Snapshot of 101 Patent Eligible Subject Matter Decisions in May 2014

Posted by: Adam Ellsworth

As the PTAB recently admitted, "the case law regarding 101 continues to evolve" (Ex parte Fickle, Appeal No. 2011-007587).

I thought it might be helpful to look at cases decided by the PTAB in the last month to see if there are any patterns in how the Board is deciding issues of patent-eligible subject matter under 35 U.S.C. 101. It turns out that the case law regarding computer-readable media has pretty-well settled at the PTAB, but it is harder to define clear patterns in decisions regarding the patent-eligibility of other types of methods and systems.

The Rejection of Computer-Readable Media

I considered 32 cases that addressed issues of patent-eligible subject matter under 35 U.S.C. 101. The majority of these cases (22 cases) involved computer-readable media. The takeaway from all of these cases is that in light of Ex parte Mewherter, 107 USPQ2d 1857 (PTAB 2013 (precedential), do not expect to prevail at the PTAB by arguing that a "computer-readable medium," or even a "computer-readable storage medium," does not include transitory signals. The decisions were unanimous.  If a claim directed to a computer-readable medium omits the words "non-transitory" and lacks other structural limitations, then the computer-readable medium encompasses transitory signals and the claim is not patent-eligible.

Among the cases directed to computer-readable media, Ex parte Makkinejad (Appeal 2011-012801; Decided May 15, 2014) is interesting, because it was not directed to just a computer-readable medium, but rather to a computer-readable storage medium. The result, however, was the same.
Claim 19 of the application is directed to a "computer readable storage medium" and the claim was rejected by the Examiner under 35 U.S.C. 101 as being directed to patent-ineligible subject matter, since, the Examiner argued, the claim encompassed transitory signals. The Appellant argued that "the term 'storage media' would not include any embodiments in which the medium is merely a propagation medium, as opposed to a medium that actually stores data." The Board disagreed and cited as an example, "circulating memory," which uses a delay line to store information in the form of a pattern of pulses. (I'm not convinced by the Board's example, since circulating memory is in itself a physical structure, and the "pattern of pulses" cannot exist without the delay line, sensors, and amplifiers described by the Board. But the Board sustained the rejection of claim 19 under 35 U.S.C. 101.) 

The Rejections of Other Types of Claims (Not Computer-Readable-Media)

Among the non-computer-readable medium cases, two were cases involving biological processes, Ex parte Schatteman (Appeal No. 2011-013696) and Ex parte Cardwell (Appeal No. 2012-001657). In both of these cases, the Board reversed rejections under 35 U.S.C. 101. Among the remaining eight cases, the Board reversed 101 rejections in three cases and upheld 101 rejections in five cases.

101 Rejections Reversed

In the cases in which 101 rejections were reversed, the claims recited physical structures.

Processor and Memory: In Ex parte Cutlip, Appeal No. 2011-011658, rejected claim 7 recited a system comprising a processor and memory configured to provide instructions to the processor, and multiple "modules" to perform various functions. The modules are not explicitly tied to the processor and memory in the claim (such as by having the processor execute instructions of the module), but the specification described functions being performed by the processor. The Board reversed the Examiner's rejection of claim 7, stating that the Examiner had not established a prima facie case of non-statutory subject matter.

Data storage device: In Ex parte Bogues, Appeal No. 2011-013523, the Board held that a claim directed to a "data storage device" excludes transitory signals.

LAN and WAN: And in Ex parte Waites, Appeal No. 2012-000932, the Board held that claim elements "local-area network" and "wide-area network" include computers and associated devices, and therefore the claim did not encompass software per se.

101 Rejections Sustained

Computer program products: In the cases in which 101 rejections were sustained, one of the cases (Ex parte Arrasvuori, Appeal No. 2012-002671) included claims directed to computer program products, and the Board held that the claims could encompass software-only embodiments, and therefore were directed to patent-ineligible subject matter.

