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 .
Restriction
Applicants’ election of claims 1-15 is acknowledged and made final. Claims 16-20 are withdrawn from consideration.
Claim Objections
Claims 1, 15 are objected to because of the following informalities:
Claim 1 recites, “video display system.” There is an antecedent base issue in this limitation.
Claim 15 recites, “wherein images or video images are displayable on the video display system are utilized to confirm the needle is in the anatomical region.” There is a grammatical issue in this feature.
Appropriate corrections are required.
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) 1-8, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dulguerov (US 6706017) in view of Mills (WO 2011103629) and further in view of Non-patent literature entitled “A New Strategy For Difficult Airway Management With Visual Needle Cricothyroidotomy: A Manikin Study.”
Regarding claim 1, Dulguerov discloses a method of performing a cricothyroidotomy or a tracheostomy with a medical device (performing a percutaneous ostomy in a body, in particular a tracheostomy), including the steps of:
providing a medical device comprising, video display system, a percutaneous needle assembly (Assembly for needle 12; FIG. 1; col. 5, lines 35-51), comprising,
a syringe port (port 32 for syringe), a needle port (channel of primary dilator 42 where the needle is inserted provides needle port. FIG. 1), a stylet port (port of channel 30 in FIG. 1 that allows Fibroscope 38 to pass through. col. 6, lines 23-49) in communication with the needle port, a needle (needle 12; col. 5, lines 35-50) that includes a lumen releasably attached to the needle port, and a fiber optic stylet (distal end of Fibroscope 38; FIG. 1) having a proximal end and a distal end that includes an image-capturing device (Fibroscope 38 is an image capturing device) and wherein the image-capturing device is in electronic communication with the video display system (display of computer 600; FIG. 33);
advancing needle into an anatomical region (A needle is inserted into the trachea; col. 4, lines 23-28);
Dulguerov does not expressly disclose least one illuminator and advancing the fiber optic stylet and needle into an anatomical region; removing the needle from the anatomical region leaving the fiber optic stylet in the anatomical region; advancing a dilator and an air cannula over the fiber optic stylet and into the anatomical region; and removing the dilator and fiber optic stylet leaving the air cannula in the anatomical region.
Mills is directed to a device providing an airway through a tracheal wall of a subject (abstract) and teaches least one illuminator (A separate light source may also be included in the device at the distal end of the optical fiber to illuminate the surrounding tissue.) and an optical fiber (Optical fibers as imaging device; The optical fibre/fiber can be provided as an additional element of the guide 400. ) and
advancing the guide (guide 400; FIG. 1) and needle into an anatomical region (needle 200; FIGS. 4A, 4B);
removing the needle from the anatomical region leaving the guide (400) in the anatomical region (guide 400; FIGS. 4C,4D; needle is removed);
advancing a dilator and an air cannula over the guide (guide 400) and into the anatomical region (tracheal tube 100 includes a dilator 140 at the distal end 102, for dilating the hole through the tracheal wall as the tracheal tube 100 is inserted. FIG. 4E); and
removing the dilator (dilator 140) and guide (guide 400) leaving the air cannula in the anatomical region (FIG. 4H).
Non-patent literature entitled “A New Strategy For Difficult Airway Management With Visual Needle Cricothyroidotomy: A Manikin Study,” teaches advancing the fiber optic stylet and needle into an anatomical region (Visual puncture system is provided with micro fiber and needle; Abstract; Visual needle cricothyroidotomy puncture system reduces that procedure related complication. abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dulguerov to use guide (guide 400) to guide the cannula during cricothyroidotomy in the surgical site in accordance with the teaching of Mills so that insertion of air cannula is guided. Further, it would have been obvious to further modify Dulguerov to use a fiber as a guide and advance the air cannula during puncturing in accordance with the teaching of the Non-patent Literature entitled “A New Strategy For Difficult Airway Management With Visual Needle Cricothyroidotomy: A Manikin Study” so that puncture related complication could be reduced (see abstract of the non-patent literature) during cricothyroidotomy by providing illumination by the fiber during puncturing of the surgical site and guiding of the air cannula through the fiber.
Regarding claim 2, Dulguerov discloses wherein the anatomical region includes an insertion site that is a person’s cricothyroid or tracheal ring (skin surface 102 through the tracheal wall 103 and into the tracheal lumen 104; FIG. 5).
Regarding claim 3, Dulguerov discloses wherein a syringe is removably attached to the syringe port (Syringe connected to port 32; FIG. 1; col. 6, lines 1-13).
