Board reveses obviousness of cardiac operation method when Examiner relies on statements in reference about suitability of device for operation

Takeaway: The Applicant appealed a claim to a "method for performing operation on a cardiac valve of a heart while the heart is beating." The Applicant argued that the operations disclosed in both references were not beating heart operations and instead were operations that required cardiopulmonary bypass. The Examiner maintained that the primary reference specifically described its perfusion catheter as being used while the heart was beating. The Board, finding that the Examiner had read too much into this teaching, reversed. The Board found that suitability of a device during beating heart operations generally was not a teaching of the claimed method step in the claimed beating heart operation. (Ex parte Lambrecht, PTAB 2012.)

Details:

Ex parte Lambrecht
Appeal 20100067805; Appl. No. 11/115,064; Tech. Center 2700
Decided: March 5, 2012

The application on appeal involved cardiac valve procedures and devices. The independent claim on appeal was a method of use for a cardiac valve:

     1. A method for performing an operation on a cardiac valve of a heart while the heart is beating, comprising the steps of:
     a) placing at least one temporary valve in a flow path of a blood vessel downstream from said cardiac valve, said temporary valve being operative to effect greater antegrade flow than retrograde flow through said vessel;
     b) placing at least one temporary filter in said flowpath downstream from said cardiac valve and within one of the ascending aortia and aortic arch of a patient, said filter being operative to restrict the passage of emboli while allowing blood to flow through said vessel; and
     c) resecting at least a portion of the cardiac valve with the temporary valve and temporary filter as positioned within said flowpath.
(Emphasis added.)

The Examiner found the claim obvious using a primary reference Macoviak for steps (a) and (b) and a secondary reference Stevens for step (c). As a motivation for adding the resecting step from Stevens to the procedur of Macoviak, the Examiner provided "in order to catch debris and avoid embolism," as taught in the second reference.

On appeal, the Applicant argued that several limitations were not disclosed by the combination, including an operation performed "while the heart is beating." The Applicant also argued that a POSITA would not look to modify the cardiac operation of the primary reference:

One of ordinary skill in the art would not look to a perfusion catheter that is used when the heart is stopped, as in Macoviak, in developing a system or method steps for performing surgery on a heart valve with the heart beating, as in the claimed invention. The perfusion catheter features of Macoviak are directed to fundamentally different types of cardiac procedures fiom operations that are to be conducted on a beating heart and that involve valve resection.

The Examiner addressed this argument in the Answer by noting that the relied-on section of the primary reference also taught that the perfusion catheter could be used in "beating heart" operations. The relied-upon section stated:

Therefore, what has been needed and heretofore unavailable, is a catheter device for standard open chest surgery and for use in minimally invasive medical procedures that is simple and relatively inexpensive. One which is capable of isolating the circulation of the arch vessels, while still allowing the heart to perform the function of perfusing the body or alternatively one that can be used in conjunction with an extracorporeal circuit. The present invention solves these problems as well as others.

The Applicant filed a Reply Brief characterizing the rejection as "an attempt to create a device that
might be usable in the claimed manner without any disclosure in either reference of the rejection of method steps." The Applicant then explained that the claimed operation was performed on a beating heart while both of the operations described in the references required a cardiopulmonary bypass. Because of this fundamental difference, the Applicant concluded that "it would not be possible to come up with the claimed method of performing an operation on a cardiac valve while the heart is beating by any combination of the Macoviak and the Stevens references."

The Board found this issue dispositive and reversed the rejection. The Board explained that Macoviak's statement about the suitability of a device during beating heart operations generally was not a teaching of a particular method step in a particular beating heart operation.

The cited disclosure addresses Macoviak’s characterization of the versatility of the disclosed devices, by virtue of their capability to be used both in procedures in which the heart continues to perfuse the body (i.e., continues to beat) and in procedures in which an extracorporeal circuit is used to perfuse the body. The text of Macoviak alluded to by the Examiner does not teach or suggest that all procedures for which the disclosed devices may be used may be performed while the heart is beating.

My two cents: This case (unlike most) does seem to be about the teachings of the reference, and the Examiner read too much into the reference. The Examiner took a teaching that a catheter device is useful during a class of cardiac operations (those performed with a beating heart) and stretched it into something it was not: disclosure of the claimed cardiac operation (operation on a cardiac valve while the heart is beating). A subtle point, and kudos to the Applicant for making a compelling argument.

