Patent Baristas

AstraZeneca’s patent on Toprol-XL® was found invalid after the CAFC affirmed a district court’s invalidity holding based on double patenting but vacated the district court’s inequitable conduct holding and remanded the case to see if the patent and another one should be held unenforceable. In re Metoprolol Succinate Patent Litigation, United States Court of Appeals for the Federal Circuit, No. 06-1254.

Make no mistake about it. This is a story that has an abundance of human drama, which manifests itself in great suffering around the world. Roughly 40 million people worldwide are infected with HIV/AIDS, including more than 1.2 million Americans.

These numbers have meaning that numbers cannot convey. The meaning emerges in the stories of individuals, families and whole societies devastated by HIV/AIDS throughout the world. This is also a story that scares the bejeebers out of the patent community and all patent holders when filing provisional patent applications.

In another challenge to patents it just doesn’t like, the nonprofit organization Public Patent Foundation (PUBPAT) got the U.S. Patent and Trademark Office (USPTO) to grant a request for reexamination of four key HIV/AIDS drug patents held by Gilead Sciences Inc. PUBPAT seems to be on a roll after successfully getting reexams of patents on Pfizer’s Lipitor and WARF’s stem cells.

PUBPAT requested ex parte reexamination under 35 U.S.C. §§ 302-307 and 37 C.F.R. § 1.510 claiming they are all invalid under 35 U.S.C. §§102 and 103 and their existence is causing significant public harm and impeding scientific progress.

The patents challenged by PUBPAT, U.S. Patents Nos. 5,922,695, 5,935,946, 5,977,089 and 6,043,230, relate to the drug known generically as tenofovir disoproxil fumarate (TDF). Tenofovir disoproxil fumarate (also referred to as TDF or bis(POC)PMPA fumarate) is a nucleotide analog reverse transcriptase inhibitor (NtRTI) that is a significant treatment for HIV/AIDS patients. Gilead markets TDF in the United States under the brand name Viread and as a part of its Atripla combination product.

The Patent Office has now ordered reexamination of all four patents.

The ‘695 patent claims compounds comprising esters of antiviral phosphonomethoxy nucleotide analogs with carbonates and/or carbamates, which are useful as intermediates for the preparation of PMPA. The ‘695 patent also claims methods of orally administering such phosphonomethoxy nucleotide analogs to patients infected with HIV.

The ‘089 patent claims (R)bis(POC)PMPA, compositions comprising (R)bis(POC)PMPA and a pharmaceutically acceptable carrier, and a method comprising orally administering to a patient infected with virus or at risk to viral infection a therapeutically effective amount of (R)bis(POC)PMPA.

The ‘230 patent claims a method of contacting a cell with an antiviral phosphonomethoxy nucleotide analog prodrug.

The ‘946 patent claims TDF, methods of making TDF and tablets containing TDF.

In order to have a reexamination declared, there must be a “substantial new question of patentability” present, which means that it is only necessary that:

(a) The prior art patents and/or printed publications raise a substantial question of patentability regarding at least one claim, i.e., the teaching of the (prior art) patents and printed publications is such that a reasonable examiner would consider the teaching to be important in deciding whether or not the claim is patentable; and

(b) The same question of patentability as to the claim has not been decided by the Office in a previous examination or pending reexamination of the patent or in a final holding of in validity by the Federal Courts in a decision on the merits involving the claim, see MPEP 2242, (I).

It is not necessary that a “prima facie” case of unpatentability exist as to the claim in order for “a substantial new question of patentability” to be present as to the claim.

Mainly, PUBPAT claims that these patents are anticipated or rendered obvious by Gilead’s own patent (U.S. Patent No. 5,922,695 issued to Arimilli et al. on July 13, 1999) and/or the prior art reference by Bischofberger et al., “Bis(POC)PMPA, an Orally Bioavailable Prodrug of the Antiretroviral Agent PMPA,” Conference on Retroviruses and Opportunistic Infections, 4th:104 (abstract no. 214) (January 2226, 1997), among others.