Hardware System: In one case, Ex parte Adam (Appeal No. 2012-002144), the claims recited a method in which requests are received, and messages published "by a publish/subscribe hardware system." However, the Board held that this recitation was insufficient to render the claims patent-eligible, stating that the "publish/subscribe hardware system" was merely a "nominal recitation of a computer."

Conclusion

While decisions directed to computer-readable media are consistent in stating that such media encompass transitory signals, other 101 decisions appear to vary on a case-by-case basis. Claims reciting physical structures that perform the steps of the claims are more likely to overcome 101 rejections at the PTAB, but a claim reciting a generic physical structure, such as a "hardware system," may not be patent-eligible.

PTAB reverses 103: statement that combining pieces is predictable doesn't explain why a POSITA would combine

Takeaway: The Applicant appealed an obviousness rejection of claims to a currency trading user interface, including the feature "determine a currency in which to quote skew for each of the risk reversals." The Examiner relied on a combination of two references. The Board found the Examiner's rationale for combining was deficient. "Apparently, the Examiner finds that using market trend indicators, such as skew, is predictable with currency swap market transactions, including risk reversals. This is hard to quarrel with as such, but does not find why one of ordinary skill would determine a currency in which to quote skew for each of the risk reversals." (Ex parte Breitenbach, PTAB 2015.)

Details:

Ex parte Breitenbach
Appeal No. 2013-005344; Appl. No. 12/197734; Tech. Center 3600
Decided:  Jan. 15, 2016
 
The application on appeal was directed to a user interface that displays currency trading information. The Examiner rejected as obvious using a combination of Rodgers ("Trading Options") and Thompson ("Displaying Trading Trends"). An independent claim on appeal read:

1.  A system comprising [a computing device operable to:]
[allegedly in Rodgers] retrieve market data for a plurality of risk reversals for a currency pair at a first time ...
[allegedly in Thompson] determine a currency in which to quote skew for each of the risk reversals;
[cause] an interface screen to be displayed [on another] computing devices
     a listing comprising the first and second risk reversals, the market data, and an indication of the determined skew for each of the risk reversals;
...

Thus, according to the rejection, the Examiner relied on Rodgers for the entirety of one limitation (retrieval of risk reversal data), and Thompson for the entirety of another (currency determination). The Examiner gave this explanation of the reason to combine: "obvious to use skew as a market indicator in the Rodgers system, in view of Thompson's teaching that skew is a market trend indicator that the investor can consult to make better trade decisions."

On appeal, the Applicant argued that Thompson merely mentioned skew as a market trend indicator, did not include the phrase "risk reversal" anywhere, and did not mention currency in the paragraphs relied on by the Examiner. Thus, Thompson did not disclose or suggest "determine a currency in which to quote skew for each of the risk reversals," as specifically asserted by the Examiner.

In the Answer, the Examiner first clarified his position on Thompson with respect to currency. The Examiner noted that Thompson contains many instances of both "currency" and "currency pairs," then explained that "a prior art reference must be considered in its entirety, i.e., as a whole," citing W.L. Gore & Assocs v. Garlock, 721 F.2d 1540, 220 (Fed. Cir. 1983). Moreover, Thompson's Summary explicitly describes the invention as related to currency pairs. Therefore "the details of the invention recited in Thompson relate to currency pairs." (Emphasis added.) With respect to risk reversals, the Examiner cited to several mentions in Rodgers – despite the reliance in the Final Office Action on Thompson for the entire "determine ... for each of the risk reversals" limitation.

The Board first made some Findings of Fact:

Rodgers describes displaying prices for currency pair risk reversals. Thompson is directed to providing a visual display of a two-line cross-over method signaling buying and selling opportunities of foreign currency pairs  in the foreign exchange.   

