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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/24/25 has been entered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 22-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 11,864,847. Although the claims at issue are not identical, they are not patentably distinct from each other because they claim the auxiliary instrument for determining a position of a second device.
Claim Rejections - 35 USC § 103
1. 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.
2. Claims 22, 26-27, 30-32, 34, 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2014/0317910) and in view of Govari et al. (US 2014/0163546).
3. Addressing claim 22, Govari discloses:
an auxiliary instrument for determining a position of a second device, the auxiliary instrument comprising a proximal end, a distal end region, and an outer diameter, said auxiliary instrument further comprising a first localization element having a position and orientation and a second localization element having a position and orientation, the position and orientation of said first localization element and said second localization element determinable with an electromagnetic position detection system, wherein the first localization element is arranged within the distal end region and comprises a first coil and the second localization element is arranged within the distal end region and comprises a second coil, wherein at least one of the first localization element and the second localization element has a length whose amount is at least ten times greater than its outer diameter (see Fig. 1, [0043] and [0046]; device 10 with sensing coils 22; coils with magnetic field is used in electromagnetic position detection system; as seen in Fig. 1, element 22 has the length at least ten times its outside diameter; element 22 wrap 5 times around the device 10; 1 wrap around the device 10 already at least 10 times the outside diameter of element 22; also look at Figs. 5-6; it is clear from the Figures the length is at least 10 times the outside diameter). Also see the prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The length that is 10 time greater than the diameter is normal in the field of coil sensor.
Govari (US 2014/0317910) does not disclose wherein said auxiliary instrument is insertable into a lumen of the second device, said lumen of the second device having an inner diameter larger than the outer diameter of the auxiliary instrument, and wherein, during insertion, the position of said second device is determinable. In the same field of endeavor, Govari (US 2014/0163546) discloses wherein said auxiliary instrument is configured to insert into a lumen of the second device, said lumen of the second device having an inner diameter larger than the outer diameter of the auxiliary instrument, and wherein, during insertion, the position of said second device is determinable (see Figs. 3-4, [0012] and [0033-0034], sheath 40 is the second device with lumen having diameter larger than outer diameter of catheter 24; the sensors 62, 64, 64 could help determine position of sheath).
4. Addressing claims 26-27, 30-32, 34, 37 and 39, Govari (US 2014/0317910) discloses:
addressing claim 26, wherein the first coil has two coil ends and an outer diameter of 0.5 millimeters or less (see [0045]).
addressing claim 27, wherein the first and second coils are electrically independent and each of the coils is electrically conductively connected to at least two electrical lines, the electrical lines being led from a respective coil to the proximal end of the auxiliary instrument (see claim 5; coils connect to multiple wires).
addressing claim 30, wherein the first and second localization elements is surrounded by a tube (see [0044] and Fig. 1; the outer layer 24 is surrounding the localization element).
addressing claim 31, wherein the tube is coated with a biocompatible material (see [0044]; the layer 24 is biocompatible to be use inside the patient).
addressing claim 32, a connection for an electrical contact arranged at the proximal end of the auxiliary instrument (see Fig. 1).
addressing claim 34, a proximal localization element at the proximal end of the auxiliary instrument (see Fig. 1; the closest one to the proximal end is considered the proximal localization element at the proximal end (according to applicant’s specification paragraph [0059]; the proximal localization element is located away from the distal end and toward the proximal end).
addressing claim 37, wherein the second device comprises a catheter (see [0012]).
addressing claim 39, wherein the catheter comprises an angioplasty catheter, a urinary catheter, a gastrointestinal catheter, or a dialysis catheter (see [0004]).
5. Claims 23, 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2014/0317910), in view of Govari et al. (US 2014/0163546) and further in view of Thomspon Smith et al. (US 2019/0015644).
6. Addressing claims 23, 33 and 35 Govari (US 2014/0317910) does not disclose wherein the distal end region and proximal end comprises a bending stiffness of less than 10 Nmm2 and wherein a distance between the proximal end and the distal end of the auxiliary instrument is between 10 cm and 150 cm. Bending stiffness of less than about 10 Nmm2 and instrument length 10-150 cm is a designer choice that only require skill in the art. Thomspon Smith discloses wherein the distal end region comprises a bending stiffness of less than 10 Nmm7 and wherein a distance between the proximal end and the distal end of the auxiliary instrument is between 10 cm and 150 cm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari (US 2014/0317910) to have bending stiffness of less than about 10 Nmm2 and instrument length 10-150 cm as taught by Thomspon Smith because this is a designer choice that is well-known in the field that only require routine skill in the art and allow the medical device to be flexible inside patient body.
7. Claims 25 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2014/0317910), in view of Govari et al. (US 2014/0163546) and further in view of England et al. (US 6,076,007).
8. Addressing claims 25 and 36, Govari (US 2014/0317910) does not disclose wherein the first localization element is configured to have a total inductance between 2 mH and 4 mH. however, it is well-known in the field that these coils are small with small inductance. Examiner only relies on England to disclose a specific values for the coils inductance (see col. 3, lines 20-25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari (US 2014/0317910) to have coil inductance of 2 mH to 4 mH as taught by England because this a well-known effective inductance values for sensing medical device position.
9. Claims 28 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2014/0317910), in view of Govari et al. (US 2014/0163546) and further in view of Lyu et al. (US 2011/0066029).
10. Addressing claims 28 and 38, Govari (US 2014/0317910) does not disclose core and catheter comprises balloon. In the same field of endeavor, Lyu discloses core and catheter comprises balloon (see [0003] and [0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari (US 2014/0317910) to have coil wrap around core and catheter comprises balloon because create electromagnetic location sensor (see [0003]).
11. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2014/0317910 (provided in the IDS)), in view of Govari et al. (US 2014/0163546) and further in view of Beach (US 2018/0093087).
12. Addressing claim 29, Govari (US 2014/0317910) does not disclose coil with variable stiffness of bending. This only require routine skill in the art and it is a designer choice. Beach discloses coil with variable flexibility (see [0098]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari to have coil with variable flexibility and bending because this allows for flexibility of movement inside patient body.
13. Claim 40-41 is rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2014/0317910), in view of Govari et al. (US 2014/0163546) and further in view of Meier et al. (US 2014/0303489).
14. Addressing claim 40, Govari (US 2014/0317910) does not disclose wherein the device comprises a bone screw, a pedicle screw, or a Jamshidi needle and wherein the second device is configured to penetrate into a vertebral body of a spine. Meier disclose bone screw (see claim 3) and a device is configured to penetrate into a vertebral body of a spine (see Figs. 1A-B, [0035-37]; penetrate and insert device to stabilize the spine). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari (US 2014/0317910) to have bone screw and wherein the second device is configured to penetrate into a vertebral body of a spine because this allow the device to be use for various applicant such as bone implant and bone surgery.
Response to Arguments
Applicant's arguments filed 10/24/25 have been fully considered but they are not persuasive. Applicant argues the references do not disclose wherein at least one of the first localization element and the second localization element has a length whose amount is at least ten times greater than its outer diameter. Applicant’s argument is not persuasive because Govari (US 2014/0317910) discloses this limitation in Figures 1 and 5-6.
Allowable Subject Matter
Claim 24 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0110965 (see [0032]; length of sensor coil is 1500 time diameter), US 2013/0303944 (see [0031]; length of sensor coil is 10 time diameter) and US 2005/0065513 (see [0062]; length of sensor coil is 10 time diameter).
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793