By: Daniel D. Wright
Why file a provisional patent application?
Have an idea for an invention but unsure of some of the details? Maybe the money isn’t quite there for some additional experiments, but you really need to get a provisional patent application (PPA) on file with the USPTO before publishing that paper or going to investors. In these circumstances and many more, the advice from a patent practitioner will be simple: “File a provisional patent application!”
For good reason, you’ll hear this suggestion almost invariantly; the benefits of provisional patent applications are numerous.
This makes provisionals a great way to get in line at the patent office quickly to secure that critical priority filing date, thereby preventing any disclosures during that year from becoming invalidating prior art.
This makes provisionals a great way to get in line at the patent office quickly to secure that critical priority filing date.
The Fidelity Risk
However, as briefly mentioned in a previous post, there’s a serious risk with playing fast and loose with provisional applications. Although the law allows provisional applications to take any shape you choose, it additionally requires that provisionals adequately describe and enable the claimed invention of the following non-provisional, according to the same standards applied to non-provisional applications themselves. Thus, considering the complicated balance between specificity and breadth in a strong non-provisional application (and lack thereof in a research paper), you can find yourself in a lot of trouble if you simply file your technical documents or otherwise skimp out on sufficient rigor in your provisional.
In a worst case scenario, the non-provisional can be outright denied the priority date, effectively forfeiting any benefit from the provisional and thus exposing you to a whole year’s worth of potential prior art.
More granularly, a lack of support can apply to specific details, meaning that any claim of the non-provisional that cites those details, unsupported by the provisional, will lose the provisional priority date. As a consequence, your application will have multiple filing dates on a claim by claim basis.
... you can find yourself in a lot of trouble if you simply file your technical documents or otherwise skimp out on sufficient rigor in your provisional.
Lessons from the Courts
So what does and does not constitute allowable “fleshing out” of the application at the conversion date? Case law can provide certain insights.
New Railhead Mfg., LLC. v. Vermeer Mfg. Co., (298 F.3d 1290, 1294, 63 USPQ2d 1843, 1846 (Fed. Cir. 2002)) continues to be the foundational case on this topic. In this case, the patentee needed to rely upon a provisional application in order to antedate a public use of the claimed horizontal directional drill bit. The brief independent claim of the non-provisional necessitates “the unitary bit body being angled with respect to the sonde housing.” However, the court noted that this feature is never recited in the provisional. The closest it gets are with oblique allusions to “leverage” being responsible for the improved performance. Furthermore, the figures of the provisional only showed the apparatus in an exploded view and not, as would have been necessary, an express depiction of the bit body’s attachment to sonde housing. The inventor himself even testified that the figures did not depict the arrangement claimed in the non-provisional, perhaps resounding the death knell for the case. Since the provisional lacked the necessitated claim element in its entire disclosure, the court ruled that the non-provisional could not claim priority to the provisional, denying it the essential date to antedate the invalidating public use. The lesson of New Railhead is pretty cut and dry: your provisional better include critical claim elements at least somewhere in its disclosure.
Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. 10-1183 (Fed. Cir. Aug. 26, 2011) shows a bit more nuanced of an example pertaining to details narrower than the absence of a critical mechanical part. The plaintiffs argued that the patents at hand should be denied their provisional priority date because the claims stated an air flow of 25,000 CFM through a tobacco curing barn while the provisional disclosed that the minimum air flow “may be about 28,000 CFM.” This argument worked for the lower courts, but was overturned at the Court of Appeals for the Federal Circuit on the grounds that the provisional provides sufficiently broad language elsewhere. In addition to giving the specific number, the provisional states that air flow “may vary according to conditions” and that it can be “sufficient to prevent an anaerobic condition.” As such, the ballpark number in light of the broader language was found to sufficiently support the specific value of the non-provisional despite the specific value not being expressly listed in the provisional and even perhaps excluded by a singular statement.
The lesson of New Railhead is pretty cut and dry: your provisional better include critical claim elements at least somewhere in its disclosure.