The Board then reversed the rejection under § 103, with this explanation:

Each of these paragraphs [in Thompson relied on by the Examiner] lists a variety of market trend indicators, among which is included skew [but do not] describe how a skew is used nor describes determining a currency in which to quote skew for risk reversals. Rodgers describes risk reversals, but does not discuss using skew at all. Apparently, the Examiner finds that using market trend indicators, such as skew, is predictable with currency swap market transactions, including risk reversals. This is hard to quarrel with as such, but does not find why one of ordinary skill would determine a currency in which to quote skew for each of the risk reversals.
(Emphasis added.) 

My two cents: Great save by the Board. I characterize this as a "save" because the real issue wasn't deficiency in the individual teachings of the reference, but the deficiency in the combination. The parties focused on the former, while the Board zeroed in on the latter. 

The Applicant focused exclusively on Thompson's failure to teach risk reversal in the context of a currency determination, as claimed. Understandable, because the rejection appeared to specifically rely on that feature being taught in Thompson.  There was one sentence in the Answer that hinted that the Examiner had instead combined the risk reversal in Rodgers with Thompson's teachings about currency and skew. But that hint was buried in the point-counterpoint structure of the Answer, and the Applicant didn't pick up on this in the Reply Brief. 

Reading in between the lines, I think the Examiner really did rely on the combination to arrive at "determine a currency in which to quote skew for each of the risk reversals." Seems like the display of risk reversal for currency pairs from Rodgers' FIG. 1 was added to Thompson's mentions of and skew as a market indicator – to arrive at "determine a currency in which to quote skew for each of the risk reversals."

But suppose we generously give the Examiner credit for what he might have been thinking (as opposed to what he actually put in the record). As the Board found, even that wasn't enough to make the combination obvious. 

The Board's analysis focused on the lack of connection between the teachings in the two references. Each reference had various pieces of the claim, but these teachings weren't related enough for a POSITA to combine them as claimed. 

Many Applicants dealing with disparate teachings from multiple references either argue non-analogous art or just simply quote the teachings and say "Hey, look, these are different things." I found the Board's explanation for non-obviousness to be persuasive, because instead of simply listing differences, they put these differences in context: Yes, reference X taught A and B, but not in the context of C. Yes, reference Y taught C, but not in the context of A and B. Simply knowing about the pieces isn't enough of a reason to combine because the contexts are different and/or have little overlap.

The Board used the magic word "predictable" in its analysis, which to me is a clear reference to KSR's "predictable results" rationale. What are we to make of the Board's reversal of obviousness despite the apparent concession that "using market trend indicators, such as skew, is predictable with currency swap market transactions, including risk reversals."

Is the Board saying that generally combining the pieces at a high level is predictable, but the claimed combination is more specific than that and so a high level predictable result isn't enough?

Thanks to Robert K S for calling my attention to the Breitenbach decision.

PTAB decisions involving computer vs. user distinctions

I reviewed quite a few 2015 ex parte appeal decisions in which the distinction made by the Applicant related to actions performed by a computer rather than a user. I'll discuss a few of these in today's post, with more to follow in a future post.

In Ex parte Furlong (Appl. No. 10/769,117, PTAB 2015), the Board found that "automatically" in a computer claim covered user input that led eventually to computer action. The Furlong application was directed to software for generating expense reports. The user tracked daily activities and tasks using the software, and the software associated these daily activities and tasks with expenses, then generated an expense report. One of the limitations at issue on appeal read: "in response to the identification of the activity item being expensable, automatically associating, by the processor, at least one expense item with the activity item." The Applicant argued that in the reference, the user does the association, not the computer:

Vance's new trip is not (and will not be) associated with a car rental until Vance's user associates the new trip with the car rental. Since Vance's act of associating is not automatic, Vance's act of associating fails to teach the claimed act of automatically associating at least one expense item with the activity item. 

The Board found that "automatically associating" was broader than the Applicant's reading:

No implementation for such automation is recited or narrowed, and no degree of automation is recited either. Thus, even were Vance to do no more than automatically record an association after a user matched an expense item with an activity item, this creation of an association by the computer following the user’s input would be within the scope of the claim.

