making the case for return on investment from university research.[29:20] Key message to policymakers is that sustained funding is essential to avoid halting critical discoveries.[30:01] Cancer research and mRNA projects at risk, including prostate cancer studies being shut down.[31:30] What gives Kate hope includes pushback from within the government, and scientists’ enduring joy, and commitment to discovery.[32:54] Where to find Kate’s articles and book, and a call to policymakers ahead of the 2026 budget cycle!Resources: Kate ZernikeKate Zernike - New York TimesKate Zernike - LinkedInExposing Discrimination in Science: The Story of Nancy Hopkins and MIT with Kate ZernikeU.S. Scientists Warn That Trump’s Cuts Will Set Off a Brain DrainThe Surprising Scientists Hit by Trump’s DEI CutsThe Exceptions: Nancy Hopkins, MIT, and the Fight for Women in ScienceFrits Zernike

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• How McGill’s Innovation Fund Turns Research Into Real-World Impact with Junji Nishihata

  The McGill Innovation Fund was created to fill a big gap in early-stage research funding and help promising ideas make the leap from the lab into the real world. In this episode, Senior Communications Advisor Junji Nishihata shares the story of how the fund came about in 2021, just as McGill University was marking its 200th anniversary, and why it’s different from other campus competitions. Instead of focusing on general entrepreneurship, the MIF is tied directly to research through a formal report of invention. With three funding tiers ranging from $25,000 to $100,000 and a yearly budget of up to $350,000, it offers serious support to faculty, startups, and researchers looking to license their work.But money is only part of the equation. Junji talks about the year-long support program that comes with every award bringing together alumni advisors, targeted mentorship, and practical workshops on everything from market strategy to regulatory pathways. The alumni network plays a huge role here, offering time, connections, and hard-won experience to help teams move forward.We also get an inside look at success stories like cleantech startup Altiro Energy and biotech company DendroTEK, plus a peek at what’s ahead for the fund. From themed competitions in AI and clean tech to a possible high-profile pitch day, the MIF is working to break down the “ivory tower” perception of academic research and show its real-world value.In This Episode:[01:15] The McGill Innovation Fund started when McGill University was looking forward to its 200th anniversary in 2021. They were looking for big moonshot ideas that they could use to excite alumni around the world.[02:05] At first they thought about making an investment fund, then they decided to focus on funding for early stage ideas.[02:50] Eligibility criteria include a report of invention because it's based on research. They declare what the concept is and then the technology transfer team examines it in detail. Is it novel? Is it patentable?[04:06] The objective of the innovation fund is to get stuff out of the lab and into the real world where it can make a difference.[06:07] The MIF is divided into three different prize tiers: the Discover at $25,000, the Develop at $50,000, and the Deploy at $100,000.[06:53] The yearly funding of a significant sum of money shows the university's commitment to innovation.[07:27] The initial funding came from royalties collected from past Innovation successes.[08:21] This shows that the university is serious about inventors and technology.[09:02] They are moving towards donor and corporate support.[10:16] The McGill Alumni Network is tremendous and has a lot of successful people who are willing to give back.[11:11] Junji shares more about the award tiers. [12:28] The McGill AMR Center or Antimicrobial Resistance Center offers a $75,000 top off in addition to the original award.[14:05] How the fund has created transformations. Altiro energy came to them in the development stage and became successful and moved on.[15:29] We learn about the support that is offered as well as funding. The big value comes in the support that follows the award. They develop a road map in conjunction with their alumni experts. They also have a series of Advisory board meetings every two months.[17:45] They also have the McGillConnect platform.[18:22] Tony Falco is a mentor that has started three companies. He's been in the trenches and knows how to help the teams.[19:34] They have about 75 alumni that they reach out to.[20:11] We learn about the success of DendroTEK.[21:26] We talk about what is next for the fund and future ideas. He would like to grow it into something similar to Shark Tank and raise the profile of the alumni.[22:36] He wants to show people the value that is created for society.Resources: Junji Nishihata - McGill UniversityJunji Nishihata - LinkedInJunji Nishihata - InstagramMcGill Innovation FundMcGillConnect Platform

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