If this was a device claim, the Applicant might run into problems with functional language being ignored as intended use. But this is a method claim, and this one is all about use. And the Board found that the references, alone or in combination, simply didn't teach the claimed use.

Finally, I note that nobody raised the issue of whether the phrase "while the heart is beating" – which appears in the preamble – should get patentable weight.

Board finds Examiner's assertion that Teflon® was "flexible, stretchable" shifted the evidentiary burden to Applicant

Takeaway: The Applicant appealed an obviousness rejection of a claim to an aortic implant, arguing that the combination did not diclose the limitation "wherein the fixing ring is made of a ... rubber like material." The Applicant argued that the Examiner had merely asserted that PTFE (better known as Teflon®) was rubber-like, without any evidence that Teflon® possessed this characteristic. The Examiner maintained that Teflon® was "a flexible, stretchable material" and was "considered to be 'rubber like'." The Board affirmed because "the Examiner made a reasonable finding that PTFE is a rubber like material" and the Applicant did not provide evidence to the contrary. (Ex parte Rasmussen, PTAB 2013.)

Details:

Ex parte Rasmussen
Appeal 2011012484; Appl. No. 11/998,532; Tech. Center 3700
Decided:  July 31, 2013

The application on appeal was directed to an aortic implant. A representative independent claim on appeal read:

     1. An aortic implant including
     a graft portion,
     a corrugated portion integral with and extending from the graft portion, and
     a fixing ring substantially at the junction between the graft and corrugated portions, the fixing ring providing a volume into which fixing sutures can be made to pass.

One of the dependent claims on appeal read:

     6. An implant according to claim 1,wherein the fixing ring is made of a foam, rubber, or rubber like material.

The Examiner rejected all claims as being obvious over a combination of two references, and maintained the rejection in a Final Office Action. The Applicant appealed, and argued several dependent claims for the first time.

In arguing dependent claim 6, the Applicant first noted that the Examiner had characterized the secondary reference, Brauker, as teaching that PTFE was a rubber like material. However, according to the Applicant, the Examiner's assertion was made "without any support," and "[this] disclosure is simply not present in either of the references."

The Examiner's Answer maintained the rejections. With respect to dependent claim 6, the Examiner noted that the Applicant's specification had no description of term "rubber like material". The Examiner then asserted that "PTFE is a flexible, stretchable material and is considered to be 'rubber like'."

The Applicant filed a Reply Brief to respond to this new information.

A person of ordinary skill in the art would understand the term "rubber like material" to have its common ordinary meaning. Merriam Websters 10th ed. defines rubber-like as "resembling rubber esp. in physical properties." The Examiner has not shown that any of the materials upon which he relies are rubber-like.

The Board affirmed the rejection of dependent claim 6:

The Examiner made a reasonable finding that PTFE is a rubber like material (Ans.6). Having done so, Appellants have the burden of showing that it is not. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”). Appellants provide no evidence to establish that PTFE would not have been considered a rubber like material to a person of ordinary skill in the art.

My two cents: The Board got this one wrong. Certainly in the Final rejection, the Examiner's "finding" was nothing more than a naked assertion. In the Answer, the Examiner provided a little more explanation of his thinking, which amounted to a claim construction for rubber-like ("flexible, stretchable") and a naked assertion that PTFE was flexible and stretchable.

So, there are actually two issues going to the PTAB: was the claim construction reasonable; and if so, did the Examiner provide enough technical reasoning to support his determination that PTFE possessed these characteristics.

The Applicant gave his own definition of "rubber-like" in the Appeal Brief – but not a particularly helpful one. The Applicant could have gone farther and gone on record with what those properties were. Sometimes the best way to beat the Examiner's unreasonable interpretation is to offer a reasonable one. 

But let's assume that "rubber-like" is properly understood as "flexible, stretchable." The Board characterized this as a burden-shifting issue, stating the Examiner's assertions about the properties of Teflon® were enough to shift the burden to the Applicant.Yet the MPEP requires the Examiner to "provide a basis in fact and/or technical reasoning to reasonably support the determination [of an inherent characteristic]." (MPEP 2112.IV.) No such reasoning appears in the record.

If the Examiner had made the bare assertion that Teflon was "slippery" or "low-friction," I doubt I'd be blogging about this case. Sure, you could make arguments about burden shifting, no evidence, bare assertion, etc. But the truth is, once you know that the material in question is Teflon®, you also know it's slippery. That's probably common knowlege, worthy of Official Notice.

