Double%20Patenting%20Simplified

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Double Patenting Simplified

• As much as possible anyway!
• Robert J. Hill, Jr.
• Quality Assurance Specialist
• Technology Center 1600

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Double Patenting in General

• The Basics

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What is a Double Patenting Rejection?

• Rejection of Claims
• Of common Applicant or Assignee
• Not Entitled to a Patent Because
• You already have a patent to the same invention
• Your claimed invention is an obvious variation of
  the claimed invention in the patent you already
  have

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The Purpose Behind the Policy

• The Constitution
• Promote the progress of science and useful arts
• Limited exclusive right in exchange for
  disclosure
• Benefits the public
• Double Patenting
• Prevents unjustified extension of exclusive
  rights
• After expiration, public should be able to
• Freely use the claimed invention
• Freely use obvious modifications of the claimed
  invention

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A Graphical Representation of the Problem
Free Public Use of the Invention and
Obvious Modifications Thereof
Filing Date
Issue Date
Patent Expiration Date
Original Application
Possible Unjust Extension Of Original Patent Term
Second Application By Applicant Or Assignee
Patent Expiration Date
Filing Date
Issue Date
Free Public Use of the Invention and
Obvious Modifications Thereof
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Focus on the Claims

• Claims of the Potentially Conflicting Patent or
  Application vs. Examined Claims
• Use of Specification of the Potentially
  Conflicting Patent or Application is Generally
  Prohibited
• Limited exception to be discussed more fully
  later

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Types of Double Patenting Rejections

• Statutory (35 U.S.C. 101) Double Patenting
• Non-Statutory Double Patenting
• Obviousness-Type Double Patenting
• Rejection based on obviousness analysis
• Rejection based on anticipation analysis
• Non-Statutory Double Patenting Based Solely on
  Improper Timewise Extension of Patent Rights

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Possible Double Patenting Situations

• Examined Application vs. Another Copending
  Application (Provisional Rejection)
• Examined Application vs. Issued Patent
• Examined Application vs. Published Application
  (Provisional Rejection)
• No need to apply this last one in an Office action

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Double Patenting and 35 U.S.C. 121

• The Third Sentence of 35 U.S.C. 121 Provides
• A patent issuing on an application with respect
  to which a requirement for restriction under this
  section has been made, or on an application filed
  as a result of such a requirement, shall not be
  used as a reference either in the Patent and
  Trademark Office or in the courts against a
  divisional application or against the original
  application or any patent issued on either of
  them, if the divisional application is filed
  before the issuance of the patent on the other
  application.

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Double Patenting and 35 U.S.C. 121

• MPEP 804.01
• This apparent nullification of double patenting
  as a ground of rejection or invalidity in such
  cases imposes a heavy burden on the Office to
  guard against erroneous requirements for
  restrictions where the claims define essentially
  the same invention in different language and
  which, if acquiesced in, might result in the
  issuance of several patents for the same
  invention.

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When Prohibition Under 35 U.S.C. 121 Does Not
Apply

• Two or More Applications Filed No Restriction
  Requirement Made
• Claims Amended Such That They Are Not
  Commensurate With the Restriction Requirement
• Linking Claim Practice Followed and Generic Claim
  Allowed
• Restriction Withdrawn

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When Prohibition Under 35 U.S.C. 121 Does Not
Apply

• Restriction (Lack of Unity) Only Made in PCT
  Application
• Examiner Withdraws Restriction Before Patent
  Issues
• Claims are Directed to Identical Subject Matter

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General Analysis

• Double Patenting Rejection Prohibited by 35
  U.S.C. 121?
• Statutory Basis Exists (35 U.S.C. 101)?
• Nonstatutory Basis Exists?

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Domination and Double Patenting

• Domination Broad or Generic Claims in One Patent
  Fully Encompass Narrower Claims in Another Patent
• Domination by Itself Cannot Support a Double
  Patenting Rejection
• Domination Does Not Preclude a Double Patenting
  Rejection

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Statutory Double Patenting

• 35 U.S.C. 101

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The Statute

• 35 U.S.C. 101
• Whoever invents or discovers any new and useful
  process, machine, manufacture, or composition of
  matter, or any new and useful improvement
  thereof, may obtain a patent therefor, subject to
  the conditions and requirements of this title.
  (Emphasis added)

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Same Invention

• Is the Same Invention Being Claimed Twice?
• Identical Subject Matter

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A Reliable Test

• Is There an Embodiment That Falls Within the
  Scope of One Claim, but Not the Other?
• Could One Claim be Literally Infringed Without
  Literally Infringing the Other Claim?

