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 Group I, Claims 1-23 in the reply filed on December 18, 2025 is acknowledged.
Claims 24-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 18, 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the surgical motor of Claim 6, the plurality of perforation expansion means of Claim 7, the pyramid shape of Claims 14-16, and the at least three expansion means of Claim 17 must be shown or the features canceled from the claims. No new matter should be entered.
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
Claim 5 is objected to because of the following informalities: the word “maintain” in line 3 should be changed to “maintains” in order to be grammatically correct. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the word “wherein” appears to be missing after “claim 1,” in line 1 and the word “comprising” in line 2 should be changed to “comprises” to be grammatically correct. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: the word “a” in line 1 should be changed to “the” in order to be consistent with the rest of the claims. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: the word “a” is missing between the words “comprises” and “body” in line 2. 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: the guided perforation drilling means and the one or more expansion means of Claims 1-23.
Because these claim limitations are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitations 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 4, 7, and 20 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.
Claim 4 recites the limitation "the perforation" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the one or more perforation expansion means” in line 2. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this limitation correlates to the “expansion means” in Claim 1 or the “guided perforation drilling means” of Claim 1.
Claim 20 recites the limitation “crown shape” is indefinite, as it is unclear what could and could not be considered “crown shape.” It is unclear if anything that can be placed on a head/crown considered “crown shape” or if additional parameters are intended for this limitation. For the purpose of examination, this limitation will be interpreted broadly.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 -5, 7, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by TARDIEU et al. (US 2010/0009314 A1, hereinafter “Tardieu”).
Regarding Claim 1, Tardieu discloses a simplified computer-guided drilling system for performing dental implant surgery (abstract), the system used with a computer made guide element (Figure 2, 11) having an opening (14), where the opening defines a drilling position and a drilling direction (as described in [0076]), the system comprising a guided perforation drilling means (Figure 6, 4), which comprises a drilling body with a pointed end (30) attached to a smooth-walled cylindrical body (33). Tardieu further discloses one or more expansion means (Figure 7, 5), each comprising a guide body with a pointed end (34) that maintains the drilling position, and a second guide body with a cylindrical- conical shape (35) and having a diameter that increases as it moves away from the pointed end (diameter increases at 36), to allow the insertion of an implant (Figure 8, 1) whose shape corresponds to a last expansion means but with a larger diameter than the last expansion means (implant is inserted after last expansion means), where the smooth-walled cylindrical body precisely fits the opening in the guide element.
Regarding Claim 2, Tardieu discloses the drilling system according to claim 1, and further discloses that the perforation drilling means has a maximum diameter and the expansion means has a larger maximum diameter than the perforation drilling means, wherein during dental implant surgery the drilling means and expansion means can be inserted sequentially (as described in [0100-0109], staged drill 4 is used sequentially with calibration drill 5).
Regarding Claim 3, Tardieu discloses the drilling system according to claim 2, and further discloses that the pointed end of the perforation drilling body corresponds to the pointed end of the guide body of a first -expansion means and during use is operative for maintaining the drilling position (as described in [0100-0109]).
Regarding Claim 4, Tardieu discloses the drilling system according to claim 2, and further discloses that during dental implant surgery the pointed end of the guide body (34) is capable of maintaining the drilling position and the cylindrical-conical body (35) is operative to expand the perforation, allowing the perforation to correspond to the shape of the pointed end of the guide body of a second expansion means, for always maintaining the drilling position (as described in [0108 -0111]).
Regarding Claim 5, Tardieu discloses the drilling system according to claim 2, and further discloses that the during dental implant surgery the drilling means (4) is capable of use with the guide element and the at least one expansion means to maintain the drilling position without requiring the guide element.
Regarding Claim 7, Tardieu discloses the drilling system according to claim 1, and further discloses that the one or more perforation expansion means comprising a plurality of perforation expansion means, each respective perforation expansion means having a respective maximum diameter, wherein the respective maximum diameters of the plurality of perforation expansion means sequentially progressively increase (as described in [0101-0111], drills 4 and 5 are sequentially used with progressive increase).
Regarding Claim 12, Tardieu discloses the drilling system according to claim 1, and further discloses that the smooth-walled cylindrical body has a diameter that is in a range between 1 to 4 millimeters and a length that is in a range between 5 to 20 millimeters ([0103]).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tardieu.
Regarding Claim 13, Tardieu discloses the invention of Claim 12 as described above, but does not specifically teach that the smooth-walled cylindrical body has a diameter of 2 millimeters and a length of 10 millimeters. However, the Examiner notes that such modification would merely involve a change in size, which has been held to be within the skill of the ordinary artisan. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Tardieu to make the diameter 2 millimeters and the length 10 millimeters which has been held to be within the skill of the ordinary artisan (see MPEP 2144.04(IV)(A)), and since such modification would allow customization of the cylindrical body, allowing for customized used of the device in a particular patient.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tardieu in view of Huwais (US 2017/0071704 A1).
Regarding Claim 6, Tardieu discloses the invention of Claim 1 as described above, but does not disclose that the perforation drilling means and the expansion means are connected to a surgical motor configured to rotate between 400 and 2000 RPM, allowing an easy perforation of the cortex of the bone, through the opening of the guide element and to the expansion without guide element. In the same art of dental tools, Huwais teaches a surgical motor for use with a dental drill that rotates between 400-2000 RPM ([0054]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize a surgical motor that rotates between 400-2000 RPM as taught by Huwais for the motor needed for the drilling system of Tardieu in order to provide a drill speed adequate to effectively remove bone during use.
