Restriction Practice for Genus Claims Species Claims Linking Claims and Ten Sequence Waiver.

1
Restriction Practice for Genus Claims Species
Claims Linking Claims and Ten Sequence Waiver.

• Julie Burke
• TC1600 QAS/Program Manager
• 571-272-0512
• julie.burke_at_USPTO.gov

2

• Objectives
• Part 1
• Basis for Requiring Restriction
• Burden
• Distinctness, Emphasis on Mutually Exclusive
• Genus Claims
• Species Claims
• Part 2
• Overview of 27 March 2007 OG Notice
• One Sequence per Application?
• Linking Claims

3
35 U.S.C. 101

• Whoever invents or discovers any new and useful
  process, machine, manufacture, composition of
  matter, or any new and useful improvement
  thereof, may obtain a patent therefor,

4
35 U.S.C. 101 WHOEVER INVENTS MAY RECEIVE A
PATENT
PATENT APPLICATION
INVENTION A
PATENT APPLICATION
PLURAL DISTINCT INVENTIONS
PATENT APPLICATION
PATENT FOR INVENTION A
INVENTION A

• DOUBLE PATENTING
• STATUTORY TYPE
• 35 USC 101
• NON-STATUTORY
• Obviousness-type
• Double Patenting

ONE PATENT FOR ONE INVENTION
RESTRICTION 35 U.S.C. 121
5
What is a Genus or Generic claim?

• A claim that encompasses two or more disclosed
  embodiments (species) within its scope is
  considered to be a generic or genus claim.
• Two types of generic claims are-
• those which use alternative language to enumerate
  species, i.e., Markush claims
• Alternatives may be
• selected from the group consisting of A, B and
  C or
• listed as A, B or C
• those which use do not use alternative language
  instead they describe the genus using generic
  terminology
• See MPEP 806.04(d) and 806.04(e) for further
  definition.

6
Three Ways to Claim a Genus

• 1. Encompassed by a generic claim that does not
  use alternative language the claim which reads
  upon but is not necessarily limited to plural
  species disclosed in the specification.
• Claim 1. A citrus fruit.
• 2. As a Markush claim listing plural species
• Claim 2. A citrus fruit selected from the
  group consisting of an orange or a lemon.
• 3. As a series of single species claims
• Claim 3. An orange.
• Claim 4. A lemon.

7
When is a Generic Claim a Linking Claim?

• When separate species claims are encompassed by a
  generic claim, the generic claim is one kind of
  linking claim.
• Claim 1. A citrus fruit. (generic linking
  claim)
• Claim 2. An orange. (separate species claim)
• Claim 3. A lemon. (separate species claim)
• Stay tuned for more on linking claims.

8
What are Species?

• Species are always specifically different
  embodiments of an invention.
• Species typically are disclosed as examples or
  figures in the specification.
• Stay tuned for more on species.
• MPEP 806.04(e).

9
Basic Restriction Guidelines

• Every restriction requirement has two criteria
• The inventions, as claimed, must be independent
  or distinct and
• There would be a serious burden on the examiner
  if restriction were not required.
• MPEP 803, subsection I

10
What is Serious Burden?

• Basically, the search and examination for one of
  the claimed inventions is not required for
  another of the claimed inventions.

MPEP 808.02
11
Showing Serious Burden

• Reasons must be provided why a serious burden
  would exist if restriction were not required.
• A serious burden may be prima facie shown if one
  or more of the following reasons apply - that the
  inventions have
• (a) separate classification
• (b) separate status in the art
• (c) a different field of search (as defined in
  MPEP 808.02)
• (d) if the prior art applicable to one invention
  would likely not be applicable to another
  invention,
• (e) the inventions are likely to raise different
  non-prior art issues under 35 USC 101 and/or 35
  USC 112, 1.
• MPEP 803, 808.02

12
Showing Serious Burden (cont.)

• Serious burden may be established based on a
  different field of search if it is necessary to
  search for one of the inventions in a manner not
  likely to result in finding art pertinent to the
  other invention(s), e.g.,
• searching different classes/subclasses
• searching different electronic resources
• employing different search queries
• MPEP 808.02