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Statutory (35 U.S.C. 101) Double Patenting

• Venn Diagram

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Statutory (35 U.S.C. 101) Double Patenting

• Venn Diagram

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Non-Statutory Obviousness-Type Double Patenting
Rejection Based on Obviousness Analysis

• ODP-Obviousness

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ODP-Obviousness Analysis

• Analogous to 35 U.S.C. 103 Analysis
• Determine the Scope and Content of the Prior
  Art
• Ascertain the Differences Between the Prior Art
  and the Claim in Issue
• Resolve the Level of Ordinary Skill in the Art
• Evaluate Evidence of Secondary Considerations

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Written Rejection

• Any Obviousness-Type Double Patenting Rejection
  Based on an Obviousness Analysis Should Make
  Clear
• The differences between a claim in the examined
  application compared to a claim in the reference
  patent (or copending application)
• The reasons for concluding that the invention
  defined in the claim at issue would have been an
  obvious variation of the invention defined in a
  claim in the patent (or copending application)

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Differences Between 35 U.S.C. 103 and
ODP-Obviousness Analysis

• Prior Art
• 35 U.S.C. 103 Analysis
• Prior art within the meaning of 35 U.S.C. 102
• ODP-Obviousness Analysis
• Claims of a potentially conflicting patent or
  application
• Alone or with prior art within the meaning of 35
  U.S.C. 102
• Reliance on specification of a potentially
  conflicting patent or application is generally
  prohibited
• Limited exceptions

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Proper Uses of Disclosure

• Exceptions to the General Prohibition of Using
  the Disclosure of a Potentially Conflicting
  Patent or Application
• Dictionary for claim terminology
• Portions of the disclosure which provide support
  for the claims in the potentially conflicting
  patent or application

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ODP-Obviousness

• Venn Diagram

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ODP-Obviousness

• Venn Diagram

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ODP-Obviousness

• Venn Diagram

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ODP-Obviousness

• Venn Diagram

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ODP-Obviousness

• Venn Diagram

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ODP-Obviousness

• Venn Diagram

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ODP-Obviousness

• Venn Diagram

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Non-Statutory Obviousness-Type Double Patenting
Rejection Based on Anticipation Analysis

• ODP-Anticipation

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ODP-Anticipation Situation

• Examined Claims
• Generic to (fully encompasses) a claim in the
  potentially conflicting patent or application
• Anticipated by the claim in the potentially
  conflicting patent or application
• Written Rejection
• No Graham v. Deere analysis needed
• Explain how the examined claim is anticipated

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ODP-Anticipation - !!CAUTION!!

• NOT for These Situations
• Examined claim species/subgenus of generic
  claim in potentially conflicting patent or
  application
• Mere overlap without anticipation
• ODP-Obviousness analysis required

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ODP-Anticipation

• Venn Diagram

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One-Way Obviousness

• Claim A Examined Application
• Claim B Potentially Conflicting Patent or
  Application
• Would Claim A Have Been Obvious Given Claim B?

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Two-Way Obviousness

• Claim A Examined Application
• Claim B Potentially Conflicting Patent or
  Application
• Would Claim A Have Been Obvious Given Claim B?
• Would Claim B Have Been Obvious Given Claim A?

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General Rule One-Way vs. Two-Way

• Apply One-Way Test Unless All Three Apply
• The examined application has an effective U.S.
  filing date before that of a potentially
  conflicting patent
• There is sufficient evidence of record that the
  claims could not have been filed in the same
  application
• There is sufficient evidence of record that there
  was administrative delay on the part of the
  Office in the application being examined

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Obviousness-Type Double Patenting Eli Lilly v.
Barr

• An Unusual Situation

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Obviousness-Type Double Patenting Eli Lilly v.
Barr

• Facts
• ODP rejection over examined claims in view of a
  patent
• Patent was statutorily disclaimed
• Patent owner cannot avoid double patenting by
  disclaiming earlier patent
• Should be Rare
• Must be Approved by TC Director
• Go to SPE first
• Then QAS
• Then TC Director

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Terminal Disclaimers

• One Avenue for Overcoming ODP Rejections

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What is a Terminal Disclaimer?

