Greenblum & Bernstein, P.L.C.



Recent News in Intellectual Property


                                                                                September-October   2011   

In This Issue

·    CAFC Construes Section 101 Patent Eligibility re: Methods To Immunize

·    AIA Signed Into Law

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Jill M. Browning

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Patent Eligibility Of Immunization Methods

The Federal Circuit has addressed patent-eligible subject matter (under 35 U.S.C. §101) in the context of patent claims directed to infant immunization schedules.  The CAFC determined that two of the three patents at issue included patentable subject matter in view of the Supreme Court’s decision in Bilski v. Kappos, because the claims included the step of immunization.  The patent claims directed only to comparing certain data sets did not meet the patent eligibility test under Section 101.

In Bilski, the Supreme Court determined that the exclusion of subject matter from patent-eligibility should be considered on a case-by-case basis and the exclusion should be applied narrowly.  Here, Classen Immunotherapies owns three related patents which state that the schedule of infant immunization for infectious diseases can affect the later occurrence of chronic immune-mediated disorders including, for example, asthma, hay fever, cancer and diabetes.  Generally, the claims of two of the patents are directed to a method whereby the immunization schedules and occurrence of chronic disease is screened and compared and the lower risk schedule is identified and the vaccine is administered on that schedule.  The claims of the third patent, however, are generally to a method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder, but the comparison or determination is not subsequently applied to any particular immunization schedule.   

The lower court found all claims invalid under 35 U.S.C. §101 because, in the court’s opinion, the claims were directed to an “abstract idea.”  Before Bilski, the CAFC agreed, finding that the claimed methods are not associated with a machine and do not transform matter.  Classen appealed to the Supreme Court, which remanded the case back to the CAFC to reconsider its ruling in view of the Supreme Court’s Bilski decision, which found that the “machine-or-transformation test” is not the sole standard of patent eligibility and further cautioned to apply Section 101 narrowly. 

The CAFC has now determined that, even where mental steps are involved, the case law does not support a universal or rigid rule to eliminate subject matter from patent-eligibility.  Rather, the CAFC concluded that the claims that included the physical step of immunizing a child in accordance with the determined schedule were directed “to a specific, tangible application” and, thus, encompasses patent eligible subject matter.  However, the claims that were directed only to the method of “determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder” (and did not include the subsequent step of immunization on an optimum schedule), were simply directed to “the idea of comparing known immunization results that are, according to the patent, found in the scientific literature, but does not require using this information for immunization purposes.”  


The Leahy-Smith America Invents Act (“AIA”) was signed into law on September 16, 2011, making sweeping changes to the U.S. patent practice.  The most significant aspects of the AIA include: 

First-to-File System: The U.S. patent system will change from a first-to-invent system to a first-to-file system for patent applications with an earliest claimed priority date of March 16, 2013.   Current interferences will eventually be replaced with derivation proceedings, which are only available in limited circumstances. 

Post-Grant Review Proceedings: A third party will be able to challenge a patent (that claims an earliest priority date of March 16, 2013) based on a broader range of issues, as long as the challenge occurs within nine (9) months of issuance of the patent (or broadening reissue).   

Inter Partes Review: Inter partes reexamination will be replaced with inter partes review proceedings, available as of September 16, 2012.  This proceeding may be instituted nine (9) months following issuance of a patent or after termination of a post-grant review, and can be based on prior art patents or printed publications. 

Preissuance Submission by Third Parties: Third parties may submit patents, published applications and other printed publications to the USPTO.  The submission must include a description of the relevance of each document, and the submission must be made within prescribed time periods. 

Supplemental Examination:  If a patent owner can show a substantial new question of patentability, supplemental examination may be requested to consider, reconsider or correct information believed to be relevant to the patent.  This procedure will allow, in certain circumstances, patent owners to cure a patent of inequitable conduct. 

Best Mode Requirement:  Disclosure of best mode remains a requirement of a disclosure, but failure to comply with the best mode requirement will no longer be a basis for invalidating a patent.

USPTO Patent Fees:  Most fees were raised by 15% and the USPTO will be able to establish new fees in the future.

Over the next several years, many aspects of the AIA will be clarified as case law develops implementing the new act. 


The NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property. The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC.  For more information, contact Jill M. Browning at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191.  Copyright 2011 GREENBLUM & BERNSTEIN, P.L.C.