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
Applicant’s election without traverse of Group I, claims 1-11 and 21-29, in reply filed on 06/15/2026 is acknowledged.
Applicant has cancelled claims 12-20 which were previously presented and drawn to an apparatus for in in the mouth during orthodontia treatment.
Claims 1-11 and 21-29 are pending and are currently under examination.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “Fig. 10, 10” has been used to designate both “end view of Fig. 6” and a straw shaped chew because there are two Fig. 10 in the drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
On page 3, the instant specification recites “Fig. 11 depicts a perspective view of an alternative chew according to the invention, with the chew being straw-shaped; Fig. 11 depicts an exploded view of the chew of Fig. 11;”.
This is a minor informality because the specification provides two explanations for the same figure and is understood to be a result of the mis-labeled figures (i.e., two Fig. 10) as discussed above.
Appropriate correction is required.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites “gel30s” in the last line which is understood to be a typo of “gels.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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.
Claims 1-11 and 21-29 are 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 phrase “has adhesive properties to permit” in claims 1 and 21 is a relative term which renders the claim indefinite. The term phrase 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. It is not clear what is meant by this phrase such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear what properties permit the claimed apparatus to be applied and remain in place as instantly claimed. It is not clear how far from the base structure one can deviate and still meet the requirement of the claim. For the purposes of examination this will be interpreted to mean “capable of”.
The term “elongated” in claims 5 and 24 is a relative term which renders the claim indefinite. The term “elongated” 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. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from the base structure one can deviate and still meet the requirement of the claim.
The term “substantially rectangular” in claims 5 and 24 is a relative term which renders the claim indefinite. The term “substantially rectangular” 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. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from a rectangle one can deviate and still meet the requirement of the claim. For the purposes of examination substantially rectangular will be interpreted as rectangular.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, “the missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.” Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998).
Even if the recitation were obvious over the disclosure of the Specification, that is not the standard for satisfaction of the written description requirement. See In re Huston, 308 F.3d 1267, 1277 (Fed. Cir. 2002) (‘“Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.’”).
Claim 21 recites “for use on or in the body” which is not present in the disclosure as originally filed. The disclosure as originally filed describes an apparatus for us in the mouth, specifically orthodontic tape and strips for use with braces and aligners (see claim 1 and specification at Summary). The entire scope of “on or in the body” is not necessarily present in the application as originally filed (e.g., “use with braces and aligners”).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7, 9-11, 21-23, 26, 28, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singha et al. (US 8,206,738 B2, date of patent 06/26/2012).
Singha relates to a hydrogel composition with an erodible backing member oral dressing wherein the hydrogel layer “comprises a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer with a complementary oligomer” [title & abstract]. “In practice, the compositions can be used simply by removing the product from its package, removing a release liner (when included) and applying the adhesive layer to the teeth that it is desired to whiten” [col. 25, lines 35-40]. Specific examples of the composition include a solid film extruded between two release liners (i.e., hydrogel film layer comprising liner for storing; limitation of instant claims 1, 2, 21 and 22) [col. 27, lines 60-67] and comprising the following ingredients (see col. 27, lines 35-60; tables reproduced below):
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According to the above: Eudragit L100-55 (methacrylic acid copolymer) is an acrylate copolymer, per instant claims 7 and 26. PVP is a polyvinylpyrrolidone, per instant claims 7 and 26. Hydrogen peroxide suffices as a whitening agent of instant claim 10 and therefore the at least one ingredient of instant claims 1. Additionally, Eudragit L100-55 is a water-swellable polymer according to Singha at column 10, lines 54-55 and 66 (i.e., synthetic water-swellable gel; instant claims 9 and 28).
Furthermore, Singha discloses that “The complementary oligomer is preferably a low molecular weight polyalkylene glycol (molecular weight 200-600) such as polyethylene glycol 400, which can also serve as a low molecular weight plasticizer” (i.e., plasticizer, per instant claims 11 and 29) [col. 13, lines 26-30].
The prior art anticipates instant claims 1, 2, 10, 11, 21, 22 and 29 because it is a composition comprising a release liner and flexible member of a single layer of a hydrogel that includes at least one ingredient (whitening agent) and a plasticizer (PEG). The prior art anticipates instant claims 7, 9, 26 and 28 because the hydrogel is synthetic water swellable gel of polyacrylate copolymers and polyvinylpyrrolidones. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e., capable of application to the teeth, capable of remaining in place for 30 minutes of more, a tape or sticker (instant claims 3 and 23).
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.
1) Claims 8 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Singha et al. (US 8,206,738 B2, date of patent 06/26/2012) as applied to instant claims 1-3, 7, 9-11, 21-23, 26, 28, and 29 above.
Singha does not anticipate instant claims 8 and 27 because it does not clearly disclose the amount of water with all the claimed components in one example or embodiment.
Regarding instant claims 8 and 27, Singha discloses “The adhesion profile can be tailored based on type of polymer, the composition ratio and the extent of water in the blend” [col. 9, lines 53-55].
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)).
In the present case, a skilled artisan would have been motivated to optimize the amount of water in composition through routine experimentation because Singha discloses that the extend of water in composition affects the adhesion profile. One would have had an expectation of success because given the exemplary compositions comprise water.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the compositions taught by Singha, as discussed above, to comprise water within the instantly claimed amounts.
2) Claims 4, 5, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Singha et al. (US 8,206,738 B2, date of patent 06/26/2012) as applied to claims 1-3, 7-11, 21-23, 26-29 above, and further in view of Rajaiah et al. (EP 3 315 172 A1, publication date 05/02/2018).
