`
`UNITED STATES
`PATENT AND TRADEMARK OFFICE
`
`
`
`Inari Exhibit 1033
`Inari v. Pioneer
`
`Inari Exhibit 1033
`
`
`
`Requirements for Information under 37
`CFR 1.105 and the Submission of Said
`Information under MPEP 724 (e.g. Trade
`Secrets).
`TC1600 Biotech/Pharma/Chem Customer
`Partnership Meeting
`
`
`
`37 CFR 1.105 (Rule 105) - Requirements for
`Information
`• An Examiner or other Office employee
`may require the submission of such
`information as may be reasonably
`necessary to properly examine or treat a
`matter in an application or a patent.
`• See MPEP 704.10 for more information.
`
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`
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`Who can be required to submit?
`
`•
`
`Individuals identified under 37 CFR 1.56(c)
`– Each inventor named in the application
`– Each attorney or agent who prepares or prosecutes the
`application, and
`– Every other person who is substantially involved in the
`preparation or prosecution of the application and who is
`associated with the inventor or the assignee
`• Assignees or anyone to whom there is an obligation to
`assign
`• See MPEP 704.10 for more information.
`
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`
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`What information may be required?
`
`•
`
`Information reasonably necessary to properly examine
`or treat a matter in a pending or abandoned application
`or in a patent
`– Information used to draft a patent application
`– Information reasonable necessary for finding prior art
`– Information used in invention process
`– See 37 CFR 1.105 (a)(1) for more examples
`– See MPEP 704.11 for more information.
`
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`
`
`•
`
`•
`
`More specific examples of information that
`may be required
`The name and citation of any particularly relevant indexed journal, or
`•
`treatise.
`The trade name of any goods or services in which the claimed subject
`matter is embodied.
`The citation for, the dates initially published, and copies of any
`advertising and promotional literature prepared for any goods or services
`in which the claimed subject matter has been embodied.
`The trade names, providers, as well as any written descriptions or analyses
`prepared by any of the inventors or assignees, of any goods or services in
`competition with the goods or services in which the claimed subject
`matter has been embodied.
`• See MPEP 704.11 for more examples
`
`•
`
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`
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`How is the criteria of “reasonably necessary”
`met?
`• The examiner’s search and preliminary analysis
`demonstrate that the claimed subject matter cannot
`be adequately searched by class or keywords among
`patents and typical sources of non-patent literature,
`or
`• Either the application file or the lack of relevant prior
`art found in the examiner’s search justifies asking the
`applicant if he or she has information that would be
`relevant to the patentability determination.
`• See MPEP 704.11 for more information.
`
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`
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`When may a requirement for information be
`made?
`• At any time once the necessity for the
`information is recognized and should be made at
`the earliest opportunity after the necessity is
`recognized.
`• The optimum time for making a requirement is
`prior to or with a first action on the merits.
`• Ordinarily, a requirement for information should
`not be made with or after a final rejection.
`• See MPEP 704.11(b) for more information.
`
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`
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`Requirement for information under 37 CFR 1.105 versus
`duty of disclosure under 37 CFR 1.56
`• 37 CFR 1.56 requires disclosure of information material to the
`patentability of the claimed subject matter.
`• 37 CFR 1.105 requires information reasonably necessary to the
`examination of the application or treatment of a matter.
`• Similar to 37 CFR 1.56, applicant is required by 37 CFR 1.105 to
`submit information already known, but no requirement to search
`for info that is unknown.
`• Unlike 37 CFR 1.56, applicant is required by 37 CFR 1.105 to submit
`information that may not be material to patentability in itself, but
`that is necessary to obtain a complete record from which
`patentability may be determined.
`• See MPEP 704.12(a) for more information.
`
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`
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`What constitutes a complete reply to a requirement
`for information?
`• Providing the information required, or
`• A statement that the information required is unknown
`and/or is not readily available to the party or parties from
`which it was requested.
`• There is NO requirement to show the required information
`was not in fact readily attainable.
`• Applicant is required to make a good faith attempt to obtain
`the information and to make a reasonable inquiry once the
`information is requested.
`• See MPEP 704.12(b) for more information.
`
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`
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`When is an information “Not readily available?”
`
`• Not readily obtained after reasonable inquiry.
`• Applicant is expected to make a reasonable inquiry
`under the circumstances to find the factual
`information requested.
