General

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Unfortunately, this decision is non-precedential.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

16Nov 2016

The USPTO has sent a proposed Fee Structure Change to take effect on October 1, 2017. Comments from the public are accepted until December 2, 2016. Below, I have provided the following tables which show the changes compared to the actual costs: Basic Filing, Search, Examination and Issue Fees (Utility).

Fee Current Large Entity Fee Rate Proposed Large Entity Fee Rate
Utility Filing Fee $280 $300
Utility Search Fee $600 $660
Utility Examination Fee $720 $760
Utility Issue Fee $960 $1,000
Total $2,560 $2,720

Basic Filing, Search, Examination and Issue Fees (Design)

Fee Current Large Entity Fee Rate Proposed Large Entity Fee Rate
Design Filing Fee $180 $200
Design Search Fee $120 $160
Design Examination Fee $460 $600
Design Issue Fee $560 $800
Total $1,320 $1,760

Excess Claims

Fee Current Large Entity Fee Rate Proposed Large Entity Fee Rate
Each Independent Claim in Excess of Three $420 $460
Each Claim in Excess of 20 $80 $100
Multiple Dependent Claim $780 $820

Information Disclosure Statements (IDS)

Fee Current Large Entity Fee Rate Proposed Large Entity Fee Rate
Submission of an Information Disclosure Statement after First Action on the Merits (FAOM), before Notice of Allowance $180 $240

Request for Continued Examination (RCE)

Fee Current Large Entity Fee Rate Proposed Large Entity Fee Rate
Request for Continued Examination (RCE) – 1st Request (see 37 CFR 1.114) $1,200 $1,300
Request for Continued Examination (RCE) – 2nd and Subsequent Request (see 37 CFR 1.114) $1,700 $1,900

Appeals

Fee Current Large Entity Fee Rate Proposed Large Entity Fee Rate
Notice of Appeal $800 $1,000
Forwarding an Appeal in an Application or Ex Parte Reexamination Proceeding to the Board $2,000 $2,500

Post-grant Proceedings

Fee Current Fee Rate Proposed Fee Rate
Inter Partes Review Request Fee – Up to 20 Claims $9,000 $14,000
Inter Partes Review Post-Institution Fee – Up to 15 Claims $14,000 $16,500
Post-Grant or Covered Business Method Review Request Fee – Up to 20 Claims $12,000 $16,000
Post-Grant or Covered Business Method Review Post-Institution Fee – Up to 15 Claims $18,000 $22,000

Mega Sequence Submissions

Fee Proposed Large Entity Fee Rate
Submission of sequence listings of 300MB to 800MB $1,000
Submission of sequence listings of more than 800 MB $10,000

Late Filing of Sequence Listings in an International Application

Fee Proposed Large Entity Fee Rate
Late Filing of Sequence Listing $300

Streamlined Re-examinations

Fee  Proposed Large Entity Fee Rate
Ex Parte Reexamination (§1.510(a)) Streamlined $6,000

Hague Agreement Fees

Fee Proposed Large Entity Fee Rate
Hague International Design Application Fees – Transmittal Fee $120

Discontinued Fees

Fee Current Fee Rates
Self-Service Copy Charge, per Page $0.25
Establish Deposit Account $10
Uncertified Statement Re Status of Maintenance Fee Payments $10
Copy of Patent-Related File Wrapper Contents That Were Submitted and are Stored on Compact Disk or Other Electronic Form (e.g., Compact Disks Stored in Artifact Folder), Other Than as Available in 1.19(b)(1); First Physical Electronic Medium in a Single Order $55
Additional Fee for Each Continuing Copy of Patent-Related File Wrapper Contents as Specified in 1.19(b)(2)(i)(A) $15
Copy of Patent-Related File Wrapper Contents That Were Submitted and are Stored on Compact Disk, or Other Electronic Form, Other Than as Available in 1.19(b)(1); if Provided Electronically Other Than on a Physical Electronic Medium, per Order $55
Petitions for documents in form other than that provided by this part, or in form other than that generally provided by Director, to be decided in accordance with merits. At cost

Please contact me with questions or comments regarding this.   Silvia Salvadori, PhD Silvia Salvadori, PhD www.salvadorilaw.com silvia@salvadorilaw.com (212) 897-1938