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 .
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,343,117. Although the claims at issue are not identical, they are not patentably distinct from each other because both application and patent claim a system for determining whether blood vessel is a vein or an artery.
U. S. Application No. 19/254,637
U. S. Patent No. 12,343,117
1.Amedical system, comprising: an optical fiber configured for use in a blood vessel, the optical fiber comprising one or more core fibers, each of the one or more core fibers including a plurality of sensors distributed along a length thereof, each sensor of the plurality of sensors configured to: reflect a light signal of a different wavelength; and change a characteristic of the light signal based on a state of the optical fiber; and a console operatively coupled with the optical fiber, the console comprising: a light source; an optical receiver; one or more processors; and a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations including: projecting light into the optical fiber; receiving the light signal from each sensor of the plurality of sensors; determining whether the blood vessel is a vein or is an artery based on the light signal; and providing an output.
2. The medical system according to claim 1, wherein: the optical fiber is configured for insertion in the blood vessel toward a heart of a patient; and the operations further include: projecting a Light defining a first wavelength away from a distal end of the optical fiber into the blood vessel; receiving a reflected light signal having a second wavelength; extracting from the reflected light signal a present wavelength shift between the first wavelength and the second wavelength; and comparing the present wavelength shift with one or more wavelength shift limits stored in the non-transitory computer-readable medium to determine whether the blood vessel is a vein or an artery.
3. The medical system according to claim 1, wherein: the state of the optical fiber includes a fluctuating movement of at least a portion of the optical fiber; and the operations further include: extracting from the light signal present fluctuating movement data; and comparing the present fluctuating movement data with a fluctuating movement limit stored in the non-transitory computer-readable medium to determine whether the blood vessel is a vein or an artery.
4. The medical system according to claim 1, wherein: the state of the optical fiber includes a compressive strain of the optical fiber caused by engagement of the optical fiber with one or more check valves of the blood vessel during advancement of the optical fiber along the blood vessel; and the operations further include: extracting from the light signal present compressive strain data; and comparing the present compressive strain data with a compressive strain limit stored in the non-transitory computer-readable medium to determine whether the blood vessel is a vein or an artery.
5. The medical system according to claim 1, wherein: the state of the optical fiber includes pressure fluctuations exerted on the optical fiber; and the operations further include: extracting from the light signal present pressure fluctuation data; and comparing the present pressure fluctuation data with a pressure fluctuation limit stored in the non-transitory computer-readable medium to determine whether the blood vessel is a vein or an artery.
6. The medical system according to claim 1, wherein: the state of the optical fiber includes pressure fluctuations exerted on the optical fiber along a length of the optical fiber disposed in the blood vessel, the pressure fluctuations caused by a pressure wave traveling longitudinally along the optical fiber; and the operations further include: receiving a plurality of reflected light signals generated from the plurality of sensors, each of the plurality of reflected light signals based on a pressure exerted on the optical fiber adjacent a respective sensor of the plurality of sensors; extracting from the plurality of reflected light signals present pressure wave data; and comparing the present pressure wave data with one or more pressure wave limits stored in the non-transitory computer-readable medium to determine whether the blood vessel is a vein or an artery.
7. The medical system according to claim 1, wherein: the state of the optical fiber includes a pressure gradient exerted on the optical fiber along a length of the optical fiber disposed in the blood vessel; and the operations further include: receiving a plurality of reflected light signals generated from the plurality of sensors, each of the plurality of reflected light signals based on a pressure exerted on the optical fiber adjacent a respective sensor of the plurality of sensors; extracting from the plurality of reflected light signals a present pressure gradient data; and comparing the pressure gradient data with a pressure gradient limit stored in the non-transitory computer-readable medium to determine whether the blood vessel is a vein or an artery.
