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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 23, 2026 has been entered.
Claim Objections
Claims 3-8 and 10-11 are objected to because of the following informalities: The preamble of the claims do not match the preamble of the independent claims in which they depend from. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 23, 2026 is noted. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 and 3-11 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.
The Metes and Bounds of the claims are not reasonably defined or determinable-
Claims 1 and 3-8, directed to a plurality of "customized ready-made abutment" are indefinite because one (e.g. the examiner, the public, users etc.) would be at a complete loss in determining whether or not a particular abutment falls within the metes and bounds of the claimed invention. More particularly, it is unclear how one could reasonably determine whether or not a particular abutment meets the claim limitation requiring each of the abutment to be "designed and manufactured for the maxillary anterior teeth, mandibular anterior teeth, canine teeth, premolar teeth, and molar teeth, each customized ready-made abutment having a standard coverage of patient-customized abutments for each group of 65% or more, the standard coverage being determined on the basis of a statistical distribution range obtained from the patient-customized abutments, the statistical distribution range being obtained by dividing horizontal and vertical lengths of an axial projection image of each customized ready-made abutment into a plurality of regions according to a unit length and calculating a ratio of the plurality of regions that fall within the statistical distribution range of the customized ready- made abutment."
Claim 1 does not set forth any particular dimensions or range of dimensions, shapes, or particular structures for the "post", "lower part" or "gingival part" to which a particular abutment in question may objectively be compared in determining whether it falls within the claim's metes and bounds. But rather, as best understood, claim 1 identifies groupings of different teeth (anterior, canine, premolar and molar teeth) and requires that the claimed "customized ready-made abutment" have a "standard coverage of patient-customized abutments for each group of 65% or more" wherein the "standard coverage" is based on a "statistical distribution range being obtained by dividing horizontal and vertical lengths of an axial projection image or each customized ready-made abutment in to a plurality of regions according to a unit length and calculating a ratio of the plurality of regions that fall within the statistical distribution range of the customized ready-made abutment."
Initially, it is noted that humans (although the claim is not limited to humans) have a wide variety of tooth shapes and sizes depending on whether the "group" of anterior, canine, premolar or molar teeth are the teeth of a child or an adult, male or female, or even the ethnicity of the individuals making up the "group." The specification, nor claims, provide any guidance on how the "patient-customized abutments" from which the "statistical distribution range" is determined are designed, what factors are used in creating the "patient-customized abutments" or the accuracy/tolerances of the "patient-customized abutments."
The specification and claims provide no guidance on what members are included within the "group" to which the claimed customized ready-made abutment have a "65% or more" "standard coverage". A "group" of customized molar abutments that includes customized molar abutments for children and adults of different ethnicities has a much greater variability than a group of high accuracy customized molar abutments for a group of 120 lb women of a single ethnicity. In short, the limitation directed to "standard coverage of patient-customized abutment for each group of 65% or more" that defines the claimed "customized ready-made abutment" is subjective and vague because the "patient-customized abutments" to which "65% or more" of the claimed "customized ready-made abutment" are not clearly or reasonably defined. Further confusing efforts in determining whether or not a particular abutment falls within the metes and bounds of claim 1 is the limitation requiring that the "statistical distribution range being obtained by dividing horizontal and vertical lengths of an axial projection image of each customized ready-made abutment into a plurality of regions according to a unit length and calculating a ratio of the plurality of regions that fall within the statistical distribution range." The claims provide no definition regarding the shape or boundaries of the "plurality of regions" or where they extend other than being somehow related to "an axial projection image." The specification provides no clear definition or examples of any particular groups from which the "65%" coverage is to be determined. The metes and bounds of the claim are indefinite and indeterminate because they vary depending on what members are subjectively selected for an arbitrary and poorly defined "group." Attention is directed to Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989) where the Board held that a limitation in a claim to a bicycle that recited "said front and rear wheels so spaced as to give a wheelbase that is between 58 percent and 75 percent of the height of the rider that the bicycle was designed for" was indefinite because the relationship of parts was not based on any known standard for sizing a bicycle to a rider, but on a rider of unspecified build. Likewise, the presently claimed customized abutment is not based on defined identifiable relationships between the claimed "post", "lower part", and "gingival part", but on an unspecified "standard coverage" for an indeterminate "group" that includes "65% or more."
Additionally, with respect to claim 1, it is unclear how the "standard coverage of patient-customized abutments for each group of 65% or more" (lines 12-13) limitation relates to the previously claimed "post", "lower part" and "gingival part" (i.e. the structural elements of the claimed "customized ready-made abutment") or how the identified and defined elements of the abutment relate to the "axial projection image of each customized ready-made abutment." The indefinite/undefined relationship between the identified structural elements of the "customized ready-made abutment" and the "standard coverage" of for a "group of 65% or more" of a "plurality of customized ready-made abutments" fails in a reasonable manner to particularly point out and distinctly claim the invention as required by statute.
