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 .
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 2/11/2026, 2/11/2026, 2/11/2026, 5/21/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 12,419,694 hereinafter Sowards ‘694. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant invention would be an obvious modification of the reference patent.
Regarding claim 1, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
A medical device system (Sowards ‘694, claim 1) comprising:
a medical device including a multi-core optical fiber having a plurality of core fibers (Sowards ‘694, claim 1),
each of the plurality of core fibers including a plurality of sensors, each sensor of the plurality of sensors (Sowards ‘694, claim 1) configured to:
reflect a light signal of a different wavelength based on received incident light (Sowards ‘694, claim 1), and
change a characteristic of the light signal based on strain experienced by the multi-core optical fiber (Sowards ‘694, claim 1); and
a console including one or more processors and a non-transitory computer-readable medium having stored thereon logic, when executed by the one or more processors (Sowards ‘694, claim 1), causes operations including:
providing an incident light signal to the multi-core optical fiber (Sowards ‘694, claim 1);
receiving reflected light signals of different wavelengths of the incident light signal by one or more of the plurality of sensors (Sowards ‘694, claim 1);
processing the reflected light signals to determine a three-dimensional (3D) shape of the multi-core optical fiber (Sowards ‘694, claim 1);
detecting a predetermined subshape of the 3D shape (Sowards ‘694, claim 1);
defining a reference plane in accordance with the predetermined subshape (Sowards ‘694, claim 1),
wherein the reference plane defines a viewing perspective of the 3D shape (Sowards ‘694, claim 1); and
orienting the reference plane in 3D space for rendering an image of the 3D shape on a display (Sowards ‘694, claim 1).
Regarding claim 2, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein detecting the predetermined subshape includes: comparing a subshape of the 3D shape with a stored subshape in memory; and as a result of the comparing, identifying the subshape as the predetermined subshape of the 3D shape (Sowards ‘694, claim 2).
Regarding claim 3, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the memory includes a plurality of stored subshapes, and wherein the operations further include selecting the stored subshape from the plurality of stored subshapes (Sowards ‘694, claim 3).
Regarding claim 4, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the predetermined subshape is defined by a predetermined pathway of the medical device (Sowards ‘694, claim 4).
Regarding claim 5, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the medical device is configured for insertion within a patient body, and wherein the predetermined pathway is defined by an anatomical pathway of the patient body (Sowards ‘694, claim 5).
Regarding claim 6, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the operations further include: receiving input from a clinician defining the anatomical pathway of the patient body; and selecting a stored subshape from memory according to input from the clinician (Sowards ‘694, claim 6).
Regarding claim 7, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the input from the clinician includes a location of an insertion site for the medical device (Sowards ‘694, claim 7).
Regarding claim 8, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the anatomical pathway extends along one or more of a basilic vein, a subclavian vein, an innominate vein, an internal jugular vein, an external jugular vein, or a superior vena cava of the patient body (Sowards ‘694, claim 9).
Regarding claim 9, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the predetermined pathway is external to a patient (Sowards ‘694, claim 10).
Regarding claim 10, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the predetermined pathway is defined by a subshape guide of the medical device, and wherein the medical device is configured for insertion in a pathway of the subshape guide (Sowards ‘694, claim 11).
Regarding claim 11, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the subshape guide is included in a package of the medical device (Sowards ‘694, claim 12).
Regarding claim 12, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the subshape guide is integral to the package (Sowards ‘694, claim 13).
Regarding claim 13, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the subshape guide is configured for attachment to a patient to maintain an orientation of the predetermined subshape with respect to the patient (Sowards ‘694, claim 14).
Regarding claim 14, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein defining the reference plane includes identifying a pair of shape segments of the predetermined subshape and defining a plane in parallel with both shape segments (Sowards ‘694, claim 15).
Regarding claim 15, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
further comprising a device guide including a lumen extending along a straight section thereof wherein the medical device is configured for insertion in the lumen, and wherein the operations further include interpreting a section of the multi-core optical fiber in the straight section as a straight line and calibrating the multi-core optical fiber in accordance with the straight section (Sowards ‘694, claim 16).
Regarding claim 16, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the medical device is selected from the group consisting of an introducer wire, a guidewire, a stylet, a stylet within a needle, a needle with the optical fiber inlayed into a cannula of the needle, and a catheter with the optical fiber inlayed into one or more walls of the catheter (Sowards ‘694, claim 17).
Regarding claim 17, reference patent Sowards ‘694 (U.S. Pat. No. 12,419,694) teaches:
wherein the operations further include rendering the image of the 3D shape on the display of the system in accordance with the reference plane (Sowards ‘694, claim 18).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The claims are currently rejected as indicated above, and thus are not currently in condition for allowance.
The claims are similar to the parent case, issued patent U.S. Pat. No. 12,419,694. The claims are otherwise similar in scope and contain the subject matter found allowable in the parent application, in that they include features such as fibers for sensing of a light signal from strain experienced by the fibers for detection of the 3D shape of the device. The claims as a whole form a nonobvious combination of features that differentiate from the closest prior art references, in light of the similar features to the parent case.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Messerly (U.S. Pub. No. 20180289927) teaches to a placement system for tracking a catheter assembly during interventional procedures. The system includes optical sensor signals from strain signals to determine position and orientation of the device.
Noonan et al. (U.S. Pub. No. 20180279909) teaches to a hub with shape sensing features for determining a portion of an elongated flexible instrument that is detachably connected to the hub device.
Donhowe et al. (U.S. Pub. No. 20180235709) teaches to a registration procedure for image guided surgical procedures that includes the use of a catheter system that includes a shape sensor system for position and orientation detection.
Duindam et al. (U.S. Pub. No. 20120289783) teaches to a steerable medical instrument for insertion into body lumens within a patient. The device includes a shape sensing portion for determining the shape of the device within the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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, Keith Raymond can be reached at 571-270-1790. 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.
/SEAN A FRITH/Primary Examiner, Art Unit 3798
Prosecution Insights