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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. A certified copy of People’s Republic of China Applications CN202110511032.8; CN202121004424.7; CN202121001022.1; and CN202121004480.0 has been filed with a priority date of 11 May 2021.
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 1-2, 15-16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Publication WO 2020057181 to Sun Yongfu et al. (herein Sun) (see machine translation provided). Note: International publication of International Search Report X Reference CN210784757.
Regarding claim 1, Sun discloses a shell-shaped dental instrument 100 that is provided with an indicator 101 (see Fig. 1). The indicator comprises three layers: a first pattern layer/first indicator 1011a, a second pattern layer 1013a, and an access control layer 1015a, wherein the layers are stacked sequentially (see Fig. 2); the first pattern layer forms a first pattern and the second pattern layer forms a second pattern; and the first and second patterns can change color under the influence of an oral cavity environment. (see [0030-0036]). The second pattern layer and the access control layer 1015a reads on the second indicator.
Regarding claim 2, Sun discloses the invention of claim 1, and Fig. 2 of Lei discloses the first pattern layer 1011a is connected to the second pattern layer 1013a.
Regarding claim 15, Sun discloses the invention of claim 1, and discloses dental instrument 100 worn in an oral cavity and comprising the indicator 101 (see Fig. 1) as mentioned in regards to claim 1 above.
Regarding claim 16, Sun discloses the invention of claim 15, and discloses wherein the dental appliance 100 comprises a dental appliance body and the indicator 101 arranged on the dental appliance body, the dental appliance body forms a cavity for receiving teeth (see Fig. 1).
Regarding claim 19, Sun discloses the invention of claim 15, and discloses the dental appliance is a shell-shaped orthodontic appliance or an orofacial muscle training appliance (see [0049]; Fig. 1).
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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over International Publication WO 2020057181 to Sun Yongfu et al. (herein Sun) (see machine translation provided) in view of International Publication WO 2005114183 to Kafai El-Khorassani Hossein (herein Kafai) as cited on the 13 November 2023 IDS (see machine translation provided).
Regarding claim 3, Sun discloses the invention of claim 2, however, fails to disclose “wherein the first pattern layer and the second pattern layer comprise different starch-iodine inclusion complexes” as recited in the instant claim.
Kafai discloses an orthodontic indicator that is a saliva-sensitive indicator paper comprising iodine dye and starch, wherein the paper will change color upon reaction of saliva with the starch present in the paper (see 5th paragraph). The enzyme amylase in the saliva breaks down the starch in the paper and disrupts the iodine-starch color effect (see 5th paragraph).
Kafai and Sun are analogous in the field of orthodontic indicators and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the patterned layers to comprise starch-iodine inclusion complexes for the benefit of detecting enzymes in saliva that break down the starch and cause fading (see 5th paragraph of Kafai).
Claims 4-9, 14, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication WO 2020057181 to Sun Yongfu et al. (herein Sun) (see machine translation provided).
Regarding claim 4, Sun discloses the invention of claim 1, but fails to explicitly disclose “wherein the first indicator further comprises a first reaction layer for blocking the first pattern layer, the second indictor further comprises a second reaction layer for blocking the second pattern layer, and the active substance controls the first reaction layer and the second reaction layer to sequentially become transparent and sequentially expose the first pattern layer and the second pattern layer ” as recited in the instant claim. However, Sun discloses the second pattern layer 1013a can change from dark to transparent in the presence of an active substance thus revealing the first pattern on the first pattern layer 1011a underneath (see [0030-0037]; Fig. 2). In this embodiment the channel control layer 1015a, the second pattern layer 1013a, and the first pattern layer 1011a read on the first indicator of the claimed invention, wherein the second pattern layer functions as the first reaction layer for blocking the first pattern layer (see Fig. 2). To arrive at the instant invention of claim 4, there would need to be a duplication of the three layers to provide a second control channel layer and a second reaction layer for blocking a second pattern layer. MPEP 2144.04 IV. B. Duplication of Parts states that the courts have held that a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In this instance, duplicating the three layers of the prior art in a stacked formation would arrive at the instant invention with predictable results of sequentially being exposed to the active substance. Furthermore, the advantage of revealing more than one pattern would be obvious to one of ordinary skill in the art as more than one active substance/parameter could be monitored.
Regarding claim 5, Sun renders obvious the invention of claim 4. Sun discloses it is the dark pattern of the reaction layer that reacts with the active substance to become transparent and thus when no more color change can occur, the reaction layer is fully saturated (see [0030-0037]).
Regarding claim 6, Sun renders obvious the invention of claim 4, wherein the pattern layers are configured to present a pattern under the action of an active substance (see [0030-0037]).
