The USPTO has announced a new pilot program to permit Applicants to obtain consideration of certain Information Disclosure Statements (IDSs) after the Issue Fee has been paid without having to reopen prosecution. The “Quick Path Information Disclosure Statement (QPIDS) Pilot Program” takes effect May 16, 2012 and will run through September 30, 2012 unless it is extended.
As announced in a recent Federal Register Notice, the USPTO is soliciting public comments on its information collection requirements, in accordance with the Paperwork Reduction Act. This is an important opportunity to highlight requirements that are unnecessarily burdensome and that may go beyond requirements authorized by statute. While my main paperwork concerns relate to the IDS rules, the Notice highlights other areas where the USPTO may be underestimating the burdens of its regulations. The USPTO will consider written comments received by May 21, 2012. Continue reading this entry
On Wednesday, February 15, 2012, the Patent Public Advisory Committee (PPAC) will hold its first public hearing on the patent fees that the USPTO proposes to charge in accordance with its new fee-setting authority conferred by the America Invents Act. In advance of this meeting, the USPTO released several documents outlining and explaining the proposed patent fees. Even taking the USPTO’s cost estimates at face value, I have several questions and concerns about some of the proposed fees. Continue reading this entry
In a Federal Register Notice issued December 1, 2011, the USPTO issued a final rule that tweaks the patent term adjustment rules to permit applicants to promptly file McKesson-type Information Disclosure Statements (IDSs) without incurring a patent term adjustment deduction. The rule change took effect on December 1, 2011.
(The Federal Register Notice indicates that previously proposed changes to the calculation of patent term adjustment when the USPTO reopens prosecution after a Notice of Appeal are being revised and will be published for comment separately.) Continue reading this entry
I know that the USPTO is busy studying the America Invents Act and drafting its implementing regulations, but it is disappointing that nothing has been done to address the inefficiencies of the current Information Disclosure Statement (IDS) rules. This inaction is even more egregious now that the Trilateral Patent Offices (EPO, JPO, USPTO) have launched the Common Citation Document Application (CCD) to provide easy access to references identified in search reports.
The UPTO has announced a preliminary plan for the retrospective analysis of USPTO regulations it will undertake pursuant to Executive Order 13563 (“Improving Regulation and Regulatory Review”). The July 7, 2011 Federal Register Notice primarily refers to information on the Department of Commerce website, but includes an open invitation for public comments and suggestions.
The Proposed Process
According to the Preliminary Plan, the USPTO’s Office of General Counsel will implement and maintain the “look back” plan, at the direction of the Deputy General Counsel and Solicitor. The Preliminary Plan indicates that additional training will be provided for involved personnel, including “additional training concerning rulemaking” and “substantive areas of law related to the USPTO’s significant regulations, such as patent and trademark law.”
The USPTO intends to conduct the review “over the next two years or more.”
(I wonder what will happen to this plan if Patent Reform is enacted and the USPTO has to write a whole new set of rules?)
Based on the results of its review, the USPTO will determine if rules “warrant modification, expansion, streamlining or repeal . . . and how that can be accomplished.”
As set forth in the Preliminary Plan, although the Office of General Counsel will drive the review process, “the ultimate determination of how to revise significant regulations based on this analysis will be made in consultation with the relevant business units at USPTO responsible for drafting the significant regulation in question.” The USPTO also will “coordinate with other Federal agencies that have jurisdictions or similar interests that relate to USPTO’s significant regulations, such as consulting with the Small Business Administration concerning the impact of rules on small businesses. The USPTO also will continue to solicit public comment.
The USPTO will maintain a webpage (“Look Back Plan: Plan for Retrospective Analysis of Existing Regulations”) with information about the plan.
The USPTO’s Top Ten List
When the regulatory review process first was announced, I was hopeful that the USPTO might seize the opportunity to alleviate some of the administrative burdens associated with Information Disclosure Statements. As I read through the Preliminary Plan, I was disappointed to see that 37 CFR § 1.98 did not make the USPTO’s top ten list. Here’s what did:
- 37 CFR § 1.52 (“Language, paper, writing, margins, compact disc specifications”)
- 37 CFR § 1.78 (“Claiming benefit of earlier filing date and cross-references to other applications”)
- 37 CFR § 1.121 (“Manner of making amendments in applications”)
- 37 CFR § 1.53 (“Application number, filing date, and completion of application”)
- 37 CFR § 1.704 (“Reduction of period of adjustment of patent term”)
- 37 CFR § 1.75 (“Claim(s)”)
- 37 CFR § 1.114 (“Request for continued examination”)
- 37 CFR § 1.321 (“Statutory disclaimers, including terminal disclaimers”)
- 37 CFR § 1.76 (“Application data sheet”)
- 37 CFR § 1.136 (“Extensions of time”)
I am underwhelmed by the this list, but given the selection criteria, it makes sense:
These ten candidate rules were selected because they have significant impact on the day-to-day operations of USPTO and the high volume of patent applications it processes. Even minor revisions that improve or simplify these rules could result in immediate, significant, and widespread benefits for patent applicants in their daily interactions with USPTO.
