Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
`
`Attorney Docket No.: 22773-826401
`
`REMARKS
`
`Upon entry of this Amendment, claims 20-39 will be pending and at issue in the present
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`application. Claims
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`l-l9 have previously been canceled without prejudice or disclaimer.
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`Applicants reserve the right to pursue any canceled subject matter in a related, future application.
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`Claims 20-26 and 29 have been amended. New claims 31-39 have been added. Support for the
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`amendments can be found in the specification as originally filed. Accordingly, no new matter
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`has been added. Reconsideration is respectfully requested.
`
`Claim Amendments
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`Claim 20 has been amended to recite that the sheet comprises “a hard polymer layer of
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`polymeric material comprising a flexural modulus greater than about 150,000 psi; and a soft
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`polymer layer of polymeric material comprising an elongation at break of greater than about
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`200%, and a hardness from about 60 A to about 85 D.” Support for this amendment can be found
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`throughout the instant application as filed, at least at paragraphs [OO27]-[OO28].
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`New claims 31-39 have been added. Support for these new claims can be found
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`throughout the specification as originally as filed, at least at the locations indicated in the table
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`below:
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`Claim Number:
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`Exemplary support at least at:
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`
`
`31
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`32
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`33
`
`34
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`35
`
`36
`
`37
`
`38
`
`39
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`
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`Paragraphs [OOO6]-[OOO7], [0026], [0030], instant
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`application as filed
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`Paragraphs [0025] and [0030], instant application as filed
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`Paragraph [003 6], instant application as filed
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`Paragraph [0029], instant application as filed
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`Paragraph [0026], instant application as filed
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`Claim 10, parent application (US 13/470,681) as filed
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`Paragraph [0023], instant application as filed
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`Paragraph [0026], instant application as filed
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`Paragraph [0028], instant application as filed
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`Accordingly, no new matter has been added by way of this claim amendment or newly
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`added claims.
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`Page 7 of 16
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`

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`Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
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`Examiner Interview
`
`Attorney Docket No.: 22773-826401
`
`Applicants thank Examiner Montiel for participating in a telephonic interview on July 18,
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`2019, with Applicants’
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`representatives, Melissa Harwood and Garrett Potter. Additional
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`participants included Primary Examiner Anthony Calandra. The Examiner’s rejections of the
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`claims made in a Non-Final Office Action mailed on March 14, 2019, were discussed.
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`Claim Rejections — 35 USC § 103
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`i. Claims 20—25 and 2 7-30
`
`Claims 20-25 and 27-30 stand rejected under 35 USC. § 103(a) as allegedly being
`
`unpatentable over Chen et al. (US. Pub. No. 2009/0246724, hereinafter “Chen”) and DeSimone
`
`et al. (US. Patent No. 7,641,828, hereinafter “DeSimone”). Specifically, the Examiner asserts
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`that “[i]t would have been obvious to one of ordinary skill in the art at the time of applicant’s
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`invention to modify CHEN by providing a positive model of the patient’s teeth in a target
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`position and fabricating an appliance as a negative of the positive model, as suggested by
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`DESJMONE”. (Office Action at pp. 2-3).
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`Independent claim 20 has been amended to incorporate subject matter of claim 26, and
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`now recites that the sheet comprises “a hard polymer layer of polymeric material comprising a
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`flexural modulus greater than about 150,000 psi, and a soft polymer layer of polymeric material
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`comprising an elongation at break of greater than about 200%, and a hardness from about 60 A
`
`to about 85 D.”
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`With regard to the amendment, the Examiner rejected claim 26 in View of Chen and
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`DeSimone, and further in View of US. Patent No. 4,791,156,
`
`(hereinafter “Hostettler”).
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`Specifically, the Examiner states that Hostettler “teaches a soft polyurethane elastomer having a
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`hardness not greater than about 65 A .
`
`.
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`. which overlaps with the claimed range of hardness of
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`about 60 A to about 85 D.” (Office Action at pp. 7-8).
