Case 1:19-cv-11586-FDS Document 238-10 Filed 09/14/21 Page 1 of 73
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`Case 1:19-cv-11586-FDS Document 238-10 Filed 09/14/21 Page
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`EXHIBIT J
`
`EXHIBIT J
`
`

`

`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 238-10 Filed 09/14/21 Page 2 of 73
`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 238-10 Filed 09/14/21 Page 3 of 73
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`801
`
`822
`
`822.01
`823
`
`Claims to Inventions That Are Not Distinct in
`Plural Applications of Same Inventive Entity
`Copending Before the Examiner
`Unity of Invention Under the Patent Coopera-
`tion Treaty
`
`
`Introduction
`801
`This chapter is limited to a discussion of the subject
`of restriction and double patenting under Title 35 of
`the United States Code and Title 37 of the Code of
`Federal Regulations as it relates to national applica-
`tions filed under 35 U.S.C. 111(a). The discussion of
`unity of invention under the Patent Cooperation
`Treaty Articles and Rules as it is applied as an Inter-
`national Searching Authority, International Prelimi-
`nary Examining Authority, and
`in applications
`entering the National Stage under 35 U.S.C. 371 as a
`Designated or Elected Office in the U.S. Patent and
`Trademark Office is covered in Chapter 1800.
`802
`Basis for Practice in Statute and
`Rules
`The basis for restriction and double patenting prac-
`tices is found in the following statute and rules:
`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.
`37 CFR 1.141. Different inventions in one national
`application.
`(a) Two or more independent and distinct inventions may not
`be claimed in one national application, except that more than one
`species of an invention, not to exceed a reasonable number, may
`
`be specifically claimed in different claims in one national applica-
`tion, provided the application also includes an allowable claim
`generic to all the claimed species and all the claims to species in
`excess of one are written in dependent form (§ 1.75) or otherwise
`include all the limitations of the generic claim.
`(b) Where claims to all three categories, product, process of
`making, and process of use, are included in a national application,
`a three way requirement for restriction can only be made where
`the process of making is distinct from the product. If the process
`of making and the product are not distinct, the process of using
`may be joined with the claims directed to the product and the pro-
`cess of making the product even though a showing of distinctness
`between the product and process of using the product can be
`made.
`
`37 CFR 1.142. Requirement for restriction.
`(a) If two or more independent and distinct inventions are
`claimed in a single application, the examiner in an Office action
`will require the applicant in the reply to that action to elect an
`invention to which the claims will be restricted, this official action
`being called a requirement for restriction (also known as a
`requirement for division). Such requirement will normally be
`made before any action on the merits; however, it may be made at
`any time before final action.
`(b) Claims to the invention or inventions not elected, if not
`canceled, are nevertheless withdrawn from further consideration
`by the examiner by the election, subject however to reinstatement
`in the event the requirement for restriction is withdrawn or over-
`ruled.
`The pertinent Patent Cooperation Treaty (PCT)
`Articles and Rules are cited and discussed in Chapter
`1800. Sections 1850, 1875, and 1893.03(d) should be
`consulted for discussions on unity of invention:
`(A) before the International Searching Authority;
`(B) before the International Preliminary Examin-
`ing Authority; and
`(C) in the National Stage under 35 U.S.C. 371.
`802.01 Meaning of “Independent” and
`“Distinct” [R-5]
`35 U.S.C. 121 quoted in the preceding section
`states that the Director may require restriction if two
`or more “independent and distinct” inventions are
`claimed in one application. In 37 CFR 1.141, the
`statement is made that two or more “independent and
`distinct inventions” may not be claimed in one appli-
`cation.
`This raises the question of the inventions as
`between which the Director may require restriction.
`This, in turn, depends on the construction of the
`expression “independent and distinct” inventions.
`
`Rev. 5, Aug. 2006
`
`800-2
`
`

