5) US

Question 1

Discuss the patent term in the US.

Answer 1

Patent term in the US is a-typical. Before 1995, the term could be calculated from the grant date rather than the filing date. In May 2000 PTA (patent term adjustment) was introduced.

• Issued before 8 June 1995
o 17 years from issue date
• Filed Before 8 June 1995 and issued after 8 June 1995
o Later of: 17 years from issue date
o Or: 20 years from filing date of original US application
• Filed on/after 8 June 1995
o 20 years from US non-provisional application filing date
o For PCT (US), 20 years from PCT filing date
o Continuations, CIPs and divisional – 20 years from filing date of earliest US nonprovisional
application.
• On/After 29 May 2000
o As above but Patent Term Guarantee Act applies (see below)

Question 2

When did patent term adjustment (PTA) come into force and what are its effects?

Answer 2

Came in force by virtue of Patent Term Guarantee Act 1999

• The term of US patents are extended if the US Patent Office delays in processing of the
application. The term of extension is one day per day of delay. The patent term is
increased if USPTO fails to:
o Issue a first Official Action or notice of allowance within fourteen months of filing;
o Issue an action within four months of an applicant’s response to an Official Action;
o Issue the patent within four months of payment of the issue fee;
o Issue a patent within three years of the actual filing date of the application, with
certain provisos;
• The patent term also increased for delays caused by interference proceedings, secrecy
orders and successful appeals.
• Conversely, patent term is reduced if the applicant takes extension of time to respond to
Official Action. You cannot have a negative adjustment to the term (i.e. you cannot reduce
the term to less than 20 years under the provision).
• The term of extension is notified along with notice of allowance, with opportunity for
applicant to dispute.

Question 3

Discuss the patent term extension (PTE).

Answer 3

• Allows term extension for drugs (human and vet), medical devices, additives which are
FDA-regulated.
• Came into force by virtue of Drug Price Competition & Patent Term Restoration Act 1984
(Hatch-Waxmann Act)
• Up to 5 year extension providing that total patent life after marketing approval is not more
than 14 years.
• Patentee must apply within 60 days of marketing approval or grant of the patent if later.

Question 4

Discuss renewal fees.

Answer 4

• Due dates 3 ½, 7 ½ and 11 ½ years after grant

* Surcharge if paid in 6 months after due date

Question 5

Discuss small entity status.

Answer 5

50% reduction in various official fees

• Small entity status is available to:
o Independent inventor or other individual
o Business with less than 500 employees
o Non-profit organisations
• However, be careful to make sure that the applicant is entitled because small entity status
is only available provided the applicant has not assigned, granted, conveyed or licensed
any rights in the invention to any non-Small Entity, and are not under any contractual or
legal obligation to do so.
• The penalty for incorrect declaration of small entity status could be unenforceability of
patent because patentee is deemed to have committed fraud on USPTO.

• The small entity rules have been revised so that compulsory licensing to a federal agency
as a condition of government funding no longer removes small entity status.

Question 6

Discuss micro entity status.

Answer 6

75% discount will apply to fees for filing, searching, examining, issuing,
appealing, and maintaining patent applications and patents

• Micro-entity status is available if:
1. has not been named on more than four previously filed patent applications – subject
to some exception such as applications in other countries, provisional application,
applications from prior employment.
2. in the calendar year preceding the calendar year in which the applicable fee is being
paid, does not have a gross income (as defined by the IRS) exceeding 3 times the
median household income for that preceding calendar year, as most recently
reported by the Bureau of the Census, and
3. has not assigned, granted, or conveyed, and is not under an obligation by contract
or law to assign, grant, or convey, a license or other ownership interest in the
application concerned to an entity that would not meet (2), above.

• “Micro Entities” also include applicants who certify that:
1. the applicant’s employer, from which the applicant obtains the majority of the
applicant’s income, is an institution of higher education as defined in section 101(a)
of the Higher Education Act of 1965 (20 U.S.C. 1001(a)); or
2. the applicant has assigned, granted, conveyed, or is under an obligation by contract
or law, to assign, grant, or convey, a license or other ownership interest in the
particular applications to such an institution of higher education.
• The rest of the rules mostly track the existing Small Entity rules - any assignment to a
non-Micro Entity would lose Micro Entity status, and so on.
• Supposed to come into effect as part of AIA in September 2011. However,
Implementation of micro-entity status was delayed. It came into force March 2013.

Question 7

What are the requirements for patentability (Subject Matter Eligibility – 35 USC 101)?

