I hereby certify that this correspondence is being filed Via
`EFS-Web with the United States Patent and Trademark Office
`on
`November 22 2016
`
`Attorney Docket N0_: 22773_826_201
`Client Ref N0 _ 1228 US P
`
`WILSON SONSINI GOODRICH & ROSATI
`
`By:
`
`/William D. TronVig/
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`Confirmation No.: 5655
`
`Examiner: Hao D. Mai
`
`Art Unit: 3732
`
`AMENDMENT
`
`Chunhua Li et al.
`
`Application No.: 13/470,681
`
`Filed: May 14, 2012
`
`For: MULTILAYER DENTAL
`
`APPLIANCES AND RELATED
`
`METHODS AND SYSTEMS
`
`Customer No.: 107046
`
`
`
`Mail Stop Amendment
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 223 13— 1450
`
`Commissioner:
`
`In response to the Office Action mailed June 22, 2016, please enter the following
`
`amendments and remarks. The fee for a Petition for Extension of Time of 2 months accompanies
`
`this response.
`
`Amendments to the Claims are reflected in the listing of claims which begins on page 2 of this
`
`paper.
`
`Remarks begin on page 10 of this paper.
`
`Page 1 of 20
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`

`

`Electronic Acknowledgement Receipt
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`“—
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`——
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`——
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`Title of Invention:
`
`MULTILAYER DENTAL APPLIANCES AND RELATED METHODS AND SYSTEMS
`
`Payment information:
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`37 CFR 1.17 (Patent application and reexamination processing fees)
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`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
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`37 CFR 1.16 (National application filing, search, and examination fees)
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`Authorized User
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`Melissa Harwood
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`37 CFR 1.1 9 (Document supply fees)
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`2016_11_22_AMD_DEC_22773
`_826_201.pdf
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`ded372202e74a4b479ae09c5fc6d5803112
`91 f99
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`Affidavit—traversing rejectns or objectns rule 132
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`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)—(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
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`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
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`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
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`If a new international application is being filed and the international application includes the necessary components for
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`

`

`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826.201
`
`REMARKS
`
`Upon entry of this Amendment, claims 1—19 and 30—41 will be pending in the
`
`present application. No claims have been amended. New claims 38—41 have been added. Support
`
`for the amendments can be found in the specification as originally filed. Accordingly, no new
`
`matter has been added. Reconsideration is respectfully requested.
`
`Examiner Interview
`
`Applicants thank Examiners Mai and Rodriguez for participating in an in—person
`
`interview on October 26, 2016. Additional participants in the interview included Applicants’
`
`representatives, Melissa Harwood and Esther Kepplinger, as well as Arthur Hsieh and Chunhua
`
`Li. The Examiner’s rejections of the claims made in a Non—Final Office Action mailed on June
`
`22, 2016, and the submission of a declaration demonstrating the unexpected results of the present
`
`invention were discussed.
`
`
`
`Claim Re'ections — 35 U.S.C. 103
`
`Claims 1—5, 9—15, 18—19, 30—32, and 34—36 stand rejected under pre—AIA 35
`
`U.S.C. § 103(a) as allegedly being obvious over US 2009/0246724 (hereinafter “Chen”) in view
`
`of US 7,641,828 (hereinafter “DeSimone”), and further in view of US 4,791,156 (hereinafter
`
`“Hostettler”) as evidenced by Boedekercom, “Polycarbonate specifications” (hereinafter
`
`“Boedeker”) and plasticsides.com/generics/57/c/t/polyurethane—thermoset—elastomer—tsu—
`
`properties—processing (hereinafter “Plastics”).
`
`In particular, with regard to the hard inner layer, the Examiner asserts that
`
`although “Chen fails to disclose the hard inner polymer layer comprising a co—polyester,” that it
`
`“would have been obvious to one of ordinary skill in the art at the time of invention to utilize the
`
`materials taught by DeSimone to form Chen's hard layer since DeSimone teaches that such
`
`materials are suitable for the intended use of such hard layer with predictable results and/or
`
`reasonable expectation of success.” Office Action at 3—4. With regard to the soft outer layer, the
`
`8490265_6.d0cx
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`Page 10 of 20
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`

