2010-14136. Request for Comments on Proposed Changes to Restriction Practice in Patent Applications

AGENCY:

United States Patent and Trademark Office, Commerce.

ACTION:

Request for comments.

SUMMARY:

In situations in which two or more independent and distinct inventions are claimed in a single patent application, the United States Patent and Trademark Office (Office) is authorized by the patent laws and implementing regulations to require the applicant to restrict the application to one invention. The practice for requiring an applicant to restrict an application to one invention in such situations is known as restriction practice. The Office is considering changes to restriction practice to improve the quality and consistency of restriction requirements made by Office personnel.

Comment Deadline Date: Written comments must be received on or before August 13, 2010. No public hearing will be held.

ADDRESSES:

Written comments should be sent by electronic mail message over the Internet addressed to [e-mail]. Comments may also be submitted by mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of Linda S. Therkorn. Although comments may be submitted by mail, the Office prefers to receive comments via the Internet.

The written comments will be available for public inspection at the Office of the Commissioner for Patents, located in Madison East, Tenth Floor, 600 Dulany Street, Alexandria, Virginia, and will be available via the Office's Internet Web site (address: http://www.uspto.gov). Because comments will be made available for public inspection, information that is not desired to be made public, such as an address or phone number, should not be included in the comments.

FOR FURTHER INFORMATION CONTACT:

Linda S. Therkorn, Office of the Associate Commissioner for Patent Examination Policy, directly by telephone to [phone], or by mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.

SUPPLEMENTARY INFORMATION:

The Office is authorized by the patent laws (35 U.S.C. 121) and regulations (37 CFR 1.141 et seq.) to require an applicant to restrict an application to one invention if two or more independent and distinct inventions are claimed in the application. Chapter 800 of the Manual of Patent Examining Procedure (MPEP) sets forth the Office's practices for reviewing applications for restriction purposes. The Office is considering revising restriction practice to improve the quality and consistency of restriction requirements.

The Office is seeking suggestions from the public regarding possible changes to restriction practice because this is a significant area of concern for the Office, applicants, and the public. Thus, the Office is soliciting comments from the public concerning several aspects of restriction practice. First, the Office is asking for comments on what should be included in an Office action that sets forth a restriction requirement. Second, because unwarranted restriction requirements can result in delays in prosecution, expenditure of excess claim fees, and/or the need to file multiple divisional applications, the Office is inviting suggestions from the public as to how to improve the process for traversing or requesting reconsideration of a restriction requirement to achieve more consistent, accurate, timely, and cost-effective review. Third, the Office is aware that restriction requirements between related product inventions or related process inventions have been problematic, and thus is inviting public comments on the changes under consideration to clarify what is necessary in order to restrict between such inventions. Fourth, the Office is also considering some changes with regard to restrictions involving claims with Markush groupings, and invites public comment on these changes as well as any other suggestions regarding the treatment of Markush claims. Fifth, the Office is considering changes to rejoinder practice in an effort to simplify what claimed inventions would be eligible for rejoinder upon the determination that all elected claims are allowable, and invites public comments on these changes. Finally, the Office invites comments specifically pointing out other areas in which restriction practice could be improved.

The Office has previously recognized the need to consider changes to restriction practice. Pursuant to the Office's 21st Century Strategic Plan, the Office sought public comment on a number of issues to help guide the scope and content of a study of changes that would be needed to implement a Patent Cooperation Treaty (PCT) style “Unity of Invention” standard in the United States. See Notice of Availability of and Request for Comments on Green Paper Concerning Restriction Practice, 70 FR 32761 (June 6, 2005). The public comments suggested broadening the scope of the study beyond just a PCT-style Unity of Invention standard in an effort to determine the best practice for restriction. Based on the public comments, the Office identified four options for modifying restriction practice. The Office studied the ease of implementation and workload/pendency impacts of these four options in an effort to achieve an appropriate balance between the priorities of the USPTO user community and limited USPTO resources. However, after reviewing the business case analyses, the Office determined that none of the options would satisfactorily achieve the desired balance.

