1 Restriction Examples Biotechnology Customer Partnership Meeting December 2006 Bruce Campell, SPE 1648 / (571)

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: 1.The conditioning effect is extended. 2.The treated hair is shinier. 3.Noncyclic silicone compounds A, B, and C 4.Cationic polymers D (polyquaternium-10), E, F, and G 5.Nonionic polymers H, I, J, K, L, and M 6.Polysaccharides N, O, P, Q, R, S, and T 7.Surfactants U, V, W, X, Y, and Z

4 Example 1 Chemical/Claims 1.A composition comprising: a)a noncyclic silicone compound selected from A through C; b)a cationic polymer selected from D through G; c)a nonionic polymer selected from H through M; d)a polysaccharide derivative selected from N through T; and, e)a surfactant selected from U through Z 2.The composition of claim 1 wherein the cationic polymer is polyquaternium A method of conditioning hair comprising applying the composition of claim 1 under conditions and for a time effective to condition hair. 4.The method of claim 2 wherein the conditioning time is 4 minutes. 5.The method of claim 3 wherein said conditioning time is carried out between about 40 to 50C.

5 Example 1 Chemical/Restriction 1.Group I contains the composition claims 1 and 2 which are initially classified in Class 424, subclass among others (in some instances, different moieties recited as variables will alter classification) 2.Group II contains the process of use claims 3 to 5 which are classified in Class 424, subclass 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?

6 Example 2 Chemical/Specification The specification indicates there is only one utility for the compounds, dysphoric disorders. Stedman’s Medical dictionary defines dysphoria as a feeling of unpleasantness or discomfort.

7 Example 2 Chemical/Claims Claim 1. A compound having the formula wherein: R is selected from C 1-6 alkyl, 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 OC 1-6 haloalkyl, NHC 1-6 haloalkyl or S(=O)C 1-6 haloalkyl. Claim 2. A method of treating dysphoric disorders by administering a compound according to Claim 1 to a patient in need thereof.

8 Chemical Example 2/Restriction 1 Claims are related as product (claim 1) and process of use (claim 2). Variables: –R classification differs for C 1-6 alkyl, phenyl, or pyridyl –X classification differs for X=C and X=N –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 OC 1-6 haloalkyl, NHC 1-6 haloalkyl or S(=O)C 1-6 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.

9 Example 2 Chemical/Restriction 2 Variables result in different compounds and classification: Compounds above separately classified.

10 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 (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 Burden - criteria are any one or more of separate classification, separate status in the art, or different field of search (MPEP ).

11 Example 3 Biotechnology/Specification 1.Wildtype protein X is 75 amino acids in length and is shown in SEQ ID NO:1. 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.

12 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 NO:1. 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 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 – 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 < 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.

13 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 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 Group III is an antibody to protein X of one or more of claims 1 – 4 classified in Class 530 subclass 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 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.

14 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 NO:1. Additional antisense sequences SEQ ID NO:2 to 6 are fully complementary to different parts of SEQ ID NO:1. Sequence 2 and 6 are complementary to the 5’ and 3’ ends respectively of the 60-mer SEQ ID NO:1. 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.

16 Example 4 Biotechnology/Drawing nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnnnnnnnnnnnnnnnnnnn - SEQ ID NO:2 nnnnnnnnnnnnnnnnnnnn - SEQ ID NO:3 nnnnnnnnnnnnnnnnnnnn - SEQ ID NO:4 SEQ ID NO:5 - nnnnnnnnnnnnnnnnnnnn SEQ ID NO:6 - nnnnnnnnnnnnnnnnnnnn

17 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 NO:1. 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.

18 Example 4 Biotechnology/Restriction Claim 1 as presented does not per se claim SEQ ID NO:1 but 20-mer fragments of SEQ ID NO:1. 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 NO:1. 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.

19 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 Abs##1-10 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.

20 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.

21 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.

22 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.

23 Example 5 Biotechnology/Restriction 1 Claims to multiple products: A binding agent (and pharmaceutical agent thereof) which is an antibody (Class 530, subclass 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

24 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.

25 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 / (571)