But the Examiner made the much more questionable statement that PTFE was "flexible, stretchable". That's not my everday experience with the Teflon® coating on my pan. And the Wikpedia article I read on the subject didn't mention these properties. So I say that before the burden shifts to the Applicant, the Examiner must provide a better explanation of exactly why a POSITA would consider Teflon® to be flexible and/or stretchable.

That said, I'm not sure I would appeal on the buden shifting issue alone. Instead, I'd consider putting my own evidence in the record about the properties of Teflon®. Probably not as far as an expert testifying that Teflon® was not flexible and/or stretchable. But how about some information about Teflon® from a materials science encylopedia, and then an argument that the evidence did not describe the material as having these properties?

Board finds disclosure that memory access time period exists is not enough to anticipate decision based on this time period

Posted by: Karen G. Hazzah

Takeaway:  At issue in this appeal was the limitation "threshold defining both a number of times a segment is accessed and a given time period for the number of times." The Applicant did not dispute that the counter in the secondary reference tracked page accesses exceeding a threshold, but did argue that the reference did so without regard to a time period. The Examiner asserted that the threshold in the reference implicitly defined a time period, in that "when the threshold is reached the amount of time it took to reach it is also defined." The Board found this interpretation to be unreasonable. The Board acknowledged that the threshold determination "inevitably involve[d] a period of time to count those events," which was "simply the time elapsed during the counting process." However, the Board found that the reference "does not measure, let alone account for [this time period] as a factor for migration" as claimed. The Board reversed the rejection. (Ex parte Jones, PTAB 2011.)

Details:

Ex parte Jones
Appeal 2009011684; Appl. No. 11/066,038; Tech Center 2100
Decided:  August 9, 2011

The application on appeal was directed to a multiprocessor memory system that caches frequently used data in a centralized switch memory.

     1. A system comprising:
     a plurality of nodes, each node comprising a processor coupled to a memory; and
     a switching device coupled to the plurality of nodes and containing
          migration logic configured to migrate segments of each memory to a memory of the switching device so that segments are accessible to each of the processors. 

To overcome an obviousness rejection, the Applicant amended claim 1 to pull in dependent claim 4, as follows: 

migration logic that is configured to identify segments of memory that are each accessed above a threshold number of times over a given time period and that is configured to migrate segments of each memory so identified to a memory of the switching device.

The Applicant distinguished the secondary reference by arguing that Schonias did not teach tracking memory access "over a threshold number with regard to a given time period." (Emphasis in original.)

The Examiner maintained the rejection, explaining that the claim language "does not require that the threshold must be met within a specific time period instead it just requires that the threshold is met over some time period, which of course is true." (Emphasis added.)

In response, the Applicant amended again as follows:

migration logic that is configured to identify segments of memory that each accessed above a threshold, said threshold defining both a number of times a segment is accessed over and a given time period for the number of times, and that is configured to migrate segments of each memory so identified to a memory of the switching device"

The Applicant again argued that Schonias tracked page accesses that exceed a threshold, but without regard to a time period.

The Examiner maintained the rejection and took the Applicant final. According to the Examiner, the claim "merely states that 'a time period' is defined by the threshold" but not "how the time is defined by the threshold or what variable the time is defined with respect to, or that the time can't vary." The Examiner then explained that in Schonias, "the time period is defined by how long is takes to reach the count threshold of the counter, therefore the threshold being reached defines the amount of time it took to reach it."

The Applicant appealed and argued that the Examiner's claim construction was erroneous:

The Examiner apparently takes the position that because it will take some finite period of time for the counter threshold in Schoinas to eventually be reached, that the count threshold reaches does define an amount of time. However, the claim requires the migration logic to implement a threshold which defines both the number of times and the time period. Schoinas' counter threshold only defines a number of accesses, not a corresponding time period. The Examiner's reading of the claim is disingenuous and counter to what one ordinary skill in the art would understand upon reading Appellant's disclosure.

In the Answer, the Examiner first noted that the claim does not require a predefined time period, since neither the claims nor the specification provided "any specific explanation as to how the time period of these claims are defined." The Examiner then explained that the broadest reasonable interpretation covered a time period defined in terms of a number of memory accesses – which does read on a time period, even if that period is not predefined. Applying this to Schoinas, "when the threshold is reached the amount of time it took to reach it is also defined."