13
Responding to applicants traversal re burden

• Where the initial requirement is traversed, it
  should be reconsidered. If, upon reconsideration,
  the examiner is still of the opinion that
  restriction is proper, it should be repeated and
  made final in the next Office action. (See MPEP
  803.01.) In doing so, the examiner should reply
  to the reasons or arguments advanced by applicant
  in the traverse. MPEP 821.01

14
When is Restriction Not an Option?

• If the search and examination of all the claims
  in an application can be made without serious
  burden, the examiner must examine all of the
  claims on the merits, even if the claims are
  drawn to independent or distinct inventions.
• If there is an express admission that the claimed
  inventions are obvious over each other within the
  meaning of 35 U.S.C. 103, restriction should not
  be required.
• MPEP section 803

15
Obvious variants are not distinct inventions

• Distinctness between related inventions requires
  that at least one invention would not have been
  obvious over the other (i.e., that the inventions
  are not obvious variants).
• If the claims on their face are obvious over each
  other, restriction is not proper.
• For example of obvious variants, the application
  claims a method of connecting two parts together.
  
• In one embodiment, the method requires a screw.
• In a second embodiment, the method requires a
  nail.
• The examiner should group together embodiments
  considered clearly unpatentable over each other
  see MPEP 806.04(h).

16
Basic Restriction Guidelines

• Every restriction requirement has two criteria
• The inventions, as claimed, must be independent
  or distinct and
• There would be a serious burden on the examiner
  if restriction were not required.
• MPEP 803, subsection I

17
Importance of Distinction

• When the inventions are not distinct as claimed,
  restriction is never proper. MPEP 806
• Where restriction is required by the Office
  double patenting cannot be held, and thus, it is
  imperative the requirement should never be made
  where related inventions as claimed are not
  distinct. MPEP 806

18
Compare Claimed Subject Matter

• In passing upon questions of double patenting and
  restriction, it is the claimed subject matter
  that is considered and such claimed subject
  matter must be compared in order to determine the
  question of distinctness or independence. MPEP
  806.01

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Test for Distinctness Between Related Products or
Between Related Processes

• Test
• each invention as claimed requires a mutually
  exclusive characteristic not required for the
  other invention
• AND
• the inventions as claimed are not obvious
  variants
• MPEP 806.05(j) FP 8.14.01

20
Test for Distinctness Between Species

• Species are distinct when
• each species, as claimed, requires a mutually
  exclusive characteristic not required for the
  other species
• AND
• the species, as claimed, are not obvious variants
  of each other
• MPEP 806.04(f) FP 8.01 and 8.02

21
Two Species must be Mutually Exclusive of each
other

• Where two or more species are claimed, a
  requirement for restriction to a single species
  may be proper if the species are mutually
  exclusive. MPEP 806.04(f)

22
What does Mutually Exclusive Mean?

• Claims to different species are mutually
  exclusive if one claim recites limitations
  disclosed for a first species but not a second,
  while a second claim recites limitations
  disclosed only for the second species and not the
  first. MPEP 806.04(f)
• This may also be expressed by saying that to
  require restriction between claims limited to
  species, the claims must not overlap in scope.
  MPEP 806.04(f)

23
Explaining mutually exclusive in terms of the
Infringement Test

• Related inventions in the same statutory class
  are considered mutually exclusive, or not
  overlapping in scope, if a first invention would
  not infringe a second invention, and the second
  invention would not infringe the first invention.
  MPEP 806.05

24
When must we apply the test for Mutually
Exclusive Characteristics? Species recited in
separate claims- FP 8.01 Species disclosed
in the specification- FP 8.02 Related
products/related processes- FP
8.14.01 Intermediate/Final products- FP
8.14 Subcombinations useable together- FP
8.16 Note FP 8.16 does not discuss mutually
exclusive but it does state that the
subcombinations must not overlap in scope.
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When do we NOT apply the test for Mutually
Exclusive Characteristics? Combination/subcombina
tion FP 8.15 Apparatus and process of using FP
8.17 Apparatus and product made FP 8.19 Product
and process of making FP 8.18 Product and
process of using FP 8.20
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Test for Distinctness Between Species