8. The medical system according to claim1, wherein: the optical fiber is included in a catheter configured to deliver an infusate to the blood vessel; the state of the optical fiber includes: a first temperature experienced by a first section of the optical fiber within the catheter; and a second temperature experienced by a second section of the optical fiber distal of the catheter; and the operations further include: receiving a first reflected light signal from a first sensor disposed along the first section, the first reflected light signal based on the first temperature; receiving a second reflected light signal from a second sensor disposed along the second section, the second reflected light signal based on the second temperature; extracting from the first reflected light signal and the second reflected light signal a present temperature difference data between the first temperature and the second temperature; and comparing the present temperature difference data with a temperature difference limit stored in the non-transitory computer-readable medium to determine whether the blood vessel is a vein or an artery.
9. The medical system according to claim 1, wherein: the optical fiber is included in a catheter configured to deliver an infusate to the blood vessel; the state of the optical fiber includes:a first temperature experienced by a section of the optical fiber distal of the catheter during non-delivery of the infusate; and a second temperature experienced by the section of the optical fiber during delivery of the infusate; and the operations further include: receiving a first reflected light signal from a sensor disposed along the section, the first reflected light signal based on the first temperature; receiving a second reflected light signal from the sensor, the second reflected light signal based on the second temperature; extracting from the first reflected light signal and the second reflected light signal present temperature difference data between the first temperature and the second temperature; and comparing the present temperature difference data with a temperature difference limit stored in the non-transitory computer-readable medium to determine whether the blood vessel is a vein or an artery.
10. The medical system according to claim 1, wherein the optical fiber is coupled with an elongate medical device, the elongate medical device including a catheter, a stylet, a probe, or a guidewire.
11. A method for identifying a blood vessel, comprising: projecting incident light into an optical fiber disposed in the blood vessel, the optical fiber comprising one or more core fibers, at least one of the plurality of core fibers including a plurality of sensors distributed along a length thereof, each sensor of the plurality of sensors configured to: reflect a light signal of a different wavelength; and change a characteristic of the light signal based on a state of the optical fiber; receiving the light signal from each sensor of the plurality of sensors; determining whether the blood vessel is a vein or an artery based on the light signal; and providing an output.
12. The method according to claim 11, comprising: projecting a light defining a first wavelength away from a distal end of the optical fiber into the blood vessel; receiving a reflected light signal having a second wavelength; determining a wavelength shift between the first wavelength and the second wavelength; and determining whether the blood vessel is a vein or an artery based on the wavelength shift.
13. The method according to claim 11, wherein the state of the optical fiber includes a fluctuating movement of at least a portion of the optical fiber, the method further comprising: extracting from the light signal present fluctuating movement data; and determining whether the blood vessel is a vein or an artery based on the present fluctuating movement data.
14. The method according to claim ll, wherein the state of the optical fiber includes a compressive strain of the optical fiber caused by engagement of the optical fiber with one or more check valves along the blood vessel during advancement of the optical fiber along the blood vessel, the method further comprising: extracting from the light signal present compressive strain data; and determining whether the blood vessel is a vein or an artery based on the present compressive strain data.
15. The method according to claim 11, wherein the state of the optical fiber includes a pressure fluctuation exerted on the optical fiber, the method further comprising: extracting from the light signal present pressure fluctuation data; and determining whether the blood vessel is a vein or an artery based on the present pressure fluctuation data.
16. The method according to claim i1, wherein the state of the optical fiber includes a pressure fluctuations exerted on the optical fiber along a length of the optical fiber disposed in the blood vessel, the pressure fluctuations caused by a pressure wave traveling longitudinally along the optical fiber, the method further comprising: receiving a plurality of reflected light signals generated from the plurality of sensors, each of the plurality of reflected light signals based on a pressure exerted on the optical fiber adjacent a respective sensor of the plurality of sensors; extracting from the plurality of reflected light signals present pressure wave data; and determining whether the blood vessel is a vein or an artery based on the present pressure wave data.
17. The method according to claim 11, wherein the state of the optical fiber includes a pressure gradient exerted on the optical fiber along a length of the optical fiber disposed in the blood vessel, the method further comprising: receiving a plurality of reflected light signals generated from the plurality of sensors, each of the plurality of reflected light signals based on a pressure exerted on the optical fiber adjacent a respective sensor of the plurality of sensors; extracting from the plurality of reflected light signals present pressure gradient data; and determining whether the blood vessel is a vein or an artery based on the present pressure gradient data.
