Patent Owner’s Demonstrative Exhibit
`Slide No. 1
`
`
`Slide No. 1
`
`
`
`THE ORIGINAL CLAIMS and SPECIFICATION
`PROVIDE AMPLE WRITTEN DESCRIPTION
`SUPPORT for “about 80 to about 500 mg of
`zoledronic acid within a period of six months."
`
`Paper No. 19, Patent Owner’s Response, p. 27.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 2
`
`
`
`DOSAGE REGIMENS SUPPORTED BY
`ORIGINAL CLAIMS AND SPECIFICATION
`
`Daily
`1. a 50-500 mg dose given over a period of five days, repeated every six
`months, and
`a lower end of 80 mg repeated every six months
`
`Weekly
`2. 50-500 mg given in 5 weekly doses, and a lower end of 80 mg
`
`Monthly
`3. 80-600 mg given over two monthly doses
`
`Paper No. 19, Patent Owner’s Response, p. 22, lines 16-20, pp. 29-31; Ex. 1009, U.S. App. No. 14/635,857, pp. 66-67.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 3
`
`
`
`TEN RANGES IN TOTAL
`WITH REPEATED INSTANCES OF
`
`Lower Limit of Range: 80 mg
`
`Upper Limit of Range: 500 mg
`
`Over a Six-Month Period
`
`Paper No. 19, Patent Owner’s Response, pp. 17-19.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 4
`
`
`
`ORIGINAL CLAIMS – MONTHLY
`
`Paper No. 19, Patent Owner’s Response, p. 19, line 20-p. 30, line 6; Ex. 1009, U.S. App. No. 14/635,857, p. 66.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 5
`
`
`
`ORIGINAL CLAIMS – WEEKLY
`
`12. The method of claim 1, wherein the zoledronic acid is orally
`administered weekly for 1 or 2 months.
`
`13. The method of claim 12, wherein about 10 mg to about 100 mg of
`zoledronic acid is orally administered weekly.
`
`Patent Owner’s Demonstrative Exhibit
`Paper No. 19, Patent Owner’s Response, p. 29, lines 8-9, p. 30, line 20, p. 31, line 3; Ex. 1009, U.S. App. No. 14/635,857, p. 66.
`Slide No. 6
`
`
`
`ORIGINAL CLAIMS – DAILY
`
`Paper No. 19, Patent Owner’s Response, p. 29, lines 12-14; Ex. 1009, U.S. App. No. 14/635,857, p. 67.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 7
`
`
`
`ORIGINAL CLAIMS – DAILY
`
`Original disclosure explicitly
`supports
`• a 50-500 mg dose given over a
`period of five days, and
`• a lower end of 80 mg.
`
`18. The method of claim 17,
`wherein the zoledronic acid is orally
`administered for 5 to 10
`consecutive days.
`
`17. The method of claim 16,
`wherein about 10 mg to about
`5
`6
`100 mg of zoledronic acid is
`orally administered daily.
`
`Days
`
`7
`
`8
`
`Six Possibilities
`
`Range
`
`50-500 mg
`
`60-600 mg
`
`70-700 mg
`
`80-800 mg
`
`90-900 mg
`
`100-1000 mg
`
`Paper No. 19, Patent Owner’s Response, p. 29, lines 12-14; Ex. 1009, U.S. App. No. 14/635,857, p. 67.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 8
`
`9
`
`10
`
`
`
`SPECIFICATION – DAILY
`
`The Specification, at col. 13, lines 35-40, says the same thing, adding a
`six month time frame:
`
`…about 10 mg to about 100 mg of zoledronic acid, and is administered
`daily for about 5 to about 10 consecutive days. This regimen may be
`repeated once monthly, once every two months, once every three
`months, once every four months, once every five months, once every
`six months, once yearly, or once every two years.
`
`Paper No. 19, Patent Owner’s Response p. 13, lines 21-23; Ex. 1003, U.S. Pat. No. 9,283,239 at col. 13:25-40.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 9
`
`
`
`ORIGINAL CLAIMS – WEEKLY
`
`The original disclosure explicitly
`supports:
`• 50-500 mg given in 5 weekly
`doses, and
`• a lower end of 80 mg
`
`13. The method of claim 12,
`wherein about 10 mg to about 100
`mg of zoledronic acid is orally
`administered weekly.
