Transcript More on Restriction Practice

Principles in Restriction Practice
TC 1600
Anthony Caputa
TC Practice Specialist
[email protected]
(571) 272-0829
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TC 1600 Restriction Team
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Anthony Caputa-TCPS
Deborah Reynolds-TCPS
Sreeni Padmanabhan - Workgroup 1610
Christopher Low - Workgroup 1610
Joseph McKane - Workgroup 1620
Cecilia Tsang – Workgroup 1620
Amy Nelson - Workgroup 1630
Jim Housel - Workgroup 1640
Bruce Campell-Workgroup 1650
Julie Burke-SPrE
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Topics for Today
 Basic Restriction Requirements
 Linking Claims
 Alternative Language and Restriction
Practice
 Rejoinder Opportunities - In re Ochiai and
others
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Basic Restriction Requirements
 Restriction is a discretionary tool to limit
the examination to one of a plurality of
claimed inventions under 35 USC 121
 Restriction is between inventions not
claims. The claims merely define the
inventions.
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Basic Restriction Requirements
 There are two criteria for a proper requirement for
restriction between patentably distinct inventions:
– The inventions must be independent (see MPEP §
802.01, § 806.04, § 808.01) or distinct as claimed
(see MPEP § 806.05 - § 806.05(i)); and
– There must be a serious burden on the examiner if
restriction is required (see MPEP § 803.02,
§ 806.04(a) - § 806.04(i), § 808.01(a), and
§ 808.02).
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Basic Restriction Requirements
 Independent Inventions
– Not disclosed as capable of use together
– Not disclosed as connected in design, operation
or effect
– MPEP 806.04, 808.01; Form Paragraph 8.20.02
– Facts relied on to establish independence may
also support the reason(s) for insisting upon
restriction (burden) (MPEP 808.01)
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Basic Restriction Requirements
 Related Invention Relationships
1. Subcombinations useable together (MPEP 806.05(d); Form
Paragraph 8.16)
2. Combination/Subcombination (MPEP 806.05(a)-(c); Form
Paragraph 8.15)
3. Process and Apparatus for its Practice (MPEP806.05(e); Form
Paragraph 8.17)
4. Product and Process of Making (MPEP 806.05(f); Form paragraph
8.18)
5. Apparatus and Product Made (MPEP 806.05(g); Form paragraph
8.19)
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Basic Restriction Requirements
 Related Invention Relationships
6. Product and Process of Using (MPEP 806.05(h); Form paragraph
8.20)
7. Intermediate/Final Product (MPEP 806.04(b); Form paragraph
8.14)
8. Special case: Product, Process of Making and Process of Using
(MPEP806.05(i); Form Paragraph 8.20.01)
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Basic Restriction Requirements
 Criteria for Burden (MPEP 808.02; Form
paragraph 8.21.01-8.21.03)
1. Separate classification
2. Separate status in the art
3. Divergent field of search
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Linking Claims - What are they?
 Definition: One or more claims inseparable
from claims to two or more otherwise
properly divisible inventions. MPEP 809.
 Effect: When found allowable, linking
claims prevent maintaining a restriction
requirement between inventions that are
otherwise divisible.
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Linking Claims – Types (MPEP
809.02 and 809.03)
 Genus claims linking species claims (809.02 and
809.03)
 Claim to the necessary process of making a
product linking proper process and product claims
(product and process of making are not patentably
distinct) (MPEP 809.03)
 Claim to “means” for practicing a process linking
proper apparatus and process claims (MPEP
809.03)
 Claim to the product linking a process of making
and a process of using (MPEP 809.03)
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Linking Claims - Caution
 If a generic or linking claim is subsequently allowed, the
restriction requirement MUST be withdrawn, even where
claims to non-elected linked inventions have been
canceled. The indication of withdrawal must also be
clearly stated on the record.
 When a restriction requirement is withdrawn, 35 USC 121
no longer shields claims from double patenting
considerations
 Double patenting situations may arise where the restriction
requirement was made subject to the nonallowance of
generic or other linking claims which are then
subsequently allowed and the restriction is then withdrawn.
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Linking Claims - Office Action
 Form Paragraph 8.12:
 Claim [1] link(s) inventions [2] and [3]. The restriction requirement [4] the
linked inventions is subject to the nonallowance of the linking claim(s), claim
[5]. Upon the allowance of the linking claim(s), the restriction requirement as
to the linked inventions shall be withdrawn and any claim(s) depending from
or otherwise including all the limitations of the allowable linking claim(s) will
be entitled to examination in the instant application. Applicant(s) are advised
that if any such claim(s) depending from or including all the limitations of the
allowable linking claim(s) is/are presented in a continuation or divisional
application, the claims of the continuation or divisional application may be
subject to provisional statutory and/or nonstatutory double patenting rejections
over the claims of the instant application. Where a restriction requirement is
withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. In re
Ziegler, 44 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also
MPEP § 804.01.
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Linking Claims - Office Action
 ¶ 8.01 Election of Species
 This application contains claims directed to the following patentably distinct species of
the claimed invention: [ 1 ].
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for
prosecution on the merits to which the claims shall be restricted if no generic claim is
finally held to be allowable. Currently, [ 2 ] generic.
Applicant is advised that a reply to this requirement must include an identification of the
species that is elected consonant with this requirement, and a listing of all claims
readable thereon, including any claims subsequently added. An argument that a claim is
allowable or that all claims are generic is considered nonresponsive unless accompanied
by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of
claims to additional species which are written in dependent form or otherwise include all
the limitations of an allowed generic claim as provided by 37 CFR 1.141. If claims are
added after the election, applicant must indicate which are readable upon the elected
species. MPEP § 809.02(a).
