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 II, claims 36 and 41-50 in the reply filed on July 31,2026 is acknowledged.
Claim 27 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
(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.
Claim(s) 36, 43-45 and 47-50 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Mason (US 2017/0007386 A1).
Regarding Claim 36, Mason anticipates making an oral appliance for delivering a medicament to an oral cavity (abs, paragraphs [0028] [0036] [0064] dental appliances capable of drug delivery; with integrally formed reservoir filled with an agent comprsing a drug and an aqueous solution), the method comprising forming a porous material into a portion of the oral appliance (Figs. 3D-3G paragraphs [0074]-[0077] where integrally formed reservoir may be directly fabricated with second material comprising pores); and applying a non-porous material to one or more discrete regions of the portion of the oral appliance to make the one or more discrete regions of the oral appliance non-porous (Figs. 3C-3H paragraphs [0074] [0076] the integrally formed reservoir may be formed from the same material as the shell of the tooth receiving appliance which comprises porous and non-porous material and where a portion may be fabricated from a second different material that implies a non-porous material) thereby forming the oral appliance (paragraphs [0008]-[0009]).
Regarding Claim 43, Mason anticipates all the limitations of claim 36 and further anticipates that the non-porous material reduces medicament release from the oral appliance (Fig. 3G, paragraph [0077] rate controlling membrane – 153 may include pores to control release of an agent from the reservoir – 152).
Regarding Claims 44 and 45, Mason anticipates all the limitations of claim 36 and further anticipates that the porous material comprises a polymer and the polymer allows the medicament to be loaded within the polymer (paragraphs [0055] [0056] agent is a dye encapsulated in a polymer which Is porous which is used for controlled drug release and where the reservoir is integrally formed with a polymeric shell for drug delivery).
Regarding Claim 47, Mason anticipates all the limitations of claim 36 and further anticipates that the oral appliance has a thickness of from about 250 µm-2 mm (paragraph [0094] where typically an orthodontic appliance has a thickness in a range of about 250 µm-2 mm where 2 mm equals approximately 0.08 inches, but does not disclose that the range is explicitly 0.06 inches to about 0.2 inches.
MPEP § 2131.03: Prior art which teaches a range within, overlapping or touching the claimed range anticipated if the prior art range discloses the claimed range with “sufficient specificity”.
Regarding Claim 48, Mason anticipates all the limitations of claim 36 and further anticipates that the oral appliance comprises a semi-solid construction (paragraphs [0109] [0119] where the direct fabrication method can include polymerization-inhibited “dead zones” where a semi-permeable membrane is positioned into the dead zone, direct fabrication can introduce material properties including various physical properties (e.g. modulus, strength, elongation)).
Regarding Claim 49, Mason anticipates all the limitations of claim 36 and further anticipates that the non-porous material has a higher density than the porous material (Fig. 3D paragraph [0074] pores present with inherently lower density than non-porous material).
Regarding Claim 50, Mason anticipates all the limitations of claim 36 and further anticipates that the non-porous material and the porous material are the same material but the non-porous material has a higher density than the porous material as the porous material has a lower density (paragraph [0074] porous material has inherent lower density where larger pore size is selected) or is configured as a sponge like lattice (paragraph [0035] pore sizes selected during manufacturing) than the non- porous material which is applied at a higher density to the oral appliance by additive manufacturing or 3D printing (paragraph [0056]).
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.
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) 41-42 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mason (US 2017/0007386 A1).
Regarding Claim 41, Mason anticipates all the limitations of claim 36 and further anticipates that the porous material is formed into the portion of the oral appliance on an exterior surface of the oral appliance (Fig. 3F paragraph [0076] integrally formed reservoir may be directly fabricated with the second material comprising pores); and the non-porous material is applied to one or more discrete regions of the portion of the exterior surface of the oral appliance to make the one or more discrete regions of the oral appliance non-porous (Fig. 3B paragraphs [0008]-[0009] [0036] [0074]-[0076] fabricating a non-porous shell and reservoir where the reservoir is integrally formed into the shell during a single fabrication step; reservoir is specifically made porous for drug release, where inherently there are non-porous discrete regions that are formed).
However, Mason does not disclose the deliberate application of a non-porous portion that is applied to a one or more discrete regions of the oral appliance.
But additionally, Mason does disclose applying a discrete material to make the one or discrete regions of the oral appliance less porous (Fig. 3G paragraphs [0074] [0077] a rate controlling membrane – 153 which can be biodegradable where the reservoir is often lacking biodegradable properties and it would be obvious for one with ordinary skill in the art to apply a non-porous material, initially, before biodegradation). See MPEP § 2143 (E) where one with ordinary skill would choose from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Regarding Claim 42, Mason anticipates all the limitations of claim 36 and further anticipates that the porous material is formed into the portion of the oral appliance on an interior surface of the oral appliance; and the non-porous material is applied to one or more discrete regions of the portion of the interior surface of the oral appliance to make the one or more discrete regions of the oral appliance non-porous, where the reservoir of claim 41 above is placed in a position that is at an interior surface (paragraph [0082] interior surface (e.g., near the received teeth)).
However, Mason does not disclose the deliberate application of a non-porous portion that is applied to a one or more discrete regions of the oral appliance.
But additionally, Mason does disclose applying a discrete material to make the one or discrete regions of the oral appliance less porous (Fig. 3G paragraphs [0074] [0077] a rate controlling membrane – 153 which can be biodegradable where the reservoir is often lacking biodegradable properties and it would be obvious for one with ordinary skill in the art to apply a non-porous material initially, before biodegradation). See MPEP § 2143 (E) where one with ordinary skill would choose from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Regarding Claim 46, Mason anticipates all the limitations of claim 36 but does not discloses that (i) the porous material comprises about 60% to about 99% by weight of the oral appliance; or (ii) the non-porous material comprises about 0.25% to 10% by weight of the oral appliance.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize these ranges of the percentages of porous material and non-porous material to the weight of the oral appliance since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. One would have been motivated to obtain these optimum range values for the purpose of facilitating a desired rate of delivery and/or desired rate of diffusion of a medicament (paragraph [0035]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE K. SWIER whose telephone number is (571)272-4598. The examiner can normally be reached M-F generally 8:30 am - 5:30 pm PST.
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/WAYNE K. SWIER/Examiner, Art Unit 1748 /JACOB T MINSKEY/Primary Examiner, Art Unit 1748
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