PPC Regulatory Compliance & Legal Framework 3 — Questions and Answers
Question 1: Under 35 U.S.C. 102(a)(1) as amended by the AIA, a prior art disclosure made within one year before the effective filing date by the inventor does NOT bar patentability. This exception is known as:
- Statutory bar exception
- Inventor grace period (Correct answer)
- Priority date safe harbor
- Public use exemption
Correct answer: Inventor grace period
The AIA's one-year grace period (inventor grace period) under 35 U.S.C. 102(b)(1) exempts disclosures made by the inventor within one year before the effective filing date from being prior art.
Question 2: A patent paralegal is tracking prosecution deadlines and notes a final office action was mailed. Under 37 CFR 1.136, how long does the applicant generally have to respond without a petition for extension?
- 30 days
- 3 months (Correct answer)
- 6 months
- 1 year
Correct answer: 3 months
The standard statutory response period for a final office action is 3 months from the mailing date, extendable up to 6 months with fee-based extensions.
Question 3: Which USPTO body conducts post-grant review (PGR) and inter partes review (IPR) proceedings?
- The Office of Patent Legal Administration (OPLA)
- The Patent Trial and Appeal Board (PTAB) (Correct answer)
- The Board of Patent Appeals and Interferences (BPAI)
- The Technology Center managing the original application
Correct answer: The Patent Trial and Appeal Board (PTAB)
The Patent Trial and Appeal Board (PTAB), established by the AIA, conducts IPR, PGR, and covered business method (CBM) review proceedings.
Question 4: The Hatch-Waxman Act created a regulatory framework that allows generic drug companies to challenge a patent by filing which type of certification?
- Paragraph I certification
- Paragraph IV certification (Correct answer)
- Section 8 Statement
- ANDA Priority Declaration
Correct answer: Paragraph IV certification
A Paragraph IV certification asserts that the listed patent is invalid, unenforceable, or will not be infringed by the generic drug, triggering a potential 30-month stay.
Question 5: Under 37 CFR 11.5, which individuals are authorized to practice before the USPTO in patent matters?
- Any licensed attorney in any jurisdiction
- Registered patent attorneys and registered patent agents (Correct answer)
- Registered patent attorneys, agents, and supervised paralegals
- Any person with a technical degree in the relevant field
Correct answer: Registered patent attorneys and registered patent agents
Only registered patent attorneys and registered patent agents are authorized to practice before the USPTO in patent matters under 37 CFR 11.5.
Question 6: A client wants to maintain a patent application as confidential. Under what authority may the USPTO keep an application in secrecy?
- 35 U.S.C. 122 and a Secrecy Order under the Invention Secrecy Act (Correct answer)
- 37 CFR 1.56 confidentiality provisions
- The Freedom of Information Act exemption
- The Patent Prosecution Highway agreement
Correct answer: 35 U.S.C. 122 and a Secrecy Order under the Invention Secrecy Act
Applications are kept confidential under 35 U.S.C. 122, and the government may impose a secrecy order under the Invention Secrecy Act (35 U.S.C. 181-188) for national security reasons.
Question 7: Which provision of 35 U.S.C. governs the requirement to mark a patented article with the patent number to recover damages from infringers?
- 35 U.S.C. 271
- 35 U.S.C. 284
- 35 U.S.C. 287 (Correct answer)
- 35 U.S.C. 301
Correct answer: 35 U.S.C. 287
35 U.S.C. 287 requires patent owners to mark patented articles with the patent number as a condition for recovering pre-suit damages from infringers.
PPC Regulatory Compliance & Legal Framework 3
Under 35 U.S.C. 102(a)(1) as amended by the AIA, a prior art disclosure made within one year before the effective filing date by the inventor does NOT bar patentability.
This exception is known as: