Post-Allowance Prosecution: The End Game That Goes On To The End

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1 Post-Allowance Prosecution: The End Game That Goes On To The End By Robert M. Hansen i Partner The Marbury Law Group, PLLC Sunrise Valley Dr., 15 th Floor Reston, VA (fax) Prepared for: AIPLA Practical Patent Prosecution Training for New Lawyers 2013 i Much of the content of this paper was originally based upon (and in places paraphrases portions of) the paper Navigating Post-Allowance Procedures, Including Patent Issuance, Certificates of Correction, Reissues, Disclaimers, and Maintenance Fees authored by Steven J. Helmer for the AIPLA Practical Patent Prosecution Training for New Lawyers course in

2 Introduction The application has been examined, prosecuted, and finally allowed. The client is thrilled. Are you finished? Of course not! This paper briefly outlines the steps that are required to continue prosecuting the application through issuance, after issuance, and on until the end of the patent s life. This paper covers issues associated with paying the issue fee, correcting errors in the application, disclaimers that may need to be filed during the life of the patent, and payment of maintenance fees required to keep the patent valid. The Notice of Allowance Three Months to Pay Fees Your first indication that a patent application has been allowed will likely be receipt of the Notice of Allowance from the PTO. The Notice of Allowance is a key document specifying important information related to the patent, including the amount of money required to be paid for the patent to issue. Issue fees must be paid within three months from the date of mailing of the Notice of Allowance to avoid abandonment of the application. See 37 CFR Key practice note: The three-month period for paying the fees is not extendable. Therefore, it is important that upon receiving the Notice of Allowance you promptly review the notice and the application to confirm it is ready to issue and send the Notice to the client to obtain authorization to pay the issue fee within that period of time. 1 Upon receiving the Notice of Allowance, it is a good idea to forward it to the client as soon as possible, consistent with your firm s procedures, due to the limited period of time for addressing the potential issues. Reviewing the Notice of Allowance The Notice of Allowance, as well as the application itself, needs to be reviewed to confirm that the application is ready to issue and that the data contained in the Notice and associated PTO documents are accurate. You can easily fix most errors in an application at this point, but once it issues as a patent your options for correcting errors are greatly diminished. There are many issues that need to be checked while reviewing the Notice of Allowance and the application. For this reason, many firms use checklists that are completed before issue fees are paid. You should be familiar with your firm s checklist and understand your role in filling it out. 1 It is possible to pay the issue fee late if the three month period is missed due to unavoidable or unintentional circumstances with a petition to revive the application, but relying on such a backup plan is not a good way to practice your profession, nor a good way to spend firm or client money. 2

3 While reviewing the Notice of Allowance, you will want to confirm that the information appearing on the form is correct, including the inventors names, the title of the patent, the small or large entity status of the client, and the address of the law firm. Such information will appear on the patent, so the Notice of Allowance presents an opportunity to find and correct errors in these details that may have been introduced during prosecution. The Notice of Allowance lists the fees required for the patent to issue which are premised on the client s small/large entity status. It is important to check whether the client s small/large entity status is still accurate. It is not uncommon for clients to change their status during the prosecution of an application, particularly from small to large. This happens more often than you might think, as many small clients grow, become acquired or license the patent portfolio during prosecution of their applications. Knowingly paying a small entity issue fee when a large entity fee is required may result in the patent being held unenforceable (at least until the error is corrected). So it is worthwhile to confirm that no change in small/large entity status has occurred. Key practice note: if the client licenses the application to a large corporation, which happens frequently, then the client has lost its small entity status, at least with respect to the licensed application. Thus, this question presents an opportunity for inadvertent slipups that can lead to lost patent rights. The second page of the Notice of Allowance is the issue fee transmittal form. This form must be included with payment of the issue fees and submitted in duplicate when the fees are paid by mail. This form provides you an opportunity to change the correspondence address and the fee address for the patent. This may be useful if your firm does not pay the maintenance fees on behalf of clients or the client would like correspondence associated with the patent (such as letters of interest in a license or acquisition) to be addressed to someone else, such as in-house counsel. The issue fee transmittal also permits you to list the names of attorneys and the law firm that will appear on the face of the patent. Also, the form allows you to name the assignee and the city and state of the assignee that will be printed on the face of the patent. Thus, this form provides a convenient way to correct the details that will be printed on the face of the patent. The Notice of Allowance also includes a determination of patent term adjustment under 35 USC 154(b). The importance of patent term adjustment is addressed later in this paper. A Notice of Allowability will accompany the Notice of Allowance in most cases. This form lists the claims that are allowed and, like many Office Actions, provides check boxes that convey valuable information regarding what is required to complete the prosecution of the application. For instance, the Notice of Allowability may require submission of an oath or declaration, corrected drawings, or deposit or information regarding a deposit of biological materials before the patent can issue. Therefore, the 3