• Legal Document
• Ensures that the term for a patent granted on the
  examined application will not extend past the
  expiration of the term of the conflicting patent
  or a patent granted on a conflicting application
• Ensures common ownership between the examined
  application and the conflicting patent or a
  patent granted on the conflicting application

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Some Interesting Things about Terminal Disclaimers

• It must operate with respect to all claims in
  the patent.
• It is not an admission of the propriety of the
  rejection.
• It is effective only with respect to the
  application identified in the disclaimer, unless
  by its terms it extends to continuing
  applications.
• Effective with respect to each application having
  the identified application number

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Some Interesting Things about Terminal Disclaimers

• A terminal disclaimer fee is required for each
  terminal disclaimer filed.
• A terminal disclaimer is required even in
  applications filed on or after June 8, 1995
• as a result of patent term adjustment provisions
  patents and conflicting claims would not
  necessarily expire on the same day
• even if patents with conflicting claims would
  expire on the same day, ensuring enforceability
  only as long as they are commonly owned is still
  required

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How to Overcome a Proper Double Patenting
Rejection

• Statutory (35 U.S.C. 101) Double Patenting
• Amend the claim(s)
• Cancel the claim(s)
• A terminal disclaimer is NOT sufficient to
  overcome such a rejection
• Declarations under 37 CFR 1.131 are NOT
  sufficient to overcome such a rejection

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How to Overcome a Proper Double Patenting
Rejection

• Non-Statutory Double Patenting (All Types)
• Amend the claim(s)
• Cancel the claim(s)
• File a proper terminal disclaimer
• Declarations under 37 CFR 1.131 are NOT
  sufficient to overcome such a rejection

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Double Patenting vs. Art Rejection

• Double Patenting
• Compares claims
• With limited use of the disclosure of the
  potentially conflicting patent or application
• Can be overcome by a terminal disclaimer (ODP
  only)
• TD removes potential harm to public

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Double Patenting vs. Art Rejection

• Art Rejection
• Reference used for all it fairly teaches
• Cannot be overcome with a terminal disclaimer

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Form Paragraphs

• See Pages 19-30 of the Training Materials
• See also the section Suggested Language for
  Clarifying Basis for Rejection on page 12
• See the examples for sample rejections
• Do Not Forget to Read the Examiner Notes for the
  Form Paragraphs
• The Examiner Notes may provide information as
  to other appropriate rejections

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Flow Chart

• Page 32 of the Training Materials

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Example 1

• 09/123,123, Filed 01/01/02
• Claim 1 Protein
• Claim 2 DNA encoding the protein
• Restricted between claims 1-2
• Elected claim 2, cancelled claim 1
• Issued 6/1/02
• 09/234,234, Filed 4/1/02
• Divisional of 09/123,123
• Claim 1 Protein (same as original claim 1 of
  09/123,123)
• Claim 1 rejected under ODP over the DNA claim of
  issued parent

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Example 1

• ODP Rejection NOT PROPER
• 35 U.S.C. 121 prohibits the rejection because of
  the restriction in the parent application

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Example 2

• Examined Application (Inventor A)
• Claim 1. A shampoo composition comprising water,
  a moisturizer, a surface-active agent, and a dye.
• Patent 8,500,000 (Inventors A and B)
• Issued less than one before the examined
  application
• Claim 37. A composition comprising water, a
  surfactant, a dye, and a moisturizer wherein the
  composition is useful as a shampoo.
• No Claimed Benefit to Patent
• No Restriction Made

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Example 2

• Statutory (35 U.S.C. 101) Double Patenting is
  Appropriate
• Rejection Under 35 U.S.C. 102(e) Would Also Be
  Appropriate

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Example 2 (Modifications)

• Patent Issued More Than One Year Before the
  Effective Filing Date of the Application
• Statutory double patenting still appropriate
• 102(b) rejection would also be appropriate
• No Common Inventor or Assignee
• 102(e) rejection would be appropriate
• If overcome - interference

