UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________________
`
`
`RIMFROST AS
`Petitioner,
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS
`Patent Owner.
`
`____________________________
`
`Case IPR2018-01730
`
`U.S Patent No. 9,072,752
`
`_______________________
`
`
`
`PATENT OWNER’S REPLY TO PETITIONER’S OPPOSITION
`TO MOTION TO AMEND CLAIMS
`
`
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________________
`
`
`RIMFROST AS
`Petitioner,
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS
`Patent Owner.
`
`____________________________
`
`Case IPR2018-01730
`
`U.S Patent No. 9,072,752
`
`_______________________
`
`
`
`PATENT OWNER’S REPLY TO PETITIONER’S OPPOSITION
`TO MOTION TO AMEND CLAIMS
`
`
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`IPR2018-01730
`U.S. Patent No. 9,072,752
`
`TABLE OF CONTENTS
`Introduction ........................................................................................... 1
`
`I.
`
`II.
`
`The contingent amended claims are not obvious .................................. 2
`Catchpole does not teach the claimed ether phospholipid
`A.
`range or how to achieve it ..................................................................... 2
`Enzymotec does not provide the claimed ether
`B.
`phospholipid range ...................................................................... 8
`The cited references do not teach or suggest the 100 to
`C.
`700 mg/kg astaxanthin ester range ...................................................... 10
`CERTIFICATE OF SERVICE ......................................................................... i
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`1
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`I.
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`IPR2018-01730
`U.S. Patent No. 9,072,752
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`Introduction
`Petitioner asserts that contingent amended claims 21-29 are obvious as
`
`follows:
`
`Ground 1. Claims 21 and 24-27 are obvious over Catchpole, Sampalis II,
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`NKO and Randolph;
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`Ground 2. Claims 22-23, 25, and 28-29 are obvious over Catchpole,
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`Enzymotec, Sampalis II, NKO and Randolph; and
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`Ground 3. Claims 21-29 are obvious over Catchpole, Enzymotec,
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`Sampalis II, NKO and Randolph.
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`It is undisputed that none of the references teach krill oil compositions
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`containing from 6% to 10% ether phospholipids as claimed. Faced with this
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`deficiency, Petitioner makes two main arguments. With respect to Grounds 1 and
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`2, Petitioner alleges that Catchpole teaches that extraction conditions can be
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`changed to achieve the claimed range 6-10% ether phospholipids. Petitioner’s
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`Opposition to MTA (“Oppo.”) at 5, 6-8, 16-17. With respect to Ground 3,
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`Petitioner alleges the ether phospholipid percentage obtained in Catchpole can be
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`used to calculate the ether phospholipid content of the Enzymotec Grade B krill oil
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`which would then be within the claimed 6-10% range. Oppo. at 9, 24-25. As
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`shown below, the data in Catchpole does not support these arguments and
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`establishes that 1) there is a missing element with respect to the claimed ether
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`1
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`phospholipid range because the combined references do not teach each element of
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`IPR2018-01730
`U.S. Patent No. 9,072,752
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`the claims and 2) there is no reasonable expectation of success in obtaining a krill
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`oil with from 6-10% ether phospholipids. Furthermore, with respect to all three
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`proposed Grounds, a POSITA would not combine the references cited to provide
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`the astaxanthin ester range (i.e., NKO, Sampalis II and Randolph) to arrive at the
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`claimed range of from 100 to 700 mg/kg astaxanthin esters.
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`II. The contingent amended claims are not obvious
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`A. Catchpole does not teach the claimed ether phospholipid range or how
`to achieve it
`Grounds 1 and 2 both rely on Catchpole for the 6 to 10% ether phospholipid
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`limitation. It is undisputed that Catchpole contains a single example of a krill oil
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`that contains 4.8% ether phospholipids. There is a missing element because
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`Catchpole does not disclose the claimed ether phospholipid range for a krill oil. As
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`indicated by the Board in the Institution Decision, there is no basis to conclude that
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`the broader ranges mentioned in Catchpole apply to krill oil as opposed to the
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`virtually unlimited number of source materials identified in Catchpole. Institution
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`Decision at 11-12.
