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05Mar 2019

Silvia Salvadori - Patent Term Adjustment Deductions — Important Lessons

In the recent decision Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit held that the USPTO wrongly imposed a Patent Term Adjustment (PTA) to the applicant for an Information Disclosures Statement (IDS) filed after a Request for Continued Examination (RCE).

Patent Term Adjustment Statute

The PTA statute establishes that an award in patent term should correspond to a deduction (of patent term) for any delay caused by the applicant’s failure to engage in activities that aim to conclude prosecution of the application. Under PTA rules, the USPTO can charge the applicant with a delay when the applicant files an IDS after having filed an RCE, but before the next Office Action or Notice of Allowance.  Continue reading

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

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

30May 2018

Silvia Salvadori - Patent Ineligibility Facts May Preclude Ineligibility, as Decided by USPTOIn February 2018, the Federal Circuit decided the case Berkheimer v. HP Inc., in which it held that evaluating patent eligibility may involve issues of facts that may preclude ineligibility.

On April 19, 2018, the United States Patent and Trademark Office (USPTO) issued a memorandum stating that elements of a patent cannot be found to be well-understood, routine, and conventional “unless the examiner finds, and expressly supports a rejection in writing” in one of the four pieces of information. Continue reading

28Nov 2017

Silvia Salvadori - Patent Examiner Withdraws Rejection Due to Impermissible Hindsight {4:18 minutes to read} In a recent decision, Merck Sharp & Dohme B.V., v. Warner Chilcott Co. LLC, the Federal Circuit reversed the district court’s obviousness ruling based on impermissible hindsight.

Unfortunately, this decision is non-precedential.

The Patent at Issue

The patent at issue was Merck’s U.S. Patent No. 5,989,581, which is listed in the Orange Book for its NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) contraceptive product. Dependent claims 4 and 11 were at issue. Dependent claim 4 is representative.

Dependent claim 4 states: A drug delivery system wherein the amount of progestogenic compound dissolved in the thermoplastic core material is 2 to 5 times the amount necessary for obtaining saturation concentration.

The claims of the patent were directed as “a drug delivery system comprising of at least one compartment which comprises….”

Warner Chilcott Co. asserted invalidity of the claims in view of a reference which disclosed a two-compartment vaginal ring and that criticizes one-compartment vaginal rings.

Nevertheless, the district court found the Merck claims to be obvious.

The Federal Court reversed citing KSR:

A patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).

Even if all elements of the claim were known, we still must resolve whether a person of ordinary skill in the art would have found it obvious to combine these elements or modify them in a way that meets the claim.

In making this inquiry, we have cautioned that “the inventor’s own path itself never leads to a conclusion of obviousness; that is hindsight.” Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012).

Thus, it is improper to combine references “like separate pieces of a simple jigsaw puzzle” without “explain[ing] what reason or motivation one of ordinary skill in the art at the time of the invention would have had to place these pieces together.”InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1349 (Fed. Cir. 2014).

The court concluded that starting from the teachings of the references—but without the impermissible hindsight—one skilled in the art would have had to use the issued patent as a roadmap.

Moreover, the Federal Circuit also raised the issue of the reasonable expectation of success in going from a two-compartment ring to a one-compartment ring, considering that the reference was teaching away from using a single compartment.

This opinion is very reassuring, since rarely the Examiner withdraws from rejections based on impermissible hindsight. It is important to remember that, even if references can be combined or modified, ”the resultant combination is not obvious unless the results would have been predictable to one of ordinary skill in the art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 538, 417, 82 USPQ2d 1385, 1396 (2007).

It must also be remembered that rejections on obviousness cannot be sustained by mere conclusory statements; instead, the examiner must articulate a reasoning with some rational underpinning to support the legal conclusion of obviousness explaining why a person of ordinary skill in the art would have made the stated modification.

Contact me with questions or comments at silvia@salvadorilaw.com.

Silvia Salvadori, PhD Silvia Salvadori, PhD

www.salvadorilaw.com

silvia@salvadorilaw.com

(212) 897-1938

28Sep 2017

Silvia Salvadori - Patent Term Adjustment Outcomes and Information Disclosures {1:55 minutes to read} When an applicant files an Information Disclosure Statement (IDS) after a response or Request for Continued Examination (RCE), the United States Patent & Trademark Office (USPTO) treats such a submission as a “supplemental paper.”

This triggers a Patent Term Adjustment (PTA) deduction for the applicant’s delay, citing 37 C.F.R. 1.704(c)(8)—even if such a submission is timely. According to USPTO rules, however, no PTA deduction should occur if the IDS is filed to submit references cited by the USPTO or by a foreign patent office within 30 days of the submission. Continue reading

17Feb 2017

Silvia Salvadori - Federal Circuit Holds That Prior Art is "But-For" Material {3:10 minutes to read} Last year, the Federal Register Notice published a proposed revision by the US Patent and Trademark Office (USPTO). This proposal suggested a change to the materiality standard for the duty to disclose information in patent applications and reexamination proceedings. In the Federal Register Notice, the USPTO further adopted the “but-for” materiality standard that the Federal Circuit reached in the Therasense case. Continue reading