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`Applicants respectfully disagree with the Examiner’s rejections under 35 USC. § 103(a)
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`at least because (1) one of ordinary skill in the art would not have had a reasonable expectation
`
`of success for combining the teachings of Chen, DeSimone, and Hostettler to produce
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`orthodontic appliances formed using the presently claimed methods of making a dental
`
`appliance, (2) the orthodontic appliances according to the instant claims were found to exhibit
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`Page 8 of 16
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`

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`Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
`
`Attorney Docket No.: 22773-826401
`
`unexpectedly beneficial results when compared with the most relevant art, and (3) the appliances
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`according to the instant claims gave rise to considerable commercial success.
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`Furthermore, a method of making or using a product is patentable if the product is itself
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`patentable (see, e. g.: MPEP § 821, see also: USPTO Official Gazette Notice, “Guidance on
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`Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. §
`
`103(b)”, published at 1184 OG 86 on March 26, 1996). As addressed in detail below, Applicants
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`submit that the appliance is patentable, and thus the instant claims directed toward making said
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`appliance is patentable.
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`These positions are supported by the present specification and further supported by the
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`September 16, 2019 Declaration under 37 C.F.R. § 1.132 of Dr. Chunhua Li (hereafter, the “Li
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`Declaration”), an expert in materials and biomechanical engineering and a co-inventor of the
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`present application. The Li Declaration describes the development history and clinical evaluation
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`comparing appliances comprising materials according to the present claims (an example of
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`which is referred to herein as ST3 O—a material that has a soft polymer layer and a hard polymer
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`layer) to appliances of the prior art, including a thermoplastic polyurethane referred to as EX30,
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`which was the standard of care prior to the release of ST30.
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`1.
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`N0 Reasonable Expectation of Success
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`One of ordinary skill in the art would not have had a reasonable expectation of success in
`
`combining the teachings of Chen, DeSimone, and Hostettler to yield the orthodontic appliances
`
`made using the claimed method, at least because of the high level of unpredictability in the art
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`and the lack of guidance provided in Chen and DeSimone suggesting which material
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`combinations should be used to produce a sufficient multilayer orthodontic appliance.
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`Over the course of more than seven years, Applicants worked diligently to develop a
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`suitable, improved appliance that would meet various criteria for effective orthodontic treatment.
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`(Li Declaration at 114). This development process was neither easy nor straightforward. During
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`the development process, Applicants evaluated, in an iterative fashion, more than 250 distinct
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`materials and/or material combinations for possible use in an improved appliance device. After
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`years of development, Applicants produced the SmartTrackTM material (also referred to herein as
`
`“ST30”) and related materials, which are products formed according to the instant claims
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`Page 9 of 16
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`

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`Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
`
`Attorney Docket No.: 22773-826401
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`comprising a multilayered material comprising a hard polymer layer and a soft polymer layer.
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`The intent of this testing was to identify a suitable replacement for Align Technology’s single-
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`layer, thermoplastic polyurethane appliance product (referred to herein as “EX30”), which was
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`the standard of the care for plastic tooth moving appliances at the time of filing, and the materials
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`were evaluated on this basis. (Id. at 11114-6). From among those over 250 materials tested, only the
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`materials according to the present claims met Align’s criteria for a multilayer orthodontic
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`appliance. (Id. at 1114-5). The tested materials included many multilayer (e.g., two-layer and
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`three-layer) materials, yet of those tested only the materials according to the present claims
`
`proved capable of performing at a level sufficient to meet Align’s criteria for an orthodontic
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`appliance, and thus as a suitable replacement for EX30. (Id. at 11115-7).
