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 .
Claim Objections
Claim 1 is objected to because of the following informalities: at line 1, “Methode” should be - - method - -. Appropriate correction is required. Additionally, the claim utilizes reference characters to identify the steps. Throughout the claim, these are utilized without appropriate spacing (e.g. “step(S10);(S20)” instead of - - step (S10); (S20) - -) and this makes the claim more difficult to read. If reference characters are to be utilized in the claim, appropriate spacing should be introduced. Appropriate correction is required
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “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 not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 be filled 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/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,502,254. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, claim 1 of the ‘254 patent claims a method for manufacturing a transparent dental alignment device comprising 3D printing a dental alignment device using a raw material for forming transparent alignment devices; removing uncured resin and liquid from the dental alignment device; post-curing the dental alignment device; post heat treating the dental alignment device; cleaning the dental alignment device obtained in the step of post heat treating; wherein, removing the uncured resin and liquid is performed by spraying compressed air with a pressure of 5-12 bar into the device; the step of post curing is performed at a temperature of 60-90°C; the step of post heat treating is performed at a rate of less than 25°C/min, starting from a temperature of 60-90°C; and cleaning includes a solution washing step, a drying step for 5 minutes or more to allow the washing fluid to completely dry, and a water rinsing step.
Claim 1 of the instant application is directed to “a whitening tray” while claim 1 of the ‘254 patent is directed to “a dental alignment device”. The structures associated with the different recitations are understood to overlap in scope. Further, to the extent the structures are possibly different, one having ordinary skill in the art would have found it prima facie obvious to have made a substantially similar transparent dental appliance, such as the claimed whitening tray, by the method set forth in the ‘254 patent in order to effectively 3D print a transparent raw material into a suitable and substantially similar dental appliance having a substantially similar shape and oral application. As to the different language associated with the post heat treating in the claims, the instantly claimed “strong temperature” has been rejected below under section 112b. To the extent its scope is understood, it is understood to sufficiently correspond with the rate claimed in the ‘254 claim to teach or render the claimed limitation prima facie obvious.
Claim Rejections - 35 USC § 112
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-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, at line 2, the claim recites “the composition”. The recitation lacks antecedent basis in the claims. It is not clear which composition is intended or necessarily in view. Appropriate correction and clarification are required.
Additionally, the claim recites “above” or “the above” at various locations. This language appears to be an attempt to help introduce a sequence to the steps. However, the word “above” in these locations raises a question of scope, in context, because it is not unambiguously clear that the “above” necessarily refers to the step listed above on the page instead of a position/location related to performing the steps. For example, in the recitation “spraying 5-12 bar of compressed air to the whitening tray above” it is not clear whether “above” is referring to the position/location from which the spraying takes place or whether it is referring to the previously described whitening tray formed in the first step of the claim, which is found “above” on the page. Further, it is not clear why the word “above” is needed at all or how it further limits the claim. In other words, it is not clear how the exemplified recitation has any difference in scope when considered with the word “above” and when considered without the word “above”. Appropriate correction and clarification are required.
Further, the claim recites “a strong temperature of 25°C/min or less with a temperature of 60-90°C as a starting temperature”. The limiting effect of the recitation is unclear. It appears the recitation is attempting to establish that the starting temperature of the post-heating step begins within the temperature range utilized to perform the post-curing step. From this starting point, the step is “performed under a strong temperature of 25°C/min or less”. It is not clear whether this means the temperature is being raised from the starting temperature at a rate of less than 25°C/min during the post-heating, whether the temperature is being lowered from the starting temperature at this rate, whether any change of temperature is required, or whether something else is intended. Appropriate correction and clarification are required.
Further still, the claim recites “which is a time when the washing liquid is completely dried” at the end of the claim. The limiting effect of the recitation is unclear. It is not clear whether this means the tray undergoes a drying step between the first and second washing step or whether the recited time itself is all that is required to consider the liquid to be completely dried or whether something else is intended. The passive language raises a question of scope. Appropriate correction and clarification are required.
