www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`16/382,918
`
`04/12/2019
`
`ChunhuaLI
`
`22773-826.305
`
`8094
`
`Align Technology, Inc. / WSGR
`650 Page Mill Road
`Palo Alto, CA 94304
`
`MAI, HAO D
`
`PAPER NUMBER
`
`ART UNIT
`
`3772
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/20/2021
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`patentdocket @ wsgr.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Office Action Summary
`
`Application No.
`16/382,918
`Examiner
`HAO D MAI
`
`Applicant(s)
`Lletal.
`Art Unit
`3772
`
`AIA (FITF) Status
`No
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133}.
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`
`
`1) Responsive to communication(s) filed on 08/09/2021.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)L) This action is FINAL. 2b)¥)This action is non-final.
`3)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4\0) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`1,5,7,9-13,17,19-25 and 29-41 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 20-25 and 29-30 is/are withdrawn from consideration.
`() Claim(s)__ is/are allowed.
`Claim(s) 1,5,7,9-13,17,19 and 31-41 is/are rejected.
`S)
`) © Claim(s)___is/are objected to.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)() The drawing(s) filedon__ is/are: a)C) accepted or b)C) objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12). Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`cc) None ofthe:
`b)L) Some**
`a)D) All
`1.1) Certified copies of the priority documents have been received.
`2.1) Certified copies of the priority documents have been received in Application No.
`3.2.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) ([] Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20200325
`
`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Page2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`The present application is being examined under the pre-AlA first to invent provisions.
`
`Priority
`
`2.
`
`The later-filed application must be an application for a patent for an invention whichis
`
`also disclosed in the prior application (the parent or earlier-filed nonprovisional application or
`
`provisional application for which benefit is claimed). The disclosure of the invention in the
`
`parent application and in the later-filed application must be sufficient to comply with the
`
`requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the
`
`best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d
`
`551, 32 USPQ2d 1077 (Fed. Cir. 1994).
`
`The originally-filed disclosures of the prior-filed applications, Application Nos.
`
`16/043,065, 15/476622, and 13/470,681, all fail to provide adequate support or enablement in
`
`the mannerprovided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or
`
`moreclaims of this application. The disclosuresof all the abovelisted prior-filed applications
`
`are directed to an appliance comprising at least three layers: a hard polymer layer 24 disposed
`
`between two soft polymerlayers 22, 26 (Fig. 2).
`
`i.
`
`Independent claims 1, 13, and 33, each broadly recites “An orthodontic
`
`appliance... comprising: a first outer polymer layer comprising co-polyester and a
`
`second outer polymer layer comprising co-polyester...; and an inner polymerlayer
`
`comprising thermoplastic polyurethane”.
`
`The claim effectively omits (i) two distinguishable soft layers, (ii) a distinguishable
`
`hard layer, and(iii) the arrangement of the hard layer being positioned between two soft
`
`layers. Such omissions amount to a broader and more generic invention. There is no
`
`support from the prior-filed applications for such broadening scopeof the instant claims.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Page3
`
`ii
`
`The prior-filed applications disclose large Markush Groupsfor:
`
`(#1) the materials for the two soft layers (paragraph 28);
`
`(#2) the materials for the hard layer (paragraph 27);
`
`(#3) the properties of the soft layer (paragraph 29); and
`
`(#4) the properties of the hard layer (paragraph 26).
`
`Claims 1, 13, and 33, each recites a combination of a small subset in each of
`
`said four (4) Markush Groups. For example, claim 33 recites: the first and second outer
`
`layers each comprising co-polyester (only one subset of the Markush Group #1); the
`
`inner polymer layer comprising thermoplastic polyurethane (only one subsetof the
`
`Markush Group #2); the first and second outer layers each hasa flexural modulus of
`
`greater than about 35,000 psi (only one subset of Markush Group #3); and “the inner
`
`polymer layer having an elongation at break of greater than about 70% (only one subset
`
`of Markush Group #4.
`
`There is no support from the prior-filed applications for such specifically claimed
`
`combination of the specifically claimed subset from each of four (4) Markush
`
`Groups, which is thus considered to be new matter. See Purdue Pharma L.P. v.