18. The method according to claim 11, wherein: the optical fiber is included in a catheter configured to deliver an infusate to the blood vessel; the state of the optical fiber includes: a first temperature experienced by a first section of the optical fiber within the catheter; and a second temperature experienced by a second section of the optical fiber distal of the catheter; and the method further includes: receiving a first reflected light signal from a first sensor disposed along the first section, the first reflected light signal based on the first temperature; receiving a second reflected light signal from a second sensor disposed along the second section, the second reflected light signal based on the second temperature; extracting from the first reflected light signal and the second reflected light signal present temperature difference data between the first temperature and the second temperature; and determining whether the blood vessel is a vein or an artery based on the present temperature difference data.
19. The method according to claim 11, wherein: the optical fiber is included in a catheter configured to deliver an infusate to the blood vessel; the state of the optical fiber includes: a first temperature experienced by a section of the optical fiber distal of the catheter during non-delivery of the infusate; and a second temperature experienced by the section of the optical fiber during delivery of the infusate; and the method further includes: receiving a first reflected light signal from a sensor disposed along the section, the first reflected light signal in based on the first temperature; receiving a second reflected light signal from the sensor, the second reflected light signal based on the second temperature; extracting from the first reflected light signal and the second reflected light signal present temperature difference data between the first temperature and the second temperature; and determining whether the blood vessel is a vein or an artery based on the present temperature difference data.
20. The method according to claim ll, wherein the optical fiber is coupled with an elongate medical device, the elongate medical device including a catheter, a stylet, a probe, or a guidewire.
1. A medical system, comprising: an optical fiber configured for insertion within a blood vessel, the optical fiber having one or more core fibers extending along a longitudinal length of the optical fiber, each of the one or more core fibers including a plurality of sensors distributed along the longitudinal length and each sensor of the plurality of sensors configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on a state of the optical fiber; and a console operatively coupled with the optical fiber, the console including a light source, an optical receiver, one or more processors, and a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations including: projecting a light distally along the optical fiber; receiving at least one reflected light signal from the optical fiber, wherein the at least one reflected light signal is generated by a sensor of the optical fiber; determining, based on the at least one reflected light signal, that the blood vessel is a vein or is an artery; and communicating a result of the determining to a user.
2. The system of claim 1, wherein: the optical fiber is inserted within the blood vessel in a direction toward a heart of a patient, and the operations further include: projecting a light defining a first wavelength distally away from a distal end of the optical fiber into blood of the blood vessel; receiving a reflected light signal having a second wavelength via the distal end; extracting from the reflected light signal a present wavelength shift between the first wavelength and the second wavelength; comparing the present wavelength shift with one or more wavelength shift limits stored in the non-transitory computer-readable medium; and determining, as a result of the comparing, that the blood vessel is a vein or is an artery.
3. The system of claim 1, wherein: the state of the optical fiber includes a fluctuating movement of at least a portion of the optical fiber, and the operations further include: extracting from the at least one reflected light signal present fluctuating movement data; comparing the present fluctuating movement data with a fluctuating movement limit stored in the non-transitory computer-readable medium; and determining, as a result of the comparing, that the blood vessel is a vein or is an artery.
4. The system of claim 1, wherein: the state of the optical fiber includes a compressive strain of the optical fiber caused by engagement of the optical fiber with one or more check valves of the blood vessel during advancement of the optical fiber along the blood vessel, and the operations further include: extracting from the at least one reflected light signal present compressive strain data; comparing the present compressive strain data with a compressive strain limit stored in the non-transitory computer-readable medium; and determining, as a result of the comparing, that the blood vessel is a vein or is an artery.
5. The system of claim 1, wherein: the state of the optical fiber includes pressure fluctuations exerted on the optical fiber, and the operations further include: extracting from the at least one reflected light signal present pressure fluctuation data; comparing the present pressure fluctuation data with a pressure fluctuation limit stored in the non-transitory computer-readable medium; and determining, as a result of the comparing, that the blood vessel is a vein or is an artery.
