DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 02/27/2026 have been fully considered but they are not persuasive. Applicant has argued that DiSimone fails to provide for the new claim limitations however DiSimone is no longer relied upon.
The new prior art of Cole et al. (US 2019/0033719 A1) provides for the new claim limitations of claim 1 and 10 and several dependent claims.
Applicant has argued the Kopelman fails to provide for the new product by process limitations of claim 10 however these new limitations are merely reciting a process to make the product and the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965). The product claims are only evaluated as to the actual product itself and as such the structural limitations of the product are still disclosed by the prior art of Kopelman. Applicant has not evidenced any difference the product that would results from the process as claimed from the product structures cited in Kopelman.
Various new depending claims are addressed by new prior art in view of Cole et al. (US 2019/0033719 A1).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 10-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cole et al. (US 2019/0033719 A1) which incorporates by reference all of Li et al. (US 2015/0004553 A1).
Regarding claim 1, Cole discloses a method of manufacturing a patient-specific aligner (Title, abstract disclosing a manufacturing of aligners, Fig. 1 element 106, paragraph [0115] lines 8-9 disclosing the aligner is customized for a patient), the method comprising:
obtaining an aligner (Fig. 1 element 106, paragraph [0020] lines 17-19 at least a first layer and thus an aligner is obtained); and
irradiating at least a first portion of the aligner to achieve a stiffness of the at least a first portion of the aligner that is different from a stiffness of a different portion of the aligner (paragraph [0021] lines 7-10 disclosing a first region having a first resin ratio of a first monomer to a second monomer with has a different ratio of the first monomer to the second monomer in a second region,[00899] lines 9-12 disclosing some regions/layers which are not exposed to irradiation by masking and as such have different levels of polymerization and thus different stiffness),
and irradiating, using a second irradiation source, at least a second portion of the aligner (paragraph [0025] lines 1-9 disclosing using a second irradiation source to selectively polymerize a second portion of the aligner, such as by masking other parts) to achieve a second stiffness of the at least a second portion of the aligner that is different from the stiffness of the different portion of the aligner and the first stiffness of the at least a first portion of the aligner (paragraph [0136] lines 9-18 disclosing the varying of monomer components when polymerized creates variable stiffness thus when the second irradiation source selectively polymerizes the second concentration of monomer cited above it would have a different stiffness than the first region and the different region that had been masked).
Regarding claim 2, Cole further discloses accessing digital three-dimensional models (paragraph [0098] lines 1-8 disclosing the use of 3d digital models) and disclose accessing dentition data of a profile of teeth of a patient (Paragraph [0133] all recites an incorporation by reference of US 2015/0004553 A1 which discloses in paragraph [0022] all that the manufacturing of the appliance includes accessing dentition data of a profile of teeth of a patient by digitally scanning the patient teeth) ; and creating a three-dimensional computer-assisted design model of the patient's teeth based on the dentition data (US 2015/0004553 A1 which discloses in paragraph [0022] and [0040] further disclosing the scanned data is manipulated to form dentitions used for repositioning teeth for application of materials to a patients teeth).
Regarding claim 3, Cole further discloses using a n additive manufacturing technique to form the aligner using the three-dimensional design model (paragraph [0098] lines 1-4).
Regarding claim 10, Cole discloses a patient specific aligner shell (paragraph [0100] line 8, paragraph [0115] lines 7-9 disclosing the appliance being customized), with a first portion having a first stiffness that is different from the stiffness of a second portion that is different from a last portion (paragraph [0136] lines 1-3 and 9-15 disclosing the stiffness being different for different monomer concentrations, paragraph [0021] lines 7-10 disclosing a first region having a first resin ratio of a first monomer to a second monomer with has a different ratio of the first monomer to the second monomer in a second region,[00899] lines 9-12 disclosing some regions/layers which are not exposed to irradiation by masking and as such have different levels of polymerization and thus different stiffness and paragraph [0136] lines 9-18 disclosing the varying of monomer components when polymerized creates variable stiffness thus when the second irradiation source selectively polymerizes the second concentration of monomer cited above it would have a different stiffness than the first region and the different region that had been masked, thus providing for at least three different regions with resulting different stiffnesses from their different monomer concentrations and resulting stiffness). Regarding the limitations of first irradiated, second irradiated and un-irradiated, these limitations are being viewed as a product by process claim of merely reciting a process to make the product as discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965). In this case the resulting product would only require three portions with each having different stiffnesses as provided for by Cole.
Regarding claim 11, Cole further discloses where the aligner is formed of a polyurethane material (paragraph [0106] lines 4-6).