• Species are distinct when
• each species, as claimed, requires a mutually
  exclusive characteristic not required for the
  other species
• AND
• the species, as claimed, are not obvious variants
  of each other
• MPEP 806.04(f) FP 8.01 and 8.02

27
In other words

• Species/inventions are distinct in terms of
  restriction when
• Each species/invention, as claimed, does not
  anticipate another under 35 USC 102
• AND
• each species/invention, as claimed, is not
  obvious over another under 35 USC 103(a)

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Example I Inventions are distinct as claimed.
Claim 1. Isolated antibody ABC. Claim 2. Isolated
antibody XYZ. The specification
discloses antibody ABC which binds to
transcription factor TF and antibody XYZ which
binds to cell surface receptor CSR. Claim 1
and 2 are distinct from each other because
claim 1 requires the mutually exclusive
characteristic of an antibody which binds
transcription factor TF which is not encompassed
by claim 2 and claim 2 requires the mutually
exclusive characteristic of an antibody which
binds cell surface receptor CSR which is not
encompassed by claim 1.
29
Claims Define Same Essential Features of a Single
Disclosed Embodiment

• Where the claims of an application define the
  same essential characteristics of a single
  disclosed embodiment of an invention, restriction
  therebetween should never be required.
• This is because the claims are not directed to
  distinct inventions rather they are different
  definitions of the same disclosed subject matter,
  varying in breadth or scope of definition. MPEP
  806.03

30
Example II Claims use different limitations to
describe a single disclosed embodiment
Claim 1. A compound of formula 1. Claim 2. A
compound having the x-ray diffraction pattern as
depicted in Fig 12. The specification discloses
a compound of formula 1 having an x-ray
diffraction pattern depicted in Figure 12. Claim
1 is not distinct from claim 2 as both claims
merely define the same essential characteristics
of a single disclosed embodiment of an
invention. Do not confuse claim limitations with
required characteristics. Claims are read in
light of specification, but do not read
limitations from specification into claims.
31
Example III Claims use different limitations to
describe a single disclosed embodiment.
Claim 1. Antibody ABC. Claim 2. An antibody
produced by hybridoma PDQ. Claim 3. An antibody
produced by hybridoma deposited at the ATCC with
deposit number HB 12345 The specification
discloses an antibody ABC which is produced by
hybridoma named PDQ deposited at the ATCC with
deposit number HB 12345. Claim 1, 2 and 3 not
distinct from each other as the claims merely
define the same essential characteristics of a
single disclosed embodiment of an invention.
32
Example IV Claims use different limitations to
describe the single disclosed embodiment
invention.
Claim 1. An isolated nucleic acid molecule having
SEQ ID No 1. Claim 2. An isolated nucleic acid
molecule encoding a protein having SEQ ID No
2. Claim 3. An isolated nucleic acid produced by
a plasmid deposited at the ATCC with deposit
number 34567. The specification discloses an
nucleic acid molecule which is produced by a
plasmid deposited at the ATCC with deposit number
34567 has SEQ ID No 1 and contains the open
reading frame to encode a protein having SEQ ID
No 2. Claim 1, 2 and 3 not distinct from each
other as the claims merely define the same
invention using different limitations.
33
Example V Claims encompass a single disclosed
embodiment.
Claim 1. A tropical fruit. Claim 2. A citrus
fruit. Claim 3. An orange. The specification
discloses that an orange is both a citrus fruit
and a tropical fruit. Claim 3 is encompassed by
both claim 1 and claim 2. Restriction among
claim 1, 2 and 3 is not proper because claims 1,
2 and 3 are not distinct- they overlap in scope.
Restriction between claim 1 and 2 is not
proper, because both claims encompass the same
disclosed embodiment, an orange. Claim 3 is NOT a
linking claim. A linking claim is broader in
scope from and encompasses the linked inventions.
Here claim 3 is narrower in scope from either
claim 1 or 2.
34
Example VI Inventions not distinct as claimed.
Claims vary in breath or scope of definition.
Claim 1. An isolated nucleic acid molecule
having SEQ ID No 1. Claim 2. A vector comprising
the nucleic acid molecule of claim 1. Claim 3. A
host cell comprising the vector of claim
2. Claims 1, 2 and 3 are not distinct because
claims 1, 2 and 3 vary in breadth or scope of
definition. claim 1 encompass (overlaps in
scope with) claim 2. claim 2 encompass
(overlaps in scope with) claim 3. claim 3 is
encompassed by both claims 1 and 2.
35