The conversion of a provisional application is not the time to introduce or reveal key features of the invention if you hope to keep your priority date, but it is indeed an opportunity to insert additional examples and supporting information to round out what was already presented and made clear in the provisional. Herein lies the danger of sloppy provisional applications. Were all those key claims in your rush job provisional? Were they all in your conference paper? Maybe. Maybe not.
The Balance Takeaway
Provisionals can be a great tool for quickly securing a priority date and a pending designation, but as long as you have the time, provisional applications should be as close to the real deal as possible. Do your diligence up front and make sure it's all in there, as best as you can, and avoid filing a provisional application that is merely a promise to have an invention at a later date. The Office (and certainly the courts) are wise to such games.
Image by Peggy und Marco Lachmann-Anke from Pixabay
As many fine practitioners will attest, there is a fine balance between the advantage of amending and arguing to win the day and the risks of saying too much, especially on record. There are two doctrines, arguably in opposition of one another, that govern such balance: the doctrine of equivalents (DOE) and the dedication disclosure doctrine (DDD).
First, let’s get on the same page with shared definitions of these doctrines.
Doctrine of Equivalents (DOE): a claim of patent infringement may arise even when each and every element of the patented invention is not identically present in the allegedly infringing product or process if the potentially infringing device performs substantially the same function in substantially the same way to obtain the same result.
Dedication Disclosure Doctrine (DDD): if subject matter is disclosed but not claimed, the patentee dedicates the unclaimed subject matter to the public and cannot recapture it through DOE. There are at least two ways to satisfy DDD, potentially negating the infringement claim:
1. Dedication-Disclosure Rule: alleged equivalent is disclosed in the specification but not claimed in the patent
2. Prosecution History Estoppel: alleged equivalent was surrendered during prosecution to obtain an allowance (e.g., by amending or argument)
Given the established tension between these doctrines, how does one maintain flexibility without saying too much?
Only argue amendments that need to be argued. In Warner-Jenkinson v. Hilton Davis Chemical Co., 520 U.S. 17 (1997), the claims were amended to recite “at a pH from approximately 6.0 to 9.0” and the accused process used pH 5.0. In the file history, the patentee only argued the upper limit, pH 9.0, to remove a prior art reference, whereas the reasoning behind the pH 6.0 amendment was unknown from the file history and the patentee could not recall any motivation for the amendment. As such, dedication disclosure doctrine did not apply to the lower pH limit of 6.0, only the upper pH limit of 9.0. See also Hubbell v. United States, 179 U. S. 77, 82 (1900).
Practical tip: if you can get away with saying less, then less is more in many arguments with the patent office. Consider interviews with the Examiner to express more while keeping less on record.
Identify or label steps of a method sequentially only when absolutely necessary. In Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2019), the patentee claimed a three step process for preparing biologic products. Sandoz’s allegedly infringing process was argued as equivalent. However, the patentee, Amgen, sequentially listed the steps in the claims and sequentially described the steps in the specification. Accordingly, the doctrine of equivalents did not apply in this case; Sandoz’s process was not found to be equivalent via DOE.
Practical tip: do not numerically or alphabetically label steps in a method claim. Do include alternative methods in the specification that combine all or some of the method steps.
Separate embodiments than that which is claimed can still trigger DDD. In Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC, No. 2019-1924 (Fed. Cir. May 8, 2020), the claimed mixture recited the pharmaceutically acceptable fluids of polyethylene glycol and propylene glycol. The allegedly infringing product (sold by Slayback) used ethanol as a pharmaceutically acceptable fluid. Eagle argued that DOE applied. Slayback argued that since Eagle recited in its specification, but did not claim, ethanol as a pharmaceutically acceptable fluid, Eagle dedicated ethanol to the public. In response, Eagle argued that ethanol was recited in a specific embodiment that was separate from the claimed embodiment, so that it could still be viewed as equivalent in the instant embodiment. However, the Federal Circuit rejected this embodiment by embodiment approach and ruled that the dedication disclosure doctrine applied to Eagle’s recitation of ethanol in the specification.
Practical tip: if there is cross use or equivalence of features from different embodiments, make sure that equivalence is explicit in the specification.