Singha, which is taught above, differs from the instant claims insofar as it does not disclose a specific shape for the oral film. However, Singha does disclose that “The systems described herein can be provided in a variety of sizes, so that the composition can be applied to the entirety or any portion of a tooth, to any number of teeth at one time, or to any portion of the oral cavity or other moist area” [col. 25, lines 40-44].
Rajaiah relates to an oral composition for tooth whitening [title] and disclosed “the oral composition may be applied via a delivery carrier, such as a strip or film of material, dental tray, sponge material or mixtures thereof. The delivery carrier is attached to the teeth via the oral compositions herein or the adhesion function can be provided independent of the present oral compositions herein” [0008]. According to Rajaiah suitable shapes for the strips include “rectangular, arched, curved, [and] semi-circular” [0022].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the shapes of Rajaiah with the films of Singha by known methods. One would have been motivated to make this combination because Rajaiah discloses shapes that are suitable for oral whitening strips that adhere to a user’s teeth, as desired by Singha. One would have had an expectation of success because Singha discloses the oral films may be provided in a variety of sizes and both Singha and Rajaiah relate to oral whitening adhesive films. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the films of Singha, as discussed above, wherein the films are rectangular and/or semi-circular.
3) Claims 6 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Singha et al. (US 8,206,738 B2, date of patent 06/26/2012) as applied to claims 1-3, 7-11, 21 21-23, 26-29 above, and further in view of Maddahi et al. (US 2018/0360732 A1, publication date 12/20/2018).
Singha, which is taught above, differs from the instant claims insofar as it does not disclose dead sea salt. Singha does disclose that the active agent may be a non-steroidal anti-inflammatory and bactericides [col. 17, lines 1-4]. Singha also welcomes the addition of salts, such as calcium salts [col. 20, line 59].
Maddahi relates to a “delivery system for whitening teeth comprised of a strip formed by combining (i) Dead Sea salt” [abstract]. According to Maddahi, dead sea salt was known to “assist in combatting bacteria and gum irritation and inflammation” [0006]. Additional components of the composition include hydrogen peroxide [0159]. Finally, Maddahi teaches there is a long-felt need for naturally derived oral care products (particularly whitening strips) [0016].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the dead sea salt of Maddahi with the whitening films disclosed by Singha. One would have been motivated to combine these prior art elements because Singha desires a bactericide active and Maddahi discloses dead sea salt is both a suitable bacterial suppressant in whitening strips and desirable because it is a natural ingredient. One would have had an expectation of success because Maddahi discloses dead sea salt is a suitable ingredient for oral whitening strips comprising hydrogen peroxide, and Singha welcomes the addition of salts. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the oral strips taught by Singha, as discussed above, to further comprise dead sea salt.
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.
1) Claims 1-11 and 21-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/177,606 in view of Xu et al. (US 2012/0301852 A1, publication date 11/29/2012).
This is a provisional nonstatutory double patenting rejection.
The copending claims recite “A therapeutic tape and wound care product for both intraoral and extraoral use comprising: a dissolvable, flexible member configured to mold around a part, said member having a material that is infused with an ingredient to improve the health of the user” [claim 1], “wherein the ingredient is one or more of sorbitol, baking soda, an antimicrobial agent, a flavoring, a breath freshener, a whitening agent, a pain reliever, and an anesthetic” [claim 9]. Wherein the flexible member comprises Poly N-vinyl pyrrolidone [claim 18]. “wherein the member is dissolvable over a 72-hour period of time” [claim 4] and “wherein the member withstands chewing in its original form for a period of time ranging from minutes to hours” [claim 17] (i.e., remains in place for 30 minutes or more).
The copending claims do not recite a hydrogel.
Xu relates to “dental strips comprising a film backing, and an adhesive layer, the adhesive layer comprising a water swellable polymer and at least one active agent” [abstract], wherein the water-swellable polymer comprises a hydrogel” [p. 3, claim 9]. “In some embodiments, the hydrogel includes cross-linked carboxyvinyl copolymers and/or cross linked polyvinyl pyrrolidones” [0024].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
In the present case it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the polyvinyl pyrrolidone hydrogel of Xu for the flexible polyvinyl pyrrolidone material desired by the copending claims because Xu discloses the hydrogel is suitable for oral films.
2) Claims 1-11 and 21-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 13-18 and 21-26 of copending Application No. 17/581,825 in view of Singha et al. (US 8,206,738 B2, date of patent 06/26/2012).
This is a provisional nonstatutory double patenting rejection.
The copending claims are directed to a product for use on soft tissue, teeth or braces comprising a layer with an ingredient such as whitening agent and an adhesive layer [claims 11 and 12]. Wherein the strip is dissolvable and withstands chewing for hours or minutes [claims 24-25].
The copending claims differ from the instant claims insofar as they do not disclose a hydrogel.
Singha discloses to a hydrogel composition with an erodible backing member oral dressing wherein the hydrogel layer “comprises a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer with a complementary oligomer” and that “[a]ctive ingredients, such as a whitening agent, may be included” [title & abstract]. Singha disclose that “For tooth whitening applications, a preferred time period is from about 10 minutes to about 8 hours (e.g., overnight), with 30 minutes to about 1 hour also being a preferred embodiment” (i.e., remain in place for 30 minute or more; limitation of instant claim 1 and 21) [col. 26, lines 10-13].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
In the present case it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the active containing hydrogel of Singha for the ingredient containing layer desired by the copending claims because Singha discloses the hydrogel layer is suitable for oral whitening films.
Additionally, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the films of the copending claims to stay in place for at least 30 minutes because Singha discloses it is preferable for oral whitening films to remain in place for 30-60 minutes. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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