4 Notice of Allowability needs to be carefully reviewed to confirm that the information is correct and that no further submissions are required before the patent issues. In many cases, a Notice of Allowance will also be accompanied by a statement of the examiner s final actions. Like every other Office Action, this is an important document within the patent file history. Statements made by the examiner can and will be used against you in a court of law if the patent is ever litigated, and therefore need to be considered for their potential estoppel effect. For example, if the examiner refers to a telephonic interview or examiner s amendment, you should carefully review such statements to confirm that they are accurate and do not include potentially misleading descriptions of your discussions with the examiner. If the last communication with the examiner was an interview, either in person or by telephone, the Notice of Allowance may also include an interview summary. This summary needs to be reviewed for accuracy and misleading statements just as if it were provided to you during pre-allowance prosecution. Often, the Notice of Allowance will include reasons for allowance or a statement by the examiner of the reasons for allowing the claims. The examiner s statement of reasons for allowance is an important part of the prosecution file history. 2 For this reason, the statement should be reviewed to ensure it is accurate, precise, and does not place unwarranted or unintended interpretations or limitations upon the claims. The examiner s statement of the reasons for allowance can be addressed in writing by filing a comment on statements of the reason for allowance when paying the issue fee. This paper will be included in the patent file history. Not addressing the examiner s statement should not be treated by courts as acquiescence to the statement. 3 However, if you do not object to an unnecessarily narrowing statement, you will have given up a good opportunity to argue against a narrow claim construction. For this reason, it is important for you and your client to consider the statement to ensure that there is nothing that should be addressed in writing before the patent issues. See MPEP for guidance for determining whether an examiner statement is inappropriate. Note that comments on the examiner s statement are placed in the file history but are generally not be given to the examiner, so receiving no response does not mean the examiner acquiesced with your comments. 4 Review of the Notice of Allowance should be conducted as soon as possible after it is received so that it can be forwarded to the client with any issues in the Notice identified. In many cases, clients are anxious to hear that a patent is allowed as their business plans may hinge on such events. For instance, your client may want to issue a press release as soon as the application has been allowed, or perhaps your client has been waiting to make a major investment until they received notice that their invention will be patented. Thus, there should be no holdup in passing the Notice of Allowance onto the 2 See e.g., Zenith Labs., Inc. v. Bristol-Myers Squibb Co., 19 F.3d 1418, 1425, fn 7-8, (Fed. Cir. 1996). 3 See Salazar v. Procter & Gamble Co., 414 F.3d 1342, 1347 (Fed. Cir. 2005). 4 MPEP V. 4

5 client. But in doing so, it is important to point out potential issues that may appear in the document. Many firms have standard reporting form letters for forwarding the Notice of Allowance to clients. Such forms may include standard paragraphs for addressing the many issues that should be considered at the time the application stands allowed. You may be required to select from various standard paragraphs to be included in the letter as applicable to the particular application. For example, you may need to select a form paragraph that addresses the examiner s reasons for allowance if such reasons appear in the Notice of Allowance. The bottom line in the reporting letter is to point out those aspects of the Notice of Allowance that the client should pay particular attention to. Like all legal advice provided to clients, the Notice of Allowance involves a number of tricky issues, and therefore recognition of the importance of such issues should not be left entirely to the client. It is worth noting, that if significant errors are identified in the Notice of Allowance, you may want to recommend that the client be called to discuss your concerns verbally rather than in writing. It is always important to keep in mind that anything you put in writing may be used against the client in a later litigation. Reviewing the application Once the Notice of Allowance has been reported to the client, you may be asked to review the application and the file history to confirm that the patent is ready to issue. Depending upon the policies of your firm and the desires of the client, this may range from a quick review for major errors to a detailed proofreading of the patent specification. The purpose of this review is to identify issues that may require amendment or even withdrawal of the application from issue so such measures can be taken before the issue fee is paid. For example, a number of major problems with an application may result in an invalid or unenforceable patent if it is allowed to issue without correction. Such errors can be addressed by filing a petition to withdraw it from issue along with a request for continuing examination (RCE), which is a more expeditious way of dealing with significant errors than filing a reissue request after the patent issues. There are several issues that should be considered when reviewing the application and its file history prior to issuance. Among these issues will be: whether the proper claim to priority (as such as foreign priority claims) has been filed and acknowledged by the PTO; whether a foreign priority document has been filed with the application. whether all potentially relevant documents have been disclosed in an IDS and that the examiner has considered each of the documents filed in an IDS; whether there is any patentable intellectual property disclosed in the application but not reflected in the claims; and whether there are any errors in the specification or claims that should be corrected. 5

