Setting the Standard for Claim Drafting

Claims often reference government or industry standards. However standards can change over time, which has the potential to change the scope of the claim, unless it is understood that the meaning is fixed as of the filing date, and that is what the BPAI does.

In Ex parte McClary, Appeal 2009-001300, Application 11/101,897 (May 17, 2010), the Board reversed the Examiner’s 112 rejection that reference to the ARINC 615 protocol (an industry standard in the field of avionics) was indefinite because it was subject to being changed in the future. The Board said:

Compliance with the provisions of 35 U.S.C. § 112 is determined as
of the filing date of the application. W.L. Gore & Assoc., Inc. v. Garlock,
Inc., 721 F.2d 1540, 1556 (Fed. Cir. 1983). There does not appear to be any
dispute here that a particular version of the ARINC 615 protocol was in
existence as of Appellant’s filing date. Thus, one of ordinary skill in the
art, with reference to the standard in effect as of the filing date of
Appellant’s application, would readily be able to determine the metes and bounds of this element found in claims 10 and 12. Accordingly, we will not sustain the rejection of claims 10 and 12 under 35 U.S.C. § 112, second paragraph, as being indefinite.

Some drafters affirmatively control the meaning of their claims by expressly referencing the standard or protocol “in effect on the filing date.

Claim 11 of U.S. Patent No. 9,945,005 provides:

11. The method according to claim 1 wherein the material is leached for a sufficient period of time that the residue after leaching meets the EPA TCLP limits according to EPA Test Method 1311 procedure in effect on the filing date of this application.

Claim 27 of U.S. Patent No. 7,043,402 provides:

27. The system of claim 20, wherein said electrical indication means is comprised of at least one of: (a) a serial communications port; (b) a bi-directional serial data bus chosen from among standards SAE/TMC J1708/J1587 protocol in effect on the filing date hereof, or SAE J1939 communications protocol in effect on the filing date hereof; (c) a CAN data bus; (d) a RF device; and/or (e) an IR device.

Claim 16 of U.S. Patent No. 6,889,385 provides:

16. The apparatus of claim 8 wherein said DOCSIS cable modem is compatible with any DOCSIS national standard for cable modems as of the filing date of the parent patent application of this patent application.

While claims referencing standards are not indefinite merely because the standard could be changed in the future, claim drafters still have to account for how infringement can be proved if the standard is in fact changed.

Marking Your Territory in Patent Claims

The use of trademarks in patent claims was previously discussed here. Trademarks continue to be used in patent claims, despite the potential for problems, not doubt because the trademark was seen as the best way to properly claim the invention. There is of course the concern that a trademark is indefinite, because the product can be changed at any time by the trademark owner. However changing meaning is a condition that can afflict any word in a claim, not just trademarks, granted changing meaning it is more likely with a trademark because it requires the action of a single person or entity, while changing the meaning of the work requires consensus.

Here are examples of trademarks recently used in patent claims:

AEROSIL– 10,154,954 (claim 2)

Android – 10,417,998 (claim 6), 10,417,008 (claim 6), 10,331,433 (claim 4).

ARSENSA – 10,154,954  (Claim 2)

Bluetooth – 10,420,011 (claim 9), 10,419,592 (claim 1), 10,365,866 (claim 10), 10,341,313 (claim 4), 10,321,516 (claim 6), 10,285,041 (claim 2), 10,027,169 (claim 7), 10,026,018 (claim 5), 9,998,996 (claim 7, 14), 9,955,515 (claim 8), 9,930,669 (claim 1), 9,912,794 (claim 1), 10,129,431 (claim 7, 16), 10,123,333 (claim 3, 14, 28), 10,019,852 (claims 2, 9,16), 9,980,059 (claims 1, 12, 23).

EPO-TEK – 10,330,233 (claim 17)

ETHERNET – 10,303,160 (claim 3,8)

Felica – 10,126,703 (claim 13)

Inconel – 10,392,728 (claim 10)

JAVA – 9,930,201 (claim 1)

JavaScript – 10,365,868 (claim 7)

Java Virtual Machine – 9,727,374 (claim 6)

Kahoot! 10,026,331 (claim 1)

KOVAR – 10,139,700 (claim 3)

Linux – 10,417,998 (claim 5), 10,417,008 (claim 5).

MIFARE – 10,126,703 (claim 13)

Monel – 10,392,728 (claim 10)

TRITON X – 10,254,276 (claim 5)

TWEEN – 10,254,276 (claim 5)

PARLEAM – 10,154,954 (claim 2)

QR Code – 10,223,625 (claim 5), 9,940,565 (claims 7, 10).

RLSA – 10,190,217 (claim 3), 10,017,853 (claim 7, 8)

SOFTISAN – 10,154,954 (claim 2)

VELCRO – 10,151,558  (claims 4, 7)

Vespel – 10,047,863 (claim 20)

VITRALI – 10,330,233 (claim 16)

Wi-Fi – 10,244,055 (claim 11), 10,044,903 (claims 6, 18), 10,129,431 (claims 6, 8, 17).

