Ex Parte Reexamination

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Last thing I remember, I wasRunning for the doorI had to find the passage backTo the place I was before — Hotel CaliforniaBack in 2005, a third party requested ex parte patent reexamination of U.S. Patent 5,916,912 (90/007,626). The ‘912 Patent is assigned to the Regents of the University of California and relates to methods of enhancing mitochondrial metabolism without a concomitant increase in metabolic production of oxygen reactive species, using specific doses of a combination of carnitine, together with lipoic acid (or N-acetyl-cysteine.). During the patent reexamination the examiner confirmed a handful of claims, while rejecting claims 1,2, 4-7,9-11,16,17,20-23,26-29,37-40,43-47, and 50-54. The rejection of these claims was appealed to the BPAI, which affirmed the rejection on September 27,2010.Rather than proceeding to the CAFC, this past Monday, Regents sued the USPTO in the United States District Court for the District of Columbia. Readers may recall this tactic was tried last year in the case of Sigram Schindler Beteilungsgesellschaft mbH v. Kappos, No. 1:09-cv-935-TSE-IDD (E.D. Va.). This case was dismissed without reaching the question of the propriety of suing the USPTO in this manner. In a nutshell, the USPTO believes that Patent Owners in ex parte patent reexaminations filed on or after November 29, 1999 must proceed to the CAFC. Others (such as Sigram and Regents) believe the position of the USPTO is based on a misapplication of the law.So, what’s the big deal with bypassing the CAFC in favor of the DC District Court?The court is significant to patent owners because a civil suit against the USPTO in the district court results in de novo review of the BPAI decision and affords the patent owner an opportunity to take third party discovery and introduce new evidence to rebut the USPTO’s position. In many cases, Patentees are hoping to introduce new evidence to rebut a perceived change in the position of the USPTO. This is because the Patentee may be precluded to do so at the USPTO due to the late stage of the ex parte patent reexamination, or at the CAFC since the appeal record cannot be changed.So, is this “do-over” tactic legitimate?The dispute as to statutory interpretation relates primarily to 35 U.S.C. § 141 and 35 U.S.C. § 306, and changes brought about by the American Inventors Protection Act of 1999 (AIPA).The USPTO interprets Public Law 107-273, section 13202(d) (codified as 35 U.S.C. § 306), as prohibiting a patent owner in an ex parte reexamination from obtaining judicial review of a decision of the BPAI by filing a civil suit against the USPTO in federal district court. Under the USPTO interpretation, codified at 37 C.F.R. § 1.303 and discussed in MPEP § 2279, the patent owner may only seek judicial review in an ex parte reexamination filed on or after November 29, 1999, by appealing the decision of the BPAI to the Federal Circuit.Patentees argue that the USPTO’s attempt to regulate outside conduct is ultra vires, and at odds with the plain language of 35 U.S.C. § 306. The AIPA of 1999 introduced inter partes reexamination; there was no purpose to change any aspect of ex parte patent reexamination practices. Of course, the Public Law does use the loose language “any reexamination,” but this same language was added to 35 U.S.C. § 141 as it relates to inter partes patent reexamination.Curiously, in the Regents complaint (here), the reexamination is referred to as an “application” in paragraphs 6, 10 and 11.  Regents also goes as far in paragraph 11 to ask that the Director to “issue a patent.” I can only assume the use of this improper terminology is deliberate. For example, 35 U.S.C. § 141 and 145 primarily refer to “applicants” and “applications.” In patent reexamination there are no “applicants” only Patent Holders (See 35 U.S.C. § 134). Perhaps Regents is hoping to convince the court that the distinction is meaningless;  of course it is not. Anyone that has ever assumed that extensions of time in patent reexamination are a matter of right (under 37 CFR § 1.136) learns very quickly that this distinction is quite meaningful. (contrast with 37 CFR § 1.956)PPG Comment: There has to be predictability and finality to patent reexamination, otherwise the entire justification for its existence is eviscerated.  With pendencies of patent reexamination lasting several years (as evidenced by Regents, filed in 2005), further de novo review will just prolong an already lengthy proceeding.Certainly in the past, the PTO has been inconsistent in the treatment of new grounds of rejections on appeal, after final, etc., In such instances, I would agree that Patentees are at a disadvantage.  However, the solution to this problem is not to provide a new avenue for delay, abuse and expense, but to allow Director Kappos to right the ship—which he appears to be doing.  The newly proposed appeal rules address the concern of new grounds of rejection. If a Patentee fails to seasonably present evidence otherwise, a second bite at the apple is simply unwarranted.Note: The current patent reform bill, S.515, seeks to end the debate once and for all by expressely foreclosing district court actions for Patentees appealing an adverse ruling in ex parte patent reexamination.