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`Data obtained by Applicants during the development of the SmartTrack material provides
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`significant evidence of the unpredictability in the art and the unexpected effectiveness of the
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`orthodontic appliances according to the present claims. (Id at 117). As mentioned above, the
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`multilayer, multi-material orthodontic appliances were developed during more than seven years
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`of diligent evaluation of over 250 materials, including numerous iterations in which materials
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`were tested and compared, with the results used to design new materials. (Id. at 114). It was clear
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`from many of the materials tested, including those from the Chen and DeSimone, that such
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`materials were not effective alone or in combination to provide the improvements sought. (Id. at
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`115). During those evaluations, Applicants determined that only the combinations of materials
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`according to the instant claims met Align’s development criteria. (Id. at 11115-6). It was not a
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`simple or predictable process to identify those materials that would work together to create the
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`multilayer apparatus which provided the unexpectedly good results. Among those 250 materials
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`tested were more than 180 materials either generically or specifically described in Chen and/or
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`DeSimone, including various copolymers (see, e. g., Chen at [0036]) and unblended polysulfones
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`(DeSimone at 6:47-59), as well as styrenic polymer materials such as acrylonitrile-butadiene-
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`styrene (ABS) (id. at 6:24-37). (Li Declaration at 15). Specifically, none of the 23 co-polymers
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`that were tested during the iterative development process met Align’s criteria. (Id.). Similarly,
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`none of the styrenic polymers nor unblended polysulfones tested met Align’s criteria. (Id.). Thus
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`none of these materials would have yielded an orthodontic device having the combination of
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`sufficient elongation, time stress-relaxation, durability, and thermoform ability. (Id.).
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`Page 10 of 16
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`

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`Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
`
`Attorney Docket No.: 22773-826401
`
`Inventor Li had extensive knowledge of the teachings of Chen and DeSimone at the time
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`of filing, and yet it still took her team many years to identify suitable materials. (Id. at 115).
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`Inventor Li is also listed as a co-inventor of Chen, and thus she was thus intimately familiar with
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`the teachings of Chen during the development of the orthodontic appliances according to the
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`present claims. Inventor Li also collaborated closely with Joseph M. DeSimone and Robert E.
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`Tricca (the inventors listed on DeSimone) while they were developing and patenting the
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`technology described in DeSimone. (Li Declaration at 119). She was thus very aware of the
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`teachings of DeSimone during the development of the orthodontic appliances according to the
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`present claims. Even with her extensive knowledge of the teachings of Chen and DeSimone, it
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`took her team over seven years to identify a suitable combination of polymer layers for use in the
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`multilayer orthodontic appliances according to the present claims. (Id). Thus, one of ordinary
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`skill in the art having far less knowledge of the teachings of Chen and DeSimone would not have
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`had a reasonable expectation of success in producing the orthodontic appliances according to the
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`present claims based on the teachings of Chen, DeSimone, and Hostettler. (Id. at 1110).
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`During the course of their evaluations, Applicants determined that merely combining
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`various materials being tested into multiple layers was insufficient to improve performance
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`relative to the EX3O material. (Id. at 11116-7). In fact, many multilayer materials tested proved
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`inferior to the EX3O material. These multilayer materials included combinations of materials
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`disclosed in Chen and/or DeSimone. (Id). In particular, the sole exemplified multilayer material
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`described in Chen would not be expected to show improved performance relative to EX30. For
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`example, Chen paragraph [0032] describes a material containing polycarbonate and polyvinyl
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`chloride (PVC), however, PVC was later evaluated by Applicants and found to be unsuitable for
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`use in orthodontic aligners due to its inadequate durability. (Id). Based on these tests, Applicants
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`determined that materials containing PVC, either alone or in a multilayer configuration, would
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`be inferior to EX30. (Id). For these reasons, a person of ordinary skill would not necessarily
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`expect combinations of any polymer layers, either in general or as particularly described in Chen,
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`to achieve performance superior to EX30.