`
`Faulding Inc., 230 F.3d 1320, 1326, 56 USPQ2d 1481, 1486 (Fed. Cir. 2000),
`
`and In re Ruschig 379 F.2d 990, 154 USPQ 118 (CCPA 1967). The court noted
`
`that with respect to In re Ruschig that “Ruschig makesclear that one cannot
`
`disclose a forest in the original application, and then later pick a tree out of the
`
`forest and say “here is my invention’.
`
`In order to satisfy the written description
`
`requirement, the blaze marksdirecting the skilled artisan to that tree must bein
`
`the originally filed disclosure.” In this case, the prior-filed applications fail to indicate
`
`blaze marks (e.g. embodiment or preferred embodiment) directing the skilled artisan to
`
`the specifically claimed combination of the material(s) and/or the properties of the layers.
`
`Therefore, all claims 1, 3-7, 9-13, 15-18, and 34-42, are not entitled to the priority
`
`benefit of any of said abovelisted parent applications. Accordingly, for purpose of examination
`
`underthe prior art, all claims 1, 3-7, 9-13, 15-18, and 34-42, are considered to haveearliest
`
`filing date of 04/12/2019.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Page4
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine groundedin public
`3.
`policy (a policy reflected in the statute) so as to preventthe unjustified or improper timewise extension ofthe “right to
`exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double
`patenting rejection is appropriate where the conflicting claims are notidentical, but at least one examined application
`claim is not patentably distinct from the reference claim(s) because the examinedapplication claim is either
`anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46
`USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759
`F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); in re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re
`Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321(d) may be used to overcome
`an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent
`either is shown to be commonly owned with the examined application, or claims an invention made as a result of
`activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to
`examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§
`706.02(1)(1) - 706.02(1}(3) for applications not subject to examination under the first inventor to file provisions of the
`AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
`The USPTOInternet website contains terminal disclaimer forms which maybe used. Please visit
`www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form
`(e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may
`befilled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-
`processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to
`www.uspto.gov/patents/process/file/efs/quidance/eTD-info-l.jsp.
`
`4.
`
`Claims1, 5, 7, 9-13, 17, 19, and 31-41, are rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over:
`
`- Claims 1-31 of U.S. Patent No. 9,655,691;
`
`- Claims 1-20 of U.S. Patent No. 9,655,693; and
`
`- Claims 1-14 of U.S. Patent No. 10,052,176.
`
`Although the claims at issue are notidentical, they are not patentably distinct from each
`
`other becausethe difference between the application claims and the patentclaims lies in the
`
`fact that the patent claims include more elements and are thus muchspecific. Thus the
`
`invention of the patent claims are in effect a “species” of the “generic” invention of the
`
`application claims. It has been held that the generic invention is “anticipated” by the “species”.
`
`See /n re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are
`
`anticipated by the patent claims, they are not patentably distinct from the patent claims.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Page5d
`
`Claim Rejections - 35 USC § 112(a)
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`(a) INGENERAL.—The specification shall contain a written description of the
`invention, and of the manner and process of making and usingit, in suchfull, clear, concise,
`and exact terms as to enable any person skilled in the art to which it pertains, or with whichit
`is most nearly connected, to make and use the same, and shall set forth the best mode
`contemplated by the inventor or joint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`The specification shall contain a written description of the invention, and of the
`manner and process of making and usingit, in suchfull, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with whichit is most nearly
`connected, to make and use the same, and shall set forth the best mode contemplated by the
`inventor of carrying out his invention.
`
`6.
`
`Claims1, 5, 7, 9-13, 17, 19, and 31-41, are rejected under 35 U.S.C. 112(a) or
`
`35 U.S.C. 112 (pre-AlA), first paragraph, as failing to comply with the written description
`
`requirement. The claim(s) contains subject matter which was not described in the specification
`
`in such a wayas to reasonably convey to one skilled in the relevant art that the inventor or a
`
`joint inventor, or for pre-AlA the inventor(s), at the time the application wasfiled, had possession
`
`of the claimed invention.
`
`i.
`
`Claims 1, 13, and 33, each broadly recites “An orthodontic appliance...
`
`comprising: a first outer polymerlayer comprising co-polyester and a second outer
`
`polymer layer comprising co-polyester...; and an inner polymer layer comprising
`
`thermoplastic polyurethane”.
