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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/13/2026 was filed after the mailing date of the application on 06/09/2022. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, see Remarks filed on 04/13/2026, have been fully considered. Applicant’s arguments against the rejections in view of the prior art of record have been fully considered, but are not persuasive as they do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the medicament is leached out of the hydrogel, empty spaces in the hydrogel open and become available to absorb and remove fluids from the environment. This creates negative crevicular fluid flow and allows the medicament while under pressure (as depicted by Pressure Points A, B, and C) to enter the top portion of the pocket to fill the negative pressure. This allows the medicament to enter even more deeply into the pockets” … “the hard portion matching the teeth or hard tissue of the oral cavity will assert pressure on pressure point C. In this case, the hard tissue causes more compression and flattens the hydrogel onto the soft tissue. On the other side of the pocket, the soft portion asserts pressure on pressure points A and B, forcing the medicament to diffuse out into the pocket specifically. This pressure gradient between the hydrogel and the subgingival space and capillary action caused by the crevicular fluid as described above contribute to the specific medicament delivery mechanism”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first pressure line and the second pressure line must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as "Annotated Sheet" and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the corrected drawing and marked-up copy will result in the abandonment of the application.
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 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.
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.
Claims 1, 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (US 20140011162 A1) in view of Keller (US 6966773 B2), in view of Kalili (US 20110020761 A1), further in view of Kopelman (US 20150366637 A1).
Regarding claim 1, Zagarelli discloses an oral appliance for delivery of medicament to an oral cavity (Abstract), the oral appliance having an interior surface (12) and an exterior surface (14), the interior surface and/or exterior surface configured to contour a treatment area and deliver medicament thereto ([0042]), wherein a portion of the interior surface comprises a soft portion having a softness to match a soft tissue of the oral cavity it contours (since the interior surface 12 is custom fit to the individual patient's mouth and configured to receive all or a portion of the teeth and/or soft tissue areas inside the mouth cavity and deliver medicament thereto; [0042]), the interior surface also having a hydrogel having the medicament for delivering the medicament to the treatment area ([0042]); and a portion of the interior surface comprising a hard portion, to match the hardness of a hard tissue of the oral cavity (since the interior surface 12 contacts one or more teeth and/or soft tissue areas of a patient. The interior surface 12 is custom fit to the individual patient's mouth and configured to receive all or a portion of the teeth and/or soft tissue areas inside the mouth ([0042]),
Zagarelli discloses that an applied pressure generates a pressure gradient between the hydrogel and the soft tissue delivering the medicament to the treatment area, and wherein the applied pressure moves the hydrogel to seal an entrance of a gingival crevice or periodontal pocket of a portion of an inflamed tissue of the oral cavity as a portion of the hydrogel exudes from the oral appliance and contacts the entrance of the gingival crevice or periodontal pocket to reduce or prevent contamination of the gingival crevice or periodontal pocket by oral fluids (since the medicament can be disposed at discrete positions adjacent to the treatment area or uniformly disposed throughout the device. As the interior and/or exterior surface of the oral appliance contacts the oral cavity the medicament is released from the polymer (e.g., gel or hydrogel) by all or parts of the oral appliance contacting the desired treatment site or pressure from the device contacting tissue or fluid at the treatment site (e.g., gums, tissue, teeth, etc. [0042]).
However, Zegarelli fails to disclose “the soft portion having a modulus of elasticity from about 2.4 to about 19.8 MPA”, “the hard portion having a modulus of elasticity from about 1330 to about 1650 MPA” and “and the oral appliance further comprises a first pressure line and a second pressure line, the first pressure line disposed on the soft portion matching the soft tissue of the oral cavity adjacent to the treatment area, and the second pressure line adjacent to the treatment area and disposed on the hard portion matching the hard tissue of the oral cavity adjacent to the treatment area; and the hydrogel having the medicament disposed between the first pressure line and the second pressure line such that an applied pressure resulting from applying a pressure apically to the oral appliance causes the first pressure line to move against the soft tissue adjacent to the treatment area and the second pressure line to move against the hard tissue adjacent to the treatment area such that the applied pressure generates a pressure gradient between the hydrogel and the soft tissue delivering the medicament to the treatment area, and wherein the applied pressure moves the hydrogel to seal an entrance of a gingival crevice or periodontal pocket of a portion of an inflamed tissue of the oral cavity as a portion of the hydrogel exudes from the oral appliance and contacts the entrance of the gingival crevice or periodontal pocket to reduce or prevent contamination of the gingival crevice or periodontal pocket by oral fluids”.
