www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/553,590
`
`12/16/2021
`
`Chunhua LI
`
`22773-826.309
`
`3538
`
`Align Technology, Inc. / WSGR
`650 Page Mill Road
`Palo Alto, CA 94304
`
`CHEN,VIVIAN
`
`PAPER NUMBER
`
`ART UNIT
`
`1787
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/22/2024
`
`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
`patents @aligntech.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Office Action Summary
`
`Application No.
`17/553,590
`Examiner
`VIVIAN CHEN
`
`Applicant(s)
`Ll etal.
`Art Unit
`1787
`
`AIA (FITF) Status
`No
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof 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 02/20/2024.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)[¥) This action is FINAL.
`2b) (J This action is non-final.
`3) 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)(2) 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*
`2,6,10-11,13,19,29-30 and 34-42 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`C} Claim(s)__ is/are allowed.
`Claim(s) 2,6,10-11,13,19,29-30 and 34-42 is/are rejected.
`(] Claim(s)__ is/are objectedto.
`C] Claim(s)
`are subjectto restriction and/or election requirement
`* 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://www.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) filed on 12/16/2021 is/are: a)[¥) accepted or b)(.) 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:
`_—_c)L) None ofthe:
`b)L) Some**
`a)Q) 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 02/20/2024.
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240517
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 2
`
`DETAILED ACTION
`
`Status of Claims
`
`Claims 2, 6, 10-11, 13, 19, 29-30, 34-42 is/are pending.
`
`Claims 2, 6, 10-11, 13, 19, 29-30, 34-42 is/are rejected.
`
`Claims 1, 3-5, 7-9, 12, 14-18, 20-28, 31-33 is/are cancelled by Applicant.
`
`1.
`
`2.
`
`3.
`
`Notice of Pre-AIA or AIA Status
`
`4,
`
`The present application is being examined underthe pre-AJAfirst to invent provisions.
`
`5.
`
`In the event the determination of the status of the application as subject to ATA 35 U.S.C.
`
`102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
`
`statutory basis for the rejection will not be considered a new groundofrejection if the prior art
`
`relied upon, and the rationale supporting the rejection, would be the same undereither status.
`
`Claim Rejections - 35 USC § 112
`
`6.
`
`The following is a quotation ofthe first paragraph of 35 U.S.C. 112(a):
`
`(a) IN GENERAL.—Thespecification shall contain a written description of the invention,
`and of the manner and process of making andusingit, in such full, clear, concise, and exact termsas to
`enable any person skilled in the art to which it pertains, or with which it 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 such full, clear, concise, and exact terms as to enable any person
`skilled in the art to which it pertains, or with which it 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.
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 3
`
`7.
`
`Claims 2, 6, 10-11, 13, 19, 29-30, 34-42 is/are rejected under 35 U.S.C. 112(a) or
`
`35 U.S.C. 112 (pre-AIA), 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 conveyto one skilled in the relevantart that the inventor or a joint
`
`inventor, or for pre-AJA the inventor(s), at the time the application wasfiled, had possession of
`
`the claimed invention.
`
`Regarding claim 2, the disclosure as originally filed only provides support for multilayer
`
`polymersheets in which one or more “hard”layers(i.e. “hard” layer 24 optionally composed of
`
`“hard” sub-layers 24-1, 24-2, 24-N) are sandwiched between two or more “soft” layers (1.e., a
`
`first “soft” layer 22 optionally composed of “soft” sub-layers 22-1, 22-2, 22-N and a second
`
`“soft” layer 26 optionally composedof “soft” sub-layers 26-1, 26-2, 26-N) as illustrated by
`
`Figure 2 in the specification. However, since the present claims do not specify the positions of
`
`the second “hard” polymerlayer and the third “hard” polymerlayer(relative to the first “soft”
`
`polymerlayer, the first “hard” polymerlayer, and the second “soft” polymerlayer), the
`
`disclosure as originally filed does not provide adequate support for multilayer polymersheets in
`
`which the second “hard” polymer layer and/or a third “hard” polymerlayeris spatially separated
`
`from the first “hard” polymerlayer -- for example, a multilayer polymer sheet with one of the
`
`following structure:
`
`hard(2) / soft(1) / hard(1) / soft(2) / hard(3);
`soft(1) / hard(1) / hard (2) / soft(2) / hard(3);
`soft(1) / hard(1) / soft(2) / hard (2) / hard(3);
`soft(1) / hard(1) / other layer / hard(2)/ other layer / hard(3) / soft(2); etc.
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 4
`
`Regarding claim 19, the disclosure as originally filed only discloses the coextrusion of a
`
`third polymerlayer anda first polymerlayer, but does not provide adequate support for the
`
`coextrusion of a “soft” polymer layer and a “hard” polymerlayer.
`
`Regarding claim 41, the disclosure as originally filed only discloses thermoplastic co-
`
`polyester elastomers, but does not provide adequate support for a “co-polyester elastomer” in
`
`general (which can encompass thermosetting or curable co-polyester elastomers).
`
`Claims 6, 10-11, 13, 29-30, 34-40, 42 are dependent on one or more of the above claims
`
`and therefore incorporate the above-described new matter.
