Emory University, so… Let's go ahead and dive in. So, first off, before we get started, just a quick disclaimer. This presentation is not legal advice and should not be relied upon as such. None of us are attorneys, and we are not providing legal advice.

The information in these slides reflects current practices and agency guidance, but is subject to change, so… just keep that in mind when, um, looking at the slides, uh, in the future, if you do so.

So let's go ahead and dive in. We're going to start the presentation with setting the stage for someone who may be brand new to tech transfer or by Dole and I. Edison, and then, um, quickly run through these high-level overviews, and then, uh, get a little deeper in the weeds for somebody who may be here.

Uh, with specific questions or wanting some, um… best, uh, practices.

So, first off, Bay Dole was enacted, uh, in December of 1980, and.

Prior to this, there was no uniform standard across agencies or funding bodies.

With respect to ownership of patents and intellectual property, so… Some agencies would allow the contractors to own them, and some wouldn't, so…

This kind of leveled the playing field and set the stage for.

The genesis of a lot of tech transfer offices across the country. This wasn't the beginning of tech transfer by any means, but… around this time, you'll see a lot of tech transfer offices pop up because.

Due to this act, institutions or universities were allowed to own or retain title to their patents.

Which then allowed them to… further develop them and commercialize them, so…

As I stated, the Baidol Act enables universities, nonprofits, and small business to retain title to the inventions, and it.

The goal was to promote the commercialization while preserving the government's rights. So in exchange for.

Accepting the federal funding and electing to maintain title of these patents, you agree to report or provide information back and then grant the government a limited.

License to practice these technologies. So, some of the key concepts of the Baido Act, uh, as I mentioned, retention of title, uh, institutions were allowed to retain title to these patents.

Uh, and the government also, uh, retained a license, a non-exclusive license.

This is all codified in 35 U.S.C. Sections 200 through 212, and implemented with 37 CFR Section 401, if you're having trouble sleeping, you can, uh.

Google those and read those sections. Two big things that are in the news lately and have always been there, but are getting much more attention now, um, are march-in rights, and that's in 35 USC Section 203.

And… or the government's right to take title, which is described in 35 U.S.C. Section 201C-1.

Paragraph 1 through 3. Um, it's important to note that the regulations were changed slightly, uh, for the first time in the existence in late 2018, um, and the main change there, uh, that affects tech transfer offices is the 10-month.

Um, timeline to convert a provisional without asking for an extension.

Um, and the other big one is the 60 days, uh, which the government can take title versus an indefinite amount of time post-2018 regulations.

And we'll talk about those, uh, two big things, uh, from the regulation change as we get, uh, deeper in the slides here.

So, why does compliance matter? So, one, it's a legal obligation of the contract… the contractor or the university, so by agreeing to take the federal funds, uh, or by taking the federal funds, you're agreeing to.

Report and disclose certain aspects of the activities back to the government, in this case by Dolan I. Edison.

It helps the agencies identify high potential, um, inventions, so which.

Projects or programs in the agencies are generating, uh, cutting-edge or new innovation.

It helped ties, uh, inventions to the programs that funded them.

Um, and avoiding the consequences. So, it's important to get the compliance aspect of this right, because the government can take title or exercise march-in rights.

If things are not done properly. Timely or correctly.

It will also… or it could also create grant closeout issues, so if there's discrepancies between what's reported in iEdison versus what's reported on a.

A closeout report or a progress report back to program managers. Those usually, uh, bubble up to the surface, and questions are asked.

Um, depending on the severity of the noncompliance, there could be funding implications. These could be limited to the inventor.

Uh, depending on how prevalent those, uh, compliance issues are, it could encompass the institution.

Specific agency, NIH, for example, could withhold funds to the institution.

Um, and they could terminate funding, so there's some real consequences that are fairly devastating to the research enterprise if the compliance is not done correctly or timely.

So there's two pillars to the compliance aspect of this from an Edison by Dole, um, standpoint.

The first part is procedural. I'm just gonna mention these, we're not gonna dig deep into these, but again, this is all stuff that's called out in the code and the regulations, uh, as things that must be done or should be done, so… I encourage you to at least be familiar with that and make sure that your entity or institution is compliant.

There needs to be an employment agreements with the faculty or researchers and the entity.

Uh, there has to be an obligation to disclose and to assign those rights to the entity or the institution.

There's also a requirement for researcher training, so there must be some sort of education or training that goes on to.

Employees of an institution or organization where federal funds are being used.

Uh, and then there needs to be clear policies, procedures, and a point of contact for all things I Edison and Beidal at the institution, so… Those are high-level organization-type things that need to be done, and sometimes get overlooked, so I mention them here briefly.

So what we're going to spend the majority or the bulk of this presentation on is the actual reporting. So, iEdison deadlines and the required data and document submissions, uh, that are required.

To be compliant with bi-dole obligations. So before we jump into some more of the weeds here, what is iEdison? I get this question from time to time, and so…

Basically, iEdison is an online platform for BIDOL reporting. It originated, uh, and was created and originally used by NIH as Edison. This was adopted by other federal agencies and became the intra-agency Edison, or iEdison as we know it today.

Um, most of the most prolific funding agencies use iEdison. However, there are some exceptions, the Navy and Air Force, for example, do not use Edison, but.

Uh, the number of agencies not utilizing Edison is slowly shrinking.

And so… NIH created Edison, started iEdison, um, in NIST a few years ago, kind of gave it a facelift, redid the interface, and took over the ownership.

Of Edison, so… The i Edison platform is now housed under, um, NIST.

And basically, the purpose of this is to track disclosures, uh, title election, patents, license, and utilization.

