In about 1996, a knock at the door caught my attention. I was a primary examiner in the transgenic and gene therapy art (Art Unit 1632). My docket included things like human stem cells, transgenic animals, gene based gamete selection, and chimeric animals. My office was next door to my supervisor (SPE). She and I often talked about the cases that the Art Unit examined..
At the door stood a junior examiner fresh from the Patent Academy. She was my mentee and was looking for work. There was a stack of cases in my office that needed docketing. One of my jobs was to help assign cases to the members of my Art Unit.
Picking up a pile of new cases, I scanned the rather generic titles like “Gene Therapy,” “Transgenic Model of Alzheimer’s Disease,” and “Gene XYZ Transgene.” There were a few cases that might be good for a new examiner to cut their teeth after reviewing the claims, but I won’t tell you exactly what I found since these cases were not subject to pre-grant publication. In one case the claims were pretty raw and directed to mixing cells from several species together. That might sound fanciful, but the invention looked pretty standard based on nebulous claim language. The case was assigned to the examiner.
About an hour later, she came back to my office and said, “Brian, I don’t think I should have this case.”
I asked why and she responded, “They are intentionally claiming people. I’m not sure I can handle this.”
The case was redocketed and life went on. The case hit the news, but the bosses (Technology Center Director and Commissioner’s staff) had been notified and they were prepared. They at least knew the case existed. They weren’t blind-sided. It was a SAWS case.
Two years later, while a TC1600 Biotechnology Practice Specialist in charge of the SAWS program, an examiner came into my office to ask advice about another case. This time, the technology involved aerosolizing bacteria for transmission across crop fields. Again, pretty standard stuff in biotechnology as bacteria are used as, among other things, pesticides. In this case, however, the list of bacteria included things like Bacillus anthracis (Anthrax), Escherichia coli (E. coli), and plant genetic vectors (tobacco mosaic virus).
Remember, this was before September 11, 2001. Dual-use technology was not an everyday word and we did not read nefarious intent into every patent application. Nonetheless, the examination staff was filled with very talented Examiners including many Ph.D.’s who had worked in some pretty high technology endeavors. This particular examiner thought that having the technology for releasing virus and bacterial aerosols into the environment might raise some eyebrows. It might even be a national security issue.
I took the case (remember, we had paper then), and showed it to the Group Director. A memo was prepared for consideration by the Security Group and for reviews by the various national security agencies. This was the normal process for consideration of potential national security patent applications. (See, e.g., 35 U.S.C. §181.)
The case was put into suspended status and the applicant informed. After a bit, (perhaps 6 months or so), the outside agency reviews came in and the case was found to be non-classifiable. The case’s status was returned to active and it was examined. Note that in contrast to the situation with an application claiming human beings, here the case was suspended.
Both of these were “SAWS” cases. How did they become such? Simple. The examining corps was asked to be on guard for cases that might be of special interest. This might be because they were directed to sensitive subject matter as illustrated above or might come under extraordinary public scrutiny. The examiners were asked to be extremely liberal in their “first-cut.” After all, the USPTO had many levels of subsequent consideration available. We (management) just wanted a chance to take a look. Each Art Unit might be assigned 3000-4000 cases a year, so first line managers (Supervisory Patent Examiners/SPEs) have to rely upon the examination staff for detailed understanding of what is in each application. That is the examiners’ job. But, if the examiners are asked to be on the lookout, the SPE has a chance at managing cases in their charge more effectively.
Subsequently, as the SPE of two art units (AU 1632 and 1633), I managed some of the most controversial subject matter in TC 1600. I saw a lot of claimed subject matter that would make the papers and sometimes even turn one’s stomach. But the examiners were the folks who knew the applications best. They were relied upon to bring extraordinary applications to management attention. Subject matter such as cloning the perfect human being, pre-birth genetic manipulation, growing embryos in vitro, and a myriad of related “inventions;” science fiction come of age.
Most of what examiners would bring to management for potential SAWS attention was summarily dismissed. As a SPE, however, I too made broad cuts and briefed the Group Director every week on cases that he might find “interesting.” Every once in a while, the Director would take a look and decide to ask the opinion of the Commissioner and their sundry offices. Memos were written and everyone up the line was briefed.
This was the SAWS program; an oversight procedure for bringing information to the attention of management. It was designed, by intention, to cast a broad and sweeping net. It was designed to permit resources to be brought to bear on high profile or complex legal, ethical, or controversial subject matter.
Ok. With the anecdotal stuff behind, let’s take a look at Alyssa Bereznak’s article “The U.S. Government Has a Secret System for Stalling Patents,” dated December 3, 2014 (the Bereznak Article). First things first…the title.
