37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

The United States Patent and Trademark Office (Office) is revising the rules of practice to implement the changes to the patent term adjustment provisions in section 1(h) of the Act to correct and improve certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code (AIA Technical Corrections Act). Section 1(h) of the AIA Technical Corrections Act revises the date from which the fourteen-month patent term adjustment period is measured, and clarifies the date from which the three-year patent term adjustment period is measured, with respect to international applications filed under the Patent Cooperation Treaty. Under section 1(h) of the AIA Technical Corrections Act, the fourteen-month patent term adjustment period and the three-year patent term adjustment period will be measured from the same date: the date on which an application was filed under 35 U.S.C. 111(a) in an application under 35 U.S.C. 111; or the date of commencement of the national stage under 35 U.S.C. 371 in an international application. Section 1(h) of the AIA Technical Corrections Act also revises the provisions for notifying applicants of patent term adjustment determinations and for requesting reconsideration and judicial review of the Office's patent term adjustment determinations and decisions.

The United States Patent and Trademark Office (Office) is correcting final regulations that were published in the Federal Register on January 18, 2013 (78 FR 4212) (“Fee Setting final rule”) to set and adjust patent fees as authorized by the Leahy-Smith America Invents Act (“AIA”). The Fee Setting rule became effective on March 19, 2013 (except that certain regulations relating to international applications become effective on January 1, 2014). This rulemaking corrects those final regulations to revise minor inconsistencies within the Fee Setting final rule or arising from other recent rulemakings under the AIA. It also corrects minor inconsistencies with a few of the Regulations under the Patent Cooperation Treaty (PCT) and typographical errors.

The United States Patent and Trademark Office (Office) published in the Federal Register of February 14, 2013, a final rule revising the rules of practice in patent cases for consistency with, and to address the examination issues raised by, the changes in the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA) (First Inventor to File Final Rule). Due to a technical issue, the First Inventor to File Final Rule as published in the Federal Register is missing text in the provisions pertaining to claims for priority to a foreign application in an application filed under the Patent Cooperation Treaty (PCT). This document corrects the omission in the First Inventor to File Final Rule as published in the Federal Register .

The United States Patent and Trademark Office (Office or USPTO) sets or adjusts patent fees in this rulemaking as authorized by the Leahy-Smith America Invents Act (Act or AIA). The fees will provide the Office with a sufficient amount of aggregate revenue to recover its aggregate cost of patent operations, while helping the Office implement a sustainable funding model, reduce the current patent application backlog, decrease patent application pendency, improve patent quality, and upgrade the Office's patent business information technology (IT) capability and infrastructure. The fees also will further key policy considerations. The Office also reduces fees for micro entities under section 10(b) of the Act by 75 percent in this rulemaking and extends the existing fee discount of 50 percent for small entities to additional fees in this rulemaking.

The United States Patent and Trademark Office (Office) is revising the rules of practice in patent cases to implement the micro entity provision of the Leahy-Smith America Invents Act (AIA). Certain patent fees set or adjusted under the fee setting authority in the AIA will be reduced by seventy-five percent for micro entities. The Office is revising the rules of practice to set out the procedures pertaining to claiming micro entity status, paying patent fees as a micro entity, notification of loss of micro entity status, and correction of payments of patent fees paid erroneously in the micro entity amount. In a separate rulemaking, the Office is in the process of proposing to set or adjust patent fees under the Leahy-Smith America Invents Act, including setting fees for micro entities with a seventy-five percent reduction. The Office has sought to address the concerns of its stakeholders as expressed in the public comment, and plans to seek additional public comment on the micro entity provisions after the Office and the public have gained experience with the micro entity procedures in operation. The Office will pursue further improvements to the micro entity procedures in light of the public comment and its experience with the micro entity procedures.

The United States Patent and Trademark Office (Office or USPTO) is adjusting certain patent fee amounts for fiscal year 2013 to reflect fluctuations in the Consumer Price Index (CPI). The patent statute provides for the annual CPI adjustment of patent fees set by statute to recover the higher costs associated with doing business as reflected by the CPI.

The United States Patent and Trademark Office (Office) is revising the patent term adjustment provisions of the rules of practice in patent cases to better reflect the period of appellate review. The patent term adjustment provisions of the American Inventors Protection Act of 1999 (AIPA) provide for patent term adjustment if, inter alia, the issuance of the patent was delayed due to appellate review by the Board of Patent Appeals and Interferences (Board) or by a Federal court, and the patent was issued under a decision in the review reversing an adverse determination of patentability. The Office is specifically revising the rules of practice to indicate that the period of appellate review under the patent term adjustment provisions of the AIPA begins when jurisdiction over the application passes to the Board rather than the date on which a notice of appeal to the Board is filed.