In addition, PUBPAT claims that these patents were also obvious in light of other prior art teachings that PMPA and bis(POC)PMPA were strong treatments for HIV and that bis(POC)PMPA fumerate would have been expected to have superior properties over free base bis(POC)PMPA. PMPA and bis(POC)PMPA were well known treatments for HIV

In a matter that really highlights the dangers of filing a provisional patent application without drafting a full application without all the details, PUBPAT points out that references can now be used against the patents where the documents published after the provisional — later than first thought.

The ‘230 and ‘695 patent claim priority to a provisional application, U.S. Appl. No. 60/022,708, filed July 26, 1996. However, PUBPAT argued, and the USPTO agreed, that the claims of these two patents are not entitled to claim priority to the ‘708 application’s July 26, 1996, filing date, because the ‘708 application’s specification was not sufficient to satisfy the written description requirement of 35 U.S.C. § 112. In the case of the ‘089 and ‘946 patents, the USPTO found that sufficient written description existed to support priority back to the ‘708 provisional.

A filing date will be accorded to a provisional application only when it contains:

a written description of the invention, complying with all requirements of 35 U.S.C. §112 1^st paragraph

any drawings necessary to understand the invention, complying with 35 U.S.C. §113.

Therefore, it is essential that the disclosure of the invention in the provisional application be as complete as possible. In order to obtain the benefit of the filing date of a provisional application the claimed subject matter in the later filed non-provisional application must have support in the provisional application.

Related Documents

Patent Office Orders Granting Reexamination

• Patent Office Order Granting Reexamination of ‘695 Patent (PDF; 596KB)
• Patent Office Order Granting Reexamination of ‘946 Patent (PDF; 447KB)
• Patent Office Order Granting Reexamination of ‘089 Patent (PDF; 485KB)
• Patent Office Order Granting Reexamination of ‘230 Patent (PDF; 519KB)

Requests for Reexamination

• PUBPAT Request for Reexamination of U.S. Patent No. 5,922,695 (PDF; 488KB)
• PUBPAT Request for Reexamination of U.S. Patent No. 5,935,946 (PDF; 502KB)
• PUBPAT Request for Reexamination of U.S. Patent No. 5,977,089 (PDF; 479KB)
• PUBPAT Request for Reexamination of U.S. Patent No. 6,043,230 (PDF; 485KB)

(For Pwned, See Owned)

One of the less-noticed items during the Senate Judiciary Committee mark-up of the Patent Reform Bill (Senate Bill S. 1145) was the adoption of Senator Specter’s amendment on venue. Following is an analysis of that amendment:

S. 1145 (before today): Implements venue reform by limiting venue to where (1) either the patent holder or infringer resides (for a corporation, this means the principal place of business or state of incorporation), or (2) where infringer has committed acts of infringement and has a regular place of business.

There was discussion and concerns raised by Senator Cornyn about a change that would limit venue to 3 states (WI, CA, VA) which I believe referred to Leahy’s 2nd manager’s amendment. From an e-report:

*Cornyn: “The manager’s amendment already fixes the problem. I oppose abusive forum shopping. But I fear the Specter provision would effectively limit patent litigation to WI, CA, and VA. There would be an inadvertent backlog in patent litigation.”

The 2nd manager’s amendment was adopted (which included venue among them), then Senator Specter’s amendment on venue was adopted, superseding the manager’s amendment. The limitation to three states does not appear to be in the Specter Amendment. However, in my opinion, its effect is worse.