`

`Case 1:19-cv-11586-FDS Document 238-10 Filed 09/14/21 Page 4 of 73
`
`RESTRICTION IN APPLICATIONS FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`803
`
`“Independent”, of course, means not dependent>,
`or unrelated<. If “distinct” means the same thing, then
`its use in the statute and in the rule is redundant. If
`“distinct” means something different, then the ques-
`tion arises as to what the difference in meaning
`between these two words may be. The hearings before
`the committees of Congress considering the codifica-
`tion of the patent laws indicate that 35 U.S.C. 121:
`“enacts as law existing practice with respect to divi-
`sion, at the same time introducing a number of
`changes.”
`The report on the hearings does not mention as a
`change that is introduced, the inventions between
`which the Director may properly require division.
`The term “independent” as already pointed out,
`means not dependent>, or unrelated<. A large number
`of inventions between which, prior to the 1952 Act,
`division had been proper, are dependent inventions,
`such as, for example, combination and a subcombina-
`tion thereof; as process and apparatus used in the
`practice of the process; as composition and the pro-
`cess in which the composition is used; as process and
`the product made by such process, etc. If section 121
`of the 1952 Act were intended to direct the Director
`never to approve division between dependent inven-
`tions, the word “independent” would clearly have
`been used alone. If the Director has authority or dis-
`cretion to restrict independent inventions only, then
`restriction would be improper as between dependent
`inventions, e.g., the examples used for purpose of
`illustration above. Such was clearly not the intent of
`Congress. Nothing in the language of the statute and
`nothing in the hearings of the committees indicate any
`intent to change the substantive law on this subject.
`On the contrary, joinder of the term “distinct” with the
`term “independent”, indicates lack of such intent. The
`law has long been established that dependent inven-
`tions (frequently termed related inventions) such as
`used for illustration above may be properly divided if
`they are, in fact, “distinct” inventions, even though
`dependent.
`
`I.
`
`INDEPENDENT
`
`term “independent” (i.e., **>unrelated<)
`The
`means that there is no disclosed relationship between
`the two or more inventions claimed, that is, they are
`unconnected in design, operation, and effect. For
`example, a process and an apparatus incapable of
`
`being used in practicing the process are independent
`inventions. See also MPEP § 806.06 and § 808.01.
`
`>RELATED BUT< DISTINCT
`II.
`Two or more inventions are related (i.e., not inde-
`pendent) if they are disclosed as connected in at least
`one of design (e.g., structure or method of manufac-
`ture), operation (e.g., function or method of use), or
`effect. Examples of related inventions include combi-
`nation and part (subcombination) thereof, process and
`apparatus for its practice, process and product made,
`etc. In this definition the term related is used as an
`alternative for dependent in referring to inventions
`other than independent inventions.
`Related inventions are distinct if the inventions as
`claimed are not connected in at least one of design,
`operation, or effect (e.g., can be made by, or used in, a
`materially different process) and wherein at least one
`invention is PATENTABLE (novel and nonobvious)
`OVER THE OTHER (though they may each be
`unpatentable over
`the prior art). See MPEP
`§ 806.05(c) (combination and subcombination) and
`§ 806.05(j) (related products or related processes) for
`examples of when a two-way test is required for dis-
`tinctness.
`It is further noted that the terms “independent” and
`“distinct” are used in decisions with varying mean-
`ings. All decisions should be read carefully to deter-
`mine the meaning intended.
`802.02
`Definition of Restriction [R-3]
`Restriction **>is< the practice of requiring an
`**>applicant to elect a single claimed invention (e.g.,
`a combination or subcombination invention, a product
`or process invention, a species within a genus) for
`examination when two or more independent inven-
`tions and/or two or more distinct inventions are
`claimed in an application.<
`803
`Restriction — When Proper [R-3]
`Under the statute>, the claims of< an application
`may properly be required to be restricted to one of
`two or more claimed inventions only if they are able
`to support separate patents and they are either inde-
`pendent
`(MPEP § **>802.01, § 806.06, and
`§ 808.01<)
`or
`distinct
`(MPEP
`§ 806.05
`-
`§ *>806.05(j)<).
`
`800-3
`
`Rev. 5, Aug. 2006
`
`