The Leahy-Smith America Invents Act (AIA) expands the scope of information that any party may cite in a patent file to include written statements of a patent owner filed in a proceeding before a Federal court or the United States Patent and Trademark Office (Office) regarding the scope of any claim of the patent, and provides for how such information may be considered in ex parte reexamination, inter partes review, and post grant review. The AIA also provides for an estoppel that may attach with respect to the filing of an ex parte reexamination request subsequent to a final written decision in an inter partes review or post grant review proceeding. The Office is revising the rules of practice to implement these post-patent provisions, as well as other miscellaneous provisions, of the AIA.

The United States Patent and Trademark Office (Office) is revising the rules of patent practice to implement the preissuance submissions by third parties provision of the Leahy-Smith America Invents Act (AIA). This provision provides a mechanism for third parties to contribute to the quality of issued patents by submitting to the Office, for consideration and inclusion in the record of a patent application, any patents, published patent applications, or other printed publications of potential relevance to the examination of the application. A preissuance submission may be made in any non-provisional utility, design, and plant application, as well as in any continuing application. A third-party preissuance submission must include a concise description of the asserted relevance of each document submitted, and must be submitted within a certain statutorily specified time period. The third party must submit a fee as prescribed by the Director, and a statement that the submission complies with the statutory provision. The Office has also revised the rules of patent practice to make related aspects of the existing protest rule more consistent with the new rule implementing the preissuance submissions by third parties provision. Further, the Office is eliminating the provision providing for public use proceedings.

The United States Patent and Trademark Office (Office or USPTO) is adopting the new USPTO Rules of Professional Conduct (USPTO Rules), which are based on the American Bar Association's (ABA) Model Rules of Professional Conduct (ABA Model Rules), which were published in 1983, substantially revised in 2003 and updated through 2012. The Office has also revised the existing procedural rules governing disciplinary investigations and proceedings. These changes will enable the Office to better protect the public while also providing practitioners with substantially uniform disciplinary rules across multiple jurisdictions.

The United States Patent and Trademark Office (Office) is revising the rules of practice to implement the changes to the patent term adjustment provisions in section 1(h) of the Act to correct and improve certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code (AIA Technical Corrections Act). Section 1(h) of the AIA Technical Corrections Act revises the date from which the fourteen-month patent term adjustment period is measured, and clarifies the date from which the three-year patent term adjustment period is measured, with respect to international applications filed under the Patent Cooperation Treaty. Under section 1(h) of the AIA Technical Corrections Act, the fourteen-month patent term adjustment period and the three-year patent term adjustment period will be measured from the same date: the date on which an application was filed under 35 U.S.C. 111(a) in an application under 35 U.S.C. 111; or the date of commencement of the national stage under 35 U.S.C. 371 in an international application. Section 1(h) of the AIA Technical Corrections Act also revises the provisions for notifying applicants of patent term adjustment determinations and for requesting reconsideration and judicial review of the Office's patent term adjustment determinations and decisions.

The United States Patent and Trademark Office (Office) is correcting final regulations that were published in the Federal Register on January 18, 2013 (78 FR 4212) (“Fee Setting final rule”) to set and adjust patent fees as authorized by the Leahy-Smith America Invents Act (“AIA”). The Fee Setting rule became effective on March 19, 2013 (except that certain regulations relating to international applications become effective on January 1, 2014). This rulemaking corrects those final regulations to revise minor inconsistencies within the Fee Setting final rule or arising from other recent rulemakings under the AIA. It also corrects minor inconsistencies with a few of the Regulations under the Patent Cooperation Treaty (PCT) and typographical errors.

The United States Patent and Trademark Office (Office) published in the Federal Register of February 14, 2013, a final rule revising the rules of practice in patent cases for consistency with, and to address the examination issues raised by, the changes in the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA) (First Inventor to File Final Rule). Due to a technical issue, the First Inventor to File Final Rule as published in the Federal Register is missing text in the provisions pertaining to claims for priority to a foreign application in an application filed under the Patent Cooperation Treaty (PCT). This document corrects the omission in the First Inventor to File Final Rule as published in the Federal Register .

The United States Patent and Trademark Office (Office or USPTO) sets or adjusts patent fees in this rulemaking as authorized by the Leahy-Smith America Invents Act (Act or AIA). The fees will provide the Office with a sufficient amount of aggregate revenue to recover its aggregate cost of patent operations, while helping the Office implement a sustainable funding model, reduce the current patent application backlog, decrease patent application pendency, improve patent quality, and upgrade the Office's patent business information technology (IT) capability and infrastructure. The fees also will further key policy considerations. The Office also reduces fees for micro entities under section 10(b) of the Act by 75 percent in this rulemaking and extends the existing fee discount of 50 percent for small entities to additional fees in this rulemaking.