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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826201
`
`Examiner asserts that “Chen also discloses that it is well known to use thermoplastic
`
`polyurethane for such appliance.” Id. at 4.
`
`Applicants respectfully disagree with the Examiner’s assertions at least because
`
`(1) the cited references provide no reason to select a polymer of DeSimone for use in Chen; (2)
`
`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 the presently claimed
`
`orthodontic appliances; (3) the presently claimed orthodontic appliances were found to exhibit
`
`unexpectedly good results when compared with the most relevant art; and (4) the presently
`
`claimed orthodontic appliances gave rise to considerable commercial success. These positions
`
`are supported by the present specification and further supported by the attached November 21,
`
`2016 Declaration under 37 C.F.R. § 1.132 of Dr. Chunhua Li (“Li Declaration”), an expert in
`
`materials and biomechanical engineering and a co—inventor of the present application. The Li
`
`Declaration describes the development history and clinical evaluation of appliances comprising
`
`material according to the present claims, which is referred to herein as ST30—a material that has
`
`soft outer layers comprising a thermoplastic polyurethane elastomer and a hard inner layer
`
`comprising a co—polyester—to the prior art, including a thermoplastic polyurethane referred to as
`
`EX30, which was the standard of care prior to the release of ST30.
`
`1. Obvious to Try Rejection—The Examiner Provides No Reason Why the
`
`Skilled Artisan Would Select a Polymer of DeSimone for use in Chen
`
`Independent claims 1 and 13 stand rejected over Chen, DeSimone, and Hostettler,
`
`as evidenced by Boedeker and Plastics. Office Action at 2. Of these, Hostettler, Boedeker, and
`
`Plastics are unrelated to orthodontic, tooth—moving appliances (e.g., Hostettler relates to
`
`dentures), and are used only in relation to flexural modulus and hardness. With regard to Chen
`
`and DeSimone, the Examiner proposes a combination of three different embodiments: the EX30
`
`thermoplastic polyurethane appliance of Chen paragraph [0003], the multilayer
`
`polycarbonate/PVC material of Chen paragraph [0032], and the co—polyester mentioned in
`
`column 5, line 66 of DeSimone. Each embodiment provides only one element of the proposed
`
`combination. Moreover, the Examiner fails to identify any reason why one of ordinary skill
`
`8490265_6.d0cx
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`Page 11 of 20
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`

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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826201
`
`would have selected these elements in combination with one another and the cited references
`
`themselves fail to provide such guidance.
`
`The Examiner improperly relies on Chen for teaching the use of a thermoplastic
`
`polyurethane elastomer as a soft outer layer, however, Chen does not teach the use of a
`
`thermoplastic polyurethane elastomer as a soft outer layer. Chen refers to thermoplastic
`
`polyurethane only in paragraph [0003], discussing the existence of dental appliances consisting
`
`of polymers such as thermoplastic polyurethane. No mention of layered materials is made in
`
`reference to thermoplastic polyurethane elastomer. Neither of the other two paragraphs cited to
`
`in Chen (i.e., paragraphs [0032] and [0036]) discusses the use of a thermoplastic polyurethane
`
`elastomer in a soft (or other) layer. Nor does Chen describe this elsewhere. Thus, contrary to the
`
`Examiner’s assertions, Chen fails to disclose the use of a thermoplastic polyurethane elastomer
`
`as a soft outer layer.
`
`The Examiner improperly uses an “obvious to try” approach and fails to provide
`
`any reason why one of ordinary skill in the art would select a co—polyester material from
`
`DeSimone for use in the multi—layer material of Chen. In fact, DeSimone lists hundreds of
`
`materials, from which the Examiner points to a single reference of “co—polyester.” (DeSimone,
`
`col. 5). Notably, neither Chen nor DeSimone provide any sort of guidance suggesting why one
`
`might select any one of these numerous materials of DeSimone over any other disclosed
`
`material. The references do not provide a finite number of identified, predictable solutions to the
`
`problem and one of ordinary skill in the art could have pursued these known potential solutions
`
`with a reasonable expectation of success. The obvious to try rationale is improper when what
`
`would have been obvious to try would have been to vary all parameters and try each of numerous
`
`possible choices until one possibly arrived at a successful result and where the prior art gave no
`
`indication of which parameters were critical or no direction as to of which of many possible
`
`choices is likely to be successful. In re Kubin (Fed. Cir. 2009). There is no guidance in the
`
`references about which of many choices might be successful. There is no indication that the hard
`
`layers described in DeSimone would have the properties recited in Chen nor any other basis for
`
`selecting them from the list of hundreds of materials. In the absence of any such guidance, the
`
`8490265_6.d0cx
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`Page 12 of 20
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`

