Status under America Invents Act
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Drawings
The drawings filed December 24, 2025 are approved.
Rejections based on 35 U.S.C. 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 “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 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.”
The claim language is unclear and confusing – In regard to claim 1, the preamble indicates that “a customized ready-made abutment” is being claimed, yet lines 9 and 10 refer to “a plurality of customized ready-made abutments” suggesting that applicant is attempting to claim a selection or plurality of abutments. It is unclear if applicant is claiming a single abutment (or perhaps a single abutment out of the claimed “plurality of customized abutments”?) or a plurality (set, kit, collection) of different sized abutments. Applicant in response asserts that the reference in claim 1, to “a plurality of customized ready-made abutments” describes “the origin of the standardized structural features of the claimed abutment.” The examiner is not persuaded. The claim includes no language specifying how the singular “customized ready-made abutment” relates to the later claimed “plurality of customized ready-made abutments.” The claim fails to particularly point out and distinctly claim in a reasonable manner how the claimed “plurality of customized ready-made abutments” of lines 9 and 10, relate to the singularly claimed “customized ready-made abutment” of the preamble.
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, 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.”
In claim 11, it is unclear how the multiple claimed regions place any objectively ascertainable structural limitations upon the claimed “customized ready-made abutment.”
Rejections based on Prior Art
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osorio et al (US 5,989,029).
Osorio et al disclose an inventory of dental implant abutments (column 7, lines 1-3) each having a post positioned at an upper end for coupling with a crown (see Fig 2A at reference numeral 12); a lower part for coupling with an implant (see Figure 2A at reference numeral 10) and a gingival part (see Figure 2A at reference numeral 22). The Osorio et al inventory of abutments are of different sizes/shapes based on the type of tooth (column 7, line 9) and include average measurements for different parts of the type of tooth. When the tooth is selected from the inventory then it is prefabricated/ready-made and sent to the dental practitioner to be installed once the dental implant has healed (column 7, lines 18-22). An abutment from the Osario et al inventory of abutments can be selected such that it has a dimension that falls within a selected group of “patient customized abutments” with “65% or more” “standard coverage.”
In response to the present rejection applicant argues that “Osorio contains no disclosure of any statistical analysis, no regional-based division of axial based images and no computation of coverage ratios for any tooth type” and that “Osorio describes only patient-specific customization based on individual site measurements.” The examiner is not persuaded. The present claims are directed to a “customized ready-made abutment”, not a “method of determining the dimensions of a customized ready-made abutment.” The manner in which applicant intends for the dimensions of a known prior art device to be determined fails to impose any objectively ascertainable structural distinction from the known prior art Osario et al abutments. Applicant does not point to any objective difference between their claimed abutment and that of Osario, only that some unspecified dimension of their claimed abutment is to be determined through some vague and loosely defined statistical analysis. Applicant’s attention is directed to MPEP 2113 – Product by Process Claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Applicant’s claims/arguments are akin to arguing that they entitled to a patent on a common medium sized t-shirt because they intend for the t-shirt to have some vague and unspecified dimension within a broad range that is related to some measured dimensions of a group of prior art medium sized t-shirts and that their medium sized t-shirt has a dimension that falls within a range that includes up to 65% of the group of the measured medium sized t-shirts.
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 and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Osorio et al (US 5,989,029).
Osorio et al disclose a computer inventory of dental implant abutments (column 7, lines 1-3) each having a post positioned at an upper end for coupling with a crown (see Fig 2A at reference numeral 12); a lower part for coupling with an implant (see Figure 2A at reference numeral 10) and a gingival part (see Figure 2A at reference numeral 22). Wherein the practitioner selects a particular type of tooth (e.g. anterior, canine, premolar, molar) and then an abutment most closely matching the needed abutment is selected and ready made for the practitioner for use on the patient. Osario et al at column 7 states -
“The inventory is preferably a pre-programmed computer inventory. A computer program, such as that described above, is used to generate an inventory of abutments of various parameters by creating versions of the type of tooth which vary according to the measurements described above. By taking measurements of the site of desired tooth replacement and determining the type of tooth to be replaced, a model of an abutment can be selected from the inventory. The measurements and tooth type are entered into the computer pre-programmed with the inventory of abutments. The measurements are compared to the available models for that tooth type, and a model that most closely approximates the measurements is selected. This model is then used to generate a prototype from which a customized dental abutment may be cast, as described above.
A customized dental abutment so fabricated is then sent to the dental practitioner for installation into the dental implant fixture implanted into the patient's jawbone. After the site of the implanted dental fixture is healed, the customized dental abutment of the invention is secured in place in the dental implant fixture by, for example, screwing it into place in the dental implant fixture.”
Osario et al does not disclose that the selected ready-made abutment has a “standard coverage” of “65% or more” of a group of patient customized abutments. One of ordinary skill in the art, however, would have found it obvious to have provided such a ready-made abutment for a particular type of tooth (e.g. a molar) that could be used on 65% or more of a group of patients so that a useful inventory of abutments was available to the practitioner. It is noted that applicant’s claims set forth no limitations regarding the accuracy of the “customized ready-made abutment” fit or the composition of the “group” to which the 65% applies (i.e. the actual structural and dimensional limitations required of the “customized ready-made abutment” are quite broad). In regard to claims 3-8, providing the Osario et al inventory with abutments for molar and premolar teeth that fall within the different stated accuracy ranges would have been obvious to one of ordinary skill in the art in order to provide for a useful inventory. In regard to claim 9, providing the Osario et al abutment inventory with an abutment that falls within the broad and vague requirements of a “region that falls within a region among a plurality of regions” would have been obvious to one of ordinary skill in the art in order to maintain a useful inventory of abutments.
Action Made Final
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Ralph Lewis whose telephone number is (571)272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eric Rosen, at (571) 272-4964. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712
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