Similarly, in Ex parte Ren (Appl. No. 12/582,142, PTAB 2015) the Board found that a particular claim limitation covered computer input originating from a user. The application was directed to a vehicle navigation system. One of the claims on appeal ("a method of displaying a navigation map") involved rendering a nonphotorealistic image based on three-dimensional data associated with buildings surrounding the vehicle. The limitation argued on appeal was "modifying a viewing angle of the nonphotorealistic image based on feedback from the user." The Applicant argued that in the reference, the viewing angle was modified based on feedback from the system/vehicle, rather than user feedback as claimed. The Board was not persuaded, and adopted the Examiner's finding that "because a user operates the system/vehicle, Herbst’s feedback is based on the user."

In Ex parte Blythe (Appl. No. 11/965,946, PTAB 2015), the Board found that the claim language did not exclude human action. The claims were directed to detecting unauthorized changes to ATMs by comparing the ATM's electromagnetic "fingerprint" to a stored reference fingerprint. The Applicant appealed a § 103 rejection and argued the limitation "receiving, with the detection device, an electromagnetic profile emitted from the financial terminal, said received electromagnetic profile including radio wave activity if present." The Examiner relied on Yuzik ("Surveillance of Suspects of ATM Fraud") for this, pointing to an "RF listening device" in the surveillance system that "listened for suspicious RF signals transmitted from the vicinity of the ATM to a nearby receiver operated by a suspect." The Applicant argued that a combination using Yuzik's RF listening device required a person to actually hear radio activity, which was "a different approach from that provided by the subject invention." In the appeal Decision, the Board noted that "nothing in the claim excludes a person from actually hearing radio activity for detecting as well."

Similarly, in Ex parte Schimpf (Appl. No. 12/647,965, PTAB 2015), the Board found that the claims did not exclude manual entry of database fields. The application was directed to a system that dynamically constructed a new database query, allowing the user to directly specify which field contents in the current record were important. The Applicant argued the reference required a user to "manually enter desired values into fields when generating a search query." In contrast, the Applicant argued that the claims required the search query to be populated from database record field values. The Board disagreed and said the Applicant's manual field entry vs. computer populated distinction wasn't present in the claim:

Those claims recite a database record contains field values (“fields in said currently active database record contain values retrieved from said database”) and a search query uses field values (“a search query requesting all records having values in said at least one user selected field”), but the claims do not recite, and therefore do not require, using database record field values as search query field values. Moreover, the claims do not restrict the source of search query field values or the manner by which search query field values are obtained.

Ex parte Granda (Appl. No. 12/651439, PTAB 2015) is an instance where the Board found that the claims did not require a particular method step to be performed by a computer. The application was directed to a resolving cell phone connectivity problems "while avoiding audible ringing and or inadvertent user pick-up during error diagnosis and correction." The claimed method on appeal involved: receiving an error message at an autonomous probe in response to a data call placed by the probe; mapping the error message to an array of corrective actions. The method also included "executing at least one corrective action from the array of corrective actions." In arguing this limitations on appeal of an obviousness rejection, the Applicant asserted that the feature relied on by the Examiner was carried out by a user:

Shabalin merely discloses directing users to articles containing instructions that a user may follow in order to resolve an application error and fails to describe executing at least one correction action as recited by Appellants’ claim 1.

In construing the claim, the Board found that the Applicant had read too narrowly:

[C]laim 1 does not require that the executing at least one corrective action be performed by any particular unit, but merely recites executing at least one corrective action from the array of corrective actions (see claim 1). Thus, We find that Appellants’ contention that Shabalin"s executing is carried out by the user, (i.e., suggesting that it must be performed by the autonomous probe) is not commensurate with the scope of the claims.