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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826201
`
`selection of the co—polyester material from DeSimone for use in Chen represents nothing more
`
`than an “obvious to try” rationale or impermissible hindsight bias.
`
`2. N0 Expectation of Success
`
`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 presently
`
`claimed orthodontic appliances at least because of the high level of unpredictability in the art and
`
`the lack of guidance provided in Chen and DeSimone suggesting which material combinations
`
`should be used to produce a sufficient multi—layer orthodontic appliance.
`
`Over the course of more than seven years, Applicants worked diligently to
`
`develop a suitable, improved appliance that would meet various criteria for effective orthodontic
`
`treatment. Li Declaration at ‘][4. This development process was neither easy nor straightforward.
`
`During the development process, Applicants evaluated, in an iterative fashion, more than 250
`
`distinct materials and/or material combinations for possible use in an improved appliance device.
`
`After years of development, Applicants produced the SmartTrackTM material (also referred to
`
`herein as “ST30”), which is a product according to the instant claims comprising a layered
`
`material with a hard co—polyester layer between two soft layers of thermoplastic polyurethane
`
`elastomer. The intent of this testing was to identify a suitable replacement for Align
`
`Technology’s single—layer, thermoplastic polyurethane appliance product (referred to herein as
`
`“EX30”), which was the standard of the care for plastic tooth moving appliances at the time of
`
`filing, and the materials were evaluated on this basis. Id. at ‘JI‘JI4—6. From among those over 250
`
`materials tested, only the materials of the present claims met Align’s criteria for a multi—layer
`
`orthodontic appliance. Id. at ‘JI‘JI4—5. The tested materials included many multi—layer (e.g., three—
`
`layer) materials, yet of those tested only the materials of the present claims proved capable of
`
`performing at a level sufficient to meet Align’s criteria for an orthodontic appliance, and thus as
`
`a suitable replacement for EX30. Id. at ‘][6.
`
`Data obtained by Applicants during the development of the SmartTrack material
`
`provides significant evidence of the unpredictability in the art and the unexpected effectiveness
`
`of the presently claimed orthodontic appliances. Li Declaration at ‘][7. As mentioned above, the
`
`8490265_6.d0cx
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`Page 13 of 20
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`

`

`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826201
`
`presently claimed multi—layer, multi—material orthodontic appliances were developed during
`
`more than seven years of diligent evaluation of over 250 materials, including numerous iterations
`
`in which materials were tested and compared, with the results used to design new materials. Id.
`
`at 4. It was clear from many of the materials tested, including those from the Chen and
`
`DeSimone, that such materials were not effective alone or in combination to provide the
`
`improvements sought. Id. at ‘][5. During those evaluations, Applicants determined that only the
`
`combinations of materials of the instant claims met Align’s development criteria. Id. at 5. It was
`
`not a simple or predictable process to identify those materials that would work together to create
`
`the multi—layer apparatus which provided the unexpectedly good results. Among those 250
`
`materials tested were more than 180 materials either generically or specifically described in
`
`Chen and/or DeSimone, including various copolymers (see, e.g., Chen at [0036]) and unblended
`
`polysulfones (DeSimone at 6:47—59), as well as styrenic polymer materials such as acrylonitrile—
`
`butadiene—styrene (ABS) (id. at 6:24—37). Li Declaration at ‘][5. Specifically, none of the 23 co—
`
`polymers that were tested during the iterative development process met Align’s criteria. Id.
`
`Similarly, none of the styrenic polymers nor unblended polysulfones tested met Align’s criteria.
`
`Id. Thus none of these materials would have yielded an orthodontic device having sufficient
`
`modulus of elasticity, elongation, time stress—relaxation, durability, and thermoform ability. Id.
`
`Inventor Li had extensive knowledge of the teachings of Chen and DeSimone at
`
`the time of filing, and yet it still took her team many years to identify a suitable material.
`
`Inventor Li is also listed as a co—inventor of Chen, and thus she was thus intimately familiar with
`
`the teachings of Chen during the development of the presently claimed orthodontic appliances.
`
`Inventor Li also collaborated closely with Joseph M. DeSimone and Robert E. Tricca (the
`
`inventors listed on DeSimone) while they were developing and patenting the technology
`
`described in DeSimone. Li Declaration at ‘][9. She was thus very aware of the teachings of
`
`DeSimone during the development of the presently claimed orthodontic appliances. Even with
`
`her extensive knowledge of the teachings of Chen and DeSimone, it took her team over seven
`
`years to identify a suitable combination of polymers for use in the claimed multi—layer
`
`orthodontic appliances. Id. Thus, one of ordinary skill in the art having far less knowledge of the
`
`teachings of Chen and DeSimone would not have had a reasonable expectation of success in
`
`8490265_6.d0cx
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`Page 14 of 20
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`