• Objectives
• Part 1
• Basis for Requiring Restriction
• Burden
• Distinctness, Emphasis on Mutually Exclusive
• Genus Claims
• Species Claims
• Part 2
• Overview of 27 March 2007 OG Notice
• One Sequence per Application?
• Linking Claims

36
Official Gazette Notice 27 March 2007
In 1996, polynucleotide molecules were often
claimed by simple reference to a nucleotide
sequence (SEQ ID No). The 1996 OG Notice
permitted examination of up to ten molecules
described by their nucleotide sequence. See
Examination of Patent Applications Containing
Nucleotide Sequences, 1192 OG 68 (19 November
1996).
37
Official Gazette Notice 27 March 2007 (cont.)

• Since 1996, the types of nucleic acid
  sequence-based claims have become more diverse
  and complex. Polynucleotide molecules are now
  often described in terms of
• homology
• percent identity
• hybridization
• variable positions specified within the sequence
  listing
• function of the nucleic acid
• partial linear nucleotide sequence
• single nucleotide polymorphisms (SNPs)
• the amino acid sequence of the protein encoded

38
Official Gazette Notice 27 March 2007

• The Office has reconsidered the policy set forth
  in the 1996 Notice in view of changes in
• the complexity of applications filed,
• the types of inventions claimed and
• the state of the prior art in this technology.

39
Official Gazette Notice 27 March 2007 (cont.)

• Since 1996, we have seen
• exponential growth in the size of nucleic acid
  sequence databases
• an increase in the number of databases and
• an increase in the complexity of such databases.
• Growth of the GenBank(R) database
• Year Nucleotides Sequences
• 1996 651,972,984 1,021,211
• 2000 11,101,066,288 10,106,023
• 2006 59,750,386,305 54,584,635

40
Official Gazette Notice 27 March 2007 (cont.)
It now requires significantly more computational
time to run individual nucleotide sequence
searches for examination purposes than in 1996,
and there is significantly more pertinent prior
art to consider. In addition, it currently
takes more Office resources to correlate the
claimed polynucleotide with the polynucleotide as
defined in the prior art because it is
increasingly common for both patent applications
and prior art references to describe a
polynucleotide molecule in different ways.
41
Official Gazette Notice 27 March 2007 (cont.)

• Consequently, with this Notice the Office
  rescinds the partial waiver of
• 37 CFR 1.141 et seq. for restriction practice in
  national applications filed under 35 U.S.C.
  111(a), and
• 37 CFR 1.475 et seq. for unity of invention
  determinations in both PCT international
  applications and the resulting national stage
  applications under 35 U.S.C. 371.

42
Official Gazette Notice 27 March 2007 (cont.)

• For National applications filed under 35 U.S.C.
  111(a), in accordance with MPEP Chapter 800,
  polynucleotide inventions will be considered for
• restriction,
• rejoinder and
• examination practice.
• As for other type of molecule, claims to
  polynucleotide molecules will be considered for
• independence,
• relatedness,
• distinction and
• burden.

43
Official Gazette Notice 27 March 2007 (cont.)

• For International applications and national stage
  filings of international applications under 35
  U.S.C. 371, unity of invention will be determined
  in view of
• PCT Rule 13.2,
• 37 CFR 1.475 and
• Chapter 10 of the ISPE Guidelines.
• In general, polynucleotide molecules, as claimed,
  must share a technical feature which makes a
  contribution over the prior art.

44
Official Gazette Notice 27 March 2007 (cont.)
This Notice is effective immediately and is
applicable to all pending applications. Note,
however, that supplemental restriction
requirements will not be advanced in applications
that have already received an action on their
merits in the absence of extenuating
circumstances.
45
One Sequence per Application?