Finally, Ex parte Rys (Appl. No. 12/111,877, PTAB 2015) is an example where the Board found that the claim language allowed for intermediate steps performed by a user. The application described techniques for renaming multiple files. The limitation at issue on appeal in the "computer-implemented method" read: "on detecting that the name is changed, automatically placing a next file in the specified collection in the rename state; [and] displaying a computer-generated name for the next file, the computer generated name based on the changed name of the single file." The Examiner mapped this claim limitation to the "Rename and Copy function with a serialization option" described in Kaplan. Kaplan's software presented the user with a series of dialog boxes, where the user provides and initial destination filename. The filename was then automatically incremented as additional files are copied, but for each filename the user was required to take action to either accept or change the filename. One of the distinctions made on appeal by the Applicant was this user interaction with Kaplan's dialog box. The Board was not persuaded.

With regard to those additional features which Appellant argues are explicitly required, we note Appellant’s claim utilizes the transitional word “comprising.” We therefore find that the possible inclusion of certain windows or dialog boxes within the process described by Kaplan does not preclude the Examiner’s reliance on Kaplan’s description of an automated serialized renaming process.
(Emphasis added.)

Read these blogs for Alice § 101 rejections

I work primarily in the computer and electronics arts, so I deal a lot with § 101 rejections in the wake of Alice v. CLS Bank. I haven't found any magic bullets for overcoming these rejections, but I have found some bloggers that feature posts on this topic.

Here are a few of my favorites:

•     The Software Intellectual Property Report ("Reporting from the nexus of software and intellectual property law" from Bejin Bieneman PLC)
•     BilskiBlog ("Analysis and Commentary on patent eligibility and patent strategy", from Fenwick and West)
•     USPTO Talk ("Observations about US patent examination and prosecution from a patent practitioner")
•     Software Patents Blog ("Software Patent Law Blog", from Schwegman, Lundberg & Woessner)

PTAB agrees with Applicant that claimed feature "would make no sense in the context" of the reference

Takeaway: The application on appeal used biometrics from multiple users to measure software application ease-of-use. The Examiner asserted that "averaging quantitative metrics across the plurality of users" was taught by the primary reference, and the Applicant argued this feature was not disclosed. The Applicant also argued that averaging would run counter to the main purpose of the primary reference. The Board reversed. "Appellants contend the claimed averaging across a plurality of users would make no sense in the context of Franz where cursor tracking responsive to keycap forces is customized for each user's preference. Id. ( see, e.g., Franz col. 2, 11. 22-26). We agree." (Ex parte Verma, PTAB 2015.)

Details:
Ex parte Verma
Appeal 2012-007587; Appl. No. 12/057,950; Tech. Center 2400
Decided:  February 3, 2015

The application on appeal used biometrics from multiple users to measure ease of use for a particular software application. "By correlating the application that a user is currently engaged in with the biometric measurements obtained from the devices, software ease of use can be done while [filtering out interactions with other concurrent applications]." "The information obtained from different users needs to be compiled into a single quantitative measure for ease of use index for the software, which can then be used as a user-independent index for its ease-of-use."

The claims on appeal recited:

     1. A computer implemented method for quantitative determination of software ease of use, comprising the steps of:
     using sensors to collect biometric data from each of a plurality of users engaged in using a software application operating on a computer  or computer network;
     monitoring and recording changes in the biometric data which occur while the software application is being used by each of the plurality  of users;
     combining recorded changes in the biometric data for each user into quantitative metrics;
     averaging quantitative metrics across the plurality of users;
     compiling the averaged quantitative metrics into a single quantitative measure for an ease of use index for the software application; and
     providing an output as a user-independent index for ease­ of-use of the software application.
(Emphasis added.)

The Examiner rejected as obvious over Franz in view of Kotzin. Franz was directed to keyboard cursor control, where cursor responsiveness could be adjusted for each user. Kotzin was directed to selecting from among multiple biometric sensors.

The Examiner read the claimed biometric sensors on Franz's keycap force sensors. The Examiner read the generating and averaging metrics steps on Franz's teaching that "several different parameters maybe stored, one for each of a plurality of users where the corresponding settings would be invoked depending upon who logged into the system." For the remaining single quantitative measure and user-independent index limitations, the Examiner relied on Kotzin's abstract, which stated: "Biometric samples are collected from multiple users [to enable a feature] when the sample matches a known sample corresponding to the user from a list of [sensors] prioritized according to accuracy and ease of use."