Answer 7

• Most things are patentable in the US. Namely:
o Any new, useful and non-obvious process, composition, machine, manufacture or
improvement, (i.e., even methods of medical treatment practiced on the human and
animal body)
o Computer program operated processes and machines, including business methods
o Medicines, pharmaceuticals
o Live, man-made micro-organisms and non-human multi-cellular living organisms
including animals
o Asexually reproduced, distinct, new and non-obvious plant varieties (PLANT
PATENTS)
o 4 Jan 2019 – USTPO announced revised guidance for subject matter eligibility
under 35 U.S.C. § 101. See: https://www.uspto.gov/patent/laws-andregulations/
examination-policy/subject-matter-eligibility

Question 8

Provide an overview of the provisions for novelty.

Answer 8

• Novelty – 35 USC §102
• The relevant provisions on both novelty and statutory bars are set out in 35 USC 102(a)-
(d). They are more complicated than in many other countries.
• Main features of US novelty are:
o first inventor to file (changed from first to invent in March 2013)
o 12 Month grace period for inventor’s own disclosures, or disclosures derived from
inventor
o prior filed / post published art can be relevant to both novelty and inventive step
• Note: there will be applications pending which were filed before the AIA came into force for
a while which will be subject to the pre-AIA provisions. However, you will not be examined
on such applications for the foundation exams.

Question 9

Discuss Novelty– 102(a1) and 102(b1)

Answer 9

102(a1): A person shall be entitled to a patent unless the claimed invention was patented,
described in a printed publication, or in public use, on sale, or otherwise available to the
public before the effective filing date of the claimed invention
1. Similar to absolute novelty requirement in Europe and other countries
102(b1): A disclosure made 1 year or less before the effective filing date of a claimed
invention shall not be prior art to the claimed invention if:
a) the disclosure was made by the inventor or joint inventor or by another who obtained the subject
matter disclosed directly or indirectly from the inventor or a joint inventor; or
b) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor
or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from
the inventor or a joint inventor.
2. Disclosures by the inventor(s) within one year of filing date are NOT prior art
3. Disclosures within one year derived from the inventor are NOT prior art
4. Disclosures by another person after inventor has disclosed are NOT prior art

Question 10

Discuss Novelty – 102(a2) and 102(b2)

Answer 10

102(a2) A person shall be entitled to a patent unless the claimed invention was described in a
[patent or US/PCT patent application], in which the patent or application names another
inventor and was effectively filed before the effective filing date of the claimed invention.
1. This section bars patenting if an earlier patent or published patent application describes
the claimed invention and was filed earlier and from a different inventor. Seems similar to
European practice, but….
102(b2) A disclosure in a patent or patent application shall not be prior art to a claimed
invention if:
a) the subject matter disclosed was obtained directly or indirectly from the inventor(s);
b) the subject matter disclosed had, before such subject matter was effectively filed
under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or
another who obtained the subject matter disclosed directly or indirectly from the
inventor or a joint inventor; or
c) the subject matter disclosed and the claimed invention, not later than the effective
filing date of the claimed invention, were owned by the same person or subject to an
obligation of assignment to the same person

Question 11

when an invention is sold privately and the purchaser is obligated to keep the
invention secret, does this sale count as “prior art” that would prevent subsequent
patenting of the invention?

Answer 11

On 22 January 2019, the US Supreme Court answered this question in Helsinn
Healthcare v. Teva Pharmaceuticals USA. The court ruled that such a private sale is
indeed prior art that prevents later patenting of the invention.

Question 12

Discuss Obviousness - 35 USC §103

Answer 12

• A patent for a claimed invention may not be obtained if the differences between the
claimed invention and the prior art are such that the claimed invention as a whole would
have been obvious before the effective filing date of the claimed invention at the time the
invention was made to a person having ordinary skill in the art to which the claimed
invention said subject matter pertains.
• Note: pre-filed but post-published patent applications are relevant to inventive step (cf
EPO).

Question 13

Discuss Obviousness - 35 USC §103

Answer 13

• A patent for a claimed invention may not be obtained if the differences between the
claimed invention and the prior art are such that the claimed invention as a whole would
have been obvious before the effective filing date of the claimed invention at the time the
invention was made to a person having ordinary skill in the art to which the claimed
invention said subject matter pertains.
• Note: pre-filed but post-published patent applications are relevant to inventive step (cf
EPO).

Question 14

What is a foreign filing license?

Answer 14

• Equivalent to the security clearance which used to be required in the UK
• If invention “made” in the US, cannot file foreign applications until 6 months after US first
filing, unless special license obtained.
• Required if:
o Any part of the disclosure came from US
o Any work done in the US appears in the patent spec – this is irrespective of whether
that work constitutes the invention
• Penalty:
o Criminal offence
o US patent may be unenforceable

Question 15

What is a provisional application?