`
`The claim effectively omits (i) two distinguishable soft layers, (ii) a distinguishable
`
`hard layer, and(iii) the arrangement of the hard layer being positioned between twosoft
`
`layers. Such omissions amount to a broader and more generic invention. There is no
`
`support from Applicant’s specification for such broadening scope of the claims, thus
`
`rendering the claims asfailing to comply with the written description requirement.
`
`Regarding the distinguishable layers, note that the specification indicates that a
`
`soft polymer layer can include a co-polyester and/or a thermoplastic polyurethane
`
`(Specification paragraphs 27 and 30); and a hard polymerlayer can also include the
`
`same materials - a co-polyester and/or a thermoplastic polyurethane (Specification
`
`paragraphs 26, 30). As such, the recited “first and second outer layers comprising co-
`
`polyester” and “an inner polymer layer comprising thermoplastic polyurethane” do not
`
`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Page6
`
`positively distinguish the “first and second outer polymer layers” from “an inner polymer
`
`layer’.
`
`Regarding the omission of the essential arrangement of the hard layer being
`
`positioned between two soft layers, note that the original specification does not define
`
`what is considered to be “outer” and “inner”. Therefore, the recited terms “outer” and
`
`“inner” allow for broadest reasonable interpretation(s), e.g. the first and the second outer
`
`polymer layers are positioned exteriorly-distal from the teeth, wherein the inner polymer
`
`is positioned interiorly-proximate to the teeth. The specification does not have support
`
`for such arrangement- first and second adjacent outer layers, and an innerlayer.
`
`Another possible interpretation is the that first and second outer polymer are
`
`arranged exteriorly, i.e. buccally toward the teeth surfaces facing exteriorly of the mouth;
`
`and the inner polymer is arrangedinteriorly, i.e. lingually toward the teeth surfaces facing
`
`interiorly of the mouth. The specification does not have support for such arrangement.
`
`ii
`
`The application’s specification discloses large Markush Groupsfor:
`
`(#1) the materials for the two soft layers (paragraph 28);
`
`(#2) the materials for the hard layer (paragraph 27);
`
`(#3) the properties of the soft layer (paragraph 29); and
`
`(#4) the properties of the hard layer (paragraph 26).
`
`Claims 1, 13, and 33, each recites a combination of a small subset in each of
`
`said four (4) Markush Groups. For example, claim 33 recites: the first and second outer
`
`layers each comprising co-polyester (only one subset of the Markush Group #1); the
`
`inner polymer layer comprising thermoplastic polyurethane (only one subsetof the
`
`Markush Group #2); the first and second outer layers each has a flexural modulus of
`
`greater than about 35,000 psi (only one subset of Markush Group #8); and “the inner
`
`polymer layer having an elongation at break of greater than about 70% (only one subset
`
`of Markush Group #4.
`
`There is no support from the original disclosure for such specifically claimed
`
`combination of the specifically claimed subset from each of four (4) Markush Groups,
`
`whichis thus considered to be new matter. See Purdue Pharma L.P. v. Faulding Inc.,
`
`230 F.3d 1320, 1326, 56 USPQ2d 1481, 1486 (Fed. Cir. 2000), and In re Ruschig 379
`
`F.2d 990, 154 USPQ 118 (CCPA 1967). The court noted that with respect toInre
`
`Ruschig that “Ruschig makes clear that one cannot disclose a forestin the original
`
`application, and then later pick a tree out of the forest and say “here is my invention’.
`
`In
`
`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Page7
`
`orderto satisfy the written description requirement, the blaze marks directing the skilled
`
`artisan to that tree mustbe in the originally filed disclosure.” In this case, the original
`
`disclosurefail to indicate blaze marks (e.g. embodiment or preferred embodiment)
`
`directing the skilled artisan to the specifically claimed combination of the materials
`
`and/or the properties of the layers.
`
`All dependent claims are rejected herein based on dependencyof the base claims 1, 13,
`
`and 33, rejected herein.
`
`Claim Rejections - 35 USC § 112(b)
`
`The following is a quotation of 35 U.S.C. 112(b):
`
`(b) CONCLUSION.—The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or moreclaims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`8.
`
`Claims 1, 5, 7, 9-13, 17, 19, and 31-41, are rejected under 35 U.S.C. 112(b) or
`
`35 U.S.C. 112 (pre-AlA), second paragraph, as being indefinite for failing to particularly point out
`
`and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AlA the
`
`applicant regards asthe invention.