Uh, activities. So the high-level buy-doll overview process, um…

Basically, everything needs to be captured from invention through commercialization. Uh, and this process all starts with the notification or the receiving of an invention disclosure. So, all dates and everything we talk about from a timeline standpoint.

All begins when that… your office is first notified, or you receive, uh, that invention disclosure.

Under the new by Dole, or 2018 on, um… It is imperative to report all disclosures to the agencies within 60 days.

Uh, and elect title within 2 years, and again, this is all based on that, uh, disclosure date.

If you take nothing else from this presentation, these are two things that I want to, uh, hammer home and can't emphasize enough.

Um, reporting disclosures within 60 days and electing title within 2 years.

If those dates or deadlines are missed, there's nothing that can be done to correct that.

And it will always… those records will always be in compliance and at risk of the federal government coming and taking title at any time.

That's the big difference between buy dole up to 2018, and then, um… by Dole 2018 and after. So, prior to 2018, the agency only had 60 days, uh, in which to come and take title, and if they didn't do it that 60-day window.

You are good. With Nubai Dole, that window doesn't close, so if you miss the 60-day or the 2-year mark.

The technologies are always at risk, and the federal government could, at any point, come in and take title.

To those. So, two very important and key, um… uh, activities and dates there not to miss.

Um, all file… you must file patents within the required timeline. We'll talk about the timelines as we get into the presentation here, and we'll also discuss utilization reports that must be submitted annually.

You must also maintain compliance with government support clauses, confirmatory licenses, and manufacturing clauses and license agreements.

Um, since the Harvard letter went out a few weeks ago, the manufacturing and U.S. Manufacturing is front and center on a lot of people's minds, so we'll talk about that and discuss it later on in the presentation as well.

So now I'd like to, uh, turn it over to my co-presenters here and let them dig a little deeper into the weeds with you here. Kim, if you want to start with, uh.

Sure. Yes, again, just to reiterate what Rick was talking about.

This one.

And we are really focusing on this. These are the two deadlines you cannot miss.

Um, it used to be, you know. We weren't overly concerned.

But now, these are the two that are under the most scrutiny by the federal government. A lot of it has to do with.

The ongoings of Harvard University and their issues. And it's brought to focus other… institutions, research institutions that.

They may find worth looking at, so… You want to make sure that you do your 60-day, uh, reporting deadline of your subject invention.

And make sure you get your two-year title election from the date of disclosure, although you can request an extension.

You just want to make sure you get it in on time.

And again, like Rick said. Missing either deadline can result in a loss of rights. Um…

And under the new rules, they can reclaim title at any time.

So, that gets a little worrisome if you've forgotten to, or you didn't report within your 60 days, or you didn't elect title, and then years later, you have a very large license.

Uh, associated with that disclosure. It could be at risk. We just don't know at this point.

The… and the good news is. Uh, that, to date, as far as I know, know the government has not taken.

Title back, um, on anything, nor have they marched in. Um, that's correct, right, Rick?

Um, there's some debate there. I think… I don't know that the government has ever marched in, but I do believe they have taken title in a few instances.

They've… okay, so they have taken title back, okay. So anyway, um, we're going to discuss these two deadlines a little bit later in the slides in more depth.

So, Ken shared with us, um, two critical deadlines for BYDOL compliance. The first of those is the initial reporting of a disclosure to the funding agency. This needs to happen within 60 days of receipt of the disclosure.

Patentable subject inventions, which are conceived or reduced to practice. Using federal funds in any amount must be reported.

The reporting entity is the owner, which could either be the awardee institution or a subawardee.

Our office uses a simple checklist to help position us for reporting.

You can see it on the right. First, is it a patentable subject invention?

If so, is there a previous enabling disclosure that needs to be listed in the iEdison record?

We verify the funding, we take a close look at the award, confirm any obligation language.

And ensure that the award numbers listed in the disclosure are accurate.

And finally, we take a look at the descriptive material provided with the disclosure.

In a later slide, Kim is going to discuss in more detail.

Her process for managing disclosures within sufficient detail. Next slide.

In our office, we utilize a cover sheet for our invention submissions.

The cover sheet pulls together in one place the details that are most important to the agency for reviewing the record.

We found that the use of the cover sheet helps us to be consistent.

And complete when we're reporting. It also has increased our acceptance rate of invention records.

No. Next. Oh, go ahead, Ken, sorry.

That's great. Um… I was just gonna… yeah, I think I was just gonna follow up on that. So, my office, we do not use a cover sheet, although I think it's a great idea.

Um. Our process, basically, is what I do, is I take the invention disclosure, I review it once it comes in.

I actually make a copy of it and use that as my working document for when I'm going to report.

So that I can go through it, I can make any changes. Um, a lot of times, a public disclosure isn't a public disclosure.

I want to make sure I mark that, that it's not, that it's maybe just a submission, or it's not a publication yet, but it's been submitted.

Or the conference date changed since this was submitted? So I can make all kinds of modifications on my copy.

Um, also, it's important if you're attaching a manuscript that you go into the manuscript and you.

Note who your inventors are. Off of the list of authors of that manuscript, you might want to put at the top as well, whether it's been published, not published, submitted.

It… you just want to give as much information so that when the agency is reviewing it, they don't have to ask themselves questions.

Um, but I've had very good, uh, success with doing it this way, and… That's… that's how we do it.

And I'll just… I'll just add one point here. So, if you put yourself in the… whoever's on the agency side reviewing these, if you're doing 100 or 50 a year or whatever, they're looking at thousands of these a year, or… I mean, even hundreds a day. So, the easier you can make it on them to find information so that they don't have to spend a ton of time on there.

The better your odds are, so… There's lots of different tricks and tools you can use to do that, but I think the whole.

Whole point here is to have all the info… the required information, make sure that it's there, and then to have it where it's easily findable, so that the agencies don't have to hunt and peck through.