Regarding claim 4, Dulguerov discloses wherein the anatomical region includes a person's tracheal lumen (skin surface 102 through the tracheal wall 103 and into the tracheal lumen 104; FIG. 5).
Regarding claim 5, Dulguerov discloses wherein the anatomical region is visible on the display system (The fibroscope 38 may be attached to a camera and video display to enable the position of needle 12 to be monitored by the entire operating team).
Regarding claim 6, Dulguerov discloses wherein the anatomical region is a person's tracheal lumen bifurcation into the person's bronchus (Skin surface 102 through the tracheal wall 103 and into the tracheal lumen 104; FIG. 5; Intended use).
Regarding claim 7, Dulguerov discloses wherein an artificial manual breathing unit is attachable to the air cannula (an artificial manual breathing unit is attachable to the air cannula; FIG. 5).
Regarding claim 8, Dulguerov discloses wherein a ventilator is attachable to the air cannula (An artificial manual breathing unit is attachable to the air cannula; FIG. 5).
Regarding claim 10, Dulguerov as modified teaches wherein the image-capturing device comprises a camera (Mills: optical fibers as imaging device).
Regarding claim 14, wherein the distal end of the fiber optic stylet is removably insertable through the stylet port to extend through the needle port and slide within the needle when the needle is affixed to the needle port (Port of channel 30 in FIG. 1 allows the Fibroscope 38 to removably pass through. col. 6, lines 23-49; FIG. 1).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dulguerov (US 6706017) in view of Mills (WO 2011103629) and further in view of Non-patent literature entitled “A New Strategy For Difficult Airway Management With Visual Needle Cricothyroidotomy: A Manikin Study,” and further in view of London (US 20170055813).
Regarding claim 9, Dulguerov does not expressly disclose wherein the video display system is portable.
London is directed to a medical device introduction system (abstract) and teaches wherein the video display system is portable (an external display device 575 or computer device 600; FIG. 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Dulguerov to include a portable display device so that display could be moved around as needed.
Claim(s) 11-12, 15, is/are rejected under 35 U.S.C. 103 as being unpatentable over Dulguerov (US 6706017) in view of Mills (WO 2011103629) and further in view of Non-patent literature entitled “A New Strategy For Difficult Airway Management With Visual Needle Cricothyroidotomy: A Manikin Study,” and further in view of London (US 20170055813).
Regarding claim 11, Dulguerov does not expressly disclose wherein the camera includes a charge-coupled device or a complementary metal oxide semiconductor image sensor.
London is directed to medical device introduction system (abstract) and teaches wherein the camera includes a charge-coupled device or a complementary metal oxide semiconductor image sensor (The imaging system 60 can comprise, for example, an optical scope, such as a fiber optic scope, a camera 61, a charge couple device (CCD). Para [0125]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Dulguerov to provide a CCD as an imaging device because this would provide an easily available alternative of fiber imaging.
Regarding claim 12, Dulguerov as modified teaches wherein the at least one illuminator includes a plurality of illuminators each including a light-emitting diodes (London: light delivery fibers have distal end element 505 for illumination; light source 425; para [0133], [0173]; light delivery mechanism can include a plurality of light delivery fibers; Para [0121]).
Regarding claim 15, Dulguerov as modified teaches wherein images or video images are displayable on the video display system are utilized to confirm the needle is in the anatomical region (When the surgical site is viewed, video display system are utilized to confirm the needle is in the anatomical region; FIG. 33).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dulguerov (US 6706017) in view of Mills (WO 2011103629) and further in view of Non-patent literature entitled “A New Strategy For Difficult Airway Management With Visual Needle Cricothyroidotomy: A Manikin Study,” and Vazales (US 20170258550).
Regarding claim 13, Dulguerov does not expressly disclose wherein the at least one illuminator includes one or more fiber optic cables coupled to an illumination source surrounding the image-capturing device.
Vazales is directed to facilitating insertion of an endotracheal tube (abstract ) and teaches wherein the at least one illuminator includes one or more fiber optic cables coupled to an illumination source (light delivery elements 112) surrounding the image-capturing device (Imaging elements 113).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dulguerov to include surrounding fiber optic cables in accordance with the teaching of Vazales so that more fibers could be accommodated in the cable providing more fibers for enhanced imaging.
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 because 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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable in view of the claims 1-15 of U.S. Patent No. US 12,109,361. See claim comparison below.
