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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 November 2025 has been entered.
Status of the Claims
Claims 21-37, directed to dental aligners, are pending, presented for examination, and rejected as set forth in greater detail below.
Claim Interpretation
Applicants claims are directed to “dental aligners” which comprise at least one dissolvable film/strip of defined thickness comprising adhesive water soluble polymers and either whitening agents comprising PVP and/or hypersensitivity agents which is adhered to the aligner, and which is configured to simultaneously straighten and whiten teeth when used. Claims 22 and 23 specify the film is to include a dissolution extender, specifically a polycarbophil. Claims 24, 27, 28, and 32 place further limitations on the active agent to be included in the film. Claims 25 and 26 specify the degree to which the film is to dissolve. Claims 29-31 place additional limitations on the dimensions of the strip of the invention. Claims 33 and 34 specify that the aligner is to additionally include a light source of particular characteristics. Claim 35 indicates that the aligner is configured to be used for a time of approximately 6-12 months; applicants are reminded that language describing the manner in which a composition or device is to be used does not affirmatively limit the scope of the invention claimed during examination. Particularly, a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Claim 36 limits the film/strip thickness, and Claim 37 defines the time within which the film/strip is to dissolve.
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-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 37 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.
The term “substantially completely” in claim 37 is a relative term which renders the claim indefinite. The term “substantially completely” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 37 recites the broad recitation “1 to 22 hours,” and the claim also recites “1 to 5 hours” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 21-37 are rejected under 35 U.S.C. 103 as being unpatentable over Rajaiah (EP3315119)(13 APR 2023 IDS FOR REF #1), in view of Perepelitsa (WO2013/162404), Akl (U.S. PGPub. 2015/0257859), and Wilburn (U.S. PGPub. 2006/0105284).
Rajaiah describes kits for whitening of teeth which combine a delivery carrier with a whitening composition and a source of electromagnetic radiation within the range of 200-1700nm, a range overlapping that of ultraviolet radiation and thereby addressing limitations of Claims 33 and 34. [0001; 0165]. Rajaiah indicates that the whitening composition may take the form of a dissolvable strip or film of material, a dental tray, or combinations of these components whereby the whitening oral composition is dispensed into the tray and then applied to the teeth. [0008; 0131-45; 0150-51; 0161-2]. Rajaiah indicates that the strips used in the kits described generally have a length greater than the width, such as a length of about 66mm, a width of about 15mm, and a thickness of about 400 microns. [0022]. An alternative embodiment of the oral compositions particularly those to be used with electromagnetic radiation treatment, have thicknesses of about 10, or about 100 microns. [0167]. The ranges of length, width, and thickness described by Rajaiah therefore fall within or overlap those of the present claims, rendering them obvious. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
Rajaiah therefore suggests a tooth whitening kit which combines a whitening composition in the form of a thin film of about 66mm, width of about 15mm, and thicknesses in a range of about 10-400 microns applied to a dental aligner/tray.
Rajaiah does not, however, specify that any of the particular whitening strip components recited by the present claims may be employed as the whitening strip, nor that the dental tray be one which is configured to straighten teeth.
This is cured in part by the teachings of Perepelitsa, which describes tooth whitening films containing each of hydrophilic film-forming polymers and hydrogen peroxides as whitening agents, addressing limitations of Claim 28. (Abs.). Perepelitsa describes compositions containing up to 30% hydrophilic polymers in addition to low molecular weight plasticizers, softeners, flavorants, antitartar agents including polyphosphates, and stabilizers, addressing limitations of Claims 24, 27, and 28. (Pg.10, L.8-17; Pg.32, L.18-28). Each of the polycarbophils of Claims 22 and 23, and polyvinyl pyrrolidone of Claim 21 are envisioned as suitable mucoadhesive polymers by Perepelitsa, particularly when the molecular weight of the hydrophilic polymer falls within the range of 20,000-2,000,000. (Pg.18, L.16-17; Pg.24, L.26-34; Pg.26, L.24 – Pg.27, L.20). Pectins as recited by Claim 32 are identified as suitable hydrophilic polymers suitable for inclusion in the tooth whitening compositions described. (Pg.23). Perepelitsa indicates these compositions may be provided as films to be adhered to the tooth surface and dissolve within the oral cavity, addressing limitations of Claims 25 and 26. (Pg.34). Perepelitsa indicates these films should be provided in thicknesses of between 100-350 microns to obtain desired transparency, (Pg.40, 44, 47), and may be configured to dissolve over a period of 30 minutes to 24 hours, a range encompassing and therefore rendering obvious that of the instant claims. (Pg.58), see Peterson, supra.
