The limitations of a “wherein” clause

Adele Critchley | October 15, 2019

Allergan Sales, LLC v. Sandoz, Inc., No. 2018-2207

August 29, 2019

Prost, Newman and Wallach.  Opinion by Wallach


Appellees (Allergan hereon in) sued Appellants (Sandoz hereon in) asserting that their Abbreviated New Drug Application (ANDA) for a generic version of Allergan’s ophthalmic drug (Combigan®) infringed on their U.S. Patent Nos. 9,770,453: 9,907,801: 9,907,802. The District Court found limiting a number of “wherein” clauses in the Patents’ and granted Allergan’s motion for Preliminary Injection. Sandoz appealed. CAFC affirmed.

As an exemplary claim, independent claim 1 of the ‘453 patent is as follows:

A method of treating a patient with glaucoma or ocular hypertension comprising topically administering twice daily to an affected eye a single composition comprising 0.2% w/v brimonidine tartrate and 0.68% w/v timolol maleate,

wherein the method is as effective as the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day and

wherein the method reduces the incidence of one o[r] more adverse events selected from the group consisting of conjunctival hyperemia, oral dryness, eye pruritus, allergic conjunctivitis, foreign body sensation, conjunctival folliculosis, and somnolence when compared to the administration of 0.2% w/v brimonidine tartrate monotherapy three times daily.

The specifications contained a clinical study, referred to as Example II, and it is the results thereof that are reflected in “the disputed “wherein” clauses (i.e., the efficacy and safety of the claimed combination).

Allergan argued that the “wherein” clauses were limiting, whereas Sandoz argued that the “wherein” clauses were not. Specifically, Sandoz argued that the “wherein” clauses “merely state the intended results” and so are not “material to patentability.” Sandoz argued that the only positive limitation in the claim[s] is the administering step. Sandoz relied upon previous cases to argue that “…whereby [or wherein] clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”); Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001).

The District Court and CAFC disagreed. The courts looked to the specification, and to the prosecution history wherein the Applicant had relied upon the results of administering the combination drug to assert patentability over the prior art. It was also noted that the Examiner had explicitly relied upon the “wherein” clauses in his explanation as to why the claims were novel and non-obvious over the prior art in the Notice of Allowance. 

The courts differentiated this case from the previous case argued by Sandoz in that, “In Bristol–Myers we expressly noted that the disputed claim terms “w[ere] voluntarily made after the examiner had already indicated . . . the claims were allowable” and such “unsolicited assertions of patentability made during prosecution do not create a material claim limitation.”

Accordingly, “the District Court “f[ound] that the ‘wherein’ clauses are limiting because they are material to patentability and express the inventive aspect of the claimed invention” and the CAFC affirmed.


“The specification is always highly relevant to the claim construction analysis and is, in fact, the single best guide to the meaning of a disputed term.” Prosecution history and the Examiner’s express rational for allowance are also highly relevant.


Sung-Hoon Kim | October 7, 2019

Curver Luxembourg, SARL, v. Home Expressions Inc.

September 12, 2019

Chen (author), Hughes, and Stoll


The Federal Circuit affirmed the district court’s grant of a defendant’s motion to dismiss a complaint for failure to state a plausible claim of design patent infringement because when all of the drawings in a design patent at issue do not describe an article of manufacture for the ornamental design, the title, claim language, figure descriptions specifying an article of manufacture, which was amended during the prosecution of the patent based on the Examiner’s proposed amendment, can limit the scope of a design patent.


The ‘946 Patent

            Curver Luxembourg, SARL (Curver) is the assignee of U.S. Design Patent No. D677,946 (‘946 patent) with a title “Pattern for a Chair” and claiming an “ornamental design for a pattern for a chair.”  The ‘946 patent claims an overlapping “Y” design, as shown below.  However, none of the figures illustrate a design being applied to a chair.


            Curver originally applied for a patent directed to a pattern for “furniture,” and the original title was “FURNITURE (PART OF-).”  The original claim recited a “design for a furniture part.” 

