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October 9, 2020by Matthew Barnet1

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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October 5, 2020by Jacob Doughty

Ex parte Porro is a 2008 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) informative decisions. Ex parte Porro is indicated by the PTAB to be informative as to “Specification and claim requirements – 35 U.S.C. § 112… Written description… species-genus.”

According to the PTAB’s Standard Operating Procedure, “[i]nformative decisions set forth Board norms that should be followed in most cases, absent justification, although an informative decision is not binding authority on the Board.”

In Ex parte Porro, the BPAI considered whether a claim defining a recombinant yeast as having a coding region encoding an enzyme having “at least about 90% identity with SEQ ID NO: 11” was properly rejected for failing to comply with the written description requirement of 35 USC 112.

Independent claim 13 was at issue:

A method of generating ascorbic acid, comprising:

a) obtaining a recombinant yeast capable of converting an ascorbic acid precursor into ascorbic acid, wherein the yeast is functionally transformed with a coding region encoding L-galactose dehydrogenase (LGDH) enzyme having at least about 90% identity with SEQ ID NO: 11,

b) culturing the recombinant yeast in a medium comprising an ascorbic acid precursor, thereby forming ascorbic acid, and

c) isolating the ascorbic acid.

In rejecting the claim, the examiner asserted that the claim encompassed a set of coding regions/amino acids (90% identity with SEQ ID NO: 11) defined by the function of the encoded protein (LGDH). Applicant acknowledged that “90% identity with SEQ ID NO: 11” included approximately 3.4 x 1041 variants. The examiner found that the specification disclosed only a single LGDH sequence, derived from Arabidopsis thaliana. The examiner further noted a teaching in the prior art that an LGDH discovered in A. thaliana was, “as far as we know, the only plant dehydrogenase acting on a non-phosphorylated sugar.” The examiner concluded that, in view of the size of the genus and the lack of guidance in the specification and the prior art, a skilled artisan “would not have been able to envision a sufficient number of specific embodiments that meet the functional limitations of the claims.”

The BPAI agreed with the examiner. The BPAI noted particularly that the specification did not provide guidance regarding what structural features were responsible for the enzymatic activity of LGDH or describe what amino acid changes could be made in the wild-type sequence without affecting the enzymatic activity of the protein. The BPAI conceded that a skilled artisan could make libraries of SEQ ID NO: 11 variants and screen them to identify specific proteins that are at least 90% identical to SEQ ID NO: 11 and that have LGDH enzymatic activity – however, this was not sufficient to demonstrate possession of the claimed invention.

The BPAI indicated that the applicant could have described a representative number of functional variants, or it could have described structural features that are common to functional variants that distinguish them from the rest of the genus. But neither was done in this case. The BPAI noted that different inventions can be described in different ways, but a chemical genus must be described in some way that demonstrates to those of skill in the art that the applicant was in possession of the claimed genus at the time the application was filed.

The result in Ex parte Porro is reflected in Example 11 of the USPTO’s Written Description Training Materials. It should be noted, however, that the USPTO has indicated in its Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials that such materials are being revised at the time of this post.

Takeaway: When claiming a genus of structures defined by a nucleic acid or amino acid sequence, it is not necessary to describe any particular number of specific sequences. However, it must be apparent (e.g., to the examiner) that the inventor(s) grasped the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. This can be achieved through disclosure of sufficient number of species that are representative of the full scope of the genus or disclosure/demonstration of a structure-function correlation common to members of the genus. Of course, this is easier to do when drafting an application than when responding to a rejection.

Judges: Scheiner, Mills, Grimes


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October 2, 2020by Richard Treanor

On September 15, 2020, the Patent Trial and Appeal Board (PTAB) issued a decision in Ex parte Lebovich reversing the Examiner’s rejection of claims directed to a packaged food assembly that allows the consumer to see the package contents from all angles while still permitting substantial labeling of the package. While the Board found that the Examiner’s rejection did present a prima facie case of obviousness, it further determined that Appellant’s objective evidence of nonobviousness was sufficient to rebut the Examiner’s prima facie case.

Perhaps the most interesting aspects of the Lebovich case are Appellant’s successful presentation of several types of secondary considerations not often encountered in typical prosecution (i.e., commercial success, industry praise and recognition, and solving a long-felt, unmet need), and their successful assertion that the development of brand loyalty beyond what is typical for a staple food, and particularly for meat, attributable to their food assembly qualified as an “unexpected result.”

Takeaway: This “out of the box” thinking in Lebovich serves to remind us of the essentially limitless contours of the unexpected results analysis, and should encourage us to consider all aspects of a claimed invention – how it is used, stored, transported, etc. – during prosecution in order to increase our level of advocacy.

Judges: J. Smith, G. Best, J. Snay


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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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September 21, 2020by Yanhong Hu

A prima facie obviousness rejection combining multiple disclosures requires a reason to modify or combine the prior art to achieve the claimed invention with a reasonable expectation of success.  In Ex parte Liu (Appeal No. 2018-001645), the Patent Trial and Appeal Board (“Board”) reversed the Examiner’s obviousness rejections because the Board found teachings in the prior art references to be inconsistent such that there would not have been a reason to modify or combine the prior art in the manner as set forth in Appellant’s claims.


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September 18, 2020by Matthew Barnet

For a prior art reference to be properly used in an obviousness rejection, the reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). MPEP 2141.01(a), citing Bigio.


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September 14, 2020by Jacob Doughty

Ex parte Hicks is a 2007 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) informative decisions. Ex parte Hicks is indicated by the PTAB to be informative as to “Specification and claim requirements – 35 U.S.C. § 112… Enablement… Indefiniteness… scope.”


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September 10, 2020by Christopher Bayne

When considering the obviousness of ranges, it is a fundamental principle of U.S. patent law that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955).  Consequently, modifications to readily optimized parameters such as temperatures and concentrations disclosed in the prior art will generally not be patentable under Section 103.  Aller, 220 F.2d at 456.  Furthermore, a presumption of obviousness exists when ranges disclosed in the prior art overlap with the ranges of a claimed invention.  Seee.g.E.I. du Pont de Nemours & Company v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018). 


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September 7, 2020by Richard Treanor

On July 14, 2020, the Patent Trial and Appeal Board issued a decision in Ex parte Park (Appeal 2019-006050) in which a rejection over an overlapping prior art genus was determined to be insufficient to establish a prima facie case of obviousness under both a lead compound analysis and an obvious equivalents/overlapping genus analysis. In addition, the Examiner’s initial rejection of subject matter beyond the elected specie was determined to be a withdrawal of the election requirement.