Update on TC1600 and TC1700’s Treatment of Markush ClaimsOriginally published on AIPLA Chemical Practice Chronicles (Summer 2020)
Julie Burke, Ph.D.
The USPTO provides examiners with the option of rejecting Markush claims for containing improper Markush groupings and/or restricting examination of Markush claims by a requirement for an election of species. The rejection of a Markush claim is appealable to the Patent Trial and Appeal Board (“PTAB”) in accordance with 35 U.S.C. § 134 and 37 C.F.R. § 41.31(a)(1). The procedural aspects of limiting examination within a Markush claim via restriction practice is petitionable to the Technology Center (“TC”) Group Directors under 37 C.F.R. § 1.144 and 37 C.F.R. §1.181. This article provides a summary of Markush claim rejections recently appealed to the PTAB and Markush claim restriction requirements recently petitioned to the Group Directors.
Rejection of Markush Claims
The 2011 Supplemental Examination Guidelines authorized examiners to reject Markush claims for containing an improper Markush Grouping, as follows:
When an examiner determines that the species of a Markush group do not share a single structural similarity or do not share a common use, then a rejection on the basis that the claim contains an “improper Markush grouping” is appropriate.
Following a seven-year hiatus, authorization for the improper Markush Grouping rejection (originally published in the 2011 Supplemental Examination Guidelines) was codified into Section 706.03(y) of MPEP Revision 08.2017, issued January 2018. Information pertaining to improper Markush groupings has since been moved to section 2117, entitled Markush Claims, in MPEP Edition 9, revision 10-2019.
The USPTO takes the position that the resulting rejections “under the judicially created theory of improper Markush grouping” are appealable to the PTAB. A text searchable library of PTAB decision is available at the FOIA reading room. A search query using the keyword “Markush” or “Harnisch” (reference to the 1980 CCPA decision In re Harnisch, 631 F.2d) identified recent decisions arising from applications under appeal in TC1600, where applications directed to biotechnology and organic chemistry are examined. No such appeals were found in applications drawn to chemical and materials engineering examined in TC1700. This unexpected disparity suggests that the improper Markush grouping rejection is limited to TC1600, even though both TC1600 and TC1700 examine applications containing Markush claims listing chemical alternatives.
The first PTAB decision on the improper Markush Grouping rejection, Ex parte Hubschwerlen, stated “[w]hat is missing from the Guidelines are examples that would be considered improper groupings based on the body of case law addressing Markush groupings.” The PTAB went on to reverse the rejection in Ex parte Hubschwerlen citing In re Harnisch, 631 F.2d at 722 for the proposition that “[I]n determining the propriety of a Markush grouping rejection the compounds must be considered as wholes and not broken down into elements or other components.”
Since then, the PTAB has considered and decided ten more appeals arising from Technology Center 1600 containing improper Markush Grouping rejections in applications directed to a variety of pharmaceutical compositions, biotechnology, and chemistry subject matter. These eleven cases can be considered examples illustrating when and why the PTAB considered an improper Markush grouping rejection appropriate or, more often, not appropriate.
Of these eleven decisions, the PTAB affirmed the improper Markush grouping rejection in only two instances: Ex parte Chettier and Ex parte Yu. In the remaining nine appeals, the improper Markush grouping rejection was reversed by the PTAB. From this sample, practitioners appealing the “judicially created” improper Markush grouping rejection have an 82% chance of being affirmed on the merits.
Although these decisions are not marked as precedential, a review of PTAB decisions containing similar fact patterns can provide a framework for formulating successful responses to rejections under examination. Likewise, citing PTAB decisions containing similar fact patterns can help bolster arguments when responding to a rejection made by an examiner in the same art unit or workgroup. Moreover, these decisions can be used as a resource when trying to decide whether and how to appeal a particular improper Markush grouping rejection.
Restriction of Markush Claims
In addition to rejecting Markush claims, the Chemical Discipline groups, TC1600 and TC1700, have a long-standing practice of requiring an election of species per MPEP § 803.02. In some instances, examiners require an “intra-claim restriction” thereby limiting examination to a single alternative of a Markush grouping. Under 37 C.F.R. § 1.144, following an election made with traverse, applicants may file a petition to request reconsideration of the requirement once the examiner makes the requirement final. There is no fee for filing this type of petition and these petitions are decided in the TCs by the Group Directors.