            However, during the prosecution, the Examiner allowed the claim but objected to the title because it was too vague to constitute an article of manufacture (in Ex Parte Quayle Action).  The Examiner suggested amending the title to read “Pattern for a Chair,” and Curver accepted the Examiner’s suggestion by replacing the title with “Pattern for a Chair” and amending the claim term “furniture part” with “pattern for a chair.”  Curver did not amend the figures to illustrate a chair.  The Examiner accepted Curver’s amendments and allowed the application. 

District Court

            Home Expressions makes and sells baskets with a similar overlapping “Y” design disclosed in the ‘946 patent.

            Curver sued Home Expressions accusing its basket products of infringing the ‘946 patent.  Home Expressions filed a motion to discuss Curver’s complaint under Rule 12(b)(6) for failing to set forth a plausible claim of infringement.

            Using a two-step analysis, the district court construed the scope of the ‘946 patent to be limited to the design pattern illustrated in the figures as applied to a chair and found that an ordinary observer would not purchase Home Expressions’s basket with “Y” design believing that the purchase was for “Y” design applied to a chair.

            Therefore, the district court granted the Rule 12(b)(6) motion.


            The CAFC held that to define the scope of a design patent, the court traditionally focused on the figures illustrated in the patent.  However, when all of the drawings fail to describe an article of manufacture for the ornamental design, the CAFC held that claim language specifying an article of manufacture can limit the scope of a design patent. 

            In addition, the CAFC uses §1.153(a) to held that “the design be tied to a particular article, but this regulation permits claim language, not just illustration along, to identify that article.”

The title of the design must designate the particular article. No description, other than a reference to the drawing, is ordinarily required. The claim shall be in formal terms to the ornamental design for the article (specifying name) as shown, or as shown and described.

            The CAFC held that the prosecution history shows that Curver amended the title, claim, figure descriptions to recite “pattern for a chair” in order to satisfy the article of manufacture requirement necessary to secure its design patent.  Therefore, the CAFC held that the scope of the ‘946 patent should be limited by those amendments.

            Therefore, the CAFC affirmed the district court’s grant of Home Expressions’s motion to dismiss the complaint for failure to state a plausible claim of design patent infringement.         


  • When figures in a design patent do not clearly show an article of manufacture for the ornamental design, the title and claim language can limit the scope of the design patent.
  • Applicant should review the Examiner’s proposed amendments carefully before placing the application in condition for allowance.
  • Applicant should be careful when crafting the title and claim language.

A Good Fry: Patent on Oil Quality Sensing Technology for Deep Fryers Survives Inter Partes Review

Cindy Chen | October 4, 2019

Henny Penny Corporation v. Frymaster LLC

September 12, 2019

Before Lourie, Chen, and Stoll (Opinion by Lourie)


In an appeal from an inter partes review, the Federal Circuit affirmed the Patent Trial and Appeal Board’s decision to uphold the validity of a patent relating to oil quality sensing technology for deep fryers. The Board found, and the Federal Circuit agreed, that the disadvantages of pursuing the challenger’s proposed modification of the prior art weighed against obviousness, in the absence of some articulated rationale as to why a person of ordinary skill in the art would have pursued that modification. In addition, the Federal Circuit reiterated that as a matter of procedure, the scope of an inter partes review is limited to the theories of unpatentability presented in the original petition.   


Fries are among the most common deep-fried foods, and McDonald’s fries may still be the most popular and highest-consumed worldwide. But, there would be no McDonald’s fries without a deep fryer and a good pot of oil, and Frymaster LLC (“Frymaster”) is the maker of some of McDonald’s deep fryers.

During deep frying, chemical and thermal interactions between the hot frying oil and the submerged food cause the food to cook. These interactions degrade the quality of the oil. In particular, chemical reactions during frying generate new compounds, including total polar materials (TPM), that can change the oil’s physical properties and electrical conductivity.

Frymaster’s fryers are equipped with integrated oil quality sensors (OQS), which monitor oil quality by measuring the oil’s electrical conductivity as an indicator of the TPM levels in the oil. This sensor technology is embodied in Frymaster’s U.S. Patent No. 8,497,691 (“691 patent”).