Thereafter, as part of its ongoing efforts to enhance patent quality and reduce pendency in accordance with the 21st Century Strategic Plan, the Office published a notice proposing to change certain rules of practice pertaining to claims that use Markush or other alternative language and requested public comment on the proposed changes to the rules of practice. See Examination of Patent Applications That Include Claims Containing Alternative Language, 72 FR 44992 (Aug. 10, 2007), 1322 Off. Gaz. Pat. Office 22 (Sept. 4, 2007). The Office is not issuing a final rule based upon the changes proposed in that previous rule making notice. The Office is instead publishing this notice to seek input from the public concerning restriction practice.

As discussed previously, the Office is considering changes to Office practice and policy with regard to restriction requirements. The Office is requesting public input on restriction practice. The Office is not presently proposing any changes to the rules pertaining to restriction practice, and this notice is not a notice of proposed rule making.

1. What should be included in an Office action that sets forth a restriction requirement? The MPEP currently explains that two criteria must be met to require restriction between patentably distinct inventions, i.e., the inventions must be independent or distinct as claimed, and there must be a serious burden on the examiner if restriction is not required. See MPEP § 803. The Office is considering clarifying the MPEP to indicate that a restriction requirement (including an election of species requirement) must always set forth the reasons why the inventions are independent or distinct and why there would be a serious burden in the absence of a restriction requirement.

The Office is considering changes to the burden requirement, an area fundamental to restriction practice. The rationales set forth in the current MPEP to support the burden prong are based on the prior art search (i.e., the inventions have acquired a separate status in the art in view of their different classification; the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries)). See MPEP § 808.02. The Office is considering whether to revise the MPEP to indicate that there would be a serious burden if restriction is not required when the prior art applicable to one invention would not likely be applicable to another invention (e.g., because of a different field of art or different effective filing date).

The Office is also considering whether to revise the MPEP to specify that “a serious burden on the examiner” encompasses search burden and/or examination burden. Typically, the burden prong has been viewed as referring to the burden imposed by searching for patentably distinct inventions. However, the determination of whether a claimed invention is allowable requires both a search of the prior art and an examination of the application to determine whether the claimed invention meets the statutory requirements for patentability. The burden imposed by the examination of patentably distinct inventions is, in many cases, as serious as the burden imposed by searching for such inventions. Therefore, the Office is considering explaining that in addition to the rationales currently set forth in the MPEP, a serious burden in support of a restriction requirement may be based on the rationale that the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. In this situation, a serious search burden and/or examination burden may exist where issues relevant to one invention are not relevant to the other invention.

The MPEP currently provides for election of species practice when an application includes a generic claim along with separate claims to different species that fall within the scope of that generic claim and that may be patentably distinct. See MPEP § 806.04. The Office is considering revising the MPEP to indicate that in setting forth the species from which an applicant is required to elect, the examiner should group together species that are not patentably distinct from each other, the examiner should require election of either a single species or a single grouping of patentably indistinct species, and the applicant should not be required to elect a specific species within a grouping of patentably indistinct species.

2. What practice changes would result in more effective ways to seek higher level review of restriction requirements? In various forums, members of the public have expressed overall dissatisfaction with the effectiveness of traversing or requesting reconsideration of requirements for restriction. Unwarranted restriction requirements can result in delays in prosecution, expenditure of excess claim fees, and/or the need to file multiple divisional applications to avoid dedication of unclaimed subject matter to the public. The Office invites suggestions from the public as to how to improve the traversal or request for reconsideration process within the framework of the current rules (see 37 CFR 1.143 and 1.144) to achieve more consistent, accurate, timely, and cost-effective review.

