“Effective and Practical Strategies for Prosecuting and Litigating Biotech Patents in an Increasingly Uncertain Legal Environment” American Conference Institute’s 14th Advanced Forum on Biotech Patents

The ongoing implementation of the America Invents Act and a massive upheaval of subject matter patentability signal that this continues to be a period of intense uncertainty for the biotechnology and pharmaceutical fields. Nevertheless, demand for biotech products continues to grow and innovation proceeds at a breakneck pace. To ensure that your company stays on the cutting edge, your patent strategies must evolve to meet new demands placed on your IP protection, and our forum on Biotech Patents will help you develop techniques to rise to the challenge. Topics to be discussed include:

  • Analyzing the PTO’s efforts to apply the America Invents Act, including how the September 16th implementation date has impacted procedure and their plans for the looming March 16th institution of the first-to-file regime.
  • Investigating how the Supreme Court’s Prometheus decision will affect personalized medicine and considering outcomes of the Myriad case and what that could mean for biotechnology.
  • Devising a biologic patenting strategy in the wake of the FDA’s newly issued biosimilar pathway regulations.
  • Enhance Your Learning Experience at the Pre- and Post-Conference Workshops


Wednesday, November 28 to Thursday, November 29, 2012


Hyatt Regency, Boston, MA


ACI’s 14th Advanced Forum on Biotech Patents brings together another top-notch faculty of expert biotech patent practitioners who will share their experience and knowledge to help you avoid pitfalls and maximize the value of your intellectual property. Do not miss the opportunity to hear experienced in-house counsel and private practice attorneys share thoughts and advice on strategic patent filing and effective defense of IP rights.


To accompany your overall experience, PTO examiners and industry leaders will guide you through changes at the PTO at our in-depth pre-conference Interactive Working Group Session: Integrating Changes at the PTO into Biotech Patent Practices.

In addition, our post-conference Master Class on Successful and Practical Strategies for Patenting Antibodies utilizes an expert faculty to assist you in protecting and promoting products that are central to the biotech industry.


Register now by calling 888.224.2480; by faxing your registration form to 877.927.1563; or register online at www.AmericanConference.com/BiotechPatents.

PatentBaristas.com is a Media Sponsor of this event.  Readers of Patent Baristas are entitled to $200 off the current conference price tier.   The discount code you will need for this is: PB 200.

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On September 16, 2011, President Barack Obama signed into law the Leahy-Smith America Invents Act.   This Act is often referred to as the most comprehensive overhaul to our patent system since 1836.

Seven provisions of the AIA and USPTO implementing final rules for these provisions go into effect today on September 16, 2012:

1.  Inventor’s oath or declaration.  

The AIA provides new flexibilities for filing a declaration.  For example, in addition to maintaining current practices, an assignment document can act as a declaration, and in applications with an application data sheet, each inventor can execute a separate declaration, and the filing of a declaration can be postponed until the application is in condition for allowance.

2.  Pre-issuance submissions.  

The rules allow third parties to file pertinent publications—and a short statement of relevance—in patent applications prior to issue. The third-party submission rules allow any third party to submit any patents, published patent applications, or other printed publications of potential relevance to examination. 37 C.F.R. § 1.290(a). This includes litigation papers and court documents not subject to a court-imposed protective or secrecy order but does not include trade secrets information, unpublished internal documents, or other unpublished documents.

3.  Supplemental examination.  

Patent owners will be able to request supplemental examination of an issued patent, which could help protect the patent against certain inequitable conduct allegations. If a request for supplemental examination is accepted, the USPTO will institute an ex parte reexamination. The threshold for acceptance is whether a substantial new question of patentability has been raised.

4.  Citation of patent owner claim scope statements.  

This provision expands the type of information that a patent owner or third party may submit into a patent file. It will allow submission of patent owner statements about claim scope that were made in a federal court or a USPTO proceeding.  The provision also defines how the Office may use such information during ex parte reexamination, inter partes reexamination, and post grant review.

5.  Post grant review.  

Post grant review provides for another method for third parties to challenge a patent’s validity. Most aspects of the post grant review is the same as the inter partes review. For example, the petition requirements and patentee response are almost the same.  However, post grant review only will apply to those patents granted through the first-inventor-to-file system. Also, patents subject to post grant review may be challenged under 35 U.S.C. § 101 (utility or patentable subject matter requirement) and 35 U.S.C. § 112 (definiteness requirement) in attrition to § 102 (novelty requirement) or § 103 (non-obviousness requirement). Finally, the post grant review petitioner has a higher burden to initiate this procedure, the petitioner must show it is more likely than not that at least one of the challenged claims is not patentable.

