PTAB Archives - Page 10 of 13

On September 30, 2020, the Patent Trial and Appeal Board (“Board”) issued a decision in Ex parte Drozdenko (Appeal No. 2020-001293) reversing an Examiner’s obviousness rejection for its erroneous applications of In re Rose, 220 F.2d 459 (CCPA 1955) and “design choice.”

Claim 1 at issue in Drozdenko is representative and stated:

A blade comprising:

an airfoil … including a body formed of an aluminum containing material;

a sheath … with a sandwich … including an outer adhesive layer adjacent the sheath, an intermediate [fabric] layer and an inner adhesive layer adjacent the body;

wherein said fabric layer is a woven fabric layer; and

wherein said woven fabric layer has holes that are less than .001 inch on average.

Decision on Appeal, Appeal No. 2020-001293, at 2 (P.T.A.B. Sept. 30, 2020) (non-precedential) (emphasis added).

Although the Examiner admitted that the prior art failed to disclose a fabric layer with holes less than 0.001 inch on average, the Examiner argued that “it would have been an obvious matter of design choice … to have [the] hole size claimed … such a modification would have involved a mere change in size of a component. A change in size is generally recognized as within the level of ordinary skill in the art.” Final Rej., at 4 (citing In re Rose) (emphasis added).

The Examiner’s rejection suffered two critical deficiencies. First, a finding of obvious design choice is precluded when the claimed structure and the function it performs are different from the prior art. See In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992). And in this case, the Appellant’s specification differentiated its woven fabric from the prior art scrim having larger holes.

Second, In re Rose applies to a change in the overall size of an article rather than the size of an individual component as explained by the Board below:

In Rose, the appellant argued that the claimed “lumber package” was large and required a lift truck for handling; whereas, the prior art packages (a package of relatively small pieces of lumber and a package of window screen frames) could be lifted by hand. The court held that “this limitation [(i.e., size and weight of the package)] is [not] patentably significant since it at most relates to the size of the article under consideration which is not ordinarily a matter of invention.

Here, in contrast, the Examiner does not propose a change in the overall size of the article under consideration (i.e., a blade (claim 1); an engine (claim 11)). Instead, the Examiner proposes changing the structure of Parker’s woven fabric (a scrim) to that of a tightly woven fabric having holes less than .001 inch on average, even though the Specification describes the tightly woven fabric as performing differently from a scrim.

Decision, at 3. Having failed to provide any other reason to substitute a woven fabric having holes that are less than 0.001 inch on average for the scrim described in the prior art, the Board declined to sustain the Examiner’s obviousness rejection.

Takeaways: The court in Rose did not address a modification in which the size of a particular component of an article is modified without a respective size change in the remaining components. Nevertheless, Rose is routinely misapplied to argue the obviousness of changing the size of a particular component analogous to Drozdenko. Thus, when Rose is applied in a rejection, the first step is to determine whether the resizing in question is for the entire article or only a component thereof. If it is the latter, then the Examiner’s reliance on Rose is misplaced.

Finally, to the extent that “design choice” may apply, the specification should be consulted to determine whether the change in size results in a difference in performance or function. A more detailed example of the “design choice” doctrine can be found here.

Judges: P. Kauffman, A. Reimers, T. Hutchings

侵害が主張されていないクレームを含むクレームについて、被告が無効の反訴をした場合、IPRがinstituteされうるか、という問題について判断した特許庁審判部の命令 (Order) が2020年9月2日に出ています (AMP Plus, Inc. (dba ELCO Lighting) v. DMF, Inc., Case IPR2019-01094)。

An examiner sometimes raises an obviousness rejection under the “design choice” doctrine, alleging a claimed feature, such as a certain dimension, shape, or arrangement, is merely a “design choice” that would have been obvious to a person of ordinary skill in the art. In Ex parte Elliott, the Patent Trial and Appeal Board (“Board”) considered the Examiner’s obviousness rejection based on “design choice” and reversed the rejection because the Board found the Examiner did not provide evidence or reasoning adequate to support such a determination and Appellant’s specification, on the other hand, presented evidence that the recited structure solved a stated problem.

