`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`Case IPR2021-00816
`Patent 9,220,631
`
`
`
`
`
`
`
`
`
`PATENT OWNERS’ OBJECTIONS TO ADMISSIBILITY OF EVIDENCE
`SUBMITTED BY PETITIONERS
`
`
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`Pursuant to 37 C.F.R. § 42.64(b), Patent Owners Novartis Pharma AG,
`
`Novartis Technology LLC, and Novartis Pharmaceuticals Corporation hereby
`
`object as follows to the admissibility of evidence filed by Petitioner Regeneron
`
`Pharmaceuticals, Inc., in conjunction with Petitioner’s Reply to Patent Owner’s
`
`Response, filed on April 15, 2022, and the Petitioner’s Opposition to Patent
`
`Owner’s Motion to Amend, filed on April 15, 2022.
`
`Evidence
`
`Objections
`
`Exhibit 1092 37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`
`
`2
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`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
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`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`
`
`3
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`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
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`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1093 37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`
`
`4
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`
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`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
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`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`
`
`5
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`
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`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
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`rely on in forming an opinion on the particular subject.
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1094 FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`FRE 901: Petitioner has not produced evidence sufficient to
`
`support a finding that the exhibit is what Petitioner claims it is.
`
`
`
`6
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`IPR2021-00816
`U.S. Patent No. 9,220,631
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`Evidence
`
`Objections
`
`Exhibit 1095 FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`Exhibit 1096 FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`
`
`7
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`
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`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
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`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1097 FRE 105: To the extent that any portion of this exhibit may be
`
`
`
`8
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`
`
`Evidence
`
`Objections
`
`deemed admissible, such admissibility should be for a limited
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1098 FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`Exhibit 1099 FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`
`
`9
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`
`
`10
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
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`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1100 Improper New Evidence. The exhibit constitutes new evidence,
`
`which Petitioner submitted for the first time with Petitioner’s
`
`Reply to Patent Owner’s Response to Petition, and which
`
`Petitioner could have submitted earlier, expressly prohibited by
`
`the applicable rules. Consolidated Trial Practice Guide,
`
`November 2019, at 73 (“Petitioner may not submit new evidence
`
`or argument in reply that it could have presented earlier, e.g. to
`
`make out a prima facie case of unpatentability.”).
`
`37 CFR § 42.23: Use of Exhibit to support any reply argument
`
`not raised in the corresponding opposition, patent owner
`
`
`
`11
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`
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`Evidence
`
`Objections
`
`preliminary response, patent owner response, or decision on
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
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`institution.
`
`37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`
`
`12
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`
`
`13
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`
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
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`Evidence
`
`Objections
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1101 37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`
`
`14
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`
`
`15
`
`
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`Evidence
`
`Objections
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1102 37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`
`
`16
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`
`
`17
`
`
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`Evidence
`
`Objections
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1103 37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`
`
`18
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`
`
`19
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`
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
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`Evidence
`
`Objections
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1104 Novartis reserves its right to object to any exhibit Regeneron
`
`attempts to introduce into this “Intentionally Left Blank” entry.
`
`Exhibit 1105 37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`
`
`20
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`
`
`21
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1106 37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`
`
`22
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`
`
`23
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1107 37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`
`
`24
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`
`
`25
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`FRE 802: The exhibit contains inadmissible hearsay if offered to
`
`prove the truth of any matter allegedly asserted therein.
`
`Exhibit 1108 Improper New Evidence. The exhibit constitutes new evidence,
`
`which Petitioner submitted for the first time with Petitioner’s
`
`Reply to Patent Owner’s Response to Petition, and which
`
`Petitioner could have submitted earlier, expressly prohibited by
`
`the applicable rules. Consolidated Trial Practice Guide,
`
`November 2019, at 73 (“Petitioner may not submit new evidence
`
`or argument in reply that it could have presented earlier, e.g. to
`
`make out a prima facie case of unpatentability.”).
`
`37 CFR § 42.23: Use of Exhibit to support any reply argument
`
`not raised in the corresponding opposition, patent owner
`
`preliminary response, patent owner response, or decision on
`
`institution.
`
`37 CFR § 42.6(a)(3): Petitioner’s reliance on this exhibit entails
`
`improper incorporation by reference of arguments from one
`
`document into another document.
`
`
`
`26
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`FRE 105: To the extent that any portion of this exhibit may be
`
`deemed admissible, such admissibility should be for a limited
`
`purpose.
`
`FRE 402/403: The exhibit includes assertions and testimony that
`
`are not relevant to any ground upon which trial was instituted
`
`and/or for which the probative value to any ground upon which
`
`trial was instituted is substantially outweighed by the danger of
`
`unfair prejudice, confusing the issues, undue delay, wasting time,
`
`or needlessly cumulative evidence.
`
`FRE 602: The exhibit includes assertions for which evidence has
`
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701-703: The exhibit author is not qualified to opine on
`
`what a person of ordinary skill in the art would understand, to
`
`opine on patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The exhibit
`
`contains improper lay and/or expert opinion. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not based
`
`
`
`27
`
`
`
`Evidence
`
`Objections
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`on personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified and
`
`unsupported generalizations. The opinion testimony fails to
`
`properly disclose the underlying facts or data on which the
`
`opinion is based. The opinion testimony includes testimony on
`
`United States patent law and/or patent examination practice. The
`
`opinion testimony includes conclusions based on documents that
`
`are subject to objections indicated herein, that have not been
`
`sufficiently authenticated as what the declarant asserts or believes
`
`them to be, and/or that an expert in the field would not reasonably
`
`rely on in forming an opinion on the particular subject.
`
`FRE 705: The exhibit includes expert testimony that does not
`
`disclose the underlying facts or data.
`
`FRE 802: The exhibit contains inadmissible hearsay i