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 Species D in the reply filed on 12/2/25 is acknowledged.
Claims 6-11, 21-24, 31-32 and 36-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/2/25.
Drawings
The drawings are objected to because the drawings contain several broken, lightly shaded or incomplete lines. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “positioning unit” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3-5, 12-17, 30 and 33-34 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 3, the claim describes a first protrusion on the driver and a first recess, however, it is unclear where the recess is located. Specifically, although the alternative choice in claim 3 specifies locations of the protrusion and recess, the first paragraph of claim 3 does not, and it is unclear where the recess is intended to be located, in order for the positioning unit to properly function. Clarification is required.
Regarding claim 12, the term “in relation to the support arm, on the other side of the at least one first protrusion, at a distance therefrom, the positioning unit comprises at least one second recess” is indefinite, as it is unclear how the positioning unit comprises a recess and protrusion on the same structure. As best understood by the Examiner, the term should read “at least one second protrusion, as support in Figs. 7-8. An embodiment with a protrusion and recess on the same structural component is not supported by the elected embodiment. Clarification is required.
Regarding claim 13, the term “at the second distance apart” lacks antecedent basis in the claims, and further it is unclear what the term “the second distance” refers to. Clarification is required.
Regarding claim 16, the term “directed onto the target tooth” is indefinite as it is unclear what the term comprises. As best understood by the Examiner, the carrier holes the tool which is directed onto the tooth, not the carrier, and will be interpreted as such. So long as the carrier faces the tooth it will be interpreted as being directed thereto. Clarification is required.
Regarding claim 34, the term “comprises or consists of a second plastic material” is indefinite at it is unclear what the “second plastic material” is directed and compared to. Specifically, no first plastic material of the carrier is recited. Further it is unclear if the second plastic material is intended to be a different material or the same, compared to a hypothetical first material. As best understood by the Examiner, the second plastic material can be interpreted as a same plastic material of the carrier, as the Shore D hardness thereof would be “equal or less” than that of the carrier, meeting the limitations of the claims as best understood by the Examiner. 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 § 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) 1-5, 16-20, 27-30, 33 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Omura (JP 2002102256, as evidenced by its Machine Translation).
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); and a positioning unit (41/51/43/45/27c) in a region of the guide and/or the driver, wherein the positioning unit 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).
Omura further discloses wherein the positioning unit comprises a spacer (27c) adapted and arranged to limit translatory movement of the driver in the guide in such a manner 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; per claim 2); wherein: the positioning unit comprises at least one first protrusion on the driver, and the positioning unit comprises at least one first recess (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 that the positioning unit comprises at least one first recess on the driver (e.g. one of 43 or 45; per claim 3); 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 protrusion in claim 4, see Fig. 5; per claim 4); 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; see Fig. 4; per claim 5); wherein the carrier has a support area (e.g. cross shape) directed onto the target tooth surface with a support notch (corners of cross shape) for a force-fit retention of the orthodontic tool (see Fig. 8; per claim 16); wherein the support notch has at least one support notch protrusion (e.g. horizontal portions of cross shape which extend from notch) for the force-fit retention of the orthodontic tool (see Fig. 8; per claim 17); 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, 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 part 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); wherein the at least one first recess is on the inner surface of the guide (not required given the choice of claim 3, as the Examiner interprets the claim based on the alternative choice; see above; per claim 30); wherein the support notch has a shape that complements the tool (see Fig. 8; per claim 33); and wherein a shape of the profiles of the template and the guide correspond to each other (see Fig. 1; per claim 35).
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) 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Omura in view of Marshall (US 2017/0325911 A1).
Regarding claims 12-15, Omura 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; per claim 12); 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; per claim 13); 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 a first distance apparat in a transfer position relative to a predetermined tooth that is assigned to the template (see either of Figs. 4-5; per claim 14); 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 a first distance apart in a transfer position relative to a predetermined tooth assigned to the template as required.
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 to include Marhsall’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 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 a first distance apart in a transfer position relative to a 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).
Claim(s) 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Omura in view of Friebauer et al (US 2019/0282345 A1).
Regarding claims 25-26, Omura teaches wherein the tooth splint is formed of a resin (see Machine translation [0018]), 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 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 Drisaldi et al (US 4523908).
Regarding claim 34, Omura does not teach wherein the support notch protrusion comprises or consists of a second 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 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see attached PTO892 form.
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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/EDWARD MORAN/Primary Examiner, Art Unit 3772