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`Furthermore, Petitioner’s arguments that a POSITA could manipulate
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`extraction conditions to arrive at the claimed range of ether phospholipids are
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`based on hindsight and undercut by the data in Catchpole which demonstrates that
`2
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`there is no reasonable expectation of success for arriving at the 6-10% ether
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`IPR2018-01730
`U.S. Patent No. 9,072,752
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`phospholipid range based on the combined references. Specifically, Petitioner
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`argues that “a POSITA desiring an extract with 6% to 10% ether phospholipids
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`would have selected one of the three marine animals, such as krill, in Example 18
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`and applied Catchpole’s recited extraction methodology.” Oppo. at 5. According
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`to Petitioner, increasing the solvent concentration to at least 20% will increase the
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`percentage of extracted phospholipids. Opp. at 5.
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`As a preliminary matter, the “three marine animals” in Catchpole are Hoki
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`head lipid extract (Example 12, Ex. 1009 at 20), green-lipped mussel lipid extract
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`(Example 17, Ex. 1009 at 23), and freeze-dried krill powder (Example 18, Ex.
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`1009 at 24). The Hoki head example utilized 31% ethanol in the second extraction
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`step and produced an extract containing 1.6% ether phospholipids. Id. at 21, Table
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`11). The green-lipped mussel example used 30.5% ethanol in the second extraction
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`step and produced an extract containing 0.9% ether phospholipids. Id. at 23, Table
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`15. The krill example used 11% ethanol in the second extraction step and produced
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`an extract containing 4.8% ether phospholipids. Id. at 24, Table 16.
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`Without the benefit of hindsight, viewing this data as a whole indicates to a
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`POSITA that there is no reasonable expectation of success in arriving at the
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`claimed ether phospholipid range from the three marine animals exemplified in
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`Catchpole. In fact, while the Hoki head example used 31% ethanol and a feed
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`3
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`material with higher starting levels of PC and AAPC as compared to the krill feed
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`U.S. Patent No. 9,072,752
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`material, the resulting extract had lower levels of PC and AAPC as can be seen by
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`comparing Tables 11 (Hoki head extract) and 16 (Krill extract) from Catchpole.
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`These data certainly cast doubt on whether increasing the ethanol co-solvent to
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`above 20% in the krill extraction would actually increase the amount ether
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`phospholipids. See Ex. 2025 (Hoem Decl.) ¶¶6-7.
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`Relying on Examples 7 and 8 of Catchpole, Petitioner further argues that
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`“extraction conditions (i.e., duration, temperature, pressure, solvents and solvent
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`concentration) could be varied depending upon the desired extract composition and
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`purity.” Oppo. at 7. Notably, Petitioner does not cite the teaching in Catchpole that
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`in addition to those factors, feed material and feed preparation also affect the
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`“operation of the process.” See Ex. 1009 at 11, lines 11-12.
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`Examples 7 and 8 describe extractions from “dairy lipid extract B” using
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`either 10% or 30% ethanol in the second step following a first step using neat CO2
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`to extract neutral lipids. Ex. 1009 at 18-19. The amount of phosphatidylcholine
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`extracted with 30% ethanol in Example 8 (22.5%, Table 8) was greater than that
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`obtained with 10% ethanol in Example 7 (4.5%, Table 7). In contrast, Example 10
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`describes a similar extraction on a different source material, egg yolk lecithin,
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`using 25% ethanol in the second extraction step following a first step using neat
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`CO2 to extract neutral lipids. Ex. 1009 at 19-20. The feed material contained
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`4
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`56.4% phosphatidylcholine while the extract contained using 25% ethanol
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`U.S. Patent No. 9,072,752
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`contained 43.5% phosphatidylcholine. Ex. 1009 at 20, Table 9. Thus, in direct
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`contrast to Example 8, the percentage amount of phosphatidylcholine in the 25%
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`ethanol extract actually decreased as compared to the feed material. See Ex. 2025
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`(Hoem Decl.) ¶¶4-5.
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`This data, especially when considered in conjunction with the Hoki head and
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`green-lipped mussel examples, clearly indicates to a POSITA that the effect of
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`increasing the co-solvent concentration does not necessarily increase the weight
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`percentage of phospholipids such as phosphatidylcholine and ether phospholipids
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`in extracts. Instead, this data demonstrates to a POSITA that the effect of changing
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`extraction conditions such as co-solvent percentage with respect to a feed material
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`is unpredictable. See Ex. 2025 (Hoem Decl.) ¶¶4-7. The only way that a POSITA
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`would arrive at the conclusion that the claimed ether phospholipid range could be
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`achieved by changing conditions such as co-solvent concentration is via hindsight.
