Source: https://www.patentdocs.org/patent_office_rules_procedures/page/3/
Timestamp: 2020-08-10 22:15:43
Document Index: 669731425

Matched Legal Cases: ['§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 151', '§ 1', 'Application No. 11', '§ 154', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 103', '§ 103', '§ 103', '§ 103', '§ 112', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 116', '§ 154', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 154', 'Application No. 12', '§ 154', '§ 132', '§ 154', 'Application No. 14', '§ 154', '§ 1', '§802']

By Aaron Gin --
On October 30, 2019, the U.S. Patent and Trademark Office released a Federal Register Notice requesting comments on issues of artificial intelligence (AI) and intellectual property, the second such request in the past three months.
In a blog post on the USPTO "Director's Forum", USPTO Director Andrei Iancu and Deputy Director Laura Peter stated that "[t]he fields of copyright, trademark, database protections, and trade secret law, among others, may be . . . susceptible to the impacts of developments in AI." As such, the USPTO has requested public feedback by way of thirteen questions involving topics ranging from whether an AI, without human intervention, can create a copyrightable work to whether and how AI might impact trade secret law. The Notice questions are summarized as follows:
1. Should a work produced by an AI algorithm or process, without the involvement of a natural person contributing expression to the resulting work, qualify as a work of authorship protectable under U.S. copyright law?
2. Assuming involvement by a natural person is or should be required, what kind of involvement would or should be sufficient so that the work qualifies for copyright protection? For example, should it be sufficient if a person (i) designed the AI algorithm or process that created the work; (ii) contributed to the design of the algorithm or process; (iii) chose data used by the algorithm for training or otherwise; (iv) caused the AI algorithm or process to be used to yield the work; or (v) engaged in some specific combination of the foregoing activities? Are there other contributions a person could make in a potentially copyrightable AI-generated work in order to be considered an "author"?
3. To the extent an AI algorithm or process learns its function(s) by ingesting large volumes of copyrighted material, does the existing statutory language (e.g., the fair use doctrine) and related case law adequately address the legality of making such use?
7. Would the use of AI in trademark searching impact the registrablity of trademarks?
8. How does AI impact trademark law? Is the existing statutory language in the Lanham Act adequate to address the use of AI in the marketplace?
9. How does AI impact the need to protect databases and data sets? Are existing laws adequate to protect such data?
10. How does AI impact trade secret law? Is the Defend Trade Secrets Act (DTSA), 18 U.S.C. 1836 et seq., adequate to address the use of AI in the marketplace?
13. Are there any relevant policies or practices from intellectual property agencies or legal systems in other countries that may help inform USPTO's policies and practices regarding intellectual property rights (other than those related to patent rights)?
In August, the USPTO previously requested comments on AI inventions with respect to patent law and policy. The questions from the first Notice covered a variety of patent-related topics, including whether revisions to patent laws may be needed. The current Notice extends similar inquiries to ask how AI may affect non-patent areas of IP (e.g., copyright, trademark, and other intellectual property rights). Notably, some of the questions could even foreshadow how examination procedures might evolve at the USPTO to include AI-based trademark searches. The Notice stated that public comments in these areas would aid the USPTO to evaluate whether further guidance to the Examining Corps is needed and to assist in the development of any such guidance with respect to intellectual property policy and its relationship with AI.
The USPTO has clearly made understanding the benefits/drawbacks of AI an action item for itself in the near future, on the policy front, and possibly in its own examination practice. The Notice itself pledges that "[t]he USPTO is committed to keeping pace with this critical technology in order to accelerate American innovation." Furthermore, the Patent Office has an open job posting for a "Senior Level Artificial Intelligence Technical Expert" whose responsibilities may include "operational implementation of Artificial Intelligence (AI) infrastructure/architecture throughout the enterprise." Going forward, it will be interesting to see how AI impacts existing patent and non-patent IP law and policy, as well as how AI-based innovations will be incorporated into the operation of the USPTO.
Written comments can be provided by email to AIPartnership@uspto.gov until December 16, 2019. Written comments will be made available for public inspection.
• Second Federal Notice: Request for Comments on Intellectual Property Protection for Artificial Intelligence Innovation (FR Doc. 2019-23638).
• First Federal Notice: Request for Comments on Patenting Artificial Intelligence Inventions (FR Doc. 2019-18443).
• Andrei Iancu and Laura Peter, "USPTO issues second Federal Register Notice on artificial intelligence and innovation," Director's Forum: A Blog from USPTO's Leadership, October 30, 2019.
• Senior Level Artificial Intelligence Technical Expert, usajobs.gov, Announcement Number OCIO-2019-0010.
Posted at 10:20 PM in Patent Office Rules & Procedures | Permalink | Comments (0)
The public comment period regarding patenting of artificial intelligence (AI), which was scheduled to close on October 11, 2019, has been extended until November 8, 2019. In a Notice posted August 27, 2019, USPTO Director Iancu sought public input on issues relating to AI-based inventions in an effort to determine whether further AI-specific guidance should be provided to the Examiner corps.
The Notice centered around twelve questions involving topics ranging from AI patent policy to whether new forms of intellectual property protection are needed. The questions are summarized as follows:
1. What are the main elements of an AI-based invention?
2. What are the different ways that a natural person can contribute to conception of an AI invention and be considered a proper inventor?
3. Do current patent laws regarding inventorship need to be revised to take into account inventions where an entity or entities other than a natural person contributed to the conception of an invention?
4. Should an entity other than a natural person, or company to which a natural person assigns an invention, be able to own a patent on the AI invention?
6. Are there any disclosure-related considerations unique to AI inventions? Does there need to be a change in the level of detail an applicant must provide in order to comply with the written description requirement, particularly for deep-learning systems that may have a large number of hidden layers with weights that evolve during the learning/training process without human intervention or knowledge?
7. How can AI-based patent applications best comply with the enablement requirement, particularly given the unpredictability of certain AI systems?
8. Does AI impact the level of a person of ordinary skill in the art? If so, how? For example: Should assessment of the level of ordinary skill in the art reflect the capability possessed by the AI itself?
11. Are there any other issues pertinent to patenting AI inventions that the USPTO should examine?
12. Are there any relevant policies or practices from other major patent agencies that may help inform the USPTO's policies and practices regarding patenting of AI inventions?