`
`Claims 1, 13, and 33, each is incomplete for omitting essential elements, such omission
`
`amounting to a gap between the elements, rendering the claim indefinite. See MPEP
`
`§ 2172.01. The omitted elements are: distinguishable first and second outer layers as
`
`soft layers and distinguishable inner layer as hard layer. Note that the specification
`
`indicates that a soft polymerlayer can include a co-polyester and/or a thermoplastic
`
`polyurethane (Specification paragraphs 27 and 30); and a hard polymerlayer can also
`
`include the same materials - a co-polyester and/or a thermoplastic polyurethane
`
`(Specification paragraphs 26, 30). As such, the recited “first and second outerlayers
`
`comprising co-polyester” and “an inner polymer layer comprising thermoplastic
`
`polyurethane’ do notpositively distinguish the “first and second outer polymerlayers”
`
`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Pages
`
`from “an inner polymerlayer’, and do not convey“soft layers” and “hard layer”
`
`respectively.
`
`«" Claims 1, 13, and 33, each is incomplete for omitting essential structural cooperative
`
`relationships of elements, such omission amounting to a gap between the necessary
`
`structural connections, rendering the claims indefinite. See MPEP § 2172.01. The
`
`omitted structural cooperative relationships are: structural cooperative relationship(s)
`
`between the first outer polymer layer, the second outer polymer layer, and the inner
`
`polymer layer.
`
`That is, the claims omit the specifically disclosed arrangement of the hard
`
`polymer 24 layer being an inner hard layer disposed betweentwosoft polymer layers 22,
`
`26, as shownin Fig. 2, Specification paragraphs [0021], [0024], [0025].
`
`Note that specification does not define what is considered to be “outer” and
`
`“inner”. Therefore, the terms “outer” and “inner” do not conveydefinite position(s) of the
`
`layers. The recited terms “outer” and “inner” allow for broadest reasonable
`
`interpretation(s), e.g. the first and the second outer polymerlayers are positioned
`
`exteriorly-distal from the teeth, wherein the inner polymer is positioned interiorly-
`
`proximate to the teeth. Another possible interpretation is the that first and second outer
`
`polymer are arrangedexteriorly, i.e. buccally toward the teeth surfaces facing exteriorly
`
`of the mouth; and the inner polymer is arrangedinteriorly, i.e. lingually toward the teeth
`
`surfaces facing interiorly of the mouth.
`
`All dependent claims are rejected herein based on dependencyof the base claims 1, 13,
`
`and 33, rejected herein.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all
`9.
`obviousnessrejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as
`set forth in section 102 ofthis title, if the differences between the subject matter sought to be
`patented and the prior art are such that the subject matter as a whole would have been obvious at
`the time the invention was made to a person having ordinary skill in the art to which said subject
`matter pertains. Patentability shall not be negatived by the manner in which the invention was
`made.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Page9
`
`10.
`
`Claims1, 5, 7, 9-13, 17, 19, and 31-41, are rejected under pre-AlA 35 U.S.C. 103(a)
`
`as being unpatentable over Chenet al. (US 2009/0246724 A1) in view Hostettler (US
`
`4,791,156) and DeSimoneetal. (US 7,641,828), as evidenced by Plastics (non-patent
`
`literature No. 107 in IDS filed 02/04/2019).
`
`Regarding claim 1, Chen discloses a removable orthodontic tooth positioning appliance
`
`100 having teeth receiving cavities 102 shaped to directly receive at least some of a patient's
`
`teeth 114 and apply a resilient positioning force to the patient's teeth (Fig. 1, paragraph 4). The
`
`appliance 100 comprises: a first and second outer polymer layers 134 comprising first and
`
`second polymeric materials; and an inner polymerlayer 132 comprising a third polymeric
`
`material (Fig. 4C; paragraphs 3, 32, 36).
`
`Regarding the first and second outer polymerlayers as claimed in claims 1, 5, 7, and
`
`31, Chenis silent to its ultimate tensile strength, elongation at break, and hardness, as claimed.
`
`However, note that Chen disclosesthatit is well known to use polymeric material such as
`
`thermoplastic polyurethane (paragraphs 3, 21-22). Hostettler teaches that it is well known that
`
`multilayer polymeric dental appliance (column 2 lines 33-38), includes a hard layer of hardness
`
`about “60D-100D” (column 2 lines 22-26, 34-35), and a separate soft layer of polyurethane
`
`elastomer having a hardness of “not greater than about 65A” (column 2 lines 36-44) which at
`
`least overlaps with the claimed range of hardness of about 60A to about 85D.