The Applicant appealed and made a variety of arguments in the Appeal Brief. One such argument related to the "averaging across users" limitation. The Applicant first argued that the reference simply did not disclose what the Examiner asserted, and then backed this up with a one sentence explanation of why the Examiner's interpretation didn't make sense:

The stored parameter settings are not combined, as specifically required by the claim. [Combining or averaging] would eliminate the personalization of the game controller response settings (the focus of Franz et al.). 

Later on in the response, the Applicant restated this argument about Franz, and then explained why averaging across users didn't make sense in Kotzin either.

Neither Franz et al. nor Kotzin average measures from different users. In Franz et al., this would make no sense whatsoever, because the purpose is to identify specific individuals and correlate their desired performance criteria (one wants to have the cursor tracking device perform in the desired manner, not in a manner averaged among several users). In Kotzin, this would also not make any sense. In Kotzin, the effort is to identify specific users so that only specific users can have access to a feature or service provided via a wireless communication device.

The Applicant also included arguments that neither reference taught the limitation "monitoring ... while the software application is being used," and that Kotzin was non-analogous art.

The Examiner's Answer included some rebuttal of each Appeal Brief argument. The Examiner explained why Kotzin was analogous by first addressing claim construction for "biometric data." The Examiner discussed the "monitoring" limitation by referring to Franz's keyboard microcontroller software. For the "averaging across users" limitation, the Examiner newly relied on a mention of averages in Franz. ("At initialization time, and periodically thereafter, the keyboard needs to read the individual sensor values and individually average them.")

The Applicant filed a Reply Brief. It mostly focused on the Examiner's claim construction position for "biometric data."

The Board reversed the § 103 rejection on the grounds that Franz did not teach, or even suggest, averaging the metrics across a plurality of users:

Appellants contend the claimed averaging across a plurality of users would make no sense in the context of Franz where cursor tracking responsive to keycap forces is customized for each user's preference. Id. ( see, e.g., Franz col. 2, 11. 22-26). We agree. Appellants further contend, in Franz, "one wants to have the cursor tracking device perform in the desired manner [(for each user)], not in a manner averaged among several users." Id. We agree.

Commenting on Franz's brief mention of "average," the Board found that the calibration procedure described in this passage was not performed across users.

My two cents: For the vast majority of Applicants, a "does not teach" argument amounts to quoting the reference, quoting the claim language, and then asserting that A is not B. And sometimes, this alone can be persuasive. But often a more persuasive argument can be made with judicious (and careful) use of paraphrasing, summarizing, and/or providing context. I  find the argument made by the Applicant in Verma to be more persuasive because it did just this.

The typical do-nothing-but-quote argument looks like:

Franz teaches "several different parameters maybe stored, one for each of a plurality of users where the corresponding settings would be invoked depending upon who logged into the system." However, this is not the same as "averaging quantitative metrics across the plurality of users" as recited in the claim.

For this argument to be persuasive, the Examiner must map the words, phrases, and concepts expressed in the reference to the words, phrase, and concepts in the claim. But claims are almost always hard to parse, and references too can be obtuse.

Paraphrase makes it easier to see the contrast between the reference teachings and the claims:

Franz stores parameters for each user, and then invokes corresponding per-user settings. In contrast, the clam recites averaging across multiple users. 

Here the Applicant went one step further and tied it all together, by providing a bit of context for the comparison:

[Combining or averaging] would eliminate the personalization of the game controller response settings (the focus of Franz et al.). ... In Franz et al., averaging measures from different users would make no sense whatsoever, because the purpose is to identify specific individuals and correlate their desired performance criteria (one wants to have the cursor tracking device perform in the desired manner, not in a manner averaged among several users).