• 35 U.S.C. 101 states Whoever invents or
  discovers any new and useful process, machine,
  manufacture, composition of matter, or any new
  and useful improvement thereof, may obtain a
  patent therefor,
• A single invention may be defined by more than
  one sequence.
• Heres some examples where restriction to a
  single sequence would and would not be
  appropriate.

46
Open Transitional Language

• Comprising
• Permits additional nucleic acids at either end of
  the sequence
• always reads upon plural species
• Consisting essentially of
• Permits additional nucleic acids at either end of
  the sequence, unless explicitly defined otherwise
  in specification
• always reads upon plural species

47
Closed Transitional Language

• Closed Transitional Language consisting of
• Prevents additional nucleic acids at either end
  of the sequence
• generally reads upon a single fully defined
  species
• note that the sequence listing permits use of
  variables which read upon more than one nucleotide

48
Example VII When sequences fully overlap.
Claim 1. An isolated nucleic acid molecule
comprising SEQ ID NO 1. Claim 2. An isolated
nucleic acid molecule comprising SEQ ID NO 2.
Claim 3. An isolated nucleic acid molecule
comprising SEQ ID NO 3. The term comprising
permits additional nucleic acids at either end of
the sequence.
49
Example VII When sequences fully overlap. (cont.)
The sequence listing shows that SEQ ID NO 1, 2
and 3 fully overlap with each other. SEQ ID NO
1ATGTGCGATA SEQ ID NO 2ATGTGCGATA ATCTG SEQ ID
NO 3ATGTGCGATA ATCTGTTATA Because nucleic acid
molecules comprising SEQ ID NO 1, 2 and 3 are
not distinct as claimed, from each other,
restriction to a single sequence of SEQ ID NO 1,
2 and 3 would not be proper.
50
Example VII When sequences fully overlap.
(cont.)
Practice Tip To highlight the common region,
consider providing a sequence alignment or using
this claim format to refer to a single
sequence Claim 1. An isolated nucleic acid
molecule comprising residues 1-10 of SEQ ID NO
3. Claim 2. An isolated nucleic acid molecule
comprising residues 1-15 of SEQ ID NO 3. Claim
3. An isolated nucleic acid molecule comprising
SEQ ID NO 3.
51
Effect of Claim Format

• A plurality of elements may be claimed
• as a combination or
• in the alternative.
• Example of a combination claim
• Claim 1. A kit comprising primers having SEQ ID
  NO 1-100.
• Example of a claim that uses alternative language
  to enumerate species, i.e., a Markush claim
• Claim 2. A primer selected from the group
  consisting of SEQ ID NO 1-100.

52
Example VIII A Combination Claim

• Claim 1. A kit comprising primers having SEQ ID
  NO 1-100.
• A combination of nucleotide molecules will
  generally not be subject to a restriction
  requirement.
• The presence of one novel and nonobvious sequence
  within the combination will render the entire
  combination allowable.

53
Example VIII A Combination Claim (cont.)

• Claim 1. A kit comprising primers having SEQ ID
  NO 1-100.
• The combination will be searched until one
  nucleotide sequence is found to be allowable.
• The order of searching will be chosen by the
  examiner to maximize the identification of an
  allowable sequence.
• If no individual nucleotide sequence is found to
  be allowable, the examiner will consider whether
  the combination of sequences taken as a whole
  renders the claim allowable.

54
Example IX A single SEQ ID NO may encompass
two or more species.

• Claim 1. An isolated nucleic acid consisting of
  SEQ ID NO 1.
• Claim 1
• refers to a single SEQ ID NO and
• uses closed transitional language consisting
  of.
• The phrase consisting of followed by a single
  SEQ ID NO generally limits
• a claim to a single fully defined nucleic acid
  molecule.