`Ex. 1009, U.S. App. No. 14/635,857, p. 66.
`
`12. The method of claim 1,
`wherein the zoledronic acid is
`orally administered weekly for
`1 or 2 months.
`
`Weeks
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`Six Possibilities
`
`Range
`
`40-400 mg
`
`50-500 mg
`
`60-600 mg
`
`70-700 mg
`
`80-800 mg
`
`90-900 mg
`
`Paper No. 19, Patent Owner’s Response, p. 29, lines 12-14, pp. 30-31; Ex. 1009, U.S. App. No. 14/635,857, p. 66.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 10
`
`
`
`DAILY AND WEEKLY DOSAGE RANGES ARE
`NEARLY IDENTICAL
`
`Daily Ranges
`
`Days
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`Range
`
`50-500 mg
`
`60-600 mg
`
`70-700 mg
`
`80-800 mg
`
`90-900 mg
`
`100-1000 mg
`
`Weekly Ranges
`
`Weeks
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`Range
`
`40-400 mg
`
`50-500 mg
`
`60-600 mg
`
`70-700 mg
`
`80-800 mg
`
`90-900 mg
`
`THEREFORE: A POSA would have readily recognized that the six-month cycle called out for the daily regimen
`could also apply to the weekly regimen.
`
`Paper No. 19, Patent Owner’s Response, p. 29, lines 12-14; Ex. 1009, U.S. App. No. 14/635,857, pp. 66-67; Ex.
`1003, U.S. Pat. No. 9,283,239 at col. 11:18-24, 11:64-12:3, 13:25-40.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 11
`
`
`
`ORIGINAL CLAIMS – MONTHLY
`
`6. The method of claim 11, wherein
`the zoledronic acid is orally
`administered for only 1 to 3
`months.
`Ex. 1009, U.S. App. No. 14/635,857, p. 66.
`
`Possibilities
`
`Range
`
`40-300 mg
`
`80-600 mg
`
`120-900 mg
`
`The original disclosure explicitly
`supports:
`• 80-600 mg given in 2 monthly
`doses, and
`• a lower end of 80 mg
`• administration for two months
`followed by a period where no
`drug is aministered
`
`Months
`
`4. The method of claim 1, wherein
`the human being receives about
`40 mg to about 300 mg of
`zoledronic acid per month.
`
`1
`
`2
`
`3
`
`Ex. 1009, U.S. App. No. 14/635,857, p. 66.
`
`Paper No. 19, Patent Owner’s Response, p. 29, lines 12-14, p. 30; Ex. 1009, U.S. App. No. 14/635,857, p. 66.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 12
`
`
`
`DAILY, WEEKLY, AND MONTHLY DOSAGE
`RANGES ARE NEARLY IDENTICAL
`
`Daily Ranges
`
`Weekly Ranges
`
`Monthly Ranges
`
`Days
`
`Range
`
`Weeks
`
`Range
`
`Months
`
`Range
`
`5
`
`6
`
`7
`
`8
`
`9
`
`50-500 mg
`
`60-600 mg
`
`70-700 mg
`
`80-800 mg
`
`90-900 mg
`
`10
`
`100-1000 mg
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`40-400 mg
`
`50-500 mg
`
`60-600 mg
`
`70-700 mg
`
`80-800 mg
`
`90-900 mg
`
`TOTAL RANGES: 10
`
`1
`
`2
`
`3
`
`40-300 mg
`
`80-600 mg
`
`120-900 mg
`
`Paper No. 19, Patent Owner’s Response, pp. 27-31; Ex. 1009, U.S. App. No. 14/635,857, pp. 66-67; Ex. 1003, U.S.
`Pat. No. 9,283,239 at col. 11:18-24, 11:64-12:3, 13:25-40.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 13
`
`
`
`BASED ON THE NEAR IDENTICAL DOSAGE RANGES FOR DAILY,
`WEEKLY, and MONTHLY ADMINISTRATION, a POSA would have
`readily recognized that the six-month cycle called out for the
`daily regimen could also apply to the weekly and monthly
`regimens.
`
`Paper No. 19, Patent Owner’s Response, pp. 34-37.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 14
`
`
`
`THE SPECIFICATION EXPRESSLY SUPPORTS
`BIANNUAL DOSING:
`
`50-500 mg given TWICE A YEAR, and
`100-500 mg given TWICE A YEAR
`
`• Confirms that the six-month period applies to similar or identical
`monthly and weekly dosage ranges.