I find this version of the argument even more persuasive. Notably, this explanation of context was preceded by an argument that stuck closely to the claim language. I think that's important. Because the "purpose" of the reference doesn't trump a reference that really does disclose the claim element. Instead, the purpose must be used to provide further explanation of how or why the relied-upon teachings do not disclose to the claim element.

I expect a lot of practitioners to disagree with me. And I can't stress enough that paraphrasing and summarizing must be done thoughtfully and carefully. Still, when done well, this form of argument can be very persuasive. 

I'll also point out that I am not advocating for arguing outside the claims, i.e., importing limitations into the claims. Here, the plain and ordinary meaning of the claim, read as a whole, actually does boil down to "averaging across multiple users." That's much different than arguing that "user" has a narrower meaning by importing statements in the Applicant's spec.

PTAB reverses obviousness of treating muscle-based disorders with a compound targeted at sensory neurons

Takeaway: The Examiner issued an obviousness rejection of claims to a method of using modified botox to treat urogenital-neurological disorders. One reference taught the modified toxin recited in the claims as a treatment for chronic pain. The other reference taught unmodified botox as a treatment for urogenital-neurological disorders, and also mentioned that pain was a symptom of these disorders. The Examiner used a substitution rationale and asserted that a POSITA would expect the modified (claimed) toxin to be "effective at treating chronic pain in urogenital-neurological disorders." The Board reversed, finding that the POSITA would have no reason to expect that "the opioid targeting moiety designed for nociceptive [sensory neuron] pain" would have any efficacy in treating the "muscle based urogenital­ neurological disorders" recited in the claims. (Ex parte Brin, PTAB 2015.)


Details:

Ex parte Brin
Appeal 201300250; Appl. No. 12/255,369; Tech. Center 1600
Decided:  Dec. 2, 2015

The application on appeal was directed to using a modified botulism toxin (botox) to treat sensory nerve bladder disorders, such as incontinence and chronic urinary tract infection.

A representative claim on appeal read:

     A method of treating urogenital-neurological disorder in a human, the method comprising the step of administering to the human in need thereof a therapeutically effective amount of a composition including a modified Clostridial toxin comprising
     an opioid peptide binding domain,
     a Clostridial toxin translocation domain and
     a Clostridial toxin enzymatic domain,
     wherein the urogenital-neurological disorder is selected from the group consisting of urinary incontinence, overactive bladder, detrusor dysfunction, lower urinary tract dysfunction, urinary retention and urinary hesitancy,
      wherein administration of the composition reduces a symptom of the urogenital­ neurological disorder, thereby treating the human.

The Examiner rejected the claims as obvious over Schmidt in view of Foster. Schmidt was used to show a method of treating urogenital-neurological disorders with (unmodified) botulinum toxin. Foster was used to show the modified toxin (having specific domains) recited in the claim.

The Examiner used a substitution rationale, asserting that Foster's modified toxin would provide several benefits mentioned in Foster (e.g., good efficacy, low dosage). "It would have been expected, absent evidence to the contrary, that the modified toxin would be effective at treating chronic pain in urogenital-neurological  disorders." The Examiner noted that Schmidt described patients with a urogenital-neurological disorder as experiencing pain, and that Foster's modified toxins were used to treat chronic pain.

The Applicant appealed the obviousness rejection and argued the prima facie case was insufficient. The Applicant focused on the different "mechanisms of action" in Schmidt and Foster. Schmidt's toxin affected a motor neuron, while Foster's modified toxin affected a sensory neuron. Thus, Schmidt treated a urogenital-neurological disorder by paralyzing a muscle, while Foster controlled pain by targeting sensory nerves (no effect on muscle).

[W]here there are two references being combined, each of which show the treatment of different diseases or conditions by a different mechanism of action, there is no reasonable expectation of success. Even an "obvious to try" approach would be insufficient to make out the prima facie case of obviousness. (See, e.g., In re May, 574 F.2d 1082, 1094, (CCPA 1978) and In re Schechter, 205 F.2d 185, 191, (CCPA 1953).)