`
`8.
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—Thespecification shall conclude with one or more claimsparticularly 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-AIA), second paragraph:
`The specification shall conclude with one or more claimsparticularly pointing out and distinctly
`claiming the subject matter which the applicant regardsas his invention.
`
`9,
`
`Claim 2, 6, 10-11, 13, 19, 29-30, 34-42 is/are rejected under 35 U.S.C. 112(b) or
`
`35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point
`
`out and distinctly claim the subject matter which the inventoror a joint inventor, or for pre-AIA
`
`the applicant regards as the invention.
`
`Claim 2 is vague and indefinite because the claim fails to clearly set forth the positions of
`
`the second “hard” polymerlayer and the third “hard” polymerlayer(relative to the first “soft”
`
`polymerlayer, the first “hard” polymerlayer, and the second “soft” polymer layer), and therefore
`
`are deemed vagueandindefinite for omitting the clear structural cooperative relationships (e.g.,
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 5
`
`relative positions) of recited elements(the first, second, and third “hard” polymerlayers; the first
`
`and second “soft” polymerlayers).
`
`Claims 36-38 are vague and indefinite because it is unclear whether the phrase “have a
`
`thickness of about...” in the limitation “wherein the first hard polymerlayer, the second hard
`
`polymerlayer, and the third hard polymerlayer have a thickness of about...” requires that: (1) the
`
`first, second, and third hard polymer layers each have individualthicknesses within the recited
`
`thickness range; or (11) the first, second, and third hard polymer layers have a combinedtotal
`
`thickness within the recited thickness range.
`
`Claim 36 is vague and indefinite because the upperlimit on thickness (1.e., “about 1100
`
`um”) is inconsistent with the upper limit on overall thickness of the multilayer sheet (i.e., “about
`
`1000 um”) as recited in independentclaim 2.
`
`If claims 36-38 require that the individualthicknessesofthe first, second, and third hard
`
`polymerlayers fall within the recited ranges, claims 36-38 are vague and indefinite because the
`
`combined thicknesses ofthe first, second, and third hard polymerlayers(i.e., about 1200-3300
`
`um for claim 36; about 1500-2700 um for claim 37; about 1650-2250 um for claim 38) are
`
`inconsistent with the upper limit on overall thickness of the multilayer sheet(1.e., “about 1000
`
`um”) as recited in independentclaim 2.
`
`Claims 6, 10-11, 13, 19, 29-30, 34-35, 39-42 are dependent on one or more of the above
`
`claims and therefore incorporate the above-described indefinite subject matter.
`
`Terminal Disclaimer
`
`10.
`
`The terminal disclaimerfiled on 02/01/2023 disclaiming the terminal portion of the
`
`statutory term which would extend beyondthe expiration date of U.S. Patent Nos. 9,655,691 and
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 6
`
`9,655,693 and 10,052,176 and 10,973,613 and 11,154,384 has been reviewed andis accepted.
`
`The terminal disclaimer has been recorded.
`
`11.
`
`The terminal disclaimerfiled on 04/19/2023 disclaiming the terminal portion of the
`
`statutory term which would extend beyondthe expiration date of any patents granted on U.S.
`
`Applications Nos. 16/043,065 and 16/264,420 and 16/382,918 and 17/858,825 has been
`
`reviewed and is accepted. The terminal disclaimer has been recorded.
`
`12.
`
`The terminal disclaimerfiled on 05/30/2023 disclaiming the terminal portion of the
`
`statutory term which would extend beyondthe expiration date of any patents granted on U.S.
`
`Applications Nos. 17/510,276 and 18/107,736 and 18/107,742 has been reviewed andis
`
`accepted. The terminal disclaimer has been recorded.
`
`13.
`
`The terminal disclaimerfiled on 07/14/2023 disclaiming the terminal portion of the
`
`statutory term which would extend beyondthe expiration date of U.S. Patent Nos. 11,213,369
`
`and 11,648,091 has been reviewedand is accepted. The terminal disclaimer has been recorded.
`
`Double Patenting
`
`14.
`
`The rejections on the ground of nonstatutory double patenting based on U.S. Patent Nos.
`
`9,655,691 and 9,655,693 and 10,052,176 and 10,973,613 and 11,154,384 in the previous Office
`
`Action mailed 10/05/2023 have been withdrawnin view of the Terminal Disclaimerfiled
`
`02/01/2023.
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 7
`
`15.
`
`The provisional rejections on the ground of nonstatutory double patenting based on U.S.
`
`Applications Nos. 16/043,065 and 16/264,420 and 16/382,918 and 17/858,825 in the previous
`
`Office Action mailed 10/05/2023 have been withdrawn in view of the Terminal Disclaimerfiled
`
`04/19/2023 has been reviewed andis accepted.
`
`16.
`
`The provisional rejections on the ground of nonstatutory double patenting based on U.S.
`
`Applications Nos. 17/510,276 and 18/107,736 and 18/107,742 in the previous Office Action
`
`mailed 05/15/2023 have been withdrawn in view of the Terminal Disclaimer filed 05/30/2023
`
`has been reviewed andis accepted.
