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This is reply #2 from "the Board"

Anonymous

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RICHARD STORER, GILLES GOSSELIN, JEAN-PIERRE SOMMADOSSI, and PAOLA LACOLLA Senior Party (US 7,608,600 B2) __________________
Interference No. 105,981 (JGN) Technology Center 1600 ________________
Order—Request for Panel Rehearing—Bd.R. 125(c)(5) ________________
Before RICHARD E. SCHAFER, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge,
2
I. 1 Junior Party Jeremy Clark (“Clark”) has requested a rehearing by the panel 2 (hereinafter the “Request”1) of the Board’s Decision of April 17, 2014 (hereinafter 3 the “Decision”)2 which denied Clark’s request to have the interference redeclared 4 with Clark as senior party as premature and therefore not authorized. Clark’s 5 Request is DENIED. 6 7 II. 8 Clark argues that the Board, having decided that Clark was entitled to an 9 earlier benefit than Storer, entered judgment against Storer in interference 105,871 10 (the “’871 interference”). Request at 3. According to Clark, the Board concluded 11 that because Storer’s US Appl. Ser. No. 10/608,907 (the “S4 application”) did not 12 enable the skilled artisan to make 2´-fluoro-2´-methyl nucleosides, Storer should 13 be denied benefit of the S4 application for purposes of priority. Id. 14 Clark argues that the present interference’s count relates to a method for 15 treating HCV infection using nucleosides substituted at the 2´ position with both a 16 fluorine atom (“F”) in the “down” position and any of CH2F, CHF2, CF3, and 17 methyl in the “up” position. Request at 3-4 (citing Paper No. 1, Declaration, p. 18 3:16-17; Ex 2001, ¶¶ 43- 50; Ex 2003, ¶¶ 26, 28, 31-33, 40-42). 19 Clark now contends that because the ’907 application, which led to Storer’s 20 US Patent No. 7,608,600 B2 (the “’600 patent”) did not enable a person of 21 ordinary skill in the art to make the compounds of the prior count, it is not possible 22

1 Paper No. 354 2 Paper No. 351
3
for the ’600 patent—which is at issue in the present interference—to likewise 1 enable an artisan of ordinary skill how to use those identical compounds of the 2 prior count in methods of treating HCV infection. Id. Therefore, contends Clark, 3 Storer is not entitled to benefit of the ’907 application in the instant interference. 4 Id. 5 Clark asserts that the present interference’s count is not enabled by the ’907 6 application, which led to Storer’s ’600 patent in this interference, or by Storer’s 7 prior applications (US Prov. Appl. Ser. No. 60/392,350 filed June 28, 2002 (“S1”); 8 Provisional Appl. Ser. Nos. 60/466,194 filed April 28, 2003 (“S2”) or 60/470,949 9 filed May 14, 2003 (“S3”))3 for the same reasons as the Board decided in its ruling 10 in the first interference (i.e., the present count pertains to a method of using 11 compounds that encompass the compounds that were at issue in the first 12 interference, and, in particular, all compounds implicated by the count in the 13 present interference and the first interference have a 2´ “down” fluorine atom 14 bound to a tertiary carbon atom). Request at 4 (citing Ex 2001, ¶ 44; Ex 2005, p. 15 24:21-26.). 16 Accordingly, argues Clark, once the Board issued judgment in the ’871 17 interference on January 29, 20144, the instant interference should have been 18 redeclared to strip Storer of benefit of its earlier-filed applications (S1-S4), instead 19 of leaving the burden upon Clark to re-prove its case again. Therefore, Clark’s 20 request is not premature 21

3 Storer did not seek benefit of the S2 or S3 applications in the ’871 interference. Request at 2. 4 Interference 105,871, Paper No. 1008.
4
We do not agree. The ’871 interference determined that Storer’s S4 1 application failed to describe an embodiment within the scope of Count 1 of the 2 ’871 interference, and ordered that benefit accorded to Storer in the Declaration5 3 with respect to Storer’s S4 application be vacated. See Interference 105,871, Paper 4 No. 426, p. 25, ll. 16-21. Clark now asks the panel to unilaterally strip Storer of 5 benefit of the S4 application (as well as the S1-S2 applications) and redeclare the 6 interference with Clark as the senior party. This we decline to do at this time. 7 On February 5, 2014, the Board ordered Storer to show cause (the Show 8 Cause order”) why it should not be denied benefit of the S4 application.6 Storer 9 timely replied,7 and on April 11, 2014 the Board issued a decision finding that, 10 because Storer had filed an action seeking review under 35 U.S.C. § 146 of the 11 Board’s judgment in the ’871 interference in the U.S. District Court for the District 12 of Delaware, Storer had shown cause why it should not, at that time, be stripped of 13 the benefit of the ’907 application and have judgment entered against it.8 Clark’s 14 subsequent request for panel rehearing9 of the Board’s decision on the Show Cause 15 order was subsequently denied.10 16 On April 17, 2014, the Board issued an order authorizing the filing of 17 Clark’s Motions 1, 2, 3, and 10 and denied as premature Clark’s request that the 18

5 Interference 105,871, Paper No. 1 6 Paper No. 21.001 7 Paper No. 33 8 Paper No. 350 9 Paper No. 353 10 Paper No. 357
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interference redeclared with Clark as senior party for the reasons recited supra.11 1 Clark’s Motion. Clark’s Motions 1, 2, 3, and 10 seek to deny Storer benefit of its 2 applications S1-S4.12 Should Clark prevail on these Motions, the interference will 3 be redeclared as appropriate without the need for a request. Because Storer 4 succeeded in its response to the Show Cause order, and because Clark’s Motions 1, 5 2, 3, and 10 have not yet been fully litigated, there is no reason to redeclare the 6 interference at this time. Clark’s Request is DENIED. 7 8 III. 9 We have granted Clark’s Request to the extent that we have heard and 10 considered its arguments. However, for the reasons cited, we deny Clark’s request 11 to reverse the decision of the administrative patent judge. 12 13 IT IS SO ORDERED14
 