`

`Case 1:19-cv-11586-FDS Document 238-10 Filed 09/14/21 Page 5 of 73
`
`803.01
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`803.01
`
`Review by Examiner with at
`Least Partial Signatory Authori-
`ty [R-3]
`
`Since requirements for restriction under 35 U.S.C.
`121 are discretionary with
`the *>Director<,
`it
`becomes very important that the practice under this
`section be carefully administered. Notwithstanding
`the fact that this section of the statute apparently pro-
`tects the applicant against the dangers that previously
`might have resulted from compliance with an
`improper requirement for restriction, IT STILL
`REMAINS IMPORTANT FROM THE STAND-
`POINT OF THE PUBLIC INTEREST THAT NO
`REQUIREMENTS BE MADE WHICH MIGHT
`RESULT IN THE ISSUANCE OF TWO PATENTS
`FOR THE SAME INVENTION. Therefore, to guard
`against this possibility, only an examiner with perma-
`nent >full signatory authority< or temporary full sig-
`natory authority may sign final ** Office actions
`containing a final requirement for restriction**>. An<
`examiner with permanent >partial signatory author-
`ity< or temporary partial signatory authority may sign
`non-final Office actions containing a final require-
`ment for restriction.
`
`803.02 Markush Claims [R-5]
`
`A Markush-type claim recites alternatives in a for-
`mat such as “selected from the group consisting of A,
`B and C.” See Ex parte Markush, 1925 C.D. 126
`(Comm’r Pat. 1925). The members of the Markush
`group (A, B, and C in the example above) ordinarily
`must belong to a recognized physical or chemical
`class or to an art-recognized class. However, when the
`Markush group occurs in a claim reciting a process or
`a combination (not a single compound), it is sufficient
`if the members of the group are disclosed in the speci-
`fication to possess at least one property in common
`which is mainly responsible for their function in the
`claimed relationship, and it is clear from their very
`nature or from the prior art that all of them possess
`this property. Inventions in metallurgy, refractories,
`ceramics, pharmacy, pharmacology and biology are
`most frequently claimed under the Markush formula
`but purely mechanical features or process steps may
`also be claimed by using the Markush style of claim-
`ing. See MPEP § 2173.05(h).
`
`If the search and examination of **>all the claims
`in an< application can be made without serious bur-
`den, the examiner must examine *>them< on the mer-
`its, even
`though **>they
`include< claims
`to
`independent or distinct inventions.
`
`> I
`
`.
`
`< CRITERIA FOR RESTRICTION BE-
`TWEEN PATENTABLY DISTINCT IN-
`VENTIONS
`There are two criteria for a proper requirement for
`restriction between patentably distinct inventions:
`(A) The inventions must be independent (see
`MPEP § 802.01, § *>806.06<, § 808.01) or distinct
`as claimed (see MPEP § 806.05 - § *>806.05(j)<);
`and
`
`(B) There *>would< be a serious burden on the
`examiner if restriction is >not< required (see MPEP
`§ 803.02, **>§ 808<, and § 808.02).
`
`> I
`
`< GUIDELINES
`I.
`Examiners must provide reasons and/or examples
`to support conclusions, but need not cite documents to
`support the restriction requirement in most cases.
`Where plural inventions are capable of being
`viewed as related in two ways, both applicable criteria
`for distinctness must be demonstrated to support a
`restriction requirement.
`If there is an express admission that the claimed
`inventions *>would have been< obvious over each
`other within the meaning of 35 U.S.C. 103, restric-
`tion should not be required. In re Lee, 199 USPQ 108
`(Comm’r Pat. 1978).
`For purposes of the initial requirement, a serious
`burden on the examiner may be prima facie shown **
`by appropriate explanation of separate classification,
`or separate status in the art, or a different field of
`search as defined in MPEP § 808.02. That prima facie
`showing may be rebutted by appropriate showings or
`evidence by the applicant. Insofar as the criteria for
`restriction practice relating to Markush-type claims is
`concerned, the criteria is set forth in MPEP § 803.02.
`Insofar as the criteria for restriction or election prac-
`tice relating to claims to genus-species, see MPEP
`§ *>806.04< - § 806.04(i) and § 808.01(a).
`
`Rev. 5, Aug. 2006
`
`800-4
`
`