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`The hindsight bias of Petitioner is confirmed by its inappropriate reliance on data
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`from the ‘752 patent itself for results obtained with a 23% ethanol co-solvent.
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`Oppo. at 5.
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`Petitioner further argues that the Board’s conclusions in the ‘295 IPR Final
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`Written Decision are pertinent to the amended claims. Oppo. at 5-6. However, the
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`Board’s finding relied in part on the fact that the specific example (Example 18)
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`5
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`provided in Catchpole taught an ether phospholipid content (4.8%) that was
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`U.S. Patent No. 9,072,752
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`adjacent to the range claimed in that case (5-8% ether phospholipids). Here, the
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`range is not adjacent. Increasing the 4.8% ether phospholipid content observed in
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`Example 18 of Catchpole to 6 to 10% as required by the amended claims would
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`require an increase of 1.2 weight% or an overall increase of 20% in relative terms
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`(i.e., an ether phospholipid content of 6% represents a 20% increase over an ether
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`phospholipid content of 4.8%).
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`Grounds 1 and 2 both rely on Catchpole for the ether phospholipid range of
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`6-10%. Oppo. at 16-17. As discussed above, a POSITA would conclude that there
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`is no reasonable expectation of success in arriving at the claimed ether
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`phospholipid range of from 6 to 10% based on Catchpole in combination with the
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`other references. Specifically, the data in Catchpole demonstrate that the amount of
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`ether phospholipids actually obtained in extracts from marine animals such as krill
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`varied from 0.9% in green-lipped mussel extract to 4.8% in krill extracts. The
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`green-lipped mussel extract was obtained with a 30.5% ethanol extraction step
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`while the krill extract was obtained with an 11% ethanol extraction step. The data
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`in Catchpole further shows that when a 25% ethanol extraction step was used on
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`egg lecithin, the amount of phosphatidylcholine in the extract was lower than in the
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`feed material. These data demonstrate that the impact of different extraction
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`6
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`conditions on different starting materials in unpredictable. See Ex. 2025 (Hoem
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`U.S. Patent No. 9,072,752
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`Decl.) ¶¶4-7, 15.
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`Petitioner’s hindsight bias is further demonstrated by statements in Dr.
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`Tallon’s Reply Declaration (Ex. 1086). Dr. Tallon states that using 3% ethanol in
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`place of neat CO2 would increase neutral lipid extraction in step 1 and thus
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`increase ether phospholipid content in Extract 2. Example 9 indicates that
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`conducting a first step with 3% ethanol resulted in extraction of 90% neutral lipids.
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`However, Dr. Tallon admitted that step 1 of Example 18 (krill) removed 88% of
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`neutral lipids. Tallon Depo., Ex. 2026 at 26:5-22. It is not believable that the 2%
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`difference would have a meaningful impact on ether phospholipid content of
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`Extract 2. See Ex. 2025 (Hoem Decl.) ¶¶12-14. It is hindsight to use the types of
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`calculations used by Dr. Tallon to goal seek particular claimed ranges and ignore
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`calculation that do not support his position.
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`Finally, the data in Catchpole is seriously flawed. As detailed by Dr. Hoem
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`examples in Catchpole (see, e.g., Examples 11 and 12) disclose that the ethanol co-
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`solvent extract and residue material contained more PC and AAPC on a weight
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`basis than the feed material. See Ex. 2025 (Hoem Decl.) ¶¶8-11. This is not
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`possible and indicates systemic problems with either data analysis or reporting. In
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`fact, during cross examination, Dr. Tallon confirmed that increasing the mass of
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`phospholipids in the extract as compared to the feed material is impossible. Tallon
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`7
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`Depo, Ex. 2026, 21:22-22:4; 23:7-22. As a result, a POSITA would not trust any of
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`IPR2018-01730
`U.S. Patent No. 9,072,752
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`the results reported in Catchpole. Id. at 11.
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`In summary, when the data in Catchpole is considered as a whole, there
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`would be no motivation to combine the references and no reasonable expectation
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`of success in arriving at the claimed krill oil extract based on the combined
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`referenced in Grounds 1 and 2.
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`B.