The 691 patent describes an oil quality sensor that is integrated directly into the circulation of cooking oil in a deep fryer, and is capable of taking measurements at the deep fryer’s operational temperatures of 150-180°C, i.e., without cooling the hot oil. 

Claim 1 of the 691 patent is representative:

1. A system for measuring the state of degradation of cooking oils or fats in a deep fryer comprising:

at least one fryer pot;

a conduit fluidly connected to said at least one fryer pot for transporting cooking oil from said at least one fryer pot and returning the cooking oil back to said at least one fryer pot;

a means for re-circulating said cooking oil to and from said fryer pot; and

a sensor external to said at least on[e] fryer pot and disposed in fluid communication with said conduit to measure an electrical property that is indicative of total polar materials of said cooking oil as the cooking oil flows past said sensor and is returned to said at least one fryer pot;

wherein said conduit comprises a drain pipe that transports oil from said at least one fryer pot and a return pipe that returns oil to said at least one fryer pot,

wherein said return pipe or said drain pipe comprises two portions and said sensor is disposed in an adapter installed between said two portions, and

wherein said adapter has two opposite ends wherein one of said two ends is connected to one of said two portions and the other of said two ends is connected to the other of said two portions.

Figure 2 of the 691 patent illustrates the structure of Frymaster’s system: 

Henny Penny Corporation (HPC) is a competitor of Frymaster, and initiated an inter partes review of the 691 patent.

In its petition, HPC challenged claim 1 of the 691 patent as being obvious over Kauffman (U.S. Patent No. 5,071,527) in view of Iwaguchi (JP2005-55198). 

Kauffman taught a system for “complete analysis of used oils, lubricants, and fluids”. The system included an integrated electrode positioned between drain and return lines connected to a fluid reservoir. The electrode measured conductivity and current to monitor antioxidant depletion, oxidation initiator buildup, product buildup, and/or liquid contamination. Kauffman’s system operated at 20-400°C. However, Kauffman did not teach monitoring TPMs.

Iwaguchi taught monitoring TPMs to gauge quality of oil in deep fryers. However, Iwaguchi cooled the oil to 40-80°C before taking measurements. If the oil temperature was outside the disclosed range, Iwaguchi’s system would register an error. Specifically, oil was diverted from the frying pot to a heat dissipator where the oil was cooled to the appropriate temperature, and then to a detection vessel where a TPM detector measured the electrical properties of the oil to detect TPMs. Iwaguchi taught that cooling relieved heat stress on the detector, prevented degradation, and obviated the need for large conversion tables.

The parties’ dispute focused on the sensor feature of the 691 patent.

In the initial petition, HPC argued simply that a person of ordinary skill in the art would have found it obvious to modify Kauffman’s system to “include the processor and/or sensor as taught by Iwaguchi.”

In its patent owner’s response, Frymaster disputed HPC’s proposed modification. Frymaster argued that Iwaguchi’s “temperature sensitive” detector would be inoperable in an “integrated” system such as that taught in Kauffman, unless Kauffman’s system was further modified to add an oil diversion and cooling loop. However, such an addition would have been complex, inefficient, and undesirable to those skilled in the art.

In its reply, HPC changed course and argued that it was unnecessary to swap the electrode in Kauffman’s system for Iwaguchi’s detector. HPC argued that Kauffman’s electrode was capable of monitoring TPMs by measuring conductivity, and that Iwaguchi was relevant only for teaching the general desirability of using TPMs to assess oil quality.

However, whereas HPC’s theory of obviousness in its original petition was based on a modification of the physical structure of Kauffman’s system, HPC’s reply proposed changing only the oil quality parameter being measured. During the oral hearing before the Board, HPC’s counsel even admitted to this shift in HPC’s theory of obviousness.

In its final written decision, the Board determined, as a threshold matter of procedure, that HPC impermissibly presented a new theory of obviousness in its reply, and that the patentability of the 691 patent would be assessed only against the grounds asserted in HPC’s original petition.

