Publications – Oblon, McClelland, Maier & Neustadt, L.L.P. Intellectual Property Law Firm en-us 09 Aug 2020 00:00:00 -0800 firmwise RCE/National Stage Kerfuffle: PTO Creates a Nightmare Scenario <p>Much has been written lately about the USPTO&rsquo;s recent enforcement of its controversial interpretation of filing Requests for Continued Examination (RCE) in National Stage applications (i.e., applications under 35 U.S.C. &sect;371) where the oath/declaration was not filed prior to filing the RCE. This post will not address the legal merits of the USPTO&rsquo;s position.</p> <p>Perhaps what is most perplexing to the patent community is the timing of the enforcement of this interpretation.&nbsp;This unexplainable delay has led to a widespread, and even unappreciated, impact upon granted patents as well as pending applications.&nbsp;Even cute names such as &ldquo;zombie patents&rdquo; have crept into patent parlance as patentees and practitioners alike grapple with the scope and impact of this new enforcement.&nbsp;But the reality is that this situation is anything but cute.&nbsp;</p> <p>In this post, I explore:</p> <p style="margin-left: 40px;">Part 1: How we got here</p> <p style="margin-left: 40px;">Part 2: Pending Applications</p> <p style="margin-left: 40px;">Part 3: Granted Patents</p> <p align="center"><b><u>Part 1: How We Got Here</u></b></p> <p><b><i><u>Background</u></i></b></p> <p>At issue is 35 U.S.C. &sect;132(b), which provides:</p> <p style="margin-left: 40px;">(b) The Director shall prescribe regulations to provide for the continued examination of applications for patent at the request of the applicant. The Director may establish appropriate fees for such continued examination and shall provide a 50 percent reduction in such fees for small entities that qualify for reduced fees under section 41(h)(1).</p> <p>The regulations that the Director prescribed appear in 37 C.F.R. &sect;114, which provides in relevant part:</p> <p style="margin-left: 40px;">(a) If prosecution in an application is closed, an applicant may request continued examination of the application by filing a submission and the fee set forth in &sect; 1.17(e) prior to the earliest of&hellip;</p> <p style="margin-left: 40px;">(e) The provisions of this section do not apply to&hellip;</p> <p style="margin-left: 80px;">(3) An international application filed under 35 U.S.C. 363 before June 8, 1995, or an international application that does not comply with 35 U.S.C. 371;</p> <p><b><i><u>Inexplicable and Prejudicial Delay</u></i></b></p> <p>Many commentators, and even some within the USPTO, have suggested that this impact dates back to 2015 when the USPTO made certain regulatory changes to Implement the Hague Agreement Concerning International Registration of Industrial Designs; however, this is not accurate.&nbsp;The problem potentially applies to every National Stage application that is subject to the America Invents Act (&ldquo;AIA&rdquo;) amendment to 35 U.S.C. &sect;115 (amended Sept. 16, 2011, Leahy-Smith America Invents Act, Public Law 112-29, sec. 4(a), 125 Stat. 284, effective Sept. 16, 2012). &nbsp;In other words, not just applications dating back five years are at issue, but more accurately every National Stage application filed under the AIA over the past <u>eight</u> years is potentially at risk.</p> <p>But how did we get here? Why now?</p> <p>The simplest answer is that the USPTO&rsquo;s position flew under the radar because (1) prior to the past couple of months, the USPTO has not enforced this interpretation and has instead let countless patents grant that do not comply with this interpretation, and (2) the USPTO&rsquo;s position runs contrary to the objectives of the AIA and the Patent Law Treaties Implementation Act of 2012 (&ldquo;PLTIA&rdquo;).&nbsp;Thus, patentees and practitioners were (falsely?) led to believe that the amendments to 35 U.S.C. &sect;115 following the AIA applied equally to all applications regardless of national origin and irrespective of whether the application was a National Stage or a non-provisional claiming Paris convention priority.&nbsp;The general thought was that this would, logically, extend to RCE practice as well.&nbsp;</p> <p>The problem first arose with the June 20, 2020 revision of the MPEP.&nbsp;In this revision, the USPTO updated &sect;706.07(h) pertaining to RCEs.&nbsp;The biggest change to this section is that the USPTO added the following paragraph:</p> <p style="margin-left: 40px;">For an effective request for continued examination (RCE) to be filed in a 35 U.S.C. 371 national stage application, <b><i><u>all required inventor&rsquo;s oaths or declarations (or substitute statements) must be submitted in the application prior to or with the RCE, notwithstanding 37 CFR 1.495(c)(3) permitting an inventor&rsquo;s oath or declaration to be postponed until an application is otherwise in condition for allowance</u></i></b>. In accordance with 37 CFR 1.114(e), an RCE cannot be filed in an international application that does not comply with 35 U.S.C. 371; 35 U.S.C. 371(c)(4) requires submission of the oath or declaration by the inventor(s) or a substitute statement. (<i>emphasis added</i>)</p> <p>Prior to the formal preparation of the June 20, 2020 update of the MPEP, the USPTO did <b><i><u>not</u></i></b> enforce this position.&nbsp;I suspect that the USPTO would be hard-pressed to identify even a single application in which they issued a notice of improper RCE citing this interpretation prior to putting the MPEP revision in process to publish.&nbsp;</p> <p>The USPTO defends its position by pointing to Changes To Implement the Hague Agreement Concerning International Registration of Industrial Designs, <a href="">80 FR 17917</a>, 17930 (Apr. 2, 2015).&nbsp;This Notice issued <u>five</u> years before the USPTO started enforcing their interpretation.&nbsp;However, the issue goes back even further.&nbsp;</p> <p>The 2015 Notice that the Office points to relates to the Patent Law Treaties Implementation Act of 2012 (&ldquo;PLTIA&rdquo;) which was passed by Congress in December 2012 and became effective on December 18, 2013.&nbsp;In other words, the USPTO took over two years to amend the regulations in response to the PLTIA, in addition to the five years it took to actually apply the interpretation.&nbsp;But the chain continues.</p> <p>The true origin of the USPTO&rsquo;s position, as noted above, is Changes To Implement the Inventor's Oath or Declaration Provisions of the Leahy-Smith America Invents Act, <a href="">77 FR 48775</a>, (Aug. 14, 2012) at 48777, 48780, 48795, in which the UPSTO makes specific reference to at 80 FR 17917, 17930.