Wi-Fi Direct – 10,416,941 (claim 8), 10,342,071 (claim 12), 9,942,759 (claim 6).

Windows – 10,275,192 (claim 9).

ZIRCON – 10,240,814 (claims 1, 2, 9)

ZYLON – 10,201,999 (claim 8, 18)

Additional examples are relatively easy to find by search for the word trademark in the text of the claims, or searching for the R-in-the-circle symbol “.RTM.”

Although the meaning of a trademark can change over time, this is apparently understood by those of ordinary skill in the art, and rarely if ever is it necessary to specify that the meaning is determined “as of the filing date.”

Hope is not Enough to Create a Reasonable Expectation of Success

In OSI Pharmaceuticals, LLC v. Apotex Inc., [2018-1925] (October 4, 2019), the Federal Circuit reversed the PTAB’s determination that claims 44-46 and 53 of U.S. Patent No. 6,900,221 on the use of erlotinib on non smallcell lung cancer (NSCLC) would have been obvious because the Board’s finding of a reasonable expectation for success was not supported by substantial evidence.

The Board found that the disclosures in OSI’s own 10-K that erlotinib targeted a variety of cancers including NSCLC, and that erlotinib had entered Phase II clinical trials, would have provided a person of ordinary skill with a reasonable expectation of success in light of the other prior art references. The Board concluded that an ordinary artisan would under-stand from the commencement of Phase I studies referenced in the 10-K that “pre-clinical animal efficacy data” had been submitted to the FDA.

The Federal Circuit said that an obviousness determination requires finding that a person of ordinary skill in the art would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success in doing so. The Federal Cicuit said that when the references are properly read, the Board’s finding that the asserted references provide a reasonable expectation of success also is not supported by substantial evidence.

The Federal Circuit noted that the record does not contain any clinical (human) data or pre-clinical (animal) data. It did not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC. The Federal Circuit added that at the same time, it is undisputed that NSCLC treatment was highly unpredictable with an over 99.5% rate of failure for drugs entering Phase II clinical studies. On this record, the Federal Circuit was not persuaded that a reasonable fact finder could conclude that a person of ordinary skill would have reasonably expected success based on the combination of the references and OSI’s 10-K.

The Federal Circuit examined one reference (Gibbs) that said “these compounds appear to have good anti-cancer activity in preclinical models, with an acceptable therapeutic index, particularly in patients with non-small cell lung cancer. The Federal Circuit consulted the footnotes and conclude that the reference as a whole would not be understood by a person of ordinary skill in the art to refer to erlotinib, because the supporting article did not refer to erlotinib. The Federal Circuit said that the Board’s finding that there is a “clear inference” in Gibbs that “erlotinib has anti-cancer activity against non-small cell lung cancer” is thus not supported by substantial evidence.

On the specific issue of reasonable expectation of success the Federal Circuit found that the asserted references do not disclose any information about erlotinib’s efficacy in treating NSCLC in a mammal (in Scnhur and Gibbs). These references contained no data or other promising information regarding erlotinib’s efficacy in treating NSCLC, just cancer generally and this was not enough “because of the highly unpredictable nature of treating NSCLC.” With respet to OSI’s own 10-K the Board emphasized the 10-K’s statement that erlotinib had completed Phase I clinical trials, which require preclinical animal efficacy data. However, the Federal Circuit noted, there was nothing in OSI’s 10-K suggesting the existence of erlotinib preclinical efficacy data that is specific to NSCLC.

The Federal Circuit concluded that “[t]hese references provide no more than hope—and hope that a potentially promising drug will treat a particular cancer is not enough to create a reasonable expectation of success in a highly unpredictable art such as this.”

When They Came for My Software and Medicine, I did Nothing; “Monstrous” Law Now Targets Mechanical Arts

In American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, [2018-1763] (October 3, 2019), the Federal Circuit affirmed summary judgment that the asserted claims of U.S. Patent No. 7,774,911 on a method for manufacturing driveline propeller shafts designed to attenuate vibrations transmitted through a shaft assembly were ineligible under §101.

1. A method for manufacturing a shaft assembly of a driveline system, the driveline system further including a first driveline component and a second driveline component, the shaft assembly being adapted to transmit torque between the first driveline component and the second driveline component, the method comprising:
providing a hollow shaft member;
tuning at least one liner to attenuate at least two types of vibration transmitted through the shaft member; and
positioning the at least one liner within the shaft member such that the at least one liner is configured to damp shell mode vibrations in the shaft member by an amount that is greater than or equal to about 2%, and the at least one liner is also con-figured to damp bending mode vibrations in the shaft member, the at least one liner being tuned to within about ±20% of a bending mode natural frequency of the shaft assembly as installed in the driveline system.