`• Applicant need not, however, derive or
`independently discover a fact, such as by
`experimentation, in response to a requirement for
`information.
`• See MPEP 704.11 and 704.12(b) for more information.
`
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`
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`Time periods for reply to a requirement for
`information?
`Independent: Requirements made without an action on the
`•
`merits should set a shortened statutory period (SSP) of 2
`months for reply.
`– May petition to extend the time period for reply up to 6
`months under 37 CFR 1.136(a).
`• Dependent: Requirements sent with an Office action on the
`merits, and not as a separate Office action, will be given the
`same period for reply as the action on the merits.
`• MPEP 704.13
`
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`
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`Rule 105 requirements in plant patent application
`under 35 U.S.C. 161
`• If an examiner finds a printed publication
`describing the instantly claimed plant
`variety in a plant application, typically the
`information to require is when, if ever, the
`plant variety was placed in the public
`domain by offer for sale or other public use
`• This information is germane because…
`
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`Printed publication alone in plant patent application
`may not be enabling.
`• Printed publications may not be enabling prior
`art, if the disclosed plant variety was not
`available to one skilled in the art.
`• “When the claims are drawn to plants, the
`reference, combined with knowledge in the prior
`art, must enable one of ordinary skill in the art to
`reproduce the plant.”
`• See MPEP 2121.03 citing In re LeGrice, 301 F.2d 929,
`133 USPQ 365 (CCPA 1962).
`
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`Printed publication in plant patent application
`
`• “A printed publication anticipates a claim if it
`discloses the claimed invention “such that a
`skilled artisan could take its teachings in
`combination with his own knowledge of the
`particular art and be in possession of the
`invention.”
`• In re LeGrice, 301 F.2d 929, 936, 133 USPQ 365, 372
`(CCPA 1962).
`
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`Printed publication in plant patent application
`
`• A printed publication can be an enabling disclosure if
`the disclosed plant variety is available to one skilled
`in the art.
`– In Ex parte Thomson, the seeds were commercially available
`more than 1 year prior to applicant’s filing date. One of
`ordinary skill in the art could grow the claimed cotton
`cultivar from the commercially available seeds. Thus, the
`publications describing the cotton cultivar had "enabled
`disclosures."
`• Ex parte Thomson, 24 USPQ2d 1618 (BPAI 1992).
`• See also MPEP 2121.03
`
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`
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`Examples of printed publications which could
`trigger a rule 105 requirement
`• Plant Breeder’s Right or Plant Variety Protection
`applications or grants disclosed in the UPOV
`database
`• Catalogs with unclear release dates, e.g. “Fall 1998,”
`“1998/1999”
`• “Preview” type articles disclosing an anticipated
`release date
`• When there is evidence suggesting that the claimed
`plant may have been in the public domain
`
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`
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`Trade secrets, proprietary, and protective
`orders submitted under MPEP 724
`• You have submitted information when responding to
`a request for information under rule 105 and that
`information is a trade secret, proprietary, or under a
`protective order.
`– How do you submit?
`– If you submit, will the submission become part of the
`record?
`– What can you do if you do not want the information
`submitted in response to a request for information (37CFR
`1.105) to become part of the record?
`
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`
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`Policy – Why allow information to be submitted
`under MPEP 724?
`• MPEP 724 governs Trade Secret, Proprietary, and Protective Order
`Materials
`– “While one submitting materials to the Office in relation to a pending patent
`application or reexamination proceeding must generally assume that such materials
`will be made of record in the file and be made public, the Office is not unmindful of
`the difficulties this sometimes imposes.”
`The Office is also cognizant of the sentiment expressed by the court in In
`re Sarkar, 575 F.2d 870, 872, 197 USPQ 788, 791 (CCPA 1978), which stated:
`– “If a patent applicant is unwilling to pursue his right to a patent at the risk of certain
`loss of trade secret protection, the two systems will conflict, the public will be deprived
`of knowledge of the invention in many cases, and inventors will be reluctant to bring
`unsettled legal questions of significant current interest . . . for resolution.”
`
`•
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`How to submit trade secret, proprietary, and/or
`protective order materials?
`Information which is considered by the party submitting the same to be
`•
`either trade secret material or proprietary material, and any material
`subject to a protective order, must be clearly labeled as such and be filed
`in a sealed, clearly labeled, envelope or container. (MPEP 724.02).