Responses to the request for public comment could lead to new and/or revised examining guidance (and practices) at the PTO. In the Notice, Director Iancu stated that such new guidance could help "promote the reliability and predictability" of patenting AI inventions.
Notably, the USPTO appears to be trying to understand whether current patent laws should be revised to take into account inventions where "an entity or entities other than a natural person" contributed to the conception of an invention. That is: for inventions arising, at least in part, through AI (e.g., machine learning systems), can or should the AI be eligible to be named as an inventor or an applicant?
In a blog post on the USPTO "Director's Forum," Deputy Director of the USPTO Laura Peter remarked that comments from the public regarding this Notice will allow the USPTO to "continue to ensure the appropriate balance in the administration of our IP system," and consider "if new legal rights are needed in the wake of more advanced AI."
Written comments can be provided by email to AIPartnership@uspto.gov during the period for comment, originally slated to end October 11, 2019, but which has been extended to November 8, 2019. Written comments will be made available for public inspection.
• Request for Comments on Patenting Artificial Intelligence Inventions (FR Doc. 2019-18443)
• Laura Peter, "USPTO announces Federal Register Notice on artificial intelligence patent issues," Director's Forum: A Blog from USPTO's Leadership, August 26, 2019.
• Aaron Gin, "Intelligent Machines – Engines of Intellectual Property Creation?" Snippets, Spring 2018
Posted at 09:02 PM in Patent Office Rules & Procedures | Permalink | Comments (2)
Earlier today, the U.S. Patent and Trademark Office announced via an e-mail to its stakeholders and in a post on the Director's Form Blog that the Office had achieved its long-term goals of reducing first action pendency to less than 15 months and reducing total pendency to less than 24 months for the 2019 fiscal year (see chart below). The Office noted that it averaged 14.7 months for first action pendency and 23.8 months for total pendency for the fiscal year, which ended on September 30, which "marks the USPTO's lowest first action pendency since January 2002, despite total application filings nearly doubling in that time, from 353,000 in FY 2002 to 667,000 in FY 2019."
In its FY 2018 Performance and Accountability Report, the Office had established targets of 14.5 months for first action pendency and 23.8 months for total pendency (see "USPTO Releases Performance and Accountability Report for FY 2018"). For FY2018, the Office had achieved an average first action pendency of 15.8 months and an average total pendency of 23.8 months.
In announcing that the Office had met its goals to reduce patent examination pendency, the Office indicated that at the same time, it had "maintained and indeed improved the quality of our examination." The Office also noted that the efforts of its employees on increasing efficiencies to accelerate the overall patent examination process had resulted in, for example, a decrease in the average processing time for an amendment filed in a patent application from 26.2 days to 6.8 days.
The Office pointed out that it will now "redouble our efforts to optimize pendency using considered analytics that make sense," including improving how cases are routed to examiners and how examination time is allocated to examiners. With respect to first action pendency, the Office will now "strive to meet in as many cases as possible the time frames outlined by the patent term adjustment statute (35 U.S.C. 154b)," which means issuing a first office action in no more than 14 months.
On Friday, the U.S. Patent and Trademark Office published a notice of proposed rulemaking in the Federal Register (84 Fed. Reg. 53090), in which the Office proposes certain revisions to the rules of practice concerning Patent Term Adjustment (PTA) in view of the Federal Circuit's decision in Supernus Pharm., Inc. v. Iancu. In particular, the Office proposes revising the period of reduction of PTA in the following provisions of 37 C.F.R. § 1.704:
• Deferral of issuance of a patent (37 C.F.R. § 1.704(c)(2));
• Abandonment of an application (37 C.F.R. § 1.704(c)(3));
• Submission of a preliminary amendment (37 C.F.R. § 1.704(c)(6));
ª Submission of papers after a decision by the Patent Trial and Appeal Board or by a Federal court (37 C.F.R. § 1.704(c)(9)); and
• Submission of papers after a notice of allowance under 35 U.S.C. § 151 (37 C.F.R. § 1.704(c)(10)).
According to the Office's notice, the proposed changes will specify a period of reduction corresponding to "the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution" as opposed to the consequences to the Office of applicant's failure to engage in reasonable efforts to conclude prosecution.
In Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit reversed the entry of summary judgment by the District Court for the Eastern District of Virginia, which concluded that the U.S. Patent and Trademark Office had not erred in calculating the PTA for U.S. Patent No. 8,747,897. During prosecution of U.S. Application No. 11/412,100, which issued as the '897 patent, the Examiner issued a final Office Action, and Supernus responded by filing a Request for Continued Examination (RCE). After filing the RCE, Supernus was notified that an opposition had been filed in related European Patent No. EP 2 010 189 (which had issued from a European application corresponding to an International application that claimed priority from the '100 application). One hundred days after the European Patent Office's notification of the opposition, Supernus filed a supplemental Information Disclosure Statement (IDS) citing the Notice of Opposition and other documents concerning the opposition. The USPTO ultimately issued the '100 application as the '897 patent, determining that the '897 patent was entitled to 1,260 days of PTA. The Office's PTA determination included an assessment of 886 days of applicant delay, of which 646 days were assessed for the time between the filing of the RCE and the submission of the supplemental IDS. Supernus filed a request for Reconsideration of Patent Term Adjustment, but the Office rejected Supernus' request, concluding that the 646-day reduction in PTA was proper.
Supernus challenged the Office's PTA determination in the Eastern District of Virginia, contending that it was entitled to at least 546 of the 646 days of PTA reduction (i.e., the period of time between the filing of the RCE and the EPO notification of opposition). The District Court granted summary judgment in favor of the USPTO, finding that the USPTO did not err in the PTA calculation for the '897 patent.
In January, the Federal Circuit reversed the District Court's grant of summary judgment in favor of the USPTO, finding that because there were "no identifiable efforts" that Supernus could have undertaken in the time period between the filing of an RCE during prosecution of the application that issued as the '897 patent and the mailing of an EPO notification of opposition for a European counterpart patent (which resulted in Supernus filing a supplemental Information Disclosure Statement during prosecution of the '897 patent), Supernus had not failed to engage in reasonable efforts to conclude prosecution during that time period. The Federal Circuit noted in Supernus that "Congress expressly granted the USPTO authority to determine what constitutes reasonable efforts [under 35 U.S.C. § 154(b)(2)(C)(i)], but the USPTO lacks any authority to exceed the statutory 'equal to' limitation by including the 546-day time period during which it does not contend that Supernus failed to undertake reasonable efforts to conclude prosecution." The Court therefore found the USPTO's PTA reduction for the '897 patent to be inconsistent with the PTA statute, accorded no deference to the USPTO's application of the regulations at issue in the circumstances of this case, and reversed and remanded the District Court's summary judgment order.