Given the variability of examiner and court interpretation, it’s impossible to derive a bullet proof formula to balance the tension between DDD and DOE, but there are some proven strategies that can, at least partially, future proof your patent application. Being mindful of the Doctrine of Equivalents and the Dedication Disclosure Doctrine can save you some potential heartache (and lost damages) in the future.
By: Daniel D. Wright
Sometimes you need a patent, and you need it fast. It could be that a new competitor has entered the field or that you want to buff up your patent count ahead of the next investor meeting. Regardless, you need something on the books ASAP to secure your IP rights. Luckily, depending on the details of your urgency, various opportunities abound.
At the start of such a patent panic, you should first resolve whether you actually need an issued patent or just a pending application. In many situations (e.g., science staff speaking at a conference, marketing releasing a promo, etc.), a pending application filed before your planned disclosure will be sufficient. Indeed, putting together a whole patent application on short notice can be a big undertaking, but you can ease the burden by taking advantage of the unique features of a US provisional filing. Provisional applications are never examined and hold the filing date for up to one year during which you can draft the full application. While the best practice is often to make the provisional filing resemble the full non-provisional application as much as possible, you are allowed, for example, to file conference papers and technical documents as a provisional and make it all look like a patent application later. The danger with this method is that the provisional must support the language of the claims of the non-provisional, but discussing this in detail would be a whole separate blog post. Anyhow, if you need a patent application on file with only 48 hours notice, you’d probably best use a provisional application.
If instead you’re after an issued patent, you’ll need more than two days and may consider skipping the provisional step. As discussed above, the primary advantage of a provisional is its easiness to file and one year hold on your filing date. Although that year does not count towards your patent term, it does literally delay prosecution. Assuming you know what you want protected and have the data and language on hand to support it, you could file it directly as a non-provisional application to enter prosecution that much sooner. In a similar manner, you could also skip the Patent Cooperation Treaty (PCT) stage. The PCT system streamlines the process to file an application worldwide at the cost of additional procedural steps that delay its appearance before the local examiners. Instead, you could take advantage of the older “Paris Convention” rules and file directly before the foreign offices of interest within one year of your US filing (provisional or non-provisional, whichever is earlier). However, both the US provisional and PCT process trade comfortable flexibility for expediency, so if you choose to forgo these standard methods, you should be extra diligent in devising your strategy and drafting your documents to ensure that nothing gets left behind. Regarding international filings, you could alternatively file your PCT application simultaneously with an identical US non-provisional. This would get the US case directly in the prosecution queue while the international cases dally in the usual PCT process.
Most patent offices also let you pay for expedited prosecution. Before the USPTO, this is called “Track One” or “prioritized examination.” For a fee of $1000.00 to $4000.00 depending on the size of your company, the patent office will enforce shorter timelines on its staff for the prosecution of your application. However, the USPTO considers Track One a mutual agreement to work quickly, and you will forfeit your special status if you take an extension of time on any item or file a request for continued examination (RCE) after a final office action. Therefore, Track One only guarantees that you get through to a notice of allowance or final rejection within their target of about one year. You can find more about Track One here. It should also be mentioned that the USPTO “accelerates” examination of applications concerning certain technology types. You will have to submit a form to notify the patent office if you believe your application qualifies, so check here to see the list of industries currently privileged.
Since 2014, certain patent offices have established the “Patent Prosecution Highway” (PPH) to expedite prosecution across a patent family. If you receive a notice of allowance for one application in a participating country and have a parallel case pending in other participating countries, you can apply for expedited prosecution under the PPH in those other jurisdictions. Frustratingly, however, you must adapt the pending claims to reflect the allowed claims, and many participating patent offices have conflicting preferences and policies regarding claim language, format, interpretation, and scope. For example, one could file a PPH request in China with broad US allowed claims; however, the Chinese Patent Office will still likely demand that the claims be narrowed to better reflect standard Chinese IP practice despite the US allowance. Conversely, you could file a PPH request in the US with Chinese allowed claims, but in this scenario, you’d likely be leaving claim scope on the table since the USPTO generally allows broader claims than the Chinese office. For example, despite that the Chinese patent office participates, a PPH request with US allowed claims likely won’t save them from that office’s standard narrow allowances, and conversely, a PPH request in the US with Chinese allowed claims likely leaves claim breadth on the table. These situations aside, the PPH can significantly speed up prosecution between jurisdictions with similar policies or in jurisdictions less valuable to your strategy, as many examiners are happy to accept someone else’s work, especially if that work comes from a reputable patent office like the European Patent Office.