`Each document or item must be clearly labeled as a “Trade Secret”
`document or item, a “Proprietary” document or item, or as an item or
`document “Subject To Protective Order.” (MPEP 724.02).
`It is essential that the terms “Confidential,” “Secret,” and “Restricted” or
`“Restricted Data” not be used when marking these documents or items in
`order to avoid confusion with national security information documents
`which are marked with these terms. (MPEP 724.02).
`Example Language from MPEP 724.02
`– “TRADE SECRET MATERIAL NOT OPEN TO PUBLIC. TO BE OPENED ONLY BY EXAMINER
`OR OTHER AUTHORIZED U.S. PATENT AND TRADEMARK OFFICE EMPLOYEE.”
`
`•
`
`•
`
`•
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`How to submit trade secret, proprietary, and/or
`protective order materials?
`• Need more than a clearly labeled envelope or container. (MPEP
`724.02)
`– Transmittal Letter
`• The envelope or container must be accompanied by a transmittal letter which also
`contains the same identifying information as the envelope or container. The
`transmittal letter must also state that the materials in the envelope or container
`are considered trade secrets or proprietary, or are subject to a protective order,
`and are being submitted for consideration under MPEP § 724.
`– Petition to Expunge
`• A Petition under 37 CFR 1.59 to expunge the information, if found not to be
`material to patentability, and the required fee under 37 CFR 1.17(g) should
`accompany the envelope or container.
`– Timing (cid:198) Needs to be filed prior to the notice of allowance. (MPEP 724.04)
`
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`21
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`
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`Contents of petition to expunge (MPEP 724.05)
`
`• Any such petition to expunge information submitted under MPEP §
`724.02 should be submitted at the time of filing the information under
`MPEP § 724.02 and directed to the Technology Center (TC) to which the
`application is assigned. Such petition must contain:
`– (A) a clear identification of the information to be expunged without disclosure of the
`details thereof;
`– (B) a clear statement that the information to be expunged is trade secret material,
`proprietary material, and/or subject to a protective order, and that the information has
`not been otherwise made public;
`– (C) a commitment on the part of the petitioner to retain such information for the
`period of enforceability of any patent with regard to which such information is
`submitted;
`– (D) a statement that the petition to expunge is being submitted by, or on behalf of, the
`party in interest who originally submitted the information;
`– (E) the fee as set forth in 37 CFR 1.17(g) for a petition under 37 CFR 1.59(b).
`
`9/20/2018
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`22
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`
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`When does the information submitted under MPEP 724
`become part of the record?
`• No petition to expunge was filed prior to the notice of
`allowability.
`• A petition to expunge was properly filed but denied.
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`
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`Petition to expunge - grant/deny
`
`• You have timely submitted a Petition to Expunge. The application
`has been allowed. What causes the petition to expunge to be
`granted or denied?
`• Grant
`– “If the application is being allowed, if the materials submitted under
`MPEP 724.02 are found not to be material to patentability, the
`petition to expunge will be granted and the materials will be expunged.”
`(MPEP 724.04).
`• Deny
`– “If the materials are found to be material to patentability, the petition
`to expunge will be denied and the materials will become part of the
`application record and will be available to the public upon issuance of
`the application as a patent.” (MPEP 724.04)
`
`9/20/2018
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`24
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`
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`Petition to expunge - abandoned applications
`
`• You have abandoned your application
`(which has information submitted under
`724.02) and there is a petition to expunge.
`– With the mailing of the notice of abandonment, if
`a petition to expunge has been filed, irrespective
`of whether the materials are found to be material
`to patentability, the petition to expunge will be
`granted and the materials expunged. (MPEP
`724.04).
`
`9/20/2018
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`25
`
`
`
`The Big Question – When is information submitted
`under MPEP 724.02 considered to be material to
`patentability?
`• What is “Material to Patentability” with respect to material submitted under
`MPEP 724.02?
`– “Materiality” is defined as any information which the examiner considers as being
`important to a determination of the patentability of the claims. See FP 7.206 in
`MPEP 724.06 – Petition under 37 CFR 1.59(b) to Expunge Information Dismissed”.
`• What is “Material to Patentability” with respect to material submitted under 37
`CFR 1.56(b).