Hundreds of pages of documents.

Right.

So I'll throw it back up to you guys for title election extension request.

Can often… yeah. Kim also highlighted the importance of the title election deadline.

And that deadline is a key to compliance, but there's a 2-year extension of the deadline available.

Um, so on this slide, I've shared the text that we utilize to request the extension.

Yes, and my only… comment on that would be that.

If for some reason you miss the deadline. If you're electing title after the deadline, you're not sure if you're going to elect title and it's after the deadline.

I would go ahead and make the request, because at least it's documented.

You may get it approved, you may not, but… I would make the request anyway, if it's after that 60 days.

Or after the two years, sorry.

And then just one question that popped up in the thing here that I'll hit. So, uh, with invention disclosure, somebody mentioned the redacting of personal information of inventors, so absolutely 100%, you want to remove.

Personal information, addresses, telephone numbers, social security numbers, whatever may be in there that's personal, and redact that or pull those out.

Exactly.

So, some practical perspectives. I'll ask a few questions here, and then let, um… Kim and Amanda respond here, so… How do you determine if a disclosure should be reported?

And, uh, Amanda, I'll throw it to you.

Sure. So, I talked a little bit about our reporting process earlier.

Um, so when… when we receive a disclosure with federal funding listed.

Um, an invention records created in our database that highlights that federal funding, and an email messages.

Generated that… that pings our compliance team. And that initiates an initial review of the record for reporting consideration.

Um, our compliance team then reaches out to our licensing team for some verifications around the invention.

Um, so historically, our office was erroneously reporting copyright-related disclosures, for example.

Um, and those records later had to be voided. So now we've designed a process that avoids unnecessary reporting, so we qualify, um.

Qualify the invention on the front end of reporting. This is an example of the email that goes out to our licensing associates.

When a funded invention record is recorded in our database.

Love that.

Perfect, thank you. So, next one. How do you handle reporting, uh, when the invention is jointly owned?

And Kim, I'll let… let you do that, and Amanda follow up if you have something to add.

Okay, so… Everybody seemingly does this differently.

However, technically. Each party should initially report their own respective funding.

Because it's our funding, we are responsible for that 60-day deadline, and I'm not sure we want to leave it up to the joint owner.

Who's not holding the award to… Uh, to make that deadline.

So, I think that… in my… from my perspective.

If there's two joint owners, both of them have funding. I'd say both of us report initially. If it's my funding, or one of us only has the funding.

Report. Once the initial obligation to report is met. Then, once a determination of who is going to actually take the lead.

For this, um, joint-owned technology, then you can go and… Um…

Designate NI Edison. By either voiding.

One EIR, or transferring an EIR. Normally, the lead institution in the IIA is going to take the role of reporting, but not always. I have a few.

Where, um… We are not the lead for marketing, licensing, and so forth, but we are the, um, award holder for the grant.

And the lead party does not really want to be involved in that, so I'm still maintaining the funding.

Uh, the reporting of the funding, and so I just have to make sure that I am in the loop on all of their patent filings and utilization time. I reach out to them.

And so forth, so… Those are the kind of things you need to think about. Um, and again, if you're not the lead, and you have reported an invention, and the lead is going to do the reporting.

You can either request. Um, make a request to void.

Your EIR. Now, in order to void it. It has to identically match what the other report is, and you don't always know if that's the case.

Um, you can request to transfer, particularly if you're going to have inventors on your disclosure that maybe aren't on the other disclosure.

So, it's like trying, you know. You figure it out as you're doing it, basically, because everything… there's so many moving parts in a joint ownership of technology.

Amanda, anything to add there, or are we, uh, are we good?

Sorry, I hope that makes sense.

So, sure, I'll just quickly add that we take a little bit of a different approach, and we… we try to avoid duplicate reporting on the front end, so as soon as we get a disclosure that appears to be jointly owned, we will reach out to that joint owner.

And try and clarify, um, where they are with reporting. Um, who… have they received a disclosure? What funding is listed, so that… so that only one of us takes the lead with reporting from the outset. That doesn't always work perfectly, so if we're forced to report.

Um, in order to meet the 60-day deadline, we will, but… but we try and… try and connect on the front end before we ever, um, initiate the report.

Yeah, and just to follow up really quick, especially in the case of companies.

That are joint owners, rather than other institutions. If a company is a joint owner in technology, and they want to take the lead.

And we have the funding. I am always going to manage the funding, whether they have the lead or not, because I can't rely on these companies to be responsible for.

For our funding.

Agreed, and there was one question here about reporting and who's filing the patents. Somebody thought that, um, by filing the patents, they should be responsible for reporting. While that does make it easier, I'm not aware of any requirement that, um.

The institution filing the patents should also do the reporting, but it would make that… easier.

Right. Yeah, it does make it easier, but doesn't happen all the time.

Alright, so… yeah, the last question here. Um, what do you do if you don't have enough technical data when you've reached a reporting deadline? So I think this gets at the question of the subject of engine or support for that invention in the invention disclosure.

Kim, I'll let you kind of… tackle that. Amanda, if you have anything to add.

Okay. Okay, just keep in mind, you only have a 60-day deadline to report.

Only if you have a subject invention. So, it's important that within that 60-day period, your licensing associates are looking at those invention disclosures.

To make a determination. Um, if the subject matter is there, we report as normal. If it's not.

We're gonna hold it until appropriate data is received. Now, I kind of always… laugh, because I feel like.

We have a… we have a codified. Description of a subject invention, but yet.

It's still gray in my mind, and… you've got people on the agency side making determinations whether it's really a subject invention or not.

And as to whether they'll accept her invention disclosure or not.