55
A Partial List of Nucleotide Symbols
Symbol Meaning Original a a adenine g g gu
anine c c cytosine t t thymine u u uracil
r g or a purine y t/u or c pyrimidine m a
or c amino k g or t/u keto s g or
c strong interactions 3H-bonds w a or
t/u weak interactions 2H-bonds
56
Example IX A single SEQ ID NO may encompass
two or more species (cont.)
The sequence listing shows that SEQ ID NO 1 is
ATGSTAMATR, where S is G or C, M is A or C
and R is G or A. SEQ ID NO 1 encompasses eight
patentably distinct sequences ATGGTAAATG ATGGTAA
ATA ATGCTAAATG ATGCTAAATA ATGGTACATG ATGGTACATA
ATGCTACATG ATGCTACATA In this situation, the
examiner may require an election of species using
FP 8.02, generic claim reads upon disclosed
species.
57
Linking Claims

• Definition A linking claim is a claim which, if
  allowable, would prevent restriction between two
  or more otherwise properly divisible
  (restrictable) inventions. MPEP 809 and 809.03.
• Linking claims and linked inventions are usually
  either product claims linking properly divisible
  product inventions, or process claims linking
  properly divisible process inventions.
• Most kinds of Linking claims are
• Genus claims linking species claims
• Subcombination claims linking plural combinations
  that require the subcombination.
• Restriction can be required when there are
  linking claims and claims to distinct inventions.
• If a linked invention is elected, the linking
  claims are examined with the elected invention.

58
Example X Distinct Inventions encompassed by a
linking claim.
Claim 1. A transgenic animal comprising SEQ ID
No 1. (linking claim) Claim 2. A transgenic dog
comprising SEQ ID No 1. Claim 3. A transgenic
cat comprising SEQ ID No 1. Claims 2 and 3 are
distinct from each other for the reasons set
forth on a previous slide. Claims 2 and 3 are
themselves both encompassed by linking claim 1.
Restriction between claim 2 and 3 may be proper,
but claim 1 must be examined with either elected
invention. Should claim 1 become allowable, the
restriction between claim 2 and 3 must be
withdrawn.
59
Allowable Linking Claims

• When a linking claim is allowable, a restriction
  requirement between the inventions it links
  cannot be maintained.
• The restriction requirement should be withdrawn,
  even if claims to non-elected linked inventions
  have been canceled.
• Any claim(s) depending from or otherwise
  requiring all the limitations of the allowable
  linking claim(s) will be rejoined and fully
  examined for patentability.
• The Office must provide Applicant with an
  opportunity to reinstate canceled claims when a
  restriction requirement is withdrawn based on the
  allowability of the linking claim.
• MPEP 809.03 and 821.04(a)

60
Dependent Claims that refer to the linked
inventions in the alternative are not linking
claims

• A linking claim must be broader in scope than
  all the linked inventions.
• A dependent claim which refers to two or more
  restrictable independent claims in the
  alternative is not a linking claim.

61
Example XI A claim that depends upon, but does
not link, plural distinct inventions.
Claim 1. An isolated nucleic acid having SEQ ID
NO 1. Claim 2. An isolated nucleic acid having
SEQ ID NO 2. Claim 3. A vector comprising the
nucleic acid of claim 1 or claim 2. Claim 4. A
host cell comprising the vector of claim 3. See
a previous slide for discussion of specification
and reasons why claim 1 and 2 are distinct from
each other.
62
Example XI A claim that depends upon, but does
not link, distinct inventions. (cont.)
A linking claim must be broader in scope than
the linked claims. Claims 3 and 4 are NOT
linking claims because claims 3 and 4 are
narrower in scope that claims 1 and 2. The
claims may be grouped as follows Group I,
claim 1, and claims 3 and 4, in part, drawn to
nucleic acid, vector and host cell having SEQ ID
NO 1. Group II, claim 2 and claims 3 and 4,
in part, drawn to nucleic acid, vector and host
cell having SEQ ID NO 2.
63
In Summary
For National applications filed under 35 U.S.C.
111(a),, as for other type of invention, claims
to polynucleotide molecules will be considered
for restriction and rejoinder in accordance with
MPEP Chapter 800 For International applications
and national stage filings of international
applications under 35 U.S.C. 371, unity of
invention will be determined in view of PCT Rule
13.2, and Chapter 10 of the ISPE Guidelines.
Supplemental restriction requirements will not
be advanced in applications that have already
received an action on their merits in the absence
of extenuating circumstances.
64
Restriction Practice for Genus Claims Species
Claims Linking Claims and 10 Sequence Waiver

• Julie Burke
• TC1600 QAS/Program Manager
• 571-272-0512
• julie.burke_at_USPTO.gov