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`Enzymotec does not provide the claimed ether phospholipid range
`In Ground 3, Petitioner apparently argues that Enzymotec provides the 6-
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`10% ether phospholipid range. Oppo. at 24-25. Petitioner relies on Dr. Tallon’s
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`opinion that Ezymotec’s Grade B krill extract contained from 8 – 9.7% ether
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`phospholipids and “satisfies the proposed ether phospholipid claim limitation.” Id.
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`At its heart, this is an inherency argument. The use of inherency in an obviousness
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`context “must be carefully circumscribed.” PAR Pharm. Inc. v. TWI Pharms., Inc.,
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`773 F.3d 1186, 1195 (Fed Cir. 2014). To support a conclusion that a property is
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`inherent, it must be shown that the property is necessarily present. In re Robertson,
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`169 F.3d 743, 745 (Fed. Cir. 1999).
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`Applying these holdings to this case, Petitioner must show that the claimed
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`range of 6-10% ether phospholipids was necessarily present in the Enzymotec
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`Grade B krill extract. Petitioner has fallen fall short of this standard. First,
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`Catchpole expressly teaches that its extraction method resulted in a krill extract
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`8
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`that was “highly enriched” for alkylacylphosphatidylcholine (“AAPC”). Ex. 1009
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`U.S. Patent No. 9,072,752
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`at 24; see also Ex. 2001 (Hoem Decl.) ¶132. There is no evidence that the
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`extraction methods used by Enzymotec, if they were known, would result in
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`similar concentration of AAPC. See Motion to Amend (“MTA”) at 16; Ex. 2001
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`¶132. As a result, there is no basis for a POSITA to conclude that the ether
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`phospholipid levels observed in Catchpole Extract 2 could be used estimate the
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`ether phospholipid levels of the Enzymotec Grade B krill lecithin. Ex. 2001 (Hoem
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`Decl.) ¶¶133. The evidence of record certainly does not establish that Enzymotec
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`Grade B krill extract necessarily contained from 6-10% ether phospholipids.
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`Petitioner appears to further rely on the argument that “extraction conditions
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`could be modified as taught by Catchpole to change the composition and purity of
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`the resulting extract.” Oppo. at 9. This argument is the same as discussed above in
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`Section II.a. with respect to Examples 8 and 9 of Catchpole. As established above,
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`other examples in Catchpole demonstrate that utilizing from 20 to 30% ethanol co-
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`solvent in the second extraction step either result in extracts with very low levels of
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`ether phospholipids (see Examples 12 and 17 of Catchpole) or can actually
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`decrease the amount of phosphatidylcholine as compared to the feed material (see
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`Example 10 of Catchpole). Ex. 2025 (Hoem Decl.) ¶¶4-7, 15. These data
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`demonstrate the unpredictability of how different extraction conditions will impact
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`phospholipid extraction from different feed materials. Id. Thus, Ground 3 fails
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`9
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`because the combined references do not provide a reasonable expectation of
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`IPR2018-01730
`U.S. Patent No. 9,072,752
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`success in achieving a krill oil with from 6-10% ether phospholipids and because
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`the claimed range of ether phospholipids is not necessarily present in the
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`Enzymotec Grade B krill extract.
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`The cited references do not teach or suggest the 100 to 700 mg/kg
`C.
`astaxanthin ester range
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`In each of the three asserted Grounds, Petitioner relies on NKO, Randolph
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`and Sampalis II to provide the claim limitation of from 100 to 700 mg/kg
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`astaxanthin esters.1 With respect to NKO, the Board has already found that NKO
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`does not provide the claimed range of 100 to 700 mg/kg astaxanthin esters.
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`IPR2018-00295, Paper 35 at 66-67. References cited by Petitioner clearly establish
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`that NKO contained greater than 1500 mg/kg astaxanthin esters. Ex. 2025, ¶16; see
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`Ex. 1070, 1071 and 1075, p. 0010. Moreover, obviousness cannot be predicated on
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`what is not known at the time an invention is made, even if the inherency of a
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`certain feature is later established. See, In re Newell, 891 F.2d 899, 901 (Fed. Cir.
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`1989). The alleged admission was not known to a POSITA. There can be no
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`1 Patent Owner notes that a Request for Rehearing is pending in IPR2018-00295 in
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`regard to the contingent motion to amend claims with respect to the astaxanthin
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`ester limitation and that collateral estoppel may apply depending on the outcome.