Claim Rejections - 35 USC § 103
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Klun et al. (US 2021/0171701) in view of Knopf et al. (US 2020/0062877) and further in view of Dubs et al. (US 2021/0214652) and/or Dias et al. (US 2021/0323233).
Regarding claim 1, Klun et al. teach a method for manufacturing a transparent/clear dental tray (paragraphs [0012], [0016], [0187], [0189], [0190], [0281], [0291]) comprising 3D printing/additive manufacturing a transparent dental tray using a raw material (Figure 1 (110) (120) (130); paragraphs [0004], [0173]-[0177]); removing uncured resin and liquid from the tray (Figure 1 (140); paragraph [0185]); post-curing the tray (Figure 1 (150); paragraph [0186]); and post heat treating the tray (Figure 1 (160); paragraph [0186]) at a temperature of 75-150°C, which overlaps the claimed range of 60-90°C (Note: The post-curing step in Klun et al. is reasonably understood to occur at the beginning of the heating and the post-heating step is understood to occur toward the end of the heating. This is reasonable because 0°C is less than 25°C and therefore both the post-curing and post-heat treating in the claim can be understood to be happening sequentially in a heating step that occurs within the claimed range of 60-90°C and that does not change the temperature. For example, 10 minutes of heating at 75°C is reasonably applied to both steps. The first 5 minutes can be considered to be the “post-curing” step and the last 5 minutes can be considered to be the “post-heating” step).
Klun et al. do not teach that removing the uncured resin and liquid is performed by spraying compressed air with a pressure of 5-12 bar, or washing/cleaning the post heat treated tray wherein the washing/cleaning step includes a liquid washing step, a 5-minute interval, and a water washing/rinsing step as claimed.
However, Knopf et al. teach an analogous method wherein compressed air at a pressure ranging from 1-100 psi is utilized to remove uncured resin and liquid (paragraphs [0325]-[0328]; overlaps the claimed range).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Klun et al. and Knopf et al. and to have sprayed air pressure at a pressure within the claimed range to remove the material in the method of Klun et al., as suggested by Knopf et al., for the purpose, as suggested by Knopf et al. of effectively removing the material in an art recognized suitable manner from the article. Overlapping ranges are prima facie obvious.
Further, Dubs et al. teach an analogous method wherein the printed part is cleaned in a post processing step wherein a wash liquid is first used, air drying is performed for a period of time within or that overlaps the claimed range, and a water wash/rinse is then employed (paragraphs [0008]-[0014], [0074]-[0078], [0084]; e.g. air removes the composition (paragraph [0014], after a length of time (paragraph [0084]), and then the article is rinsed in water (paragraph [0014], this is suggested and rendered prima facie obvious by the utilized language in Dubs specifying what materials are removed at each step and the “and/or” language regarding water “and/or” air). Additionally, or alternatively, Dias et al. teach an analogous cleaning method (Abstract; paragraph [0042] for applicability to free radical polymerization applications), wherein a cleaning step of the final article (paragraphs [0078]-[0082] – washing and rinsing performed after the post-curing/post-heating steps; paragraphs [0095]-[0101] – “another cleaning step” after the washing step to remove the cleaner; [0106], [0129] and [134]) is performed that includes washing, drying, and an additional cleaning/rinsing step.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Klun et al. with Dubs et al. and/or Dias et al. and to have washed/cleaned the tray of Klun et al. in a post processing step, as suggested by Dubs et al. and/or Dias et al., for the purpose, as suggested by Dubs et al. and/or Dias et al. of preparing the article for its final usage by removing any remaining contaminants with a suitable cleaning composition. Each of the references individually is understood to sufficiently teach and suggest the claimed cleaning steps as a final step at the end of producing the 3D printed article. Taken together, the references more explicitly set forth and suggested performing the recited sequences of steps with a water rinse in the method of Klun et al. utilizing either cleaning composition/wash liquid.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeff Wollschlager whose telephone number is (571)272-8937. The examiner can normally be reached M-F 7:00-3:30.
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/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742