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 06/12/2023 was filed after the mailing date of the application on 06/12/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 AlA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/e T D-info-l.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,510,767 and claims 1-20 of U.S. Patent No. 11,701, 212. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the claims requires an edentulous mouth insert appliance for mounting upon a fully edentulous gum of a patient, the edentulous mouth insert appliance comprising: a frame to cover the fully edentulous gum with a space between inner surfaces of the frame and the gum; wherein the frame is structured to receive a curable material in the space between the frame and the gum to provide a seal between the edentulous mouth insert appliance and the gum.
Claim Rejections - 35 USC § 112
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(s) 7 and 8 is/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.
Claim 7 recites that the appliance further comprises “a medicament associated with the curable material”. Claim 1 does not positively claim the curable material as part of the appliance. Therefore, even though the medicament is positively claimed in claim 7 as part of the appliance, it is not clear if the curable material is now positively claimed as well. If it is not positively claimed, it is unclear what is meant by the phrase “associated with”.
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) 1-2, 5-7, 9 and 14-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sanders (US 20180228574 A1).
Regarding claim 1, Sanders discloses an edentulous mouth insert appliance (Figures 1-10, Abstract) for mounting upon a fully edentulous gum of a patient. The Examiner notes that it could be for a fully edentulous gum of a patient since the appliance conforms to the gum ridge anatomy, wherein the appliance forms an enclosed protective cover over the gum ridge, wherein the holes for passage of erupted teeth are optional and the appliance substantially fully cover over portion of the gum ridge that are edentulous ([0016]).
The edentulous mouth insert appliance comprising: a frame (11) to cover the fully edentulous gum with a space (channels 9 shown in Figure 10) between inner surfaces of the frame and the gum (Figure 10, [0080]); wherein the frame is structured to receive a curable material (10) in the space between the frame and the gum to provide a seal between the edentulous mouth insert appliance and the gum (Figure 10, [0080]).
Regarding claim 2, Sanders discloses wherein the frame (11) includes a base (9) and a pair of inner and outer side walls (both the buccal ridge 2a and lingual ridge 2b) spaced apart by the base (9); and the frame (11) is structured to receive the curable material (10) to position the appliance on the gum such that an outer surface of the base (9) is oriented at a level corresponding to a gingival margin of the gum with an outer surface of the base aligned with a corresponding occlusal plane (Figure 10). The Examiner notes that the appliance forms an enclosed protective cover over the gum ridge (therefore, a level corresponding to a gingival margin of the gum; see [0016] and [0056]) and an outer surface of the base aligned with a corresponding occlusal plane, as shown in Figure 10.
Regarding claim 5, Sanders discloses wherein the frame (11) incudes at least one of an aperture or a cutout portion (13; see Figure 10).
Regarding claim 6, Sanders discloses wherein the frame is formed from a material selected from a group consisting of plastic, composite, and rubber medical grade materials ([0061]).
Regarding claim 7, Sanders discloses further comprising a medicament associated with the curable material for release when the appliance is worn (since the appliance includes a gum treatment layer on its inner surfaces for the delivery of one or more therapeutic treatment materials or medicinal materials to the gums [0084]).
Regarding claim 9, Sanders discloses wherein the frame includes a securance structure to secure the curable material to the frame (see plugs 8 and positioning bumps 12 [0075]).
Regarding claim 14, Sanders discloses wherein the frame (11) includes a portion (both the buccal ridge 2a and lingual ridge 2b) that projects upwardly from the base (9) a distance such that, with the curable material (10) positioning the appliance on the gum in alignment with a gingival margin of the gum, a top surface of the portion is aligned with a corresponding occlusal plane (occlusal aspect 2c) (Figure 8, [0076]).