6 Often the claim to an early priority date is very important to the validity of the patent. For this reason, it is important to confirm that the proper claims to priority have been made in the application, reflected in the application file history and acknowledged by the PTO. It is easier to correct the record prior to issuance than it is afterwards, and far less expensive for the client. In this respect, it is important in the case of U.S. applications that claim priority to a foreign application to confirm that the foreign priority document has been received and acknowledged by the USPTO. For many countries like Japan and the EPO this is automatic for utility applications as part of the cooperation between patent offices. HOWEVER, this is not the case for design patents. So, confirm that the priority document has been provided. If not, you can petition for late acceptance of the priority document and get it on file prior to or as part of paying the issue fee. Key practice note: The applicant s duty to disclose all potentially relevant documents continues until the day the patent issues. Thus, if you or the client have recently become aware of potentially relevant documents, those documents must be submitted to the PTO in an IDS. If you find that not all potentially relevant documents have been submitted to the PTO, it may be appropriate to withdraw the application from issuance so that you can file an appropriate IDS for consideration by the examiner. This can happen when the patent is examined very quickly, with the Notice of Allowance arriving before the client has sent you documents for an IDS. Thus, your post allowance review should include careful consideration of all submitted IDSs and prior art known to you and the applicant. It is far less expensive to withdraw an application from issue and file a proper IDS than it is to defend a patent in litigation against allegations of inequitable conduct for failing to do so. Another detail to check is whether the examiner has initialed all prior art cited in IDS filings. It may be important to a future enforcement of the patent to have an indication in the file history that the examiner considered all of the documents previously submitted in an IDS. While a patent enjoys the presumption of validity, that presumption has special significance when the examiner has actually considered a prior art reference that is asserted against the patent in litigation. For this reason it is important to check that the examiner has initialed, checked or otherwise indicated that each reference was considered. In some cases, it may be appropriate to contact the examiner and request that an initialed IDS be issued and included in the file history. As part of your post allowance review, you may be asked to proofread the specification or the claims. Obvious errors in the specification and claims can be corrected by an amendment before issue but only by a certificate of correction or reissue after issue. The importance of correcting errors in claim language and the specification before the patent issues cannot be overemphasized. This is illustrated in my favorite case as a patent litigator, Chef America v. Lamb-Weston. In Chef America the Federal Circuit held that a claim reciting heating dough to a temperature in the range of about 400 F to 6

7 850 F was clear and unambiguous, and therefore could not be corrected as an error, even though it is obvious that bread dough heated to that temperature, rather than at that temperature, would be burned to a crisp. 5 It was too late to correct the error after the patent issued when the patent holder attempted to enforce it against its rival. Thus, the post allowance review of the claims is your last opportunity to find and correct a Chef America mistake. Some clients will pay for a proofreader to review the entire application to identify errors that can be included in a certificate of correction. If you have such a client, such reviews represent money well spent since a fresh set of eyes will often find errors that you, the prosecutor, failed to see. Correcting such errors may foreclose some expensive issues that would otherwise have developed during patent litigation. Finally, your review of the application should determine whether there are any patentable inventions or details not included in the allowed claims. The client should be asked whether a continuation application should be filed before the issue fee is paid. A continuation application allows the client to pursue new claims that are supported by the specification. The Federal Circuit has ruled that subject matter disclosed in an application but not recited in a claim may be dedicated to the public and excluded from the scope of the claims under the Doctrine of Equivalents. 6 Also, once a patent issues and the application dies, the patent becomes prior art to any subject matter disclosed in the specification. Thus, it is important to consider whether there is any patentable subject matter of value disclosed to the specification but not reflected in the claims. As a minimum, the opportunity to file a continuation and the merits for doing so should be explained to the client in the letter forwarding the Notice of Allowance, along with an explanation of the implications of not claiming such subject matter. If you recognize subject matter that could be reflected in claims filed in a continuation, you should point this out to the client and explain the opportunity they have to file a continuation to pursue such claims. Many law firm checklists include a box for indicating whether a continuation should be filed. You would be wise to consider this question as one of whether there is any unclaimed patentable subject matter and not just whether you have received instructions from the client to file a continuation. Amendments after Allowance If you discover that the application or the claims have errors that will require an amendment, you may need to file a continuation application to make the corrections. Under limited circumstances, you may amend the case under 37 CFR 1.312, even after allowance. Under 37 CFR 1.312, no amendment may be made as a matter of right in an application after the mailing of the Notice of Allowance. Any amendment filed pursuant F.3d 1371, 1373 (Fed. Cir. 2004). 6 See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Service Co., Inc., 285 F.3d 1046, 1054 (Fed. Cir. 2002). 7