&nbsp;Here the USPTO explains:</p> <p style="margin-left: 40px;">The Office recently revised its rules to permit applicants, including applicants in national stage applications under 35 U.S.C. 371, to postpone filing the inventor's oath or declaration until the application is otherwise in condition for allowance (subject to certain conditions). See Changes to Implement the Inventor's Oath or Declaration Provisions of the Leahy-Smith America Invents Act, 77 FR 48776 (Aug. 14, 2012) (final rule). An international application, however, does not comply with the requirements of 35 U.S.C. 371 until the application includes the inventor's oath or declaration. See 35 U.S.C. 371(c)(4); see also 77 FR at 48777, 48780, 48795 (explaining that the inventor's oath or declaration is still required for a PCT international application to comply with 35 U.S.C. 371, notwithstanding the changes permitting applicants to postpone filing the inventor's oath or declaration until after a PCT international application enters the national stage)</p> <p>Despite the USPTO having this interpretation for <b><u>eight</u></b> years, only now has the USPTO started enforcing their interpretation.&nbsp;However, the USPTO has not published any specific points or guidance on this topic, much less any explanation of how their past lack of enforcement should be taken.&nbsp;</p> <p>In fact, yesterday our firm contacted the Office of Patent Legal Administration (OPLA) at the USPTO to discuss this issue.&nbsp;OPLA has been given a series of &ldquo;talking points&rdquo; by the Office of Petitions, but neither OPLA nor the Office of Petitions has any statutory authority, regulations, nor jurisprudence to point to that supports its advice to applicants on what to do with pending cases.&nbsp;More problematic is that the USPTO is refusing to &ldquo;weigh in on issued patents&rdquo;, perhaps trying to find a way to ignore any culpability that they have.</p> <p><b><i><u>The very definition of arbitrary and capricious </u></i></b></p> <p>It is hard to prognosticate where this will go, but it seems that the USPTO&rsquo;s treatment is the very definition of arbitrary and capricious in terms of enforcement.&nbsp;First, the USPTO elected not to enforce this interpretation for nearly eight years, only now rolling it out for enforcement.&nbsp;Second, the USPTO appears to be adopting a waiver of 37 C.F.R. &sect;1.114(c)-(d) while enforcing 37 C.F.R. &sect;1.114(e).&nbsp;Third, OPLA indicated that in cases where the oath/declaration was already received after the improper RCE, they will not be mailing out notice of abandonments for prior improperly filed RCEs, which implies that they may be implicitly waiving 37 C.F.R. &sect;1.114(e) for pending cases.&nbsp;Fourth, OPLA stated that the USPTO will not weigh in on issued patents, yet they do weigh in as their &ldquo;talking points&rdquo; state that where continuity is of concern, applicants should consider filing a petition to revive in the patented parent case in order to preserve continuity, thus implying that they are not considering waiver of 37 C.F.R. &sect;1.114(e) for granted patents.&nbsp;Fifth, the USPTO&rsquo;s position runs contrary to the objectives of the AIA and the Patent Law Treaties Implementation Act of 2012 (&ldquo;PLTIA&rdquo;).&nbsp;It certainly will be interesting to see where the legal challenges go.</p> <p align="center"><b><u>Part 2: Pending Applications</u></b></p> <p><b><i><u>Pending Cases With Notice of Improper RCE Where an Oath/Declaration is not Filed</u></i></b></p> <p>The proper course for pending cases that received a notice of improper RCE where an oath/declaration has not been filed is relatively straightforward.&nbsp;In these cases, it is pretty clear that the proper remedial action is to file the executed oath/declaration along with a new RCE, and payment of the RCE fee. In this situation, it appears likely that the USPTO will apply the previously paid RCE fee at the applicant request.&nbsp;</p> <p>However, what happens when the notice of abandonment was issued for an RCE that was filed a couple of years ago?&nbsp;The answer to this question is that applicants must file a petition to revive under 37 C.F.R. &sect;1.137 for unintentional abandonment.&nbsp;In addition, applicants must file a proper RCE, payment of the first RCE fee, and the necessary oath/declaration.&nbsp;It is not clear at this time if the USPTO will apply the previously paid RCE fee at the applicant request; however, it may be worth trying or paying a second time and requesting a refund.&nbsp;</p> <p>In the vast majority (if not all) of the cases in this category, substantial prosecution has occurred between the RCE filing and the notice of abandonment.&nbsp;What happens to the prosecution history once the petition to revive is granted?&nbsp;Where do we pick up examination?</p> <p>37 C.F.R. &sect;1.114(c)-(d) implies that applicants have to &ldquo;go back in time&rdquo; before the improper RCE was filed and ensure that they meet the submission requirement.&nbsp;But what submission is required?&nbsp;Would the oath/declaration be all that is required? In the overwhelming majority of cases, when the RCE was filed it was to obtain entry of a response to the (then) outstanding Office Action.&nbsp;Accordingly, 37 C.F.R. &sect;1.114 appears to effectively reset prosecution to a point that could be several years ago and also requires that in addition to the oath/declaration, the RCE must request entry of a compliant response to the preceding, e.g., final office action and that prosecution should restart from that point.</p> <p>When OPLA was asked about this issue, they stated that once the petition to revive is granted the status of the application will return to the status held just before the notice of abandonment. &nbsp;If there are outstanding due dates, those dates will be reset.&nbsp;However, where is the basis for this position in the statute or regulations?&nbsp;Moreover, beyond the OPLA talking points, there is no public notice or guidelines to address this issue or upon which applicants can rely.</p> <p>So, based on the OPLA talking points, is the USPTO waiving the requirements of 37 C.F.R. &sect;1.114(c)-(d) while enforcing the requirements of 37 C.F.R. &sect;114(e)?&nbsp;No wonder the patent community is confused.</p> <p align="center"><b><u>Part 3: Granted Patents (The Real Problem)</u></b></p> <p>&nbsp;</p> <p><b><i><u>What to do About Granted Patents?</u></i></b></p> <p>This is the true conundrum that is no doubt keeping many practitioners awake at night.&nbsp;For the past eight years following the AIA, National Stage applications were prosecuted in good faith and in a manner that was believed to be in full compliance with the patent statute and regulations.