In May, the USPTO issued a Federal Register notice notifying stakeholders of the impact of the Supernus decision on its PTA determinations (see "USPTO Issues Notice on Impact of Federal Circuit's Supernus Decision on PTA Procedures"). In its earlier notice, the Office indicated that it was "modifying its patent term adjustment procedures in view of the decision." However, that notice stated that "the USPTO will continue to make the patent term adjustment determinations indicated in patents under the existing regulations using information recorded in its PALM [Patent Application Locating and Monitoring] system," and that a patentee who believes there were no identifiable efforts it could have undertaken to conclude prosecution of an application (as Supernus argued with respect to the '897 patent) "may raise the issue in a timely request for reconsideration of the patent term adjustment, providing any relevant information that is not recorded in the USPTO's PALM system."
In the Office's latest notice regarding the impact of the Federal Circuit's Supernus decision, the Office points out that "[t]he Federal Circuit in Supernus held that a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application." As a result, the Office is now proposing revisions to certain provisions of 37 C.F.R § 1.704 for consistency with the Federal Circuit's decision in Supernus. The Office's notice explains that the Federal Circuit's decision in Supernus involved a reduction in PTA under the provisions of 37 C.F.R. § 1.704(c)(8), which specifies a period of reduction of PTA equal to "the number of days, if any, beginning on the day after the date the initial reply was filed and ending on the date that the supplemental reply or other such paper was filed," which "corresponds to 'the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution,' except in the rare situation in which such period includes 'a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.'" The Office notes that "[w]hile the Federal Circuit decision in Supernus involved 37 CFR 1.704(c)(8), there are several provisions in 37 CFR 1.704(c)(1) through (c)(14) whose period of reduction corresponds to or includes the consequences to the Office of applicant's failure to engage in reasonable efforts to conclude prosecution, rather than 'the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution.'"
Marked-up versions of the rules that the Office has proposed revising are as follows:
1.704 Reduction of period of adjustment of patent term.
(2) Deferral of issuance of a patent under § 1.314, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under § 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued;
(i) The number of days, if any, beginning on the day after the mailing date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the original Office action or notice of allowance national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date of mailing of the supplemental Office action or notice of allowance; the preliminary amendment or
(ii) Four months other preliminary paper was filed;
(9) Submission of an amendment or other paper after a decision by the Board of Patent Appeals Trial and Interferences Appeal Board, other than a decision designated as containing a new ground of rejection under § 1.19641.50(b) of this title or statement under § 1.19641.50(c) of this title, or a decision by a Federal court, less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or supplemental notice of allowance, in which case the period of adjustment set forth in § 1.703 shall be reduced by the lesser of:
(i) The number of days, if any, beginning on the day after the mailing date of the original Office action decision by the Patent Trial and Appeal Board or notice of allowance by a Federal court and ending on the mailing date of the supplemental Office action or notice of allowance; amendment or
(ii) Four months other paper was filed;
(i) The number of days, if any, beginning on the day after the mailing date of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under § 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under § 1.312 or such other paper; or
While the Office notes that "prior notice and opportunity for public comment for the changes proposed by this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law," the Office has issued the notice of proposed rulemaking in order "to benefit from the public's input." Those interested in submitting comments regarding the proposed revisions to §§ 1.704(c)(2), (c)(3), (c)(6), (c)(9), and (c)(10), must do so by December 3, 2019. Comments may be submitted by e-mail to: AD38.comments@uspto.gov; by regular mail addressed to: Mail Stop Comments-Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Kery Fries, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal.
Intra-Cellular Therapies, Inc. v. Iancu (Fed. Cir. 2019)
Last week, in Intra-Cellular Therapies, Inc. v. Iancu, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia affirming a determination by the U.S. Patent and Trademark Office of Patent Term Adjustment (PTA) for U.S. Patent No. 8,648,077. In affirming the District Court's grant of summary judgment in favor of the USPTO, the Federal Circuit concluded that the USPTO's determination of applicant delay was based on a permissible interpretation of statute and proper reading of the regulations.
During prosecution of the application that issued as the '077 patent, the USPTO issued a final Office action in which no claims were allowed, and the Examiner repeated the same § 103 rejections from the previous non-final Office action (and also presented new objections). Intra-Cellular responded on the three-month deadline, continuing to dispute the § 103 rejection using the same arguments that were previously found unpersuasive by the Examiner, and amending the claims to address other objections and rejections (including adding a new claim). The USPTO then issued an Advisory Action indicating that Intra-Cellular's after-final response failed to overcome the § 103 rejection for "reasons of the record" (despite overcoming certain other rejections and objections). In the Advisory Action, the Examiner also suggested amending or cancelling certain claims to overcome the outstanding § 103 and § 112 rejections and new formality objection. Twenty-one days after filing its unsuccessful first response to the final Office action, Intra-Cellular filed a second response in which it overcame all outstanding rejections and objections by adopting the Examiner's suggestions and cancelling or amending every rejected or objected to claim based on the Examiner's positions. The USPTO issued a Notice of Allowance, and the '077 patent was issued.
In calculating PTA for the '077 patent, the USPTO determined that the extra 21 days it took Intra-Cellular to file a successful response after the three-month deadline for responding to the final Office action constituted applicant delay. In particular, the USPTO determined that even though Intra-Cellular filed a response to the final Office action on the three-month deadline, that response did not constitute a proper "reply" under § 1.704(b). Intra-Cellular filed a complaint in the District Court for the Eastern District of Virginia seeking judicial review of the USPTO's PTA determination. The District Court granted summary judgment in favor of the USPTO, pointing out that "nothing in the plain language of the statute indicates that 'reasonable efforts to conclude prosecution' should be read to include an incomplete submission which fails to place the application in condition for allowance, but in some manner advances it closer to allowance." Intra-Cellular appealed the District Court's decision to the Federal Circuit.