Claims 8-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tardieu in view of Mills (US 6,196,636 B1).
Regarding Claims 8-11, Tardieu discloses the invention of Claim 1 as described above, but does not disclose that the expansion means comprises a plurality of lateral faces, which in a cross-sectional view have a regular polygon shape that is hexagonal in shape with 6 faces. In the art of cutting tools, Mills teaches an expansion means (Figure 1, 10) with a plurality of lateral faces (as seen in Figure 5, the drilling body of the expansion means has a plurality of lateral faces) with a cross-sectional view having a regular polygon shape (Figure 5) that is hexagonal in shape with 6 faces (as described in Column 4, lines 7-10 other polygonal pyramid configurations can be used). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to choose a 6 faces polygonal shape for the expansion means as is taught by Mills for the expansion means of Tardieu in order to provide a durable and effective tip for drilling bone.
Regarding Claims 14-16, Tardieu discloses the invention of Claim 1 as claimed as described above, but does not disclose that the drilling body comprises a sharp pointed pyramid shape with 6 lateral faces. In the similar art of cutting tools, Mills teaches a drilling body (Figure 4, body 19) with a sharp pointed pyramid shape (Figure 4) with 6 lateral faces (as described in Column 4, lines 7-10 other polygonal pyramid configurations can be used). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to choose a drilling body with 6 lateral faces for the tip as is taught by Mills for the configuration of the drilling body of Tardieu in order to provide a durable and effective tip for drilling bone.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tardieu in view of KIM et al. (US 2016/0287336 A1, hereinafter “Kim”).
Regarding Claims 17 and 18, Tardieu discloses the invention of Claim 1 as described above, but does not disclose at least three expansion means, where wherein the first expansion means at its widest part has a diameter of 2.6 mm, the second expansion means at its widest part has a diameter of 3.2 mm, the third expansion means at its widest part has a diameter of 3.8 mm. In the similar art of dental surgical systems, Kim teaches a drilling system with three expansion means ([0060] discloses three drills of progressive diameters) with diameters progressing from 2.7, to 3.0 to 3.2mm. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the teaching of progressively larger diameter surgical drills to achieve the known result at taught by Kim with the device of Tardieu in order to provide a safe system for incrementally increasing a drilled hole without unnecessary trauma to the bone tissue. Additionally, it would have been obvious to one having ordinary skill in the art to provide the diameters of the drills at 2.6, 3.2, and 3.8 mm as this modification would merely involve a change in size, which has been held to be within the skill of the ordinary artisan. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Tardieu in view of Kim to make the progressive drill diameters 2.6, 3.2, and 3.8 mm as this modification has been held to be within the skill of the ordinary artisan (see MPEP 2144.04(IV)(A)), and since such modification would allow customization of the drill size, allowing for customized used of the device in a particular patient.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tardieu in view of KIM et al. (US 2019/0321144 A1, hereinafter “Kim ‘44”).
Regarding Claim 19, Tardieu discloses the drilling system according to claim 1, but does not disclose that the one or more expansion means each comprise a perforation in a central area to allow the passage of a coolant liquid flow. In the same art of dental drills, Kim ’44 teaches a drill for a dental implant (Figure 3, 100) with a perforation in a central area (Figure 3, 114) to allow the passage of a coolant liquid ([0007]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the central are of the expansion means of Tardieu with a perforation for a coolant liquid as taught by Kim ’44 in order to prevent overheating.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tardieu in view of Kim ’44 in further view of Harris (US 2015/0018844 A1).
Regarding Claim 20, Tardieu in view of Kim ’44 discloses the invention of Claim 19 as claimed as described above, but does not disclose that the expansion means has at the pointed end that is a crown shape with rounded corners. In the similar art of surgical tools, Harris teaches an expansion means (300) with an end that is a crown shape with rounded corners (Figure 3). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the device of Tardieu in view of Kim ’44 with an end that is a crown shape with rounded corners as taught by Harris for use when the bone tissue of the patient is brittle.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Tardieu in view of Lozada (US 2020/0188067 A1).
Regarding Claims 21-23, Tardieu discloses the invention of claim 1 as described above, but does not disclose an implant to be inserted with a body with a conical cylinder shape, with a sharp point at a tip of the implant, and that corresponds to the shape of the expansion means and has a double spiral thread (as seen in Figure 6) with a width of the thread that thins and a depth of the thread increases from a back of the implant towards the tip of the implant (as seen in Figure 6). In the same art of dental implants, Lozada teaches an implant (63) to be inserted with a body with a conical cylinder shape (as seen in Figure 6), with a sharp point at a tip of the implant (64), and that corresponds to the shape of the expansion means (expansion means 30 as seen in Figure 3) with a double spiral thread and a width of the thread that thins and a depth of the thread increases from a back of the implant towards the tip of the implant. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize an implant with a conical cylinder shape and sharp point as taught by Lozada with the drilling system of Tardieu for use in cases where the anatomy of the patient would not support a large diameter and extra purchase in the bone is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE L NELSON whose telephone number is (571)270-5368. The examiner can normally be reached M - F 7:30-4:30 PT.
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/CHRISTINE L NELSON/ Examiner, Art Unit 3772
/EDWARD MORAN/ Primary Examiner, Art Unit 3772