(Also, maybe these rules would be unaffected by Patent Reform . . . .)
It is interesting to see the Patent Term Adjustment (PTA) rule include in a list of rules that otherwise are largely procedural.
Is The USPTO Plan Responsive To Public Comments?
Included in the Preliminary Plan is a summary of the public comments the USPTO has reviewed to date. Because the USPTO did not respond to the comments, it is not clear whether they were taken into account when selecting the initial rules for review.
It is possible that aspects of the plan reflect some comments, such as:
- That USPTO appoint an individual tasked with ensuring USPTO compliance with regulatory principles and administrative rules and procedures.
It would be interesting to know if the selected rules are associated with problems, or simply apply to a large percentage of applications. For example, did they arise from any of the following comments:
- That USPTO consult its own personnel about inefficiencies or problems in regulations that could be corrected.
- That USPTO conduct review of regulations in areas where there are a disproportionate number of applicant or USPTO procedural mistakes, which may be an indicator the regulations need improvement.
- That USPTO give high priority to pendency issues in considering regulatory reform, and apply its resources in revising or developing new rules to those that will contribute most to a decrease in pendency, for example, reviewing rules concerning after-final practice and reexamination.
Clearly, this comment was not persuasive, or the IDS rules would be under consideration:
- That USPTO seek to reduce the burden on patent and trademark applicants by eliminating requirements for them to provide information to USPTO that is already available elsewhere.
I have to point out the irony of this comment:
- That USPTO seek to improve the extent and quality of its transparency and openness in a variety of ways, including in how it addresses public comments and in its other processes and with its data concerning applications.
The Federal Register Notice indicates that the Preliminary Plan is available at http://www.commerce.gov, but does not provide a full web address for the document. After poking around the Department of Commerce website and using its search function to no avail, I resorted to Google and found the plan at http://open.commerce.gov/news/2011/06/27/commerce-preliminary-plan-retrospective-analysis-existing-rules. Even the USPTO’s webpage for the plan does not provide a link to the plan!
In case you missed it, here is a link to the Department of Commerce Preliminary Plan For Retrospective Analysis of Existing Rules, which includes the USPTO’s plan.
As I noted last week, the USPTO is revisiting its guidance on the Duty of Disclosure in the wake of the Federal Circuit’s en banc decision in Therasense. While the USPTO is reviewing the substantive requirements of the Duty of Disclosure, I hope that it also takes this opportunity to ease the procedural burdens associated with Information Disclosure Statements (IDSs).
The oracle told Julius Caesar to “beware the ides of March,” but patent practitioners have more cause for concern about the IDSs they will have to file in March.
The McKesson Problem
Federal Circuit decisions such as McKesson indicate that there can be a duty to disclose information from co-pendng U.S. applications, including Office Actions and cited references. However, the USPTO’s current IDS rules do not provide an efficient framework for citing information from a co-pending U.S. application that is undergoing parallel examination. As a result, applicants are forced to submit copies of documents already in the hands of the USPTO.
I have proposed three changes to the MPEP and USPTO regulations that the USPTO could adopt to alleviate the burdens of complying with the duty of disclosure in this context. I have pointed out that the required refiling of documents that the USPTO already has burdens the USPTO as well as applicants. I have noted that “McKesson IDS” is one of the most common search topics that bring people to this blog.
The IDS of March
The “IDS of March” is an IDS that caught my attention as symbolizing the wastefulness imposed by the current IDS rules that require applicants to file copies of documents in one application that the USPTO already has in connection with another (identified) application.
There has to be a more efficient way to get this information in front of examiners without needlessly burdening applicants, the USPTO and the environment.
Do you have a McKesson-type IDS that should be featured as an IDS of March?
Leave a comment and I will follow-up with you.
As the USPTO begins the process of updating the Manual of Patent Examining Procedure (MPEP) and the Trademark Manual of Examining Procedure (TMEP), it is inviting public comment on specific sections through new “online discussion tools.” I am encouraged by the USPTO’s interest in public input on these guidance materials, and hope that members of the patent community take advantage of this opportunity to provide meaningful comments and suggestions on the procedural and substantive guidance they provide.
According to the USPTO’s press release, the tools will facilitate discussion and feedback by:
- Encouraging readers to post comments about the current text, on a section-by-section basis, to point out errors, suggest clarifications, and suggest examples of interpretations.
- In some circumstances, posting preliminary content and encouraging the community to comment on the preliminary content before it becomes official.
- Periodically summarizing and following up on the comments on each section to ensure that meritorious suggestions are acted upon while streamlining the comment process.
- Providing a forum for the community to discuss and debate topics such as how to interpret recent court decisions.
As set forth on the Terms of Participation page:
The ultimate objective is to create an MPEP that will enable practitioners and examiners to find information quickly, get accurate and complete guidance, and ensure that all patent applications comply with the laws and regulations governing the patent system.