Judge Chen, writing for the Court, begins by noting that 37 C.F.R. § 1.704(b), which provides that "an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the [Patent] Office making any rejection, objection, argument, or other request . . . " (emphasis in opinion), is relevant to the appeal. Thus, according to § 1.704(b), if an applicant takes longer than three months to file a "reply" to an Office action, applicant delay will accrue. Judge Chen notes, however, that § 1.704(b) does not define what constitutes a proper "reply" for cutting off applicant delay. The opinion then looks to the "backdrop of long-existing regulations governing patent prosecution practices," including 37 C.F.R. §§ 1.113(a) and (c), 1.114(b) and (c), and § 116, which establish that a "final" Office action marks the end of normal prosecution as of right, that an examiner is not obligated to engage in further examination and review of a patent application or applicant arguments after a final Office action is issued, and that an applicant has restricted options for responding to a final Office action.
With respect to the dispute before the Court, the opinion indicates that it concerns whether a particular period of 21 days, following the three-month deadline for responding to a final Office action, counts as applicant delay, and whether the District Court erred in upholding the agency's determination that Intra-Cellular's first response did not constitute a proper "reply." This determination hinged in part on the USPTO's interpretation of statutory text, and in reviewing an agency's statutory interpretation, a court does so by applying the two-step framework established in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).
In Step 1 of its Chevron analysis, the Court asks whether a statute's plain terms directly address the precise question at issue. Here, the opinion refers to 35 U.S.C. § 154(b)(2)(C)(i) and notes that:
The precise question at issue is whether an applicant submission, filed after a final Office action, that continues to argue the merits of the examiner's rejection, without good cause, constitutes a "fail[ure] to engage in reasonable efforts to conclude prosecution" such that applicant delay would accrue under the PTA statute.
Intra-Cellular argued that because its first after-final submission addressed each outstanding objection and rejection to the claims made in the final Office action, this submission constituted a bona fide attempt to advance prosecution, thus constituting "reasonable efforts to conclude prosecution" under a plain reading of the PTA statute. However, the opinion points out that "Intra-Cellular's reading appears to be in tension with the fact that it no longer had the right to continue debating the merits of the rejection once the final Office action issued in this case." Nevertheless, the Court concluded that "[w]hen read in the context of the overall statutory scheme, . . . the language of the PTA statute does not answer the question of what type of action by an applicant constitutes 'reasonable efforts to conclude prosecution' for purposes of responding to a final Office action" (emphasis in opinion).
Moving to Step 2 of its Chevron analysis, the Court asks whether the USPTO's answer to the precise question at issue is based on a permissible construction of the statute. With respect to this question, the Court concluded that "it is permissible to interpret an after-final submission that merely continues to argue the merits of an examiner's final rejection as a 'fai[lure] to engage in reasonable efforts to conclude prosecution' such that such an applicant submission would not stop the accrual of applicant delay under the PTA statute." The opinion adds that "[w]hile § 1.704(b) does not explicitly define 'reply,' that does not mean that any type of submission by the applicant, no matter how flimsy or superficial, necessarily qualifies as a 'reply' for purposes of stopping accrual of applicant delay." Moreover, the opinion explains that:
Intra-Cellular's proposed interpretation of "reply" under § 1.704(b) as any bona fide attempt to address all rejections and objections in an Office action is impermissible because it incorrectly applies the standard for a compliant "reply" to a non-final Office action as set forth in § 1.111 to the reply to a final Office action at issue here [emphasis in opinion].
The opinion also points out that "under Intra-Cellular's interpretation, an applicant would be allowed to continue to liberally argue and make amendments without accruing applicant delay as long as it addressed all outstanding issues in the final Office action," which "would give the applicant the benefits of an RCE (which re-opens prosecution) without the concomitant PTA reduction that comes with an RCE."
The opinion concludes by rejecting Intra-Cellular's arguments against the permissibility of the Patent Office's PTA determination, including that the USPTO's PTA determination violates the Court's holdings in Gilead Scis., Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015), and Pfizer, Inc. v. Lee, 811 F.3d 466 (Fed. Cir. 2016); that the USPTO's reading of the generic recitation of "reply" in § 1.704(b) to mean a "reply in compliance with § 1.113(c)" constituted "unfair surprise"; and that the USPTO's interpretation conflicts with the USPTO's promotion of various after-final "pilot" programs that encourage applicants to engage in further prosecution after a final Office action. The Federal Circuit therefore determined that the USPTO's determination of applicant delay was supported by a permissible reading of the PTA statute, and found that the District Court did not err in granting summary judgment in favor of the USPTO.
Panel: Circuit Judges Wallach, Chen, and Hughes
Posted at 11:59 PM in Federal Circuit, Patent Office Rules & Procedures | Permalink | Comments (0)
On Monday, in Mayo Foundation for Medical Education and Research v. Iancu, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia affirming a determination by the U.S. Patent and Trademark Office regarding the Patent Term Adjustment for U.S. Patent No. 8,981,063. In affirming the District Court, a divided panel concluded that the USPTO's interpretation of "any time consumed by continued examination of the application requested by the applicant under section 132(b)" in 35 U.S.C. § 154(b)(1)(B)(i) was correct.
The '063 patent, which relates to antibodies for treating disease conditions characterized by immunosuppression (such as cancer, AIDS, and certain congenital immune deficiencies), issued from U.S. Application No. 12/421,310. During prosecution of the '310 application, the Examiner invited Mayo to make a priority showing with respect to U.S. Patent 7,635,757, and Mayo responded by filing a Request for Continued Examination, arguing that it has priority of invention over the '757 patent, and suggesting an interference. Mayo then filed a supplemental amendment cancelling claims that the Examiner had indicated would not correspond to the count in the impending interference; some of the cancelled claims had been previously withdrawn in response to a restriction requirement, and the Examiner advised Mayo that, for the purposes of eventual PTA calculation, claims not relevant to the impending interference should be removed. The cancelled claims were pursued in a separate continuation application, which issued as U.S. Patent 8,460,927.
An interference was subsequently declared between the '310 application and the '757 patent, with the Board ultimately awarding priority to Mayo's '310 application and cancelling the claims in the '757 patent. The Board then returned the '310 application to the Examiner, who issued an Office Action rejecting the claims for non-statutory double patenting in view of the '927 patent. Mayo responded by arguing that the claims of the '310 application and '927 patent were patentably distinct, and the Examiner withdrew the rejection and mailed a Notice of Allowance.