"According to Clark, the Board concluded that because Storer’s US Appl. Ser. No. 10/608,907 (the “S4 application”) did not enable the skilled artisan to make 2´-fluoro-2´-methyl nucleosides, Storer should be denied benefit of the S4 application for purposes of priority. Id. Clark argues that the present interference’s count relates to a method for 15 treating HCV infection using nucleosides substituted at the 2´ position with both a 16 fluorine atom (“F”) in the “down” position and any of CH2F, CHF2, CF3, and methyl in the “up” position"

The first BPAI board bought into this argument and denied Idenix their earlier patents.

As a chemist myself, I never bought into this for one second. It child's play to produce this molecule for "Those Skilled in the art" - in other words not even ordinary chemists but Nucleoside Chemists.

In my opinion, the was an excellent call by the second Interference Board and will result in a win for Idenix due to their earlier dated Conception and Patents.

Again, it takes balls to hold onto Gilead stock. Good Luck ( you will need it - if not now, then later)
 




Idenix will probably lose the fight on S1, but not on S1-3. They forgot the Sp diastereoisomer (the Flouro in the "down" position) on S1. They had the Rp isomer (the flouro in the "up" position.

Idenix corrected that mistake on all patents and patent applications thereafter including S2, S3 and S4

This Board "gets" it. So will the Jury.
 








"According to Clark, the Board concluded that because Storer’s US Appl. Ser. No. 10/608,907 (the “S4 application”) did not enable the skilled artisan to make 2´-fluoro-2´-methyl nucleosides, Storer should be denied benefit of the S4 application for purposes of priority. Id. Clark argues that the present interference’s count relates to a method for 15 treating HCV infection using nucleosides substituted at the 2´ position with both a 16 fluorine atom (“F”) in the “down” position and any of CH2F, CHF2, CF3, and methyl in the “up” position"

The first BPAI board bought into this argument and denied Idenix their earlier patents.

As a chemist myself, I never bought into this for one second. It child's play to produce this molecule for "Those Skilled in the art" - in other words not even ordinary chemists but Nucleoside Chemists.

In my opinion, the was an excellent call by the second Interference Board and will result in a win for Idenix due to their earlier dated Conception and Patents.

Again, it takes balls to hold onto Gilead stock. Good Luck ( you will need it - if not now, then later)

k... that's nice.

But Sommadossi asserts that its inventors conceived of an embodiment within the scope of the Count as of 18 December 2001, again on 23 July 2002, and reduced it to practice as of 25 March 2005 (Clark argues it was 2 June 2008)

This date is AFTER the filing date, 30 May 2003, of Clark’s accorded benefit application and, thus, after the date that Clark constructively reduced the invention to practice

So which exhibits show diligence until 2005?

Diligence
One who is the last to reduce the invention to practice but the first to conceive of the invention may establish priority by showing continuous and reasonable diligence (i.e., activities) towards reduction to practice, during the critical period from just before the other person’s conception until his own reduction to practice. Diligence is a stringent standard and most of the inventor’s time must be spent developing the invention. Constant effort is not required and the inventor need not spend all of his time working on the invention. But the inventor must account for the entire critical period by showing either activity aimed at reduction to practice or legally adequate excuses for the inactivity (e.g. reasonable delays in receiving ordered parts, purchasing capital equipment or requesting technical services). Most excuses for gaps in the record of invention will not be accepted within the diligence standard.
 




2 june 2008 is actually S5; It was Application No. 12/131,868

https://acts.uspto.gov/ifiling/disp...identifier=105871&tabSel=4&downloadChoice=pdf

There is about 45,000 pages of documents here. Actual lab books showing the actual chemists daily logs in making the 2' Flouro 2' Methyl. I just cant remember which one off the top of my head.

They will not need to show diligence through 2008 if S1 through S4 is "allowed" to be considered. It should be with this panel of judges. There is documented "diligence" all the way through to C1 and C2 which are Gilead's or Pharmasetts patents.

Great question though.
 




















I just found something delicious!!!! It is the first drawing of "sofosbuvir" well, not really because we all know the Sovaldi is the active molecule + a prodrug.

Ok, I found the first conceptual drawing of the key Molecule involved: The 2' Flouro 2' Methyl

Its found under exhibit #1250 Page 14021 ; Document #517

Its beautiful!!!!!!!!
 












The conception (unchallenged by Gilead by the way) is from a Novirio (the name before it changed to Idenix) Chemistry Discussion Meeting.

These happened regularly to discuss new concepts to "develop"; and also challenges and the like. Similar to company "strategy meetings"
 








2 june 2008 is actually S5; It was Application No. 12/131,868

https://acts.uspto.gov/ifiling/disp...identifier=105871&tabSel=4&downloadChoice=pdf

There is about 45,000 pages of documents here. Actual lab books showing the actual chemists daily logs in making the 2' Flouro 2' Methyl. I just cant remember which one off the top of my head.

They will not need to show diligence through 2008 if S1 through S4 is "allowed" to be considered. It should be with this panel of judges. There is documented "diligence" all the way through to C1 and C2 which are Gilead's or Pharmasetts patents.

Great question though.

Interesting! Thanks
 












I actually think this is overblown. If there was anything , even a smidgen of truth to any of this, the analysts would be all over it. Haven't seen one word. Must not anything to any of this. So sorry.