Back in 2005, a third party requested ex parte patent reexamination of U.S. Patent 5,916,912 (90/007,626). The ‘912 Patent is assigned to the Regents of the University of California and relates to methods of enhancing mitochondrial metabolism without a concomitant increase in metabolic production of oxygen reactive species, using specific doses of a combination of carnitine, together with lipoic acid (or N-acetyl-cysteine.). During the patent reexamination the examiner confirmed a handful of claims, while rejecting claims 1,2, 4-7,9-11,16,17,20-23,26-29,37-40,43-47, and 50-54. The rejection of these claims was appealed to the BPAI, which affirmed the rejection on September 27,2010.

Rather than proceeding to the CAFC, this past Monday, Regents sued the USPTO in the United States District Court for the District of Columbia. Readers may recall this tactic was tried last year in the case of Sigram Schindler Beteilungsgesellschaft mbH v. Kappos, No. 1:09-cv-935-TSE-IDD (E.D. Va.). This case was dismissed without reaching the question of the propriety of suing the USPTO in this manner. In a nutshell, the USPTO believes that Patent Owners in ex parte patent reexaminations filed on or after November 29, 1999 must proceed to the CAFC. Others (such as Sigram and Regents) believe the position of the USPTO is based on a misapplication of the law.

So, what’s the big deal with bypassing the CAFC in favor of the DC District Court?

The court is significant to patent owners because a civil suit against the USPTO in the district court results in de novo review of the BPAI decision and affords the patent owner an opportunity to take third party discovery and introduce new evidence to rebut the USPTO’s position. In many cases, Patentees are hoping to introduce new evidence to rebut a perceived change in the position of the USPTO. This is because the Patentee may be precluded to do so at the USPTO due to the late stage of the ex parte patent reexamination, or at the CAFC since the appeal record cannot be changed.

So, is this “do-over” tactic legitimate?
Continue Reading Regents of the University of California Pursue New Patent Reexamination in District Court

64ChangingHorsesAs I noted last week, patents exit reexamination everyday. Most such occurrences pass without much notice to the public (aside from typical Business Wire fanfare manufactured by some Patent Owners). Yesterday was different, since the greatest invention EVER exited reexamination…no not the business method patent for the NFL Redzone Channel (probably doesn’t exist, but should), even better, the Tivo time warp patent, U.S. Patent 6,233,389….known to couch potatoes the world over as the “fast forward through commercials patent.”

This is the second go-round for the Tivo Patent in reexamination, now the subject of a very interesting dispute with Echo Star relating to a $300 million dollar judgment.

Although the NIRC is not yet posted to PAIR, it appears that claims 31 and 61 (the only claims subject to reexamination) were confirmed. Looking at the last response, the USPTO must have been convinced that the secondary indicia of non-obviousness for such a household name was persuasive; of course, there were technical distinctions made as well. Also apparent from the last response is that Tivo changed reexamination counsel once they received the final rejection.
Continue Reading Tivo’s Change in Horses Leads to Termination of Patent Reexamination

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Updated October 6th (see end of post)

While living dangerously, Star Scientific seems to have somehow avoided disaster. Although the petition decisions have not yet been posted to PAIR, a press release issued yesterday noted that the USPTO had revoked the NIRCs of May 12, 2010. (petitions granted-in-part). A revised press release seems to have issued later noting that the PTO was just “considering” reopening prosecution.