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`Based on the unpredictability exhibited in the Applicants’ material evaluations, a person
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`of ordinary skill in the art would not have had a reasonable expectation of success in producing
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`Page 11 ofl6
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`

`

`Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
`
`Attorney Docket No.: 22773-826401
`
`an effective orthodontic appliance by combining materials from Chen and DeSimone to arrive at
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`the appliances according to the present claims. (Id. at 1118-10).
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`2.
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`Unexpected Results
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`Applicants have also established that the appliances according to the present claims are
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`unexpectedly superior to the most relevant art. The Li Declaration describes two clinical studies
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`comparing appliances made from the prior art material described in paragraph [0003] of Chen—
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`a thermoplastic polyurethane called EX3 O—to appliances made of a multilayer material, referred
`
`to as ST30, that has a hard polymer layer comprising a flexural modulus greater than about
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`150,000 psi and soft polymer layers having an elongation at break greater than about 200% and a
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`hardness from about 60 A to about 85 D. (Li Declaration at 1111-18).
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`As described in the Li Declaration, each study found that ST30 appliances provided
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`strongly superior performance relative to the closest prior art appliances. In the first study
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`described, a group of 1,015 patients treated with ST30 appliances for five months were 26%
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`more likely than equivalent patients treated with EX30 appliances to have their teeth respond to
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`treatment as intended. (Id. at 1111-15). This result establishes the superiority of ST30 to EX30 to
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`a high degree of statistical significance (p < 0.001). (Id. at 1114). A second study of 110,000 cases
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`confirmed these findings, demonstrating strongly significant
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`(p < 0.001) improvements in
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`predictability in tooth movement for 14 different movement types. (Id. at 1116, Appendix B).
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`Overall, patients treated with ST30 appliances showed a greater than 75% improvement in tooth
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`movement predictability over patients treated with EX30 appliances. (Id. at 1117). This surprising
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`improvement would not have been predicted by a person of ordinary skill in the art. (Id.).
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`In the above-described clinical studies, the appliances contained a hard polymer layer,
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`which provided the forces needed to generate movement of the teeth, while the soft polymer
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`layers increased the durability of the aligners allowing them to better withstand wear due to
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`aligner reinsertion and removal and other mechanical stresses put on the aligner during
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`treatment, as well as improving the elastic properties allowing for less degradation in the shape
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`of the teeth receiving cavities. The surprising results observed for the ST30 appliances can be
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`attributed to the combination of the hard and soft polymer materials combined together in an
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`appliance according to the present claims. (Id. at 111115, 18). Although the clinical results were
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`found for a three layer appliance, a single hard polymer layer and a single soft polymer layer
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`Page 12 of 16
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`

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`Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
`
`Attorney Docket No.: 22773-826401
`
`according to the current claims would also be expected to exhibit these beneficial functions in a
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`two-layered appliance because the superior performance properties flow from the claimed
`
`combination of polymer layers utilized together. (Id). Thus, one would expect superior results
`
`from the appliances formed using the methods of current claim 20.
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`Comparison of EX30 and the Claimed Materials is Proper for Establishing
`Unexpected Results
`
`EX30 was the standard of care in orthodontic appliances prior to the development of
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`ST30, and a person of ordinary skill would have considered it the closest relevant art. Thus, the
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`skilled artisan would consider the superiority of the orthodontic appliances according to the
`
`present claims relative to EX30 to be predictive of similar superiority of ST3O relative to other
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`prior art appliances. (Li Declaration at 1117). During the course of Applicants’ evaluations, they
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`determined that merely combining any materials into multiple layers was insufficient to improve
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`performance relative to the EX30 material. (Id. at 116). In fact, many multilayer materials tested
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`proved inferior to the EX30 material. (Id). Based on these evaluations, none of these inferior
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`multilayer materials would be expected to achieve performance comparable to EX30, much less
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`to exceed the performance of EX30. Because the EX30 material was the standard of care during
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`Applicants’ development of the SmartTrack material and related materials, and was superior to
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`many multilayer materials tested, the EX30 material should be considered a proper comparison
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`for assessing unexpected results.
