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Principles in Restriction Practice

Principles in Restriction Practice. TC 1600 Anthony Caputa TC Practice Specialist Anthony.Caputa@uspto.gov (571) 272-0829. TC 1600 Restriction Team. Anthony Caputa-TCPS Deborah Reynolds-TCPS Sreeni Padmanabhan - Workgroup 1610 Christopher Low - Workgroup 1610

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Principles in Restriction Practice

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  1. Principles in Restriction Practice TC 1600 Anthony Caputa TC Practice Specialist Anthony.Caputa@uspto.gov (571) 272-0829

  2. TC 1600 Restriction Team • 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

  3. Topics for Today • Basic Restriction Requirements • Linking Claims • Alternative Language and Restriction Practice • Rejoinder Opportunities - In re Ochiai and others

  4. 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.

  5. 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).

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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.

  11. 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)

  12. 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.

  13. 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.

  14. 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 other invention.

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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).

  20. 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

  21. 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.

  22. 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.

  23. 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.

  24. 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

  25. 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

  26. 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

  27. Other Rejoinder Situations • MPEP 806.05(c) • Combination/subcombination inventions when an evidence claim is found to be non-allowable

  28. 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

  29. 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 non-elected subject matter • Send petitions to the deciding official before you complete an office action

  30. The End

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