The Applicant filed a Reply Brief and again distinguished the claim from Schoinas:

In Schoinas, it will not matter whether it took 5 minutes or 5 hours to reach the terminal count for accessing a given memory area. In claim 1, it will matter. In Schoinas, a memory area that is accessed, say, 50 times is migrated even if it took a week to be accessed that number of times. The number of accesses alone is not enough for claim 1; the corresponding time period is also considered.

The Board reversed the rejection. The Board framed the dispositive issue as whether Schoinas' threshold defines a time period that is associated with the number of times a memory segment is accessed. The Board found that the Examiner had acknowledged that Schoinas' threshold did not explicitly define the time period. The Board further found that the Examiner relied on a defined time period that was "implicit in the length of time take to reach the specific count threshold." The Board found this reading of Schoinas was unreasonable in light of the specification:

     To be sure, counting discrete events, such as memory accesses, to determine whether those events reach a predetermined threshold amount will inevitably involve a period of time to count those events. But that hardly means that this inexorable passage of time is accounted for in this determination. It is simply the time elapsed during the counting process – a period of time that Schoinas does not measure, let alone account for as a factor for migration.
     By specifically defining both a count and a time period, the claimed threshold sets particular limits on the rate at which counts occur (i.e. their frequency) – a key temporal restriction that Schoinas simply does not contemplate.

My two cents: The Board recognized the Examiner's flawed logic, which boils down to what I call a "mere existence" analysis. The Examiner took a teaching of the existence of X (here, a time period) and asserted that the mere existence of X satisfied the claim limitation. Here, the claim as properly interpreted required not simply the existence of a time period during which memory was accessed, but also an action – identifying a segment – based on this property.

Board finds Machine-or-Transformation test, applied alone, insufficient to sustain 101 rejections

Posted by: Adam Ellsworth

Takeaway: In an appeal involving e-learning games, the Board reversed a rejection under 35 USC § 101 of a method claim directed to constructing e-learning games, where the rejection was based solely on the grounds that the claims did not satisfy the machine-or-transformation test. The Board relied on the Federal Circuit's decision in Cybersource, stating that the Examiner should have determined if the claim was directed to an unpatentable mental process. The Board also suggested that claims be analyzed based on the “Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos” to determine whether a claim is patent-eligible under 35 U.S.C. § 101.

Details

Ex parte Bagley

Appeal 2011-001822, App. No. 10/853,298, Center 3700

Decided: May 31, 2013 

The application on appeal was directed to e-learning games. Two representative claims read:

1.     Apparatus for dynamic construction of e-learning games, said apparatus comprising:at least one learning object assessment object;   a repository comprising a plurality of video scenes; and  a game generator for associating a video scene with an assessment object, dynamically responsive to an answer to the assessment question by a student, whereinthe video scene is selected from a plurality of video scenes capable of being associated with the assessment question.

…

8.     A method for constructing e-learning games dynamically, comprising the acts of:          selecting a learning object from a repository of learning objects;selecting a learning object assessment object associated with the learning object from a repository of learning object assessment objects;testing an e-learning student according to an assessment question from the learning object assessment object; andselecting a video scene from a video repository, responsive to an answer to the question by the student, for display to the student, whereinthe video scene is selected from a plurality of video scenes capable of being associated with the assessment question.

The Examiner initially rejected claims 1-12 as being directed to non-statutory subject matter under 35 U.S.C. § 101, but the Examiner withdrew the rejections of the apparatus claims 1-7 on appeal. As a result, the only 35 U.S.C. § 101 rejections argued on Appeal were those directed to the method claims 8-12.

In rejecting claim 8, the Examiner applied only the machine-or-transformation test to determine whether the claim was directed to non-statutory subject matter under 35 U.S.C. § 101. The Examiner set forth the standard as follows:

“[I]n order for a claimed process to be considered statutory it must be: (1) tied to a particular machine or apparatus, or (2) transform a particular article into a different state or thing.”

On appeal, the Applicant, paraphrasing the Supreme Court decision in Bilski v. Kappos which had issued a few weeks previously, argued that the Examiner “failed to produce substantial evidence that the claim was directed to one of the exceptions to statutory subject matter.” The Applicant further argued that the claim was tied to a machine, stating:

“Specifically, claim 8 refers to ‘a repository of learning objects,’ ‘a repository of object assessment objects,’ and a ‘video repository.’ All of these items are devices, and thus, the claimed invention is not directed to one of the exceptions to statutory subject matter.”