Regarding claim 15, Sanders discloses a kit for an edentulous mouth insert appliance for mounting upon a fully edentulous gum of a patient (Figures 1-10, [0016]), the kit comprising: a frame (11) to cover the fully edentulous gum (the Examiner notes that it could be for a fully edentulous gum of a patient since the appliance conforms to the gum ridge anatomy, wherein the appliance forms an enclosed protective cover over the gum ridge, wherein the holes for passage of erupted teeth are optional and the appliance substantially fully cover over portion of the gum ridge that are edentulous [0016]) with a space (channels 9 shown in Figure 10) between inner surfaces of the frame and the gum; and a curable material, to be placed within the frame to be located between the frame and the gum to provide a seal between the edentulous mouth insert appliance and the gum ([0056]).
Regarding claim 16, Sanders discloses wherein the curable material includes a base and a catalyst; and when the base and the catalyst are combined (see e.g. urethane acrylate oligomers and photo-initiators [0087]), a curing mechanism in the curable material is activated such that the curable material hardens following a curing time (it could be visible or UV light catalyzed [0086]).
Regarding claim 17, Sanders discloses wherein the curable material is to be placed within the frame in an uncured state and provides the seal between the edentulous mouth insert appliance and the gum when the curable material has cured ([0056]).
Regarding claim 18, Sanders discloses wherein the frame (11) includes a base (9) and a pair of inner and outer side walls (both the buccal ridge 2a and lingual ridge 2b) spaced apart by the base (9); and when the curable material provides the seal between the edentulous mouth insert appliance and the gum, the curable material positions the appliance on the gum such that an outer surface of the base is oriented at a level corresponding to a gingival margin of the gum with an outer surface of the base aligned with a corresponding occlusal plane (occlusal aspect 2c) (Figure 10, [0016] and [0056]).
Regarding claim 19, Sanders discloses wherein the frame (11) includes a portion (both the buccal ridge 2a and lingual ridge 2b) that projects upwardly from the base (9); and when the curable material provides the seal between the edentulous mouth insert appliance and the gum ([0016] and [0056]), a top surface of the portion of the frame is aligned with a corresponding occlusal plane (occlusal aspect 2c).
Regarding claim 20, Sanders discloses an apparatus for mounting an edentulous mouth insert appliance upon a fully edentulous gum of a patient (Figures 1-10, Abstract), the apparatus comprising: a curable material to be placed in a space between a frame and the fully edentulous gum to provide a seal between the edentulous mouth insert appliance and the gum ([0056]); wherein the frame covers the fully edentulous gum with the space between inner surfaces of the frame and the gum ([0016] and [0056]). The Examiner notes that it could be for a fully edentulous gum of a patient since the appliance conforms to the gum ridge anatomy, wherein the appliance forms an enclosed protective cover over the gum ridge, wherein the holes for passage of erupted teeth are optional and the appliance substantially fully cover over portion of the gum ridge that are edentulous ([0016]).
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.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders as applied to claim 1 above, and further in view of Fowler (US 6491521 B1).
Regarding claim 3, Sanders discloses wherein the frame (11) includes a base (9) and a pair of inner and outer side walls spaced apart by the base (both the buccal ridge 2a and lingual ridge 2b), but fails to disclose “and portions of outer surfaces of the outer side walls are incised to replicate the appearance of teeth”.
Fowler discloses a mouth insert appliance (Abstract), wherein portions of outer surfaces of the outer side walls are incised to replicate the appearance of teeth (col 4, lines 5-12) and wherein portions of the outer surfaces of the outer side walls are colored to replicate the appearance of at least one of teeth or natural gums (col 2, lines 41-44). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Sanders’ appliance to make it comprising portions of outer surfaces of the outer side walls are incised to replicate the appearance of teeth and wherein portions of the outer surfaces of the outer side walls are colored to replicate the appearance of natural gums, as taught by Fowler, since such modification would improve the appearance of the appliance.
Regarding claim 4, Sanders and Fowler, as combined above, discloses the invention substantially as claimed. Fowler discloses wherein portions of the outer surfaces of the outer side walls are colored to replicate the appearance of at least one of teeth or natural gums (col 2, lines 41-44).