Back in May, we discussed Star’s submission of an interview agenda in place of an interview summary. (See 90/009,372 and 90/009,375). Subsequently, Star tried to convince the USPTO that the proposed agenda (which was submitted prior to the interview) actually was a summary of the the interview itself. On May 17, 2010, Star submitted the agenda again, with an expert declaration explaining that the PTO rules were satisfied by the interview agenda.

While the actual petition decisions are not yet available, it is clear that the PTO is accepting that Star submitted “something” thus avoiding termination (for now anyway), but is requiring Star either explain how the agenda reflects the actual discussion of the interview, or to petition for revival of the proceeding under 37 C.F.R. § 1.137 along with an actual interview summary. In their press release, Star reports the later action as the simple filing of a “routine petition”….which begs the question: Why didn’t Star just do that in the first place?
Continue Reading Star Scientific Avoids Termination of Patent Reexaminations

roadblockass=”alignleft size-full wp-image-3880″ title=”roadblock” src=”https://www.patentspostgrant.com/wp-content/uploads/2010/09/roadblock.jpg” alt=”roadblock” width=”203″ height=”144″ />This past Monday the BPAI pointed out that a Patent Holder may not swear behind a patent that claims the same invention, the proper forum for such a priority contest being a patent interference proceeding. The decision, Ex parte Regents of the University of California (“Regents”) (decision here), affirmed-in-part the rejection of U.S. patent No. 5,916,912 in ex parte reexamination.  In particular, the Board held that Regents could not antedate U.S. Patent No. 5,998,474 (“Cavazza”) because the ‘912 patent and Cavazza were claiming the same patentable invention. Applying, 37 C.F.R. 41.203(a), the Board reasoned that the two patents were directed to “the same patentable invention” since a claim of the Regents patent is obvious in view of a claim of Cavazza, and vice versa. This leaves the Regents in a bind, aside from challenging the BPAI decision to the CAFC, how can an interfering patent applied in patent reexamination be overcome?
Continue Reading What to do with an Interfering Patent in Patent Reexamination?

New Ex Parte Patent Reexamination Pilot Program a Tough Sell

Back in August, I reported on a new USPTO pilot program designed to decrease pendency in ex parte patent reexamination by seeking waiver of the right to file a Patent Owner Statement.

According to 2009 PTO statistics, Patent Owners filed statements in 10% of ex parte reexaminations. This is because filing of such a statement gives a Third Party a one-time rebuttal opportunity. Otherwise, Third Party participation is precluded by statute in ex parte reexamination. Therefore, by simply waiting for the Office to issue the first action, the Third Party is effectively silenced for the duration of the proceeding.

The new pilot program seeks to avoid the period of time the USPTO must wait to receive a Patent Owner Statement by requesting an early waiver of this right from the Patent Owner. Assuming the Patent Owner cooperates upon receiving notice of the initial request filing, the USPTO can reduce pendency by avoiding this front loaded, down time.

Since the program has been in operation for a few weeks now, it seemed like a good time to review the early results, and caution certain Patent Owners on how this seemingly trivial question of procedure may come back to haunt them. …
Continue Reading Waiver of Patent Owner Statement Disfavored in Ex Parte Patent Reexamination

Proposed Patent Reexamination Pilot Program Touted as Pro-Business

In Monday’s Federal Register, a pilot program entitled Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System was introduced (here). The notice requests comments from the public on a newly proposed enhancement to ex parte patent reexamination that would allow certain Patent Holders to advance to the head of the USPTO line. The Patent Holders qualifying for this enhanced treatment would be those “demonstrating humanitarian practices with patented technologies.”

The notice primarily presents 12 questions proposed to the public, seeking guidance on a test that would properly identify a humanitarian practice stemming from a subject patent. Specifically, comment is sought on weighting and filtering factors that would best define the “humanitarian use” and  “humanitarian research” definitions that would entitle a patent to consideration under the pilot program.

