“The USPTO is on the receiving end of a lot of pressure to improve patent quality…and the agency is responding to that pressure in the only way that it can: by heightening standards surrounding certain examination practices that receive more public scrutiny.”
On November 4, the U.S. Patent and Trademark Office (USPTO) hosted a webinar regarding the agency’s recent request for comments (RFC) on initiatives that the USPTO is exploring to enhance the robustness and reliability of patent rights issued by the agency. While the USPTO senior legal advisors moderating the webinar indicated that the agency was interested in hearing all viewpoints, the types of initiatives being considered could lead one to believe that ensuring robust and reliable patent rights means encouraging fewer U.S. patent filings.
Senators’ Concerns About Drug Patent Thickets Spur RFC
The USPTO first announced its RFC on the robust and reliable patent rights initiatives back in early October. “Robust and reliable patent rights” has become a buzzword phrase during the early days of Kathi Vidal’s tenure as USPTO Director, as Day One of IPWatchdog LIVE this September made clear. During a fireside chat with IPWatchdog CEO Gene Quinn, Hope Shimabuku, Director of the USPTO’s Texas Regional Office, said that the USPTO under Director Vidal was pursuing several key initiatives designed to help the agency issue robust and reliable patent rights. The USPTO’s RFC, issued this October, included a list of 11 questions, including several with multiple subparts, regarding changes to patent examination practice at the agency to produce patent rights that “incentivize and protect the immense research and development investment essential to bringing such products to market and to spur the collaboration necessary for quick and speedy drug and biologic development.”
In part, the RFC was spurred by a letter this June signed by six U.S. Senators raising concerns with the agency’s issuance of continuation patents. While the letter made several unsubstantiated claims about the effects of continuation patent filings on so-called “patent thickets” within the drug industry, and neglected to mention that the USPTO remains under a permanent injunction preventing the agency from engaging in rulemaking that would limit the issuance of continuation patents, all six of the questions raised in the Senators’ letter were included verbatim in the USPTO’s RFC on robust and reliable patent rights initiatives.
Robust, Reliable Patents Should Create Expectations That Claims Will Pass Later Scrutiny
The USPTO’s webinar on the RFC began with a quick tutorial by Raul Tamayo, Senior Legal Advisor in the USPTO’s Office of Patent Legal Administration, on how to properly submit a comment on the RFC. Comments must be posted through the U.S. government’s comment portal at regulations.gov, although a Patent Alert on the RFC posted on the USPTO’s website includes a link to the comment portal. As of the start of last Friday’s webinar, Tamayo indicated that 10 comments have been received so far, although the notice page on regulations.gov indicates that 47 comments have been received as of 11:59 PM on November 4. The docket number for the RFC is PTO-P-2022-0025, although browsers searching the docket number on regulations.gov should be aware that comments can only be submitted through the page for the original October RFC and not the notice from early November extending the comment period.
In his presentation, Tamayo noted that robust and reliable patent rights best fulfill the constitutional mandate to promote the progress of science. Tamayo said that a robust and reliable patent is one that clearly defines the scope of the patent right and permits those in the relevant field of technical art to identify the boundary of a patent owner’s right to exclude. Further, such patents provide both inventors and their investors with the reasonable expectation that their patent rights will pass scrutiny if challenged.
In discussing each question contained within the RFC, Tamayo talked about a few of the initiatives that the USPTO could adopt in order to address perceived issues in patent examination practice. While patent examiners currently have useful tools for conducting prior art searches of patents and printed publications, Tamayo indicated that the USPTO was interested in finding better data sources for invalidating prior art, such as public uses or offers to sell an invention. Tamayo also discussed the RFC’s questions regarding the agency’s practice on continuation filings, noting that the June letter from the U.S. Senators indicated heavy interest in the agency’s process for issuing continuation patents with new claims with support from the written description and drawings of an earlier issued patent.
Examples of Independent and Distinct Inventions That Trigger a Restriction Requirement
June Cohan, Senior Legal Advisor in the USPTO’s Office of Patent Legal Administration, covered the portion of the webinar discussing the RFC’s questions on restriction practice. Under 35 U.S.C. § 121, a patent examiner will issue a restriction requirement to a patent applicant if the examiner deems the patent application to contain two independent or distinct inventions. Patent applicants facing a restriction must either “elect” one of the inventions identified by the patent examiner, who then withdraws the claims covering the unelected invention, or provide reasons why the restriction is inappropriate. Cohan noted that such situations often involve genus claims or Markush groups, which are patent claims that cover alternative elements within an invention when those elements share a structural similarity and common use.
To provide an example of restriction practice, Cohan offered a hypothetical to explain the differences between inventions that are independent and those that are distinct under the agency’s interpretation of Section 121. A situation with two distinct inventions might arise if a patent applicant filed a claim covering a genus of cash registers, including a manual register and a register with an electronic display. While proper claim drafting could provide a basis for the examiner to consider such a claim as a Markush group, claims that do not connect the members of the group in design, operation or effect will likely lead to a restriction requirement being filed. Cohan distinguished this scenario with patent applications that receive restriction requirements for containing inventions that are completely independent of each other, such as patent claims covering a cash register and a step ladder. Cohan noted that, while both of those inventions would be useful in a retail store setting, the respective inventions are not connected in design, operation or effect.
Cohan also covered the RFC’s questions related to divisional, rejoinder, and non-statutory double patenting practice at the USPTO. While double patenting doctrine forbids patent applicants from obtaining more than one patent on the same invention, Cohan noted that patent examiners analyze double patenting issues based on the same distinctiveness standard that is assessed for restriction practice. As already reflected by the original RFC issued by the USPTO, Cohan reaffirmed that the agency was considering whether it should require patent applicants to overcome double patenting issues by conceding that problematic claims are not patentably distinct, which is currently not a condition of obtaining a terminal disclaimer.
Adding More Steps to a Patent Examination Staircase That Leads to Section 101 Issues
The upshot of the USPTO’s RFC on robust and reliable patent rights seems to be that the USPTO is on the receiving end of a lot of pressure to improve patent quality, without calling it “patent quality,” and the agency is responding to that pressure in the only way that it can: by heightening standards surrounding certain examination practices that receive more public scrutiny. It’s an unenviable task, and one that highlights the downstream issues that can occur when controversial data sets that arguably confuse the public debate about patents are able to infiltrate the halls of Congress with ease. Further, as long as Congress allows Section 101 subject matter eligibility issues created by the federal judiciary to continue swallowing all of patent law, the USPTO’s search for more robust and reliable patent rights is somewhat reminiscent of a trip through the Winchester Mystery House: the agency can keep adding steps to the patent examination staircase, but patent owners reaching the threshold of U.S. courts are met with a blank wall at the top of the steps.