Machine-Or-Transformation Test After Myriad: Implications To The Prosecution Of Process Claims

Michael Davitz, Partner at Axinn, Veltrop & Harkrider and Practice Center Contributor, recently sent in this article he wrote with colleague’s Josephine Liu and Stacie Ropka discussing recent case law on the patentability of process claims.

Not all inventions are patentable.  The Federal Circuit recently handed down its decision in Myriad[i] and the Supreme Court will be hearing Prometheus[ii] in the term beginning in October 2011.  The issues in both Myriad and Prometheus highlight the difficulty in determining when a claim directed to a process is patentable subject matter under § 101, a determination that is particularly troubling in many inventions related to the life sciences.

A first step for granting a patent is determining whether or not a patent application claims patentable subject-matter.  In a line of cases from the late 70s to early 80s and reaffirmed in 2010, the Supreme Court explained that 35 U.S.C. § 101 is to be interpreted broadly and has articulated only three exceptions to what is patentable:  (1) laws of nature; (2) physical phenomena; and (3) abstract ideas.[iii] With respect to process claims, the line between patentable “processes” and unpatentable principles or abstract ideas is not always clear.  The Supreme Court has yet to provide a concrete test by which such a distinction can be made.[iv] It did, however, provide a hint in Gottschalk v. Benson stating that “[t]ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.”[v] From this pronouncement, the Federal Circuit formally presented and applied the machine-or-transformation test in In re Bilski.[vi] (more…)

Post-Bilski: “Patent Strategy for Personalized Medicine”

Today’s guest post comes from Michael J. Shuster, Ph.D. (a partner in Fenwick & West’s Intellectual Property group and co-chair of  the lifes sciences group) and Pauline Farmer-Koppenol (associate in Fenwick & West’s intellectual property group).

Protecting inventions in personalized medicine with patents is essential to making the investment in research and development of those inventions worthwhile.  Absent meaningful patent protection, however, companies will be less likely to pursue such innovation since there is nothing to prevent competitors from free-riding on the back of the many hours and millions of dollars expended by the innovator company.

Personalized medicine diagnostics can produce meaningful improvements in patient outcome and medical economics.  Diagnostic innovations developed by University of California Professors Dan Pinkel and Joe Gray allowed for the first time sensitive and accurate measures of gene amplifications in breast cancer patient biopsies. This allows physicians to determine whether Herceptin® (trastuzumab) treatment is likely to improve the patient’s outcome because only tumors with the amplification respond to Herceptin®.  Pinkel and Gray’s remarkable invention was exclusively licensed to Abbot Laboratories which devoted years of effort and millions of dollars to bring this innovation to market.  Considering the cost of a full course of treatment with Herceptin®, approximately $70,000, the development of the HER2/neu amplification diagnostic test is valuable not only in minimizing the use of an expensive treatment for patients for whom it is unlikely to provide benefit, but it also helps patients by not wasting valuable time pursuing a treatment that is unlikely to be beneficial. (more…)

Article Of Manufacture Claims for Software Inventions: Should They Be Included in Your Patent?

Burt Magen, partner at Vierra Magen Marcus & Deniro LLP and Practice Center Contributor passed along this article he wrote entitled Article of Manufacture Claims for Computer Related Inventions.  According to Magen, article of manufacture claims can offer advantages over apparatus and process claims, including providing an easier mechanism for enforcement of the patent.  With the knowledge provided in his article, Magen says, “patent practitioners can efficiently draft appropriate article of manufacture claims to more effectively protect software inventions.”  Here is the Introduction:

The software industry is growing and becoming more important to the global economy.  As a result, the number of software patent applications has increased dramatically.  To maximize the value of software patents, it is important that the claims of such patents properly protect the invention.  Typically, software patents include apparatus claims, method claims, and/or article of manufacture claims.  Because of the nature of the software industry, for some inventions the article of manufacture claims may be the most important class of claims.  Yet, many software patents do not include article of manufacture claims or include an incomplete set of article of manufacture claims as an afterthought. (more…)

Patent Office Releases Interim Bilski Guidelines

Written by Gene Quinn (of and Patent Center Contributor)

This morning the United States Patent and Trademark Office published Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos. The Interim Bilski Guidance is effective July 27, 2010, and applies to all applications filed before, on or after the effective date. Most noteworthy is that the Patent Office is encouraging examiners to issue 101 rejection in only “extreme cases” and allow patentability to be decided by sections 102, 103 and 112.

These interim guidelines build upon the memo sent to the examining corps the day the Supreme Court issued its decision in Bilski v. Kappos, and is intended for use by Office personnel when determining subject matter eligibility under 35 U.S.C. 101. According to the Federal Register Notice, this guidance supersedes previous guidance on subject matter eligibility that conflicts with the Interim Bilski Guidance.

Significantly, the guidelines explain:

Therefore, examiners should avoid focusing on issues of patent eligibility under Sec. 101 to the detriment of considering an application for compliance with the requirements of Sec. Sec. 102, 103, and 112, and should avoid treating an application solely on the basis of patent eligibility under Sec. 101 except in the most extreme cases.

This should be music to the ears of the patent bar and applicants who were previously stopped dead in their tracks by a seemingly insurmountable 101 rejection. (more…)