S. 1145 (after today):

(1) prohibits patent holders from “manufacturing venue” by assignment/incorporation to establish venue for a specific district (e.g., companies setting up shells in ED Texas to invoke that venue); [probably ok]

(2) expands venue restrictions to apply not just to claims for infringement as well as declaratory judgment actions [outrageous result when considered with changes below — DJ filers (infringers taking a preemptive strike) can file suit and take advantage of the subsequently described venue restrictions];

(3) Provides that venue for a US infringer will be (a) where infringer resides (the principal place of business or state of incorporation) or (b) where infringer has committed “substantial” acts of infringement and has a “regular and established physical facility”. [note the expansion of limitation from “regular place of business” to “physical facility of significance”];

(4) Provides that venue for a foreign infringer will be (a) the foreign corp’s residence, which is where its main U.S. subsidiary is located or (b) where the foreign corp. has committed “substantial” acts of infringement AND has a “regular and established physical facility” [this is an *outrageous* result — (a) provides LESS jurisdiction over a foreign corp than a U.S. corp. by limiting the jurisdiction only to where the U.S. subsidiary is located, and it gives incentive for a foreign corp with a U.S. subsidiary to “locate” in the most infringer friendly forum of their choosing; and (b) provides no jurisdiction over those foreign corporations without a U.S. subsidiary who do not meet the criteria of a “regular and established physical facility” in the U.S.]

(5) Provides a “safe harbor” for universities from venue reform restrictions by allowing venue for university plaintiffs to be where the university resides [nice nod to universities on its face, but universities (a) are, at best, reluctant plaintiffs, and (b) have no protection for their tech-transferees, which means that the incidences of universities having to be plaintiffs will rise, their tech-transferees will be further disadvantaged, and ridiculous accusations and controversy of further “commercial” activity and Bayh-Dole abuse by universities be further fed.];

(6) provides a safe harbor for individual inventor plaintiffs who qualify as a micro-entity by allowing venue where the individual resides [again, nice on its face, but any individual inventor who has $4.5 million necessary to litigate will be highly unlikely to qualify for micro-entity status].

Finally, the inclusion of the safe harbors for universities and individual inventors highlights the most outrageous component of this amendment: that which is missing and removed. The original language of S.1145 provided jurisdiction where either the infringer *or* patent holder resides (for a corp, this means the principal place of business or state of incorporation).

The amendment eliminates jurisdiction where the patent holder resides for all but universities and micro-inventors! This means 99% of aggrieved patent holders who need to turn to litigation to defend their patent rights will now be forced to seek recourse against U.S. based accused infringers only on the infringer’s “home turf” with friendly jury pools predisposed to the substantial local business operations of the accused infringer. Worse, an aggrieved patent holder who needs to enforce his rights against a foreign patent holder will have even more restrictive avenues, and in some cases, will have NO recourse where a “regular and established physical facility” of a foreign corp. cannot be established.

This means that the traditional rule that the plaintiff chooses the forum is eliminated for most all constitutionally protected patent holders. Worse, it also means that *neutral* sites are eliminated as forums which have jurisdiction over patent suits. The only jurisdiction where patent infringement remedies can be brought for most all patent infringement cases is based upon the forum which, if at all, is that which is most favorable to the accused infringer!

Today’s post comes from Guest Barista David P. Vandagriff, Vice President of Intellectual Property at Helius, Inc.

In a unanimous vote, the U.S. House Judiciary Committee gave the thumbs-up to new patent-reform legislation, the Patent Reform Act of 2007, H.R. 1908 (see also  S. 1145, which the tech industry has been pushing.

The Patent Reform Act would:

Allow a second review of patents after they have been granted to challenge the validity of a newly issued patent.

Narrow the definition of willful infringement, which brings treble damages in infringement lawsuits.

Limit infringement damages to the economic value of the patent’s contribution to an overall product. Currently, damages are based on the entire market value of the product.

Implement a first-to-file standard.

Concerns by 3M Eli Lilly, General Electric, Johnson & Johnson and Proctor & Gamble were muted after amendments to the bill narrowed the “second window” of post-grant reviews.

One of the biggest changes limits post-grant review process by allowing challenges only in the first 12 months.  The Senate Judiciary Committee approved much the same amendments.

According to Sen. Patrick Leahy, infringement damages would be limited, “unless the claimant shows that the patent’s specific contribution over the prior art is the predominant basis for market demand for an infringing product or process.”

Sen. Arlen Specter added an amendment to the Senate version that seeks to eliminate the popular practice of “forum shopping” by limiting venues for patent-infringement cases.

