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 .
Response to Amendment
This action is in response to Applicant’s amendment filed 5/26/26.
The amendments to the drawings filed 5/26/26 have been entered.
Response to Arguments
Applicant's arguments filed 5/26/26 have been fully considered but they are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments.
Briefly, Applicant argues that Omura does not teach that the orthodontic tool is held by a clamping force by the carrier. The Examiner points to the combination of Omura/Marshall below which discloses such features. Further, Applicant argues that Omura does not teach that the carrier of the template is present at a predetermined position relative to the tooth splint as required, however the Examiner disagrees. Specifically, the Examiner notes that the predetermined position is dependent on a particular tooth the device is used therewith. As the limitation is a functional recitation, the Examiner maintains that the device is capable of being used with a particular tooth in order to meet the functional language as claimed. Additionally, the claim recites that the spacer limits movement of the driver such that the carrier is present at a first distance relative to the splint (emphasis added) and not the tooth surface as argued. The Examiner maintains that the spacer is capable of limiting movement of the driver such that the carrier is present at a first distance relative to the splint, does not need to occur while in the mouth, does not need to be achieved while the carrier carries the tool, and additionally depends on the size and shape of the particular tooth used therewith.
Regarding Applicants arguments to claims 12-15, the Examiner points to the arguments against the use of Omura as explained above. Further, the Examiner notes that for the instant claims Marshall is only relied on to teach that multiple engaging projections can be provided on the device. Additionally, the specific type of motion between the components of the systems of Omura and Marshall are not relied on, only the teaching of providing multiple holding projections. Further, regarding Applicant’s arguments to the term “interpreted” the Examiner notes that such statement is made in view of the indefiniteness of the claims and the 112 issues created thereby. Different claims recite the same projections as different structures (e.g. first or second), which arranges the carrier and a first or second distance either for transfer or holding. The claims are unclear as to which projection is interpreted as the first and second (see below), which therefore requires the need for the “can be interpreted” position, in order to examine the claims as best understood. The Examiner notes the claims remain indefinite for the reasons below.
Regarding claims 25-26, the Examiner notes Friedman discloses a tooth splint formed of a material as claimed. Additionally the Examiner maintains the use of such material is related to the Omura and the instant invention as it is in the same field of endeavor (tooth splints) and reasonably pertinent to the problem faced as both devices are needed to rest securely on the teeth.
Regarding claim 34, the Examiner notes that the claim does not require different materials or hardness in the components. Additionally, components formed of the same material would have the same hardness, regardless if discussed. Applicant’s arguments are not commensurate with the scope of the claims.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Therefore, Applicant’s arguments have been fully considered but are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments.
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.
Claims 1, 5, 12-20, 25-29, 33-35 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.
Regarding claim 1, the claim recites the positioning unit comprises “a spacer” and later “at least one first protrusion…”. However, it is unclear whether or not Applicant intends for the positioning unit to comprise both the space and the protrusion, or alternatively, one of the spacer or protrusion. As best understood by the Examiner the claim is intended to state that the positioning unit comprises the spacer and the protrusion. As such the second instance of the term “wherein the positioning unit comprises” should be deleted or amended to recite “further comprising”. Additionally, the terms “a predetermined first distance” in regards to the spacer and “a first distance” in regards to the protrusion and recess are indefinite as it is unclear whether or not the terms intend to refer to the same or different predetermined distances. Clarification is required.
Regarding claim 5, the claim depends from claim 1, which recites that during a pairing of the first protrusion with the first recesses, the carrier is located at a first distance in a transfer position. However, claim 5 recites that during a pairing of the first protrusion and the first recess, the carrier is alternatively present at a second distance in a holding position. As such the claim contradicts the limitations of claim 1 as claim 1 requires the first limitations. Clarification is required.
Regarding claim 13, the claim depends from claim 1, which recites that during a pairing of the first protrusion with the first recesses, the carrier is located at a first distance in a transfer position. However, claim 13 recites that during a pairing of the first protrusion with the first recess, the carrier is present at a second distance in a holding position, which contradicts the limitations of claim 1. Clarification is required.
Regarding claim 14, the claim depends from claim 1, which recites that during a pairing of the first protrusion with the first recesses, the carrier is located at a first distance in a transfer position. However, claim 14 recites that during a pairing of the second protrusion with the first recess, the carrier is present at the first distance in the transfer position, which contradicts the limitations of claim 1. Clarification is required.
Regarding claim 15, the claim depends from claim 1, which recites that during a pairing of the first protrusion with the first recesses, the carrier is located at a first distance in a transfer position. However, claim 15 recites that during a pairing of the first protrusion with the second recess, the carrier is present at the first distance in the transfer position, which contradicts the limitations of claim 1. Clarification is required.
Regarding claim 16, the term “force fit retention” is indefinite as it is unclear whether or not it intends to refer back the “clamping force” of claim 1 or another force. As best understood by the Examiner they refer to the same force which retains the tool via a friction fit, and will be interpreted as such. Clarification is required.
All other claims not specifically addressed above are rejected based on their dependency on a previously rejected claim.