Claim(s) 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders as applied to claim 1 above, and further in view of Zegarelli (US 6626669 B2).
Regarding claim 8, Sanders discloses that the curing agent/material, when cured, will allow the operator to intimately conform the appliance to the specific gum ridge anatomy of any patient and so allow for a very snug fit of the appliance to the patient's specific gum ridge anatomy so as to provide for a superior seal of the appliance on the gum ridge to effectively contain and prevent the leakage of medicaments ([0056]), but fails to specifically disclose “wherein the medicament is incorporated into the curable material”.
Zegarelli discloses a mouth insert appliance for mounting upon a fully edentulous gum of a patient for delivering medicament to a patient's oral soft tissue (claim 1); wherein the medicament is incorporated into a curable material (col 3, lines 19-41 and claim 63). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Sanders’ appliance to make it comprising the medicament incorporated into pockets/reservoirs created by the curable material, since such modification would allow movement of a medicament towards the target areas (claim 23).
Regarding claim 13, Sanders discloses wherein the frame includes a base (9) and a pair of inner and outer side walls (both the buccal ridge 2a and lingual ridge 2b) spaced apart by the base, but fails to disclose “and a thickness of each of the base and the inner and outer walls of the frame is in a range of 1 mm to 2 mm”.
Zegarelli discloses a mouth insert appliance for mounting upon a fully edentulous gum of a patient for delivering medicament to a patient's oral soft tissue (claim 1), including a frame (made of a thermoplastic sheet) and a thickness of the frame is in a range of 0.04 inches to about 0.2 inches (1.02 mm to 5. 8 mm) (col 3, line 64 to col 4, line 12). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Sanders’ appliance to make a thickness of each of the base and the inner and outer walls of the frame is in a range of 1.02 mm to 5. 8 mm, as taught by Zegarelli, since such modification would provide the frame with a proper stiffness of the appliance as desired (col 3, line 64 to col 4, line 12).
Should applicant traverse the Examiner’s position above, the Examiner further notes that Zegarelli teaches ranges overlapping the claimed limitations with respect to the thickness of the frame. In this case since the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (Please see MPEP 2144.05(I)).
In an alternative interpretation claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders as applied to claim 1 above, and further in view of Weitzman (US 20120267811 A1).
Regarding claims 9-10, Sanders fails to specifically discloses “wherein the frame includes a securance structure to secure the curable material to the frame” and “wherein the securance structure includes at least one of an aperture or a bore in the frame”.
Weitzman discloses a mouth insert appliance (Abstract, Figure 2A), including a frame 103 and a curable material 105 ([0027]); wherein the frame includes a securance structure (301) to secure the curable material to the frame ([0044]), wherein the securance structure includes at least one of an aperture or a bore in the frame (see apertures 301 in Figure 3B). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Sanders’ frame to add the securance structures, as taught by Weitzman, since such modification would allow the curing material to protrude through the hole before it has set/cured (i.e. for better securement).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders as applied to claim 1 above, and further in view of Bowers (US 1293627 A).
Regarding claim 11, Sanders fails to disclose “wherein the frame includes an insert to facilitate retaining the frame in a desired flexed orientation” and “wherein the insert includes a wire embedded in the frame”.
Bowers discloses a mouth insert appliance (col 2, lines 58-83, Figure 1); including a frame (see rubber base plate); wherein the frame includes an insert to facilitate retaining the frame in a desired flexed orientation and wherein the insert includes a wire embedded in the frame (see loop wire in Figure 13 and col 2, lines 58-83). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Sanders’ frame to add the insert, as disclosed by Bowers, since such modification would add additional strength to the soft material that forms the frame.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Howe (US 20180042705 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS MIGUEL RUIZ MARTIN whose telephone number is (571)270-0839. The examiner can normally be reached M-F 8 Am - 5 PM (EST).
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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/
Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772