So, basically, we just kind of do a rule of thumb. If we have a manuscript, if we have PowerPoints that.

So a lot of data, posters are excellent examples of with a lot of data.

We're gonna report them. Um… If we have a grant.

Uh, proposal. That's not… that's not what the government's going to accept. Um…

We will hold the invention disclosures if we just don't have enough.

And when time comes that we do have enough. I've come up with a little process that, on the invention disclosure.

I have created a stamp, it's not… I just go in and PDF it, but… I update the… I update the disclosure date.

Uh, using the code. As approved to a subject invention.

And I put a new date, and that's the date that I use as having received it in our office as a subject invention.

Um, I've created a user-defined field in our database that also allows me to put that.

New date, even though the original date still exists that. The invention was received on this date.

This is the date that it actually became a subject invention.

So, it's… it's been years in the making. I mean, it's always been confusing, and… one thing that I think a lot of institutions struggle with, but this seems to work. I've never gotten pushback from the government on doing it this way.

So, this is what I do.

Excellent. Amanda, do you have anything to add there?

We take just a little bit of a different approach, um, if we have kind of what's an incomplete disclosure, we make an assessment of whether it's.

Premature, i.e. Not… does not yet qualify as a subject invention, in which case we do not report it.

Or we go ahead and proceed with reporting with an incomplete description, recognizing that we anticipate the disclosure will be rejected.

Um, at some point when it's reviewed by the agency, and at that point of rejection.

Then we anticipate we would have more descriptive material, and we can.

Um, re-upload a refreshed disclosure description material that would be acceptable at that point.

Yeah.

Yeah, I would say that if you… don't know what your 60-day deadline, if you're still uncertain, go ahead and report it, just so that it's documented.

That you've reported it within the 60 days.

Yeah, that I think both of you guys kind of illustrate two different approaches here.

I don't think one's more correct than the other, but I think what's important is that you have a… a process in place that you follow, and you do that for everything so that it is defendable.

Yeah.

Alright, so I'm going to move on and talk about timelines relatively quickly, just so we can get through here and have some time for questions at the end if we need. So, this is the standard timeline, uh, and again, this is all predicated on the quote-unquote disclosure date, so the clock or the timeline is all started and based on that date of disclosure, or the date that you receive notification of.

Of an invention. So… you have 60 days to report the disclosure. Hopefully you remember that, and then 2 years to elect title.

And then you have one additional year from, uh, election of title to file your patent filing. So.

From date of disclosure to your first patent filing, uh, you could… have, uh, theoretically up to 3 years. That doesn't mean you have to wait the 3 years.

Uh, but you could, um, stretch it out for that 3-year period. Again, this is the standard timeline without asking for, um.

Any extensions. So what we have on this slide here.

Is if you maxed out, uh, all the possible extensions. Again, the disclosure.

Date starts the clock ticking. Um, you have 2 years to, uh, elect title from that date of disclosure.

You can request a 1- or 2-year title election extension, so you can push that out to 3 or 4 years.

Um, the title, uh, after you elect title, uh, you then, again, have the one year to file that initial patent application.

You can request an initial patent extension of up to 1 year.

Um, and so that could push that filing out to 6 years, potentially.

And then if you file a provisional followed by a PCT by the time you file a non-provisional application or nationalized somewhere, you could be out to the eight and a half year mark, so… The standard timeline versus the timeline with extensions.

I would say… 95% of the time, the standard timelines should be sufficient. My argument would be that if you don't know something within 2 years, 4 years, or 5 years, pushing it out to 8 years is.

Probably not gonna change, uh, too much. I would recommend that people kind of close that… close that case or technology out and say, whenever you have whatever it is you're waiting on.

Please re-disclose this. There may be some instances and cases where these extensions make sense, but by and large.

Um, I think you should be able to get most of the business done and make decisions following the standard timeline, so… I'm not gonna dwell on these, you guys will get the slides, and we can do more questions at the end if there are questions regarding this.

So, moving on from the timelines, we'll spend a few minutes here with government support clauses and confirmatory licenses, and.

What… what happens if they get rejected. So, Kim, do you want to, um…

Yeah, yeah. Government support clauses, my favorite topic in the whole world. Um, not.

Um, so… It's a federal requirement that the wording be exact in your government support clause.

And it's indicated below, so if you don't have it, take it, copy it.

Um… It's funny how NIST keeps updating the iEdison system, because all of a sudden, I started seeing.

Rejections on my confirmatory licenses. Because my government support clause was not correct. And I'm like, wait a minute, my confirmatory license is correct.

Why are they rejecting it? So, honestly, I have reached out via a discussion on iEdison with NIH.

Arguing my point that. The confirmatory license is absolutely correct, it matches the funding in the technology record.

And the problem is the government support clause is off by a digit, or… Something is wrong with it, and we have reached out to patent counsel.

To have it fixed. And surprisingly enough, they have come back and cleared my rejection on my confirmatory licenses. So, just to… tip that you can try that to, um.

Get it cleared if you're coming up with some rejections on your confirmatory licenses.

Another… another tip, at least for the government support clauses. To reduce the number of errors you might get is when…

At the Patent Council only use the two-letter institution code and the six-digit grant number.

Do not include the prefix of the R01 or whatever, just.

Keep it simple in the government support clause, keep it consistent.

And that is a great way to limit errors, um, because.

Even though the grant number might be right. I've gotten rejected when it's an R01, and it says R23. So…

Just to kind of save yourself the trouble. Try to limit it. And also, note that the agencies want you to designate your funding at the highest level, meaning.

Do not include the Center for Allergies and Infectious Diseases. They want you to note NIH, or National Institutes of Health.