8 to 37 CFR must be filed before or with payment of the issue fee, and may only be entered on the recommendation of the primary examiner. 7 In general, amendments under 37 CFR may be entered if they involve merely the correction of formal matters in the specification or drawings, or formal matters in a claim without changing the scope, or the cancellation of claims from the application. See MPEP A change in inventorship may also be entered as an amendment under 37 CFR Such amendments are often entered when they are needed for proper disclosure or protection of the invention and require no substantial amount of additional work on the part of the PTO. Id. When submitting an amendment under 37 CFR 1.312, the amendment should state in the remarks: (A) why the amendment is needed; (B) why the proposed amended or new claims require no additional search or examination; (C) why the claims are patentable; and (D) why they were not presented earlier. MPEP Depending on the circumstances, you may want to telephone the examiner when filing an amendment under 37 CFR When you talk with the examiner, you can explain the circumstances, such as why the amendment should be entered. Since afterallowance amendments are not automatically entered, you may want to confirm entry of the amendment before paying the issue fee. Then, if the examiner refuses to enter the amendment you can file a request to withdraw the application from issue under 37 CFR or file an RCE that requests entry of the amendment. Keep in mind that the three month period to pay the issue fee (or file an RCE if necessary) cannot be extended, so filing such an amendment and calling the examiner should not be put off. Checking the Checklist At some firms, your first exposure to the Notice of Allowance checklist will be when it comes time to pay the issue fee. Hopefully, by then you have had an opportunity to inform the client of any issues in the Notice of Allowance and have an opportunity to review the application for the issues discussed above. Often, in a large firm the checklist may be filled out by the prosecution support staff and provided to you for review and sign off. It is still important for you to consider all of the entries made by the prosecution staff and double check that the important information in the Notice of Allowance and associated documents are correct. Paying and Reporting Payment of the Issue Fee Once the Notice of Allowance and the application have been reviewed, and the client has provided instructions to pay the issue fee, you can pay the fee. It is worth noting that an important step in this process is to receive formal instructions from the 7 See also MPEP to (e). 8

9 client to actually pay the issue fee. I have seen circumstances where, for reasons known only to the client, there was a decision not to pay the issue fee. Also, the client may have found more prior art that needs to be disclosed (along with an RCE). So, do not presume that the issue fee is to be paid without the client s consent. Since the date for paying the issue fee is not extendable, you should avoid paying the issue fee on the due date. You (and your boss) will not appreciate the excitement of paying the issue fee on the last day, particularly during hurricanes and winter storms. If you pay the issue fee electronically, you will receive an immediate receipt that the fee has been submitted. However, if you pay the fee by mail as many do, there will be a week of anxious time before the PTO website reflects that the fee has been received and recorded. When paying the issue fee, be sure to confirm that any issues that you spotted while reviewing the Notice of Allowance are properly corrected in the issue fee transmittal form. For instance, be sure that the name of the assignee is correct and that the payment being submitted is appropriate (e.g., large or small entity fee as appropriate). After the issue fee has been paid, you will need to report the payment to your client. This is an important reporting letter even though it may seem unnecessary, because many clients are aware that they only have three months to make the payment. If you neglect to promptly inform them that the issue fee was paid, you may receive a panic call from the client the day after the fee was due. Deferring Issue While infrequently implemented, it is possible to petition to defer issue of a patent for a short period of time such as a month or two after the issue fee has been paid. This might be necessary if licensing negotiations are on going, or in the case where the application has not yet published and the client is not ready to reveal their invention to the world or a foreign filing needs to be made. This may be made by filing a Petition to Defer Issue along with the petition fee and a showing of good and sufficient reasons why deferral is necessary. See MPEP for further information on this process. Withdrawal from Issue If your post allowance review indicates that a significant issue exists with the application, you may withdraw the application from issue by filing a petition and paying the appropriate PTO fee. For example, if a foreign search report includes a highly relevant prior art, or you learn of a potentially interfering application or patent, the best course of action may be to withdraw the application from issue so that such issues can be properly addressed by the examiner. If an issue can be addressed by the examiner, the patent enjoys a heightened presumption of validity with respect to that issue. Thus, if the client is likely to assert the patent in litigation, it is generally better to accept the delay and additional cost of continuing prosecution, rather than leaving a newly discovered issue to be addressed in litigation. 9