The SAWS program is not a system of stalling patents. While the Bereznak Article asserts “(a)ny application that is categorized in SAWS … is placed in a special type of patent purgatory.” This is just not true.
This is apparent if one considers the actual documents provided by the USPTO in response to the FOIA request listed in the Bereznak Article. Rather than delay, the purpose seems pretty clear when looking at the Technology Center 1600 Memo updated January of 2013 (TC1600 Memo). The first line of this memo states that the SAWS program is “designed as an information gathering system.” It further highlights in the “Operational Overview” section that “(p)rosecution of SAWS applications should proceed just as with any other application (i.e. where necessary – review by primary, conference with SPE, and/or consult with QAS.)” (Emphasis added.) The memo continues at Bullet No. 3, which states, “the intent is to minimize any direct impact on the examination process.” (Emphasis added.)
Rather than delay things, the management oversight exercise is specifically tailored to avoid delay while avoiding public outrage from avoidable errors. Of course, naïve people do not run the USPTO and mistakes do happen. They would, however, like to avoid issuing patent applications that would endanger the public. Just take a look at Bullet No. 3 of the TC1600 Memo where SAWS subject matter includes biological weapons. Could we not agree that things like that should get a second look even while avoiding tainting the file record with undue potential estoppel issues?
The Technology Center 1700 (TC1700 Memo) similarly characterizes the SAWS program as an information gathering system. Here again the program only flags the case to prevent allowance before management review. (See Bullet No. 3). This gives management a last minute chance to catch potential gross errors. As for the list of TC 1700 subject matter, beauty (and SAWS subject matter) is in the eye of the beholder. I would also, however, be cautious before issuing a patent to “controversial, illegal, objectionable, or derogatory” subject matter or to things that are in active litigation. Wouldn’t that be prudent?
Moving on to the Technology Center 2100 Sensitive Application Warning System (SAWS) memo (TC2100 Memo) we see in the forth paragraph that the “purpose of this program is to track the progress of potentially sensitive applications…and keep TC Directors informed, through the chain-of-command, when a potentially sensitive application is ready for allowance.” (Emphasis added.) Here again, it is a management quality oversight tool, not a cabalistic system to hold up patent applications in an arbitrary manner.
Let’s take a look at the March 27, 2006 memo from Technology Center 2800 (the TC2800 Memo). On page 2 of that memo in the section entitled “A. Technology Center 2800 Practice,” the procedure calls for a flag to be placed in PALM. (See Bullet No. 2.) This is not limbo. Instead, it simply calls for a human being to take a look at an application prior to issuance. Consider, e.g., a patent application claiming cold fusion. Since cold fusion is not (as of now) considered technically feasible, PTO management might want to make sure that before an application claiming such technology issues it meets all the applicable the standards such as of 35 U.S.C. §§101, 102, and 112.
One might say, “Well, all applications must meet that standard,” and they would be correct. But, what if an application is filed with claims to cold fusion methods. Absent some evidence, a rejection based on inoperability might be made and evidence required to overcome the rejection. As a manager, I would want to keep track of that case to ensure mistakes did not happen and inadvertently issue until I had a chance to do a final “smell test” before issue. Of course, claims are usually amended during prosecution, so a case that initially claimed inoperable subject matter might change to a means of forming atomic plasma. Why not? The latter might be patentable but the former not. Once ready for allowance, it would be in everyone’s interest to double check that in such a high profile technology there were no clerical mistakes or ensure that the examiner did not overlook an errant claim that should have been cancelled, for example. The PALM flag provides that opportunity. The prosecution of the case would proceed until allowance and then a final approval would be required to remove the PALM flag before issue.
No harm, no foul, just good management oversight. Isn’t this a common sense approach to improve patent quality?
Let’s continue our look at the TC2800 Memo. At bullet 5 it is noted that “(f)or uniformity and process improvements…SAWS processing guidelines and criteria [will be]…continually update(d) and revise(d).” This sounds like a good plan. The USPTO has a management system in place that continually updates and revises with changing circumstances. What’s the problem?
Now look at some of the SAWS case subject matter in TC 2800. On page 3, the TC2800 Memo talks about “perpetual motion machines” and “anti-gravity devices.” What should a PTO manager do to ensure that such applications not only receive proper examination, but also only issue after thorough vetting?