Um, do not note the U.S. Army, but rather note. The Department of Defense. So just keep it at your highest level. Um…

You can fix your government support notifications, and Amanda's going to talk a little bit about that on a slide, and… Lately, the confirmatory licenses.

Sorry.

Um, that's okay. Um… The government is wanting you to generate your confirmatory licenses via the iEdison system more and more.

Rather than use your own template. So, I'm not sure if they're getting rejected at this point, but I know they're urging us to use.

The, uh, the Edison system to generate the confirmatory licenses.

Yeah, I'm pretty sure NIH will reject it if it's not generated out of iEdison. It's just more… again, it's more work on them to have to go through and look at a document that's not their standard approved template already, so…

So I just saw somebody mention that the DoD had updated their name, which is great. We don't have a lot of DOD.

Uh, funding, so you might… you might want to post that on the chat, what it is.

So everybody knows.

Yeah, I think the DoD is, uh, being referred to as Department of War now. I do not believe that's been changed in.

Um, I think, you know, these are still official, according to Jody.

Okay. Oh, DOD is the official name, okay, yeah. Gotcha. Okay. Thank you. Thank you for clarifying.

Because I didn't know.

All right, so, uh, how to fix GSCs if they, um… are rejected. Uh… I'll let Amanda talk about some of her experiences here.

Sure. So, the first step in fixing GSCs is to determine what's wrong with the GSC, or in other words, what's the correct GSC.

So sometimes there's an award number missing, um, sometimes there's an extra award number.

And in these cases, it's important to confirm which awards actually contributed to the conception and or reduction to practice.

It's possible that the GSC is actually correct, and that the iEdison record needs to be updated.

Other times, it's as simple as the GSC language is in the wrong order.

Once it's determined how the GSC should read. If it's an active patent.

You need to just request counsel file an amendment to update.

Um, in the case that you have a rejected provisional or PCT, um, GSC, once you have an accepted national stage GSC.

Then those notifications should deactivate, or can be request… you can request that they're deactivated if that doesn't happen automatically.

Um, for abandoned and expired patents, the NIH, as you may or may not be aware, is no longer accepting ePass.

So, in these cases, you upload the proof of abandonment or expiration.

Um, in iEdison, and then update the patent record status, and then the.

The notification should automatically deactivate, um. If not, you can request that they be deactivated.

Um, I think that's all I have on that.

All right. Um, so again, I'll ask a few more questions here for our panelists to kind of work through these. Um, first one, what does utilization… what… changing gears here now from GSCs and CLs.

What does the utilization process look like? And I don't want… tons of detail, but maybe from a high level, um, what does this look like for, uh, YouTube?

Um, for me. It looks compartmentalized. Um…

I solely manage. The utilization in my office.

Um, with little input from others, which honestly is not a bad thing. It keeps me focused and… uh, not distracted. So, I create a spreadsheet from the iEdison notifications, and I work completely off that spreadsheet.

It's just easier than having to switch back and forth off of Edison from one record to another.

I work off the spreadsheet, I know exactly. Um…

Well, let me back up. So I work off that, and what I do is I complete all my non-licensed.

First, I saved my commercialized for last. And the reason I do that is because it makes that project seem a lot less…

Smaller with everything else. Already having been done. Um, my financial data is good. You want to make sure it's good.

I report directly via iEdison. I don't use our database to report. I don't do bulk uploads.

And prior to notifications, note that just because the notifications are going to start October 1st.

It doesn't mean you can't access it and do a utilization report prior to that time.

So I work on utilization for disclosures that have been made inactive throughout the year.

Um, so that's kind of a bird's-eye view.

Perfect. Thank you. I'll, uh, in essence of time. Move on to the, uh, your email here that you send out, just as an example for, uh, what you send out to licensees in order to.

Okay. Yes. So quickly, in September, I sent an email out to our licensees and our joint.

Obtain information that's needed for the utilization.

Owners that are actually the lead where I'm reporting, and I use this to get information, or for them to confirm information from the year before.

And it works pretty well, so… just, um, a tip that you may want to have some sort of email.

Template and plan to reach out to your licensees.

Um, you guys manufacturing requirements. Uh, I, I think… This is probably on the top of everybody's mind. It's certainly been in the news, as has Baid Dole itself in general over the past couple of months.

Manufacturing requirements, even more so with the, uh, the Harvard letter here, so… just… just be certain that you know, um…

Exclusive U.S. Rights to… federally funded, uh, technologies that are licensed.

If they're sold in the US, they're required to be substantially manufactured in the U.S, so it's important that you have this language or requirement in any license agreements.

That, um, deal with technologies that have federal funding. It is possible, uh, to…

Request and be granted a waiver, but you must show that efforts to find a U.S. Manufacturer have failed. This must be a documented effort.

Or domestic manufacturing is not feasible, and explain the reasons why this is not feasible.

Um, there was an executive order, uh, July 28th of 23. One part of that executive order was to try and.

Harmonize or unify and make transparent. The manufacturing waiver process.

You can find more information about this on the NIST website. They do have a quote-unquote application that the working group there has worked on.

Uh, and I have been part of submitting a couple waivers over the last year and a half or so.

And most of the agencies are asking or requiring that we use that form, so I'm not going to say that everybody is using it now, but there are a good number of agencies out there that are using the form that are on… that can be found there on the, uh, the NIST website.

Um, notifications. We got, uh, a few minutes here. I'd like to wrap up so we save some time for questions, but… I'll let Kim kind of talk about some of the notifications, and just because you have a notification doesn't mean things are bad. I mean, notifications are sometimes useful, or they're always useful if looked at in the right light, so Kim, maybe I'll give you a few minutes to talk about this slide.

Right, I'll just do it quickly, because I know there's lots of questions out there. I love notifications, um, I always review every week when we get that, um, overview of what we've got.