Claim 1 was illustrative of the claims on appeal in Elliott and was directed to an edible animal chew that had a particular structure, including “an internal support structure comprising inner walls and at least three struts.”

The Examiner found the primary reference, Nie, disclosed an extruded animal chew and the secondary references, Heyman and Tintle, taught edible food products (such as ice cream cones and pasta) that included internal walls and struts. The Examiner thus concluded it would have been obvious to provide Nie’s extruded animal chew with internal walls and struts as taught in Heyman and Tintle “as a manufacturing choice for the design of the pet chew.”

The Board, however, agreed with the Appellant that “there is no teaching or suggestion in [Heyman or Tintle] that it would be desirable to provide the support structures disclosed therein in a dog chew.”

Citing In re Kuhle, in which the court found the use of a claimed feature would be an obvious matter of design choice when it “solves no stated problem” and “presents no novel or unexpected result” over the disclosed alternatives, the Board noted that “[d]esign choice may serve as a basis for obviousness where alternative elements or configurations in the prior art perform the same function as the claimed aspects with no unexpected results.” The Board further emphasized “[i]n the context of a rejection based on design choice, the relevant issue is whether the alleged differences between the claimed invention and the prior art ‘result in a difference in function or give unexpected results.’”

The Board found Appellant’s specification taught that the recited internal support structure had certain functions, such as increased chewing time and reduced calorie content, in that the specification explicitly described that the internal support structure within the edible chew “provides longer lasting time per gram of product.” Therefore, the Board found Appellant’s specification presented evidence that the recited structure solved a stated problem. By contrast, as noted by the Board, the Examiner failed to identify evidence or provide sufficient reasoning supporting his determination that the difference between Nie’s animal chew having no internal structure and Appellant’s claimed animal chew having the specified internal walls and struts would have been an obvious design choice.

Because Appellant’s specification presented evidence showing the claimed feature solved a stated problem while the Examiner merely presented a conclusory finding, the Board reversed the Examiner’s obviousness rejection based on “design choice.”

Takeaway: A critical issue in addressing an obviousness rejection based on “design choice” is whether a claimed feature and the function it performs solve a stated problem or are otherwise different from the prior art. As illustrated by Elliott, a disclosure in the specification of the benefits or results provided by a claimed feature of purported design choice could weigh against obviousness. Therefore, when drafting a patent application, an applicant should consider including possible results, advantages, and benefits of every inventive feature, when applicable, to address a potential obviousness rejection based on “design choice.”

Judges: D. M. Praiss, C. C. Kennedy, and J. R. Snay

U.S. patent examiners sometimes rely on the theory of inherency to fill gaps in the prior art. This usually occurs when patent claims recite structural limitations in combination with one or more properties. If the prior art describes the claimed structural limitations, but not the claimed properties, examiners often take the position that the claimed properties would be inherent in the structure of the prior art, even though the properties are not explicitly described in the prior art.

Under U.S. law, however, the mere possibility that the prior art possesses the claimed properties is insufficient to establish inherent anticipation or obviousness. Instead, to establish inherency, the examiner must provide a rationale that the claimed properties are necessarily present in the prior art.

This issue is illustrated in the recent Patent Trial and Appeal Board (“Board”) case of Ex parte Liu. The claims at issue recited:

A polymer composite composition comprising:

an eggshell component, wherein the eggshell component possesses a lipid-protein structure substantially similar to that of the eggshell from which the eggshell component is derived, and wherein the eggshell component is substantially free of eggshell inner membrane material; and

a polymer component.