The Examiner, ignoring the Applicant’s reference to Bilski, responded by stating that that “the claim does not make any implicit or explicit recitation of a particular machine which is critically tied to the performance of the method.”

Regarding the limitations recited in the claims of storing objects in a repository, the Examiner dismissed this limitation as merely being an extra-solution activity, stating that “it is not part of the critical steps and procedures of the claimed process.”

The Board agreed with the Applicant and reversed the rejection of claims 8-12 under 35 U.S.C. § 101 for not following the most recent guidance from the Supreme Court, the Federal Circuit, and the U.S.P.T.O. The Board stated:

“Following the Federal Circuit’s post-Bilski approach in Cybersource, the Examiner should have analyzed the method claim to determine whether ‘it is drawn to an unpatentable mental process-a subcategory of unpatentable abstract ideas.’ The Examiner’s analysis, however, is devoid of any mention of an ‘abstract idea’ or ‘mental process.’”

The Board noted that since the Examiner’s rejection was issued four months prior to the Supreme Court’s Bilski decision, the Examiner’s rejection in the Final Office Action was not based on the most recent guidance from the Courts or the Patent Office. The Board stated:

“[T]he Examiner presumably had neither the benefit of the Court’s analysis nor the benefit of this Office’s ‘Interim Guidance for Determining Subject MatterEligibility for Process Claims in View of Bilskiv. Kappos,’ 75 Fed. Reg. 43,922, 43926, which became effective July 27, 2010. The Guidance provides in exquisite detail the analysis that the Examiner should follow in determining whether a method claim is claiming an abstract idea.”

Although the Board reversed the § 101 rejections, the rejections of all of the claims were ultimately affirmed by the Board, either under 35 U.S.C. §§ 102 or 103.

My two cents:

The Board analyzed the rejections of claims 8-12 under 35 U.S.C. § 101 exactly right. The Examiner provided no analysis of whether the claims were directed to an abstract idea. In addition, the Applicant in this case was lucky that the Board was aware of the Interim Guidance and directed the Examiner to follow the Interim Guidance, since most Examiners and PTAB judges are either unaware of the Guidance or choose to ignore it.

Other panels of judges at the PTAB have interpreted the Supreme Court’s language in Bilski that “the machine-or-transformation test is not the sole test for determining the patent eligibility of a process” to mean that, although other tests may exist, the machine-or-transformation may be the sole test applied by an Examiner in any given application. This interpretation is inconsistent with the Supreme Court’s decision, which rejected the Federal Circuit’s application of only the machine-or-transformation test to reject the claims in Bilski, and this interpretation is definitely inconsistent with Cybersource, in which the Federal Circuit further stated that “the machine-or-transformation test is not dispositive of the § 101 inquiry.”

The more logical interpretation of Bilski is set forth in the “Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos,” 75 Fed. Reg. 43,922, 43926. In the Interim Guidance, the machine-or-transformation test is one test to determine whether a method claim is directed to patent-eligible subject matter, but not the sole test. In addition to the machine-or-transformation test, the Guidance directs Examiners to determine whether an abstract idea has been practically applied. The Guidance includes factors that weigh in favor of patent-eligibility of a claim and factors that weigh against patent-eligibility of a claim.

Here, although the Examiner had access to Bilski at the time of the Examiner’s Answer, the Examiner did not have access to the Interim Guidance. Examiners do not generally follow or analyze court cases without guidance from the PTO, and this Examiner was no exception. When the Applicant relied on Bilski to argue that the Examiner had not provided substantial evidence that the rejected claims were directed to abstract ideas, the Examiner ignored the argument and instead relied upon the outdated guidance from the Patent Office that directed Examiners to apply only the machine-or-transformation test to method claims to determine patent-eligibility of the claims.

Prosecution Tip: My tip for responding to § 101 rejections in which an Examiner rejects a method claim using only the machine-or-transformation test is to direct the Examiner to the Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos. Applicants should not only cite the location of the Interim Guidance in the Federal Register, and possibly even provide a hyperlink to the Guidance on the USPTO website, but Applicants should also point out the specific features in the rejected claims that weigh in favor of patentability according to the Interim Guidance. This provides concrete reasons on the record, supported by case law, why the claims are directed to patent-eligible subject matter.

New contributor to All Things Pros

I'm pleased to announce that starting this week, Adam Ellsworth will join All Things Pros as a contributor. Adam is a colleague of mine at Cantor Colburn LLP. He will initially focus on Board decisions involving § 101.