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.