Regarding claim 12, Cole further discloses where the aligner is formed with an additive manufacturing technique (paragraph [0018] lines 1-3 disclosing additive manufacturing for the appliance). The limitation of additive manufacturing is being viewed as a product by process claim of merely reciting a process to make the product as discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965).
Regarding claim 13, Cole further discloses wherein the first stiffness of the first irradiated portion is different from the third stiffness of the second irradiated portion (paragraph [0136] lines 9-18 disclosing the varying of monomer components when polymerized creates variable stiffness thus when the second irradiation source selectively polymerizes the second concentration of monomer cited above it would have a different stiffness than the first region and the different region that had been masked).
Regarding claim 14, Cole further discloses where irradiating with the first irradiation source, the second irradiation source, or both increases or decreases a stiffness of the aligner at a location of irradiation (paragraph [0064] lines 1-14 the irradiation can increase or decrease the amount of monomer that is crosslinked and as such the increased or decreased crosslinking would increase or decrease the stiffness).
Regarding claim 15, Cole further discloses wherein the first stiffness is greater than the stiffness of the different portion of the aligner and the second stiffness is less than the stiffness of the different portion of the aligner. (paragraph [0064] lines 1-14 the irradiation can increase or decrease the amount of monomer that is crosslinked and as such the increased or decreased crosslinking would increase or decrease the stiffness, thus the region with an increased amount of diffused monomer would have increased cross linking would be stiffer than the starting monomer concentration and the second stiffness that would result from the lower amount of monomer diffusion and thus lower cross linking would be less stiff than the region that did not having diffusion increase or decrease due to masking).
Regarding claim 16, Cole further discloses wherein irradiating the aligner with the first irradiation source, the second irradiation source, or both, is performed using at least one of an ultraviolet (UV) light or a light-emitting diode (LED) light source (paragraph [0023] lines 8-9 disclosing at least one of the irradiation sources is ultraviolet light).
Regarding claim 17, Cole further discloses wherein irradiating the aligner with the first irradiation source, the second irradiation source, or both, is performed by irradiating the aligner with light of a wavelength in a range of 350 to 800 nanometers (paragraph[0034] lines 11-12 disclosing the wavelength of a light source is in the wavelength range of 350nm-800nm).
Claims 10-13 and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kopelman et al. (US 2017/0007360 A1).
Regarding claim 10, Kopelman further discloses a patient-specific aligner (Fig. 1b elements 112, 114, 116) comprising :
a first irradiated portion (Fig. 9 element 902);
a second irradiated portion (Fig. 9 element 904);
and at least one un-irradiated portion (Fig. 9 element 906),
wherein a first stiffness of the first irradiated portion is different from a second stiffness of the un-irradiated portion, and wherein a third stiffness of the second irradiated portion is different from the second stiffness of the un-irradiated portion (paragraph [0147] disclosing portions 902, 906 and 904 having different levels of stiffness either by irradiation during formation or regions photopolymerized in post processing paragraph [0336] all disclosing that after the aligner would be fabricated it would then be post-process irradiated after being printed that would increase cross-linking and thus increase stiffness).
Claim 10 recites process limitations of “irradiated” by a first or second irradiation source, or ”un-irradiated” and these limitations are being viewed as product by process claims of merely reciting a process to make the product as discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965). In this case the resulting structure only requires three portion with different stiffnesses from each other which is provided for my Kopelman.
Regarding claim 11, Kopelman further discloses, wherein the aligner is formed of a polyurethane material (paragraph [0326] lines 1-6).
Regarding claim 12, Kopelman further discloses wherein the aligner is formed with an additive manufacturing technique ( Fig. 39 element 3930, paragraph [0321] and [0339] all disclosing the manufacturing of aligners using the 3d data from the previous step by additive manufacturing). The limitation of additive manufacturing is being viewed as a product by process claim of merely reciting a process to make the product as discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965).
Regarding claim 13, Kopelman further discloses wherein the first stiffness of the first irradiated portion is different from the third stiffness of the second irradiated portion (paragraph [0147] disclosing portions 902, 906 and 904 having different levels of stiffness).
Regarding claim 21, Kopelman further discloses wherein the first stiffness of the first irradiated portion is greater than the second stiffness of the un-irradiated portion (paragraph [0147] disclosing portions 902, 906 and 904 having different levels of stiffness either by irradiation during formation or regions photopolymerized in post processing paragraph [0336] all disclosing that after the aligner would be fabricated it would then be post-process irradiated after being printed that would increase cross-linking and thus increase stiffness). The limitation of irradiated vs un-irradiated is being viewed as a product by process claim of merely reciting a process to make the product as discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965). In this case the product is only an aligner with a first stiffness greater than the stiffness of a second portion which Kopelman provides.