Regarding claim 7, Sun renders obvious the invention of claim 4, wherein the duplication of parts results in a first channel control layer and a second channel control layer (i.e., adsorption layers 1015a) connected to the reaction layers 1013a (see Fig. 2). As Sun discloses the layers are stacked sequentially (see Fig. 2), each layer would become saturated with the active substance before moving onto the next.
Regarding claim 8, Sun renders obvious the invention of claim 7, and as mentioned above, in regards to claim 4, Sun renders obvious the first adsorption layer 1015a, the first reaction layer 1013a, the first pattern layer 1011a, a second adsorption layer, a second reaction layer, and a second pattern layer being sequentially stacked (see Fig. 2).
Regarding claim 9, Sun renders obvious the invention of claim 7. In order, to reveal the pattern of the pattern layers, the adsorption layer would have to be transparent for visualization. Furthermore, Sun reveals the adsorption layers can be made of polyurethane which can transparent.
Regarding claim 14, Sun renders obvious the invention of claim 1, however fails to explicitly disclose “wherein an outer contour of the second pattern layer is located on an outer side of the outer contour of the first pattern layer” as recited in the instant claim. This would amount to changing the shape of the first or second pattern layer to arrive at the instant invention. MPEP 2144.04 IV. Changes in Shape states that the configuration of the claimed element is considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence the that particular configuration of the claimed element was significant. Therefore, it would have been obvious to one of ordinary skill in the art to modify the size of the second pattern layer to be larger than the first pattern layer so that the outer contour of the second pattern layer is located outside the outer contour of the first pattern layer for the benefit of the second pattern layer being exposed to the active substance without having to go through the first pattern layer.
Regarding claim 17, Sun discloses the invention of claim 16, however, fails to disclose “wherein the first indicator is located on a side of the second indicator away from the teeth” as recited in the instant claim. Per MPEP 2144.04 VI. Rearrangement of Parts, the position of a claimed element is not considered patentable if shifting the position of the claimed element would not modify the operation of the device. In this instance, it would be obvious to one of ordinary skill in the art to position the first indicator and second indicator as desired for the benefit of controlling exposure to the active substance.
Regarding claim 18, Sun discloses the invention of claim 16, however, fails to disclose “wherein the first indicator and the second indicator are arranged side by side in a teeth arrangement direction” as recited in the instant claim. Per MPEP 2144.04 VI. Rearrangement of Parts, the position of a claimed element is not considered patentable if shifting the position of the claimed element would not modify the operation of the device. In this instance, it would be obvious to one of ordinary skill in the art to position the first indicator and second indicator as desired for the benefit of controlling exposure to the active substance.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication WO 2020057181 to Sun Yongfu et al. (herein Sun) (see machine translation provided) in view of Chinese Application CN 101686852 to Chen et al. (herein Chen) as cited on the 13 November 2023 IDS (see machine translation provided).
Regarding claim 10-12, Sun discloses the invention of claim 1, however fails to disclose “wherein the indicator further comprises an encapsulation layer for encapsulating the first indicator and the second indicator” as recited in the instant claim.
Chen discloses dental device with a compliance indicator (see [0008]), wherein the dental device includes an instrument disposed on one or more teeth, and a release agent container, the release agent container disposed on the surface of the instrument (see [0024]). Chen discloses the release agent container comprises active ingredients such as dyes, pigments, or other indicator materials (see [0106]). Chen discloses wherein an inner portion comprising indicator materials 1352 is encapsulated by an outer portion 1350 (see [0119-0122]; Fig.13). Chen discloses the encapsulation layer comprises hole 1354 (see Fig. 13) and wherein the encapsulation layer is made of material for isolating the active substance, such as an enzyme (see [0033-0036]).
Chen and Sun are analogous in the field of orthodontic indicators and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the indicator of Sun to comprise the encapsulation layer of Chen with a through-hole and configured to isolate an active substance for the benefit controlling the rate at which the indicator is exposed to the oral environment (see [0034] of Chen).
Regarding claim 13, the combination of references above render obvious the invention of claim 10, however, fails to disclose “wherein at least part of the encapsulation layer is made of material penetrable to the active substance” as recited in the instant claim.
Chen discloses an embodiment of the dental device indicator 200 wherein the device comprises a semi-permeable barrier 202 between the oral environment and the indicator materials 204 (see [0050-0051]; see Figs. 2A-C).
Chen and Sun are analogous in the field of orthodontic indicators and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the encapsulation layer of Sun in view of Chen to be semi-permeable (i.e., penetrable to the active substance) for the benefit of controlling color change (see [0051] of Chen).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797
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