When One Patent Application Begets 10

Once a restriction requirement is asserted, the applicant must elect one invention from the groups presented by the examiner. The applicant may traverse the restriction, by arguing that the restriction is improper. Arguments are essentially limited to these: 1) that the inventions are not patentably distinct; and/or 2) that searching and examining all the claimed inventions are not serious burdens on the examiner. The former is clearly not a good choice, because any argument that the inventions are not patentably distinct means that any art uncovered that anticipates one of the inventions will also anticipate the others. This leaves applicants with only one argument – that no serious burden to the examiner exists or that the examiner has not shown that a serious burden exists. Unfortunately, this argument is rarely successful.

Strategies to Reduce the Number of Divisional Applications

Strategies are available for minimizing the number of divisional applications to be filed. These are: 1) to minimize the number of groups; 2) to use “linking” or generic claims that link or cover more than one of the groups; 3) to ask for rejoinder of claims once allowable subject matter is found, and 4) to petition the Director.

To minimize the number of groups, start by discussing the restriction requirement with the examiner. Discuss how searching for one group would necessarily provide art for another. If the examiner is less than helpful, call a technology specialist for the examiner's art unit. Many of the PTO technology centers (within which the art units of the examiners are located) have technology specialists. For example, Technology Center 1600 (biotechnology, pharmaceutical, and organic chemistry arts) has biotechnology specialists. Work with the specialist to show how a search for art for one group will provide art in another group.

Draft applications with linking claims, and claims in a more European style, with emphasis on the core invention. The use of linking claims is basically the use of generic claims that connect claims to otherwise divisible inventions. A linking claim is broad enough to read on (or link or encompass) two or more groups of claims subject to the restriction requirement. The patent examiner should identify any generic or linking claims in the application. At the time of restriction, if no linking claim exists, call the examiner to discuss what options the applicant may have to submit generic claims. Linking or generic claims in an application will not eliminate the restriction requirement but will allow for the possibility of rejoinder once the generic claim is found patentable.

As to rejoinder, if a linking claim is allowed, be sure to ask the examiner to rejoin other claims that are covered or linked to the linking or generic claim. Even if there is no linking claim but a product claim is deemed patentable, ask to have any claims to methods of using the product or making the product (with all the limitations of the product claim) rejoined into the application.

If a restriction requirement merits (and it has been traversed), the applicant can petition to the Director. This is, of course, a last resort, and can result in increased pendency for an application while a decision from the Director is sought.

Another Strategy for U.S. National Stage PCT Applications

For U.S. patent applications that enter the national stage from the Patent Cooperation Treaty (PCT), another strategy is available. A PCT application, during its international phase, is reviewed for unity of invention. Claimed inventions in a single application have unity if they share a single general inventive concept. In other words, these are inventions that share special technical features that define a contribution over the prior art. Those inventions that are considered to have unity include product claims, method-of-making-the-product claims and method-of-using-the-product claims. Although a lack of unity of invention may be asserted, the applicant is invited to pay for the searching of additional inventions. Thus, all claims, and hence, all inventions, may be kept in a single application. The applicant, of course, may argue the impropriety of a lack of unity of invention assertion; however, the argument takes on a different look than arguing the impropriety of a restriction requirement. Burden on the examiner is not an issue. The only way to get the lack of unity of invention assertion withdrawn is to show that all claims share the same technical feature. If unsuccessful, the applicant can pay for the additional inventions.

Patent applications that enter the United States through the PCT – because they are filed under 35 U.S.C. ' 371 — must be examined under the unity-of-invention standard. On the other hand, if an international application enters the United States under 35 U.S.C. ' 111, rather than the customary ' 371, the U.S. corresponding application will be examined under the U.S. restriction practice standard. If a restriction requirement is asserted in the U.S. prosecution, and if the applicant had a lack of unity of invention determination in the international phase and paid for the searching of all inventions, the applicant may argue that there is no burden on the examiner because the examiner has already searched all inventions. This is, of course, predicated on the PCT search having been done in the U.S. PTO and the U.S. application in the U.S. national phase being assigned to the same examiner as in the PCT proceeding.

Restriction Relief May Arrive from the PTO

Relief from the hyperproliferation of restriction requirements may be closer than we think. During the past year, the PTO has been studying possible changes to restriction practice. As noted above, the PTO has announced that it will address its statutory interpretation of ' 121 as to whether a new interpretation — ie, a return to the actual statutory language of “independent and distinct” — is in order. The PTO has also solicited comments on whether the United States should adopt the unity-of-invention standard. As noted above, with this standard's emphasis on technical feature, a unity-of-invention standard would permit grouping-of-product, method-of-making and method-of-using the product claims in the same application. The PTO is also studying a fee structure so that applicants may pay to have a limited number of additional inventions searched. As another fee option, the PTO is considering a three-tiered fee structure based on the degree of relatedness of the inventions and the search burden. Substantially similar inventions would be searched together for a base fee. A further surcharge would be added for election of a number of related inventions that would require additional searching but include similar patentability issues. A higher surcharge would be in order for the election of multiple unrelated inventions that require additional searching and present dissimilar patentability issues. Practitioners should be alerted and should voice comments when the PTO asks for such, as will very likely be the case as it continues its study.