The inventors discovered that an improved polymer composite could be produced by using an eggshell component possessing its original lipid-protein structure and being free of the inner membrane of the original eggshell. The original lipid-protein structure was thought to maintain the hydrophobicity of the eggshell component when dispersing the eggshell component as a powder into the polymer component.

The examiner rejected the claims as obvious over a combination of references. The primary reference (“New”) described separating pulverized eggshells from their attached membranes using airflow. A secondary reference (“Minagoshi”) described combining eggshell powders in polymeric rubber compositions. The examiner took the position that it would have been obvious to use the pulverized eggshells from New as the powder in Minagoshi, to obtain the claimed polymer composite composition.

The references did not specifically describe that the eggshell component possessed a lipid-protein structure substantially similar to that of the eggshell from which the eggshell component was derived, as recited in the claims. To fill this gap in the prior art, the examiner took the position that the eggshell powder produced in New would inherently retain the original lipid-protein structure. This position was based on New allegedly “using airflow without harsh chemicals or high temperatures” to separate the membrane from the eggshells. Since the reference was silent with respect to its processing temperature, the examiner took the position that it was performed at room temperature.

The applicant provided a declaration explaining that “[e]ggshell can be denatured at a relatively low temperature” and “temperatures above 41°C will break the interactions of many proteins and denature them.” The applicant acknowledged that New did not specifically disclose the temperature used in its process, but argued that the high-speed airflow in this process would result in a temperature above 41°C. Such a temperature would denature the eggshell, such that it would not possess the lipid-protein structure recited in the claim.

Thus, the examiner argued that New used a temperature below 41°C (resulting in a product meeting the claimed limitation), whereas the applicant argued that New used a temperature above 41°C (resulting in a product not meeting the claimed limitation).

Considering these conflicting arguments and evidence, the Board found the examiner’s inherency position untenable. The Board found that “it is uncertain what temperature New’s process suggests. The preponderance of the evidence of record, therefore, does not support a finding that New’s process inherently takes place at a temperature of less than 41°C.” The Board concluded that “[t]he evidence, therefore, also does not support a finding that New’s process necessarily results in an eggshell composition which possesses a lipid-protein structure substantially similar to that of the eggshell from which the eggshell component is derived,” as recited in the claims. Accordingly, the Board reversed the obviousness rejections.

To be clear, the Board did not find that New’s process was inherently performed at a temperature above 41°C, as applicant argued. Instead, the Board found that the evidence was inconclusive as to what temperature the process occurred. This uncertainty in temperature was the key to the Board’s decision on inherency. As the Board noted, “[i]nherency…may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient” (citing In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)). Even though it was possible that New’s process was performed at a temperature below 41°C, as alleged by the examiner, this possibility was insufficient to establish that the temperature inherently was below 41°C.

Takeaway: Inherency requires necessity, not merely possibility. That is, just because it might be possible for the prior art to satisfy a claimed property, that does not mean that the prior art necessarily satisfies the property. If the prior art does not necessarily satisfy the claimed property, then inherency has not been established. When there is conflicting evidence, some in support of a claimed property being present and some in support of a claimed property being absent, this conflict itself can support an argument against inherency.

Judges: Gaudette, Wilson, Range

Ex parte Chuang 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 Chuang is indicated by the PTAB to be informative as to “Anticipation – 35 U.S.C. § 102… cDNA.”

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 Chuang, the BPAI considered whether a claim reciting an isolated polypeptide was properly rejected as anticipated by prior art disclosing a cDNA encoding the recited polypeptide.

Independent claim 4 was at issue:

An isolated polypeptide, comprising the amino acid sequence of SEQ ID NO: 1.

In rejecting the claim, the examiner relied on prior art that disclosed isolation of a polynucleotide that encoded a polypeptide having 100% homology to SEQ ID NO: 1. While applicant conceded that, in the prior art, “[o]ne of the myriad cDNAs encodes an amino acid sequence identical to SEQ ID NO: 1,” it was undisputed that the claimed proteins were not physically created in the prior art. Relying on a prior BPAI decision (Lee v. Dryja, 79 U.S.P.Q.2d 1614 (B.P.A.I. 2005)), applicant asserted that disclosure of the cDNA at best rendered its encoded protein obvious – “the fact that a novel product can be readily made does not render the product not novel.”