In claim 9, it is indefinite, failing to particularly point and distinctly claim the invention because the metes and bounds of the claim are not reasonably determinable. More particularly, the limitation that a height, length or angle of the abutment, post or gingival part of the claimed abutment "falls within a region among a plurality of regions obtained by dividing a statistical distribution range of corresponding patient-customized abutments on the basis of a predetermined unit length or angle" because it is unclear what constitutes a "corresponding patient-customized abutment" or what constitutes a "region among a plurality of regions." It is unclear what shape or boundaries the "regions" have or how they are defined. The public, users, competitors, and the examiner are at a complete loss in determining whether or not a particular abutment falls within the metes and bounds of the claimed invention. Applicant's claims to not set forth an objective range of dimensions from which a given abutment can be compared to the claim language, but rather attempts to define the structure of the claimed device based on a vague and undefined data set from which a "statistical distribution range" is computed. The present claims are directed to an abutment, not a method of designing an abutment, or a set of abutments, and as such, one would be at a loss in determining whether or not a particular abutment fell within the metes and bounds of the claim.
In claim 10, there is no antecedent basis for "the tooth type." It is noted that for examination purposes, the limitation is interpreted as one of the tooth types of the claimed in claim 9.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. It is noted that claim 9 has been amended to include all the claimed tooth types of claim 10, therefore, claim 10 does not appear to further limit claim 9. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1 and 3-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osorio et al. (5,989,029) in view of Engman (2006/0099549) in view of Bergersen (6,967,379).
With respect to claim 1, Osorio discloses a plurality of customized ready-made abutments (column 7, lines 1-3, such that an “inventory” implies multiple abutments) comprising the plurality of customized ready-made abutments including customized ready-made abutment for (i.e. shaped for the tooth to be replaced) maxillary anterior teeth and mandibular anterior teeth (col. 3, ll. 15-18, such that teether are anterior teeth of the upper and lower jaw), each customized ready-made abutment comprising a post positioned at an upper end thereof to be allowed to be coupled to an inside of a crown (see Fig 2A at reference numeral 12, see fig. 1 showing a crown 14 coupled to the post); a lower part positioned at a lower end thereof such that a part of all of the lower part is allowed to be coupled to an implant (see Figure 2A at reference numeral 10, see fig. 1 showing the lower part coupled to an implant 10) and a gingival part positioned between the post and the lower part to e in contact with gingiva without being coupled to the implant (see Figure 2A at reference numeral 22). Osorio teaches the plurality of abutments are of different sizes/shapes based on the type of tooth (col. 3, ll. 6-22, column 7, line 9) and include average measurements for different parts of the type of tooth (col. 3, ll. 9-22, col. 7, ll. 1-17). Osorio does not specifically teach the plurality of abutments include abutments for canine, premolar, or molar teeth and the customized ready-made abutments collectively provide a standard coverage of corresponding patient-customized abutments of 65% or more, the standard coverage being determined on the basis of a statistical distribution range obtained from the patient-customized abutment, the statistical distribution range being obtained by dividing horizontal and vertical length of an axial projection image of each customized ready-made abutment into a plurality of regions according to a unit length and calculating a ration of the plurally of regions that fall within the statistical distribution range of the customized ready-made abutment.
Engman teaches a plurality of customized ready-made abutments comprising the plurality of customized ready-made abutments including customized ready-made abutments for maxillary anterior teeth, mandibular anterior teeth, canine teeth, premolar teeth, and molar teeth (see pars. 30-31, 72, such that the abutment includes the coping). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the plurality of customized ready-made abutments taught by Osorio to specifically include maxillary anterior teeth, mandibular anterior teeth, canine teeth, premolar teeth, and molar teeth as taught by Engman in order to have an abutment properly shaped to replace any desired tooth depending on the patient’s need. Osorio/Engman teaches the invention as substantially claimed and discussed above, however, does not specifically teach how the plurality of abutments in different shapes and sizes based on average tooth shapes is calculated including specifically the customized ready-made abutments collectively provide a standard coverage of corresponding patient-customized abutments of 65% or more, the standard coverage being determined on the basis of a statistical distribution range obtained from the patient-customized abutment, the statistical distribution range being obtained by dividing horizontal and vertical length of an axial projection image of each customized ready-made abutment into a plurality of regions according to a unit length and calculating a ration of the plurally of regions that fall within the statistical distribution range of the customized ready-made abutment.