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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826201
`
`producing the presently claimed orthodontic appliances based on the teachings of Chen,
`
`DeSimone and Hostettler. Id. at ‘][10.
`
`During the course of their evaluations, Applicants determined that merely
`
`combining the materials into multiple layers was insufficient to improve performance relative to
`
`the EX30 material. Id. at ‘][6—7. In fact, many three—layer materials tested proved inferior to the
`
`EX30 material. These three—layer materials included combinations of materials disclosed in Chen
`
`and/or DeSimone. Id. In particular, the sole exemplified multi—layer material described in Chen
`
`would not be expected to show improved performance relative to EX30. For example, Chen
`
`paragraph [0032] describes a material containing polycarbonate and polyvinyl chloride (PVC);
`
`however, PVC was later evaluated by Applicants and found to be unsuitable for use in
`
`orthodontic aligners due to its inadequate durability. Id. Based on these tests, Applicants
`
`determined that materials containing PVC, either alone or in a multi—layer configuration, would
`
`be inferior to EX30. Id. For these reasons, a person of ordinary skill would not necessarily expect
`
`the addition of multiple material layers, either in general or as particularly described in Chen, to
`
`achieve performance superior to EX30.
`
`Based on the unpredictability exhibited in the Applicants’ material evaluations, a
`
`person of ordinary skill in the art would not have had a reasonable expectation of success in
`
`producing an effective orthodontic appliance by combining materials from Chen and DeSimone
`
`to arrive at the appliances described in the present claims. Id. at ‘][‘][7—10.
`
`3. Unexpected Results
`
`Applicants have also established that the presently claimed appliances are
`
`unexpectedly superior to the most relevant art. The Li Declaration describes two clinical studies
`
`comparing appliances made from the prior art material described in paragraph [0003] of Chen—
`
`a thermoplastic polyurethane called EX30—to appliances made of a multilayer material, called
`
`ST30, that has soft outer layers comprising a thermoplastic polyurethane elastomer and a hard
`
`inner layer comprising a co—polyester. Li Declaration at ‘JI‘JIl 1—16.
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`8490265_6.d0cx
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`Page 15 of 20
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`

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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826201
`
`As described in the Li Declaration, each study found that ST30 appliances
`
`provided strongly superior performance. In the first study described, a group of 1,015 patients
`
`treated with ST30 appliances for five months were 26% more likely than equivalent patients
`
`treated with EX30 appliances to have their teeth respond to treatment as intended. Id. at ‘JI‘JI13—14.
`
`This result establishes the superiority of ST30 to EX30 to a high degree of statistical significance
`
`(p < 0.001). Id. at ‘][14. A second study of 110,000 cases confirmed these findings, demonstrating
`
`strongly significant (p < 0.001) improvements in predictability in tooth movement for 14
`
`different movement types. Id. at ‘][15, Appendix B. Overall, patients treated with ST30 appliances
`
`showed a 75% improvement in tooth movement predictability over patients treated with EX30
`
`appliances. Id. at ‘][16. This surprising improvement would not have been predicted by a person
`
`of ordinary skill in the art. Id.
`
`The unexpected results described above are commensurate in scope with
`
`independent claims 1, 13, and 38. Each claim describes orthodontic appliances with a hard co—
`
`polyester layer between soft layers of thermoplastic polyurethane elastomer. This corresponds to
`
`the material tested in the studies, ST30. Li Declaration at M4, 11. Accordingly, the unexpected
`
`results demonstrated by the studies, as described in the Li Declaration, correspond to the present
`
`claims.
`
`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 ST30 and as of the present filing date, and a person of ordinary skill would have considered it
`
`the closest relevant art. Thus, the skilled artisan would consider the superiority of the presently
`
`claimed orthodontic appliances relative to EX30 to be predictive of similar superiority of ST30
`
`relative to other prior art appliances. Li Declaration at ‘][16. During the course of Applicants’
`
`evaluations, they determined that merely combining the materials into multiple layers was
`
`insufficient to improve performance relative to the EX30 material. Id. at ‘JI6 In fact, many three—
`
`layer materials tested proved inferior to the EX30 material. Id. Based on these evaluations, none
`
`of these inferior multi—layer materials would be expected to achieve performance comparable to
`
`8490265_6.d0cx
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`Page 16 of 20
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`