The first MPEP chapters open to this process include:
- Chapter 500 – Receipt and Handling of Mail and Papers
- Chapter 600 – Parts, Form, and Content of Application
The “tools” are in essence discussion forums where members of the public can submit comments, read and comment on other comments, and “vote” on comments with a “thumb up” (“I agree”) or “thumb down” (“I disagree”).
Those interested in reviewing or contributing comments can access the MPEP tool here and the TMEP tool here. No registration is required to review the comments, but registration (name, email address, and password) is required to provide any input.
Although the USPTO seems to be kicking off this effort with non-controversial sections of the MPEP, there already are some interesting comments on the ”requirements” for patent application abstracts. There also is a comment asking for guidance on McKesson-type Information Disclosure Statements that I promise I didn’t write, but I do hope that the USPTO understands and addresses the serious burden associated with these IDSs.
In a recent post on his blog, Director Kappos discussed the progress the USTPO has made towards improving patent processes. He reports that in fiscal year 2010 the USPTO "[e]ntered more than 2.9 million documents." Now, he doesn’t categorize these documents, but I wonder how many include Information Disclosure Statements that submit copies of references or Office Actions that the Patent Office already has in the electronic files of other patent applications. Yes, I am referring to the McKesson IDS problem again!
One of my first blog articles proposed three easy solutions to the McKesson IDS problem. I understand that this problem is not a major prioirty for the USPTO, but I was hopeful that it would make the agenda after Director Kappos wrapped up his first year leading the USPTO.
When the EPO waived its new disclosure requirements for applications where it could readily obtain the information itself, I thought that the USPTO would take notice. How can the USPTO require US applicants to submit in one application copies of references and Office Actions from another application, when the EPO has decided that applicants with US priority applications do not have to submit copies of US Office Actions, because the EPO can obtain those documents itself from the USPTO’s PAIR website?
Now, Director Kappos has shined a spotlight on the overwhelming number of documents the USPTO must process on a yearly basis. If the USPTO has not investigated what portion of these documents is made up of Information Disclosure Statements, and what portion of Information Disclosure Statements submit copies of documents that the USPTO already has on file in association with another application, it should. And, if it has looked at those numbers, it should share them with the public.
The current IDS processes waste applicant resources, USPTO resources, and paper:
If we recieve an Office Action in one application, we may decide (pursuant to McKesson) to cite it (and any newly cited references) in an IDS in a copending application. Even though the USPTO already has a copy of the Office Action and the references from the first application, the current IDS rules require us to submit copies in the second application in order to have them considered by the examiner.
If the IDS includes a large number of documents or lengthy documents, we are likely to file hard copies, because copying documents is faster than scanning and uploading them one by one to PAIR.
When the USPTO receives the hard copies, it then scans them into its own electronic files to be indexed in PAIR with the second application.
Thus, the current rules require the same documents to be processed three times:
- First, when the USPTO issues the first Office Action and provides copies of non-patent references.
- Second, when the applicant copies the Office Action and references for the IDS in the copending application.
- Third, when the USPTO scans the Office Action and references from the IDS for the electronic file of the copending application.
Even if only a small fraction of the 2.9 million documents processed by the USPTO in 2010 are McKesson-type IDSs, it is clear that the USPTO could realize signficant process improvements if it at least waived the requirement to submit copies of documents already in its possession. As the number of pending applications continues to grow year over year, the number of IDSs will only increase. The USPTO’s failure to address this issue will undermine its efforts to improve its internal processes and could delay the overall patent process if examination is delayed while IDS documents are entered into the USPTO’s system.
This week the Federal Circuit heard oral arguments in its en banc rehearing of Therasense, Inc. v. Becton, Dickinson & Co. As reflected in the en banc order, the court took this case en banc in order to reconsider—and hopefully reform—the law of inequitable conduct. The court’s decision could solve the McKesson problem and rein in the threat of inequitable conduct charges that drives practitioners to submit references even when they are not believed to be relevant to patentability.
David Kappos has wrapped up his first year as Director of the USPTO. As noted in his blog, he has implemented a number of new programs and rolled out several new initiatives. Perhaps most importantly, he has fostered an atmosphere of cooperation between the USPTO and the stakeholder community. With that in mind, I again urge the USPTO to take action to solve the McKesson Information Disclosure Statement (IDS) problem. I am not the only one concerned with this issue. One of the most common search topics that bring people to this blog relate to "McKesson" and "IDS." Clearly, stakeholders are burdened by this problem and are looking for guidance and solutions.
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.
Federal Circuit decisions such as McKesson Information Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897 (Fed. Cir. 2007), indicate that there can be a duty to disclose information from co-pendng U.S. applications, including Office Actions and cited references. However, the USPTO’s current IDS rules do not provide an efficient framework for citing information from a co-pending U.S. application that is undergoing parallel examination. As a result, applicants are forced to submit copies of documents already in the hands of the USPTO and to undertake the costly and time-consuming process of filing Requests for Continued Examination (RCEs) in order to comply with the current IDS rules.
Now that it has been three years since the McKesson decision was issued, the time for the USPTO to relieve the burden of these decisions is long overdue. Here are three simple solutions that the USPTO could adopt: