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 .
Information Disclosure Statement
Examiner notes that the U.S. Patent Application Publication Cite No. 1, 20060017225, appears to have an incorrect publication number. Examiner notes that the correct publication number appears to be 20060172251 as in the Specification p. 2 line 27.
Drawings
The drawings are objected to because two copies of Figures 5 and 6 have been provided. The copies of Figures 5 and 6 appear to be identical.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
34 in Figure 6 and Figure 7a.
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 Objections
Claims 1, 7, and 10 are objected to because of the following informalities:
Examiner suggests amending claim 1 line 6 to “[[the]]a jawbone” and claim 1 line 12 to “[[the]]a splint”.
Examiner suggests amending claim 7 line 1 to “The system according to claim 1, wherein the splint is:”.
Examiner suggests amending claim 10 line 1 to “a method for producing”, claim 10 line 1 to “[[the]]a dental arch and palate area”, and claim 10 line 6 to “[[the]]a position”.
Appropriate correction is required.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“means of a screw thread” in claim 1 line 9, which recites “means”, does not recite functional language, and recites the sufficient structure of a screw thread.
“means of printing, in particular 3D printing” in claim 7 line 2, which recites “means”, does not recite functional language, and recites the sufficient acts “in particular 3D printing”.
“means of a scan” in claim 10 lines 3-4, which recites “means”, does not recite functional language, and recites a sufficient act of a scan.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-10 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “splint” in claims 1-2, 5-7, and 9-10 is used by the claim to mean “aligner,” while the accepted meaning is “a material or a device used to protect and immobilize a body part” (https://www.merriam-webster.com/dictionary/splint, definition 2c). The term is indefinite because the specification does not clearly redefine the term. For purposes of examination, Examiner will interpret the limitation “splint” in claims 1-2, 5-7, and 9-10 as referring to an aligner, and suggests Applicant amend to clarify.
Claim 9 recites the limitation “at least two cup-shaped recesses or at least two openings” in lines 1-2. These limitations are unclear as claim 1 recites the limitations “at least one cup-shaped recess or an opening” in line 12, and it is unclear whether the “at least two cup-shaped recesses or at least two openings” is limiting the at least one cup-shaped recess or opening of claim 1, or are referring to other recesses or openings. For purposes of examination, Examiner will interpret the limitation of claim 9 lines 1-2 as referring to the at least one cup-shaped recess or opening of claim 1 line 12, and suggests Applicant amend to clarify.
Claim 10 recites the limitation “the intermediate stage” and “the current and the desired alignment” in lines 4-5. There is insufficient antecedent basis for these limitations as the limitations “intermediate stage” and “current and desired alignment” are not recited in claim 10 or claim 1. For purposes of examination, Examiner will interpret claim 10 lines 4-5 as, and suggests amending to, “[[the]]an intermediate stage between [[the]]a current and [[the]]a desired alignment of the teeth”.
Claim 10 recites the limitation "these data" in line 6. There is insufficient antecedent basis for this limitation in the claim as the limitation “data” is not recited in claim 10 or claim 1. Examiner notes that the limitation appears to be referring to data from a calculation of an intermediate state between the current and desired alignment of the teeth as recited in claim 10 lines 4-5. For purposes of examination, Examiner will interpret claim 10 line 6 as, and suggests amending to, “the basis of of the intermediate stage and the position of the fastening elements”.
Claims 3-4 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for their dependence on one or more rejected base and/or intervening claims.
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.
Claims 1-4, 6-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Baughman et al (U.S. Patent No. 8,444,412 B2, hereinafter “Baughman”) in view of Schmid (DE 102018114830 A1, see translated PDF).
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In regard to claim 1, Baughman discloses an orthodontic aligner system (Fig. 12 and see Figs. 6-8), for treating tooth misalignments in a patient (Abstract), the system comprising:
a. a fastening device (513 in Fig. 12, col. 3 lines 57-64) for fastening a splint to a temporary anchoring element (512 in Fig. 12, see Fig. 3, col. 3 lines 57-64) and, the temporary anchoring element can be anchored in a jawbone of the patient (col. 2 lines 3-6 and 18-20), and,
b. the fastening device has a head (head in annotated Fig. 12) and a stem (513a in Fig. 12), and the stem is connectable to the temporary anchoring element (col. 3 lines 57-64),
c. a splint (col. 3 lines 57-64, clear orthodontic appliance, see 310 in Fig. 8) has at least one cup-shaped recess (see 322 in Figs. 7 and 8, col. 1 lines 51-54, complementary female pocket) for receiving the head of the fastening device (col. 1 lines 51-54), and,
d. the head of the fastening device is shaped in such a manner that it can be inserted into the cup-shaped recess in the splint such that the fastening device can be releasably connected with a force fit to the splint (col. 1 lines 51-54, col. 3 lines 57-64).
Baughman does not disclose that the fastening device is helical shaped and that the stem is connectable by means of a screw thread.
Schmid teaches a helical shaped fastening device (38d in Fig. 10, para. 0043, 38d is screwed into 26d) for fastening an appliance to a temporary anchoring element (para. 0043), and the fastening device has a head and a stem (head and stem in annotated Fig. 10) and the stem is connectable to a temporary anchoring element (26d in Fig. 10, para. 0043) by means of a screw thread (para. 0043, 38d is screwed into 26d).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of orthodontic appliances with temporary anchorage devices. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fastening device and temporary anchoring element of Baughman by replacing the tapered stem with a stem with a screw thread so that the fastening device is helical shaped, and make associated changes to the temporary anchorage device as taught by Schmid in order to allow improved adaptability and comfort (Schmid para. 0003).
In regard to claim 2, Baughman in view of Schmid discloses the invention of claim 1. Baughman further discloses wherein the head of the fastening device is latchable to the splint (col. 1 lines 51-54, col. 3 lines 57-64).
In regard to claim 3, Baughman in view of Schmid discloses the invention of claim 2. Baughman does not disclose wherein the head of the fastening device has an undercut.
The embodiment of Figs. 10a-10d of Baughman discloses wherein the head of the fastening device has an undercut (Figs. 10a-10d).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the head of the fastening device of the embodiment of Figs. 12 of Baughman in view of Schmid by modifying the head to have an undercut and adding complementary mating portions to the splint so that the head of the fastening device is latchable to the splint as taught by the embodiment of Figs. 10a-10d of Baughman in order to allow for accurate positioning of the splint, removably retaining the splint and heavier loading of the splint for improved orthodontic results (Baughman col. 1 lines 36-41).
In regard to claim 4, Baughman in view of Schmid discloses the invention of claim 1. Baughman further discloses wherein the head (head in annotated Fig. 12) of the fastening device (513 in Fig. 12) has a side wall (side wall in annotated Fig. 12) and an equator (equator in annotated Fig. 12), and, the sidewall is: c) has a convex shape on the equator of the head (Fig. 12). Examiner further notes that the embodiments of Figs. 6-8 and Figs. 10a-10d teach head shapes which are equivalent structures used based on the desired applied force with sidewalls that are a). cylindrical and circular (Fig. 6), b) tapered like a truncated cone in the direction of the stem (Fig. 10b) and c) has a convex shape (Figs. 10a and 10c).
In regard to claim 6, Baughman in view of Schmid discloses the invention of claim 1. Baughman further discloses wherein the splint is: a) transparent (col. 3 lines 63-64, clear orthodontic appliance), for the application of forces for tooth movement in a jaw (Abstract, col. 3 lines 65-67, col. 4, lines 1-3).
In regard to claim 7, Baughman in view of Schmid discloses the invention of claim 1. Baughman further teaches that the splint is formed to the geometry of the teeth and is a clear orthodontic appliance (col. 1, ll. 51-54, col. 3, ll. 57-64), but is silent as to the method of producing. The claimed phrase “is produced by: a) vacuum or overpressure technology, or, b) by means of printing, in particular 3D printing, or, c) by additive manufacture, in particular additive 3D printing” is being treated as a product by process limitation, that is, that the splint is made by one of the listed methods. As set fourth in MPEP 2113, product by process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Thus, even though Baughman is silent as to the process used to make the splint, it appears that the product Baughman would be the same or similar as that claimed.
In regard to claim 9, Baughman in view of Schmid discloses the invention of claim 1. Baughman further discloses wherein the splint comprises at least two cup-shaped recesses (see 322 in Figs. 7 and 8, col. 1 lines 51-54, complementary female pocket).
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Baughman in view of Schmid and Riley et al (U.S. Patent No. 11,045,283 B2, hereinafter “Riley”).
In regard to claim 5, Baughman in view of Schmid discloses the invention of claim 1. Baughman does not disclose wherein the cup-shaped recesses in the splint have constrictions.
Riley teaches a similar apparatus (Figs. 1A-8) wherein cup-shaped recesses (110 in Fig. 1C) in the splint (100 in Fig. 1A) have constrictions (sloped surfaces in annotated Fig. 1C, col. 11 lines 59-62).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of orthodontic appliances with temporary anchorage devices. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the recesses of Baughman in view of Schmid by modifying the recesses to have constrictions as taught by Riley in order to allow for facilitation of insertion of the fastening device into the recesses (Riley col. 11 lines 59-62).
In regard to claim 10, Baughman in view of Schmid discloses the system according to claim 1, which includes the fastening devices fastened to the implanted temporary anchoring elements (Fig. 12) and discloses wherein the splint is a transparent plastic material (col. 1 line 14, clear plastic orthodontic appliance), but does not disclose a method for producing the system, wherein a dental arch and palate area of the patient, including the implanted temporary anchoring elements, are molded or captured by means of a scan, a 3D model is produced therefrom, an intermediate stage between a current and a desired alignment of the teeth is calculated therefrom, and, on the basis of data of the intermediate stage and a position of the fastening elements, one or more splints with cup-shaped recesses are produced from a transparent plastic material having a selected elasticity.
Riley teaches a method (Figs. 7 and 8) for producing the system of a similar apparatus (col. 16 lines 9-10), wherein a dental arch and palate area of the patient, including the implanted temporary anchoring elements, are captured by means of a scan (700 in Fig. 7, col. 16 lines 13-20, imaging), a 3D model is produced therefrom (702 in Fig. 7, col. 16 lines 14-17), an intermediate stage between a current and a desired alignment of the teeth is calculated therefrom (704, 706, 708 in Fig. 7, Fig. 8, col. 16 lines 26-30, moving the teeth in a desired direction and amount), and, on the basis of data of the intermediate stage and a position of the fastening elements, one or more splints (100 in Fig. 1A) with cup-shaped recesses (110 in Fig. 1C) are produced from a material having a selected elasticity (Figs. 7 and 8, col. 16 lines 42-44, col. 12 lines 10-15).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of orthodontic appliances with temporary anchorage devices. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Baughman in view of Schmid by adding steps wherein a dental arch and palate area of the patient, including the implanted temporary anchoring elements, are molded or captured by means of a scan, a 3D model is produced therefrom, an intermediate stage between the current and the desired alignment of the teeth is calculated therefrom, and, on the basis of data of the intermediate stage and a position of the fastening elements, one or more splints with cup-shaped recesses are produced from a transparent plastic material having a selected elasticity as taught by Riley in order to allow for dynamic flexibility to change the locations, sizes, and shapes of the features of the splint at specified stages in the treatment (Riley col. 15 lines 63-66).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Baughman in view of Schmid and Voudouris (U.S. Publication No. 2006/0172251 A1).
In regard to claim 8, Baughman in view of Schmid discloses the invention of claim 1. Baughman does not disclose wherein the fastening device is made of: a) a mouth-resistant medical steel, or, b) a hard plastic material approved for the oral cavity, in particular PMMA.
Voudouris teaches an apparatus (Figs. 1-4) wherein a fastening device (48 in Fig. 4) is made of: a) a mouth-resistant medical steel (para. 0021, stainless steel).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of orthodontic appliances with temporary anchorage devices. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fastening device of Baughman in view of Schmid by fabricating the fastening device out of steel as taught by Voudouris in order to allow for the fastening device to be made of a suitable material for stable anchorage (Voudouris paras. 0010 and 0021).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY N HUYNH whose telephone number is (571)272-7219. The examiner can normally be reached M-F 7:30AM-5:00PM (EST) flex, 2nd Friday off.
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/COURTNEY N HUYNH/Examiner, Art Unit 3772
/HEIDI M EIDE/Primary Examiner, Art Unit 3772
9/5/2025