08Feb 2019

Silvia Salvadori - USPTO Update: Revised Patent Subject Matter Eligibility Guidance On January 7, 2019 the United States Patent and Trademark Office (USPTO) issued a Revised Patent Subject Matter Eligibility Guidance in the Federal Register Notice. The Guidance revises the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas) under Step 2A of the USPTO’s Subject Matter Eligibility Guidance in two ways. Continue reading

10Jan 2019

Silvia Salvadori - USPTO Announces RPA Initiative for Continuing Applications  The United States Patent and Trademark Office (USPTO) is implementing the first phase of the Access to Relevant Prior Art Initiative (“RPA Initiative”) to import from the immediate parent application into the continuing application.

RPA Initiative Explained:

In a continuing application, the citations corresponding to the documents considered by the examiner will be printed on the face of the patent issuing from the continuing application without the applicant having to resubmit the information on an Information Disclosure Statement. Additionally, an applicant’s duty to disclose information in the continuing application will continue to be satisfied for information considered in the parent application — and will be satisfied for any additional information made of record by the USPTO  in the continuing application.

The USPTO plans to implement the RPA Initiative in phases, to consider and address public and examiners’ feedback at each phase and determine how to effectively expand the RPA Initiative in future phases. Continue reading

20Nov 2018

Silvia Salvadori - Roche Molecular Systems, Inc. v. CepheidIn a recent case, Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit affirmed that claims directed to a nucleotide primer and claims directed to a detection method are invalid under 35 USC § 101.

The patent covered primers and methods for a rapid detection of M. tuberculosis on the basis of the presence of nucleotides specific for M. tuberculosis (MTB). Continue reading

12Oct 2018

Silvia Salvadori - Patent Law: 4 Ways to Overcome Obviousness Rejections In a recent case, E.I. DuPont De Nemours & Co. v. Synvina C.V., the Federal Circuit outlined four (4) ways to overcome obviousness rejections based on routine optimization. The patent at issue covered methods for preparing a compound under reaction conditions already described in three prior art references.

The court made reference to the classic rationales to support an obviousness rejection. That is, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation,” and “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” Continue reading

10Sep 2018

Silvia Salvadori - Understanding the Difference Between Prior Art Publication and Prior UseIn a recent case, Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the validity of two patents listed in the Orange Book. This decision is significant because it illustrates the difference between prior art publication vs. prior use.

Below, some of the claim language is included, including two noteworthy claims under litigation — dependent Claim 2 and Claim 18:

Claim 1) A composition formulated for intramuscular injection in a form for single injection which contains 250 mg/ml testosterone undecanoate in a vehicle containing a mixture of castor oil and benzyl benzoate wherein the vehicle contains castor oil in a concentration of 40 to 42% vol. Continue reading

15Jun 2018

Silvia Salvadori - Patent Priority Claim: Incorporation by Reference is Not EnoughIn a recent case, Droplets, Inc. v. E*Trade Bank, the Federal Circuit agreed with the United States Patent and Trademark Office (USPTO) and with the Patent Trial and Appeal Board (PTAB) that a patent belonging to Droplets, Inc. was invalid because of a defective priority claim.

In so holding, the Court affirmed that a priority claim must be explicitly stated in the patent and cannot be incorporated by reference from an earlier patent. Continue reading

30Apr 2018

Silvia Salvadori - Schizophrenia Drug Patent Case Divides Federal CircuitIn a recent case, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided Federal Circuit held valid a patent directed to a schizophrenia drug, finding that the claims met the “Mayo standard”.

The patent at issue directs physicians to treat patients who have low CYP2D6 activity (an enzyme) with a lower amount of iloperidone, a drug to treat schizophrenia.

Iloperidone is metabolized by CYP2D6, thus, a patient who is characterized with lower CYP2D6 activity is more prone to iloperidone cardiac side effects.

The Court held that the patent specifically tells physicians how to connect the relationship between dosage and a patient’s genotype to find the correct treatment, and that the claims do not describe any natural factor.

According to the Court, the claims were directed to “a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” These claims differ from the claims cited in the “Mayo standard” because they recite more than a natural phenomenon since they link the activity of the enzyme CYP2D6 and a cardiac rhythm parameter.

Thus, the Court held that the claims were eligible under step 2 of the “Mayo test” (they were directed to significantly more than just a law of nature or a natural phenomenon) because the discovered results are not routine and conventional.

Judge Prost, dissented saying, “the patent was just an optimization of an existing treatment of schizophrenia, just as the claims in Mayo.”

Ultimately, the Federal Circuit held that the patent was valid.

Please contact me at with questions or comments.

Silvia Salvadori, PhD

Silvia Salvadori, PhD