Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 1 of 34
`
`Exhibit 4
`
`

`

`801
`802
`802.01
`802.02
`803
`803.01
`
`803.04
`804
`804.01
`
`804.02
`804.03
`
`804.04
`805
`806
`
`806.01
`806.03
`
`806.04
`806.04(b)
`
`806.04(h)
`
`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 2 of 34
`Chapter 800 Restriction in Applications Filed Under 35 U.S.C.
`111; Double Patenting
`806.05(j)
`Related Products; Related Processes
`806.06
`Independent Inventions
`807
`Patentability Report Practice Has No Effect on
`Restriction Practice
`Reasons for Insisting Upon Restriction
`Reasons for Holding of Independence or Dis-
`tinctness
`Species
`808.01(a)
`Establishing Burden
`808.02
`Linking Claims
`809
`809.02(a) Election of Species Required
`809.03
`Restriction Between Linked Inventions
`810
`Action on the Merits
`811
`Time for Making Requirement
`811.02
`New Requirement After Compliance With Pre-
`ceding Requirement
`Repeating After Withdrawal Proper
`Proper Even Though Grouped Together in Par-
`ent Application
`Who Should Make the Requirement
`Telephone Restriction Practice
`Indicate Exactly How Application Is To Be Re-
`stricted
`Make Requirement Complete
`815
`Outline of Letter for Restriction Requirement
`817
`Election and Reply
`818
`Election Fixed by Action on Claims
`818.01
`Election Other Than Express
`818.02
`818.02(a) By Originally Presented Claims
`818.02(b) Generic Claims Only — No Election of Spe-
`cies
`818.02(c) By Optional Cancellation of Claims
`818.03
`Express Election and Traverse
`818.03(a) Reply Must Be Complete
`818.03(b) Must Elect, Even When Requirement Is Tra-
`versed
`818.03(c) Must Traverse To Preserve Right of Petition
`818.03(d) Traverse of Restriction Requirement With
`Linking Claims
`Office Generally Does Not Permit Shift
`Treatment of Claims Held To Be Drawn to Non-
`elected Inventions
`After Election With Traverse
`After Election Without Traverse
`Claims for Different Invention Added After an
`Office Action
`Rejoinder
`821.04
`821.04(a) Rejoinder Between Product Inventions; Re-
`joinder Between Process Inventions
`821.04(b) Rejoinder of Processes Requiring an Allowable
`Product
`
`808
`808.01
`
`811.03
`811.04
`
`812
`812.01
`814
`
`819
`821
`
`821.01
`821.02
`821.03
`
`800-1
`
`Rev. 5, Aug. 2006
`
`Introduction
`Basis for Practice in Statute and Rules
`Meaning of “Independent” and “Distinct”
`Definition of Restriction
`Restriction — When Proper
`Review by Examiner With at Least Partial Sig-
`natory Authority
`Markush Claims
`803.02
`Transitional Applications
`803.03
`803.03(a) Transitional Application — Linking Claim Al-
`lowable
`803.03(b) Transitional Application — Generic Claim Al-
`lowable
`Nucleotide Sequences
`Definition of Double Patenting
`Prohibition of Double Patenting Rejections
`Under 35 U.S.C. 121
`Avoiding a Double Patenting Rejection
`Commonly Owned Inventions of
`Different Inventive Entities; Non-Commonly
`Owned Inventions Subject to a Joint
`Research Agreement
`Submission to Technology Center Director
`Effect of Improper Joinder in Patent
`Determination of Distinctness or Independence
`of Claimed Inventions
`Compare Claimed Subject Matter
`Single Embodiment, Claims Defining Same
`Essential Features
`Genus and/or Species Inventions
`Species May Be Independent or Related Inven-
`tions
`806.04(d) Definition of a Generic Claim
`806.04(e) Claims Limited to Species
`806.04(f) Restriction Between Mutually Exclusive Spe-
`cies
`Species Must Be Patentably Distinct From
`Each Other
`806.04(i) Generic Claims Presented After Issue of Spe-
`cies
`Related Inventions
`806.05
`806.05(a) Combination and Subcombination
`806.05(c) Criteria of Distinctness Between Combination
`and Subcombination
`Subcombinations Usable Together
`806.05(d)
`Process and Apparatus for Its Practice
`806.05(e)
`Process of Making and Product Made
`806.05(f)
`806.05(g) Apparatus and Product Made
`806.05(h)
`Product and Process of Using
`806.05(i)
`Product, Process of Making, and Process of Us-
`ing
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 3 of 34
`
`RESTRICTION IN APPLICATIONS FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`804
`
`(C), will be subject to a restriction requirement.