The United States Patent and Trademark Office (Office) is revising the rules of practice in patent cases to implement the micro entity provision of the Leahy-Smith America Invents Act (AIA). Certain patent fees set or adjusted under the fee setting authority in the AIA will be reduced by seventy-five percent for micro entities. The Office is revising the rules of practice to set out the procedures pertaining to claiming micro entity status, paying patent fees as a micro entity, notification of loss of micro entity status, and correction of payments of patent fees paid erroneously in the micro entity amount. In a separate rulemaking, the Office is in the process of proposing to set or adjust patent fees under the Leahy-Smith America Invents Act, including setting fees for micro entities with a seventy-five percent reduction. The Office has sought to address the concerns of its stakeholders as expressed in the public comment, and plans to seek additional public comment on the micro entity provisions after the Office and the public have gained experience with the micro entity procedures in operation. The Office will pursue further improvements to the micro entity procedures in light of the public comment and its experience with the micro entity procedures.

The United States Patent and Trademark Office (Office or USPTO) proposes to align the USPTO's professional responsibility rules with those of most other U.S. jurisdictions by replacing the current Patent and Trademark Office Code of Professional Responsibility, adopted in 1985, based on the 1980 version of the Model Code of Professional Responsibility of the American Bar Association (“ABA”), with new USPTO Rules of Professional Conduct, which are based on the Model Rules of Professional Conduct of the ABA, which were published in 1983, substantially revised in 2003 and updated through 2011. Changes approved by the ABA House of Delegates in August 2012 have not been incorporated in these proposed rules. The Office also proposes to revise the existing procedural rules governing disciplinary investigations and proceedings.

The United States Patent and Trademark Office (USPTO) published a notice of proposed rulemaking and a notice of proposed examination guidelines to implement the first-inventor-to-file (FITF) provisions the Leahy-Smith America Invents Act (AIA). The USPTO also conducted a roundtable to obtain public input from organizations and individuals on issues relating to the USPTO's proposed implementation of the FITF provisions of the AIA. The Office has received several requests for additional time to submit comments on the USPTO's implementation of the FITF provisions of the AIA. The USPTO is reopening the comment period to provide interested members of the public with an additional opportunity to submit comments to the USPTO.

The United States Patent and Trademark Office (Office or USPTO) proposes to set or adjust patent fees as authorized by the Leahy-Smith America Invents Act (Act or AIA). The proposed fees will provide the Office with a sufficient amount of aggregate revenue to recover its aggregate cost of patent operations, while helping the Office implement a sustainable funding model, reduce the current patent application backlog, decrease patent pendency, improve patent quality, and upgrade the Office's patent business information technology (IT) capability and infrastructure. The Office also proposes to reduce fees for micro entities under section 10(b) of the Act (75 percent discount). The proposed fees also will further key policy considerations. For example, the proposal includes multipart and staged fees for requests for continued examination and appeals, both of which aim to increase patent prosecution options for applicants.

The United States Patent and Trademark Office (Office or USPTO) is adjusting certain patent fee amounts for fiscal year 2013 to reflect fluctuations in the Consumer Price Index (CPI). The patent statute provides for the annual CPI adjustment of patent fees set by statute to recover the higher costs associated with doing business as reflected by the CPI.

The United States Patent and Trademark Office (Office) is revising the patent term adjustment provisions of the rules of practice in patent cases to better reflect the period of appellate review. The patent term adjustment provisions of the American Inventors Protection Act of 1999 (AIPA) provide for patent term adjustment if, inter alia, the issuance of the patent was delayed due to appellate review by the Board of Patent Appeals and Interferences (Board) or by a Federal court, and the patent was issued under a decision in the review reversing an adverse determination of patentability. The Office is specifically revising the rules of practice to indicate that the period of appellate review under the patent term adjustment provisions of the AIPA begins when jurisdiction over the application passes to the Board rather than the date on which a notice of appeal to the Board is filed.

The Leahy-Smith America Invents Act (AIA) expands the scope of information that any party may cite in a patent file to include written statements of a patent owner filed in a proceeding before a Federal court or the United States Patent and Trademark Office (Office) regarding the scope of any claim of the patent, and provides for how such information may be considered in ex parte reexamination, inter partes review, and post grant review. The AIA also provides for an estoppel that may attach with respect to the filing of an ex parte reexamination request subsequent to a final written decision in an inter partes review or post grant review proceeding. The Office is revising the rules of practice to implement these post-patent provisions, as well as other miscellaneous provisions, of the AIA.

The United States Patent and Trademark Office (Office) is revising the rules of patent practice to implement the preissuance submissions by third parties provision of the Leahy-Smith America Invents Act (AIA). This provision provides a mechanism for third parties to contribute to the quality of issued patents by submitting to the Office, for consideration and inclusion in the record of a patent application, any patents, published patent applications, or other printed publications of potential relevance to the examination of the application. A preissuance submission may be made in any non-provisional utility, design, and plant application, as well as in any continuing application. A third-party preissuance submission must include a concise description of the asserted relevance of each document submitted, and must be submitted within a certain statutorily specified time period. The third party must submit a fee as prescribed by the Director, and a statement that the submission complies with the statutory provision. The Office has also revised the rules of patent practice to make related aspects of the existing protest rule more consistent with the new rule implementing the preissuance submissions by third parties provision. Further, the Office is eliminating the provision providing for public use proceedings.