It is understood that all applications should be thoroughly vetted. In an ideal world, all would be. No matter how much we would wish otherwise, however, the world is not perfect. So, if I were a SPE and saw a claim to an anti-gravity device I would first ensure that it was assigned to an experienced examiner. Then, I might tell the examiner to keep me in the loop. Is there a tool to help me monitor the application? Yes, a SAWS flag in PALM. It ensures that no matter how busy I get and no matter how many years go by before the case goes to issue, management and quality review will have a chance to take a look to make sure things are good-to-go. Further, consider that SPEs change over time, new managers take over units, and examiners leave the PTO. Applications are transferred and corporate memory sometimes gets stymied. By placing the flag in PALM, there is a last minute reality check that must take place. That’s it!
Now what about the TC2800 Memo’s reference in section C. to “Applications with a very old effective filing date (pre-GATT) with broad scope?” These applications are also called submarines and, when issued can and have had great impact on technologies already in place prior to their issue. Even in 2014, there are still a few of these floating around. This is not because the PTO has stalled them or somehow chose to bury them in a bureaucratic morass. Rather, in my experience, it is because there are tenacious patent applicants or because there has been court reviews that take time; sometimes a long time.
The PTO would face great criticism if it issued a submarine patent because, for example, a new patent examiner that had a continuing case transferred to them had decided to drop a prior art rejection without good reason. The examiner could have received a continuation of a case that was on appeal or that had lost in a court battle. There are numerous possibilities. But, the point remains. It is in everyone’s interest to identify such cases and monitor them. A simple flag put on a computer file easily accomplishes the goal. It does not delay anything. It simply provides a tool for oversight and quality management.
The remaining Technology Centers have the same procedures and the above illustrations suffice to make the point that the SAWS program is not designed or intended to be a delaying tactic or interfere with normal patent application review.
Now, Ms. Bereznak’s article states “(a)ny application that is categorized in SAWS …is placed in a special type of patent purgatory. SAWS-marked patents must be approved by anywhere from three to nine people and can be delayed for years.” Is that accurate in light of the evidence provided by the USPTO? Take a look at the Technology Center memos. There is no purgatory, just a flag in a computer docketing system that begs a sign off before issuing things like nuclear bombs, weapons of mass destruction, cloned people, and cases that are already being litigated.
As for the “three to nine people” reviewing SAWS cases, please note what is being reviewed. What the SAWS review folks do is look at a memo regarding the case. A memo that includes information like the serial number, filing date, a sample claim and a quick paragraph about the subject matter. The “actual” application file is only occasionally reviewed. (See, e.g., TC1600 Memo at paragraph No. 3.)
A couple of weeks after the Bereznak article, Devon Rolf posted an article on IPWatchdog.com entitled “Secret Examination Procedure at the USPTO: My Experience with SAWS,” (Rolf Article) The Rolf Article states in paragraph 8 that a patent examiner informed him that he was “instructed not to allow patent applications he was examining” because it was in the SAWS program. On the other hand, the Rolf Article reports that upon inquiry he was informed that the program was informational only. Nonetheless, the examiner apparently indicated that since he could not allow the case because it was in SAWS status, he needed to make a rejection. The Examiner seems to have used SAWS as reasons for not allowing an application. It does not appear, from the evidence, that any management activity caused the rejection.
The Rolf Article relays that the USPTO’s ombudsman told him that “GoFigure’s pending patent application…read on iTunes…” and that the “Primary Examiner had been appointed who expressed concern that “this is like iTunes™.” While the asserted priority date of GoFigure’s patent application was 1999, a time earlier than iTunes™, it is unclear from the Rolf Article whether they actually were granted the priority date. It is also unclear, without a file wrapper review, what reference the “appointed” primary examiner might have used to reject the patent application while it was flagged in the SAWS system.
What is clear is that the application was eventually allowed, even in light of concerns with it reading on iTunes™.
My personal comment here is that if I were the examiner and been responsible for a case that read on iTunes™ I would be very cautious and thorough before issuing the case. I would take special care to make sure that all the i’s were dotted and t’s were crossed. This seems just common sense. As a practical matter, examiners have too little time to examine each application to the “nth degree.” Those applications that would likely be closely scrutinized are the ones where the most time is spent. The squeaky wheel…
So far, it is hard to see the grossest conspiracy. An examiner would admittedly be cowed a bit when a specific application comes under management scrutiny. This is human nature. It would be naïve to think otherwise. A SAWS application is no different from any other quality review program with the exception that an examiner is actually in the loop. If examiners do their jobs they have little to worry about.
Now, I have personal knowledge of one SAWS case of great economic value. It was a submarine application and was about as controversial as could be (at the time). The application concerned human embryonic stem cells. The application had been in the news, was subject to moral and economic public outrage, and contained very subtle legal issues. As I recall, there were numerous obviousness rejections under 35 U.S.C.§103 as well as a few enablement rejection under 35 U.S.C. §112/1. The legal issues were close.