3. How could the Office clarify requirements for restriction between related product inventions or related process inventions where the relationship is not specifically provided for in MPEP Chapter 800? The Office is considering providing for a new section in the MPEP to address restriction between related product inventions or related process inventions not otherwise provided for in MPEP §§ 806 through 806.05(j). See, e.g., MPEP § 806.04 et seq. for restricting between inventions in a genus/species relationship; MPEP § 806.05(c) for an explanation of the requirements to restrict between inventions in a combination/subcombination relationship; MPEP § 806.05(d) for restricting between subcombinations disclosed as usable together; and MPEP § 806.05(j) for restricting between an intermediate and a final product. Specifically, the Office is considering explaining that to support a requirement for restriction between two or more related product inventions, or between two or more related process inventions, that are not otherwise provided for in MPEP §§ 806 through 806.05(j), there must be two-way distinctness (see MPEP § 802.01) and a serious burden if restriction were not required. The Office is considering explaining that for such related product inventions or such related process inventions, the inventions are distinct if: (1) The inventions as claimed have mutually exclusive characteristics (see MPEP §§ 806 through 806.05(f)); (2) the inventions as claimed are not obvious variants over each other; and (3) each invention as claimed can be made by, or used in, a materially different process or product. In an effort to reduce the number of improper requirements for restriction between related product inventions or related process inventions, the Office is considering explaining that where claims of an application define the same essential characteristics of a single invention, e.g., the claims vary from each other only in breadth or scope (ranging from broad to detailed), the examiner should not require restriction between such claims.

4. How could the Office modify Markush practice? The Office is considering whether to revise Markush practice in three particular ways. First, if the examiner determines that the elected species is allowable, the Office is considering specifying that the examination of the Markush-type claim will be extended to the extent necessary to determine the patentability of the claim, i.e., to determine whether any nonelected species is unpatentable for any reason (35 U.S.C. 101, 102, 103, or 112, or nonstatutory double patenting). If a nonelected species is determined to be unpatentable, the Markush-type claim would be rejected, and the search and examination would not be extended to cover all nonelected species.

Next, the Office is considering revising the treatment of amended Markush-type claims to clarify that whether an Office action may be made final is determined by whether the conditions in MPEP § 706.07 for making a second or subsequent Office action final are met and is not dependent upon whether the examiner previously required a provisional election of species.

Lastly, the Office is considering situations where restriction may be proper between a subcombination and a combination when a subcombination sets forth a Markush grouping of alternatives. In particular, the Office is referring to a subcombination that (1) encompasses two or more subcombination embodiments within its scope, and (2) lists those embodiments using Markush-type claim language, i.e., lists the embodiments as a group of alternatives from which a subcombination embodiment is selected. For example, the Office is considering whether restriction would be proper between a subcombination claim to an individual DNA molecule selected from a list of alternative embodiments and a combination claim to an array comprising a plurality of DNA molecules wherein one or more of the DNA molecules are selected from the list of alternative embodiments set forth in the subcombination claim. In such a situation, the combination claim does not require all the elements of any particular claimed subcombination to be present in the claimed array.

Apart from these specific considerations, the Office invites suggestions from the public regarding changes to the practice of requiring election/restriction of Markush claims in a manner that balances the interests of the Office and those of the public in the context of the current statutory and regulatory framework.

5. How could the Office improve rejoinder practice? The Office is considering changes to rejoinder practice as part of an effort to institute more uniform treatment of claims directed to nonelected subject matter upon the determination that all claims to the elected invention are allowable. The Office is considering whether to define “rejoinder” as the practice of withdrawing a restriction requirement as between some or all groupings of claims and reinstating certain claims previously withdrawn from consideration that occurs when the following conditions are met: (1) All claims to the elected invention are allowable; and (2) it is readily apparent that all claims to one or more nonelected inventions are allowable for the same reasons that the elected claims are allowable. Claims that meet the second condition for rejoinder may include, for example, those that (1) properly depend from an allowable elected claim; (2) include all of the limitations of an allowable elected claim; or (3) require no further search and/or examination. Claims that may not be eligible for rejoinder would include, for example, those that require additional consideration of the prior art or raise utility, enablement, or written description issues not considered during examination of the allowable elected claims.

Separately, the Office is also considering instructing examiners that when all claims directed to an elected invention are allowable, nonelected claims must be considered for rejoinder and withdrawal of the restriction requirement. In making this decision, examiners must reevaluate both aspects of the restriction requirement, i.e., whether the nonelected invention(s) as now claimed are independent or distinct from the claim(s) to the allowable elected invention and whether there would be a serious burden if the nonelected inventions were rejoined.

6. What other areas of restriction practice can the Office improve and how? While the Office has set forth particular restriction practice issues for which comments are specifically being requested, the Office is in this request for comments inviting comments on any area in which restriction practice could be improved.

Dated: May 17, 2010.

David J. Kappos,

Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.