Restriction Examples

1
Restriction Examples

• Biotechnology Customer Partnership Meeting
  December 2006
• Bruce Campell, SPE 1648
• bruce.campell_at_uspto.gov / [phone]

2
Subject Matter Of Examples

• Two Chemical examples
• Three Biotechnology examples
• Supplied by non USPTO Biotechnology Customer
  Partnership attendees

3
Example 1 Chemcial/Specification

• The specification discloses
• The conditioning effect is extended.
• The treated hair is shinier.
• Noncyclic silicone compounds A, B, and C
• Cationic polymers D (polyquaternium-10), E, F ,
  and G
• Nonionic polymers H, I, J, K, L, and M
• Polysaccharides N, O, P, Q, R, S, and T
• Surfactants U, V, W, X, Y, and Z

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Example 1 Chemical/Claims

• A composition comprising
• a noncyclic silicone compound selected from A
  through C
• a cationic polymer selected from D through G
• a nonionic polymer selected from H through M
• a polysaccharide derivative selected from N
  through T and,
• a surfactant selected from U through Z
• The composition of claim 1 wherein the cationic
  polymer is polyquaternium-10.
• A method of conditioning hair comprising applying
  the composition of claim 1 under conditions and
  for a time effective to condition hair.
• The method of claim 2 wherein the conditioning
  time is 4 minutes.
• The method of claim 3 wherein said conditioning
  time is carried out between about 40 to 50C.

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Example 1 Chemical/Restriction

• Group I contains the composition claims 1 and 2
  which are initially classified in Class 424,
  subclass 70.1 among others (in some instances,
  different moieties recited as variables will
  alter classification)
• Group II contains the process of use claims 3 to
  5 which are classified in Class 424, subclass
  70.1
• The relationship between Group I and II are
  product and process of use.
• Can the group I compounds be used in a different
  processes of use?
• Is there a reason to request an election of
  species and how many species are there?
• Can the complete set of claims be searched with
  one search?
• Are the claims generic?
• What would the computer based search consist of?
• Would the search take any longer to consider all
  possibilities of all variables?
• Is there a difference in the amount of art to be
  considered?
• Does shinier hair and conditioning lifetime
  extension need consideration?

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Example 2 Chemical/Specification

• The specification indicates there is only one
  utility for the compounds, dysphoric disorders.
• Stedmans Medical dictionary defines dysphoria as
  a feeling of unpleasantness or discomfort.

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Example 2 Chemical/Claims

• Claim 1. A compound having the formula
• wherein
• R is selected from C1-6alkyl, phenyl and
  pyridyl
• X is C or N
• Y is a saturated, partially-saturated or
  unsaturated 5-, 6-, 7-membered monocyclic ring
  containing 0, 1, 2 or three heteroatoms selected
  from O, N and S and
• R is OC1-6haloalkyl, NHC1-6 haloalkyl or
  S(O)C1-6 haloalkyl.
• Claim 2. A method of treating dysphoric
  disorders by administering a compound according
  to Claim 1 to a patient in need thereof.

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Chemical Example 2/Restriction 1

• Claims are related as product (claim 1) and
  process of use (claim 2).
• Variables
• R classification differs for C1-6 alkyl, phenyl,
  or pyridyl
• X classification differs for XC and XN
• Y classification differs for saturated,
  partially-saturated or unsaturated 5-, 6-,
  7-membered monocyclic ring containing 0, 1, 2 or
  three heteroatoms selected from O, N and S
• R classification differs for OC1-6haloalkyl,
  NHC1-6 haloalkyl or S(O)C1-6 haloalkyl
• The compound and classification change via
  substitution of a carbon with N.
• Classification of the moieties for each variable
  differ.
• Each different variable combined with each moiety
  of each variable result in a different compound.
  Please note the number of different combinations.
• Each different moiety for each variable can
  result in a different search due to different
  classification and specifics of the moiety and
  required search.
• Result may be requirement for electing a specific
  moiety for each variable.

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Example 2 Chemical/Restriction 2

• Variables result in different compounds and
  classification
• Compounds above separately classified.