Should applicant traverse on the ground that the species are not patentably distinct,
applicant should submit evidence or identify such evidence now of record showing the
species to be obvious variants or clearly admit on the record that this is the case. In
either instance, if the examiner finds one of the inventions unpatentable over the prior
art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the
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other invention.
Linking Claim - Product
 Claim 1. A composition for reducing HIV viral load in an
HIV infected patient, comprising an agent inhibiting viral
replication and a pharmaceutically acceptable carrier.
 Claim 2. The composition of claim 1, wherein the agent is
a polypeptide having the amino acid sequence of SEQ ID
NO:2.
 Claim 3. The composition of claim 1, wherein the agent is
a polynucleotide having the sequence of SEQ ID NO:5.
 Claim 4. The composition of claim 1, wherein the agent is
3,3’-methoxysilyl-3,3’-organophosphate.
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Linking Claim - Method
 Claim 1. A method for treating a
neurodegenerative disorder comprising
administering a peptide conjugate to a patient.
 Claim 2. The method of claim 1, wherein the
neurodegenerative disorder is Alzheimer’s disease.
 Claim 3. The method of claim 1, wherein the
neurodegenerative disorder is multiple sclerosis.
 Claim 4. The method of claim 1, wherein the
neurodegenerative disorder is encephalitis.
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Linking Claims - Notes
 Applicant is entitled to retain claims
directed to non-elected inventions
 If a linking claim is allowed, examination
must extend to the linked non-elected
inventions
 At that time, the restriction requirement is
withdrawn and the linked inventions are
rejoined together
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Linking Claims - Helpful Hints
 When writing a restriction involving linking claims per
MPEP 809.03, the linking claims should not appear in the
list of claims for any particular invention group. The
linking claim itself appears only in form paragraph 8.12.
 When writing a restriction involving genus-species linking
claims per MPEP 809.02, there are no groupings and the
linking claim(s) appears as the generic claims in form
paragraph 8.01.
 If claims to non-elected inventions are canceled, but a
linking claim is allowed, the Office must notify Applicant
and provide an opportunity to reinstate the canceled claims
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Markush practice
 Since the decisions in In re Weber, 580 F.2d 455,
198 USPQ 328 (CCPA 1978) and In re Haas, 580
F.2d 461, 198 USPQ 334 (CCPA 1978), it is
improper for the Office to refuse to examine that
which applicants regard as their invention, unless
the subject matter in a claim lacks unity of
invention. In re Harnisch, 631 F.2d 716, 206
USPQ 300(CCPA 1980); and Ex parte Hozumi, 3
USPQ2d 1059 (Bd. Pat. App. & Int. 1984).
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Markush Practice
 Markush Language – Ex. “selected from the
group consisting of…” or “any of A, B, or
C”.
 Apply In re Harnisch test for “unity of
invention”
– Compounds have a common utility
– Compounds as a whole have a substantial
structural similarity
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Markush practice
 Broadly, unity of invention exists where
compounds included within a Markush
group (1) share a common utility, and (2)
share a substantial structural feature
disclosed as being essential to that utility.
See MPEP 803.02.
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Markush Practice – Example
 Unity exists under Harnisch test
Claim 1: A method of treating diabetes
comprising administering compound X and
further administering a compound selected
from the group consisting of A, B and C.
Disclosure: A, B and C have similar
function and have a common structure.
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Markush practice-MPEP 803
 If the members of the Markush group are
sufficiently few in number or so closely related
that a search and examination of the entire claim
can be made without serious burden, the examiner
must examine all the members of the Markush
group in the claim on the merits, even though they
are directed to independent and distinct
inventions.
 Should no prior art be found that anticipates or
renders obvious the elected species, the search of
the Markush type claim will be extended.
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In re Ochiai Rejoinder
 MPEP 821.04, See also the Clarification Memo of
March 2004
 Proper restriction between product and process
claims
 Applies only where product claims are elected
 Requires allowable product claim
 Applies only to process claims that depend from
or include all the limitations of the allowable
product claim
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In re Ochiai Rejoinder
 If application discloses both product and
process(es) of making and/or using, but claims the
product only and a product claim is allowed,
process claims may be entered prior to final
rejection
 After final rejection is governed by 37 CFR 1.116
 After allowance practice is governed by 37 CFR
1.312
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In re Ochiai Rejoinder
 Rejoinder by the Office is sua sponte
 Less than all pending process claims may be
rejoined where less than all process claims
include all the limitations of the allowable
product.
 Obviousness double-patenting may be
applied where product and process claims
are voluntarily filed in separate applications
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Other Rejoinder Situations
 MPEP 806.05(c)
 Combination/subcombination inventions
when an evidence claim is found to be nonallowable
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Helpful Hints
 Use the correct rule– For applications filed under 35 USC 111, use 35 USC
121
– For applications filed under 35 USC 371, use 35 USC
372 and 35 USC 121
• When a continuation or divisional is filed under 35 USC 111
based on a 371, use 35 USC 121
 If the inventions, now being restricted, were
searched and examined together in either the
current application or a parent, it will be difficult
to justify the assertion of burden
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Helpful Hints
 Provide detailed explanation of why each group is
restrictable from each other group
– Include facts and/or reasoning to support the conclusion
– Also include the reasoning as to why there is an undue
burden
 All claims must be accounted for
– Either in a group, or in a linking claim paragraph
 In the ensuing Office Actions on the merits do not
reject claims solely because they encompass nonelected subject matter
 Send petitions to the deciding official before you
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complete an office action
The End
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