On appeal, Mayo provided the following timeline for prosecution of the '310 application:
The appeal concerned the third bracketed time period of 194 days. After the '063 patent had issued, Mayo, dissatisfied with the USPTO's PTA determination, requested a redetermination of PTA, arguing that the Examiner's sua sponte reopening of prosecution after termination of the interference did not constitute time consumed by continued examination of the application requested by the applicant under 35 U.S.C. § 154(b)(1)(B)(i) (i.e., "RCE time"). The USPTO disagreed, asserting that the RCE time did not end when the interference was declared, but rather ended when the Notice of Allowance was mailed. Mayo requested reconsideration, the USPTO denied Mayo's request, and Mayo appealed to the Eastern District of Virginia.
Before the District Court, Mayo argued that a declaration of an interference terminates RCE time for the purposes of calculating B Delay (i.e., which entitles the applicant to PTA for each day the application is pending beyond three years). In support of its argument, Mayo asserted that Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014), stood for the proposition that continued examination ends once the claims are "deemed allowable," and not necessarily on the date the Notice of Allowance is mailed, and that a declaration of interference (which requires that an application "otherwise be in condition for allowance") is tantamount to a Notice of Allowance. Mayo also asserted that the Examiner's reopening of examination after remand from the Board is time attributable to the PTO, not the applicant, because Mayo never requested examination after remand. The District Court rejected Mayo's arguments and affirmed the USPTO's PTA determination, and Mayo appealed to the Federal Circuit.
Before the Federal Circuit, Mayo argued that it never "requested" examination after the Board's remand following termination of the interference, and that under USPTO regulations, an interference cannot be declared unless at least some claims are deemed allowable but for the outcome of the interference. The USPTO countered that a declaration of an interference does not close prosecution on the merits, and that examination may continue afterward. The USPTO also argued that as a practical matter, Mayo's suggestion that the Court look to the time when the claims are deemed allowable, as opposed to the mailing of a Notice of Allowance would turn PTA calculations into a "wildly impractical" and "hotly contested factual inquiry in nearly every PTA case."
In an opinion authored by Judge Lourie and joined by Judge Dyk, with Judge Newman dissenting, the majority agreed with the USPTO, affirming the District Court's decision affirming the USPTO's PTA determination. In response to Mayo's argument that a declaration of interference is tantamount to a Notice of Allowance, the opinion notes that "[w]hile the PTO's regulations do indicate that at least one claim in an application should be in condition for allowance before an interference is declared, . . . the regulations also explicitly contemplate that the Board may recommend further action by the examiner, including issuing a rejection" (citation omitted), and therefore, "the PTO's regulations as a whole do not indicate that a declaration of an interference is tantamount to a Notice of Allowance." The majority also disagreed with Mayo's interpretation of Novartis, stating that "Mayo only gets to its conclusion by placing more weight on the term 'requested'—a word having little more than clerical significance on a fair reading of the statute—than it can reasonably bear." In particular, the opinion indicates that "[n]othing in § 132(b) implies that an RCE entitles the applicant to a special form of examination, where the claims must be allowed once the grounds of rejection presented in the Final Rejection are resolved; nor does the statute imply that continued examination is no longer requested by the applicant once the PTO issues a new ground of rejection." According to the majority, "Mayo requested continued examination, and that is what it received, both before and after the interference proceeding." The majority therefore held that "where an RCE has previously been filed, the time between termination of an interference and the date of mailing of the Notice of Allowance is 'time consumed by continued examination of the application requested by the applicant under section 132(b)' pursuant to 35 U.S.C. § 154(b)(1)(B)(i)," and affirmed the District Court.
Judge Newman, writing in dissent, contended that the majority's holding "does not comport with the statutory provisions and precedent, and is contrary to the purpose of term adjustment," adding that the post-interference examination period "plainly is examination delay due to PTO procedures." With regard to the Court's holding in Novartis, Judge Newman explained that:
Novartis held that "'examination' presumptively ends at allowance, when prosecution is closed and there is no further examination on the merits in the absence of a special reopening." . . . Novartis did not relate to ongoing or continuing prosecution or any activity before mailing of the notice of allowance. Novartis was concerned only with the "time from allowance to issuance."
According to Judge Newman, "[h]ere the post-interference examination was PTO activity, part of the examination procedure before issuance of the notice of allowance," which "plainly is within the purpose of the term adjustment statute."
Panel: Circuit Judges Newman, Lourie, and Dyk
In a Patent Alert e-mail distributed today, the U.S. Patent and Trademark Office announced that PKI authentication for EFS-Web and Private PAIR has been permanently disabled. The Office had previously announced in late December that the initial December 31, 2018 deadline for the retirement of PKI certificates was being postponed until February 15, 2019. And then on February 14, 2019, the Office announced that due to technical issues, the retirement of PKI certificates was being postponed until further notice. The end of PKI authentication should not come as a surprise to most practitioners, however, as the Office recently announced an outage of the system from May 30 to May 31 and then another outage beginning on June 5.
In announcing the permanent disablement of PKI authentication, the Office also announced that the deadline for practitioners to migrate a PKI certificate to a USPTO.gov account will be July 16, 2019. Practitioners who fail to migrate their PKI certificates by the July 16 deadline will have to obtain a verified USPTO.gov account using the Office's new verification process (in the same manner that new practitioners will be required to obtain a verified USPTO.gov account). Information regarding the new verification process can be obtained here. Briefly, the new verification process consists of completing a Patent Electronic System Verification Form (PTO-2042a), having the form notarized, and mailing the original, notarized form to the USPTO. Thus, if you have a PKI certificate, but have not yet migrated that certificate to a USPTO.gov account, you will probably want to do so before the July 16 deadline.
As the Office indicated last October, the new authentication system for accessing the EFS-Web and Private PAIR is safer and simpler than the old system, allowing for access to multiple USPTO systems with one consolidated sign-in, eliminating the need to share credentials by providing practitioners and their support staff with their own USPTO.gov accounts, and helping resolve browser compatibility issues (see "USPTO Moving to New Authentication System for EFS-Web and Private PAIR"). The Office has also noted that the new system will provide users with access to the EFS-Web and Private PAIR until the full release of Patent Center, the next generation tool that will replace the EFS-Web and Private PAIR in 2020.