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Example 2 Chemical/Restriction 3

• Group I, claim 1, the compound.
• Group II, claim 2, the method of use.
• Inventions of Group I and II are related as
  product and process of use. The inventions can
  be shown to be distinct if either or both of the
  following can be shown (1) the process for using
  the product as claimed can be practiced with
  another materially different product or (2) the
  product as claimed can be used in a materially
  different process of using that product
  (MPEP 806.05(h)). In the instant case, one or
  more of the compounds can be used in a process of
  treating inflammation which differs treating
  dysphoria.
• Based on differences in classification of the
  compounds, an election of species appears
  appropriate. have different processes or methods
  of use, e.g., treating inflammation as opposed to
  dysphoria of claim 2.
• In one direction there is rejoinder practice if
  the product (compound) is elected.
• There were 233,497,792 possibilities. A
  preliminary search of the core did not run to
  completion (too many hits).
• MPEP 803 - Burden - criteria are any one or more
  of separate classification, separate status in
  the art, or different field of search (MPEP
  808.02).

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Example 3 Biotechnology/Specification

1. Wildtype protein X is 75 amino acids in length
   and is shown in SEQ ID NO1.
2. Total of 50 claims (sample claims next slide).
3. Prior art teaches protein X mutants are toxic.
4. The application teaches current claimed mutant
   proteins are not toxic and different from the
   prior art mutants by residue position.

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Example 3 Biotechnology/Claims

1. A mutant of protein X which is not cytotoxic when
   introduced into cells.
2. The mutant protein of claim 1 wherein the
   N-terminal amino acid is changed.
3. The mutant protein of claim 1wherein the
   C-terminal amino acid is changed.
4. The mutant protein of claim 1 wherein the changed
   amino acid is at one or more of positions 1, 13,
   29, 31, or 57 wherein the amino acid residue is
   not the residue shown in SEQ ID NO1.
5. A DNA encoding a mutant protein X of any one of
   claims 1 4.
6. The DNA of claim 5 operably linked to a promoter.
7. The DNA of claim 6 wherein the promoter is
   inducible, constitutive, repressible, tissue
   specific, or heat shock activated.
8. A vector comprising the DNA of claim 7.
9. Host cells transformed with the vector of claim
   7.
10. The host cells of claim 9 where the cells are
    bacterial, fungal, animal or plant cells.
11. Host cells of claim 10 wherein the cells are an
    intact animal or plant or protoplast mass.
12. A method of producing mutant protein X comprising
    culturing the host cells of claims 9 11 for a
    time and under conditions effective to express
    protein X and isolating said protein X from said
    cells.
13. An antibody to the protein X of one or more of
    claims 1 4.
14. The antibody of claim 13 which is polyclonal or
    monoclonal (MabX).
15. The antibody of claim 14 wherein the binding
    constant for the protein X mutant is lt10-8.
16. A method of modulating toxicity of protein X by
    administering MabX to bind wildtype protein X and
    thereby lower the amount of cellular protein X.

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Example 3 Biotechnology/Restriction 1

• Group I is a noncytotoxic mutant of protein X
  where the N-, C- and other residues are altered,
  are classified in class 530 subclass 324. Claim
  1 is a genus type claim which can also be
  considered a linking claim.
• Group II comprises bacterial, fungal, animal or
  plant or protoplasts containing a vector with DNA
  encoding a mutant protein X classified in Class
  536 (subclass 23.1), Class 435 subclasses 320.1
  and 325 and, a method of producing mutant
  protein X comprising culturing the host cells for
  a time and under conditions effective to express
  protein X and isolating said protein X from said
  cells classified in Class 435 subclass 69.1.
• Group III is an antibody to protein X of one or
  more of claims 1 4 classified in Class 530
  subclass 387.1.
• Group IV is a method of modulating toxicity of
  protein X by administering MabX to bind wildtype
  protein X and thereby lower the amount of
  cellular protein X classified in Class 424
  subclass 130.1.
• Independent of the election of one of Groups I
  through III, an election of species is required.
  Each position (N-, C-, 1, 13, 19, 31, or 57) that
  is changed in amino acid sequence compared to
  wildtype protein X needs to be identified by a
  specific amino acid residue and/or codon in the
  case of invention II.

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Example 3 Biotechnology/Restriction 2

• Groups I and II and, I and III are directed to
  different products. Each is differently
  classified and searched (Groups I, II, and III).
  Neither mutant protein X nor a Mab substitute
  for the DNA, vector and host cell. Mutant
  protein X and a Mab are different proteins with
  different chemical, physical, and biological
  properties and functions.
• Group I and II are related as product and process
  of making. The mutant protein can be made by
  traditional chemical synthesis (alternate method
  of making).
• Group I is a mutant protein X whereas Group IV is
  a method of administering MabX to bind wildtype
  protein X and thereby lower the amount of
  cellular protein X - the method of IV is not
  indicated in the claim to alter level(s) of
  mutant protein X.
• Independent of the election of one of Groups I
  through III, an election of species is required.
  Each position (N-, C-, 1, 13, 19, 31, or 57) that
  is changed in amino acid sequence compared to
  wildtype protein X needs to be identified by a
  specific amino acid residue and/or codon in the
  case of invention II.
• Searches for Group I through IV are different.
  Protein databases (I and III) v nucleotide
  databases (II) and one protein v 4 proteins
  forming one (1) Mab.