BIO expressed its concern with the bill stating that it threatens continued biotech innovation stating that:

We remain concerned, however, with provisions in the legislation that would change how damages against patent infringers are calculated, in a way that would often make infringement cheaper. We also believe changes are required to the provision that would require that courts peel away from the patented and infringed invention the value of all previously known elements and award damages based solely on the remaining elements. This provision severely devalues all underlying patent rights and could seriously undermine the incentive to develop novel new forms of medicines and other biotechnologies. Further, the bill continues to contain broad new rulemaking authority for the PTO, which is of great concern to BIO.

The Coalition for Patent Fairness sent out a press release giving a big group hug to the bill and stating that it supports patent reform legislation that will:

Balance the apportionment of damages. The standard for calculating damages should be based on the fair share of the patent’s contribution to the value of a product, and not on the value of a whole product that has many other components.

Establish fair standards for punitive damages. Awarding punitive, triple damages for “willful” patent infringement should be reserved for cases of the most egregious conduct, as required by the U.S. Supreme Court for virtually all other punitive damages.

Restrict forum shopping. Cases should be brought in courts with some reasonable connection to the case and not, by gaming the system, in courts solely because they historically favor patent claims.

Improve patent quality. The system should promote quality patents by providing a meaningful second chance for the experts at the PTO to review potentially problematic patents in a timely manner, and should promote sharing of information with the PTO to improve the process and increase innovation.

The bill now goes before the full U.S. House for a floor vote.

Earlier:

• DOJ: US Needs More Prior User Rights
• Patent Reform Letter: The Re-Mix
• Senate Judiciary Republican Letter on Patent Reform

Yali Friedman, chief science office at New Economy Strategies and author of Building Biotechnology and the BiotechBlog, recently set out his picks for the top-5 must read blogs for keeping track of all the developments in biotechnology.

The following blogs are his picks as best-in-class and should be an integral part of your daily read to keep abreast of advances and back stories in biotechnology:

1) DRUG WONKS
http://www.drugwonks.com/

As the forum for the Center for Medicine in the Public Interest, Drug Wonks covers policy affecting biotechnology. This blog also tracks and responds to Op-Eds and other news items, providing additional perspective on many important topics.

2) IN THE PIPELINE
http://pipeline.corante.com/

This blog is unique in that it is written by an actual scientist. Although he sometimes gets carried away with scientific details, author Derek Lowe provides valuable insight on the back-stories behind industry developments and also provides his unique perspectives on life as a scientist. His occasional battles with Kevin Trudeau and his acolytes over the legitimacy of pharmaceutical drugs versus vitamin supplements, and the ensuing arguments in the comments sections, also make for good reading.

3) PATENT BARISTAS
https://patentbaristas.com/

Somewhat complementing the policy coverage presented by Drug Wonks, but also delving deep into the world of biotechnology patents, the Patent Baristas effectively cover the foundations that define the scope of commercial biotechnology. When new regulations or patent rulings are announced, head over to Patent Baristas for background and an in-depth overview.

4) PHARMA MARKETING BLOG
http://pharmamkting.blogspot.com/

In many ways, the Pharma Marketing blog embodies what makes blogs worth reading. The site opens with an unapologetic disclaimer that the site contains blogger John Mack’s personal opinions. In his blog, Mack launches spirited attacks at questionable ethics in marketing and perceived lacks of oversight by industry organizations.

5) MARS BLOG
http://blog.marsdd.com/

This blog is hosted by MaRS, a convergence innovation center located in downtown Toronto. MaRS staffers and guests blog on topics such as emerging science and technology, entrepreneurship and business, and innovation policy. What sets MaRS apart from other blogs is the depth of coverage in each of these categories and well as the demonstrated desire to ask, and address, fundamental questions.

See the article here.