6. The system of claim 1, wherein: the state of the optical fiber includes pressure fluctuations exerted on the optical fiber along a length of the optical fiber disposed within the blood vessel, the pressure fluctuations caused by a pressure wave traveling longitudinally along the optical fiber, and the operations further include: receiving a plurality of reflected light signals generated from the plurality of sensors disposed along the length of the optical fiber disposed within the blood vessel, each reflected light signal based on a pressure exerted on the optical fiber adjacent each respective sensor; extracting from the plurality of reflected light signals present pressure wave data; comparing the present pressure wave data with one or more pressure wave limits stored in the non-transitory computer-readable medium; and determining, as result of the comparing, that the blood vessel is a vein or is an artery.
7. The system of claim 1, wherein: the state of the optical fiber includes a pressure gradient exerted on the optical fiber along a length of the optical fiber disposed within the blood vessel, and the operations further include: receiving a plurality of reflected light signals generated from the plurality of sensors disposed along the length of the optical fiber disposed within the blood vessel, each reflected light signal based on a pressure exerted on the optical fiber adjacent the respective sensor; extracting from the plurality of reflected light signals a present pressure gradient data; comparing the pressure gradient data with a pressure gradient limit stored in the non-transitory computer-readable medium; and determining, as a result of the comparing, that the blood vessel is a vein or is an artery.
8. The system of claim 1, wherein: the optical fiber is inserted within the blood vessel in a direction toward a heart of a patient, the optical fiber is inserted within a lumen of a catheter, the catheter delivering an infusate to the blood vessel, the state of the optical fiber includes: a first temperature experienced by a first section of the optical fiber disposed within the catheter; and a second temperature experienced by a second section of the optical fiber extending distally beyond a distal end of the catheter, and the operations further include: receiving a first reflected light signal from a first sensor disposed along the first section, the first reflected light signal based on the first temperature; receiving a second reflected light signal from a second sensor disposed along the second section, the second reflected light signal based on the second temperature; extracting from the first reflected light signal and the second reflected light signal a present temperature difference data between the first temperature and the second temperature; comparing the present temperature difference data with a temperature difference limit stored in the non-transitory computer-readable medium; and determining, as a result of the comparing, that the blood vessel is a vein or is an artery.
9. The system of claim 1, wherein: the optical fiber is inserted within the blood vessel in a direction toward a heart of a patient, the optical fiber extends along a catheter, the catheter configured to deliver an infusate to the blood vessel, the state of the optical fiber includes: a first temperature experienced by a section of the optical fiber extending beyond a distal end of the catheter during non-delivery of the infusate; and a second temperature experienced by the section of the optical fiber during delivery of the infusate; and the operations further include: receiving a first reflected light signal from a sensor disposed along the section during non-delivery of the infusate, the first reflected light signal based on the first temperature; receiving a second reflected light signal from the sensor, the second reflected light signal based on the second temperature; extracting from the first reflected light signal and the second reflected light signal present temperature difference data between the first temperature and the second temperature; comparing the present temperature difference data with a temperature difference limit stored in the non-transitory computer-readable medium; and determining, as a result of the comparing, that the blood vessel is a vein or is an artery.
10. The system of claim 1, wherein the optical fiber is coupled with an elongate medical device, the elongate medical device including a catheter, a stylet, a probe, or a guidewire.
11. A method performed by a medical system of identifying a blood vessel, comprising: projecting incident light distally along an optical fiber of the medical system, the optical fiber disposed within the blood vessel, the optical fiber including a number of core fibers, at least one of the number of core fibers including a plurality of sensors distributed along a longitudinal length of the optical fiber, wherein each sensor of the plurality of sensors is configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on a state of the optical fiber; receiving at least one reflected light signal from the optical fiber, wherein the at least one reflected light signal is generated by a sensor of the optical fiber; identifying the blood vessel as a vein or as an artery based on the at least one reflected light signal; and communicating an identification of the blood vessel to a user.
12. The method of claim 11, comprising: projecting the incident light distally away from a distal end of the optical fiber, the incident light having a defined wavelength; receiving a reflected light signal emanating from particles within the blood vessel via the optical fiber; determining a wavelength shift between the incident light and the reflected light signal; and identifying the blood vessel as a vein or as an artery based on the wavelength shift.