&nbsp;Evidence to this effect was provided in the form of a granted U.S. patent.&nbsp;Now, the USPTO has called the validity and enforceability of those patents into question.</p> <p>As the USPTO &ldquo;talking points&rdquo; state that they will not weigh in on issues related to granted patents, there really is no clear answer at this point.&nbsp;Further, it is highly likely that resolution of this issue will take years to work through judicial scrutiny.</p> <p>First and foremost, the USPTO will not issue a notice in a granted patent that an improper RCE was filed during prosecution.&nbsp;Further, patentees have no obligation to do anything at the USPTO if such a situation exists.&nbsp;But, can a patentee rely upon a patent that was granted in a National Stage application with an improper RCE?&nbsp;Should the patentee proactively do something to &ldquo;correct&rdquo; the &ldquo;problem&rdquo;?&nbsp;Is there even a &ldquo;problem&rdquo; to &ldquo;correct&rdquo;?&nbsp;If there is a &ldquo;problem,&rdquo; how do you &ldquo;correct&rdquo; it?&nbsp;&nbsp;</p> <p>There are many schools of thought on this issue which loosely follows as:</p> <p style="margin-left: 40px;">1)&nbsp;&nbsp;&nbsp;&nbsp; Do nothing because the patent is of little value or the issue isn&rsquo;t all that interesting;</p> <p style="margin-left: 40px;">2)&nbsp;&nbsp;&nbsp;&nbsp; Take the view that the USPTO&rsquo;s failure to raise this issue during examination constitutes a waiver of 37 C.F.R. &sect;114(e);</p> <p style="margin-left: 40px;">3)&nbsp;&nbsp;&nbsp;&nbsp; Take a measured approach where you wait and see if, and when, this issue is litigated, then address as needed;</p> <p style="margin-left: 40px;">4)&nbsp;&nbsp;&nbsp;&nbsp; Take a proactive approach where, for example, the patentee files a petition for revival under 37 C.F.R. &sect;1.137(a) for unintentional abandonment, along with a copy of the already-filed signed oath/declaration, an RCE, and a brief cover page explaining why this is being done.</p> <p>Arguments can be made <i>ad nauseum</i> about which of these approaches is best approach, but they are each fraught with potential adverse consequences.&nbsp;For example, (1) and (2) may put the patent&rsquo;s enforceability in jeopardy.&nbsp;(3) may run the risk that the USPTO&rsquo;s position is held to be proper and that any remedial action at that time will be considered &ldquo;late.&rdquo;&nbsp;</p> <p>However, the one that may raise the most concerns is (4).&nbsp;This procedure raises more questions and potential problems than it seeks to solve.&nbsp;Some include:</p> <ul> <li>As the patent is granted, can patentee even file a petition for revival?&nbsp;</li> <li>If patentee can file a petition for revival, should the RCE also request entry of the last response filed before the first improperly filed RCE?&nbsp;</li> <li>What happens to the prosecution history after the first improperly filed RCE?&nbsp;</li> <li>If the petition is granted, does this reopen examination subjecting the patent to the evolving (and sometimes incorrect) examination standards related to 35 U.S.C. &sect;101 and &sect;112, as well as a new prior art search and specious obviousness rejections?</li> <li>Does the filing of a petition for revival trigger a new duty to disclose obligation under 37 C.F.R. &sect;1.56?</li> <li>What is the impact if the USPTO denies the petition for revival?</li> </ul> <p>Herein lies an impossible riddle.&nbsp;Once the patent is granted, regulatory provisions such as a petition to revive for unintentional abandonment are not generally available except for the limited purpose of reviving due to failure to pay a fee.&nbsp;However, if an application was abandoned, then it cannot be patented.&nbsp;</p> <p>If patentee files a petition to revive for unintentional abandonment, they have essentially admitted that the patent should have been abandoned as of the first RCE filing (i.e., the patent is void <i>ab initio</i>).&nbsp;The granting of that petition then should mean that examination is still open starting with the properly entered RCE/response in accordance with 37 C.F.R. &sect;1.114(c)-(d) as noted above.&nbsp;Accordingly, the granting of the petition should be viewed as effectively erasing the prosecution history (except the bad stuff under <i>Festo</i>) after the case was &ldquo;abandoned&rdquo; as it is a legal impossibility to prosecute and secure a patent on an abandoned case.&nbsp;This would reset examination to the point in time where the first improper RCE was filed, unless of course the USPTO is <i>sua sponte</i> waiving 37 C.F.R. &sect;1.114(c)-(d) in response to enforcing 37 C.F.R. &sect;1.114(e).&nbsp;</p> <p>Unfortunately, this is largely unchartered territory.&nbsp;If we apply the OPLA talking points to granted patents, then it would appear that if the USPTO grants the petition, then the failure to file a proper RCE would be cured and the application that matured into the patent would remain a patent.&nbsp;However, what is the legal basis to conclude or USPTO statement to support that if the petition is granted that it would or should remain a patent. &nbsp;Can this even be true legally or procedurally?</p> <p><b><i><u>Other Options?</u></i></b></p> <p>There are other options available for the correction of patents, which may be more appropriate under the circumstances.</p> <p><b><u>Reissue</u></b> &ndash; As noted above, the petition to revive route above is an admission that the patent was void <i>ab initio</i> and is akin to the &ldquo;partially or wholly inoperative or invalid&rdquo; standard for filing a reissue application.&nbsp;Thus, as opposed to wading into legally unchartered and perhaps improper waters of filing a petition to revive, the more appropriate route may be to file a reissue application.</p> <p>However, a reissue application would be costly.&nbsp;Further, if granted, it is well-established that the reissue application would subject the entire patent to examination <i>de novo</i>.&nbsp;As such, this may be an undesirable route, is unlikely to bring a better outcome than the petition to revive route, is likely to cost more in the long-run, is likely to lead to a reduced claim scope, and is likely to take substantially longer to resolve. &nbsp;This route may at least help put to rest the procedural concerns and the &ldquo;where does examination start&rdquo; questions.</p> <p><b><u>Supplemental Examination</u></b> &ndash; The option that seems to be almost forgotten is that of supplemental examination.&nbsp;This issue appears to be tailor-made for supplemental examination and should provide a favorable resolution of the issue.