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Unity of Invention Biotechnology Practice

Unity of Invention Biotechnology Practice. Julie Burke USPTO TC1600 Special Program Examiner. Groups of Molecules PCT Rule 13.2 “Markush” Practice Example 17; Administrative Instructions Claim Order, Claim Breadth, Lack of Unity within a Claim and Tips Points of Contact.

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Unity of Invention Biotechnology Practice

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  1. Unity of Invention Biotechnology Practice Julie Burke USPTO TC1600 Special Program Examiner

  2. Groups of Molecules PCT Rule 13.2 “Markush” Practice Example 17; Administrative Instructions Claim Order, Claim Breadth, Lack of Unity within a Claim and Tips Points of Contact

  3. Molecules, grouped together, in the alternative, may share a common Structure Function Source from which they were isolated or Intended use

  4. Types of Nucleic Acid Molecule Groups DNA molecules cloned from a tissue human liver library or small cell lung cancer cDNAs cloned from a developmental stage mRNA expressed in nematode ectoderm Genes encoding proteins with same function tumor suppressors Cell type specific gene regulatory elements G1 cell cycle promoters Variants of a single gene polymorphisms or splice variants of cytokine X cDNA which encodes one protein DNA encoding SEQ ID NO:1

  5. Types of Protein Groups Proteins sharing a structural domain Zinc finger domain Proteins sharing homology Protein 80% identical to Protease XYZ Protein sharing common function Antibodies that bind the ABC antigen Proteins with common structure Splice variants of a protein Proteins in an art recognized class Threonine kinases Proteins isolated from one source Liver cell surface proteins Proteins isolated from an organism S. typhii proteins

  6. Example of molecules claimed in the alternative: Claim: An isolated molecule consisting of Formula 1-999 or 1000. OR Claim: An isolated nucleic acid molecule consisting of SEQ ID NO: 1-999 or 1000. What is the technical feature that links the molecules?

  7. Groups of Molecules PCT Rule 13.2 “Markush” Practice Example 17; Administrative Instructions Claim Order, Claim Breadth and Lack of Unity within a Claim Points of Contact

  8. Claim: An isolated nucleic acid molecule consisting of SEQ ID NO: 1-999 or 1000, wherein the nucleic acid molecule encodes a lymphokine. PCT Rule 13.2, first sentence  Is the function, encoding a lymphokine, the technical feature which links the molecules? PCT Rule 13.2, second sentence Are lymphokine-encoding nucleic acid molecules a contribution over the prior art?

  9. Claim: An isolated rat liver kinase comprising SEQ ID NO: 101-199 or 200. PCT Rule 13.2, first sentence Is rat liver kinase the shared technical feature? PCT Rule 13.2, second sentence Is rat liver kinase a contribution over the prior art?

  10. Claim: An isolated DNA molecule consisting of SEQ ID NO: 1-99 or 100 which is useful for detecting Salmonella typhii strains. PCT Rule 13.2, first sentence Are the molecules linked by the technical feature DNA molecule for detecting S. typhii? PCT Rule 13.2, second sentence Is this technical feature a contribution over the prior art?

  11. Groups of Molecules PCT Rule 13.2 “Markush” Practice Example 17; Administrative Instructions Claim Order, Claim Breadth, Lack of Unity within a Claim and Tips Points of Contact

  12. Claim: An isolated protein selected from the group consisting of SEQ ID NO: 1-99 and 100. The disclosure teaches that SEQ ID NO: 1-100 are each 200 amino acids in length; each contain Protein XYZ that is 180 amino acids in length. The remaining 20 amino acids are N-terminal epitope tags to aid in purifying Protein XYZ and do not interfere with the enzymatic activity of Protein XYZ. Is Protein XYZ the technical feature that links the claimed molecules? Is Protein XYZ a contribution over the prior art? PCT Rule 13.2 Does the grouping meet the criteria for Markush Practice?AI, Annex B Do the proteins (A) have a common property or activity and (B)(1) have a common structure present, i.e, significant structural element or (B)(2) belong to an art recognized class of compounds?

  13. Claim: An isolated DNA molecule of Table 1. Note: Table 1 recites 35 sequences, each of which vary from SEQ ID NO: 1 at a single nucleotide site. Do the DNA molecules share a common structure or belong to an art recognized class of compounds? Is common structure a contribution over the prior art? Do the DNA molecules share a common property or activity?  

  14. Claim: An isolated DNA molecule of Table 1 wherein detection of the DNA molecule is diagnostic for cancer. Note: Table 1 recites 35 sequences, each of which vary from SEQ ID NO: 1 at a single nucleotide site.  Do the DNA molecules have a common structure present, or belong to an art recognized class of compounds? Is common structure a contribution over the prior art? Do the DNA molecules share a common property or activity?

  15. Molecules Grouped by Structure Molecules Grouped by Structure Molecules Grouped by Structure Common Structure? Common Structure? Common Structure? YES YES YES Unity of Invention Lacking Significant Structural Element? NO NO NO YES YES YES Is Common Structure a Contribution over the Prior Art? Is Common Structure a Contribution over the Prior Art? Is Common Structure a Contribution over the Prior Art? YES YES YES Do the molecules share a common property or activity? Do the molecules share a common property or activity? Do the molecules share a common property or activity? Unity of Invention Present Unity of Invention Present Unity of Invention Present YES YES YES

  16. Molecules Grouped by Function Do the molecules share a common property or activity? YES Unity of Invention Lacking Is common property or activity a Special Technical Feature? NO YES Shared Common Structure, Significant Structural Element? YES Is the Common Structure a Contribution over the Prior Art? Unity of InventionPresent YES

  17. Groups of Molecules PCT Rule 13.2 “Markush” Practice Example 17 of Annex B of the Administrative Instructions Claim Order, Claim Breadth, Lack of Unity within a Claim and Tips Points of Contact

  18. Example 17; Annex B of the Administrative Instructions Scenario A Claim 1. Isolated Protein X. Claim 2. Isolated DNA encoding Protein X. Wherein Protein X and DNA are a contribution over the prior art? Scenario B Claim 1. Isolated Protein X. Claim 2. Isolated DNA encoding Protein X. Wherein DNA or Protein X are NOT a contribution over the prior art? Do the DNA and protein share a special technical feature?