In Pharmastem Therapeutics v. ViaCell (No. 05-1490/1551) , the U.S. Court of Appeals for the Federal Circuit upheld an earlier decision by the U.S. District Court for the District of Delaware that ViaCell, through its marketing of ViaCord does not infringe PharmaStem’s U.S. Patent No. 5,192,553 and U.S. Patent No. 5,004,681, which relate to certain aspects of collection, cryopreservation, storage and use of hematopoietic stem cells from umbilical cord blood. The court went even further in finding the ‘553 and the ‘681 patents invalid based on prior art.

The district court judge, in overturning a jury verdict against ViaCell and the other defendants, found that PharmaStem had failed to prove infringement. The district court focused on the requirement that the recited compositions contain stem cells “in an amount sufficient to effect hematopoietic reconstitution of a human adult.”

The court felt that PharmaStem did not attempt to prove by testing or by reference to data collected by the defendants that at least some of the cord blood samples preserved by the defendants satisfied that requirement. Instead, PharmaStem used representations made by the defendants in their marketing materials.

As to infringement of the ’553 patent, the district court concluded that PharmaStem had failed to prove that the defendants were guilty of contributory infringement despite the fact that the jury found (1) that cryopreserved cord blood has no substantial noninfringing uses; (2) that the defendants and transplant physicians were acting in concert or working together to complete the process of infringement of the asserted claims of the ’553 patent; and (3) that the defendants contributorily infringed “by selling or offering to sell cryopreserved cord blood that was actually used by a third party in the direct infringement” of the asserted claims.

The jury found the defendants liable for “acting in concert or working together” with the transplant physicians, or contributing to the infringement of the ‘553 patent but the trial court judge decided to go against the juries findings and held:

Although the defendants charge enrollment, processing, and banking fees with respect to their storage services, they do not sell or offer to sell the cord blood units. Indeed, the record evidence on this issue is clear that the defendants sell a service, not cord blood units.

Disregarding the jury’s findings, the court ruled that liability for contributory infringement “is clearly dependent upon the accused infringer’s selling or offering to sell a component of the patented process, here cord blood units,” the court held that the jury’s verdict could not stand.

With respect to infringement of the ’681 patent, the Federal Circuit agreed with the lower decision finding that none of the statements represented that the stem cells in any of the cryopreserved cord blood samples were sufficient in number to effect hematopoietic reconstitution of an adult:

Instead, the defendants’ statements emphasized the potential therapeutic usefulness of the cord blood in general and referred to future uses of stored blood in adult transplants only as possibilities. (emphasis added)

The contributory infringement section of the Patent Act, 35 U.S.C. § 271(c) provides:

“Whoever offers to sell or sells . . . a component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent” shall be liable as a contributory infringer.

The district court construed the contributory infringement statute to require a sale or an offer of sale of a product because liability under section 271(c) “is clearly dependent upon the accused infringer’s selling or offering to sell a component of the patented process, here cord blood units.” The court held that the statute is not satisfied by the provision of a service for compensation.

Huh?

PharmaStem had argued that the jury could properly characterize the transaction as a “sale” but the Federal Circuit, through some sort of linguistic jujitsu, is able to turn this around and say that there was not a sale since “title” of the cells remained with the patients:

While cord blood is certainly a product, the transaction between the defendants and their clients is plainly not the sale of “a material or apparatus for use in practicing a patented process,” as is required by section 271(c) with respect to method patents. The evidence at trial showed that the cord blood remained the property of the families throughout the period in which the defendants stored it.

But section 271(c) is not limited to the sale of a product and extends to the sale of a service.

Au contraire, says the Federal Circuit:

Although that language describes in various different ways the items that may be sold for purposes of creating liability for contributory infringement, all of the descriptions refer to the sale of a product of some sort; none of them refer to the provision of a service.

The court said thusly:

[T]here was no evidence that any of the defendants made a sale of either products or services to the transplanters. To the contrary, the evidence showed that the service the defendants provided was a service to the donor families, for which the families paid a fee, and that there was no sale of any sort by the defendants to the transplanters or any fee paid by the transplanters to the defendants. The defendants simply transferred the cord blood units to designated transplanters upon direction from the families. Such a transaction does not constitute a “sale” to a transplanter under any definition of the term “sale.”