6.  Inter partes review.  

Under the AIA, inter partes review under 35 U.S.C.  § 311(c) will take the place of inter partes reexamination. A person who is not the patent owner and has not previously filed a lawsuit challenging the validity of a patent claim may file an inter partes review. An inter partes review petitioner, however, only may request to invalidate one or more patent claims on the basis of lack of novelty under 35 U.S.C. § 102 (novelty requirement) or as obvious under 35 U.S.C. § 103 (non-obviousness requirement) and only based on prior art consisting of patents or printed publications. An inter partes review cannot be filed until after the later of nine months after the grant of a patent or the date of termination of any post grant review of the patent. The patentee may file a preliminary response, providing reasons why no inter partes review should be conducted. An inter partes review petition must show there was a reasonable likelihood that the petitioner would prevail as to at least one of the claims.

7.  Covered business method review.  

The AIA also creates a transitional program for some business method patents so that alleged infringers can challenge a covered business method patent’s validity through post-grant review. The AIA defines covered business method patents as those claiming a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological innovations.  The final rules, however, don’t say what exactly constitutes a “technological innovation.”

Want to learn more?:

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With the passage of the Leahy-Smith America Invents Act (AIA) last year, which converted the patent system from a ‘first to invent’ to a ‘first inventor to file’ system. The AIA, signed into law in September 2011, indeed brought significant changes in certain areas. But it did not address the calculation of damages in patent infringement matters, as had been suggested in prior drafts of the bill.

The absence of reform guidance in this regard leaves patent damages issues squarely for the courts. Additionally, the elimination of the 25 percent rule of thumb and rulings in other court decisions demonstrated that the courts, not Congress, would continue to shape the future of patent law and play the primary role in how patent damages are determined.

Without the 25 percent rule of thumb, a complex mathematical proof for determining royalty apportionment, known as the Nash Bargaining Solution, has recently appeared in some patentees’ damages calculations, receiving mixed reviews from the courts. In Oracle v. Google, the Court excluded expert testimony:

“[T]he Nash Bargaining Solution would invite a miscarriage of justice by clothing a fifty-percent assumption in an impenetrable facade of mathematics.”

“Instead, the normal Georgia-Pacific factors, which have been approved by the Court of Appeals for the Federal Circuit and which are more understandable to the average fact-finder, will guide our reasonable royalty analysis.”

Recognizing these developments and business leaders’ continuing deep interest in intellectual property matters, PwC maintains a database of patent damages awards extending from 1980 through 2011. They collect information about patent holder success rates, time-to-trial statistics, and practicing versus nonpracticing entity (NPE) statistics from 1995 through 2011.

New to this year’s study is an analysis of Abbreviated New Drug Application (ANDA) cases, which are increasingly prevalent in the dockets. The volume of such cases has increased substantially over the last five years, and the success rates experienced by the patent holders, or the brand drug manufacturers, have to date been higher than traditional patent actions.

The analysis yields a number of observations that can help executives, legislators, and litigators assess their patent enforcement or defense strategies, as well as the impact of NPEs.

Download the PDF

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The Leahy-Smith America Invents Act (AIA) dictates that at least three satellite offices be opened by the USPTO in three years. The Detroit satellite office was the first of four selected by the USPTO to increase outreach, improve retention and recruitment of patent examiners, decrease the patent application backlog and improve the quality of examination.

It is claimed to be the first stage of the USPTO’s Nationwide Workforce Program, which has been working to recruit more experienced patent professionals with the intention that these individuals will be more productive and have a higher retention rate.

The city of Detroit was selected as an important national innovation center with a high percentage of scientists and engineers in the workforce. In politico-speak, that means politicians are not going to get re-elected without throwing something towards the unemployment rate in Detroit (which spiked at 27.8% in 2009 and now runs 21.1% after dipping to 15.8% in May).

I guess technically they did help with employment.  Director Kappos anticipates the Detroit office having 100 patent examiners and 20 judges on site there by next summer.  But, with a population of 713,777 and a population of 4,296,250 for the six-county metro area, will 120 jobs amount to much?

The USPTO Satellite Office in Detroit will provide access to the Agency’s public electronic patent and trademark collections with a public search room. That means that the Detroit office has two public workstations available for conducting searches that have the same access requirements and print capabilities as identical public workstations in USPTO’s Public Search Facility.  Video conferencing equipment is also available for use for patent application interviews.

Are satellite offices the answer?  And what was the question?  I can’t help but feel like this is too little, too late.  It’s like proposing to open up US Postal Service branch offices now that that everything is moving to digital.  Seems like a lot more could have been accomplished by just giving every examiner a web cam and allowing video Skype calls.

 What do you think?

The USPTO also recently announced that it plans to establish three more satellite offices in (1) Silicon Valley, California, (2) Dallas, Texas, and (3) Denver, Colorado by September 2014.