`Applicants will be required to select one combination
`for examination. If the selected combination contains
`ten or fewer sequences, all of the sequences of the
`combination will be searched. If the selected combi-
`nation contains more than ten sequences, the combi-
`nation will be examined following the procedures set
`forth above for example (B). More specifically, the
`combination will be searched until one nucleotide
`sequence is found to be allowable with the examiner
`choosing the order of search to maximize the identifi-
`cation of an allowable sequence. The identification of
`any allowable sequence(s) will cause all combinations
`containing the allowed sequence(s) to be allowed.
`In applications containing all three claims set forth
`in examples (A)-(C), the Office will require restric-
`tion of the application to ten sequences for initial
`examination purposes. Based upon the finding of
`allowable sequences, claims limited to the allowable
`sequences as in example (A), all combinations, such
`as in examples (B) and (C), containing the allowable
`sequences and any patentably indistinct sequences
`will be rejoined and allowed.
`**>Nonelected claims< requiring any allowable
`>nucleotide< sequence(s) >should be considered for
`rejoinder. See MPEP § 821.04<. **
`804
`Definition of Double Patenting
`[R-5]
`35 U.S.C. 101. Inventions Patentable.
`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.
`35 U.S.C. 121. Divisional Applications.
`If two or more independent and distinct inventions are claimed
`in one application, the Director may require the application to be
`restricted to one of the inventions. If the other invention is made
`the subject of a divisional application which complies with the
`requirements of section 120 of this title it shall be entitled to the
`benefit of the filing date of the original application. A patent issu-
`ing 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 refer-
`ence 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.
`If a divisional application is directed solely to subject matter
`described and claimed in the original application as filed, the
`Director may dispense with signing and execution by the inventor.
`
`The validity of a patent shall not be questioned for failure of the
`Director to require the application to be restricted to one inven-
`tion.
`
`The doctrine of double patenting seeks to prevent
`the unjustified extension of patent exclusivity beyond
`the term of a patent. The public policy behind this
`doctrine is that:
`
`The public should . . . be able to act on the assumption that
`upon the expiration of the patent it will be free to use not
`only the invention claimed in the patent but also modifica-
`tions or variants which would have been obvious to those
`of ordinary skill in the art at the time the invention was
`made, taking into account the skill in the art and prior art
`other than the invention claimed in the issued patent.
`In re Zickendraht, 319 F.2d 225, 232, 138 USPQ
`22, 27 (CCPA 1963) (Rich, J., concurring). Double
`patenting results when the right to exclude granted by
`a first patent is unjustly extended by the grant of a
`later issued patent or patents. In re Van Ornum, 686
`F.2d 937, 214 USPQ 761 (CCPA 1982).
`Before consideration can be given to the issue of
`double patenting, two or more patents or applications
`must have at least one common inventor and/or be
`either commonly assigned/owned or non-commonly
`assigned/owned but subject to a joint research agree-
`ment as set forth in 35 U.S.C. 103(c)(2) and (3) pursu-
`ant to the CREATE Act (Pub. L. 108-453, 118 Stat.