However, the PTO has implemented an action plan for restriction practice in Technology Center 1600 where excessively numerous restriction requirements have been asserted against applications examined in that center. The action plan, targeted to improve the quality of examination of biotech patent applications by establishing best practices related to restriction of the number of inventions and/or claim sets in biotechnology, pharmaceutical and organic chemistry patent applications, is a five-point plan. The plan includes: 1) publishing examples of claim sets that currently do not place a serious burden on examiners; 2) emphasizing rejoinder practice; 3) updating the training of examiners to analyze and recognize claim sets that should be examined together; 4) enhancing quality review by providing a “second pair of eyes” to review restriction decisions made by examiners to promote consistency; and 5) assessing the progress of the action plan to ensure that it meets the needs of the PTO and the customers. The PTO will also publish examples of claim sets where current rules regarding restriction are difficult to apply. All TC 1600 examiners will receive update restriction practice instruction, including training examples targeted to specific workgroups within TC 1600. The review by the second pair of eyes will begin in those art units where either 1) the number of restrictions is particularly high; or 2) indications of poor quality restrictions are noted in the reviews. The review will also include not only first action restrictions, but also all restriction requirements in second and subsequent Office Actions. The continuous assessment will include: 1) sampling restrictions at periodic intervals to monitor quality and average number of divided inventions; 2) monitoring the number and quality of second and subsequent restrictions; and 3) surveying customers for their perception of TC 1600 restriction practices.

Conclusion

The current state of hyperproliferation of restriction requirements has resulted at least in part in the PTO's response to complex, mega-applications with numerous claims, although ordinary applications have been affected as well. If (and until) relief comes from the PTO, applicants can use the strategies outlined herein to ease the financial stress of multi-way restriction requirements.

In last month's newsletter, we discussed the financial burdens pharmaceutical and biotech firms face due to the Patent and Trademark Office's (PTO) policy of restriction practice — the restriction of a patent application to prosecution of a single claimed invention per filing fee. Now we look at ways potential patentees can economically work with these restrictions.

How to Save the Patent Budget

Arguing That Restriction Is Improper

Once a restriction requirement is asserted, the applicant must elect one invention from the groups presented by the examiner. The applicant may traverse the restriction, by arguing that the restriction is improper. Arguments are essentially limited to these: 1) that the inventions are not patentably distinct; and/or 2) that searching and examining all the claimed inventions are not serious burdens on the examiner. The former is clearly not a good choice, because any argument that the inventions are not patentably distinct means that any art uncovered that anticipates one of the inventions will also anticipate the others. This leaves applicants with only one argument – that no serious burden to the examiner exists or that the examiner has not shown that a serious burden exists. Unfortunately, this argument is rarely successful.

Strategies to Reduce the Number of Divisional Applications

Strategies are available for minimizing the number of divisional applications to be filed. These are: 1) to minimize the number of groups; 2) to use “linking” or generic claims that link or cover more than one of the groups; 3) to ask for rejoinder of claims once allowable subject matter is found, and 4) to petition the Director.

To minimize the number of groups, start by discussing the restriction requirement with the examiner. Discuss how searching for one group would necessarily provide art for another. If the examiner is less than helpful, call a technology specialist for the examiner's art unit. Many of the PTO technology centers (within which the art units of the examiners are located) have technology specialists. For example, Technology Center 1600 (biotechnology, pharmaceutical, and organic chemistry arts) has biotechnology specialists. Work with the specialist to show how a search for art for one group will provide art in another group.

Draft applications with linking claims, and claims in a more European style, with emphasis on the core invention. The use of linking claims is basically the use of generic claims that connect claims to otherwise divisible inventions. A linking claim is broad enough to read on (or link or encompass) two or more groups of claims subject to the restriction requirement. The patent examiner should identify any generic or linking claims in the application. At the time of restriction, if no linking claim exists, call the examiner to discuss what options the applicant may have to submit generic claims. Linking or generic claims in an application will not eliminate the restriction requirement but will allow for the possibility of rejoinder once the generic claim is found patentable.

As to rejoinder, if a linking claim is allowed, be sure to ask the examiner to rejoin other claims that are covered or linked to the linking or generic claim. Even if there is no linking claim but a product claim is deemed patentable, ask to have any claims to methods of using the product or making the product (with all the limitations of the product claim) rejoined into the application.