`
`It would have
`
`been obvious to one of ordinary skill in the art at the time of invention to use soft polyurethane
`
`elastomer for the soft polymer layers of Chen as taught by Hostettler in order to provide a soft
`
`layer which providestissue relief, is inexpensive, trouble-free, and easy to keep clean (column1
`
`lines 40-41, 50-59). Hostettler also discloses the material having certain tensile strength and
`
`elongation % (Table 1), indicating that such variables are of result-effective variables. The
`
`Plastics document showsthat polyurethane elastomer has an elongation at break of 75 to
`
`1400% which overlaps with the claimed range of greater than about 200%, and a hardnessof
`
`14 to 96 D which overlaps with the claimed range of 60 A to about 85 D. Therefore, such
`
`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Page10
`
`claimed range would have been obvious to one having ordinary skill in art at the time the
`
`invention was madesince it has been held that discovering an optimum or workable rangesis
`
`well within the skill of an artisan via routine experimentation in order to improve upon whatis
`
`already generally known. See MPEP §§ 2144.05.
`
`Regarding the inner polymerlayer as claimed in claims 1, 9-10, and 12, Chenfails to
`
`disclose the hard polymer layer comprising a co-polyester and having the specifically claimed
`
`characteristics. DeSimone et al. discloses a polymer orthodontic appliance 10 madeof co-
`
`polyesters and blends (column 5 lines 66-67). DeSimone also teaches that polyester,
`
`thermoplastic polyurethane, acrylic, polyamide, or polyetherimide (col. 6 Il. 47-59), polyethylene
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`terephthalate, or polybutylene terephthalate (col. 7 Il. 24-31) may be used for hard layers (col. 6
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`Il. 47-59: polymeric materials with high glass transition temperatures). It would have been
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`obvious to one of ordinaryskill in the art at the time of invention to utilize the materials taught by
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`DeSimone to form Chen's hard layer since DeSimone teaches that such materials are suitable
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`for the intended use of such hard layer with predictable results and/or reasonable expectation of
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`success. DeSimone also discloses such hard polymer layer comprising tensile modulus greater
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`than 200,000 psi, a tensile strength at yield of greater than 8,800 psi, elongation at yield of
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`greater than 4%, elongation at break of greater than 80%, a flexural modulus of greater than
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`200,000 psi, stress relaxation of not more than 50%, and light transmission between 400 nm
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`and 800 nm of greater than 75% (column 2 lines 5-16), which ranges overlapping with or
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`indicating that the claimed rangesare of result-effective variables. Therefore, such claimed
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`range would have been obvious to one having ordinary skill in art at the time the invention was
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`made since it has been held that discovering an optimum or workable rangesis well within the
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`skill of an artisan via routine experimentation in order to improve upon whatis already generally
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`known. See MPEP §§ 2144.05.
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`Asto claim 11, Chen discloses the appliance and the layers therein may have certain
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`thicknesses (paragraphs 30-31), indicating that such thicknessis of result-effective variable.
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`

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`Application/Control Number: 16/382,918
`Art Unit:3772
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`Page11
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`Therefore, such claimed range of thickness would have been obvious to one having ordinary
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`skill in art at the time the invention was madesince it has been held that discovering an
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`optimum or workable rangesis well within the skill of an artisan via routine experimentation in
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`order to improve upon whatis already generally known. See MPEP §§ 2144.05.
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`Regarding claims 13, 17, 19, and 32, Chen discloses a plurality of such incremental
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`tooth position adjustment appliances 100, where the appliances are successively worn by a
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`patient to move teeth from one arrangement to a successive arrangement(paragraphs 14-15).
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`Chen/Hostettler/DeSimone discloses the elements as claimed as detailed above with respectto
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`claims 1-12).
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`Regarding claims 33-41, Chen/Hostettler/DeSimone discloses the elements as claimed
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`as detailed above with respect to claims 1, 5, 7, 9-12, and 31, as detailed above.
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`Response to Arguments
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`11.