Finally, the Applicant used these differences to rebut the Examiner's substitution rationale:

The Examiner is arguing that the respective methods of treating chronic pain by blocking the neuron are similar to blocking a receptor that activates a muscle by means of a neuron that provides a neurotransmitter such as acetylcholine. But the Examiner has provided no reference to show that these methods are similar. And, in fact, since the mechanisms of action are different, they are not similar.

In the Answer, the Examiner noted that the claims did not recite "different mechanisms of action." The claims did recite "reducing a symptom of a urogenital-neurological disorder." The Applicant's spec listed pain as a symptom of such disorders, and both Schmidt and Foster taught their toxin was useful to treat pain.

The Examiner was not persuaded by the Applicant's attack on the substitution rationale, since "the features upon which applicant relies (i.e., "mechanisms of action) are not recited in the rejected claim(s)." The Examiner maintained there was a reasonable expectation for the modified toxin to effectively treat chronic pain "absent convincing evidence to the contrary."

The Applicant did not file a Reply Brief.

The Board reversed the obviousness rejection as not being supported by the references. While the Examiner focused on pain treatment as a reason to combine the references, and asserted a reasonable expectation of success, the Board disagreed.

     Pain is not one of the recited conditions in claim 1. Foster's modified clostridium toxin would have been expected to treat pain, not the conditions recited in claim 1. We therefore agree with Appellants that there would have been no reason, based on Foster, to expect that a modified clostridium toxin with an opioid targeting moiety would have any efficacy on muscle based urogenital­ neurological disorders "selected from the group consisting of urinary incontinence, overactive bladder, detrusor dysfunction, lower urinary tract dysfunction, urinary retention and urinary hesitancy" (Claim  1). Schmidt also provides no reason to modify the clostridial toxin with an opioid targeting moiety because Schmidt is focused on treatment of voiding dysfunction, not pain. Neither Foster nor Schmidt provide any suggestion that an opioid targeting moiety designed for nociceptive pain would have any efficacy treating the conditions recited  in claim 1.

My two cents: The Applicant was wise not to frame this as a non-analogous art argument. The references were probably similar enough to be analogous, yet the Applicant successfully argued that the differences undermined the rationale to combine.

The Applicant leveraged a basic distinction between the two references – targeting muscles vs. targeting sensory nerves – into two slightly different arguments. One, the Examiner's substitution rationale was flawed because the treatment mechanisms were different, not similar.  Two, a POSITA reading the references would not expect the modified botox to effectively treat the claimed disorders.

The Applicant was wise to address substitution, because the Examiner brought it up. And I'm not surprised to see a no-expectation-of-success argument, since biotech cases seem to lend themselves to this. Not so in electronics, computers, and mechanical cases, since components (functional and structural) are generally expected to work in combination.

However, even when working in these technologies, you sometimes do find basic differences between the references, analogous to sensory vs motor neuron. If so, you might use these differences to craft a slightly different argument, basically explaining how/why wouldn't make sense for a POSITA to combine because of these differences.

Another way of thinking about this case is that the connection between the two references was too attenuated. One described treating chronic pain with the modified toxin, the other with treating nerve-based urological disorders with the unmodified toxin. The connection between the two was pain, in that the primary reference mentioned pain as a symptom of the treated nerve-based urological disorders. The Examiner reasoned that the claims recited "administration of the composition reduces a symptom of the urogenital­ neurological disorder", and pain was a symptom, so they were combinable. But the way I see it, the Examiner used pain as an intermediary to jump from the primary reference to the secondary. I'm not sure this was part of the Board's reasoning.

Here's something that I really don't understand about this case. The original claims recited "treating urogenital-neurological disorder." The Applicant narrowed during prosecution to include a specific set of disorders: "urinary incontinence," "overactive bladder," and four others. The Applicant didn't  mention this limitation in the response or the Appeal Brief. The Examiner failed to address it in both the Final Office Action and the Answer. And the Board mentioned this set of disorders in its obviousness analysis, but did not make a finding that the reference did (or did not) disclose the feature.