Invalidity of a Patent Claiming Antibodies Characterized by Their Function In View of Amgen

Attorney: Marina I. Miller, Ph.D.
January 12, 2024

Baxalta Inc. and Baxalta GmbH (Baxalta) appealed a district court decision that the claims of U.S. Patent No. 7,033,590 were invalid for lack of enablement. The Federal Circuit (the Court) affirmed the decision.<... Read more

A Broad Outline of a Genus's Perimeter Is Insufficient For Written Description of the Members of the Genus

Attorney: Marina I. Miller, Ph.D.
April 7, 2023

The Regents of the University of Minnesota (“Minnesota”) appealed from a final decision of the U.S. PTO Patent Trial and Appeal Board (“the Board”) holding that the claims of U.S. Patent 8,815,830 were unpatentable as anticipated. The Court of Appeals for the Federal Circuit (“the Court”) affirmed.<... Read more

Anticipation Under the Public Use Bar

Attorney: Marina I. Miller, Ph.D.
April 4, 2023

Minerva Surgical, Inc. sued Hologic, Inc. and Cytyc Surgical Products, LLC in the District of Delaware for infringement of U.S. Patent No. 9,186,208. After discovery, the district court granted summary judgment that the asserted claims were anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b). Minerva appealed. The Court of Appeals for the Federal Circuit (the Court) affirmed.<... Read more

Claims Directed to Detecting Natural Phenomena Using Conventional Techniques Are Patent Ineligible

Attorney: Marina I. Miller, Ph.D.
February 22, 2023

CareDx is the exclusive licensee of U.S. Patents 8,703,652, 9,845,497, and 10,329,607 entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients” owned by Stanford. The patents describe diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (“cfDNA”). When an organ transplant is rejected, the recipient’s body, through its natural immune response, destroys the donor cells, thus releasing cfDNA from the donated organ’s dying cells into the blood. The increased levels of donor cfDNA, which occur naturally as the organ’s condition deteriorates, can be detected and used to diagnose the likelihood of an organ transplant rejection. Claim 1 of the ’652 patent reads (simplified):<... Read more

A Class of 957 Predicted Salts Is Insufficient To Meet the ‘At Once Envisage' Standard

Attorney: Marina I. Miller, Ph.D.
October 26, 2022

Mylan Pharmaceuticals, Inc. (“Mylan”) appealed from the final written decision of the USPTO Patent Trial and Appeal Board (the “Board”) holding that Mylan failed to show that claims 1–4, 17, 19, and 21–23 of U.S. Patent 7,326,708 (the “’708 patent”) were anticipated or would have been obvious over the cited prior art.<... Read more

USPTO Extends Cancer Immunotherapy Pilot Program

Attorney: Marina I. Miller, Ph.D.
October 24, 2022

To accelerate innovation in the health and medical fields, the USPTO published a Federal Register Notice announcing a fifth extension of its Cancer Immunotherapy Pilot Program. Petitions requesting participation in the pilot program that are compliant with the program’s requirements and are filed on or before January 31, 2023, will be accepted. The extension will also allow the USPTO to continue the program while it evaluates potential expansion opportunities. The USPTO first implemented the Cancer Immunotherapy Pilot Program in June 2016, in support of the White House’s National Cancer Moonshot initiative, which sought to accelerate cancer research. It permits patent applications pertaining to cancer immunotherapy to be advanced out of turn for examination and reviewed earlier. The extension reflects the continued effectiveness of the pilot program. All parameters will remain the same as in the original pilot through the January 31, 2023, extension.<... Read more

Failure to Identify the Invention and to Explain How you Do It May Lead to Invalidity under Section 101

Attorney: Marina I. Miller, Ph.D.
October 5, 2022

Integrated Technology Solutions, LLC (“ITS”) alleged that products manufactured and distributed by iRacing.com Motorsport Simulations, LLC ("iRacing") infringed on U.S. Patent 10,046,241. iRacing moved to dismiss, arguing that the ‘241 patent was invalid under 35 U.S.C Section 101, as construed by Alice Corp. Pty. Ltd. v. CLS Bank Int'l., 573 U.S. 208 (2014), and its progeny, because the asserted claims were directed to an abstract idea and were patent-ineligible. The U.S. District Court, D. Massachusetts (“the Court”) found that the claims at issue were directed at patent-ineligible concepts, and that the elements of each claim did not transform the claim into patent-eligible application, and granted the motion to dismiss. <... Read more

Product-by-Process Claim: The Focus is On the Product and Not the Process of Making It

Attorney: Marina I. Miller, Ph.D.
September 6, 2022

Kamstrup A/S appealed a final written decision of the Patent Trial and Appeal Board (“the Board”). The Board found claims 1–15 of Kamstrup’s U.S. Patent No. 8,806,957 unpatentable as obvious or anticipated. On appeal, Kamstrup challenged the Board’s claim constructions. In addition, Kamstrup challenged the Board’s anticipation and obviousness determinations largely on the basis that the Board erred in rejecting Kamstrup’s claim construction arguments.<... Read more

Patent Invalidation Under Section102(b)'s On-Sale Bar Based on a Letter Including Commercial Terms Sent Before the Critical Date

Attorney: Marina I. Miller, Ph.D.
March 28, 2022

Mr. Junker, the named inventor of U.S. Design Patent No. D450,839, sued Medical Components, Inc. and Martech Medical Products, Inc. (“MedComp”) for infringement of the D’839 patent. The parties filed cross-motions for summary judgment, debating whether a letter sent before the critical date was a commercial offer for sale of the claimed design, rendering the claim invalid under the on-sale bar, 35 U.S.C. § 102(b). The district court granted Mr. Junker’s motion for summary judgment of no invalidity under the on-sale bar. MedComp appeals the district court’s summary judgment of no invalidity under the on-sale bar, the judgment of infringement, and the damages award.<... Read more

Another Example of Invalid Claims For Lack of Written Description and Enablement

Attorney: Marina I. Miller, Ph.D.
October 18, 2021

In its recent decision, the PTAB (“the Board”) determined that all challenged claims of U.S. Patent No. 10,301,638 B2 were unpatentable under 35 U.S.C. § 328(a) for lack of written description and lack of enablement.<... Read more