Further to our May 8, 2013 post, on June 14, 2013, ALJ Robert K. Rogers, Jr. issued the public version of the Initial Determination (“ID,” dated May 6, 2013) finding a violation of Section 337 in Certain Digital Models, Digital Data, and Treatment Plans for Use, in Making Incremental Dental Positioning Adjustment Appliances Made Therefrom, and Methods of Making the Same (Inv. No. 337-TA-833).  Due to its size, we have split the 815 page ID in thirteen parts here:  part 1, part 2, part 3, part 4, part 5, part 6, part 7, part 8, part 9, part 10, part 11, part 12, and part 13.

By way of background, the International Trade Commission instituted this investigation on March 20, 2012 based on a complaint filed by Complainant Align Technology, Inc. (“Align”).  In the Complaint, Align alleged that Respondents ClearCorrect Operating, LLC and ClearCorrect Pakistan (Private), Ltd. (collectively, “Respondents”) violated Section 337 in the importation into the U.S. and sale of certain digital models, digital data, or treatment plans for use in making incremental dental positioning adjustment appliances that infringe—or are made, produced, or processed by means of a process that infringes—one or more claims of U.S. Patent Nos. 6,217,325 (the ‘325 patent), 6,705,863 (the ‘863 patent), 6,626,666 (the ‘666 patent), 8,070,487 (the ‘487 patent), 6,471,511 (the ‘511 patent), 6,722,880 (the ‘880 patent), and 7,134,874 (the ‘874 patent) (collectively, the “asserted patents”).  See our March 2, 2012 post for more details on the complaint.

The ‘325 Patent

According to the ID, the parties disputed the claim term “Fabricating a plurality of successive tooth repositioning appliances.”  ALJ Rogers construed the claim term to mean, “fabricating two or more dental appliances to be used successively to adjust the position of teeth.”

As to invalidity, ALJ Rogers determined that the asserted claims are valid.  Specifically, ALJ Rogers held that Respondents failed to prove that their anticipation reference disclosed every limitation disclosed in the independent claims.  ALJ Rogers held that the dependent claims are also not invalid because they depend upon the valid, broader independent claims.  Additionally, ALJ Rogers held that the Respondents failed to prove that the asserted claims were obvious in light of their cited prior art references.  Further, ALJ Rogers held that Respondents failed to prove that a person of ordinary skill in the art would have had a reason to combine prior art references, or that there would have been a reasonable expectation of success if the references were combined.

Regarding infringement, ALJ Rogers first addressed several issues relevant to all asserted patents.  First, ALJ Rogers held that “Respondents do not escape a violation of Section 337 as a matter of law merely because they practice some elements of the asserted method claims within the United States and other elements of the asserted method claims outside of the United States.”  Second, ALJ Rogers held that Respondents’ argument that the digital data sets are not “articles” within the scope of 19 U.S.C. § 1337 is unpersuasive.  Third, ALJ Rogers rejected Respondents’ argument that Align cannot meet its burden of proving infringement through its expert witness, Mr. Beers.

Turning to the asserted claims of the ‘325 patent, ALJ Rogers held that Respondents’ and their accused products infringe, directly and through contributory infringement, the asserted claims of the ‘325 patent.  Specifically, ALJ Rogers determined that Respondents infringe the asserted claims of the ‘325 patent by creating the digital data sets to fabricate aligners.

The ‘880 Patent

According to the ID, the parties disputed the claim terms “a predetermined series of dental incremental position adjustment appliances”/”predetermined series of dental incremental position adjustment appliances.”  ALJ Rogers construed the claim term to mean, “two or more dental appliances to be used successively to adjust the position of teeth between an initial tooth arrangement and a repositioned tooth arrangement, the digital data sets on which they are based having been created before any of said two or more dental appliances in the series are fabricated.”

As to invalidity, ALJ Rogers determined that the asserted claims are valid.  ALJ Rogers held that Respondents’ anticipation reference fails to disclose, among other limitations, “obtaining a series of successive digital data sets representing a series of successive tooth arrangements,” as required by independent claim 1.  Regarding obviousness, ALJ Rogers determined that the two rejections based on a combination of prior art references failed to disclose each and every element of the asserted claims of the ‘880 patent.

Regarding infringement, ALJ Rogers held that Respondents directly and contributorily infringe the asserted patent claims.  ALJ Rogers rejected Align’s induced infringement arguments because Align failed to prove that Respondents possessed the necessary specific intent.

The ‘487 Patent

According to the ID, the parties disputed the claim term “treatment plan.”  ALJ Rogers construed the claim term to mean “two or more successive digital data sets representing arrangements of a patient’s teeth progressing from an initial tooth arrangement toward a final tooth arrangement.”

As to invalidity, ALJ Rogers determined that the asserted claims are valid.  ALJ Rogers held that the anticipation references fails to disclose calculating positions in between an initial data set and a final data, as required by independent claim 1.  Despite discussing eleven different references, Respondents failed to identify specific combinations of references that disclosed each and every element of the assert claims of the ‘487 patent.