If you’re unable to expedite prosecution, you can potentially speed up the normal process by drafting the claims of your patent narrowly, although this is not necessarily advisable. By drafting very specific, very detailed claims you make it less probable that the examiner will discover prior art documents that alone or in combination teach or describe every feature of your “broad” claim, as the law requires them to do. A narrow claim can therefore potentially set the stage for a “first action allowance,” thereby saving you the lengthy and expensive process of a protracted prosecution. The obvious danger with this strategy is that you are likely excluding veritable patent scope surrounding your invention which in turn risks that a competitor can dodge your IP right with a simple change to your tech.
Finally, you might hear that a design patent is a quick way to score an issued patent. While indeed the fees and prosecution time on design patents are substantially less than that of a utility patent (i.e., what most people mean when they say a “patent”), design patents have a very different scope, format, and intended use than a utility patent. You can check out our previous blog post for more details on the nature of design patents, but the strategy here can be stated quite simply: only pursue a design patent if such a patent is actually of interest and value to your operation. Design and utility patents are different beasts and cannot be used interchangeably.
Overall, there are a variety of means available to those who need a patent “fast,” with “fast” meaning within 12 to 24 months in this industry. Each of these methods has their nuances and complexities that this blog post could not fully describe, so regardless of which option you choose, please do consult with a patent practitioner before committing to any option.
In late April, we announced an award program to help innovators impacted by the COVID-19 pandemic. Our original intent was to offer the award of a free provisional application or $5,000 toward a non-provisional for one startup whose impact potential rose above the rest. What followed the announcement exceeded our wildest expectations. The response was overwhelming in the best possible way, but did make for an incredibly difficult selection process. Your stories broke our hearts and your perseverance inspired us – so much so, that we decided that the original plan for a single award was far too constraining under the circumstances. Given the high volume of quality submissions and our desire to help as many as possible during these trying times, we expanded the offering beyond the single $5,000 award to include the addition of $2,500 awards to three other exceptional finalists.
We couldn't be more pleased to announce that the first place award goes to CAPNOS, with runner up awards going to PedalCell, realLINGUA, and Kaiser Precision Software, LLC. The recipients are a truly gifted collection of entrepreneurs who will surely do great things. All bring hugely impactful and timely innovations, backed by groups that have what it takes to deliver commercial success. We couldn’t be more thrilled about the potential to be a part of their journey and endurance during this critical time.
By: Daniel D. Wright
Finance wants to brag about R&D’s big discoveries before the next round of fundraising. Marketing is itching to release new promos to show the tech in action. The science staff is campaigning to attend the big conference next month. Their requests all seem reasonable; as you know, attention is paramount in this economy. However, you’re also well aware that no amount of short-term hype can compensate for squandered IP rights, especially when innovation provides the core of your business.
On the surface, the law regarding disclosures made before filing seems pretty straightforward. Simply put, 35 U.S.C. §102 states that if your invention is known to the public before the filing date of your application, no patent can be had. So, with this simple understanding comes a simple solution: before doing any of the above, file at least a provisional patent application on the fundamentals of your technology. That provisional application (never examined) will then hold your filing date for up to one year before you need to file a full non-provisional application, which is examined. In the meantime, you can much more safely discuss your technology knowing that you’ve already secured a filing date before the disclosure.
However, sometimes something has already slipped from the lips of your staff or you discover that the university gave you the wrong date for the collaborating graduate student’s dissertation publication. Depending on the details, you may or may not have any recourse for these inadvertent disclosures, but what’s certain is that, in many of these situations, this simple law no longer looks so simple. Here, we will discuss some of the more nuanced aspects of 35 U.S.C. §102, including some related case law.