Um, because I can see where I can find some quick cleanup on iEdison, and… I would say compartmentalize your time for specific tasks under those notifications, because some are reminders.

And some are actually past due. Work on those that are past due. You can always housekeep.

Um, when you have time. So, and I also run quarterly reports from these notifications, and I use them.

With our licensing associates and reminders. For… next slide, uh, next slide, please, please.

Sorry.

Oh, that's okay, um, and you can… some of my priority ones are titled to the invention, a 160, which is a date of first publication, which is going to bar your record if you don't do something, and a 265, which is.

Where patent must be timely filed at the 10-month mark. So, that's a priority for me. Next slide.

Um, and again, I'm just describing these and why. Um, I make these my priority.

Alright, so some… some common rejections, or something that you will, um… see there. So, the non-provisional extension request, this is going to be a 265, so we didn't, um, get into a lot about asking requests.

Uh, actually, we… I don't know that we did mention that, um, from the 10-month to the 12-month.

Uh, for the conversion there. So when you get a 265, that's kind of… I think that's received at the 3-month mark, so you'll have.

A month to ask for the extension, or to file the, uh, not for personal patent application, so… That's a common one. Um, transferring of records, uh, or patents, uh, more precisely, so if you have created joint records and somebody reported the provisional, and somebody reported the utility.

Transferring whichever application you want to the other partner, and then having the duplicate record voided, so that's one.

And then assignments, so if you're assigning to an inventor, you've received… you've requested and received permission to assign it.

Um, that is another, uh, fairly common request that's found in the, uh, the system there.

Void Request, um, examples here, so I think we kind of talked about that, uh.

If you all don't mind, I'll go through this quickly. So, duplicate records. You don't need to transfer duplicate records if the records are truly.

Duplicative, whoever's being… whoever's the lead needs to make sure all the patents are in their record, and then the other party needs to have that record voided, uh, as a duplicate record.

Non-patentable, um, so if you, uh, in your process, just disclose or submit everything to Edison so you don't, uh, miss that 60-day window, and then find out later on down the road that, hey, this really isn't a subject convention, there wasn't enough there, there's nothing novel, whatever it may be.

You can always come back and say, hey, can you please void this record? There was no subject invention.

Uh, what have you. And the other thing that comes up from time to time is the funding did not contribute, so sometimes you'll get a disclosure and it'll have 3 or 4 grants on there, and then as the patent gets written and the claims are.

Are fleshed out, uh, it becomes apparent that an award or multiple awards did not contribute to this, so you can, um, create a discussion to have a funding removed as maybe appropriate.

Um… when to start a discussion. Amanda, I'll let you take this one.

Sure, just quickly, when to start a discussion is pretty much any time that you're having issues with a record that can't be resolved with the request function.

So we're frequently using, um. Discussions to request deactivations of particular notifications, or if we need to make changes to locked fields.

Um, following up on document review and unresolved requests, or complex scenarios. As I said, um.

Anything that you're not able to resolve through the request function.

Um, what we've found is that it's important to take time to ensure that your discussion prompt is simple, yet thorough, so that it can be understood by the agency.

And then one thing that I will point out here, and I think Courtney has made this in the comments as well, to deactivate, um… 233s in provisional applications or PCT applications.

If you filed a non-provisional application, uh, and that GSC has been accepted.

And the patents are linked correctly, child or parent, child, child. Those notifications should automatically, um, go away without a discussion question. I think that's been an update that's been made.

Relatively recently, but it's been my experience that when those things are linked properly.

And the GSE is accepted in the non-provisional that those PCTs and provisional GSC 233s do get deactivated. I don't think that's the case with the 220. I think you have to submit something.

With a filing receipt, even if it's incorrect. In order to get the 233 and then to have it, um, deactivated.

So, common pitfalls and agency nuances, um, again, I've got to hammer home the first.

Point here, the 60-day and the 2-year deadline, you can't fix that, that I'm aware of. If somebody.

Knows of a way, or, uh… that disagrees with that, I'd love to hear that, but I think you have to get the 60-day and the 2 years, um, correct if you're not asking for extensions.

Incorrect grant numbers in Edison, either through typo, or you got the wrong number on the application, it's hard to put in a number that's not formatted correctly anymore, because it doesn't allow that.

Um, make sure that GSCs are included, uh, in the patent filings to begin with. I saw there was a lot of discussion in the chat there.

Always tell the attorneys up front, give them a copy of the GSC that you generated out of Edison, assuming you put the correct grants and grant numbers in there, that GSC will be correct.

Give that to them to minimize it. It just creates a lot of work on.

On everybody and time, uh, and energy to go through and correct GSCs, either if they're missing or incorrect, what have you, so… try to get the GSCs, um, correct up front.

Lack of agreement clauses for licensing reporting, so the utilization requirements or the data required for utilization has increased somewhat over the last couple of years.

Uh, so if you don't have requirements in your license agreements for your licensees to give you or provide you that information, it makes utilization reporting very difficult, so… review your standard licensing templates and make sure that you're asking for the minimum information necessary for utilization reporting from that standpoint.

And the other thing that I see, um… from time to time, or more often than I think should be, is just having patents linked correctly in a record.

They shouldn't all be, uh, vertical. I mean, horizontal, there should be some vertical structure to that, so…

You're gonna generate, uh, additional and extra notifications if your patent families aren't linked correctly, so… just look at that and be mindful. It's easy in the new NIST system, you can drag and drop, or you can go in there and do it the old way by putting in parent-child relationships.

So, best practices, uh, I think we got one slide after this, so I'll let Amanda and Kim, uh, hit their, their favorite best practices here, and then I'll summarize and open it up for questions.