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(s) 1, 5, 12-20, 27-29, 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Omura (JP 2002102256, as evidenced by its Machine Translation) in view of Marshall (US 2017/0325911 A1).
Regarding claim 1 Omura discloses a system for transferring at least one orthodontic tool (33) onto a target tooth surface in the upper jaw or in the lower jaw of a patient (see Figs. 1-5, 8), comprising: at least one tooth splint for a plurality of teeth (e.g. tray 21), adapted and arranged in order to enter into a force-fit pairing with at least one tooth in the upper jaw or in the lower jaw of the patient (see Figs. 4-5), wherein the at least one tooth splint has at least one guide (23) comprising an entry opening (25), at least one template (27), comprising: a support arm (27d) with a carrier (27b), which is adapted and arranged to detachably hold an orthodontic tool (see Figs. 4-5, 8), and a driver (27a/c) which is adjusted to the guides (see Figs), wherein in the region of the guide and/or the driver, the system comprises a positioning unit (41/51/43/45/27c) that is adapted and arranged to affix the driver in the guide in a detachable, translatory manner, so that the carrier of the template is present in a predetermined position relative to the tooth splint (see Figs. 1-3 and the positions of Figs. 4-5; also see Machine Translation at abstract, and pages 5-6; positioning unit positions carrier at positions relative to the tooth splint when various components of positioning unit are engaged with each other or splint); wherein the positioning unit comprises a spacer (27c) adapted and arranged to limit translatory movement of the driver in the guide such that the carrier of the at least one template is present at a predetermined first distance relative to the tooth splint (27c capable of being pushed into contact with guide to limit movement and position at a predetermined distance); wherein the positioning unit comprises at least one first protrusion on the driver, and the positioning unit comprises at least one first recess on the inner surface of the guide (not chosen for interpretation), or the positioning unit comprises at least one first protrusion (41b) on an inner surface of the guide (see Figs. 1-3), and at least one first recess on the driver (e.g. one of 43 or 45); and wherein during a pairing of the first protrusion and the first recess, the carrier of the at least one template is present at a first distance apart in a transfer position relative to a predetermined tooth that is assigned or assignable to the template (45 is interpreted as first recess, see Fig. 5).
Omura further discloses wherein during a pairing of the first protrusion and the first recess, the carrier of the at least one template is present at a second distance apart in a holding position relative to a predetermined tooth that is assigned or assignable to the template (43 is interpreted as first protrusion in claim 5 as the “alternative” interpretation; see Fig. 4; per claim 5, as best understood by the Examiner); wherein the template is movably held on the tooth splint (see Figs. 4-5), wherein movement of the template occurs into the guide and out of the guide along two axes, X and Y, running essentially parallel to each other, wherein the axis X is the longitudinal axis of the guide (see axis of movement of 27a into guide) and the axis Y is the direction of insertion of the orthodontic tool into a support notch (e.g. see parallel horizontal movement of tool onto 27a forming support notch, essentially parallel to movement into and out of guide, Figs. 4-5; per claim 18); wherein the template and/or the guide have a polygonal profile (rectangular, see Fig. 1-3 and citations above; per claim 19); wherein the driver comprises at least two side arms (e.g., each side of loop portions of 27c) which extend in a direction of the support arm from an end of the driver located opposite the support arm (e.g. at least in part as the arms have a dimension in said direction), and wherein the at least two side arms are spaced apart from each other to such an extent that the side arms are movable towards each other, so that the driver is insertable into the guide (end portions of arms are spaced apart from each other and capable of being squeezed of moved towards each other with sufficient force, and further above said end portions, arms are capable of being separated and then moved toward each other if so desired during insertion; capable of being used as such per claim 20); a kit of parts comprising at least one system according to claim 1 and at least one orthodontic tool (33; see Fig. 4; per claim 27); comprising precisely one tooth splint for a plurality of teeth (tray 21), or wherein the at least one tooth splint is adapted and arranged in order to enter into a force- fit pairing with multiple teeth of the plurality of teeth (tray 21, see citations above; per claim 28); wherein the at least one guide is a guide channel, or wherein the carrier has a complementary shape to the guide (see Fig. 1; per claim 29); and wherein a shape of the profiles of the template and the guide correspond to each other (see Fig. 1; per claim 35).
Omura, however, does not teach wherein the carrier holds the orthodontic tool by a clamping force as required.
Marshall, however, teaches a similar system for transferring an orthodontic tool comprising a tooth splint (20/30) and a driver/carrier (14) having support notch protrusions (40a/b) which allow the carrier to hold the orthodontic tool by a clamping force (e.g. frictional connection between tool and carrier, see [0025] and [0047]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Omura to include Marshall’s teaching of providing the carrier with support notch protrusions which provide a clamping force to hold the tool, as such modification would provide a secure and easily removable/repositionable connection between the tool and carrier, without the use of additional materials, improving the speed and efficiency of the procedure, or allow the tool to be securely maintained in position prior to being secured with resin.