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`10
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`motivation to combine the astaxanthin ester ranges from Patent Owner’s own
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`IPR2018-01730
`U.S. Patent No. 9,072,752
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`specification with the other cited references, let alone for achieving the ranges of
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`each of the claimed components.
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`Randolph also does not provide the astaxanthin ester range as discussed in
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`detail by Dr. Hoem. Ex. 2025, ¶¶17-19. First, the passages relied on by Petitioner
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`teach that a composition can contain any amount of astaxanthin, not that krill oil
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`can contain any amount of astaxanthin. Id. The compositions of Randolph can
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`contain more than 25 ingredients, one of which can be krill oil, and further indicate
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`that astaxanthin can come other sources. Id., see Ex. 1013 at [0021]. The krill oil
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`content in listed in [0040] of Randolph (i.e., 300 mg and about 3000 mg of a krill
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`oil ingredient) is not related to the astaxanthin content of the composition as a
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`whole listed in [0044] Randolph (i.e., 0.5 mg and about 50 mg of an astaxanthin
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`ingredient). Id. Second, even assuming those ranges can be combined, Dr.
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`Tallon’s calculations cherry pick the high end of the first range (3000 mg krill oil)
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`and the low end of second range (0.5 mg astaxanthin) in order to arrive at the
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`claimed range. A POSITA would not combine the ranges in this manner. Ex.
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`2025, ¶15.
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`Finally, as detailed by Dr. Hoem, a POSITA would not derive the claimed
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`astaxanthin ester range from Sampalis II. Ex. 2025, ¶¶20-22. First, the first
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`passage relied on by Petitioner at l. 1-7, p. 0032 of Sampalis II refers to the content
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`11
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`of antioxidants in general and states that they can be present at levels greater than
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`IPR2018-01730
`U.S. Patent No. 9,072,752
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`20 or 200 mg/ml. This passage does not state that astaxanthin is present at those
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`levels. Second, the astaxanthin values listed in Table 5 of Sampalis II would be
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`discredited by a POSITA. Ex. 2025, ¶21. Table 5 lists both canthaxanthin and
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`flavonoids as being present in the krill extract. A POSITA would recognize that
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`this is impossible because as disclosed in Grynbaum, which has been cited by
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`Petitioner in these proceedings, the only carotenoid present in krill is astaxanthin.
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`Ex. 1039 at 0008. This would indicate to a POSITA that however those values
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`were determined, they cannot be trusted because of the inclusion of compounds
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`that cannot be present in a krill extract. Ex. 2025, ¶21. Third, Sampalis II
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`discloses that the claimed product is NKO and discloses the same production
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`process as used in the NKO GRAS submission (Ex. 1075) which would be
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`understood to provide at least 1500 mg/kg astaxanthin esters. Id. at ¶¶16, 22.
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`It is respectfully submitted that the contingent amended claims are
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`Respectfully submitted,
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`By: /David A. Casimir/
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`patentable.
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`Dated: October 18, 2019
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`IPR2018-01730
`U.S. Patent No. 9,072,752
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that on this 18th day of October 2019, a
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`copy of the foregoing PATENT OWNER’S REPLY TO PETITIONER’S
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`OPPOSITION TO MOTION TO AMEND CLAIMS, Exhibit List and
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`Exhibits 2025 and 2026 were served in their entirety electronically (as consented
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`to by Petitioner) to the attorneys of record as follows:
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`James F. Harrington
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`Reg. No. 44,741
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`Hoffmann & Baron, LLP
`jfhdocket@hbiplaw.com
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`Ronald J. Baron
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`Reg. No. 29,281
`Hoffman & Baron, LLP
`rjbdocket@hbiplaw.com
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`453ipr@hbiplaw.com
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`Michael I. Chakansky
`Reg. No. 31,600
`Hoffman & Baron, LLP
`micdocket@hbiplaw.com
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`John T. Gallagher
`Reg. No. 35,516
`Hoffman & Baron, LLP
`jtgdocket@hbiplaw.com
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`By: /David A. Casimir/
`David A. Casimir, Ph.D.
`Registration No. 42,395
`Counsel for Patent Owner
`CASIMIR JONES, S.C.
`2275 Deming Way
`Suite 310
`Middleton, Wisconsin 53562
`(608) 662-1277
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