`3596 (2004)). Congress recognized that the amend-
`ment to 35 U.S.C. 103(c) would result in situations in
`which there would be double patenting rejections
`between applications not owned by the same party
`(see H.R. Rep. No. 108-425, at 5-6 (2003)). For pur-
`poses of a double patenting analysis, the application
`or patent and the subject matter disqualified under 35
`U.S.C. 103(c) as amended by the CREATE Act will
`be treated as if commonly owned. See also MPEP §
`804.03. Since the doctrine of double patenting seeks
`to avoid unjustly extending patent rights at the
`expense of the public, the focus of any double patent-
`ing analysis necessarily is on the claims in the multi-
`ple patents or patent applications involved in the
`analysis.
`There are generally two types of double patenting
`rejections. One is the “same invention” type double
`patenting rejection based on 35 U.S.C. 101 which
`states in the singular that an inventor “may obtain
`a patent.” The second is the “nonstatutory-type” dou-
`ble patenting rejection based on a judicially created
`
`800-11
`
`Rev. 5, Aug. 2006
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 4 of 34
`
`804
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`doctrine grounded in public policy and which is pri-
`marily intended to prevent prolongation of the patent
`term by prohibiting claims in a second patent not pat-
`entably distinguishing from claims in a first patent.
`Nonstatutory double patenting includes rejections
`based on either a one-way determination of obvious-
`ness or a two-way determination of obviousness.
`Nonstatutory double patenting could include a rejec-
`tion which is not the usual “obviousness-type” double
`patenting rejection. This type of double patenting
`
`rejection is rare and is limited to the particular facts of
`the case. In re Schneller, 397 F.2d 350, 158 USPQ
`210 (CCPA 1968).
`Refer to Charts I-A, I-B, II-A, and II-B for an over-
`view of the treatment of applications having conflict-
`ing claims (e.g., where a claim in an application is not
`patentably distinct from a claim in a patent or another
`application). See MPEP § 2258 for information per-
`taining to double patenting rejections in reexamina-
`tion proceedings.
`
`Rev. 5, Aug. 2006
`
`800-12
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 5 of 34
`
`RESTRICTION IN APPLICATIONS FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`804
`
`Chart I-A. Conflicting Claims Between: Two Applications
`
`800-13
`
`Rev. 5, Aug. 2006
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 6 of 34
`
`804
`
`**>
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`Chart I-B. Conflicting Claims Between: Two Applications
`
`
`
`
`
`
`
`
`
`
`CONFLICTING CLAIMS BETWEEN
` CHART I-B
`TWO APPLICATIONS
`
`No Common
`Assignee or
`Inventor
`
`DIFFERENT INVENTIONS
`(Not Patentably Distinct)
`
`Currently
`Commonly Owned:
`
`Different Inventive Entities
`
`Different Inventive
`Entities, At Least One
`Common Inventor, No
`Common Assignee
`
`Same
`Inventive
`Entity
`
`Proper Joint Research
`Exclusion under 103(c)
`
`No Joint Research
`Exclusion under 103(c)
`
` And
`
` And
`
`Proper Joint Research
`Exclusion under 103(c)
`
`Provisional Obviousness
`Double-Patenting
`Rejection1
`
`(Provisional)2 Rejection
`of Later Application
`under 102(e)/103(a)
`
`8.33 & 8.35 or 8.37
`
`7.21.01 or 7.21.02
`
`Rejection under
`102(f)/103(a)
`or 102(g)/103(a)
`based on evidence
`
`7.21
`
`No Joint Research
`Exclusion under 103(c)
`
`Let Earlier Application
`Issue or Publish and Reject
`Later Application under
`102(e)/103(a)
`
`7.21
`
`Provisional Obviousness
`Double-Patenting Rejection
`
`8.33 & 8.35 or 8.37
`
`Commonly Owned at Time
`of Applicant’s Invention
`
`Provisional Obviousness
`Double-Patenting
`Rejection1
`
`8.33 & 8.35 or 8.37
`
`No Showing of Common Ownership at Time of Applicant’s Invention/No Joint Research Exclusion under 103(c)
`
`And/Or
`
`And
`
`And
`
`Rejection under
`102(f)/103(a)
`or
`102(g)/103(a)
`based on
`evidence
`
`7.21
`
`Assignee Required to Either:
`
`(a) Name First Inventor of Conflicting
`Subject Matter under 102(f) or (g)
`or
`(b) Show Inventions Were Commonly
`Owned at Time of Applicant’s
`Invention
`
`8.28
`
`Provisional Obviousness
`Double-Patenting
`Rejection
`
`(Provisional)2 Rejection
`of Later Application
`under 102(e)/103(a)
`
`8.33 & 8.35 or 8.37
`
`7.21.01 or 7.21.02
`
`1 Where the reference is available as anticipatory prior art, a (provisional)2 rejection should be made under 102(e).