10 The requirements for withdrawing an application from issue vary depending upon whether the issue fee has been paid. If the issue fee has not been paid, there are three ways to withdraw an application from issue. First, you can file a petition that includes a showing of good and sufficient reasons why withdrawal of the application is necessary under 37 CFR Second, you can file a request for continued examination (RCE) and pay the appropriate fee. Third, you can file a continuation application and allow the parent application to go abandoned for failure to pay the issue fee within the three month period. The choice among these three options will depend upon the circumstances and the client s business objectives. For example, you may want to file a petition to withdraw from issue in order to cancel invalid claims. You may want to file an RCE in order to permit an examiner to consider newly disclosed prior art or to review amended claims which may be considered broader than what was allowed. Filing a continuation will delay the ultimate issuance of a patent significantly, but will allow you to claim a different invention or add new material. If the issue fee has already been paid, you must file a petition to withdraw from issue under 37 CFR There are three reasons that a petition withdrawing the patent from issue may be granted. Each reason requires filing a petition providing a showing of good and sufficient reasons why withdrawal of the application from issue is necessary. The three reasons are: (1) unpatentability of one or more claims, which must be asserted in a petition accompanied by an unequivocal statement that one or more claims are unpatentable, an amendment to such claim or claims, and an explanation as to how the amendment causes such claim or claims to be patentable; (2) consideration of a request for continued examination (RCE); or (3) express abandonment of the application, e.g., in favor of a continuing application. See 37 CFR It is important to keep in mind that once the issue fee has been paid, an RCE is not a new application, so the PTO cannot grant a petition to convert an untimely RCE to a continuing application. MPEP Therefore, you are strongly cautioned to consider and decide whether an RCE should be filed prior to paying the issue fee. Id. If you do decide that you need to withdraw an application from issue after the issue fee has been paid, you must submit the petition in time for it to be received, reviewed and granted by the appropriate PTO officials all before the application issues. See 37 CFR For this reason the MPEP suggests faxing or hand-delivering the petition. See MPEP 1308 I.B. If you are facing a situation in which you must file a petition to withdraw an application from issue well after the issue fee has been paid, you may need to contact the Petitions office of the PTO for advice, and ensure your petition is properly filed and timely considered. In this regard, keep in mind that the PTO is becoming ever more efficient in issuing patents, so the issue date may happen quicker than you think. 10

11 PTO Quality Review Program may Vacate Notice of Allowance The PTO conducts a Quality Review Program in which they review selected examined and allowed applications for patentability. 8 Allowed applications are randomly selected by computer and passed to a review quality assurance specialist for an independent review of the claims. This random review is intended to improve patent quality and reduce the number of patents that may be found invalid. Reviewed applications may be returned to the examiner if the examiner s search is found to be inadequate or one or more claims are found to be unpatentable. If this happens, prosecution on the merits of the application will be reopened and the Notice of Allowance will be vacated. If this happens after the issue fee has been paid, a refund may be requested immediately or the applicant can wait to see if the application is eventually allowed. If it is later allowed, the applicant can request that the previous submitted issue fee be applied. If the application is later abandoned, a refund can be requested at that point. Submitting Relevant Documents after Paying the Issue Fee After the issue fee as been paid, the duty to disclose relevant documents remains in force. While the time is short now between when the issue fee is paid and the patent issues, relevant documents sometimes pop up. Relevant documents may be brought to your attention from foreign prosecution of related applications. If such documents are received after the issue fee is paid but before the patent issues, such documents should be submitted in an IDS as soon as possible. Last year the USPTO conducted a pilot program, entitled the Quick Path Information Disclosure Statement (QPIDS) Pilot Program to permit examiners to consider an IDS after payment of the issue fee without the need to reopen prosecution. 9 The USPTO has been collecting feedback on the program, so it is possible that USPTO may elect to implement something similar on permanent basis. Issuance After the issue fee as been paid, the PTO transfers the application to Publications and, in time, a patent issues. The PTO has been working hard to reduce the time between payment of the issue fee and publication; I am currently advising clients that a patent may issue within two months or so after payment of the issue fee. Two weeks before the patent issues the PTO will mail an Issue Notification that will indicate the issue date and the assigned patent number. The Issue Notification is not always received before the patent issues, particularly if there is a long delay in your firm s internal mail distribution. Therefore, it is good practice to plan on filing continuation applications at least by the time the issue fee is paid, and at worst within a 8 See MPEP See 11

12 week or two after payment of the fee. Waiting until you receive an Issue Notification to file the continuation is like playing Russian Roulette. Clients appreciate learning about the issuance of their patents from their patent attorneys. Your client may be waiting for a patent to issue before taking some significant business action, such as issuing a press release or sending a notice letter to potential infringers and competitors. Also, clients may not appreciate learning that their patent has issued from a competitor, the press, or other law firms. Therefore, it is good practice to immediately report to your client when their patent issues. The policies and procedures of law firms vary as to what happens to patents after they issue. Therefore, you should be familiar with your firm s practice so that you can support the process. For instance, if issued patent files are forwarded to the client, you will want to review the file in order to remove personal or extraneous materials and to include important documents that should be part of a file that may be lying around your office. Certificates Of Correction Even though the patent has now issued, your job is not finished. It is a good idea to proofread the patent when it issues to confirm that there are no typographical errors resulting from publication. However, not all clients will pay you for such proofreading. Therefore, in your reporting letter, you should point out the need to carefully review the patent so that printing errors can be identified and corrected by petition. Correcting errors in patents can increase the value of the patent. If an error goes uncorrected, a competitor or future infringer may argue that the claims are ambiguous in view of the error, and therefore invalid. Alternatively, an infringer may argue for claim constructions based on errors that free them from liability. See Chef America for example. 10 Also, patents that include numerous errors are inherently expensive to enforce in litigation due to the issues for argument and motions that such errors may present. Some errors that appear in patents may be corrected by certificates of correction. Those errors outside the realm of a certificate of correction will need to be corrected by reissue which is discussed below. Errors that were made by the PTO may be corrected by a certificate of correction at no charge to the patent holder. For a mistake in a patent caused by the PTO that is clearly disclosed in the records of the PTO, the PTO may issue a certificate of correction under 35 USC 254. Alternatively, the PTO may issue a corrected patent without charge with the same effect as a certificate of correction under the same law. 10 The Federal Circuit noted that the Chef America patentees made no attempt to have such an error corrected, either by obtaining a certificate of correction from the Patent and Trademark Office pursuant to 35 U.S.C. 255, or by action of the district court. 12