In addition, the Office announced the release of a migration tool last October, which allows existing PKI digital certificate holders to link their USPTO.gov accounts to their current PKI digital certificates. To migrate an existing PKI digital certificate, users must have a USPTO.gov account. Users who need to create a USPTO.gov account can do so by following the steps under the "Create a USPTO.gov Account" tab at the Office's authentication change webpage. Once a USPTO.gov account has been created, users can follow the steps under the "Migrate your PKI Certificate" tab at the Office's authentication change webpage (or refer to the Guide for Migration) to link that account to their PKI certificate. The Office notes that users should allow 1–2 business days after the migration steps are finished for the migration process to be completed. Once the process is completed, users will be able to sign into the EFS-Web or Private PAIR using their USPTO.gov account:
Additional information regarding the new authentication process can be found in the Office's Patent Electronic System Access Document. This resource includes information about USPTO.gov accounts; two-step authentication; signing in and signing out from USPTO systems; Patent Electronic Access roles for practitioners, support staff, and inventors; suspension of accounts; authorization; authentication steps; the sponsorship process (by which practitioners can grant or remove sponsorship for support staff individuals to work under their direction and control); and the Office's verification policy and identity proofing of sponsored support staff. With respect to identity proofing, the Office has stated that "[e]ach practitioner will be responsible for verifying the identity of the person using any sponsored support Staff account."
Shortly after announcing the new authentication system last October, the Office also announced the availability of a sponsorship tool for sponsorship of support staff. With respect to sponsorship, the Office emphasized that practitioners no longer have to share their credentials, and in fact, would no longer be permitted to share accounts with support staff, who need to establish their own USPTO.gov accounts in order to access the EFS-Web Registered and Private PAIR. USPTO.gov accounts are now being used as the first step to log into EFS-Web Registered and Private PAIR. The second step of the two-step authentication system requires users to choose to receive an e-mail or phone call which will provide a 6-digit code that is to be entered along with their USPTO.gov password (or use an authenticator app on their mobile phone to provide the additional secure verification). The Office's sponsorship tool, which allows practitioners to grant or remove sponsorship for support staff individuals (under the direction and control of sponsoring practitioners) to work on their behalf, can be accessed here.
Practitioners should familiarize themselves with the identify verification (or proofing) requirements of the new authentication system. Under the identity proofing and enrollment process, the identity evidence and attributes of users of the Office's Patent Electronic System are collected, uniquely resolved to a single identity within a given population or context, then validated and verified. Current PKI certificate holders who migrate their PKI certificates using the migration tool will be considered to have met the identity proofing requirements. However, for support staff being sponsored by practitioners, sponsoring practitioners are "responsible for proofing the identity of the person being sponsored," and "[e]ach sponsoring practitioner will establish a procedure for identity proofing sponsored users and maintain a record of that procedure." Additional details regarding identity verification requirements can be found in the Office's Patent Electronic System Access Document.
Users requiring assistance to create a USPTO.gov account should call the USPTO Contact Center (UCC) at 800-786-9199. Users requiring assistance with migration should contact the Patent Electronic Business Center at ebc@uspto.gov or 866-217-9197. Questions or comments related to the new authentication method may be sent to eMod@uspto.gov. A list of Frequently Asked Questions (FAQs) about the authentication change for EFS-Web and Private PAIR can be found here.
• "USPTO Further Delays PKI Certificate Termination Date," February 14, 2019
• "USPTO Delays PKI Certificate Termination Date," December 23, 2018
• "USPTO Director Issues Notice on New Authentication System for EFS-Web and Private PAIR," December 3, 2018
• "USPTO Moving to New Authentication System for EFS-Web and Private PAIR," October 4, 2018
Posted at 11:41 PM in Patent Office Rules & Procedures | Permalink | Comments (2)
On June 24th, the U.S. Patent and Trademark Office declared an interference between patents (and an application) assigned to the Broad Institute (and other institutions) and applications assigned to the University of California/Berkeley. If this sounds like deja vu all over again it is and it isn't; as will be seen, the strategy employed by Berkeley has induced the Office to address the issues of priority raised in the earlier interference between the parties.
That interference involved these Broad patents (and their involved claims, which constitute all of the granted claims of all of the Broad patents):
• U.S. Patent No. 8,697,359 - claims 1-20
• U.S. Patent No. 8,771,945 - claims 1-29
• U.S. Patent No. 8,795,965 – claims 1-30
• U.S. Patent No. 8,865,406 – claims 1-30
• U.S. Patent No. 8,871,445 – claims 1-30
• U.S. Patent No. 8,889,356 – claims 1-30
• U.S. Patent No. 8,895,308 – claims 1-30
• U.S. Patent No. 8,906,616 – claims 1-30
• U.S. Patent No. 8,932,814 – claims 1-30
• U.S. Patent No. 8,945,839 – claims 1-28
• U.S. Patent No. 8,993,233 – claims 1-43
• U.S. Patent No. 8,999,641 – claims 1-28,
against only one pending (at that time) application from the Berkeley group:
• U.S. Patent Application Publication No. US 2014/0068797 A1 - claims 165, 200, 202-218, 220-222, and 224-247.
The Patent Trial and Appeal Board decided that interference was a nullity, because there was no interference-in-fact between Berkeley's claims (which broadly recited aspects of the CRISPR technology) and those in the Broad patents (which were specifically directed to reagents, systems, and methods for practicing CRISPR in eukaryotic cells. The Federal Circuit affirmed, leaving the Broad's patent estate intact (albeit arguably dominated by Berkeley's broader claims not limited to eukaryotic cells).
Berkeley adopted a strategy of filing several applications last fall specifically directed to eukaryotic cell-directed aspects of CRISPR that would provoke an interference with the Broad claims (although the USPTO declared this interference on the basis that the claims of the Berkeley application were patentable but for the interfering granted claims in the Broad patent).
The Broad patents and applications included in the interference (i.e., having claims considered to fall within the scope of the interference count) are: U.S. Patent Nos. 8,697,359; 8,771,945; 8,795,965; 8,865,406; 8,871,445; 8,889,356; 8,895,308; 8,906,616; 8,932,814; 8,945,839; 8,993, 233; 8,999,641; 89,840,713; and U.S. Application No. 14/704,551. Broad patents not not involved in this interference are U.S. Patent Nos. 8,889,418 and 9,882,372.