I recall the very senior primary examiner in charge of the case coming to me for counsel. She knew the case contained sensitive subject matter. She knew it was being closing scrutinized by the public. She also expressed that the evidence for patentability was strong, just not over the 50/50 edge that made her comfortable with an allowance. She wanted to be removed from the case. We cooperated and she worked under my direction with me taking responsibility for the application. The application was eventually allowed. Note that here; the examiner was concerned with both rejecting and allowing. In many cases, this is the kind of thing that goes to appeal. In this case, however, the additional resources brought to bear after recognition as a SAWS case expedited allowance.
This brings me to one of the questions asked in the Rolf Article; Why is the PTAB notified when a case is in the SAWS program? My response, why not? The administrative patent judges are just as busy as examiners and their judgments serve as final agency decisions appealable to the courts. I would certainly want to know if something was of special significance if I were a judge and my actions would be expected to bring undue public attention upon a particular application. That would not affect my decisions, but it shines light on the application and, again, it helps in allocating limited resources where they are best needed.
The next question: “Are there scenarios…in which the USPTO identifies prior art that is material to a patent or patent application under review but does not cite (or delays citing) that prior art?”
My response as a former Quality Assurance Specialist is that examiners are charged with making the best noncumulative rejections. (See MPEP 706.02.) Sometimes additional prior art is found during quality review programs and these are brought to the examiner’s attention on a case-by-case basis. Quality review is not intended as a supplemental examination, but prior art sometimes does emerge. It is the examiner, however, who needs to determine whether any references not of record need to be put in the application file or applied as rejections. So, sometimes prior art can be identified and not used, but that is only in cases where the references are cumulative or where issues raised by the new reference have been addressed in other elements of examination. Examiners are, as a rule, conservative; few ignore good prior art.
The next questions in the Rolf Article concerns how many cases are in SAWS? It is presumed this ebbs and flows and if the public really wants USPTO resources to develop even more statistics, why not? On the other hand, what would be learned?
The last question in the Rolf Article asks how applications are removed from SAWS status? While I cannot address current practice, in the past this was done at allowance. Once ready to allow, the applications were signed off and the PALM flags removed. This process must work since the Rolf Article notes that their SAWS case issued. As for what facts are considered? The main one would be whether the file wrapper record was clear and complete.
Many folks bridle at the thought of extraordinary secret processes, but SAWS is just not one of those. This view is based on having administered the program in the past and reviewing the evidence in the memos released in the FOIA request and discussed in the Bereznak Article.
Finally, it is important to address the numerous comments (many anonymous) posted on IPWatchdog in response to the Rolf Article. There are comments calling the procedures “arbitrary and capricious” (c.1), “illegal” (c.4,5), inconsistent with 27 C.F.R. §§1.2 and 1.104 (c.7,11), “reprehensible” (c.9), consistent with a “secret society” (c.13), in violation of the APA/Title 5 (c.18), and a CYA program (c.27).
These characterizations simply express ignorance or misunderstanding of governmental administrative processes. The same characterizations could equally apply to the quality review program and its underlying computer algorithms for random case selection. They could be used to suggest that examination assignments are not transparent or are arbitrary because a single individual usually assigns cases based on experience and instinct. These comments might apply to the USPTO’s computerized methodologies for computer based claim scanning and subsequent classification. These comments might apply to the internal processes for promoting examiners and how their individual cases are reviewed during the signatory review program.
Taking the last example, consider that during an examiner’s promotion reviews multiple people review their work. If errors are discovered they are corrected. Is this type of quality control another secret cabal of arbitrary and capricious activity? Should the record reflect debates held by supervisory staff as to whether a specific action taken by an examiner is a “clear error”? Should the record reflect different examination “styles” where the end result is the same?
The USPTO is an organization with over 8,000 patent examiners. These people all have technical degrees. Many also have advanced degrees (MD/Ph.D./DDS, etc.). They are all professionals and intelligent beings who are trained to do the best job possible. Smart people can differ in approaches and methods, however, so management oversight needs to take into account not only substance but process as well. Would patent applicants truly benefit by clouding substantive issues with administrative observations? Would litigators really desire to defend their IP from administration actions taken during prosecution?
The comments also suggest that the SAWS program results in 9 different people reviewing an application (c.16). This deserves specific response. Let’s take the simplest of situations.