Two types of attenuation were involved — resistive attenuation and reactive attenuation. Resistive attenuation of vibration employs something that deforms as vibration energy is transmitted through it absorbing the vibration energy. Reactive attenuation of vibration refers to a mechanism that can oscillate in opposition to the vibration energy to thereby ‘cancel out a portion of the vibration energy.

The analysis of § 101 follows the Supreme Court’s two-step test established in Mayo and Alice, asking first whether the claims are directed to a law of nature, natural phenomenon, or abstract idea, and second whether the claims embody some “inventive concept”—i.e., whether the claims contain “an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.

The claims are directed to tuning liners—i.e., controlling a mass and stiffness of at least one liner to configure the liner to match the relevant frequency or frequencies. It was known that vibrations could be damped by resistive attenuation and that bending mode vibrations could be damped by reactive attenuation. the selection of frequencies for the liners to damp the vibrations of the propshaft at least in part involves an application of Hooke’s law. The problem, the Federal Circuit found, was that the solution to these desired results is not claimed in the patent.

The elements of the method here that AAM argues take the patent outside the realm of ineligible subject matter i.e., the mechanisms for achieving the desired result—are not actually claimed in the claims. The Federal Circuit noted that “the patent specification recites only a nonexclusive list of variables that can be altered to change the frequencies exhibited by a liner and a solitary example of a tuned liner (though not the process by which that liner was tuned).” “Most significantly,” the Federal Circuit said, the claims do not instruct how the variables would need to be changed to produce the multiple frequencies required to achieve a dual-damping result, or to tune a liner to dampen bending mode vibrations.

The Federal Circuit said that this case might well be significantly different, if, for example, specific models were included in the claims. But, the claims’ general instruction to tune a liner amounts to no more than a directive to use one’s knowledge of Hooke’s law, and possibly other natural laws, to engage in an ad hoc trial-and-error process of changing the characteristics of a liner until a desired result is achieved. The Federal Circuit said that this claiming of a natural law runs headlong into the very problem repeatedly identified by the Supreme Court in its cases shaping eligibility analysis.

Citing Parker v. Flook, the Federal Circuit said “if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is nonstatutory.” In contrast, the Federal Circuit noted that in Diamond v. Diehr, the claims recited other steps apparently adding to the formula something that in terms of patent law’s objectives had significance—they transformed the process into an inventive application of the formula.

The Federal Circuit concluded that the claims here simply instruct the reader to tune the liner—a process that, as explained above, merely amounts to an application of a natural law (Hooke’s law) to a complex system without the benefit of instructions on how to do so. The focus of the claimed advance here is simply the concept of achieving that result, by whatever structures or steps happen to work. Thus the subject matter of the claims was not patent eligible.

Judge Moore dissented, observing that “[t]he majority opinion parrots the Alice/Mayo two-part test, but reduces it to a single inquiry: If the claims are directed to a law of nature (even if the court cannot articulate the precise law of nature) then the claims are ineligible and all evidence of non-conventionality will be disregarded or just plain ignored.” Judge Moore quoted the majority that “it makes no difference to the section 101 analysis whether the use of liners to attenuate bending mode vibration was known in the prior art,” saying that this disregarded the second part of the Mayo test.

Judge Moore argues that the majority’s concern with the claims at issue had “nothing to do with a natural law and its preemption and everything to do with concern that the claims are not enabled.” Respectfully, there is a clear and explicit statutory section for enablement, § 112. We cannot convert § 101 into a panacea for every concern we have over an invention’s patentability, especially where the patent statute expressly addresses the other conditions of patentability and where the defendant has not challenged them.”

Judge Moore was also concerned that the natural law two which the claims were supposedly directed, was never identified, saying “Section 101 is monstrous enough, it cannot be that now you need not even identify the precise natural law which the claims are purportedly directed to.”

Judge Moore also took exception to the majority’s rejection of the inventive concepts asserted by the patentee, first as inaccurate (a fact finding made by the majority on appeal and contrary to all the evidence of record) and second as irrelevant. Judge Moore said that “[u]ltimately, the majority says the inventive concept “makes no difference to the section 101 analysis” — a statement she takes to be an outright rejection of the second step of the Alice/Mayo test.

Judge Moore concludes that “[t]he majority’s true concern with these claims is not that they are directed to Hooke’s Law (because this is clearly a much more complex system not limited to varying mass and stiffness), but rather the patentee has not claimed precisely how to tune a liner to dampen both bending and shell mode vibrations.” Thus the issue was really not one of eligibility, but rather one of enablement. She said: “[a] patentee’s failure to enable his invention renders the claims invalid under § 112, it does not, however, render the claims ineligible under § 101.

Judge Moore finishes: “The majority’s validity goulash is troubling and inconsistent with the patent statute and precedent. The majority worries about result-oriented claiming; I am worried about result-oriented judicial action. I dissent.”

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