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 .
Election/Restrictions
Claim 40 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7 August 2026.
Claim Rejections - 35 USC § 102
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.
Claim(s) 21, 30-35 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Maligie et al. (U.S. Patent 6,440,566). Regarding Claims 21, and 34, Maligie et al., hereafter “Maligie,” show that it is known to have a releasable film (Abstract) which comprises a polypropylene copolymer (claim 5) having an average thickness of 37-75 microns, a melting point which is lower than a thermoforming temperature of the thermoformable sheet material, and an acceptable trouser tear strength (Column 6, lines 13-38; Column 11, lines 9-18, 38-43).
Regarding Claim 30, Maligie shows that it is known to have a releasable film which is not 100% oriented (Column 3, lines 4-10).
Regarding Claim 31, Maligie shows the film of claim 21 above, including one wherein the separator film comprises two or more layers with different melting points (Abstract; Column 6, lines 14-43; Column 13, lines 1-25).
Regarding Claim 32, Maligie shows the film of claim 21 above, including a releasable film which comprises the claimed melt index values (Examples 1-6).
Regarding Claim 33, Maligie shows the film of Claim 21 above, including one wherein the releasable film which comprises a mold release agent of esters or siloxanes (Column 9, lines 34-41).
Regarding Claim 35, Maligie shows the film of claim 21 above, including a releasable film which comprises polyolefin and vinyl acetate (Column 6, lines 53-65).
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.
Claims 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maligie. Maligie shows the film of claim 21, but he does not give dimensions of his separator film. However, it would have been obvious to one of ordinary skill in the art to choose a separator film which is an appropriate size for the dental mold application, such as that which is claimed, in order to sufficiently cover the mold during the thermoforming process.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maligie, in view of Adamko et al. (U.S. Patent 5,817,386). Adamko et al., hereafter “Adamko,” show that it is known to have a release film whose peel force adhesion level after forming is less than about 100 g/cm (Column 2, lines 49-54). It would have been obvious to one of ordinary skill in the art to use a film with Adamko’s peel force level as that in Maligie’s film in order to provide the desired release of the liner from another article (Column 1, lines 4-34).
Claims 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirsch (U.S. Patent Application Publication 2020/0113651), in view of Maligie et al. (U.S. Patent 6,440,566). Regarding Claim 14, Hirsch shows that it is known to have a system for producing a thermoformed dental appliance (Abstract) comprising a male model, a thermoformable sheet material, a detached releasable separator film, and a thermoforming device (0014: element 20, 21). Hirsch does not specifically describe the details of the detached releasable separator film. Maligie et al., hereafter “Maligie,” show that it is known to have a releasable film which comprises an average thickness of 37-75 microns, a melting point which is lower than a thermoforming temperature of the thermoformable sheet material, and an acceptable trouser tear strength (Column 6, lines 13-38; Column 11, lines 9-18, 38-43). It would have been obvious to use Maligie’s specific separator film in Hirsch’s apparatus in order to prevent sticking of the material to the thermoformable sheet.
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.
Claims 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,240,163, as noted below. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader versions of the patented claims, and therefore not patentably distinct therefrom, as they are effectively anticipated by the patented claims.
Instant Application Claims
Claims of 12,240,163
21+35
1+14
22
2
23
3
24
4
25
5
26
6
27
7
28
8
29
9
30
10
31
11
32
12
33
13
34
15
36
16
37
16
38
17
39
18
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA HUSON whose telephone number is (571)272-1198. The examiner can normally be reached M-F 8a-4p.
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, Christina Johnson can be reached on 571-272-1176. 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.
MONICA ANNE HUSON
Primary Examiner
Art Unit 1742
/MONICA A HUSON/Primary Examiner, Art Unit 1742
Prosecution Insights