The Board’s final written decision thus addressed only whether the person skilled in the art would have been motivated to “include”—that is, integrate—Iwaguchi’s detector into Kauffman’s system. The Board found no such motivation.

The Board’s reasoning largely mirrored Frymaster’s arguments. Kauffman’s system did not include a cooling mechanism that would have allowed Iwaguchi’s temperature-sensitive detector to work. Integrating Iwaguchi’s detector into Kauffman’s system would therefore necessitate the addition of the cooling mechanism. The Board agreed that the disadvantages of such additional construction outweighed the “uncertain benefits” of TPM measurements over the other indicia of oil quality already being monitored in Kauffman. 

On appeal, HPC raised two issues: first, the Board construed the scope of HPC’s original petition overly narrowly; and second, the Board erred in its conclusion of nonobviousness.[1]

The Federal Circuit sided with the Board on both issues.

On the first issue, the Federal Circuit did a straightforward comparison of HPC’s petition and reply. In the petition, HPC proposed a physical substitution of Iwaguchi’s detector for Kauffman’s electrode. In the reply, HPC proposed using conductivity measured by Kauffman’s electrode as a basis for calculating TPMs. The apparent differences between the two theories of obviousness, together with the “telling” confirmation of HPC’s counsel during oral hearing that the original petition espoused a physical modification, made it easy for the Federal Circuit to agree with the Board’s decision to disregard HPC’s alternative theory raised in its reply.

The Federal Circuit reiterated the importance of a complete petition:

It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.

On the second issue of obviousness, HPC argued that the Board placed undue weight on the disadvantages of incorporating Iwaguchi’s TPM detector into Kauffman’s system.

Here, the Federal Circuit reiterated “the longstanding principle that the prior art must be considered for all its teachings, not selectively.” While “[t]he fact that the motivating benefit comes at the expense of another benefit…should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another”, “the benefits, both lost and gained, should be weighed against one another.”

The Federal Circuit adopted the Board’s findings on the undesirability of HPC’s proposed modification of Kauffman, agreeing that the “tradeoffs [would] yield an unappetizing combination, especially because Kauffman already teaches a sensor that measures other indicia of oil quality.”

At first glance, the nonobviousness analysis in this decision seems to involve weighing the disadvantages and advantages of the proposed modification. However, looking at the history of this case, I think the problem with HPC’s arguments was more fundamentally that they never identified a satisfactory motivation to make the proposed modification. HPC’s original petition argued that the motivation for integrating Iwaguchi’s detector into Kauffman’s system was to “accurately” determine oil quality. This “accuracy” argument failed because it was questionable whether Iwaguchi’s detector would even work at the operating temperature of a deep fryer. Further, HPC did not argue that the proposed modification was a simple substitution of one known sensor for another with the predictable result of measuring TPMs. And when Kauffman argued that the substitution was far from simple, HPC failed to counter with adequate reasons why the person skilled in the art would have pursued the complex modification.


  • The petition for a post grant review defines the scope of the proceeding. Avoid being overly generic in a petition for post grant review. It may not be possible to fill in the details later.
  • Context matters. If an Examiner is selectively citing to isolated disclosures in a prior art out of context, consider whether the context of the prior art would lead away from the claimed invention.
  • The MPEP is clear that the disadvantages of a proposed combination of the prior art do not necessarily negate the motivation to combine (see, e.g., MPEP 2143(V)). The disadvantages should preferably nullify the Examiner’s reasons for the modification.  

[1] On the issue of obviousness, HPC also objected to the Board’s analysis of Frymaster’s proffered evidence of industry praise as secondary considerations. This objection is not addressed here.

A Change in Language from IPR Petition to Written Decision May Not Result in A Change in Theory of Motivation to Combine

Bernadette McGann | September 25, 2019

Arthrex, Inc. v. Smith & Nephew, Corp.