Regarding claims 16-17 and 33, Omura/Marshall, as combined above, teaches wherein the carrier has a support area (area of carrier which faces tooth, Marshall) facing the target tooth surface with a support notch (38a Marshall) for a force-fit retention of the orthodontic tool (see Marshall, citations above, per claim 16); wherein the support notch has at least one support notch protrusion (40A/B) for the force fit retention of the tool (see Marshall, citations above; per claim 17); wherein the support notch has a shape that complements the tool (see Fig. 1a, Marshall; per claim 33).
Regarding claims 12-15, Omura/Marshall, as combined above discloses in relation to the entry opening, the positioning unit comprises the first protrusion (41b); and wherein in relation to the support arm, on the other side of the at least one first recess, at a distance therefrom, the positioning unit comprises at least one second recess (e.g. either 43 or 45 can be interpreted as first or second recess, Omura; per claim 12, as best understood by the Examiner); wherein during a pairing of the first recess of the driver and the first protrusion of the guide, the carrier of the at least one template is present at a second distance apart in a holding position relative to a predetermined tooth that is assigned to the template (see either of Figs. 4-5, Omura; per claim 13, as best understood by the Examiner); and wherein during a pairing of the second recess of the driver (43 or 45) and the first protrusion of the guide (41), the carrier of the template is present at the first distance apparat in the transfer position relative to the predetermined tooth that is assigned to the template (see either of Figs. 4-5, Omura; per claim 14, as best understood by the Examiner); but does not teach wherein the guide comprises a second protrusion on the other side of the first protrusion at a distance therefore, such that during a pairing of the first recess of the drive and the second protrusion of the guide, the carrier of the template is present at the first distance apart in the transfer position relative to the predetermined tooth assigned to the template as required and as best understood by the Examiner.
Marshall, however, teaches a similar orthodontic bonding system comprising a tray and guide (20/30) and a driver/carrier (14), wherein a plurality of pin projections (54) and corresponding matching means (52) may be used to retain the device in place, and notes that more or fewer of said projections can be provided as desired (see [0030]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Omura/Marshall, as combined above, to include Marshall’s teaching of providing a plurality of projections and/or recesses on the guide, as such modification would provide for improved retention of the device in a given position, and would merely involve a duplication of known parts of the device, which has been held to be within the skill of the ordinary artisan (see MPEP 2144.04(VI)(B)). The Examiner notes that should the device of Omura/Marshall, as combined above in regards to claim 1, be modified with the teaching of providing a plurality of mating projections, as taught by Marshall, the resultant guide would comprise a second projection (as taught by Marshall), arranged next to the first, such that during a pairing of the first recess of the drive and the second protrusion of the guide, the carrier of the template would be present at the first distance apart in the transfer position relative to the predetermined tooth that is assigned to the template (e.g. which protrusion or recess that is interpreted as the first or second can be varied to meet the claim language, when the device is positioned in the transfer position (see Omura, Figs. 4-5; as best understood by the Examiner).
Claim(s) 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Omura in view of Marshall, as combined above, further in view of Friebauer et al (US 2019/0282345 A1).
Regarding claims 25-26, Omura/Marshall, as combined above teaches wherein the tooth splint is formed of a resin (see Machine translation [0018], Omura), but does not specifically teach a dimensionally stable first plastic material with a Shore D hardness in a range of 74-93 and formed of a plastic material selected from polyacrylates, polyolefins, polyurethanes, polyetherketones, polyetherimides, polyesters, polycaprolactones, acrylic-butadiene-styrene-copolymers, polyamides and polylactides as required.
Friebauer et al, however, teaches a resin based tooth splint which is formed of acrylic-butadiene-styrene-copolymers (ABS) with a Shore D hardness in a range of 74-93 (see [0051] and [0053]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Omura/Marshall, as combined above to include Friebauer’s use of ABS having a Shore D hardness as claimed, as such modification would merely involve a selection of a known material which has been held to be within the skill of the ordinary artisan based on its suitability for its intended use (see MPEP 2144.07).
Claim(s) 34 is rejected under 35 U.S.C. 103 as being unpatentable over Omura in view of Marshall, as combined above, further in view of Drisaldi et al (US 4523908).
Regarding claim 34, Omura/Marshall, as combined above does not teach wherein the support notch protrusion comprises or consists of a plastic material with a Share D hardness that is equal or less than that of the carrier as required, and as best understood by the Examiner.
Drisaldi et al, however, teaches a similar orthodontic bracket placement tool comprising a carrier (e.g. neck and front surface of 12) and a support notch protrusion (e.g. portions of 12 which bend around tie wings), which comprises a second plastic material with a Shore D hardness that is equal to that of the plastic material of the carrier (e.g. both the carrier and support notch protrusion are formed of ABS and as such would have the same Shore D hardness; see col 3, lines 5-6). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Omura/Marshall, as combined above, to include Drisaldi’s plastic material of the carrier and support notch protrusion, as such modification would merely involve a selection of a known material which has been held to be within the skill of the ordinary artisan based on its suitability for its intended use (see MPEP 2144.07).
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD MORAN whose telephone number is (571)270-5349. The examiner can normally be reached Monday-Friday 7 AM-4 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 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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/EDWARD MORAN/Primary Examiner, Art Unit 3772
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