The USPTO promotes the Patent Prosecution Highway (PPH) as a way to “fast-track” a U.S. patent application when a corresponding foreign application has been allowed, or when a corresponding PCT application has received a favorable Written Opinion from a Searching Authority that participates in the PPH program. While a USPTO Examiner still will conduct an independent search and examination of the application, USPTO statistics indicate that PPH applications do enjoy a more compact patent prosecution process and a higher allowance rate. Applicants considering the PPH program for a pharmaceutical patent application should be aware of one pothole that could lead to an improper (in my view) denial of a Request to participate in the PPH. Continue reading this entry
In a press release issued July 1, 2011, the USPTO announced pilot changes to the Patent Prosecution Highway (PPH) that will make the PPH much more widely available, and hence much more useful, to many applicants. Most welcome is the change that will permit PPH filings based on an indication of allowability from any participating patent office, not just the patent office of the priority country.
The USPTO has announced that starting January 24, 2011, the Patent Proecution Highway between the USPTO and Australia will expand to include positive patentability determinations made under the PCT. While the details of the this PCT program have not yet been promulgated, I assume they will be similar to those in place for the current PCT-PPH programs.
Patent Prosecution Highways – Express Lanes To Examination
As I explained in my first detailed article on PPH programs, each PPH offers “fast tracked” examination in a “second” patent office (Office of Second Filing, OSF) for claims that have been determined to be patentable by a “first” patent office (Office of First Filing, OFF).
For the non-PCT (direct) PPH programs, the OFF is the Patent Office of the priority application country. If there is no priority application, the OFF can be the first Patent Office to issue a favorable patentability ruling. But, if the priority application was filed in one country (such as France) and a favorable patentability ruling is first received from another patent office (such as Australia), it is not possible to use the favorable ruling to fast-track examination in the U.S.
The USPTO has PPH agreements with fourteen patent offices:
Australia, Austria, Canada, Denmark, Europe, Finland, Germany, Hungary, Japan, Korea, Russia, Singapore, Spain, and United Kingdom
The existing PCT-PPH programs are somewhat less restrictive, and do not base eligibility on the presence or absence of a specific priority claim:
[A]n applicant receiving a written opinion or an international preliminary examination report from [a participating patent office] or the USPTO that at least one claim in a PCT application has novelty, inventive step, and industrial applicability may request that the other office fast track the examination of corresponding claims in corresponding applications.
With the new Australian PCT-PPH program, the USPTO will have PCT-PPH agreements with eight patent offices:
Australia, Austria, Europe, Finland, Japan, Korea, Russia, and Spain.
Advantages of the PCT-PPH Programs
The PCT-PPH programs offer several advantages over the direct PPH programs.
First, the PCT-PPH programs do not have the restrictive priority requirements that apply to the other PPH programs. These requirements exclude a number of applications that otherwise might have been able to benefit, and prevent the USPTO from reusing the work of another patent office simply because it is not the office of the application’s priority country.
Second, the PCT-PPH programs may be available earlier in an application’s lifetime, because a PCT written opinion or international preliminary examination report is likely to be issued before a patent office makes a patentability determination. In such cases, an applicant may be able to use the PPH to avoid months or years of waiting for examination.
Third, although the PPH programs still are based on bilateral agreements, PCT-PPH programs may exist between multiple patent offices. That means that a favorable patentability finding from the EPO PCT searching/examination authority could be used to fast-track examination in multiple countries, such as the U.S., Japan, and Korea.
Disadvantages of the PCT-PPH Programs
The PPH programs require the applicant to amend the claims to correspond to those determined to be patentable by the OSF. In the context of PCT-PPH programs, this means that only claims found to be patentable initially (in the written opinion), or after only one response (in the international preliminary examination report) can be presented in a PCT-PPH application. While other claims could be pursued in a continuation or divisional application, applicants may not want to bear the expense of prosecuting and maintaining separate applications and patents.
Should You Take The Highway?
While I still am not convinced that the PPH programs will achieve the USPTO’s goals of improving the quality and efficiency of patent examination and reducing the USPTO’s workload, I do think that it is something that applicants should consider when they receive an indication of patentability in an OFF or PCT written opinion or international preliminary examination report. With the average wait to a first office action from the USPTO still hovering at 24 months, many applicants are interested in knowing about all possible strategies for obtaining examination sooner rather than later.