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`(See MPEP § 7l6.02(e)(I) (“Applicants may compare the
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`claimed invention with prior art that is more closely related to the invention than the prior art
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`relied upon by the examiner.”)). Additionally, it is not a trivial matter to conduct a clinical trial.
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`It requires regulatory approval and a considerable amount of time and thus cannot be done for
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`any or all materials. Accordingly, because the test comparison provided compares the standard of
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`care (the material commercially being utilized),
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`it should be accepted as the appropriate
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`comparison for demonstrating unexpected results.
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`Additionally, the Li Declaration establishes that the surprising results observed for the
`
`ST3O appliances are attributed to the combination of the hard and soft polymer layers combined
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`in layers together in an appliance according to the present claims. (Id. at 111115, 18). The Li
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`Declaration further establishes that a single hard polymer layer and a single soft polymer layer
`
`according to the current claims would also be expected to exhibit these beneficial functions in a
`
`two-layered appliance. (Id). Thus, the experimental comparisons between EX30 and ST3O as
`
`Page 13 ofl6
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`Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
`
`Attorney Docket No.: 22773-826401
`
`described in the Li Declaration should be accepted as the appropriate comparison for
`
`demonstrating unexpected results for the appliances according to the present claims.
`
`Therefore, Applicants have demonstrated that there would have been no reasonable
`
`expectation of success in combining the cited art to achieve the presently claimed invention and
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`that the appliances according to the present claims produce unexpectedly positive results relative
`
`to the closest relevant art.
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`3.
`
`Commercial Success
`
`In addition to the comparative, developmental, and clinical data presented above, the
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`commercial success of appliances comprising the ST3O material as set forth in the present claims
`
`provides further evidence of their non-obviousness. Prior to the Applicants’ development of the
`
`ST3O material,
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`the primary appliance material
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`in the orthodontic market was EX30.
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`(Li
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`Declaration at 1119). Upon establishing the superiority of ST3O appliances relative to EX3O
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`appliances, Align Technology switched virtually all new appliance manufacturing to ST3O over
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`the course of only a few months. (Id). Thereafter, ST3O appliances captured over 90% of the
`
`total US market for clear plastic orthodontic appliances. (Id; see also: Baird 2014 Analyst
`
`Report at 6, and Baird Q3 2013 Report at 9 (submitted in an IDS filed March 31, 2017)). This
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`striking commercial success was due to the superior performance of ST3O appliances to EX3O
`
`and other appliances on the market. (Li Declaration at 111119-20).
`
`Indeed, as the Federal Circuit has stated that, “[w]hen a patentee can demonstrate
`
`commercial success, usually shown by significant sales in a relevant market, and that the
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`successful product is the invention disclosed and claimed in the patent, it is presumed that the
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`commercial success is due to the patented invention.” GrafTech Inl’l Holdings, Inc. v. Laird
`
`Techs. Inc., No. 2015-1796, 652 Fed. Appx. 973, 978-79 (Fed. Cir. June 17, 2016) (quoting 1T
`
`Eaton & Co. v. Ail. Paste & Glue C0., 106 F.3d 1563, 1571 (Fed. Cir. 1997)). As appliances
`
`made of the ST3O material are appliances according to the present claims, and as these
`
`appliances have demonstrated commercial success as shown by significant sales in the relevant
`
`market of clear plastic orthodontic appliances, it is presumed that the invention as claimed has
`
`led to this commercial success.