`
`17.
`
`The rejections on the ground of nonstatutory double patenting based on U.S. Patent Nos.
`
`11,213,369 and 11,648,091 in the previous Office Action mailed 06/15/2023 have been
`
`withdrawn in view of the Terminal Disclaimer filed 07/14/2023.
`
`Claim Rejections - 35 USC § 103 (AIA)
`
`18.
`
`The following is a quotation of 35 U.S.C. 103 which formsthebasis for all obviousness
`
`rejections set forth in this Office action:
`
`A patent for a claimed invention maynotbe obtained, notwithstanding that the claimed inventionis not
`identically disclosed as set forth in section 102, if the differences between the claimed invention and the
`prior art are such that the claimed invention as a whole would have been obviousbefore the effective
`filing date of the claimed invention to a person having ordinaryskill in the art to which the claimed
`invention pertains. Patentability shall not be negated by the mannerin which the invention was made.
`
`19.
`
`This application currently namesjoint inventors. In considering patentability of the
`
`claims the examiner presumesthat the subject matter of the various claims was commonly
`
`ownedasofthe effective filing date of the claimed invention(s) absent any evidenceto the
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 8
`
`contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and
`
`effective filing dates of each claim that was not commonly ownedasofthe effective filing date
`
`of the later invention in order for the examinerto consider the applicability of 35 U.S.C.
`
`102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
`
`20.
`
`The rejections under 35 U.S.C 103 based on WO 2006/0996558 (WEN-WO‘558)in the
`
`previous Office Action mailed 08/17/2023 have been withdrawn in view of the Claim
`
`Amendments filed 02/20/2024.
`
`However, the withdrawalof these rejections does NOT constitute a concession as to the
`
`applicability or non-applicability of the previously cited prior art to the previously presented
`
`claimsor to the claims as presently amended. Upon cancellation of any new matter, the
`
`rejections maybereinstated.
`
`Response to Arguments
`
`21.
`
`Applicant’s arguments filed 2/20/2024 have been considered but are moot because in
`
`view of the new groundsof rejection regarding: (i) issues of new matter under 35 U.S.C. 112(a)
`
`or 35 U.S.C. 112 (pre-AIA), first paragraph; and(ii) issues of indefiniteness under 35 U.S.C.
`
`112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph; necessitated by the Claim Amendments
`
`filed 02/20/2024.
`
`However, the Examiner makes no concession as to the applicability or non-applicability
`
`of the previously cited prior art to the previously presented claimsor to the claims as presently
`
`amended. The Examinerreserves any discussion as the merits of the previously cited priorart
`
`references until the issue of new matter has been resolved.
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 9
`
`In particular, Applicant’s arguments that the Examinerhas no basis forstating that “a
`
`skilled artisan would have wanted to optimize various properties to producea better aligner” are
`
`not deemed persuasive in view of the extensive discussion in WEN-WO‘558 (e.g., but not
`
`limited to, paragraph 00189, 00197-00231, etc.) with respect with advantageous material
`
`selection and design considerations, in particular with respect to multilayer constructions, and
`
`associated benefits associated with different materials and/or structures.
`
`Conclusion
`
`22.
`
`Applicant's amendment necessitated the new ground(s) of rejection presented in this
`
`Office action. Accordingly, THIS ACTION IS MADEFINAL. See MPEP § 706.07(a).
`
`Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
`
`A shortenedstatutory period for reply to this final action is set to expire THREE
`
`MONTHSfrom the mailing date of this action. In the eventa first reply is filed within TWO
`
`MONTHSofthe mailing date of this final action and the advisory action is not mailed until after
`
`the end of the THREE-MONTHshortened statutory period, then the shortened statutory period
`
`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
`
`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
`
`however,will the statutory period for reply expire later than SIX MONTHSfrom the date of this
`
`final action.
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 10
`
`23.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Vivian Chen (Vivian.chen @uspto.gov) whose telephone number
`
`is (571) 272-1506. The examiner can normally be reached on Monday through Thursday from
`
`8:30 AM to 6 PM. The examiner can also be reached on alternate Fridays.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Callie Shosho, can be reached on (571) 272-1123. The fax phone numberfor the
`
`organization wherethis application or proceeding is assigned is (571) 273-8300.
`
`The General Information telephone numberfor Technology Center 1700 is (571) 272-
`
`1700.
`
`Information regarding the status of an application may be obtained from Patent Center.
`
`Status information for published applications may be obtained from Patent Center. Status
`
`information for unpublished applications is available through Patent Center for authorized users
`
`only. Should you have questions about access to Patent Center, contact the Electronic Business
`
`Center (EBC) at 866-217-9197 (toll-free).
`
`Examinerinterviews are available via telephone, in-person, and video conferencing using
`
`a USPTO supplied web-based collaboration tool. To schedule an interview, applicantis
`
`encouraged to use the USPTO Automated Interview Request (AIR) Form at
`
`https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
`
`May18, 2024
`
`/VIVIAN CHEN/
`Primary Examiner, Art Unit 1787
`
`