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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826201
`
`EX30, much less to exceed the performance of EX30. Because the EX30 material was the
`
`standard of care during Applicants’ development of the SmartTrack material and was superior to
`
`many three—layer materials tested, the EX30 material should be considered a proper comparison
`
`for assessing unexpected results. See MPEP 716.02(e)(I) (“Applicants may compare the claimed
`
`invention with prior art that is more closely related to the invention than the prior art relied upon
`
`by the examiner”) Additionally, it is not a trivial matter to conduct a clinical trial. It requires
`
`regulatory approval and a considerable amount of time and thus cannot be done for any or all
`
`materials. Accordingly, because the test comparison provided compares the standard of care (the
`
`material commercially being utilized), it should be accepted as the appropriate comparison
`
`for demonstrating unexpected results.
`
`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 that the presently claimed appliances produce unexpectedly positive results
`
`relative to the closest relevant art.
`
`4. Commercial Success
`
`In addition to the comparative, developmental, and clinical data presented above,
`
`the commercial success of appliances comprising the ST30 material as set forth in the present
`
`claims provides further evidence of their non—obviousness. Prior to the Applicants’ development
`
`of the ST30 material, the primary appliance material in the orthodontic market was EX30. Li
`
`Declaration at ‘][18. Upon establishing the superiority of ST30 appliances relative to EX30
`
`appliances, Align Technology switched virtually all new appliance manufacturing to ST30 over
`
`the course of only a few months. Id. Thereafter, ST30 appliances captured over 90% of the total
`
`US market for clear plastic orthodontic appliances. 1d,; see also Baird 2014 Analyst Report at 6,
`
`Baird Q3 2013 Report at 9 (submitted herewith in an accompanying IDS). This striking
`
`commercial success was due to the superior performance of ST30 appliances to EX30 and other
`
`appliances on the market. Li Declaration at (HIS—l9.
`
`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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`Page 17 of 20
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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826.201
`
`successful product is the invention disclosed and claimed in the patent, it is presumed that the
`
`commercial success is due to the patented invention.” Graffech Int’l Holdings, Inc. v. Laird
`
`Techs. Inc., No. 2015-1796, 652 Fed. Appx. 973, 978-79 (Fed. Cir. June 17, 2016) (quoting J. T.
`
`Eaton & Co. v. Atl. Paste & Glue C0., 106 F.3d 1563, 1571 (Fed. Cir. 1997)). As appliances
`
`made of the ST30 material are appliances as disclosed and claimed, 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
`
`ST30 appliances is due to the appliances’ superior performance. An analysis by Stifel, Nicolaus
`
`& Company, Inc. shortly after the introduction of ST30 concluded that the introduction of
`
`SmartTrack (ST30 material) appliances resulted in an increase from 59% to 63% in the total
`
`addressable market for orthodontic malocclusions. Stifel 4Ql3 Report at 6 (submitted herewith
`
`in an accompanying IDS). 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, ST30 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 ST30 appliances according to
`
`the present claims provides evidence of the claims’ non—obviousness.
`
`Independent claims 1, l3, and 38 are not obvious over the combination of Chen,
`
`DeSimone, and Hostettler, as evidenced by Boedeker, and Plastics for at least the reasons
`
`described above. Claims 2—5, 9—15, 19, 30—32, 34—36, and 39—41 depend from claims 1, l3, and
`
`38 respectively, and are therefore allowable for similar reasons, as well as on their own merits.
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`8490265_6.docx
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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
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`Attorney Docket No.2 22773-826201
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`Accordingly, for the reasons set forth above, withdrawal of the rejection of claims
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`1-5, 9—15, 18—19, 30—32, and 34—36 under pre—AIA 35 U.S.C. § 103(a) is respectfully requested.
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`Claims 6—8, 16—17, 33, and 37 stand rejected under pre—AIA 35 U.S.C. § 103(a) as
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`being unpatentable over Chen in view of DeSimone and Hostettler, as applied to claims 1 and 13
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`above, and further in view of U.S. Pub. No. 2010/0055639 (hereinafter “Lewis”).
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`Lewis fails to remedy the deficiencies of Chen, DeSimone, and Hostettler as
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`described above. Accordingly, as claims 6—8, 16—17, 33, and 37 depend respectively from
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`allowable claims 1 and 13, they are allowable for similar reasons, as well as on their own merits.
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`Accordingly, for the reasons set forth above, withdrawal of the rejection of claims
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`6-8, 16—17, 33, and 37 under pre—AIA 35 U.S.C.§ 103(a) is respectfully requested.
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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
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`Attorney Docket No.2 22773-826201
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`CONCLUSION
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`In view of the foregoing, Applicants believe all claims now pending in this
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`Application are in condition for allowance. The issuance of a formal Notice of Allowance at an
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`early date is respectfully requested.
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`Further, the Commissioner is hereby authorized to charge any additional fees or
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`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
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`this application, please telephone the undersigned at 206—883—2500.
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`Dated: November 22, 2016
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`/Melissa M. Harwood/
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`Respectfully submitted,
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`Melissa M. Harwood, Ph.D.
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`Registration No. 60,229
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`WILSON SONSINI GOODRICH & ROSATI
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`650 Page Mill Road