&nbsp;Supplemental examination under 35 U.S.C. &sect;257 provides patentees the opportunity to request supplemental examination of a patent by the USPTO to consider, reconsider, or correct information believed to be relevant to the patent.&nbsp;</p> <p>The information presented in a request for supplemental examination is very broadly construed by the UPSTO.&nbsp;The information is not limited to patents and printed publications, and may include, for example, issues of patentability under 35 U.S.C. 101 and 112, a document related to factual information, priority information, a declaration under 37 C.F.R. &sect;1.132 submitted during examination. (see 37 C.F.R. &sect;1.605 and MPEP &sect;2809).&nbsp;The improper timing of the oath/declaration with respect to an RCE is based upon a written document and should fall squarely within the information that the USPTO should consider as proper supplemental examination.</p> <p>Within three months of the receipt of a request for supplemental examination (meeting the requirements of 35 U.S.C. &sect;257 including the requirements established by the USPTO), the USPTO shall conduct a supplemental examination and conclude the supplemental examination proceeding with the issuance of a supplemental examination certificate. The supplemental examination certificate shall indicate whether the items of information presented in the request raise a substantial new question of patentability.&nbsp;</p> <p>It is hard to envision a scenario where the USPTO would find the submission of an oath/declaration in a National Stage application after the filing of the first RCE to raise a substantial new question of patentability or to order reexamination.&nbsp;As such, if this route is followed, the USPTO should promptly issue a favorable supplemental examination certificate.&nbsp;Moreover, the receipt of a favorable supplemental examination certificate would also put to rest any possible allegation of inequitable conduct related to this issue.</p> <p>Of note, however, the supplemental examination route is slightly more expensive than the petition to revive route, but likely much less than the reissue route.&nbsp;Specifically, the supplemental examination route would cost $4400 under the current USPTO fee schedule, while the petition to revive would be $2000 plus an additional $1300 for the first RCE.&nbsp;Despite the increased cost, this route would subject the patent to less uncertainty in the process and should be resolved promptly and favorably.&nbsp;Therefore, if patentee believes that some action is necessary, supplemental examination should be strongly considered.</p> <p><b><i><u>The Continuity Problem</u></i></b></p> <p>Aside from the patent being important, the question remains whether there is a compelling reason to take any action in a granted patent.&nbsp;Flying under the radar, but one of the more devastating impacts of the USPTO&rsquo;s position, if it is allowed to stand, is that it possibly creates a continuity problem.&nbsp;Here lies yet another almost impossible question to answer and perhaps an even harder problem to properly resolve.&nbsp;</p> <p>When a later-filed application claims benefit of a prior-filed non-provisional application under 35 U.S.C. &sect;120, 121, 365(c), or 386(c), the later-filed application must be co-pending with the prior application or with an intermediate non-provisional application similarly entitled to the benefit of the filing date of the prior application.&nbsp;Co-pendency as set forth in these clauses requires that the later-filed application must be filed before: (A) the patenting of the prior application; (B) <i><u>the abandonment of the prior application</u></i>; or (C) the termination of proceedings in the prior application.&nbsp;</p> <p>Accordingly, if one accepts the USPTO&rsquo;s current view that National Stage application is abandoned when an RCE is filed prior to the oath/declaration, then any continuation or divisional application filed after the improper RCE lacks proper co-pendency with the National Stage application. &nbsp;This could mean that each and every family-member patent, including those currently pending, are at risk or outright invalid under 35 U.S.C. &sect;119(a) and/or 35 U.S.C. &sect;102.</p> <p>OPLA does include this issue in their talking points.&nbsp;Specifically, the talking points state that where continuity is of concern, applicants should consider filing a petition to revive in the patented parent case in order to preserve continuity.&nbsp;The talking points do not point to this as a &ldquo;must,&rdquo; but rather something that can be done if applicants are &ldquo;worried about continuity&rdquo;.&nbsp;</p> <p>However, this leads us back to the conundrum above of whether the petition to revive route is legally or procedurally proper.&nbsp;Further, it is not clear that a reissue application or supplemental examination would resolve this issue or ensure that the requirements for co-pendency are met. &nbsp;&nbsp;</p> <p><b><i><u>Suspension of the Rules as a Remedy?</u></i></b></p> <p>From the OPLA &ldquo;talking points&rdquo; it is clear that the USPTO is making this up as they go without any regard for the potentially devastating impact of their position.&nbsp;Sadly, considering the substantial petition and, possibly, prosecution fees that the USPTO will collect with each affected application, it certainly does appear to be the &ldquo;money grab&rdquo; that many commentators have speculated.&nbsp;However, the USPTO is unapologetic and ducks getting involved in discussions of what consequences their most recent recalcitrance may have on the enforceability of an uncalculatable number of patents and pending applications.&nbsp;If the UPTO truly cared about this issue and its &ldquo;stakeholders&rdquo; the solution is really quite simple and clearly within the authority of the Director.&nbsp;</p> <p>Specifically, the requirements for filing an RCE under 37 C.F.R. &sect;.114, including the timing requirement for the oath/declaration in a National Stage application, is created by <i><u>rule</u></i> based on the authority granted to the Director under 35 U.S.C. &sect;132(b).&nbsp;If fact, 35 U.S.C. &sect;371(d) further grants the Director the authority to accept and establish fees for an oath/declaration filed after the date of the commencement under 35 U.S.C. &sect;371(c).&nbsp;Thus, the filing of an oath/declaration is required under statute (35 U.S.C. &sect;115 and 35 U.S.C. &sect;371); however, the timing requirement for a proper RCE is set by rule (37 C.F.R. &sect;1.114).</p> <p>Accordingly, the Director can put this entire issue to rest by exercising his supervisory authority under 37 C.F.R. &sect;1.183, 37 C.F.R. &sect;2.146(a)(5), and/or 37 C.F.R. &sect;2.148 and <i>sua sponte</i> waiving the requirements of 37 C.F.R. &sect;1.114(e)(3) for all patents granted before June 20, 2020.