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November 13, 2020by Richard Treanor

On November 9, 2020, the Patent Trial and Appeal Board issued a decision in Ex parte Tramontano et al. (Appeal 2020-002413) in which a misplaced claim interpretation/35 U.S.C. 112 argument distracted the Board from finding clear error in the Examiner’s obviousness rejection.

In Tramontano Claim 25, relating to the formation of a gel at a tissue treatment site, was the representative claim:

25. A process for forming a gel comprising:

forming an oxidized cellulose solution;

forming a precipitating composition; and

contacting the oxidized cellulose solution and the precipitating composition at a tissue treatment site thereby precipitating oxidized cellulose from the oxidized cellulose solution and forming the gel.

As explained in the Tramontano specification, the claimed gel may be used as an adhesive to seal tissue and/or to provide for the delivery of bioactive agents ([0274]).

During prosecution, the Examiner concluded that it would have been obvious to a person of ordinary skill in the art to substitute the cellulose ether used as the polymer in the cross-linked gels taught by Gehrke, with oxidized cellulose as taught by Blaskovich, at a tissue treatment site, as taught by Hubbard. In their Appeal Brief Appellants argued, among other things, that none of the cited references disclosed their claimed “precipitating composition” and, in response to a statement made by the Examiner in the Advisory Action (“it is not clear what the precipitation composition ….comprises”) argued to the Board that the lack of a 35 U.S.C. 112 rejection meant that the claim term “precipitation composition” was definite. Appellants further provided the Board with a legal framework for determining the meaning of a claim term, and argued that the references did not disclose the use of a “precipitating composition” as properly understood under their framework.

In affirming the rejection the Board first felt “obliged to make several initial points,” constituting over four full pages of their nine page analysis, the first of which was to correct Appellants’ legal framework for determining the meaning of a claim term, and the second of which was to apply the correct standard and find that the Blaskovich reference did indeed disclose the use of a “precipitating composition.” In coming to this conclusion and affirming the rejection, the Board characterized Appellants’ arguments regarding definiteness as “largely irrelevant” in view of the acknowledged fact that no 35 U.S.C. 112, second paragraph, rejection was at issue.

In Tramontano, the Board was clearly distracted (and perhaps irritated) by Appellants’ unnecessary arguments regarding definiteness to the point that Appellants’ other, stronger, arguments were ignored. In this regard, one of the applied references, Hubbard, was cited as teaching the delivery of oxidized cellulose, in gel form, to a tissue site. However, while Appellants argued that the combined references failed to suggest contacting an oxidized cellulose solution and a precipitating composition at a tissue treatment site, thereby forming the gel at the treatment site as claimed, this argument was not specifically addressed by the Board. Instead, the Board emphasized the presence of a “precipitating composition” and “oxidized cellulose solution” in the Gehrke and Blaskovich references.

Takeaways:  The Tramontano case illustrates the importance of leading with the best arguments and focusing the Appeal Brief on issues of clear error in the rejections of record. In addition, the Tramontano case provides us with a reminder to review claims for the presence of unnecessary steps, such as the “forming” steps in Claim 25 above. Such unnecessary steps can provide infringers with the possible defense of “divided infringement” if third parties perform certain steps within a claimed method.

25. (Amended) A process for forming a gel comprising:

forming an oxidized cellulose solution;

forming a precipitating composition; and

contacting the an oxidized cellulose solution and the a precipitating composition at a tissue treatment site thereby precipitating oxidized cellulose from the oxidized cellulose solution and forming the gel.

Judges: Prats, Katz, New


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October 9, 2020by Matthew Barnet

U.S. patent claims usually contain the term “comprising.” This term indicates that an item in the claim must include certain specified components, but that the item also may include other, unspecified components. Alternatively, patent claims sometimes contain the term “consisting of.” This term indicates that an item in the claim is closed to unspecified components.

In between the open term “comprising” and the closed term “consisting of” is the term “consisting essentially of.” This semi-closed term indicates that an item in the claim is limited to the components specified in the claim “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52 (CCPA 1976) (emphasis in original).

The semi-closed nature of “consisting essentially of” sometimes is attractive during patent prosecution. For example, if the prior art discloses the combination of components A, B and C, it might be difficult to distinguish a patent claim with an item comprising components A and B since the item is open to the unspecified component C by virtue of the open term “comprising.” Amending the claim so that the item consists of components A and B (rather than comprises components A and B) might distinguish the claim from the prior art, if the prior art requires component C. However, such an amended claim might be easy for a competitor to design around, simply by adding component D to components A and B in the competitor’s product. The term “consisting essentially of” can provide a middle ground, allowing a patent applicant to distinguish a claim from prior art without excessively narrowing the scope of the claim.

However, when using the term “consisting essentially of,” the patent applicant often must explain to the examiner what the “basic and novel characteristic(s)” of the claimed invention are, and why they would be “materially affect[ed]” if the claimed invention were to include an additional component from the prior art. This issue is illustrated in the recent Patent Trial and Appeal Board (“Board”) case of Ex parte Nakajima.

Claim 1 in Nakajima recited:

A method of modifying starch, comprising subjecting a powdery mixture consisting essentially of starch and water-soluble hemicellulose at a weight ratio of 95:5 to 80:20 to moist-heat treatment at 100 to 200°C.