13 The PTO will issue a certificate of correction to correct PTO mistakes at the patentee s request, on their own initiative to correct errors that the PTO discovers, or when informed of a mistake by a third party. See 37 CFR 1.322; MPEP Errors that were made by the applicant may be corrected by a certificate of correction under some circumstances with the payment of a suitable fee. To obtain such a certificate of correction, the error must have been a mistake made in good faith and be (1) of a clerical nature, (2) of a typographical nature, or (3) a mistake of minor character. See 35 USC 255; MPEP Additionally, the nature of the change must not involve new matter or require reexamination. Id. Thus, significant errors in claim language, such as a need to change to to at as in Chef America, may not be suitable for a certificate of correction, since the scope of the claims is implicated, potentially requiring reexamination. The Federal Circuit has found that broadening corrections to clerical and typographical errors in the claims are permitted by 35 USC 255 where both the error in the corrections are clearly evident from the specification, drawings, and prosecution history. 11 If you detect an error requiring correction, you need to decide whether it is appropriate for a certificate of correction or whether the application should be withdrawn from issue to correct the error in an RCA or continuation. Check with the client to see if there is a preference. Under some circumstances, you may file for a certificate of correction to add or correct the assignee s name, to correct inventorship, or to add or correct claims of priority under 35 USC 119 and 120. If you feel that a change is covered by a certificate of correction, you may file for it and then see if the PTO accepts the request. If the PTO does not grant the request, you may then request reexamination or reissue to correct the error using those procedures. However, it is important to keep in mind that a broadening reissue can only be filed within two years after the patent issues. Therefore, if you are concerned that the PTO may not accept your request for a certificate of correction, your request should be filed well before that two year date to permit the PTO to act and for you to file for a reissue application if necessary. In filing for a request for a certificate of correction, you need to address the statutory and PTO rule requirements in your request and file a special certificate of correction form, an example of which is available on the PTO web site as form sb0044.pdf ( If the PTO agrees with your request, they will issue a printed copy of the certificate of correction, which will be published in the Official Gazette and is considered a part of the original patent. The patent together with its certificate of correction then has the same effect as if the patent originally issued in the correct form. Thus, a certificate of 11 Superior Fireplace Co. v. The Majestic Products Co., 270 F.3d 1358, 1376, (Fed. Cir. 2001). 13

14 correction has retroactive effect, which is not the case for claims changed in reissue and reexamination procedures. Key practice note: The easiest way to fix an error in a patent is through a certificate of correction. The process is simple and the change has retroactive affect. However, the mistake must have been made in good faith and be of a clerical nature, a typographical nature, or of minor character, and correction of the error may not introduced new matter or require reexamination. Patent Term Adjustments During the last few years, the patent statutes have been revised to allow the patent term to be extended beyond twenty years after the date of filing if the PTO delayed issuance of the patent and the applicant did not contribute to that delay. Additionally, patents directed to medical and drug product technologies which require regulatory approval may benefit from patent term extension covering the time required to complete such regulatory reviews. The Notice of Allowance will include a statement of the calculated patent term extension. When there has been PTO-caused delay in the allowance of an application, the statement may indicate a number of days that are added to the patent term. In the case of patents dealing with products with very long market lives, such as drugs and medical devices, each day of patent term extension may be quite valuable since revenues earned on such products often reach their peak at the end of the patent term. Therefore, it is important to check the PTO calculation of patent term extension to ensure it is correct. The rules for determining and calculating the amount of patent term extension are extensive and arcane. They are provided at 37 CFR and in MPEP chapter Rather than attempt to explain the details of calculating the patent term extension, the reader is referred to those sections of the PTO rules. Also, there are a number of software programs on the market for calculating patent term extension. Such tools are recommended to the practitioner to minimize the potential for math errors in this important calculation. Bottom line: if you are reviewing the PTO s calculation of patent term extension, get help. Errors in the PTO s calculation of patent term extension may be corrected by filing an application for patent term adjustment under 37 CFR See MPEP This application must be filed no later than payment of the issue fee. 37 CFR 1.705(d). Thus, this important detail to be checked in the Notice of Allowance must be addressed within the same three months you have to pay the issue fee. The provision of patent term extension has imposed additional burdens on the patent prosecutor. Since the delays caused by the patent attorney during the prosecution of an application are subtracted from delays caused by the PTO, the patent prosecutor needs to be extra diligent about minimizing the delays which may end up reducing the term of the client s patent. However, this is an issue for pre allowance activities, and thus is not explored further in this paper. 14