`• Claim 1 (80-500 mg in six months) merely requires substitution of
`the 80 mg lower limit specified in the daily, weekly, and monthly
`ranges.
`
`Ex. 1003, U.S. Pat. No. 9,283,239 at col. 13:20-47.
`
`Paper No. 19, Patent Owner’s Response, pp. 13-14, 22; Ex. 1003, U.S. Pat. No. 9,283,239 at col. 13:20-47.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 15
`
`
`
`CONTRARY TO PETITIONERS’ ASSERTION, THE
`’239 PATENT HAS NUMEROUS BLAZE MARKS
`
`Paper No. 2, Petition for Post Grant Review, p. 22.
`
`Paper No. 19, Patent Owner’s Response, pp. 16-19; Ex. 1003, U.S. Pat. No. 9,283,239 at col. 10:40-64; Paper No. 2,
`Petition for Post Grant Review, p. 22.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 16
`
`
`
`"Blaze Marks" in Dose Ranges from Column 10, lines 40-64
`
`2100
`2000
`1900
`1800
`1700
`1600
`1500
`1400
`1300
`1200
`1100
`1000
`900
`800
`700
`600
`500
`400
`300
`200
`100
`0
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33
`
`Paper No. 19, Patent Owner’s Response, pp. 13-17, 36-37; Ex. 1003, U.S. Pat. No. 9,283,239 at col. 10:40-64.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 17
`
`
`
`PETITIONER ADMITS THAT THE SPECIFICATION
`EXPLICITLY DISCLOSES AN 800-900 MG DOSAGE
`
`Paper No. 2, Petition for Post Grant Review, p. 44.
`
`Ex. 1003, U.S. Pat. No. 9,283,239 at col. 18:50-54.
`
`As admitted by Petitioner, a monthly human dose of about 800-900 mg is disclosed in the
`specification. However, contrary to the Petition, this disclosure provides support for the
`about 80 to about 500 mg dosage claimed.
`
`Paper No. 19, Patent Owner’s response, pp. 23-26; Ex. 1003, U.S. Pat. No. 9,283,239 at col. 18:50-54;
`Paper No. 2, Petition for Post Grant Review, p. 44.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 18
`
`
`
`EXAMPLE 7 TAUGHT THAT IF THE DISODIUM SALT
`FORM IS USED, AN 800-900 MG DOSE IS
`REDUCED TO AN ABOUT 80-500 MG DOSE
`
`Ex. 1003, U.S. Pat. No. 9,283,239 at col. 20:16-33.
`Example 7 taught that if the disodium salt form of
`zoledronic acid is used, an 84% (or about 90%) to
`46% (or about 40%) lower dosage should be used.
`
`Ex. 1003, U.S. Pat. No. 9,283,239 at col. 10:40-64.
`
`The Specification further taught that if the
`disodium salt form of zoledronic is used, a 40% to
`90% lower dosage should be used.
`
`An 800 mg dose reduced by 90% is about 80 mg.
`An 800 mg dose reduced by 40% is about 480 mg (about 500 mg).
`Thus, the 800-900 mg dosage disclosed in Example 3, combined with the teachings of Example 7, discloses a
`dosage of about 80 to 500 mg for the disodium salt form of zoledronic acid.
`
`Paper No. 19, Patent Owner’s Response, pp. 25-26; Ex. 1003, U.S. Pat. No. 9,283,239 at col. 10:40-64, col. 20:16-33.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 19
`
`
`
`CONCLUSION: THE CLAIMS ARE NOT INVALID
`FOR LACK OF WRITTEN DESCRIPTION
`
`• The dosage range upper limit of 500 mg and lower limit of 80 mg are
`repeatedly supported by the disclosure.
`• The number of dosing ranges based on the original claims and
`specification are limited (10).
`• The six month period is one of only six time frames specified in the
`disclosure over which doses are to be administered.
`
`BASED ON THE DISCLOSURE, A POSA CAN READILY SEE
`THAT THE PATENTEE WAS IN POSSESSION OF THE CLAIMED
`INVENTION
`
`Paper No. 19, Patent Owner’s Response, p. 37.
`
`Patent Owner’s Demonstrative Exhibit
`Slide No. 20
`
`
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