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“We are complying with Congress’ mandate to set fees at a level that enables the USPTO to recover the actual costs of the services it provides, while enabling us to implement all of the provisions of the Act.”
~Under Secretary of Commerce for Intellectual Property and
Director of the USPTO David Kappos

The U.S. Patent and Trademark Office (USPTO) announced that it is taking steps to raise fees for patent applcicants. The Office published a Notice of Proposed Rulemaking (NPRM) in the Federal Register seeking public input on proposed patent fees, including reductions to fees for new procedures and programs created by the broadly bipartisan Leahy-Smith America Invents Act (AIA) that allow robust reviews of issued patents, and provides discounts to individual inventors and small businesses.

The public has 60 days after this notice of proposed rulemaking to comment on the proposed fees before the USPTO sets the final rule (Sunday, November 25, 2012). The PTO would then revise the fees as needed and the new fees would go into effect “at least 45 days” after that.  The office has said that it was targeting implementation of the new fee structure sometime in February 2013.

Fees are currently set by statute. The AIA directed the USPTO to set these fees on a cost-recovery basis and to seek public and stakeholder input in setting those fees, a change widely supported by businesses, entrepreneurs, and educational institutions.

According to the USPTO, the proposed fees are at least 22 percent lower for a routine patent process—i.e., filing, search, examination, publication, and issue fees—than the current fee schedule. The current proposed fees also are lower than those originally proposed by the USPTO in February.

With the publication of the NPRM, the USPTO is opening a 60-day comment period in which the public can provide input on the latest proposal. Following the comment period, the Office will prepare the final fee-setting rule, which would go into effect no less than 45 days after it is published in the Federal Register. Further information about the NPRM for proposed fees is here.

The proposed fees also will enable the USPTO to implement a discounted fee structure that provides 75% savings on many patent fees for micro entities, primarily individual inventors and small entrepreneurial ventures. Also included in the proposed fees is an expansion of the existing 50% discount for small entities.

New rules and procedures mandated under the AIA go into effect on September 16, 2012, including three new administrative trial processes. Under the AIA, those reviews must be completed by the Patent Trial and Appeal Board (PTAB) within one year of filing. The proposed fees introduced in the NPRM reduce the cost recovery fee amounts effective on September 16, 2012.

Along with the 60-day comment period, the USPTO will seek feedback at eight public hearings in the month of September. These events, called AIA Roadshows, will include a presentation on the proposed fee schedule, with an opportunity for questions and comments from the public. The first three of the Roadshows will also be webcast.

The proposal would raise the total fees for patent application filing, search, and examination from $1,250 for a large entity to $1,600, a 28 percent increase, but still represents only about 42 percent of the PTO’s cost of providing those services.  The PTO originally proposed higher fees for RCEs from $930 to $1,700.  After complaints, the agency now would allow a first RCE for $1,200, while keeping the $1,700 fee for the second and subsequent RCEs.

The combined notice of appeal and appeal brief cost would be lowered from its current level of $1,240 to $1,000.  However, the appeal filer would incur an additional $2,000 fee if the examiner does not withdraw the rejection and the applicant files an appeal brief.

The publication fee was eliminated and the issuance fee proposed at $960 is almost a 50 percent reduction from the current fee.   A fee to correct inventorship was retained but is now proposed to be $1,000.

Total fees for the three maintenance stages–at 3.5, 7.5, and 11.5 years–would be $11,600, an increase of 45 percent above the current total payment.

For non-press inquiries about the NPRM, please contact Michelle Picard, USPTO Senior Advisor for Financial Management, at (571) 272-9200.

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“The objective of ArchPatent is providing the simplest, most intuitive USPTO search tool.” ~Tony Rainoldi

ArchPatent is a new service for searching U.S. patent information.  It offers a number of tools for searching for patents and then refining search results according to various parameters. The basic service is free or you can upgrade to ArchPatent Pro to unlock additional, premium features.

I’ve been trying out this new service and with ArchPatent, you can do a Quick Search or an Advanced Search of multiple patent fields simultaneously.  You can search for the full patent text by keyword or by patent number, title, inventor, assignee, examiner, and attorney. You can put together complex search strings using Boolean logic, proximity and wildcard operators, and keyword stemming.

A quick search of the word “metabolite” brings up a search result of 29365 patents.  Change that typing Metabolite into the assignee field and the search brings up US Pat. Nos. 6,207,651, 5,563,126, 6,297,224 and 5,795,873, all assigned to Metabolite Laboratories, Inc.  But, type in Metabolite into the complete assignee records field and it pulls up an additional patent, US 6,528,496, which was assigned after issue.