Both AIA and Pre-AIA forms of the law state that no patent can be had if the invention had previously been “described in a printed publication.” Obviously, a “printed publication” must be narrower than a “printed document;” otherwise, all of your private lab notebooks would block your patent. As such, what constitutes whether a document is a “printed publication”? The courts have long held that “publicly accessibility” is a key determining factor. To put it directly though not necessarily succinctly, “A reference is publicly accessible ‘upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it…’” (Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1350 (Fed. Cir. 2008) quoting SRI Int’l, Inc. v. Internet Sec. Sys. Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008)). The last part is easily overlooked. To qualify, the document need not be available to the broad public, only to at least those who are interested. Nor must it immediately fall into the lap of anyone looking; the searcher may have to work a bit to find it, within reason of course.
Sandoz Inc. v. Abbvie Biotechnology Ltd. (IPR2018-00156) brings these points to an interesting forefront. In the petition, Sandoz presented a 2003 drug insert from the FDA’s website as it was preserved on the Internet Archive (also known as the Wayback Machine). The patent holder Abbvie, conceded that the document was posted on the FDA’s website as of the date in question, but they held that the insert was not “publicly accessible”. Abbvie argued that there had been no showing that the 2003 website had adequate search functions or indexing to enable the document’s discovery in its own time. This might have been sufficient reasoning if not for the Sandoz’s expert testimony indicating that physicians (i.e. an interested person) knew that these sorts of documents were available on the FDA’s website and could be discovered with reasonable diligence. So, while the FDA perhaps never advertised the availability of these documents to the general public and potentially couched it in frustrating early-2000’s web design, the Patent Trial and Appeal Board (PTAB) held that the drug insert indeed qualified as a printed publication because those of interest could and did access these sorts of webpages.
The advent of the internet, however, does not turn every online document case into a slam dunk. In In-Depth Geophysical, Inc. v. ConocoPhillips Company (IPR2019-00849), the petitioner presented a screenshot depicting a link to a conference paper in question, the link labeled with a non-contextualized and nebulous date of “September 2012”. The September 2012 date, if accurate, would predate the patent’s November filing. On face value, it would appear that the evidence is damning; however, the patent holder successfully demonstrated that the vague “September 2012” date alone did not suggest publication in that month. Moreover, they showed that the conference required the paper’s first presentation during the conference in the first week of November and its subsequent publication at the conference’s conclusion. The PTAB found this convincing, and without any further evidence to the contrary, they ruled that the petitioner had failed to demonstrate that the link labeled “September 2012” made the paper publicly available prior to the filing date.
These are just two examples of when the context of the disclosure and its very medium of publication combine to make this “simple” law far more involved. This is ignoring further potential complications such as the “one year self-disclosure grace period” exception of §102(b) that plays a role in the latter of the above cases. Therefore, diligent tracking of your own publications, no matter how small, and preemptive provisional filing, will at least save you a headache if not your IP rights entirely.
Despite some unfortunate history, design patent filings have been steadily increasing overtime. Even big tech companies like Samsung, Apple, Microsoft, LG, and Panasonic are getting into the design patent filing game. Further, recent court cases have shown the power of design patents.
If it looks like getting a design patent is in your future or you’d like it to be, keep these design patent key features front of mind:
Functionality. Are you trying to protect a functional (rather than ornamental) design? In other words, if you are touting specific functionality of the design during advertising – your design might be functional. If your design represents the “best” design – your design might be functional. If alternative designs would adversely affect function – your design might be functional. If you are concurrently filing utility patents on the same feature(s) – your design might be functional. Getting the idea?
Patentability. Is your design new and non-obvious? If you are coming from the utility patent world – I am not necessarily talking about a combination of elements resulting in an obviousness or lack of novelty determination. Design patents are a bit different. Think about the overall visual impression (e.g., airiness, rigidness, suspension, etc.) of the design to be patented and then see if you can find a reference that creates a similar visual impression or a combination of references that create the same overall visual appearance and impression. Get some feels about the design.
