IDS And Amendments Filed After Final Rejection Presented By:Steven P. Scuderi Pepe & Hazard LLP Pepe & Hazard LLP

Final Rejection: 37 CFR I)On the second or any subsequent action, an Examiner can make an action final when: A)The Examiner repeats a rejection previously made; or B)Makes a rejection which was necessitated by an action of the applicant. II)A final rejection is not literally “final”; rather it establishes a restrictive set of rules which govern what the applicant can do and how prosecution or appeal can be continued. 2

Reply To Final Rejection: 37 CFR I)A reply under 37 CFR is limited to: A)An amendment complying with 37 CFR 1.116; B)A Notice of Appeal (and appeal fee); or C)A request for continued examination (RCE) filed under 37 CFR with a submission, i.e., an amendment that meets the reply requirement of 37 CFR 1.111, and the fee set forth in 37 CFR. II)Failure to properly reply under 37 CFR to the final rejection results in abandonment. III)Alternatively, a continuation or CIP can be filed and the original case can be abandoned. 3

Amendments After Final Action Or Appeal: 37 CFR (a)An Amendment after final action or appeal must comply with Section or this section. (b)After a final rejection or other final action (Section 1.113) in an application or in an ex parte re-examination filed under Section 1.510, or an action closing prosecution (Section 1.949) in an inter partes re-examination filed under Section 1.913, amendments may be made canceling claims or complying with any requirement of form expressly set forth in a previous Office Action. Amendments presenting rejected claims in better form for consideration on appeal may be admitted. The admission of, or refusal to admit, any amendment after a final rejection, a final action, an action closing prosecution, or any related proceedings will not operate to relieve the application or patent under re-examination from its condition as subject to appeal or to save the application from abandonment under Section 1.135, or the re-examination from termination. No amendment can be made in an inter partes re-examination proceeding after the right of appeal notice under Section except as provided for in paragraph (d) of this section. (c)If amendments touching the merits of the application or patent under re-examination are presented after final rejection, or after appeal has been taken, or when such amendment might not otherwise be proper, they may be admitted upon a showing of good and sufficient reasons why they are necessary and were not earlier presented. (d)No amendment can be made as a matter of right in appealed cases. After decision on appeal, amendments can only be made as provided in Sections and 1.981, or to carry into effect a recommendation under Section or Section

Amendments Permitted Under 37 CFR 1.116(b) I)Amendments may be entered under 1.116(b) only if: A) They will place the application in condition for allowance; B) In better form for appeal; or C)Are to comply with objections or requirements as to form. II)Ordinarily, amendments filed after the final action are not entered unless approved by the Examiner. See, MPEP Section (f), Section and Section

Amendments Not A Matter Of Right: 37 CFR 1.116(c) I)Amendments “touching the merits of the application,” are not a matter of right, including: A)Amending any finally rejected claims; B)Adding new claims; or C)Reinstating previously canceled claims under Section 1.116(c). II) A showing of good and sufficient reasons why they are necessary and were not earlier presented. 6

III) A refusal to permit such an amendment is not a rejection on the merits and leaves the application in the same status it was in after the final rejection. IV)Allowance of amendments after final rejection is a matter of discretion and the remedy therefrom is a petition to the Commissioner under Rule 181. In RE: Berger, 61 USPQ2d 1523 (CA FC 1/29/2002). Amendments Not A Matter Of Right: 37 CFR 1.116(c) (continued) 7

Genzyme Corp. v. Transkaryotic Therapies, Inc., 68 USPQ2d 1596 (CA FC 10/9/2003) I)Ruling: Amendments made to claims after final rejection cannot alter substantive scope of claims without explanation regarding necessity of amendment and reasons for delay in proposing change. II)Facts: A) Infringement case involving a method of producing a human enzyme; B)Language for an amendment after final was accepted by the Examiner during an Examiners interview; C)The record did not explain the reasons the Examiner accepted the language; and D)Genzyme argued that the amendment after final broadened the scope of the claims. 8