University of California/Berkeley patents included in the interference as declared by the USPTO are: U.S. Application Nos. 15/947,680; 15/947,700; 15/947,718; 15/981,807; 15/981,808; 15/981,809; 16/136,159; 16/136,165; 16/136,168; and 16/136,175. Berkeley patents and applications not included in the interference are: U.S. Patent Nos. 10,000,772; 10,113,167; 10,227,611; 10,266,850; 10,301,651; 10,308,961 and U.S. Application Nos. 15/435,233; 15/925,544; 16/201,836; 16/201,848; 16/201,853; and 16/20,855.
A more in depth analysis of this interference with be provided in subsequent posts. One pattern that can be discerned, however, is that Berkeley has taken advantage of the PTAB's decision that there was no interference in fact between its patents directed to CRISPR claims not limited to eukaryotic cells as a shield to protect its patents and applications having such broad claims from the current interference. Its strategy of filing applications having claims directed expressly towards CRISPR embodiments for use in eukaryotic cells enabled Berkeley to target the majority of Broad's patents and applications while putting "at risk" its newly filed applications and not its legacy patents to CRISPR.
The next step will be for the parties to propose preliminary motions to the PTAB, involving patentability issues, the propriety of the claims designated as corresponding (or not corresponding) to the count, and prima facie priority determinations regarding whether the Board properly designated the Broad as senior party (an important strategic consideration involving which party will have the burden of proof). These matters will also be discussed in subsequent posts. For now, it is enough to say that ownership of this technology remains uncertain, a state of affairs that will remain for the next 24-36 months unless these parties decide to settle (an unlikely outcome given the history of their interactions and behavior on the ownership question).​
Posted at 11:02 PM in Patent Office Rules & Procedures | Permalink | Comments (0)
USPTO Issues Notice on Impact of Federal Circuit's Supernus Decision on PTA Procedures
In January, the Federal Circuit determined in Supernus Pharmaceuticals, Inc. v. Iancu that the U.S. Patent and Trademark Office had erred in calculating the Patent Term Adjustment for Supernus' U.S. Patent No. 8,747,897. In particular, the Court found that because there were "no identifiable efforts" that Supernus could have undertaken in the time period between the filing of an RCE during prosecution of the application that issued as the '897 patent and the mailing of an EPO notification of opposition for a European counterpart patent (which resulted in Supernus filing a supplemental Information Disclosure Statement during prosecution of the '897 patent), Supernus had not failed to engage in reasonable efforts to conclude prosecution during that time period.
In response to the Federal Circuit's decision in Supernus, the USPTO issued a Federal Register notice (84 Fed. Reg. 20343) earlier this month notifying stakeholders of the impact of the decision on its PTA determinations. In the notice, entitled "Patent Term Adjustment Procedures in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu," the Office indicates that it is "modifying its patent term adjustment procedures in view of the decision." However, the notice states that "the USPTO will continue to make the patent term adjustment determinations indicated in patents under the existing regulations using information recorded in its PALM [Patent Application Locating and Monitoring] system," and that a patentee who believes there were no identifiable efforts it could have undertaken to conclude prosecution of an application (as Supernus argued with respect to the '897 patent) "may raise the issue in a timely request for reconsideration of the patent term adjustment, providing any relevant information that is not recorded in the USPTO's PALM system."
The Office did note -- in support of essentially maintaining the status quo on PTA determinations and challenges to those determinations -- that "[t]he event from which the Federal Circuit measured the beginning of the patent term adjustment reduction in Supernus (the EPO's notice to Supernus of the opposition on August 21, 2012) is an event external to the USPTO and is thus not an event that is recorded in the USPTO's PALM system." Therefore, until the Office is better able to track actions in foreign counterpart applications and patents (using, for example, the Citation List of its Global Dossier Initiative; see "USPTO News Briefs," October 25, 2017), it is hard to see what additional modifications the Office could make to its PTA procedures.
The notice also points out that "the USPTO expects that the situation in Supernus should arise infrequently," explaining that:
An extended delay between the filing of a request for continued examination and the subsequent Office action (932 days in Supernus) should be a rare occurrence now, as the average time between the filing of a request for continued examination and the subsequent Office action is currently only 79 days.
In addition, the Office reminds stakeholders in a footnote that:
The patent term adjustment reduction at issue in Supernus can be avoided by the prompt submission of the information disclosure statement. Specifically, 37 CFR 1.704(d) provides a "safe harbor" in that a paper containing only an information disclosure statement in compliance with 37 CFR 1.97 and 1.98 will not be considered [a] failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10) if the information disclosure statement is accompanied by one of the statements set forth in 37 CFR 1.704(d)(1)(i) or (d)(1)(ii).
Noting that the Office has "adopted ad hoc procedures for seeking reconsideration of the patent term adjustment determination in the past when there have been changes to the interpretation of the provisions of 35 U.S.C. 154(b) as a result of court decisions," the notice indicates that such ad hoc procedures were necessary because former provisions of 35 U.S.C. § 154(b)(4) "provided a time period for seeking judicial review that was not related to the filing of a request for reconsideration of the USPTO's patent term adjustment determination or the date of the USPTO's decision on any request for reconsideration of the USPTO’s patent term adjustment determination." The Office therefore determined that no such ad hoc procedures were required in response to the Supernus decision because 37 C.F.R. § 1.705 allows patentees to file a request for reconsideration up to seven months after a patent is issued and to wait until after the Office reaches a final PTA determination before seeking judicial review of that determination.
Posted at 11:44 PM in Patent Office Rules & Procedures | Permalink | Comments (1)
By George "Trey" Lyons, III, Eric Moran, Nicole Grimm, and Brett Scott --
Last week, the U.S. Patent and Trademark Office released its new guidelines on how it will examine federal trademark applications for cannabidiol (CBD) products in light of the 2018 Farm Bill. While these new guidelines are encouraging for canna-businesses that manufacture, market, and sell CBD products, considering the carve outs and caveats included therein, it may end up creating more questions than it answers. Below are a few key takeaways:
The New Guidelines Delineate between Federal Trademark Protection for CBD Products Based on Source and THC Concentration
From the outset, the new guidelines reiterate the USPTO's continuing prohibition of federal trademark protection for all parts of the currently-Schedule I substance, "'Marihuana' (commonly referred to as 'marijuana')."[1] These are defined as:
[A]ll parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin [(subject to certain exceptions)]. 21 U.S.C. §802(16).