If a restriction requirement merits (and it has been traversed), the applicant can petition to the Director. This is, of course, a last resort, and can result in increased pendency for an application while a decision from the Director is sought.

Another Strategy for U.S. National Stage PCT Applications

For U.S. patent applications that enter the national stage from the Patent Cooperation Treaty (PCT), another strategy is available. A PCT application, during its international phase, is reviewed for unity of invention. Claimed inventions in a single application have unity if they share a single general inventive concept. In other words, these are inventions that share special technical features that define a contribution over the prior art. Those inventions that are considered to have unity include product claims, method-of-making-the-product claims and method-of-using-the-product claims. Although a lack of unity of invention may be asserted, the applicant is invited to pay for the searching of additional inventions. Thus, all claims, and hence, all inventions, may be kept in a single application. The applicant, of course, may argue the impropriety of a lack of unity of invention assertion; however, the argument takes on a different look than arguing the impropriety of a restriction requirement. Burden on the examiner is not an issue. The only way to get the lack of unity of invention assertion withdrawn is to show that all claims share the same technical feature. If unsuccessful, the applicant can pay for the additional inventions.

Patent applications that enter the United States through the PCT – because they are filed under 35 U.S.C. ' 371 — must be examined under the unity-of-invention standard. On the other hand, if an international application enters the United States under 35 U.S.C. ' 111, rather than the customary ' 371, the U.S. corresponding application will be examined under the U.S. restriction practice standard. If a restriction requirement is asserted in the U.S. prosecution, and if the applicant had a lack of unity of invention determination in the international phase and paid for the searching of all inventions, the applicant may argue that there is no burden on the examiner because the examiner has already searched all inventions. This is, of course, predicated on the PCT search having been done in the U.S. PTO and the U.S. application in the U.S. national phase being assigned to the same examiner as in the PCT proceeding.

Restriction Relief May Arrive from the PTO

Relief from the hyperproliferation of restriction requirements may be closer than we think. During the past year, the PTO has been studying possible changes to restriction practice. As noted above, the PTO has announced that it will address its statutory interpretation of ' 121 as to whether a new interpretation — ie, a return to the actual statutory language of “independent and distinct” — is in order. The PTO has also solicited comments on whether the United States should adopt the unity-of-invention standard. As noted above, with this standard's emphasis on technical feature, a unity-of-invention standard would permit grouping-of-product, method-of-making and method-of-using the product claims in the same application. The PTO is also studying a fee structure so that applicants may pay to have a limited number of additional inventions searched. As another fee option, the PTO is considering a three-tiered fee structure based on the degree of relatedness of the inventions and the search burden. Substantially similar inventions would be searched together for a base fee. A further surcharge would be added for election of a number of related inventions that would require additional searching but include similar patentability issues. A higher surcharge would be in order for the election of multiple unrelated inventions that require additional searching and present dissimilar patentability issues. Practitioners should be alerted and should voice comments when the PTO asks for such, as will very likely be the case as it continues its study.

However, the PTO has implemented an action plan for restriction practice in Technology Center 1600 where excessively numerous restriction requirements have been asserted against applications examined in that center. The action plan, targeted to improve the quality of examination of biotech patent applications by establishing best practices related to restriction of the number of inventions and/or claim sets in biotechnology, pharmaceutical and organic chemistry patent applications, is a five-point plan. The plan includes: 1) publishing examples of claim sets that currently do not place a serious burden on examiners; 2) emphasizing rejoinder practice; 3) updating the training of examiners to analyze and recognize claim sets that should be examined together; 4) enhancing quality review by providing a “second pair of eyes” to review restriction decisions made by examiners to promote consistency; and 5) assessing the progress of the action plan to ensure that it meets the needs of the PTO and the customers. The PTO will also publish examples of claim sets where current rules regarding restriction are difficult to apply. All TC 1600 examiners will receive update restriction practice instruction, including training examples targeted to specific workgroups within TC 1600. The review by the second pair of eyes will begin in those art units where either 1) the number of restrictions is particularly high; or 2) indications of poor quality restrictions are noted in the reviews. The review will also include not only first action restrictions, but also all restriction requirements in second and subsequent Office Actions. The continuous assessment will include: 1) sampling restrictions at periodic intervals to monitor quality and average number of divided inventions; 2) monitoring the number and quality of second and subsequent restrictions; and 3) surveying customers for their perception of TC 1600 restriction practices.

Conclusion

The current state of hyperproliferation of restriction requirements has resulted at least in part in the PTO's response to complex, mega-applications with numerous claims, although ordinary applications have been affected as well. If (and until) relief comes from the PTO, applicants can use the strategies outlined herein to ease the financial stress of multi-way restriction requirements.