Instant Claims
US Patent
12,109,361
A method of performing a cricothyroidotomy or a tracheostomy with a medical device, including the steps of:
providing a medical device comprising,
video display system, a percutaneous needle assembly, comprising, a syringe port, a needle port, a stylet port in communication with the needle port, a needle that includes a lumen releasably attached to the needle port, and
a fiber optic stylet having a proximal end and a distal end that includes an image-capturing device and at least one illuminator, wherein the image-capturing device is in electronic communication with the video display system;
advancing the fiber optic stylet and needle into an anatomical region;
removing the needle from the anatomical region leaving the fiber optic stylet in the anatomical region;
advancing a dilator and an air cannula over the fiber optic stylet and into the anatomical region; and
removing the dilator and fiber optic stylet leaving the air cannula in the anatomical region.
A method of performing a cricothyroidotomy or a tracheostomy with a video-assisted system, including the steps of:
providing a video-assisted system, comprising, a display monitor for displaying still or video images, a percutaneous needle assembly, comprising, a syringe port, a needle port, a stylet port in communication with the needle port, a hollow needle that includes a single lumen releasably attached to the needle port, the hollow needle including a beveled tip, a syringe including a cavity for holding a liquid or gas therein, a syringe tip in fluid communication with the cavity, and a plunger associated with the cavity and configured to extract or retract the liquid or gas through the syringe tip; a fiber optic stylet having a proximal end and a distal end that includes an image-capturing device and at least one illuminator;
a communication module operatively coupled to the proximal end of the fiber optic stylet; and a communication transmitter for transmitting communication signals between the communication module, the image-capturing device, the at least one illuminator, and the display monitor;
locating an insertion site;
inserting the needle at the insertion site and positioning the needle at a desired anatomical region;
advancing the fiber optic stylet further into the anatomical region;
removing the needle from the first anatomical region leaving the fiber optic stylet in the anatomical region;
advancing a dilator and an air cannula over the fiber optic stylet and into the anatomical region; and
removing the dilator and fiber optic stylet leaving the air cannula in the anatomical region.
2. The method of claim 1, wherein the anatomical region includes an insertion site that is a person’s cricothyroid or tracheal ring.
2. The method of claim 1, wherein the insertion site includes a person's cricothyroid or tracheal ring.
3. The method of claim 1, wherein a syringe is removably attached to the syringe port.
3. The method of claim 1, wherein the syringe tip is removably attached to the syringe port.
4. The method of claim 1, wherein the anatomical region includes a person's tracheal lumen.
4. The method of claim 1, wherein the anatomical region includes a person's tracheal lumen.
5. The method of claim 1, wherein the anatomical region is visible on the display system.
5. The method of claim 1, wherein the anatomical region is visible on the display monitor.
6. The method of claim 1, wherein the anatomical region is a person's tracheal lumen bifurcation into the person's bronchus.
6. The method of claim 1, wherein the anatomical region is a person's tracheal lumen bifurcation into the person's bronchus.
7. The method of claim 1, wherein an artificial manual breathing unit is attachable to the air cannula.
7. The method of claim 1, wherein an artificial manual breathing unit is attachable to the air cannula.
8. The method of claim 1, wherein a ventilator is attachable to the air cannula.
8. The method of claim 1, wherein a ventilator is attachable to the air cannula.
9. The method of claim 1, wherein the video display system is portable.
9. The method of claim 1, wherein the display monitor is transportable.
10. The method of claim 1, wherein the image-capturing device comprises a camera.
10. The method of claim 1, wherein the image-capturing device comprises a camera.
11. The method of claim 10, wherein the camera includes a charge-coupled device or a complementary metal oxide semiconductor image sensor.
11. The method of claim 10, wherein the camera includes a charge-coupled device or a complementary metal oxide semiconductor image sensor.
12. The method of claim 1, wherein the at least one illuminator includes a plurality of illuminators each including a light-emitting diodes.
12. The method of claim 1, wherein the at least one illuminator includes a plurality of illuminators each including a light-emitting diodes.
13. The method of claim 1, wherein the at least one illuminator includes one or more fiber optic cables coupled to an illumination source surrounding the image-capturing device.
13. The method of claim 1, wherein the at least one illuminator includes one or more fiber optic cables coupled to an illumination source surrounding the image-capturing device.
14. The method of claim 1, wherein the distal end of the fiber optic stylet is removably insertable through the stylet port to extend through the needle port and slide within the needle when the needle is affixed to the needle port.
14. The method of claim 1, wherein the distal end of the fiber optic stylet is removably insertable through the stylet port to extend through the needle port and slide within the hollow needle when the needle is affixed to the needle port.
15. The method of claim 1, wherein images or video images are displayable on the video display system are utilized to confirm the needle is in the anatomical region.
15. The method of claim 1, wherein the images or video displayed on the display monitor is utilized to confirm the needle is in the desired anatomical region.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached on 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 03/03/2026