The BPAI disagreed, stating that an invention need not have been actually made in the prior art for disclosure of such invention to be enabling. The BPAI noted that applicant did not dispute that the prior art was enabling for expression of the claimed polypeptide, and further distinguished over its prior decision in Lee v. Dryja. The BPAI pointed out that, in Lee v. Dryja, the issue was whether a party was in possession of a single enabled embodiment and, further, there was evidence in Lee v. Dryja that the disclosed nucleotide sequence did not, in fact, express the protein at issue.

The BPAI affirmed the examiner’s anticipation rejections and noted that there is no “generic rule that cDNAs cannot anticipate proteins.”

Takeaway: This case provides insight into how the USPTO has viewed the relationship between nucleotide sequences and the polypeptides they encode in the context of identifying enabling prior art. It is apparent that the BPAI would have required some evidence of obstacles preventing a skilled artisan from navigating from the disclosed cDNA to the claimed isolated polypeptide to reverse the examiner’s rejections. Of course, this case predates the Supreme Court’s recent eligibility jurisprudence, including Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), which likely would have even further complicated applicant’s quest for enforceable patent rights.

Judges: Grimes, Lebovitz, Fredman

A threshold issue in the context of double patenting is whether the applications/patents in question have (i) at least one common applicant, and/or are (ii) commonly assigned/owned or (iii) non-commonly assigned/owned but subject to a joint research agreement. See M.P.E.P. § 804.

On September 30, 2020, the Patent Trial and Appeal Board (“Board”) issued a decision in Ex parte Bayer CropScience NV reversing nonstatutory obviousness-type double patenting rejections issued against U.S. Patent No. 5,561,236 (“the Leemans `236 patent”), because the Examiner construed the phrase “commonly owned” to include different assignees that are wholly-owned subsidiaries of a common owner.[1]

The Examiner issued two sets of nonstatutory obviousness-type double patenting rejections against the Leemans `236 Patent—(a) double patenting rejections over U.S. Patent No. 5,273,894 (“the Strauch `894 patent”), and (b) double patenting rejections over U.S. Patent No. 5,276,268 (“the Strauch `268 patent”). Throughout the decision, the Board refers to the Strauch `894 patent and the Strauch `268 patent collectively as “the Strauch patents.”

It was undisputed by the parties that the Leemans `236 patent is currently co-assigned to both Bayer CropScience NV and Biogen Idec NA Inc., and that the Strauch patents are currently assigned to Bayer Cropscience AG—as illustrated below. It was also undisputed that the subject matter claimed in the Leemans `236 and Strauch patents is overlapping.

Although the parties agreed that the Leemans `236 and Strauch patents do not have any inventors in common, the Examiner determined that—because Bayer CropScience NV and Bayer CropScience AG are wholly-owned subsidiaries of Bayer AG—Bayer AG is a “common owner” of the Leemans `236 and Strauch patents.

The Board disagreed with the Examiner’s finding that the Leemans `236 and Strauch patents are “commonly owned” and, instead, agreed with the Patent Owners of the Leemans `236 patent that Bayer CropScience NV and Bayer CropScience AG are “two separate and independent companies.”

Citing earlier decisions by the US Supreme Court, the Federal Circuit and several District Courts, the Patent Owners argued that under U.S. law “a parent company does not own or have legal [title] to its subsidiary’s patents even when the subsidiary company is incorporated in a U.S. jurisdiction.” The Board agreed that the cases cited by the Patent Owners—including cases dealing with “choice of law”—are highly relevant to determining whether the Leemans `236 and Strauch patent are “commonly owned.”