When Director Kappos wrote on his blog about international worksharing programs, he also provided a summary of current options for prioritized U.S. examination. While most are well-known, it is good to keep all options in mind when prompt examination is important, such as when a commercial product is on the market (or will be within the average 3-5 year pendency time) or infringement is suspected.
During his first year as Director of the USPTO, David Kappos has championed international worksharing as a key mechanism for addressing the growing workload—and backlog—facing patent offices around the world. Patent Prosecution Highway programs were the first international worksharing initiatives, and a recent announcement on Kappos’ blog indicates that more programs are on the horizon.
Patent Prosecution Highway (PPH) Programs
Each PPH program is based on the same basic principle:
[A]n applicant receiving a ruling from the Office of First Filing (OFF) that at least one claim in an application filed in the OFF is patentable may request that the Office of Second Filing (OSF) fast track the examination of corresponding claims in corresponding applications filed in the OSF.
Since I first wrote about PPH programs a few weeks ago, new programs have been announced with Austria and Spain. The USPTO now has PPH agreements with the following fourteen patent offices:
Australia, Austria, Canada, Denmark, Europe, Finland, Germany, Hungary, Japan, Korea, Russia, Singapore, Spain, United Kingdom
The PCT-PPH program also has expanded, and the USPTO now has PCT-PPH agreements with Austria, Russia and Spain in addition to Europe, Japan and Korea.
PPH programs permit an applicant to expedite examination in one country after the “OFF” (usually the priority country) has determined that at least some of the claims are patentable. To gain entry into a PPH program, the applicant usually must limit the PPH application to the claims that were determined to be patentable by the OFF.
Because of stringent priority, timing and claim requirements, the PPH programs have limited applicability and usefulness. Still, Director Kappos announced at a September 23, 2010 press conference at the WIPO General Assemblies Meetings in Geneva that the USPTO has processed nearly 4,000 PPH applications.
Next Up: SHARE and FLASH
In addition to the applicant-initiated PPH programs, Director Kappos is promoting office-initiated programs such as the Strategic Handling of Applications for Rapid Examination (SHARE) and First Look Application Sharing (FLASH) programs. A one-year SHARE/FLASH pilot program is planned to start this month (October 2010) and will involve about 100 applications per month.
What is SHARE?
Under SHARE, a patent office will “focus examination efforts” on applications for which it is the OFF, so that other offices can benefit from the OFF’s search and examination results.
In some USPTO outlines of how SHARE might work, a non-OFF patent office (an Office of Second Filing, or OSF) could delay examination until at least preliminary search and examination results are available from the OFF. When the USPTO included this concept in its proposed Enhanced Examination Timing Control Initiative, it was soundly criticized by myself and others. It is my understanding that the USPTO plans to withdraw or modify this aspect of its proposed “three track examination” system, but still may adopt a “default rule” for foreign-origin applications that would delay examination until the OFF issues a substantive examination report, unless the applicant requests accelerated examination.
What is FLASH?
FLASH appears to be an internal program that will help the USPTO effectuate its SHARE obligations when it is the OFF. As summarized by the USPTO, FLASH will be initiated when a U.S. applicant files in Europe or Japan, and requests a copy of the U.S. priority document through the existing Priority Document Exchange (PDX) system.
The PDX request will trigger the USPTO to expedite its search and examination of the U.S. application, and the U.S. examiner will be expected to act on the case within three months. The USPTO will notify the EPO and/or JPO when examination has commenced, and will make the results available through the USPTO’s Public Patent Application Information Retrieval (PAIR) system.
The overall goal for SHARE and FLASH is to have U.S. search and examination results within 18-22 months from the U.S. filing date, to facilitate examination in other countries. This is somewhat depressing when you realize that this means that 18-22 months will be the new target for a first Office Action in applications that the USPTO is giving prioritized treatment to meet its own goals.
Will SHARE Result in Examination Efficiencies?
The SHARE program is based on the premise that having search and examination results from the OFF will facilitate examination in the OSFs. However, examination efficiencies will be realized only if :
- The OFF raises issues that are relevant under OSF patent laws.