`

`Case 1:19-cv-11586-FDS Document 238-10 Filed 09/14/21 Page 6 of 73
`
`RESTRICTION IN APPLICATIONS FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`803.02
`
`If the members of the Markush group are suffi-
`ciently 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 may be directed
`to independent and distinct inventions. In such a case,
`the examiner will not follow the procedure described
`below and will not require provisional election of a
`single species. >See MPEP § 808.02.<
`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 appli-
`cants regard as their invention, unless the subject mat-
`ter 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). Broadly, unity of invention exists where com-
`pounds included within a Markush group (1) share a
`common utility, and (2) share a substantial structural
`feature essential to that utility.
`This subsection deals with Markush-type generic
`claims which recite a plurality of alternatively usable
`substances or members. In most cases, a recitation by
`enumeration is used because there is no appropriate or
`true generic language. A Markush-type claim may
`include independent and distinct inventions. This is
`true where two or more of the members are so unre-
`lated and diverse that a prior art reference anticipating
`the claim with respect to one of the members would
`not render the claim obvious under 35 U.S.C. 103
`with respect to the other member(s). In applications
`containing a Markush-type claim that encompasses at
`least two independent or distinct inventions, the
`examiner may require a provisional election of a sin-
`gle species prior to examination on the merits. An
`examiner should set forth a requirement for election
`of a single disclosed species in a Markush-type claim
`using form paragraph 8.01 when claims limited to
`species are present or using form paragraph 8.02
`when no species claims are present. See MPEP §
`808.01(a) and § 809.02(a). Following election, the
`Markush-type claim will be examined fully with
`respect to the elected species and further to the extent
`necessary to determine patentability. If the Markush-
`type claim is not allowable **, the provisional elec-
`tion will be given effect and examination will be lim-
`
`ited to the Markush-type claim and claims to the
`elected species, with claims drawn to species patent-
`ably distinct from the elected species held withdrawn
`from further consideration.
`As an example, in the case of an application with a
`Markush-type claim drawn to the compound X-R,
`wherein R is a radical selected from the group consist-
`ing of A, B, C, D, and E, the examiner may require a
`provisional election of a single species, XA, XB, XC,
`XD, or XE. The Markush-type claim would then be
`examined fully with respect to the elected species and
`any species considered to be clearly unpatentable over
`the elected species. If on examination the elected spe-
`cies is found to be anticipated or rendered obvious by
`prior art, the Markush-type claim and claims to the
`elected species shall be rejected, and claims to the
`nonelected species would be held withdrawn from
`further consideration. A second action on the rejected
`claims can be made final unless the examiner intro-
`duces a new ground of rejection that is neither neces-
`sitated by applicant’s amendment of the claims nor
`based on information submitted in an information dis-
`closure statement filed during the period set forth in
`37 CFR 1.97(c) with the fee set forth in 37 CFR
`1.17(p). See MPEP § 706.07(a).
`On the other hand, should **>the examiner deter-
`mine that< the elected species >is allowable<, the
`*>examination< of the Markush-type claim will be
`extended. If prior art is then found that anticipates or
`renders obvious the Markush-type claim with respect
`to a nonelected species, the Markush-type claim shall
`be rejected and claims to the nonelected species held
`withdrawn from further consideration. The prior art
`search, however, will not be extended unnecessarily
`to cover all nonelected species. Should applicant,
`in response to this rejection of the Markush-type
`claim, overcome the rejection, as by amending the
`Markush-type claim to exclude the species anticipated
`or rendered obvious by the prior art, the amended
`Markush-type claim will be
`reexamined. The
`**>examination< will be extended to the extent nec-
`essary to determine patentability of the Markush-type
`claim. In the event prior art is found during the reex-
`amination that anticipates or renders obvious the
`amended Markush-type claim, the claim will be
`rejected and the action can be made final unless the
`examiner introduces a new ground of rejection that is
`neither necessitated by applicant’s amendment of the
`
`800-5
`
`Rev. 5, Aug. 2006
`
`