Bergersen teaches a plurality of customized ready-made dental devices wherein the customized ready-made dental devices collectively provide a standard coverage of corresponding patient-customized dental device of 65% or more (see col. 5, ll. 59-68, col. 6, ll. 1-13, such that they fit 95% of the population), the standard coverage being determined on the basis of a statistical distribution range obtained from the patient, the statistical distribution range being obtained by dividing a measurement of the patient into a plurality of regions according to a unit length and calculating a ratio of the plurality of regions that fall within that statistical distribution range of the customized ready-made dental device (see col. 5, ll. 59-68, col. 6, ll. 1-13, col. 8, ll. 35-46, such that a known range of measurements are used to determine/create a customized ready-made dental device having a variety of sizes to fit the majority of the population, such that the unit length is 3mm in this case making 7 regions). It would have been obvious to one having ordinary skill in the art to modify the plurality of customized ready-made implants as taught by Osorio/Engman to provide standard coverage of 65% or more as taught by Bergersen in order to provide a plurality of customized ready-made abutment that fit virtually the entire population. It is noted that the applicant is claiming the apparatus (i.e. a plurality of abutments) and NOT the method of making measuring and making them.
With respect to claims 3-5, Osorio/Engman/Bergersen teaches the invention as substantially claimed and discussed above including the Engman teaching the tooth type being a molar (see par. 31). Bergersen further teaches the statistical distribution range is divided into 7 regions and is 85% or more (see col. 5, ll. 59-68, col. 6, ll. 1-13, col. 8, ll. 35-46). Osorio/Engman/Bergersen does not specifically teach the unit length corresponds to 0.5mm and is divided into 5 or 9 regions, however, does teach that having more regions creates a greater coverage (col. 8, ll. 35-46). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the unit length taught by Osorio/Engman/Bergersen to have the desired coverage based on the measurement/size of the patient specific abutment. Such that it is noted that the size of the device would be directly related to the unit length. It is noted that the claimed unit length and regions is not related to the claimed plurality of abutments relative to the structure and only how they are grouped in order to obtain the desired coverage and therefore, it is noted that it would have been obvious to one having ordinary skill in the art modify the teachings of Osorio/Engman/Bergersen to be divided by the claimed unit length and into the desired number of regions in order to obtain the desired coverage.
With respect to claims 6-7, Osorio/Engman/Bergersen teaches the invention as substantially claimed and discussed above including the Engman teaching the tooth type being a premolar (see par. 31). Bergersen further teaches the statistical distribution range is divided into 7 regions and is 85% or more (see col. 5, ll. 59-68, col. 6, ll. 1-13, col. 8, ll. 35-46). Osorio/Engman/Bergersen does not specifically teach the unit length corresponds to 0.5mm and is divided into 5 or 9 regions, however, does teach that having more regions creates a greater coverage (col. 8, ll. 35-46). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the unit length taught by Osorio/Engman/Bergersen to have the desired coverage based on the measurement/size of the patient specific abutment. Such that it is noted that the size of the device would be directly related to the unit length. It is noted that the claimed unit length and regions is not related to the claimed plurality of abutments relative to the structure and only how they are grouped in order to obtain the desired coverage and therefore, it is noted that it would have been obvious to one having ordinary skill in the art modify the teachings of Osorio/Engman/Bergersen to be divided by the claimed unit length and into the desired number of regions in order to obtain the desired coverage.
With respect to claim 9, Osorio discloses a plurality of customized ready-made abutments (column 7, lines 1-3, such that an “inventory” implies multiple abutments) comprising the plurality of customized ready-made abutments including customized ready-made abutment for (i.e. shaped for the tooth to be replaced) maxillary anterior teeth and mandibular anterior teeth (col. 3, ll. 15-18, such that teether are anterior teeth of the upper and lower jaw), each customized ready-made abutment comprising a post positioned at an upper end thereof to be allowed to be coupled to an inside of a crown (see Fig 2A at reference numeral 12, see fig. 1 showing a crown 14 coupled to the post); a lower part positioned at a lower end thereof such that a part of all of the lower part is allowed to be coupled to an implant (see Figure 2A at reference numeral 10, see fig. 1 showing the lower part coupled to an implant 10) and a gingival part positioned between the post and the lower part to e in contact with gingiva without being coupled to the implant (see Figure 2A at reference numeral 22). Osorio teaches the plurality of abutments are of different sizes/shapes based on the type of tooth (col. 3, ll. 6-22, column 7, line 9) and include average measurements for different parts of the type of tooth (col. 3, ll. 9-22, col. 7, ll. 1-17). Osorio further teaches for each of the different teeth, at least one of a (i) horizontal and vertical lengths of an axial projection image of the abutment, (ii) a height of the gingival part, (iii) a height of the post, and (iv) an angle of the past is measured (see col. 3, ll. 9-22, col. 7, ll. 1-15, such that the height of the gingival part, i.e. the height of the gum line to the top of the implant, is measured) however does not specifically teach the measurements falls within a region amount a plurality of regions obtained by dividing a statistical distribution range of corresponding patient-customized abutment on the basis of a predetermined unit length or unit angle.