Basically, the court allows all of the participants to escape liability by playing a “hide the sale” shell game.

The court went even further in holding the patents invalid for obviousness. Using what could look like hindsight, the court found the patented invention obvious even where experts in the field could not come up with the same invention and even though the USPTO allowed the ’681 and ’553 patents, and the ’681 patent following reexamination, over some of the same references.

The court felt that the patents’ own specification told a different story. Citing a number of references, the inventors stated the following:

A human hematopoietic colony-forming cell with the ability to generate progenitors for secondary colonies has been identified in human umbilical cord blood. In addition, hematopoietic stem cells have been demonstrated in human umbilical cord blood, by colony formation, to occur at a much higher level than that found in the adult.

Admissions in the specification regarding the prior art are binding on the patentee for purposes of a later inquiry into obviousness.

Judge Newman, dissenting, did not mince words: 

I respectfully dissent. After a three week trial the jury sustained the validity of these patents, the district court in a thorough opinion upheld the verdicts of validity, and validity was confirmed in three reexaminations by the Patent and Trademark Office. Today my colleagues on this panel hold that the inventions in the ‘681 patent and its continuation-in-part the ‘553 patent are obvious to them, and not infringed.

The panel majority scours the prior art for clues that could fit the eventual achievement, and then rules that the achievement was obvious, no matter that it eluded the others whose work is now compiled by this court so as to invalidate these patents.

On the ‘681 Patent:

The theory that each stored sample had to be separately analyzed by PharmaStem to show infringement was not presented as law to the jury. This was a new standard for infringement, for the jury was not told that the defendants’ analyses of stem cell content could not provide evidence of stem cell content.

When there is substantial evidence in support of the jury’s verdict, it is irrelevant whether the appellate court would have preferred different or additional evidence.

On the ‘553 Patent:

The jury found the defendants liable for “acting in concert or working together” with the transplant physicians, or contributing to the infringement of the ‘553 patent.

My colleagues grant JMOL on the ground that since the defendants are providing a service, not selling a product, they can not meet the “sale” requirement of contributory infringement, 35 U.S.C. ‘271(c). PharmaStem points out that a reasonable jury could have found that the defendants sell (rent) their blood-storage facilities to the donor’s family, and that the defendants either contribute to or act in concert with the transplanting surgeon to practice the claimed method.

The principles of patent infringement are not negated when the steps of a method claim are performed by more than one entity.

It is irrelevant whether any steps of a method claim can be viewed as a “service;” infringement requires only that the steps be performed. As discussed in Dawson Chemical Co. v. Rohm and Haas Co., 448 U.S. 176, 188 (1980), the purpose of the contributory infringement statute is “to protect patent rights from subversion by those who, without directly infringing the patent themselves, engage in acts designed to facilitate infringement by others,” a criterion that the jury could have found was met by the facts and relationships of this case.

Patent law is seldom full of drama so it is with great excitement that we watch the latest little interlude unfold. This one involves law, politics and intellectual property — often the staple of dramatic television shows.

Our story starts back in April 2007, when Commerce Secretary Carlos Gutierrez appointed Margaret J.A. Peterlin, formerly a national security House aide, to serve as Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the Commerce Department’s United States Patent and Trademark Office (USPTO).

Before joining the USPTO, Ms. Peterlin was Counsel for Legal Policy and National Security Adviser for the Speaker of the U.S. House of Representatives, J. Dennis Hastert. In this role, she advised the Speaker, House and Senate leadership, and senior staff on legislative policy and strategy, including judiciary issues such as intellectual property protection, and international relations issues. She previously was General Counsel to Richard Armey, Majority Leader of the U.S. House.