15
Example 4 Biotechnology/Specification

• Antisense oligonucleotides are 20-mers which are
  themselves fully complementary to a 60-mer of SEQ
  ID NO1.
• Additional antisense sequences SEQ ID NO2 to 6
  are fully complementary to different parts of SEQ
  ID NO1.
• Sequence 2 and 6 are complementary to the 5 and
  3 ends respectively of the 60-mer SEQ ID NO1.
• SEQ ID NO 2 through 6 have a 10 bp overlap with
  the next higher numbered sequence, i.e., sequence
  2 and 3 share a 10 bp overlap and sequences 3 and
  4 share a 10 bp overlap, etc.

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Example 4 Biotechnology/Drawing

• nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn
  nnnnnnnnnnnn
• 1 10 20 30 40
  50 60
• nnnnnnnnnnnnnnnnnnnn - SEQ ID NO2
• nnnnnnnnnnnnnnnnnnnn - SEQ ID NO3
• nnnnnnnnnnnnnnnnnnnn - SEQ
  ID NO4
• SEQ ID NO5 -
  nnnnnnnnnnnnnnnnnnnn
• SEQ ID NO6 -
  nnnnnnnnnnnnnnnnnnnn

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Example 4 Biotechnology/Claims

• Claim 1. An antisense sequence 20 nucleobases in
  length having full-length complementarity within
  nucleotides 1 to 60 of SEQ ID NO1.
• Claim 2. The antisense sequence of claim 1,
  wherein the antisense sequence has a nucleotide
  sequence consisting of SEQ ID NO 2, 3, 4, 5, or
  6.

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Example 4 Biotechnology/Restriction

• Claim 1 as presented does not per se claim SEQ ID
  NO1 but 20-mer fragments of SEQ ID NO1. This
  is a genus type claim which can also be
  considered a linking claim for claim 2.
• Claim 1 has all 20-mers of the 60-mer which is
  SEQ ID NO1.
• In claim 2, all antisense sequences are
  considered distinct and different from each other
  regardless of overlap, since
• one sequence does not render another obvious
• while they overlap, the overlap does not
  constitute a common core structure, (such as a
  consensus sequence) related to its function
• All antisense sequences of claim 2 are embraced
  by generic claim 1, and are thus subject to
  rejoinder should claim 1 be found allowable.

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Example 5 Biotechnology/Specification

• Disclosed making human novel protein X Ab by
  panning a phage library. Heavy (Hc) and light
  (Lc) chains are converted to full length IgG (Ab
  1 to 10).
• SEQ ID NO 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 are
  Hc variable regions of Ab 1 to 10. SEQ ID NO
  2, 4, 6, 8, 10, 12, 14, 16, 18, and 20 are Lc
  variable regions of Ab 1 to 10.
• Complementary-determining regions (CDRs) of heavy
  chains and light chains of the Abs1-10 are
  determined and the residues corresponding to each
  of the 3 heavy chain and light chain CDR1, CDR2,
  and CDR3 are identified and listed in the
  specification.
• Various uses of the Abs to make therapeutic
  binding agents are described and enabled. The
  specification teaches Novel Protein X is involved
  in generating the genus of Undesired Condition
  and the sub-genus of Undesired Sub-Condition A
  and Undesired Sub-Condition B. The specification
  teaches the Abs to Novel Protein X can be used to
  treat the Undesired Condition, the Undesired
  Sub-Conditions A and B, and specifically Disease
  I, Disease II, Disease III, etc.

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Example 5 Biotechnology/Claims 1

• Claim 1. A specific binding agent comprising at
  least one peptide selected from the group
  consisting of SEQ ID NO. 1 SEQ ID NO. 3 SEQ ID
  NO. 5 SEQ ID NO. 7 SEQ ID NO. 9 SEQ ID NO. 11
  SEQ ID NO. 13 SEQ ID NO. 15 SEQ ID NO. 17 SEQ
  ID NO. 19 SEQ ID NO. 2 SEQ ID NO. 4 SEQ ID
  NO. 6 SEQ ID NO. 8 SEQ ID NO. 10 SEQ ID NO.
  12 SEQ ID NO. 14 SEQ ID NO. 16 SEQ ID NO. 18
  SEQ ID NO. 20 and fragments thereof.
• Claim 2. The specific binding agent of Claim 1
  that is an antibody.
• Claim 3. The antibody of claim 2 that is a
  polyclonal, monoclonal, chimeric,
  humanized, or fully human antibody.
• Claim 4. A hybridoma that produces the monoclonal
  antibody according to
  Claim 3.
• Claim 5. A nucleic acid molecule encoding the
  specific binding agent of one of Claims 1 to
  4.
• Claim 6. A vector comprising the claim 5
  nucleic acid molecule.
• Claim 7. A host cell containing the vector
  according to Claim 6.