`Palo Alto, CA 94304—1050
`Tel: 650—493—9300
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`Fax 650—493—6811
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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
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`Amendments to the Claims:
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`Attorney Docket No.2 22773-826201
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`This listing of claims will replace all prior versions, and listings of claims in the application:
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`Listing of Claims:
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`1.
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`(Previously Presented) A removable orthodontic tooth positioning
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`appliance having teeth receiving cavities shaped to directly receive at least some of a patient's
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`teeth and apply a resilient positioning force to the patient's teeth, the appliance comprising:
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`a hard inner polymer layer comprising a co—polyester and having a hard polymer
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`layer elastic modulus; and
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`a first soft outer polymer layer and a second soft outer polymer layer each
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`comprising a thermoplastic polyurethane elastomer and each having a soft polymer elastic
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`modulus less than the hard polymer layer elastic modulus, a flexural modulus of greater than
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`about 35,000 psi, a hardness of about 60A to about 85D, and a thickness in a range from 25 um
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`to 100 um,
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`wherein the hard inner polymer layer is disposed between the first soft outer
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`polymer layer and the second soft outer polymer layer so as to reduce degradation of the resilient
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`positioning force applied to the teeth when the appliance is worn.
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`2.
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`(Previously Presented) The appliance of claim 1, wherein the hard inner
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`polymer layer comprises a blend of polymeric materials including the co—polyester and one or
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`more of: a polyester, a thermoplastic polyurethane, a polypropylene, a polyethylene, a
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`polypropylene and polyethylene copolymer, an acrylic, a polyetheretherketone, a polyamide, a
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`polyethylene terephthalate, a polybutylene terephthalate, a polyetherimide, a polyethersulfone, a
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`polytrimethylene terephthalate, or a combination thereof.
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`3.
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`(Previously Presented) The appliance of claim 1, wherein the hard inner
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`polymer layer comprises a plurality of co—extruded or laminated polymer layers.
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`Appl. No. 13/470,681
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
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`Attorney Docket No.2 22773-826201
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`4.
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`(Previously Presented) The appliance of claim 1, wherein the hard inner
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`polymer layer comprises at least two layers including a first layer comprising the co—polyester
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`and a second layer comprising one or more of: a polyester, a co—polyester, a thermoplastic
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`polyurethane, a polypropylene, a polyethylene, an acrylic, a polyetheretherketone, a polyamide, a
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`polyethylene terephthalate, a polybutylene terephthalate, a polyetherimide, a polyethersulfone, or
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`a polytrimethylene terephthalate.
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`5.
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`(Previously Presented) The appliance of claim 1, wherein the hard inner
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`polymer layer has a thickness in a range from 400 um to 1100 um.
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`6.
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`(Previously Presented) The appliance of claim 1, wherein each of the first
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`soft outer polymer layer and the second soft outer polymer layer comprises a blend of polymeric
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`materials including the thermoplastic polyurethane elastomer and one or more of: a silicone
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`rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV)
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`elastomer, a polyolefin blend elastomer, a thermoplastic co—polyester elastomer, a thermoplastic
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`polyamide elastomer, or a combination thereof.
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`7.
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`(Previously Presented) The appliance of claim 1, wherein each of the first
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`soft outer polymer layer and the second soft outer polymer layer comprises a blend of polymeric
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`materials including the thermoplastic polyurethane elastomer and one or more of: an elastomeric
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`alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a
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`thermoplastic co—polyester elastomer, or a polyester elastomer.
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`8.
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`(Previously Presented) The appliance of claim 1, wherein at least one of
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`the first soft outer polymer layer and the second soft outer polymer layer comprises at least two
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`layers including a first layer comprising the thermoplastic polyurethane elastomer and a second
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`layer selected from the group consisting of: a silicone rubber, an elastomeric alloy, a
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`thermoplastic elastomer (TPE), a th