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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group 1, claims 1-11, drawn to an actuator comprising a housing formed from a non-ferrous, non-magnetic material.
Group 2, claims 12-20, drawn to a robotic system for preforming medical procedures.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups 1 and 2 lack unity of invention because even though the inventions of these groups require the technical feature of an actuator comprising a first and second plurality of fibers connected to a member, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Altshuler et al. (US 20210121051 A1), hereinafter Altshuler.
Altshuler discloses an actuator (para. 0032 (steerable instrument includes an actuation unit and a bendable body)) comprising:
a housing formed from a non-ferrous, non-magnetic material, the housing having a front end and an opposite back end and a sidewall extending between the front end and the opposite back end;
a member positioned within the housing;
a first plurality of fibers operatively connected to the member (Fig. 2B, element 115 – driving wires, Fig. 1B, element 3 – bendable body);
a second plurality of fibers operatively connected to the member such that the second plurality of fibers are configured to allow for providing forces opposite of the first plurality of fibers (para. 0009 (plurality of driving wires), 0041 (Each bending section is actuated by a set of antagonistic driving wires which operate by a pulling or pushing force (an actuating force) to bend each bending section independently));
and switching electrically connected to each of the first plurality of fibers and each of the second plurality of fibers to provide for selectively activating each of the first plurality of fibers and each of the second plurality of fibers;
wherein the housing consists essentially of materials which are non-magnetic and non-ferrous;
wherein each of the first plurality of fibers and the second plurality of fibers consist essentially of materials which are non-magnetic and non-ferrous.
During a telephone conversation with John Goodhue on 06/03/2026 a provisional election was made without traverse to prosecute the invention of Group 1, claims 1-11. Affirmation of this election must be made by applicant in replying to this Office action. Claims 12-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/27/2024 is being considered by the examiner.
Drawings
The drawings are objected to because Figure. 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 11 is objected to because of the following informalities: Claim 11 reads “selected from a set including a computed tomography (CT) scanner and a magnetic resonance imaging (MRI) scanner”. T.
Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 8-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Altshuler et al. (US 20210121051 A1), hereinafter Altshuler.
Regarding claim 1, Altshuler teaches an actuator (para. 0032 (steerable instrument includes an actuation unit and a bendable body)) comprising:
a housing formed from a non-ferrous, non-magnetic material (para. 0003 (tubular sheath has a plurality of bendable segments is typically made of biocompatible polymers)), the housing having a front end and an opposite back end and a sidewall extending between the front end and the opposite back end (para. 0034 (steerable instrument having a distal steerable section… and a proximal part), 0038 (tubular structure comprising an outer surface and an inner surface defining a wall));
a member (Fig. 1B, element 3 – bendable body) positioned within the housing;
a first plurality of fibers operatively connected to the member (Fig. 2B, element 115 – driving wires);
a second plurality of fibers operatively connected to the member such that the second plurality of fibers are configured to allow for providing forces opposite of the first plurality of fibers (para. 0009 (plurality of driving wires), 0041 (Each bending section is actuated by a set of antagonistic driving wires which operate by a pulling or pushing force (an actuating force) to bend each bending section independently));
and switching electrically connected to each of the first plurality of fibers and each of the second plurality of fibers to provide for selectively activating each of the first plurality of fibers and each of the second plurality of fibers (para. 0036 (controller system is configured to control the actuation unit… [actuator] can actuate all driving wires independently), 0053 (actuator can control various (or all) driving wires 115 individually));
wherein the housing consists essentially of materials which are non-magnetic and non-ferrous (para. 0003 (tubular sheath has a plurality of bendable segments is typically made of biocompatible polymers), 0039 (ring-shaped wire-guiding members can be made of biocompatible polymer materials));
wherein each of the first plurality of fibers and the second plurality of fibers consist essentially of materials which are non-magnetic and non-ferrous (para. 0003 (Driving wires or tendons are typically made of metallic material such as nickel-titanium (NiTi) alloy)).
Regarding claim 8, Altshuler teaches the actuator of claim 1 wherein an electronic control system includes the switching for selectively activating each of the first plurality of fibers and selectively activating each of the second plurality of fibers (para. 0034 (steerable instrument is controlled by a robotic controller system via the actuation unit), 0053 (actuator that can control various (or all) driving wires 115 individually)).