Okay, I'm gonna do these quickly. Um… Educate your tech transfer professionals and researchers on the importance of timely disclosure.

Well, uh, educating the tech transfer professionals is not the problem. The researchers is a little bit more… Um… Hmm.

Difficult. I think that's pretty subjective for them, and I think that would have to be a high-level.

High-level conversation, uh, not coming from the OTT office at, uh… at your institution.

Um… license agreement clauses, as Rick pointed out. You want to put your licensees on notice that it's federally funded.

And to expect there are certain obligations that we have to comply with.

Uh, regularly review iEdison records. I do that, um… I have integrity checks, uh, every quarter.

I want to know where I'm at with, uh… uh… provisional…

Conversions, uh, election of title. And I also send emails out to my licensing associates to remind them of these dates so they can make decisions.

If they haven't… if they haven't already. Um… And the document, uh, Manufacturing and licensing efforts for compliance.

Just make sure you're using your database to have all the information available so that when you have to do utilization.

You will have it easily available to you. I think those are the ones I think I…

Amanda, I think we got 4, 6, and 7 left, if you want to hit those.

We're gonna have…

Sure. Yeah, so it seems like… a little bit like common sense, but it's important to sync, um.

Your grant closeouts with iEdison, so we have a process in which our compliance team reviews grant closeout reporting, um, to ensure that it matches iEdison.

Pis are sometimes confused about what should be listed on those final invention statements.

Um, another rather common sense practice that we put in place is to copy our compliance staff on patent correspondence. This way, we have somebody in the role of ensuring.

That, um, funding is not… incorrectly communicated to Council and awards are not…

Inadvertently added or left off, um, of filings. And finally, um, using database alerts to help.

Um, ensure your compliance, um, that's an important… important thing for our team.

Excellent. So, just to kind of put a bow, or hopefully put a bow on what we've talked about, this… there's a lot of areas where we could have spent an hour, you know, talking about utilization, or what have you, so we tried to give a high-level overview of Edison, and then kind of dig down into a little deeper into some of the more common.

Um, Edison, uh, issues that we see on a regular basis, so… I, Edison, hopefully what comes across here is Edison is the operational backbone here, so it needs to be not an isolated, um, activity. It needs to go across the organization.

Um, I always tell people that compliance is a contact sport or a team sport. It can't be done in a silo, so… the LAs are talking to inventors, they can help educate them, the grants and all that.

Everybody needs to be aware of this and be part of it in order for the process to run smoothly.

Again, in bold here, you're probably sick of me saying it, but again, don't miss the 60-day invention disclosure reporting or electing title within 2 years. Again, assuming that you're not.

Requesting and being granted, um, extensions there. Maintain accuracy in GSC confirmatory licenses and utilization reports.

Again, I would encourage you to use the templates in iEdison to.

To generate the correct or proper GSC for you. Pass that along to the attorneys or anybody involved in the prosecution of that to make sure that a.

Correct and proper GSC is included in all patent filings. Same with confirmatory licenses, again, generate those out of Edison and have them signed.

Nih lately is not accepting confirmatory licenses if there is a GSC issue.

Um, some people will submit them anyway. I… personally won't submit the confirmatory licenses until the GSCs are accepted. It's just what's creating.

A lot of work, so just keep that in mind, make sure that you don't have GSC issues when you're doing the confirmatory licenses.

And the utilization reports, I think we, uh, we hit that… kind of… fairly well, so you know what sort of data you need to have, so…

Prepare for what is coming October 1, have your systems and processes in place to gather that information, and then be able to report that back out.

And finally, build compliance into the processes and agreements from day one. So, compliance at Edison needs to run through the entire.

Operation, not just sit with any one person, in my opinion.

With that, we thank you all for your time and participating with us today, and Autumn for allowing us to give this presentation. So with that.

Uh, we'll stop and try to answer any questions, if there are any.

There's a lot.

Um… if you guys want to help me go through the list here, uh, there were a lot of…

Questions in the webinar there, and I think. A good number of them got responded by…

I'm… Sorry.

Are responded to by various people. And again, I… I would encourage you all to look through the chat, because there are some… some good resources that were linked in there as well for various questions, grant formats, um…

Tutorials, or, uh… how-to videos that NIST has on their website.

Um…

Some great responses from their colleagues. I mean, there's good answers in that chat.

Uh, so… Yeah.

Absolutely, and I think I may have misspoken in the very beginning and said that Navy does not utilize iEdison. If I did, that's incorrect. Navy does use iEdison. Air Force does not.

And NASA is now in Edison as well.

I saw a question that I've seen several times about the subject matter and what… how do you determine that?

I'm not a scientist, so I really rely on my licensing associates to make that determination.

For me, um, they should be able to read it and know if it's a subject invention, if there's enough data there.

Um, and again, like I said, if you are uncertain and you can't get a reply by the 60-day deadline, go ahead and report it.

Just so you have it on record.

I absolutely agree with that. Um, if patents are expired and there's notifications related to it, how do you address it? They need to be addressed. It doesn't…

Matter if the patent's expired. If it's a provisional or a PCT and it's a GSC issue, you can upload the filing receipt and the specifications, and then change the status of the patent to abandon.

Um, and that will… likely take care of the notifications there.

Um…

Do you ever ask the agency to change the original disclosure date to the date the invention?

Well, I'm not sure the agency will do it, but we can do it. We can… submit a disclosure. Now, are you saying that it's already been submitted?

If it's already been submitted, yes, you could do a discussion with the agency and say that.

But I would assume that you're… invention disclosure would have been rejected.

If it's been accepted, there's no need to do that.

Agreed. Um… I'm trying to just scroll back through some of these here…

Ashley, do they have the ability to raise their hand and be unmuted?

