Friday, August 3, 2012

BPAI affirms enablement rejection of "detecting at least one gamma ray" aftering finding POSITA knows that detection requires multiple rays

Takeaway: In an application involving the use of radiation to test materials, the Applicant appealed an enablement rejection for claims that included the step of  "detecting at least one emitted prompt gamma ray." The Examiner asserted that "[i]t is a notorious scientific fact that statistically meaningful data requires collection of information from not one but from a plurality of events and nuclear interactions.The Applicant argued that the specification need not enable every embodiment, and that the burden was on the Examiner to show that all multiple ray embodiments were inoperative or not enabled. The Board affirmed the rejection, based at least in part on the Applicant's admission that detection required more than one ray.  "As such, Appellant has conceded that the disclosure of the present application does not provide an enabling description for the full scope of Appellant’s claims. Appellant, having chosen the broad claim language, must make sure that the broad claims are fully enabled." (Ex parte Akers, BPAI 2010.)

Details:
Ex parte Akers
Appeal 200900591; Appl. No. 10/383,096; Tech. Center 3600
Decided:  March 15, 2010

The technology on appeal was materials testing using radiation. The only independent claim on appeal read:

1. A method for evaluating a material specimen, comprising:
     bombarding the material specimen with neutrons to create prompt gamma rays within the material specimen, some of the prompt gamma rays being emitted from the material specimen, some of the prompt gamma rays resulting in the formation of positrons within the material specimen by pair production;
     detecting at least one emitted prompt gamma ray;
     detecting at least one emitted annihilation gamma ray resulting from the annihilation of a positron; and
     calculating positron lifetime data based on the detected emitted prompt.

The Applicant then went to appeal on several non-prior art rejections, including a rejection under § 112 First, Enablement. According to the Examiner, the specification did not enable detection of a single gamma ray as recited in the independent claim:
The limitation "at least one" admits having only one. There is neither an adequate description nor enabling disclosure as to how and in what manner detecting only one prompt gamma ray and only one annihilation gamma ray can collect adequate experimental data. It is a notorious scientific fact that statistically meaningful data requires collection of information from not one but from a plurality of events and nuclear interactions.

In the Appeal Brief, the Applicant argued that § 112, First did not require enabling every embodiment of the claim (citing Ex parte Saito, BPAI 2008). Since "at least one ... gamma ray" encompassed many embodiments involving multiple gamma rays, and the Examiner failed to demonstrate that these embodiments were inoperative or not enabled, the Examiner failed to carry the burden in showing lack of enablement.

The Applicant did not rely solely on the lack of a prima facie case of enablement, but went further to specifically argue that the claims were enabled to a POSITA. The Applicant cited to In re Skrivan, 427 F.2d 801 (Fed. Cir. 1970), for the proposition that an enabling disclosure was not required to include information presumed to be within the level of ordinary skill in the art. After quoting the Examiner's "notorious scientific fact" characterization, the Applicant asserted that "persons having ordinary skill in the art will recognize that a plurality of gamma rays will need to be detected in order to collect meaningful data." As evidence, the Applicant pointed to two prior art references of record that showed "these kinds of calculations and thus also the underlying data collections have been performed by skilled artisans for upwards of 60 or even 70 years."

The Examiner's Answer challenged the Applicant's use of Ex parte Saito, noting that the Applicant had selectively quoted from the opinion. The Examiner quoted additional material from Saito which said: "if the number of inoperative combinations becomes significant, and in effect forces one of ordinary skill in the art to experiment unduly to practice the claimed invention, the claims might indeed be invalid." The Examiner then applied Saito to the application on appeal, and concluded that:
Neither one, two, three, or even fifty or more prompt gamma rays in combination with each of one, two, three, or fifty or more annihilation gamma rays would not yield an operative embodiment. The number of inoperative combinations is significant and an artisan would have to perform undue experimentation to practice the claimed invention.
(Emphasis added.)

The Board affirmed the rejection. The Board agreed with the Applicant that "an application for patent need not necessarily provide an enabling disclosure of every embodiment of the claimed invention." However, the Board found that the Applicant had not provided any enabling disclosure for detecting one gamma ray, which is explicitly included in the scope of the claim. In fact, the Applicant had specifically conceded that a POSITA would understand that detection of multiple gamma rays would be required to collect meaningful data. The Board concluded its analysis as follows:

As such, Appellant has conceded that the disclosure of the present application does not provide an enabling description for the full scope of Appellant’s claims. Appellant, having chosen the broad claim language, must make sure that the broad claims are fully enabled. In this case, as conceded by Appellant, the scope of the claims, by encompassing a method wherein one emitted prompt gamma ray and one emitted annihilation gamma ray are detected, is not less than or equal to the scope of the enablement, as required by the first paragraph of 35 U.S.C. § 112.
(Emphasis Added.)

Backstory: The above summary of the prosecution history leaves out a lot of details. The actual prosecution history is quite convoluted: multiple Answers and Reply Briefs, a reopening of prosecution, and a return to appeal. I simplified greatly so I could focus on the specific issue of enablement.

Postscript: The Applicant let the case go abandoned after the appeal decision – despite the fact that the Examiner withdrew the only prior art rejection before appeal, the Board reversed the other § 112 rejections, and the affirmed enablement rejection could probably have been overcome by appropriate claim amendment.

