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 .
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.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12,109,086. Although the claims at issue are not identical, they are not patentably distinct from each other because a concave and convex curvature of a mouthpiece is well known in the art and would be expected of a mouthpiece fitting a dental arch, a flexible circuit placed on the concave surface would also be expected to be concave, and a control circuit and power source are well known components for a device utilizing a circuit to generate light. Additionally having the walls be harder than the bite platform is known for cushioning the bite pressure and not permanently deforming, as evidenced by Edgren below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims recite part of the human body in combination with the device, e.g. “each of a user’s teeth that is positioned within the channel”. It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of limited, but exclusive property right in a human being is prohibited by the constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). For examination purposes, all claims will be considered as if such limitations involving the combination with a human were not present. Language such as “adapted to be attached” or “for attachment to” or “when in use” is suggested, or the “channel that is configured to” language present in independent claim 12.
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 7 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.
Claim 7 recites “the electromagnetic radiation source is enclosed within the wall of the mouthpiece”, however claim 1 from which it depends has already stated that “the electromagnetic radiation source mounted to the inner surface of the wall”. It is unclear how it could be both within the wall, but also mounted on an outer surface thereof.
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.
Claims 1-4, 7, 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brawn et al. (US 2014/0072932).
Brawn shows a teeth whitening system comprising a mouthpiece (Fig. 45-46) comprising a wall (2185 in Fig. 46) comprising an inner surface having a first concave curvature (at 2185 in Fig. 46) and an outer surface opposite the inner surface having a convex curvature (opposite 2185 at 2180 in Fig. 46), the wall formed of a first material ([0094] discusses the use of a rigid plastic for the wall); an electromagnetic radiation source ([0182]; Fig. 52) comprising a front surface and a rear surface opposite the front surface (Fig. 52 opposite sides thereof), a first flexible circuit (as seen at 2130 in Fig. 52; [0182]), and a plurality of first illumination elements embedded within the first flexible circuit (2132 embedded within circuit 2130 as seen in Fig. 52) that generate light which is emitted from the rear surface of the electromagnetic radiation source (2132; [0195]); the electromagnetic radiation source mounted to the inner surface of the wall so that the rear surface of the electromagnetic radiation source assumes a first concave curvature (Fig. 52 placed along 2185 in Fig. 46; [0182]), the electromagnetic radiation source operably coupled to a control circuit having a power source (controller 2314 and battery 2194 for instance); and a bite platform extending from the inner surface of the wall, the bite platform formed of a second material having a hardness that is less than a hardness of the first material (2182; [0181] discusses the different materials of the bite platform, including a silicone which would be less hard than a rigid plastic). With respect to claim 2, wherein the first flexible circuit comprises a flat, flexible sheet and the plurality of first illumination elements are positioned on or embedded within the flat, flexible sheet (as seen in Fig. 52; [0182]). With respect to claim 3, wherein more than one of the plurality of first illumination elements is aligned with each of a user’s teeth that is positioned within the channel (due to the distribution shown in Fig. 52, each tooth will have several LEDs aligned therewith). With respect to claim 4, wherein the first flexible circuit is disposed within a recess formed in the inner surface of the wall ([0203] discusses it being at least partially enclosed to embedded within the wall; when partially enclosed it would be present in the recess it occupies on the face of the wall). With respect to claim 7, wherein the electromagnetic radiation source is enclosed within the wall of the mouthpiece (see 112 above; [0203] when embedded therein), a portion of the wall that covers the electromagnetic radiation source being transparent so the light emitted by the electromagnetic radiation source is configured to pass through the portion of the wall (the wall must be transparent in this location in order for the light to irradiate out as discussed in [0182]; the wall is also referred to as clear, such as in [0094] or seen in Fig. 43 for instance). With respect to claim 9, wherein the mouthpiece seals a perimeter of the electromagnetic radiation source, a central portion of the electromagnetic radiation source remaining exposed (addressed similarly to claim 4 where the circuit is partially enclosed; when partially enclosed, will be surrounded/sealed around its perimeter by the mouthpiece wall). With respect to claim 10, wherein the electromagnetic radiation source emits the light having a wavelength in a range of 375 nm to 520 nm ([0298] discusses overlapping ranges with that claimed; “from about 400 nm to about 1200 nm”). With respect to claim 11, wherein the electromagnetic radiation source emits the light having a wavelength in a range of 405 nm to 415 nm ([0298] discusses overlapping ranges with that claimed “from about 400 nm to about 1200 nm”).
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wasylucha (US 2004/0110111).
Wasylucha shows a teeth whitening system comprising a mouthpiece (such as seen in Fig. 5) comprising a wall (interior vertical wall in Fig. 5 for instance) comprising a proximal end (at the top of the vertical wall) and a distal end opposite the proximal end (at the bottom of the vertical wall); and a bite platform (top flat portion in Fig. 5) extending inwardly from the proximal end of the wall (Fig. 5), the bite platform comprising a cavity ([0093]; cells 204 act as reservoirs) for storing a tooth whitening material ([0093] states whitening compositions within beads); an electromagnetic radiation source coupled to the mouthpiece and configured to emit electromagnetic radiation ([0093] phosphorescent light source integral to the support; [0082] discusses including a diode light source on the support); and a bladder (bead) comprising a rupturable or dissolvable material ([0046] discusses dissolving and [0051] discusses the release by pressure), the tooth whitening material housed within the bladder (beads [0050] or [0093]), and wherein the bladder is removably positioned within the cavity of the bite platform (the cells act as reservoirs and can therefore receive and release the bladder).