Regarding claim 9, Altshuler teaches the actuator of claim 8 wherein the electronic control system is configured to selectively activate specific fibers within the first plurality of fibers and the second plurality of fibers to provide at least one of tilt and rotation (para. 0041 (Forces F1 and F2 of different magnitude can be applied in the lengthwise direction of each driving wire to bend the various bending sections in desired directions)).
Regarding claim 10, Altshuler teaches a system comprising the actuator of claim 9 and further comprising an imaging system operatively connected to the electronic control system and configured for acquiring imagery of a medical procedure associated with the actuator (para. 0035 (the navigation system, the controller system, and the actuation unit, are operably connected to each other), 0045 (The navigation system processes data provided by the controller system, data provided by images stored on the image server)).
Regarding claim 11, Altshuler teaches the system of claim 10 wherein the imaging system is selected from a set including a computed tomography (CT) scanner and a magnetic resonance imaging (MRI) scanner (para. 0045 (The navigation system is also connected to… an image server… which may include the CT scanner, a magnetic resonance imaging (MRI) scanner)).
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.
Claims 2-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler and in view of Lima (US 11746760 B2).
Regarding claim 2, Altshuler teaches the actuator of claim 1.
Altshuler does not teach wherein the first plurality of fibers forms a first twisted and coiled artificial muscle and the second plurality of fibers forms a second twisted and coiled artificial muscle.
Lima teaches wherein the first plurality of fibers forms a first twisted and coiled artificial muscle and the second plurality of fibers forms a second twisted and coiled artificial muscle (Fig. 1, element 120 – actuator, col. 3, lines 28-30 (actuators are made of twisted polymeric fibers that are coiled).
Altshuler and Lima are considered to be analogous to the claimed invention because they are in the same field of having selective actuation of an instrument. Therefore, 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 Altshuler to incorporate the teachings of Lima and provide a plurality of fibers forming a twisted and coiled artificial muscle. Altshuler teaches a plurality of tendons, but does not teach the tendons being twisted and coil (para. 0003). Therefore, incorporating a twisted and coiled artificial muscle as taught by Lima would allow a simpler actuator design, while reducing manufacturing costs (Lima; col. 1, lines 26-28).
Regarding claim 3, Altshuler (in view of Lima) teaches the actuator of claim 2 wherein the housing is a cylindrically shaped casing (Fig. 1B).
Regarding claim 4, Altshuler (in view of Lima) teaches the actuator of claim 3 wherein the member comprises a shaft (Fig. 1B, element 19 – non-bending proximal part).
Regarding claim 5, Altshuler (in view of Lima) teaches the actuator of claim 3 wherein the member comprises a centrally positioned disc configured to move along inner walls of the housing (Fig. 2B, element 120 - wire-guiding members).
Regarding claim 7, Altshuler (in view of Lima) teaches the actuator of claim 3 wherein the member comprises a centrally positioned disc (Fig. 2B, element 120 - wire-guiding members) and a stabilizing disc (Fig. 2B, element 120A).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Altshuler (in view of Lima) and in further view of Alvarez et al. (US 11464586 B2), hereinafter Alvarez.
Regarding claim 6, Altshuler (in view of Lima) teaches the actuator of claim 5.
Altshuler (in view of Lima) does not teach wherein the centrally positioned disc is configured to move along the inner walls of the housing using a rack and pinion configuration.
Alvarez teaches wherein the centrally positioned disc is configured to move along the inner walls of the housing using a rack and pinion configuration (col. 15, lines 56-58 (pull wires may be disposed within…lumens of the push tubes), col. 18, lines 41-43 (the drive mechanisms in a control unit of a catheter system may include racks and pinions for operating or driving the push tubes)).
Altshuler, Lima, and Alvarez are all considered to be analogous to the claimed invention because they are in the same field of steerable medical devices that are applicable to guide interventional instruments. Therefore, 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 Altshuler to incorporate the teachings of Alvarez and provide a centrally positioned disc is configured to move along the inner walls of the housing using a rack and pinion configuration. Doing so would allow mechanical actuation of the pulling wires with the combination of the rack and pinion configuration, thereby providing controlled movement of the disc within the housing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Vunjak-Novakovic et al. (US 11738175 B2), Duval et al. (US 20110071508 A1), Simaan et al. (US 11596770 B2), and Kaiser (US 20210259790 A1) are additional examples of steerable instruments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 8:00 - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EILEEN ROBLES/Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
Prosecution Insights