Answer 15

• Intended to provide a method for an applicant to gain an early US filing date relatively
inexpensively.
• Must contain a specification, drawings and cover sheet but need not contain claims or
include an oath/declaration. There is also a filing fee. (although deferred-fee pilot program
started on 28 September 2020).
• Specification must satisfy best mode requirement as well as written description and
enablement requirements.
• The application automatically lapses after 12 months. Conversion into a non-provisional
application is possible but usually not advised since, as in a GB priority, it is better to claim
priority from the non-provisional and get a longer patent term.
• Equivalent of a GB priority application, can form a basis for a priority claim.

Question 16

What is a complete application?

Answer 16

• Must include a specification, including a claim or claims; drawings, when necessary and
the prescribed filing fee.
• Oath/Declaration
o The oath or declaration must be signed by all of the actual inventors but can be filed
any time up until allowance.
o States applicant believes himself to be the original and first inventor of the invention.
• Priority docs can be supplied at any stage until issue fee paid
• Priority right claimed within four months of the actual filing date or sixteen months from the
filing date of the foreign or earlier-filed US application, whichever is later.

Question 17

Discuss the requirements for claims.

Answer 17

• The US has different requirements for claim format as compared to the EPO. The notable
differences are:
o claim fees are due on independent claims over 3 and on claims over 20;
o Multiple dependent claims (MDC) may not be used as a basis for any other MDC -
extra fees due for MDCs
o Multiple independent claims are possible and recommended.

Question 18

What should be considered when considering a US claim set?

Answer 18

• When considering a US claim set the following things should be considered:
o Some subject matter that is not patentable in the UK or Europe may be patentable in
the US, for example methods of treatment or business methods
o Some subject matter is not patentable in the US, e.g. signal structures
o means-plus-function claims are allowable, but that there may be a limitation in scope
when such claims are interpreted by a court (to what is in specification)
o multiple independent claims in the same category are allowed
o claims fee structure (independent, dependent, multiply dependent) and how this
influences claim drafting
o Multiply dependent claims based on multiply dependent claims are not allowed
o Features defined in a claim must be illustrated in a figure
o Certain terms have a recognized meaning, e.g. “consisting of”
o Omnibus claims are not allowed
• The presence of an independent claim that can be granted without amendment may
be desirable

Question 19

Discuss publication

Answer 19

• Eighteen months after the effective filing date of the application.
• Applicant may request upon filing of the application, that an application not be published if
the invention has not been and will not be the subject of an application filed in another
country (or under international agreement) that requires eighteen-month publication.
• If Applicant does foreign file, must notify USPTO within 45 days of foreign filing date –
otherwise US application abandoned, unless can show delay unintentional.

Question 20

Discuss restriction requirements.

Answer 20

• If 2 or more ‘independent and distinct’ inventions are claimed in one application USPTO
may ‘require’ application to be ‘restricted’ to one invention.
• Response period 30 days (extendable with fees).
• Restriction requirement properly raised:
o ‘elect’ claimed subject matter to be considered by Examiner. No consideration given
to non-elected claimed subject matter.
• Restriction requirement improperly raised:
o Request reconsideration and withdrawal/modification of restriction requirement giving
reasons; and make a provisional election
o Examiner will reconsider restriction requirement and withdraw it, modify it or repeat it
and make final.
• If Examiner makes it final he will at the same time proceed to examine the provisionally
elected claims.
• Claimed inventions not elected may be made the subject of divisional applications.

Question 21

Discuss election of species requirements.

Answer 21

• Occurs if the Examiner finds the scope of the claims too broad and difficult to search and
examine.
• They ask you to elect a particular species (i.e. narrower subset or individual species).
• Once elected, the Examiner will examine that species and if found allowable will go back
and apply this to the broader claims.

Question 22

Describe an office action.

Answer 22

• No separate search report – citations included in Office Actions.
• Must make full and complete response to every objection and rejection of the Examiner.
• There is a period of three months (extendible to six months with increasingly expensive
monthly extension fees) to respond to Examiner’s action.
• Extension request can be made at time of filing the response.
• Second (or later) Office Actions may be made “Final” if previous ground of rejection
maintained, or new grounds of rejection necessitated by amendment.
• Can request an interview with the Examiner either in person, by phone or via the
Automated Interview Request (AIR) Tool. AIR is an online interview scheduling tool which
enables video conferencing via WebEx.

Question 23

Describe a final office action.

Answer 23

Once Final Office Action issues, the application may choose to:

• File arguments and/or amendments: request reconsideration. Note that claim
amendments or new arguments often NOT considered.
• AFCP 2.0: after final rejection an applicant is generally not entitled to further consideration
without filing an RCE. Under AFCP 2.0 if an applicant files a suitable submission
(amendment to at least one independent claim that does not broaden, statement that the
applicant is willing to conduct an interview and the required fee), the examiner may
consider the response under AFCP 2.0 without the need for an RCE to be filed
• Request for Continued Examination (RCE): requires Examiner to issue a non-final
office action. Respond to “final objections” at the same time. Fee is required to file an
RCE. Note: can also be used to submit IDS documents ‘late’.
• Continuation application: (start again)
• Appeal: File a Notice of Appeal (only a formal notice) within 3 months of date of rejection
(extendible by 3m). Can file Pre-Appeal Brief Request for Review at time of filing Notice of
Appeal. Prompts review of application by 3-member panel of patent examiners. Appeal
brief must be filed within 2 months of Notice of Appeal. Due date can be extended an
additional 5 months with payment of extension of time fees

Question 24

What is the duty of candor?

