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 .
Detailed Action
This is in response to the amendment filed 03/20/2026.
Restriction/Election
Applicant’s election without traverse of Group I in the reply filed on 03/20/2026 is acknowledged.
Claims 6-11, 13, 14, 16, 18 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/20/2026.
Note: claim 18 is withdrawn as it is clearly a part of Group II because it is dependent on claim 6. It was inadvertently left out of group II in the original restriction requirement.
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 1-14, 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 1 refers to “at least one positioning structure relative to the skull of the patient of said at least one operating guide” which renders the claim indefinite. It appears to be a literal translation into English from a foreign document is grammatically and idiomatically incorrect. It is unclear “relative to the skull of the patient” is intended to mean.
The Office suggests the following amendment to withdraw the rejection: “at least one positioning structure positionable relative to the head of the patient
Allowable Subject Matter
Claim 3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claim 3 recites means for adjusting the relative angular position of the two beams and for adjusting the distance between the articulation and the operating guide.
The Office agrees the art of record fails to teach or suggest these features.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 4, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0119902 (Rurling et al.) in view of U.S. Patent Number 6,355,049 (Gill)
Regarding claim 1, Rurling et al. discloses a shown in Figure 2, a stereotactic device, for operation on the head of a patient, comprising: at least one operating guide ( structure of needle holder 20 which actually holds the needle, see paragraph [0044]) configured to guide, during the operation, a surgical instrument to an operating zone; and at least one positioning structure (frame docking device 16, frame 1, square frame of needle holder 20, see paragraph [0043]) relative to the skull of the patient of said at least one operating guide; wherein said at least one positioning structure is fastened the at least one operating guide, wherein said at least one positioning structure capable of being determined to ensure the positioning of said operating guide on an axis of intervention determined from at least one preoperative image.
Rurling fails to disclose the stereotactic device comprising a dental support configured to anchor the positioning structure to the maxillae of the patient such that the dental support ensures the positioning of the stereotactic device relative to the head of the patient, wherein said at least one positioning structure is fastened on the one hand to the dental support and on the other hand to the at least one operating guide, wherein the dental support and said at least one positioning structure being determined to ensure the positioning of said operating guide on an axis of intervention determined from at least one preoperative image.
Gil from the same field of endeavor teaches a similar Stereotactic device as shown in Figures 1, 3, where the device includes a dental support (cast 30, see col. 7, lines 12-20) capable of anchoring a positioning structure (frame 2) to the maxillae of the patient such that the dental support ensures the positioning of the stereotactic device relative to the head of the patient, wherein at least one positioning structure is fastened on the one hand to the dental support, wherein the dental support and said at least one positioning structure being determined to ensure the positioning of said operating guide on an axis of intervention determined from at least one preoperative image.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Stereotactic device disclosed by Rurling to include the dental support taught by Gil such that the device includes a dental support configured to anchor the positioning structure to the maxillae of the patient such that the dental support ensures the positioning of the stereotactic device relative to the head of the patient, wherein said at least one positioning structure is fastened on the one hand to the dental support and on the other hand to the at least one operating guide, wherein the dental support and said at least one positioning structure being determined to ensure the positioning of said operating guide on an axis of intervention determined from at least one preoperative image in order to assist in securing the position of the patient’s mouth to the positioning device, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 2, Rurling et al. discloses wherein the positioning structure (frame docking device 16, frame 1, square frame of needle holder 20, see paragraph [0043]) is a fixed one-piece structure (frame docking device is fixed to other pieces to form a single structure) the dimensions of which are custom-determined (capable of being determined in the mind of the operator) using the position of the maxillae, the operating zone and the position of the operating guide.
Regarding claims 4, 5 Rurling et al. in view of discloses wherein the dental support comprises a splint (bridge portion 30) made to be capable of measure relative to the maxillary arch of the patient in such a way that the positioning structure is hyperstatic when the splint is fitted to the teeth of the patient, wherein the splint is attached to the positioning structure by removable fastening means (bolts 50, see col. 8, lines 4-8).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0119902 (Rurling et al.) in view of U.S. Patent Number 6,355,049 (Gill) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2012/0143213 (Myrman)
Regarding claim 12, Rurling fails to disclose wherein the operating guide comprises a stop to limit the travel of the surgical instrument when the operating zone is reached.