`
`2 Where the application being applied as a reference has NOT been published, the rejection under 102(e)/103(a) should be
`provisional.
`
`<
`
`Rev. 5, Aug. 2006
`
`800-14
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 7 of 34
`
`RESTRICTION IN APPLICATIONS FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`804
`
`Chart II-A. Conflicting Claims Between: Application and a Patent
`
`800-15
`
`Rev. 5, Aug. 2006
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 8 of 34
`
`804
`
`**>
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`Chart II-B. Conflicting Claims Between: Application and a Patent
`
`
`
`
`
`
`
`CONFLICTING CLAIMS BETWEEN
`
`AN APPLICATION AND A PATENT
`
`
`
`CHART II-B
`
`No Common
`Assignee or
`Inventor
`
`DIFFERENT INVENTIONS
`(Not Patentably Distinct)
`
`Currently
`Commonly Owned:
`
`Different Inventive Entities
`
`Different Inventive
`Entities, At Least One
`Common Inventor, No
`Common Assignee
`
`Same
`Inventive
`Entity
`
`Proper Joint Research
`Exclusion under 103(c)
`
`No Joint Research
`Exclusion under 103(c)
`
` And
`
` And
`
`Proper Joint Research
`Exclusion under 103(c)
`
`Obviousness Double-
`Patenting Rejection1
`
`Rejection under
`102(e)/103(a)
`
`8.33 & 8.34 or 8.36
`
`7.21.02
`
`No Joint Research
`Exclusion under 103(c)
`
`Rejection under
`102(e)/103(a)
`
`7.21
`
`Commonly Owned at Time of Applicant’s Invention
`
`Obviousness Double-
`Patenting Rejection1
`
`8.33 & 8.34 or 8.36
`
`Rejection under
`102(f)/103(a)
`or 102(g)/103(a)
`based on evidence
`
`7.21
`
`Obviousness Double-
`Patenting Rejection
`
`8.33 & 8.34 or 8.36
`
`No Showing of Common Ownership at Time of Applicant’s Invention/No Joint Research Exclusion under 103(c)
`
`And/Or
`
`And
`
`And
`
`Rejection under
`102(f)/103(a)
`or
`102(g)/103(a)
`based on
`evidence
`
`7.21
`
`Assignee Required to Either:
`
`(a) Name First Inventor of Conflicting
`Subject Matter under 102(f) or (g)
`or
`(b) Show Inventions Were Commonly
`Owned at Time of Applicant’s
`Invention
`
`8.28
`
`Obviousness Double-
`Patenting Rejection
`
`Rejection under
`102(e)/103(a)
`
`8.33 & 8.34 or 8.36
`
`7.21.02
`
`1 Where the reference is available as anticipatory prior art, a rejection should be made under 102(e).
`
`<
`
`Rev. 5, Aug. 2006
`
`800-16
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 9 of 34
`
`RESTRICTION IN APPLICATIONS FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`804
`
`I.
`
`INSTANCES WHERE DOUBLE PATENT-
`ING ISSUE CAN BE RAISED
`
`A double patenting issue may arise between two or
`more pending applications, or between one or more
`pending applications and a patent. A double patenting
`issue may likewise arise in a reexamination proceed-
`ing between the patent claims being reexamined and
`the claims of one or more applications and/or patents.
