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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 October 2025 has been entered.
Status of the Claims
Claims 1-5, 7, 8, 10-19, and 29-35 are pending.
Claims 2-4 are withdrawn from consideration as directed to non-elected inventions.
Claims 1, 5, 7, 8, 10-19, and 29-35 are presented for examination.
Claim Interpretation
Applicants claims are directed to polymer films of defined thickness containing “one or both of a non-hydrogen peroxide bleaching agent and hydrogen peroxide in a hydrogen peroxide-polymer complex.” As applicants have elected, examination has been limited to films containing a hydrogen peroxide-polymer complex as a “dental bleaching agent.” This is combined with each of at least a cyclic polyphosphate of formula (II), and a linear polyphosphate of formula (III). Claim 31 replicates the limitations of former Claim 1 by including each of a film forming polymer, plasticizer, and emulsifier, each in defined concentrations, as well as a peroxide/PVP complex such as is recited by Claim 5. Claim 5 specifies that the peroxide-polymer is to be a complex of hydrogen peroxide and PVP. Claims 7 & 8 specify the cyclic polyphosphate as, ultimately, sodium hexametaphosphate, in defined concentrations. Claim 10 & 11 require the linear polyphosphate be present in defined concentrations, ultimately specifying the liner polyphosphate is to be sodium tripolyphosphate. Claim 12 provides for defined concentrations of each of the hexametaphosphate and tripolyphosphate in combination. Claim 13 includes a film-forming polymer, Claims 14 and 29 a plasticizer, and 15 an emulsifier, each in defined concentrations. Claim 16 additionally required the presence of water in defined concentrations. Claim 17 and 18 require the inclusion of additional components, such as peppermint flavoring. Claim 19 places further limitations on the thickness of the film of Claim 1. The examiner notes that each of Claim 1, 19, and 31 recite particular manners in which the films otherwise fully defined by the claim may be used; “tooth whitening” and “to provide at least one of enhanced bleaching or improved stain resistance” of Claims 1 and 31, and “for use with a dental aligner” in Claim 19. Applicants are reminded that claim language which reflect 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). As such, the above language in these claims is not afforded patentable weight in the Examiner’s estimation. Claim 30 specifies the one or more polyphosphates are provided without a barrier layer, and Claims 32-35 placing further limits on the peroxide and PVP, or peroxide/PVP complex, present in the films of Claim 31 and 1.
Terminal Disclaimer
The terminal disclaimer filed on 27 October 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent issuing from U.S. application 17/922,864 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed 27 October 2025 have been fully considered.
The examiner notes applicants have once more failed to address the second non-statutory double patenting rejection of record, that over the copending 18/008,696 application. This rejection is therefore maintained for the reasons set forth previously and again below.
The Declaration of Dr. Cullen under 37 CFR 1.132 filed 27 October 2025 is sufficient to overcome the rejection of claims 1, 5, 7, 8, 10-19, and 29-34 under 35 USC 103 based upon the teachings of Perepelitsa and Gebreselassie, either alone or in combination with Boyd. The Cullen declaration demonstrates that compositions falling within the scope of the claimed compositions, as amended, provide an improvement in tooth whitening that is unexpected given the state of the prior art. It is this unexpected improvement in tooth whitening that serves to distinguish the compositions claimed from the prior art, and which therefore justifies the WITHDRAWAL of the obviousness rejections of record.
However, based on the amendments made to the claims, the following rejections are made. The Examiner reached out on each of January 21 and 26, 2026, to discuss place the application in condition for allowance, but was unable to reach the attorney of record.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4, 8, 11, and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2-4 refer to the “non-hydrogen peroxide bleaching agent” of Claim 1, where Claim 1 has been amended, in accord with applicants elected species, to eliminate non-hydrogen peroxide bleaching agents from the scope of the claims. Claims 8, 11, and 12 recite polyphosphate concentration ranges that fall outside the scope of, and therefore fail to further limit, Claim 1. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
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 1, 5, 7, 8, 10-19, and 29-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/008,696 (reference application), in view of Perepelitsa and Gebreselassie as discussed in greater detail previously. Although the claims at issue are not identical, they are not patentably distinct from each other because while the ‘696 application requires the combination of whitening strips of overlapping thicknesses containing film-forming polymer in the form of an acrylic acid polymer hydrogen peroxide as a whitening agent, plasticizers, phosphates, and emulsifiers, the reference application does not require the particular polyphosphates or HP/PVP complex required by the present claims. However, as set forth above, Perepelitsa and Gebreselassie establish that each of these additional ingredients are commonly employed in tooth whitening strips, rendering their inclusion little more than the he predictable use of prior art elements according to their established functions, and obvious thereby. See KSR, supra.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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