August 21, 2019

Dyk, Chen, Opinion written by Stoll


            The CAFC affirmed the Board’s decision that claims 10 and 11 of Patent ‘541 were obvious over Gordon in view of West and that the IPR proceeding was constitutional.  The CAFC held that minor variations in wording, from the IPR Petition to the written Final Decision, do not violate the Administrative Procedure Act (APA).  Further, the CAFC rejected Arthrex’s argument to reconsider evidence that was contrary to the Board’s decision since there was sufficient evidence to support the Board’s findings of obviousness by the preponderance of evidence standard. 


Arthrex’s Patent No. 8,821,541 (hereinafter “Patent ’541”) is directed towards a surgical suture anchor that reattaches soft tissue to bone.  A feature of the suture anchor of Patent ‘541 is that the “fully threaded suture anchor’ includes ‘an eyelet shield that is molded into the distal part of the biodegradable suture anchor’”, wherein the eyelet shield is an integrated rigid support that strengthen the suture to the soft tissue. Id. at 2 and 3.  The specification discloses that “because the support is molded into the anchor structure (as opposed to being a separate component), it ‘provides greater security to prevent pull-out of the suture.’ Id at col 5 ll. 52-56.” Id. at 3.  Figure 5 of Patent ‘541 illustrates an embodiment of the suture anchor (component 1), wherein component 9 is the eyelet shield (integral rigid support) and component 3 is the body wherein helical threading is formed.

Claims 10 and 11 of Patent ‘541 are herein enclosed (emphasis added to the claim terms at issue in the dispute)

10. A suture anchor assembly comprising:

an anchor body including a longitudinal axis, a proximal end, a distal end, and a central passage extending along the longitudinal axis from an opening at the proximal end of the anchor body through a portion of a length of the anchor body, wherein the opening is a first suture opening, the anchor body including a second suture opening disposed distal of the first suture opening, and a third suture opening disposed distal of the second suture opening, wherein a helical thread defines a perimeter at least around the proximal end of the anchor body;

a rigid support extending across the central passage, the rigid support having a first portion and a second portion spaced from the first portion, the first portion branching from a first wall portion of the anchor body and the second portion branching from a second wall portion of the anchor body, wherein the third suture opening is disposed distal of the rigid support;

at least one suture strand having a suture length threaded into the central passage, supported by the rigid support, and threaded past the proximal end of the anchor body, wherein at least a portion of the at least one suture strand is disposed in the central passage between the rigid support and the opening at the proximal end, and the at least one suture strand is disposed in the first suture opening, the second suture opening, and the third suture opening; and

a driver including a shaft having a shaft length, wherein the shaft engages the anchor body, and the suture length of the at least one suture strand is greater than the shaft length of the shaft.

11. A suture anchor assembly comprising:

an anchor body including a distal end, a proximal end having an opening, a central longitudinal axis, a first wall portion, a second wall portion spaced opposite to the first wall portion, and a suture passage beginning at the proximal end of the anchor body, wherein the suture passage extends about the central longitudinal axis, and the suture passage extends from the opening located at the proximal end of the anchor body and at least partially along a length of the anchor body, wherein the opening is a first suture opening that is encircled by a perimeter of the anchor body, a second suture opening extends through a portion of the anchor body, and a third suture opening extends through the anchor body, wherein the third suture opening is disposed distal of the second suture opening;

a rigid support integral with the anchor body to define a single-piece component, wherein the rigid support extends across the suture passage and has a first portion and a second portion spaced from the first portion, the first portion branching from the first wall portion of the anchor body and the second portion branching from the second wall portion of the anchor body, and the rigid support is spaced axially away from the opening at the proximal end along the central longitudinal axis; and

at least one suture strand threaded into the suture passage, supported by the rigid support, and having ends that extend past the proximal end of the anchor body, and the at least one suture strand is disposed in the first suture opening, the second suture opening, and the third suture opening.

