Principles in Restriction Practice

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Principles in Restriction Practice

• TC 1600
• Anthony Caputa
• TC Practice Specialist
• Anthony.Caputa_at_uspto.gov
• [phone]

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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

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Topics for Today

• Basic Restriction Requirements
• Linking Claims
• Alternative Language and Restriction Practice
• Rejoinder Opportunities - In re Ochiai and others

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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.

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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).

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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)

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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)

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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)

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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

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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.

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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)

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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.

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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.

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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.

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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 NO2.
• Claim 3. The composition of claim 1, wherein
  the agent is a polynucleotide having the sequence
  of SEQ ID NO5.
• Claim 4. The composition of claim 1, wherein the
  agent is 3,3-methoxysilyl-3,3-organophosphate.

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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 Alzheimers
  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.

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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

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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

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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).

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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

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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.

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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.

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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.

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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

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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

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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

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Other Rejoinder Situations

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

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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

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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

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The End