Keller discloses an oral appliance for delivery of medicament to an oral cavity (Abstract), the oral appliance having a first pressure line and a second pressure line, the first pressure line disposed on the soft portion matching the soft tissue of the oral cavity adjacent to the treatment area (since a seal surrounds the recess at a location corresponding to the patient's gum line for applying pressure at the patient's gum line when the patient's teeth are disposed in the recess), and the second pressure line adjacent to the treatment area and disposed on the hard portion matching the hard tissue of the oral cavity adjacent to the treatment area (since the tray is constructed from resilient material molded to conform to the teeth; see col 3, lines 30-55); and the medicament disposed between the first pressure line and the second pressure line such that an applied pressure resulting from applying a pressure apically to the oral appliance causes the first pressure line to move against the soft tissue adjacent to the treatment area and the second pressure line to move against the hard tissue adjacent to the treatment area such that the applied pressure generates a pressure gradient between the medicament and the soft tissue delivering the medicament to the treatment area, and wherein the applied pressure moves the medicament to seal an entrance of a gingival crevice or periodontal pocket of a portion of an inflamed tissue of the oral cavity as a portion of the medicament exudes from the oral appliance and contacts the entrance of the gingival crevice or periodontal pocket to reduce or prevent contamination of the gingival crevice or periodontal pocket by oral fluids (col 3, lines 30-55). The Examiner notes that Keller device has all the necessary structures to allow the medicament to seal any pockets in the patient's gums proximate the teeth; see col 3, lines 43-46. Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Zegarelli’s oral appliance to make it comprising the pressure lines that apply pressures to the soft and hard tissues of the oral cavity, as taught by Keller, since such modification would enable a practitioner to manage the positive pressure environment to correspond to the diseased state of the patient and to modify this environment as healing occurs (col 3, lines 53-55).
Kalili discloses an oral appliance comprising an elastic moduli which differs in different parts of the appliance; wherein the elastic moduli ranges from 0.1 to 10 GPa (therefore, 10 to 10000 Mpa), although some parts of the appliance may be outside of this range. The elastic modulus of one part may differ from another part by 10% to 500%, or more ([0070]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Zegarelli/Keller’s oral appliance to make it comprising an elastic moduli which differs in different parts of the appliance, as disclosed by Kalili, since such modification would create an appliance that applies less pressure to specific parts of the oral cavity, therefore protecting the patients from bone and root resorption ([0072]).
Therefore, Zegarelli, Keller and Kalili, as combined above discloses wherein a portion of the interior surface comprises a soft portion having a softness to match the soft tissue of the oral cavity it contours and a portion of the exterior surface comprising a hard portion to match the hardness of the hard tissue of the oral cavity. However, the combination of Zegarelli, Keller and Kalili fails to disclose “the soft portion having a modulus of elasticity from about 2.4 to about 19.8 MPa” and “the hard portion having a modulus of elasticity from about 1330 to about 1650 MPa”.
Kopelman discloses an oral appliance having different elastic moduli in different parts of the appliance; wherein for instance, the exterior layer has an elastic modulus within a range from about 10,000 psi to about 700,000 psi (68 MPa to 4826 MPa) and the interior layer has an elastic modulus within a range from about 100 psi to about 8000 psi (0.6 MPa to 55Mpa) [0025]. Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Zegarelli/Keller/Kalil’s oral appliance to make it comprising the claimed elastic modulus in specific parts of the appliance, since such modification would create an appliance that applies less pressure to specific parts of the oral cavity, therefore protecting the patients from bone and root resorption as explained by Kalili in [0072].
Regarding claim 6, Zegarelli, Keller, Kalili and Kopelman discloses the invention substantially as claimed. Zegarelli discloses wherein the soft tissue of the oral cavity comprises muco-buccal folds, soft palate, lining mucosa, buccal and labial mucosa, attached and unattached gingival tissue, tongue and floor of mouth tissue ([0041]).