`Double patenting does not relate to international
`applications which have not yet entered the national
`stage in the United States.
`
`A.
`
`Between Issued Patent and One or More
`Applications
`
`Double patenting may exist between an issued
`patent and an application filed by the same inventive
`entity, or by a different inventive entity having a com-
`mon inventor, and/or by a common assignee/owner.
`Double patenting may also exist where the inventions
`claimed in a patent and an application were made as a
`result of activities undertaken within the scope of a
`joint research agreement as defined in 35 U.S.C.
`103(c)(2) and (3). Since the inventor/patent owner
`has already secured the issuance of a first patent, the
`examiner must determine whether the grant of a sec-
`ond patent would give rise to an unjustified extension
`of the rights granted in the first patent.
`
`B.
`
`Between Copending Applications—Provi-
`sional Rejections
`
`Occasionally, the examiner becomes aware of two
`copending applications that were filed by the same
`inventive entity, or by different inventive entities hav-
`ing a common inventor, and/or by a common
`assignee, or that claim an invention resulting from
`activities undertaken within the scope of a joint
`research agreement as defined in 35 U.S.C. 103(c)(2)
`and (3), that would raise an issue of double patenting
`if one of the applications became a patent. Where this
`issue can be addressed without violating the confiden-
`tial status of applications (35 U.S.C. 122), the courts
`have sanctioned the practice of making applicant
`aware of the potential double patenting problem if one
`of the applications became a patent by permitting the
`
`examiner to make a “provisional” rejection on the
`ground of double patenting. In re Mott, 539 F.2d
`1291, 190 USPQ 536 (CCPA 1976); In re Wetterau,
`356 F.2d 556, 148 USPQ 499 (CCPA 1966). The mer-
`its of such a provisional rejection can be addressed by
`both the applicant and the examiner without waiting
`for the first patent to issue.
`rejection
`The “provisional” double patenting
`should continue to be made by the examiner in each
`application as long as there are conflicting claims in
`more than one application unless that “provisional”
`double patenting rejection is the only rejection
`remaining in at least one of the applications.
`
`1.
`
` Nonstatutory Double Patenting Rejections
`
`If a “provisional” nonstatutory obviousness-type
`double patenting (ODP) rejection is the only rejection
`remaining in the earlier filed of the two pending appli-
`cations, while the later-filed application is rejectable
`on other grounds, the examiner should withdraw that
`rejection and permit the earlier-filed application to
`issue as a patent without a terminal disclaimer. If the
`ODP rejection is the only rejection remaining in the
`later-filed application, while the earlier-filed applica-
`tion is rejectable on other grounds, a terminal dis-
`claimer must be required in the later-filed application
`before the rejection can be withdrawn.
`If “provisional” ODP rejections in two applications
`are the only rejections remaining in those applica-
`tions, the examiner should withdraw the ODP rejec-
`tion in the earlier filed application thereby permitting
`that application to issue without need of a terminal
`disclaimer. A terminal disclaimer must be required in
`the later-filed application before the ODP rejection
`can be withdrawn and the application permitted to
`issue. If both applications are filed on the same day,
`the examiner should determine which application
`claims the base invention and which application
`claims the improvement (added limitations). The
`ODP rejection in the base application can be with-
`drawn without a terminal disclaimer, while the ODP
`rejection in the improvement application cannot be
`withdrawn without a terminal disclaimer.
`
`800-17
`
`Rev. 5, Aug. 2006
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 10 of 34
`
`804
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`Where there are three applications containing
`claims that conflict such that an ODP rejection is
`made in each application based upon the other two, it
`is not sufficient to file a terminal disclaimer in only
`one of the applications addressing the other two appli-
`cations. Rather, an appropriate terminal disclaimer
`must be filed in at least two of the applications to link
`all three together. This is because a terminal dis-
`claimer filed to obviate a double patenting rejection is
`effective only with respect to the application in which
`the terminal disclaimer is filed; it is not effective to
`link the other two applications to each other.