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Example 3

• Examined Application (Inventors A and B)
• Claim 1. A compound having the following formula
• R1-(CH2CH2)n-R2
• wherein R1 is alky, alkyoxy, or hydroxy, R2 is
  cycloalkyl, unsubstituted phenyl, or substituted
  phenyl, and n is 1-10.
• Patent 8,500,000 (Inventors A and B)
• Filed before but issued after the effective
  filing date of the examined application
• Claim 10. A compound having the following
  formula CH3OCH2CH2CH2CH2CH2CH2-Phenyl or
  CH3OCH2CH2CH2CH2-Phenyl.
• Benefit to Patent Claimed
• No Restriction Made

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Example 3

• Obviousness-Type Double Patenting Anticipation
  Analysis Appropriate

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Example 4

• Examined Application (Inventors A and B)
• Claim 1. A method of treating high blood pressure
  in a patient in need thereof comprising
  administering to the patient an aqueous solution
  of compound X wherein the aqueous solution
  includes a thickener in an amount such that the
  aqueous solution has a viscosity of 50-80
  centipoise at 37 oC.
• Patent 8,500,000 (Inventors A and B)
• Filed before but issued after the effective
  filing date of the examined application
• Claim 20. A method of treating high blood
  pressure in a patient in need thereof comprising
  administering to the patient an aqueous solution
  of compound X.
• CIP Benefit to Patent Claimed
• No Restriction Made

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Example 4

• Specification of 8,500,000
• The aqueous solution of compound X can be
  administered by various routes including,
  subcutaneous, intravenous, and oral.
• Hill et al
• More than one year before the effective filing
  date of the application
• Better results are obtained from drugs that are
  administered subcutaneously
• When the viscosity of the composition is 50-60
  centipoise at 37oC
• Better drug availability at the disclosed
  viscosity
• Viscosity can be adjusted using thickening
  agents.

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Example 4

• Examined Application (Inventors A and B)
• Claim 1. A method of treating high blood pressure
  in a patient in need thereof comprising
  administering to the patient an aqueous solution
  of compound X wherein the aqueous solution
  includes a thickener in an amount such that the
  aqueous solution has a viscosity of 50-80
  centipoise at 37 oC.
• Patent 8,500,000 (Inventors A and B)
• Claim 20. A method of treating high blood
  pressure in a patient in need thereof comprising
  administering to the patient an aqueous solution
  of compound X.
• Obviousness-Type Double Patenting Obviousness
  Analysis Appropriate

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Example 4 (Modifications)

• Patent and Hill et al Issued More Than One Year
  Before the Effective Filing Date of the
  Application
• 103 rejection would also be appropriate
• Obviousness-type double patenting still
  appropriate
• Not necessary overcoming 103 rejection would
  overcome ODP rejection
• No Common Inventor or Assignee
• 102(e)/103 rejection would be appropriate
• If overcome - interference

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Example 6

• Examined Application (Inventors A and B)
• Claim 1. A method of making compound C comprising
  reacting compound A with compound B in aqueous
  solution at a temperature from 50oC to 90oC.
• Patent 8,500,000 (Inventors A and B)
• Filed before but issued after the effective
  filing date of the examined application
• Claim 70. A method of making compound C
  comprising reacting compound A with compound B in
  aqueous solution at a temperature from 80oC to
  150oC.
• Discloses several examples wherein the reaction
  is carried out at 80oC, 90oC, 100oC, 110oC,
  120oC, 130oC, 140oC, and 150oC
• CIP Benefit to Patent Claimed
• No Restriction Made

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Example 6

• Obviousness-Type Double Patenting Obviousness
  Analysis Appropriate

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Example 6 (Modification)

• Examined Application (Inventors A and B)
• Claim 1. A method of making compound C comprising
  reacting compound A with compound B in aqueous
  solution at a temperature from 50oC to 90oC.
• Patent 8,500,000 (Inventors A and B)
• Claim 70. A method of making compound C
  comprising reacting compound A with compound B in
  aqueous solution at a temperature from 40oC to
  150oC.
• Discloses several examples wherein the reaction
  is carried out at 80oC, 90oC, 100oC, 110oC,
  120oC, 130oC, 140oC, and 150oC
• Obviousness-Type Double Patenting Obviousness
  Analysis Appropriate
• Using specifically disclosed embodiments (80oC
  and 90oC) that support the temperature range in
  claim 70

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The End