Answer 24

• Each individual associated with the filing and prosecution of a patent application has a
duty of candour and good faith in dealing with the Office, which includes a duty to disclose
to the Office all information known to that individual to be material to patentability.
• This applies not only to the inventor(s) but also to anyone else who may be involved in the
patent application.
• Failure to disclose relevant information to the USPTO can result in a patent being invalid
and unenforceable.

Question 25

What is an IDS?

Answer 25

• Information Disclosure Statement (IDS) = A list of all patents, publications or any other info
which may be material to patentability.
• A legible copy of each item on the list must be provided (except US patents and published
applications).
• Each non-English language document must be accompanied by an English translation or
a concise explanation of its relevance, if available to the applicant. An English language
examination report describing the reference’s purported relevance is sufficient.

Question 26

What are the relevant time period for IDSs and their requirements?

Answer 26

Up to 3 months from filing
date or until first Office
Action - no fee

After first Office action but before close of prosecution
(e.g. before final OA or Notice of Allowance) - Either:
Pay fee or Provide certification

After close of prosecution but before issue fee is paid - Must: Pay fee and Provide certification

After issue fee paid but before the patent issues - Petition to withdraw application from issue and file
an RCE with fee and petition to withdraw fee
Or Request consideration under QPIDS

Question 27

What must IDS certification state?

Answer 27

• Each item in IDS was cited by a foreign patent office in a counterpart application not more
than 3 months prior to the filing of the IDS; or
• No item was cited by a foreign office and no individual associated with the filing or
prosecution of the application knew of the item(s) more than 3 months prior to filing the
IDS

Question 28

What is QPIDS?

Answer 28

QPIDS (much cheaper than filing an RCE)
• Quick Path Information Disclosure Statement (QPIDS) allows an applicant to submit new
references to the USPTO after payment of the issue fee and the office will consider those
references without an automatic RCE.
• Must still submit an RCE and pay the fee but it is considered conditional until the examiner
decides whether any item of information necessitates reopening prosecution.
• To use QPIDS must certify document was not known to applicant more than 3 months
before filing IDS

Question 29

Discuss allowance/issuance.

Answer 29

• Notice of Allowance signals allowance
• Issue Fee due within 3 months of day of Notice of Allowance (no extensions available)
• Letter Patent may issue any time after payment of issue fee, typically between 2 and 4
months from date of payment.
• Therefore, file any continuations before issue fee paid

Question 30

Discuss double patenting

Answer 30

• There are 2 types of double patent rejections:
1. The “same invention” type under 35 USC 101.
2. An “obvious” type objection intended to prevent prolongation of the patent monopoly
by prohibiting claims in the 2nd patent that are not patentable distinct from claims in
a 1st patent.
• For double patenting rejection respective patents must have common inventor ship and/or
ownership.
• To overcome an “obvious” type double patenting objection you can use a terminal
disclaimer.
• The excess term over another patent that a granting patent may have been entitled to is
specifically disclaimed so as to equalise it with that of the other patent. Both
application/patent must have common inventor ship and/or ownership. Note, this does
not overcome the “same invention” type double patenting rejection.

Question 31

Discuss continuation.

Answer 31

• Earlier filed is ‘parent’ and continuing application is ‘daughter’. A continuation must be
filed before the parent has been abandoned or granted. EVERYTHING in parent is
included for purposes of file wrapper estoppel and no new matter allowed into the
application
• To a certain extent you are really starting again. The application goes back into the pool
and there is generally quite some considerable delay before it comes before the examiner
again. You might get a different examiner but generally the same one

Question 32

Discuss divisionals

Answer 32

• New filing considered a divisional if filed in response to a restriction requirement
• Advantage over continuation is it avoids linked patent term adjustment with obviousness
type double patenting

Question 33

Discuss continuation in part (CIP)

Answer 33

• Must be filed before the parent has been abandoned or granted
• Repeats substantial part (or all) of parent and adds matter – e.g. claiming improved
version of the invention
• New matter has date of CIP, not parent. Old matter in CIP and also in parent takes filing
date of parent
• New oath and declaration if CIP adds and claims further matter.
• Must up-date best mode
• Requirements:
o The two related applications must have at least one common inventor. Must be copendency
of the earlier and later applications.
o Later application must include a cross-reference to the earlier application in order to
benefit from the filing date of its parent.