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Example 5 Biotechnology/Claims 2

• Claim 8. A method of making a specific binding
  agent comprising
• (a) transforming a host cell with at
  least one nucleic acid molecule encoding the
  specific binding agent of Claim 1
• (b) expressing the nucleic acid molecule in
  said host cell and
• (c) isolating said specific binding agent.
• Claim 9. A method of inhibiting undesired
  condition in a mammal comprising administering a
  therapeutically effective amount of a specific
  binding agent according to Claim 1.
•  Claim 10. A method of treating one of Disease
  I, II, III, or IV in a mammal comprising
  administering a therapeutically effective amount
  of a specific binding agent according to Claim 1.
• Claim 11. A pharmaceutical composition
  comprising the specific binding agent of one of
  claims 1 to 3, and, a pharmaceutically acceptable
  formulation agent.

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Example 5 Biotechnology/Claims 3

• Claim 12. A method of detecting the level of
  Novel Protein X in a biological sample comprising
  (a) contacting an antibody of Claim 1 with said
  sample and (b) determining the extent of binding
  of the antibody to said sample.

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Example 5 Biotechnology/Restriction 1

• Claims to multiple products
• A binding agent (and pharmaceutical agent
  thereof) which is an antibody (Class 530,
  subclass 387.1 as well as 424/130.1) - claims
  1-3 and 11 and, a hybridoma (i.e., a cell or
  cell line, Class 435, subclass 326 also
  424/93.21) - claim 4
• A DNA (536/23.53), vector (435/320.1) and host
  cell (transformed but not a hybridoma, 435/328) -
  claims 5-7
• Claims to multiple processes
• Method of making a binding agent (claim 8) -
  culturing cells and obtaining the protein -
  435/69.1 and/or 70.1
• Method of inhibiting an undesired condition and
  species of Disease I, II, III, and IV (claims 9
  and 10) by administering an Ab - 424/130.1 and
  514/2
• Method of detection of protein X in a biological
  sample by contacting the Ab (claim 12) is
  classified in Class435/7.1

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Example 5 Biotechnology/Restriction 2

• Group I (claims 1-3 and 11) is directed to
  different structure(s), different chemical,
  physical and biological effect(s) and function(s)
  from that of Group II (DNA, vector and host
  cells). The products of Group I and of Group II
  do not substitute one for the other.
• Group II (claims 5-8) is directed to DNA,
  vectors, host cells, and a process of making an
  Ab. This group differs from Group I as indicated
  above. The process of II is one of making
  product I.
• Group III (claims 9 and 10) is directed to
  treatment of an undesired condition (e.g,,
  Diseases I, II, III, and IV) by administering an
  Ab.
• Group IV (claim 12) is directed to a diagnostic
  assay to detect protein X.

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Example 5 Biotechnology/Restriction 3

• Relationships
• Product I (Ab) and product II (DNA, vector, Host
  cells) are distinct/different products not
  substitutable, different classification and
  search. Product I can be make, e.g., by
  traditional chemical synthesis which is an
  alternative of the process of II.
• I is related to III and to IV as product and
  process of use where III and IV demonstrate
  alternative processes of use
• II compared to III and to IV are different
  methods - II is a method of producing the Ab used
  in the process of use III or IV. No DNA, vector,
  or host cell of II is used in the processes of
  III or IV.
• III and IV are distinct, different processes with
  different steps and outcome. The practice of III
  does not result in the practice of IV.
• Specie election absent evidence to the contrary,
  in this instance, each heavy chain and each light
  chain pair is a distinct/different Ab on the
  basis of at least structure and binding
  specificity.
• Claim 1 as presented is in Markush format but as
  written only needs one (1) sequence (need dimer
  of one Hc and one Lc to make Ab).
• Claim 9 and 10 are genus and species.

26
Restriction Examples

• Questions
• Bruce Campell, SPE 1648
• bruce.campell_at_uspto.gov / [phone]