The USPTO provides petition pendency and grant rate data via the Data Visualization Center. Petition pendency data for review of restriction requirements (37 C.F.R. § 1.144 and MPEP § 818.03(c)) is available at the Petition Timelines, under the General and Miscellaneous Petitions.
The twelve-month rolling average, last updated Jan. 1, 2020 shows a 125 average day pendency for deciding the petition, with a 56% grant rate. This data is not broken down by Technology Center. Anecdotally, the timeliness and grant rate vary across the TCs.
Further, the constructive grant rate is somewhat difficult to determine. PAIR image file wrapper tab does not include decision outcome. The decision itself may include contradictory information. Confusingly, a 2018 final agency decision in TC1700 was “GRANTED to the extent that the Technology Center Directors decision has been reviewed, but DENIED with respect to overturning the Technology Center Director’s decision.” (Emphasis added). PAIR Transaction History tab indicates whether the USPTO considers a petition granted, dismissed or denied. A decision withdrawing an intra-claim restriction requirement and replacing it with an election of species requirement may be labeled as a denial, yet it is constructively a grant-in-part and “win” for the applicant. In some instances, the USPTO labels a decision as dismissed when the examiner sua sponte withdraws the requirement prior to petition decision, another “win” for applicant. Taken together, these types of grants and denials/dismissals result in statistics which might misrepresent the constructive grant rate.
It is difficult to obtain access to USPTO Petition Decisions pertaining to restriction practice. The rare final agency decisions for restriction practice are filed under the all-encompassing “Other” category. However, these documents are neither further categorized by type nor in a text searchable form.
The recently launched Petition.ai database has made it possible to easily and efficiently obtain patent petition decisions highlighted in this article. Petition.ai is the first comprehensive searchable database of patent petition documents filed with the USPTO. A search query of the Petition.ai database using the keywords “Markush” or “Harnisch” quickly identifies recent chemical Markush practice petition decisions. The resulting decisions from 2019 are evenly split between TC1600 and TC1700 and include a mix of both grants and denials.
Current information about petition pendency (number of calendar days between the day the petition was filed to the day the decision was mailed) and grant rate can help practitioners make informed decisions while considering whether to file a petition.
Pendency: In 2019, the Chemical Discipline processed the restriction practice petitions pertaining to Markush claims on average within 136 days. This is comparable to the corps-wide petition pendency statistic of 125 days for processing of petitions directed to restriction practice in general. Drilling into the TC-level data revealed some petition processing differences. From this albeit small sample, TC1600 pendency averaged 201 calendar days while TC1700 pendency averaged 82 calendar days. Both TC1600 and TC1700 exhibit a broad pendency range from 48-673 days in TC1600 to 63-113 days range in TC1700. Some petition processing delays arise because a petition is mis-indexed or mis-routed. To help ensure a prompt petition decision, practitioners may consider making a quick call to alert a TC Quality Assurance Specialist of the petition filing.
Grant Rate: From this sample, the chemical discipline exhibits a 64% actual grant rate or a 73% constructive grant rate, significantly more than the 56% corps-wide grant for all types of restriction petitions. In short, petitions requesting withdrawal of Markush claim-type restriction requirements are favorably treated by TC1600 and TC1700.
Although these decisions are not marked as final agency decisions, identification of petition decisions with similar fact patterns can provide a framework for formulating successful traversals to similar restrictions required for Markush claims. Citing granted petition decisions with similar fact patterns can help bolster arguments when responding to a similar requirement made by an examiner working in the same art unit or workgroup. Three examples are:
A traversal of a US-style restriction requirement made in a national phase application filed in compliance with 35 U.S.C. § 371 can be supported by a petition decision granting an applicant’s arguments that US-style election of species practice is not applicable in a national phase application filed.
When facing an intra-claim restriction requirement made amongst alternatives of a Markush grouping, it may be helpful to review a decision which withdraws an intra-claim restriction requirement and replaces it with an election of species requirement.
When facing a requirement to select a single nucleotide sequence from a group of overlapping nucleotide sequences, it may be helpful to review a decision which withdraws an election of species requirement made amongst overlapping nucleotide sequences.
Petition decisions from other TCs can also have value when the facts and concepts under dispute are similar. For example, when a TC1600 examiner fails to establish that the species are independent or distinct, a decision from TC1700 which withdraws a requirement because the examiner failed to establish independence or distinction may be persuasive.
In summary, these petition decisions can be used as a resource when trying to decide whether and how to traverse or petition a particular election of species or restriction requirement made amongst alternatives of a Markush claim.