Claim Rejections - 35 USC § 103
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Brawn in view of McDonough et al. (US 8,684,956).
Brawn discloses the device as previously described above, but fails to show that a first ridge extending upwardly from the bite platform and spaced apart from an upper wall portion of the wall by a first gap, and a second ridge extending downwardly from the bite platform and spaced apart from a lower wall portion of the wall by a second gap, the first and second ridges offset from one another.
McDonough similarly teaches an oral mouthpiece care device (Fig. 14 for instance) wherein a first ridge (148 above the bite platform in Fig. 14) extending upwardly from the bite platform (156) and spaced apart from an upper wall portion (146 above the bite platform in Fig. 14) of the wall by a first gap (between 146 and 148 top), and a second ridge (148 below the bite platform in Fig. 14) extending downwardly from the bite platform and spaced apart from a lower wall portion (146 below the bite platform in Fig. 14) of the wall by a second gap (between 146 and 148 bottom), the first and second ridges offset from one another (cross section shows both the walls and ridges offset from one another on either sides of the bite platform). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Brawn’s mouthpiece by including lower walls and offset ridges as taught by McDonough in order to treat upper and lower jaws simultaneously and better match typical occlusion.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Brawn in view of Jones (US 2009/0322227).
Brawn discloses the device as previously described above and additionally discusses “one or more light emitters” without an upper range, but fails to explicitly show with respect to claim 8, wherein the electromagnetic radiation source comprises at least one thousand of the first illumination elements (overlaps range with “one or more light emitters” and the many illumination elements shown in Fig. 52 as an example).
Jones similarly teaches LED arrays for providing a large light radiation dose to the teeth with at least one thousand of first illumination elements ([0087], [0090]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Brawn’s device to have at least one thousand of the LEDs as taught by Jones in order to allow for the providing of a light radiation dose to a large area of a patient’s teeth ([0087]).
Claims 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Brawn in view of McDonough and further in view of Edgren (US 2013/0280670).
Brawn/McDonough and additionally the upper wall portion and an upper surface of the bite platform forming a first channel that is configured to receive a user’s upper teeth (equivalent to first gap above), the lower wall portion and a lower surface of the bite platform forming a second channel that is configured to receive the user’s lower teeth (equivalent to second gap above), the bite platform being positioned between the user’s upper and lower teeth (accepts both sets of teeth simultaneously); and a second electromagnetic radiation source coupled to the lower wall portion and configured to emit light onto surfaces of the user’s lower teeth that are positioned in the second channel, the second electromagnetic radiation source comprising a second flexible circuit and a plurality of second illumination elements located on the second flexible circuit (including a lower wall and corresponding lighting to match that of the top wall in the combination); and the wall being formed of a food grade polymer ([0168]; silicone used in medical devices is a food grade polymer). However, Brawn/McDonough fails to show the bite platform being formed of a hard rubber.
Edgren similarly teaches a dental device exposed to bite pressure, wherein the material used for cushioning the bite pressure and not permanently deforming is hard rubber ([0029]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Brawn/McDonough’s device by utilizing the hard rubber material for the bite platform exposed to bite pressure as taught by Edgren in order to utilize known materials in the art for handling a patient’s bite pressure.
With respect to claim 13, wherein the first and second electromagnetic radiation sources are flexible printed light emitting diodes (Brawn: [0445]; “flexible printed circuit board” with light emitting diodes) or flexible organic light emitting diodes. Claim 14 addressed similarly to claim 2. With respect to claim 15, the combination especially of Brawn/McDonough as detailed above has the upper wall portion comprises an inner surface and the lower wall portion comprises an inner surface, the first electromagnetic source located on the inner surface of the upper wall portion and the second electromagnetic source located on the inner surface of the lower wall portion, and wherein the inner surfaces of the upper and lower wall portions are offset from one another (addressed similarly to claim 6 above but with regards to the offset walls for the same motivation). With respect to claim 16 wherein the first electromagnetic radiation source is offset from the second electromagnetic radiation source (Brawn’s illumination panels on the offset walls as taught by McDonough will result in this configuration in the combination). Claim 17 is rejected similarly to claim 4 above but with a second circuit in the combination with McDonough. With respect to claim 18, wherein the first and second electromagnetic radiation sources are enclosed within the upper and lower wall portions, respectively, of the wall of the mouthpiece (rejected similarly to claim 7 but additionally with the lower mirroring the upper arch). With respect to claim 19, wherein the first electromagnetic radiation source and the second electromagnetic radiation source emit light having a wavelength in a range of 405 nm to 415 nm (rejected similarly to claim 11 but additionally with the lower mirroring the upper arch).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, in addition to overcoming the double patenting rejection.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of Brawn shows similar structure of a mouthpiece with electromagnetic radiation source in the form of a first flexible circuit, but does not show where the wall extends from a bit platform up to a shoulder for a first distance, and then from the shoulder to the top of the wall for a second distance so that the first distance is recessed relative to the second distance of the wall. While Brawn has a recessed portion when the radiation source is partially enclosed by the mouthpiece, this would not specifically start at the height of the bite platform, nor would it be expected based on Brawn’s structure and intent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW NELSON whose telephone number is (571)270-5898. The examiner can normally be reached on Monday-Friday 7:30am-5:00pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eric Rosen, at (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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/MATTHEW M NELSON/Primary Examiner, Art Unit 3772