In response to arguments made by the Examiner based on the policy justifications undergirding obviousness-type double patenting, the Board pointed out that the Federal Circuit in a related case found that the policy justifications underlying obviousness-type double patenting alone do not warrant a conclusion that the Leemans `236 and Strauch patent are “commonly owned” by Bayer AG. As explained by the Board,

Thus, for similar reasons to those relied upon in the Dow arbitration decision, the legal authority and evidence Patent Owners rely on to support their position that an overlap in ownership does not exist between the Leemans ’236 and Strauch patents is more persuasive than the Examiner’s public policy justification. We are not persuaded that Bayer AG’s alleged “beneficial ownership” of the Leemans ’236 and Strauch patents alone is sufficient to render the Leemans ’236 and Strauch patents “commonly owned” for the purposes of obviousness-type double patenting. Nor are we persuaded that the underlying policy justifications for obviousness-type double patenting show common ownership.

Judges: R.M. LIBOVITZ, R-L.P. GUEST and J.E. INGLESE (Opinion by INGLESE)

[1] See also related Ex parte Bayer Cropscience NV and Ex parte Bayer Cropscience NV issued by the Board on September 30, 2020.

On September 29, 2020, the Patent Trial and Appeal Board (“Board”) issued a decision in Ex parte Brinhaus (Appeal No. 2019-006794) and reversed an Examiner’s obviousness rejection for failing to consider the prior art as a whole.

At issue in Ex parte Brinhaus were the requirements in independent claims 1 and 11 for “a bismuth nitrate crosslinking catalyst consisting of a water-insoluble basic bismuth nitrate” and “wherein the water-insoluble basic bismuth nitrate is the only metal nitrate.”

The prior art relied on by the Examiner mandated the presence of “at least one water-soluble metal nitrate” and differentiated prior compositions that included water-insoluble organic nitrates and/or nitrates. See U.S. Patent No. 7,211,182 (“the ‘182 patent”), col. 2, ll. 14–40. Thus, the prior art was clearly focused on the use of water-soluble nitrates and their benefits relative to water-insoluble nitrates.

Paradoxically, when describing the preferred water-soluble metal nitrates, the prior art apparently included a water-insoluble metal nitrate– Bi₅O(OH)₉(NO₃)₄:

The metal nitrates are selected from among the water-soluble nitrates of metals from the group consisting of metals of atomic numbers 20 to 83, wherein chromium, arsenic, rubidium, ruthenium, rhodium, palladium, cadmium, antimony, caesium, osmium, iridium, platinum, mercury, thallium and lead are excepted.… Preferred nitrates are those of titanium, vanadium, iron, zinc, yttrium, zirconium, tin, cerium, neodymium or bismuth, in particular of yttrium, neodymium or bismuth, especially of bismuth. Examples of bismuth nitrates are Bi(NO₃)₃and Bi₅O(OH)₉(NO₃)₄.

The ’182 patent, col. 3, l. 55–col. 4, l. 3 (emphasis added). According to the Examiner, this was sufficient to present a case of obviousness despite the claims stating that “the water-insoluble basic bismuth nitrate is the only metal nitrate.”

On balance, the Board found the Examiner’s position untenable because the prior art “as a whole, so strongly emphasizes use of a water-soluble nitrate … that a person of ordinary skill in the art would not have understood the last sentence of this paragraph as teaching or suggesting use of water-insoluble Bi₅O(OH)₉(NO₃)₄ as a sole metal nitrate.” Consequently, the Board reversed the Examiner’s obviousness rejection.

