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
In 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
In 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
{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Unfortunately, this decision is non-precedential.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
(212) 897-1938
{2:10 minutes to read} In the recent case, In re Stepan Co., the Federal Circuit vacated an obviousness rejection that had been affirmed by the USPTO Patent Trial and Appeal Board (PTAB). Continue reading
{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
{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
{2:50 minutes to read} Recently, the Federal Circuit issued a decision stating that a reasoning that it is “intuitive” to combine references is insufficient to support an obviousness-type rejection. Continue reading
{2:50 minutes to read} There is much to be learned from the recent case, Perfect Surgical Techniques, Inc. v. Olympus America, Inc. The Federal Circuit held that the Patent Trial and Appeal Board (PTAB) ruling was incorrect and found that there was evidence that the inventor conceived of the invention before the cited prior art. Continue reading
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 www.salvadorilaw.com silvia@salvadorilaw.com (212) 897-1938