`
`Independent analysis provides further evidence that the commercial success of ST3O
`
`appliances is due to the appliances’ superior performance. An analysis by Stifel, Nicolaus &
`
`Page 14 of 16
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`Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
`
`Attorney Docket No.: 22773-826401
`
`Company,
`
`Inc. shortly after the introduction of ST3O concluded that
`
`the introduction of
`
`SmartTrack (ST3O material) appliances resulted in an increase from 59% to 63% in the total
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`addressable market for orthodontic malocclusions. (Stifel 4Ql3 Report at 6 (submitted in an IDS
`
`filed March 3 l, 2017)). Survey results confirmed the conclusion among doctors that SmartTrack
`
`appliances allow a larger range of cases to be treated:
`
`Approximately 80% of our respondents now believe SmartTrack will help them
`treat more complex cases. Over 60% of our doctors said that SmartTrack has
`already allowed them to perform more complex cases, an increase from 48% and
`29% when we surveyed the same respondents in July and April, respectively.
`
`(Id. at 4). Thus, in addition to commanding a dominant market share, ST3O appliances have
`
`increased the size of the market treatable by clear plastic orthodontic appliances.
`
`Accordingly, in addition to the unexpected results and lack of reasonable expectation of
`
`success described above, the commercial success of ST3O appliances according to the present
`
`claims provides evidence of the claims’ non-obviousness.
`
`The Li Declaration establishes that
`
`the commercial
`
`successes observed for
`
`the
`
`SmartTrack appliances can be attributed to the combination of the hard and soft polymer material
`
`layers combined together in an appliance according to the present claims. (Id. at 111119-20). Thus,
`
`the commercial successes observed for ST3O as described in the Li Declaration should be
`
`accepted as providing evidence for the patentability of the present claims.
`
`Independent claim 20 is not obvious over the combination of Chen, DeSimone, and
`
`Hostettler for at least the reasons described above. Claims 21-25 and 27-30 depend from claim
`
`20, and are therefore allowable for similar reasons, as well as on their own merits. Accordingly,
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`for the reasons set forth above, withdrawal of the rejection of claims 20-25 and 27 -30 under 35
`
`U.S.C. § lO3(a) is respectfully requested.
`
`ii. Claim 26
`
`Claim 26 stands rejected under 35 U.S.C. § lO3(a) as allegedly being unpatentable over
`
`Chen and DeSimone as applied to claim 20, and further in view of Hostettler (US. Patent No.
`
`4,791,156, hereinafter “Hostettler”). Specifically, the Examiner states that “[i]t would have been
`
`obvious to one of ordinary skill in the art at the time of the applicant’s invention to modify
`
`CHEN and DESHVIONE by having a soft layer with a hardness not greater than 65A .
`
`.
`
`. in order
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`Page 15 ofl6
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`Appl. No.: 15/476,655
`Reply to Office Action of March 14, 2019
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`Attorney Docket No.: 22773-826401
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`to provide a soft layer which provides tissue relief, is inexpensive, trouble-free, and easy to keep
`
`clean.” (Office Action at pp. 7-8).
`
`As discussed further above, amended claim 20 is allowable over the combined references
`
`of Chen, DeSimone, and Hostettler. Dependent claim 26 is at least allowable for depending from
`
`allowable independent claim 20, and on its own merits. Accordingly, for the reasons set forth
`
`above, withdrawal of the rejection of claim 26 under 35 U.S.C.
`
`§ 103(a) is respectfully
`
`requested.
`
`CONCLUSION
`
`In view of the foregoing, Applicants believe all claims now pending in this Application
`
`are in condition for allowance. The issuance of a formal Notice of Allowance at an early date is
`
`respectfully requested.
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`Further, the Commissioner is hereby authorized to charge any additional fees or credit
`
`any overpayment in connection with this paper to Deposit Account No. 23-2415.
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`If the Examiner believes a telephone conference would expedite prosecution of this
`
`application, please telephone the undersigned at 206-883-2500.
`
`Dated: September 16, 2019
`
`/Garrett T. Potter/
`
`Respectfully submitted,
`
`Garrett T. Potter, PhD.
`Registration No. 76,602
`
`WILSON SONSINI GOODRICH & ROSATI
`
`650 Page Mill Road
`Palo Alto, CA 94304-1050
`Tel: 650-493-9300
`
`Fax 650-493-6811
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`Page 16 of 16
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