Post-Wyeth PTA Calculation Errors?

As many practitioners understand,  a patentee is entitled under 35 U.S.C. 154(b)(1)(A-C) to a patent term adjustment (PTA).  Subject to certain limitations, a PTA is determined if (A) the USPTO fails to take certain actions during the examination and issue process within specified time frames, if (B) the USPTO fails to issue a patent within three years of the actual filing date of the application, and for (C) delays due to interference, secrecy order, or successful appellate review.  Delay due to the applicant (D) is also taken into account in calculating the entirety of the PTA. 

Earlier this year, the USPTO announced an interim recalculation procedure to comply with the Federal Circuit Decision in Wyeth v. Kappos, which had held that the USPTO had been calculating under 35 U.S.C. § 154 incorrectly.  Under its previous interpretation of the PTA rules, the USPTO had calculated PTA such that the patentee received the longer of the (A) delay or the (B) delay under the statute.  Wyeth contended, and the CAFC agreed, that a patentee deserves both the (A) delay and the (B) delay, minus any time that the adjustments overlap.  The recalculation procedure has been made available to any patentee whose patent issued prior to March 2, 2010, and who requests the PTA recalculation no later than 180 days after the issue date.

Many patentees have availed themselves of the post-Wyeth recalculation procedure, sometimes with the result of significantly greater PTA.  We have seen PTA increases ourselves on the order of 200-400 days.  Strangely, however, a number of recalculations have also resulted in a lower PTA than was originally calculated.  This author is aware of at least three such patents where the post-Wyeth calculation determined that no (B) delay was present during examination (e.g., due to the filing of an RCE that cut short the pendency for purpose of the PTA calculation under 37 CFR 1.703(b)(1)).  Even though no (B) delay should result in the same PTA as originally calculated, however, the PTA was subsequently determined to be a handful of days fewer under the post-Wyeth calculation!

When the Office of Patent Legal Administration was contacted about these patents, it was suggested that the USPTO possibly had been making errors pre-Wyeth that were different from those identified in Wyeth, which errors may have accidentally credited the patentee with additional days of PTA under the pre-Wyeth calculation.  Surprisingly, when the USPTO Legal Administration was asked to identify what may have now changed in the (A),  (C), or (D) calculations to cause a decrease in post-Wyeth PTA, it was stated that the earlier PTA determinations were no longer available for comparison, as they were deleted when the new PTA determinations were made.  In other words, unless the patentee had printed off a copy of the PTA determination at PAIR prior to requesting the recalculation, it is very difficult to identify what the USPTO did differently pre-Wyeth for purposes of identifying the error causing the difference in PTA.

To be fair, the PTA decreases observed in the handful of patents affected were on the order of 2-4 days.  Nothing too significant for the particular patents in question.  But one can certainly envision patents (e.g., big Pharma) where these 2-4 days could be of immense value.   

Patentees do have means for challenging PTA recalculation decisions such as the ones described above.  First, they may call the Office of Patent Legal Administration at 571-272-7702 with questions concerning the decision.  Prior to issuance of a certificate of correction reflecting the recalculated PTA, the patentee is also afforded an opportunity to request reconsideration.  The request must be made within thirty (30) days, with no extension of time being granted.  The request must comply with 37 CFR 1.705(b)(2) and have a statement of the facts involved, including the correct PTA and the basis for the adjustment. 

We observe that the request for recalculation is made particularly difficult by the apparent fact that the pre-Wyeth determination is destroyed by the USPTO when PAIR is updated with the post-Wyeth determination.  However, we conjecture that the pre-Wyeth determination probably exists in a backup somewhere at the USPTO, should one really wish to press the issue in order that such a comparison may be made. 

Have any of our readers also come across this situation?  Any thoughts on how a determination of no (B) delay under the post-Wyeth calculations can result in a lower PTA than was originally calculated?  We’ll update this post in due course, should we come across any answers with respect to the abovementioned patents.  In the meanwhile, your comments are welcomed.

They Invented What? (No. 167)

U.S. Pat. No. 2,602,996:  Revolving spaghetti fork.

 

What I claim is:

A revolving spaghetti fork comprising a handle and a shank with prongs on the end thereof ro- 25 tatable with respect to said handle, said handle being of a somewhat flat elongated formation with arcuately shaped ends, a lug formed on the front end of said handle and extending downward at right angles thereto and being integral therewith, said lug having a centrally located hole extending therethrough, said handle having a cut-out portion in the forward central portion thereof, and the aforementioned cut-out portion forming a lug extending downward at right angles to said handle and being located at the rear of the same cut-out, said lug formed from the cut-out in said handle having a centrally located hole, said shank extending through the centrally located openings in each of the aforesaid lugs, a rotatable member fitting over the rear portion of said shank and fixedly secured thereto, said rotatable member extending partially through the cut-out in said handle, being suitably knurled on the periphery thereof and accordingly facilitating the rotation of said shank and said prongs by manipulation of said rotatable member through the cut-out in said handle.