Engman teaches a plurality of customized ready-made abutments comprising the plurality of customized ready-made abutments including customized ready-made abutments for maxillary anterior teeth, mandibular anterior teeth, canine teeth, premolar teeth, and molar teeth (see pars. 30-31, 72, such that the abutment includes the coping). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the plurality of customized ready-made abutments taught by Osorio to specifically include maxillary anterior teeth, mandibular anterior teeth, canine teeth, premolar teeth, and molar teeth as taught by Engman in order to have an abutment properly shaped to replace any desired tooth depending on the patient’s need. Osorio/Engman teaches the invention as substantially claimed and discussed above, however, does not specifically teach the measurements fall within a region amount a plurality of regions obtained by dividing a statistical distribution range of corresponding patient-customized abutment on the basis of a predetermined unit length or unit angle
Bergersen teaches a plurality of customized ready-made dental devices wherein an measurement of a patient specific dimension is provided and falls within a region amount a plurality of regions obtained by dividing a statistical distribution range of corresponding patient-customized abutment on the basis of a predetermined unit length or unit angle (see col. 5, ll. 59-68, col. 6, ll. 1-13, col. 8, ll. 35-46, such that a dimension of a plurality of teeth is provided and a known range of measurements are used to determine/create a customized ready-made dental device having a variety of sizes to fit the majority of the population, such that the unit length is 3mm in this case making 7 regions). It would have been obvious to one having ordinary skill in the art to modify the plurality of customized ready-made implants as taught by Osorio/Engman to provide statistical distribution as taught by Bergersen to provide a plurality of customized ready-made abutment that fit virtually the entire population. It is noted that the applicant is claiming the apparatus (i.e. a plurality of abutments) and NOT the method of making measuring and making them.
With respect to claim 10, Osorio/Engman/Bergersen teaches the invention as substantially claimed and discussed above including the Engman teaching a tooth type is a maxillary anterior teeth, mandibular anterior teeth, canine teeth, premolar teeth, and molar teeth (see par. 31).
With respect to claim 10, Osorio/Engman/Bergersen teaches the invention as substantially claimed and discussed above including Bergersen further teaching a predetermined length and the regions being 7 (i.e. more than 4 and less than 9), however, does not specifically teach unit length is 0.4mm or more and less than 1.1 mm and the specific regions for the specific tooth types, however, does teach that having more regions creates a greater coverage (col. 8, ll. 35-46). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the unit length taught by Osorio/Engman/Bergersen to have the desired coverage based on the measurement/size of the patient specific abutment. Such that it is noted that the size of the device would be directly related to the unit length. It is noted that the claimed unit length and regions is not related to the claimed plurality of abutments relative to the structure and only how they are grouped in order to obtain the desired coverage and therefore, it is noted that it would have been obvious to one having ordinary skill in the art modify the teachings of Osorio/Engman/Bergersen to be divided by the claimed unit length and into the desired number of regions in order to obtain the desired coverage. Such that if it is determined that there is not much variation between the plurality of abutments regarding the measurement, it would be obvious to have less groups since the statistical distribution is smaller and therefore, less groups is required to obtain a large coverage range. In the reverse if there was determined to be a large variation between the measurements of the abutments, it would be obvious to provide more regions in order to encompass a larger percentage of the statistical distribution in order to obtain a large coverage range.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed June 24, 2026 have been fully considered but they are not persuasive. The applicant argues that the claims are clear as to how the statistical distribution and coverage is determined. However, it is noted that as discussed above the claims have not been amended to clarify what is being claimed. The amendments to the claims did overcome the issue of the single abutment being claimed but the body of the claim referring to a plurality of abutments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior rat of Neumeyer a set of abutments in a plurality of sizes based on known measurements (see abstract).
The pir art of Tuke which teaches providing a set of implants that include an abutment based on a statistical distribution of patient specific measurements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEIDI MARIE EIDE whose telephone number is (571)270-3081. The examiner can normally be reached Mon-Fri 9:00-4:00.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 9/23/2026