15 Those practicing in the pharmaceutical and related arts would be wise to familiarize themselves with the option and requirements of 35 U.S.C. 156(d)(5) and 37 CFR which allows patent owners to request an interim extension of patent term when it appears that a regulatory review for a patented product may extend beyond the expiration of the patent term. Such a first request must be filed during the period beginning 6 months and ending 15 days before the patent term is due to expire. The request for extension is good for a year. Each subsequent application for interim extension must be filed during the period beginning 60 days before and ending 30 days before the expiration of the preceding interim extension. These dates are critical, so special docketing of those dates is advised if a patented invention may be subject to extensive regulatory review. Disclaimers While it is difficult to obtain patent rights, there are a number of simple ways by which a patent holder can give up patent rights. In particular, a patent holder may disclaim some or all of their patent rights in either a statutory or terminal disclaimer. In a statutory disclaimer, the patent holder disclaims any claim, claims or the entire patent under 37 CFR In a terminal disclaimer, a patent applicant or patent holder disclaims part or all of the entire term of the entire patent that may be granted. Id. Statutory disclaimers Statutory disclaimers arise most often in the context of litigation. A patent holder may disclaim a patent or selected claims within a patent as part of a settlement agreement. Also, if a claim or claims are considered to be too broad or otherwise invalid, a patent holder may want to disclaim those claims to avoid or terminate litigation (such as declaratory judgment actions) or to remove such claims from a lawsuit. However, in normal circumstances, there is no obligation to disclaim any patent or claims that are discovered to be invalid or unenforceable. To be effective, a statutory disclaimer must be signed by the patent holder, or the attorney or agent of record. See 37 CFR 1.321(a). In order for an assignee to sign the disclaimer, there must be a showing of ownership of interest, such as by filing evidence of a chain of title from the original owner to the assignee, or specifying where such evidence is recorded in the PTO. See MPEP Where an assignment has been recorded, you may point to the proper reel and frame number that is associated with that assignment. Also, the person signing the disclaimer should be a recognized officer of the assignee, such as CEO, or should have a statement indicating that the signer is empowered to sign the terminal disclaimer on behalf of the organization. A form for establishing ownership is PTO form sb0096 which is available on the PTO web site ( 15

16 A statutory disclaimer must also state what the patentee ownership interest is in the patent, for example, does the patentee own the full rights or is it a co-owner of the patent. Finally, a statutory disclaimer must identify the patent and the claim or claims of which are disclaimed, and state that the disclaimer is binding on the grantee, its success source, or assigns. A filing fee is also required with a statutory disclaimer. A form for filing a statutory disclaimer is PTO form sb0043.pdf available on the PTO web site ( Terminal disclaimers Terminal disclaimers often arise in the context of patent prosecution in order to overcome a rejection under the judicially created doctrine of double patenting. The judicially created doctrine of double patenting typically involves an obviousness type double patenting situation where the claims of the application being prosecuted are held to be obvious in view of the previously filed patent or application. This doctrine was created to prevent the prolongation of patent term by prohibiting claims in a second application or patent that are very similar to claims in an earlier filed patent or application. MPEP 804 provides further details on the issues of double patenting. In a terminal disclaimer, a patent holder typically disclaims the term of the patent beyond the termination of the earlier filed patent or application. Thus, a terminal disclaimer must specify the portion of that term that is being disclaimed, such as disclaiming any term beyond the expiration of U.S. patent X,XXX,XXX. Further, the terminal disclaimer must state the present applicant s ownership in the application to be granted, and state that the disclaimer is binding on the grantee, its successors or assigns. Terminal disclaimers must be signed by the applicant where the application is not assigned, by the assignee of record, or by the attorney or agent of record. Unlike statutory disclaimers, a terminal disclaimer cannot be limited to particular claims. Thus, even though one claim may be rejected under an obviousness double patenting rejection, all claims must come under the terminal disclaimer in order to use this method for overcoming the rejection. A terminal disclaimer used to overcome a judicially created double patenting rejection must also include a provision that any patent granted on that application shall be enforceable only for the time such patent is commonly owned with the application or the patent that formed the basis of the rejection. See 37 CFR 1.321(c). A form for filing a terminal disclaimer to overcome a provisional double patenting rejection is on the PTO web site as form sb0025.pdf ( and a form for a terminal disclaimer to obviate a double pending rejection over a prior patent is form sb0026.pdf ( The double patenting rejection may also arise in the context of an application owned by two organizations involved in a joint research effort. A terminal disclaimer 16