However, in light of the 2018 Farm Bill, "hemp" has been removed from this classification. Under the new guidelines, "cannabis plants and derivatives such as CBD that contain no more than 0.3% THC on a dry-weight basis are no longer controlled substances under the CSA," but again "only if the goods are derived from 'hemp.'" The USPTO also indicated that it will treat services involving hemp similarly to how it treats goods. For applications involving hemp cultivation or production, the examining attorney will inquire into the Applicant's authorization to produce hemp.
Finally, Applicants (and/or their attorneys) will have to certify and/or specify in goods and services identifications that the goods or services sought to be protected comport with these requirements.
The New Guidelines Are Retroactive
The new guidelines also make clear that the date the 2018 Farm Bill was signed into effect, December 20, 2018, will be the watermark for if previously-filed federal trademark applications can benefit from the 2018 Farm Bill. For applications filed on or after December 20, 2018, assuming a description of goods and services that comports with the new guidelines, everything should be compliant; but those filed before December 20, 2018 have a tougher path.
Specifically, for those use-based applications filed before enactment of the 2018 Farm Bill, "that identify goods encompassing CBD or other cannabis products, registration will be refused due to the unlawful use or lack of bona fide intent to use in lawful commerce under the CSA." However, the new guidelines allow applicants of such applications to amend the application to change: (1) the filing date to December 20, 2018 and, for applications based on use in commerce, (2) the filing basis to intent-to-use (as the USPTO will consider any such previously submitted use as illegal prior to the 2018 Farm Bill), to provide a proper, legal basis for registration. The USPTO will also require applicants to amend goods identifications to "specify that the CBD or cannabis products contain less than 0.3% THC" and are derived from hemp. Unfortunately for applicants of amended applications, the guidelines also require the USPTO to conduct a new search based on the amendments, including the new filing date.
The New Guidelines Do Not Affect FDA Prohibitions for Consumable CBD Products
The new guidelines also cautioned that consumable CBD products (for humans and pets) must also be legal under the Federal Food Drug and Cosmetic Act (FDCA) in order for marks covering such products to be registrable. Specifically, because "foods or dietary supplements of a drug or substance undergoing clinical investigations without approval of the U.S. Food and Drug Administration (FDA) violates the FDCA," applicants will have to ensure compliance with the FDCA prior to applying for federal trademark protection under the new guidelines.
Furthermore, the 2018 Farm Bill itself "explicitly preserved FDA's authority to regulate products containing cannabis or cannabis-derived compounds under the FDCA," as "CBD is an active ingredient in FDA-approved drugs and is a substance undergoing clinical investigations." It is, therefore, difficult to imagine any consumable CBD product gaining federal trademark protection without FDCA compliance (whether by gaining FDA approval or falling under a class of good or services that do not require FDA approval). Currently, Epidiolex is the only FDA-approved drug containing an active ingredient (CBD) derived from a cannabis plant.
However, all is not lost, as the FDA continues to acknowledge and address this challenging crossroad of the 2018 Farm Bill and CBD-based drugs and consumables. So far, the FDA has taken several concrete new steps to address these issues, including:
(1) Scheduling a public hearing on May 31, 2019 for CBD stakeholders to "share their experiences and challenges with these products, including information and views related to product safety," as well as provide a "broader opportunity for written public comment."[2]
(2) Forming "a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health."[3]
(3) Updating the FDA's website with "answers to frequently asked questions on this topic to help members of the public understand how the FDA's requirements apply to these [CBD] products."[4]
(4) Issuing "multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations [including dangerous marketing efforts that CBD cures or otherwise slows the progression of diseases including cancer, Alzheimer's, and fibromyalgia, among others]."[5]
Thus, while the tides may still be shifting, Applicants should carefully consider both the timing and content of any federal trademark application aimed at any CBD products that potentially need FDA approval.
The New Guidelines Do Not Affect Current Prohibition for Federal Canna-Trademarks under the Lanham Act and CSA
Finally, and frustratingly (albeit not surprisingly), the USPTO also confirmed that it is not revising its stance on federal trademark registration of cannabis related products and services. By way of background, the USPTO has refused to register trademarks on cannabis goods or services, particularly those in the context of the cannabis product itself (e.g., a particular strain of leafy cannabis), due to the lack of any lawful uses of the applied for marks in commerce. The Lanham Act expressly prohibits registration of illegal products and services, such as those still falling under the Controlled Substances Act (CSA). And the new guidelines unequivocally reiterate this prohibition.
That said, the new guidelines provide some additional guidance on how the USPTO will treat federal trademark applications in the canna-industry. For applicants with pending applications for marks covering products or services that are now legal under the CSA, examination should proceed under the new requirements. For those with marks covering products or services that may still be illegal under the CSA, but that may be legal under some state laws, federal protection is still elusive and applicants may need to seek protection under individual state trademark laws. And, as the USPTO's examination has been historically inconsistent concerning cannabis products,[6] it is not a stretch of the imagination to think that the USPTO may continue to swing back toward more canna-friendly policies in the future.[7]
[1] Unless otherwise indicated, all quotations come from the USPTO's "Examination Guide 1-19: Examination of Marks for Cannabis and Cannabis-Related Goods and Services after Enactment of the 2018 Farm Bill," a copy of which can be found here and is referred to herein as "the new guidelines."
[2] Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency's continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products, FDA (April 2, 2019), available at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-advance-agencys-continued-evaluation
[6] Beginning in 2010, the USPTO invited applicants to apply for federal trademark registrations on cannabis goods and services by creating a new entry in its Acceptable Identification of Goods and Services Manual for: Class 5: "Processed plant matter for medicinal purposes, namely medical marijuana." See Justin Scheck, Patent Office Raises High Hopes, Then Snuffs Them Out, Wall Street Journal (July 19, 2010), available at http://www.wsj.com/articles/SB10001424052748704682604575368783687129488. Within a matter of months, and countless applications later, a spokesperson for the USPTO, Peter Pappas, noted that the newly articulated class "raise[d] examination issues . . . was a mistake and [that the USPTO] ha[d] removed it." Id.
[7] For context, federal trademarks and service marks have been granted (and continue to be granted) in the context of ancillary products and services (e.g., cannabis apparel companies, and informational services/cannabis networking organizations). Regardless, applicants should always be prepared to controvert USPTO rejections and readily show how the cannabis-related mark does not violate the CSA -- no matter how strained the nexus between the goods or services offered by the applicant to the currently illegal product may be.
Posted at 10:10 PM in Patent Office Rules & Procedures | Permalink | Comments (0)