Typing an asterisk (*) tells ArchPatent that you have a truncated search term and want to find all instances that include that information. In this case, you can type *469 into the “Grant or Application Number” field – this will return all patents numbers containing “469”.

What seems to make ArchPatent convenient is the ability to search within results without having to go back and start over.  Once you’ve entered a search, you can use filters to begin to narrow the search results in various ways to get you only the results you need.  You can filter by US Classification, Original Assignee, Reassignee, Current Assignee, Examiner, Agent, Applicant and Most Referenced.

The only downside is that applying filters — at least the times I have used the service — sometimes seems to hang and takes longer than my limited patience can tolerate.  The service seems to still be a work in progress with some features marked “Coming Soon” and not yet available.

Another convenient feature is the Personal Workspace.  As you are working with searches, you can keep track of your work by saving patents and searches to a custom workspace. You have the ability to go back over past searches, which have been automatically saved. Access to workspaces is free with basic registration.

ArchPatent Pro subscribers are able to track changes to the patent database as the USPTO publishes new patent applications and issued grants. You can set an alert for a keyword, patent classifications, a competitor’s name or even set one to look for changes to assignment records.

You can download full patent images as PDFs.  ArchPatent links cited references to individual patent detail pages and to patents referencing a particular patent since it was granted.

The ArchPatentPro version adds some useful fields but costs $39.99/month or $239.88/year.  With the Pro version, you can see all the results (not just the top 10) and you get special features like being able to export the results into a .csv spreadsheet file.  You can choose the columns to include in the export including the patent number, invention title, issue date, filing date, current assignees, assignees at issue, applicants, and a link to the AchPatent Detail Page.

You can try out ArchPatent at: http://archpatent.com/

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Patexia is offering a $5000 prize to the winner of a research contest involving charge pumps in voltage controlled oscillators. The goal is to find relevant, published material pre-dating a certain patent. This is a chance to win money, to tackle a real problem, to showcase your technical skills, and to gain visibility in the industry (maybe).

The prior art hunters are looking for previously undiscovered references (see: patent and prior art basics and tips for Patexia’s prior art contests) including patents and non-patent literature (English and foreign language) that can help invalidate US patent 5,825,640, which relates to a charge pump circuit used in a Phase Locked Loop (PLL) block as part of a RF receiver system. The best submission is guaranteed to receive the prize.

One of the key features of this design is the presence of a charge conduction path (transistors 42 and 43 in the following circuit diagram) to discharge the parasitic capacitance of nodes 38 and 39 into the discharge node of 45 and as a result reduce the error current in the output. The charge conduction path is enabled only on one transition edge of the input pulse and is disabled on the other transition edge of the input pulse to isolate the node from the output.

Participate now.

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Join your fellow innovators at the Texas Regional Independent Inventors Conference in Austin as the next stage of the America Invents Acts goes into effect. The United States Patent and Trademark Office (USPTO), National Inventors Hall of Fame and the University of Texas at Austin invite you to get practical advice from successful inventors, entrepreneurs and intellectual property experts. Meet and network with your creative colleagues.

Space is limited, so click here to register early.

The conference will be held September 14-15 at the University of Texas at Austin in the Thompson Conference Center located at 2405 Robert Dedman Drive, Austin, Texas. Presentations and workshops will be conducted by senior USPTO officials, Supervisory Patent Examiners, Trademark staff attorneys and a limited number of one-on-one advisory sessions will also be available, with guaranteed slots for the first 20 registrants.

Presenters will include:

Robert Metcalfe, 2007 National Inventors Hall of Fame Inductee
Karen C. Parker, Director and International Trade Specialist, Austin U.S. Export Assistance Center
John Calvert, Acting Associate Commissioner for Patents Office of Innovation Development
 Elizabeth Dougherty, Director of Inventor Education, Outreach and Recognition, Office of Innovation Development
Darnell Jayne, Supervisory Patent Examiner, Technology Center 3600
Catherine Cain, Trademark Staff Attorney

Afternoon breakout sessions will focus on the America Invents Act (AIA), patent and trademark basics, searching sessions for patents and trademarks, and advanced patent prosecution.

A networking reception will be held on Friday evening, September 14.

Again, space is limited, so click here to register early, guarantee your advice session, and view the conference agenda.

The registration fee is $80 per person ($70 for seniors or students) and includes all sessions and presentations, morning and afternoon refreshments, lunch both days and the networking reception.

Keynote and plenary speakers will be announced soon, so follow updates on the conference at USPTO.gov and on Twitter at@USPTOEvents.

If you have questions about the conference agenda contact the Office of Innovation Development at 866-767-3848.

If you have questions about registration contact the National Inventors Hall of Fame at 330-849-6929.

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