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`Applicant's arguments filed 10/28/2019 have been fully considered. Regarding the 35
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`USC § 103 ground(s) of rejection underprior art, Applicant argue that (1) the cited references
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`provide no reason to select a polymer of DeSimone for use in Chen, and (2) one of ordinary
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`skill in the art would not have had reasonable expectation of success for combining the
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`teachings of Chen, DeSimone, and Hostettler to produce the presently claimed orthodontic
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`appliances.
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`It is maintained that Chen, DeSimone, and Hostettler, are all directed to orthodontic
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`shell appliances. Thus it would have been obvious to one of ordinary skill in the art at the time
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`of invention to utilize the materials taught by DeSimone to form Chen's hard layer since
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`DeSimone teachesthat such materials are suitable for the intended use of such hard layer with
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`predictable results and/or reasonable expectation of success. And as Hostettler teachesthatit
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`is well known that a multilayer polymeric dental appliance (column 2 lines 33-38), includes a
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`hard layer of hardness about “60D-100D”(column 2 lines 22-26, 34-35), and a separate soft
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`layer of polyurethane elastomerhaving a hardnessof “not greater than about 65A” (column 2
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`

`

`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Pagel2
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`lines 36-44), indicating that such claimed ranges of properties are of result-effective variables.
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`Thus, such claimed range would have been obvious to one having ordinary skill in art at the
`
`time the invention was madesince it has been held that discovering an optimum or workable
`
`rangesis well within the skill of an artisan via routine experimentation in order to improve upon
`
`whatis already generally known. See MPEP §§ 2144.05.
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`Furthermore, Applicant argued that (3) the presently claimed appliances were found to
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`exhibit unexpectedly beneficial results, and (4) the presently claimed appliances gaverise to
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`considerable commercial success. Regarding the hard polymer layer, Applicant argue that
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`there is no reason provided for why one of ordinary skill in the art would select a co-polyester
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`material from DeSimone for the hard polymer layer because DeSimone lists hundreds of
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`materials. Applicant cite unexpected results for the specifically claimed material of co-polyester
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`for the hard polymer layer. However, Applicant fails to provide evidence for such cited
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`unexpectedresult or criticality of using specifically co-polyester for the hard polymer layer.
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`In
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`fact, similar to DeSimone listing co-polyester among the list of many suitable material, Applicant
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`also discloses co-polyester amongalist of many materials that can be used for the hard
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`polymer layer:
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`“For example, the hard polymer layer can include several polymerlayers
`laminated together to form the hard polymer layer. The laminated hard
`polymerlayer can include at least two layers of any combination ofthe
`following polymer materials: a polyester, a co-polyester, a polycarbonate, a
`thermoplastic polyurethane, a polypropylene, a polyethylene, a
`polypropylene and polyethylene copolymer, an acrylic, a cyclic block
`copolymer, a polyetheretherketone, a polyamide, a polyethylene
`terephthalate, a polybutylene terephthalate, a polyetherimide, a
`polyethersulfone, and a polytrimethylene terephthalate.”
`(Specification paragraph 30).
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`Applicant cited the affidavit/declaration by co-inventor Chunhua Li, filed 10/28/2019, as
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`to provide evidences for the unexpected results and commercial success. However, note that
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`the affidavit only refers to the system, i.e. SmartTrack™ (ST30) as a multilayered material with a
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`

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`Application/Control Number: 16/382,918
`Art Unit:3772
`
`Page13
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`hard polymer layer between two soft polymer layers, and notto the individual claims of the
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`application, particularly “a first outer polymer layer, a second outer polymer layer, and an inner
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`polymer layer’ . The affidavit fails to provide a nexus to the claimed invention(s).
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`In view of the foregoing, when all of the evidence is considered, the totality of the
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`rebuttal evidence of nonobviousnessfails to outweigh the evidence of obviousness.
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`Note the new ground(s) of rejection under 35 USC § 112(a) and 112(b).
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`Conclusion
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`16.
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`Anyinquiry concerning this communication or earlier communications from the examiner
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`should be directed to HAO D MAI whosetelephone numberis (571)270-3002. The examiner
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`can normally be reached on Mon-Fri 8:00-4:30.
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`If attempts to reach the examiner by telephone
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`are unsuccessful, the examiner’s supervisor, Cris Rodriguez can be reached on (571) 272-
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`4964. The fax phone numberfor the organization where this application or proceeding is
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`assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
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`ma