Smith & Nephew (hereinafter “Smith”) initiated an inter partes review of claims 10 and 11 of Patent ‘541.  Smith alleged that claims 10 and 11 of Patent ‘541 were invalid as obvious over Gordon (U.S. Patent Application Publication No. 2006/0271060) in view of West (U.S. Patent No. 7,322,978) and alleged that claim 11 was anticipated by Curtis (U.S. Patent No. 5,464,427) (The discussion regarding Curtis (U.S. Patent No. 5,464,427) is not herein included).  Smith argued that Gordon disclosed all the features claimed except for the rigid support.  Gordon disclosed “a bone anchor in which a suture loops about a pulley 182 positioned within the anchor body. Figure 23 illustrates the pully 182 held in place in holes 184a, b.”  Id. at 5 and 6. 

Figure 23 of Gordon

Smith acknowledged that the pulley of Gordon was not “integral with the anchor body to define a single-piece component”, a feature recited in claim 11 of Patent ‘541.  Smith cited West to allege obviousness of this feature.  West also disclosed a bone anchor wherein one or more pins are fixed within the bore of the anchor body.  In West, “to manufacture the bone anchor, ‘anchor body 12 and posts 23 can be cast and formed in a die.  Alternatively anchor body 12 can be cast or formed and post 23a and 23b inserted later.’”  Id. at 7.

Figure 1 of West

Smith argued that it would have been obvious to a skilled artisan to form the bone anchor of Gordon by the casting process of West to thereby create a rigid support integral with the anchor body to define a single piece component, as recited in claim 11 of Patent ‘541.  Smith’s expert testified that the casting process of West would “minimize the materials used in the anchor, thus facilitating regulatory approval, and would reduce the likelihood of the pulley separating from the anchor body.”  Id. at 7.  Smith asserted that the casting process of West was well-known in the art and that such a manufacturing process “would have been a simple design choice.”  Id. at 7.  Arthrex argued that a skilled artisan would not have been motivated to modify Gordon in view of West.  The Board agreed with Smith that the claims were unpatentable.  Arthrex filed an appeal. 

Arthrex appealed the Board’s decision that Smith proved unpatentability of claims 10 and 11 in view of Gordon and West, on both a procedurally and a substantively basis, and the constitutionality of the IPR proceeding.  The CAFC found that Arthrex’s procedural rights were not violated; that the Decision by the Board was supported by substantial evidence and the application of IPR to Patent ‘541 was constitutional. 

IPR proceedings are formal administrative adjudications subject to the procedural requirements of the APA. See, e.g., Dell Inc. v. Acceleron, LLC, 818 F.3d 1293, 1298 (Fed. Cir. 2016); Belden, 805 F.3d at 1080. One of these requirements is that “‘an agency may not change theories in midstream without giving respondents reasonable notice of the change’ and ‘the opportunity to present argument under the new theory.’” Belden, 805 F.3d at 1080 (quoting Rodale Press, Inc. v. FTC, 407 F.2d 1252, 1256–57 (D.C. Cir. 1968)); see also 5 U.S.C. § 554(b)(3). Nor may the Board craft new grounds of unpatentability not advanced by the petitioner. See In re NuVasive, Inc., 841 F.3d 966, 971–72 (Fed. Cir. 2016); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016).

Id. at 9. 

Arthrex argued that the Board’s decision relied on a new theory of motivation to combine.  Arthrex argued that the new theory violated their procedural rights by depriving them an opportunity to respond to said new theory.  Arthrex argued that the Board’s reasoning differed from the Smith Petition by describing the casting method of West as “preferred.”  The CAFC held that while the language used by the Board did differ from the Petition, said deviation did not introduce a new issue or theory as to the reason for combining Gordon and West.  West disclosed “an ‘anchor body 12 and posts 23 can be cast and formed in a die. Alternatively anchor body 12 can be cast or formed and posts 23a and 23b inserted later’.”  Id. at 10.  The Smith Petition asserted that “a person of ordinary skill would have had ‘several reasons’ to combine West and Gordon, including that the casting process disclosed by West was a ‘well-known technique [whose use] would have been a simple design choice’.” (emphasis added) Id. at 10.  In the written decision by the Board, the Board characterized West as disclosing two manufacturing methods, wherein the casting method was the “primary” and “preferred” method, and thus, a skilled artisan would have “applied West’s casting method to Gordon because choosing the ‘preferred option’ presented by West ‘would have been an obvious choice of the designer’.” Id. at 11.   The CAFC noted that while the Board’s language of “preferred” differed from the language of the Petition, i.e. “well-known”, “accepted” and “simple”, the Board nonetheless relied upon the same disclosure of West as the Petition, the same proposed combination of the references and ruled on the same theory of obviousness, as presented in the Petition.  “[t]he mere fact that the Board did not use the exact language of the petition in the final written decision does not mean it changed theories in a manner inconsistent with the APA and our case law…. the Board had cited the same disclosure as the petition and the parties had disputed the meaning of that disclosure throughout the trial. Id. As a result, the petition provided the patent owner with notice and an opportunity to address the portions of the reference relied on by the Board, and we found no APA violation.”  Id. at 11.