&nbsp;If the Director expressly waives the requirements of 37 C.F.R. &sect;1.114(e)(3) for all patents granted before June 20, 2020, then there can be no doubt as to the co-pendency requirement and Pandora&rsquo;s box will be closed leaving the parade of evils safely secured.&nbsp;</p> <p>Even if the Director will not take action on his own, for granted patents, patentees can always consider the option of filing a petition under 37 C.F.R. &sect;1.183 asking the Director to waive the requirement in a National Stage application for an oath/declaration to be filed prior to an RCE.&nbsp;This same approach can be considered even for pending applications in which the oath/declaration is already filed, but after the first RCE. &nbsp;</p> <p>&nbsp;</p> <p>Disclaimer: The views expressed in this post are those of the author.&nbsp;Any opinions expressed in this article do not necessarily reflect the views of Oblon, its partners, or its clients. This post is not intended to convey specific legal advice.&nbsp;As each situation has its own unique facts, please consult with a licensed attorney to discuss your own situation prior to acting.&nbsp;</p> Article 06 Aug 2020 00:00:00 -0800 Mitigating Joint Infringement Liability After Del. Patent Ruling Joint Infringement Liability After Del. Patent Ruling.pdf&anc=995&format=xml <b>Alexander Englehart</b> wrote the article &ldquo;<a href="">Mitigating Joint Infringement Liability After Del. Patent Ruling</a>&rdquo; featured in <i>Law360.</i> Article 04 Aug 2020 00:00:00 -0800 Joint Infringement Liability After Del. Patent Ruling.pdf&anc=995&format=xml A Diagnostic Patent Is Found Patent Eligible At the Federal Circuit <p>In March the Federal Circuit reversed a lower court decision finding Illumina&rsquo;s patents (U.S.Ps. 9,580,751 and 9,738,931) for diagnosing Down&rsquo;s Syndrome to be patent ineligible, 952 F.3d 1367 (Fed. Cir. 2020).&nbsp;On August 3, the Federal Circuit denied a petition for rehearing and rehearing <i>enbanc</i> but did issue a new decision adding the term &ldquo;human-engineered&rdquo; in several portions of the opinion discussing the separation of fetal DNA from maternal DNA which the inventors had discovered were of different sizes, fetal cell DNA is shorter than the maternal DNA.&nbsp;The inventors recognized that the DNA to be analyzed for genetic aberrations was that of the fetus.&nbsp;The problem was to isolate the small amount of fetal DNA from the maternal DNA so the fetal DNA could be analyzed for genetic aberrations. Prior to the invention there was no known way to distinguish and separate maternal DNA from the tiny fraction of fetal DNA present. The inventors found that by selectively removing DNA having more than 500 or 300 base pairs they could produce a sample where the fetal DNA content in the sample would be enriched and analyzed. The following claim is exemplary:</p> <p style="margin-left: 40px;">1. A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:</p> <p style="margin-left: 40px;">(a) extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;</p> <p style="margin-left: 40px;">(b) producing a fraction of the DNA extracted in (a) by:</p> <p style="margin-left: 80px;">(i) size discrimination of extracellular circulatory DNA fragments, and</p> <p style="margin-left: 80px;">(ii) selectively removing the DNA fragments greater than approximately 500 base pairs,</p> <p style="margin-left: 80px;">wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and</p> <p style="margin-left: 40px;">(c) analyzing a genetic locus in the fraction of DNA produced in (b).</p> <p>The natural phenomenon according to the dissent was the size difference between maternal DNA and fetal DNA.&nbsp;However, the size difference is not claimed, but is used in the claim to as part of a method preparing DNA fractions from a mother for analysis. Until the inventors discovered the natural phenomenon, it had not been possible to separate fetal and maternal DNA in the sample.&nbsp;The inventors did not claim the size difference but used to prepare a sample for analysis.&nbsp;This use was recognized by the majority as being patent eligible under the Supreme Court decision, citing <i>Diamond v. Diehr,</i> 450 U.S. 175, 185 (1981). The Court went further and noted that the admonishment by the Supreme Court in <i>Mayo Collaborative Servs. v. Prometheus Labs., Inc.</i>, 566 U.S. 66, 70 (2012) that too broad an interpretation of the 35 U.S.C. &sect; 101 exceptions &ldquo;could eviscerate patent law.&rdquo;&nbsp;</p> <p>The dissent focused myopically on the discovery of the size difference between maternal DNA and fetal DNA and not on the claim language. The claim does not seek to claim the size of fetal DNA, it uses the size of the fetal DNA to allow for its enrichment in the sample. The use of a natural as being patentable was sanctioned by the Supreme Court in <i>O&rsquo;Reilly v. Morse</i>, 56 U.S. 62 (1853). In <i>Morse</i> the Court sanctioned the use of the natural law of electromagnetism to send telegrams. As in <i>Morse</i>, here the patent does not claim the natural law to preempt all uses of the DNA size difference but claims a specific use of the difference.</p> <p>The Federal Circuit is emphasizing that to be patent eligible a claim must use the natural law and not claim it.The Federal Circuit is emphasizing that to be patent eligible a claim must use the natural law and not claim it.<br /> <br /> &nbsp;</p> Article 04 Aug 2020 00:00:00 -0800 The Federal Circuit Provides a Refresher on Joint Inventorship <p>The decision in Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceuticals Co., Ltd, Tasuku Honjo, E.R. Squibb &amp; Sons, L.L.C., Bristol-Myers Squibb Company (Fed. Cir., July 14, 2020) was an appeal of a determination of joint inventorship from the United States District Court for the District of Massachusetts. <a href=""></a>.</p> <p style="margin-left: 40px;">This is a story of scientists, one of which is a Nobel Laureate (Honjo) where:</p> <p style="margin-left: 40px;">This appeal presents an inventorship dispute over groundbreaking work in the field of cancer treatment. Each patent at issue claims a method of treating cancer by administering antibodies targeting specific receptor-ligand interactions on T cells.