A patent application is filed solely in the United States. The Office of Initial Patent Examination reviews it for completeness (touch 1). Then it is classified (touch 2). After it shows up in a Technology Center it is reviewed by an SPE (touch 3), then perhaps a junior examiner (touch 4) and a primary examiner (touch 5). Then consider a sampling of cases pulled for quality review programs. It is reviewed by a Quality Assurance Specialist (touch 6). If there is an issue identified such as the application of prior art, inadequacy of the record, or questions of enablement or written description, the case might go to a second SPE or TC Director (touch 7). Now when the case moves to appeal, there would be two more touches, from another SPE and/or primary examiners (touches 8 and 9).
Nine touches possible in a case that undergoes no special recognition and a relatively routine process. In the SAWS process, all the same actors would see the application. If it is very high profile, it might get attention of the Commissioner or her staff. Here, the review is not different than if an examiner appeals a promotion decision of a finding of examination error. Yes, in the SAWS program there might be some additional management touches after an examiner allows a case. Why not? If someone in my Art Unit allowed a case to a means of doing eugenics, I’d have certainly appreciated a heads up before my phone started ringing!
There are no “secrets” here; simply internal administrative processes to help ensure efficient effective patent examination. If the USPTO were to spend its time publishing every program, every process, every touch that an application undergoes, it would surely impact the resources available to perform substantive examinations. The goal is to improve quality with the resources available, not detract from it.
It would be quite a stretch to find “secret cabals” and “star chambers” in the USPTO. I’ve worked with these folks at every level up to and including the Secretary of Commerce for more than two decades. Yes, folks make mistakes. The staff at the USPTO is human. However, I would challenge anyone to find a better trained more professional workforce anywhere. They work to do the best they can in an imperfect and constantly changing legal and technical landscape.
SAWS is just one element of a comprehensive quality review system. I am an ardent advocate for increasing USPTO examination quality. In fact, I believe that quality is a key to keeping errant court decisions to a minimum and providing the best service and rewards to the public. What does not issue as a patent is as or more important as what does issue. The public should not be limited by the grant of an inappropriate right. SAWS, Quality review, management oversight, and consistent policy implementation are critical components of the United States patent system.
In closing, I urge the public to continue to challenge the USPTO and its management to do the best job possible. Knee-jerk and uninformed accusations and character assassinations, however, do little to encourage an open dialogue.
Brian R. Stanton, Ph.D. is a principle with Stanton Consulting Services, LLC. Former posts included Director, Division of Policy at the NIH Office of Technology Transfer and over a decade at the USPTO in the biotechnology and pharmaceutical technology centers. He is a coauthor of the USPTO’s 2001 Utility and Written Description Patent Examination guidelines.
Disclaimer and note: The views and opinions expressed in this article are the author’s own. They are based upon his experience. No consultation has been made with government officials. The article was prompted solely by the author’s desire to bring an ex-insider’s perspective.
 The patent application had been published in Europe and therefore did not meet the criteria for imposing a secrecy order.
 https://www.yahoo.com/tech/the-u-s-government-has-a-secret-system-for-104249688314.html, last visited December 16, 2014.
 PALM is the USPTO’s Patent Application Location and Management System. It allows for the workflow management of all patent applications and is the equivalent of a legal docket management system.
Devon Rolf, SECRET Examination Procedure at the USPTO: My Experience with SAWS, IPWatchdog, http://www.ipwatchdog.com/2014/12/14/secret-examination-procedures-at-the-uspto-my-experience-with-saws/id=52638/, last visited December16, 2014.
 MPEP §706.02, §I, “Choice Of Prior Art; Best Available, Prior art rejections should ordinarily be confined strictly to the best available art. Exceptions may properly be made, for example, where:
- (A) the propriety of a 35 U.S.C. 102 or 103 rejection depends on a particular interpretation of a claim;
- (B) a claim is met by a reference which does not disclose the inventive concept involved; or
- (C) the most pertinent reference seems likely avoided by invoking an exception in a 37 CFR 1.130 declaration or to be antedated by a 37 CFR 1.131 affidavit or declaration depending on the applicable version of 35 U.S.C. 102.
Such rejections should be backed up by the best other art rejections available. Merely cumulative rejections, i.e., those which would clearly fall if the primary rejection were not sustained, should be avoided.
 It astonishes that criticism regarding openness and transparency comes from anonymous sources. If one has an issue, it seems only fair to step into the light.
 http://www.ipwatchdog.com/2014/12/14/secret-examination-procedures-at-the-uspto-my-experience-with-saws/id=52638/, last visited December 17, 2014.
 Number references comments in the ROLF ARTICLE. Thus, “C.1” refers to comment 1.