13. The method of claim 11, wherein the state of the optical fiber includes a fluctuating movement of at least a portion of the optical fiber, the method further comprising: extracting from the at least one reflected light signal present fluctuating movement data; and identifying the blood vessel as a vein or as an artery based on the present fluctuating movement data.
14. The method of claim 11, wherein the state of the optical fiber includes a compressive strain of the optical fiber caused by engagement of the optical fiber with one or more check valves along the blood vessel during advancement of the optical fiber along the blood vessel, the method further comprising: extracting from the at least one reflected light signal present compressive strain data; and identifying the blood vessel as a vein or as an artery based on the present compressive strain data.
15. The method of claim 11, wherein the state of the optical fiber includes a pressure fluctuation exerted on the optical fiber, the method further comprising: extracting from the at least one reflected light signal present pressure fluctuation data; and identifying the blood vessel as a vein or as an artery based on the present pressure fluctuation data.
16. The method of claim 11, wherein the state of the optical fiber includes a pressure fluctuations exerted on the optical fiber along a length of the optical fiber disposed within the blood vessel, the pressure fluctuations caused by a pressure wave traveling longitudinally along the optical fiber, the method further comprising: receiving a plurality of reflected light signals generated from the plurality of sensors disposed along the length of the optical fiber disposed within the blood vessel, each reflected light signal based on a pressure exerted on the optical fiber adjacent each respective sensor; extracting from the plurality of reflected light signals present pressure wave data; and identifying the blood vessel as a vein or as an artery based on the present pressure wave data.
17. The method of claim 11, wherein the state of the optical fiber includes a pressure gradient exerted on the optical fiber along a length of the optical fiber disposed within the blood vessel, the method further comprising: receiving a plurality of reflected light signals generated from the plurality of sensors disposed along the length of the optical fiber disposed within the blood vessel, each reflected light signal based on a pressure exerted on the optical fiber adjacent each respective sensor; extracting from the plurality of reflected light signals present pressure gradient data; and identifying the blood vessel as a vein or as an artery based on the present pressure gradient data.
18. The method of claim 11, wherein: the optical fiber is inserted within the blood vessel in a direction toward a heart of a patient, the optical fiber is inserted within a lumen of a catheter, the catheter delivering an infusate to the blood vessel, the state of the optical fiber includes: a first temperature experienced by a first section of the optical fiber disposed within the catheter; and a second temperature experienced by a second section of the optical fiber extending distally beyond a distal end of the catheter, and the method further includes: receiving a first reflected light signal from a first sensor disposed along the first section, the first reflected light signal based on the first temperature; receiving a second reflected light signal from a second sensor disposed along the second section, the second reflected light signal based on the second temperature; extracting from the first reflected light signal and the second reflected light signal present temperature difference data between the first temperature and the second temperature; and identifying the blood vessel as a vein or as an artery based on the present temperature difference data.
19. The method of claim 11, wherein: the optical fiber is inserted within the blood vessel in a direction toward a heart of a patient, the optical fiber extending along a catheter, the catheter configured to deliver an infusate to the blood vessel, the state of the optical fiber includes: a first temperature experienced by a section of the optical fiber extending beyond a distal end of the catheter during non-delivery of the infusate; and a second temperature experienced by the section during delivery of the infusate; and the method further includes: receiving a first reflected light signal from a sensor disposed along the section during non-delivery of the infusate, the first reflected light signal in based on the first temperature; receiving a second reflected light signal from the sensor, the second reflected light signal based on the second temperature during delivery of the infusate; extracting from the first reflected light signal and the second reflected light signal present temperature difference data between the first temperature and the second temperature; and identifying the blood vessel as a vein or as an artery based on the present temperature difference data.
20. The method of claim 11, wherein the optical fiber is coupled with an elongate medical device, the elongate medical device including a catheter, a stylet, a probe, or a guidewire.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANJAY CATTUNGAL whose telephone number is (571)272-1306. The examiner can normally be reached M-F 9-5 EST.
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.
/SANJAY CATTUNGAL/Primary Examiner, Art Unit 3798