  19. Variations of Example 17 (cont.) Scenario C Claim 1: Isolated Protein X. Claim 2: Isolated DNA encoding Protein X or variant DNA thereof. Would the variant DNA necessarily encode Protein X? Is a technical feature shared between Claims 1 and 2? Scenario D Claim 1: Isolated Protein X or a functional equivalent thereof. Claim 2: Isolated DNA encoding protein X. Could DNA of Claim 2 encode the functional equivalent of Protein X? Is a technical feature shared between Claims 1 and 2?

  20. Groups of Molecules PCT Rule 13.2 “Markush” Practice Example 17; Administrative Instructions Claim Order, Claim Breadth, Unity within a Claim & Tips Points of Contact

  21. Importance of Claim Order 37 C.F.R. 1.475(d) If multiple products, processes of manufacture, or uses are claimed, the first invention of the category first mentioned in the claims of the application and the first recited invention of each of the other categories related thereto will be considered as the main invention in the claims, see PCT Article 17(3)(a) and § 1.476(c).

  22. When claims are presented in this order: Claim 1. A purified PQR molecule.   Claim 2. A purified antibody that binds to PQR, produced by hybridoma ABC. Claim 3. Method of making antibody of claim 1 by culturing hybridoma ABC. Claim 4. Method of detecting cancer by using antibody of claim 1. then lack of unity results in four groups Group I, claims 1, drawn a PQR molecule. (First product) Group II, claim 2, drawn an antibody. (Second Product) Group III, claim 3, a method of making the antibody. (Method of making the second product) Group IV, claim 4, drawn a method of using the antibody. (Method of using the second product)

  23. If the claim order is rearranged as follows: Claim 1. A purified antibody that binds to PQR, produced by hybridoma ABC.   Claim 2. A purified PQR molecule.  Claim 3. Method of making antibody of claim 1 by culturing hybridoma ABC. Claim 4. Method of detecting cancer by using antibody of claim 1. and if antibody is a contribution over the prior art, then only Two Groups: Group I, claims 1, 3-4, drawn an antibody, a method of making and a method of using the antibody. (First product & first methods) Group II, claim 2, drawn PQR molecule. (Second Product) Note: if the antibody is NOT a contribution over the prior art, unity is lacking between the first product and first methods. PCT Rule 13.2

  24. Unity of Invention depends on Breadth of Claims Claim: An isolated molecule consisting of A, B, or C protein or fragment thereof. A, B, and C share the special technical feature of a new ligase domain. Identify the technical feature shared by all: a fragment of A, B, or C protein. Is this technical feature a contribution over the prior art? Is any protein fragment a contribution over the prior art? Structure & function are lacking with respect to the term “fragment.”

  25.  Unity of Invention Within a Claim PCT Rule 13.3 37 CFR 1.475(e) The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim.

  26. Multiple inventions presented in a claim Claim 1. A purified molecule selected from the group consisting of G, H or I. If molecules G, H and I fail to share a special technical feature then: Group I, claim 1, in part, drawn to molecule G. Group II, claim 1, in part, drawn to molecule H. Group III, claim 1, in part, drawn to molecule I.

  27. Tips For Unity of Invention in Biotechnology Applications Present the main invention and its most preferred method of use at the top of the claim set. If claiming multiple products, narrowly define the scope of the main invention so that the special technical feature is required for each product, for the first method of use and first method of making. When claiming multiple products, present the special technical feature and common property/activity as a limitation in the claims. Include SEQ ID NOs in claims reciting specific DNA or protein molecules. Provide SEQ ID NOs for any shared significant structural element. Be willing to elect additional inventions over the phone. Protest may be filed within 15 days of receipt of the USPTO 210/299 or within 30 days of receipt of the USPTO 408/499.

  28. Groups of Molecules PCT Rule 13.2 “Markush” Practice Example 17, Administrative Instructions Claim Order, Claim Breadth, Lack of Unity within a Claim and Tips Points of Contact

  29. Points of Contact for Lack of Unity, PCT & 371 Questions Examiner and SPE TC1600 Special Program Examiners Bill Dixon (703) 308-3824 Cecilia Tsang (703) 308-0254 Julie Burke (703) 308-7553 PCT Helpdesk (703) 305-3257 for PCT and 371 procedural questions and problems

  30. For help related to downloading PatentIn 3.1 call: General Information Services (GIS) at (800) 786-9199 or (703) 308-4357 For help related to using PatentIn 3.1 or to report problems encountered running the program call or email: PatentIn Help Line at (703) 306-4119 (patin3help@uspto.gov) For help related to sequence rule compliance call or email: Robert A. Wax 703-308-4216 (robert.wax@uspto.gov) As an alternative call or email: Christopher Low 703-308-2923 (christopher.low@uspto.gov) Mark Spencer 703-308-04266 (mark.spencer@uspto.gov)

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