Many countries differ on what qualifies as prior art, and on the standards for obviousness, enablement, and written description. These differences will limit the ability of an OSF to leverage the work of the OFF.
- The OSF can expend less effort on its own search and examination.
We know that U.S. examiners still will conduct a search and examination in accordance with U.S. requirements and apply U.S. laws, rules and MPEP guidance. This will limit the efficiency gains from having access to the OFF search and examination report.
SHARE may be most effective at identifying novelty-destroying prior art, but applicants already give the USPTO prior art identified in foreign search reports and office actions, to ensure compliance with the duty of disclosure. When a PCT application is filed in parallel to a U.S. application, the U.S. examiner very well may have PCT search results prior to examination even when the USPTO is the OFF. And, while most other countries do not have a duty of disclosure, many examiners in other patent offices already follow a practice of checking PAIR (and other patent office websites) for search and examination reports from other offices, regardless of which office is OFF and which is OSF. (The EPO is launching a new program that will require submission of the OFF search results, if available.) Thus, it is not clear that this complicated program of delaying and synchronizing examination will give examiners information that they don’t already have on hand or at their disposal.
Will SHARE Help Applicants?
Some will say that all applicants will benefit if SHARE is successful at reducing global patent office workloads, but how will SHARE affect a given application?
For a first-filed U.S. application to benefit from SHARE, the applicant also would have to file in the EPO and/or JPO and make a PDX request. Most U.S. applicants enter the EPO and/or JPO via PCT filings, about 30 months after the U.S. priority date. If the U.S. and PCT applications claim priority to a U.S. provisional application, the EPO and JP applications will be filed about 18 months after the U.S. application. If the PDX request is made promptly and the three month examination goal is met, the U.S. application will receive an Office Action about 21 months after filing, which is in accordance with the USPTO’s SHARE/FLASH goals. This amounts to a five month shortcut over the USPTO’s current average time to first Office Action.
The benefit to foreign-origin U.S. applications is murkier. Presumably the EPO and JPO will have programs similar to SHARE and FLASH when they are the OFF, but the USPTO has not announced how it will leverage those search and examination results for U.S. applications. Some applications may be candidates for a PPH program, but will the USPTO expedite prosecution of other applications when EPO and JPO search and examination results are available?
Then there is the impact on U.S. applications that do not qualify for these or other accelerated examination programs. Unless the USPTO really is able to increase overall productivity, prioritized examination of SHARE applications necessarily will translate to further delayed examination of other applications. This may have a particular impact on independent inventors, small businesses and universities who have more limited budgets for pursuing foreign applications.
Making Sure Worksharing Works
Because SHARE and FLASH are internal, USPTO-initiated programs, it may be difficult to obtain information on program operations and results. I hope that the USPTO publishes data throughout the pilot program, and lets us know how it plans to measure its success. Prompt examination reports from the OFF is just the first step. Unless OFF examination reports lead to increased productivity in OSFs (such as through reduced examination time for OSF applications), SHARE may only complicate global patent protection.
As of August 25, 2010, the USPTO has entered into Patent Prosecution Highway (PPH) agreements with twelve countries. While USPTO press releases tout these programs as “cooperative initiatives that streamline the patent system and promote expeditious, inexpensive and high-quality patent protection throughout the world,” their benefits for the U.S. patent system as a whole, and U.S. applicants in particular, remain to be proven.
In "Ten Tips for Streamlining Patent Prosecution," Director Kappos outlines ten steps that he would like practitioners to take in order to promote compact prosecution. While I agree with most of these steps in principle, often the realities of patent prosecution, business decisions and innovation itself get in the way. Here I discuss items 6-9 of his list.
6) ADVANCE AMENDMENTS/ARGUMENTS EARLY: File arguments and amendments at the earliest stage of prosecution, and prior to a final rejection if at all possible. Amendments submitted after final are more difficult to deal with procedurally, are not automatically entered, and extend prosecution.
- I agree that arguments should be presented early, but there may be many different arguments against a rejection, and an applicant may decide to focus on the strongest arguments for maximum impact and/or to minimize prosecution history estoppel. Often, once an argument is made, the examiner will refine the rejection, so that the real issue is not crystallized until a subsequent Office Action. At that point, a different argument may be more responsive to the examiner’s concerns.