Rurling fails to disclose wherein the operating guide comprises a stop to limit the travel of the surgical instrument when the operating zone is reached
Myrman, from the same field of endeavor teaches a similar device as shown in Figure 1, wherein the operating guide comprises a stop to limit the travel of the surgical instrument when the operating zone is reached for the purpose of preventing insertion of the tool further than intended. See paragraph [0066].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed by Rurling to include the stop to limit taught by Myrman such that wherein the operating guide comprises a stop to limit the travel of the surgical instrument when the operating zone is reached in order to preventing insertion of the tool further than intended, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0119902 (Rurling et al.) in view of U.S. Patent Number 6,355,049 (Gill) as applied to claim 1 above, and further in view of U.S. Patent Number 5,961,527 (Whitmore, III et al.)
Regarding claim 13, Rurling fails to disclose wherein the stereotactic device also comprises at least one power grip, configured to be fastened to an operating table on which the patient rests during the operation.
Whitmore, III et al., from the same field of endeavor teaches a similar device a shown in Figure 1, wherein the stereotactic device also comprises at least one power grip (handle 126), configured to be fastened to an operating table on which the patient rests during the operation for the purpose of opening and closing a table clamp. See col. 5, lines 60-64.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the stereotactic device disclosed by Rurling to include the power grip taught by Whitmore, III et al. in order to open and close a table clamp.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0119902 (Rurling et al.) in view of U.S. Patent Publication Number 2019/0090994 (Garrec)
Regarding claim 15, Rurling view of Gill disclose a method for manufacturing a stereotactic device according to claim 1, determining at least one operating zone; detecting the position and shape of the maxillae of the patient; determining at least one entry point so as to reach the at least one operating zone with at least one predetermined axis of intervention; determining the position of at least one operating guide so that the central axis of said at least one operating guide is coaxial with the at least one predetermined axis of intervention connecting the at least one entry point and the at least one operating zone; determining the dimensions of the dental support as a function of the shape of the maxillae of the patient; determining the dimensions of the positioning structure as a function of the determined positions of the at least one operating guide and the maxillae; and producing the stereotactic device on the basis of the determined dimensions.
Rurling fails to disclose wherein the method comprises the following steps: creating a three-dimensional image of the head of the patient.
Garrec, from a related field of endeavor teaches a similar method of manufacturing as shown in Figure 1, wherein the method comprises the following steps: creating a three-dimensional image of the head of the patient for the purpose of manufacturing that device according to qualities determined from the 3d image. See paragraph [0082].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Rurling to include ethe step of creating a three-dimensional image of the head of the patient such that the method comprises the following steps: creating a three-dimensional image of the head of the patient; determining at least one operating zone in the three-dimensional image; detecting the position and shape of the maxillae of the patient in the three-dimensional image; determining at least one entry point so as to reach the at least one operating zone with at least one predetermined axis of intervention; determining the position of at least one operating guide so that the central axis of said at least one operating guide is coaxial with the at least one predetermined axis of intervention connecting the at least one entry point and the at least one operating zone; determining the dimensions of the dental support as a function of the shape of the maxillae of the patient; determining the dimensions of the positioning structure as a function of the determined positions of the at least one operating guide and the maxillae; and producing the stereotactic device on the basis of the determined dimensions in order to manufacture the device to a particular patient’s specifications.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0119902 (Rurling et al.) in view of U.S. Patent Publication Number 2019/0090994 (Garrec) as applied to claim 15 above, and further in view of U.S. Patent Publication Number 2011/0093023 (Lee et al.)
Regarding claim 17, Rurling et al. fails to disclose wherein the manufacturing of the stereotactic device starting out from the determined dimensions comprises at least one step of 3D printing of the positioning structure, the operating guide, and/or the dental support.
Lee et al., from the same field of endeavor teaches a similar method of manufacture as shown in Figure 1, where wherein the manufacturing of the device starting out from the determined dimensions comprises at least one step of 3D printing. See paragraph [0031].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Rurling by substituting the step for manufacturing the device for the 3d printing steps taught by Lee such that the manufacturing of the stereotactic device starting out from the determined dimensions comprises at least one step of 3D printing of the positioning structure, the operating guide, and/or the dental support because it would only require the simple substitution of known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
Prosecution Insights