`
`2.
`
`Statutory Double Patenting Rejections (35
`U.S.C. 101)
`A terminal disclaimer cannot be filed to obviate a
`statutory double patenting rejection.
`If a “provisional” statutory double patenting rejec-
`tion is the only rejection remaining in one of the
`applications (but not both), the examiner should with-
`draw the rejection in that application and permit that
`application to issue as a patent, thereby converting the
`“provisional” double patenting rejection in the other
`application into a double patenting rejection when the
`application issues as a patent.
`If a “provisional” statutory double patenting rejec-
`tion is the only rejection remaining in both applica-
`tions, the examiner should withdraw that rejection in
`the application with the earlier filing date and permit
`that application to issue as a patent. If both applica-
`tions were filed on the same day, the applicant should
`be given an opportunity to elect which of the two
`should be allowed. In either situation, the examiner
`should maintain the double patenting rejection in the
`other application as a “provisional” double patenting
`rejection, which will be converted into a double pat-
`enting rejection when one application issues as a
`patent.
`
`C.
`
`Between One or More Applications and a
`Published Application - Provisional Rejections
`Double patenting may exist where a published
`patent application and an application are filed by the
`same inventive entity, or by different inventive enti-
`ties having a common inventor, and/or by a common
`assignee. Double patenting may also exist where a
`published application and an application claim inven-
`tions resulting from activities undertaken within the
`
`scope of a joint research agreement as defined in 35
`U.S.C. 103(c)(2) and (3). Since the published applica-
`tion has not yet issued as a patent, the examiner is per-
`mitted to make a “provisional” rejection on the
`ground of double patenting when the published appli-
`cation has not been abandoned and claims pending
`therein conflict with claims of the application being
`examined. See the discussion regarding “provisional”
`double patenting rejections in subsection B. above.
`
`D.
`
`Reexamination Proceedings
`
`A double patenting issue may raise a substantial
`new question of patentability of a claim of a patent,
`and thus be addressed in a reexamination proceeding.
`In re Lonardo, 119 F.3d 960, 966, 43 USPQ2d 1262,
`1266 (Fed. Cir. 1997) (In giving the Director authority
`under 35 U.S.C. 303(a) in determining the presence of
`a substantial new question of patentability, “Congress
`intended that the phrases ‘patents and publications’
`and ‘other patents or publications’ in section 303(a)
`not be limited to prior art patents or printed publica-
`tions.” (emphasis added)). Accordingly, if the issue of
`double patenting was not addressed during original
`prosecution, it may be considered during reexamina-
`tion.
`Double patenting may exist where a reference
`patent or application and the patent under reexamina-
`tion are filed by inventive entities that have at least
`one inventor in common and/or are filed by a com-
`mon owner/assignee. Where the patent under reexam-
`ination was granted on or after December 10, 2004,
`double patenting may also exist where the inventions
`claimed in the reference and reexamination proceed-
`ing resulted from activities undertaken within the
`scope of a joint research agreement pursuant to 35
`U.S.C. 103(c)(2) and (3), and if evidence of the joint
`research agreement has been made of record in the
`patent being reexamined or in the reexamination pro-
`ceeding. A double patenting rejection may NOT be
`made on this basis if the patent under reexamination
`issued before December 10, 2004. See MPEP §
`804.04. The prior art exclusion under 35 U.S.C.