Takeaway: It is important to confirm that the portions of the prior art cited by the Examiner are not taken out of context and are consistent with the prior art as a whole. Occasionally, an isolated passage of a prior art reference may be inconsistent with its broader teachings. This is why a basic tenet of patent law is that the prior art must be considered in its entirety, including any portions that diverge from the claimed invention. See, e.g., In re Fine, 837 F.2d 1071, 1075 (Fed. Cir. 1988) (“One cannot use hindsight reconstruction to pick and choose among isolated disclosures in the prior art to deprecate the claimed invention.”); In re Dow Chemical Co., 837 F.2d 469, 473 (Fed. Cir. 1988) (“The full field of the invention must be considered … including that which might lead away from the claimed invention.”); W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983) (“In its consideration of the prior art, however, the district court erred … in considering the references in less than their entireties, i.e., in disregarding disclosures in the references that diverge from and teach away from the invention at hand.”).

Judges: T. Ownes, J. Snay, B. Range

It is well-settled that if a proposed modification or combination of prior art would change the principle of operation of the prior art invention being modified, the teachings of the references are not sufficient to render the claims prima facie obvious. In Ex parte Binder (Appeal No. 2019-003108), the Patent Trial and Appeal Board (“Board”) reversed the Examiner’s obviousness rejection on the ground that the Examiner’s proposed modification changed the principle of operation of the primary reference.

The subject matter disclosed in the application at issue related to “electric shavers having electronic imaging functions.” Claim 1 was illustrative of the claims on appeal and was drawn to a handheld device “for capturing and displaying images and for identifying an element in the images.” The claimed device included, among other components, “a first digital camera for capturing a first image,” “a second digital camera for capturing a second image distinct from the first image,” and “a digital image processor coupled to the digital cameras for receiving the digital signals for receiving and processing the captured images.” Further, the digital image processor identified the element in the captured images “using pattern recognition.”

The Examiner relied primarily on Oswald, which described a mobile communication device having two video cameras, for the claimed device. The Examiner admitted that Oswald did not disclose the image identification was accomplished “using pattern recognition.” However, the Examiner introduced Doughty, which described 3D image correlation photogrammetry, and argued it would have been obvious to “modify” Oswald to use Doughty’s pattern recognition technique to “determine strain fields on the skin surface” and to “quickly and conveniently apply a removable pattern.”

The Board disagreed. The Board first found Oswald explicitly described in the specification and illustrated in the figures that the two video cameras were on opposite sides of the device and pointed in opposite directions. The Board further noted Oswald taught the first camera was used to track the user “in real-time to determine their body and facial movement” while the second camera was pointing in the “direction as the movement of the user.” Therefore, the two cameras of Oswald’s device not only were directed at opposite directions but were focused upon different objects. The mobile device described in Oswald thus could be used to “allow a reporter to capture a sequence of images of the scene, and simultaneously capture a sequence of images of himself or herself describing the scene.” By contrast, as noted by the Board, the dual cameras’ focus in the technique depicted in Doughty was in the same general direction and was upon the same object to achieve a 3D representation of the object for strain measurement purposes. Accordingly, the Board found combining Oswald’s apparatus with Doughty’s pattern recognition teachings “in order to determine strain fields on the skin surface” as alleged by the Examiner would require both of Oswald’s cameras to focus in essentially the same direction and upon the same object, which contradicted Oswald’s teaching that the two cameras faced in opposite directions and were upon different objects.

Therefore, the Board found the Examiner’s alleged modification would change the principle of operation of Oswald and agreed with the Appellant that the Examiner relied on an “improper rationale for combining [] the Oswald and Doughty references.” Consequently, the Board reversed the Examiner’s obviousness rejection.

Takeaway: When an Examiner relies on a secondary reference for a feature missing from a primary reference in an obviousness rejection, she tends to use the benefits or advantages described in the secondary reference to justify her reliance on the secondary reference. Under such circumstances, it is important to investigate what is the underlying reason described in the secondary reference that leads to the identified benefits and to compare it with the principle of operation described in the primary reference. As illustrated by Binder, if the underlying reason contradicts and thus would change the principle of operation of the primary reference, no prima facie case of obviousness is established.

Judges: J. C. Kerins, M. L. Hoelter, and A. R. Reimers

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

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.”

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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