They Invented What? (No. 166)

U.S. Pat. No. 6,863,536: Endoscopic tutorial system with a bleeding complication.

 

What is claimed:

1. A system for performing a simulated medical procedure, comprising: (a) a simulated organ; (b) a simulated instrument for performing the simulated medical procedure on said simulated organ; (c) a locator for determining a location of said simulated instrument within said simulated organ; and (d) a visual display for displaying images according to said location of said simulated instrument within said simulated organ for providing visual feedback, such that said images simulate actual visual data received during an actual medical procedure as performed on an actual subject, said visual display including: (i) a three-dimensional mathematical model for modeling said simulated organ according to a corresponding actual organ, said model being divided into a plurality of segments, said plurality of segments being arranged in a linear sequence; (ii) a loader for selecting at least one of said plurality of segments from said linear sequence for rendering, said at least one of said plurality of segments being selected according to said location of said simulated instrument within said simulated organ; (iii) a controller for rendering a simulated image from said segment according to said location of said simulated instrument; (iv) a bleeding model for simulating a presence of blood in said simulated image wherein said blood is simulated and rendered according to said bleeding model, and wherein said rendered blood is added to said rendered simulated image wherein said bleeding model simulates bleeding caused by a pathological condition simulated for said simulated organ and bleeding caused by an action with said simulated instrument; and (iv) a displayer for displaying said rendered simulated image. 

USPTO Launches Ombudsman Pilot Program.

Per this press release at the USPTO today.

One-Year Pilot Program to Assist Applicants with
Patent Prosecution Issues

Washington – The Department of Commerce’s United States Patent and Trademark Office (USPTO) today launched a new “Ombudsman Program” designed to provide patent applicants with more assistance in handling application-processing problems if the normal channels have not been successful.  This one-year pilot program is intended to provide applicants with additional resources to ensure application-processing problems are handled in a more efficient way, thereby saving applicants and the Agency both time and resources and improving patent quality. 

Under this new program, applicants, attorneys or agents who have application-processing concerns, and haven’t been able to get the assistance they need through normal channels in the Technology Center (TC), can contact the ombudsman representative for the TC through the USPTO Web site (www.uspto.gov).  The applicant will receive a phone call within one business day for a discussion of the specifics of the issue.  From there, the ombudsman representative will work with TC staff to address the concerns expressed by the applicant and try to get the application back on track.

“This program is a direct response to feedback we’ve received from members of the patent community who have told us that they need a dedicated resource they can turn to when they have concerns about the prosecution of their application,” said Under Secretary of Commerce for Intellectual Property and Director of the USPTO David Kappos. “We are always striving for ways to improve the quality and efficiency of patent examinations, and we believe this initiative is an important step forward on both these fronts.”

Each TC will have one ombudsman representative and a back-up, both of whom were selected based on their experience.  The program is supported by senior supervisors and TC staff, including supervisory patent examiners, training quality assurance specialists, and subject matter experts.

The program will use a specially designed tracking database, containing only general information about the problems or concerns and whether the issue is open or closed.  Appropriate safeguards are built into the system so that all applicants will be treated with a high degree of fairness.  The ombudsman representatives will regularly review the database to ensure that the issues are addressed within 10 business days and to look for trends within the examination process that may indicate additional training needs.  Information from the database also will be used to build a Web site page that provides commonly seen problems and the resolutions to help attorneys and applicants resolve issues without the need for ombudsman assistance, and will also be used for bi-monthly USPTO-hosted conference calls with the intellectual property community on various topics.

The Ombudsman Pilot Program does not replace other existing resources available to patent applicants, attorneys or agents.  The ombudsman should only be contacted if an applicant, attorney or agent feels that examination has stalled and that their efforts to move their application forward through the normal channels (e.g., contacting the examiner or supervisory patent examiner) have not been effective.  

Additional details on the program are available at www.uspto.gov.

Questions from applicants should be directed to 571-272-4020.

They Invented What? (No. 165)

U.S. Pat. No. 3,984,595:  Inflatable rug.

What is claimed is:

1. An inflatable rug comprising a rug member laminated on top of a generally planar flexible walled hollow backing member, the walls of said backing member enclosing a cavity in said member, and valve means carried by said member in communication with said cavity to enable the introduction of pressurized gas into said cavity.