Regarding claim 22, Kopelman further discloses wherein the third stiffness of the second irradiated portion is less than the second stiffness of the un-irradiated portion (paragraph [0147] disclosing portions 902, 906 and 904 having different levels of stiffness ). The limitation of irradiated vs un-irradiated is being viewed as a product by process claim of merely reciting a process to make the product as discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965). In this case the product is only an aligner with a third stiffness less than the stiffness of a different portion which Kopelman provides.
Regarding claim 23, Kopelman further discloses wherein the first irradiated portion, the irradiated portion, or both, is irradiated with at least one of an ultraviolet (UV) light or a light-emitting diode (LED) light (paragraph [0318] lines 35-36 disclosing ultraviolet light), The limitation the manner of irradiation by a type of light is being viewed as a product by process claim of merely reciting a process to make the product as discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965). In this case the product is only result is a product as recited in claim 10.
Regarding claim 24, Kopelman wherein the first irradiated portion, the irradiated portion, or both, is irradiated with light of a wavelength in a range of 350 to 800 nm (paragraph [0318] lines 35-36 disclosing ultraviolet light which UV wavelength range includes 400 nanometers, however the limitation the manner of irradiation by a type of wavelength is being viewed as a product by process claim of merely reciting a process to make the product as discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965). In this case the product is only result is a product as recited in claim 10).
Regarding claim 25, Kopelman further discloses wherein the aligner is formed of at least one of a polyamides, polyesters, polycarbonates, polymethylmethacrylates, polypropylenes, polyester sulfones, acrylic, photosensitive polymer, or a photopolymer (paragraph [0323] line 8 disclosing at least polyamide).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is 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 obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the 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 owned as of the effective filing date of the later invention in order for the examiner to 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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. (US 2019/0033719 A1) in view of Dorfinger et al. (US 2024/0051246 A1).
Regarding claim 18, Cole discloses steps substantially identical to the instant application as discussed above but fails to explicitly disclose wherein the light source comprises a tip that it configured for locally applied irradiation.
However, Dorfinger discloses a method of manufacturing a dental appliance (title and abstract, paragraph [0033] all disclosing manufacturing aligners) by exposing a dental appliance to a first light source and then a second light source (Fig. 6a/6b first light source 620/630a-b and second light source 624) where one of the light sources has a tip that is configured for locally applied irradiation (Fig. 6a/6b element 618 is a tip that shows the light is irradiated locally, Fig. 6b elements 630a-c each being a light source with a tip that light is irradiated onto a local area, paragraph [0151] lines 1-20 disclosing the light source of a laser is configured to be pointed and targeted to a local object portion and not a second object portion).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the irradiating with a first or second or both irradiation sources using a light source tip that is configured for locally applying irradiation to one area and not another area as taught by Dorfinger into the method of manufacturing as taught by Cole for the purpose of providing a manufacturing that would provide accurate spatial control over the material properties of the object which would improve the function of the object as taught by Dorfinger (paragraph [0029] lines 1-5).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. (US 2019/0033719 A1, hereafter Cole’719) in view of Cole et al. (US 2022/0098350 A1, here after Cole’350)
Regarding claim 19, Cole’719 further discloses where wherein irradiating the aligner with the first irradiation source, the second irradiation source, or both, is performed using a global irradiation are by exposure of a print area of a built platform(Fig. 3-7 showing the irradiation is globally applied to the print area of the build platform) but fails to explicitly disclose where the print area and build platform are part of a light box.
However, Cole’350 discloses a method of manufacturing a dental appliance (title and abstract) by exposing a dental appliance to light by a light box ( paragraph [0359] lines 5-6).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the manufacturing by irradiation to include use of a light box as taught by Cole’350 into the method of manufacturing as taught by Cole’719 for the purpose of allowing for post curing as taught by Cole’350 (paragraph [0359] lines 5-6).
Regarding claim 20, Cole’719 further discloses wherein irradiating the aligner in the light box further comprises at least partially masking the aligner prior to irradiation with the first irradiation source, the second irradiation source, or both to block masked regions from irradiation (paragraph [0024] lines 12-14 disclosing using a mask for defining t first or second regions for irradiation).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) 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 MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P SAUNDERS whose telephone number is (571)270-3250. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at (571) 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.P.S/Examiner, Art Unit 3772 05/28/2026
/EDWARD MORAN/Primary Examiner, Art Unit 3772
Prosecution Insights