- I do not agree that claim amendments should be presented early, particularly when an applicant has a good faith belief that the rejections are not sound. The costs of amending claims—loss of literal claim scope, possible loss of doctrine of equivalents, and creation of prosecution history estoppel—are too high to make claim amendments that the applicant does not believe are legally necessary.
7) COORDINATE US/FOREIGN APPLICATIONS: Draft or amend your U.S. application in view of the prosecution in a corresponding foreign or international application. Success of the Patent Prosecution Highway (PPH) shows that applications drafted or amended in response to search reports and patentability opinions in corresponding foreign or international applications have a much higher allowance rate and shorter prosecution.
- I approach this suggestion with caution. An applicant legitimately would resist amending U.S. claims in view of foreign prosecution if the reasons for making the foreign claim amendments do not apply under U.S. law. While the concepts of novelty may be largely universal (assuming the reference at issue qualifies as prior art in all countries), standards for obviousness/inventive step, enablement, and written description vary across countries. In the biotech and pharmaceutical fields, where patentability often turns on obviousness or enablement issues, and where different claim formats are permitted in different countries, coordinating claim language may not serve the applicant’s best interests.
- If an application qualifies for a PPH, amending U.S. claims to conform to allowed foreign claims may be a good strategy. Of course, if the applicant believes that the allowed foreign claims are not as broad as it is entitled to obtain in the U.S., the applicant may file a continuing application to pursue broader claims.
8) DRAFT CLAIMS TOWARD THE INVENTION: Know what you want to protect before you file the application and draft the claims toward the invention. If the claim set is not initially drafted to capture the protection needed or desired by the applicant, the examiner will have difficulty doing a comprehensive search on first action. Furthermore, the examiner will have difficulty anticipating what might be claimed in the future, if the initial claim set is misdirected or overly broad. All of this extends prosecution at everyone’s expense.
- This suggestion is one with which the realities of innovation and business development may interfere. In the biotech and pharmaceutical fields, where patent applications may be filed long before any commercial product is finalized, it can be difficult to draft original claims that encompass the eventual commercial embodiments. In pioneering inventions, the "protection needed or desired" can change between the filing date and the first Office Action. If the original claims do not encompass these embodiments, or do not recite them as clearly as the applicant would like, the applicant needs flexibility to amend the claims or pursue new claims.
- This suggestion carries risks if an applicant waits too long to file its application. Other researchers working in the same field may file their own patent applications or publish their work. Because a reference can invalidate a claim even if it would not adequately enable it for patent purposes, applicants have to walk a fine line when deciding whether to file an application or wait until the invention is further developed.
9) KEEP INFORMATION DISCLOSURE STATEMENTS MATERIAL: Submit a focused Information Disclosure Statement (IDS). Include in an IDS only those references material to patentability. The citation of references that are not material to patentability does not promote a focused examination. Also, be careful to avoid the repeated citation of the same reference.
- If it were only this easy! If I had more confidence in determining whether a reference is "material" my IDS submissions would be much smaller. The Federal Circuit told us in McKesson that a reference that does not teach any new elements beyond references already of record may nonetheless be material because of the specific combination of elements it discloses or because of the specific context of the disclosure. McKesson also emphasized the duty to disclose specific rejections made in copending applications, which promoted the practice of including Office Actions in IDSs. Then, the Federal Circuit told us in Larson that an examiner’s misinterpretation of a reference was material for the few months until he realized his error and withdrew the rejection, so that the Office Action should have been submitted in an IDS in a copending application. Decisions like these have made the process of identifying "references that are not material to patentability" difficult and risky.
- I know that many practitioners have thrown up their hands and adopted a "disclose everything" policy. I know that this creates a burden on examiners. I know that this kills too many trees. (I have proposed three specific USPTO solutions to some aspects of the McKesson problem.) But, with the penalty of inequitable conduct, patent unenforceability and loss of professional reputation at stake, practitioners are only being rational when they err on the side of over-disclosure.
As the USPTO develops programs to promote compact prosecution, it must not lose sight of the realities that drive applicant conduct. While compact prosecution is a goal that most applicants share in principle, the circumstances of a given application may warrant prosecution strategies that are focused on overriding goals, such as achieving an appropriate scope of patent protection and complying with the duty of disclosure.