Akl indicates that dental trays may be adapted for various dental procedures. [0003]. Among these are included each of teeth whitening procedures whereby whitening compositions are maintained in close contact with the teeth [0088], as well as orthodontic procedures where the dental tray is employed to adjust alignment of the teeth. [0092]. Wilburn adds to this knowledge by indicating dental trays can be used as positioners to straighten teeth into ideal alignment. (Abs.); [0005; 0012-13].
It would have been prima facie obvious to have selected various combinations of PVP, a polycarbophil, pectin, polyphosphate, and plasticizer to obtain a tooth whitening film dissolvable over a period of 30 minutes to 24 hours per the guidance of Perepelitsa and used this transparent film as the whitening composition film taught by Rajaiah. This is because Rajaiah describes the use of transparent polymeric tooth whitening strips with the tooth whitening dental trays suggested, and Perepelitsa establishes that the polymeric tooth whitening strips recited by the instant claims in combination with dental trays were at the time the present application was filed, known to be useful as tooth whitening compositions. In reliance on the teachings of Akl and Wilburn, the skilled artisan would further understand that adapting the dental trays so formed to align and straighten teeth while also whitening them represents a use to which dental trays are commonly put, as whitening and aligning teeth represent embodiments of dental trays taught as alternatives by Akl. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). (“[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.”).
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 21-25, 27, 28, and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/922,864 in view of Rajaiah, Akl, and Wilburn as discussed in greater detail above. The ‘864 Claims are directed to whitening strips combining PVP and polycarbophils with peroxide and additional dental active agents such as polyphosphates and hydroxyapatites, but do not place those films into a dental straightener which, as set forth above, is a suggested application of such dental whitening films as advocated by the teachings of Rajaiah, Akl, and Wilburn.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 26 November 2025 have been fully considered but they are not persuasive.
Applicants arguments that the combination of Perepelitsa and Rajaiah fail to teach the newly recited limitation that the aligner is one which straightens teeth is persuasive; However, the examiner, in response to these amendments, newly relies on the teachings of Akl and Wilburn to address these newly added limitations.
Applicants assertion that Rajaiah fails to suggest combining a dental tray and strip into one embodiment is contradicted by the record. Rajaiah indeed indicates that “[t]he patient or dental professional dispenses the present oral composition into a soft or rigid dental appliance and then the participant places the appliance over the participant’s dental arch (or fits the device around his or her teeth to keep the tray in position.” [0162]. Indeed, Rajaiah indicates “[t]he oral delivery composition be applied directly or can also be combined with a delivery carrier, e.g. such as a strip of material…” [0160]. This indicates that Rajaiah contemplates the oral composition as a strip of material which can be placed within a dental tray to fix the whitening composition in place on the teeth.
That Perepelitsa fails to describe dental aligners is immaterial to the Examiner’s prima facie case of obviousness: the Examiner has not indicated Perepelitsa does. The Examiner indicates that the dissolving whitening strips of Perepelitsa may be used as the oral composition in strip form which Rajaiah indicates may be combined with a dental tray to arrive at what applicants recite as their invention.
What applicants recite as “synergistic technical benefits” are exactly what the skilled artisan would expect from combining the whitening dental trays and strips suggested by Rajaiah and Perepelitsa with the dental aligners and whitening compositions suggested by Akl and Wilburn, as these are each individual benefits which the art ascribes to each of the elements which have been combined. “Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.” In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967), see also In re Skoner, 517 F.2d 947, 950 (CCPA 1975).
Applicants assertion that neither Rajaiah nor Perepelitsa suggest combining a dissolvable whitening strip with a dental aligner in the manner claimed. Again, so far as this goes, that is accurate; However, Rajaiah and Perepelitsa do suggest combining a dissolvable dental whitening strip with a dental tray to maintain contact of the whitening composition with the tooth surface. This is here augmented by the teaching off Akl concerning combining whitening compositions with dental aligners, and of Wilburn of using dental aligners to straighten teeth.
Applicants assert that the claims of the ‘864 application differ from those of the instant claims in that the ‘864 claims teach only a whitening film while the instant claims a film within a dental aligner. Applicants are reminded that this rejection is over the claims of the ‘864 application in view of Rajaiah, Akl, and Wilburn which as set forth previously and again above suggests incorporating a film such as that of the ‘864 claims into a dental straightener as required by the present claims.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614