`

`Case 1:19-cv-11586-FDS Document 238-10 Filed 09/14/21 Page 7 of 73
`
`803.03
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`claims nor based on information submitted in an
`information disclosure statement filed during the
`period set forth in 37 CFR 1.97(c) with the fee set
`forth in 37 CFR 1.17(p). See MPEP § 706.07(a).
`Amendments submitted after the final rejection fur-
`ther restricting the scope of the claim may be denied
`entry if they do not comply with the requirements of
`37 CFR 1.116. See MPEP § 714.13.
`If a Markush claim depends from or otherwise
`requires all the limitations of another generic or link-
`ing claim, see MPEP § 809.
`803.03
`* Transitional
`[R-3]
`
` Applications
`
`PRACTICE RE TRANSITIONAL APPLICA-
`TION
`37 CFR 1.129. Transitional procedures for limited
`examination after final rejection and restriction practice.
`*****
`
`(b)(1) In an application, other than for reissue or a design
`patent, that has been pending for at least three years as of June 8,
`1995, taking into account any reference made in the application to
`any earlier filed application under 35 U.S.C. 120, 121 and 365(c),
`no requirement for restriction or for the filing of divisional appli-
`cations shall be made or maintained in the application after June
`8, 1995, except where:
`(i)
` The requirement was first made in the application or
`any earlier filed application under 35 U.S.C. 120, 121 and 365(c)
`prior to April 8, 1995;
`(ii) The examiner has not made a requirement for restric-
`tion in the present or parent application prior to April 8, 1995, due
`to actions by the applicant; or
`(iii) The required fee for examination of each additional
`invention was not paid.
`(2) If the application contains more than one independent
`and distinct invention and a requirement for restriction or for the
`filing of divisional applications cannot be made or maintained
`pursuant to this paragraph, applicant will be so notified and given
`a time period to:
`(i) Elect the invention or inventions to be searched
`and examined, if no election has been made prior to the notice,
`and pay the fee set forth in 1.17(s) for each independent and dis-
`tinct invention claimed in the application in excess of one which
`applicant elects;
`(ii) Confirm an election made prior to the notice and
`pay the fee set forth in § 1.17(s) for each independent and distinct
`invention claimed in the application in addition to the one inven-
`tion which applicant previously elected; or
`(iii) File a petition under this section traversing the
`requirement. If the required petition is filed in a timely manner,
`the original time period for electing and paying the fee set forth in
`§ 1.17(s) will be deferred and any decision on the petition affirm-
`
`ing or modifying the requirement will set a new time period to
`elect the invention or inventions to be searched and examined and
`to pay the fee set forth in § 1.17(s) for each independent and dis-
`tinct invention claimed in the application in excess of one which
`applicant elects.
`(3) The additional inventions for which the required fee
`has not been paid will be withdrawn from consideration under
`§ 1.142(b). An applicant who desires examination of an invention
`so withdrawn from consideration can file a divisional application
`under 35 U.S.C. 121.
`(c) The provisions of this section shall not be applicable to
`any application filed after June 8, 1995.
`“Restriction” under 37 CFR 1.129(b) applies to
`both restriction requirements under 37 CFR 1.142 and
`election of species requirements under 37 CFR 1.146.
`37 CFR 1.129(b)(1) provides for examination of
`more than one independent and distinct invention in
`certain applications pending for 3 years or longer as
`of June 8, 1995, taking into account any reference to
`any earlier application under 35 U.S.C. 120, 121, or
`365(c). Applicant will not be permitted to have such
`additional invention(s) examined in an application if:
`
`(A) the requirement was made in the application
`or in an earlier application relied on under 35 U.S.C.
`120, 121, or 365(c) prior to April 8, 1995;
`(B) no restriction requirement was made with
`respect to the invention(s) in the application or earlier
`application prior to April 8, 1995, due to actions by
`the applicant; or
`(C) the required fee for examination of each addi-
`tional invention was not paid.
`
`Only if one of these exceptions applies is a normal
`restriction requirement appropriate and telephone
`restriction practice may be used.
`Examples of what constitute “actions by the appli-
`cant” in 37 CFR 1.129(b)(1) are:
`
`(A) applicant abandoned the application and con-
`tinued to refile the application such that no Office
`action could be issued in the application,
`(B) applicant requested suspension of prosecution
`under 37 CFR 1.103(a) such that no Office action
`could be issued in the application,
`(C) applicant disclosed a plurality of independent
`and distinct inventions in the present or parent appli-
`cation, but delayed presenting claims to more than
`one of the disclosed independent and distinct inven-
`tions in the present or parent application such that no
`
`Rev. 5, Aug. 2006
`
`800-6
`
`