The proposal appears modeled after an FDA program that provides “vouchers” to such patent holders for advancing them to the front of that agencies review line. The PTO proposes a similar system in which the ex parte reexamination of such patents would be completed (excluding periods spent by the Patent Owner to respond) within 6 months.

The USPTO is to be applauded for their efforts to address real world business realities, yet, in this instance, I am left wondering if this proposed program can meet its stated goals.
Continue Reading Jumping to the Head of the Line in Ex Parte Patent Reexamination?

Estoppel of 35 USC § 317(b) Applies Only to Inter Partes Patent ReexaminationOne of the risks often associated with ex parte patent reexamination is that an outcome favorable to a patent holder is considered to “gold plate” a patent that is later asserted against the requester in district court, especially with respect to the same or similar art. This notion was tested recently in Crestron Electronics Inc. v. RGB Systems Inc., CV 09-8402 (CDCA).Crestron’s U.S. Design Patent D569,863 is asserted against RGB in the California District Court. RGB had earlier sought ex parte reexamination of the same patent based upon the same prior art now applied in the district court proceeding. Not surprisingly, Crestron noted that the reexamination attempt based on the same art now before the district court had failed to invalidate the patent. In other words, without any presumption of validity, and the ability to invalidate the patent by a mere preponderance of the evidence, RGB failed. Thus, Crestron argued that the reexamination results should preclude an invalidity defense on the same art. The court decided that not only can RGB argue the same invalidity positions over again, but that the court need not even show deference to the reexamination results.More specifically, the court sided with RGB’s argument that:…a district court must make its own validity determination and may not rubberstamp the PTO’s reexamination decision. E.g. Quad Environmental Tech. Corp. v. Union Sanitary Dist., 946 F.2d 870, 876 (Fed. Cir. 1991) (“The courts are the final arbiter of patent validity and, although courts may take cognizance of, and benefit from, the proceedings before the patent examiner, the question is ultimately for the courts to decide, without deference to the rulings of the patent examiner.”).PPG Comment: Part of the problem with reading Quad Environmental so extensively is that the facts are quite distinguishable. While Quad also dealt with the issue of an earlier concluded reexamination on some of the same art, the key invalidity issue before the Quad Court related to public use evidence not considered in the concluded reexamination. Thus, it is quite clear why the Quad Court concluded that the earlier reexamination was not to be accorded deference, and why the Court must do their own validity analysis in most cases. However, here where the art and issues are identical, and RGB failed to prove invalidity under much more liberal USPTO standards, some deference seems appropriate. To be sure, courts often cite to the potential results of patent reexamination to justify staying a case, yet when given the opportunity to actually conserve judicial resources based on such results………Of course, inter partes reexamination remedies this dilemma by operation of statutory estoppel (317 (b

One of the risks often associated with ex parte patent reexamination is that an outcome favorable to a patent holder is considered to “gold plate” a patent that is later asserted against the requester in district court, especially with respect to the same or similar art. This notion was tested recently in Crestron Electronics Inc. v. RGB Systems Inc., CV 09-8402 (CDCA).

Crestron’s U.S. Design Patent D569,863 is asserted against RGB in the California District Court. RGB had earlier sought ex parte reexamination of the same patent based upon the same prior art now applied in the district court proceeding. Not surprisingly, Crestron noted that the reexamination attempt based on the same art now before the district court had failed to invalidate the patent. In other words, without any presumption of validity, and the ability to invalidate the patent by a mere preponderance of the evidence, RGB failed. Thus, Crestron argued that the reexamination results should preclude an invalidity defense on the same art. The court decided that not only can RGB argue the same invalidity positions over again, but that the court need not even show deference to the reexamination results.
Continue Reading Concluded Ex Parte Reexamination Results Ignored by District Court?

speedYesterday, the USPTO announced a pilot program, effective immediately, aimed at reducing the pendency of ex parte patent reexamination. The program entitled “Pilot Program for Waiver of Patent Owner’s Statement in Ex Parte reexamination Proceedings” will be triggered once a new ex parte reexamination request is accorded an initial filing date.