Application. Can your design (e.g., fabric pattern) be used for or on different articles of manufacture? If so, consider a separate design patent for each article of manufacture. Seems heavy handed but design patents are relatively inexpensive (no maintenance fees but lasts 15 years), and you’ll be happy you did when someone puts your design on a different article of manufacture than the one you patented.
In the end, design patents are an awesome addition to a portfolio if they’re the right answer for protecting your innovation and if done correctly. Find a trusted draftsperson for the figures and a knowledgeable practitioner – because in the end, it’s all in the design.
A vaccine for COVID-19 remains a hot topic in many people’s minds as a prerequisite for a return to normalcy. Thus it should come as little surprise that a number of companies both large and small are hot on the trail. As of April 20, 2020, WHO reported knowledge of 76 unique endeavors worldwide to generate a vaccine - with each pursuing one of a number of different approaches. While the exact numbers of new applications are still hidden behind the standard confidentiality policies of patent offices worldwide, it is practically certain that this torrent of interest will be matched with a similar storm of new IP.
Vaccines, along with diagnostic tests that have played a critical roll in areas with a strong handle on the epidemic, can sometimes fall into a troublesome section of U.S. patent law precedent based on the very fundamentals of their operation. Vaccines intend to bolster a person’s immune response against a pathogen by exposing the subject to a weaker version or fragment of it, and diagnostics frequently employ known complementary or relevant biomolecules to accurately identify its targets. Ever since the 2013 U.S. Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., which primarily dealt with human DNA sequences for cancer screens, unmodified products of nature, even when isolated outside of their natural environments, are not patent eligible.
Therefore, none of these contenders in the race for a vaccine will be able to simply claim the COVID-19 RNA sequence or any of its protein components and call it a day. If they want patent protection for their vaccine, their claims must more closely match the subsequent effort that produces modern efficacious vaccines beyond mere identification and sequencing. This often includes modifications to the fundamental biomolecules to improve its exposure to the body’s immune system or its manufacture by some clever, synthetic process. Sometimes, this means packing together or fusing biomolecules from different sources, such as an Oxford University group’s use of a chimpanzee adenovirus vector. Furthermore, the vaccine needs to be properly formulated so it can be safely transported and administered to patients, leading to rigorous experiments testing the shelf life of the chosen biomolecules in various solutions and under wide ranging conditions.
In this manner, we will find not just one, but many, COVID-19 vaccine patents once the pre-publication window at the patent offices ends and we all are able to peer into the technical details. Until then, we will have to wait and see which of the many projects will yield successful vaccines and strong patents (all of the aforementioned modifications, while circumventing the natural product exclusion, must still be novel and non-obvious to one of skill in the art), but during this public health crisis, it is encouraging to know that no simple catch-all vaccine patent can threaten to stifle the widespread ingenuity and hard labor we very much need.
The COVID-19 crisis has brought unprecedented demands on small businesses and inventors. Through these challenging times, we know that so many are making courageous sacrifices to preserve employee well-being while keeping the lights on. Consistent with our mission to support emerging growth companies, we feel that such sacrifices should not include the loss of hard-fought R&D efforts.
We'd like to help. Aurora Consulting is proud to announce the RISE Award, which offers a free provisional U.S. patent application or $5,000 towards a non-provisional U.S. patent application to a selected applicant. We hope that this award can help provide stability and encouragement to diligent innovators.
COVID-19 is touching all aspects of our personal and work lives in profound ways. Below you'll find a roundup of our best coverage on how this is impacting venture-backed startups, what we might learn coming out of this crisis, some tips on how to navigate the Paycheck Protection Program, and a guide to effectively working from home.
The COVID-19 crisis has triggered a tsunami of folks working from home. This has spurred a ton of questions from friends, family, and not yet liberated former colleagues about remote work. As a company that has been fully distributed since day 1, we have some thoughts. We’ve seen people harness the autonomy and do the best work of their lives. We’ve seen others fail hard. This guide has been assembled with much love to help sway the balance in your favor … at least as much as is humanly possible under present circumstances.
Ashley Sloat, Ph.D.
Startups have a unique set of patent strategy needs - so let this blog be a resource to you as you embark on your patent strategy journey.