`

`Case 1:19-cv-11586-FDS Document 238-10 Filed 09/14/21 Page 8 of 73
`
`RESTRICTION IN APPLICATIONS FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`803.03
`
`restriction requirement could be made prior to April 8,
`1995, and
`(D) applicant combined several applications, each
`of which claimed a different independent and distinct
`invention, into one large “continuing” application, but
`delayed filing the continuing application first claim-
`ing more than one independent and distinct invention
`such that no restriction requirement could be made
`prior to April 8, 1995.
`
`In examples (A) and (B), the fact that the present or
`parent application claiming independent and distinct
`inventions was on an examiner’s docket for at least 3
`months prior to abandonment or suspension, or in
`examples (C) and (D), the fact that the amendment
`claiming independent and distinct inventions was first
`filed, or the continuing application first claiming the
`additional independent and distinct inventions was on
`an examiner’s docket, at least 3 months prior to April
`8, 1995, is prima facie evidence that applicant’s
`actions did not prevent the Office from making a
`requirement for restriction with respect to those inde-
`pendent and distinct inventions prior to April 8, 1995.
`Furthermore, an extension of time under 37 CFR
`1.136(a) does not constitute such “actions by the
`applicant” under 37 CFR 1.129(b)(1).
`NOTE: If an examiner believes an application falls
`under the exception that no restriction could be made
`prior to April 8, 1995, due to applicant’s action, the
`application must be brought to the attention of the
`Technology Center (TC) Special Program Examiner
`for review.
`Under 37 CFR 1.129(b)(2), if the application con-
`tains claims to more than one independent and distinct
`invention, and no requirement for restriction or for the
`filing of divisional applications can be made or main-
`tained, applicant will be notified and given a time
`period to:
`
`(A) elect the invention or inventions to be
`searched and examined, if no election has been made
`prior to the notice, and pay the fee set forth in 37 CFR
`1.17(s) for each independent and distinct invention
`claimed in the application in excess of one which
`applicant elects,
`(B) in situations where an election was made in
`reply to a requirement for restriction that cannot be
`maintained, confirm the election made prior to the
`notice and pay the fee set forth in 37 CFR 1.17(s) for
`
`each independent and distinct invention claimed in
`the application in addition to the one invention which
`applicant previously elected, or
`(C) file a petition under 37 CFR 1.129(b)(2) tra-
`versing the requirement without regard to whether the
`requirement has been made final. No petition fee is
`required.
`37 CFR 1.129(b)(2) also provides that if the peti-
`tion is filed in a timely manner, the original time
`period for electing and paying the fee set forth in
`37 CFR 1.17(s) will be deferred and any decision on
`the petition affirming or modifying the requirement
`will set a new time period to elect the invention or
`inventions to be searched and examined and to pay
`the fee set forth in 37 CFR 1.17(s) for each indepen-
`dent and distinct invention claimed in the application
`in excess of one which applicant elects.
`Under 37 CFR 1.129(b)(3), each additional inven-
`tion for which the required fee set forth in 37 CFR
`1.17(s) has not been paid will be withdrawn from con-
`sideration under 37 CFR 1.142(b). An applicant who
`desires examination of an invention so withdrawn
`from consideration can file a divisional application
`under 35 U.S.C. 121.
`37 CFR 1.129(c) clarifies that the provisions of
`37 CFR 1.129(a) and (b) are not applicable to any
`application filed after June 8, 1995. However, any
`application filed on June 8, 1995, would be subject to
`a 20-year patent term.
`Form paragraph 8.41 may be used to notify appli-
`cant that the application is a transitional application
`and is entitled to consideration of additional inven-
`tions upon payment of the required fee.
`¶ 8.41 Transitional Restriction or Election of Species
`Requirement To Be Mailed After June 8, 1995
`This application is subject to the transitional restriction provi-
`sions of Public Law 103-465, which became effective on June 8,
`1995, because