I think if we can unmute some people, or… I don't know if that's a good idea, but, um… And really…

Yeah.

Yes, absolutely.

If a provisional was submitted without a GSC and was abandoned, and there were no subsequent applications, you can, um, submit the filing receipt and the specifications and update the statuses to the patent and the technology as abandoned, and that should deactivate.

Clear it. Mm-hmm. Right.

The notifications.

Um, and as you see, we all have our email addresses, um, addresses. You are welcome to email any of us.

With questions.

Rozzy's got a question here about what's the best way to deal with an invention, learning about it after the fact.

Fact. So, um, I'm sure there are a few cases out there where people.

Learn about an invention, uh, well after the 60 days, and I don't know if you guys have any, uh, advice or thoughts on.

On what you do in that case, uh, Kim and Amanda?

We, you know, if we don't have the invention disclosure in our office, then there's no date to be… there's no 60-day deadline yet.

If there's an invention out there. It needs to be submitted to our office. I mean, we've had cases where patents are filed before we even know about them.

Fathom. And I'm sure a lot of people have that. Um, situation as well.

So, we're using the date that it's coming into our office, whether it's an existing invention out there, and.

You know, invention land or not, but… We can only do so much. I mean, we're not mind readers.

And I think… I think the agencies are, you know. They understand that.

Um, there's a… Natasha asked question, what if a co-applicant is a foreign university and the university decides to abandon the app?

How… and our university decides to abandon the application, sorry. How do we proceed, um.

With regards to that. I think you would… proceed the same way. Um, I would encourage you to reach out to the program manager officer and let them know what's going on, but…

You can abandon the US application and still have the foreign applications in Edison.

Probably not the most ideal situation, but I'm sure it happens.

Yeah, it does.

Looks like there's several of you that want to talk about, uh, inventions after the fact, that's great.

Are there options to maintain title and commercialize without filing a patent? So, yes.

For NIH, if it's a research material or tool. You can elect title as such and commercialize it as such. I don't know that any of the other agencies.

Um, do that maybe USDA, don't hold me to that, I don't… NSF does as well, somebody's on there, so maybe NIH and NSF, I knew that… I thought there were two.

It's not.

Um, USDA, maybe 3. So, yes, there is a way to do that. You would just select a title as a research tool or material, and then utilization, all that's provided, but you don't get any of the patent notifications, uh, once you elect title that.

Right. I mean, I don't think we have to do it, but we do it. We… If it's a software that's licensed and we're making a lot of money off of it.

We've elected it as a research tool in the utilization. I put a little note that it's not really a research tool, but it is a licensed software, because sole… Sully Software is not necessarily… it's not reportable under by Dole.

Um, at least that's what NIH told me when I asked them.

I would agree, it's not a subject invention.

Right.

Any other last questions on that? I know we're past time, so feel free to drop off, but we'll hang out for another few minutes if, uh… If there's some additional questions.

Nasa is using iEdison.

They are? Oh.

They are.

Yes.

If software is patentable, would it be reportable? Yes. So, that's a good distinction. So, if software could be patented, it should be reported, regardless of whether you choose to patent it or not.

Right.

So, if it's… if it's… not patentable, then it should not be reported, but if it is patent eligible, then it should be reported.

Is there an iEdison SIG on autumn? That's a good question.

Becky or somebody still here, maybe? Why I'd say, yes.

Yeah, there's a compliance SIG, yeah.

Notifications, how many of them is reasonable. I get this question all the time.

Um, and I don't think you can look. At only outstanding notifications, so I've had.

Clients that have 2 or 3 notifications, but they haven't put, you know, 100 plus different technologies into the system. So, of course, if it's not in there, it's not going to generate a notification.

I think what's reasonable is, um, you'll just have to look at your number of pending patents that are coming up for conversion, so… provisional PCT, you're gonna get that 2 months out, or the 265 3 months out.

Pct to utility, you're gonna get those as well, and so you can see how many patents you're gonna have that fall in that area, and then… use that number, plus or minus, uh, a few there.

Would be my recommendation, but… I cringe when somebody asks for what's an average number of notifications, because all institutions are different, and volumes are different, so it's going to be.

They're different.

Institution dependent.

Yeah.

Would a Stanford v. Roche-compliant IP policy meet the employment requirement?

I… I think that's more of a legal question, and I will, uh… skip that one, I'm not sure. It's the, um…

So how do you handle existing disclosures that initially didn't have funding? That happens all the time with us.

So, if the disclosure's in our office, but. It wasn't designated as federal.

Then we find out it's funded. The day we find out it's funded is the day it becomes a federally funded.

Funded invention as far as we're concerned, and that's the date we use.

For the 60-day. Now, whether that's correct or not, I don't know, but we've never gotten pushback on it.

Yeah, and then I agree with you there, and I'd also just say make a note in the comments of that record, so that if anybody ever comes back to it, there's at least a paper trail on why there may be a.

Right.

Discrepancy in the dates. Which I think was the next comment there. Um…

Any plans on putting IIDAS and help documents into a single PDF so we can put them into a custom ChatGBT?

Interesting. I'll leave that to, uh, Autumn.

Yeah. Ernest, yeah. Yeah. They do, mm.

Or NIST, yeah. Nist has a pretty good site. I would encourage you to go to NIST. They have a… They have a lot of videos and a lot of tools on their website that walk through just about everything you can encounter.

All right, any last-minute parting questions?

Again, if you, uh… didn't want to put your question out there to the public, feel free to reach out to any of us here. Happy to continue the conversation.

If we don't know the question, we can, uh, hopefully at least point you in the right direction to find the answer.

Again, uh, on behalf of Kim and Amanda, thank you guys for your time, and I appreciate you guys presenting with me today, and for Autumn, uh, giving us the opportunity.