Regarding infringement, ALJ Rogers held that Respondents directly infringe claims 1, 3, and 5 of the ‘487 patent, but do not infringe claims 7, 8, and 9.  Specifically, ALJ Rogers held that Respondents do not infringe claims 7, 8, and 9 because Respondents import the digital data sets by transmitting them electronically, not on a computer readable media.

The ‘511 Patent

According to the ID, the parties disputed the claim term “computer-implemented method.”  ALJ Rogers construed the claim term to mean “a method accomplished using a computer.”

As to invalidity, ALJ Rogers held that asserted claim 1 was not invalid pursuant to 35 U.S.C. §§ 102 or 103.  ALJ Rogers determined that Respondents’ anticipation reference failed to disclose, among other limitation, “a segmentation of the aggregate tooth paths into a plurality of treatment segments.”  Regarding obviousness, ALJ Rogers held that Respondents’ combination of prior art references fails to disclose, either alone or in combination, all the limitations of asserted claim 1 of the ‘511 patent.

Regarding infringement, ALJ Rogers held that Respondents directly infringe claim 1 of the ‘511 patent.  ALJ Rogers rejected Respondents’ argument that their processes are not “computer implemented” based on his construction of the term.  Accordingly, ALJ Rogers held that the Respondents infringe claim 1 of the ‘511 patent by creating the digital data sets and using them to fabricate aligners.

The ‘666 Patent

According to the ID, ALJ Rogers held that the asserted claims of the ‘666 patent are not invalid under 35 U.S.C. §§ 102 or 103.  ALJ Rogers determined that Respondents’ prior art references failed to disclose each and every claim limitation individual or in combination.  Additionally, ALJ Rogers determined that a person of ordinary skill in the art would not have had a reason to combine the prior art references and would not have had a reasonable expectation of success in doing so.  

As to infringement, ALJ Rogers held that Respondents directly infringe the assert claims of the ‘666 patent.  Specifically, ALJ Rogers determined that the Respondents infringe the assert claims when they create the intermediate digital data sets.

The ‘863 Patent

According to the ID, the parties disputed the claim terms “distinct successive incremental dental positional appliance”/“successive incremental dental positional appliance.”  ALJ Rogers construed the claim terms to mean “a single separate appliance to be used during a particular interval for repositioning teeth.”

As to invalidity, ALJ Rogers held that the asserted claims are valid.  ALJ Rogers determined that Respondents’ anticipation reference failed to disclose, among other limitations, “producing a plurality of modified digital models of the dentition, wherein the modified models represent successive treatment stages of an orthodontic treatment,” as required by the asserted independent claim 1.  Additionally, ALJ Rogers rejected Respondents’ arguments that the cited prior art references in combination disclosed every asserted claim limitation.

As to infringement, ALJ Rogers held that Respondents directly infringe the asserted claims of the ‘863 patent.  Specifically, ALJ Rogers determined that Respondents’ process for producing digital models of dental positioning appliances infringe the asserted claims.

The ‘874 Patent

According to the ID, the parties disputed the claim terms “computer-implemented method” and “treatment plan.”  ALJ Rogers construed the claim term “computer-implemented method” to mean “a method accomplished using a computer.”  ALJ Rogers construed the claim term “treatment plan” to mean “two or more successive digital data sets representing arrangements of a patient’s teeth progressing from an initial tooth arrangement toward a final tooth arrangement.”

As to invalidity, ALJ Rogers held that the asserted claims are valid.  ALJ Rogers determined that the asserted anticipation reference failed to, “in any way, address, disclose, or hint at, multiple removable appliances or generating successive appliances,” as required by independent claim 1.  Regarding obviousness, ALJ Rogers held that Respondents’ general citation to the “knowledge of one of ordinary skill in the art” fails to render any asserted claim of the ‘874 patent obvious.

As to infringement, ALJ Rogers held that Respondents infringe the asserted claims of the ‘874 patent.  Specifically, ALJ Rogers determined that Respondents infringe the asserted claims of the ‘874 patent directly, contributorily, and through inducement.

Domestic Industry

According to the ID, ALJ Rogers held that Respondents waived their right to contest the issue of domestic industry.  ALJ Rogers noted that he would only require Align to make a prima facie showing of domestic industry.  Accordingly, ALJ Rogers held that Align did, in fact, make a prima facie showing of the economic prong to the domestic industry requirement by “showing that it has made significant investments in plant and equipment related to the articles protected by the patents in suit.”  As to the technical prong to the domestic industry requirement, ALJ Rogers held that Align also made a prima facie showing for all the asserted patents, except for the ‘666 patent.  ALJ Rogers determined that Align failed to present evidence that showed that Align’s products practice the step for interpolating positional differences between the initial and final position of teeth, which is required by claim 7 to the ‘666 patent.

Remedy & Bond

In the event the Commission finds a violation of Section 337, ALJ Rogers recommended the issuance of a cease and desist order.  ALJ Rogers recommended that the Commission not issue a limited exclusion order to the imported digital data sets because the accused data sets are imported electronically and, therefore, U.S. Customs would have difficulty enforcing such an order.  As to bond, ALJ Rogers held that Align failed to prove that a 100% bond was appropriate.  Accordingly, ALJ Rogers did not recommend a bond during the Presidential review period.