The examiner rejected claim 1 as obvious over two references, Yoshino in view of Narimatsu. The examiner relied on Yoshino for a method of subjecting starch to moist-heat treatment. The examiner acknowledged that Yoshino did not disclose water-soluble hemicellulose, and relied on Narimatsu for this component. Narimatsu described mixing water-soluble hemicellulose as a powder with wheat flour and starch. The examiner took the position that it would have been obvious to combine the water-soluble hemicellulose of Narimatsu with the starch of Yoshino, and then to treat the mixture of hemicellulose and starch with moist heat.

The applicant argued that the combination of Yoshino and Narimatsu would require the presence of wheat flour along with water-soluble hemicellulose and starch. Because of this, the applicant argued that the combination of these references would not satisfy the requirement that the powdery mixture consist essentially of starch and water-soluble hemicellulose.

In particular, the applicant argued that the presence of wheat flour would materially affect the basic and novel characteristics of the claimed invention. The applicant identified the basic and novel characteristics of the claimed invention as suppression of swelling or disintegration of starch granules. The applicant explained that including wheat flour with starch and water-soluble hemicellulose would not lead to such suppression. This explanation was supported by experimental data, submitted in a declaration, showing that samples containing wheat flour did not show the same inhibitory effect on swelling and disintegration of starch granules that was observed in samples without wheat flour.

Since the presence of wheat flour would materially affect the basic and novel characteristics of the claimed invention, the applicant argued that wheat flour should be excluded by the “consisting essentially of” phrase.

In response, the examiner contended that it would have been obvious to combine the water-soluble hemicellulose of Narimatsu with the starch of Yoshino, without including the wheat flour of Narimatsu.

The Board sided with the applicant. The Board found that Narimatsu taught adding water-soluble hemicellulose to a mixture of wheat flour and starch, but did not teach or suggest adding water-soluble hemicellulose to starch alone. The Board agreed that the applicant had provided sufficient evidence that including wheat flour in the powdery mixture of claim 1 would materially affect the basic and novel properties of the claimed invention. Accordingly, the Board found wheat flour to be excluded by the “consisting essentially of” phrase, and reversed the obviousness rejection.

Takeaway: The transitional phrase “consisting essentially of” provides a middle-ground between the open “comprising” and the closed “consisting of” phrases. When using the phrase “consisting essentially of,” applicants should be prepared to identify, on the record, what the basic and novel characteristics of the claimed invention are. Applicants also should be prepared to provide a technical argument, possibly supported by experimental data, explaining why the basic and novel characteristics would be materially affected if the claimed invention were to include an additional component from the prior art.

Judges: Franklin, Snay, Ren


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September 24, 2020by Beau Burton

The term “comprising,” when used in the preamble of a claim, permits the inclusion of other elements or materials in addition to those specified in the claim. However, “‘comprising’ is not a weasel word with which to abrogate claim limitations.” Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337, 1343 (Fed.Cir.2007).

Ex parte Martino involved a claim that required “[a] hand held olfactory tester comprisinga single odorant chamber.” Decision on Appeal, Appeal No. 2020-001003, at 2 (P.T.A.B. Sept. 11, 2020) (non-precedential).

In rejecting the claim, the Examiner only presented prior art having a tester with a plurality of chambers. Yet, the Examiner argued that the claim was obvious because “the plurality of containers shown [in the prior art] also include a single container.” Id. at 6. According to the Examiner, the claims needed to recite that the tester consists of only a single chamber because the term “comprising” allowed for additional, unrecited elements.

The Applicant disagreed, because the claim explicitly required a single chamber. The Board sided with the Applicant.

The Board noted that “[t]he presumption raised by the term ‘comprising’ does not reach into each of the [elements] to render every word and phrase therein open-ended,” and must be read in view of the specification. Id. at 4. The Board then applied a two-step analysis. First, the Board found that the ordinary and customary meaning of the term “single” is “one and only one.” Next, the Board confirmed that the specification was consistent with this meaning. Here, the Board highlighted, among other things, that the specification differentiated prior art testers having a number of odorant chambers, described a housing  with “an odorant chamber,” and depicted a device with only one chamber. Consequently, the Board found that the term “comprising” in the preamble did not negate the meaning of “single” as understood by one in the art.

Without any prior art disclosing or otherwise suggesting a tester comprising a single chamber, the Board reversed the Examiner’s obviousness rejection.

Takeaway: The scenario in Martino is quite common because of the presumption to construe the term “comprising” to be nonexclusive and the tendency for some examiners to play wordsmith. Martino also shows that even when there is no ambiguity in the claim language, the Board may still consult the specification for consistency with the ordinary and customary meaning of a term like “single.” So, what other options are available if you want to claim a limited number (e.g., one) of an element but the specification permits a plurality? One option is to add a wherein clause that states, “wherein the [device, article, composition, etc.] comprises no more than one element.”

Judges: A. Fetting, U. Jenks, A. Shah


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June 29, 2020by Yanhong Hu

During patent examination, examiners must give claim terms “their broadest reasonable interpretation consistent with the specification.” MPEP 2111. The Patent Trial and Appeal Board (“Board”) emphasized the importance of correct application of the broadest reasonable interpretation standard in Ex parte Blum, reversing the examiner’s anticipation rejection because the examiner interpreted a key claim term in an unreasonably broad manner.