Genzyme Corp. v. Transkaryotic Therapies, Inc., 68 USPQ2d 1596 (CA FC 10/9/2003) (continued) III)Court’s analysis: A)According to PTO rules (37 CFR 1.116), the Examiner could not accept supplemental amendment broadening scope of claims without formal comment from applicants; and B)Accordingly, the Examiner could not have allowed this amendment if it changed at all the scope of the claims set forth in the prior prosecution history. 9

Conflicts Between Amendments After Final And The Second Eye Review 10 I)On March 29, 2000, the USPTO announced an Action Plan for business method patents to improve the quality of the examination process in technologies related to electronic commerce and business methods, i.e., in Class 705. II)Second Eye Review: A new second-level review of all allowed applications in Class 705 is now required. A)Not a full re-examination; and B)Purpose to ensure compliance with search requirements, reasons for allowance and a determination as to whether the scope of claims should be reconsidered.

Conflicts Between Amendments After Final And The Second Eye Review (continued) III)Second Eye Reviews take extra time and can often extend past the 6 month deadline for reply. 11 A)110 Patent Examiners in Class 705. Only 2 to 4 Examiners for Second Eye Reviews; B)Approximately 500 issued patents in Class 705 in 2003; C)Can still take 3 to 4 months for a Second Eye Review; and D)Amendments after final alone are not considered an official reply and do not toll the deadline for abandonment.

War Story 12 I)May 6, 2003: Final Office Action issued by USPTO. Only rejection was for obvious-type double patenting. II)May 20, 2003: Filed a terminal disclaimer. III)August 4, 2003: Contacted Examiner. Informed of allowance and Second Eye Review. Examiner said that the process could take up to 6 months. IV)Early November 2003: Filed a Notice of Appeal to prevent the application from going abandoned.

War Story (continued) 13 VI)End of December 2003: Filed a petition to request a refund of fees spent due to keeping the application from going abandoned in view of the undue delays at the USPTO. VII)Early January 2004: Became necessary to file an Appeal Brief on behalf of the client. V)Late November 2003: Informed that new prior art had been discovered and that a new, non-final Office Action would be issued in the near future.

Recommendations I)Check to see if you have to be in Class 705. II)File an RCE with the Amendment After Final on any final rejection in Class 705. A)Removes finality of the action; B)Amendments become a matter of right; and C)Tolls the 6 month deadline date. 14 III)File a Notice of Appeal with an Appeal Brief with the Amendment After Final. A)May be less expensive than the RCE to file; B)Will not avoid the Second Eye Review; and C)Will extend the prosecution time.

Recommendations (continued) IV)If getting close to the 6 month deadline date, call the Examiner and request that the Second Eye Review be expedited, i.e., taken out of order. A)Do not have to file a petition to make special as in a normal review; B)Informal process and discretionary with the Examiner; and C)Examiners want to expedite the Second Eye Review. 15

Related Problems With Amendments And/Or IDS Filed After Notice Of Allowance I)How the system works in theory: A)If an application is in paper form, than after a Notice of Allowance, the application is mailed to the off-site Publication Branch Data Capture Facility (Pubs); B)If an IDS and/or amendment is filed after the application is mailed to Pubs, the application is returned to the Examiner for consideration upon request; C)If the application is filed as an Image File Wrapper (IFW) file in the USPTO electronic database, the IDS or amendment is scanned into the IFW file and a message is sent to the Examiner; and D)The Examiner can view the whole IFW file at anytime from their desktop. 16

17 Related Problems With Amendments And/Or IDS Filed After Notice Of Allowance (continued) II)Problems with the system in practice: A)Examiners sometimes have difficulty obtaining paper application files in a timely fashion once it has been mailed to Pubs; B)The issue fee must be paid within 3 months from the date of the NOA or the case is abandoned; and C)The case could issue without the IDS being considered. III)Recommendations: A)File an RCE before paying the issue fee.

B)Problem is only a temporary one: Related Problems With Amendments And/Or IDS Filed After Notice Of Allowance (continued) i)All pending paper applications are now being scanned into IFW database as soon as an action is generated from the applicant on the case, e.g., IDS, amendment, response to an Office Action; ii)Once scanned, a message is sent to the Examiner indicating that a reply is required; and iii) Should effectively eliminate problem in about 2 to 4 months. 18