Next, Arthrex argued that even if the Board’s decision was procedurally proper, an error was made by finding Smith had established a motivation to combine the cited art by a preponderance of the evidence.  The CAFC held that there was sufficient substantial evidence to support the Board’s finding that a skilled artisan would be motivated to use the casting method of West to form the anchor of Gordon.  First, the Board noted West’s disclosure of two methods of making a rigid support.  Second, the wording by West suggested that casting was the preferred method.  Third, Smith’s experts testified that the casting method would likely produce a stronger anchor, which in turn would be more likely to be granted regulatory approval.  Also, casting would decrease manufacturing cost, produce an anchor that is less likely to interfere with x-rays and would reduce stress concentrations on the anchor.  The CAFC agreed with Arthrex that there was some evidence that contradicts the Board’s decision, such as Arthrex’s expert’s testimony.  However, “the presence of evidence supporting the opposite outcome does not preclude substantial evidence from supporting the Board’s fact finding. See, e.g., Falkner v. Inglis, 448 F.3d 1357, 1364 (Fed. Cir. 2006)”.  Id. at 14.  The CAFC refused to “reweight the evidence.” Id. at 14. 

Lastly, the CAFC addressed Arthrex’s argument that an IPR is unconstitutional when applied retroactively to a pre-AIA patent.  Since this argument was first presented on appeal, the CAFC could have chosen not to address it.  However, exercising its discretion, the CAFC held that an IPR proceeding against Patent ‘541 was constitutional.  Patent ‘541 was filed prior to the passage of the AIA, but was issued almost three years after the passage of the AIA and almost two years after the first IPR proceedings, on September 2, 2014.  “As the Supreme Court has explained, ‘the legal regime governing a particular patent ‘depend[s] on the law as it stood at the emanation of the patent, together with such changes as have since been made.’” Eldred v. Ashcroft, 537 U.S. 186, 203 (2003) (quoting McClurg v. Kingsland, 42 U.S. 202, 206 (1843)). Accordingly, application of IPR to Arthrex’s patent cannot be characterized as retroactive.” Id. at 18.  The CAFC further explained that even if Patent ‘541 issued prior to the AIA, an IPR would have been constitutional.  “[t]he difference between IPRs and the district court and Patent Office proceedings that existed prior to the AIA are not so significant as to ‘create a constitutional issue’ when IPR is applied to pre-AIA patents.”  Id. at 18. 


  • Slight changes in language does not create a new theory of motivation to combine.
  • However, a new theory of motivation to combine may exist when:
    •  the Board creates a new theory of obviousness by mixing arguments from two different grounds of obviousness presented in a Petition.
      • In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1372–73, 1377 (Fed. Cir. 2016).
    • the claim construction by the Board varies significantly from the uncontested construction announced in an institution decision.
      • SAS Institute v. ComplementSoft, LLC, 825 F.3d 1341, 1351 (Fed. Cir. 2016).
    •  the Board relies upon a portion of the prior art, as an essential part of its obviousness finding, that is different from the portions of the prior art cited in the Petition.
      • In re NuVasive, Inc., 841 F.3d 966, 971 (Fed. Cir. 2016).

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