In devising the pilot program, the USPTO has explained that only 10% of Patent Holder’s take advantage of the opportunity to submit a Patent Owner statement. (Inter Partes Reexamination does not provide for Patent Owner’s Statements). The reason behind the lack of enthusiasm in filing Patent Owner statements is that the filing of such a statement entitles the Third Party to a rebuttal. Outside of the filing of such a statement, Third Party participation in ex parte reexamination is precluded by statute. Therefore, simply waiting for the Office to issue the first action effectively silences the Third Party for the remainder of the proceeding.

The Federal Register Notice explains that the new pilot program will seek to reduce overall pendency by cutting out this front loaded, dead time found in 90% of ex parte reexaminations. [T]he USPTO will contact the patent owner and request the optional waiver of the right to file a patent owner’s statement after the proceeding has been granted a filing date and before the examiner begins his or her review. This will enable the USPTO in suitable cases to issue the first Office action on the merits (including an NIRC) together with or soon after the order for reexamination, and thereby reduce the pendency of the proceeding by about three to five months.

This pilot program is a very positive step, and makes perfect procedural sense. The USPTO is to be commended for attempting to tackle the pendency issue. Yet, I expect that few Patent Holders, given the chance, will take advantage of the program.
Continue Reading USPTO Pilot Program Announced to Accelerate Ex Parte Patent Reexamination

080526155300-largeass=”alignleft” src=”http://www.bioresearchnews.com/wp-content/uploads/2009/09/080526155300-large-300×225.jpg” alt=”080526155300-large” width=”213″ height=”185″ />The USPTO has recently upheld Genetic Technologies Ltd.’s (GTG’s) patent for non-coding DNA technologies.  U.S. Patent No. 5,612,179 titled “Intron sequence analysis method for detection of adjacent locus alleles as haplotypes” claims a method for facilitating the detection of specific gene variations.

The third party initiated ex parte re-examination Control No. 90/010,318, was filed on October, 15, 2008 requesting that each of claims 26-32 be found invalid in view of a new reference, which was not previously cited in the prosecution of the ‘179 patent; namely a printed publication titled “Comparison of Multiple HLA-A Alleles at the DNA Level by Using Southern Blotting and HLAA-A-Specific Probes” by Beverly Koller et al. (“Koller I”).  The request submitted that Koller I raised a substantial new question of patentability and renders claims 26-30 and 32 of the ‘179 patent invalid as anticipated under § 102(b) and claim 31 invalid under § 103(a).  The request further argued that Koller I discloses characterizing the alleles of the multi-allelic HLA-A genetic locus using polymorphisms found in non-coding regions of that locus, including polymorphisms in introns and polymorphisms in flanking regions of the HLA-A locus.

In a reply filed July 24, 2009, GTG argued
Continue Reading Genetic Technologies Ltd.’s Non-coding DNA Patent Upheld on Reexamination

80px-Baseball_umpire_2004ass=”alignleft size-full wp-image-3003″ title=”80px-Baseball_umpire_2004″ src=”https://www.patentspostgrant.com/wp-content/uploads/2010/07/80px-Baseball_umpire_2004.jpg” alt=”80px-Baseball_umpire_2004″ width=”80″ height=”120″ />In the world of pharmaceuticals, every day counts.  Indeed, when the subject matter is a block-buster drug like Bristol-Myers/Sanofi’s anti-blood clot drug Plavix® every day of U.S. sales averages nearly $15.5 million dollars (reported U.S. sales for 2009 of $5.6 billion).  So, it comes as no surprise that Apotex Inc., a Canadian manufacturer of a generic version of the drug, refuses to sit on the side-lines waiting for the Plavix® patent (U.S. 4,847,265) to expire.  However, the playing field has not been so kind to Apotex.
Continue Reading Three Strikes, You’re Out!? Apotex’s Latest Attempt to Invalidate the PLAVIX® Patent Denied by USPTO