While Peterlin offers an impressive resume, it is now being alleged that her legislative background fails to satisfy federal law — 35 USC 3(b)(1) requires:

(1) DEPUTY UNDER SECRETARY AND DEPUTY DIRECTOR.- The Secretary of Commerce, upon nomination by the Director, shall appoint a Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office who shall be vested with the authority to act in the capacity of the Director in the event of the absence or incapacity of the Director. The Deputy Director shall be a citizen of the United States who has a professional background and experience in patent or trademark law.

There’s the rub. Just what does it mean to have “a professional background and experience in patent or trademark law“?

Now, a lawsuit has been filed asking the courts to order Secretary Gutierrez to prove that Ms. Peterlin’s legislative experience satisfies the law. If not so satisfied, they want the court to order Secretary Gutierrez to immediately dismiss Ms. Peterlin from her position.

The Plaintiff’s are asking the Court to grant the following relief:

1. Hold that Peterlin fails to meet the statutory requirements defined by 35 U.S.C. 3(b)(1) to hold the position of Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office;

2. Hold that Defendant Gutierrez’ appointment of Peterlin violates 35 U.S.C. 3(b)(1);

3. Order Defendant Gutierrez to dismiss Peterlin from the position of Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office immediately;

4. Order Defendant Gutierrez to establish Department of Commerce agency rules to assess what qualifies as a “professional background and experience in patent or trademark law” under 35 U.S.C. 3;

5. Order Defendant Gutierrez to appoint a new Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office who fulfills all of the requirements of 35 U.S.C. 3(b)(1);

6. Award Plaintiffs their costs and reasonable fees in this action; and

7. Grant any further relief as this Court may deem just and proper.

If anyone knows precisely how to determine the definition of “a professional background and experience in patent or trademark law,” please let me know. Having said that, I wonder if it’s really wise to include a requirement in a job description (for such a high level position) that is not defined.

See the complaint at: http://www.bustpatents.com/peterlin.pdf.

Despite the complaints directed to the Office of Management and Budget, OMB has given its thumbs-up to the USPTO’s proposed rules on continuations and claims:

RIN: 0651-AB93, Changes to Practice for Continuing Applications, Requests for Continued Examination Practice, and Applications Containing Patentably Indistinct Claims (Fed. Reg. 71: 48-61 (January 3, 2006) (“Continuations Rule”)

RIN: 0651-AB94, Changes to Practice for the Examination of Claims in Patent Applications, 71 Fed. Reg. 61 (Jan. 3, 2006) (“Limits on Claims Rule”)

While we have to wait to see what the final rule is, OMB concluded that the rules, as amended, were not “economically significant.”

Those interested in trying further steps to limit these rule changes should send an email to David Boundy of Cantor Fitzgerald at: DBoundy@Cantor.com

He is exploring two additional avenues:

(a) Congressional oversight. According to David, several senators and representatives have said “Get back to me when the executive branch is done. I understand the problem, and if it still exists at the end of executive branch review, let me know, and we’ll see.”

(b) Administrative Procedure Act judicial review. Under another FOIA request, information confirmed that the PTO did absolutely NO analysis of any significant issue

OIRA Conclusion of EO 12866 Regulatory Review

Abstract: The Office revises the rules of practice to share the burden of examining an application if the applicant has filed multiple continuing applications or multiple requests for continued examination. The revised rules would require that second or subsequent continuation applications and second or subsequent requests for continued examination of an application include a showing as to why the amendment, argument, or evidence presented was not previously submitted. The revised rules would also ease the burden of examining multiple applications that have the same effective filing date, overlapping disclosure, a common inventor, and common assignee by requiring that all patentably indistinct claims in such applications be submitted in a single application absent good and sufficient reason. These changes would allow the Office to apply the patent examining resources currently absorbed by multiple continuing applications and requests for continued examination that simply recycle earlier applications to the examination of new applications and thus allow the Office to reduce the backlog of unexamined applications. This will mean faster, more efficient examination for the typical applicant without any additional work on the applicant’s part, but a small minority of applicants who consume a disproportionate share of Agency resources will be required to share the burden they place on the Agency.

OIRA Conclusion of EO 12866 Regulatory Review

I think I may ask for more Dennis Crouch predictions.