</p> <p style="margin-left: 40px;">The discovery behind the present patents was the ex-istence of an inhibitory receptor on T cells, PD-1, and that, when PD-1 binds to one of its ligands, either PD-L1 or PD-L2, the T cell is inhibited and does not attack the cell ex-pressing the ligand. Expression of the PD-1 ligands in healthy cells generally shields them from attack, but some tumor cells can also express the ligands, allowing them to circumvent an immune response. The patents in this case capitalize on the discovery of the PD-1 receptor-ligand in-teraction. Each claim recites uses of antibodies that target either the PD-1 receptor or its PD-L1 ligand, blocking the receptor-ligand interaction.</p> <p style="margin-left: 40px;">The background of this case, as described in the opinion, tells a common tale in university involved research-- labs collaborating on the science. However, when it came time to patent the invention, one party does not think the other did much to contribute to the invention. The collaborating labs were Dr. Honjo&rsquo;s lab in Kyoto University&rsquo;s medical school, which discovered the PD-1 receptor in the early 1990s, Dr. Wood, a researcher at Genetics Institute, who apparently suggested developing antibodies against PD-1 receptor for therapeutic applications, and Dr. Freeman, a researcher at Dana-Farber. There are numerous facts in the opinion as to the time line and details of this collaboration but what is clear is that all three professors contributed something significant to this invention. However, the patents listed only Dr. Honjo and his people while excluding Drs. Wood and Freeman--Ono Pharmaceutical Co., Ltd. is the assignee of the patents.</p> <p>So as not to consider that Dr. Honjo was the only one who did not think his collaborators were inventors, it appears from the opinion that Drs. Wood and Freeman also filed applications while excluding Dr. Honjo:</p> <p style="margin-left: 40px;">Dr. Honjo&rsquo;s attorneys were pursuing his inventorship claim, but Genetics Institute, the assignee of Drs. Freeman and Wood&rsquo;s patents, and its attorneys de-clined to voluntarily add him to their patents. Genetics Institute stated that Dr. Honjo could pursue his inventorship claim at the PTO. Inventorship of those patents is not at issue here.</p> <p>One can wonder, however, if the inventorship dispute was driven by the scientists or some well-meaning patent attorneys and/or the assignees. Notably, from the opinion: &ldquo;In 2018, Dr. Honjo won the Nobel Prize in Physiology or Medicine, and it is not without interest that in his acceptance speech he credited Dr. Freeman as a major collaborator in his work.&rdquo;<br /> <br /> The District Court held that Drs. Wood and Freeman were co-inventors on Dr. Honjo&rsquo;s patents. The Federal Circuit affirmed the District Court decision while reminding the parties of what co-inventorship means:</p> <p style="margin-left: 40px;">&ldquo;[A] joint invention is simply the product of a collaboration between two or more persons working together to solve the problem addressed.&rdquo; <i>Fina Oil &amp; Chem. Co. v. Ewen</i>, 123 F.3d 1466, 1473 (Fed. Cir. 1997) (citing <i>Burroughs Wellcome Co. v. Barr Labs., Inc.</i>, 40 F.3d 1223, 1227 (Fed. Cir. 1994)). To be a joint inventor, one must:</p> <p style="margin-left: 40px;">(1) contribute in some significant manner to the conception or reduction to practice of the invention, (2) make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention, and (3) do more than merely explain to the real inventors well-known concepts and/or the current state of the art. <i>Pannu v. Iolab Corp.</i>, 155 F.3d 1344, 1351 (Fed. Cir. 1998); <i>quoted in VerHoef</i>, 888 F.3d at 1366. There is no &ldquo;explicit lower limit on the quantum or quality of inventive contri-bution required for a person to qualify as a joint inventor.&rdquo; <i>Eli Lilly &amp; Co. v. Aradigm Corp.</i>, 376 F.3d 1352, 1358 (Fed. Cir. 2004) (quoting <i>Fina Oil</i>, 123 F.3d at 1473). &ldquo;People may be joint inventors even though they do not physically work on the invention together or at the same time, and even though each does not make the same type or amount of contribution.&rdquo; <i>Burroughs Wellcome</i>, 40 F.3d at 1227 (citing 35 U.S.C. &sect; 116).</p> <p style="margin-left: 40px;">Conception is the touchstone of the joint inventorship inquiry, <i>Sewall v. Walters</i>, 21 F.3d 411, 415 (Fed. Cir. 1994), and conception is complete when an idea is definite and permanent enough that one of skill in the art could under-stand the invention, <i>Burroughs Wellcome</i>, 40 F.3d at 1228. An inventor need not know, however, that an invention will work for its intended purpose in order for conception to be complete, as verification that an invention actually works is part of its reduction to practice. <i>Id. </i>(citing <i>Applegate v. Scherer</i>, 332 F.2d 571, 573 (CCPA 1964) and <i>Oka v. Youssefyeh</i>, 849 F.2d 581, 584 n.1 (Fed. Cir. 1988)).</p> Article 28 Jul 2020 00:00:00 -0800 3 Takeaways As Fed. Circ. Boosts PTAB Amendment Scrutiny <strong>Christopher Riccuiti</strong> is quoted in the <em>Law360</em> article &quot;3 Takeaways As Fed. Circ. Boosts PTAB Amendment Scrutiny.&quot;<br /> <br /> In a split panel decision on July 22, 2020, the Federal Circuit endorsed the PTAB&rsquo;s existing practice of addressing subject matter eligibility when reviewing proposed claim amendments submitted as part of an IPR motion to amend. The majority&rsquo;s holding reinforces the fact that patent owners should not only be prepared to defend against anticipation and obviousness challenges as part of the motion to amend process, but that they also need to consider whether there are any underlying written description, enablement, or subject matter eligibility issues that may undermine the proposed amendment. I previously addressed the PTAB&rsquo;s decision in this case in my February 1, 2019 article (which can be found <a href="">here</a>). <br type="_moz" /> Article 28 Jul 2020 00:00:00 -0800 Navigating Patent Drafting and Prosecution of Standards-Related Technologies <h3>&ldquo;The collaboration and efficiency achieved by standards and the SDOs that create them advance the state of technology and business. However, this same collaboration creates crowded innovation spaces in which competitors are simultaneously innovating to solve the same problem.&rdquo;</h3> <p>As far back as the Roman Empire, standardization has improved the efficiency of human endeavors. In the present day, as high-bandwidth communication and Internet of Things (IoT) applications expand, standardization continues to be key in advancing new technologies. From the standpoint of protecting intellectual property, however, the collaboration required to standardize a technology presents unique challenges, as industry competitors disclose and assess various options for the standard.