`– Information is material to patentability when it is not cumulative to information
`already of record or being made of record in the application, and
`(1) It establishes, by itself or in combination with other information, a prima facie case of
`•
`unpatentability of a claim; or
`(2) It refutes, or is inconsistent with, a position the applicant takes in:
`– (i) Opposing an argument of unpatentability relied on by the Office, or
`– (ii) Asserting an argument of patentability.
`
`•
`
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`26
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`
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`Example - material to patentability determination for
`information submitted under MPEP 724.
`• Hypothetical Application
`– Claim 1. A seed of soybean variety XYZ, wherein a
`representative sample of the seed has been deposited
`under ATCC Accession No. PTA-123456.
`• Note – Applicant has not submitted the breeding history of
`Soybean XYZ with the application.
`– Specification discloses that soybean variety XYZ has the
`following traits (Only traits disclosed):
`• Flower Color – Purple
`• Pod Wall Color – Brown
`• Seed Coat Color - Yellow
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`
`
`Example - material to patentability determination for
`information submitted under MPEP 724.
`• Hypothetical Prior Art
`– Claim 1. A seed of soybean variety ABC, wherein a
`representative sample of the seed has been deposited
`under ATCC Accession No. PTA-654321.
`• Note – Prior Art discloses that Soybean ABC was made by
`crossing Plant A with Plant BC .
`– Specification discloses that soybean variety ABC has the
`following traits (Only traits disclosed):
`• Flower Color – Purple
`• Pod Wall Color – Brown
`• Seed Coat Color - Yellow
`
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`28
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`
`
`Example - material to patentability determination for
`information submitted under MPEP 724.
`• Examiner makes a 102 rejection.
`– Soybean seed XYZ and Soybean seed ABC have identical traits.
`• Phenotypically Identical.
`– Because the breeding history of XYZ is not known, it is not possible for
`examiner to determine whether soybean seed XYZ was made from
`plants A and BC.
`• Not possible to determine if the Soybean seed XYZ and Soybean Seed ABC are
`genetically identical.
`• Examiner when mailing the non-final office action makes the 102
`rejection and also submits a requirement for information under 37
`CFR 1.105.
`– The request seeks to identify the breeding history of Soybean seed XYZ.
`
`9/20/2018
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`29
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`
`
`Example - material to patentability determination for
`information submitted under MPEP 724.
`• Applicant responds to a non-final office action by submitting proprietary
`information under MPEP 724:
`– Responds to the 105 request by providing the breeding history (proprietary) of
`Soybean Seed XYZ.
`Soybean Seed XYZ was produced by crossing Plant X with Plant YZ.
`•
`– In remarks accompanying the information submitted in response to the 105 request,
`applicant argues that the 102 rejection should be withdrawn as Soybean seed XYZ and
`Soybean seed ABC are genetically different due to different breeding histories.
`Examiner Action
`– Compares the breeding histories of Soybean Seed XYZ and Soybean Seed ABC
`• Determines that the seeds are different genetically.
`– Examiner withdraws 102 rejection presented in the non-final office action and allows
`the application.
`In the reasons for allowance, the examiner indicates that the 102 rejection was withdrawn due
`•
`to the information obtained from the rule 105 request.
`
`•
`
`9/20/2018
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`30
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`
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`Example - material to patentability determination for
`information submitted under MPEP 724.
`• Petition To Expunge has been filed to expunge the
`information submitted under MPEP 724, specifically the
`breeding history of Soybean Seed XYZ.
`• Should the Office grant the petition?
`– Answer (cid:198) No.
`• “Materiality” is defined as any information which the examiner considers
`as being important to a determination of the patentability of the claims.
`See FP 7.206 in MPEP 724.06 – Petition under 37 CFR 1.59(b) to Expunge
`Information Dismissed”.
`– In this application (cid:198) The examiner determined patentability by withdrawing a
`rejection due solely due to the information submitted under MPEP 724. The
`patentability was determined based on the information submitted under MPEP
`724 and thus it is material to patentability.
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`31
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`
`
`Contact Information
`• Shubo (Joe) Zhou (SPE AU 1661 and AU 1662)
`– Phone: 571-272-0724
`– Email: Shubo.Zhou@uspto.gov
`• Amjad Abraham (SPE AU 1663)
`– Phone: 571-270-7058
`– Email: Amjad.Abraham@uspto.gov
`
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`32
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