`103(c) cannot be used to overcome an obvious double
`patenting rejection. See MPEP § 706.02(l) for more
`information on 35 U.S.C. 103(c). See MPEP § 2258
`for more information on making double patenting
`rejections in reexamination proceedings. >Subsection
`II., below, describes situations wherein a double pat-
`
`Rev. 5, Aug. 2006
`
`800-18
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 11 of 34
`
`RESTRICTION IN APPLICATIONS FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`804
`
`enting rejection would be appropriate. In particular,
`see paragraph II.B.1. for the analysis required to
`determine the propriety of an obviousness-type dou-
`ble patenting rejection.<
`
`II. REQUIREMENTS OF A DOUBLE PAT-
`ENTING REJECTION (INCLUDING PRO-
`VISIONAL REJECTIONS)
`When a double patenting rejection is appropriate, it
`must be based either on statutory grounds or nonstatu-
`tory grounds. The ground of rejection employed
`depends upon the relationship of the inventions being
`claimed. Generally, a double patenting rejection is not
`permitted where the claimed subject matter is pre-
`sented in a divisional application as a result of a
`restriction requirement made in a parent application
`under 35 U.S.C. 121.
`Where the claims of an application are substan-
`tively the same as those of a first patent, they are
`barred under 35 U.S.C. 101 - the statutory basis for a
`double patenting rejection. A rejection based on dou-
`ble patenting of the “same invention” type finds its
`support in the language of 35 U.S.C. 101 which states
`that “whoever invents or discovers any new and use-
`ful process ... may obtain a patent therefor ....” Thus,
`the term “same invention,” in this context, means an
`invention drawn to identical subject matter. Miller v.
`Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel,
`422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In
`re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA
`1957). Where the claims of an application are not the
`“same” as those of a first patent, but the grant of a
`patent with the claims in the application would
`unjustly extend the rights granted by the first patent, a
`double patenting rejection under nonstatutory grounds
`is proper.
`In determining whether a proper basis exists to
`enter a double patenting rejection, the examiner must
`determine the following:
`(A) Whether a double patenting rejection is pro-
`hibited by the third sentence of 35 U.S.C. 121 (see
`MPEP § 804.01; if such a prohibition applies, a dou-
`ble patenting rejection cannot be made);
`(B) Whether a statutory basis exists; and
`(C) Whether a nonstatutory basis exists.
`Each determination must be made on the basis of
`all the facts in the application before the examiner.
`
`Charts I-A, I-B, II-A, and II-B illustrate the methodol-
`ogy of making such a determination.
`Domination and double patenting should not be
`confused. They are two separate issues. One patent or
`application “dominates” a second patent or applica-
`tion when the first patent or application has a broad or
`generic claim which fully encompasses or reads on an
`invention defined in a narrower or more specific
`claim in another patent or application. Domination by
`itself, i.e., in the absence of statutory or nonstatutory
`double patenting grounds, cannot support a double
`patenting rejection. In re Kaplan, 789 F.2d 1574,
`1577-78, 229 USPQ 678, 681 (Fed. Cir. 1986); and
`In re Sarrett, 327 F.2d 1005, 1014-15, 140 USPQ 474,
`482 (CCPA 1964). However, the presence of domina-
`tion does not preclude double patenting. See, e.g., In
`re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA
`1968).
`
`A.
`
`Statutory Double Patenting — 35 U.S.C. 101
`
`In determining whether a statutory basis for a dou-
`ble patenting rejection exists, the question to be asked
`is: Is the same invention being claimed twice?
`35 U.S.C. 101 prevents two patents from issuing on
`the same invention. “Same invention” means identical
`subject matter. Miller v. Eagle Mfg. Co., 151 U.S. 186
`(1984); In re Vogel, 422 F.2d 438, 164 USPQ 619
`(CCPA 1970); and In re Ockert, 245 F.2d 467,
`114 USPQ 330 (CCPA 1957).
`A reliable test for double patenting under 35 U.S.C.