</p> <p>Standard Development Organizations (SDOs), each directed to a particular technical area, adopt standards that allow devices to communicate with each other and process information consistently. Notable examples of such SDOs are Advanced Television Systems Committee (responsible for the ATSC 3.0 standard), 3<sup>rd</sup> Generation Partnership Project (responsible for the 5G standard), International Telecommunication Union (responsible for the HEVC and H.265), and Zigbee Alliance.</p> <p>Technical experts representing companies or trade associations in an SDO may submit proposals for consideration and adoption. However, such proposals may include patentable solutions invented within the submitting organizations. By virtue of submitting such proposals for consideration, the solutions could be considered publicly disclosed &ndash; or, at the very least, disclosed to industry competitors.</p> <h2><strong>Patent Drafting and Prosecution Considerations for SDO Participants</strong></h2> <p>It is prudent for companies participating in an SDO to create internal procedures ensuring that innovations made in the course of their participation are fully protected. The First Inventor to File provision of the American Invents Act (AIA) increases the importance of filing relevant applications prior to submitting a proposal to an SDO, since an earlier time of invention alone may not be sufficient to secure patent rights. If there is not enough time prior to submitting a proposal to the SDO in order to draft a full application, a provisional application in raw form can be filed to secure the filing date.</p> <p>Drafters of patent applications involving technologies proposed to SDOs should work closely with the participating experts, in order to anticipate possible variations or changes to the proposal. Upon drafting a full patent application, care should be taken to consider and disclose all conceivable embodiments of the invention, as well as possible implementations. A broad, comprehensive disclosure will allow for claims and continuation applications directed not only to the initial SDO proposal, but also to any changes introduced prior to adoption. In addition, a more thorough disclosure can address optimal implementations related to the standard.</p> <p>Collaboration with experts participating in the SDO can also assist in understanding other possible approaches proposed by competitors. Because of the narrow focus of many technical problems addressed by SDO working groups, and because members are likely to pursue patents directed to their competing approaches, filings of members working on the same problem are likely to be used as prior art against one another. Whenever such competing approaches are mutually exclusive, it can be helpful to discuss them in the patent application, in order to differentiate how the claimed solution is better, or at least different. During prosecution, affirmative descriptions of such differences can support arguments directed to the criticality of various features of the claimed solution. It is also important for prosecuting counsel to keep abreast of the latest versions of the standard, in order to maintain claim correspondence. Such efforts are facilitated by a broadly drafted disclosure that considers alternative embodiments and implementations, which may be relied upon to craft optimal claim scope.</p> <h2><strong>Patent Drafting and Prosecution Considerations for Standard Stakeholders</strong></h2> <p>Patent applicants not participating in SDOs are nonetheless affected by adopted standards. Such applicants are likewise well-served by closely monitoring the changing standard landscape and mindfully drafting and prosecuting applications to maintain options for amendment and continuation applications. Many SDOs maintain email lists open to the public and online repositories of technical documents. On the one hand, such tools increase the chances of public disclosure of innovations proposed by SDO members. On the other hand, availability of internal documents allows all stakeholders in the standardized technology to keep an eye on SDO deliberations, and to steer research and subsequent patent filings in line with standard development.</p> <p>The collaboration and efficiency achieved by standards and the SDOs that create them advance the state of technology and business. However, this same collaboration creates crowded innovation spaces in which competitors are simultaneously innovating to solve the same problem. Accordingly, the potential actions of SDOs and their member companies should be considered by intellectual property practitioners during patent drafting and prosecution, to ensure the full protection of patent rights for standards-related innovations.</p> Article 27 Jul 2020 00:00:00 -0800 Deep Learning <strong>Sameer Gokhale</strong> is quoted in the NVTC magazine <em>The Voice of Technology </em>in an article entitled: &quot;Deep Learning.&quot; This article is featured in the July 2020 issue. Article 24 Jul 2020 00:00:00 -0800 An Automated Notification System for Providing Advance Notification of the Pickup or Delivery of Goods was Found Patent Ineligible <p>Electronic Communication Technologies, LLC (&ldquo;ECT&rdquo;) sued, LLC (&ldquo;ShoppersChoice&rdquo;), alleging that ShoppersChoice infringed claim 11 of U.S. Patent 9,373,261 (&ldquo;the &rsquo;261 patent&rdquo;). The district court granted ShoppersChoice&rsquo;s motion for judgment on the pleadings that claim 11 was invalid under 35 U.S.C. &sect; 101. ECT appealed. The Federal Circuit (&ldquo;the Court&rdquo;) affirmed the judgment of the district court.</p> <p>The district court found that claim 11 was directed to the abstract idea &ldquo;of providing advance notification of the pickup or delivery of a mobile thing.&rdquo; The court explained that &ldquo;business practices designed to advise customers of the status of delivery of their goods have existed at least for several decades&rdquo; and further concluded that claim 11 did not include an inventive concept. &ldquo;The claim recites generic computer components that can be configured to perform purely conventional computer functions.&rdquo;</p> <p>The Court agreed with the district court that claim 11 of the &rsquo;261 patent was directed to an abstract idea.&nbsp;Claim 11 recites conventional computer components and &ldquo;computer program code&rdquo; that (1) enables a first party to input authentication information; (2) stores the authentication information; (3) monitors the location of a mobile thing; (4) initiates notification to the first party in advance of arrival of the mobile thing based in part on the location of the mobile thing; (5) provides the authentication information to the first party; and (6) enables the first party to select whether or not to communicate with a second party having access to particulars of the pickup or delivery. Two of the six identified functions, monitoring the location and notifying a party, &ldquo;amount to nothing more than the fundamental business practice of providing advance notification of the pickup or delivery of a mobile thing.