On the other hand, this application was in the middle of a continuity chain of three applications, and the Applicant was successful in getting two issued patents out of the chain. So maybe the Applicant got what it needed elsewhere. Also, it may be that the claims in this particular application had no commercial value by the time of the BPAI decision. The decision came down a full six years after filling of the first Appeal Brief, and a full seven years after the application was filed.

My two cents: I don't know much about this area of technology, but I feel that's unnecessary to understand this decision: both sides agreed on the facts, but not the law. I say this was the right result, and it looks like the Applicant misunderstood the law of enablement.

Once the Examiner explained the rejection in the Answer, it was clear [to me] that the rejection could be overcome with a simple claim amendment to exclude the inoperative embodiments.

The most interesting aspect may be: what's the appropriate amendment? Seems to me "plurality of gamma rays" doesn't help, because that still includes small numbers like 2, 3, and 50, which apparently can't be detected.

My first stab at an amendment would be "a stream of gamma rays". Avoids a specific number of rays (important) and doesn't seem indefinite -- to me, but I'm admittedly not a POSITA. Perhaps there is a better term of art.

9 comments:

  1. As a former physicist, I feel that PHOSITA, here, would, with knowledge of both the wave/particle duality of gamma radiation and of the requirement for obtaining meaningful statistics, construe the "detecting at least one emitted ... gamma ray" integer to mean "detecting, at a statistically meaningful level, that at least one ... gamma ray has been emitted". On such a construction, the claim is enabled.

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    1. Anon, thanks for chiming in. Always good to have a POSITA viewpoint.

      >As a former physicist, I feel that
      >PHOSITA [would understand claim to
      >mean] "detecting, at a statistically
      >meaningful level, that at least one >...
      >gamma ray has been emitted"

      Perhaps a sworn declaration from a POSITA, offering evidence as to the meaning of claim term, would have been persuasive.

      OTOH, it can be hard to overcome "plain and ordinary meaning", and the words themselves do clearly say "detecting AT LEAST ONE". The better course, I believe, would be to amend so that the claim is enabled even with plain meaning.

      Delete
  2. As a former Nuclear Engineer, I believe that the positron lifetime can be determined by a PHOSITA by detecting a single prompt gamma and annihilation gamma event. It appears the problem for the Applicant in this case is the calculating step. Without reading the specification, it appears that the Board did not find adequate support because the specification did not provide an equation, algorithm and the like for doing such a determination. If true, I would be surprised that the Applicant did not provide some sort of method for calculating the positron lifetime from at least one prompt gamma and annihilation gamma event, after all this is the invention.

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    Replies
    1. Anon, thanks for contributing.

      >As a former Nuclear Engineer, I
      >believe that the positron lifetime can
      >be determined by a PHOSITA by
      >detecting a single prompt gamma and
      >annihilation gamma event.

      Interesting. Unfortunately, the Applicant did not submit *evidence* to this effect, only attorney argument. To make this argument, the Applicant should have submitted declaration(s) from POSITA(s).

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    2. >appears the problem [here] is the
      >calculating step. Without reading
      >spec, it appears that the Board did
      >not find adequate support because
      >spec did not provide equation,
      >algorithm and the like for doing
      >such a determination.

      Well, the Applicant had *multiple* problems in this case. The Examiner did indeed give another rejection (indefiniteness) based on the lack of detail in the spec about the calculating. The Board actually reversed the indefiniteness, noting that the issue really appeared to be enablement. But the Board did not raise enablement of the "calculating" step as a new ground of rejection.

      >surprised that Applicant did not
      >provide some sort of method for
      >calculating positron lifetime from
      >at least one prompt gamma and
      >annihilation gamma event, after all
      >this is the invention.

      You mean the novelty appears to be the lifetime calculation?

      I've no idea, so won't comment on that particular point.

      I will note that in arguing the indefiniteness rejection of the "calculating" step, the Applicant did rely on the knowledge of a POSITA to fill in the gaps in the spec. For example, the decision notes that "[articles cited by both Examiner and Applicant] establish that these data processing techniques were quite familiar to those of ordinary skill in the field of non-destructive material evaluation._

      Delete
  3. BTW...the calculating step given above is incomplete. The step should read:

    "calculating positron lifetime data based on the detected emitted prompt based on the detected emitted prompt gamma ray and the detected emitted annihilation gamma ray."

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  4. I'm a tad confused. This case was decided over 2 years ago; why are you posting on it now? It's a tad misleading that this is breaking news.

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    Replies
    1. >case was decided over 2 years ago; why are you
      >posting on it now?

      Because I found it interesting.

      >tad misleading that this is breaking news.

      Who said anything about "breaking news"? Not me.

      Delete
  5. Once again, we have both sides claiming that one of ordinary skill would have known this or would have known that, but (from what I gather) at no point does either side bother to actually make any determination of the level of ordinary skill in the art. The burden is on the PTO to determine the level of skill. Even if the PTO relies on inherently determining skill level via the cited prior art, the PTO must still explain why the art reflect an appropriate level of skill and that the PTO's failure to make a finding on skill level did not impact the ultimate conclusion. The analysis for determining skill level for enablement should be no less rigorous than for determining skill level for obviousness. IMHO, the skill level determination should be held to a higher standard for enablement than for obviousness.

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