Regarding claim 15, Zegarelli, Keller, Kalili and Kopelman discloses the invention substantially as claimed. Zegarelli discloses wherein the medicament is configured to contact at least a portion of an inflamed tissue of the oral cavity including at least a portion of a subgingival space when the oral appliance is worn to cause delivery of the medicament to at least the portion of the subgingival space of the inflamed tissue. Since the medicament is configured to treat inflamed and/or bleeding gums, mucosal wounds, lesions, tooth abscesses, gingivitis, periodontal disease, and post-surgical dressings ([0113]).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli, in view of Keller, in view of Kalili, in view of Kopelman, as applied to claim 1 above, and further in view of Bertassoni (US 20210283311 A1).
Regarding claims 10, 11 and 12; Zegarelli, Keller, Kalili and Kopelman fails to disclose “the hydrogel has a modulus of elasticity from about 8 to about 60 kPa”, “wherein the hydrogel is a soft hydrogel and has a modulus of elasticity from about 8 kPa” and “wherein the hydrogel is a hard hydrogel having a modulus of elasticity (i) from about 10 kPa to about 50 kPa; or (ii) from about 50 kPa to about 60 kPa”.
Bertassoni teaches a dental hydrogel composition having a modulus of elasticity of (7 kPa) and/or 12 kPa ([0089]). Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Zegarelli/Keller/Kalili/Kopelman’s disclosure with the teachings of Bertassoni in order to create a device comprising a hydrogel having a modulus of elasticity as taught by Bertassoni, since such modification would create an appliance that carries the medicament in a slightly flexible material that is resistant to degradation.
Regarding claim 13, Zegarelli, Keller, Kalili, Kopelman and Bertassoni discloses the invention substantially as claimed. Zegarelli discloses wherein the medicament comprises an anticariogenic agent ([0112]), an antimicrobial ([0107]) or a combination thereof.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli, in view of Keller, Kalili, in view of Kopelman, as applied to claim 1 above, further in view of Fontenot (US 20080199830 A1), and further in view of Thomas (US 20180153294 A1).
Regarding claim 23, Zegarelli, Keller, Kalili and Kopelman discloses the invention substantially as claimed. Zegarelli discloses that the polymeric matrix is comprised by a hydrogel and that the hydrogel has a viscosity of about 300 to about 5,000 centipoise ([0083]). However, Zegarelli fails to disclose “wherein the hydrogel has a viscosity of from about 50,000 cps to about 1x107 cps at 25°C”.
Fontenot teaches a dental tray for the active delivery of medicaments into hard and soft tissues of the oral cavity (Abstract). Fontenot teaches that the dental tray comprises a hydrogel having a viscosity of 100,000 to 1,000,000 cp ([0041]). Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Zegarelli/Keller/Kalili/Kopleman’s device with the teachings of Fontenot in order to create a hydrogel with a viscosity of 100,000 to 1,000,000 cp for the purpose of medicament delivery to the oral cavity via a dental appliance, since a hydrogel with a high viscosity would be advantageous to hold large amount of medicament and other biological materials ([0041]). However, Zegarelli/Kalili/Kopelman/Fontenot fails to disclose at what temperature is the viscosity measured.
Thomas discloses that room temperature is between 20° C to about 25° C ([0078]). Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Zegarelli/Keller/Kalili/Kopelman/Fontenot to incorporate the teachings of Thomas in order to take the measurements at 25 °C, since Thomas teaches a temperature range overlapping the limitation, as being room temperature conditions, and would merely involve choosing from a finite number of identified predictable solutions with a reasonable expectation of success (e.g. one of ordinary skills would recognize the temperatures around 25° C would provide room temperature conditions and a reasonable expectation of success). Additionally, it would be obvious to measure the viscosity at room temperature to mimic repeatable and normal conditions, and to mimic conditions where the device would be used.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli, in view of Keller, in view of Kalili, in view of Kopelman, as applied to claim 1 above, further in view of Puleo (US 20150290361 A1).
Regarding claim 24, Zegarelli, Keller, Kalili and Kopelman fails to disclose “wherein the hydrogel has a porosity of from about 60 to about 600 µm”.
Puleo discloses a hydrogel polymeric matrix for delivery of medicament into the oral cavity having a porosity of around 100 μm ([0125]). Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Zegarelli/Keller/Kalili/Kopelman’s device in order to create a porous hydrogel having pores size of around 100 μm, since such modification has the advantage of creating a hydrogel porous material that can carry medicament on the pockets generated by the pores which facilitates the delivery of the medicine ([0077]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS RUIZ whose telephone number is (571)270-0839. The examiner can normally be reached on M-F 8 Am - 5 PM (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Luis Ruiz Martin/
Patent Examiner
Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
Prosecution Insights