&rdquo;</p> <p>The Court concluded that although &ldquo;claim 11 also recites added measures that purport to increase security, those claimed functions are also abstract.&rdquo;&nbsp;Businesses have long been supplying customers with order numbers and recording customer information. &ldquo;Claims, like claim 11, that are directed to longstanding commercial practices do not pass step one of the two-part &sect; 101 test.&rdquo;&nbsp;&ldquo;In addition, the process of recording authentication information&mdash;such as the customer&rsquo;s name, address, and telephone number&mdash;and including that information in a subsequent communication with the customer is abstract not only because it is a longstanding commercial practice, but also because it amounts to nothing more than gathering, storing, and transmitting information.&rdquo;</p> <p>ECT argued that claim 11 was not directed to an abstract idea because it was &ldquo;unique&rdquo; (directed to and addressed solutions to minimize hackers&rsquo; impacts). ECT&rsquo;s arguments were unpersuasive. Even if claim 11 is &ldquo;unique,&rdquo; &ldquo;that alone is insufficient to confer patent eligibility&rdquo; and that &ldquo;uniqueness&rdquo; is itself abstract.</p> <p>ECT also argued that claim 11 was patent eligible due to three aspects of the patent&rsquo;s prosecution history: (1) the application that became the &rsquo;261 patent &ldquo;sailed through&rdquo; the USPTO by receiving an allowance in the very first Office action; (2) ECT &ldquo;obtained the &rsquo;261 patent with complete and total transparency&rdquo;; and (3) ECT requested the USPTO to &ldquo;double-check&rdquo; its work on &sect; 101 after ECT received the notice of allowance, upon which the USPTO reconfirmed its finding that the claims were patent eligible.</p> <p>The Court explained that these specific details relating to prosecution before the USPTO &ldquo;bear no relationship to the subject matter to which claim 11 is directed and do not negate the fact that claim 11 is directed to longstanding business practices. Nor do ECT&rsquo;s purported diligence and good faith during patent prosecution before the USPTO in any way shield the patent&rsquo;s claims from Article III review for patent eligibility.&rdquo; The Court agreed with the district court that claim 11 was directed to an abstract idea.</p> <p>When addressing step two of the framework, the Federal Circuit concluded that the claims did not include an inventive concept sufficient to transform the claimed abstract idea into a patent eligible application. &ldquo;[C]laim 11 is specified at a high level of generality, is specified in functional terms, and merely invokes well-understood, routine, conventional components and activity to apply the abstract idea identified previously.&rdquo;</p> <p>In response to ECT&rsquo;s arguments that &ldquo;this court held a far shorter, far less enabled claim valid,&rdquo; the Court explained that &ldquo;patent eligibility turns on the content of the claims, not merely on the number of words recited in the claims. In addition, just because a patent claim is enabled does not mean that the claim is patent eligible&mdash;subject matter eligibility and enablement are separate inquiries, irrespective of any overlap between the two.&rdquo;&nbsp;</p> <p>The Court also rejected ECT&rsquo;s arguments that the district court should have engaged in claim construction before deciding claim 11&rsquo;s eligibility.&nbsp;&ldquo;ECT has not identified a single claim term that it believes requires construction before the eligibility of claim 11 can be decided, much less how this construction could affect the analysis.&rdquo; The Court concluded that &ldquo;the district court properly resolved patent eligibility at the pleadings stage of the proceedings.&rdquo;</p> <p><i>Electronic Communication Technologies, LLC v.</i>, No. 2019-1587 (Fed. Cir. May 14, 2020)</p> <p><a href=""></a></p> Article 20 Jul 2020 00:00:00 -0800 Section 101 at the Patent Trial and Appeals Board – A Surprising Result? <p>It is well accepted that the number of section 101 rejections issued during examination dropped significantly after the 2019 Revised Subject Matter Eligibility Guidance was released by the USPTO in January 2019 (see <a href=""></a>). Similarly, it has been noticeably easier to overcome section 101 rejections issued during prosecution as a result of the USPTO&rsquo;s application of the 2019 Revised Guidance. Although following the 2019 Revised Guidance has resulted in more applicant friendly outcomes under section 101 during examination than in the past, the same does not seem to be the case for ex parte appeals at the Patent Trial and Appeal Board (PTAB). Although the 2019 Revised Guidance makes it clear that the 2019 Revised Guidance applies to all USPTO personnel and has, on its face, been applied by the PTAB, it appears clear from our review of the cases that overcoming a section 101 rejection at the PTAB remains a very difficult proposition. In particular, according to our study of PTAB decisions addressing section 101 from April 23, 2020 to June 12, 2020 only 18% of section 101 rejection were reversed. This number is significantly lower than the 29.2% reversal rate for typical appeals (see USPTO FY20 appeals statistics from Oct. 1, 2019 to Jun. 1, 2020) and is surprising since most of the section 101 rejections being addressed by the PTAB during this period were issued before the 2019 Revised Guidance was issued and presumably should have been deficient in some way under the requirements of the 2019 Revised Guidance.</p> <p><img src=" post.png" hspace="0" vspace="0" align="absmiddle" alt="" border="0" width="481" height="289" /></p> <p>Although, the PTAB appears to be following &nbsp;the USPTO requirements of applying the 2019 Revised Guidance in ex parte appeals, it appears to be doing so differently from how the guidelines are being applied by the USPTO examining corps.&nbsp;<br /> <br /> This article is written by James Love and Summer Associate Karolyn Watson.&nbsp;</p> Article 13 Jul 2020 00:00:00 -0800 Intellectual Ventures v. Aisin Seiki et al. <strong>Eric Schweibenz</strong> and <strong>Alexander Englehart </strong>wrote an article featured in the <em>Intellectual Property Magazine</em>-July issue, entitled &quot;Intellectual Ventures v. Aisin Seiki, et al.&quot; Article 13 Jul 2020 00:00:00 -0800