`101 is whether a claim in the application could be lit-
`erally infringed without literally infringing a corre-
`sponding claim in the patent. In re Vogel, 422 F.2d
`438, 164 USPQ 619 (CCPA 1970). Is there an embod-
`iment of the invention that falls within the scope of
`one claim, but not the other? If there is such an
`embodiment, then identical subject matter is not
`defined by both claims and statutory double patenting
`would not exist. For example, the invention defined
`by a claim reciting a compound having a “halogen”
`substituent is not identical to or substantively the
`same as a claim reciting the same compound except
`having a “chlorine” substituent in place of the halogen
`because “halogen” is broader than “chlorine.” On the
`other hand, claims may be differently worded and still
`define the same invention. Thus, a claim reciting a
`widget having a length of “36 inches” defines the
`
`800-19
`
`Rev. 5, Aug. 2006
`
`

`

`Case 1:19-cv-11586-FDS Document 241-4 Filed 09/28/21 Page 12 of 34
`
`804
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`same invention as a claim reciting the same widget
`having a length of “3 feet.”
`If it is determined that the same invention is being
`claimed twice, 35 U.S.C. 101 precludes the grant of
`the second patent regardless of the presence or
`absence of a terminal disclaimer. Id.
`Form paragraphs 8.30 and 8.31 (between an issued
`patent and one or more applications) or 8.32 (provi-
`sional rejections) may be used to make statutory dou-
`ble patenting rejections.
`¶ 8.30 35 U.S.C. 101, Statutory Basis for Double Patenting
`“Heading” Only
`A rejection based on double patenting of the “same invention”
`type finds its support in the language of 35 U.S.C. 101 which
`states that “whoever invents or discovers any new and useful pro-
`cess... may obtain a patent therefor...” (Emphasis added). Thus,
`the term “same invention,” in this context, means an invention
`drawn to identical subject matter. See Miller v. Eagle Mfg. Co.,
`151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619
`(CCPA 1970); and In re Ockert, 245 F.2d 467, 114 USPQ 330
`(CCPA 1957).
`A statutory type (35 U.S.C. 101) double patenting rejection can
`be overcome by canceling or amending the conflicting claims so
`they are no longer coextensive in scope. The filing of a terminal
`disclaimer cannot overcome a double patenting rejection based
`upon 35 U.S.C. 101.
`Examiner Note:
`The above form paragraph must be used as a heading for all
`subsequent double patenting rejections of the statutory (same
`invention) type using either of form paragraphs 8.31 or 8.32.
`¶ 8.31 Rejection, 35 U.S.C. 101, Double Patenting
`Claim [1] rejected under 35 U.S.C. 101 as claiming the same
`invention as that of claim [2] of prior U.S. Patent No. [3]. This is a
`double patenting rejection.
`Examiner Note:
`1.
`This form paragraph must be preceded by form paragraph
`8.30 and is used only for double patenting rejections of the same
`invention claimed in an earlier patent; that is, the “scope” of the
`inventions claimed is identical.
`2.
`If the conflicting claims are in another copending applica-
`tion, do not use this form paragraph. A provisional double patent-
`ing rejection should be made using form paragraph 8.32.
`3. Do not use this form paragraph for nonstatutory-type double
`patenting rejections. If nonstatutory type, use appropriate form
`paragraphs 8.33 to 8.39.
`4.
`This form paragraph may be used where the conflicting
`patent and the pending application are:
`(a) by the same inventive entity, or
`(b) by a different inventive entity and are commonly assigned
`even though there is no common inventor, or
`(c) not commonly assigned but have at least one common inven-
`tor, or
`
` made as a result of activities undertaken within the scope of
`(d)
`a joint research agreement.
`5.
`In bracket 3, insert the number of the conflicting patent.
`6.
`If the patent is to a different inventive entity and is com-
`monly assigned with the application, form paragraph 8.27 should
`additionally be used to require the assignee to name the first
`inventor.
`7.
`If evidence is of record to indicate that the patent is prior art
`under either 35 U.S.C. 102(f) or (g), a rejection should also be
`made using form paragraphs 7.15 and/or 7.19 in addition to this
`double patenting rejection.
`8.
`If the patent is to a different inventive entity from the appli-
`cation and the effective U.S. filing date of the patent antedates the
`effective filing date of the application, a rejection under 35 U.S.C.
`102(e) should additionally be made using form paragraph 7.15.02.
`¶ 8.32 Provisional Rejection, 35 U.