17 may overcome such a rejection, but to be effective, the terminal rejection requires a further statement. Specifically, the disclaimer must (3) Include a provision waiving the right to separately enforce any patent granted on that application or any patent subject to the reexamination proceeding and the patent or any patent granted on the application which formed the basis for the double patenting, and that any patent granted on that application or any patent subject to the reexamination proceeding shall be enforceable only for and during such period that said patent and the patent, or any patent granted on the application, which formed the basis for the double patenting are not separately enforced. See 37 CFR 1.321(d). Due to the complexity of terminal disclaimers, and the infrequency with which they come up during prosecution, I recommend checking the latest version of the rules and referring to the PTO supplied forms before preparing such a disclaimer. Reissue Once a patent issues, prosecution may not necessarily be over for good. There are opportunities for reentering prosecution including reissue and re-examination. Reissue is the mechanism that is available to the patent holder for correcting significant errors in issued patents. The most common reasons for filing a reissue application include that the claims are too narrow or too broad, the disclosure or the claims contained some inaccuracies, the applicant failed to or incorrectly claimed foreign priority, there is a mistake in the named mentorship, or the applicant failed to make reference to or properly incorporate reference to co-pending applications. Reissue applications are often filed within 2 years of the patent issuing in order to broaden the claims. After 2 years, however, only narrower claims can be added in a reissue examination. In filing for reissue, the patent holder must show that there is at least one error in the patent that meets the standards for reissue. Merely adding additional claims without amending or canceling an issued claim will not be a sufficient basis for obtaining reissue. M.P.E.P Since granting a reissue is not automatic, and filing for reissue is not something that happens frequently, the practitioner is wise to closely read the relevant sections of the MPEP (i.e., 1402) before preparing the reissue application. If reissue is granted, then examination of the application is reopened, providing the patent owner the opportunity to file arguments and claim amendments. A reissue application will be examined in the same manner as a non-reissue, non-provisional application, and will be subject to all the requirements of the rules related to non-reissue applications. 37 CFR However, the practitioner should keep in mind that since the prosecution is reopened, the examiner is free to reject all the claims under any new grounds that may be found. Thus, every reissue filing presents a risk that the patent may be lost in the process. Also, since the patent is back in examination, the duty of candor and the requirement to disclose documents relevant to patentability known to the patent holder apply. 17

18 At the conclusion of the reissue process, a reissue patent is granted, which looks very much the same as a regular patent and replaces the original patent. Upon issue of a reissue patent, the original patent is surrendered and the re-issued patent takes effect as if the same had been the originally granted patent. The only exception to this is that new or substantially amended claims may result in intervening rights to any person or business that was practicing the new or substantially amended claims prior to the date the reissue patent issues. See 35 U.S.C Re-examination Another option available for addressing limited issues in an issued patent is the ex parte re-examination process. Any person, including patent holders, can file a request for an ex parte re-examination at any time. A request for ex parte re-examination can only be made based upon publish documents which establish a substantial new question of patentability. See 35 U.S.C. 303(a). While many re-examinations are filed by third parties, such as those accused of infringement, the patent holder may also file for reexamination in order to establish the patentability of claims in view of newly discovered prior art. This often happens in the case of litigation or threatened litigation. For example, a patent holder planning to litigate a patent may conduct a validity search and file for ex parte re-examination based on any newly found references in order to strengthen the presumption of validity that the patent will enjoy when it is asserted against others in litigation. If re-examination is granted, then the claims are examined with special dispatch in the same manner as a normal prosecution. However, there are strict time limits that must be met which differ from those during normal prosecution. During re-examination, the patent holder is free to amend the claims as may be necessary to overcome rejections. Also, during re-examination the duty of candor and the obligation to submit documents known to the patent owner that are relevant to patentability apply. At the conclusion of a re-examination, a notice of re-examination is issued which is attached to the patent and may include additional or amended claims allowed by the US PTO. Since the requirements for a filing for re-examination and the procedures involved are somewhat unique, the practitioner is urged to study the relevant portions of the MPEP ( ) before embarking on an ex parte re-examination effort. Supplemental Examination Recently added in the America Invents Act (AIA) is a new procedure referred to as supplemental examination. This post-issuance procedure is available to the owner of the patent to enable reexamination based on issues beyond just prior art. In essence, the process will be an ex parte reexamination proceeding that can be requested to consider, reconsider or correct information determined to be relevant to patentability. Among the issues that may be addressed and cured during a supplemental examination are issues that might otherwise be grounds for invalidating the patent during litigation based on inequitable conduct, misrepresented information, and misleading arguments. Thus, the process provides the patent owner with a mechanism 18